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Target Study Title: Evaluation of the HF20™ Filter for Pediatric Continuous Renal Replacement Therapy (CRRT)
Target Study Description: #Study Description
Brief Summary
Historically, innovations for acute kidney injury (AKI) and continuous renal replacement therapy (CRRT) have centered around an adult population. However, research has shown that over 10% of pediatric patients develop severe AKI within the first week in an intensive care unit (ICU). When a pediatric patient requires renal replacement therapy for AKI in the ICU, CRRT is usually the modality of choice. The HF20™ is indicated for supporting patients weighing 8 to 20 kilograms, addressing a critical clinical need for critically ill children who require CRRT. Current US Food and Drug Administration (FDA) approved CRRT filters are designed for patients weighing more than 20 kg or less than 10 kg, leaving a gap in appropriately designed filters for pediatric patients.
A previous trial in the US showed that the HF20™ is safe and effective, however the membrane composition of the HF20™ used in that trial is different than what is currently manufacturer and available. Baxter Healthcare Corporation has received an Emergency Use Authorization (EUA) for the currently available HF20™ to be used in the era of the COVID-19 pandemic, however participants do not need to be infected with the SAR-CoV-2 virus in order to be treated. The EUA for the HF20™ allows for treatment for any children weighing between 8 and 20 kilograms in need of CRRT. This registry will collect clinical data related to the safety and efficacy of the HF20™ filter for CRRT in pediatric patients weighing 8 to 20 kilograms at participating institutions, however participation in this registry is not a requirement in order to be treated with the HF20™ filter.
#Intervention
- DEVICE : HF20™
- HF20™ will be used for CRRT
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Receiving or plan to receive CRRT with the HF20™ filter as standard of care
* Acute kidney injury (AKI) or fluid overload as defined as one of the two below:
1. AKI defined as Kidney Disease Improving Global Outcomes (KDIGO) Stage 1 or higher by either:
1. Serum creatinine criteria (0.3 mg/dL increase over baseline in 48 hours, or a 50 percent increase within the previous 7 days) or
2. Urine output criteria (less than 0.5 mL/kg/hr for 6 or more hours)
2. Severe fluid overload defined as greater than 10 percent fluid accumulation based on ICU admission weight
Exclusion Criteria:
* Weight less than 8 kilograms
* Weight more than 20 kilograms
* Patient not expected to survive more than 48 hours
* Received renal replacement therapy in the previous 5 days
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 0 |
Target Study Title: Safety and Tolerability of Multiple Ascending Doses of LY2140023 in Subjects With Schizophrenia
Target Study Description: #Study Description
Brief Summary
This is an inpatient, open-label, multiple-dose, multicenter study to evaluate the safety and tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated therapeutic exposure under clinical investigation. In the event of poor tolerability in Part A of this study Part B may be conducted to explore higher doses using titration. Participants in both Parts A and B will participate in a 9 day wash-out period of current medication (Study Days 1-9); participants coming into the study on aripiprazole will remain on their current therapy throughout.
Detailed Description
The primary objective of this study was to evaluate the safety and tolerability of escalating doses of LY2140023 in subjects with schizophrenia.
The secondary objectives of this study were:
* to characterize the pharmacokinetic (PK) parameters of LY2140023 and its active moiety - LY404039 in subjects with schizophrenia
* to explore higher doses of LY2140023 in subjects with schizophrenia for use in further regulatory studies
* to compare safety of LY2140023 to aripiprazole (ARP)
* to access changes in pharmacodynamic (PD) measures (Clinical Global Impression-Severity Scale \[CGI-S\], Extrapyramidal Symptoms \[EPS\], and Brief Psychiatric Rating Scale \[BPRS\])
This was an inpatient, open-label, multiple-dose, multi-center study to evaluate the safety and tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated maximum therapeutic exposure under investigation.
#Intervention
- DRUG : LY2140023
- Administered orally
- Other Names :
- pomaglumetad methionil
- DRUG : Aripiprazole
- Administered orally
- Other Names :
- Abilify
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Have a diagnosis of schizophrenic disorder
* Female participants who test negative for pregnancy at screening and agree to use a reliable method of birth control for the duration of the study and for at least 3 months after the last LY2140023 dose or are postmenopausal
* Not have been hospitalized for psychiatric illness for at least 12 weeks prior to Day 1 of washout period and have a Clinical Global Impression -Severity (CGI-S) scale score of <4
* Be willing and able as determined by the investigator to be hospitalized from the beginning of the washout period to the end of the study
* In the opinion of the investigator, the participant can be washed out of their Standard of Care (SOC) therapy (other than aripiprazole for the aripiprazole participants) for the duration of the study without detrimental effect to the participant's mental health (CGI-S <4 after completion of the washout period)
* Be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
* Be able to understand the nature of the study and have given their own informed consent
* Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
* Have venous access sufficient to allow blood sampling
* Clinically acceptable sitting blood pressure and pulse rate, as determined by the investigator
Participants on Aripiprazole prior to study entry must:
* On a stable dose of aripiprazole within the approved range in product labeling (less than or equal to 30 milligrams [mg]/day) for at least 60 days prior to Day 1 and with no anticipation of changes to dose, regimen (except as required for this study) or treatment within the next 1 month
Exclusion Criteria:
* Currently enrolled in, or discontinued within the 30 days prior to screening from, a clinical trial involving an investigational drug or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Have known allergies to LY2140023, LY404039, aripiprazole, or related compounds
* Participants with moderate to severe renal impairment as defined by creatinine clearance (CrCl) <60 milliliters (mL)/minute (min)
* Have previously completed this study or have discontinued from any study investigating LY2140023 after having received at least 1 dose of LY2140023
* Participants for whom treatment with LY2140023 or aripiprazole as specified in this protocol, is relatively or absolutely clinically contraindicated
* Participants who have received treatment with clozapine
* Participants who have a diagnosis of schizophrenia who are taking either thioridazine or thiothixene
* Participants receiving treatment with depot antipsychotic medication within 12 weeks, prior to screening
* Participants who are taking any of medications that are specifically excluded
* Participants who have answered 'yes' to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the 'Suicidal Ideation' portion of the Columbia suicide severity rating scale (C-SSRS), or answer 'yes' to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the 'Suicidal Behavior' portion of the C-SSRS; and the ideation or behavior occurred within the past 3 months
* Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (Text Revision) (DSM-IV-TR) diagnosis of substance dependence or substance abuse (except nicotine and caffeine) within the 6 months prior to admission
* Diagnosis of substance-induced psychosis by DSM-IV-TR criteria within 7 days of admission (or at any time during the dosing period)
* Have a history of one or more seizures except for either of the following 2 situations: a single simple febrile seizure between ages 6 months and 5 years or a single seizure with an identifiable etiology, which has been completely resolved
* Have a screening electroencephalogram (EEG) with paroxysmal (epileptiform) activity, for example, one that demonstrates 3 or more focal sharp or spike waves, any sharp and slow wave complex, or any epileptiform discharge that is rhythmic, sustained, or generalized, or as locally defined
* Participants who have had electroconvulsive therapy (ECT) within 3 months of observation period or who are expected to have ECT at any time during the live phase of this study
* A diagnosis of Parkinson's disease, dementia-related psychosis, or related disorders
* Participant with untreated hyperthyroidism or hypothyroidism needing a thyroid hormone supplement who have not been on a stable dose of medication for at least 2 months prior to screening
* Have leukopenia or history of leukopenia during the participant's lifetime
* Participants with alanine aminotransferase (ALT/SGPT) or aspartate aminotransferase (AST/SGOT) values >2 times the upper limit of normal (ULN) of the performing laboratory, or total bilirubin values >1.5 times the ULN of the performing laboratory at screening
* Participants with corrected QT interval (Bazett's); QTcB >450 milliseconds (msec) (male) or >470 msec (female) at admission
* Have acute, serious or unstable medical conditions, including (but not limited to) inadequately controlled diabetes (hemoglobin A1c [HgbA1c] >8%), severe hypertriglyceridemia (fasting triglycerides greater than or equal to 500 mg/dL or 5.65 micromoles/liter [umol/L]), hepatic insufficiency (specifically any degree of jaundice), recent cerebrovascular accidents, seizure disorders, serious acute systemic infection or immunology disease, unstable cardiovascular disorders (including ischemic heart disease), renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases
* Prolactin level of >200 nanograms/milliliter (ng/mL) (200 micrograms/liter [ug/L], or 4228 milli international units/liter [mIU/L]) at screening with the exception of participants treated with risperidone. Participants treated with risperidone are excluded if the prolactin level is >300 ng/mL (300 ug/L, or 6342 mIU/L) at screening
* Participants with known medical history of Human Immunodeficiency Virus positive (HIV+) status
* Test positive for (1) Hepatitis C virus antibody or (2) Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody. Participants with positive Hepatitis B core antibody test and negative HBsAg may be included in the study if ALT/SGPT and AST/SGOT levels are less than 2 times the ULN and total bilirubin does not exceed the ULN of the central laboratory
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 1 |
Target Study Title: An Alternative Technique for Measuring Blood Pressure
Target Study Description: #Study Description
Brief Summary
This cross design study will be conducted to evaluate the combination of palpation and auscultation techniques as an alternative technique for the measurement of blood pressure. The main questions it aims to answer are:
* Is there a statistical difference between the results of systolic blood pressure measured with the old and new technique?
* Is there a statistical difference between the results of systolic blood pressure measured with the old and new technique? Participants' blood pressure will be measured twice.
Detailed Description
As a result of clinical observations, a common practice is to inflate the cuff to a high and random mmHg value and start auscultation directly. Alternatively, many healthcare workers determine the moment when pulse beats disappear by palpation and increase this value by 30 mmHg without lowering the cuff and without taking a break for 1-2 minutes and start auscultation. In the literature, there is a similar technique called 'one-step method'. According to this technique, the sphygmomanometer is wrapped around the individual's arm and the stethoscope is placed in the ear. The brachial artery is then palpated and identified. The cuff is inflated up to 30 mmHg above the systolic blood pressure of the individual. The cuff is then depressurized to 2-3 mmHg/second. It is observed that many healthcare professionals and students use this technique today because it is more practical in terms of measurement time. However, it is thought that the step of 'inflating the cuff up to 30 mmHg above the systolic blood pressure value of the individual' in the process steps of the technique is not reliable enough. It is thought that it may lead to erroneous results in capturing sudden blood pressure changes in the individual. In this context, it is thought that it would be more reliable to determine the value at the moment when the pulse is not felt with the palpation technique, add 30 mmHg to this value without interruption and without lowering the cuff and continue auscultation. At the same time, combining palpation and auscultation and continuing them consecutively will shorten the measurement time and provide a practical application.
It is aimed to measure blood pressure in approximately 202 healthy adults. The purpose and method of the study will be explained in detail to all participants included in the sample group. Participants will be allowed to rest for 15-30 minutes before blood pressure measurement. Blood pressure will be measured with two different techniques according to the order in which the participants are included in the study. The first participant's blood pressure will first be measured with the standard technique in the literature (with a break between palpation and auscultation). After a 60-second pause, blood pressure will be measured with the alternative recommended technique (palpation and auscultation combined). In the second participant, blood pressure will be measured first with the alternative recommended technique (combining palpation and auscultation). After a 60-second break and with the arm in the same position, blood pressure will be measured with the standard technique in the literature (with a break between palpation and auscultation). The cross-over method will be applied as possible differences between measurement times should be taken into account.
#Intervention
- OTHER : blood pressure measurement starting with standard technique or alternative new technique. manual sphygmomanometer will be used.
- Each participant will have their blood pressure measured with two different techniques.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion criteria:
* Over 18 years,
* no chronic disease,
* not taking any medication and/or treatment that affects the cardiovascular or circulatory system,
* volunteering to participate in the research.
Exclusion Criteria:
* has a chronic disease,
* taking medication that affects the cardiovascular or circulatory system,
* wants to leave the study at any stage.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 2 |
Target Study Title: A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
Target Study Description: #Study Description
Brief Summary
This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.
#Intervention
- DRUG : brentuximab vedotin
- 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
- Other Names :
- Adcetris; SGN-35
- DRUG : brentuximab vedotin
- 2.4 mg/kg every 3 weeks by intravenous (IV) infusion
- Other Names :
- Adcetris; SGN-35
- DRUG : brentuximab vedotin
- 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion
- Other Names :
- Adcetris; SGN-35
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy
* Have failed, refused, or have been deemed ineligible for standard therapy
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70
Exclusion Criteria:
* Primary diagnosis of lymphoma or central nervous system (CNS) malignancy
* History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years
* Evidence of active cerebral/meningeal disease
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 3 |
Target Study Title: COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae (COLUMBIA CARDS) Registry
Target Study Description: #Study Description
Brief Summary
COLUMBIA CARDS is a pilot study to understand how COVID-19 affects the heart. It is known that COVID-19 can affect the heart in different ways. COLUMBIA CARDS is studying why some COVID-19 survivors develop clinical conditions such as heart inflammation, fluid buildup, blood clots, and other cardiac problems during or after their COVID-19 illness, and why other ones do not. In this study, we will use cardiovascular magnetic resonance (CMR) and transthoracic echocardiography (TTE) to better understand the impact of COVID-19 on the heart.
Detailed Description
This is a pilot study aiming to collect preliminary data on cardiac imaging (CMR and TTE) in outpatients who recovered from COVID-19.
CMR offers the unique ability to comprehensively characterize myocardial tissue and assess the heart's structure and function, through a variety of complementary imaging techniques using different pulse sequences. The investigators propose to provide a multi-sequence CMR evaluation of a spectrum of convalescent COVID-19 patients, compare COVID-19 survivors to controls, and study the relationships between myocardial characteristics by CMR and echocardiography and health outcomes, and how these are modulated through patient characteristics, and clinical characteristics of COVID-19 illness. Broadly, this myocardial characterization will not just provide diagnosis but serve as a potentially powerful tool for risk stratification, therapeutic decision making, and monitoring response to therapies in COVID-19 survivors.
Transthoracic echocardiography (TTE) is the most widely used imaging technique for the assessment of cardiac morphology and function. While its capability for myocardial tissue characterization is inferior to that of CMR, TTE provides several advantages that make it an ideal complement to CMR for the assessment of cardiac involvement in COVID-19 patients. TTE offers a rapid noninvasive evaluation of myocardial and valvular function, in addition to the assessment of other cardiac abnormalities of interest (such as presence and amount of pericardial effusion) and important hemodynamic variables (noninvasive estimation of pulmonary pressures is an example). TTE is easily performed and reproducible, and does not involve the use of radiations or contrast agents, which allows the performance of repeat evaluations to assess serial changes over time in the cardiac parameters of interest.
#Intervention
- OTHER : Transthoracic echocardiogram (TTE)
- Subjects will undergo TTE imaging.
- OTHER : Cardiovascular Magnetic Resonance (CMR) Imaging
- Subjects will undergo CMR Imaging using a gadolinium based contrast agent (GBCA).
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Convalescent COVID-19 patient
* If COVID-19 patient, at least 4 weeks after beginning of symptoms, and at least 2 weeks after hospital discharge if had been hospitalized.
* Control patients who have had a negative COVID-19 screening without prior positive tests.
* Willingness to undergo Clariscan-enhanced CMR scan.
* Ability to hold breath for 15 seconds.
* Willingness to give informed consent.
* Greater than or equal to 18 years of Age.
Exclusion Criteria:
* Subjects who are Pregnant or nursing
* Severe valvular heart disease
* History of congestive heart failure preceding COVID-19
* History of obstructive coronary artery disease with known stenosis >70% or fractional flow reserve < 0.8
* Contraindication to MRI
* Known allergy to gadoterate
* Estimated glomerular filtration rate <30 ml/min/1.73m2
* History of receiving more than 2 doses of a gadolinium-based contrast agent
* Subject is of prisoner status
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 4 |
Target Study Title: Comparison of Two Different Anesthesia Methods During Oocyte Retrieval for in Vitro Fertilization
Target Study Description: #Study Description
Brief Summary
In this study; during the oocyte retrieval procedure, it was aimed to compare two different general anesthesia methods, in which propofol was administered as infusion according to the patient's Bispectral index system (BIS) value or in bolus doses according to the patient's clinic.The hypothesis of the study; during the oocyte retrieval process, when propofol is administered as an infusion and accompanied by BIS monitoring, adequate anesthesia level will be achieved with less amount of bolus doses according to the clinical condition of the patient.
Detailed Description
130 patients over the age of 18, ASA I-II, who underwent oocyte retrieval for IVF treatment were included in the study. The patients divided into two groups. In induction, 2mg/kg fentanyl, 40mg lidocaine and 2mg/kg propofol administered to all patients. Patients in group 1; propofol added in bolus doses of 0.5mg/kg. Doses determined according to the clinical condition of the patient. Patients in group 2; propofol administered as 10mg/kg/hour infusion. The infusion dose adjusted so that the Bispectral index (BIS) is in the range of 40-60.
#Intervention
- DRUG : propofol bolus
- Propofol will be added in bolus doses of 0.5mg/kg.
- DRUG : propofol infusion
- Propofol will be administered as 10mg/kg/hour infusion.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Over 18 years
* ASA I-II
* Patients who underwent oocyte retrieval for IVF treatment
Exclusion Criteria:
* The patient does not want to participate
* ASA > II patients
* Patients under 18 years
* Patients who are allergic to the drugs used
* Patients with mental illness
* Patients with alcohol or substance addiction
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 5 |
Target Study Title: Microdrilling Surgery for Full Thickness Chondral Lesions of the Knee Augmented With Concentrated Bone Marrow Aspirate, Platelet Rich Plasma and Hyaluronic Acid
Target Study Description: #Study Description
Brief Summary
This study seeks to evaluate a treatment for multiple full thickness chondral lesions in the knee. Eligible subjects will undergo a microdrilling surgery and up to 12 post operative intra-articular injections of bone marrow aspirate concentrate (BMAC), platelet rich plasma (PRP) and hyaluronic acid (HA).
#Intervention
- PROCEDURE : Microdrilling Surgery
- All patients will undergo an arthroscopic surgical procedure in which small holes are drilled throughout the areas of damaged cartilage (standard of care)
- PROCEDURE : Injections of BMAC + PRP + HA
- All patients will receive up to 12 intra-articular knee injections of BMAC (derived from iliac crest), PRP (derived from peripheral blood) and HA
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria: MRI-confirmed full-thickness unipolar or bipolar chondral lesion(s) from osteoarthritis.
Exclusion Criteria:
* Inflammatory arthritis
* Body mass index (BMI) greater than 35
* Presence of significant varus or valgus knee instability or unusually stiff knee
* Greater than 50% deviation of the mechanical axis
* Presence of active cardiac disease
* Presence of active pulmonary disease
* Prior septic arthritis of the involved joint
* Presence of active bacterial or Mycobacterial infection
* Presence of a known hypercoagulable state
* Pregnant or lactating females
* Subject known to be positive for hepatitis B, hepatitis C, or HIV
* Known allergy to hyaluronic acid
* Patients who are unable or unwilling to participate fully in post-operative physical therapy
* Patients with a contraindication to MRI scanning
* Any disorder that compromises ability to give consent or comply with study procedures
* Patients who are felt to be at significantly increased risk for elective orthopedic surgery
* Non-ambulatory patients
* Patients with cognitive impairment
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 6 |
Target Study Title: Rapid Gastric and Pancreas Cancer Staging Utilizing Peritoneal Lavage
Target Study Description: #Study Description
Brief Summary
This study is being done to develop a new method that can rapidly stage patients with gastric and pancreas cancer. Staging means finding out what is the extent of the cancer in a patient's body.
Currently before patients have the surgery to remove their cancer, a surgical exam is done in the operating room to see if their cancer has spread. A thin tube-like instrument with lens and a light is placed into the abdomen. This is done by making small cuts into the body. This exam is called a diagnostic laparoscopy. If cancer spread is not seen, fluid is put into the abdomen and then taken out. This is called 'lavage' or washing. The fluid is then looked at in a laboratory. If the fluid contains cancer cells surgery is often delayed.
The investigators are testing a new method to put the fluid into the abdomen. It is called percutaneous lavage. Percutaneous means 'through the skin'. A needle is put through the skin into the abdomen. Tubing is then placed over the needle so that fluid can be put into the abdomen and then taken out. The fluid is then looked at in a laboratory. The investigators want to see if the two methods are equal because if they are equal, in the future, patients may be able to have this procedure done outside of the operating room.
#Intervention
- PROCEDURE : Diagnostic peritoneal lavage
- The Veress needle will be inserted in the abdominal wall, at a site to be left up to the individual surgeon. Caudal traction will be applied to the abdominal wall to provide a firm abdominal wall to insert the needle through, minimizing the peritoneum from tenting down closer to visceral structures. Intraperitoneal placement of the catheter will be confirmed by injection of saline into the needle with no resistance and with the saline in the hub of the needle falling into the peritoneal cavity spontaneously. A guide wire will be placed through the Veress and utilizing the Seldinger technique, a 9Fr peritoneal catheter will be placed.
- Other Names :
- 800cc of saline will be infused and 60ml will be extracted and sent to the, cytopathology lab. When the laparoscope is inserted for laparoscopic guided, lavage, no additional fluid will be instilled, unless there is no available, fluid in the RUQ, LUQ, and pelvic locations that are currently sampled., Instead, the fluid already present from the percutaneous lavage will be, utilized.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Men and women 18 years and older
* Informed consent in keeping with the policies of Memorial Sloan-Kettering Cancer Center
* Presentation of gastric or pancreatic cancer based on objective findings by either:
* CT scan
* Endoscopy
* Pathologic examination
* Candidate for surgical treatment and are scheduled for laparoscopy with peritoneal lavage.
Exclusion Criteria:
* Under 18 years
* Inability to speak or read English, and an appropriate translator is not identifiable
* Unable or unwilling to give informed consent
* Patients with synchronous cancers of other abdominal organs
* Multiple prior surgical procedures on the abdomen where the surgeon feels that percutaneous lavage may be dangerous.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 7 |
Target Study Title: An Open Label, Two Way Crossover, Balanced, Single Dose, Comparative Evaluation of Relative Bioavailability of Tacrolimus Capsules 5 mg With That of 'Prograf' Capsules 5 mg in Healthy Subjects Under Fasting Conditions.
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to compare the relative bioavailability study of tacrolimus capsules 5 mg with prograf capsules 5 mg in healthy, adult, human subjects under fasting conditions and to monitor safety of subjects
Detailed Description
An open label, randomized, two period, two treatment, two sequence, crossover, balanced, single dose, comparative evaluation of relative bioavailability of tacrolimus capsules 5 mg with that of 'prograf' capsules 5 mg in healthy adult human subjects under fasting conditions.
#Intervention
- DRUG : Tacrolimus Capsules
- Tacrolimus Capsules, 5 mg of Dr. Reddy's Laboratories Limited
- Other Names :
- Prograf capsules of Astellas Pharma US, Inc.,
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* The subjects should be healthy human between 18 and 45 years.
* The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
* The subjects should have a BMI between 18.5 and 24.9 weight in kg/ height2 in meter.
* The subjects should be able to communicate effectively with study personnel.
* The subjects should be able to give written informed consent to participate in the study.
If subject is a female volunteer and
* Is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms,foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
* Is postmenopausal for at least 1 year.
* Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
Exclusion Criteria:
* The subjects who have a history of allergic responses to tacrolimus or other related drugs.
* The subjects who have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG, and X-ray recordings.
* The subjects who have any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
* The subjects who have a history or presence of bronchial asthma.
* The subjects who have used enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
* The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol uses.
* The subjects who are smokers who smoke more than or equal to 10 cigarettes per day or more than or equal to 20 biddies per day or those who cannot refrain from smoking during study period.
* The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins.
* The subjects who have donated 1 unit (350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication.
* The subjects who have a positive hepatitis screen (include subtypes A, B, C and E).
* The subjects who have a positive test result for HIV antibody and / or syphilis (RPR/VDRL).
* The subject who receives an investigational product, or has participated in a drug research study within a period of 90 days prior to the first dose of the study medication application.
* Female volunteers demonstrating a positive pregnancy screen.
* Female volunteers who are currently breast-feeding.
* Female volunteers not willing to use contraception during the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 8 |
Target Study Title: Pharmacodynamic and Pharmacokinetic Properties of Insulin Glulisine (Apidra) in Comparison to Insulin Lispro (Humalog) in Healthy Lean and Obese Subjects
Target Study Description: #Study Description
Brief Summary
Primary objective
* To investigate pharmacodynamic and pharmacokinetic parameters after s.c. administration of two different doses (low dose, 0.2 IU/kg and high dose, 0.4 IU/kg) of insulin glulisine across healthy subjects in 4 different BMI-classes (lean, overweight, moderately obese, severely obese), using the euglycemic clamp technique with the Biostator™.
Secondary objective
* To investigate the pharmacodynamic and pharmacokinetic properties after subcutaneous administration of insulin glulisine in comparison to insulin lispro and to investigate the safety and tolerability after subcutaneous administration of insulin glulisine in comparison to insulin lispro.
#Intervention
- DRUG : Insulin Glulisine
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion criteria :
* Normal HbA1c
* Women have to either be postmenopausal, surgically sterilized, or not pregnant and using adequate contraception.
Exclusion criteria :
* Systemic concomitant medication
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 9 |
Target Study Title: A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.
Target Study Description: #Study Description
Brief Summary
This study will assess the efficacy of a 12-week treatment with darifenacin in increasing warning time, the time from first sensation of urgency to voiding, in patients with OAB.
#Intervention
- DRUG : Darifenacin
- Darifenacin 15 mg tablets once daily
- Other Names :
- Enablex
- DRUG : Placebo
- Placebo tablets once daily
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Three symptoms of OAB (urge incontinence, frequency and urgency) for at least six months prior to Visit 2.
* Patients capable of independent toileting and able of independently completing the patient diary.
Exclusion Criteria:
* Patients in whom the use of anticholinergic drugs was contraindicated
* Evidence of severe liver disease
* Patients with other clinically significant urinary or gynecological conditions
Other protocol-defined inclusion/exclusion criteria may apply.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 10 |
Target Study Title: The Effect of Muscular Strength Training in Patients With Drug Addiction
Target Study Description: #Study Description
Brief Summary
Physical health does not have a high priority in today's treatment of patients with substance use disorder (SUD). SUD patients have a poor physical health not only due to injuries related to the substance abuse, but also because of the addiction-related lifestyle. There are few studies today that provide information about SUD patient's physical health, and especially there is little information about their muscular strength. One of the project's aims is to measure muscular strength in SUD patients who are being treated for their addiction, and see if they have decreased neuromuscular function. If so, we will investigate the effect of maximal strength training on neuromuscular function in these patients.
#Intervention
- BEHAVIORAL : strength training
- BEHAVIORAL : no training (control)
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* being treated for drug abuse
* not using drugs during intervention period
Exclusion Criteria:
* participated in strength training in previous 6 months
* cardiovascular disease
* any other disease that impedes to finish tests
* not showing up for testing sessions
* carried out less than 85% of planned exercise sessions
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 11 |
Target Study Title: Patient Empowerment Through Predictive Personalised Decision Support (PEPPER)
Target Study Description: #Study Description
Brief Summary
Patient Empowerment through Predictive PERsonalised decision support (PEPPER) is an European Union (EU) funded research project to develop a personalised clinical decision support system for Type 1 Diabetes Mellitus (T1DM) self-management. The tool provides insulin bolus dose advice, tailored to the needs of individuals. The system uses Case-Based Reasoning (CBR), an artificial intelligence methodology that adapts to new situations according to past experience. The PEPPER system also incorporates a safety module that promotes safety by providing glucose alarms, low-glucose insulin suspension, carbohydrate recommendations and fault detection.The principal research objectives are to assess the usability, safety, and technical proof of concept and feasibility of the PEPPER in participants with T1DM. Evaluation of safety is a priority and will be assessed throughout the clinical studies. The safety components only of the PEPPER system will initially be evaluated in an out-of-clinic environment (phase 1) and will measure incidence and percentage time spent in hypoglycaemia, evaluate usability and incidence of technical faults. Following the initial safety study, the overall PEPPER system (integrated with the CBR algorithm) will be assessed (phase 2) and the primary outcome will be percentage time spent in hypoglycaemia.
Detailed Description
1. Description of the components of the PEPPER system: Decision support algorithm The decision support algorithm is based on case-based reasoning (CBR). CBR is an artificial intelligence technique that tries to solve newly encountered problems by applying the solutions learned from solved problems encountered in the past. A combination of parameters makes up the case problem presented to the CBR algorithm. Using this information the algorithm will find a similar case scenario from the pool of previously encountered cases and recommend an improved solution (insulin dose) to achieve the best possible outcome (post-prandial blood glucose). Each new case includes information about the problem (e.g. capillary blood glucose, meal information etc), solution (recommended insulin dose) and outcome (post-prandial blood glucose).
PEPPER offers a dual architecture for both Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) therapy. In both cases, the user periodically wears a continuous glucose monitor (CGM) and an activity monitor.
Handset CSII version: The handset is a portable touch-screen device, which communicates directly with the insulin pump or Smartphone with PEPPER application running and participants can administer an insulin bolus with their usual pump.Its primary function in PEPPER is to allow the user to precisely manage insulin therapy by accepting or rejecting bolus insulin dose recommendations, calculated by the CBR based decision support algorithm, via a graphical interface. In addition, it measures and automatically records glucose levels (via a built-in Blood Glucose (BG) strip reader) and allows logging of food intake and other parameters.
MDI version: This handset is a commercially available Smartphone with the insulin recommendation application running locally on a standard operating system such as iPhone Operating System (iOS) or Android. It has the same functionality as the CSII version, except that it does not have a built-in capillary blood glucose (CBG) reader but instead imports data wirelessly from external CBG monitors.
Secure web server Revision: The handset wirelessly reports the user's case history to the secure portal, a web site which allows the clinician to add new patients, and review the cases to decide which ones should be kept. A case comprises multiple parameters such as carbohydrate intake, BG reading, meal composition, physical activity and hormone cycle.
Personal Health Record on the secure portal allows patients and clinicians to view and update selected components of the detailed history.
Insulin delivery system MDI: it will be provide insulin pens with 0,5 IU of insulin. CSII: will use Cellnovo insulin pump or their usual pump.
Continuous glucose monitoring system The glucose sensor that will be used throughout the clinical studies is the Dexcom sensor (CE marked, manufactured by Dexcom). This current is proportional to the glucose concentration in interstitial fluid and is calibrated against blood glucose a minimum of 12-hourly. The Dexcom CGM data is automatically transmitted to a secure web-based server and the secure PEPPER web-portal. Participants will be able to see their CGM data at all times and this will be used continuously throughout the studies.
Safety features Low and high glucose alarms will be incorporated to alert the user when hypo- and hyperglycaemia is detected to enable the user to act accordingly to bring the glucose levels back to target range.
Glucose prediction algorithm for hypoglycaemia prediction The hypoglycaemia prediction algorithm will enable the system to automatically activate the low glucose suspension feature in pump participants (suspension of insulin delivery until glucose levels are within the target range) and/or trigger an adaptive carbohydrate adviser, which will recommend a personalised carbohydrate snack.
Insulin safety constraints Personalised maximum insulin dose thresholds will be incorporated to prevent overdosing on insulin.
Fault detection Insulin pumps and CGMs are well-established technologies, but faults in these devices (e.g. pump occlusion, loss of sensor sensitivity) may occur. A fault detection system will identify such faults and alert the user to recommend a corresponding action to revert to the normal state.
Participants will have the opportunity to call a physician for medical support and an engineer for technical support 24 hours a day.
2.2 Recruitment This is a multicentre study and recruiting for the clinical study will be undertaken in the diabetes clinics at the Institut d'Investigació Biomédica de Girona (IdIBGi) (Spain) and the Imperial College London (ICL) (UK) from registered research databases and from interested participants who contact us.
2.3 Clinical studies: 2.3.1 Phase 1 Objective: To demonstrate safety and technical proof of concept of the PEPPER safety system (without the CBR algorithm) in the participant's own environment.
Primary outcome and secondary outcomes are defined in Outcome Measures. Timescale: Each participant will be in the study for 8 weeks: run-in period (2 weeks period) and intervention period (6 weeks period). It is anticipated that it will take 6 months to complete this phase.
Population: 15 adults with T1DM (7 on MDI and 8 in CSII)
Visit 1: Screening Signed and dated informed consent Demographics data (date of birth, gender, race and ethnicity) Medical and surgical history and allergies to medication Details of the diabetes history Menstrual history and contraception (females) Medications and supplements Social history including drinking, smoking and drug habits Vital signs ECG Random venous blood and urine sample Urine pregnancy test in female participants of childbearing age Basic diabetes education revision, Insulin treatment adjusted if needed Questionnaires to be completed Participants will be provided with the real-time (RT) CGM (Dexcom) The participant will be instructed how to make correct CGM calibration. Quality control testing will be performed on the study devices as recommended in the manufacturer guidelines Participants will be shown how to insert the sensor themselves, interpret the CGM data in real time and to set the hypo- and hyperglycaemia threshold alarms. The alarm threshold will be set at 4mmol/l and 11mmol/l and participants will be encouraged to keep it at those levels and not to reduce the hypoglycaemia threshold below 3.3mmol/L) Participants to complete a 2-weeks run-in period using RT-CGM (Dexcom) and a standard bolus calculator to familiarize themselves with RT-CGM. Participants on MDI will be provided with the study CBG meter Participants on CSII will be provided with the Cellnovo study pump or they will used their usual pump. A standardised physical activity monitor will be provided and participants will be shown how to use it.
Detailed user guides (Cellnovo, Dexcom CGM, PEPPER handset) will be given to the participants and an instruction sheet with 24-hour contact information of the research team to address any problems or questions.
Visit 2: CGM review and study start Attend 2 weeks after visit 1 CGM data review Insulin treatment adjusted if needed.Switch on the PEPPER handset (CBR algorithm disabled).
Visit 3: 2-week visit Attend 2 weeks after visit 2 at clinical research unit CGM data review Insulin treatment adjusted if needed Review any technical issues.
Visit 4: Final visit (6 weeks after visit 2) CGM data review Switch off PEPPER system and return device Participants to revert to their usual treatment Questionnaires to be completed.
2.3.2 Phase 2: Clinical evaluation of safety, feasibility and usability of the PEPPER system.
Objective: To demonstrate safety and technical proof of concept of the overall PEPPER system (integrated with the CBR algorithm).
Primary outcome and secondary outcomes are defined in Outcome Measures. Timescale and population are the same as in phase 1. Visit 1: Screening Same as for phase 1 Visit 2: CGM review and study start Switch on the PEPPER handset (CBR algorithm and PEPPER safety system enabled) The rest of steps the same as in phase 1 visit 2 Visit 3: 2-week visit Same as in phase 1 visit 3 Visit 4: 6-week visit (6 weeks after visit 2) Same as in phase 1 visit 4 Visit 5: Final visit Step 5 of usability study 2.3.3 Usability study Usability of the system will be evaluated throughout the clinical trial phases and redevelopment of the system will be done accordingly.
Objectives: to evaluate usability of the PEPPER handsets over a sustained time period.
Step 1: Training observation Participants will be trained in use of devices. The handset will be filmed during the training to see which aspect is being described.
Step 2: Contextual interview The aim is to gather data at an early stage of the usability engineering process. They will be used to understand the intended use of all parts of the system and the characteristics that relate to safety, within an everyday context. The interview will be semi-structured with choice of questions.
Step 3: Diary study Data will be collected via the Smartphone in a variety of formats. The study follows on from the contextual interview and concludes with an exit interview. Participants will also be phoned at weekly intervals to see how they are finding the bolus advice and to check that there are no problems.
Data collection. Participants will be asked to make diary entries each time they use the PEPPER bolus advisor. Data will be collected using a Smartphone app. It may take a variety of formats including photos, voice memos, text. In addition, written notes will be made after each weekly phone call.
Step 4: Diary exit interview The purpose is to drill down into some of the diary entries to discover supplementary information. Participants will be asked to review each of the diary entries, giving further explanation.This will be followed by an unstructured interview.
The diary will be filmed during the conversation to see which entry is being described.
Step 5: Contextual group All of the members of the feasibility study will be invited to a social meeting in an informal location. The purpose of the session will be to validate the findings from the previous steps.The researcher will endeavour to be an unobtrusive bystander in the discussion, and not offer personal opinions but listen for common issues and themes.
Data collection. Data will be gathered on a notepad or laptop in a visible way. Data will be gathered using an audio recorder in steps 1-4. 2.4 Statistics The sample size is comparable to other technology pilot safety studies, is a realistic number for recruitment and provides robust safety data. The study is not powered to show a change in the primary or secondary outcomes compared with usual care but is an assessment of a new technology.
2.5 Confidentiality of data collected during interviews To ensure security, data obtained during the course of the interviews will be encrypted and stored securely, with access limited solely to the researchers. Data will be de-identified such that only the researchers will be able to link the data to the participant involved using reversible codes. This is done purely for the purpose of comparison and evaluation across the separate interviews. Any resulting publications using the data will not identify the participants, and any quotes will kept anonymous should participants consent to this.
2.6 Electronic data storage on secure web-server Data security and privacy will be a priority whilst dealing with medical data such as that held in the PEPPER system. During the clinical studies (phases 1-2) anonymous clinical data will be entered and stored on a secure web-server. Anonymous data collected by the PEPPER handset (such as glucose, meal information, physical activity, alcohol, exercise) and the Dexcom CGM system will be automatically transmitted to the secure web-server. For this purpose, EU regulatory procedures (Directives 95/46/EC and 2002/58/EC) will be observed. Medical data will be stored and protected against non-authorised access; transmission of data will be secured; only authorised users will have access to services and stored data. Authentication will be required for application use and data synchronisation. PEPPER will operate according to standard interoperability guidelines (e.g. HL7), so that information can be exchanged seamlessly between the various components. Authorised users will include study team members from the PEPPER collaborators. Collaborators will only be able to view anonymous PEPPER handset data.
The data generated by the study will be analysed by the collaborative PEPPER research team at their respective sites. The analysis will be on anonymised data which will be aggregated during joint meetings on either clinical site.
Missing, unused, and spurious data will be assessed on an individual basis and may be ignored, withdrawn or the visit may be removed from the analysis with appropriate justification adjudicated by the Principal Investigator.
2.7 Adverse Events (AEs) Reporting Procedures All adverse events will be reported. Depending on the nature of the event the reporting procedures below will be followed. Any questions concerning adverse event reporting will be directed to the Chief Investigator in the first instance.
Non serious AEs: All such events will be recorded. Serious Adverse Events (SAEs): An SAE form will be completed and faxed to the Chief Investigator within 24 hours. However, hospitalisations for elective treatment of a pre-existing condition do not need reporting as SAEs.
Reports of related and unexpected SAEs will be submitted within 15 days of the Chief Investigator becoming aware of the event. The Chief Investigator will also notify the Sponsor of all SAEs, where in the opinion of the Chief Investigator, the event is:
* 'related', i.e resulted from the administration of any of the research procedures; and
* 'unexpected', i.e an event that is not listed in the protocol as an expected occurrence Local investigators will report any SAEs as required by their Local Research Ethics Committee, Sponsor and/or Research \& Development Office.
#Intervention
- DEVICE : PEPPER system
- In the phase 1 participants will use PEPPER safety system (with the CBR algorithm enabled) and in the phase 2 participants will use whole PEPPER system (with the CBR algorithm integrated).
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Adults >=18years of age
* Diagnosis of T1DM for > 1 year
* On MDI using a basal-bolus insulin regime or CSII (insulin pump) for at least 6 month
* Structured education done and good ability perform carbohydrates (CHO) counting
* HbA1c >= 48mmol/mol and <= 86mmol/mol
* Using insulin carbohydrates ratio (ICR) and insulin sensitivity factor (ISF) to calculate the mealtime bolus
* An understanding of and willingness to follow the protocol and sign the informed consent
* CBG measurements at least 2 times per day for calibration of the CGM
Exclusion Criteria:
* Severe episode of hypoglycaemia (requiring 3rd party assistance) in the 6 months prior to enrolment
* Diabetic ketoacidosis in the last 6 months prior to enrolment
* Impaired awareness of hypoglycaemia (based on Clarke score)
* Pregnancy, breastfeeding or intention of becoming pregnant over time of study procedures
* Enrolled in other clinical trials
* Have active malignancy or under investigation for malignancy
* Suspected or diagnosed endocrinopathy like adrenal insufficiency, unstable thyroidopathy, endocrine tumour
* Gastroparesis
* Autonomic neuropathy
* Macrovascular complications (acute coronary syndrome, transient ischaemic attack, cerebrovascular event within the last 12 months prior to enrolment in the study)
* Visual impairment including unstable proliferative retinopathy
* Reduced manual dexterity
* Inpatient psychiatric treatment
* Abnormal renal function test results (calculated Glomerular Filtration Rate (GFR) <40 mL/min/1.73m2)
* Liver cirrhosis
* Not tributary to optimization to insulin therapy
* Abuse of alcohol or recreational drugs
* Oral steroids
* Regular use of the acetaminophen, beta-blockers or any other medication that the investigator believes is a contraindication to the participant's participation.
Participant withdrawal criteria:
* Loss of capacity to give informed consent
* The subject has a serious event related to study
* Cessation of MDI of insulin as usual care for T1DM
* Severe hypoglycaemia
* Diabetic ketoacidosis
* Positive pregnancy test
* Terminal illness
* Investigators initiated discontinuation of study due to participant or equipment concerns
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 12 |
Target Study Title: Phase II Trial of Gemcitabine-Eribulin (GE) in Cisplatin Ineligible Patients With Advanced or Unresectable Urothelial Carcinoma of the Bladder
Target Study Description: #Study Description
Brief Summary
This phase II trial studies how well gemcitabine hydrochloride and eribulin mesylate work in treating patients with bladder cancer that has spread to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Detailed Description
PRIMARY OBJECTIVES:
I. To estimate the objective response rate of gemcitabine (gemcitabine hydrochloride)-eribulin (eribulin mesylate) (GE) when given to cisplatin ineligible patients with advanced or unresectable urothelial carcinoma who have not received any prior chemotherapy for the advanced disease.
SECONDARY OBJECTIVES:
I. To estimate the median progression-free survival (PFS). II. To summarize the toxicity profile (using Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 4 criteria) of the GE regimen in these patients.
OUTLINE:
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8 and eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 36 months.
#Intervention
- DRUG : Eribulin Mesylate
- Given IV
- Other Names :
- B1939 Mesylate, E7389, ER-086526, Halaven, Halichondrin B Analog
- DRUG : Gemcitabine Hydrochloride
- Given IV
- Other Names :
- dFdCyd, Difluorodeoxycytidine Hydrochloride, FF 10832, FF-10832, FF10832, Gemcitabine HCI, Gemzar, LY-188011, LY188011
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have locally advanced or metastatic predominantly urothelial carcinoma of the bladder, ureter, or urethra that is not amenable to curative surgical treatment
* Patients must have histologically confirmed predominantly urothelial carcinoma of the bladder, ureter, or urethra
* Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
* Patients must be ineligible for treatment with cisplatin, based on one of:
* Calculated creatinine clearance (CrCl) >= 30 and < 60 mL/min (Cockcroft-Gault)
* CTCAE grade (Gr) >= 2 hearing loss
* CTCAE Gr >= 2 neuropathy
* Patients must not have received prior systemic therapy for their advanced cancer; prior intravesical therapy completed 4 weeks prior to enrollment and adjuvant/neoadjuvant chemotherapy completed more than 6 months prior to diagnosis of advanced disease are permitted
* Zubrod performance status =< 2 (Karnofsky >= 60%)
* Life expectancy of greater than 3 months
* Leukocytes >= 3,000/mcL
* Absolute neutrophil count >= 1,500/mcL
* Platelets >= 100,000/mcL
* Total bilirubin < 1.5 times the upper limit of normal (x ULN) for the institution
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional upper limit of normal
* Creatinine clearance; calculated creatinine clearance (CrCl) >= 30 mL/min and < 60 mL/min (Cockroft-Gault) unless the patient qualified based on hearing loss or neuropathy
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of gemcitabine and eribulin administration
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients with a small cell component in their histology are excluded
* Patients who have had chemotherapy for the treatment of the advanced or unresectable urothelial cancer of the bladder are not eligible; patients who were previously treated for local disease must not have received radiotherapy or chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study and must have recovered from adverse events due to agents administered more than 4 weeks earlier; patients who have received neoadjuvant or adjuvant chemotherapy must have completed treatment at least 6 months prior to diagnosis of metastatic disease
* Patients who are receiving any other investigational agents
* Patients with known brain metastases should be excluded from this clinical trial
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and eribulin
* Uncontrolled intercurrent illness including, but not limited to, a second cancer diagnosis within the past 5 years, or a cancer undergoing any treatment, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with eribulin and gemcitabine
* Human immunodeficiency virus (HIV)-positive patients with inadequate cluster of differentiation (CD)4 counts or those who are on combination antiretroviral therapy with strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) effects are ineligible for this trial
* Patients with baseline corrected QT (QTc) prolongation greater than grade 1 are excluded from this study; patients with grade 1 QTc elevation are eligible but must be monitored with electrocardiogram (ECG) (EKG) exams, for the first 3 cycles of treatment; eribulin time to maximum concentration (Cmax) after infusion is about 10 minutes, and half life is 40 minutes; ECG (EKG) should be performed between 10 to 40 minutes after eribulin administration (on day 1 and day 8 of treatment); continued ECG (EKG) monitoring beyond cycle 3 can be done at the discretion of the treating physician
* Patients with congenital long QT syndrome are excluded from this study
* Other medications known to prolong QT interval should be discontinued and if not possible, patient is excluded from this study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 13 |
Target Study Title: Enhancing Medication Safety in Children With Polypharmacy Using Parent- Reported Symptom Assessments
Target Study Description: #Study Description
Brief Summary
This study plans to learn about how to measure symptoms (like tiredness or rash) in children with special healthcare needs who take 5 or more medications. Sometimes symptoms change in severity over time or new symptoms develop. This can happen after a new medication is started. This can also happen after the dose of an existing medication is changed. The Investigators believe that parents will be able to provide the best assessment of any symptoms that their child might be experiencing. This study asks parents to report any symptoms their child is currently experiencing.
Detailed Description
An increasing number of children with complex chronic conditions (CCCs) who have intractable illnesses or multi-organ dysfunction are exposed to daily polypharmacy. Parents of children with polypharmacy often administer 5 or more medications each day, sometimes for months, including high-risk medications prescribed by many different specialists in multiple settings of care. While medications can be life-saving, polypharmacy increases the risk of additive adverse effects, drug-drug interactions, and can lead to serious adverse drug events (ADEs). Pediatric ADEs result in over 4.3 million estimated ambulatory visits annually, including \>150,000 pediatric emergency room visits. Despite the risks associated with polypharmacy, little is known about how polypharmacy escalates and how polypharmacy should be managed. To enable children to thrive at home using medications while minimizing unwanted symptoms, this proposal aims to implement a prospective, parent-reported symptom assessment system to guide and monitor pharmaceutical care for high-risk children. Strategies to improve recognition of problematic symptoms will have a substantial impact on the health of children.
#Intervention
- OTHER : Parent-Reported Symptom Assessment
- As the basis for PRSA, the investigator will use the PediQuest Memorial Symptom Assessment Scale (PQ-MSAS), which is an adapted pediatric-specific version of the validated adult MSAS that assesses 28 physical and psychological symptoms over the past week. The study instrument is designed to be completed by a full-proxy parent, and 2 versions tailored for specific age groups are available (0-3, 3-18 years-old). Spanish versions are available for both instruments. The PQ-MSAS contains 28 symptom items, each with 4-point scores for domains of frequency, severity, and extent of bother. Based on these components, a global symptom score and individual symptom scores can be calculated (0-100 scale, with 100 being the worst).
- Other Names :
- PRSA
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Neurological impairment
* 5 or more scheduled medications
* English- or Spanish-speaking
Exclusion Criteria:
* Receives primary care outside outside of the Children's Hospital Colorado Network of Care
Sex :
ALL
Ages :
- Minimum Age : 1 Day
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 14 |
Target Study Title: Permanent Celiac Plexus Block: Comparison of Pain Score in Unilateral and Bilateral Posterior Percutaneous Approach
Target Study Description: #Study Description
Brief Summary
The goal of this prospective, interventional, non-randomized study was to compare pain score in unilateral and bilateral posterior percutaneous neurolytic celiac plexus block (NCPB) in upper abdominal cancer patients.
The main questions it aimed to answer are:
1. Whether unilateral or bilateral NCPB technique has a better pain relief
2. Was there any difference in terms of complication rates between these two approaches All participants were having upper abdominal cancer whether operated or non-operable cancer were given a unilateral or bilateral neurolytic celiac plexus block.
Pain scores and adverse events at multiple time points post-procedure were recorded.
Detailed Description
After Institutional Research Committee clearance and Ethical Review Committee approval from the Sindh Institute of Urology \& Transplantation, the patients were divided into two groups, 15 patients in each group. Forty milliliters of the study drug were prepared in a 50 milliliters (mL) syringe by a pharmacy person. Patients were nil per oral (NPO) for six hours and after a written informed consent, patients were brought in the operating room. A 20-gauge (G) intravenous (I/V) cannula was passed and started injection ringer lactate at 10 mL/kg body weight, for all patients except diabetic mellitus who received normal saline. Monitors were applied as per American Society of Anesthesiologist (ASA) standards i.e., electrocardiogram (ECG), oxygen saturation (SpO2), and non-invasive blood pressure (NIBP), and vitals were recorded at intervals of 5 minutes (min). Patients were then positioned prone on the operation table and their arms were rested on the arm board. Pillows were placed under the abdomen between the ribs and iliac crest.
First, a mark was made between the 12 Thoracic (T12) and 1st Lumbar (L1) vertebra under the Fluoroscopic C arm view. Then a line was drawn between the points at 5 and 7 cm lateral from the spinous process of the L3 vertebra. Injection 2% plain xylocaine 3-5 milliliters (mL) was locally infiltrated and a 20-centimeter (cm) 22gauge (G) Chiba needle was inserted at an angle of 45 degrees with the skin and directed medially and in cephalic direction. After making contact with the body of the L1 vertebra needle was withdrawn and reinserted with an increased angle between the needle shaft and the skin until the tip of the needle slipped off the body of the L1 vertebra. Then the needle was advanced 1-1.5 cm in front of the T12 \& L1 vertebrae. The position of the needle was confirmed in the anterior and lateral views of the vertebra with the help of radiopaque dye under a fluoroscopic C arm view. After the proper confirmation of the tip of the needle, 40 mL of absolute alcohol was injected into the unilateral block. Whereas, in the bilateral technique 20 mL absolute alcohol on both sides were injected. During and after the drug administration the pattern of the drug distribution was observed very carefully anterior to the body of the L1 vertebra and psoas fascia, and any visceral and I/V drug administration was avoided. After alcohol administration, 0.25 % Bupivacaine 5 mL was given, and then withdrawn the needle. The patient remained in the prone position for 20 mins. After the patients were turned supine and shifted to the post-anesthesia care unit (PACU) for monitoring of vitals for 30 mins after which they shifted to the ward. Pain score was recorded immediately and then at 30 mins in PACU, then at 6, 12, and 24 hours. Patients were discharged after 24 hours or when stable, pain score was recorded on telephonic conversation/ outpatient clinic visits at 7 days, 1 month, 3 months, and 6 months after the procedure or till death if the patient expired before 6 months.
#Intervention
- DRUG : Unilateral Neurolytic Celiac Plexus Block with Absolute Alcohol
- Participants assigned to the unilateral neurolytic celiac plexus block group underwent a minimally invasive procedure where a solution of absolute alcohol was injected unilaterally into the celiac plexus under image guidance. The procedure was performed by an experienced interventional pain specialist. Prior to the injection, local anesthesia was administered to minimize discomfort. Once positioned correctly, a needle was inserted into the designated area, and a small amount of absolute alcohol was injected to disrupt the neural pathways responsible for transmitting pain signals from the abdominal region. The intervention aims to provide long-term pain relief for participants suffering from chronic abdominal pain.
- DRUG : Bilateral Neurolytic Celiac Plexus Block with Absolute Alcohol
- Participants allocated to the bilateral neurolytic celiac plexus block group underwent a similar minimally invasive procedure as described above, with the exception that the injection of absolute alcohol was administered bilaterally into the celiac plexus. The procedure was performed by an experienced interventional pain specialist under image guidance, with local anesthesia administered prior to the injection to ensure patient comfort. Following correct needle placement, absolute alcohol was injected into both sides of the celiac plexus to disrupt neural pathways responsible for transmitting pain signals from the abdominal region. The intervention aims to provide comparable or potentially enhanced long-term pain relief compared to the unilateral approach, with the additional benefit of targeting both sides of the celiac plexus.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* All upper abdominal malignancy adult patients
* on palliative care,
* having a visual analog scale (VAS) of more than 7
Exclusion Criteria:
* Patients on anti-coagulant medications,
* having an INR > 1.50 and or
* Platelets count < 80000,
* inability to provide informed consent, or
* those who have previously undergone celiac plexus intervention.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 15 |
Target Study Title: Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to establish reliability and validity of the Norwegian version of the Comfort behavioral scale.
Detailed Description
Structured pain assessment is the foundation for the management of pain. Several different pain measurement tools exists, among them the Comfort behavioral scale (van Dijk, 2005), developed from the original Comfort scale (Ambuel, 1992). The psychometric properties of the Comfort scale have been tested in several studies, but so far no Norwegian version of the scale has been developed and tested. Neither has the scale been tested in spontaneously breathing children undergoing minor surgery. The aim of this study is to establish incipient psychometric properties of the Norwegian version of the scale among children aged 0-3 years admitted for elective minor surgery.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Younger than 3 years at the time of surgery
* Day care patients admitted for minor elective surgery
Exclusion Criteria:
* Pre-entry use of sedation and/or analgesics
* Neurological or other diseases or drugs (neuromuscular blockers) thet significantly influence motor activity, facial expression, cognition, or emotional state, ex. cerebral palsy, myopathy, severe mental retardation, severe hypotonia, neuromuscular disease
Sex :
ALL
Ages :
- Minimum Age : 40 Weeks
- Maximum Age : 3 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 16 |
Target Study Title: A Randomised Controlled Trial Investigating the Efficacy and Effectiveness of Text Message Reminders to Improve Uptake of Breast Screening by Prevalent Women Living in the London Borough of Hillingdon
Target Study Description: #Study Description
Brief Summary
Breast Cancer is the single most common cancer, and the third leading cause of cancer cancer deaths, in the United Kingdom. Breast screening is able to detect breast cancer in the early stages of development, during which time it is more easily treatable. Unfortunately, many patients do not attend screening, and surveys issued to these women consistently report 'forgetfulness' as the primary reason for missing the appointment. Both telephone reminders and postal reminders have been shown to reduce non-attendance, however, these are time consuming and expensive.
Mobile telephones are becoming an increasingly popular tool for communication between healthcare professionals and patients, one which might offer an inexpensive solution for delivering reminders. Text message reminders have been able to prevent missed appointments in other areas of healthcare, and the same might be true for breast screening.
The investigators are conducting a trial to confirm whether this is the case or not.
In this trial, the investigators will send some women a text message to reminder them of their appointment, and other women no reminder for their appointment. The investigators will then compare the number of women in each group that went to their breast screening appointment.
Detailed Description
Breast cancer is the single most common cancer in the United Kingdom, accounting for 16% of all cancer incidences and 7% of all cancer deaths. Fortunately, the natural progression of this malignancy can be beneficially changed through mammographic screening techniques, which enable early detection and treatment of benign and malignant breast disease. However, the success of screening programmes depends not only on the analytical specificity and sensitivity of the screening test itself, but also its ability to attract the 'at risk' population. In the United Kingdom, the National Health Service Breast Screening Programme attracts about three quarters of the invited population every three years. In the last screening round (2007-2010), all but one region reported a triennial coverage of more than 75%; London was the exception, reporting a regional coverage of 69%. London consistently fails to meet the national target.
Missed appointments are a primary cause of inefficiency in healthcare delivery, with adverse clinical implications for the non-attending patient, and substantial monetary costs to the health service. To ensure the future success of the breast screening programme it is imperative that strategies for improving uptake of hard to reach populations be developed. Research has demonstrated that receiving an appointment reminder by text message has been successful in improving uptake in other areas of healthcare; the same might be true for breast screening.
Primary Aim: To establish whether text message reminders can significantly improve the uptake of breast screening by women on an 'intention-to-treat' basis in the London Borough of Hillingdon.
Secondary Aim: To evaluate whether text message reminders are an effective intervention for improving uptake of the breast screening programme by hard to reach patients such as women living in deprived areas, and those of Black and Minority ethnic backgrounds.
Methodology: A single blind randomised controlled trial evaluating the effectiveness, efficacy, and acceptability of sending a text message appointment reminder to prevalent women (women aged 47-53 years) living in the London Borough of Hillingdon 48 hours prior to their first breast screening appointment. 2,239 women without a history of breast screening, implant, or bilateral mastectomy were included in the study and randomly assigned in a 1:1 ratio to either the control group (n= 1,118) or the intervention group (n= 1,121). Women in the control group were invited to screening but received no reminder for their appointment, whilst women in the intervention group received a text message reminder 48 hours in advance. All women received an information letter about the study with their invitation from the West of London Breast Screening Service, which included a patient 'opt-out' request form. Patients were not told whether they would be receiving a text message reminder or not. iPlato Patient Care Messaging was used to deliver the text-message reminders.
#Intervention
- OTHER : Text Message Reminder for Breast Screening Appointment
- Non-clinical/administrative.
- Other Names :
- iPlato Patient Care Messaging will be used to send the text message reminder to the patient.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
Women aged 47 <= age <= 53 years, being invited for their first breast screen, without a history of breast disease or malignancy, living in the London Borough of Hillingdon, were eligible for inclusion in the trial.
Exclusion Criteria:
Women with a history of breast disease, malignancy, bi-lateral mastectomy, or breast screen, aged > 54 years were not eligible for inclusion in the trial. Non-routine appointments, male appointments, and self referrals were also not eligible for inclusion.
Sex :
FEMALE
Ages :
- Minimum Age : 47 Years
- Maximum Age : 53 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 17 |
Target Study Title: Examining the Effect of a Behavioural-based Intervention on Injury Prevention Program Adherence in Canadian Female Youth Soccer Players
Target Study Description: #Study Description
Brief Summary
Soccer accounts for more than 10% of all sport injuries in youth requiring medical attention. The injury rates in youth soccer where there is no established injury prevention program are estimated at 22-30 injuries/100 participants/year, or 3.4-5.6 injuries/1000 participation hours. Risk reductions ranging from 32-43% have been found for youth players participating in neuromuscular training programs, such as the FIFA 11+, that include agility, balance training, and strengthening components. Although studies have shown that the FIFA 11+ is effective at reducing injuries, there is poor uptake of the program in the youth soccer community. It is therefore important to develop ways of delivering the program to soccer coaches and players in order to maximize its protective benefit. The Health Action Process Approach (HAPA) is a behavior change theory that has been used to successfully predict the uptake of health behaviours in a number of populations, such as cancer screening and exercise, but has not been tested in sport injury prevention settings.
The primary objective of this study is to examine the effect of a HAPA-based coach education intervention on adherence to the FIFA 11+ in a group of female youth soccer players over the course of one outdoor and one indoor season. The secondary objective is to examine the dose-response relationship between program adherence and injury, comparing program adherence and injury rates in outdoor and indoor soccer. Our hypothesis is that teams whose coaches receive a HAPA-based intervention will have greater adherence to the program than teams whose coaches do not receive the intervention, and that that injury incidence will decrease as adherence to the program increases. It is expected that program adherence will be lower and injury rates will be higher in indoor soccer compared to outdoor soccer.
Detailed Description
The first wave of 16 teams will be recruited in spring 2013, and will be followed through the 2013 outdoor season, followed by the 2013-2014 indoor season. The second wave of 16 teams will be recruited in fall 2013, and will be followed through the 2013-2014 indoor season, followed by the 2014 outdoor season.
#Intervention
- BEHAVIORAL : HAPA-based coach education workshop
- A 3.5 hour workshop will target HAPA constructs by providing injury risk information (risk perceptions), FIFA 11+ effectiveness evidence (outcome expectancies), and hands-on experience administering the 11+ program to a soccer team (task self-efficacy). Action planning and coping planning exercises will also be conducted.
- BEHAVIORAL : placebo attention control
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* 14 or U-16 female soccer team competing in a Calgary Minor Soccer Association league at the commencement of the 2013 outdoor season and/or the 2013 <= age <= 2014 indoor season and/or the 2014 outdoor season
* Female youth soccer player (ages 13 <= age <= 16) participating on a Calgary Minor Soccer Association Club team at the commencement of the 2013 outdoor season and/or the 2013 <= age <= 2014 indoor season and/or the 2014 outdoor season in a U14 or U16 league
Exclusion Criteria:
* Coach who has used the 11+ with a team he/she has previously coached
* Player with recent (within 6 weeks) history of back or lower extremity injury requiring medical attention or the inability to participate in soccer for at least one day and preventing the player from participating fully at the commencement of the 2013 outdoor season and/or the 2013 <= age <= 2014 indoor season and/or the 2014 outdoor season
* Player with a history of systemic disease (e.g. cancer, arthritis, heart disease) or neurological disorder (i.e. head injury, cerebral palsy), preventing the ability to participate fully at the commencement of the 2013 outdoor season and/or the 2013 <= age <= 2014 indoor season and/or the 2014 outdoor season.
Sex :
FEMALE
Ages :
- Minimum Age : 11 Years
- Maximum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 18 |
Target Study Title: Conversion of Twice-a-day Tacrolimus to Once-Daily Tacrolimus Extended-Release Formulation in Stable Pediatric Kidney Transplant Recipients
Target Study Description: #Study Description
Brief Summary
This study was designed to compare the pharmacokinetics of Prograf and Advagraf in stable pediatric kidney transplant recipients.
Enrolled patients on prograf will have pharmacokinetic study of tacrolimus for 24 hours and after that, the same dose of advagraf will be prescribed. The patients will have another pharmacokinetic study of tacrolimus after conversion to advagraf.
#Intervention
- DRUG : tacrolimus
- Other Names :
- Prograf, Advagraf
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* ABO-compatible kidney-only transplantation
* more than 1 year after kidney transplantation
* 5 <= age <= 15 old
* patients maintained on Prograf
* tacrolimus level of determined previously: 4 to 20 ng/ml
* eGFR by Schwartz equation > 50mL/min
Exclusion Criteria:
* patients with acute rejection within 90 days
* patients with acute rejection requiring antibody therapy within 6 months
* patients with more than 2 times of acute rejection within 1 year
* AST/ALT 2 times more than upper normal limit
* ABO-incompatible or crossmatch-positive transplantation
* multiorgan transplantation
Sex :
ALL
Ages :
- Minimum Age : 5 Years
- Maximum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 19 |
Target Study Title: Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients
Target Study Description: #Study Description
Brief Summary
This research study will assess cruciferous vegetable intake in patients presenting for screening colonoscopy and correlate intake with histone status and histone deacetylace (HDAC) expression in tissue biopsy specimens and peripheral blood mononuclear cells (PBMCs). The investigators will also measure sulforaphane (SFN) metabolites in blood as a biomarker of cruciferous vegetable intake.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion criteria:
* scheduled for screening colonoscopy
* off NSAID or aspirin therapy in accordance with OHSU endoscopy clinic guidelines
* INR 0.90 <= age <= 1.20
* hemoglobin >= 13.5 (men) or 12.0 (women)
* platelets >=100,000/μL
* Chem screen results within normal limits
* negative (serum or urine) pregnancy test done <=7 days prior to colonoscopy for women of childbearing potential only
* ASA performance status <2
Exclusion criteria:
* history of colon cancer or adenomatous polyps
* current smoker
* medical history of chronic obstructive pulmonary disease
* current oral steroid therapy
* current therapy with valproate or other pharmacological drugs associated with HDAC inhibition
* use of oral antibiotics within 3 months prior to entry into study
* significant active medical illness which in the opinion of the investigator would preclude collection/interpretation of colon tissue
* diagnosis of hemophilia, van Willebrand's disease or other bleeding disorder
* use of warfarin or other blood thinning agents
* inflammatory bowel disease.
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 20 |
Target Study Title: Phase I Trial to Evaluate the Safety of Platelet Derived Growth Factor B (PDGF-B) and a Limb Compression Bandage in Venous Leg Ulcers
Target Study Description: #Study Description
Brief Summary
Most chronic (long-lasting) wounds of the leg (also known as venous ulcers) fail to heal in a reasonable period of time. Although researchers have made great progress in understanding how the body repairs wounds, attempts to develop new treatments have been disappointing. In general, treatments based on recent findings about the details of wound repair have not greatly reduced the number of people who have chronic wounds. The long-term goal of this study is to evaluate a new approach for healing a chronic wound. Current methods of directly applying substances that are involved in wound healing to a chronic wound do not cause enough healing. PDGF-B (platelet-derived growth factor B), a factor associated with wound healing, might dramatically enhance healing if a genetically engineered virus is injected into the wound that causes cells in the wound to produce PDGF-B in large quantities.
Detailed Description
Most chronic wounds of the leg fail to heal in a reasonable period of time. In fact, despite considerable advances in elucidating the molecular basis of wound repair, attempts to develop new therapies have been disappointing. In general, therapies based on recently elucidated mechanisms of wound repair have had minimal effect on the overall number of individuals with a treated healed chronic wound. The long-term goal of this study is to evaluate a new approach for healing a chronic wound. Current methods of applying cytokines as a topical protein to treat chronic wounds result in an inadequate response. PDGF-B, a growth factor associated with wound healing, might dramatically enhance wound healing when produced in large quantities in the wound bed via adenovirus-mediated gene overexpression by the cells of the wound bed.
This study consists of two trials. The goal of Trial A, a dose-escalation trial, is to determine the maximum tolerated dose (MTD) of PDGF-B/Ad5, an adenovirus vector designed to overexpress PDGF-B, with respect to local and systemic toxicity and biologic feasibility. The primary objective is to evaluate the acute safety, both local and systemic, of an intra-ulcer injection of PDGF-B/Ad5, thereby determining the recommended dose. Upon evaluating patients, they will be treated with a single intra-ulcer injection of PDGF-B/Ad5 in the wound. Patients will receive only one dose, which will be administered during a 72-hour inpatient stay in a research unit at the Hospital of the University of Pennsylvania.
This study will use a standard three-six dose-escalation scheme. The MTD is defined as the highest dose for which fewer than two of six subjects experience a severe adverse reaction. Each patient will be closely monitored for clinical adverse reactions resulting from treatment with PDGF-B/Ad5. Toxicity will be graded according to the National Cancer Institute's Common Toxicity Criteria Scale.
The primary objective of Trial B is to evaluate the safety and biologic feasibility of the MTD of PDGF-B/Ad5 reported in Trial A in a standard 24-week trial for treatment of a venous leg ulcer. For this study, 15 consecutive patients will be treated using the MTD. All patients will receive a single intra-ulcer injection of PDGF-B/Ad5 and a limb compression bandage to be changed weekly.Study participants will be followed for 24 weeks, which is the length of most FDA-approved venous leg ulcer trials.
#Intervention
- DRUG : PDGF-B/Ad5
- This is a dose finding study to evaluate the safety of a single injection of PDGF dna in an adenoviral vector.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Patient must have a venous leg ulcer.
* Patient must have failed at least 6 weeks of limb compression.
* Wound must be free of necrotic debris.
* Wound must be greater than 5 cm2 and less than 20 cm2.
* Wound must be more than 6 months old.
* Affected limb must have an ankle-brachial index (ABI) > 0.85.
* Patient must be more than 18 years.
Exclusion Criteria:
* Any active cancer or cancer in remission for less than 10 years.
* Patients with life expectancy of less than 6 months.
* Liver function tests (Alanine Transaminase(ALT) Aspartate Amino Transfer (AST) Alkaline Phosphatase (ALK PHOS) and bilirubin) greater than 1.5x upper limit of normal for the reference lab.
* Patients with intercurrent organ damage or medical problems.
* Pregnant or lactating females.
* Any requirement for systemic corticosteroids or immunosuppressives, or history of corticosteroid or immunosuppressive use in the 4 weeks previous to study entry.
* Seropositive for hepatitis B surface antigen or hepatitis C antibody.
* Any concurrent medical illness that may be exacerbated by PDGF-B/Ad5 administration.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 21 |
Target Study Title: Effects of Shockwave Therapy on Crouched Gait and Hamstring Flexibility in Children With Diplegic Cerebral Palsy.
Target Study Description: #Study Description
Brief Summary
Randomized controlled trial will be conducted on thirty-two cerebral palsy children in Punjab Special School. Spastic Diplegic CP children with GMFCs level III, IV, V with age range of 6 to 12. These children have limited range of hamstring muscles. Assessment will be measured Pre and Post treatment by goniometer of crouched gait in standing and lying on couch. Crouched gait will be measured by Knee flexion in standing and lying. To measure hamstring flexibility ROM of knee extension is measured with 90 flexion at hip joint. Spasticity in this study will be assessed by GMFM-88 and modified Ashworth scale.
Detailed Description
Shortwave therapy, stretching and orthotics will be provided to Group A. Shock wave session will be provided for 20 minutes thrice a week. Five days, five minutes with 30 seconds sustained stretch will be provided and than orthotics will be used to obtained the sustained effect.
In Group B spastic diplegic children just given stretching with strengthening and orthotics. We provide sustained 30 seconds stretch with 30 seconds rest for 5 minutes and followed with forty repetition of hip flexor and knee flexors and range will be maintained by applying orthosis.
#Intervention
- OTHER : Shock wave therapy, stretching and orthosis
- Shortwave therapy, stretching and orthotics will be provided to Group A. Shock wave session will be provided for 20 minutes thrice a week. Five days in a week provided five minutes with 30 seconds sustained stretch will be provided and than orthotics will be used to obtained the sustained effect.
- OTHER : Stretching, strengthening and orthosis
- In Group B spastic diplegic children just given stretching with strengthening and orthotics. We provide sustained 30 seconds stretch with 30 seconds rest for 5 minutes and followed with forty repetition of hip flexor and knee flexors and range will be maintained by applying orthosis.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Children with GMFCS level I, II & III.
* Passive range of motion of knee extension is limited to 20 degree with hip 90 degree.
* Age between 6 <= age <= 12.
Exclusion Criteria:
* Children with epileptic history
* Previous muscular lengthening technique applied
* Previous history of botox injection used.
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 22 |
Target Study Title: Early Warning for Desaturation by Oxygen Reserve Index During Induction of General Anesthesia
Target Study Description: #Study Description
Brief Summary
During the induction of general anesthesia, the anesthesiologist needs to provide the oxygen supply to meet the patient's needs continuously. In the clinical scenario, the pulse oximeter is used as a standard to monitor hemoglobin oxygen saturation (SpO2) but is limited to assess the oxygenation status beyond the measurement of 100%. The Oxygen Reserve Index (ORi) is a dimensionless parameter between 0 and 1 that is related to real-time oxygenation reserve status. This study was designed to evaluate the duration of warning time for desaturation provided by different ORi alarm triggers during prolonged apnea in surgical patients. The primary endpoint was the duration of additional warning time provided by the ORi trigger. The secondary endpoint was the correlation of ORi and PaO2.
Detailed Description
This is an observational study of the routine clinical practice with no specific additional interventions required.
The investigators enrolled the American Society of Anesthesiologists (ASA) physical status I to III patients scheduled for elective surgery with planned arterial catheter placement before induction. Patients were positioned supine on the operating room table. Standard monitors and the ORi sensor were placed. The patients were preoxygenated with a facemask (flow rate of 8 to 10 liters/minute) for 3 minutes with spontaneous ventilation. Propofol (2-2.5 mg/kg), fentanyl (2-3 mcg/kg) and rocuronium (0.6-0.9 mg/kg) were administrated to achieve anesthesia induction during following 3 minutes. The patient was keeping ventilated manually by the anesthesiologist during the induction phase and intubated under direct visualization with a video-assisted laryngoscope at 6 minutes. The endotracheal tube was not connected to the breathing circuit to avoid apneic oxygenation. The patients remained apneic. Ventilation was resumed when SpO2 fell to 90%. ORi and SpO2 were recorded every ten seconds. Arterial blood is sampled every minute, from preoxygenation to resumed ventilation, to observe blood oxygen concentration changes.
#Intervention
- DEVICE : Oxygen reserve index
- This is an observational study of the routine clinical practice with no specific additional interventions required. The investigators enrolled the ASA physical status I to III patients scheduled for elective surgery with planned arterial catheter placement before induction. ORi and standard monitors were placed. The patients were preoxygenated and received anesthesia induction as routine clinical practice. Intubation was done by video-laryngoscope. The endotracheal tube was not connected to the breathing circuit to avoid apneic oxygenation. Ventilation was resumed when SpO2 fell to 90%. ORi and SpO2 were recorded every ten seconds.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Male and female patients aged 18 <= age <= 80 with ASA physical status I to III scheduled for elective surgery with planned arterial catheter placement before induction of general anesthesia.
Exclusion Criteria:
* Age <18 years
* Inability to give primary consent
* Pregnancy
* History of chronic obstructive pulmonary disease (COPD)
* History of asthma
* Suspected difficult intubation
* Preoperative hemoglobin less than 10 mg/dl.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 23 |
Target Study Title: A Randomized, Double Blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Ulcerative Colitis
Target Study Description: #Study Description
Brief Summary
The primary objective of this study is to evaluate the effect of abrilumab on induction of remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as assessed by a total Mayo Score ≤ 2 points, with no individual subscore \> 1 point.
Detailed Description
The study consisted of a 24-week double-blind, placebo-controlled treatment period followed by an open-label period of approximately 108 weeks. Participants were eligible to enter the open-label period of the study early if they did not achieve a response at week 8 and had an inadequate response at week 12 or later or if they experienced disease worsening after achieving response and/or remission at week 8. Failure to achieve response at week 8 was defined as failure to achieve a decrease from baseline in total Mayo Score ≥ 3 points and ≥ 30% decrease from baseline. Inadequate response at week 12 or later was defined as failure to achieve a 2-point decrease and 25% improvement in partial Mayo Score compared with screening and minimum partial Mayo Score ≥ 5 points. Disease worsening was defined as an increase in partial Mayo Score ≥ 3 points from the week 8 value and minimum partial Mayo Score ≥ 5 points with recto-sigmoidoscopy sub-score ≥ 2.
Participants were planned to be randomized in a 2:1:2:2:2 ratio to placebo or abrilumab at 7 mg, 21 mg, 70 mg (on day 1, week 2, week 4, and every 4 weeks thereafter until week 24), or 210 mg (on day 1 followed by placebo in weeks 2 and 4 and every 4 weeks thereafter until week 24), respectively. Due to a consistent discrepancy between the investigational product (IP) instruction manual (IPIM) description of vial positions and the actual vial positions in the IP package participants were initially randomized to 3 arms (placebo, 70 mg, and 210 mg) with a randomization ratio of 4:3:2. The study was temporarily paused while this issue was investigated. Once the discrepancy was corrected, Protocol Amendment 3 implemented, and affected participants completed their double-blind treatment period, the study resumed enrollment and randomization per protocol. Neither the randomization nor study blind was compromised and therefore the intent-to-treat principle was maintained.
#Intervention
- BIOLOGICAL : Abrilumab
- Administered by subcutaneous injection.
- Other Names :
- AMG 181
- DRUG : Placebo
- Placebo matching to abrilumab administered by subcutaneous injection
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of ulcerative colitis (UC) established >= 3 months before baseline by clinical and endoscopic evidence and corroborated by a histopathology report.
* Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with a centrally read rectosigmoidoscopy score >=2 prior to baseline
* Inadequate response to, loss of response to, or intolerance to at least one of the following treatments:
* Immunomodulators
* Anti-TNF agents
* Corticosteroids (non-US sites only).
* Neurological exam free of clinically significant, unexplained signs or symptoms during screening and no clinically significant change prior to randomization
Exclusion Criteria:
* Disease limited to the rectum (ie, within 10 cm of the anal verge)
* Toxic megacolon
* Crohn's Disease
* History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC
* Planned bowel surgery within 24 weeks from baseline
* Stool positive for C. Difficile toxin at screening
* History of gastrointestinal surgery within 8 weeks of baseline
* Primary Sclerosing Cholangitis
* Any uncontrolled or clinically significant systemic disease
* Condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with study evaluation, procedures or completion.
* Known to have tested positive for hepatitis B virus surface antigen, hepatitis C virus antibody or human immunodeficiency virus (HIV)
* Underlying condition that predisposes subject to infections (eg, uncontrolled diabetes; history of splenectomy)
* Known history of drug or alcohol abuse within 1 year of screening
* Malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of screening visit (if a malignancy occurred > 5 years ago, subject is eligible with documentation of disease free state since treatment)
* Immunosuppressive therapy with either cyclosporine A, tacrolimus, or mycophenolate mofetil, within 1 month prior to baseline
* Prior exposure to anti tumor necrosis factor (TNF) agents, within 2 months, or 5 times the respective elimination half life (whichever is longer) prior to baseline
* Any prior exposure to vedolizumab, rituximab, efalizumab, natalizumab
* Use of topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal) steroids within 2 weeks prior to baseline
* Use of intravenous or intramuscular corticosteroids within 2 weeks prior to screening and during screening
* Previously treated with AMG 181
* Received any type of live attenuated vaccine < 1 month prior to baseline or is planning to receive any such live attenuated vaccine over the course of the study
* Treatment of infection with intravenous (within 30 days of baseline) or oral (within 14 days prior to baseline) antibiotics, antivirals, or antifungals
* Abnormal laboratory results at screening
* Any other laboratory abnormality, which, in the opinion of the investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results
* Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 24 |
Target Study Title: Phase IV Study of Coronally Advanced Flap With or Without Porcine Collagen Matrix for Treatment of Gingival Recession: a Randomized Controlled Clinical Trial
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to compare the clinical outcomes after coronally advanced flap technique (CAF) associated or not to a porcine collagen matrix graft (CM) in the treatment of single gingival recessions. For this blinded randomized controlled clinical trial, 40 patients with Miller Class I or II gingival recession ≥ 2 mm in canines or premolars will selected and randomly assigned to receive either CAF or CAF+CM. The clinical parameters evaluated will be probing depth, clinical attachment level, gingival recession height, height and thickness of keratinized tissue. Clinical measurements will be taken at baseline and 45 days, 2, 3 and 6 months after surgery.
#Intervention
- PROCEDURE : Coronally Advanced Flap
- DEVICE : Mucograft
- Other Names :
- Porcine collagen matrix for soft tissue regeneration
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years.
* Presence of at least one Class I or II Miller gingival recession >= 2 mm in maxillary canines or premolars with identifiable cementum-enamel junction (CEJ) and without deep non-carious cervical lesions (< 0.5 mm): A + (Pini-Prato et al. 2010).
* Aesthetic complaint and/or presence of dentin hypersensitivity to air stimulus.
* Full-mouth visible plaque index <= 20% (Ainamo & Bay 1975).
* Full-mouth sulcus bleeding index <= 20% (Mühlemann & Son 1971).
Exclusion Criteria:
* Smoking.
* Pregnancy.
* Presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery).
* Use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair).
* Previous periodontal surgery in the area.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 25 |
Target Study Title: An Observational Study 'FOLLITROPIN' Comparing the Efficacy of Follitropin Alpha Biosimilar: the Real-world Data
Target Study Description: #Study Description
Brief Summary
Aim to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.
Detailed Description
A retrospective observational anonymized cohort study of follitropin alpha biosimilar (Primapur®) as a pre-filled pen injector with a dose adjustment of 5 IU, aimed to investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART) was carried out. The ovarian stimulation (OS) protocols included:
monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists of gonadotropin-releasing hormone (GnRH) and long protocols with GnRH agonists. The stimulation protocols were analyzed with Primapur® application for at least 5 days.
#Intervention
- DRUG : Follitropin Alfa
- Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH or agonist of GnRH.
- Other Names :
- Primapur, Biosimilar
- DRUG : Follicle Stimulating Hormone/Luteinizing Hormone
- Subcutaneous injection of follitropin alpha biosimilar, with daily dose 100-300 IU for at least 5 days, than added another gonadotropin for a maximum of 10 days, using antagonists of GnRH or agonist of GnRH.
- Other Names :
- Follitropin beta, Follitropin alfa + Lutropin alfa, Corifollitropin alfa, Menotropins, Follitropin alfa, Follitropin alfa biosimilar
- DRUG : Follitropin Alfa
- Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH only for suppression.
- Other Names :
- Primapur, Biosimilar, Follitropin alfa biosimilar
- DRUG : Follitropin Alfa
- Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using agonists of GnRH only for suppression.
- Other Names :
- Primapur, Biosimilar, Follitropin alfa biosimilar
- DRUG : Follicle Stimulating Hormone/Luteinizing Hormone
- Overall ovarian stimulation protocols with follitropin alpha biosimilar for at least 5 days+other recombinant and menotropins and short (antagonists of GnRH) or long protocol (agonist of GnRH).
- Other Names :
- Follitropin beta, Corifollitropin alfa, Follitropin alfa + Lutropin alfa, Menotropins, Follitropin alfa biosimilar, Follitropin alfa
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Women with established causes of infertility and indications for the use of ART methods, according to the Order of the Ministry of Health of the Russian Federation 'On the use of assisted reproductive technologies, contraindications and limitations to their use' No. 107 n dated August 30, 2012.
* Infertility due to female and/or male factor.
* Presence of ovaries accessible for aspiration of follicles.
* Anatomical and functional capability of uterus to bear pregnancy.
Exclusion Criteria:
* Women with established contraindications to the use of ART methods, according to the Order of the Ministry of Health of the Russian Federation 'On the use of assisted reproductive technologies, contraindications and limitations to their use' No. 107 n dated August 30, 2012.
* Presence of pregnancy
* Hypersensitivity to follitropin alfa or excipients.
* Ovarian cysts (not associated with polycystic ovarian syndrome), uterine hemorrhage of unclear etiology
* Premature ovarian failure
* Presence of clinically significant systemic disease
* Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
* Neoplasia
* Narcomania, alcoholism
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 43 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 26 |
Target Study Title: Ultracet (Tramadol HCL [37.5 mg]/Acetaminophen [325 mg]) Combination Tablets in the Treatment of the Pain of Fibromyalgia
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to evaluate the analgesic effect of combination of tramadol hydrochloride and acetaminophen in participants for treatment of fibromyalgia pain (chronic widespread pain and presence of tender points).
Detailed Description
This is an open-label (all people know the identity of the intervention) and multi-center (conducted in more than one center) study of combination of tramadol hydrochloride and acetaminophen in treatment of participants with pain of fibromyalgia. The duration of this study will be 56 days per participant. The study consists of 2 parts: Screening (that is, 3 weeks before study commences on Day 1) and Treatment (that is, up to Day 56). All the eligible participants will receive oral tablet for combination of tramadol hydrochloride and acetaminophen. Rescue medication (a medication intended to relieve symptoms immediately) of tylenol (500 milligram, up to 6 oral tablets daily) will be permitted throughout the study duration. Efficacy of the participants will primarily be evaluated by Pain Visual Analog Scale. Participants' safety will be monitored throughout the study.
#Intervention
- DRUG : Tramadol hydrochloride
- Tramadol hydrochloride oral tablet will be administered at a dose of 37.5 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
- DRUG : Acetaminophen
- Acetaminophen oral tablet will be administered at a dose of 325 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Participants must meet the American College of Rheumatology 1990 criteria for the classification of fibromyalgia (that are, Participants must have had widespread pain [pain in three quadrants and in the axial skeleton] for at least three months and pain on digital palpation in 11 or more of the 18 tender-point sites
* Female participants must not be pregnant, breast feeding or postmenopausal for at least one year
* Participant must be able to take oral medication
* Participants must have completed the Screening or wash-out procedures and have a visual analog scale score greater than or equal to 40 milliliter
* Fail to non-opioid analgesics
Exclusion Criteria:
* Participants who previously failed tramadol hydrochloride therapy or those who discontinued tramadol hydrochloride due to adverse events
* Participants diagnosed with either any active connective tissue or musculo-skeletal diseases, or malignancy or history of malignancy within past 5 years, or painful, symptomatic osteoarthritis, or regional periarticular pain syndromes, spondyloarthropathy and major endocrine disease
* Participants who currently have more severe pain than the pain of fibromyalgia
* Participants who have taken antidepressants, cyclobenzaprine or anti-epileptic drugs for pain within three weeks of the Treatment Phase
* Participants who have taken short-acting analgesics, topical medications and anesthetics and/or muscle relaxants for a period of less than 21 days of the given medication prior to the Treatment Phase
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 27 |
Target Study Title: Sleep Apnea. Concordance Between Non-reference and Reference Centres
Target Study Description: #Study Description
Brief Summary
When a disorder is as prevalent as sleep apnea hypopnea syndrome various medical levels and strategies should be implicated. We to evaluate the degree of concordance in management between a sleep reference centre and non-reference centres.
Detailed Description
INTRODUCTION: When a disorder is as prevalent as SAHS, different medical levels should be involved to facilitate diagnosis for all patients, or at least those that are in moderate-severe or risk groups. A good option could be to transfer the patient assessment to non-reference centres (NRC). Therefore, the aim of the present study was to evaluate this strategy by analysing the degree of concordance between RC and NRC in treatment decision and management of SAHS patients.
MATERIALS AND METHODS: Study subjects: The study population consisted of 88 consecutive subjects with a suspicion of SAHS (age 50±11 years, 81 % male, BMI 30±4 K/m2) from the out-patient clinics of three NRC in the Barcelona area: Hospital Asil de Granollers, Hospital General de Vic and Hospital de Terrassa.
Study design: The patients were evaluated independently, at random, over the course of 1 month in the RC and NRC. In both types of centre, the patient evaluation was carried out on the basis of the clinical history, with a specific questionnaire about sleep disordered breathing, and a sleep study in the hospital. The evaluation was performed by a sleep physician in the RC and by a respiratory physician with training in sleep medicine in the NRC. In both cases, the choice of treatment was registered on an ordinal scale with four points: 1= No diagnosis of SAHS and patient is discharged; 2= Mild SAHS, patient should follow a conservative treatment and clinical control; 3= Moderate to severe SAHS, patient should begin continuous positive air pressure (CPAP) treatment; 4= Other sleep disorders are diagnosed (RC), or there is a need for full-night PSG owing to a discordance between clinical features and respiratory polygraphy in NRC. The indication for CPAP treatment followed the national-SEPAR guidelines summarized as: 1) Patients with severe SAHS-related symptoms with an AHI\>10; or 2) Patients with mild to moderate clinical symptoms with an AHI\>30. The human ethics committee of our hospital approved the protocol and informed consent was obtained from all the patients. Sleep studies: Reference hospital: Full-night polysomnography was performed in the usual manner. Briefly, the variables registered were electroencephalogram, chin electromyogram, electro-oculogram, tibial electromyogram, arterial oxygen saturation, ribcage and abdominal motion and their sum. Airflow was measured by cannula/thermistor. An apnea was defined as the absence or airflow equal to or greater than 10 seconds. Hypopnoea was defined by any discernible reduction in the amplitude of the airflow signal ending in an arousal and/or association with a 3% desaturation, with a duration of at least 10 seconds. An expert technician scored sleep stages and respiratory variables manually. An apnea-hypopnoea index (AHI) equal to or greater than 10 was considered abnormal.Non-reference centres: patients received a respiratory poligraphy with recording of body position, ribcage and abdominal motion, snoring, arterial oxygen saturation and airflow using a cannula/thermistor. The respiratory physician performed a manual scoring of the recording. The definitions of hypopnoea and apnea resembled those mentioned above, except in the case of arousal. Data analysis: Data were entered using SPSS 10.0 and imported to STATA 7.0 to perform the analysis (StatatCorp. 1999. Stata Statistical software: Release 7.0. College Station, TX: Stata Corporation). Descriptive analysis: Data were expressed as mean ± SD or percentage for quantitative and qualitative variables, respectively. For continuum variables, a logarithmic transformation was undertaken to normalise the distribution, if necessary. If the distribution was not symmetrical, data were expressed as percentiles. Concordance analysis: Evaluation of the concordance of the final outcome and the choice of treatment, between the RF and the NFC centres, was performed by using the statistic Kappa balanced, penalizing extreme discrepancies, following the classification of Landis \& Koch (25). This procedure was also used for the concordance in the result of the AHI of the sleep study, categorised as follows: \<10, 10-29, ≥30. Concordance in the results of the sleep study (AHI and CT90) was evaluated in accordance with the Band \& Altman methodology and the concordance coefficient of Lin.
#Intervention
- PROCEDURE : SAHS diagnosis
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Supected sleep apnea
Exclusion Criteria:
* Major diseases
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 28 |
Target Study Title: Repetitive TMS of the Precuneus: a Randomized Double-blinded Placebo-controlled Trial in Alzheimer's Disease Patients.
Target Study Description: #Study Description
Brief Summary
Alzheimer's disease is a global health challenge. Efforts aim at developing an effective treatment able to meet the needs of patients and their families. Thus, the primary aim of this project is to investigate the efficacy of a non-invasive brain stimulation, namely repetitive transcranial magnetic stimulation (rTMS), on cognition in patients with mild Alzheimer's disease. rTMS is considered a safe, well tolerated and relatively cheap treatment. The appealing idea of the intervention is to improve memory by directly modulating the activity of precuneus, key area linked to memory impairment. Patients will be treated with rTMS in two phases: an intensive phase and a maintenance phase for a total of six months. This project aims to provide a valid treatment to slow the worsening of symptoms and improve quality of life for those with Alzheimer's and their caregivers.
Detailed Description
Background: Alzheimer's disease (AD) is a neurodegenerative disorder characterized by severe disruption of large-scale brain networks connectivity. AD pathophysiology has been mainly associated with a breakdown of the Default Mode Network (DMN) and with a structural disconnection of parietal nodes. It has been shown that the precuneus (PC), a central hub of the DMN, is involved in successful episodic memory retrieval, working as a key area of the network activated by recognition memory. Recent anatomical works have shown that medial parietal regions are interconnected with the medial temporal region, which is implicated in memory retrieval. In particular, the PC was identified as a region demonstrating strong functional interconnectivity with the hippocampal formation. This is of particular relevance because PC is altered in AD. At early clinical stages of AD, PC is selectively vulnerable to early amyloid deposition, and plays a critical role in the conversion towards dementia.
Hypothesis: a novel therapeutic intervention for AD is repetitive Transcranial Magnetic Stimulation (rTMS). rTMS is a non- invasive approach that can be used to induce long lasting modulation of specific brain functions, inducing neuroplastic changes not only in the cortical site of stimulation, but also in remote interconnected areas. In a recent double blind randomized cross-over clinical pilot study, we found that a two-week course of daily high-frequency rTMS (20 Hz) treatment targeting the DMN (Stimulation site: PC) was able to induce an improvement in episodic memory compared to placebo. Indeed, TMS-EEG measurements showed that rTMS treatment, applied over the DMN, was capable to modulate the cortical activity in both the targeted areas (PC) as well as in functional connected regions of the DMN (Koch et al., 2018).
Specific aims: to investigate clinical efficacy and safety of DMN rTMS applied during 6 months in mild AD patients. To provide novel evidence that non-invasive treatment of network dysfunction, through stimulation of the PC, will represent an effective strategy to enhance cognitive functions and lead to substantial slowing of cognitive and functional decline in patients with mild AD. The findings yielded by the present project will have a potential strong impact on clinical practice of AD patients. Since rTMS is well tolerated and relatively low-priced, a positive result could lead to a fast application of the present proposal to the clinical experience. If successful, the proposed project will provide support for a novel treatment for cognitive dysfunction in AD patients.
#Intervention
- DEVICE : REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION
- daily treatment session of REPETITIVE TRANSCRANIAL MAGNETIC STIMULATIO will be applied over precuneus for 20 minutes of consecutive blocks of 20Hz pulses for two seconds followed by 28 seconds of no stimulation.
- Other Names :
- RTMS
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* The patient and the responsible caregiver have signed the Informed Consent Form.
* The patient has probable AD, diagnosed according to NINCDS-ADRDA criteria.
* The patient is a man or woman, aged <= 85 years.
* The patient has a CDR total score of 0.5 or 1 (mild) and MMSE score of 18 <= age <= 26 (inclusive) at Screening.
* Has at least one identified adult caregiver
* The patient has been treated with acetylcholinesterase inhibitor (AChEI), i.e., donepezil, galantamine, or rivastigmine, at the time of Screening
* For at least 3 months
* The current dosage regimen must have remained stable for >= 8 weeks
* It must be planned that the dosage regimen will remain stable throughout participation in the study
* The patient is able to comply with the study procedures in the view of the investigator.
Exclusion Criteria:
* Significant neurodegenerative disorder of the central nervous system other than Alzheimer's disease
* Significant intracranial focal or vascular pathology seen on brain MRI scan
* History of seizure (with the exception of febrile seizures in childhood)
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM IV-TR) criteria met for any of the following within specified period:
* Major depressive disorder (current)
* Schizophrenia (lifetime)
* Other psychotic disorders, bipolar disorder, or substance (including alcohol) related disorders (within the past 5 years)
* Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MR imaging.
* Treatment currently or within 3 months before Baseline with any of the following medications:
* Typical and atypical antipsychotics (i.e. Clozapine, Olanzapine)
* Antiepileptics drugs (i.e. Carbamazepine, Primidone, Pregabalin, Gabapentin)
* Memantine
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 29 |
Target Study Title: Defining the Role of ERCP in the Evaluation and Treatment of Idiopathic Recurrent Acute Pancreatitis
Target Study Description: #Study Description
Brief Summary
The therapeutic impact of ERCP with sphincterotomy in the management of patients with idiopathic recurrent acute pancreatitis (RAP) needs further study. The investigators conducted a single center, feasibility, randomized trial to determine 1) the role of pancreatic manometry in predicting future episodes of RAP and 2) differences in the efficacy of no, biliary (BES) or pancreatobiliary (dual) endoscopic sphincterotomy (DES).
Detailed Description
Patients with idiopathic RAP, defined as ≥2 unexplained (per the treating physician) episodes of acute pancreatitis (based on standard criteria) requiring hospitalization, will be prospectively enrolled. All patients will undergo ERCP with manometry, with stratified randomization based on the assessment of pancreatic basal sphincter pressure. If \<40mmHg, the patient will be randomized to sham or biliary sphincterotomy (BES). If ≥40mmHg, the patient will be randomized to BES or pancreatobiliary ('dual') sphincterotomy (DES).
Patients and physicians will not be blinded to the assignment group. Patients will be followed for up to 10 years to determine 1) incidence of RAP requiring hospitalization (using standard definitions) or 2) interval development of chronic pancreatitis (CP).
Differences between patients who did and did not develop RAP during follow-up will be compared to evaluate for factors associated with AP during follow-up.
#Intervention
- PROCEDURE : Biliary sphincterotomy
- Cutting of the biliary sphincter muscle.
- PROCEDURE : Pancreatobiliary sphincterotomy
- Cutting of both the biliary and pancreatic sphincter muscles.
- PROCEDURE : Sham
- No sphincterotomy is performed in patients randomized to sham with normal SOM.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Idiopathic recurrent acute pancreatitis, defined as two or more episodes requiring hospitalization
* ERCP with SOM planned
Exclusion Criteria:
* Chronic pancreatitis
* Pancreas divisum
* Alternate etiology identified (e.g., CBD stone, IPMN)
* Inability to perform pancreatic manometry
* Pregnancy, age < 18, incarceration
* Inability to provide informed consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 30 |
Target Study Title: An Open, Comparative Phase II Study of Immediate Versus Delayed Treatment With Topotecan HCl Given as a Continuous 21-Day Infusion Every 28 Days to Patients With AIDS-Related Progressive Multifocal Leukoencephalopathy
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to see if it is safe and effective to give topotecan through a vein to treat HIV-infected patients with PML, an opportunistic (AIDS-related) infection caused by a virus that infects brain tissue and causes damage to the brain and the spinal cord.
Topotecan fights HIV and the JC virus (the virus that causes PML) in laboratory experiments.
Detailed Description
Topotecan, a cytotoxic DNA topoisomerase-I inhibitor that crosses the blood-brain barrier, inhibits the replication of JC virus (the virus that causes PML) in vitro, at concentrations that are not toxic to human cells. Topotecan also inhibits the replication of HIV-1 and the function of Tat (which upregulates the replication of JC virus).
Patients are randomized to be treated immediately with topotecan or to have treatment delayed for 8 weeks. The dosing schedule for patients receiving immediate or delayed treatment is topotecan as a continuous 21-day intravenous infusion every 28 days. All patients must have received optimal, stable antiretroviral therapy for 3 weeks prior to entry and preferably will continue that therapy during the study.
#Intervention
- DRUG : Topotecan
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
* Are HIV-positive.
* Have PML, including symptoms of PML.
* Are able to complete the study.
* Agree to have a catheter inserted in a vein.
* Have taken at least 3 weeks of a stable anti-HIV drug combination (unless they are unable to take anti-HIV drugs).
* Are at least 18 years.
* Agree to use effective methods of birth control.
Exclusion Criteria
Patients will not be eligible for this study if they:
* Have a history of certain central nervous system (CNS) diseases.
* Have a history of certain psychiatric disorders, such as bipolar disorder or schizophrenia.
* Have syphilis that has not been treated.
* Have certain severe medical problems, including AIDS-related opportunistic infections (such as PCP) that require treatment.
* Have received chemotherapy in the past 30 days.
* Have ever received chemotherapy for PML.
* Are pregnant or breast-feeding.
* Are taking certain medications, including any other investigational drugs.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 31 |
Target Study Title: Clinical Outcomes in Pediatric Plasmodium Falciparum Malaria According to Host Cytoadherence Factors
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to determine the importance of key blood group molecules in the clinical outcome of Plasmodium falciparum malaria infection in children.
Detailed Description
Every year, nearly 2 million children die from infection with Plasmodium falciparum malaria. When red blood cells (RBC) become infected with malaria, a sticky parasite-derived knob protein, termed PfEMP-1, erupts on the RBC surfaces. PfEMP-1 attaches to several blood group molecules, including those found on other RBC, on blood vessels, and on the cells that normally help to stop bleeding (platelets). The cellular sticking results in a dangerous interruption in blood flow to vital organs, causing brain injury (cerebral malaria), systemic shock (lactic acidosis), and death. Depending on an individual's inherited blood groups of relevance, adhesion may be extensive or limited. In the laboratory, PfEMP-1 adheres to RBCs via the A or B (but not the O) antigens of the ABO blood group system, and to platelets and blood vessels via platelet glycoprotein IV (CD36) and ICAM-1. Consistent with the expected evolutionary advantage of being deficient in these binding targets, blood type O and low-expression of CD36 are found more frequently among Africans. The 'Cytoadherence in Pediatric Malaria' (CPM) project is determining the distribution of adhesive blood group molecules in a cohort of 2000 Ugandan children according to the extent of malaria severity and death, and thus their ultimate clinical and evolutionary significance in malarial survival. This knowledge may serve as the grounds for developing targeted cytoadhesion-interruption therapies in our fight against malaria.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of Plasmodium falciparum malaria infection
Exclusion Criteria:
* HIV or significant malnutrition
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 32 |
Target Study Title: Safety & Immunogenicity of a Booster Dose of dTPa Vaccine (Boostrix®) Co-admnd. With Aventis Pasteur's Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Vaccine (Menactra™) vs Admn. of Either Vaccine Alone in Healthy Adolescents
Target Study Description: #Study Description
Brief Summary
New immunization recommendations in the US include vaccination of adolescents against pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommends that Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine Adsorbed) and MCV4 (Meningococcal conjugate vaccine against serotypes A, C, Y and W-135) vaccines be administered to adolescents at the same office visit if vaccination with both vaccines is indicated. Therefore, this study is designed to evaluate the safety and immunogenicity of a booster vaccination with Boostrix co-administered with Menactra as compared to the administration of either vaccine alone in healthy adolescents 11 - 18 years of age.
Detailed Description
A phase IV, randomized, partially blinded multicenter study to evaluate the safety and immunogenicity of a booster vaccination with GlaxoSmithKline's tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed \[Tdap Boostrix®\] co-administered intramuscularly with Aventis-Pasteur's meningococcal (serogroups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (Menactra™) as compared to the administration of either vaccine alone in healthy adolescents 11-18 years of age. 'Experimental design: Prospective, randomized, controlled multicenter study with three groups:
Group 1: Boostrix + Menactra on Day 0, blood samples at Month 0 and Month 1 Group 2: Boostrix on Day 0, Menactra at Month 1, blood samples at Month 0, Month 1, and Month 2 Group 3: Menactra on Day 0, Boostrix at Month 1, blood samples at Month 0, Month 1 and Month 2 Treatment allocation: randomized 1:1:1 Type of study: self-contained Duration of the study: Approximately one month for each subject in Group 1 and approximately two months for each subject in the Group 2 and Group 3.'
#Intervention
- BIOLOGICAL : Boostrix®
- GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.
- BIOLOGICAL : Menactra™
- Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
* Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases according to the recommended vaccination schedule at the time.
* Females of childbearing potential at the time of study entry are required to have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or use adequate contraceptive precautions for one month prior to vaccination. Subjects also are required to agree to continue such precautions for two months after vaccination.
Exclusion Criteria:
* Administration of a pre-school booster of DTP vaccine within the previous 5 years
* Administration of a diphteria-tetanus (Td) booster within the previous 5 years
* Previous vaccination against N. meningitidis
* Hypersensitivity to latex
* History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphteria toxoid or pertussis-containing vaccine or any component of the study vaccines
* History of encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) within seven days of administration of a previous dose of pertussis vaccine taht is not attributable to another identifiable cause
* Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized
* Previous history of Guillain-Barré syndrome
Sex :
ALL
Ages :
- Minimum Age : 11 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 33 |
Target Study Title: Phase I Study of Neoadjuvant Nivolumab in Patients With Non-metastatic High-risk Clear Cell Renal Cell Carcinoma
Target Study Description: #Study Description
Brief Summary
This study will evaluate the use of nivolumab before surgery in patients with high-risk clear cell renal cell carcinoma who are eligible for nephrectomy. Nivolumab is an antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1).
#Intervention
- DRUG : Nivolumab
- 3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy.
- Other Names :
- MDX-1106, BMS-936558, Opdivo
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria (abbreviated):
* Confirmed non-metastatic high-risk clear cell renal cell carcinoma (T2a-T4NanyM0 or TanyN1M0)
* Schedule to undergo either partial or radical nephrectomy as part of treatment plan
* Patient agrees to have a tumor biopsy
* ECOG performance status of 0 or 1
* Adequate organ and marrow function defined by study-specified laboratory tests
* Must use acceptable form of birth control while on study and for approximately 31 weeks post-treatment completion
* Willingness and ability to comply with scheduled visits, treatment plans, lab tests and other study procedures
Exclusion Criteria (abbreviated):
* Other active malignancies within last 3 years (with some exceptions for skin, prostate, cervical, or breast cancer)
* Need for urgent or emergent nephrectomy to relieve symptoms
* Prior treatment for RCC including surgery, radiation, thermoablation or systemic therapy
* Surgery within 28 days of starting study treatment (some exceptions for minor procedures)
* Received live vaccine for infectious diseases within 28 days of starting study treatment
* Prior treatment with any antibody or drug targeting T-cell costimulation or immune checkpoint pathways (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, etc)
* Use of immunosuppressive doses of systemic medications within 14 days prior to starting study drug.
* Current use of immunosuppressive agents
* History of severe hypersensitivity reaction to other monoclonal antibodies
* Current signs or symptoms of severe progressive or uncontrolled hepatic, hematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to RCC
* Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements.
* Active infection requiring therapy.
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
* Positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA).
* History of autoimmune disease or syndrome requiring systemic steroids or immunosuppressants (some exceptions apply).
* Pulse oximetry of <92% on room air
* Pregnant or breastfeeding women
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 34 |
Target Study Title: The Effect of the Popliteal Plexus Block on Postoperative Opioid Consumption, Pain, Muscle Strength and Mobilization After Total Knee Arthroplasty - a Randomized, Controlled, Blinded Study
Target Study Description: #Study Description
Brief Summary
In this study we wish to investigate the analgesic effect 3 different nerve block regimes in patients following primary total knee arthroplasty (TKA). All nerve blocks were performed as single shot blocks with the administration of Marcain 5 mg/ml.
Regime A: proximal Femoral Triangle Block (FTB) with 10 ml including Intermediate Femoral Cutaneous Nerve Block (IFCNB) with 5 ml + Popliteal Plexus Block (PPB) with 10 ml.
Regime B: proximal FTB with 10 ml including IFCNB with 5 ml.
Regime C: Adductor Canal Block (ACB) with 25 ml.
Detailed Description
The Adductor Canal Block (ACB) is frequently used after TKA, but it is limited to provide anesthesia from the anteromedial part of the knee region. The proximal Femoral Triangle Block (FTB) is also used for TKA, and also limited to provide anesthesia from the anterior medial part of the knee joint. The FTB anesthetize the saphenus nerve, the nerve to vastus medialis, and may anesthetize the medial femoral cutaneous nerve which innervates the distal medial thigh as well as the anteromedial knee region. We included the Intermediate Femoral Cutaneous Nerve block (IFCNB) in the FTB, as the nerves can be targeted in the subcutis on the anterior thigh and easily be anesthetized during the same procedure as FTB. IFCNB anesthetize the distal anterior thigh, which may include the proximal part of the surgical incision for TKA. In the following text the proximal FTB including IFCNB will be refered as 'FTB' and the dose of 15 ml will refer to 10 ml for the proximal FTB and 5 ml used for the IFCNB.
A new nerve block technique, called Popliteal Plexus Block (PPB), is specifically designed to anaesthetize nerves involved in innervation of the back of the knee joint. The analgesic effect of PPB has not yet been evaluated in randomized, controlled, blinded trials. In order to optimize pain treatment for primary TKA by improving the pain-relieving effect of peripheral nerve blocks, we aim to evaluate the analgesic effects of three different nerve block regimens (FTB + PPB versus FTB versus ACB) after primary unilateral TKA. Our outcomes include postoperative pain scores, opioid consumption, muscle strength and mobilization.
Our hypothesis is that the combination of FTB + PPB provides superior postoperative pain treatment after TKA in comparison to both FTB or ACB. The combination of FTB + PPB will reduce opioid consumption (primary outcome) and postoperative pain scores without reducing muscle strength or impairing mobilization.
#Intervention
- DRUG : Marcain 5 mg/ml
- Total volumes of Marcain differs in each arm, depending on which nerve blocks the patients is randomized to receive. Sham block does not include injection of placebo saline, due to the risk of hydrodissection between the anatomical sections which may erase the isolation of the different nerve blocks. Instead the sham block include imitation of the real nerve block, including correct placement of the needle on the target for the block.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Scheduled to undergo primary total knee arthroplasty in spinal anesthesia
* Able to perform a Timed Up and Go (TUG) test
* Age > 50 years
* Ability to give their written informed consent to participating in the study after having fully understood the contents of the study
* American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
Exclusion Criteria:
* Patients who cannot cooperate
* Patients who cannot understand or speak Danish.
* Patients with allergy or intolerance to the medicines used in the study
* Patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl)
* Patients suffering from alcohol and/or drug abuse - based on the investigator's assessment
* BMI > 40
* Diagnosed with chronic central or peripheral neurodegenerative disorders
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 35 |
Target Study Title: Efficacy of Specified Manual Therapies in Combination With a Supervised Exercise Protocol on Managing Pain Intensity and Functional Disability in Patients With Knee Osteoarthritis
Target Study Description: #Study Description
Brief Summary
Osteoarthritis (OA) is referred to a group of conditions that involve mostly the larger weight-bearing joints such as the hip, knee, and ankle. It is the result of an intricate, multifaceted, progressive softening and break-down of articular cartilage along with capsular fibrosis and re-growth of new cartilages and bones called osteophytes at the margin of the articular surfaces to increase the surface area of them.
The current study aimed to find out the efficacy of specified manual therapies in combination with a supervised exercise protocol on managing pain intensity and functional disability in patients with knee osteoarthritis.
Detailed Description
Out of 70-millions older adults in the America, the majority of females have been suffering from osteoarthritis (OA) that progressively lead to chronic pain, joint stiffness, reduced mobility, muscle atrophy, poor balance, and ultimately, physical disability. Other physiological changes such as reduction in quadriceps' muscle strength and range of motion (ROM) in sagittal plane, and shortening of soft tissues around the joints collectively yield the distinctive clinical features such as articular pain; worsening on weight -bearing activities, resting/morning joint stiffness, progressive decline in physical activities and increasing to deformities/disabilities.Researchers observed the effectiveness of a structured exercise programs including an aerobic exercise program, a resistance exercise program, and a health education program in improving functional outcomes (self-reported disability) and decreasing the knee pain among older adults with knee OA at short-term and long term.the manual therapy along with supervised exercise protocol revealed a significant reduction in joint stiffness and knee pain and improvement in functional status of the patients with knee OA for short-term and long-term (1-year follow-up) than the placebo therapy (sub-therapeutic dose of ultrasound).
The study based on a randomized, pretest-posttest experimental group design, included a total of 32-participants with knee osteoarthritis randomly divided into groups A and B. Group A received a supervised exercise protocol, however group B received specified manual therapies in a combination of a supervised exercise protocol. Pain and functional disability measured with NPRS and WOMAC index respectively. Data collected on day-1st pre-intervention (baseline), day-14th posttest, and day-28th follow-up and analyzed using t-test and one-way ANOVA by keeping the level of significance at p\<0.05.
#Intervention
- OTHER : Supervised exercise protocol
- Strengthening exercises:It included a sets/group of exercises such as a static quad set in knee extension, standing terminal knee extension, seated leg-press, partial squats weight-lessened with arm support as needed, and step-ups Stretching Exercises:A slow, sustained stretching was performed in different positions for different group of muscles with holding time 30-seconds, a gap of 1-minute between two repetitions, and repeated 3-times per session on alternate day for 2-weeks. The stretching performed for the calf muscle, hamstring muscle, and quadriceps femoris muscle in standing, supine, and prone positions respectively.
- OTHER : Specified Manual Therapies
- Myofascial Mobilization: Patellar glide performed in all available ROM and direction such as superior-inferior and lateral-medial translation/glides of patella over patellar fossa.
Myofascial manipulation technique: Manipulation of knee joint. An impulse type thrust was delivered, directed in the caudal direction to mobilize the joint in a near-full extension position.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* aged between 47 <= age <= 60;
* mild to moderate pain in one/both knees for 3-months;
* the pain intensity score between 2 to 6 on NPRS;
* morning stiffness <30-minutes;
* Self-reported crepitus on knee motion;
* grade 1 to 3 on Kellgren-Lawrence radiographic grading scale for Knee OA
Exclusion Criteria:
* diagnosed case of post-traumatic knee stiffness;
* history of bone infection and malignancy (osteomyelitis and tumour); neurological disorder (sciatica);
* history of joint replacement/meniscal surgery/mechanical knee pain/infection to the knee joint; suffering from severe cardiopulmonary disease (chronic obstructive pulmonary disease);
* Patient showed non-cooperation
Sex :
ALL
Ages :
- Minimum Age : 47 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 36 |
Target Study Title: Comparison of Efficacy, Safety and Economic Outcomes Between Once-Daily Versus Twice-Daily Amikacin in Combination With Cloxacillin in Febrile Neutropenic Children
Target Study Description: #Study Description
Brief Summary
Once-daily dose administration of aminoglycoside in adults is effective and economical. However, its value in febrile neutropenic children, especially in Thailand, is less well researched. In the area where Pseudomonas aeruginosa prevalence in febrile neutropenic children is low, the combination of cloxacillin and amikacin is an appropriate approach. This study would like to compare the efficacy and safety including cost between these two amikacin administrations (once-daily or twice-daily) in combination with cloxacillin as an empirical therapy in febrile neutropenic children.
Hypothesis: Once-daily amikacin plus cloxacillin can be used to treat febrile neutropenic children in Khon Kaen, Thailand.
Detailed Description
Fever: a single oral temperature of \>/= 38.3 degrees C; or \>/= 38.0 degrees C for \>/= 1 hour.
Neutropenia: neutrophil count, \< 500/cu mm or \<1,000/cu mm with a predicted decrease to \<500/mm3.
#Intervention
- DRUG : cloxacillin and amikacin (once or twice daily dosage)
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Aged 1 year - 14 years
* A single oral temperature of >= 38.3 degrees C; or >= 38.0 degrees C for >= 1 hour.
* Neutropenia: neutrophil count, < 500/cu mm or <1,000/cu mm with a predicted decrease to <500/mm3.
* During the course of chemotherapy
Exclusion Criteria:
* History of amikacin or cloxacillin allergy
* Creatinine clearance < 30 ml/min/m2
* Central nervous system infection: meningitis or brain abscess
* History of hearing abnormality
* Severely ill: shock
* Chronic liver diseases or SGPT > 10 times of upper normal limit
* Received aminoglycoside within 14 days prior to enrolment
* Received any intravenous antibiotics within 7 days
* Cancer which is newly diagnosed or relapsed
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 14 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 37 |
Target Study Title: Benefit of Assistive Listening Device for Lateralization and Spatial Hearing
Target Study Description: #Study Description
Brief Summary
Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss using a Phonak Roger microphone and hearing aid with compatible Phonak Roger receiver. Target speech will be presented from multiple directions while competing diffuse background noise is presented simultaneously. Participants will repeat back words and percent correct is calculated.
#Intervention
- DEVICE : Roger On microphone
- Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids
- DEVICE : Roger Select microphone
- Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Experienced hearing aid users, age >= 18 years
* Bilateral, symmetric moderate to moderate-severe sensorineural hearing loss
* Good understanding of the English language
* Health outer ear as confirmed by otoscopy
* Informed consent as documented by signature
Exclusion Criteria:
* Contraindications to the medical device noted upon otoscopy
* Known hypersensitivity or allergies to materials of the investigations device or comparator
* Inability to produce reliable test results
* Known psychological problems
* Self reported symptoms of vertigo or dizziness
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 38 |
Target Study Title: Efficacy of Sterile Dressing in the Prevention of of Peripheral Intravenous Catheters Associated Phlebitis in Patients From the Western Brazilian Amazon: Pragmatic, Randomized, Blinded and Controlled Trail
Target Study Description: #Study Description
Brief Summary
Pragmatic, randomized, single-blinded, controlled clinical trial of the effect of dressing and stabilization of peripheral intravenous catheters on the occurrence of phlebitis in adult patients attended at a hospital from the Western Brazilian Amazon.
Detailed Description
Peripheral venous catheterization is the most commonly performed invasive procedure in healthcare. Care practices and the use of technologies may influence the results of the use peripheral intravenous catheters (PIC), contributing to the reduction of complications and adverse events. Phlebitis is characterized as one of the most serious complication related to the use of PIC and this study has as hypothesis to analyze if the occurrence of phlebitis associated with PIC is influenced by the use of sterile dressing. Objectives: To verify the effect of using sterile dressing and sterile adhesive tape compared to non-sterile adhesive tape in PIC on the occurrence of phlebitis in adult patients attended at a hospital from the Western Brazilian Amazon. Methods: Pragmatic, randomized, controlled and single-blinded clinical study conducted in Rio Branco, Acre. The sample was calculated in 330 patients, aged 18 years or older and who met the inclusion criteria. Data collection took place between June 2018 and September 2019, after approval of ethical merit. To identify the type of sterile transparent dressing to be studied, was carried out an implementation study with a final sample of 71 patients, focusing analysis from the perspective of the patient, professional and clinics. The patients of the clinical study were randomly allocated to one of the study groups: Experimental group (sterile transparent dressing) or Standard Group (non-sterile adhesive tape). Phlebitis was diagnosed by the bedside nurse, according to presence and severity. If present, the nurse removed the CIP and an external evaluator was called to perform a diagnose of phlebitis with blindness regarding the intervention. Variables related to patient characterization, intravenous therapy, peripheral venipuncture, reasons for withdrawal and length of PIC stay, reasons for removal and length of coverage, and associated complications were investigated. For the statistical analysis, Chi-square, Fisher's Exact, student t test, and Mann-Whitney U tests were used. The multiple analysis was performed using the logistic regression model to estimate the Relative Risk (RR) and the Kaplan-Meier model, Cox regression, for survival analysis. RR calculation for 95% Confidence Interval (IC) was applied to estimate the degree of association between variables. In all tests, the significance level of 5% was considered.
#Intervention
- DEVICE : Transparent dressing
- Use of sterile transparente dressing
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* IV access for more 48 hours obtained in the studied wards.
* IV access 20 and 22 G.
* without confusion or agitation
* Aged more or equal 18 years
Exclusion Criteria:
* Sepsis
* Skin lesions
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 39 |
Target Study Title: Can FloSeal Reduce the Risk of Intra-abdominal Bleeding After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Performed for the Treatment of Peritoneal Carcinomatosis ?
Target Study Description: #Study Description
Brief Summary
Introduction
Modern treatment of peritoneal carcinomatosis (PC) combines an aggressive cytoreductive surgery (CRS) of all macroscopic disease and hyperthermic intraperitoneal chemotherapy (HIPEC) performed at the time of surgery. It is considered a high risk procedure and post-operative intra-abdominal bleeding is a major issue as it can delay recovery and promote intra-abdominal infections. In most severe cases (10 to 20% of patients), a second surgery to control the bleeding will be necessary. Major causes of bleeding are : radical resection, extensive peritonectomy, length of surgery, massive transfusion and use of HIPEC.
To reduce the risk of intra-abdominal hemorrhage, many strategies have been tried and one of these is the liberal use of FloSeal, but there is no data in this particular field of interest. Over the last 18 months, the investigators have started to use FloSeal in all their cases with large PC and they have observed a dramatic reduction in the rate of reoperation for bleeding and probably secondarily, in the use of blood products, but this has not been measured.
Hypothesis
FloSeal can reduce the risk of bleeding after CRS and HIPEC procedure.
Primary objective
To evaluate if the use of FloSeal can reduce the risk of reoperation after CRS and HIPEC procedure in the treatment of PC.
Secondary objectives
* To evaluate if the use of FloSeal can reduce operative blood loss.
* To evaluate if the use of FloSeal can reduce the need of blood products after CRS and HIPEC procedure.
* To evaluate if the use of FloSeal can have an impact on other common surgical complications (which can be indirectly bleeding related).
* To evaluate if the use of FloSeal can have an impact on length of hospital stay.
#Intervention
- OTHER : FloSeal
- Other Names :
- gelatin matrix thrombin solution (Baxter)
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Male and female patients older than 18 year old
* All cases of PC regardless of primary tumour (colorectal carcinoma, peritoneal mesothelioma, appendiceal carcinoma etc.)
Exclusion Criteria:
* Prophylactic HIPEC
* Peritoneal Carcinomatosis Index (PCI) < 5
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 40 |
Target Study Title: A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination With Trans-arterial ChemoEmbolization (TACE) in Patients With Intermediate-stage Hepatocellular Carcinoma (HCC)
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer.
#Intervention
- DRUG : nivolumab
- Specified dose on specified days
- Other Names :
- Opdivo, BMS-936558
- DRUG : ipilimumab
- Specified dose on specified days
- Other Names :
- Yervoy
- PROCEDURE : TACE
- TACE (Trans-arterial ChemoEmbolization)
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Participant has intermediate-stage hepatocellular carcinoma (HCC) whose tumor characteristics exceed the Beyond Milan and Up-to-7 (BMU7) criteria and is eligible for trans-arterial ChemoEmbolization (TACE)
* Participant has no extrahepatic spreading (EHS), no regional lymph node involvement, no main, left main, or right main portal vein thrombosis, and no macrovascular invasion (MVI)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Exclusion Criteria:
* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Prior liver transplant or participants who are on the waiting list for liver transplantation
* Active, known, or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria apply
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 41 |
Target Study Title: Efficiency of a Nursing Intervention in Sleep Hygiene in Prediabetes and Diabetes Mellitus 2
Target Study Description: #Study Description
Brief Summary
Background: The relationship between the appearance of insulin resistance phenomena and insufficient or poor-quality sleep is scientifically documented.
Objectives: To determine the effectiveness of an intervention based on behavioural techniques on sleep in the nursing consultation in the Primary Care setting to improve the level of HbA1c in patients diagnosed with diabetes mellitus 2 (DM2) or prediabetes.
Hypothesis: Patients diagnosed with DM2 or prediabetes with poor sleep quality would improve their HbA1c levels after an intervention on healthier sleep hygiene practices. Sleeping 6 or less hours in adults diagnosed with DM2 or prediabetes would be related to worse metabolic control results. Patients diagnosed with DM2 or prediabetes who would value their sleep as poor quality would have poorer metabolic control.
Methodology: Design: Not masked randomized clinical trial. Target population: Patients diagnosed up to the time of DM2 (E11) or prediabetes (R73, R73.9) with age over 18 attending the chronic nurses' follow-up visits of the Basic Health Area of Balaguer in the time range from November 2017 to December 2018. Determinations: Dependent variables: Glycemia and HbA1c. Independent variables: Sex, age, value of the Pittsburgh Sleep Quality Index (PSQI), declared hours of sleep, sleep efficiency, body mass index (BMI), pharmacologic antidiabetic treatment, changes in it, changes in diet, physical exercise and sleep hygiene. Statistical analysis: Analysis of the comparability of the groups and calculation of the confidence interval of the difference in the glycaemic values and HbA1c at the end of the follow-up, with respect to the initiation within the intervention group and within the control, and control group with respect to the group intervention.
Detailed Description
Several studies have shown the association between short and poor sleep quality and alterations in glucose metabolism as well as the appearance of insulin resistance phenomena. This issue makes the research on this subject relevant to establish interventions aimed at improving the quality of sleep. Nursing professionals in the field of Primary Care have a decisive role in the monitoring and control of chronic diseases, among which DM2 stands out due to its high prevalence, great morbidity and mortality and healthcare pressure. Therefore, it is necessary to check the efficiency of healthy sleep hygiene to carry out prevention and achieve good metabolic control of the patient. Therefore, it is, in this way, important to prevent the development of the disease in the case of patients with prediabetes and the appearance of complications in patients with DM2.
Therefore, the overall objective is to determine the efficiency of an intervention based on behavioural techniques on sleep in the nursing consultation in the Primary Care setting to improve the level of HbA1c in patients diagnosed with DM2 or prediabetes.
The specific objectives are:
1. Describe the mean and range of hours that patients with DM2 or prediabetes declare to sleep.
2. To analyse the assessment of the quality of sleep referred by people with DM2 or prediabetes through the PSQI.
3. Calculate the correlation between the number of hours of sleep declared and the HbA1c values.
4. Compare the amount and quality of sleep and HbA1c value in the control group and the experimental group.
In the other hand, the hypotesis are:
-Patients diagnosed with DM2 or prediabetes with poor sleep quality would improve their HbA1c levels after an intervention on healthier sleep hygiene practices.
* Sleeping 6 or less hours in adults diagnosed with DM2 or prediabetes would be related to worse results of metabolic control.
* Patients diagnosed with DM2 or prediabetes who would value their sleep as poor quality would have worse metabolic control.
The variables are:
Dependent variable:
* Value of the difference between the basal glycemia figure at the beginning and at the end of the study. Measurement in mg / dL.
* Value of the difference between the HbA1c level at the beginning and at the end of the study. Measure in%.
Independent variable:
* Age. Measure in years.
* Sex. Man/Woman.
* Diagnosis (International Classification of Diseases, 10th version). E11 Non-insulin-dependent Diabetes Mellitus/R73 Elevated blood glucose level/ R73.9 Hyperglycaemia, unspecified.
* Antidiabetic pharmacological treatment. Yes/No.
* BMI. Measure in kg/m2. PSQI (pre and post-intervention). Good sleep quality (≤ 5 points)/ Bad sleep quality (\> 5 points).
* Declared sleeping hours (pre and post-intervention). Measure in hours/day.
* Sleeping efficiency (pre and post-intervention). Measure in%
* Change in antidiabetic pharmacological treatment 3 months after the first visit. Yes/No
* Change in diet 3 months after the first visit. Yes/No.
* Change in physical exercise 3 months after the first visit. Yes/No.
* Change in sleep hygiene (post-intervention). Yes/No.
The data will be collected through the computerized clinical record ECAP and through the patient's own consent and acceptance of their participation in the study.
Necessary data for the selection of the sample:
- Computerized clinical and administrative database (ECAP) of the participating centres: this source will be used to obtain the complete list of patients with the diagnostic codes E11 (E11.2-E11.9), R73 and R73.9 and the criterion of age (≥ 18 years).
Necessary data to obtain the values of the dependent variables:
- HbA1c and baseline glycaemia values for the experimental group and control group performed pre and post-intervention. The results of the analytics will be obtained, according to laboratory criteria.
Necessary data to obtain the values of the independent variables:
* Declared sleep hours, efficiency and quality of sleep from the PSQI performed on the patient. The average number of hours of sleep on weekdays will be requested at the time of introducing the individual into the study regardless of whether the individual is active or a pensioner. The values will be recorded in the initial and final visit through the PSQI.
* BMI obtained in the nursing consultation in the follow-up visits before 6 months from the date of the visit. Otherwise, it will be calculated after the measurement of weight and size at the time of the visit.
* Antidiabetic pharmacological treatment that patients currently take through the computer clinical history.
* Changes in the antidiabetic pharmacological treatment, in the diet, in physical exercise and in sleep hygiene through a clinical interview with the patient.
The instrument used is the PSQI that is a validated version in Spanish facilitated by its authors from the University of Pittsburgh. It consists of 24 items, 19 are answered by the patient and 5 are answered by the couple or roommate. In the event that the patient only goes to the consultation, only the first 19 items will be answered.
The maximum score of the questionnaire is 21 points. Scores greater than five points indicate poor quality in the sleep standard.
The questionnaires will be completed by the nursing professionals assigned to the patients through an individual, directed and structured interview, after explaining the study and justifying the access and review of the clinical history. The data collection will be by manual registration in a grill.
The data collection will be made in the Primary Care Nursing consultation when the patient goes to a visit.
The principal investigator will be responsible for the review of clinical histories to obtain the variables and analysis of the PSQI, noting the result in the clinical history.
Two sections will be used in the registry of the information collected in the consultation to which the principal investigator has access.
* General data section where all the variables mentioned above will be included.
* Specific data section for PSQI analysis, in which the responses of the questionnaire will be introduced to obtain the variables of declared hours, sleep efficiency and the result.
A screening visit and three follow-up visits will be carried out to each patient included in the study in which the professionals will follow a support guide by presenting the project to the team.
* Screening visit:
* Identify the patient with diagnosis prediabetes or DM2. Analyze inclusion and exclusion criteria.
* Once included, explain the study and give a fact sheet.
* Provide informed consent to be signed by the patient.
* Pass the first PSQI. Patients with good sleep quality will be excluded.
* Ask for previous HbA1c if the last one registered exceeds 6 months.
* Schedule the patient in a month. The principal investigator will write down the result of the PSQI and the clinical order to follow
* First visit:
• Look at clinical course. The PSQI result and the clinical order will appear depending on the group to which the patient belongs (experimental or control).
- Experimental: the educational intervention will be carried out and the booklet of Recommendations on Sleep Hygiene will be delivered.
- Control: no educational intervention will be carried out.
• Ask for the analysis of HbA1c and basal glycaemia to be done in the 3 months after in both groups.
• Schedule the patient for results (3 months).
* Schedule a telephone contact (1 month)
* Second visit:
* Carry out telephone contact as an educational reinforcement on sleep hygiene recommendations one month after the intervention.
* Third visit:
• Look at analytical results.
* Ask about changes in the antidiabetic pharmacological treatment, diet, physical exercise and sleep hygiene.
* Re-pass PSQI. The principal researcher will review the clinical history to obtain the variables to study. When the study ends at the last visit, the results of the PSQI will be re-analysed, as well as the remaining variables to perform the statistical analysis of the results and the final report of the study.
First, the initial comparability of the groups will be checked by calculating the Student's T value and its statistical significance for the quantitative variables: basal glycemia, HbA1c, declared sleep hours, sleep efficiency, age and BMI. The variables: sex, diagnosis, PSQI and antidiabetic treatment will be compared by the significance of the chi-square test.
The premise of randomness will remain intact, and patients will be analysed according to intention to treat.
On the other hand, subsets of the study groups will be analysed (by sex, age group, treatment, BMI).
As a global result of the clinical trial, the difference between the glycemia and HbA1c values of the final figure with respect to the initial one will be calculated with its respective 95% confidence interval within the intervention group and within the control group and the control group with respect to the group intervention, also with the 95% confidence interval.
Through our study we want to corroborate the available evidence on the influence of sleep duration and quality on the ethology of DM2.
There have been few studies in the field of Primary Care on the importance of sleep on the health of people. Sleeping is a health habit and, as such, is a tributary of educational interventions in the health environment.
The scientific demonstration that a concrete measure of health education such as the one proposed in this study, is useful in demonstrable biological terms, would open a door to healthy sleep promotion activities in routine clinical practice.
Regarding the socioeconomic aspect, information as a basis for health education and, specifically, in the topic of sleep hygiene does not require expensive resources and, through our study, we intend to demonstrate that it can be done from the primary care nursing consultation.
#Intervention
- BEHAVIORAL : Sleep hygiene intervention
- An individual education will be carried out following a bidirectional feedback method. It is intended to develop skills to make conscious and autonomous decisions. The explanation will consist:
1. Information and reading with discussion of the educational sheet: The 9 tips for a healthy sleep will be read, point by point. The nurse will be open to discuss those that generate doubt.
2. Confrontation: even if the patient does not ask any questions about it, it will be necessary to ask if he has understood the advice.
3. Participated information: Questions will be asked to the patient such as: 'Did you already know any of these tips?'.
A telephone call per month will be made as an educational reinforcement to the intervention.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Age greater than or equal to 18 years.
* Hb1Ac greater than or equal to 5.7% at the time of diagnosis.
* PSQI greater than 5 points (poor sleep quality).
* Acceptance of participation in the study.
Exclusion Criteria:
* People diagnosed with:
* Obstructive Sleep Apnea Syndrome.
* Narcolepsy
* Fibromyalgia
* Dementias
* Schizophrenia
* Psychosis
* Major depression
* People with shift working hours.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 42 |
Target Study Title: Randomized Case-Control Trial About the Impact of Targeted Physical Activity and Diet Modification on Kidney Transplant Recipients' Outcome
Target Study Description: #Study Description
Brief Summary
This randomized controlled trial (RCT) will examine the effect of a novel 12 month personalized exercise rehabilitation program compared to standard care following kidney transplantation. Return to work or find work rates, markers of subclinical atherosclerosis, functional capacity, body composition, quality of life, kidney function, and adherence to exercise will be measured. The investigators' primary hypothesis is that a 12 month exercise rehabilitation program will increase the return to work or find work rate in kidney transplant recipients. The investigators additionally hypothesize that a 12 month exercise rehabilitation program will prevent a decline in subclinical atherosclerosis, increase functional capacity, and increase lean muscle mass.
Detailed Description
The proposed study, data collection, and intervention will be performed in the Integrative Physiology Laboratory at the University of Illinois at Chicago. Blood samples will be collected in the Transplant Clinic at the University of Illinois at Chicago. The study will use a two-arm RCT design to examine the effects of personalized exercise rehabilitation versus standard clinical care in kidney transplant (KT) recipients. The primary outcome will be patient return to work/find work rates. Secondary outcomes will include physical and vascular function, body composition, perceived quality of life, kidney function and blood lipid markers, and adherence. 120 kidney transplant recipients will be randomized 2:1 into either an exercise rehabilitation program or a control group, which involves standard clinical care only. Randomization will be done after obtaining informed consent and baseline testing, utilizing a computerized randomization program as a way to prevent potential selection bias. The exercise rehabilitation arm includes low intensity, personalized resistance trainings two times per week for a 12 month period in addition to standard clinical care (including regular check-ups and blood work as recommended by their post-transplant physician). The control group will continue standard care as advised by their post-transplant medical team with no additional intervention. The investigator will collect data on employment status, and all physiological and psychological data at baseline (before intervention), during (6 months), and immediately after the intervention (12 months). Adherence will be monitored throughout the entirety of the study by recording study visits as well as having the exercise trainers keep record of the patient's attendance in the exercise arm. A 2 X 3 (condition X time) mixed factor, analysis of variance with intent-to-treat principles will be utilized for testing the effect of the intervention on the outcome variables. The investigators' primary hypothesis is that a 12 month exercise rehabilitation program will increase the return to work/find work rate in kidney transplant recipients. It is additionally hypothesize that a 12 month exercise rehabilitation program will prevent a decline in subclinical atherosclerosis, increase functional capacity, and increase lean muscle mass. Outcome measures for subclinical atherosclerosis include aortic pulse wave velocity (PWV), carotid intima-media thickness (IMT), endothelial function and carotid arterial stiffness. The outcome measures for functional capacity include the 6 minute walk test (6MW), unilateral isometric strength test, and free-living accelerometry. Fat and lean muscle mass will be assessed via Dual-energy X-ray absorptiometry (DXA). Quality of life and perceptions of pain will be assessed utilizing the Patient Reported Outcomes Measurement Information System (PROMIS) Global health and PROMIS 29 v 2 questionnaires. Additionally, fasting blood lipid profile, inflammatory markers, and markers of kidney function including glomerular filtration rate (GFR) and creatinine levels will be measured.
#Intervention
- BEHAVIORAL : Exercise Rehabilitation
- 12 month personalized exercise rehabilitation in addition to standard clinical care
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* at least 2 moths post-transplant
* must have adequate cognitive ability to complete questionnaires, give consent for the study and follow the physical instructions
Exclusion Criteria:
* any other organ besides kidney or kidney/pancreas mix
* any surgery or procedure to assist in weight loss (ie bariatric surgery)
* non-ambulatory or significant orthopedic problems
* cardiac/pulmonary disease that contraindicates the physical training
* any contraindication to exercise testing per the American Heart Association
* if the patient is unable to comply with the training program
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 43 |
Target Study Title: MomMoodBooster Randomized Components Trial: A Program for Perinatal Depressed Female Veterans
Target Study Description: #Study Description
Brief Summary
The MomMoodBooster intervention is an empirically validated treatment for postpartum depression symptoms. The intervention was created by Brian Danaher and Milagra Tyler, who have continued to update the intervention technology and content. The intervention is now available for pregnant and postpartum Veterans, and it is accessible on browsers via computer, tablet, or mobile phone. The intervention contains six cognitive-behavioral modules that span six weeks, and it includes identification of pleasant activities, tracking mood and thoughts, and identification of goals. The current trial is an expansion of a nationwide service delivery project that has been ongoing for six years with the goal of offering the intervention to postpartum Veterans nationwide. Within that study, Veterans completed the online modules in concert with weekly phone coaching calls wherein coaches applied the content to the Veteran's current life. In addition, two booster modules and associated coaching calls were developed to continue application of the skills beyond the six-week intervention period. The present study seeks to investigate the incremental utility of the phone coaching component of the intervention by randomizing pregnant and postpartum Veterans to the MomMoodBooster intervention or the MomMoodBooster intervention plus phone coaching. Primary outcomes will include depressive symptoms, behavioral activation, and negative automatic thoughts.
Detailed Description
The purpose of the current study is to: 1) expand the MomMoodBooster intervention to pregnant Veterans and 2) to randomize Veterans to one of two intervention conditions. Veterans may be randomized to either 1) MomMoodBooster online intervention only or 2) MomMoodBooster online intervention and phone coaching. The study will examine the incremental utility of the phone coaching component of the intervention with the ultimate goal of VA-wide implementation. Veterans who report a history of or current mania or psychosis will be referred to mental health care locally. Patients who report elevated suicide risk will be directed to go to the nearest emergency room.
The study will recruit Veterans from around the nation. Investigators expect that 20% of female Veterans may be eligible. Based on national data, approximately 152,046 female Veterans in the USA are likely to have received care at a VA facility and are within the eligible age range. Centers for Disease Control and Prevention (CDC) data indicate that birth rates per 1000 women is 12.7. As such, about 3,866 female Veterans may be eligible per year. Veterans are eligible throughout the duration of pregnancy and up to 26 weeks postpartum.
Use of the medical record has proved successful in screening and enrolling postpartum Veterans nationwide. Veterans who are noted to be pregnant or postpartum in the VA medical record will be contacted to determine interest and eligibility.
Data will be obtained from the Veterans Health Administration (VHA) Corporate Data Warehouse through the VA Informatics and Computing Infrastructure, which includes pregnancy and postpartum diagnoses by the International Classification of Disease Tenth Revision Clinical Modification (ICD-9 and ICD-10 CM) codes, VHA outpatient visit dates, community care consults and medical services, patient demographics (such as race, ethnicity, date of birth, patient mailing address, and Rural-Urban Commuting Area Codes), and contact information. These data will be stored in a Microsoft Access database on VA servers, and the database will only be accessible to select members of the research team. The data will be imported to Access by a VA employee who does not have access to any participant data following enrollment. Demographic data are expected to be complete due to data being extracted from electronic medical records. All obstetric information will be verified in the screening process to ensure updated information is considered. Oversampling for rural Veterans will be conducted with the hopes of enrolling more rural Veterans (2:1 rural:non-rural Veteran ratio).
Veterans may also be referred through Maternity Care Coordinators (MCCs) or providers at VA medical centers. The MCCs may provide Veterans with the study's contact information or call the study team directly with the Veteran's permission. Veterans may also self-refer to the program by calling the research team or expressing interest via the MomMoodBooster website through the Contact link.
Based on VA medical records that identify a Veteran as being pregnant, Veterans will be mailed a letter detailing the study, and a return letter with prepaid envelope will be provided if the Veteran wishes to decline or express interest. If interest is expressed or if no return letter is received, a member of the research team will follow-up with a phone call to determine interest and answer questions. The study team will wait at least 5 days before following up with a phone call to ensure that the participant received the letter. The study team will call no more than 10 times without a returned phone call. A phone number is included in the letter so that Veterans can call and indicate that the Veteran is not interested in participating. The research team member will tell them about the study prior to screening if the Veteran is interested in being screened.
If interested, Veterans will be screened by phone. First, the study procedures will be reviewed orally. If a Veteran wishes to review the consent document prior to screening, the study team will mail her a copy of the consent form and call her 7 days later to review any questions and screen her if she remains interested. Veterans will be told that participation is entirely a personal choice, and participation has no bearing on healthcare at the VA or elsewhere. If a Veteran is not eligible at first screening, at the Veteran's request, the research team can call her in the future to re-screen, provided that the factor determining ineligibility is dynamic.
The screening will include access to internet/smartphone, less than 50 years of age, the PHQ-9 for depressive symptoms, basic demographic information, contact information, and the M.I.N.I. depression, mania, and psychosis modules. If a Veteran meets criteria (10 or more on the PHQ-9, no history or current mania, no history or current psychosis), a research team member will review the consent document and study procedures with her by phone. If she remains interested, a consent cover letter, consent document (one to sign and one for the Veteran's records), VA form for authorization to audio tape, VA HIPAA form, sociodemographic form, and baseline questionnaires will be mailed to her. Veterans will have until 26 weeks postpartum to consider whether the potential participant want to participate, at the end of which the person will no longer be eligible. Subjects will sign the VA 10-0493 HIPAA authorization form to give permission for access to medical records. Upon receipt of the signed forms and baseline questionnaires, forms will be reviewed by the research team. After completing the baseline assessment, the Veteran will be randomly assigned to condition -- either MMB online only or MMB + phone coaching. Veterans will then be assigned a phone coach. If a Veteran is assigned to MMB online only, the phone coach will call the Veteran for symptom monitoring during weeks 1, 3, and 5 of the intervention and administer the PHQ-9 by phone. If assigned to the phone coaching condition, the phone will call for all six weeks of the program to discuss the online content, and the PHQ-9 will be administered during weeks 1, 3, and 5 as well. Only members of the research team have access to study data, and files have restricted access to only the team members who require access.
The baseline questionnaire includes background and demographic information, the PHQ-9, the IDAS-II for internalizing symptoms, the BADS for behavioral avoidance and activation in depression, the Automatic Thoughts Questionnaire (ATQ) for negative automatic thoughts, the DAS for an individual's perception of the partner relationship, the Childhood Trauma Questionnaire (CTQ) for childhood trauma history, and a screening for military sexual trauma.
The program will be completed in 6-8 weeks. The program tracks use of the program, and this information is necessary for phone coaches to know whether a Veteran has logged in and completed relevant modules. This assists in the personalization of phone coaching calls.
After completion of the program, Veterans are offered the opportunity to complete two booster session modules at 14- and 20-weeks after enrollment. Participants in the MMB + phone coaching condition will receive two additional calls to discuss the booster session content, and Veterans who are in the online intervention only condition will receive two calls to monitor symptoms with the PHQ-9.
At any point in the program, if a Veteran expresses suicidality on the PHQ-9, the Columbia Suicide Severity Risk Scale will be administered by a member of the research team to determine suicide risk. If a Veteran is at high risk, the Veteran will be referred to emergency care. If the Veteran is not at high risk, recommendations will be developed with the Veteran to keep them safe and encourage connection with local providers.
Phone coaches are trainees who receive training and ongoing supervision in the intervention, interviewing, women's mental health, and the research protocol. The maximum number of calls per Veteran is 6 during the MMB portion of the intervention and 2 booster calls following completion of MMB. Duration of the calls is approximately 15-20 minutes. Reminders will be sent via text message about 24 hours prior to the scheduled call. Text messages will contain reminder of an appointment on \[date\] at \[time\] as well as the study phone number for reference if she has questions. Reminders to log into the program may occur via MyHealthEVet or by phone call. Calls will be audio recorded and saved on the University's secure data drive. The calls will be accessible by the research team. Recorded calls will be used for supervisory and training purposes, as well as coding of fidelity and competency.
After completion of the intervention, a follow-up survey will be mailed to the Veteran for completion at 3- and 6-months following enrollment. The follow-up questionnaires include PHQ-9, IDAS, BADS, ATQ, PSOC, DAS-8, and the Program Evaluation Questionnaire. If a Veteran prefers, the questionnaires can be completed by phone with a research team member. All interviews or coaching calls will be audiotaped to ensure fidelity. Veterans who report depressive symptoms in the mild or higher range (10 or more on PHQ-9) at follow-up will be referred to closest local VA for services.
Statistical analyses will compare differences between conditions over time using longitudinal modeling. The model will include condition (MMB, MMB + phone coach). Randomization will be stratified by pregnancy status (pregnant, postpartum).
#Intervention
- BEHAVIORAL : MomMoodBooster
- MomMoodBooster is an empirically validated online intervention for perinatal women.
- BEHAVIORAL : Phone Coaching
- Phone coaching calls occur weekly in conjunction with MomMoodBooster online modules.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Currently pregnant or within 26 weeks postpartum
* 18 - 50 years
* Experiencing elevated depressive symptoms at screening (PHQ-9 score of 10 or more)
* Have access to internet or smartphone
Exclusion Criteria:
* Past or current mania
* Current hypomania
* Past or current psychoses
* Active suicidality
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 44 |
Target Study Title: Pathological Cerebral Venous Drainage System Giving Large Pressure Difference Between Brain and Eye at Upright Posture: a Possible Cause to Normal Tension Glaucoma.
Target Study Description: #Study Description
Brief Summary
The main aim of this study is to determine the trans-laminal cribrosa pressure difference (TLCPD) for normal tension glaucoma (NTG) patients from the brain and the eye in supine, upright and minor head down tilt positions. It is also to investigate the venous drainage system in the same body positions.
Detailed Description
The trans-lamina cribrosa pressure difference (TLCPD), i.e. the difference between the intraocular pressure (IOP) and the intracranial pressure (ICP) has been suggested as a pathophysiological component in glaucoma. The theory is that high TLCPD, either due to elevated IOP or reduced ICP, can cause glaucomatous damage.
Normal tension glaucoma (NTG) patients has been found to have a slightly reduced ICP when measured in horizontal position. However, in a previous study in healthy adult volunteers the investigators have measured TLCPD at supine, sitting and 9 degree head down tilt positions and found that the TLCPD was posture dependent, with the largest difference in the upright position. Since humans are upright approximately two thirds of the day, one can expect that TLCPD in a diurnal perspective is primarily influenced by the ICP in the upright position.
In this study the TLCPD in different positions in patients with NTG will therefore be measured.
The study will be carried out in three parts.
1. TLCPD will be investigated by simultaneous measurements of IOP and ICP. For IOP the Applanation resonance tonometer (ART), developed by our research group, will be used. ART is independent of gravitation and possible to use in all body postures. In this study measurements will be performed in supine, sitting and head down tilt positions. ICP is measured continuously during the period of body position changes with a CELDA lumbar pressure measurement apparatus.
2. Brain and eye MRI investigation will be performed at a 3 Tesla GE scanner with a new generation 32-channels head coil. The images will be used to measure the cross-section area, the blood flow velocity and the flow direction in the jugular veins, as well as the structural properties of the optic nerve and optic nerve head.
3. Ultrasound imaging, using a high-resolution apparatus, will be performed to study the effects of postural changes on the blood flow velocity and the cross-section area of the right and left internal jugular veins and external jugular veins.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Subject has normal tension glaucoma in one or both eyes (glaucomatous optic nerve head and corresponding visual field defects)
* Intraocular pressures before treatment did not exceed 21 mmHg. Occasional measurement up to 24 is accepted.
Exclusion Criteria:
* History of brain disease or brain surgery
* History of other neurologic or ocular disease causing visual field loss
* Use of anticoagulants other than acetylsalicylic acid
* Use of carbonic anhydrase inhibitors
* Previous lumbar puncture
* Claustrophobia
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 45 |
Target Study Title: Efficacy of Post-Surgical Intralesional Injection With Triamcinolone Versus Triamcinolone Plus Fluorouracil in the Treatment of Keloids
Target Study Description: #Study Description
Brief Summary
There have been many modalities utilized in the treatment of keloids of the head and neck, however none have been universally successful. The most widely utilized non-surgical intervention is primary intralesional injection with triamcinolone (TAC) which inhibits the proliferation of fibroblasts, inhibits collagen synthesis, and increases collagenase production, or fluorouracil (5-FU), a potent inhibitor of fibroblast proliferation. Despite the abundance of studies evaluating primary intralesional injection for keloids, there are limited studies available regarding the efficacy of primary surgical excision followed by adjuvant intralesional injection. The proposed study herein would serve to improve the level of evidence and to establish the safety and efficacy of combined intralesional TAC+5FU for keloids following surgical excision.
Detailed Description
This is a single blinded, prospective randomized controlled trial of patients who elect for surgical treatment of keloids at the Center for Facial Plastic and Reconstructive Surgery at Our Lady of the Lake Regional Medical Center (OLOLRMC), a tertiary referral center affiliated with the Louisiana State University Health Sciences Center (LSUHSC) teaching system. Power analysis estimated approximately 134 patients total (67 per group) for 80% power to detect a difference at the 5% confidence level. This is based off of a prior group's study comparing primary intralesional injection with TAC vs TAC+5FU (no surgery). That study showed 39.2% recurrence with TAC vs 17.5% with TAC+5FU.
The patients enrolled in the study will be randomized to one of two arms: surgical excision+TAC or surgical excision+TAC+5FU. Randomization will be performed using a permuted block randomization algorithm (Ex. AABBABABABBABBAA, where A=TAC only group and B=TAC +5FU). All patients will undergo surgical excision of the keloid, either under general anesthesia in the operating room or local anesthesia in the clinic setting depending on patient age and preference. The goal of excision will be complete extra-lesional excision with primary closure. It will be noted if a patient requires intra-lesional excision or additional reconstructive techniques such as advancement flap, skin grafting, or allografting (i.e. Integra). Monofilament sutures will be used preferentially to prevent local inflammatory reaction which can precipitate keloid formation. In group 1 (surgical excision+TAC), all patients will be treated with adjuvant intralesional TAC 40mg/mL 7-10 days post-op and then every 4 weeks for a total of 3 injections. The triamcinolone vial will be obtained from pharmacy and drawn up by the physician prior to injection. In group 2 (surgical excision+TAC+5FU), all patients will be treated with adjuvant intralesional TAC and 5FU at a dose of 0.1mg TAC for every 0.9mg 5FU 7-10 days post-op then every 4 weeks for a total of 3 injections. The mixture of TAC+5FU will be prepared by the pharmacy and delivered to the physician prior to injection. The goal volume of injection for both arms of the study will be 0.1cc per cm2 of scar excised, though any deviations from this and the rationale will be noted.
Assessments will be performed at 3, 6, 9, and 12 months after completion of treatment. At each time point, a member of the study team and patient will complete their respective portion of the Patient and Observer Scar Assessment Scale (POSAS) which has been proven as a reliable and valid method of assessing keloid scars (5). The observer portion of the survey to be completed by the study team assesses vascularity, pigmentation, thickness, pliability, and surface area of the lesion. The patient portion of the survey focuses on the overall cosmetic and functional sequela including pain, itching, color, stiffness, thickness, and irregularity. Patients will also be asked about any side effects experienced. Each portion of the POSAS will be blinded from the study team member and the participant until both have completed the survey at each visit, so that one set of answers will not bias the other. If a patient demonstrates signs of recurrence or return of symptoms, there will be the option for additional injections within the patient's originally designated study arm. However, if early analysis demonstrates the alternative study arm to have superior efficacy, there will be the option to continue injections with the alternative study arm injection.
Data collection will include demographic data such as age, gender, race, and Fitzpatrick skin type, as well as location of the keloid, etiology (trauma, post-surgical, etc.), and prior treatments if any. The size and thickness of each lesion, secondary defect size following adjacent tissue transfer, and amount of adjuvant medication injected during each adjuvant injection will be collected. Data analysis will include overall efficacy as well as stratification by variables such as the location of the lesion, size of the lesion, and prior treatment.
#Intervention
- DRUG : Triamcinolone Injection
- Post surgical injection at site of keloid with TAC for 3 injections
- Other Names :
- TAC
- DRUG : Triamcinolone Injection and 5-fluorouracil injection
- Post surgical injection at site of keloid with TAC and 5FU for 3 injections
- Other Names :
- TAC + 5FU
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Subjects of any age
* Subjects with at least one keloid of any size located in the head and neck region
Exclusion Criteria:
* subjects with comorbidities prohibiting local injection of either TAC or 5FU including pregnancy, lactation, or planning pregnancy.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 46 |
Target Study Title: Effectiveness of Perimenopausal Hormone Therapy in Suppression of Ovulation, Stabilization of Reproductive Hormones and Symptom Control
Target Study Description: #Study Description
Brief Summary
Hormonal treatment of perimenopausal women has frequently utilized oral contraceptive pills (OCPs). Because of their ability to suppress ovulation and establish cycle control, OCPs have become a popular option, and one that is FDA approved for use until menopause. However, use of OCPs in women in their 40's and 50's carries significant cardiovascular risks. Venous thromboembolism risk is 3-6 fold greater in OCP users, and the risk of myocardial infarction (MI) is approximately doubled in OCP users over the age of 40. This occurs at an age where the background population risk of MI begins to increase, such that the absolute number of cases rises substantially. Women with additional risk factors for cardiovascular disease have a much greater risk for MI (6-40-fold) in association with OCPs. There are also large subgroups of midlife women who are not candidates for OCP use, such a smokers and migraineurs. Moreover, the trend towards lower estrogen dosing with OCPs containing 20 micrograms of ethinyl estradiol has not led to a detectable decrease in thromboembolic risk.
Because of their increased potential risks, it is appropriate to seek alternatives to OCPs and to explore lower doses of hormones to relieve perimenopausal symptoms that occur prior to a woman's final menses. Recent evidence indicates that the hypothalamic-pituitary axis of reproductively aging women is more susceptible to suppression by sex steroids that previously believed. It is possible that hormone doses as low as 50 micrograms of transdermal estradiol (TDE) can suppress the hypothalamic-pituitary axis of midlife women. It is also tempting to speculate that the low but measurable circulating doses of levonorgestrel that are present when a woman uses the Mirena intrauterine system (IUS) can contribute to or even independently suppress the hypothalamic-pituitary axis, and reduce the hormonal fluctuations that result in worsening of perimenopausal symptoms. The combination of low dose TDE plus Mirena may therefore confer superior symptom control as well as contraceptive effectiveness, at far less risk.
Detailed Description
The Specific Aims of the present proposal are therefore as follows:
Aim 1: To test the hypothesis that low dose estrogen therapy in concert with the low doses of levonorgestrel that circulate when Mirena is used will suppress ovulation in perimenopausal women.
Aim 2: To examine ovulation rates and symptom control with Mirena alone, and to assess the tolerability of combined estrogen therapy plus the Mirena IUS as a treatment option for symptomatic perimenopausal women.
The proposed pilot study is designed to test the feasibility and tolerability of the proposed regimens: Mirena alone or Mirena plus low-dose TDE in treating symptoms in perimenopausal women and to provide the preliminary data for a larger, comparative effectiveness study of optimal symptom control and provision of long term contraception for midlife women within 5 years of their final menstrual period.
#Intervention
- DRUG : Mirena
- Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
- Other Names :
- IUD
- DRUG : Estradiol
- Topical, .06%, Applied once daily for 50 days.
- Other Names :
- TDE
- DRUG : Placebo Gel
- Topical Gel, Applied once daily for 50 days, Placebo comparator.
- Other Names :
- placebo
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Age 40 <= age <= 52
* History of regular menstrual cycles every 20 <= age <= 35 days in mid-reproductive life (20 <= age <= 35 years)
* At least 1 period within the past 3 months
* BMI less than 35 kg/m2
* Presence of at least one of the following perimenopausal symptoms:
1. Hot flashes (vasomotor symptoms)
2. Cyclical headache, bloating or adverse mood
3. Self-reported poor quality of sleep
Exclusion Criteria:
* Age < 40 years
* Hysterectomy or bilateral oophorectomy
* Cigarette smoking
* Signs or symptoms of restless leg syndrome or sleep apnea
* Any chronic renal or hepatic disease that might interfere with excretion of gonadotropins or sex steroids
* Moderate/vigorous aerobic exercise > 4 hours per week
* Inability to read/write English
* Pregnant Women
* Prisoners
* Decisionally challenged subjects
* Any medical condition that makes use of Topical estradiol or Mirena contraindicated.
* Sex hormone use within the past 30 days
* History of cancer, blood clots or blood clotting disorder
Sex :
FEMALE
Ages :
- Minimum Age : 40 Years
- Maximum Age : 52 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 47 |
Target Study Title: 10 Day Concomitant Versus 14 Day Hybrid Regimen as First Line H. Pylori Eradication Treatment in a High Clarithromycin Resistance Area. A Multicenter Randomized Equivalence Trial
Target Study Description: #Study Description
Brief Summary
10 day concomitant versus 14 day hybrid regimen as first line H. pylori eradication treatment in a high clarithromycin resistance area. A multicenter, randomized, equivalence trial.
Detailed Description
RESEARCH PROTOCOL:
TITLE '10 day concomitant versus 14 day hybrid regimen as first line H. pylori eradication treatment in a high clarithromycin resistance area. A multicenter, randomized, equivalence trial.'
INTRODUCTION
Helicobacter pylori (H. pylori) is a global human pathogen implicated in the pathogenesis of prevalent and serious diseases mainly peptic ulcer disease and gastric malignancy.1 Recent guidelines propose H. pylori eradication every time that it is found with the usual detection methods.2 Successful eradication largely depends on the choice of antibiotics in which the microbe is mostly sensitive.3 Usual first line therapies contained a proton pump inhibitor (PPI) and two antibiotics, clarithromycin with amoxicillin or metronidazole when amoxicillin wasn't indicated.4 Eradication rates have been initially acceptable reaching over 80% in per protocol analyses.5,6 However in late years H. pylori has developed an increasingly high resistance profile which has reached over 20% in most European countries, including ours. As a consequence, eradication rates with triple regimens declined to percentages less than 80% in per protocol analyses.7-9 Currently acceptable schemes include the already known bismouth containing quadruple regimen and the non bismouth quadruples namely concomitant, sequential and hybrid.10,11 In our country the 10 days concomitant regimen presents stable and high eradication rates which are significantly better than the standard triple and sequential regimens of the same duration.12-14 In two recent studies concomitant had a significant advantage over sequential on metronidazole resistant strains as well as on dual resistant to both clarithromycin and metronidazole strains.14,15 The hybrid regimen is the less studied first line regimen in Europe.16 In a recent study, on a Greek population, a 14 days hybrid regimen achieved encouraging results and the only predictive factor for failure has been dual resistance.17 To date there hasn't been any comparative study between 10 days concomitant and 14 days hybrid regimens.16
PURPOSE OF STUDY The investigators designed an equivalence trial between the 10 days concomitant and 14 days hybrid regimens in a Greek population.The investigators primary outcome is to compare total eradication rates between these two regimens in intention to treat and per protocol analyses. Secondary outcomes are to compare eradication rates in respect to genotypic and phenotypic resistance profiles, the effect of antibiotic resistance on therapy, patient's compliance, adverse events and economic evaluation of the two regimens.
PATIENTS - METHODS
Patient selection Patients of 18 years or older with dyspepsia / or iron deficiency anaemia, referring for upper GI endoscopy and found to be infected with H. pylori (positive rapid urease test), naïve to H. pylori eradication treatment, will be invited to participate in the study. Exclusion criteria are: age below 18 years, presence of severe co-morbidities (i.e. liver cirrhosis, renal failure, haematological, neurological, psychiatric, cardiovascular or pulmonary disease), previous gastric surgery, gastric malignancies, Zollinger-Elisson syndrome, known allergy or other contraindications to the study medications, previous H. pylori treatment, use of antibiotics , bismuth salts , NSAIDS or aspirin in the preceding month, use of PPI in the preceding two weeks and not willing to participate in the study. Pregnant or lactating women will also be excluded.
Study Design The study will be prospective. Upper GI endoscopy including two antral biopsies for rapid urease test (CLO-test) will be performed at each patient. In patients tested positive two additional specimens (from the antrum and corpus) will be sent to a reference laboratory for culture and antibiotic susceptibility tests. In cases with indication for histology or equivocal CLO-test results, at least two specimens will be taken from the antrum and corpus respectively, to confirm H. pylori gastritis using haematoxylin-eosin and modified Giemsa staining. In equivocal cases an immunohistochemical method can be used. Patients tested positive by urease test and/or histology will be allocated to either treatment group. Every patient will sign an informed consent in order to participate in the study. Additionally, a careful medical history will be obtained and complete clinical examination performed (including appropriate blood or other tests if indicated) prior to inclusion into the study.
Participants will be randomly assigned, in a 1:1 basis, to one of two treatment groups namely concomitant and hybrid. Randomization will be organized centrally by an independent assistant investigator using a computer-generated randomization method, using a block size of four. This will produce a separate number for each patient sealed in an opaque envelope and kept in his office throughout the study. After obtaining informed consent, the investigators would call the research assistant to open the envelope for the allocated regimen. All data will be inserted in a computer database and elaborated by the participating investigators. The trial is not blinded for patients and recruiting physicians, regarding treatment regimen, as in most randomized controlled H. pylori eradication trials.
Interventions
After the confirmation of H. pylori infection, eligible patients randomly assigned to either concomitant or hybrid treatment group will receive:
* Concomitant for 10 days, including 40 mg of esomeprazole bid, amoxicillin 1g bid, clarithromycin 500mg bid and metronidazole 500mg bid.
* Or Hybrid for 14 days, including 40 mg of esomeprazole bid and amoxicillin 1g bid, for the first 7 days followed by esomeprazole 40mg bid, amoxicillin 1g bid, clarithromycin 500mg bid and metronidazole 500mg bid, for another 7 days.
Esomeprazole will be given before and antibiotics after meals, in both regimens. In the post-treatment period, symptomatic patients will be allowed to use antacids on demand. Antibiotics or other medications interfering with the treatment results will be prohibited during the study period. Efficacy of treatment will be evaluated 4-6 weeks after completion of antibiotic therapy by 13C-urea breath test (13C-UBT) performed according to the standard European protocol. In patients requiring a follow-up endoscopy due to peptic ulcer disease, persisting or recurring symptoms, the diagnostic test of choice will be histological examination of four samples taken, in pairs, from the antrum and from the corpus and stained by modified Giemsa.
Tolerability and adherence Side effects of treatment will be assessed on a structured clinical interview with a specific questionnaire completed immediately after the end of eradication therapy and at the final re-evaluation. During the interview, patients will be asked to grade the severity of each adverse event experienced as 'mild' (transient and well tolerated), 'moderate' (causing discomfort and partially interfering with common everyday activities), or 'severe' (causing considerable interference with patients' daily activities).18 Incapacitating or life-threatening complications will be classified as serious and will be reported to regulatory agency (National Organization of Medicines). Adherence to treatment will be assessed by providing all patients with a pre-structured printed table with all dosages illustrated, asking to tick each time a pill was consumed and bring it back along with any tablet not consumed, for pill counting. In case of discrepancies found between the structured printed table and residual medication, the latter will be taken into account to evaluate patient's adherence. Poor adherence is defined as \<90% of the total medication taken.
Culture and antibiotic susceptibility tests Isolation of clinical H. pylori strains H. pylori clinical strains will be isolated from gastric biopsies. All biopsies will be placed in thioglycollate medium (Oxoid, Basingstoke, UK) and will be sent to the Laboratory of Medical Microbiology (Hellenic Pasteur Institute) for H. pylori isolation within 2-4 hours after endoscopy. Following addition of sterile glass beads, biopsy samples will be vigorously vortexed and 100μl of homogenate will be cultured for up to 7 days, at 37°C under microaerophilic conditions (CampyPak-Plus, Becton-Dickinson, Cockeysville, MD), on Columbia agar plates containing antibiotics (vancomycin 10μg/mL, trimethoprim 10μg/mL, polymyxin B 104 IU/L, amphotericin B 2μg/mL, nalidixic acid 10μg/mL, bacitracin 30μg/mL and fluorocytosine 5μg/mL), supplemented with 8%v/v horse blood and 1% v/v Vitox (Oxoid, Basingstoke, UK). Culture sweeps, as well as individual colonies will be collected and frozen at -80°C, until used.
Antibiotic susceptibility testing Antibiotic susceptibility testing of H. pylori will be performed utilizing E-test strips (BioMerieux, Marcy l'Étoile, France), according to the manufacturer's instructions, on Mueller Hinton agar medium (Beckton Dickinson) supplemented with 10% horse blood. Briefly, agar plates will be freshly prepared and used within 7 days following their preparation. Bacterial inoculum will be prepared from a 1 or 2 day old culture and bacterial suspension will be adjusted to McFarland 3 turbidity (approx. 108 colony forming units-CFU/mL). E-test strips will be applied with sterile forceps to the dried agar surface, following application of the bacterial inoculum and plates will be incubated at 37°C under microaerophilic conditions. Results will be read at 72 hours. MIC clinical breakpoints used to define resistance according to EUCAST will be: clarithromycin (\>0.5 mg/L), levofloxacin (\>1 mg/L), tetracycline (\>1 mg/L), metronidazole (\>8 mg/L) and amoxicillin (\>0.12 mg/L). To detect genotypic resistance to clarithromycin and levofloxacin a real time PCR will be implemented in cultured H. pylori strains.
Sample size calculation The study is designed to prove or reject equivalence between the two eradication regimens under study namely 10 days concomitant and 14 days hybrid (equivalence trial). Based on the results of previous studies eradication rates over 85% in intention to treat and over 90% in per protocol analyses have been found for both regimens.17 According to international statistical rules (FDA) two regimens are considered equivalent when the confidence intervals of the difference between their eradication rates do not exceed 15%. Using the Monte Carlo (500 X 500 runs) simulation system and taken into account that in the existing Greek studies14-16 eradication rates for hybrid regimen are between 86 and 90% in intention to treat analysis we calculated a sample size of 150 patients in each treatment arm (with a 10% drop out rate) in order to get an 80% power in the study.
Statistical analysis Comparisons of proportions will be done using the chi-square test. Continuous non-parametric data will be compared using the t test. Stepwise multivariate logistic regression analysis will be performed to evaluate factors influencing H. pylori eradication in patients who had a final treatment outcome with either concomitant or hybrid therapy.
#Intervention
- DRUG : 10 day concomitant regimen
- 10 Day Concomitant Hp therapy Concomitant for 10 days, including 40 mg of esomeprazole bid, amoxicillin 1g bid, clarithromycin 500mg bid and metronidazole 500mg bid
- Other Names :
- Amoxicillin 1gr bid from day 1 to day 10, Clarithromycin 500mg bid from day 1 to day 10, Metronidazole 500mg bid from day 1 to day 10, Esomeprazole 40mg bid from day 1 to day 10
- DRUG : 14 day hybrid regimen
- 14 Day Hybrid Hp therapy Hybrid for 14 days, including 40 mg of esomeprazole bid and amoxicillin 1g bid, for the first 7 days followed by esomeprazole 40mg bid, amoxicillin 1g bid, clarithromycin 500mg bid and metronidazole 500mg bid, for another 7 days.
- Other Names :
- Amoxicillin 1gr bid from day 1 to day to day 14, Clarithromycin 500mg bid from day 8 to day 14, Metronidazole 500mg bid from day 8 to day 14, Esomeprazole 40mg bidfrom day 1 to day to day 14
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion criteria:
* patients of >= 18 years referring for upper GI endoscopy
* infected with H. pylori (verified with 2 out of 3 tests - rapid urease test, histology, culture)
* without previous H. pylori eradication treatment (naïve)
Exclusion criteria are:
* age below 18 years
* presence of severe co-morbidities (i.e. liver cirrhosis, renal failure, haematological, neurological, psychiatric, cardiovascular or pulmonary disease)
* previous gastric surgery
* gastric malignancies
* Zollinger-Elisson syndrome
* known allergy or other contraindications to the study medications
* previous H. pylori treatment
* use of antibiotics , bismuth salts , NSAIDS or aspirin in the preceding month
* use of PPI in the preceding two weeks
* not willing to participate in the study
* pregnant or lactating women
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 48 |
Target Study Title: Innovative Technology to Improve Patient Adherence to Weight Loss Recommendations
Target Study Description: #Study Description
Brief Summary
The proposed project addresses the significant problem of obesity and uses innovative technology to improve adherence to a behavioral weight loss strategies. If the program is effective, it would provide an outstanding resource for physicians to use with their patients and thus would have tremendous clinical impact.
Detailed Description
Overweight/obesity is a major health problem that affects over two-thirds of Americans, increases morbidity and mortality and has annual medical costs exceeding $75 billion. Although many Americans indicate that they are trying to lose weight, adherence to weight loss regimens is often poor. Programs are needed that can improve adherence and weight loss for overweight/obese individuals. Physicians play an important role in motivating patients to improve health behaviors and recent reviews suggest that having physicians advise patients to lose weight and then referring patients to an effective program produces the best behavior change and maintenance. The problem, however, is that physicians currently have limited options for such referrals. The challenge for the field is to develop a program to which physicians can refer their overweight/obese patients. The program must be low cost, easily accessible, and must promote adherence to the weight loss regimen and consequently improve weight loss outcomes.
The goal of this Challenge Grant application is to develop and test an innovative web-based program that would provide an accessible and effective approach to enhancing adherence to clinical recommendations for weight loss. If effective, the program would provide an outstanding resource for physicians and their patients and could consequently have important clinical and public health impact.
We propose to develop a program based on our prior research that uses innovative Internet technology to provide a low cost, easily disseminated program that captures two critical elements of effective behavioral weight loss programs-namely, training in key behavioral weight control strategies and increased participant accountability. Patients, referred by their physician for weight loss, will be offered a 12 week program that they can view at their convenience on their computer. The program will use Web-based interactive multi-media approaches for presentation of the behavioral skills and provide a Web-based form for submission of self-monitoring and weight data; to maximize patient accountability, the program will include a system of automated feedback for participants, which comments on their weight loss to date and their performance within several behavioral weight-loss domains, with suggestions tailored to the characteristics and performance of the individual. Periodic reports on the patients' progress will also be sent to the referring physician. We will test this program in a randomized trial with 250 patients referred by their physicians who will be randomly assigned to either Internet Education (Control) (N=125) or to the Innovative Technology program (N=125). Participants in both groups will receive a 12 week Internet program of either basic weight loss education or the Innovative Technology program and will be weighed at the start and end of the 3 month program and at 3 month follow-up. The primary hypothesis is that patients who are assigned to the Innovative Technology program will achieve larger average weight losses than those in the control group over the 12-week program. Secondary hypotheses are that the Innovative technology group will adhere better over the 12-weeks (assessed by log-ins to the web site and self-reported changes in diet and activity) and achieve better weight losses at 6 months than the control group.
The proposed project addresses the significant problem of obesity and uses innovative technology to improve adherence to a behavioral weight loss strategies. If the program is effective, it would provide an outstanding resource for physicians to use with their patients and thus would have tremendous clinical impact.
#Intervention
- BEHAVIORAL : Diet and Activity Education
- Education about behavioral modification of eating and activity habits for weight loss.
- BEHAVIORAL : Self-monitoring with Feedback
- Participants self-monitor diet and activity behaviors, which are submitted via a website. Automated feedback on the self-monitoring record is provided to participants.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* BMI between 25 and 45 kg/m2
* Referred by their physician because of an obesity-related co-morbidity, such as diabetes, hypertension or metabolic syndrome
* All ethnic groups will be recruited
* No health problems that make weight loss or unsupervised exercise unsafe
* English speaking
* Have access to a computer and the Internet
Exclusion Criteria:
* report a heart condition, chest pain during periods of activity or rest, or loss of consciousness
* are currently pregnant or intend to become pregnant in the next 12 months
* are planning to move outside of the state within the next 12 months
* have participated in a study conducted by the Weight Control & Diabetes Research Center in the past 2 years
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 49 |
Target Study Title: Efficacy, Safety and Efficiency of the nMARQ Pulmonary Vein Isolation System in the Treatment of Paroxysmal Atrial Fibrillation - A Pilot Study
Target Study Description: #Study Description
Brief Summary
This is a pilot study designed to investigate the effectiveness of the nMARQ Pulmonary Vein Isolation system in the treatment of Paroxysmal Atrial Fibrillation (AF) at different ablation settings.
AF is a common condition which causes a fast and erratic heartbeat. There are estimated to be 50,000 new cases diagnosed per year in the UK. The fast heart beat can cause symptoms such as palpitations, lightheadedness, chest pains, shortness of breath and fatigue.
Catheter ablation is a technique used for the control of AF. In this procedure a catheter (a long thin wire) is passed into the chambers of the heart via a large blood vessel in a leg. The tip of the catheter can destroy tiny sections of heart tissue that may be the source or trigger of the abnormal electrical impulses. One of the challenges of AF ablation is to maximize success rates, as such there is currently rapid advances in technology to carry out this procedure.
Different catheters exist which deliver this energy in different ways. This study uses one such system to perform this procedure. It is called the nMARQ system for Pulmonary Vein Isolation produced by Biosense Webster. Currently this system is used in practice in the UK for patients with this medical condition.
What we seek to research is when ablating what is the optimum setting to perform ablation at. There is currently no data to guide best clinical practice in this area.
Detailed Description
This is a pilot study designed to investigate the use of the nMARQ Pulmonary Vein Isolation system in the treatment of Paroxysmal Atrial Fibrillation (AF) at different ablation settings.
At least one month prior to the ablation procedure, an Implanted Loop Recorder (ILR) (the REVEAL XT) will be implanted into the patient for robust, continuous, long term monitoring of the burden of arrhythmia following the case.
It has been decided to use continuous implanted rhythm monitors to allow for robust complete data capture of arrhythmia recurrence and burden with little impact to the patient after implantation. These are increasingly being used in the follow up of patients undergoing AF ablation. They give a continuous data feed showing the presence and quantity of abnormal rhythm seen after ablation. Their use has been approved in the follow up of AF ablation procedures within recent consensus guidelines formulated by the American College of Cardiology, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, and the Heart Rhythm Society. There are several papers showing the validation of data collected by the REVEAL XT ILR and the benefit of continuous monitoring versus conventional methods of intermittent ambulatory ECGs.
The settings chosen for ablation are guided both by preclinical data collected by Biosense Webster and also the settings being used clinically worldwide when utilising this system. It has been decided to have a two by two study design varying the wattages 20W and 25W and also varying the time periods per lesion 20 seconds and 40 seconds.
We feel that this project can be carried out as a pilot study to potentially inform further research. There is very little clinical data published on how best to use of this device. At present it is left to individual clinicians to form their own 'best practise' when choosing ablation settings. We seek to formalise the potential ablation variables into a structured format that will allow for comparisons to be drawn at the end of the study and to form the basis of future research.
Following the current pathway, patients are admitted 24 hours prior to their treatment for further, standard, tests (including an Echo TOE and pregnancy test); at this point patients will be randomised to one of the arms of the trial, at an equal 1:1:1:1 ratio. As the study is ' unblinded ' and the procedure constitute standard care in the NHS , it would be at this point that the participant and Consultant have time to discuss the impact of the setting that the participant has been randomised to, thereby reducing any anxiety on the day of the procedure.
The following day, the procedure would be carried according to standard treatment and following national guidelines using one of the ablation presets as per randomisation.
Within the UK it is standard practice to have a follow-up visit at 6 weeks, 3 months, 6 months and 12 months. At each visit, in addition to the standard tests, the patient and Consultant would complete questionnaires.
After one year the patient will attend for removal of the ILR unless it is deemed to have clinical use for them.
Recruitment and Consent Our target population will be patients who would routinely be having catheter ablation of their AF. They will have the kind of AF that comes and goes and will be troubled symptomatically by it. This research study has been constructed around a patients' normal care pathway, minimising the need for additional visits or activities.
Risks, burdens and benefits Potential risks and burden of participation in the study centre on the use of the ILR for rhythm recording both before and after the ablation procedure. This device is small and implantation is a minor day case procedure done under local anaesthetic. The risk of implantation is very small. Its use in the follow up after AF ablation is endorsed by international clinical guidelines and backed up by scientific data. The use of the ILR after AF ablation is becoming more commonplace and if anything is constrained by financial issues in the NHS rather than any ethical considerations about the risks or burdens of implantation.
Potential benefit to the participant also involves the ILR. By having a continuous monitor of heart rhythm after ablation the consultant has information that can guide clinical management decision making after the ablation occurs. In clinical practise, without the ILR in place, the patient would otherwise have to undergo a number of ambulatory ECG monitors periodically throughout the follow up period
#Intervention
- PROCEDURE : ablation
- Ablation ranging from 20-25 watts / 30-45 seconds
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* 18 <= age <= 80 years
* Symptomatic Paroxysmal Atrial Fibrillation
* Drug refractory to one or more antiarrhythmic medication
* 1st Procedure for Patients
* LA <5.5cm (TTE)
Exclusion Criteria:
* LV EF <30%
* Patient with correctable cause of AF
* Previous cardiac surgery
* History of previous CVA
* Pregnancy
* Smoke or LAA thrombus seen in LA on pre-procedural TOE
* Sub-therapeutic warfarinisation
* Contraindication to formal anticoagulation
* Life expectancy less than 365 days (12 months).
* Enrolment in an investigational study evaluating another device or drug
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 50 |
Target Study Title: Impact of Oropharyngeal Administration of Mother's Milk Prior to Gavage Feeding on Hospital Acquired Neonatal Infection
Target Study Description: #Study Description
Brief Summary
The protective effect of mother's milk and colostrum on oropharyngeal cavity is not achievable with gavage feeding. This may be increase the risk of colonization of the oropharyngeal cavity with pathogenic bacteria and subsequent increase in the risk of neonatal sepsis. We aim to study the impact of Oropharyngeal Administration of Mother's Milk (OPAMM) before gavage feeding on clinical outcome, bacterial colonization of the GIT of preterm infants with pathogenic bacteria. We also aim to study the immune-protective effect of OPAMM on the incidence of nosocomial sepsis.
Detailed Description
Preterm, very low Birth Weight (VLBW), infants are at increased risk of feeding intolerance as they have shorter GIT with lower digestive, absorptive and motility capabilities than those of full term infants. Intolerance to enteral feeding has been associated with abdominal distention, initiation of an inflammatory cascade, edema of the bowel, and subsequent development of necrotizing enterocolitis (NEC).
Oral feeding is the best and physiologic method for enteral nutrition of preterm infants. However, because of immaturity of suckling reflex and poor coordination between suckling and swallowing, gavage (oro-gastric or nasogastric tube feeding) has been used as an alternative method of enteral nutrition in preterm infants.
The gut of preterm infants is frequently colonized with pathogenic bacteria due to prematurity, increase gut mucosal permeability, delayed initiation of feeding, formula feeding, and frequent use of antibiotics. This pathogenic bacteria increase the chance of development of nosocomial acquired sepsis and NEC.
Mother's milk, particularly colostrum, is rich in cytokines and other immune agents that provide bacteriostatic, bacteriocidal, antiviral, anti-inflammatory and immunomodulatory protective agents against infection. Thus early gut priming and initiation of enteral feeding of preterm infants with mother's colostrum and milk decrease pathogenic bacterial colonization and subsequent development of sepsis and NEC.
During breast feeding, mother's milk comes in contact with the mouth and oro-pharyngeal pouch which, theoretically, stimulate both oropharyngeal receptors that improves the motility, secretory and absorptive ability of the GIT. Furthermore, anti-inflammatory and pro inflammatory cytokines, which are present abundantly in mother's colostrum and milk, may exert an immuno-protective effect when they come in contact with oropharyngeal as well as GIT mucosa.
We aim to study the impact of Oropharyngeal Administration of Mother's Milk (OPAMM) before gavage feeding on clinical outcome, bacterial colonization of the GIT of preterm infants with pathogenic bacteria. We also aim to study the immune-protective effect of OPAMM on the incidence of nosocomial sepsis.
#Intervention
- PROCEDURE : Oropharyngeal Administration of Mother's Milk (OPAMM)
- 0.2 ml of own mother's milk will be given by dropper to the oro-pharyngeal pouch, tongue and cheeks and the remaining amount will be given by the regular gavage feeding on intervals and amount regulated by the feeding protocol
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Preterm infants delivered at less than 32 weeks gestation and less than 1500 grams birth weight will be included in the study
Exclusion Criteria:
* Preterm infants < 32 weeks gestation unable to be fed on own mothers' colostrum or milk.
* Preterm infants with major congenital anomalies or chromosomal abnormalities.
* Preterm infants delivered to mothers with confirmed chorioamnionitis
* Preterm infants with confirmed early onset sepsis.
Sex :
ALL
Ages :
- Minimum Age : 1 Day
- Maximum Age : 90 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 51 |
Target Study Title: The Analgesic Effect of Qudratus Lomborum Block II Type After Robotic-Assisted Laparoscopic Radical Prostatectomy.
Target Study Description: #Study Description
Brief Summary
The analgesic effects of Quadratus Lomborum Block II type after robotic-assisted laparoscopic radical prostatectomy, will be assessed.
Detailed Description
Quadratus Lomborum Block II type will be performed before performing robotic-assisted laparoscopic radical prostatectomy.
The post-operative analgesic effect will be assessed, by using Numeric Rate Scale for pain.
The pain assessment will be evaluated during the first 24 hours from surgery. The opioids requirement and side effects will be also assessed.
#Intervention
- OTHER : Levobupivacaine in QLB II
- Quadratus Lomborum Block II type will be performed by injecting levobupivacaine 0.375% 20 ml between latissimus dorsi and quadratus lomborum muscle.
- Other Names :
- Quadratus Lomborum Block II type
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiologist status I-III
* Written informed consent
Exclusion Criteria:
* Body mass Index > 35 kg/m2
* Allergies to local anesthetics
* primaries or secondaries coagulopathies
* addiction to drugs
* severe kidney and liver diseases
* cognitive impairment
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 52 |
Target Study Title: Beijing Tiantan Hospital,Capital Medical University.
Target Study Description: #Study Description
Brief Summary
Objective: To investigate the relationship between Helicobacter pylori (Hp) infection and the prognosis of acute coronary syndrome (ACS) in a Chinese population and to explore the significance of Hp eradication therapy in preventing major adverse cardiac events (MACE) and upper gastrointestinal bleeding (UGIB) in patients on dual antiplatelet treatment. Methods: To analyze 472 ACS patients with drug-eluting stent (DES) implantation from January 1, 2008 to December 31, 2010 in the department of cardiology at Beijing Mentougou District Hospital. Patients were divided into three groups: Group 1, the Hp-negative patients (Hp-); Group 2, the Hp-positive patients with eradication therapy (Hp+ Therapy); and Group 3, the Hp-positive patients without eradication therapy (Hp+ No Therapy). All patients took 13C urea breath test, high sensitive C-reactive protein (hs-CRP)，homocysteine (HCY) and other biochemical indicators. The investigators explored the correlations of Hp eradication therapy with MACE (including recurrent myocardial infarction, revascularization and death) and UGIB after 3 to 5 years of follow-up using survival analysis.
Detailed Description
This study is a single-center and random analysis. The consecutive hospitalized patients with ACS at Beijing Mentougou District Hospital from January 1, 2008 to December 31, 2010 were enrolled. Figure 1 is a flow diagram of the trial. There were 259 males (54.9%) and 213 females (45.1%) with an average age of 61.1 ± 11.0 years. Patient's history, physical examination, and laboratory results were recorded. All patients were divided into the Hp-negative group (Hp-, group 1.) and the Hp-positive group (Hp+). The Hp+ group were randomly divided into two groups: Group 2, the Hp+ with eradication therapy (Hp+ Therapy); and Group 3, the Hp+ without eradication therapy (Hp+No Therapy).
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Patients were diagnosed acute coronary syndrome according to the 2012 ESC guidlines.
* All the patients took dual antiplatelet therapy after implanting drug eluting stent (DES) during hospitalization and had no any digestive symptoms.
Exclusion Criteria:
* Subjects who had suffered gastrointestinal bleeding within one week.
* Subjects had a history of gastrectomy, cardiac insufficiency, thyroid dysfunction, and any ongoing infections were eliminated.
* Patients with the use of antibiotics, bismuth, or sucralfate within one month and without impanting DES because of ACS during hospitalization were also excluded.
* Those who had gastrointestinal symptoms, such as acid reflux, heartburn, nausea, vomiting, stomach ache and diarrhea, or had a confirmed peptic ulcer with Hp infection were excluded because these patients may be taken gastroenterology treatment.
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Maximum Age : 73 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 53 |
Target Study Title: Targeting Inflammation in Type 2 Diabetes: Clinical Trial Using Salsalate
Target Study Description: #Study Description
Brief Summary
Growing evidence over recent years supports a potential role for low grade chronic inflammation in the pathogenesis of insulin resistance and type 2 diabetes. In this study we will determine whether salsalate, a member of the commonly used Non-Steroidal Anti-Inflammatory Drug (NSAID) class, is effective in lowering sugars in patients with type 2 diabetes. The study will determine whether salicylates represent a new pharmacological option for diabetes management. The study is conducted in two stages. Enrollment in the first stage is complete. The primary objective of the first stage was to select a dose of salsalate that is both well-tolerated and demonstrates a trend toward improvement in glycemic control. The primary objective of Stage 2 of the study is to evaluate the effects of salsalate on blood sugar control in diabetes; the tolerability of salsalate use in patients with type 2 diabetes (T2D); and the effects of salsalate on measures of inflammation, the metabolic syndrome, and cardiac risk.
#Intervention
- DRUG : Salsalate
- Salsalate 3.5 g/d orally, divided dosing
- Other Names :
- disalsid
- DRUG : Salsalate Placebo
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes on diet and exercise therapy or monotherapy with metformin, insulin secretagogue (including SFU, non-SFU, and dipeptidyl peptidase IV (DPP-4) inhibitors), alpha-glucosidase inhibitors, or bile acid sequestrants (dosed once per day such that study drug can be administered >= 4 hours prior to sequestrant); or a combination of up to two of these at maximal dose. Dosing must be stable for 8 weeks prior to screening. Participant must have been diagnosed with T2D at least 8 weeks before screening.
* FPG <= 225 mg/dL and HbA1c>=7% and <= 9.5% at screening.
* Age >=18 and <75
* Women of childbearing potential agree to use an appropriate contraceptive method (hormonal, IUD, or diaphragm)
Exclusion Criteria:
* No prior participation in Stage I of TINSAL-T2D ; exception: a participant who failed screening for HbA1c in Stage I will be allowed to re-screen for Stage II.
* Type 1 diabetes and/or history of ketoacidosis determined by medical history
* History of severe diabetic neuropathy including autonomic neuropathy, gastroparesis or lower limb ulceration or amputation
* History of long-term therapy with insulin (>30 days) within the last year
* Therapy with rosiglitazone (Avandia) or pioglitazone (Actos), alone or in combination in the previous 6 months; or exendin-4 (Byetta), alone or in combination in the previous 3 months
* Pregnancy or lactation
* Patients requiring oral corticosteroids within 3 months or recurrent continuous oral corticosteroid treatment (more than 2 weeks)
* Use of weight loss drugs [e.g., Xenical (orlistat), Meridia (sibutramine), Acutrim (phenylpropanol-amine), or similar over-the-counter medications] within 3 months of screening or intentional weight loss of >= 10 lbs in the previous 6 months
* Surgery within 30 days prior to screening
* Serum creatinine >1.4 for women and >1.5 for men or eGFR <60 [possible chronic kidney disease stage 3 or greater calculated using the Modification of Diet in Renal Disease (MDRD) equation
* History of chronic liver disease including hepatitis B or C
* History of peptic ulcer or endoscopy demonstrated gastritis
* History of acquired immune deficiency syndrome or human immunodeficiency virus (HIV)
* History of malignancy, except participants who have been disease-free for greater than 10 years, or whose only malignancy has been basal or squamous cell skin carcinoma
* New York Heart Association Class III or IV cardiac status or hospitalization for congestive heart failure
* History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack or any revascularization within 6 months
* Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg or diastolic blood pressure >95 mmHg on three or more assessments on more than one day). If on blood pressure medications, dosing should be stable for 2 weeks prior to randomization.
* History of drug or alcohol abuse, or current weekly alcohol consumption >10 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed DCCktail containing 1 ounce of alcohol)
* Hemoglobin <12 g/dL (males), <10 g/dL (females) at screening*
* Platelets <100,000 cu mm at screening
* AST (SGOT) >2.50 x ULN or ALT (SGPT) >2.50 x ULN at screening
* Total Bilirubin >1.50 x ULN at screening
* Triglycerides (TG) >500 mg/dL at screening
* Poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study
* Previous allergy to aspirin
* Chronic or continuous use (daily for more than 7 days) of nonsteroidal anti-inflammatory drugs within the preceding 2 months
* Use of warfarin (Coumadin), clopidogrel (Plavix), dipyridamole (Persantine), heparin or other anticoagulants
* Use of probenecid (Benemid, probalan), sulfinpyrazone (Anturane) or other uricosuric agents
* Macroalbuminuria, defined as spot urine protein >300 mcg/mg Cr at screening
* Pre-existing chronic tinnitus
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 54 |
Target Study Title: An Open-Label, Phase 1 Study of the Safety and Immunogenicity of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Subjects With Metastatic Castration-resistant Prostate Cancer
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to find and evaluate the recommended Phase 2 dose (RP2D) of JNJ-64041809, a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in which two virulence genes, which encode molecules that help cause disease, have been removed) when administered intravenously to participants with metastatic castration-resistant prostate cancer (mCRPC).
Detailed Description
This is a first-in-human (FIH), Phase 1, open-label, multicenter and 2-part study. The Part 1 of study will be Dose Escalation phase to determine the recommended Phase 2 dose (RP2D) based on safety and pharmacodynamic assessments and Part 2 will be Dose Expansion Phase to evaluate 2 expansion cohorts (Cohort 2A and 2B) after the RP2D for JNJ-64041809 is determined in Part 1. The study will consist of a Screening Period (from signing of informed consent until immediately before the first dose), an open-label Treatment Period (from the first dose of study drug until the End-of-Treatment Visit); and a Post treatment Follow-up Period (after the End-of Treatment Visit until study discontinuation). Participants will be primarily evaluated for RP2D. Participants safety will be evaluated throughout the study.
#Intervention
- BIOLOGICAL : JNJ-64041809 (Cohort 1A and 1B)
- JNJ-64041809 will be administered IV at a lower dose in Cohort 1A (1x10\^8 colony forming units \[CFU\]) and at a higher dose in Cohort 1B (1x10\^9 CFU).
- BIOLOGICAL : JNJ-64041809 (Cohort 2A and 2B)
- JNJ-64041809 will be administered intravenously (IV) once every 21 days at the recommended dose as determined in Cohort 1A or 1B.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate with progressive metastatic disease which, in the opinion of the investigator, requires initiation of new treatment. The assessment of disease progression can be based on either PSA rise, new or progressive soft tissue disease (based on computed tomography [CT] or magnetic resonance imaging [MRI] scans), or new or progressive bony disease based on radionuclide bone scan or 18F-sodium fluoride positron emission tomography/computed tomography [NaF PET/CT] scans). Participants being considered for Cohort 2B must, in addition, have primary or metastatic lesions amenable to tumor biopsies
* Must have received at least 2 prior approved therapies
* Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone analog or inhibitor, or orchiectomy (surgical or medical castration)
* Serum testosterone levels less than (<) 50 nanogram per deciliter (ng/dL) determined within 4 weeks prior to start of study drug
* For participants previously treated with first generation anti-androgens (ie, flutamide, nilutamide, or bicalutamide), discontinuation of flutamide or nilutamide therapy must occur greater than (>) 4 weeks (>6 weeks for bicalutamide) prior to start of study drug with no evidence of an anti-androgen withdrawal response (no decline in serum PSA)
Exclusion Criteria:
* Untreated brain metastases. Participants must have completed treatment for brain metastasis, and be neurologically stable off steroids, for at least 28 days prior to first dose of study drug
* Untreated spinal cord compression
* History of listeriosis or vaccination with a listeria-based vaccine or prophylactic vaccine (example influenza, pneumococcal, diphtheria, tetanus, and pertussis [dTP/dTAP]) within 28 days of study treatment
* Known allergy to both penicillin and trimethoprim/sulfamethoxazole. Participants who are allergic to only one of these antibiotics are allowed to enroll
* Concurrent treatment with anti -Tumor necrosis factor (TNF) alpha therapies, systemic corticosteroids (prednisone dose >10 mg per day or equivalent) or other immune suppressive drugs within the 2 weeks prior to Screening. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 55 |
Target Study Title: A Pilot Study of a Novel Ad Libitum Plant-Based Behavioral Weight Loss Treatment
Target Study Description: #Study Description
Brief Summary
Many individuals do not achieve clinically significant weight loss following traditional lifestyle modification interventions, potentially because weight loss is dependent upon calorie tracking compliance (to achieve calorie prescriptions), which decreases over time for most. By contrast, non-energy-restricted whole food plant-based diets (WFPBD) have been demonstrated to promote clinically significant weight loss even without calorie prescriptions. The present pilot trial represents the first, to the knowledge of our study team, to empirically test a remotely delivered WFPBD behavioral weight loss intervention for adults with overweight or obesity. Over 12-weeks, participants (N = 21) will follow a non-energy-restricted WFPBD and received nutritional counseling and behavioral weight loss intervention. Participation will occur in two phases (Phase 1: n = 7; Phase 2: n = 14), between which iterative changes to the intervention will be made. Assessments will occur at baseline, mid-treatment, post-treatment, and 3-month follow-up. Data will be analyzed using an intent-to-treat approach. The primary aims of the study will be to assess retention feasibility and acceptability. The secondary aims will be to evaluate the preliminary effectiveness of the intervention on: (1) percent weight loss; (2) dietary intake (i.e., increased intake of low-fat plant-based whole foods and decreased in intake of processed foods and animal products); and (3) waist circumference. The exploratory aims will be to evaluate the preliminary effectiveness of the intervention on physical- and mental health-related quality of life, and to examine potential moderators of treatment success (plant-based diet history, internal disinhibition, social support vs. social sabotage, self-compassion, and psychological flexibility).
#Intervention
- BEHAVIORAL : Whole Food Plant-Based Behavioral Weight Loss Treatment
- Over the course of 12-weeks, participants will be prescribed a non-energy-restricted whole food plant-based diet and will learn behavioral weight loss strategies through an e-learning platform. Each week, participants will also complete a 15-minute coaching call to provide positive reinforcement and problem-solving support.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Aged 18 <= age <= 75
* Current BMI >= 25 kg/m2
* Reporting a desire to lose weight
* Have at-home internet access
* Proficiency in speaking, reading, and writing English
* Willing to consume a whole foods plant-based diet for the study duration
Exclusion Criteria:
* Use of medications for weight loss
* Recent weight loss (>=5% weight loss in prior 3-months)
* Current or planned pregnancy within the study period
* History of bariatric surgery
* Currently following a low-fat plant-based diet
* Diagnosis of a serious medical condition influencing weight, appetite, or eating behavior
* Diagnosis of a serious psychiatric condition that may influence weight, appetite, or eating behavior
* Current substance use disorder
* Participation in a concurrent weight loss program
* Planning on quitting smoking over the intervention period (if current smoker)
* Eating pathology (lifetime history of an eating disorder, >= 9 binge eating episodes in the past 3 months, or > 5 compensatory episodes in the past 3 months)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 56 |
Target Study Title: Phase I Trial of Targeted Atomic Nano-Generators (Actinium-225-Labeled Humanized Anti-CD33 Monoclonal Antibody HuM195) in Patients With Advanced Myeloid Malignancies
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to find a safe dose of actinium-225 when it is labeled to HuM195. This will be done with a 'phase I trial,' in which a preset schedule of doses gets more powerful for each new group of patients as the trial progresses. If too many serious side effects are seen with a certain dose, no one will be treated with a higher dose, and some additional patients may be treated with a lower dose to make sure that this dose is safe. The starting dose of actinium-225 in this study is less than doses that are known to be safe in animals.
Antibodies are proteins that are produced by the immune system and help the body to fight foreign substances, such as bacteria or viruses. HuM195 was made by putting human leukemia cells into mice. Most of the mouse parts of this antibody were replaced with human parts. Only the part of the antibody that binds to the leukemia cells was kept from the mouse. HuM195 attaches to leukemia cells but does not attach to most normal cells. It can kill small amounts of disease by identifying the leukemia cells as 'foreign.' HuM195 has worked less well against large amounts of leukemia since the normal immune cells needed to kill leukemia cells are lowered in most patients with leukemia.
#Intervention
- BIOLOGICAL : ACTINIUM-225-LABELED HUMANIZED ANTI-CD33 MONOCLONAL ANTIBODY HuM195
- A single infusion of 225Ac-HuM195 will be administered at a starting dose of 0.5 μCi/kg. Additionally, 100 mCi of 213Bi-HuM195 have been administered with full dose cytarabine (200 mg/m2 daily for 5 days) without dose-limiting toxicity.Serial sampling of blood, urine, and bone marrow will be performed following treatment to determine the toxicity, pharmacokinetics, immunogenicity, and antileukemic effects. Three to six patients will be treated at each dose level. Dose escalation will proceed if less than 33% of patients in a cohort experience dose-limiting toxicity.Patients will be followed until completion of therapy as outlined in the study, loss to follow-up, death, or until the day the patient is removed from the study.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have one of the following pathologically confirmed diagnoses:
* AML in relapse,
* AML refractory to at least 2 courses of standard induction chemotherapy or one course of high-dose cytarabine-containing induction chemotherapy,
* CML in accelerated phase or myeloid blast crisis that has progressed after treatment with imatinib and a second generation tyrosine kinase inhibitor (e.g., dasatinib or nilotinib)
* RAEB with International Prognostic Scoring System (IPSS) score >= 2.5, or - CMMOL with IPSS score >= 2.5 refractory to or relapsed after a hypomethylating agent (e.g., azacitidine or decitabine) refractory to or relapsed after a hypomethylating agent (e.g., azacitidine or decitabine).
* Greater than 25% of bone marrow blasts must be CD33 positive.
* Patients must have a life expectancy of at least 6 weeks and a Karnofsky performance status of >= 60%.
* Adequate renal function as demonstrated by a serum creatinine <= 1.5 mg/dl, a creatinine clearance > 60 ml/min, and < 1 gram urinary protein/24 hours.
* Adequate hepatic function as demonstrated by a bilirubin <= 1.5 mg/dl (unless attributable to leukemia or Gilbert's disease) and alkaline phosphatase and AST <= 2.5 times the upper limit of normal.
Exclusion Criteria:
* Untreated AML, regardless of prognostic features.
* Treatment with chemotherapy or biologic therapy within 3 weeks of 225Ac- HuM195 administration. Hydroxyurea is permitted but must be discontinued prior to treatment on study. Patients must have recovered from the effects of previous treatment.
* Treatment with radiation therapy within 6 weeks of 225Ac-HuM195 administration. Patients must have recovered from the effects of previous treatment.
* Active serious infections not controlled by antibiotics.
* Pregnant women or women who are breast-feeding.
* Concurrent active malignancy requiring therapy.
* Clinically significant cardiac disease (NY Heart Association Class III or IV)or pulmonary disease.
* Patients with HLA-compatible donor bone marrow who are immediate candidates for bone marrow transplantation.
* Patients who are candidates for alternative treatments of known effectiveness.
* Patients eligible for protocols of higher priority.
* Patients previously treated with any monoclonal antibody for any reason.
* Active CNS leukemia
* Other serious or life-threatening conditions deemed unacceptable by the principal investigator.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 57 |
Target Study Title: Diet Treatment of Patients With Ulcerative Colitis in Remission
Target Study Description: #Study Description
Brief Summary
The study examines the effect of a low FODMAP diet in patients with UC in remission but still having GI symptoms (IBS in IBD). 15 patients will be on watchful waiting. 15 patients will be on low FODMAP diet. 15 patients with recieve FODMAPs in their diet.
Detailed Description
Patients are randomized to either standard care, low FODMAP diet or a normal FODMAP diet. Run-in on a low FODMAP diet, thereafter parallel design where one arm is assign a blinded food supplement with low FODMAP content and the other arm is assigned a blinded food supplement containing FODMAP. A control group is 'watchful waiting'.
Symptom reports, blood, and fecal samples are collected.
#Intervention
- DIETARY_SUPPLEMENT : Low FODMAP
- Blinded food supplements containing only items with a low content of FODMAPs
- DIETARY_SUPPLEMENT : Standardized FODMAP
- Blinded food supplements containing FODMAPs
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Colitis ulcerosa in remission (calciprotectin<200 and normal sigmoidoscopy)
* ROM IV criteria fullfilled
* Stable medical therapy
Exclusion Criteria:
* Intake of a low FODMAP diet within the past 6 weeks prior to baseline
* Atypical colitis ulcerosa primarily right sided disease and calciprotectin >50 unless normal sigmoidoscopy
* If diarrhea: Clostridium difficile infection
* Lactose intolerance
* Systemisk or local treatment for CU other than 5-aminosalicylicacid or biological therapy
* Antibiotics within 6 weeks
* Pregnancy
* Activity in UC
* Coeliac disease
* Abnormal transglutaminase
* Eating disorder
* Special diet preventing the low FODMAP diet
* Other GI disease or other disease explaining symptoms
* Medication intake explaining symptoms
* Not able to follow protocol
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 58 |
Target Study Title: Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation
Target Study Description: #Study Description
Brief Summary
The objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation
Detailed Description
Many efforts have been made to prevent residual hearing loss after cochlear implantation, such as the development of soft surgical techniques and pharmacological protection.
In this study we investigate whether the topical application of dexamethasone and hyaluronic acid prevents residual hearing loss.
#Intervention
- DEVICE : Cochlear Implantation
- Cochlear implantation using Hybrid L24 Implant
- Other Names :
- Hybrid L24 Implant
- DRUG : Cochlear Implantation+dexamethasone
- Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window
- Other Names :
- Hybrid L24 Implant, Dexamethasone (4mg/ml)
- DRUG : Cochlear Implantation+dexamethasone+hyaluronic acid
- Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window and hyaluronic acid (10mg/ml) in the electrode array
- Other Names :
- Hybrid L24 Implant, Dexamethasone (4mg/ml), Hyaluronic acid (10mg/ml)
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Adults (greater than 18 years) with severe/profound, bilateral sensorineural hearing loss with indication of cochlear implantation.
* Hearing thresholds better than 80 dB in 125 Hz, 90 dB in 250Hz and 100 dB in 500, 1000, 2000, 3000 and 4000 Hz in at least 3 of these frequencies
Exclusion Criteria:
* Malformation or cochlear ossification
* Developmental Disabilities
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 59 |
Target Study Title: Prescription of Benzodiazepines by General Practitioners: Characteristics of Prescribing Trend and Implementation of an Online Educational Program
Target Study Description: #Study Description
Brief Summary
Portugal has the highest benzodiazepine utilization compared to other European countries. The high utilization of benzodiazepines has been a concern due to reported side effects of long-term use and dependence. Also, these data demonstrate that doctors are possibly choosing an inadequate treatment to manage anxious and depressive syndromes.
This research aims to develop and implement in primary health care units an online educational program, following a cluster randomized study design; to study the impact of this educational program for changing general practitioner's benzodiazepine prescription pattern; to analyze of barriers and facilitators to the implementation of the e-PrimaPrescribe program.
Detailed Description
BZD excessive prescription has long been considered a serious mental health concern in many countries. A large number of interventions using different methodologies have been implemented to change BZD prescription pattern at primary health care settings, with limited positive results.
The investigators propose the implementation of an effectiveness-implementation hybrid type 1 intervention. In the study it was developed an online platform, named ePrimaPrescribe, which was delivered using a Digital Behavior Change Intervention(DBCI).
The investigators included all primary health care units from one region in Portugal which were randomly allocated to receive a Digital Behavior Change Intervention (DBCI) in the format of an online platform to reduce BZD prescription (ePrimaPrescribe) or an online platform concerning communication techniques (control).
The investigators primarily aimed to evaluate the effectiveness of the Digital Behavior Change Intervention (DBCI) using as outcome measure the frequency of BZD prescriptions issued per month. Secondarily the investigators aimed to analyze the effect of ePrimaprescribe on antidepressant prescriptions, to study the effect of ePrimaprescribe on diagnosis definition associated with BZD and antidepressant prescription; to perform a cost analysis considering the monthly National Health Service spending with BZD co-payment. The investigators finally aim to analyze the implementation process using quantitative and qualitative methods.
#Intervention
- BEHAVIORAL : ePrimaPrescribe online educational program
- online training program aiming to change general practitioners' benzodiazepine prescription
- BEHAVIORAL : ComunicaSaudeMental online educational program
- online training program aiming to improve general practitioners' communication with mentally ill patients
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Primary care units using the Portuguese online prescription tool (created by the Portuguese Shared Services of the Ministry of Health and Finance - SPMS)
Exclusion Criteria:
* Primary care units involved in another trial concerning mental health topics directly related with the subject of this thesis
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 60 |
Target Study Title: Determinants of Alpha-aminoadipic Acid (2-AAA) and Relationship to Diabetes: Study 2
Target Study Description: #Study Description
Brief Summary
This study aims to assess the effect of controlled dietary lysine intake on plasma and urine α-aminoadipic acid (2-AAA).
Detailed Description
Diabetes is an important health concern worldwide. It is associated with significantly increased mortality as well as high incidence of co-morbidities. Unfortunately, treatment efficacy and successful disease management is highly variable among treated patients, and this is partly due to the fact that diabetes has multiple underlying causes most of which are still unknown. A newly identified biomarker, α-aminoadipic acid (2-AAA), has the potential to successfully predict the development of diabetes in humans, even before the development of other known risk markers. However, little is known about the function of 2-AAA; it is unclear whether 2-AAA itself causes the development of diabetes or if it is a biomarker for altered metabolic processes that then lead to diabetes.
The aim of the first phase of the study was to measure plasma 2-AAA levels from healthy individuals from the general population to identify subjects with high or low 2-AAA. Now in the second phase of the study, 80 subjects with high or low 2-AAA will be invited to participate in a dietary lysine modification study to access the effect of controlled lysine intake on plasma and urine 2AAA. Participants will be asked to complete two one-week dietary interventions. Subjects will be screened and consented via email, online, or phone. Each subject will be required to come to Vanderbilt University Medical Center for four study visits, at which the study team will obtain a blood sample, a urine sample, stool sample, vital signs, waist and hip circumference, and 1-3 surveys will be completed if the subject did not complete them prior to the visit. Each subject that completes the entire study visit will be compensated $250. DNA samples will be obtained to allow for identification of genetic predictors of 2-AAA levels. Some individuals may be asked to return for a future follow-up study.
#Intervention
- DIETARY_SUPPLEMENT : Lysine
- Lysine is an essential amino acid which is acquired from dietary sources.
- DIETARY_SUPPLEMENT : Controlled Diet
- Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Prior participant in 2-AAA screening study.
* Identified as eligible due to high or low plasma 2-AAA, in the absence of hyperglycemia, as defined by study team.
Exclusion Criteria:
* Individuals who currently use tobacco products.
* Use of prescription or over-the-counter medications or dietary supplements which could modulate levels of 2-AAA and unwilling to discontinue use (from 24 hours prior to first study visit until completion of study). Hormonal birth control is acceptable.
* Follow a severely restricted diet or have food allergies, which would preclude adherence to study diet.
* Newly diagnosed disease (since screening visit), including cardiovascular, renal, or liver disease, or Diabetes mellitus.
* Individuals who are pregnant or lactating
* Inability to provide written or electronic informed consent
* Inability to fast for 8 hours
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 61 |
Target Study Title: Video-Assisted Palliative Care Intervention for Patients With Advanced Dementia at Home
Target Study Description: #Study Description
Brief Summary
The proposed project is a randomized controlled trial of a new home-based palliative care program for adults with advanced dementia and their caregivers within the Mount Sinai Health System. Potential subjects will be identified from Mount Sinai records or referred by a Mount Sinai healthcare provider. Patients will only be approached after authorization by their Mount Sinai physician. Participants who consent to enrollment will be randomized to receive the intervention (home-based palliative care program) or usual care (with their nominated Mount Sinai physician). Patients will be enrolled in the study for 6 months.
Effectiveness of the intervention will be determined through assessment of patient and caregiver reported outcomes and abstraction of data from medical records and administrative claims. Impact on the following parameters will be measured: (i) Patient symptoms, quality of life, satisfaction with care, documentation of advanced directives, receipt of care consistent with preferences (ii) Caregiver burden, satisfaction with care, and depression (iii) Healthcare utilization and costs of care.
Detailed Description
The objective of this randomized controlled trial is to study the impact of a new home based palliative care program on patients' symptoms, quality of life, satisfaction with care, completion of advance care planning documentation and receipt of care consistent with preferences. In addition, the study will examine the impact of this model of care on patient healthcare utilization, including hospitalization, emergency department utilization, and hospice use prior to death. The trial will also include patients' caregivers, in order to examine the impact of the intervention on caregiver burden and prevalence of depression.
Patients randomized to the intervention will be scheduled for an intake visit. This visit will be undertaken by the team's registered nurse and/or social worker, together with a community health worker, and other team members (advanced practice nurse, MD), depending on patients' needs. Visits will combine a combination of video-teleconferencing technology and in person visits. Following this visit, and in conjunction with the nurse practitioner and/or MD, a care plan will be developed to address areas of clinical need highlighted during the intake visit.
Patients in the intervention arm will receive ongoing monitoring and input (telephone-based, video-based, and in-person) from members of the clinical team, dependent on their identified needs. Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the level of clinical need. Patients and caregivers will be provided with access to a 24 hour telephone line, staffed by a Mount Sinai based physician, which acts as an advice line out of hours. These physicians will be able to provide advice to patients and caregivers.
#Intervention
- BEHAVIORAL : Home Palliative Care
- Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Presence of advanced dementia
* Subject has a Mount Sinai physician who authorizes their participation in the study and receipt of the program
* Subject is resident in Manhattan outside of a long term care facility and is not receiving hospice 5.
* Subject has evidence of capacity to benefit from enrollment in palliative care program
* Subject is conversant in English or Spanish
* Subject has capacity to consent or has a caregiver who can provide consent for the patient
Exclusion Criteria:
* Subject has no usual physician within Mount Sinai
* Subject's usual physician doesn't provide authorization to patient participation
* Subject resident outside of Manhattan or in long term care facility or receiving hospice
* Subject is not conversant in English or Spanish
* Subject cannot provide consent or has no caregiver who can provide consent
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 62 |
Target Study Title: An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
Target Study Description: #Study Description
Brief Summary
Five hundred patients with a confirmed clinical diagnosis of Cervical Dystonia (CD)are planned for enrollment into this open label study. These patients will be Type B toxin naive patients with CD. During this study patients will receive repeat injections of MYOBLOC when deemed appropriate by the Investigator. However, it will be recommended that injections occur not more frequently than every 12 weeks. Total duration of exposure to MYOBLOC will be targeted for at least two years, with potential exposure for up to 7 years in patients with earliest enrollment
#Intervention
- BIOLOGICAL : Botulinum Toxin Type B
- Eligible patients could receive injections of MYOBLOC once every 12 weeks. Total Dose could range from 5,000 Units up to 25,000 Units.
- Other Names :
- MYOBLOC
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* 18 years or older
* body weight of at least 46 kilograms
* History of Cervical Dystonia of at least one year's duration who in the opinion of the Investigator requires treatment
Exclusion Criteria:
* Inability to give informed consent
* Patient who has been previously treated with botulinum Toxin Type B
* Patient who has received a Botulinum toxin Type A injection in the last 12 weeks.
* History of phenol injections involving the neck or shoulder region in the last 12 months.
* Patients with neck contractures or cervical spine disease
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 63 |
Target Study Title: Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA in the Administered Rt-PA
Target Study Description: #Study Description
Brief Summary
intravenous rt-PA is effective to reduce the risk of death or dependency after ischaemic stroke. This effect is due to an early recanalization secondary to the lysis of the clot. However this effect may be counterbalanced by the increased risk of bleeding and also the neurotoxicity of rt-PA, which has been shown in animals to depend on the ratio single chain (sc) / double chain (tc) in the rt-PA administered. The main objective of OPHELIE is to determine whether the functional outcome after treatment by iv rt-PA depends on the ratio sc-rtPA / tc-rtPA. Secondary objectives were to identify the influence on the risk of brain haemorrhage, and the influence of the cognitive state (OPHELIE-COG substudy).
Detailed Description
OPHELIE is a multicenter study conducted in France in 25 centers where patients treated by iv rt-PA will be included. Patients are treated according to the local protocol, without any modification specifically for this study. A sample of 2 drops of the rt-PA used for the treatment is stored for analysis, to determine the sc-tPA/tc-tPA ration (immunostaining).
700 patients are needed for the study assuming that a difference of 5% will be found in the primary outcome measure (modified Rankin scale 0-1 at 3 months) with alpha and beta risks respectively of 5% and 20%.
The participating clinical centres recruit altogether more than 500 patients per year for thrombolysis. Assuming that 70% will be eligible, the recruitment should take less than 2 years.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Being treated by iv tPA for acute cerebral ischaemia
Exclusion Criteria:
* absence of reliable informant
* no rtPA left in the syringe after treatment
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 64 |
Target Study Title: Introducing a New and Validated Placebo Development Method to Healing Water Based Rehabilitation Research
Target Study Description: #Study Description
Brief Summary
The study aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.
Detailed Description
Introduction: The beneficial health effects of healing waters have been reported by numerous studies. However, the lack of proper placebo substance makes the 'medication-like' investigation of healing waters difficult. The investigators aimed to develop and validate an easy-to use cheap method capable of producing placebo from tap water.
Methods: Both medical water and tap water will be colored. The temperature and the pH of the tap water will be adjusted to the temperature pH of the healing water. The patients will be divided into two groups, colored healing water and placebo group. A single 20 minutes-long treatment will be performed in bath tubs. Considering the healing waters odor, the treatment will be given in the same room. Patients will be asked to tell whether they are treated with colored healing water or placebo or could not tell. Questions will be asked before the treatment, 10 minutes after the beginning of the treatment, immediately after the end of the treatment and after shower. The study will be performed in a double blind setup. Patients will be scored, one point for each correct answer.
Target patient number:174
#Intervention
- OTHER : Colored healing water
- Patients will be treated with colored healing water for 20 minutes.
- OTHER : Placebo treatment (colored tap water)
- Patients will be treated with colored tap water for 20 minutes.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* willingness to participate in the study
* age between 18 <= age <= 80 years
Exclusion Criteria:
* patients physically unable to enter or exit the bath tub
* autoimmune diseases
* any kind of malignity
* acute inflammation
* infection
* acute coronary syndrome or recent surgical interventions (6 month before enrollment)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 65 |
Target Study Title: A Phase I/II Study of PI-88 in Advanced Malignancies (Phase I), and in Advanced Melanoma (Phase II)
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to determine whether PI-88 is safe and effective in the treatment of advanced melanoma.
Detailed Description
PI-88 is an investigational drug that works by a novel mechanism which may reduce the rate of growth of tumors, and also the spread of cancer cells around the body. It also has an effect upon blood clotting. The purpose of this study is to assess if PI-88 has any benefit to patients with advanced melanoma, as well as to gain further information on the safety of the drug. All patients in the study will receive the study drug at the same dose level. The dose of PI-88 that will be given is based on the dose that was found to be the best in the phase I portion of this study. The drug will be injected subcutaneously (under the skin) once daily for 4 days every week. Patients will be treated with PI-88 for up to 6 months, but if the drug is well tolerated and effective, patients may be offered further treatment with the drug.
#Intervention
- DRUG : PI-88
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria
* Current diagnosis of metastatic melanoma, where other effective therapy is not available or has failed.
* Measurable disease. Metastatic lesions must be measurable by MRI or CT, and cutaneous lesions by physical examination.
* Aged at least 18 years.
* Have voluntarily given written informed consent to participate in this study.
* Performance status: ECOG 0 - 2 (Karnofsky 70 -100%)
* Life expectancy of at least 3 months.
* Neutrophil count greater than 1.5 x 109/L (1,500/mm3)
* Calculated creatinine clearance, using the Cockcroft-Gault formula, greater than 60 mL/min. If just below 60 mL/min, then GFR greater than 60 mL/min as determined by EDTA or DTPA scan.
* Platelet count at least 100 x 109/L (100,000/mm3)
* Bilirubin less than 1.5 x ULN
* AST and ALT up to 2 x ULN, except in the presence of liver metastases; up to 5 x ULN.
* Prothrombin time less than 1.5 x ULN
* APTT normal (20 - 34 sec)
Exclusion Criteria:
* History of allergy and/or hypersensitivity to anti-coagulants/thrombolytic agents, especially heparin.
* Chemotherapy, investigational or hormonal therapy in the previous 4 weeks.
* Radiotherapy to a major bone marrow bearing area such as pelvis, femoral heads, lumbar-sacral spine, within the previous 4 weeks. Radiotherapy to other sites within the past 2 weeks.
* Uncontrolled infection or serious infection within the past 4 weeks.
* Clinically significant non-malignant disease.
* Known HIV infection or AIDS-related illness.
* Myocardial infarction, stroke or congestive heart failure within the past 3 months.
* Current symptomatic central nervous system involvement, or active brain or meningeal metastases.
* Pregnancy, breast feeding, or women of childbearing potential in whom pregnancy cannot be excluded.
* History of abuse of alcohol, drugs, or other substances.
* History of acute or chronic gastrointestinal bleeding within the last two years, inflammatory bowel disease, any other abnormal bleeding tendency, or patients at risk of bleeding due to open wounds or planned surgery.
* Concomitant use of aspirin (more than 100 mg/day), non-steroidal anti-inflammatory drugs (except COX-2 Inhibitors), heparin, low molecular weight heparin or warfarin (more than 1 mg/day) is ongoing or anticipated during the study period. Low-dose aspirin (up to 100 mg/day) or low-dose warfarin (up to 1 mg/day) is permissible.
* Heparin or low molecular weight heparin within the previous 2 weeks.
* Not recovered from major surgery if conducted prior to the study.
* History of heparin-induced thrombocytopenia, immune mediated thrombocytopenia, thrombotic thrombocytopenic purpura or other platelet disease, or laboratory evidence of anti-heparin antibodies.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 66 |
Target Study Title: High Dose Weekly Use First-generation EGFR-TKI Instead of Daily Regular Dose in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)
Target Study Description: #Study Description
Brief Summary
EGFR-TKI is the main is the first line therapy for local advanced or metastatic non-small cell lung cancer with EGFR gene mutation. The median progression free survival time is around 11 months with the first generation EGFR-TKI. Patients with acquired resistance with first generation EGFR-TKI usually with EGFR exon 20 mutation (T790M). Change the drug administration maybe prolong patients PFS and evently prolong OS.
Detailed Description
1st generation EGFR-TKI has reversible binding to EGFR, it also bind to T790M in a high dose which is account about 60% patients acquired resistance to the drug. Resistance patients may be benefit to a bolus drug use to block T790M gene.
#Intervention
- OTHER : history data
- history data of PFS after 1st line or second line theray
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* NSCLC with EGFR mutation progressed after first generation EGFR-TKI, or progressed after chemotherapy and 1st generation EGFR-TKI or progressed after 1st generation EGFR-TKI and chemotherapy. Expected survival more than 3 months with a ECOG <=3.
Exclusion Criteria:
* liver function (ALT, AST) and renal function 2 times higher than normal limit; IPD; uncontrolled diarrhea; severe anemia.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 67 |
Target Study Title: Comparison of Sufentanil and Remifentanil Infusion During General Anaesthesia for Removal of Wisdom Teeth in Ambulatory Surgery
Target Study Description: #Study Description
Brief Summary
Wisdom teeth removal under general anaesthesia is usually suitable for ambulatory surgery.
The choice of opioid in dental day surgery is based on the need for a rapid and full recovery, as well as less morphine administration. Whether remifentanil can achieve these goals remains to be proved, especially regarding remifentanil-induced hyperalgesia, the potential prolonged Post Anesthesia Care Unit (PACU) stay, or remifentanil-induced workload for nurses.
Detailed Description
Patients will be enrolled during the preoperative anaesthetic assessment. Premedication will be achieved with oral administration of hydroxyzine 1 mg/kg the morning before surgery.
The induction of general anaesthesia will be achieved using TARGET CONTROLLED INFUSION (TCI) of propofol associated to TCI of remifentanil or sufentanil, depending on randomization.
The conditions of endotracheal intubation will be evaluated by the Percentage Of Glottic Opening Score (POGO) and the Cormack and Lehane Score.
Mechanical volume-controled ventilation will aim to maintain normocapnia. The baseline inspiratory gas will be a mixture of 45% oxygen and 55% nitrous oxide.
Bispectral Index recording and vital signs monitoring (heart rate and arterial blood pressure) will be used to monitor the depth of anaesthesia.
Dexamethasone 0.3 mg/kg will be administered after induction of general anaesthesia as part of our routine practice.
Patients will be extubated as soon as possible after the end of the surgery and transferred to the PACU.
Nurses in charge patients included in the study will be blinded to the opiod agent administered peroperatively.
Postoperative pain will be assessed using the simple numeric scale. A pain score above 3/10 will prompt the intravenous administration of titrated morphine chlorhydrate, as guided by a written protocol.
Patient will be transferred from the PACU to the ambulatory surgery unit when the Aldrete score is greater or equal to 9. Every patient included will received 1 gr of intravenous paracetamol two hours after the arrival hour in the PACU.
Pain monitoring will be continued in the ambulatory surgery unit, and morphine chlorhydrate will be orally administered (10 mg) if pain score is above 3/10.
Post anaesthetic discharge for home readiness will be given when the Post Anesthetic Discharge Scoring System (PADSS) is greater or equal to 9.
48 hours after the surgery, one of us, blinded to the opiod agent received by the patient, will contact every included patient by phone, in order to evaluate postoperative pain, potential side effects including nausea and vomiting, and patient satisfaction.
#Intervention
- DRUG : Remifentanil
- Wisdom teeth removal under general anaesthesia is usually suitable for ambulatory surgery.
The choice of opioid in dental day surgery is based on the need for a rapid and full recovery, as well as less morphine administration. Whether remifentanil can achieve these goals remains to be proved, especially regarding remifentanil-induced hyperalgesia, the potential prolonged Post Anesthesia Care Unit (PACU) stay, or remifentanil-induced workload for nurses.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* -age between 15 and 35 years
* American Society of Anaesthesiologists (ASA) physical status I or II
* Surgical removal of three to four wisdom teeth
* general anaesthesia
* Ambulatory surgery
Exclusion Criteria:
* Obesity (Body mass index > 30 kg.m-²)
* Pregnancy
* Contraindication for nitrous oxide inhalation
* Patient refusal
Sex :
ALL
Ages :
- Minimum Age : 15 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 68 |
Target Study Title: Skills Training for Schizophrenia: Enhancing Outcomes
Target Study Description: #Study Description
Brief Summary
This study will determine the effectiveness of skills training in people with schizophrenia and the applicability of the acquired skills in the 'real world.'
Detailed Description
People with schizophrenia have a large number of social and symptom management training programs available to them. Studies suggest that these training programs are effective, but their generalizability and effectiveness in outpatient settings has not been thoroughly examined. This study will examine the treatment outcomes of a skills training approach in schizophrenic individuals taking antipsychotic medication.
Participants taking stable doses of risperidone, olanzapine, or quetiapine will be randomly assigned to receive either intensive symptom management and social skills training or group therapy for 12 months. A verbal memory test will be used to stratify the randomization procedure and to control for neurocognitive functioning.
#Intervention
- PROCEDURE : Social skills and symptom management training
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of schizophrenia or schizoaffective disorder for > 5 years
* Use of stable dose risperidone, olanzapine, or quetiapine for at least 1 month with no planned medication changes
* Social Behavior Scale (SBS) score > 45
* Willing and able to provide informed consent
Exclusion Criteria:
* Intelligence Quotient < 70
* Use of more than one antipsychotic medication
* Use of benzodiazepines, tricyclic antidepressants, or anticholinergic medication commonly used to treat extrapyramidal symptoms
* Diagnostic and Statistical Manual (DSM)-IV criteria for alcohol or other substance dependence
* History of any traumatic brain injury leading to loss of consciousness for > 30 minutes
* Diagnosis of a comorbid medical condition that could interfere with antipsychotic medication treatment or the ability to complete the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 69 |
Target Study Title: A Multi-Center, Double-Blind, Randomized, Placebo-controlled, Crossover Study to Assess the Clinical Benefit of Midodrine Hydrochloride in Subjects With Moderate to Severe Neurogenic Orthostatic Hypotension
Target Study Description: #Study Description
Brief Summary
The purpose of this clinical study is to evaluate the clinical effect of midodrine hydrochloride (ProAmatine®) compared to placebo in patients with orthostatic hypotension by measuring the time to onset of near syncopal symptoms and assessing several cardiovascular measurements, such as heart rate, blood pressure, and ECG, using the tilt table test.
#Intervention
- DRUG : Midodrine hydrochloride
- one dose, 10-30mg, given orally
- Other Names :
- ProAmatine
- DRUG : Placebo
- Placebo
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* The male or female subjects must be 18 years or older and ambulatory. (Subjects must not require assistance with a walker or wheelchair to perform regular daily activities at all times.)
* Women of childbearing potential must have a negative serum beta HCG pregnancy test at screening and baseline.
* The subject has been diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease, multiple system atrophy, pure autonomic failure or autonomic neuropathy (i.e. neurogenic orthostatic hypotension).
* The subject manifests one of the following symptoms while standing or has a history of one of the following when not treated for orthostatic hypotension: dizziness, lightheadedness, feeling faint or feeling like they may black out.
* The subject is willing and able to undergo the procedures required by this protocol including morning office visits, assessment completion, protocol compliance and participation in the wash-out period.
* The subject has signed an Institutional-Review-Board approved written informed consent form prior to any study procedures taking place.
Exclusion Criteria:
* The subject is a pregnant or lactating female.
* The subject has pre-existing sustained supine hypertension greater than 180 mm Hg systolic and 110 mm Hg diastolic.
* The subject is taking medications such as vasodilators, pressors, diuretics, ACE inhibitors, angiotensin receptor blockers, beta-blockers, combined alpha and beta-blockers, MAOI's, herbals or specific mixed effect medications.
* The Principal Investigator deems any laboratory test abnormality clinical significant.
* The subject has a diagnosis of any of the following disorders at the time of screening: pheochromocytoma; cardiac conditions including: congestive heart failure within the previous 6 months, myocardial infarction within the previous 6 months, symptomatic coronary artery disease, history of ventricular tachycardia, or uncontrolled cardiac arrhythmias; thyrotoxicosis; uncontrolled diabetes mellitus (uncontrolled defined as a HgbA1c greater than or equal to 10%); history of cerebrovascular accident, transient ischemic attack (TIA) or symptomatic carotid artery stenosis within the previous 6 months; history of coagulopathies; pulmonary hypertension; severe psychiatric disorders; renal failure (Creatinine equal to or greater than 2 times the upper limit of normal)
* The subject has a concurrent chronic or acute illness, disability, or other condition that might confound the results of the tests and/or measurements administered in this trial, or that might increase the risk to the subject.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 70 |
Target Study Title: Urinary T Lymphocytes Predict Renal Flares in Patients With Inactive Anti-neutrophil Cytoplasmic Antibody (ANCA) Associated Glomerulonephritis
Target Study Description: #Study Description
Brief Summary
Urinary CD4+ and CD8+ T lymphocytes may predict renal flares in patients with inactive ANCA-associated vasculitis and thus serve as early non-invasive biomarkers. Urine samples of patients with inactive renal ANCA-vasculitis will be analysed by flow cytometry and compared to clinical outcome after 6 months.
Detailed Description
Data of previous studies have shown that counts of urinary T lymphocyte subsets correlate with disease activity in several immunological renal diseases, e.g. ANCA-associated glomerulonephritis. Thus, study authors hypothesise that CD4+, respectively CD8+, T effector memory lymphocytes found in urine samples of patients with inactive ANCA-vasculitis predict subsequent renal flares. Therefore, quantification of these cellular subsets might reliably predict relapse of ANCA associated glomerulonephritis at an early stage. In a prospective experimental study urine of patients with ANCA-vasculitis and no renal involvement or patients in renal remission will be analysed by flow cytometry. After 6 months of observation, clinical outcome and potential renal relapse will be determined and correlated to initial T lymphocyte count.
#Intervention
- DIAGNOSTIC_TEST : Analysis of urine samples with flow cytometry
- Urine samples will be conserved and frozen upon arrival. All samples will be stained according to T cell and TEC (tubular epithelial cells) panel with fluorochromes.
T cell panel: CD3, CD4, CD8, CCR7, CD45RO, CD28, CD279; TEC panel: vimentin, cytokeratine, CD10, CD13, CD227, CD326
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* diagnosed ANCA-associated vasculitis (clinical diagnosis of granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis or microscopic polyangiitis consistent with the Chapel-Hill consensus definitions AND positive test for proteinase 3-ANCA or myeloperoxidase-ANCA)
* no currently active renal involvement (defined as BVAS = 0 with exception of hematuria or proteinuria as signs of renal scars)
* written and informed consent
Exclusion Criteria:
* urinary tract infection
* active menstrual bleeding
* active renal involvement
* other active renal disease (e.g. diabetic nephropathy)
Initially, we defined treatment with rituximab as exclusion criteria. However, upon closer examination, we recognized that this exclusion criterion was overly restrictive and may have inadvertently excluded eligible participants who met our other inclusion criteria. As a result of this reassessment, we have revised our exclusion criteria to no longer exclude individuals solely on the basis of receiving rituximab treatment.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 71 |
Target Study Title: Randomized Trial of Maternal Hydration on the Increase of Amniotic Fluid Index
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to determine the effect of maternal hydration with oral isotonic solution and water on amniotic fluid (AF) index in women with normohydramnios.
Detailed Description
Objective: To determine the effect of maternal hydration with oral isotonic solution and water on amniotic fluid (AF) index in women with normohydramnios.
Subjects and Methods: Women with normal AF index and gestational age between the 33 and 36 weeks without maternal complications were randomized into three groups (isotonic solution, water, control). The isotonic solution and water groups were instructed to drink 1.5L of respective solution; the control group was instructed to drink 200mL of water. AF index was measured before and after hydration. The investigator performing the AF index was blinded to the subject's group.
Results: Ninety-nine women completed the study without any maternal adverse effects. The mean increase in amniotic fluid index after hydration was significantly greater in the isotonic solution and water groups (12.1mm, p=0.02; 13.1mm, p=0.05; respectively) than the control group (1.4mm, p=0.74). There was no significant difference between the isotonic solution and water groups. Hydration with isotonic solution and water improved the chance of 20% of increase of amniotic fluid index in 10.2 (95% CI 1.9-98.9) and 6.0 (95% CI 1.0-45.5) times respectively.
Conclusion: Maternal hydration with isotonic solution or water increased AF index in women with normohydramnios.
#Intervention
- OTHER : isotonic solution
- 1.5 L- during 2-4hours
- Other Names :
- Isotonic
- OTHER : water
- 1.5 L- during 2-4hours
- Other Names :
- Water 1.5
- OTHER : water
- 200mL- during 2-4hours
- Other Names :
- Water 200
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* gestational age between 33 and 36 weeks
* singleton pregnancy
* intact membranes
* initial AF index between 5 and 95 per cent
Exclusion Criteria:
* no maternal complications
* no fetal structural malformation
* no evidence of fetal distress on nonstress test
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 72 |
Target Study Title: A Phase One Open Label, Crossover Study in Healthy Adult Subjects to Quantify Lung Deposition and Distribution of 99mTc Radiolabelled S-770108 Inhalation Powder Formulation Delivered by a Novel Inhaler Device
Target Study Description: #Study Description
Brief Summary
The primary objective of this study is to assess the total lung deposition of radiolabelled S-770108 inhalation powder formulation after each of two separate single inhaled doses in healthy adult participants at two different target peak inspiratory flow rates (PIFRs)
#Intervention
- DRUG : Radio-labelled S-770108
- 99mTc radio-labelled S-770108 supplied as a capsule containing 6 mg active pirfenidone for inhalation
- DEVICE : S-770108 Inhaler A1
- Dry powder inhaler
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Subjects who are able to understand this study and comply with all study procedures, are able to be trained and use the device correctly at screening and willing to provide written informed consent before screening.
* Subjects judged to be healthy by the principal or sub investigator, based on medical history and clinical evaluation.
* Male and female subjects >= 40 to <= 80 years at the time of informed consent.
* Subjects whose body mass index (BMI) is >= 18.0 and < 30.0 kg/m2 during the screening visit．
* Subjects able to produce a peak inspiratory flow rate of at least 30.00L/min at screening using the investigational device attached to an electronic flow meter.
* Subjects who have smoked within 12 months before admission cannot be entered the study.
* Subjects judged to have normal lung function. Specifically, with percent predicted forced expiratory volume in 1 second (%FEV1) >= 80% and forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio >=70%.
* Male subjects are eligible to participate if they agree to the following during the treatment period and for at least 3 months (a spermatogenesis cycle) after the last dose of study intervention.
* Refrain from donating sperm.
* Must agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as described in Appendix 2, as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
* Female subjects who agree to use of appropriate contraception measures from time of screening until 3 months after the last dose of study drug, except for female subjects who are surgically sterile by bilateral oophorectomy for at least 6 weeks with appropriate documentation or who are post-menopausal (defined as at least 6 months of spontaneous amenorrhea in woman > 45 years with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL at screening, or at least 12 months of spontaneous amenorrhea in woman > 45 years)
Exclusion Criteria:
* Subjects deemed by the principal or sub investigator to be ineligible for the study due to history of, or concurrent and clinically significant metabolic or endocrine, hepatic, renal, haematological, respiratory, cardiovascular, gastrointestinal, urological, immunological, neurological or psychiatric disorders, or any malignant neoplasms at any diagnosed stage.
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2018, shall participate in the study.
* Subjects who have a history of clinically relevant respiratory disease, diseases affecting respiratory function, E.N.T. diseases, or lung surgery.
* Subjects who have had an upper respiratory infection in the last 7 days which could affect inhalation/absorption of study medication.
* Subjects who use regular medication (prescribed and/or over the counter) or have used any medication (excluding non-prescription drugs, vitamins, and dietary or herbal supplements which do not interfere with respiratory function according to their labelling) within 14 days before admission; exceptions may be permitted on a case by case basis if considered not to interfere with the aims of the study and agreed by the investigator and sponsor's medical monitor.
* Subjects with a history of lactose intolerance, intolerance to dairy products, or a history of gluten intolerance.
* Subjects with a history of serious adverse reaction or serious hypersensitivity to the active ingredient or excipients in any drug.
* Subjects with a history of drug and/or alcohol addiction within the past 2 years before screening or a positive test for drugs or alcohol at screening or admission visit.
* Regular alcohol consumption in males of > 21 units per week, or females of > 14 units per week (1 unit = 1/2 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
* Subjects with a positive result on any of the tests for the serologic detection of human immunodeficiency virus (HIV) antigen/antibody, hepatitis B surface antigen (HBsAg), and hepatitis C antibody.
* Female subjects who are pregnant, breast-feeding, have a positive pregnancy test result during the screening assessment or admissions; or intending to become pregnant during the study period or within 3 months after the last dose of study treatment.
* Subjects who have donated > 400 mL of blood within 3 months before screening, > 200 mL within 4 weeks before screening, or who donated blood between screening and admission.
* Subjects who have been exposed to an investigational drug within 90 days prior to study drug administration.
* Subjects who have previously received pirfenidone (Esbriet®, Pirespa®) in any form, or S 770108.
* Subjects who are study site employees or immediate family members of a study site employee, or sponsor employees.
* Subjects who are ineligible for the study for any other reason, as judged by the investigator or sub investigator.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 73 |
Target Study Title: Phase 3 : Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis on Adult Face
Target Study Description: #Study Description
Brief Summary
Seborrheic dermatitis is a chronic inflammatory dermatological disease, evolving by relapses, affecting mainly the face and scalp. It would be important to have a maintenance treatment for severe forms of seborrheic dermatitis witch is both effective and relatively well tolerated to reduce the frequency of relapses, prolong remissions obtained after attack treatment and reduce the use of topical steroids.
#Intervention
- DRUG : Protopic (R)
- Protopic® 0.1% ointment - 2 applications per week for 6 months
- Other Names :
- Tacrolimus
- DRUG : Mycoster (R)
- Mycoster 1% - 2 applications per week for 6 months
- Other Names :
- Ciclopirox olamine
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* in Phase 1: Attack Treatment (open)
1. over the age of eighteen patient,
2. Seborrheic dermatitis Severe,
3. participation with an informed consent,
4. Women of childbearing age in effective contraception for the duration of the study or postmenopausal women.
* in Phase 2: Phase 2: 'Randomization' (blind)
1. Patient achieved a complete or almost complete clinical remission after the initial treatment,
2. known immunodeficiency (HIV patient receiving chemotherapy) or immunosuppressive therapy or biotherapy,
3. patient taking regular systemic corticosteroids at a dose> 20 mg / day
4. erythematous lesions with topography other than the face and evocative scalp psoriasis (elbows, knees ...), by referring to the possibility that the facial lesions correspond to lesions sebopsoriasis,
5. woman pregnant, nursing or in childbearing potential without effective contraception,
6. man wishing to have a child during the study period,
7. Ultra Violet (UV) phototherapy or usual realization of UV sessions aesthetic purposes,
8. Seborrheic dermatitis symptomatic of an underlying disease known or revealing
9. history of cancer or lymphoma,
10. progressive cancer or lymphoma,
11. Seborrheic dermatitis exclusively affecting the scalp,
12. known allergy to one-component products study ,
13. malnourished patient or sick history of chronic pancreatitis by a suspect to deficiency dermatitis,
14. participation in a clinical trial on the Seborrheic dermatitis in the previous 90 days,
15. patient with lesions considered potentially malignant or pre-cancerous,
16. patient with abnormal skin barrier.
Exclusion Criteria:
* in Phase 1: Attack Treatment (open)
1) Patient had already been treated with Protopic ® for Seborrheic Dermatitis,
* Phase 2: 'Randomization' (blind) 1) Patient with no complete or almost complete clinical remission after the initial treatment,
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 74 |
Target Study Title: Effect of Ulinastatin on Postoperative Renal Function in Patients Undergoing Robot-assisted Laparoscopic Partial Nephrectomy
Target Study Description: #Study Description
Brief Summary
Ulinastatin reduces systemic inflammatory responses and protects organs from ischemia/reperfusion-induced injury. The aim of this study is to evaluate the effect of ulinastatin on postoperative renal function in patients undergoing robot-assisted laparoscopic partial nephrectomy. Seventy patients, aged 20 to 79 years, scheduled for robot-assisted laparoscopic partial nephrectomy will be divided into ulinastatin (n=35) and control (n=35) groups. Randomly selected patients of the ulinastatin group are given ulinastatin. In contrast, patients in the control group receive an equivalent volume of normal saline as a placebo. The primary endpoints are postoperative renal function measured by serum creatinine, cystatin C, and urine output.
#Intervention
- DRUG : ulinastatin
- DRUG : normal saline
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* patients who are scheduled to undergo robot-assisted laparoscopic partial nephrectomy with an American Society of Anesthesiologists (ASA) physical status I-III
Exclusion Criteria:
* Subjects are ineligible if they have severe respiratory or cardiovascular disease, renal insufficiency before operation, cognitive dysfunction, are unable to communicate or speak Korean
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 75 |
Target Study Title: A Prospective Clinical Study for GreenLight HPS in the Treatment of Obstructive Benign Prostatic Hyperplasia (BPH)
Target Study Description: #Study Description
Brief Summary
To gain clinical experience with the GreenLight HPS System, a system designed to vaporize and coagulate tissue in the treatment of benign prostatic hyperplasia to reduce lower urinary tract symptoms.
Detailed Description
Enlarged prostate or Benign Prostatic Hyperplasia (BPH) is one of the most common diseases of aging men and can be associated with lower urinary tract symptoms (LUTS) such as having to urinate very often, a sudden strong feeling of having to urinate, having to get up at night to urinate, decreased and intermittent force of stream and the feeling of incomplete bladder emptying. These symptoms affect quality of life by interfering with normal daily activities and sleep patterns. When surgery is the best treatment option for the patient, the most common technique is a 'transurethral resection of the prostate' (TURP). TURP involves removing the some of the extra tissue of the prostate gland. Even though TURP is a good treatment, there are concerns about the frequency of complications following treatment as well as the significant costs to patients, doctors, and insurance providers.
Photoselective vaporization of the prostate (PVP) is a relatively new technology that has similar benefits with fewer side effects than TURP. PVP is a minimally invasive procedure that uses a special high-energy laser to eliminate excess prostate tissue and seal the treated area. This technology has been used for more than a decade with over 200,000 procedures performed worldwide.
The focus of this study is to 1) document the long-term advantages of GreenLight HPS 120w and 2) to show that the stronger laser is a more flexible and efficient device which allows for a shorter procedure time, may be done in an out-patient setting in healthy patients, allows for shorter catheterization time, may result in a rapid urinary flow rate with minimal side effects, and may allow a quick return to normal activities. This device has been approved by the United States Food and Drug Administration (FDA) for treatment of obstructive BPH.
#Intervention
- DEVICE : GreenLight HPS
- Greenlight HPS laser system for treatment of BPH
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* All male subjects >= 45 years who have a history of symptomatic/obstructive symptoms secondary to BPH greater than 3 months, an International Prostate Symptom Score (IPSS) / American Urology Association (AUA) score >14, require surgical intervention, and are an acceptable risk for anesthesia and surgery are eligible to participate in this study
Exclusion Criteria:
* American Society of Anesthesiologists (ASA) classification of physical status > III
* An unstable cardiopulmonary disorder, previously or recently diagnosed by standard methods
* A myocardial infarction or coronary artery stent placement within 6 months of the treatment
* Neurogenic lower urinary dysfunction
* A post-void residual (PVR) volume >= 400 mL
* Pre-existing urinary incontinence
* Active localized or systemic infection, including urinary tract infection (UTI) or prostatitis affecting bladder function
* Pre-existing damage of external urinary sphincter
* Presence of cystolithiasis, urethral stricture, or bladder neck contracture
* Prostate volume (PV), as measured by transrectal ultrasound (TRUS), less than 30cc or greater than 200cc
* Previously confirmed or suspected malignancy of prostate or bladder, treated or untreated
* Immunocompromised subjects
* Serious bleeding disorders and coagulopathy. For example: hemophilia or Von Willebrand's disease
* Desire to preserve antegrade ejaculation
* Calcification of prostate tissue, usually after severe prostatitis
* Deemed unfit for laser vaporization as determined by the attending physician
* Enrollment in a concurrent clinical trial of any treatment (drug or device) that could affect urogenital function without sponsors' approval
* Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all follow-up requirements
Sex :
MALE
Ages :
- Minimum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 76 |
Target Study Title: Berlin PRehospital Or Usual Delivery of Acute Stroke Care - Functional Outcomes After Advanced Prehospital Stroke Care
Target Study Description: #Study Description
Brief Summary
Prehospital stroke care in specialized ambulances increases thrombolysis rates, reduces alarm-to-treatment times, and improves prehospital triage. Preliminary analyses suggest cost-effectiveness. However, scientific proof of improved functional outcome compared to usual care is still lacking. The objective of this trial is to show improved functional outcomes after deployment of the Stroke Emergency Mobile (STEMO) compared to regular care.
Detailed Description
This is a pragmatic, prospective, multi-center trial with blinded outcome assessment of treatment candidates three months after stroke. Treatment candidates will be defined as patients with final discharge diagnosis of cerebral ischemia, and onset-to-alarm time ≤4 hours, symptoms not resolved at time of ambulance arrival, and able to walk without assistance prior to emergency. These patients will be included if their emergency call from a predefined catchment area in Berlin, Germany, caused a stroke alarm at the dispatch center during STEMO hours (7am-11pm, Monday-Sunday). About 45% of STEMO dispatches will be handled by regular ambulances since STEMO will be already in operation creating the quasi-randomized control group.
B_PROUD uses data from the B-SPATIAL registry. The B-SPATIAL registry has started recruitment in January 2016. However, B_PROUD recruits patients with symptom onset October 1st, 2016 or later (because data access at the dispatch center had to be established first).
#Intervention
- PROCEDURE : STEMO
- STEMO, the intervention, includes prehospital neurological emergency assessment with the option to perform CT and CT-angiography, start specialized treatment at the door-step of the patient's house, including thrombolysis with tissue Plasminogen Activator and blood pressure Management (choice of drug at discretion of treating physician), use telemedicine for further expertise as well as results of point-of-care laboratory, prenotification (e.g. for endovascular treatment), triage and transport.
- PROCEDURE : Regular care
- A regular ambulance, the comparator intervention, not equipped with advanced point-of-care laboratory or CT scanner, without telemedicine and not staffed with a neurologist.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion criteria:
* Suspected acute stroke according to the dispatcher stroke identification algorithm during STEMO hours (7am-11pm, Monday-Sunday) and within the STEMO catchment area
Inclusion criteria for primary study population:
* Final diagnosis of ischemic stroke (ICD 10: I63) or TIA (ICD 10: G45 except G45.4)
* Confirmed onset-to-alarm time <= 4 hours at dispatch
* Pre-stroke modified Rankin scale <= 3 (being able to ambulate, in routine clinical care, patients with mRS up to 3 are usually deemed suitable for tissue plasminogen activator treatment)
Exclusion criteria:
* Symptom remission until arrival of emergency medical service
* Malignant or other severe primary disease with life expectancy < 1 year
Exclusion criteria for primary study population:
* Major surgery within 4 weeks before study inclusion
* Confirmed stroke within 3 months before study inclusion
* Absolute contraindications for thrombolysis AND thrombectomy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 77 |
Target Study Title: A Phase 2, Multi-site, Randomized, Double-blind, Vehicle-controlled Study of the Efficacy and Safety of Squaric Acid Dibutyl Ester (SADBE) in Subjects With Recurrent Herpes Labialis - Single Versus Two-dose Arm Application
Target Study Description: #Study Description
Brief Summary
This study evaluates the safety and efficacy of SADBE in the prevention of recurrent herpes labialis in adults. Two-thirds of the participants will receive a SADBE solution, while the other third will receive only the vehicle as a placebo control. The solutions will be administered topically to the patient's arms. The study will compare a single-arm application versus a two-arm application versus two placebo doses on the arm.
#Intervention
- DRUG : SADBE
- Topical solution
- Other Names :
- Squaric acid dibutyl ester
- OTHER : Placebo
- Topical solution
- Other Names :
- Vehicle-DMSO
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Age >=18
* Clinical diagnosis of herpes labialis, which may be made at the screening visit based on the patient's self-reported history of symptoms. An active herpes labialis outbreak at the time of entry into the clinical trial will neither be required nor will be an exclusion criteria.
* Self report having four or more episodes of herpes labialis in the past 12 months
Exclusion Criteria:
* People that have had treatment with anti viral therapy within 2 weeks before sensitization dose.
* Pregnant or lactating females.
* Current or recurrent non-herpetic infection or any underlying condition that may predispose to infection or anyone who has been admitted to the hospital due to bacteremia, pneumonia or any other serious infection.
* Therapy with glucocorticoid or immunosuppressants at time of recruitment or within past 4 weeks, except for inhaled corticosteroids for asthma or topical steroids in sites other than face.
* History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers)
* History of organ transplantation
* HIV-positive status determined by history at screening or known history of any other immunosuppressive disease.
* Severe co-morbidities (diabetes mellitus requiring insulin, CHF (EF<50% at baseline will be exclusionary) MI, CVA or TIA within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease
* History of exposure to squaric acid or squaric acid dibutyl ester.
* Known hypersensitivity to DMSO
* Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
* Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit.
* Previous or current participation in a clinical trial of SADBE to treat herpes labialis.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 78 |
Target Study Title: Effect of Intraoperative Neuromuscular Blockade on Postoperative Sore Throat and Hoarseness in Patients Undergoing Spinal Surgery
Target Study Description: #Study Description
Brief Summary
Investigators assess and compare postoperative sore throat and hoarseness in the group using the muscle relaxant and not using it during the operation.
Detailed Description
The muscle relaxant is usually used during the operation to maintain moderate relaxation but, it can't be used in the surgery to need eletrophysiological monitoring during the operation. In this sturdy, the investigators assess the postoperative sore throat and hoarseness and compare the effect of muscle relaxant in the group using the muscle relaxant and not using it in terms of the incidence and severity of postoperative sore throat and hoarseness.
#Intervention
- DRUG : Rocuronium
- In the group to need the eletrophysiological monitoring during the operation, we don't inject muscle relaxant except anestheitic induction.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion criteria
* patients scheduled to undergo elective lumbar spinal surgery Exclusion criteria
* known or predicted difficult airway
* neuromuscular diseases
* hepatic or renal dysfunction
* diseases or anatomical abnormalities in the neck, larynx, or pharynx
* requirement for postoperative mechanical ventilation
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 79 |
Target Study Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Demonstrate Lot-to-Lot Consistency of 3 Lots of a Tetravalent Dengue Vaccine Candidate in Healthy Adults in Non-Endemic Country(Ies) for Dengue
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to investigate lot-to-lot consistency in terms of equivalence of the immune responses induced by 3 consecutive TDV lots in healthy participants aged 18 to 60 years in non-endemic country(ies) for dengue.
Detailed Description
The vaccine tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV). The primary objective of this trial is to investigate lot-to-lot consistency in terms of equivalence of the immune responses induced by 3 consecutive lots of TDV in healthy participants in non-endemic country(ies) for dengue.
The study will enroll approximately 924 healthy participants. Participants will be randomized in 2:2:2:1 to one of 4 trial groups to receive TDV (Lots 1, 2 or 3) or placebo:
* TDV 0.5 mL subcutaneous injection OR
* Placebo normal saline solution (0.9% NaCl) for injection.
In each trial group, all participants will receive 2 doses of TDV or placebo by subcutaneous injection on Days 1 (Month 0) and 90 (Month 3). Immunogenicity will be assessed in participants included in the immunogenicity subset (TDV groups: 176 participants each and placebo group: 88 participants) and safety will be assessed in all participants in each group.
This multi-center trial will be conducted in the United States. The overall time to participate in this study is 270 days. Participants will make multiple visits to the clinic including a final visit at Day 270.
#Intervention
- BIOLOGICAL : TAK-003
- TDV subcutaneous injection
- Other Names :
- TDV
- BIOLOGICAL : Placebo
- TDV Placebo-matching normal saline (0.9% NaCl) subcutaneous injection
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and the clinical judgment of the Investigator.
* Signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
Exclusion Criteria:
* Has an elevated oral temperature (>=38°C or 100.4°F) within 3 days of the intended date of vaccination.
* Known hypersensitivity or allergy to any of the vaccine components (including excipients of the investigational vaccine or placebo).
* Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barré syndrome).
* Known or suspected impairment/alteration of immune function, including:
1. Chronic use of oral steroids (equivalent to 20 mg/day prednisone >=12 weeks/>=2 mg/kg body weight/day prednisone >=2 weeks) within 60 days prior to Day 1 (M0) (use of inhaled, intranasal, or topical corticosteroids is allowed)
2. Receipt of parenteral steroids (equivalent to 20 mg/day prednisone >=12 weeks/>= 2 mg/kg body weight/day prednisone >=2 weeks) within 60 days prior to Day 1 (M0).
3. Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial.
4. Receipt of immunostimulants within 60 days prior to Day 1 (M0).
5. Hepatitis C virus infection.
6. Genetic immunodeficiency.
* Has abnormalities of splenic or thymic function.
* Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
* Has any serious chronic or progressive disease according to judgment of the Investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
* Has body mass index (BMI) greater than or equal to 35 kg/m^2 (= weight in kg/[height in meters^2]).
* Has history of substance or alcohol abuse within the past 2 years.
* Had previous and planned vaccination (during the trial conduct) against any flavivirus including dengue, yellow fever (YF), Japanese encephalitis (JE) viruses or tick-borne encephalitis.
* Has a current or previous infection with a flavivirus such as dengue, Zika, YF, JE, West Nile (WN) fever, tick-borne encephalitis or Murray Valley encephalitis and participants with a history of prolonged (>=1 year) habitation in a dengue endemic area.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 80 |
Target Study Title: Combination of Acetaminophen and Ibuprofen in the Management of Patent Ductus Arteriosus in Premature Infants: A Pilot Study
Target Study Description: #Study Description
Brief Summary
Patent ductus arteriosus or PDA is a blood vessel that connects the right and left side of the heart that usually closes after birth but remains open in some premature infants born before 30 weeks' gestation. When this blood vessel remains open for a long time, it may cause problems such as bleeding in the lung and brain, lung injury due to prolonged need of ventilator, and poor kidney function. It sometimes becomes necessary to close this blood vessel in the preterm infant. Currently, this blood vessel can be closed either by medication or surgery. Pain medications such as Ibuprofen and Indomethacin are routinely used medications to close PDA. However, in the last 5 year, acetaminophen has been found as an alternative medication to close PDA in preterm infants. In multiple studies, acetaminophen is found to be a safe alternative medication with lower side effects than current standard management. Intravenous Ibuprofen is approved by FDA to treat PDA in preterm infants. Although not approved by FDA, oral ibuprofen is being used for the management of PDA. However, the success rate of a single medication is approximately 70%. Both medications have been used in the previous clinical studies to treat the same condition in the preterm infants and fewer side effects were reported. Mechanism of both medications to close PDA is different and may work more effectively together than single medication alone. In this study, the investigator are going to use these two medications (Ibuprofen and Acetaminophen) at the same time if the child needs treatment and is eligible to participate in this study. This study is based on the assumption that by using both medications at the same time, investigator can close this blood vessel more effectively than with either drug alone.
Detailed Description
The ductus arteriosus is an essential blood vessel that connects the pulmonary artery and the aorta in the fetus. The patent ductus arteriosus (PDA) allows oxygenated blood that returns from the placenta to bypass the lungs and supply the fetal systemic circulation. In fetal life, ductus remains open due to low partial pressure of oxygen, circulating or locally produced prostaglandins and local nitric oxide production. Constriction of ductal vascular smooth muscle (functional closure) occurs within few hours of delivery due to decrease level of prostaglandin and rising oxygen concentrations. Closure of ductus can be affected by several perinatal and postnatal factors such as growth restriction, sepsis, and fluid overload. Spontaneous PDA closure occurs in \> 34% extreme premature infants compared to \> 95% in infants with birth weight more than 1500 grams. In a prospective study, 65 infants less than 1500 g birth weight were closely followed by serial echocardiograms. Sensitivity of ductal tissue to oxygen and prostaglandin differs in preterm compared to term infants. Without sufficient physiologic hypoxia, the ductus may fail to close or may reopen after initial constriction. Several co-morbidities have been associated with prolonged patency of the ductus in preterm infants (e.g., prolonged ventilator support, bronchopulmonary dysplasia, pulmonary hemorrhage, impaired renal function, intraventricular hemorrhage and cerebral palsy). Preterm infants with uncomplicated respiratory course, PDA is commonly managed conservatively. Currently hemodynamically significant PDA are managed medically (indomethacin and ibuprofen) and surgically. Recently, acetaminophen has gained attention as an alternative for PDA management due to its low cost, wide availability and the potential for fewer side effects. In two randomized controlled trials comparing acetaminophen with ibuprofen, authors have shown comparable closure rate of PDA with acetaminophen.
To our knowledge, a combination of the drugs has not been used to treat PDA in preterm infants and prospective study has not been conducted or published to determine the effectiveness of a combination of ibuprofen and acetaminophen in the treatment of PDA. As both medications are metabolized through different organs (hepatic and renal), the investigator assume that incidence of adverse events should not be affected. The Investigator hypothesize that the combination of oral ibuprofen and oral acetaminophen will be more effective, because the mechanisms of action differ for the two medications and hence may produce therapeutic synergy.
#Intervention
- DRUG : Acetaminophen
- Oral acetaminophen \[160 mg/5ml concentration\] will be administered every 6 hours with dose of 15 mg/kg/dose for a total of twelve doses
- Other Names :
- Tylenol
- DRUG : ibuprofen
- Oral ibuprofen \[100 mg/5 ml\] at 10 mg/kg/dose on first day followed by 5 mg/kg/dose at 24 and 48 hours for a total of three doses
- Other Names :
- Motrin
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Infant with gestational age 23 to 30 weeks at birth and birth weight between 500 - 1000 grams
* Postnatal age less than equal to 14 days
* Hemodynamically significant PDA as defined by any of the following:
1. Increased ventilator support attributed by the clinician to be due to PDA
2. Hypotension and/or widening pulse pressure requiring vasopressors
3. Signs of congestive heart failure such as pulmonary congestion
* Echocardiographic criteria:
1. Ratio of the smallest ductal diameter to the ostium of the left pulmonary artery > 0.5
Exclusion Criteria:
* PDA-dependent congenital heart disease
* Prior treatment with prophylactic indomethacin
* Significant hyperbilirubinemia requiring exchange transfusion
* Active or suspected necrotizing enterocolitis (NEC) and/or intestinal perforation
* Abnormal liver enzymes
* Platelets count < 50000 /l and / or active intracranial or gastrointestinal bleeding or from any other site
* Major congenital anomalies such as neural tube defect, chromosomal abnormality and gastrointestinal defect
Sex :
ALL
Ages :
- Minimum Age : 23 Weeks
- Maximum Age : 30 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 81 |
Target Study Title: Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi (Prevention of Prematurity and Xylitol)
Target Study Description: #Study Description
Brief Summary
The hypothesis of the investigators' project is that comprehensive primary preterm birth prevention, inclusive of maternal oral health with xylitol chewing gum (the intervention), will reduce the rate of periodontal disease and caries, preterm birth prevalence, and neonatal mortality.
Detailed Description
Significance and Impact: Adverse birth outcomes related to the length of gestation (preterm birth) are recognized as one of the most significant disorders in maternal-child health at a global scale. In the developed world, the preterm birth rate approximates 7%. In Malawi, the investigators have recently demonstrated that this rate more than triples to approximate 26.1%. Of the 4 million newborn deaths annually, nearly 1/3 (27%) are directly attributable to prematurity with another 36% secondary to related opportunistic infections (sepsis, pneumonia, gastrointestinal). 75% of the 4 million deaths occur within the first week of life, with the vast majority occurring in the first 48 hours. For those that do survive, there are persistent and lifelong risks due to stunted growth, chronic infection, retinopathy of prematurity, and bronchopulmonary dysplasia. The link between maternal oral health (periodontal disease in particular) and risk of preterm birth has been demonstrated across all populations (rural and urban, in both industrialized and developing regions) studied to date. However, in multiple randomized controlled trials treatment of active periodontal disease with scaling and planning during pregnancy has failed to demonstrate a significant benefit in preventing preterm birth.
Why would maternal oral health impact preterm birth? In rodents, subcutaneous inoculations with periodontal pathogens cause dose-dependent decreases in pup weights, and elicit inflammatory responses that can trigger preterm birth when present in amniotic fluid. Periodontitis (defined as a destructive inflammation of the periodontium) has a prevalence of 30% or greater in women of child bearing age. By definition, it involves microbial infiltration of the periodontium, which stimulates a chronic inflammatory response, recurrent bacteremia, and the production of cytokines and prostaglandins which trigger risk of preterm birth. It is the same production of prostaglandins which are felt to mediate the risk of preterm birth. So if the investigators know that there is biologic evidence that periodontitis is related to preterm birth, but treating active periodontitis does not reduce these morbidities, is it possible that preventing periodontitis might prevent preterm birth and low birth weight? If so, what are the least expensive efficacious preventative measures? The investigators' overarching hypothesis is that comprehensive primary preterm birth prevention, inclusive of maternal oral health with xylitol chewing gum (the intervention), will reduce the rate of periodontal disease and caries, preterm birth prevalence, and neonatal mortality.
#Intervention
- DIETARY_SUPPLEMENT : Xylitol gum
- This is a cluster randomized trial, whereby 4 sites will receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Enrollment at <20 weeks gestation by best obstetrical estimate, or
* Enrollment post partum with an anticipated next pregnancy within 18 months, or
* Enrollment preconception with an anticipated pregnancy within 18 months (preconception); and
* Cognitively aware enough to participate in the study
* >18 years (in Malawi, constitutes a legal adult and capacity to consent for study)
* Willing to participate in the study
* Willing to undergo at least two periodontal exams
* Willing to chew 1 piece of xylitol gum for 10 minutes after the morning and evening meal (intervention sites)
* Anticipating to remain within the region for 18 months
Exclusion Criteria:
* >20 weeks gestation by best obstetrical estimate
* Post partum and not anticipating another pregnancy within 18 months
* Preconception and not anticipating another pregnancy within 18 months
* Not cognitively aware enough to participate in the study
* Not willing to undergo at least two periodontal exams
* <18 years
* Not willing to chew 1 piece of xylitol gum for 10 minutes after the morning and evening meal (intervention sites)
* Anticipating a move outside of the region within 18 months
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 82 |
Target Study Title: Molecular Genetic Study of Schizophrenia: Parent-Offspring Trios
Target Study Description: #Study Description
Brief Summary
Schizophrenia is a chronic and devastating major psychiatric disorder. Family, twin, and adoption studies indicated that schizophrenia has a significant genetic component. The mode of transmission is still not clear and a multilocus model was proposed. The location of susceptibility gene of schizophrenia is still under active search using molecular genetic methods.
We propose to collect genomic DNA and lymphoblast cell lines of a total of 150 DSM-IV schizophrenic patients and their first degree relatives including parents (parent-offspring trios) and non-affected siblings in three years. Adequate statistical power of molecular genetic studies is a great concern. For this concern, we will examine the patients and their parents clinically by using the Diagnostic Interview for Genetic Studies (DIGS) for diagnostic assessment, and by using neuropsychological battery including sustain attention, executive function, verbal memory and general intelligence for neuropsychological evaluations.
The project is feasible because (1) The PI and his research team have experience in successfully collecting co-affected sib-pair families of schizophrenia and in setting-up molecular genetic laboratory in the past decade. We are experienced and competent to execute this project. (2) The PI and his research team have established the instruments using to clarify the phenotypes including the DIGS, the neuropsychological battery these years.
Major goals of this project are: (1) to cooperate with this important Taiwan Genotype Consortium proposed by the NHRI; (2) to detect major schizophrenia susceptibility genes related to the neuropsychological endophenotype; (3) to do further fine mapping on suggestive linkage markers to replicate previous linkage studies results using our previously-collected co-affected sib-pair family sample; and (4) to deposit the lymphoblast cell lines into NHRI Cell Bank serving as a national resource for basic research in Taiwan.
Detailed Description
1. Specific Aims We propose to collect genomic DNA and lymphoblast cell lines of a total of 150 families with the probands fulfilling the criteria of DSM-IV schizophrenia in three years. The first degree relatives of the probands, including parents (parent-offspring trios) and non-affected siblings, a total of about 3 to 6 subjects, will also be recruited in study. Adequate statistical power of molecular genetic studies is the great concern. For this concern, we will examine the probands and family members clinically by using the Diagnostic Interview for Genetic Studies (DIGS) for diagnostic assessment, and using neuropsychological battery including sustain attention, executive function, verbal memory and general intelligence.
This specific aims of this project are: (1) to cooperate with this important Taiwan Genotyping Consortium proposed by the NHRI; (2) to detect major schizophrenia susceptibility genes which are related to the neuropsychological endophenotype; (3) to do further fine mapping on suggestive linkage chromosome regions to replicate previous linkage studies results using our previously-collected co-affected sib-pair family sample; and (4) to deposit the lymphoblast cell lines into NHRI Cell Bank serving as a national resource for basic research in Taiwan.
2. Background
1. Genetic Basis of Schizophrenia Most family studies confirm that schizophrenia and related disorders is a familial disorder and that the risk to first degree relatives of schizophrenic patients is approximately ten times the risk to relatives of controls. Twin studies have found concordance rates from 46%\~53% for MZ twin pairs, and from 14%\~15% for DZ twin pairs (Kendler KS 1983; Gottesman II 1993; Prescott and Gottesman II, 1993); thus provide strong evidence for an hereditary component to schizophrenia. However, the concordance rates in MZ twins is far from 100% , which also emphasizes the importance of environmental factors in the etiology of schizophrenia. The evidence of genetic contribution to the etiology of schizophrenia is further supported by adoption study. Adoption studies of schizophrenia have shown that when biological offspring of schizophrenic mothers were raised by adoptive parents, they showed higher rates of schizophrenia as adults, compared to control adoptees.
Segregation analyses indicate that multifactorial polygenic model, which posit a large, unspecified number of loci to combine additively in causing schizophrenia, better fit the observed patterns of schizophrenia in family studies than do single major locus model. It was suggested that several genes of small effect in epistasis might responsible for genetic etiology of schizophrenia.
The location of susceptibility gene of schizophrenia is still under active search using molecular genetic methods. This way of approach included linkage analysis, candidate genes association study, and positional candidate gene approach, there is no a priori hypothesis that would lead one to focus on any given chromosomal region. Thus, the whole genome needs to be systemically screened. A few genome-wide scans of schizophrenia have been published for the decade and many chromosome regions showed suggestive evidences for linkage, including chromosome 1q21-q22, 1q31-q42, 2p22-q21, 4q24-q32, 6p24-p22, 6q16-q23, 8p24-p21, 10p14-p13, 13q14-q32, 15q13-q14, 22q11-q13. However, only a few chromosome regions were ever reported to have genome-wide significant linkage evidences, including chromosome 1q21-q22, 6p24-p22, 8p21 and 13q32.
Candidate genes studies revealed inconsistent results in the past decade. Neurotransmitter related genes, such as dopamine (D1, D2, D3, D4, D5), serotonin, r-aminobutyric acid and Glutamate receptor genes had been studied using both association and linkage studies and no consistent results obtained. Neuron growth related genes, phospholipase genes, and a potassium channel gene (hKCa3/KCNN3) have been reported association with schizophrenia. The hypothesis about the pathophysiological mechanism of schizophrenia provide the probable candidate genes approach in the molecular genetic study. There exists two issues to be resolved for candidate gene approach using case-control design. Firstly, a critical issue in assessing the significance of association with phenotypic measures is the likelihood of type I errors. Since many genes and phenotypes can be evaluated for schizophrenia, the significance level needs to be adjusted due to the low prior probability and multiple testing. Secondly, the effects of different population admixture between cases and controls may inflate the type I errors Positional candidate gene approach using linkage dysequilibrium strategy may resolve the above two problems raised by the approach of candidate gene association study basing upon the previous linkage results to increase the prior probability and using parent-offspring trios as internal control. This approach is more powerful than linkage study to locate the susceptibility genes of complex disorder as schizophrenia. With the fine mapping linkage evidences, the whole genome sequence and single nucleotide polymorphism (SNP) map, and the advancing microarray technique available, this approach is more efficient to locate the susceptibility genes of schizophrenia. Recently, a study using above strategy has been reported significant linkage dysequilibrium evidence of schizophrenia to a microsatellite polymorphism and a SNP of a gene, NOTCH4 gene, at chromosome 6p21.
Considering the potentials of positional candidate gene approach using linkage dysequilibrium strategies, we propose to collect parent-offspring trios of schizophrenia as the sample of further molecular genetic study of schizophrenia. With our previous and ongoing efforts in linkage studies of schizophrenia using co-affected sib-pairs of schizophrenia (see preliminary results), this sample can be used for further positional candidate gene studies.
3. Neuropsychological Deficit in Schizophrenia In the domain of neuropsychology, schizophrenia have been shown to have unique pattern of impairments in central executive function, sustained attention and working memory were rather unique in schizophrenia and are suggestive of frontostriatal dysfunction. It was agreed by most researchers that neuropsychological impairments of schizophrenia were best demonstrated by comprehensive test batteries tapping on various neuropsychological process, rather than single, isolated test and at present, the impairments strongly suggested dysfunction of frontal-temporal-limbic circuit.
Among the neuropsychological deficits in schizophrenia, visual sustained attention measured by the Continuous Performance Test (CPT) and executive function measured by the Wisconsin Card Sorting Test (WCST) were studied more thoroughly. Common features of the CPT are that participants must respond to predesignated targets among stimuli that are presented at a rapid fixed rate. The discrimination vigilance task of the CPT may consist of a single stimulus (CPT-X, single character or number as the target ) or two successive stimuli (CPT-AX, a character or number preceded by another character or number as the target). The difficulty level of the CPT can be raised further by blurring the stimuli (degraded CPT) or using a relative target (CPT-Identical Pairs Version or CPT-IP). The different CPT versions might tap on different components of sustained attention: the more difficult ones are stable vulnerability indicators, while the simpler ones might be mediating vulnerability indicators in schizophrenia. Among studies specifically examining the relationships between CPT performance indexes and clinical symptom dimensions, one of the most consistent findings is that CPT deficits are associated with negative symptoms. Many studies also found that poorer performance on the CPT were associated with thought disorder or disorganized symptoms.
Executive function deficits measured by WCST referred to abnormal function of prefrontal cortex. Deficits in WCST performance are enduring and core features of schizophrenia, and predict long term disability, independent of other cognitive deficits. Functional neuroimaging studies have found that the WCST activates the dorsolateral prefrontal cortex and that the dopamimetic drugs improves performance on this task in patients with schizophrenia and enhance the signal to noise of the prefrontal physiological response.
Previous studies confirmed that deficits in sustained attention and executive function are specific to schizophrenia and related to schizophrenic pathophysiological process. The deficits have also been associated with genetic risk of schizophrenia and may serve as an endophenotype in genetic analysis in schizophrenia.
4. Endophenotype Approach in Molecular Genetic Studies of Schizophrenia To resolve the problems of insufficient power of genetic analyses and genetic heterogeneity of schizophrenia, an alternative strategy was advocated that the use of a specific neurobiological characteristic of the illness as an additional phenotype that might reflect more closely the effect of a single genetic alteration.
The visual sustained attention deficits as measured by CPT was an potential endophenotype of the genetic susceptibility to schizophrenia. CPT deficits were present not only in schizophrenia patients, but also in their non-psychotic relatives. Using data from 148 non-psychotic relatives and 345 community adults found that the recurrence risk ratio λwas greater than 15 for the undegraded CPT and greater than 30 for the degraded CPT.
The executive function deficits as measured by WCST may also serve as an endophenotype in genetic studies of schizophrenia. WCST deficits presented both in schizophrenic patients and their healthy siblings.
Thus, using CPT deficits and WCST deficits as endophenotypes of schizophrenia would provide a valuable measure of genetic risk, would improve the power of genetic analyses and may help identify susceptibility genes for schizophrenia.
This endophenotype strategy has been successful in mapping of a neurophysiological deficit of schizophrenia, decrease of P50 inhibition, to loci at chromosome 15q13-14, recently. The genome-wide linkage analysis of the P50 inhibition deficit in nine multiplex schizophrenia families found a significant lod score (Z = 5.30, = 0) at a loci chromosome 15q14. When the clinical diagnosis of schizophrenia was used as the affected phenotype, the maximum lod score at the same marker was not statistically significant. The other neurobiological deficit, eye tracking dysfunction of schizophrenia has been mapped to chromosome 6p23-21 with the maximum multipoint lod score of 4.02. Again, while the clinical diagnosis of schizophrenia was used as the affected phenotype, the linkage result was non-significant.
In summary, with our preliminary studies in linkage analyses using co-affected sib-pairs of schizophrenia and neuropsychological deficits in schizophrenia, this project to collect schizophrenics of parent-offspring trios with well-defined neuropsychological endophenotypes, is considered to be one crucial project for searching the susceptibility genes of schizophrenia.
3. Preliminary Studies
1. Collection of Schizophrenia Co-affected Sibpairs Family The P.I. has been committed himself in collecting the schizophrenia co-affected sib-pairs family since 1990. With the awareness of the importance and critical necessity of diagnostic assessment, these probands, co-affected sib and available non-affected sib as well as the parents were assessed with a semi-structured psychiatrist diagnostic interview using diagnostic criteria of DSM-III-R and/or DSM-IV. Besides, under the evolutionary theoretical model of psychopathology, developmental data were also collected. All these clinical data and family-tree data were established in the data bank of the molecular genetic laboratory (DBMGL) in the Department of Psychiatry, College of Medicine, National Taiwan University under the auspice of the P.I. In total, there are around 120 schizophrenia co-affected sib-pairs families available for linkage analysis in the DBMGL. As a rule, the DNA samples were obtained from the peripheral white cells of all available subjects of the family, especially the co-affected sibs, at least one non-affected sib and the parents. In total, around 1000 DNA samples were in the DBMGL. Cell-lines of EBV-958 transformed lymphoblast cells were established too. All these study subjects were well informed for this study and informed consent obtained. All families participated in this study were invited to join a 'New-Hope Family Club' for periodic meeting and discussion. Around 150 schizophrenia cases who received detail clinical assessment and regular follow-up and comprehensive neuropsychological assessment, including CPT, WCST, WAIS-R, and WMS, were recruited for obtaining DNA samples. Around 200 normal control subjects were also recruited for obtaining DNA samples.
The instruments used in genetic studies have been established. The Diagnostic Interview Schedule for Genetic Study (DIGS) and schizotypy interview schedule (SIS) were translated and modified to be useful in Taiwan subjects. The Perceptual aberration scale (PAS) and Schizotypal personality questionnaire (SPQ) were also used in community study on schizophrenia-related personality disorders. The cross-cultural consideration was employed.
A 5-year nation-wide collaborative work in Taiwan (Taiwan Schizophrenia Linkage Study, TSLS), sponsored by the NIMH, U.S.A., to collect families with co-affected sib-pairs with schizophrenia has been going on in the third years. A total of 600 families will be collected. DNA samples, cell-lines and clinical data of DIGS, FIGS, as well as neuropsychological testing data were collected. The DNA sample would be open to research teams all over the world.
2. Molecular Genetic Studies of Schizophrenia Our molecular genetic studies of schizophrenia were supported by three consecutive projects: the molecular genetic project sponsored by the National Science Council (1989-1992), the molecular genetic project of MPGRP (1993-1998) and the molecular genetic project of MPSS (1998-2001) sponsored by NHRI. The early phase (1989-1992) of this molecular genetic project focused on establishing laboratory facilities and collecting co-affected schizophrenic sib-pair families. The 2nd phase of this molecular genetic project (1993-1998) continued the collection of families, and the collection was extended to collect the co-affected bipolar sib-pairs, schizophrenic cases and normal controls. We found the polymorphism of androgen receptor gene of (CAG)n had a probable association with schizophrenia. This finding supported the finding of DeLisi et al. The molecular genetic methods of linkage analysis and candidate gene association were promoted, this laboratory of the P.I. (Dr. Hwu) moved to emphasize in this area too. The results of this laboratory were: (1) The polymorphism of (48bp) repeats in DRD4 receptor gene was not significantly linked with schizophrenia; (2) A single mutation in DRD2 was found not to be associated with schizophrenia (3) The samples of the data bank of this project had joined three international collaboration studies using positional cloning approach which need relatively large sample. The one is organized by Gill et al entitled as 'Schizophrenia Collaborative Linkage Group', another was led by Dr. Moises in Kiel University, Germany and the third one is with Dr. Powell in London. All these results revealed the possible markers in chromosomes 6p, 11q, 13q, 19q and 22q. This suggests that Taiwanese patients may have possible susceptibility genes in these regions, except chromosome 13q, fitting an oligogenetic model. (4) The association study on 5-HT2 receptor gene located on chromosome 13q was found to be negative; (5) Clinical epidemiological analysis using co-affected sib-pairs demonstrated the tendency of 3 independent symptom clusters of reality disorganization, disorganization and negative state. (6) Weak linkage evidence to loci at chromosome 6p24-22.
The 3rd phase of the molecular genetic study (1998-2001) continued focusing at collecting co-affected schizophrenic sib-pair families and linkage analysis on reported suggestive evidences of chromosome regions, including chromosome 1q21-q22, 1q31-q42, 8p24-p21, 15q13-q14, 22q11-q14. The linkage results were (1) suggestive evidence of linkage for schizophrenia with and without the negative symptoms on chromosome 6p24 and 22q12 (2) no linkage evidence of GABAA receptor α1 (GABRA1) , β1 (GABRB1) andβ3 (GABAB3) subunit gene with schizophrenia (3) no linkage evidence of Glutamate GluR5 and GluR6 receptor gene with schizophrenia (4) no linkage evidence of SCA1 gene with schizophrenia (5) suggestive linkage evidence on markers of chromosome 8p with schizophrenia (Hwu et al., 2001a) (6) weak linkage evidence of markers of chromosome 1q31-42 with schizophrenia (7) suggestive linkage evidence of markers on 15q13-14 with schizophrenia (8) modest linkage evidence of schizophrenia to loci at chromosome 1q21-22. The candidate gene approach has revealed the following results: (1) possible association between Dopamine D4 receptor (DRD4) gene polymorphism with quick treatment response of schizophrenia (Liu et al., 2001d) . (2) no association between cytosolic phospholipase A2 (c-PLA2) gene polymorphism and schizophrenia.
3. Studies on Neuropsychological Deficits in Schizophrenia We found impaired sustained attention by continuous performance test (CPT) as the trait marker of schizophrenia. Family studies have indicated that sustained attention deficits as measured by the CPT are vulnerability markers of schizophrenia. The results are: (1) a substantial proportion of non-psychotic relatives of schizophrenia probands (19-34%) have CPT deficits, which can be predicted from their probands' CPT performance; (2) subjects with schizotypal personality features also exhibit CPT deficits, which are specifically associated with negative factors of schizotypy; (3) CPT deficits are present in schizophrenic patients, are particularly associated with negative and disorganized symptoms, and those with more difficult CPT versions are not amenable to neuroleptic treatment.
The specificity of CPT was studied in a group of schizophrenia patients (n=41) in contrast to the group of bipolar patients with psychotic symptoms (n=46) and the group of bipolar patients without psychotic symptoms (n=22) and a group of patients with non-psychotic major depressive disorder (n=22). It was found that CPT deficits are stable vulnerable indicators of schizophrenia, mediating vulnerability indicators for bipolar disorder, and state-dependent indicator for major depression. These results demonstrate that CPT deficits are valid trait marker of schizophrenia.
All these preliminary data support that the PI and his associates is capable in executing this project including collection of parent-offspring trios families, DNA extraction and cell culture laboratory techniques, and the neuropsychological assessment.
4. Research Design and Methods
1. Subjects We prepare to collect parent-offspring trios families from the Medical Center of National Taiwan University Hospital and the affiliated psychiatric hospitals, the Taoyuan Psychiatric Center. The proband cases to be recruited are the residents of the Northern part of Taiwan. Informed consent will be obtained before the recruitment for study. The first degree relatives to be recruited are the parents and at least one of the unaffected siblings. The diagnosis of the proband cases is of schizophrenia defined by DSM-IV criteria.
1. Clinical Assessment Measures I. The Diagnostic Interview for Genetic Studies (DIGS) All subjects will be personally interviewed with the DIGS, which was created by Tsuang and Faraone from the NIMH Human Genetics Initiative. The DIGS makes a detailed assessment of the course of illness, and makes a careful assessment of substance abuse and mood symptoms. This allows for an easier differential diagnosis between schizophrenia and substance related psychoses, schizoaffective disorders and psychotic mood disorders. This detailed assessment helps protect against false positive diagnosis.
In addition, the DIGS provides a rich description of many domains of psychopathology: somatization, major depression, mania/hypomania, dysthymia/depressive personality/hyperthymic personality, alcohol abuse disorders, pathological gambling, and antisocial personality disorder. It also collects self-reported demographic and medical history data. Ratings are also made on the Global Assessment Scale and the Scales for the Assessment of Positive and Negative Symptoms. Schizotypal and other Axis II Cluster A personality features are assessed by using a modified version of the Structured Interview for Schizotypy.
II. The Family Interview for Genetic Studies (FIGS) As an additional source of pedigree information, the FIGS will be conducted with all members of the family. This interview systematically questions an informant about the presence of psychiatric illness in relatives. We administer the FIGS in three steps. First, the structure of the family pedigree is drawn and reviewed with the informant. Next, psychiatric screening questions are asked about all relatives in the pedigree. Then based on the responses to the screening questions, one or more of five symptom checklists (depression, mania, substance abuse, psychosis, paranoid /schizoid/ schizotypal personality disorder) are completed for each first-degree relative, spouse, or other relative well known to the informant.
The DIGS and FIGS were translated into Chinese. The reliability and validity have been established in our preliminary studies.
III. The Diagnostic Procedure All diagnoses will be made using DSM-IV. These diagnoses will be made by two board certified psychiatrists with clinical and research experience in the diagnosis of psychotic patients. Final diagnoses of probands and relatives will be based on the content of the interview, the case vignette, information provided by relatives and a complete review of the medical record by each diagnostician. If the two diagnosticians disagree about any of the patient's diagnoses, a third diagnostician will be used as a tie-breaker.
IV. Training of Interviewers The training program will certify the interviewers: (1) establish a working knowledge of the diagnostic systems used in the DIGS and FIGS; (2) develop expertise in the administration and scoring of the structured diagnostic instrument; and (3) fully understand the process of informed consent and the need for strict adherence to consent procedures.
The training program is divided into two stages: (1) formal didactic training and (2) supervised experience using the structured diagnostic interview.
The didactic training begins with trainees reading and familiarizing themselves with the diagnostic systems used by the DIGS. This initial exposure is supplemented by lectures which review diagnostic criteria for all psychiatric disorders covered by the interview. Central issues addressed in these lectures are: (1) the importance of establishing diagnoses on the basis of objective behavioral description; (2) careful delineation and differentiation of syndromes which involve both psychotic and affective phenomena; and (3) clarification of major differences in syndrome definition among diagnostic systems.
The second component of training focuses on the structured diagnostic instruments. Trainees first gain familiarity with the structure of the interview. This is facilitated by having trainees conduct practice interviews in which they alternately play the roles of interviewer and subject. These initial interviews are conducted with a senior psychiatrist in attendance to identify problem areas in administration and to ensure clinically sensitive use of the interview.
The training program also includes a module on the modified Structured Interview for Schizotypy (SIS). The SIS training includes a review of the literature about schizotypal personality disorder, an orientation and review of the instrument, an opportunity for trainees to observe and make clinical ratings of a live interview, and a review and discussion of clinical ratings to clarify scoring criteria. All the training courses have been well established in our preliminary studies.
2. Neuropsychological Evaluations
Considering the complexity of the proposed neuropsychological deficits in schizophrenia, a test battery tapping multiple aspects of cerebral process is chosen to explore patients' overall pattern of neuropsychological deficits. The battery consists of tests supposed to measure:
1. Sustained attention (the Continuous Performance Test (CPT), both in undegraded and degraded test situations)
2. Central executive functions (Wisconsin Card Sorting Test (WCST); Trail-making B);
3. Memory function (Weschler Memory Scale-third edition, WMS-III).
4. Test for general intellectual achievements (block design; picture completion; information; similarity; arithmetic; digit span; digit symbol substitution).
The neuropsychological test used in present study and validity of the test battery have been well established in our preliminary studies. We prepare to administer the neuropsychological test battery to the probands and all the recruited family members as possible. The neuropsychological test battery is rather time-consuming, estimated to take 3 to 4 hours to complete. Hence, the neuropsychological test battery will be administrated in divided sessions, completed in two days. Two master degree research assistants majored in psychology will perform all the tests.
2. Laboratory Work: This project has two lines of laboratory work
1. Collection of blood samples and extraction of DNA Twenty to thirty ml of venous blood will be obtained from all study subjects into purple top and green top vacutainer tubes. The blood sample in purple top tubes will be used for DNA extraction. We prepare to extract the DNA using a modified salting-out method.
2. Cell-line set-up All blood samples newly collected will have the lymphocyte transformed into lymphoblastic cell for preservation of cell-line which will be deposited into the cell bank of NHRI as the proposal requested. The detail procedures of cell culture established in our molecular genetic laboratory are listed as attached files molecular genetic study.
3. Data Management We have already set up the computerized DIGS database software in our previous study (Taiwan Schizophrenia Linkage Study, TSLS) and neuropsychological databank in another previous study (Multidimensional Psychopathological Study for Schizophrenia, MPSS). All the clinical and neuropsychological data in this project will be incorporated into these databanks.
The family pedigree data, DNA data, and cell culture data will be incorporated into our previously established databank: Bank of Molecular Genetic Laboratory Data (BMGLD). This BMGLD will include 4 sets of Data: (1) family tree and genotyping data bank. These data are set-up using the cyrillic program ; (2) DNA sample bank; (3) clinical data and endophenotype bank and (4) cell-line bank. This well organized BMGLD will be of great value for continous research work.
The data entry procedures will follow the guidelines that we use for our ongoing projects. These procedures seek to maximize the accuracy of data. The data will be double-entered, and the original and verification files will be compared for discrepancies. All datasets will be backed up to disc regularly. The backup and original data sets will be maintained in different locked offices.
The datasets in this project will be available to other investigators following the guidelines of the RFA. We will create a dataset which will include all data required by the RFA and whatever additional data the NHRI desires to incorporated into the Cell Bank. These data will be sent to the data management center designated by the NHRI for subsequent distribution to the member of genotyping consortium.
5. Anticipated Results We anticipate through this project to attain the following goals: (1) to cooperate with this important Taiwan Genotyping Consortium proposed by the NHRI, (2) to detect major schizophrenia susceptibility genes which are related to the neuropsychological endophenotype, (3) to do further fine mapping on suggestive linkage chromosome regions to replicate previous linkage studies results using our previously-collected co-affected sib-pair family sample, and (4) to deposit the lymphoblast cell lines into NHRI Cell Bank serving as a national resource for basic research in Taiwan.
6. Human Subjects This is a genetic study, all subjects recruited will present his signed informed consent before being enrolled for study. There is no invasive procedure of potential hazard in the process of the clinical interview and the neuropsychological evaluations. Blood samples of 30 c.c. will be drawn. This will be done using a needle and this may cause some painful sensation which is usually negligible in clinical setting. These participating subjects will be reassured as any discomfort feeling happens during the study procedures.
All researchers participated in this study procedure are all well trained. If these is any unexpected emotional or physical reaction happens during the study procedure, the P.I. of the project should be informed and necessary actions will be taken immediately. Since this is a genetic study, in the study procedure, there may have the genetic counseling issue raised. The participating researchers will be educated before attending this study for this topic of genetic counseling. These subjects or their family who are in need of specific genetic counseling will be refer to the special clinic, locating in the outpatient department of the National Taiwan University Hospital, of the P.I. of this project for special care.
7. Animal Investigation not involved.
8. Potential Hazards The clinical interview, the neuropsychological evaluations, and the blood sample drawn will be very safe. However, this genetic study might provoke some emotional reaction of the family, especially regarding the genetic heritability. In this case, the attending researchers, well trained, will give immediate assurance and assessment. If anything considered to be necessary, these subjects will be referred to the special clinic of the P.I. of this project for special psychiatric care.
The procedure of blood sample drawing might create mild degree of painful sensation or fearful feeling. These cases will be reassured immediately. Generally speaking, this study procedure is safe and the potential hazards is minimal and is manageable if anything happen.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* DSM-IV schizophrenic patients and their first degree relatives including parents (parent-offspring trios) and non-affected siblings
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 83 |
Target Study Title: A Randomized, Controlled, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of ARTISS (FS VH S/D 4 S-apr) for Flap Adherence in Subjects Undergoing Abdominoplasty
Target Study Description: #Study Description
Brief Summary
The purpose of the study is to compare the safety and efficacy of ARTISS versus standard of care in adhering tissue places and reducing seroma/hematoma formation in subjects undergoing abdominoplasty.
#Intervention
- BIOLOGICAL : FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)
- Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed.
- Other Names :
- ARTISS
- PROCEDURE : Standard of care
- Standard of care
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Subject is 18 <= age <= 75 of age at the time of screening
* Subject is planned for primary standard abdominoplasty (status post Cesarean section or liposuction performed more than 6 months prior to enrollment in the study are allowed)
* If the subject is of childbearing potential; presents with a negative pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
* Subject resides within 100 miles of the investigational site and is willing and able to comply with the scheduling requirements of the protocol (notably home visits by study personnel)
* Subject is willing and able to comply with the requirements of the protocol
Exclusion Criteria:
* Subject is obese (body mass index [BMI] > 30 before surgery)
* Subject has experienced massive weight loss (subject has a history of obesity during adult life; subject lost more than 20 BMI unit score, subject has undergone a bariatric surgery)
* Subject has a history of active smoking within the previous 12 months
* Subject is elected for a non-standard abdominoplasty (extended, limited or mini-abdominoplasty, endoscopic, fleur-de-lis or circumferential abdominoplasty) or panniculectomy
* Subject has scars on the abdominal wall above the umbilicus. Vertical midline, laparoscopic punctures, or liposuction punctures are permitted
* Subject is planned for other 'body lifting' procedures (eg to the arms, legs, back etc.)
* Subject is planned for combined abdominoplasty with other cosmetic procedures including liposuction (restricted liposuction of the waist line and the lower back is allowed, as long as the integrity of the surgical spaces is maintained)
* Subject has an active or chronic skin disorder, history or evidence of keloid formation, or hypertrophic scarring
* Subject has a history of gastrointestinal disorders (eg Irritable Bowel Syndrome) requiring prescription medications
* Subject has a known abdominal hernia that requires mesh fixation
* Subject has a documented hiatal hernia or acid reflux disease
* Subjects with congenital or acquired immunodeficiency disorders
* Subject has uncontrolled diabetes mellitus (HbA1c > 7.0)
* Subject has a history of cardio-vascular disease including uncontrolled hypertension (> 140/90 mm Hg)
* Subject has a clinically diagnosed psychiatric disorder (including obsessive compulsive disorders)
* Subject has a known (documented) bleeding or coagulation disorder including history of thromboembolic events
* Subject is being treated with anti-coagulants or with Aspirin (that was not discontinued 7 days prior to surgery)
* Subject is receiving active treatment for a malignancy
* Subject has a connective tissue disorder
* Subject has received chronic treatment with immunosuppressive drugs, systemic corticosteroids, or other chronic treatments within 30 days prior to the surgery
* Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
* Subject has a known sensitivity to fibrin sealants
* Subject is a friend, employee, or relative of the investigator or other study personnel
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 84 |
Target Study Title: Omega-3 Fatty Acids to Combat Sarcopenia
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to determine how omega-3 fatty acids influence muscle protein metabolism and mitochondrial physiology in the context of human aging.
#Intervention
- DRUG : Omega-3 fatty acids
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 35 or 65 <= age <= 85 years
Exclusion Criteria:
* Current use of omega-3 nutritional supplements
* Fasting plasma glucose >=126 mg/dL
* Active coronary artery disease
* Participation in structured exercise (>3 times per week for 30 minutes or longer)
* Smoking
* Medications known to affect muscle metabolism (e.g., beta blockers, corticosteroids, tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, anticoagulants)
* Renal failure (serum creatinine > 1.5mg/dl)
* Chronic active liver disease (Bilirubin > 17mmol/L, AST>144IU/L, or ALT>165IU/L)
* Anti-coagulant therapy (warfarin/heparin)
* INR >3
* Use of systemic glucocorticoids
* Chronic use of NSAIDS or aspirin
* Pregnancy or breastfeeding
* Alcohol consumption greater than 2 glasses/day
* Hypothyroidism
* Fish or shellfish allergy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 85 |
Target Study Title: Parent Focused Obesity Intervention for Low-Income African American Preschoolers
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to preliminarily validate a parent-focused obesity intervention program for parents of low-income, African American preschoolers who are currently overweight (\> 85th BMI %tile). Half of the participants will receive an intervention that is eight sessions in length and carried out in the participant's home. The sessions will target the nutrition and physical activity knowledge of parents and their motivation for changing parenting related to family eating habits and activity level. The remaining participants will receive an attention comparison control condition (ACCC), which includes one home visit, 7 newsletters and 4 monthly support phone calls. It is hypothesized that children of parents receiving the intervention will have decreases in BMI %tile, consume more fruits/vegetables and fewer sugary beverages, and engage in more activity as compared to ACCC.
Detailed Description
This study will do a preliminarily validation of a parent-focused obesity intervention program for parents of low-income, African American preschoolers who are currently overweight (\> 85th BMI %tile). Participants will be randomly assigned to an intervention or attention control condition. Those in the intervention will receive an intervention that is eight sessions in length and carried out in the participant's home. The sessions will target the nutrition and physical activity knowledge of parents and their motivation for changing parenting related to family eating habits and activity level. Sessions include psycho-education and skills building exercises. The attention comparison control condition (ACCC) participants will receive one home visit, 7 newsletters and 4 monthly support phone calls. The content of this condition also focuses on nutrition and activity knowledge, motivation and parenting. Outcomes for the intervention and ACC conditions will be assessed at baseline, post-intervention and at a 6-month and 1-year followed up. Child BMI %tile, consumption of fruits/vegetables and sugary beverages, and activity level will be analyzed to examine intervention effectiveness across time.
#Intervention
- BEHAVIORAL : Intervention
- Home-based session targeting the parent
- BEHAVIORAL : Attention Control
- Attention condition with newsletters and support phone calls
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Parents of children enrolled in Head Start preschool in Detroit, MI will be included. Parents must be 18 years or older and their child must be of preschool age, between 3 and 5 years. Based on recruitment from Detroit Head Start, families will be low-income and of African American descent. Children will have a current body mass index percentile at or above the 85th percentile.
Exclusion Criteria: Child BMI percentile below the 85th percentile.
*
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 86 |
Target Study Title: Piloting a Complex Intervention Involving Physical Exercise, Cognitive Training and Socialising to Delay the Onset of Dementia in Mild Cognitive Impairment
Target Study Description: #Study Description
Brief Summary
Dementia is serious problem and around 700 000 people are affected in the UK alone. Currently there is no cure however early diagnosis and effective treatment offers hope for reducing the impact. Dementia sufferers require care due to physical disability, cognitive deficits, social isolation and emotional symptoms (depression). Delaying the onset of dementia will improve quality of life for patients and reduce the cost of residential care (£42 000 per person per year).
People with mild cognitive impairment (MCI) are at high risk of developing dementia. They have impaired cognitive abilities, such as memory, but still manage their everyday activities. Studies show that 8 out of 10 people with MCI will have developed dementia 6 years after diagnosis.
Regular physical activities and performing a variety of cognitive activities reduce the risk of dementia and improves abilities and quality of life in healthy people. Therefore a combination of these activities may reduce the risk of developing dementia in MCI. The investigators want to see if they can develop a program which combines these activities in a fun and social way that gets people active and keeps them active. The aims are to improve fitness, cognition and quality of life. The investigators plan to use computers and the internet to help with the activities and to make them available to people who are isolated. Physical activity will involve walking from home, cognitive activities will be computer based games and puzzles and socialising will involve regular varied group-based activities. Participants (128) will be recruited from the UCL Derwent Memory Clinic and will complete a 26 week program. They will then be followed up yearly to monitor their progress. The main outcome of the study is engagement in the activities. The investigators will also measure fitness, cognition, quality of life and conversion to dementia.
#Intervention
- PROCEDURE : ThinkingFit programme
- Combined physical, cognitive and social stimulation activties.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion criteria for patients with MCI
* Patients fulfilling criteria for AMCI [Petersen et al. 2001b]:
i. Memory impairment for age and education ii. No impairment in other cognitive domains iii. Normal social activities iv. Patient is not demented
* For the other subtypes of MCI, cognitive impairment in one or more nonmemory domain
* Sedentary lifestyle with no regular participation in physical exercise defined as two or three times a week for at least 20 minutes duration, or participation in active sport more than once a week, in the previous six months.
* Willing and able to give informed consent.
* Availability and access to safe exercise environments, such as paths or roads with sidewalks for walking or cycling.
* At low risk from serious adverse effects from increased physical activity as indicated by performance on the revised Physical activity readiness questionnaire (PARQ).
Exclusion Criteria:
Exclusion criteria for patients with MCI
* Type 1 (insulin dependent) diabetes mellitus.
* Blood pressure of 160/100 mmHg or more.
* Body weight more than 140% of ideal body weight.
* Musculoskeletal or other medical problems preventing safe participation in regular moderate intensity exercise (65 <= age <= 77% of predicted maximum heart rate). This will include a resting tachycardia (heart rate above 100 bpm) and history of myocardial infarction or unstable angina within the last month.
Participants with modifiable exclusion criteria will be reconsidered after successful management. Patients will be referred for medical treatment prior to commencing exercise if indicated by the PARQ and the intervention will be guided by the PARmedX.
Participants taking medications affecting heart rate will need to be on a stable dosing regime for 3 months prior to commencing in order to control for potential spurious results on fitness measures caused by these treatments.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 87 |
Target Study Title: The Effect of Use of Virtual Reality Glasses and Manual Pressure Method on the Level of Pain and Fear in Children During Intramuscular Injection
Target Study Description: #Study Description
Brief Summary
This study was planned to determine the effects of using virtual reality glasses and manual pressure during intramuscular injection on the level of pain and fear in children. The study will consist of children aged 6-10 years who come to the Pediatric Emergency Service injection room for prescription penicillin injection and meet the inclusion criteria. One of the main purposes of nursing care is to relieve the child's pain and improve the quality of life. In this context, it has been suggested that two different methods used by the researcher can positively affect the levels of pain and fear. For this reason, it is aimed to determine the efficiency level of two different methods.
Detailed Description
75 children and parents meeting the inclusion criteria will be included in the study. For the penicillin injection prescribed by the doctor, the child and the parent who come to the pediatric emergency injection room of the hospital where the research is carried out are informed about the study and the parent is asked to sign the 'Informed Consent Form'. . After obtaining the consent of the family, the 'Child-Parent Information Form' is filled by the researcher through the parent. Simple randomization will be done to give an equal number of samples to the control, virtual reality glasses and manual pressure group to be applied to the child who will participate in the study. Randomization of the study will be done with the online program at the URL https://www.randomizer.org/. Children to be included in the sample will be divided into three groups by randomization method. The numbers from 1 to 75 will be entered into the program without repeating, in order to determine which group the children included in the study will be in. The children who will form the study group through the program will be randomly distributed into 3 groups. . The two interventions in the study will be virtual reality glasses (n=25) and manual pressure (n=25) and control group (n=25).
In the control group (n=25), the child, the parent and the researcher will evaluate the children's fear levels before the procedure with the Child Fear Scale. In this group, a routine intramuscular injection will be made into the vastus lateralis muscle and the researcher will perform the application. No intervention other than routine will be applied. After the intramuscular injection, the pain level of the children will be evaluated by the child, the parent and the researcher with the Facial Expressions Pain Scale-Remodeled.
The group (n=25) wearing VR Glasses will be shown an age-appropriate VR video alongside the routine practice. Before the procedure, the level of fear will be evaluated as in the control group. A virtual reality VR video is watched 1 minute before the intramuscular injection. The child who continues to watch the video is placed on his back and penicillin is injected intramuscularly into the vastus lateralis muscle. Post-injection pain level will be evaluated as in the control group. Virtual reality glasses compatible with 'VR BOX 3D' smartphones will be used in this group. Product weight: 0.414 kg. Product size (length x depth x height): 19.5 x 14 x 11 cm/ 7.66 x x5.50 x 4.32 inches. No power adapter or connection cable other than the phone will be needed during use. All children participating in the research will watch the 'Hidden Underwater World', which is recommended by taking the opinion of an expert (child developmentist) suitable for their age. The virtual reality glasses used in the application will be disinfected and ready for the next application.
The manual pressure group (n=25) will be evaluated with the Child Fear Scale before the procedure. In addition to the routine application, pressure will be applied to the area to be injected for 10 seconds before the injection process. Pressing with the thumb of the hand, which will be passive in the pressing application, will be understood by the whitening of the nail, and thus pressure will be applied to the skin. Then, as in other groups, an injection will be made into the vastus lateralis area. After the injection, the child will be evaluated in terms of pain with the Facial Expressions Pain Scale revised by the parent and the researcher.
Informed Consent Form, Child-Parent Information Form, Child Fear Scale and Facial Expressions Pain Scale-Revised will be filled for each child who will participate in the study. It is planned to fill the Child Fear Scale before the injection and the Facial Expressions Pain Scale-Revised after the injection.
It is planned that the scales to be applied to the child and parent who will participate in the research will be applied face to face in the injection room of the hospital and 10-15 minutes will be given for each application.
The obtained data will be evaluated using the necessary statistical tests in the computer environment. Evaluation methods will be chosen based on whether the data is homogeneously distributed. If it has a homogeneous distribution, parametric tests will be used. If it does not have a homogeneous distribution, non-parametric methods will be used.
#Intervention
- OTHER : Virtual reality glasses group
- It is suggested that the use of virtual reality glasses during the injection will positively affect the pain and fear levels in children who received penicillin injection in the pediatric emergency department where the study was conducted.
- OTHER : Manual pressure group
- In the pediatric emergency department where the study was conducted, pressure will be applied to the area to be injected for 10 seconds before the injection procedure in children who received penicillin injection. Pressing with the thumb of the hand, which will be passive in the pressing application, will be understood by the whitening of the nail, and thus pressure will be applied to the skin. It is suggested that it can positively affect pain and fear levels.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Having applied to the pediatric emergency service for the administration of a penicillin antibiotic group drug,
* Absence of a significant chronic disease,
* Absence of visual and auditory disabilities,
* Having no communication problems and being conscious,
* No previous history of fainting during injection,
* Not taking analgesics in the last three hours,
* Percentile value is in the range of 3 <= age <= 97 points,
* Injection into the vastus lateralis muscle can be applied,
* The child's and parent's willingness to participate in the research.
Exclusion Criteria:
* The percentile value is below 3 and the percentile value is above 97,
* Family's inability to cooperate in the assessment of pain and fear,
* Having a diagnosed physical or mental disability,
* To have taken analgesics in the last 3 hours,
* Presence of incision and scar tissue in the area to be injected,
* The child's and parent's refusal to participate in the research.
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 10 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 88 |
Target Study Title: Phase I/II Double Blind Randomized Trial of Lenalidomide/Dexamethasone/Anakinra vs. Lenalidomide/Dexamethasone/Placebo in Patients With Early Stage Multiple Myeloma and High Plasma Cell Growth Rate
Target Study Description: #Study Description
Brief Summary
This partially randomized phase I/II trial studies the side effects and best dose of anakinra when given together with lenalidomide and dexamethasone in treating patients with early stage multiple myeloma. Biological therapies, such as lenalidomide and anakinra, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether lenalidomide and dexamethasone are more effective with or without anakinra in treating patients with multiple myeloma.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD)/maximum allowable dose (MAD) of anakinra that can be combined with lenalidomide and dexamethasone. (Phase I) II. To compare the time to progression of the standard treatment arm (lenalidomide/dexamethasone) to the experimental arm (lenalidomide/dexamethasone + anakinra). (Phase II)
SECONDARY OBJECTIVES:
I. To compare the response rate of the standard treatment arm (lenalidomide/dexamethasone) to the experimental arm (lenalidomide/dexamethasone + anakinra).
II. To compare the toxicity of the standard treatment arm (lenalidomide/dexamethasone) to the experimental arm (lenalidomide/dexamethasone + anakinra).
III. To compare the overall survival of the standard treatment arm (lenalidomide/dexamethasone) to the experimental arm (lenalidomide/dexamethasone + anakinra).
OUTLINE: This is a phase I, dose-escalation study of anakinra followed by a phase II study.
PHASE I: Patients receive lenalidomide orally (PO) on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Patients also receive anakinra subcutaneously (SC) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive lenalidomide PO on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Patients also receive anakinra SC on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive lenalidomide and dexamethasone as in Arm A. Patients also receive placebo SC on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
#Intervention
- BIOLOGICAL : Anakinra
- Given SC
- Other Names :
- Kinaret, Kineret, rIL-1ra, rIL1RN
- DRUG : Dexamethasone
- Given PO
- Other Names :
- Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Fluorodelta, Fortecortin, Gammacorten, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, Visumetazone
- OTHER : Laboratory Biomarker Analysis
- Correlative studies
- DRUG : Lenalidomide
- Given PO
- Other Names :
- CC-5013, CC5013, CDC 501, Revlimid
- OTHER : Placebo
- Given SC
- Other Names :
- placebo therapy, PLCB, sham therapy
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Absolute neutrophil count (ANC) >= 1700/mm^3
* Platelet count >= 100,000/mm^3
* Hemoglobin >= 8.0 g/dL
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x upper limit of normal (ULN)
* Creatinine clearance >= 30 mL/min (as determined by Cockroft-Gault equation)
* Diagnosis of multiple myeloma according to International Myeloma Working Group criteria and one of the following:
* Smoldering multiple myeloma (SMM)
* Indolent multiple myeloma (IMM)
* Newly diagnosed multiple myeloma (MM)
* Note: patients with lytic disease and anemia are eligible
* High risk disease defined by all of the following:
* >= 10% bone marrow plasma cells AND
* Abnormal serum free light chain (FLC) ratio (< 0.26 or > 1.65) by serum FLC assay AND
* Monotypic plasma cell S-phase >= 0.3%
* Measurable level of M-protein > 1 g/dL on serum protein electrophoresis or > 200 mg of M-protein on a 24 hour urine protein electrophoresis
* Negative tuberculosis (TB) testing (Quantiferon - TB blood test or skin test) =< 7 days prior to registration
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Provide signed informed consent
* Negative (serum or urine) pregnancy test done =< 7 days prior to registration, for women of childbearing potential only; NOTE: a second pregnancy test must be performed within 24 hours prior to the start of lenalidomide; the subject may not receive lenalidomide until the study doctor has verified that the results of these pregnancy tests are negative
* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
* Willing and able to comply with the requirements of the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program
* Females of childbearing potential must be willing to adhere to the scheduled pregnancy testing as required by the Revlimid REMS program
Exclusion Criteria:
* Prior treatment with any other agent that may affect M-protein =< 30 days prior to registration
* Acute/chronic infections, open wounds, or any active infection requiring intravenous antibiotic therapy =< 12 weeks prior to registration
* Other active malignancy (=< 3 years) prior to registration; exceptions: basal cell skin cancer or carcinoma-in-situ of the cervix or low-risk prostate cancer after curative therapy
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* New York Heart Association (NYHA) class 3 or 4 congestive heart failure (CHF) symptoms
* Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are allowed while on protocol treatment
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 89 |
Target Study Title: Inspiratory Muscle Training in Respiratory Capacity, Life Quality, Lumbar Pain, Phase Angle and Body Composition in Patients With Fibromyalgia.
Target Study Description: #Study Description
Brief Summary
Context/background: people affected by fibromyalgia see their own life totally disturbed after the diagnosis. This disease also courses, apart from the functional and depressing worsening, with internal damage manifested by a cardio respiratory deterioration. There are not many clinical studies publications about this disease given that is considered a weird illness with short prognosis.
Objectives: to examine the effects of the inspiratory muscle training (IMT) on respiratory muscle strength, lumbar pain, quality of life, phase angle and body composition in patients with Fibromyalgia.
The participants of experimental group will conduct 5 sets of 10 inspirations per day, 5 days per week, through 8 weeks.
Detailed Description
Methods: 40 volunteer patients, female, with fibromyalgia will take part of the cuasi-experimental study and they will be divided into two groups: an experimental group (n = 20) and a control group (n = 20). The Maximum Inspiratory Pressure (PIM), the quality of life, lumbar pain, phase angle and body composition will be measured.
Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Each day, each subject perform 5 sets of 10 inspirations, 5 days a week. The endurance of the device increases along the study, initiating with the 50% of their own maximum inspiratory pressure (MIP) during the first week, 2nd week: 55% MIP, 3rd week: 60% MIP, 4th week: 65% MIP, 5th week: 70% MIP, 6th week: 75% MIP, 7th week: 80% MIP and 8th week:80% MIP
After 8 weeks, all participants will fill up again all scales and post training measurements will be taken.
#Intervention
- OTHER : Inspiratory Muscle Training with Powerbreath IMT device.
- Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks. Each day, each subject perform 5 sets of 10 repetitions, 5 days a week. The endurance of the device increases along the study, initiating with the 50% of their own maximum inspiratory pressure (MIP) during the first week, 2nd week: 55% MIP, 3rd week: 60% MIP, 4th week: 65% MIP, 5th week: 70% MIP, 6th week: 75% MIP, 7th week: 80% MIP and 8th week:80% MIP
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* subjects with fibromyalgia
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 90 |
Target Study Title: Evaluation of the Efficacy of Procedural Sedoanalgesia and Infraclavicular Nerve Blockade on Analgesia in Forearm Fractures in the Emergency Department
Target Study Description: #Study Description
Brief Summary
The aim is to evaluate the success of reduction procedures and pain palliation in patients with forearm fractures undergoing reduction under procedural sedation-analgesia (PSA) and ultrasound (US)-guided infraclavicular nerve block (ICB) in the emergency department.
Detailed Description
Forearm fractures are among the most frequent reasons for adults to visit the emergency department. These fractures cause significant pain both due to the fracture itself and during the reduction process. Pain management in emergency departments (ED) is crucial. Therefore, multimodal approaches are available to reduce or eliminate pain during the reduction process. The aim of this study is to evaluate the success and pain palliation of the reduction process with procedural sedation-analgesia (PSA) and with reduction under ultrasound (US)-guided infraclavicular nerve block (ICB) in patients with forearm fractures. The secondary aim is to compare patient comfort, physician comfort, side effects, length of stay in the emergency department, and the need for painkillers after discharge between these two procedures, and to identify the most suitable method. This study aims to contribute to practical applications in order to provide optimal pain control in patients with forearm fractures in emergency departments.
Patients' pain levels at arrival, pre-reduction procedure, and post-reduction procedure will be recorded using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).The success of the reduction procedure, whether further reduction attempts were necessary, and findings from post-reduction control X-rays (radial height, radial tilt, and volar tilt) will be noted and evaluated by orthopedic physicians.
#Intervention
- DRUG : Bupivacaine Hydrochloride
- After preparing the infraclavicular block site, a 22-gauge needle, guided by ultrasound, will be placed in the 6-7 o'clock position in the same plane as the ultrasound probe. Subsequently, lateral, medial, and posterior cords described as hypoechoic nerve fascicles within hyperechoic structures will be identified. Initially, 2 mL of saline will be administered to confirm proper spread. Once confirmed, 20 mL of 0.25% bupivacaine (prepared by diluting 10 mL of 0.5% bupivacaine with 10 mL of normal saline) will be injected in fractional doses with intermittent negative aspiration. Fifteen minutes after this procedure, anesthesia depth will be assessed using a cold-hot test, followed by reduction and application of the cast.
- Other Names :
- Infraclavicular nerve block (ICB)
- DRUG : Ketamine
- Until the recovery period, patients will be closely monitored by an experienced doctor or nurse during sedation. Emergency equipment will be readily available in case of any complications. The following protocol will be used for procedural sedation-analgesia (PSA): Ketamine will be administered intravenously at a dose of 0.5-1 mg/kg. Patients with Numeric Rating Scale (NRS) scores above 5 may receive additional doses of 0.25-1 mg/kg, repeated every 5 to 10 minutes as needed.
- Other Names :
- procedural sedation-analgesia
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years and older,
* Diagnosed with forearm fracture using standard radiography,
* Hemodynamically stable individuals,
* Without vascular or nerve injury,
* Without infection in the skin or tissues where the needle will pass,
* Able to provide written and verbal consent and are capable of giving consent
Exclusion Criteria:
* Those with allergies to drugs used for sedoanalgesia and peripheral nerve blockade,
* Those who are hemodynamically unstable,
* Patients with ASA (American Society of Anesthesiologists) classification 3 <= age <= 4 will not be included in the group for whom PSA will be applied,
* Patients with coagulopathy, liver, or kidney failure,
* Patients with opioid, alcohol, or substance dependency,
* Those with skin infections or open wounds in the area where local anesthetic will be administered,
* Pregnant or suspected pregnant individuals,
* Those who do not provide written and verbal consent.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 91 |
Target Study Title: Forecasts Impact of the Pre-therapeutic TEP-TDM in the 18-FDG Restaging of Upper Aero-digestive Tract Cancers
Target Study Description: #Study Description
Brief Summary
Head and neck (HN) cancer is the sixth most common malignancy worldwide, with around 800 000 new cases and 320 000 deaths in 2015. These malignancies encompass cancers of the oral cavity, oropharynx, hypopharynx and larynx and concern squamous cell carcinomas (HNSCC) 90% of the time. Despite aggressive treatment strategies, the five-year survival rate has only marginally improved in the past decade. The prognosis is strongly dependent on initial staging. The 5-year relative survival rate is 80,3% for patients with localized disease whereas it decreases to 47.2% when regional lymph node metastasis is known, and to 32.5% when distant metastasis is known. Hence, precise cancer staging is essential as it allows clinicians to select the appropriate treatment strategies and predict the prognosis of the patients.
The conventional work-up (CWU) includes physical examination, endoscopy, computed tomography (CT) and/or magnetic resonance imaging (MRI) of the head and neck to evaluate the initial local and regional HNSCC staging. Thoracic CT is recommended because the thorax is the most frequent location of remote metastasis and synchronous second cancer outside of the upper aerodigestive tract.
Some authors demonstrated that 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) had a higher sensitivity and specificity for determining the extent of the disease and was able to detect occult second primaries. Moreover 18-FDG PET-CT allows whole body assessment. This is why the use of 18-FDG PET-CT has increased significantly over the last several years. Added to initial CWU, 18-FDG PET-CT may restage HNSCC and as a result may alter the clinical management.
Pre-therapeutic 18F-FDG PET/CT is recommended by guidelines to assess remote extension of locally advanced HNSCC and/or to look for synchronous cancer but is not systematically indicated, particularly for localized disease.
Restaging impact on prognosis and clinical management remains poorly understood.
Therefore, the objective of this study is to assess the impact of the additional information provided by 18F-FDG PET-CT on HNSCC initial staging and whether restaging modify prognosis and clinical management, whatever the CWU stage.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* biopsy proven HSNCC
* written consent
Exclusion Criteria:
* previous head and neck malignancy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 92 |
Target Study Title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of a Single Intra-articular Injection of Ampion in Adults With Pain Due to Osteoarthritis (OA) of the Knee
Target Study Description: #Study Description
Brief Summary
This study will evaluate the efficacy of an Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.
Detailed Description
A Randomized, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.
The primary study objective was to evaluate the efficacy of 4 mL Ampion versus 4 mL saline intra-articular (IA) injection in treating knee pain when administered to subjects suffering from osteoarthritis (OA) of the knee (OAK).
The secondary study objectives included evaluation of the safety of an IA injection of Ampion vs saline, efficacy of IA injection of Ampion vs saline in improving knee function.
#Intervention
- BIOLOGICAL : 4 mL injection of Ampion
- 4 mL injection of Ampion
- DRUG : 4 mL Injection of Placebo
- 4 mL Injection of Placebo
- Other Names :
- Saline
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Male or female, 35 years to 85 years (inclusive) who are ambulatory but suffering from moderate to moderately severe pain from osteoarthritis in the index knee as evidenced by a rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Pain Subscale at screening.
* Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of OA and supported by radiological evidence (Kellgren Lawrence Grade II, III, IV). Confirmatory x-ray must be taken at Screening and assessed using Kellgren Lawrence grading system.
* Moderate to moderately-severe OA pain in the index knee even with dosing of nonsteroidal anti-inflammatory drug (NSAID) in the 4 weeks prior to screening.
* No analgesia (including acetaminophen [paracetamol]) taken 12 hours prior to an efficacy measure; and,
* Able to provide written informed consent to participate in the study.
* Willing and able to comply with all study requirements and instructions of the site study staff.
Exclusion Criteria:
* Previous participation in an Ampion™ study.
* Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or joint replacement in the affected knee, as assessed locally by the principal investigator.
* Isolated patella femoral syndrome, also known as chondromalacia.
* Any other disease or condition interfering with the free use and evaluation of the index knee for the duration of the trial (e.g., cancer, congenital defects, spine OA).
* Major injury to the index knee within the 12 months prior to screening.
* Severe hip OA ipsilateral to the index knee.
* Presence of tense effusions.
* Any pain that could interfere with the assessment of index knee pain (e.g., pain in any other part of the lower extremities, pain radiating to the knee).
* Initiation or change in any pharmacological or non-pharmacological treatment for OA during the 4 weeks prior to randomization or likely to be changed during the duration of the study.
* Use of the following medications anticipated to be required during the study:
* Intra-articular pain medications in the study knee
* Analgesics containing opioids. (NSAIDs may be continued at levels preceding the study and acetaminophen is available as a rescue medication during the study from the provided supply.)
* Topical treatment on osteoarthritis index knee needed during the study
* Use of significant anticoagulant therapy, oral or injectable, during the study (aspirin and clopidogrel are allowed)
* Systemic treatments that may interfere with safety or efficacy assessments during the study such as immunosuppressants
* Use of corticosteroids >10 mg prednisolone equivalent per day (if <=10 mg prednisolone, the dose must be stable).
* Use of human albumin treatment in the 3 months before randomization.
* A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion).
* A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).
* Principal Investigator considers the patient unfit for the study based on medical review and screening.
Sex :
ALL
Ages :
- Minimum Age : 35 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 93 |
Target Study Title: A 3-month Cycle of Virtual Weekly Montreal Museum of Fine Arts Tours to Promote Social Inclusion, Well-being, Quality of Life and Health in Older Community Members : a Pilot Study
Target Study Description: #Study Description
Brief Summary
Social isolation is defined as the objective and/or subjective reduction of number and quality of interpersonal contacts leading to a loss of an individual's social role and stigmatization. It is a major problem in Canadian society with a high prevalence in the older population (30% in individuals aged 65 and over, representing 1.5 million individuals). Social isolation is associated with a wide range of mental and physical health problems that leads to an increase in the use of health and social services. This issue increased with the coronavirus disease (COVID-19) pandemic which attacking your society at its core. Social distancing and in particular home confinement exacerbated social isolation of frailer groups like the elderly people.
In 2016, the International Federation on Ageing reported that 'the main new problem facing seniors in Canada is maintaining their social contacts and activities'. This highlights the need for efficient and effective interventions to improve the social inclusion of older adults experiencing social isolation.
Research suggests that art-based activities carried out at museums have significant benefits for older adults experiencing social isolation, and may foster social inclusion, well-being, quality of life and mitigate frailty. Yet few studies have examined empirically the effects of museum art-based activities in older adults experiencing social isolation. In 2019, the principal investigator of this research conducted an experimental pilot study based on a pre-post intervention (i.e., 3-month cycle of weekly guided tours carried out at the Montreal Museum of Fine Arts (MMFA)), single arm, prospective and longitudinal follow-up named 'Effects of Montreal Museum of Fine Arts visits and older community dwellers with a precarious state: An experimental study', which indicated the potential of museum tours to improve social inclusion, well-being, the quality of life and frailty in older community members experiencing social isolation.
However, these studies were performed before the COVID-19 crisis and were in-site activities. The principal investigator hypothesizes that a 3-month cycle of virtual weekly MMFA tours may induce changes in well-being, quality of life and health condition in older community dwellers participating like the 'Beautiful Thursday' cycle, and that this activity can prevent the worsening of vulnerability and social isolation due to social distancing.
#Intervention
- OTHER : Museum virtual guided tours
- The intervention is a participatory art-based activity which consists in MMFA virtual guided tours. Each virtual guided tour is performed with a group of 5 participants. They meet online one time per week for a 20 to 25 min of a visit tour during a 3-month period. Each tour is different and supervised by a MMFA trained guide.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Being 65 years and over
* Having an Internet access and an electronic device (smartphone and/or tablet) at the participant's place of living as the repetitive assessments for this study will be performed on the web platform of the Centre of Excellence on Longevity of McGill University, and the guided tours will be virtual.
* Understanding and writing the language of the recruitment centre (i.e., French or English)
Exclusion Criteria:
* a concomitant participation to an experimental study,
* planning to have a journey over one week during the cycle of visits,
* having participated to a participatory art-based activity of the MMFA during the 6 month-period before the recruitment,
* not speaking the language of the study.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 94 |
Target Study Title: Effect of Parotid Mass Location on Benign Tumor Parotidectomy Scar's Characteristics
Target Study Description: #Study Description
Brief Summary
Parotidectomy is the treatment of choice for tumors in the parotid gland, with the modified Blair is the most common incision used. In our medical center, the incision is tailored to the size and location of the specific parotid tumor. This retrospective analysis aims to determine the incidence of complications and to assess the relation between the mass and scar characteristics in patients who had undergone parotidectomy.
Detailed Description
The scar characteristics of patient who had undergone parotidectomy for benign neoplasms at our medical center between 2013 and 2019 will be evaluated. Patients will complete a questionnaire regarding the occurrence of complications.
#Intervention
- OTHER : Questionnaire
- QoL questionnaire
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Age above 18 years during the surgery
* Clinical diagnosis of a benign parotid pathology
Exclusion Criteria:
* A malignant pathology of the parotid gland
* Unavailable data
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 95 |
Target Study Title: A Phase 2, Double-blind, Placebo-controlled Study of RSLV-132 in Subjects With Post-acute COVID-19 (Long COVID)
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to assess the efficacy (decrease in profound fatigue), safety and pharmacokinetics of RSLV-132 in subjects with long Corona Virus (COVID) syndome
Detailed Description
This is a double-blind placebo-controlled study in approximately 70 subjects with long COVID syndrome. After being informed about the study and potential risks, all subjects giving written informed consent will be screened to determine eligibility in the 21 days before the start of study treatment. Prior to the first study treatment administration, subjects will be randomized in a 2:1 ratio to receive six administrations of 10 mg/kg RSLV-132 or placebo on Days 1, 8, 15, 29, 43 and 57. Subjects will then attend an end of study visit approximately 10 weeks after the start of treatment (Day 71).
#Intervention
- DRUG : RSLV-132
- 10 mg/kg RSLV-132 administered by intravenous infusion
- DRUG : Sodium Chloride 0.9%
- 0.9% sodium chloride administered by intravenous infusion
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative Polymerase Chain Reaction (PCR) at least 24 weeks prior to Baseline
* PROMIS Fatigue SF 7a raw score of 21 or greater at Screening (confirm onset of fatigue was post-infection)
* Able to communicate and able to provide valid, written informed consent
* Ages 18 to 75 inclusive
* Minimum weight of 45 kg
* Female participants shall be either of non-child-bearing potential (permanently sterilized by bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy), or menopausal (more than one year since last menstrual cycle and confirmed by blood FSH levels > 22 mIU/mL) OR practicing highly effective contraception (e.g., oral (but not including progestogen-only oral contraceptives), injectable, implantable or transdermal contraceptives, a non-hormonal intrauterine device [IUD] or an intrauterine hormone releasing system [IUS]) for at least 2 months prior to dosing and until 125 days after the last dose. In terms of sexual relations, female participants not practicing highly effective contraception as described above should abstain or only engage with male partners who are sterile or vasectomized. Female participants of child-bearing potential will also be required to have a negative serum pregnancy test [beta human chorionic gonadotropin [ß-hCG]) at Screening and negative pregnancy urine test at Baseline. Female participants must agree not to donate eggs from the first dose until 125 days after the last dose
* Male participants, who are not sterile or vasectomized, must agree to abstain or only engage with female partners who use highly effective contraception from the first dose until 125 days after the last dose. Male participants must also agree not to donate sperm from the first dose until 125 days after the last dose
Exclusion Criteria:
* Previous admission to the intensive care unit for COVID-19-related symptoms
* Presence of orthostatic hypotension or tachycardia at Screening
* Completion of COVID-19 vaccination less than 4 weeks of Baseline (i.e., 4 weeks after the second dose of a two-dose vaccine or 4 weeks after a single dose vaccine)
* Use of therapies to treat COVID-19 symptoms such as remdesivir, dexamethasone (or any other corticosteroid), or convalescent plasma within 14 days of Baseline
* Use of concomitant medications that are sedating
* Screening lab abnormalities that may cause fatigue such as severe anemia or hypocalcaemia
* History of anaphylaxis to a medication, diet, or environmental exposure such as bee sting
* Previous diagnosis of chronic fatigue syndrome, fibromyalgia, lupus, Sjogren's syndrome, or postural orthostatic tachycardia syndrome (POTS)
* Previous diagnosis of sleep apnea
* Participation in another clinical study with receipt of an investigational product within 3 months or 5 half- lives, of last administration (whichever is longer) from Baseline
* The presence of a clinically significant infection in the judgement of the Investigator, within seven days of Baseline
* Positive test for hepatitis B, C, or HIV at Screening
* Positive pregnancy test at Screening or Baseline
* Female subjects currently pregnant or breast feeding at Baseline
* Inability or unwillingness to comply with protocol-specified procedures which, in the opinion of the Investigator, would make the subject unsuitable for study participation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 96 |
Target Study Title: Structuring Financial Incentives to Increase Physical Activity
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness of different structures of long term financial incentives on increasing physical activity performed by subjects, as measured by the number of steps walked per day.
Investigators are interested in studying whether physical activity increases during an intervention period (with incentives) and a post-intervention period (with no incentives).
Detailed Description
The proposed study is a field experiment. Adults within the ages of 25 and 60 years of age, and with a body mass index of 22 or higher will be eligible to participate.
The study will consist of (1) a two-week baseline period, (2) a 36-week intervention period, and (3) a 12-week follow-up period.
At the beginning of the study, subjects will be given a wearable fitness device and their daily step count will be monitored for two weeks; this is the baseline period. After the two-week baseline period, the subjects will be randomly assigned to one of the five different conditions (Control, Gain, Loss, Gain Streak, or Loss Streak) and will be given the goal to increase their baseline step counts by 2,500 steps.
=====
HYPOTHESES -- Investigators expect the following:
1. Loss Aversion: Subjects in the Loss treatment will achieve the goal on a greater number of days than subjects in the Gain treatment.
2. Streak: Subjects in the Gain treatment will achieve the goal on a greater number of days than subjects in the Gain Streak treatment.
3. Loss Streak: Subjects in the Loss treatment will achieve the goal on a greater number of days than subjects in the Loss Streak treatment. Whether subjects in the Loss Streak treatment will perform better or worse than subjects in the other two treatments will be investigated.
CONTRIBUTION -- Prior research has not examined the effect of a long term financial incentive (36 weeks) on individual behavior in achieving a goal. In this study, the investigators also examine two additional financial incentive structures: Gain Streak and Loss Streak. If the hypotheses are correct, the results have important implications for designing financial incentives to encourage good behavior and to encourage good habit formation across domains.
#Intervention
- BEHAVIORAL : Financial Incentive
- Giving different structures of long term (36 weeks) financial incentives to increase physical activity
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Singapore citizens and permanent residents
* Adults with BMI greater than 22
* Ownership of a smartphone or tablet
* Only one member per household can participate in the study
Exclusion Criteria:
* Women who are pregnant or breast feeding, or who intend to become pregnant over next year
* Subjects who are already participating in another physical activity program or study
* Subjects who are unable to participate for a total of 1 year
* Subjects who are unwilling to wear the fitness device
* Subjects who already walk more than 10,000 steps a day (self-reported per-day-average over seven days)
* Subjects who have any of the following health conditions:
* high blood pressure
* high cholesterol
* heart attack
* heart failure
* stroke
* chronic obstructive pulmonary disease
* kidney disease
* diabetes (type 2)
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 97 |
Target Study Title: PROspective PioglitAzone Clinical Trial In MacroVascular Events: A Macrovascular Outcome Study in Type 2 Diabetic Patients Comparing Pioglitazone With Placebo in Addition to Existing Therapy
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to determine whether pioglitazone, once daily (QD), can delay the time to death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg bypass surgery or amputation in patients with type 2 diabetes.
Detailed Description
Diabetes mellitus is one of the most common non-communicable diseases worldwide. More than 22 million persons have been diagnosed with diabetes in the European region of the International Diabetes Federation. Complications of diabetes involving both microvascular and macrovascular systems contribute to increased disability and reduced life expectancy. Damage to the coronary, cerebral (brain), and peripheral vascular beds as a consequence of diabetes is responsible for the increased macrovascular illness and death associated with the disease.
Insulin resistance is common to the genesis of both atherosclerosis and type 2 diabetes mellitus. In diabetes, insulin resistance is coupled to receptor dysfunction. In atherosclerosis, insulin resistance may have both direct effects on the cardiovascular system as well as indirect effects provoked by imbalances in blood glucose, lipids, clotting factors, endothelial function, and other factors. Considerable indirect evidence suggests that peroxisome proliferator-activated receptor agonists may favorably influence macrovascular outcome, either through modification of risk factors (such as blood lipids) or through effects on the vessel wall.
Pioglitazone, a thiazolidinedione compound discovered by Takeda Pharmaceutical Company, Ltd, functions as a peroxisome proliferator-activated receptor agonist as its mode of action.
This study is designed to assess whether pioglitazone in combination with other medications administered for glycemic management of type 2 diabetes might reduce the incidence of macrovascular events associated with this disease compared with placebo. Individuals who participate in this study will provide written informed consent and will be required to commit to screening and randomization visits and approximately 17 additional visits (1 every 2 months for the first year and every 3 months thereafter) at the study center. Study participation is anticipated to be about 40 months (or approximately 3 years and 4 months). Multiple procedures will occur at each visit which may include fasting, blood collection, physical examinations and electrocardiograms.
#Intervention
- DRUG : Pioglitazone
- Pioglitazone 15 mg to 45 mg, tablets, orally, once daily for up to 48 months.
- Other Names :
- Actos, AD4833
- DRUG : Placebo
- Pioglitazone placebo-matching tablets, orally, once daily for up to 48 months
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria
* Type 2 diabetes mellitus
* Glycosylated hemoglobin above the upper limit of normal (ie, the local equivalent of 6.5% for)
* Established history of macrovascular disease, defined as 1 or more of:
* Myocardial infarction at least 6 months before entry into the study.
* Stroke at least 6 months before entry into the study
* Percutaneous coronary intervention or coronary artery bypass graft at least 6 months before entry into the study.
* Acute coronary syndrome at least 3 months before entry into the study.
* Objective evidence of coronary artery disease.
* Peripheral arterial obstructive disease
Exclusion Criteria
* Signs of type 1 diabetes.
* Patients prescribed insulin as sole therapy for glycemic control of diabetes for 2 weeks or more at any time in the previous 3 months.
* Myocardial infarction, stroke, coronary artery bypass graft, or percutaneous cardiac intervention in the 6 months prior to enrolment.
* Acute coronary syndrome in the 3 months prior to enrolment.
* Heart failure at entry defined as patient having a New York Heart Association functional score of II or above.
* Had an appointment for a coronary angiogram or endovascular or surgical intervention.
* Leg ulcers, gangrene, or ischemic rest pain.
* Had an appointment for an angiogram or endovascular or surgical intervention for leg ischemia.
* Had undergone a major operation (defined as a surgical procedure lasting for more than 30 minutes) at any time in the previous 4 weeks.
* Significantly impaired hepatic function, defined as alanine aminotransferase greater than 2.5 times the upper limit of normal.
* Familial polyposis coli.
* Required dialysis.
* History of alcohol or drug abuse.
* Any other intercurrent disease believed to be likely to have a significant impact on the patient's life expectancy during the course of the study (eg, cancer).
* Patient was undergoing follow-up as part of another clinical trial or less than 3 months had elapsed since the last dose of an investigational drug or procedure.
* Hypersensitivity to pioglitazone or other TZD.
* Current use of pioglitazone or other TZD.
* Patient was known to be infected with human immunodeficiency virus or was known to have viral hepatitis.
* Women who were any of the following: pregnant, breast feeding, wished to become pregnant during the course of the study or of childbearing potential and not planning to use a reliable method of contraception throughout the study.
Sex :
ALL
Ages :
- Minimum Age : 35 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 98 |
Target Study Title: Clinical Non-inferiority Study Between Diosmin 600 mg Tablets and Diosmin 900 mg + Hesperidin 100 mg Tablets in Symptomatic Chronic Venous Insufficiency After 6 Months of Treatment: Single-blind, Randomized, Parallel Group Study
Target Study Description: #Study Description
Brief Summary
Clinical non-inferiority study between Diosmin 600 mg tablets and Diosmin 900 mg + Hesperidin 100 mg tablets in symptomatic chronic venous insufficiency after 6 months of treatment. Prospective, single-blind, randomized study in parallel groups (total patient population 120, 60 subjects per treatment group), with a total of 4 clinical assessment at months 0, 2, 4, and 6 of treatment.
Detailed Description
The primary study objective is to demonstrate the clinical non inferiority of efficacy between Diosmin 600 mg tablets versus combination Diosmin 900 mg + Hesperidin 100 mg tablets in improving lower limb symptoms assessed by a 100 mm visual analogue scale (VAS) over 6 months among adult patients presenting chronic venous insufficiency of the lower limbs.
The secondary study objectives are to compare between Diosmin 600 mg tablets and combination Diosmin 900 mg + Hesperidin 100 mg tablets in terms of:
* The oral acceptability,
* The tolerability,
* The global patient's satisfaction,
* The global physician's satisfaction.
Clinical assessments will take place at the study center during the study visits at M0, M2, M4 and M6 including:
* Efficacy on venous symptoms : The VAS of 100 mm is rated by the patient from '0' = Absence of venous symptoms up to '100' = Maximal intensity of the venous symptoms. The VAS is completed by the patient at the investigator's office. This VAS globally assesses the venous symptomatology of the most symptomatic leg : Heavy legs, Painful legs, Tired legs, Sensation of swelling and/or tension in the legs).
* Acceptability : Easiness to swallow assessed by a VAS of 100 mm rated by the patient from '0' = Very easy to swallow, up to '10' = Very difficult to swallow
* Patient's global satisfaction related to the treatment efficacy : Four levels scale rated as following : bad, acceptable, good, and very good
* Investigator's global satisfaction related to the treatment efficacy : Four levels scale rated as following : bad, acceptable, good, and very good
* Tolerability (related adverse events)
* Compliance : Accountability of treatments returned by the patient
The primary endpoint will be the change between the VAS symptoms scores at M0 and M6 / end of study visit (early withdrawal). Secondary endpoints include assessments of efficacy, oral acceptability of study drug, and tolerance.
#Intervention
- DRUG : Diosmin
- Diosmin 600mg tablet, once daily
- DRUG : Diosmin / Hesperidin
- Diosmin 900 mg / Hesperidin 100mg tablet, once daily
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Patients of both genders >18 years
* Patient presenting a C0 to C3 venous disease grade of the lower limbs, according to the clinical component of the CEAP classification,
* Clinical symptoms of chronic venous insufficiency of the lower limbs as defined by a VAS of 100 mm rated by the patient between 20 mm and 60 mm on the most symptomatic leg. The VAS is a global evaluation of the following symptoms: Heavy legs, Painful legs, Tired legs, Sensation of swelling and / or tension in the legs.
* Premenopausal female subjects not pregnant or breastfeeding, in use of reliable contraceptive
* Subject has read, understood, dated and signed the informed consent form
Exclusion Criteria:
* Treatment by compression stocking within the 2 months before inclusion
* Treatment by venotonics within the 2 months before inclusion
* Premenopausal women who are pregnant, breastfeeding or who do not wish to use contraception during the study period
* Known allergy or hypersensitivity to any component of the study drug
* Known clinically significant laboratory alterations
* CEAP levels 4, 5 & 6
* Patient with venous disease requiring surgery / chemical endovenous sclerotherapy
* Patient suffering from a painful pathology other than the venous pain in the lower limbs
* Patient with history of venous thrombosis or thromboembolic disease within the 6 months before inclusion
* Patient with alteration of general condition incompatible with his / her participation in the trial
* Patient wishing to be pregnant in the 6 following months
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 99 |
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