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{
"NCT_ID" : "NCT04157296",
"Brief_Title" : "Neurally Targeted Cognitive Training to Augment CBT Outcomes in Pediatric Anxiety",
"Official_title" : "Neurally Targeted Cognitive Training to Augment Cognitive Behavioral Therapy (CBT) Outcomes in Pediatric Anxiety",
"Conditions" : ["Anxiety Disorders"],
"Interventions" : ["Behavioral: computerized cognitive training (CCT)", "Behavioral: Cognitive behavioral therapy (CBT)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-02-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-11-07",
"Study_Completion_Date(Actual)" : "2021-11-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-11-06",
"First_Submitted_that_Met_QC_Criteria" : 2023-01-31",
"First_Posted(Estimated)" : 2019-11-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-11-06",
"Last_Update_Posted(Estimated)" : 2023-02-01",
"Last_Verified" : 2023-01"
}
}}
|
#Study Description
Brief Summary
This study will assign participants with anxiety to cognitive behavioral therapy (CBT) with computerized cognitive training (CCT). In addition, the study will have a control group and enroll age- and gender-matched anxious children assigned to CBT.
The hypothesis of this trial is that CCT with CBT will further increase task control network (TCN) activation and connectivity.
Both groups will have one CBT therapy session each week for 12 weeks. However, for participants in the CCT arm plus CBT they will also receive up to 4 weeks of at home CCT to complete during the two weeks prior to the first CBT session and during the two weeks after the first CBT session. CCT is to be done at home for approximately 30 minutes per day, 5 days per week. Additionally, participants in the CCT arm plus CBT will receive CCT for 30 minutes just prior to CBT sessions 4-12.
Each group will also have pre and post therapy functional magnetic resonance imaging (fMRI) and be asked to complete anxiety severity interviews and questionnaires throughout the study as well as after the treatment.
Update as of 4/7/2020: Enrollment and in-person-only interactions/interventions are temporarily paused due to COVID-19 and are expected to resume in the future. This is not a suspension of IRB approval.
Update as of 7/20/2020: Enrollment and in-person-only interactions/interventions are resumed.
#Intervention
- BEHAVIORAL : Cognitive behavioral therapy (CBT)
- The CBT intervention will consist of 12 weekly 60 minute sessions of the manualized therapy, adapted from the Coping Cat program, for the treatment of pediatric anxiety disorders.
- BEHAVIORAL : computerized cognitive training (CCT)
- CCT intervention will consist of approximately 30 minutes of CCT games prior to each CBT session, to engage cognitive control capacity prior to receipt of CBT. The CCT games will be designed to target focused attention, response inhibition, working memory and multiple simultaneous attention to constitute a general executive function training, and activate neural systems associated with executive function/cognitive control. Difficulty of the games will be titrated individually and by session to avoid boredom and progressively activate the functional systems underlying cognitive control.
|
#Eligibility Criteria:
Inclusion Criteria:
* Parent or guardian willing to give informed consent, and children willing to give informed assent to participate in the study
* Must be actively enrolled and maintain eligibility in Dimensional Brain Behavior Predictors of CBT Outcomes in Pediatric Anxiety (HUM00118950; P.I. Fitzgerald) to participate in the study.
Exclusion Criteria:
* Color blindness
Sex :
ALL
Ages :
- Minimum Age : 7 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04157296
| 56,217 |
{
"NCT_ID" : "NCT00712582",
"Brief_Title" : "Therapy for Patients With Untreated Age-Adjusted International Prognostic Index Low-Intermediate Risk, High-Intermediate Risk, or High Risk Diffuse Large B Cell Lymphoma",
"Official_title" : "Risk-Adapted Therapy for Patients With Untreated Age-Adjusted International Prognostic Index Low-Intermediate Risk, High-Intermediate Risk, or High Risk Diffuse Large B Cell Lymphoma",
"Conditions" : ["Non-Hodgkin's Lymphoma"],
"Interventions" : ["Drug: Etoposide, carboplatin, ifosfamide", "Drug: Rituximab, Ifosfamide, Etoposide, Carboplatin", "Drug: Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-07-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-03-12",
"Study_Completion_Date(Actual)" : "2021-03-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-07-08",
"First_Submitted_that_Met_QC_Criteria" : 2022-05-23",
"First_Posted(Estimated)" : 2008-07-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-07-08",
"Last_Update_Posted(Estimated)" : 2022-06-21",
"Last_Verified" : 2021-03"
}
}}
|
#Study Description
Brief Summary
About 60% of patients with DLBCL can be cured with a chemotherapy program. It is called RCHOP-21 (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). It is given once every 3 weeks, for 18 weeks. Each three weeks is a cycle. Some factors predict that you may not be cured with R-CHOP-21. The most common ones are:
* Stage - how much DLBCL, PMBL, or FL3B you have
* LDH - a blood chemistry marker; and
* Whether you can do your normal daily activities. (performance status) We think that the best way to cure more patients with poor risk factors is to add new treatment to R-CHOP. You will get different chemotherapy after 4 cycles. This type of treatment is called risk-adapted therapy.
#Intervention
- DRUG : Etoposide, carboplatin, ifosfamide
- Patients in consolidation A will receive three drugs in a regimen called ICE. You will have 3 cycles. Each new cycle begins 2 to 3 weeks after the last one.
- DRUG : Rituximab, Ifosfamide, Etoposide, Carboplatin
- It consists of four drugs in a regimen called augmented RICE (augRICE). It is given every 3 weeks for 2 cycles.
- DRUG : Rituximab, Ifosfamide, Etoposide, Carboplatin, Stem Cell Collection, Mitoxantrone, Cyclophosphamide and etoposide, Carmustine
- It consists of four drugs in a regimen called augRICE. It is given every 3 weeks for 2 cycles. After the rituximab on day 3, you will then be admitted to the hospital for 2 to 3 nights.
Part 2: Stem Cell Collection, Part 3: High dose chemoradiotherapy and stem cell transplant. Your doctor may want you to get radiation therapy. If so, it will start 2 weeks before the highdose chemotherapy. This regimen is called CBV-N chemotherapy. It is given by vein in the hospital.
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologic diagnosis of diffuse large B cell lymphoma, PMLBL, or follicular lymphoma grade 3B confirmed by the department of hematopathology at MSKCC: Patients with discordant bone marrow involvement (i.e. involvement by small cleaved cells or small lymphocytic lymphoma) are eligible.
* Tumors express CD20 as determined by immunohistochemistry.
o Ki-67 evaluation of tumor tissue
* Patients must have stage III, or IV disease. Patients with IIX, disease must have at least one other age-adjusted IPI risk factor.
* KPS <= 70
* LDH > upper limit of normal
* All patients must have FDG-PET avid (minimum SUV 2.5) measurable disease
* Patients must have normal baseline cardiac function based upon echocardiogram or gated blood pool scan (MUGA) with an ejection fraction >= 50%
* Patients must have a serum creatinine of <= 1.5 mg/dl; if creatinine >1.5 mg/dl creatinine clearance must be >60 ml/minute.
* Patients must have ANC>1000/mcl and Platelets>50,000/mcl. If patient has cytopenias due to bone marrow involvement, these requirements are not applicable.
* Patients must have a bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's)
* Patients must be Hepatitis B surface antigen negative, Hepatitis B core antibody negative, and Hepatitis C negative.
* All patients of childbearing and child creating age must be using an acceptable form of birth control from the initiation of treatment on study until 1 year after completion of chemotherapy and/or transplant.
* Women who are pre-menopausal must have a negative pregnancy test
* Age between 18 and 65
* Patients must be HIV negative. This test may be pending in a patient without risk factors, as determined by the patient's physician.
* If patients have a history of malignancy other than cutaneous basal cell or squamous cell carcinoma, they must be disease-free for >= 5 years at the time of enrollment.
* Patients or their guardians must be capable of providing informed consent.
* Patients must be suitable to undergo stem cell transplant.
Exclusion Criteria:
* Any lymphoma subtype other than DLBCL, PMLBL, follicular lymphoma grade 3B
* Patients with either parenchymal brain or lepto-meningeal involvement.
* No more than 14 days of prednisone therapy between the diagnostic biopsy of either DLBCL, PMLBL, or follicular lymphoma grade 3B and the initiation of treatment on study.
* Known pregnancy or breast-feeding
* Medical illness unrelated to NHL which in the opinion of the attending physician and principal investigator will preclude administration of chemotherapy safely. This includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease.
* History of any malignancy for which the disease-free interval is <5 years, excluding curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma in-situ of the cervix.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00712582
| 1,305 |
{
"NCT_ID" : "NCT02104245",
"Brief_Title" : "Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)",
"Official_title" : "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension",
"Conditions" : ["Non Cystic Fibrosis Bronchiectasis"],
"Interventions" : ["Drug: Placebo", "Drug: Ciprofloxacin dispersion for inhalation"],
"Location_Countries" : ["Georgia", "Romania", "New Zealand", "Spain", "United States", "Australia", "Italy", "Korea, Republic of", "Hungary", "United Kingdom", "Canada", "France", "Peru", "Poland", "Former Serbia and Montenegro", "Israel"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-05-28",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-08-11",
"Study_Completion_Date(Actual)" : "2016-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-03-28",
"First_Posted(Estimated)" : 2014-04-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-04-02",
"Last_Update_Posted(Estimated)" : 2021-03-26",
"Last_Verified" : 2021-03"
}
}}
|
#Study Description
Brief Summary
This study (ARD-3150-1202, ORBIT-4) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.
#Intervention
- DRUG : Ciprofloxacin dispersion for inhalation
- DRUG : Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of non-CF bronchiectasis
* History of P. aeruginosa respiratory infections
* At least two pulmonary exacerbations treated with antibiotics in the previous year
Exclusion Criteria:
* Have a clinical diagnosis of CF
* Are pregnant
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02104245
| 266,375 |
{
"NCT_ID" : "NCT05458531",
"Brief_Title" : "Monitoring of Inflammatory Conditions",
"Official_title" : "Exploring Patient and Healthcare Professional Views and Experiences of the Current and Recommended Monitoring Strategies for Inflammatory Conditions Treated With Commonly Used Immune Suppressing Drugs",
"Conditions" : ["Inflammatory Disease", "Crohn Disease", "Ulcerative Colitis", "Rheumatoid Arthritis", "System; Lupus Erythematosus", "Psoriatic Arthritis", "Reactive Arthritis", "Inflammatory Arthritis", "Psoriasis"],
"Interventions" : ["Other: Semi-structured interview", "Other: Questionnaire"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-06-28",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-02-08",
"Study_Completion_Date(Actual)" : "2023-02-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-07-11",
"First_Posted(Estimated)" : 2022-07-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-07-11",
"Last_Update_Posted(Estimated)" : 2024-02-28",
"Last_Verified" : 2024-02"
}
}}
|
#Study Description
Brief Summary
People with inflammatory diseases treated with immune-suppressing medication are recommended to have regular blood-tests to monitor for potential side-effects of this treatment on their blood count, liver and kidneys. However, it is not clear that monitoring is needed as frequently as currently recommended in the long-term, with side-effects being rare after one year of treatment. A study is currently underway to determine the optimal blood-test monitoring strategy which is cost-effective but still safe. Any changes in the monitoring strategy must be acceptable to patients and the healthcare professionals (HCP) that treat them.
This study aims to measure how often patients' with common inflammatory conditions on long-term immune suppressing medication attend their monitoring blood tests as currently recommended, and uncover patients' and HCP views and experiences of the current blood-test monitoring strategy, and the acceptability of potential changes to this in the future.
Firstly, patients with an inflammatory condition on long-term immune suppressing treatment will be invited to complete a questionnaire which will ask about their demographic information, medical condition(s), immune-suppressing treatment, adherence to the monitoring blood tests and willingness to take part in an interview. Then, both patients and HCPs who care for such patients will be invited to take part in a single, semi-structured interview. Interviews will be face-to-face, by telephone or video-call, last up to one hour and digitally audio-recorded. Patient interviews will explore their perceptions of risk, benefits and experiences of current testing, and views on the new testing frequencies emerging from the study prior. HCP interviews will explore their perceptions of current testing including, the practicalities, usefulness, risks and benefits of the blood tests, and views on the new testing frequencies emerging from the study prior.
The findings will shape the recommendations for a new monitoring strategy, ensuring it is acceptable to patients and HCPs.
#Intervention
- OTHER : Questionnaire
- A single questionnaire
- OTHER : Semi-structured interview
- A single semi-structured qualitative interview conducted face-to-face or by telephone or video-conference call.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 years and over
* Ability to give informed consent
* Diagnosis with one of the following inflammatory diseases: rheumatoid arthritis, inflammatory arthritis, inflammatory bowel disease, psoriasis +/- arthritis, ankylosing spondylitis, systemic lupus erythematosus, or reactive arthritis, and
* Currently treated with one of the following immune suppressing treatments for six months or longer: methotrexate, azathioprine, 5-acetyl salicylates, sulfasalazine, mycophenolate mofetil, leflunomide or biologics (anti-TNF-α agents e.g. etanercept, adalimumab, infliximab, golimumab, or certolizumab or their biosimilar).
Exclusion Criteria:
* Chronic kidney disease: stage 4 or stage 5
* Chronic liver disease: Autoimmune hepatitis, hepatitis B or C, cirrhosis.
* Pre-existing haematological abnormalities: Myelodysplasia, primary haematological diseases with neutropenia or thrombocytopenia.
* Dementia.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05458531
| 11,779 |
{
"NCT_ID" : "NCT04883203",
"Brief_Title" : "The Effect of Vitamin D Supplementation on COVID-19 Recovery",
"Official_title" : "The Effect of Vitamin D Supplementation on Recovery Delays for Non Severe COVID-19 Cases",
"Conditions" : ["Covid19"],
"Interventions" : ["Drug: Physiological Irrigating Solution", "Drug: Vit-D 0.2 MG/ML Oral Solution [Calcidol]"],
"Location_Countries" : ["Tunisia"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-04-22",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-09-30",
"Study_Completion_Date(Actual)" : "2020-10-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-04-20",
"First_Posted(Estimated)" : 2021-05-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-05-10",
"Last_Update_Posted(Estimated)" : 2021-05-12",
"Last_Verified" : 2021-05"
}
}}
|
#Study Description
Brief Summary
The COVID-19 caused by SARS-CoV-2 has transmitted quickly as a global public health emergency. The median duration for Sars-CoV-2 carrying in COVID-19 patients was 20 days (IQR 16-28) What is the role of vitamin D supplementation on the recovery time of asymptomatic and pauci-symptomatic COVID-19 subjects? the intervention group will have vitamin D supplementation (200,000 IU / 1 ml of Cholecalciferol (1 ml) Oral form). Control group will have a placebo treatment (physiological saline).
the negative RT-PCR date will be compared in the two groups
Detailed Description
Introduction In 2020 The world is incurring coronavirus pandemic. The epidemic of the new coronavirus started in Wuhan, China, in late 2019, originally called 2019-nCoV and then COVID-19 by the World Health Organization in February 2020.
COVID-19 presented a heavy health systems burden having caused more than 170,000 deaths worldwide as of April 20, 2020. However, the treatment protocols for this infection remain controversial. It is the subject of several ongoing studies.
The use of vitamin D as a strategy to reduce the frequency and severity of respiratory infections and in particular COVID-19 must be seriously considered.
Several studies have studied the role of vitamin D in reducing the risk of viral infections. Indeed, vitamin D supplementation could be a useful measure in improving the immune response of subjects affected by the new coronavirus. This, taking into account the high prevalence of vitamin D deficiency in our country.
The beneficial effects of vitamin D on protective immunity is partly due to innate immune system action. It reduces the cytokine storm induced by the innate immune system, by decreasing the expression of pro-inflammatory cytokines and increasing that of anti-inflammatory cytokines. Vitamin D played a major role in the modulation of adaptive immunity. However, evidence on the effectiveness of vitamin D in improving the immune response of confirmed COVID-19 remains lacking.
The prolonged duration of the disease may increase the likelihood of transmission. Indeed, the R0 depends on three factors including the contact rate between individuals in the population, the probability of transmission of the infection during contact and the duration of infectiousness. The COVID-19 caused by SARS-CoV-2 has transmitted quickly as a global public health emergency. The median duration for Sars-CoV-2 carrying in COVID-19 patients was 20 days (IQR 16-28)(9).
1. Research question:
What is the role of vitamin D supplementation on the recovery time of asymptomatic and pauci-symptomatic COVID-19 subjects?
2. Objectives of the study:
To assess the effect of vitamin D supplementation on the duration of carriage of the COVID-19 virus in patients with SARS Cov2 with a positive control RT-PCR on day 14 of the date of confirmation of the disease.
3. Type of study:
This is a randomized clinical trial without the patient's knowledge in subjects diagnosed with COVID-19.
B. Method:
1. Study setting: this study will be carried out in the governorate of Monastir in the collective isolation center
2. Eligibility criteria: patients with SARS Cov2 and having a positive RT-PCR at control in
* 14 days from confirmation of infection for asymptomatic subjects and
* 7 days after the disappearance of symptoms for pauci-symptomatic subjects. Non-inclusion criteria: Pregnant women and children under the age of 18 will not be included.
3. Intervention: the intervention group will have vitamin D supplementation (200,000 IU / 1 mL of Cholecalciferol (1 ml) Oral form). Control group will have a placebo treatment (physiological saline).
4. Output: the negative RT-PCR date will be compared in the two groups.
5. Variables: we will study the socio-demographic characteristics (age, sex, level of study) and the recovery dates (dates of confirmation samples, disappearance of symptoms and control) the presence of hospitalization.
6. Sample size: for a gain of 07 days for healing, with 90% power and a 2-sided 0.05 significance level, 130 patients were required (65 in each group).
C. Allocation of interventions:
After a phone agreement, a doctor ensures the treatment distribution. D. Ethical considerations This survey will be carried out respecting the research ethical considerations: consent (free, informed, written, clear and loyal) anonymity; confidentiality; protection and assistance.
E. Study budget The Monastir University Hospital of Monastir will fund study (buying Vit D). F. Study schedule This interventional investigation will begin in July 2020. Patient monitoring will be carried out until the recovery date. (2 negative RT-PCR tests).
#Intervention
- DRUG : Vit-D 0.2 MG/ML Oral Solution [Calcidol]
- ARM 1 : Cholecalciferol 200,000 IU / 1 mL .
- DRUG : Physiological Irrigating Solution
- ARM 2 : placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* patients with COVID 19 and having a positive RT-PCR at control in
* 14 days from confirmation of infection for asymptomatic subjects and
* 7 days after the disappearance of symptoms for pauci-symptomatic subjects
Non inclusion Criteria: Pregnant women and children under the age of 18 will not be included
Exclusion Criteria:
* None
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04883203
| 183,343 |
{
"NCT_ID" : "NCT00540046",
"Brief_Title" : "Immediate vs. Delayed Insertion of Copper T 380A IUD After Termination of Pregnancy Over 12-weeks Gestation",
"Official_title" : "Immediate vs. Delayed Post-abortal Copper T 380A IUD Insertion in Cases Over 12 Weeks of Gestation",
"Conditions" : ["Contraception Behavior"],
"Interventions" : ["Device: Copper T 380A IUD"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "HEALTH_SERVICES_RESEARCH",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-02",
"Study_Completion_Date(Actual)" : "2010-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-10-04",
"First_Submitted_that_Met_QC_Criteria" : 2015-01-01",
"First_Posted(Estimated)" : 2007-10-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-10-04",
"Last_Update_Posted(Estimated)" : 2015-02-09",
"Last_Verified" : 2015-01"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to compare delayed vs. immediate insertion of the Copper T 380 IUD after termination of pregnancy after 12 weeks.
Detailed Description
Patients presenting to ParkMed Women's Clinic and the Reproductive Choice clinic at Bellevue Hospital for second trimester termination will be offered participation in this study. They will be randomized to either delayed or immediate Copper T 380A IUD insertion. The subjects will be seen at a 6 month follow-up visit and Copper T 380A IUD placement will be verified by physical exam. At this 6 month follow-up visit, subjects will fill out a satisfaction questionnaire.
#Intervention
- DEVICE : Copper T 380A IUD
- Copper T 380A IUD will be placed at the 2-4 week post-operative visit.
|
#Eligibility Criteria:
Inclusion Criteria:
* women 16 years and older
* intrauterine pregnancy > 14 weeks gestation
* desires termination of pregnancy
* desires IUD for contraception
* ability to give informed consent
* no contraindication for D+E
Exclusion Criteria:
* unable to give informed consent
* less than 16 years
* congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
* acute pelvic inflammatory disease (PID)
* known or suspected uterine or cervical neoplasia or unresolved abnormal PAP smear
* untreated acute cervicitis or vaginitis, until infection treated/controlled
* confirmed Chlamydia trachomatis or Neisseria gonorrhea infection in the previous 90 days
* acute liver disease or liver tumor (benign or malignant)
* woman or partner currently with multiple sexual partners
* history of Wilson's disease
* hypersensitivity to any component of Copper T IUD
Sex :
FEMALE
Ages :
- Minimum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00540046
| 69,054 |
{
"NCT_ID" : "NCT00143351",
"Brief_Title" : "Mozart Relapse Study",
"Official_title" : "Open Extension Study Evaluating the Long-term Efficacy, Safety, and Tolerability of Oral Ziprasidone in the Treatment of Resistant/Intolerant Schizophrenic Patients Who Have Acutely Responded to Ziprasidone in the Mozart Study",
"Conditions" : ["Schizophrenia"],
"Location_Countries" : ["Italy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2003-06",
"Study_Completion_Date(Actual)" : "2005-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-08-31",
"First_Posted(Estimated)" : 2005-09-02"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-08-31",
"Last_Update_Posted(Estimated)" : 2021-02-21",
"Last_Verified" : 2021-02"
}
}}
|
#Study Description
Brief Summary
To assess the long-term efficacy of oral Ziprasidone in the maintenance treatment of resistant schizophrenic subjects who have benefited from participation in the phase III ziprasidone study A1281039 (MOZART study), to assess the efficacy of ziprasidone in the relapse prevention of schizophrenia, to collect long-term data on safety and tolerability of oral Ziprasidone
#Intervention
- DRUG : Ziprasidone
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects who have completed MOZART study and who are responders to Ziprasidone:
* Responders: patients with a 20% or more reduction in the PANSS total score at the endpoint of the Mozart Study (recorded at V18 in the Mozart) as compared with the baseline value
* Patients not hospitalised in an acute psychiatric service
* Written, informed consent to participation.
* Female patients of at risk of pregnancy must avoid to remain pregnant; if already used, an adequate method of contraception can be continued
Exclusion Criteria:
* Psychiatric:
* Subjects with a score of greater than or equal to 5 and an increase of at least 2 points (with respect to baseline value of MOZART study) at one of the following PANSS items: P7 (hostility), G8 (uncooperativeness) or G14 (poor control impulse)
* Subjects with a score equal to 3 and an increase of at least 1 point (with respect to baseline value of MOZART study) at item 8 (suicide) of CDSS
* General:
* Patients who, during MOZART study, have developed one of the following diseases will be excluded: (or patients who do not satisfy anymore one of the following general exclusion criteria of MOZART study)
* Subjects with a history of clinically significant and/or currently relevant haematological, renal (including single kidney), hepatic, gastrointestinal, endocrine (except for current adequately treated hypo- or hyperthyroidism), pulmonary (excluding chronic bronchitis, mild emphysema or chronic obstructive pulmonary disease), dermatological, oncological, or neurological disease, excluding tardive dyskinesia but including all forms of epilepsy (febrile convulsions in childhood acceptable). The only subjects with known prior malignant disease who are eligible are those with cured prior skin cancer. Controlled Type II diabetes (glucose < 180 mg/100 ml at screening and baseline with dietary or oral hypoglycemic treatment) will not be considered a significant medical illness and would not exclude a subject from the study
* Patients with a non stabilized somatic disease - Acute or chronic heart disease
* Clinically significant ECG abnormalities
* Subjects with QTc greater than or equal to 500 msec (subjects with QTc greater than or equal to 450 msec and < 500 msec should be discussed with the cardiologist) - Concomitant treatment with medications that prolong QTc interval (please review prescribing information of other treatments)
* Subjects with serum K+ outside the normal range
* History of seizure (should be discussed with the Sponsor)
* Subject with any confirmed laboratory values that deviate from the upper or lower limits of normal prior to study entry, except for clinically insignificant deviations as determined by investigator
* Pregnant or lactating women
* Subjects who intend to donate blood or blood products during the 4 weeks prior to the study, during the study or in the 30 days after the study ends
* Subjects unable or unlikely to follow the study protocol
* Subjects with a history of neuroleptic malignant syndrome developing from the administration of antipsychotic compounds
* Diagnosis of substance dependence using DSM-IV criteria (305.xx)
* Positive urine drug screen at screening for amphetamines, cocaine or opioids
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00143351
| 274,262 |
{
"NCT_ID" : "NCT00235157",
"Brief_Title" : "A Comparison of Coated and Uncoated Stents in Renal Artery Treatment.",
"Official_title" : "Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent, Comparing a Sirolimus Coated Versus an Uncoated Stent in REnal Artery Treatment.",
"Conditions" : ["Renal Artery Stenosis"],
"Interventions" : ["Device: Sirolimus-eluting Palmaz Genesis peripheral stent"],
"Location_Countries" : ["Germany", "France", "Netherlands"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2001-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2002-11",
"Study_Completion_Date(Actual)" : "2005-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-10-06",
"First_Posted(Estimated)" : 2005-10-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-10-07",
"Last_Update_Posted(Estimated)" : 2008-08-06",
"Last_Verified" : 2008-08"
}
}}
|
#Study Description
Brief Summary
The primary objective of this study is to compare the safety and performance of the Palmaz Genesis™ balloon expandable stent, with or without sirolimus coating in the treatment of renal artery stenosis, measured at 6 months follow up via angiography.
Detailed Description
Multi-center, prospective, controlled, non-randomized investigational feasibility study. One hundred (100) patients with de novo or restenotic renal artery lesions consisting of \>= 50% stenosis and reference vessel of \>= 4.0 to \<= 8.0 mm in diameter will be sequentially included, 50 without sirolimus coating, followed by 50 with sirolimus coating Palmaz GenesisTM. Patients will be followed for 24 months post-procedure, with all patients having clinical assessments at discharge, 1,6, 12 and 24 months. This study will be conducted at twelve investigational sites.
It is anticipated that the total length of time required to complete the study will be 46 months.
#Intervention
- DEVICE : Sirolimus-eluting Palmaz Genesis peripheral stent
- treatment of renal artery stenosis with a renal stent
- Other Names :
- Palmaz Genesis Stent
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical indication for renal artery revascularization of atherosclerotic renal artery stenosis >=50% as measured by operator or estimated original vessel diameter, based on healthy vessel segment and contralateral side.
* The reference vessel renal artery must be >= 4mm and <= 8 mm by visual estimate.
* The patient must have a baseline serum creatinine of <= 5.0 mg/dl.
Exclusion Criteria:
* Total occlusion of the renal artery.
* Lesions which would require more than 2 stents.
* Lesions which are in arteries to transplanted or bypassed kidneys.
* Abdominal aortic aneurysm > 4.0 cm in diameter.
* Patients with ASA classification >=4.
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00235157
| 30,188 |
{
"NCT_ID" : "NCT04852315",
"Brief_Title" : "Acute Caffeine Ingestion on Futsal Performance",
"Official_title" : "Effects of Acute Caffeine Ingestion on Futsal Performance in Sub-elite Players",
"Conditions" : ["Caffeine", "Placebo"],
"Interventions" : ["Dietary Supplement: Placebo", "Dietary Supplement: Caffeine"],
"Location_Countries" : ["Spain"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-10-16",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-10-18",
"Study_Completion_Date(Actual)" : "2019-10-18},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-04-19",
"First_Posted(Estimated)" : 2021-04-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-04-19",
"Last_Update_Posted(Estimated)" : 2021-04-21",
"Last_Verified" : 2021-04"
}
}}
|
#Study Description
Brief Summary
Caffeine supplementation has been recognized such as an useful strategy for improving performance in intermittent sports, however caffeine ingestion in futsal has been barely studied. In this randomized placebo-controlled study, we investigated the effects of acute caffeine supplementation in improving neuromuscular performance and physical match activity in futsal players.
Detailed Description
To date, no previous investigation has studied the effect of acute caffeine ingestion on futsal performance during futsal-specific testing and during a simulated match. Therefore, the aim of this investigation was to establish the effects of acute caffeine intake on futsal-specific tests (e.g. futsal kicking velocity) and match-play running performance in male futsal players.
#Intervention
- DIETARY_SUPPLEMENT : Caffeine
- Gelatine capsule with caffeine (3 mg/kg body mass of caffeine) (Bulk Powders, London, United Kingdom). The capsule containing the treatment was ingested with 150 mL of water 60 minutes before the onset of the experiment to allow substance absorption.
- DIETARY_SUPPLEMENT : Placebo
- Gelatine capsule with placebo (Cellulose; Guinama, Valencia, Spain). The capsule containing the treatment was ingested with 150 mL of water 60 minutes before the onset of the experiment to allow substance absorption.
|
#Eligibility Criteria:
Inclusion Criteria:
* Sub-elite men futsal players
Exclusion Criteria:
* Intolerance to caffeine,
* Suffering from any chronic pathology or an injury in the month prior to the investigation
* Use of medicines or dietary supplements during the study.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04852315
| 242,204 |
{
"NCT_ID" : "NCT02600260",
"Brief_Title" : "Thromboprophylaxis in Pregnant Women in Hospital: A Prospective Clinical Trial",
"Official_title" : "Thromboprophylaxis in Pregnant Women in Hospital: A Prospective Clinical Trial",
"Conditions" : ["Thrombophilia Associated With Pregnancy", "Perioperative/Postoperative Complications", "Venous Thrombosis", "Pulmonary Embolism", "Other Specified Risk Factors in Pregnancy", "Deep Vein Thrombosis"],
"Interventions" : ["Other: No intervention", "Drug: Enoxaparin"],
"Location_Countries" : ["Brazil"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-12-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-07-31",
"Study_Completion_Date(Actual)" : "2019-12-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-10-30",
"First_Posted(Estimated)" : 2015-11-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-11-06",
"Last_Update_Posted(Estimated)" : 2021-04-28",
"Last_Verified" : 2021-04"
}
}}
|
#Study Description
Brief Summary
Hospitalization in pregnancy and childbirth greatly increases the thromboembolic risk of these patients. The application of a protocol for assessing the risk of VTE reduces mortality and morbidity of these phenomena.
Detailed Description
Thromboembolic events are among the leading causes of maternal morbidity and mortality in pregnancy / postpartum period. They are the leading cause of maternal death in developed countries. Risk factors for venous thromboembolism (VTE) during pregnancy and postpartum as family history or personal history of VTE, thrombophilia, age over 35, obesity and high parity has been the most studied. One of the main risk factors is hospitalization, which increases up to 20 times the risk of VTE.
Objective: The objective of the study is to identify early risk factors for VTE in hospitalized pregnant women and institute appropriate prophylaxis to reduce the incidence and morbidity.
Methods: A prospective study that will evaluate all pregnant women admitted for clinical treatment and / or surgery in the Department of Obstetrics and Gynecology, Clinics Hospital, University of São Paulo through the application of a thromboprophylaxis protocol with risk assessment score. The patient in whom prophylaxis would be indicated are those with scores greater than or equal to 3. The drug to be used is enoxaparin and the dose to be used depends on the weight of the patient.
It will be further assessed: adverse effects of treatment with enoxaparin, protocol failure in the group treated and untreated (without anticoagulation) and bleeding incidence in the untreated group.
Risk score description: score 3 - previous thrombosis/thromboembolism, homozygous mutations, combined thrombophilia risk factors, antiphospholipid syndrome, cancer(stomach, pancreas, lung), inflammatory conditions, lupus, sickle cell disease, nephrotic syndrome, heart disease; Score 2 - Protein C deficiency, Protein S deficiency, heterozygous F5 Leiden, heterozygous F2 G20210A mutation, cancer(last 6 months), chemotherapy(last 6m), immobility, bed rest \>4d prior to C-section, current serious infections, BMI≥40 kg/m2 , age≥40y, lung disease(cyanosis), postpartum hemorrhage \>1L; Score 1 - age ≥ 35 and ≤39 y, parity ≥3, multiple pregnancy, hyperemesis, gross varicose veins, smoker ≥20, surgical procedure.
#Intervention
- DRUG : Enoxaparin
- Patients who score higher or equal to 3, receive a prophylactic dose of enoxaparin. The first dose of enoxaparin is administered 8 hours after vaginal or abdominal delivery. Subsequent doses are administered daily for up to 15 days. The dose depends on patient weight.
- Other Names :
- lovenox, clexane
- OTHER : No intervention
- Hospitalized patients that score less than three are not prescribed enoxaparin.
- Other Names :
- No enoxaparin, Score lower than three
|
#Eligibility Criteria:
Inclusion Criteria:
* All pregnant women hospitalized.
Exclusion Criteria:
* Previous use of anticoagulation
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02600260
| 79,271 |
{
"NCT_ID" : "NCT03427047",
"Brief_Title" : "Comparing Surgical and Economical Parameters of Total Knee Replacement.",
"Official_title" : "A Prospective, Randomized Study Comparing Surgical and Economic Parameters of Total Knee Replacement Performed Using Two Different Surgical Techniques: Medacta MyKnee® Surgical Technique Using Efficiency Single-use Instruments Versus Stryker Navigation Surgical Technique Performed With Conventional Metal Instruments.",
"Conditions" : ["Osteo Arthritis Knee", "Total Knee Arthroplasty"],
"Interventions" : ["Device: MyKnee with single use Efficiency Instrument", "Device: Stryker Navigational with conventional metal instruments"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-08-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-01-01",
"Study_Completion_Date(Actual)" : "2022-01-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-02-02",
"First_Submitted_that_Met_QC_Criteria" : 2023-05-18",
"First_Posted(Estimated)" : 2018-02-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-02-02",
"Last_Update_Posted(Estimated)" : 2023-06-13",
"Last_Verified" : 2023-05"
}
}}
|
#Study Description
Brief Summary
Randomized study comparing surgical and economic parameter of Total Knee Arthroplasty performed using two different specific surgical techniques.
Detailed Description
Randomized 1: ratio study comparing Medacta MyKnee surgical technique using Efficiency single use instruments versus Stryker Navigation surgical techniques performed with conventional instruments. MyKnee surgical technique patients will receive a CT scan of the surgical knee which enables custom manufacturing of the MyKnee cutting blocks. Stryker Navigational surgical technique patients will not require a CT scan. Both groups of patients will undergo total knee arthroplasty.
#Intervention
- DEVICE : MyKnee with single use Efficiency Instrument
- Total Knee Arthroplasty utilizing a CT scan for customization of cutting blocks with single use instrumentation
- DEVICE : Stryker Navigational with conventional metal instruments
- Total Knee Arthroplasty without customization of cutting blocks using conventional metal instruments.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 75 2) BMI <=35 3) Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA) with the Medacta GMK Sphere 4) Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks
Exclusion Criteria:
* Is participating in another clinical study 2) Has inflammatory arthritis 3) Has knee avascular necrosis 4) Has severe deformity, defined as greater than 15 degrees varus or 10 degrees valgus relative to the mechanical axis. 5) Has retained hardware in the knee that requires removal and interferes with TKA procedure 6) Has prior high tibial osteotomy (HTO)
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03427047
| 264,333 |
{
"NCT_ID" : "NCT03215563",
"Brief_Title" : "PET-MRI Imaging in Patients With Acute Neurovascular Syndrome",
"Official_title" : "Hybrid 18F-Fluoride Positron Emission Tomography-Magnetic Resonance Imaging in Patients With Acute Acute Neurovascular Syndrome",
"Conditions" : ["Stroke", "Carotid Stenosis"],
"Interventions" : ["Radiation: 18F PET-MRI", "Diagnostic Test: Transcranial Doppler"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-10-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-01-10",
"Study_Completion_Date(Actual)" : "2020-01-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-06-14",
"First_Posted(Estimated)" : 2017-07-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-07-10",
"Last_Update_Posted(Estimated)" : 2020-02-11",
"Last_Verified" : 2020-02"
}
}}
|
#Study Description
Brief Summary
Ischaemic stroke is a major cause of death and disability worldwide. In patients with recent stroke, the 18F-fluoride positron emission tomography-computed tomography highlights high-risk culprit carotid plaque and is more discriminatory than 18F-fluorodeoxyglucose. Using hybrid positron emission tomography-magnetic resonance imaging investigators propose to build upon these findings by prospectively assessing 18F-fluoride uptake in a broad range of patients with acute transient ischaemic attack or ischaemic stroke. Investigators will specifically examine the association of 18F-fluoride uptake with multiparametric magnetic resonance imaging assessments of atherosclerotic plaque, especially the role of thrombus and lipid. Finally, using transcranial Doppler and diffusion-weighted magnetic resonance brain imaging, an assessment of the functional consequences of 18F-fluoride-positive atherosclerotic plaque will be performed. If successful, this technique has a number of valuable translational applications including the better selection of patients for carotid intervention.
Detailed Description
The ability to identify the culprit carotid plaque represents a key goal in carotid artery imaging. Although an array of non-invasive imaging techniques can detect a wide spectrum of complementary high-risk characteristics, no single modality can reliably identify vulnerable plaques associated with future stroke development. Substantial histological data suggests that specific plaque components identify patients at high-risk for future ipsilateral stroke and cardiovascular events. This implies that investigators need to look beyond the traditional paradigm where the basis for carotid endarterectomy were formulated by an invasive imaging modality that provided no information on the arterial wall composition. Alternative imaging strategies are therefore required targeting not only in vivo carotid morphology but also plaque biology and disease activity. This is fundamental to optimal risk-stratification and appropriate selection of patients for high-risk vascular intervention. One new approach is to use non-invasive molecular imaging targeted at plaque biology using hybrid systems such as positron emission tomography-magnetic resonance imaging.
#Intervention
- RADIATION : 18F PET-MRI
- 18F-fluoride Hybrid PET-MRI
- DIAGNOSTIC_TEST : Transcranial Doppler
- Microembolic Signals detection
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients above 40 years with carotid artery stenosis that do not achieve criteria for CEA (<50% for men, <70% for women, by NASCET criteria) or the patient has declined CEA.
* Patients above 40 years with atherosclerotic disease of aortic arch and its branches.
Exclusion Criteria:
* Patients with new stroke and a modified Rankin score >3
* Chronic kidney disease with an estimated Glomerular Filtration Rate (eGFR) of <30 ml/min/1.73 m2
* Atrial fibrillation
* Pregnant women
* Prior ipsilateral carotid intervention
* Prior neck radiotherapy
* Inability to tolerate the supine position
* Participation in the study would result in delay to surgery
* Psychiatric illness/social situations that would limit compliance with study requirements
* History of allergic reaction attributed to 18F-Fluoride
* History of allergic reaction to gadolinium contrast media
* Metal implants or devices including pacemakers and defibrillators
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03215563
| 81,076 |
{
"NCT_ID" : "NCT00414310",
"Brief_Title" : "Decitabine (DAC) w/ or w/o Valproic Acid (VPA) in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)",
"Official_title" : "Phase II Randomized Study of Low-Dose Decitabine (5-AZA-2'-Deoxycytidine) With or Without Valproic Acid in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia -'SPORE'",
"Conditions" : ["Myelodysplastic Syndrome", "Acute Myelogenous Leukemia"],
"Interventions" : ["Drug: Decitabine", "Drug: Valproic Acid"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-05",
"Study_Completion_Date(Actual)" : "2015-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2006-12-19",
"First_Submitted_that_Met_QC_Criteria" : 2015-07-15",
"First_Posted(Estimated)" : 2006-12-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2006-12-20",
"Last_Update_Posted(Estimated)" : 2019-05-21",
"Last_Verified" : 2019-05"
}
}}
|
#Study Description
Brief Summary
The goal of this clinical research study is to find out if decitabine, given with or without valproic acid, can help to control AML or MDS. The safety of both treatments will also be studied.
Detailed Description
Decitabine and valproic acid are both designed to cause changes in different groups of proteins that are attached to DNA (the genetic material of cells), which may cause cancer cells to die. Researchers want to see if a combination of valproic acid with decitabine can help improve disease response as well as how long responses last in treating MDS and AML.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. Participants in one group will receive decitabine. Participants in the other group will receive decitabine and valproic acid. You will have an equal chance of being assigned to either group at first. After 20 participants are enrolled in each group, you will have a greater chance of being assigned to the group that is showing better results.
Participants in both groups will receive decitabine on Day 1 through a central venous catheter (CVC) in a vein over 1 hour each day for 5 days. A central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure. Participants who are assigned to also get valproic acid will take the drug by mouth on Days 1-7 (7 days in a row).
On Day 0 (the day before treatment begins) or on Day 1, you will have a physical exam, including measurement of your vital signs. Blood (about 2 teaspoons) will be drawn on or about Days 0 or 1, 5, and 10 (if your routine blood tests were found to be abnormal) to learn the status of the disease.
Routine blood draws (about 4 teaspoons) will be done 1-2 times weekly for the first cycle and then every 2-4 weeks in further cycles. You will have another bone marrow aspiration to check disease response to treatment, and then you will have one every 1-3 cycles. One (1) cycle of treatment is 4-8 weeks long.
You may remain on this study as long as you are benefitting or up to 2 years after you first achieve a complete response. Your dose level may be decreased depending on the side effects you may experience. However, if the disease gets worse or you experience any intolerable side effects, you will be taken off this study.
This is an investigational study. Decitabine is FDA approved and commercially available for the treatment of MDS. Valproic acid is FDA approved and commercially available for the treatment of seizure disorders. Up to 150 patients will take part in this study. All will be enrolled at MD Anderson.
#Intervention
- DRUG : Decitabine
- 20 mg/m\^2 IV over 1 hour daily for 5 days.
- Other Names :
- Dacogen
- DRUG : Valproic Acid
- 50 mg/kg orally daily for 7 days
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with MDS and > 5% blasts or IPSS risk intermediate or high; patients with CMML; patients with AML who are age >= 60 years. No prior intensive chemotherapy or high-dose ara-C (> 1g/m2). No prior azacytidine for 3 cycles or more or prior decitabine for 2 cycles or more. Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
* Continued from #1: Hydroxyurea is permitted for control of counts prior to treatment. Procrit, granulocyte colony-stimulating factor (GCSF) are allowed before therapy. Procrit, GCSF or other growth factors are permitted on therapy. Use of hydroxyurea with rapidly proliferative disease is allowed for the first two weeks on therapy.
* Performance 0 <= age <= 2 (ECOG). Adequate liver function (bilirubin of < 2mg/dl) and renal function (creatinine < 2mg/dl). Adequate cardiac functions (NYHA cardiac III-IV excluded). ALT < 2.5x institutional upper limit of normal.
* Signed informed consent.
Exclusion Criteria:
* Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Active and uncontrolled infections.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
* Known ornithine transcarbamylase disorder.
* Patients requiring continuous valproic acid treatment for the control of seizure disorders.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00414310
| 109,853 |
{
"NCT_ID" : "NCT00146185",
"Brief_Title" : "Efficacy and Safety of ALGRX 3268 in Children Undergoing Minor Needle-Stick Procedures.",
"Official_title" : "A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Confirm the Effectiveness and Safety of ALGRX 3268 in Pediatric Subjects.",
"Conditions" : ["Pain"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-02",
"Study_Completion_Date(Actual)" : "2005-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-09-04",
"First_Posted(Estimated)" : 2005-09-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-09-04",
"Last_Update_Posted(Estimated)" : 2005-11-16",
"Last_Verified" : 2005-04"
}
}}
|
#Study Description
Brief Summary
Minor needlestick procedures often cause significant pain and distress in pediatric patients yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use, prefilled, needle-free product that immediately delivers powdered lidocaine into the epidermis and provides local analgesia in 2-3 minutes. The purpose of this phase III, prospective, randomized, double-blind, placebo-controlled study is to investigate the efficacy, safety and tolerability of ALGRX 3268 versus placebo in pediatric patients aged 3 to 18 years undergoing venipuncture or peripheral venous canulation procedures. The trial will enroll approximate 504 evaluable subjects at centers located in the US.
Detailed Description
Pain management due to minor procedures such as venipuncture or peripheral venous canulation still represents an unmet medical need, especially in pediatric setting. Current therapeutic products have a relatively delayed onset of analgesia of at least 10 minutes; moreover the most used products require application with at least 30-60 minutes prior to procedure. Development of ALGRX 3268 is aimed at addressing this unmet need in management of pain associated with needlestick procedures.
ALGRX 3268 (Previously known as PowderJect(R) Dermal Lidocaine) is used for local anesthesia within 3 minutes to provide painless needle or cathether insertion for blood drawing. ALGRX 3268 is a single-use disposable system, incorporating a drug cassette and cylinder into a single hand held device, with a button to actuate the system.
The purpose of this phase III, multicenter, prospective, randomized, double-blind, placebo-controlled study is to investigate the efficacy, safety and tolerability of ALGRX 3268 versus placebo in pediatric patients 3 to 18 years of age, who undergo venipuncture or peripheral venous canulation procedures. The trial will enroll approximate 504 evaluable subjects at centers located in the US.
Three age groups are enrolled: 3-7 years, 8-12 years, 13-18 years. Within each age group subjects are randomized to receive ALGRX 3268 0.5 mg/20 bar or pressure matched placebo. One to 3 minutes after administration of study treatment at the back of the hand or antecubital fosa, venipuncture is performed with a needle/Vacutainer, needle/syringe or 'butterfly', at the discretion of the investigator.
Subjects 3-18 years are asked to assess pain on venipuncture using Wong-Baker FACES pain rating scale, anchored at 0 for 'no hurt' and 5 for 'hurts worst'.
Children in the middle (8-12) and older (13-18) age groups will additionally rate pain at the ACF and BOH using a 100 mm VAS anchored at 0 for 'no pain' and at 100 for 'extreme pain'. Parent/legal guardian will evaluate child's level of pain on a 100 mm VAS anchored at 0, for 'no pain', and at 100 for 'extreme pain'.
Safety ratings of skin are completed immediately prior, after, at 15 and 30 minutes following the procedure. All AEs/SAEs will be monitored.
#Intervention
- DRUG : ALGRX 3268
|
#Eligibility Criteria:
Inclusion Criteria:
* Outpatient children of either gender [M/F: 1:1] undergoing venipuncture or peripheral venous cannulation at the ATF or BOH. Children must have sufficient cognitive skills to identify faces depicting extremes of pain on the Wong-Baker FACES Pain Rating Scale, (ages 3 <= age <= 12) and/or the extremes of pain on a 100 VAS (ages 8 <= age <= 18).
* Ages 3 <= age <= 7, 8 <= age <= 12, 13 <= age <= 18 years inclusive. Informed consent forms must have been approved by the appropriate IRB. Signed informed consent must have been granted by the parent/legal guardian and assent to participate should have been sought (either verbally or in writting) from each child.
* In females of childbearing potential who in the judgement of the investigator or designee were sexually active, a negative preganancy test must have been documented prior to enrollment. A negative urine preganancy test was required in all teenage girls over the age of 14 years. Surgically sterile females do not require a pregnancy test.
Exclusion Criteria:
* Previous history of allergic reactions to any local anesthetic. Any medical condition or instability that in the judgement of the investigator might have adversely impacted the conduct of the study and the collection of data.
* Subjects in whom the investigator determined that venipuncture could not be accomplished cleanly.
* Active local infection or other skin pathology on the dorsum of the hand. Subjects with tattos, surgical scars, ports, implantable devices or a skin condition that may have interfered with placement of study treatment or skin site assessments.
* Female subjects who were pregnant or lactating; females with a positive serum or urine pregnancy test; females of childbearing potential who were not using adequate contraception.
* Prior participation in an ALGRX 3268 study.
* Venipuncture at the proposed site within the prior 2 weeks (longer if bruising was apparent).
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00146185
| 207,699 |
{
"NCT_ID" : "NCT02781428",
"Brief_Title" : "To Detect the Sensitivity of the UroMark Assay",
"Official_title" : "A Multicentre Observational Study Design to Determine the Sensitivity of the UroMark Assay, a Urine Test, to Detect New and Recurrent Low, Intermediate and High Grade Bladder Cancer",
"Conditions" : ["Bladder Cancer"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-09-26",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-12-19",
"Study_Completion_Date(Actual)" : "2018-12-19},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-05-11",
"First_Posted(Estimated)" : 2016-05-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-05-19",
"Last_Update_Posted(Estimated)" : 2023-12-04",
"Last_Verified" : 2023-12"
}
}}
|
#Study Description
Brief Summary
This is a prospective multicentre observational study to assess the sensitivity of the UroMark assay to detect bladder cancer in participants with new or recurrent disease. The study will recruit patients with newly detected or recurrent bladder cancer. The reference standard will be histopathological confirmation of tumour stage and (Ta, T1, ≥T2) and grade 1, 2 or 3 diseases with or without CIS, or CIS alone.
Patients with a visual diagnosis of bladder cancer following cystoscopy will be approached and asked to consent for this study. Consenting participants will be provided with a urine sample collection kit and asked to provide a urine sample. Samples can be provided at home and posted to the receiving lab using the stamped addressed envelope. The urine sample must be obtained before TURBT and following TURBT, patients with NMIBC who require surveillance cystoscopy will be asked to provide a urine sample at 3 monthly intervals for up to 2 years.
The study will be conducted in at least 11 NHS trusts. As DETECT II is an observation study requiring provision of a urine sample, it will be possible for patients in DETECT II to be recruited to other trials.
Detailed Description
This study is an observational study and participants will receive the standard of care according to local MDT guidelines for the treatment and surveillance of bladder cancer. As the study involves collection of a urine sample, subjects are permitted to be entered into other trials. The DETECT II study will recruit patients with newly diagnosed and recurrent bladder cancer. As this study is only observational and no intervention is trial related the patients will be given minimum 24 hours to consider this study and decide to take part as they will be approached in clinic at first instance. Due to the initial urine sample being required before any standard of care is received they will be consented within 24 hours of being informed of the study. Most newly diagnosed bladder cancers are detected in patients being investigated for haematuria and attending a haematuria clinic. Most recurrent bladder cancers are detected by cystoscopy at bladder cancer check cystoscopy clinics.
Patients with a visual diagnosis or new or recurrent bladder cancer will be eligible for the DETECT II study. The baseline UroMark urine collection will be collected once the visual diagnosis of bladder cancer is established. The UroMark sample must be provided before TURBT in all cases.
Patients will be approached following cystoscopy and asked to consent to study entry. The DETECT II study will involve obtaining a voided urine sample. Patients will be given a UroMark urine sample kit and asked to provide the urine sample at home and post the sample to the receiving lab using the stamped addressed envelope.
Patients will receive the standard tests and investigations for bladder cancer. The standard treatment for bladder cancer is summarised as:
* TURBT following which it is recommended that patients with NMIBC receive a single instillation of chemotherapy unless contraindicated.
* Intermediate risk NMIBC will be considered for a 6 week inductive course of intravesical chemotherapy after TURBT.
* High risk NMIBC may require a second TURBT called re-resection TURBT, usually within 6 weeks of the first. The re--resection or second TURBT is performed for pathological stage pT1 tumours to exclude residual detrusor muscle invasion (stage pT2 at least). There are 2 treatment choices when the high risk status has been confirmed clinically:
* A course of inductive followed by maintenance intravesical BCG
* An operation to remove the bladder (a cystectomy).
* Cystectomy or radiotherapy are the options for patients diagnosed with MIBC
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants must be > 18 years.
* Visual diagnosis or suspected diagnosis of bladder cancer following cystoscopy.
* Able to give informed written consent to participate
Exclusion Criteria:
* Unwilling to undergo TURBT
* Unable to give informed consent.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02781428
| 273,308 |
{
"NCT_ID" : "NCT01053598",
"Brief_Title" : "Evaluation Of The Performance Of The Nitrate Reductase And Resazurin Titre Assay For The Detection of Mycobacterium Tuberculosis Complex From Sputum In A High Tb and Hiv Setting",
"Official_title" : "EVALUATION OF THE PERFORMANCE OF THE NITRATE REDUCTASE AND RESAZURIN TITRE ASSAY FOR THE DETECTION OF MYCOBACTERIUM TUBERCULOSIS COMPLEX FROM SPUTUM IN A HIGH TB AND HIV SETTING",
"Conditions" : ["Tuberculosis", "HIV", "AIDS", "HIV Infections"],
"Location_Countries" : ["Uganda"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-09",
"Study_Completion_Date(Actual)" : "2012-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-01-19",
"First_Posted(Estimated)" : 2010-01-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-01-20",
"Last_Update_Posted(Estimated)" : 2013-02-20",
"Last_Verified" : 2013-02"
}
}}
|
#Study Description
Brief Summary
The Principle objective of this study is To evaluate the performance of NRA, NRA-p and REMA-p for the detection of M. tuberculosis complex from sputum samples from adult pulmonary TB suspects in a high TB and HIV prevalence setting, using LJ and MGIT culture as gold standard.
The Secondary objectives are:
* To measure the performance of each assay (NRA, NRA-p, REMA-p) in sputum smear-negative patients
* To describe the results of the colorimetric methods in HIV-positive and HIV-negative patients
* To assess the time to detection of both NRA/NRA-p, REMA-p methods.
* To evaluate the feasibility of the NRA, NRA-p, REMA-p methods.
* To determine the rate of contamination of the NRA, NRA-p and REMA-p assays.
* To evaluate the proportion and the clinical relevance of NTM among TB suspects in a high TB and HIV prevalence setting.
* To provide capacity building for TB diagnosis in Mbarara.
Detailed Description
Tuberculosis (TB) remains a leading cause of death in developing countries and its burden has been exacerbated by the concurrent HIV epidemic. Despite the advances in medicine, TB diagnosis still remains a challenge, especially in developing countries where diagnosis relies mostly on the detection of Mycobacterium tuberculosis complex (MTBC) by smear microscopy and/or culture. Smear microscopy is rapid, simple and not expensive but it lacks sensitivity. Culture on solid medium, which is performed in some well equipped laboratories, is more sensitive than microscopy but takes up to 8 weeks to obtain the result.
Colorimetric methods have been used for the rapid detection of drug sensitivity in M. tuberculosis either from isolates or directly from sputum. These methods rely on the detection of live bacteria through either enzymatic activity (nitrate reduction) or their ability to reduce an oxidation-reduction indicator, either in solid or liquid medium. They are fast, simple, and offer a good potential that should be evaluated for the diagnosis of TB.
The objective of this study is to evaluate the performance of colorimetric assays for the detection of M. tuberculosis complex from sputum samples from adult pulmonary TB suspects in a high TB and HIV prevalence setting, using Löwenstein Jensen (LJ) and Mycobacterium growth indicator tube (MGIT) culture as gold standard. The colorimetric methods evaluated here will be the solid medium-based nitrate reductase assay as described (NRA) or with an additional step using para Nitrobenzoic (PNB) acid for differentiation of MTBC and NTM (NRA-p), and the modified resazurin microplate assay, also using PNB for differentiation of MTBC and NTM (REMA-p).
. If any of the colorimetric assays is found to be accurate, significantly faster than conventional culture methods, and easy to perform, then it could be implemented in a tuberculosis culture laboratory. By reducing the time to detection compared to conventional culture and the costs compared to recent commercial methods, these assays offer a good alternative to conventional methods and might help to improve TB diagnosis in developing countries.
|
#Eligibility Criteria:
Inclusion Criteria:
* Pulmonary TB suspects as defined by a cough for more than 2 weeks
* Age 15 years and above
* Written informed consent signed
Exclusion Criteria:
* Producing pure blood sputum or clear saliva
* Producing less than 1 mL of sputum
* Receiving anti TB treatment (isoniazid, rifampicin, streptomycin, pyrazinamide, ethambutol) or quinolone for more than 1 week in the month before inclusion.
Sex :
ALL
Ages :
- Minimum Age : 14 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01053598
| 267,671 |
{
"NCT_ID" : "NCT01783678",
"Brief_Title" : "A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults",
"Official_title" : "A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects",
"Conditions" : ["Chronic Hepatitis C", "Human Immunodeficiency Virus"],
"Interventions" : ["Drug: Sofosbuvir", "Drug: RBV"],
"Location_Countries" : ["Germany", "Spain", "Australia", "Italy", "United Kingdom", "France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-04",
"Study_Completion_Date(Actual)" : "2014-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-01-31",
"First_Submitted_that_Met_QC_Criteria" : 2015-04-15",
"First_Posted(Estimated)" : 2013-02-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-02-01",
"Last_Update_Posted(Estimated)" : 2015-04-30",
"Last_Verified" : 2015-04"
}
}}
|
#Study Description
Brief Summary
This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.
#Intervention
- DRUG : Sofosbuvir
- Sofosbuvir 400 mg tablet administered orally once daily
- Other Names :
- Sovaldi®, GS-7977, PSI-7977
- DRUG : RBV
- Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years with HIV-1 and chronic HCV genotype 1, 2, 3, or 4 co-infection
* HCV RNA > 10,000 IU/mL at screening
* HCV treatment history:
* Treatment-naive for HCV genotypes 1, 2, 3, or 4, or
* Treatment-experienced for HCV genotypes 2 or 3
* HIV antiretroviral (ARV) criteria:
* On a stable, protocol-approved, HIV ARV regimen with undetectable HIV RNA for > 8 weeks prior to screening, or
* ARV untreated for >= 8 weeks prior to screening, with a CD4 T-cell count > 500 cells/mm^3
* Presence or absence of cirrhosis; a liver biopsy may be required
* Healthy according to medical history and physical examination with the exception of HCV and HIV diagnosis
* Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
Exclusion Criteria:
* HCV genotype 1 or 4 with previous HCV treatment
* Poor control with HIV ARV regimen requiring a possible dose modification of therapy within 4 weeks of study medication dosing
* A new AIDS-defining condition diagnosed within 30 days prior to screening
* Prior use of any other inhibitor of the HCV NS5B polymerase
* History of any other clinically significant chronic liver disease
* Evidence of or history of decompensated liver disease
* Chronic hepatitis B virus (HBV) infection
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of immunosuppressive agents or immunomodulatory agents
* Clinically relevant drug or alcohol abuse within 12 months of screening
* History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study or not be in the best interest of the participant in the opinion of the investigator
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01783678
| 225,816 |
{
"NCT_ID" : "NCT05054023",
"Brief_Title" : "Topical Piroxicam vs Soulagel in the Treatment of Acute Extremity Pain After Emergency Department Discharge",
"Official_title" : "Randomized Clinical Trial of Topical Piroxicam Versus a New Herbal Medicine Based Gel in the Treatment of Acute Extremity Pain After Emergency Department Discharge",
"Conditions" : ["Acute Pain"],
"Interventions" : ["Drug: Arthrosyl®", "Drug: Soulagel®"],
"Location_Countries" : ["Tunisia"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2", "PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-10-21",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-03-21",
"Study_Completion_Date(Actual)" : "2022-03-21},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-09-10",
"First_Posted(Estimated)" : 2021-09-23"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-09-22",
"Last_Update_Posted(Estimated)" : 2022-06-21",
"Last_Verified" : 2022-06"
}
}}
|
#Study Description
Brief Summary
Acute soft tissues injuries are a common complaint for emergency department (ED) visit. RICE and Topical non-steroidal anti-inflammatory drugs (NSAIDs) are frequently used to reduce pain and inflammation. Herbal therapy is commonly used to treat pain but few studies assessed its efficacy and tolerability.
Detailed Description
Materials and methods :
Study design It is a randomized, prospective, double blind, controlled, multicentric trial.
Study setting and selection of participants :
The trial is conducted in three community teaching hospitals :
* Emergency department, fattouma bourgiba university hospital, monastir, tunisia.
* Emergency department, sahloul university hospital, sousse, tunisia.
* Emergency department, farhat hached university hospital, sousse, tunisia.
The study includes patients aged 18 to 60 years who presented to the ED with acute soft-tissues limb trauma pain occurring within 24 hours before presentation, with a visual numeric scale (VNS) of 5 or more on a standard 11 point (0-10) and who required a prescription for home use analgesic treatment upon discharge. An informed consent is necessary. Pain was considered traumatic if it is reported as appearing immediately after the trauma.
Protocol :
After medical evaluation, every patient who meet the inclusion criteria, will receive randomly either Piroxicam gel or Soulagel tubes as detailed above according to the predetermined randomization.
None of the treating physician or nurses are aware about the medication received.
Adhesive and/or immobilizing casts, bandages, splints, and treatment by rest, ice, compression, or elevation were prohibited after randomization.
Patients could not take additional medications such as oral NSAIDs, opioids, muscle relaxants, or supplemental topical therapies.
Patients were phonelly contacted in order to ensure treatment adherence and evaluate VAS once a day until the end of the treatment. After the end of the treatment, patients' satisfaction with the treatment was noted and quoted as 'not satisfied', 'satisfied', and 'very satisfied'.
Need for rescue analgesic treatment was noted as well as the dose and duration. All patients were encouraged to report all adverse events during the treatment period. S
All data recorded on data collection sheets, including sex, demographics, medical history, and vital signs, were entered into SPSS (version 20.0 ; IBM corps) by the research manager.
Patients's informed consent is obtained. The ethic commitee of our institution approved the study.
#Intervention
- DRUG : Soulagel®
- topic gel
- DRUG : Arthrosyl®
- topic gel
- Other Names :
- piroxicam
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who presented to the ED with acute non-penetrating minor soft tissues musculoskeletal limb trauma occurring within 24 hours before presentation, and who required a prescription for home use analgesic treatment upon discharge for pain-on-movement (POM) with intensity >50 on a visual numeric scale (VNS) on a standard 11 point (0 <= age <= 10).
* Pain was considered traumatic if it is reported as appearing immediately after the trauma and no anterior pain was described in the same limb.
Exclusion Criteria:
* Pregnancy/Breastfeeding
* Skin lesions (excessive dryness or redness of the skin, atopic dermatitis, and eczema) in the painful region
* Presence of wound, joint dislocation, or more than one injury
* Presence of a fracture
* Severe trauma (ISS > 16)
* Hospitalization or surgery, daily use of NSAIDs or other analgesia within 2 weeks
* Previous treatment with analgesia for the same injury
* History of previous adverse reaction or known allergy or hypersensitivity
* Physical, visual, or cognitive impairment (inability to use the VNS pain score)
* Refusal to consent or to communicate
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:
No
|
NCT05054023
| 147,811 |
{
"NCT_ID" : "NCT00752687",
"Brief_Title" : "A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected Adults",
"Conditions" : ["Hepatitis C"],
"Interventions" : ["Drug: placebo", "Drug: ABT-072"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-05",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-09-12",
"First_Posted(Estimated)" : 2008-09-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-09-12",
"Last_Update_Posted(Estimated)" : 2010-10-21",
"Last_Verified" : 2010-09"
}
}}
|
#Study Description
Brief Summary
To evaluate the safety, tolerability and pharmacokinetics of ABT-072 in healthy volunteers and its anti-viral activity in HCV infected subjects.
Detailed Description
A blinded, randomized, placebo-controlled trial to study the safety, tolerability, antiviral activity and pharmacokinetic profiles of ABT-072 in healthy and HCV genotype-1 infected adults.
#Intervention
- DRUG : ABT-072
- Capsule or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.
- DRUG : placebo
- Capsule, or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.
|
#Eligibility Criteria:
Inclusion Criteria:
Criteria for Healthy Adults:
* Informed consent has been obtained
* Subject is in general good health
* If female, then postmenopausal
* If female, then not pregnant
* If male, must be surgically sterile or both he and the partner must use birth control
* Body Mass Index is 18 to 29, inclusive
Criteria for HCV-infected Adults:
* Infected with HCV for at least 6 months as shown by either detectable HCV RNA or reactive antibody, or liver biopsy with pathology indicative of HCV infection, or disclosure of a risk factor
* Subject is infected with HCV genotype 1 with detectable HCV RNA of > 50,000 IU/mL
Exclusion Criteria:
Criteria for Healthy Adults:
* If female, then pregnant or breast feeding
* Positive HAV-IgM, HBs-Ag, HCV Ab or HIV Ab
* Within 6 months of start of study, drug or alcohol abuse and use of nicotine products
* Alcohol intake within 48 hours prior to study drug administration
Criteria for HCV-infected Adults:
* Need for prescription or over-the-counter medication
* Child Pugh score > 5 or clinical evidence of cirrhosis
* No other cause for liver disease other than HCV infection
* ALT or AST > 4 x ULN
* Creatinine > ULN
* Clinically significant abnormal ECG
* HCV RNA levels above the level of assay quantification
* TSH values outside normal range
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00752687
| 217,922 |
{
"NCT_ID" : "NCT06277609",
"Brief_Title" : "A Trial Investigating Lu AF28996 in Healthy Adult Participants",
"Official_title" : "Interventional, Open-label, Repeated Single-dose Trial Investigating the Effects of Enzyme Inhibition on the Pharmacokinetic Profile of Lu AF28996 and Its Metabolites in Healthy Participants",
"Conditions" : ["Healthy Participants"],
"Interventions" : ["Drug: Acetylsalicylic Acid", "Drug: Amoxicillin/clavulanic acid", "Drug: Mefenamic Acid", "Drug: Lu AF28996"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SEQUENTIAL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2024-02-27",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-05-19",
"Study_Completion_Date(Actual)" : "2024-05-19},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-02-19",
"First_Posted(Estimated)" : 2024-02-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-02-19",
"Last_Update_Posted(Estimated)" : 2024-06-11",
"Last_Verified" : 2024-06"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to investigate repeated doses of Lu AF28996 in healthy participants and co-administered with two other compounds, and in a separate cohort following co-administration with antibiotics, to see how well the doses are tolerated and what the body does to the drug after administering it.
Detailed Description
The study has 2 parts: Part A and Part B.
Part A will consist of 2 cohorts (Cohorts A1 to A2), with 8 participants per cohort and will receive single doses of Lu AF28996 alone and in combination with enzyme inhibitors.
Part B will consist of one cohort (Cohort B1), with 8 participants who will all receive single doses of Lu AF28996 alone and in combination with amoxicillin/clavulanic acid.
#Intervention
- DRUG : Lu AF28996
- Capsule
- DRUG : Acetylsalicylic Acid
- Tablet
- DRUG : Mefenamic Acid
- Tablet
- DRUG : Amoxicillin/clavulanic acid
- Tablet
|
#Eligibility Criteria:
Inclusion Criteria:
* The participant has a body mass index (BMI) >=18.5 and <=30 kilograms per meter squared (kg/m^2) at the Screening Visit and at the Safety Baseline Visit.
* The participant has a resting supine pulse >=50 and <=100 beats per minute (bpm) at the Screening Visit and at the Safety Baseline Visit.
* The participant has a resting supine systolic blood pressure >=90 and <=140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure >=50 and <=90 mmHg at the Screening Visit and at the Safety Baseline Visit.
* The participant has a normal circadian rhythm, defined as a person who usually wakes between 6:00 and 9:00 a.m. and goes to sleep between 9:00 p.m. and midnight.
Exclusion Criteria:
* The participant is a member of the site staff or of their immediate families or is a subordinate (or immediate family member of a subordinate) to any of the site staff.
* Part B only, the participant is a woman of childbearing potential AND is using oral hormonal contraceptives.
* The participant has previously been enrolled in this trial.
* The participant has previously been dosed with Lu AF28996.
Note: Other inclusion and exclusion criteria may apply.
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:
Yes
|
NCT06277609
| 213,960 |
{
"NCT_ID" : "NCT03058263",
"Brief_Title" : "Effect of Neostigmine on the Recovery of Rocuronium: A Comparison Between Partial and TOF Ratio-Based Dose",
"Official_title" : "The Effectiveness of Neostigmine on the Recovery of Rocuronium-Induced Neuromuscular Blockade: A Comparison Between Partial Dose and TOF Ratio-Based Adjustment Dose",
"Conditions" : ["Muscle Relaxant", "General Anesthesia"],
"Interventions" : ["Drug: Dose of Neostigmine"],
"Location_Countries" : ["Indonesia"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-02-01",
"Study_Completion_Date(Actual)" : "2017-02-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-02-12",
"First_Posted(Estimated)" : 2017-02-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-02-15",
"Last_Update_Posted(Estimated)" : 2017-08-18",
"Last_Verified" : 2017-08"
}
}}
|
#Study Description
Brief Summary
This study aimed to evaluate the effect of Neostigmine partial dose towards neuromuscular blockade of rocuronium
Detailed Description
Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups. Intravenous (IV) cannula with Ringer Lactate fluid, non-invasive blood pressure monitor, electrocardiogram (ECG) and pulse-oxymetry were set on the subjects in the operation room. After preoxygenation was given with 100% oxygen, general anesthesia induction was done with midazolam 0.01-0.02 mg/kg, fentanyl 3 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Following induction, endotracheal intubation or laryngeal mask insertion was performed. Maintenance was done by sevoflurane 1.2 vol%, and fentanyl 1.2 mcg/kg. After the surgery had finished, fentanyl drip was stopped. Subjects were then observed until spontaneous breaths occured adequately (tidal volume ≥ 5 ml/kg) before train of four (TOF) ratio was evaluated using acceleromyography (AMG). Before reversal (neostigmine) was given, anesthetic gas was stopped and duration of operation as well as post-operative TOF ratio was recorded. The time since reversal was given then recorded. Group A received neostigmine partial dose (0.02 mg) in combination with atropine 0.4 mg for every milligram of neostigmine. Group B received TOF ratio-based dose of neostigmine in combination with atropine 0.4 mg for every milligram of neostigmine. After administration of neostigmine, TOF ratio was measured every 5 minutes until TOF ratio of ≥ 90% was achieved, and finally definitive airway could be removed. For Group A, another partial dose of neostigmine was given after 10 minutes from the first reversal dose if the TOF ratio of ≥90% had not been reached. For Group B, another TOF ratio-based dose of neostigmine was given after 10 minutes from the first reversal dose if the TOF ratio of ≥90% had not been reached. Subjects were then transported to recovery room. Data was analyzed using Statistical Package for the Social Sciences (SPSS), for numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square test or Fischer Exact's Test. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p\<0.05.
#Intervention
- DRUG : Dose of Neostigmine
- Subjects were given partial dose of neostigmine as rocuronium reversal after the surgery had finished; subjects were given TOF ratio-based dose of neostigmine after the surgery had finished
- Other Names :
- prostigmin
|
#Eligibility Criteria:
Inclusion Criteria:
* patients aged 18 <= age <= 60 years
* American Society of Anesthesiologists (ASA) physical status I-II who were planned to undergo any elective surgery at operating room in general anesthesia
* subjects had been explained about the study, and agreed to enroll and have signed the informed consent form
Exclusion Criteria:
* BMI >= 30
* had any severe kidney or liver disease
* had neuromuscular disease or asthma
Drop out Criteria:
* Duration of operation less than one hour or more than 2 hours
* during surgery received maintenance dose of neuromuscular block
* intraoperative cardiac arrest was occurred
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
|
NCT03058263
| 82,354 |
{
"NCT_ID" : "NCT02442661",
"Brief_Title" : "Clinical Validation of a Predictive Model for the Presence of Cervical Lymph Node Metastasis in Papillary Thyroid Cancer",
"Official_title" : "Clinical Validation of a Predictive Model for the Presence of Cervical Lymph Node Metastasis in Papillary Thyroid Cancer",
"Conditions" : ["Papillary Thyroid Cancer"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-12",
"Study_Completion_Date(Actual)" : "2017-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-04-22",
"First_Posted(Estimated)" : 2015-05-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-05-08",
"Last_Update_Posted(Estimated)" : 2017-06-12",
"Last_Verified" : 2017-06"
}
}}
|
#Study Description
Brief Summary
This research study is performed to compare the accuracy of two methods of lymph node evaluation: research method versus standard method. Standard method is what is usually performed as standard of care where the radiologist evaluates the images overall and decides whether each node seen should or should not be biopsied. In the research method, a second radiologist will evaluate the ultrasound images of the lymph nodes separately, and use a small specific checklist of ultrasound appearance to determine whether each node should or should not be biopsied. Results of both the standard and research method will be used to decide which node(s), if any should be biopsied. Neck ultrasound examination, lymph node evaluation by standard method and subsequent lymph node biopsy are part of the standard clinical care. It is less likely but possible that the research method may identify additional lymph nodes for biopsy to check if that lymph node contains thyroid cancer.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of PTC and at least one sonographic examination of the cervical lymph nodes.
* Patients can only be included in the study once. Thus, if they have two sonographic examinations, only one can be included in the study results.
* All patients who fit the study criteria after the start of the study will be included, using the first sonographic exam as the study exam.
Exclusion Criteria:
* Lymph node with oval shape, hypoechoic cortex, smooth border, hyperechoic hilum and hilar Doppler flow by ultrasound are considered to be normal and be excluded from FNAB per standard clinical practice.
* Lymph node less than 5 mm in short axis on ultrasound.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02442661
| 232,196 |
{
"NCT_ID" : "NCT05391035",
"Brief_Title" : "The Antibiotic Guardian Study- Clinical Evaluation of a Novel, Rapid Diagnostic for Gonorrhoea and Mycoplasma Infections.",
"Official_title" : "The Antibiotic Guardian Study- a Clinical Evaluation of a Rapid Diagnostic of Mycoplasma and Gonorrhoea Infections and Antibiotic Resistance.",
"Conditions" : ["Sexually Transmitted Diseases, Bacterial", "Antibiotic Resistant Infection"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-10-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-05-17",
"Study_Completion_Date(Actual)" : "2024-05-17},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-12-23",
"First_Posted(Estimated)" : 2022-05-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-05-20",
"Last_Update_Posted(Estimated)" : 2024-05-20",
"Last_Verified" : 2021-11"
}
}}
|
#Study Description
Brief Summary
Primary research question:
Are novel molecular tests for rapid detection of Mycoplasma and Gonorrhoea infections and antimicrobial resistance sensitive and specific in symptomatic patients attending a sexual health clinic?
Secondary research question:
Are novel molecular tests for detection of antimicrobial resistance in Mycoplasma and Gonorrhoea infections more accurate than standard laboratory culture techniques?
Detailed Description
This clinical study aims to clinically evaluate a novel, rapid molecular diagnostic for Mycoplasma and Gonorrhoea infections. This diagnostic detects both infection and also detects any antimicrobial resistance. These tests detect these organisms and provide information about antimicrobial resistance in a laboratory, but are not widely used in sexual health clinics in the UK and have not been clinically evaluated in symptomatic patients in detail.
Our primary objective is to determine if the novel molecular test for rapid detection of Mycoplasma and Gonorrhoea infections and antimicrobial resistance is sensitive and specific in symptomatic patients attending a sexual health clinic.
Our secondary research objective is to determine whether the novel molecular test for detection of antimicrobial resistance in Mycoplasma and Gonorrhoea infections more accurate than standard laboratory culture techniques.
Eligible participants will be aged between 16 and 99 years and attend a sexual health clinic at Cwm Taf Morgannwg Sexual Health department. They will be symptomatic.
Participants will have routine swabs performed as per routine sexual health care, following gaining participant consent in writing. Waste urine and discharge from vaginal swabs will be utilised in the study. Samples will be given a unique study number and sent to the normal NHS laboratory for analysis as per routine care. Left-over samples of urine and swabs will be pseudo-anonymised and then transported to the academic laboratory for analysis with the novel diagnostic with the unique study ID.
Results from routine tests for Mycoplasma and Gonorrhoea detection and for antimicrobial resistance will be compared to results of the novel diagnostic.
This study has had a substantial amendment reviewed and passed by an ethics committee, due to COVID disruptions in healthcare. It has changed from an interventional study to an observational study.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients that are sexually active.
* Patients that are symptomatic with:
* Dysuria
* Urethral discharge
* Vaginal discharge
* Rectal discharge
* Dysparenia (pain during sex)
* Pelvic pain
* Testicular pain
* Post-coital bleeding (bleeding after sex)
* Vulval/Glans/Perianal pain.
Exclusion Criteria:
* Pregnancy.
* Aged under 16 years.
* Sexual assault case.
* Patients with very severe symptoms that need admission to a ward or referral for urgent gynaecology or urology interventions.
* Patients lacking capacity to consent.
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT05391035
| 89,859 |
{
"NCT_ID" : "NCT04660695",
"Brief_Title" : "Nasobiliary Drain Assisted EUS-guided Gastroenterostomies in Unresectable Malignant Gastric Outlet Obstruction",
"Official_title" : "Serie de Casos Prospectiva de Gastroenteroanastomosis Guiada Por Ecoendoscopia Para la obstrucción al Vaciado gástrico en Neoplasias Avanzadas Mediante la técnica Del Drenaje Nasobiliar",
"Conditions" : ["Gastric Outlet Obstruction", "Gastric Cancer", "Pancreatic Cancer"],
"Interventions" : ["Device: EUS-guided gastroenterostomy"],
"Location_Countries" : ["India", "Spain"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-08-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-05-12",
"Study_Completion_Date(Actual)" : "2021-05-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-11-23",
"First_Posted(Estimated)" : 2020-12-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-12-08",
"Last_Update_Posted(Estimated)" : 2021-05-14",
"Last_Verified" : 2021-05"
}
}}
|
#Study Description
Brief Summary
Gastric outlet obstruction in malignant disease appears when the tumor affects the gastroduodenal area, precluding the passage of food into the small bowel. This condition severely affects the quality of life. In patients with unresectable tumors, there are various available treatments:a surgical bypass connecting the stomach to the small bowel, placing a stent through the tumor to widen the passage and creating a gastrointestinal bypass with a lumen apposing metal stent. These stents are deployed with an echoendoscope, which allows to identify a small bowel loop and to deploy the stent, connecting the small bowel and the stomach. This is called a EUS-guided gastroenterostomy (EUS-GE).
EUS-GE is a rather novel procedure. Various techniques to create EUS-GE have been proposed. In this study, the investigators will retrieve data from the procedure and during the thirty following days from consecutive patients undergoing an EUS-GE. The objectives of the study are:
* To perform a detailed step by step description of the nasobiliary drain assisted EUS-GE
* To describe the adverse events encountered
* To describe the proportion of clinical and technical success
* To assess its impact on the patients' quality of life.
* To assess the evolution of the oral intake during the first month after the procedure
Detailed Description
DESIGN
Prospective multicenter case series
AIMS
Primary aim To describe the proportions of technical and clinical success. To describe different variants in the nasobiliary drain assissted EUS-GE technique, offering a detailed step by step description of the procedure performance by different endoscopists
Secondary aims:
To describe the adverse encountered, their severity according to ASGE standards and their management.
To describe the time elapsed between the procedure and the initial oral intake.
To describe the evolution of the oral intake during the first month after the procedure To assess the impact of the operators experience on procedure times, adverse events and technical issues.
To assess the impact of the procedure on the quality of life of the participating patients.
STUDY POPULATION
All consecutive patients over 18 years of age receiving a nasobiliary drain assisted EUS-GE for unresectable malignant GOO are eligible to participate in this study. Patients with a previous gastroduodenal surgery, a previous endoscopic or surgical treatment for GOO, a simultaneous malignant biliary obstruction requiring endoscopic treatment, a distal bowel obstruction, ascites grade 2 or superior, uncorrectable coagulation disorders (INR\>1,5) or severe thrombocytopenia (\<50000 platelets/mm3). or unable to understand the questionnaires will be excluded.
INTERVENTION
At inclusion
Informed consent will be obtained. A clinical interview and a physical examination will be performed. TheEuropean Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30), which includes 30 items covering a global health status scale, five functional scales and ten symptom scales will be assessed in a telephone interview.
Endoscopic procedure
All procedures will be performed under sedation. An assistant endoscopist or research nurse will retrieve all data regarding the procedure. Firstly, un upper digestive endoscopy is performed with a conventional gastroscope. A guidewire is passed through the malignant lesion causing the gastric outlet obstruction. Once the guidewire is located in the distal duodenum/proximal jejunum, a nasobiliary drain (Nasal Biliary Drainage Sets, Cook medical, Indiana) is advanced over the guidewire until its distal end is placed in the distal duodenum/jejunum. At this point the gastroscope is substituted by a therapeutic echoendoscope. With the echoendoscope in place, the target bowel loop is filled with saline combined with methilene blue and radiopaque contrast. The echoendoscope is used to identify the target bowel loop. AFter identifying the target, a lumen apposing metal stent (Axios, Boston Scientific, Massachusetts) is deployed across the gastric and bowel using its electrocautery enhanced deployment device.
Post procedure: Oral liquid intake can be restarted 4h after the procedure in patients presenting no signs or symptoms suggesting any adverse event. Pacients with an adequate tolerance might be discharged.
Follow-up
Clinical telephone interviews by an experienced research nurse will be held via telephone calls 1 day, 7 days and 30 days after the procedure. Oral intake and adverse events will be assessed every visit. Thirty days after the procedure a second evaluation of the EORTC-QLQ-C30 will be performed.
STATISTICAL ANALYSIS
Categorical variables were reported as percentages. Normally distributed continuous variables were reported as the mean with the standard deviation values. Non-normally distributed continuous variables were reported as the median and interquartile range. The EORTC QLQ-C30 descriptive analysis was performed with a specifically programmed Stata command (10). Variables regarding the procedure step by step analysis will only undergo a descriptive analysis. Differences between the different outcomes of the EORTC-QLQ-C30 will be assessed using linear mixed models with fixed effects for baseline values, and interaction with oncological treatment. The statistical analysis will be performed using the Stata package (StataCorp. 2013, College Station, Texas).
#Intervention
- DEVICE : EUS-guided gastroenterostomy
- Firstly, un upper digestive endoscopy is performed with a conventional gastroscope. A guidewire is passed through the malignant lesion causing the gastric outlet obstruction. Once the guidewire is located in the distal duodenum/proximal jejunum, a nasobiliary drain (Nasal Biliary Drainage Sets, Cook medical, Indiana) is advanced over the guidewire until its distal end is placed in the distal duodenum/jejunum. At this point the gastroscope is substituted by a therapeutic echoendoscope. With the echoendoscope in place, the target bowel loop is filled with saline combined with methilene blue and radiopaque contrast. The echoendoscope is used to identify the target bowel loop. AFter identifying the target, a lumen apposing metal stent (Axios, Boston Scientific, Massachusetts) is deployed across the gastric and bowel using its electrocautery enhanced deployment device.
- Other Names :
- AXIOS™ Stent and Electrocautery Enhanced Delivery System (Boston Scientific, Mass)
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients > 18 years
* unresectable malignant gastric outlet obstruction
* Undergoing placement of nasobiliary drain assisted EUS-GE
Exclusion Criteria:
* Previous gastroduodenal surgery
* Previous endoscopic or surgical treatment for gastric outlet obstruction
* Simultaneous biliary obstruction (malignant or benign) requiring endoscopic treatment
* Simultaneous upper digestive tract disease requiring endoscopic treatment in the same procedure
* Unable to understand the questionnaires
* Distal bowel obstruction
* Ascites grade 2 or superior
* Uncorrectable coagulation disorders (INR>1,5) or severe thrombocytopenia (<50000 platelets/mm3).
* Active, symptomatic SARS-CoV-2 infection
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04660695
| 125,533 |
{
"NCT_ID" : "NCT00343109",
"Brief_Title" : "Vaccine Therapy in Treating Patients Receiving Trastuzumab For HER2-Positive Stage IIIB-IV Breast Cancer",
"Official_title" : "Phase II Study of a HER-2/Neu (HER2) Intracellular Domain (ICD) Peptide-Based Vaccine Administered to Patients With Locally Advanced or Stage IV HER2 Positive Breast Cancer",
"Conditions" : ["HER2-positive Breast Cancer", "Male Breast Cancer", "Stage IIIB Breast Cancer", "Stage IIIC Breast Cancer", "Stage IV Breast Cancer"],
"Interventions" : ["Other: immunologic technique", "Procedure: leukapheresis", "Other: laboratory biomarker analysis", "Biological: HER-2/neu intracellular domain protein", "Biological: sargramostim", "Biological: synthetic tumor-associated peptide vaccine therapy"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2004-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-06",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2006-06-20",
"First_Posted(Estimated)" : 2006-06-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2006-06-20",
"Last_Update_Posted(Estimated)" : 2020-02-12",
"Last_Verified" : 2019-05"
}
}}
|
#Study Description
Brief Summary
This phase II trial is studying how well vaccine therapy works in treating patients receiving trastuzumab for HER2-positive stage IIIB- IV breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells
Detailed Description
PRIMARY OBJECTIVES:
1. To estimate the RFS in patients with HER2 positive locally advanced breast cancer vaccinated with a HER2 ICD peptide-based vaccine.
SECONDARY OBJECTIVES:
1. To assess the safety of a HER2 ICD peptide-based vaccine administered concurrently with trastuzumab.
2. To determine the immunogenicity of the HER2 ICD peptide based vaccine when given within one year of initiating standard treatment which includes trastuzumab.
1. To determine the incidence of the development of T cell immunity specific for the HER2 ICD.
2. To determine the incidence of the development of intramolecular epitope spreading.
3. To determine the magnitude of the HER2 ICD specific CD4+ and CD8+ immune response generated with immunization.
3. To assess whether there is an association between RFS and the development of an immune response (HER2 specific T cell immunity and/or the development of intramolecular epitope spreading).
OUTLINE:
Patients receive HER-2/neu intracellular domain peptide-based vaccine mixed with GM-CSF intradermally (ID) once monthly for 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 4, 8, and 12 months and then annually thereafter for up to 5 years.
#Intervention
- BIOLOGICAL : HER-2/neu intracellular domain protein
- Given ID
- Other Names :
- HER-2 ICD Peptide, HER-2/neu ICD Protein
- PROCEDURE : leukapheresis
- Optional correlative studies
- OTHER : laboratory biomarker analysis
- Correlative studies
- BIOLOGICAL : sargramostim
- Given ID
- Other Names :
- GM-CSF, Leukine, Prokine
- OTHER : immunologic technique
- Correlative studies
- Other Names :
- immunological laboratory methods, laboratory methods, immunological
- BIOLOGICAL : synthetic tumor-associated peptide vaccine therapy
- Given ID
|
#Eligibility Criteria:
Inclusion Criteria:
* Stage IIIB or Stage IIIC breast cancer who are within 1 year of diagnosis and initiating treatment with chemotherapy and trastuzumab; and are in complete remission
* Stage IV breast cancer in first complete remission and defined as NED (no evidence of disease) or with stable bone only disease who are within 6 months of initiating maintenance trastuzumab
* NED status should be documented by chest/abdominal CT, PET or PET/CT within the last 90 days
* Bone only disease documented as stable or healed by PET, PET/CT, or MRI within the last 90 days; stable bone-only disease must be documented with bone scan performed within the last 6 months
* HER2 overexpression by IHC of 2+ or 3+, in the primary tumor or metastasis or documented gene amplification by FISH analysis; if overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by FISH
* Eligible subjects must have been treated to NED or stable bone only disease status with trastuzumab and/or chemotherapy and be off cytotoxic chemotherapy or immunosuppressive agents (e.g. systemic steroids) for at least 30 days prior to enrollment (concurrent hormonal therapy allowed; concurrent bisphosphonate therapy allowed)
* Patients on trastuzumab should continue trastuzumab monotherapy per standard of care (the dosing and schedule of trastuzumab should follow standard guidelines as described below: trastuzumab 2mg/kg IV weekly or trastuzumab 6mg/kg IV every 3 weeks)
* Subjects must have an ECOG Performance Status Score =< 1
* Non-menopausal female subjects must agree to contraception for the remainder of their childbearing years
* Male subjects must use an acceptable form of contraception throughout the course of the study
* Hematocrit >= 30,000
* Platelet count >= 100,000
* WBC >= 3000/mcl
* Stable creatinine =< 2.0 mg/dl or a creatinine clearance greater than 60 ml/min
* Serum bilirubin < 1.5 mg/dl
* SGOT < 2x ULN
* Laboratory tests should be performed within 60 days of enrollment
* Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
* Patients on trastuzumab monotherapy must have adequate cardiac function as demonstrated by normal ejection fraction (EF) on MUGA scan or echocardiogram performed within last 6 months
Exclusion Criteria:
* Subjects cannot be simultaneously enrolled in other treatment studies
* Patients cannot be receiving any other concurrent immunomodulators besides trastuzumab
* Any contraindication to receiving GM-CSF based vaccine products
* Cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, New York Heart Association functional class III-IV heart failure on active treatment with normalized LVEF on therapy, and symptomatic pericardial effusion
* Active autoimmune disease
* Subjects can not have active immunodeficiency disorder, e.g. HIV
* Cannot be pregnant or breast feeding
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00343109
| 215,470 |
{
"NCT_ID" : "NCT00241475",
"Brief_Title" : "Gefitinib in the Treatment of the First Relapse of Prostate Cancer Beyond Prostatectomy or Radiotherapy",
"Official_title" : "An Open Label, Non-Comparative, Phase II Study of ZD1839 (Iressa) as First-Line Treatment in Subjects With Relapsed Prostate Cancer Following Radical Prostatectomy or Radiotherapy",
"Conditions" : ["Prostate Cancer"],
"Location_Countries" : ["Finland"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2003-12",
"Study_Completion_Date(Actual)" : "2005-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-10-18",
"First_Posted(Estimated)" : 2005-10-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-10-18",
"Last_Update_Posted(Estimated)" : 2009-04-23",
"Last_Verified" : 2009-04"
}
}}
|
#Study Description
Brief Summary
To evaluate activity of gefitinib in subjects with relapsed prostate cancer by estimating PSA response rate at study closure
#Intervention
- DRUG : Gefitinib
|
#Eligibility Criteria:
Inclusion Criteria:
* Relapsed prostate cancer after prostatectomy or radiotherapy
* PSA levels below 10 ng/mL
* Lymph node negative
* Metastasis negative
* Withdrawal of hormone therapy at least 6 months before entry into the study
* Written informed consent
Exclusion Criteria:
* Metastatic disease
* Hormonal treatment 6 months before study entry
* Concomitant radiotherapy, surgery and/or chemotherapy
* ILD
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00241475
| 143,571 |
{
"NCT_ID" : "NCT03258437",
"Brief_Title" : "Efficacy and Safety of DA-9401 on Improvement of Sperm Motility",
"Official_title" : "A 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Allium Cepa L. and Cuscuta Chinensis Lam. Extract Mixtures (DA-9401) on Improvement of Sperm Motility",
"Conditions" : ["Spermatocele"],
"Interventions" : ["Dietary Supplement: Placebo", "Dietary Supplement: DA-9401"],
"Location_Countries" : ["Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-04-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-01-30",
"Study_Completion_Date(Actual)" : "2018-01-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-07-05",
"First_Posted(Estimated)" : 2017-08-23"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-08-21",
"Last_Update_Posted(Estimated)" : 2018-03-20",
"Last_Verified" : 2018-03"
}
}}
|
#Study Description
Brief Summary
This study was conducted to investigate the effects of daily supplementation of Allium cepa L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) on improvement of sperm motility.
Detailed Description
This study was a 12 weeks, multi-center, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Allium cepa L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) or a placebo group. sperm motility profiles before and after the intervention.
#Intervention
- DIETARY_SUPPLEMENT : DA-9401
- Other Names :
- capsules (4cap/d, 2.16 g/d) for 12 weeks.
- DIETARY_SUPPLEMENT : Placebo
- Placebo for 12 weeks.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 20 <= age <= 55 years
* sperm motility 40~69%
Exclusion Criteria:
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 1 months
* intense constipation
Sex :
MALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03258437
| 200,787 |
{
"NCT_ID" : "NCT06091800",
"Brief_Title" : "Interleukin 20 and Periodontal Tisuue Destruction",
"Official_title" : "Determination of Levels of IL-20, TNF-α, IL1β/IL-10, RANKL/OPG and MMP8 in Serum and Gingival Crevicular Fluid (GCF) in Peridontally Healthy and Periodontitis Individuals",
"Conditions" : ["Periodontitis"],
"Interventions" : ["Other: biochemical analysis"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-06-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-03-06",
"Study_Completion_Date(Actual)" : "2023-06-06},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-10-11",
"First_Posted(Estimated)" : 2023-10-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-10-18",
"Last_Update_Posted(Estimated)" : 2023-10-19",
"Last_Verified" : 2023-10"
}
}}
|
#Study Description
Brief Summary
Periodontitis is an inflammatory disease that causes destruction of periodontal tissues. IL-20, on the other hand, is known as a potent angiogenic, chemotactic, and pro-inflammatory cytokine associated with various chronic inflammatory disorders. IL-20 has a significant role in the regulation of osteoclastogenesis and osteoblastogenesis. The aim of this study was to evaluate the effect of IL-20 on periodontal destruction.
In the study, a total of 60 participants were included, 30 of whom were systemically and periodontally healthy (control group) and 30 of whom were systemically healthy and had periodontitis (periodontitis group). GCF and serum samples were collected from the participants for biochemical analysis. ELISA method was used to determine IL-20, TNF-α, IL1β/IL-10, RANKL/OPG and MMP8 levels
#Intervention
- OTHER : biochemical analysis
- GCF and serum samples were collected from the participants for biochemical analysis.
|
#Eligibility Criteria:
Inclusion Criteria:
* The following criteria were required for inclusion: being systemically healthy, not smoking, not using antibiotics or systemic corticosteroids within the previous three months, not being pregnant or nursing, not having a chronic inflammatory disease, not receiving periodontal therapy within the previous six months, and possessing at least 20 teeth
Exclusion Criteria:
* smoking, using antibiotics or systemic corticosteroids within the previous three months, pregnant, receiving periodontal therapy within the previous six months
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06091800
| 166,431 |
{
"NCT_ID" : "NCT01579994",
"Brief_Title" : "Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers",
"Official_title" : "A Phase I Study of Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers",
"Conditions" : ["Advanced Lung Cancer"],
"Interventions" : ["Drug: Ganetespib (STA-9090) and crizotinib"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-04-16",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-12-28",
"Study_Completion_Date(Actual)" : "2020-12-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-04-16",
"First_Posted(Estimated)" : 2012-04-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-04-17",
"Last_Update_Posted(Estimated)" : 2020-12-30",
"Last_Verified" : 2020-12"
}
}}
|
#Study Description
Brief Summary
About 18 patients will take part in the phase 1 portion of the trial. In the beginning of the study, 3 patients will be treated with a low dose of ganetespib (STA-9090) and the standard dose of crizotinib. If this dose does not cause significant side effects, it will be increased as new patients take part in the study. The study will only be open at Memorial Sloan Kettering Cancer Center.
#Intervention
- DRUG : Ganetespib (STA-9090) and crizotinib
- Ganetespib (STA-9090) is given intravenously (days 1 and 8 of a 21 day cycle). Crizotinib will be given at the FDA approved dose of 250mg orally twice daily in a continuous fashion.
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically proven diagnosis confirmed at MSKCC of advanced lung adenocarcinoma that is locally advanced or metastatic (stage III/IV).
* Positive for translocation or inversion events involving the ALK gene locus as determined standard methods (including but not limited to by FISH and IHC testing).
* No prior treatment with crizotinib, but they may have received prior cytotoxic chemotherapy.
* Age >= 18 years.
* Measurable (RECIST 1.1) indicator lesion not previously irradiated.
* Karnofsky Performance Status >= 70%
* Able to take oral medications
* A negative serum pregnancy test obtained within two weeks prior to administration of the experimental agents in all pre-menopausal women (last menstrual period <= 24 months ago).
* All women of child bearing potential (WOCBP) and sexually active men must agree to use adequate methods of birth control throughout the study which include use of oral contraceptives with an additional barrier method, double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy and/or tubal libation and total abstinence.
Exclusion Criteria:
* Prior crizotinib therapy
* Inadequate recovery from any toxicity related to prior treatment (to Grade 1 or baseline).
* Inadequate hematologic function defined as:
* Absolute neutrophil count (ANC) < 1,000 cells/mm³.
* Platelet count < 75,000/mm³
* Hemoglobin < 9.0g/dL.
Inadequate hepatic function defined by:
* AST and/or ALT > 3x upper limited of normal (ULN).
* Total bilirubin > 2x ULN.
* Alkaline phosphatase > 3x ULN.
* Patients with hepatic metastases may have ALT/AST <= 5x ULN.
* Patients with hepatic and/or bone metastases may have an AP <= 5x ULN.
* Inadequate renal function defined by serum creatinine > 2x ULN Uncontrolled systemic fungal, bacterial, viral or other infection (defined as exhibiting ongoing signs/symptoms related to infection without improvement, despite appropriate anti-infective medications or other treatment).
* Patients with clinically active brain metastasis (requiring therapy with steroids or radiation therapy). Patients with clinically stable brain metastases (previously treated or untreated) for two weeks are eligible.
* Significant cardiac disease (e.g. New York Heart Association (NYHA) Class 3 or 4; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty or coronary artery bypass graft (CABG) within the past 6 months; or uncontrolled atrial or ventricular cardiac arrhythmias).
* Previously or current malignancies at other sites within the last 2 years, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, or prostate cancer that does not require active treatment per National Comprehensive Cancer Network (NCCN) guidelines.
* Women who are pregnant or lactating
* Use of drugs or food that are known potent CYP3A4 inhibitors (see Appendix C)
* Use of drugs that are known potent CYP3A4 inducers (see Appendix D)
* Any other condition that, in the opinion of the Investigator, may compromise the safety, compliance of the patient, or would preclude the patient from successful completion of the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01579994
| 46,279 |
{
"NCT_ID" : "NCT02768389",
"Brief_Title" : "Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma",
"Official_title" : "A Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma",
"Conditions" : ["Glioblastoma", "Brain Tumor"],
"Interventions" : ["Drug: Bevacizumab", "Behavioral: Modified Atkins Diet"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["EARLY_PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-09-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-11",
"Study_Completion_Date(Actual)" : "2018-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-05-09",
"First_Posted(Estimated)" : 2016-05-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-05-10",
"Last_Update_Posted(Estimated)" : 2019-03-15",
"Last_Verified" : 2019-03"
}
}}
|
#Study Description
Brief Summary
Patients may participate in this research study if they have glioblastoma. (a brain tumor) that has come back after being treated. Standard treatment for this cancer is a chemotherapy drug called bevacizumab. This research study involves bevacizumab in combination with a special diet called the Modified Atkins Diet (MAD).
The purpose of this study is to research if patients can stay on the MAD when it is added to the standard bevacizumab treatment.
Detailed Description
Primary Objective
- Determine compliance to treatment at 6 and 12 weeks. Compliance is assessed by review of the daily food diary and the urine and serum ketone levels. Diet compliance is defined as following the diet guidelines 80% of the time with resultant ketosis 80% of the time. If 60% of the patients are compliant with the diet, as defined above, that is a considered a positive result.
Secondary Objective(s)
* Determine patient compliance in monitoring of blood glucose and urine levels of ketosis.
* Determine obstacles to compliance.
* Determine the frequency of achieving ketosis, as measured by urine ketones checked daily and serum BHB checked every two weeks.
* Determine quality of life (FACT-BR) and adverse events.
* Determine response, progression free survival at 6 months (PFS 6), and overall survival (OS).
Exploratory Objective
* To correlate levels of ketosis and blood sugar with treatment outcome.
* To correlate the level of MCT4 expression and IDH1 mutation status with treatment outcome.
#Intervention
- DRUG : Bevacizumab
- Subjects receive Bevacizumab as standard of care
- BEHAVIORAL : Modified Atkins Diet
- The modified Atkins diet (MAD) includes high fat, unlimited protein, and restricted carbohydrates (\< 20gm/day).
- Other Names :
- MAD
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed glioblastoma or other grade IV malignant glioma (i.e. gliosarcoma, small cell glioblastoma, etc.), recurrent after prior external beam fractionated radiotherapy and temozolomide chemotherapy.
* Any number of prior recurrences are allowed
* Karnofsky Performance status >=60
* Patients must have normal organ and marrow function as defined below:
* Hemoglobin >= 9.0 g/dl
* Absolute neutrophil count >= 1.5 x 10^9/L
* Platelet count >= 100 x 10^9/L
* Total bilirubin <= 1.5 X institutional upper limit of normal
* Aspartate aminotransferase (AST) (SGOT) <= 3.0x institutional upper limit of normal
* Alanine aminotransferase (ALT) (SGPT) <= 3.0x institutional upper limit of normal
* Serum Creatinine <= 1.5 X institutional upper limit of normal
* Cr <2, blood urea nitrogen (BUN) < 100mg/dL
* Blood coagulation parameters: international normalized ratio (INR) <= 1.5
* Minimum interval since last drug therapy;
* 3 weeks since last non-cytotoxic therapy
* 3 weeks must have elapsed since the completion of non-nitrosourea-containing chemotherapy regimen.
* 6 weeks since the completion of a non-nitrosourea-containing therapy regimen.
* Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treatment stage I or II cancer from which the patient is in complete remission. Patients with other malignancies must also be disease free for at least three years.
* Patients must be maintained on a stable corticosteroid regimen from the time of their baseline scan until the start of the treatment and/or for at least 5 days before starting treatment.
* Patients with the potential for pregnancy or impregnating their partners must agree to follow acceptable birth control methods to avoid conception. The effects of bevacizumab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence prior to study entry, for the duration of study participation and after completing treatment. Should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately.
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
* Patients who are receiving any other investigational agents.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab.
* Patients who have had previous treatment with bevacizumab.
* Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active bowel instruction, diabetic (insulin dependent), Active or remote pancreatitis, Pancreatic insufficiency, symptomatic congestive heart failure (NYHA > 2), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant or breastfeeding women are excluded from this study because bevacizumab is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with bevacizumab, breastfeeding should be discontinued if the mother is treated with bevacizumab. These potential risks may also apply to other agents used in this study.
* Known diagnosis of human immunodeficiency virus (HIV). (HIV testing is not required).
* Patients who have undergone major surgery (ie, intra-thoracic, intra abdominal or inra-pelvic), open biopsy or significant traumatic injury =< 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device <= 1 week prior to starting study drug, or who have not recovered from side effects of previous procedure or injury.
* Patients with cirrhosis, or active viral or nonviral hepatitis.
* Implanted pacemaker, defibrillator, deep brain stimulator, or other implanted electronic devices in the brain or other documented clinically significant arrhythmias.
* Evidence of increased intracranial pressure (clinically significant papilledema, vomiting, and nausea, or reduced level of consciousness).
* Patients who are unwilling to comply with protocol.
* Myocardial infarction within the last 6 months.
* Symptomatic atrial fibrillation.
* Patients with a body mass index (BMI) >35, < 20.
* Patients with a genetic disorder of fat metabolism.
* Patients who are allergic to milk.
* Insulin dependent diabetes mellitus.
* Patients with uncontrolled hypertension. Patients with a history of hypertension must be well controlled (<160/90) on a regimen of hypertensive medication.
* Patients with known inborn errors of metabolism of primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, beta-oxidation defects, pyruvate carboxylase deficiency and porphyria.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02768389
| 50,156 |
{
"NCT_ID" : "NCT05681793",
"Brief_Title" : "Survey on the Clinical Assessment of the Psychological Status of a Patient Over 75 Years Old in Oncology During the Realization of the G8 Score (CADEPO)",
"Official_title" : "Survey on the Clinical Assessment of the Psychological Status of a Patient Over 75 Years Old in Oncology During the Realization of the G8 Score",
"Conditions" : ["Depression"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-01-17",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-03-02",
"Study_Completion_Date(Actual)" : "2023-04-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-12-28",
"First_Posted(Estimated)" : 2023-01-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-12-28",
"Last_Update_Posted(Estimated)" : 2023-06-22",
"Last_Verified" : 2023-06"
}
}}
|
#Study Description
Brief Summary
The goal of this observational study is to make a statement concerning the identification of depressive symptoms at the time of the realization of the G8 score in patients over 75 with cancer and followed in oncology.
The main question it aims to answer are:
* Compare the medical hetero-evaluation of depressive symptoms via the G8 'neuro-psychiatric disorders' item score with a self-evaluation via the GDS-15 score
* Evaluate the number of patients over 75 treated with antidepressants
* Evaluate the proportion of patients with depressive symptoms according to the predisposing factors
* Compare the number of patients followed in oncogeriatrics over the period from 01/01/2022 to 02/28/2022 and the period from 01/01/2023 to 02/28/2023
Participants will complete a self-questionnaire (GDS-15 score) as well as a socio-demographic sheet.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients aged 75 and over
* Patients receiving treatment at the day hospital or oncology week hospital
* Patients informed and having not presented any opposition to their participation
Exclusion Criteria:
* Patients under the age of 75
* Patients under guardianship or curatorship
* Patients without social security
* Cognitive disorders compromising the understanding of the information and the performance of the study (in particular the completion of a self-administered questionnaire), in the opinion of the oncologist
Sex :
ALL
Ages :
- Minimum Age : 75 Years
- Maximum Age : 95 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05681793
| 227,127 |
{
"NCT_ID" : "NCT00596154",
"Brief_Title" : "Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma",
"Official_title" : "Rituximab, Methotrexate, Procarbazine and Vincristine Followed by High-dose Chemotherapy With Autologous Stem-cell Rescue in Newly-diagnosed Primary CNS Lymphoma (PCNSL)",
"Conditions" : ["CNS Lymphoma", "CNS Brain Cancer", "Non-Hodgkin's Lymphoma"],
"Interventions" : ["Other: Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2004-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-02-02",
"Study_Completion_Date(Actual)" : "2023-02-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-01-07",
"First_Submitted_that_Met_QC_Criteria" : 2024-03-29",
"First_Posted(Estimated)" : 2008-01-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-01-07",
"Last_Update_Posted(Estimated)" : 2024-04-01",
"Last_Verified" : 2023-02"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to determine the safety of this new treatment offered in this study. PCNSL can be cured in less than half of patients with standard treatment, a combination of chemotherapy and brain radiation. Also, the combination of chemotherapy and brain radiation may result in serious lasting side effects. Most patients older than age 60 develop memory problems, difficulty walking or inability to control their bladder. Some patients younger than age 60 also develop these side effects.
#Intervention
- OTHER : Rituximab, Methotrexate, Vincristine, Procarbazine, PBPCs collection, Busulfan, Thiotepa, and Cyclophosphamide
- The initial treatment will consist of cycles of 14 days. Each cycle will start with rituximab, which will be given by vein on day 1.
On day 2 you will be admitted to the hospital and will receive 3 other drugs:
Methotrexate will be given by vein over 2 to 3 hours only on day 2. Vincristine will be given as a single injection over a few minutes only on day 2.
Procarbazine is a pill that you will take at bedtime for 7 nights starting on day 2. Procarbazine is only given every other cycle.
- Other Names :
- During each cycle, you will receive Rituximab typically as an outpatient on day 1 and then be, admitted on day 2 to receive the other chemotherapy. You will be in the hospital for about 5 days and will be re-admitted to the hospital about 9 days, later to start the next cycle. After each cycle of chemotherapy you will take a medicine called G-CSF to protect you against, infection. PBPCs will be collected when determined by your doctor and may occur with cycle 1 or cycle 2., You will be admitted again for the high-dose chemotherapy and will receive supportive, medications to help avoid complications, including antibiotics and blood transfusions. Three, drugs, Busulfan, Thiotepa, and Cyclophosphamide will be given to you over 8 days. After a, rest period of approximately 1-2 days, we will give your PBPCs (or bone marrow) back to you, by vein. You will be in the hospital for at least 3 weeks.
|
#Eligibility Criteria:
Inclusion Criteria:
* All patients must have non-Hodgkin's lymphoma involving the brain, as demonstrated by CT or MRI and histologic confirmation by one of the following: A positive CSF cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers.
A biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma. Brain biopsy.
* Patients must be HIV-1 negative.
* Patient must have left ventricular ejection fraction >= 50%.
* Patients must have no evidence of systemic lymphoma. This must be demonstrated by a CT scan of the chest, abdomen and pelvis prior to registration.
* Patients must have adequate bone marrow function (defined as peripheral leucocyte count >3000 cells/mm3 and platelet count > 100,000 cells/mm3), liver function (bilirubin < 2.0 mg%), and adequate renal function (serum creatinine < 1.5 mg/dl or creatinine clearance > 50cc/min/1.73M2).
* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
* Patients must be between 18 and 72 years-old.
* Patients must sign an informed consent.
Exclusion Criteria:
* Prior cranial irradiation
* Other active primary malignancy with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ.
* Pre-existing immunodeficiency such as renal transplant recipient.
* Prior treatment with chemotherapy for CNS lymphoma.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 72 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00596154
| 272,637 |
{
"NCT_ID" : "NCT00162825",
"Brief_Title" : "Role of CD7 in Skin Inflammation and Psoriasis",
"Conditions" : ["Psoriasis", "Inflammation"],
"Location_Countries" : ["Taiwan"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2004-01",
"Study_Completion_Date(Actual)" : "2006-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-09-12",
"First_Posted(Estimated)" : 2005-09-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-09-12",
"Last_Update_Posted(Estimated)" : 2008-07-11",
"Last_Verified" : 2003-06"
}
}}
|
#Study Description
Brief Summary
Role of CD7 in skin inflammation and psoriasis
Detailed Description
Psoriasis is a debilitating, chronic inflammatory skin disorder characterized by scaly skin patches caused by infiltration of inflammatory cells into the dermis and epidermis, with secondary epidermal cell (keratinocyte) hyperproliferation. Psoriasis is a complex disease and a combination of genetic and environmental factors are likely to be causative. T-cell-mediated immune process, including cytokines (eg. IFN-γ) and chemokines, play an essential role in psoriasis. Susceptibility genes for psoriasis map to PSORS1 in the HLA region at chromosome 6p21, PSORS2 in the chromosome 17q24-q25, and others.
Recently our colleagues in the Academia Sinica and we performed a genome-wide linkage analysis with polymorphic microsatellites in one five-generation affected psoriasis kindred, and the result revealed a close linkage at D17S928, close to CD7. CD7+ T cells produce IFN-γ when activated, and have been located in skin inflammatory lesions. Therefore, in this study we first want to examine the role of CD7 in skin inflammations conditions. CD7+ cells will be stimulated by a variety of methods, and will be used to treat keratinocyte cultures or be injected intradermally to mice. We will watch for skin inflammation and possible proliferation and changes in keratinocytes. Possible changes in CD7 function in patients with psoriasis will be explored, for example, polymorphisms of the CD7 gene may predispose skin inflammation and abnormal interaction with the keratinocytes. CD7- T cells, which could be derived from CD7+ cells and are enriched in skin inflammation lesions, secrete the Th2 cytokine IL-5. We are also interested in the mechanism and the consequences of this CD7 shift. We hope this study will be helpful in the understanding and management of skin inflammation conditions, including psoriasis.
|
#Eligibility Criteria:
Inclusion Criteria:
clinical diagnosis of psoriasis
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00162825
| 84,592 |
{
"NCT_ID" : "NCT00915460",
"Brief_Title" : "Open-Label Safety Extension Study of Avonex",
"Official_title" : "An Open-Label Safety Extension Study of AVONEX® (Interferon Beta-1a) Treatment in Subjects Who Completed Biogen Studies C95-812, C96-823, or C97-830",
"Conditions" : ["Multiple Sclerosis"],
"Interventions" : ["Drug: Interferon beta-1a (Avonex)"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "1999-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2003-06",
"Study_Completion_Date(Actual)" : "2003-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-06-05",
"First_Posted(Estimated)" : 2009-06-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-06-05",
"Last_Update_Posted(Estimated)" : 2009-06-08",
"Last_Verified" : 2009-06"
}
}}
|
#Study Description
Brief Summary
To collect data on serious adverse events which occur during extended treatment with Avonex in subjects at high risk for developing multiple sclerosis (MS) and in subjects with secondary progressive MS.
#Intervention
- DRUG : Interferon beta-1a (Avonex)
- dosage and frequency as per Biogen Idec protocol
- Other Names :
- Avonex
|
#Eligibility Criteria:
Inclusion Criteria:
* Must have completed (as defined below) one of the following Biogen AVONEX® clinical studies and meet the other criteria indicated.
* Subjects enrolled from studies C95 <= age <= 812 and C97 <= age <= 830 must have completed their respective study within 12 months prior to enrollment in C98 <= age <= 838. Subjects enrolled from study C96 <= age <= 823 must have completed the study within 24 months prior to enrollment in C98 <= age <= 838.
* have not been diagnosed with any other disease that accounts for their neurologic symptoms.
Exclusion Criteria:
* History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta.
* History of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin.
* History of seizure within the 3 months prior to enrollment.
* Abnormal laboratory results at the screening visit:
* History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment into this study.
Other inclusion and exclusion criteria apply as per Biogen Idec Protocol
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00915460
| 49,784 |
{
"NCT_ID" : "NCT04942106",
"Brief_Title" : "Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position",
"Official_title" : "Biobehavioral Efficacy of the Semi-Elevated Side-Lying Position for Feeding Preterm Infants",
"Conditions" : ["Feeding, Bottle", "Infant, Premature, Diseases", "Behavior, Infant"],
"Interventions" : ["Other: Arm 1 - Side-lying position followed by Supine position", "Other: Arm 2 - Supine position followed by Side-lying position"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-03-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-05-31",
"Study_Completion_Date(Actual)" : "2024-05-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-05-30",
"First_Posted(Estimated)" : 2021-06-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-06-22",
"Last_Update_Posted(Estimated)" : 2024-07-12",
"Last_Verified" : 2024-07"
}
}}
|
#Study Description
Brief Summary
The objective of the proposed research is to conduct a within-subject cross-over trial that will compare the efficacy of the two bottle-feeding positions on physiologic and behavioral responses of preterm infants prior to, during, and after feeding. As an exploratory aim, the investigators will also identify potential infant characteristics associated with the intervention response by evaluating infant sex, maturity level, and/or comorbidity. The two bottle-feeding positions will be the semi-elevated side-lying position (hereafter referred to as side-lying position) and the semi-elevated supine position (hereafter referred to as supine position), which is the traditional feeding position when preterm infants are bottle-fed. The investigators hypothesize that compared to the supine position, the side-lying position will be associated with greater physiologic stability in heart rate, respiratory rate, oxygen saturation, and/or autonomic nervous system regulation during and after feeding. The investigators also hypothesize that compared to the supine position, the side-lying position will be associated with more mature patterns of suck-breathe coordination and/or greater feeding skills.
#Intervention
- OTHER : Arm 1 - Side-lying position followed by Supine position
- Infants will be observed for two bottle feedings within a 24-hour period when they reach approximately 30-50% oral feeding. In this arm, infants will be bottle-fed in the side-lying position first followed by the supine position. In the side-lying feeding position, the infant will be placed on the caregiver's lap with one ear and hip facing the ceiling at a 45 to 60 degree angle. In the supine feeding position, the infant will be placed facing the caregiver in a reclining position at a 45 to 60 degree angle. In both feeding positions, the infant's head, neck, and upper body will be supported by the caregiver to maintain a neutral straight alignment with the chin tilted down slightly without the neck being extended or in excessive flexion. The infant will also be loosely swaddled with a single blanket so their legs, shoulders, and elbows are supported in a flexed position but with the lower arms free to move.
- OTHER : Arm 2 - Supine position followed by Side-lying position
- Infants will be observed for two bottle feedings within a 24-hour period when they reach approximately 30-50% oral feeding. In this arm, infants will be bottle-fed in the supine position first followed by the side-lying position. In the side-lying feeding position, the infant will be placed on the caregiver's lap with one ear and hip facing the ceiling at a 45 to 60 degree angle. In the supine feeding position, the infant will be placed facing the caregiver in a reclining position at a 45 to 60 degree angle. In both feeding positions, the infant's head, neck, and upper body will be supported by the caregiver to maintain a neutral straight alignment with the chin tilted down slightly without the neck being extended or in excessive flexion. The infant will also be loosely swaddled with a single blanket so their legs, shoulders, and elbows are supported in a flexed position but with the lower arms free to move.
|
#Eligibility Criteria:
Inclusion Criteria:
* Preterm infants who are born at <= 35 weeks of GA
Exclusion Criteria:
* Congenital anomaly that may interfere with feeding (e.g., cleft palate or tracheoesophageal fistula)
* Grade IV intraventricular hemorrhage
* Ventilator-dependence beyond 60 days of life
* Inability to orally feed prior to discharge
Sex :
ALL
Ages :
- Maximum Age : 2 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04942106
| 193,444 |
{
"NCT_ID" : "NCT04233931",
"Brief_Title" : "Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM",
"Official_title" : "Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM",
"Conditions" : ["Hiv"],
"Interventions" : ["Behavioral: PrEP medication adherence mobile app"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-06-21",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-05-20",
"Study_Completion_Date(Actual)" : "2019-05-20},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-01-15",
"First_Posted(Estimated)" : 2020-01-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-01-16",
"Last_Update_Posted(Estimated)" : 2020-01-18",
"Last_Verified" : 2020-01"
}
}}
|
#Study Description
Brief Summary
The proposed project involves the development and testing of an mhealth intervention to increase adherence to PrEP treatment using texts providing tailored pill reminders, motivational messages, and health education messages. The intervention targets culturally-diverse young adult men who have sex with men (YMSM), who are at high risk for both HIV and non-adherence to PrEP medication. Supporting PrEP adherence would help reduce new HIV infections in this group.
Detailed Description
Specific Aims: Pre-exposure prophylaxis (PrEP) treatment greatly reduces HIV risk. When the PrEP pill (Truvada) is taken daily, it can reduce HIV risk up to 92%. NIH has designated reducing HIV/AIDS as a high-priority topic for research support using AIDS-designated funds. Among other groups, the CDC recommends PrEP for men who have sex with men (MSM) who are HIV-negative and in a relationship with an HIV+ partner, and MSM who have had anal sex without a condom or have been diagnosed with an STD in the past 6 months; about 1 in 4 MSM meet these criteria. Young people, age 13-29, accounted for 27% of new HIV cases in 2009. The highest concentration of new cases was among 20-29-year olds; 70% of these were MSM. Disparities are pronounced: 57% of new HIV cases reported in 2008-2010 were among African American MSM; 21% of cases were young Latino MSM. In PrEP trials to date, adherence has been generally low. Across these trials, younger age was the most consistent factor associated with lower PrEP adherence. Medication adherence can be difficult for young people. While young adults better comprehend benefits of prevention than teens, decision-making maturity is still developing through the 20s. It is not until the late 20s that two brain systems, one that spurs sensation-seeking and one that undergirds self-regulation and planning ahead, become integrated. Males may lag behind females in this regard. Furthermore, this developmental process can be hampered for those who have experienced the stress of victimization as have many MSM. PrEP adherence interventions for young adult MSM (YMSM) must take into account developmental factors that can affect decision-making. CDC strongly encourages PrEP prescribers to offer adherence support; foundational to that support is patient education. CDC also suggests adherence plans: 1) individually tailor dosing time 2) use pill reminders 3) use supports to address changes in routine and 4) consider disclosure issues, i.e. help patients identify social network members who can support adherence or ways to overcome adherence barriers due to lack of social disclosure. To date, no PrEP adherence intervention has been developed specifically for YMSM, despite increasing HIV rates in this group and their increased risk for non-adherence. High rates of texting by young adults, coupled with strong evidence base that text reminders can improve adherence, point to mobile health (mhealth) as an ideal way to support PrEP adherence among YMSM.
The goal of the proposed SBIR is to develop and test the feasibility and short-term effectiveness of an individually-tailored, developmentally- and culturally-sensitive mhealth PrEP adherence intervention for culturally-diverse YMSM. Its scientific premise rests on three large well-conducted adherence follow-up studies to PrEP efficacy trials, i.e. VOICE, FEM-PrEP, and iPrEx, which identified adherence facilitators/barriers being targeted in the proposed study, and on meta-analyses of a large and growing literature pointing to the effectiveness of mhealth for medication adherence across chronic conditions, including HIV. The intervention will be modeled on Dr Patricia Weitzman's (proposed PI) SBIR Phase 1 and 2 mhealth anti-retroviral therapy (ART) adherence intervention for HIV+ African Americans. That intervention employed a three-pronged approach of tailored pill reminders with age- and culturally-sensitive motivational and educational texts. Texts were designed to increase ART self-efficacy, and based on principles from social learning theory and positive psychology. Using a similar approach, formative research will be conducted to create motivational and educational texts that are culturally- and developmentally-sensitive for diverse YMSM. Moreover, formative research will allow us to identify and target unique PrEP adherence barriers and facilitators among culturally-diverse YMSM. Findings will be used to create and pilot a 6-week randomized mhealth PrEP adherence intervention addressing adherence barriers and facilitators identified in PrEP RCTs, and our formative research, as well as CDC PrEP adherence recommendations. Our long-term goal is to reduce HIV infection rates among culturally-diverse YMSM by supporting PrEP adherence.
Specific Aim 1: Develop a individually-tailored, culturally- and developmentally-sensitive mhealth intervention to promote adherence to PrEP among YMSM, ages 20-29. Aim 2: Implement 6-week pilot randomized controlled trial to evaluate short-term effectiveness (did it improve PrEP adherence, PrEP knowledge and PrEP treatment self- efficacy). CONSORT guidelines for the RCT will be followed in order to ensure scientific rigor. Primary Hypothesis: Young adult MSM who receive tailored daily pill reminder plus motivational/ educational texts for 6 weeks will show greater PrEP adherence compared to controls. Secondary Hypothesis: Young adult MSM who receive tailored daily pill reminder plus motivational/educational texts for 6 weeks will show greater PrEP knowledge and PrEP treatment self-efficacy compared to controls. Aim 3: Evaluate feasibility of the intervention, e.g. implementation fidelity (to what extent was intervention delivered as planned), program appeal (how well did participants like the intervention) and program reach (how well did it reach participants). CDC estimates PrEP is appropriate for the roughly 500,000 MSM in the US. Impact models show even modest adherence to PrEP could reduce new HIV infections among MSM by 29% over 20 years. An mhealth PrEP adherence tool targeting young adult MSM, a group experiencing increased HIV incidence, could not only support that reduction but-due to easy access and low cost-actually improve upon it.
#Intervention
- BEHAVIORAL : PrEP medication adherence mobile app
- Participants use a PrEP medication adherence mobile app for six weeks.
|
#Eligibility Criteria:
Inclusion criteria
* Male
* Age 20 <= age <= 29
* Currently taking PrEP
* Own smartphone
Exclusion criteria
* Current participation in PrEP or other HIV-related study
* Uncomfortable with potential privacy loss risks
Sex :
MALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 29 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04233931
| 17,768 |
{
"NCT_ID" : "NCT04803032",
"Brief_Title" : "Trident Landmark as a Safe and Easy Method for Facial Nerve Trunk Identification During Superficial Parotidectomy",
"Official_title" : "Trident Landmark as a Safe and Easy Method for Facial Nerve Trunk Identification During Superficial Parotidectomy",
"Conditions" : ["Parotid Tumor", "Parotid Neoplasms", "Surgery", "Head and Neck Disorder"],
"Interventions" : ["Procedure: Superficial parotidectomy"],
"Location_Countries" : ["Egypt"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-12-28",
"Study_Completion_Date(Actual)" : "2020-01-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-03-14",
"First_Posted(Estimated)" : 2021-03-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-03-14",
"Last_Update_Posted(Estimated)" : 2021-03-17",
"Last_Verified" : 2021-03"
}
}}
|
#Study Description
Brief Summary
The parotid has a close relationship with the extra temporal course of the facial nerve. The study aimed to evaluate the accuracy and safety of trident landmark during superficial parotidectomy in the identification of the facial nerve trunk.
Detailed Description
A prospective study was conducted between January 2018 and January 2020 at Kafr El-Sheikh university hospital (KUH) and Al Fayoum University Hospital (FUH), Egypt, on 60 patients with benign parotid tumors in the superficial lobe. All patients were subjected to superficial parotidectomy. The outcome was evaluated regarding the clinical success of facial nerve identification by trident landmark and early postoperative complications.
#Intervention
- PROCEDURE : Superficial parotidectomy
- The parotid gland was exposed with its capsule by subplatysmal and SMAS flaps. Dissection was performed from the tragal cartilage until the bony anterior wall of the external auditory canal; from there, the dissection was done using a blunt instrument. The styloid process's base is the upper point of the trident landmark; it is the superior portion of the trident landmark. Identification of the posterior belly of the digastric muscle till its origin was performed deep to the sternocleidomastoid muscle. ); it is the lower point of the landmark. The FNT is located in the region between these two structures. The dissection after identification of the main trunk of the facial nerve was similar to the routine parotidectomy. The surgical defect was closed over a removac suction drain using Vicryl materials; the skin was closed by 6-0 absorbable sutures. A dressing was applied to the surgical site. Then, a gauze was wrapped over the parotid area and secured around the forehead and neck.
|
#Eligibility Criteria:
Inclusion Criteria:
* patients with benign tumors of the superficial lobe of the parotid gland
Exclusion Criteria:
* cancers
* unfit patients for surgery
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04803032
| 255,867 |
{
"NCT_ID" : "NCT04086407",
"Brief_Title" : "Apnea Hypopnea Index Severity Versus Head Position During Sleep",
"Official_title" : "The Effect of Head Pitch and Roll Rotation Independent of Torso Rotation on the AHI in Positional Obstructive Sleep Apnea",
"Conditions" : ["Sleep Disordered Breathing", "Sleep Hypopnea", "Sleep Apnea", "Sleep Apnea, Obstructive", "Snoring"],
"Interventions" : ["Device: Dual-axis inclinometer attached to the subject's forehead with tape"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-11-28",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-11-19",
"Study_Completion_Date(Actual)" : "2017-11-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-08-29",
"First_Submitted_that_Met_QC_Criteria" : 2020-06-16",
"First_Posted(Estimated)" : 2019-09-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-09-09",
"Last_Update_Posted(Estimated)" : 2020-06-30",
"Last_Verified" : 2020-06"
}
}}
|
#Study Description
Brief Summary
This study evaluates the correlation of the position of the head during sleep, independent of the position of the torso, and the severity of apnea hypopneas in obstructive sleep apnea.
Detailed Description
Obstructive Sleep Apnea (OSA) is a common diagnosis in the general population, with a prevalence in the United States of 3-7% in men and 2-5% in women. It is defined as a sleep-related breathing disorder that results in decreased or complete cessation of airflow while the patient has ongoing breathing effort.
It is well documented that trunk position significantly affects the severity of OSA. In fact, 50-75% of individuals with a diagnosis of OSA show supine predominance or worsened apnea-hypopnea index (AHI) when sleeping in the supine position. Positional Obstructive Sleep Apnea (POSA) is defined as an AHI ≥5 with \>50% AHI reduction between the supine and non-supine positions and AHI. Studies show 49.5% of individuals with mild OSA (AHI 5-15), 19.4% with moderate OSA (AHI 15-30) and 6.5% in severe OSA (AHI \> 30) had POSA. Due to this high prevalence of POSA, especially in the mild and moderate OSA populations, positional therapies have been developed and researched.
In this clinical trial, if only the head position is considered, all subjects are positional sensitive and OSA severity can be calculated and consistently minimized by limiting the allowable range of head roll angle during sleep. Ten subjects underwent a standard polysomnography with an additional head angle sensor and coached to fall asleep in various head positions. Torso position was changed between supine and non-supine for a given head roll angle epoch to show the OSA severity change with torso position. Each sleep epoch of unique head pitch and roll angle was scored individually for AHI and Oxygen Saturation (SPO2) de-saturation.
Investigators hypothesize that specific head roll angles independent of torso position will significantly reduce AHI and SpO2 desaturation severity in patients. The primary aim is to determine the head roll angles that significantly improve POSA independent of torso position. By doing this, Investigators believe to identify a 'safe zone' of head roll angles that improve POSA and that can be used to support the development of head positional therapy for POSA patients.
#Intervention
- DEVICE : Dual-axis inclinometer attached to the subject's forehead with tape
- This is the first clinical trial in the industry to address OSA symptom severity and snoring as a direct function of head pitch and roll angle. The head pitch and roll angle can be used with high consistency to predict OSA symptom severity. The apnea equation is based on the gravitational crush forces of the mass of the tongue and nearby tissue on the upper air way and is valid for most OSA sufferers.
|
#Eligibility Criteria:
Inclusion Criteria:
* Participant has provided written informed consent
* Participant is diagnosed with Positional Obstructive Sleep Apnea
* Participant age is between 21 and 60 years
* If currently on Positive Air Pressure (PAP) therapy, is able to produce compliance data within the last week before screening visit
* Is able to follow directions during the overnight sleep study
* If currently on PAP therapy participant self-report that excessive daytime sleepiness persists when PAP therapy is not in use
* Able to be of 'PAP' therapy for 4 nights
Exclusion Criteria:
* Documented diagnosis of Insomnia
* Chronic ear infections
* Persistent neck 'pains'
* Persistent chronic posture physical issues
* Previous C-Spine fusion
* History of Cardiac Arrythmia
* History of seizures
* Allergic to Standard Tape used in Sleep Centers
* Non-English speaking.
* Hospitalization within the previous 4 weeks
* Use of antibiotics or steroids within the previous 4 weeks
* Any major uncontrolled disease or condition, such as congestive heart failure, malignancy, end-stage heart disease, end-stage heart disease. Arterial Laterial Sclerosis (ALS), or sever stroke, or other condition as deemed appropriate by investigator as determined by review of medical history and/or participant reported medical history
* History of severe osteoporosis
* Excessive alcohol intake (> 6oz hard liquor, 48 oz beer or 20 oz wine daily), or illicit drug use by review of medical history and/or participant reported medical history
* Daily use of prescribed narcotics (greater than 30 mg morphine equivalent)
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04086407
| 255,290 |
{
"NCT_ID" : "NCT05713097",
"Brief_Title" : "TSI and Its Relationship With Graves' Disease Relapse",
"Official_title" : "Thyroid-stimulating Immunoglobulins Level in Patients With Graves' Disease Undergoing Maintenance-dose of Antithyroid Drug and Its Relationship With Disease Relapse",
"Conditions" : ["Graves Disease", "Immunoglobulin", "Anti-Thyroid Antibodies Disorder"],
"Interventions" : ["Diagnostic Test: TSI"],
"Location_Countries" : ["Vietnam"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-01-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-08-31",
"Study_Completion_Date(Actual)" : "2022-08-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-01-13",
"First_Posted(Estimated)" : 2023-02-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-02-02",
"Last_Update_Posted(Estimated)" : 2023-02-06",
"Last_Verified" : 2023-02"
}
}}
|
#Study Description
Brief Summary
The goal of this observational study is to determine the role of TSI, as well as clinical signs and thyroid function tests in predicting Graves' disease (GD) relapse after withdrawing anti thyroid drug (ATD). The main questions it aims to answer are:
1. To investigate the serum TSI concentration in patients with GD undergoing maintenance-dose ATD.
2. To determine an optimal cut-off of TSI level for predicting GD relapse.
3. To determine the role of TSI in predicting Graves' disease relapse after withdrawing ATD.
Detailed Description
Retrospective follow-up study of patients with hyperthyroidism due to Graves' disease, treated at the endocrine outpatient clinic of Medic Medical Center, Ho Chi Minh City from January 2000 to April 2021. TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician). ATD withdrawal would be planned when patients achieved euthyroid status clinically with normal FT4 tests for at least 3 months with minimal dose of ATD. The decision was also based on TSI concentration, goiter's characteristics and parenchymal vascularity on Doppler ultrasound.
#Intervention
- DIAGNOSTIC_TEST : TSI
- TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician).
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with hyperthyroidism due to Graves' disease according to the criteria of the Japan Thyroid Association.
* TSI: measured during the course of treatment when planning to stop medication (normal FT4 at maintenance-dose of ATD) Methimazole (MMI): at doses of <=10 mg. Propylthiouracil (PTU): at doses of <=200 mg.
Exclusion Criteria:
* Hyperthyroidism due to other causes
* Patients who were intolerant to ATD or had serious side effects with ATD.
* TSIs were measured in pregnancy.
* Patients treated with surgery or radioactive iodine.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05713097
| 240,832 |
{
"NCT_ID" : "NCT04305067",
"Brief_Title" : "PRECISE: Pancreatic Cancer and Exercise",
"Official_title" : "PRECISE: PancREatic Cancer and Individualised Supervised Exercise: a Feasibility Study",
"Conditions" : ["Pancreas Adenocarcinoma"],
"Interventions" : ["Other: Exercise"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-08-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-07-31",
"Study_Completion_Date(Actual)" : "2022-08-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-02-28",
"First_Posted(Estimated)" : 2020-03-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-03-09",
"Last_Update_Posted(Estimated)" : 2024-02-16",
"Last_Verified" : 2024-02"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to establish the feasibility of delivering a prescribed, individualised supervised aerobic and resistance exercise programme during adjuvant therapy, to improve survival and reduce symptom burden in pancreatic cancer
Detailed Description
Pancreatic ductal adenocarcinoma (PDAC) is the most common malignancy of the pancreas, representing 90% of all pancreatic neoplasms. The late presentation of symptoms and a lack of effective screening methods, means a large proportion (80-90%) are diagnosed with unresectable advanced disease, contributing to an unfavorable prognosis and dismal 5-year survival rate of \~5%. Intensive cancer treatments (i.e. surgery and chemotherapy) have debilitating complications including fatigue, pain and impaired physical function. Therefore, the maintenance of physical function and quality of life are seen as primary treatment goals for pancreatic patients, particularly during adjuvant therapy. Exercise training is emerging as an accepted component of patient care and evidence suggests regular exercise may induce an array of physiological and psychosocial benefits. However, there is a lack of evidence on the feasibility of delivering supervised exercise interventions to individuals with resectable PDAC undergoing adjuvant therapy. This study aims to explore the initial feasibility of delivering a supervised, individualized, and progressive concurrent exercise intervention to individuals with resectable PDAC who are undergoing adjuvant therapy, and provide data required to design a future randomized controlled trials.
#Intervention
- OTHER : Exercise
- Exercise programs will be individually tailored to the capabilities of each participant and gradually progressed accordingly. Each patient will be asked to complete one home-based aerobic exercise sessions each week. At baseline, 16 weeks and 3 month followup patients will complete a physical fitness assessment (30 second sit to stand and six minute walking tests) and a range of quality of life questionnaires. Upon completion of the 16 week exercise intervention, patients will be invited to partake in semi-structured interviews to determine the effectiveness of the program and their experience throughout.
|
#Eligibility Criteria:
Inclusion Criteria:
* age >= 18 years
* histologically proven pancreatic ductal adenocarcinoma
* complete macroscopic resection (R0 or R1 resection)
* patients recovering from surgery in time for chemotherapy to be delivered with adjuvant intent
* prior malignancy active within the previous 3 years other than locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
* Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2
* deemed medically fit by treating team to participate in exercise programme
* able to provide informed consent.
Exclusion Criteria:
* Macroscopically remaining tumour (R2 resection or tumour node metastasis (TNM) stage IV disease)
* Pre-existing cardiac conditions; Congestive heart failure or recent serious cardiovascular event
* Chest pain while undertaking physical activity
* Any related co-morbidities (diabetes; unstable angina; degenerative neuromuscular disease; mental health disorders; substance abuse)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04305067
| 72,730 |
{
"NCT_ID" : "NCT04465357",
"Brief_Title" : "Efficacy of Erenumab on Functional Impact of Migraine",
"Official_title" : "A Multicenter, Open Label Study Assessing the Efficacy of Erenumab on Functional Impact of Migraine",
"Conditions" : ["Migraine"],
"Interventions" : ["Drug: Erenumab-Aooe 140 MG/ML [Aimovig]"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-10-22",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-06-03",
"Study_Completion_Date(Actual)" : "2022-06-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-07-07",
"First_Submitted_that_Met_QC_Criteria" : 2022-09-07",
"First_Posted(Estimated)" : 2020-07-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-07-07",
"Last_Update_Posted(Estimated)" : 2022-10-05",
"Last_Verified" : 2022-09"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to assess the efficacy of erenumab on functional impact due to Migraine in adults.
Detailed Description
This is a single group, multicenter, open-label study with a study population of patients who meet International Classification of Headache Disorders 3rd edition (ICHD-III) criteria for migraine with or without aura and have 4 to 20 migraine days per month. This is a single-group supportive care study with one arm and no masking. A maximum of 54 participants will be enrolled to study intervention. All participants in this single-group study will complete a 4-week run-in period. After the run-in period, eligible participants will be enrolled to study intervention and enter a 12-week treatment period.
#Intervention
- DRUG : Erenumab-Aooe 140 MG/ML [Aimovig]
- 140 mg/mL administered subcutaneously
- Other Names :
- Erenumab, Aimovig
|
#Eligibility Criteria:
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
* willing to participate and sign informed consent;
* ability to understand informed consent and study procedures, including able to use the electronic Daily Headache Diary;
* in good general health based on investigator's judgment;
* must be between 18 <= age <= 65 of age, inclusive, at time of Visit 2;
* have migraine with or without aura meeting the diagnostic criteria listed in the International Classification of Headache Disorders 3rd edition (ICHD-III; Appendix 5);
* verification of headache frequency through prospectively collected baseline information during the 28-day screening/baseline phase reporting 4 <= age <= 20 migraine days and no more than 20 total headache days;
* onset of migraine before age 50;
* able to differentiate migraine from other primary headache types allowed in the study (e.g., tension-type headache);
* stable history of migraine at least 3 months prior to screening with headache free periods;
* not currently taking a migraine preventive OR has been taking a stable dose of a preventive for at least 90 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period;
**participants on migraine preventive should have stable headache pattern
* must have a score of >= 3 on the Migraine Functional Impact Questionnaire (MFIQ) overall impact on usual activities item at screening;
* women may be included only if they have a negative pregnancy test at screening and baseline, are sterile, or postmenopausal. Women of childbearing potential (WOCBP) whose male partners are potentially fertile (i.e., no vasectomy) must use highly effective birth control methods for the duration of the study (i.e., starting at screening). Definitions of WOCBP, sterile and postmenopausal women, male contraception, and highly effective and acceptable birth control methods are to be determined based on investigator's judgment;
* demonstrated compliance with the electronic Daily Headache Diary during the 28-day screening/baseline phase as defined by entry of headache data on a minimum of 23 days;
* is willing to wear activity/sleep tracker throughout the duration of the trial;
* has a smartphone and willing to install activity tracker app on phone.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* unable to understand the study requirements, the informed consent, or complete headache records as required per protocol;
* pregnant, actively trying to become pregnant, or breast-feeding;
* history of substance abuse and/or dependence, in the opinion of the Investigator;
* history of impaired renal function that, in the investigator's opinion, contraindicates participation in this study;
* suffers from a serious illness, or an unstable medical condition, one that could require hospitalization, or could increase the risk of adverse events;
* a psychiatric condition, in the opinion of the investigator, that may affect the interpretation of efficacy and safety data or contraindicates the participant's participation in the study;
* received nerve blocks or trigger point injections in the previous 8 weeks or plans to receive them during the study;
* prior exposure in the last 6 months to biologics or drugs specifically targeting the calcitonin gene-related peptide (CGRP) pathway;
* has failed more than 3 classes of medications for the prevention of migraine, or >6 migraine preventative medications of any type due to lack of efficacy;
* received any investigational agents within 30 days prior to Visit 1 (6 months for any investigational biological products unless previous study blind has been broken and subject was known to have received placebo);
* plans to participate in another clinical study at any time during this study;
* history of medication overuse of opioids or butalbital, as defined by opioid or butalbital use >=10 days/month in previous 12 months or during run-in period; Medication Overuse Headache (MOH) with other medication types will be allowed but must be documented;
* unstable medication use for migraine prevention (changes in the last 3 months);
* clinically relevant lab results at screening as determine by the investigator;
* clinically relevant or significant ECG abnormalities as determine by the investigator, including ECG with QT interval corrected for heart rate (QTc) using Fridericia's correction formula (QTcF) > 500 msec;
* history of any of the following cardiovascular conditions:
1. Moderate to severe congestive heart failure (New York Heart Association class III or IV);
2. Recent (within past 12 months) cerebrovascular accident, myocardial infarction, coronary stenting;
3. Uncontrolled hypertension as defined by a confirmed systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg.
* active HIV or Hepatitis C infection;
* allergy to latex;
* score of > 0 on question 9 on Patient Health Questionnaire (PHQ-9) at any visit;
* have any other condition, that in the judgment of the investigator, would make the participant unsuitable for inclusion, or would interfere with the participant participating in or completing the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04465357
| 35,877 |
{
"NCT_ID" : "NCT02968602",
"Brief_Title" : "Minocycline and Tobacco Craving in Smokers With Schizophrenia",
"Official_title" : "Minocycline and Tobacco Craving in Smokers With Schizophrenia",
"Conditions" : ["Schizophrenia", "Tobacco Use"],
"Interventions" : ["Drug: Minocycline", "Other: Placebo"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-03-31",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-07-23",
"Study_Completion_Date(Actual)" : "2019-07-23},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-11-15",
"First_Submitted_that_Met_QC_Criteria" : 2021-09-23",
"First_Posted(Estimated)" : 2016-11-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-11-16",
"Last_Update_Posted(Estimated)" : 2022-01-06",
"Last_Verified" : 2022-01"
}
}}
|
#Study Description
Brief Summary
Craving for cigarettes is an important aspect that leads to challenges with smoking cessation. Persons with schizophrenia are more likely to smoke and to be heavier smokers than persons without schizophrenia, and may experience craving differently as well. Minocycline is an antibiotic medication that may impact craving. We will conduct a two-week randomized, double-blind, placebo-controlled, parallel group pilot study to investigate the effects of minocycline vs. placebo on craving and smoking behaviors in smokers with schizophrenia. Participants will take minocycline or matching placebo for two weeks. Participants will be assessed on aspects of craving and smoking behavior at baseline and after 1 and 2 weeks of minocycline or placebo treatment.
Detailed Description
Nicotine dependence is high in schizophrenia; nearly three times more prevalent than the general population. In smokers with schizophrenia, the risk of all-cause mortality is doubled and cardiovascular mortality risk is twelvefold higher than nonsmokers. Many factors influence smoking in persons with schizophrenia, but predictors of craving and smoking behavior are not well established. Craving is a major contributor to smoking behaviors, and, importantly, is a predictor of relapse risk. Since craving may precede relapse, it can be advantageous as a screening tool for those attempting cessation. In addition, focusing on treatments aimed to reduce craving may lead to better therapeutic targets. Minocycline may affect craving, perhaps due to inhibition of nitric oxide (NO) formation, as NO acts as a second messenger for glutamate and dopamine receptors. NO also facilitates the effects of nicotine in the reward circuit, and blockade of NO has been demonstrated to eliminate nicotine abstinence symptoms in rats. A small study has demonstrated that minocycline reduces cigarette craving in human subjects without severe mental illness. The investigators will conduct a two-week randomized, double-blind, placebo-controlled, parallel group pilot study to investigate the effects of minocycline vs. placebo on craving and indicators of smoking intensity in smokers with schizophrenia. Participants will take minocycline up to 200 mg daily or matching placebo for two weeks. Participants will complete cigarette cue-elicited craving platforms and related assessments at baseline, and after 1 and 2 weeks of minocycline or placebo treatment.
#Intervention
- DRUG : Minocycline
- Minocycline capsules taken twice daily for two weeks.
- OTHER : Placebo
- Placebo capsules taken twice daily for two weeks.
|
#Eligibility Criteria:
Inclusion Criteria
* DSM-IV or DSM-5 diagnosis of schizophrenia or schizoaffective disorder
* Male or Female
* Age: 18 <= age <= 65
* Caucasian or Non-Caucasian
* Smoke at least 10 cigarettes daily
* Urine cotinine level >= 100 ng/ml (NicAlert® reading >= 3)
* Agrees to wear a head mounted display (HMD) for up to 45 minutes
* Able to complete the Evaluation to Sign Consent (ESC) with minimum score of 80%
Exclusion Criteria
* History of organic brain disease
* DSM-IV diagnosis of Alcohol or Substance Dependence within the last six months (except nicotine) or DSM-5 diagnosis of Substance Use Disorder in the last six months (except nicotine)
* DSM-IV diagnosis of Alcohol or Substance Abuse within the last one month (except nicotine) or DSM-5 diagnosis of Substance Use Disorder in the last six months (except nicotine)
* Pregnancy or lactation
* Severe liver dysfunction (LFT 3X upper limit of normal)
* Previous known hypersensitivity to tetracyclines
* Current treatment with tetracycline or derivative
* Treatment with oral contraceptives (unless a second form of birth control is used and documented)
* Treatment with cholestyramine or colestipol
* Treatment with Urinary alkalinizers (e.g., sodium lactate, potassium citrate)
* Treatment with warfarin
* Treatment with bupropion, varenicline, or nicotine replacement products in the month prior to study inclusion
* Less than two months treatment of adjunctive medications AND less than one month on same dose: beta blockers, antidepressants, mood stabilizers, antianxiety medications.
* Medical condition whose pathology or treatment would significantly increase the risk associated with the proposed protocol.
* History of head injury, seizures, or stroke
* Positive urine toxicology screen for substances of non-therapeutic use prior to craving assessments
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02968602
| 175,122 |
{
"NCT_ID" : "NCT01890785",
"Brief_Title" : "Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers",
"Official_title" : "A Phase 1, Open-label, Randomized, 3-period Crossover Study Evaluating the Relative Bioavailability of SPD489 When the Contents Are Emptied Into a Soft Food and Orange Juice in Healthy Adult Subjects",
"Conditions" : ["Healthy Volunteers"],
"Interventions" : ["Drug: Lisdexamfetamine Dimesylate"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-07-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-08-22",
"Study_Completion_Date(Actual)" : "2013-08-22},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-06-27",
"First_Submitted_that_Met_QC_Criteria" : 2014-03-14",
"First_Posted(Estimated)" : 2013-07-02"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-06-27",
"Last_Update_Posted(Estimated)" : 2021-06-03",
"Last_Verified" : 2021-05"
}
}}
|
#Study Description
Brief Summary
Compare the pharmacokinetic profiles when the contents are emptied into a soft food and orange juice compared to the SPD489 when swallowed as an intact capsule.
#Intervention
- DRUG : Lisdexamfetamine Dimesylate
- Single dose of a 70 mg capsule on Day 1
- Other Names :
- SPD489
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 55 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the first screening visit.
* Willingness to comply with any applicable contraceptive requirements fo the protocol and is:
* Male, or
* Non pregnant, non lactating female
* Females must be at least 90 days post partum or nulliparous
* Must be considered 'healthy'. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram, hematology, blood chemistry, and urinalysis.
* An understanding, ability, and willingness to fully comply with study procedures and restrictions
* Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with International Conference on harmonisation Good Clinical Practice Guideline E6 (1996) and applicable regulations, before completing any study related procedures
* A body mass index between 18.5 <= age <= 30.0kg/m² inclusive. This inclusion criterion will only be assessed at the first screening visit.
* A hemoglobin value of >=12.0g/dL at the Screening Visit and on Day -1 of Treatment Period 1.
* Ability to swallow a dose of investigational product according to the study conditions.
Exclusion Criteria:
Subjects are excluded from the study if any of the following criteria are met at the Screening Visit or at Day 1 of Treatment Period 1 (if reassessed):
* Current or recurrent disease (eg, cardiovascular, renal, liver, gastrointestinal, malignancy, or other conditions) that could affect the action, absorption, or disposition of the investigational products, or could affect clinical or laboratory assessments.
* Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
* Significant illness, as judged by the investigator, within 2 weeks of the first dose of investigational product.
* History of significant anxiety, tension, or agitation as assessed by the investigator.
* History of or current diagnosis of glaucoma.
* History of a seizure disorder (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or known family history of Tourette's Disorder.
* History or presence of known structural cardiac abnormalities, syncope, cardiac conduction problems, exercise-related cardiac events, or clinically significant bradycardia.
* History of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, transient ischemic attack or stroke or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
* History of controlled or uncontrolled hypertension or a resting supine systolic blood pressure >139mmHg or diastolic blood pressure >89mmHg.
* Known family history of sudden cardiac death or ventricular arrhythmia.
* Currently considered a suicide risk, has previously made a suicide attempt, or has a history of, or is currently demonstrating suicidal ideation.
* Current use of any medication (including prescription, over-the-counter, herbal or homeopathic preparations) with the exception of hormonal replacement therapy or hormonal contraceptives (current use is defined as use within 14 days of first dose of investigational product).
* Use of any medication known to inhibit or induce the cytochrome P450 (CYP450) enzymes responsible for the metabolism of the investigational product within 14 days of first dose of investigational product.
* Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
* Known or suspected intolerance or hypersensitivity to orange juice or vanilla yogurt.
* History of alcohol or other substance abuse within the last year.
* A positive screen for alcohol or drugs of abuse at the Screening Visit or on Day 1 of Treatment Period 1.
* Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day. (1 alcohol unit=1 beer=1 wine [5oz]=one liquor [1.5 oz]=0.75oz alcohol.).
* A positive human immunodeficiency virus antibody screen, Hepatitis B surface antigen, or Hepatitis C virus antibody screen.
* Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products in any form (eg, gum, patch) within 30 days prior to the first dose of investigational product.
* Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches or have a history of caffeine withdrawal headaches. (One caffeine unit is contained in the following items: one 6oz cup of coffee, two 12oz cans of cola, one 12oz cup of tea, three 1oz chocolate bars. Decaffeinated coffee, tea, or cola are not considered to contain caffeine).
* Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to the first dose of investigational product.
* Use of another investigational product within 30 days prior to receiving the first dose of investigational product or active enrollment in another drug or vaccine clinical study.
* Substantial changes in eating habits within 30 days prior to receiving the first dose of investigational product, as assessed by the investigator.
* An inability to follow a standardized diet and meal schedule or inability to fast, as required during the study.
* Prior screen failure, randomization, participation, or enrollment in this 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:
Yes
|
NCT01890785
| 207,910 |
{
"NCT_ID" : "NCT00485732",
"Brief_Title" : "A Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine/Cervarix TM Vaccine in Healthy Females Aged 15-25 Years",
"Official_title" : "A Phase IIIb, Double-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV-16/18 L1 VLP AS04 Vaccine, Administered Intramuscularly in Healthy Female Subjects Aged 15 - 25 Years",
"Conditions" : ["Infections, Papillomavirus"],
"Interventions" : ["Biological: Placebo", "Biological: HPV-16/18 VLP/AS04 vaccine (Cervarix TM)"],
"Location_Countries" : ["Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-06-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-03-30",
"Study_Completion_Date(Actual)" : "2008-03-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-06-12",
"First_Submitted_that_Met_QC_Criteria" : 2009-11-12",
"First_Posted(Estimated)" : 2007-06-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-06-12",
"Last_Update_Posted(Estimated)" : 2018-07-20",
"Last_Verified" : 2016-11"
}
}}
|
#Study Description
Brief Summary
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to cervical cancer in women. This study will evaluate the immunogenicity and safety of the GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) vaccine.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
#Intervention
- BIOLOGICAL : HPV-16/18 VLP/AS04 vaccine (Cervarix TM)
- Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
- Other Names :
- GSK Biologicals' HPV-16/18 VLP/AS04 vaccine
- BIOLOGICAL : Placebo
- Three doses of placebo administered intramuscularly according to a 0, 1, 6-month schedule.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A female between, and including, 15 and 25 years at the time of the first vaccination.
* Written informed assent obtained from the subject and informed consent obtained from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Subjects must have a negative urine pregnancy test.
* Subjects of childbearing potential at the time of study entry must be abstinent, or must be using adequate contraceptive precautions for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series.
Exclusion Criteria:
* Use of any investigational or non-registered product (drug or vaccine) other than the study/ control vaccine within 30 days preceding the first dose of study/ control vaccine, or planned use during the study period.
* Pregnant or breastfeeding.
* Planning to become pregnant or likely to become pregnant.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine. However, the administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
* Previous administration of components of the investigational vaccine
* Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
* Any medically diagnosed or suspected immunodeficient condition such as HIV infection based on medical history and physical examination.
* History of thrombocytopenia or hemostatic disorder in which case the study vaccine should under no circumstances be administered intramuscularly.
* History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study/control vaccines.
* Hypersensitivity to latex.
* Known acute or chronic, clinically significant neurologic, pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
* History of chronic condition(s) requiring treatment.
* Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study/control vaccine or planned administration during the study period. Enrolment will be deferred until the subject is outside of specified window.
* Acute disease at the time of enrolment.
Sex :
FEMALE
Ages :
- Minimum Age : 15 Years
- Maximum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00485732
| 216,638 |
{
"NCT_ID" : "NCT00150579",
"Brief_Title" : "Efficacy and Safety of SPD465 in Adults With ADHD",
"Official_title" : "A Phase III, Randomized, Double-blind, Multi-center, Placebo-Controlled, Parallel-Group, Safety and Efficacy Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).",
"Conditions" : ["Attention Deficit Disorder With Hyperactivity"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-01-27",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2005-06-14",
"Study_Completion_Date(Actual)" : "2005-06-14},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-09-06",
"First_Posted(Estimated)" : 2005-09-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-09-06",
"Last_Update_Posted(Estimated)" : 2021-06-30",
"Last_Verified" : 2021-06"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects sleep and how the participants perceive their quality of life.
#Intervention
- DRUG : Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate
|
#Eligibility Criteria:
Inclusion Criteria:
* Primary diagnosis of ADHD
* Baseline ADHD-RS-IV score >= 24
* Non-pregnant females of childbearing potential must comply with contraceptive restrictions
Exclusion Criteria:
* Significantly underweight or morbidly obese
* Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Axis I disorders
* History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder
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
|
NCT00150579
| 186,148 |
{
"NCT_ID" : "NCT03528928",
"Brief_Title" : "Viewing Surface Electrical Stimulation on Pelvic Floor With Ultrasound",
"Official_title" : "Evaluation of Pelvic Floor Muscle With Surface Electrical Stimulation",
"Conditions" : ["Pelvic Floor Disorders"],
"Interventions" : ["Device: Surface electrical stimulation"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "NA",
"Interventional_Model" : "SEQUENTIAL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-04-17",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-04-17",
"Study_Completion_Date(Actual)" : "2019-01-21},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-05-07",
"First_Submitted_that_Met_QC_Criteria" : 2024-11-25",
"First_Posted(Estimated)" : 2018-05-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-05-17",
"Last_Update_Posted(Estimated)" : 2024-12-17",
"Last_Verified" : 2023-03"
}
}}
|
#Study Description
Brief Summary
Subjects will place a surface electrode on their perineal area after a bladder-filling protocol. Transabdominal ultrasound will image the base of the bladder at rest, voluntary pelvic floor contraction, with the surface electrical stimulation and with a combined pelvic floor contraction and electrical stimulation active.
#Intervention
- DEVICE : Surface electrical stimulation
- Thin electrode with four conductive areas placed over the perineal area.
- Other Names :
- Elitone
|
#Eligibility Criteria:
Inclusion Criteria:
* Age:18 <= age <= 80y
* Gender: female
Exclusion Criteria:
* Moderate-severe stress incontinence*: As determined by self-reported >3 accidents in 24-hr period
* Currently pregnant, may be pregnant (Unsure pre and peri-menopausal women should take a pregnancy test.)
* Active urinary tract infection (UTI)
* Pelvic pain, Painful bladder syndrome, underlying neurologic/neuromuscular disorder that may impact ability to partake in the trial
* implanted cardiac device or untreated cardiac arrhythmia
* Obesity as defined by BMI >= 30 (height, weight recorded)
* Anyone with impaired decision making, drug or alcohol dependence, or potentially suicidal.
* Anyone who lacks the capacity to consent for themselves or who requires a legal representative to give informed consent * Stress urinary incontinence: as determined by an answer of 'Yes' to a standard question (from King's Health Questionnaire): 'Do you lose urine with physical activities such as coughing, sneezing, running?'
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03528928
| 241,055 |
{
"NCT_ID" : "NCT05535114",
"Brief_Title" : "Intradialytic Yoga-resistance Exercise for Hemodialysis Patients",
"Official_title" : "The Effects of an Intradialytic Yoga-Resistance Exercise on Muscle Strength, Fatigue, Depression, and Sleep Quality in Hemodialysis Patients: a Randomized Controlled Trial",
"Conditions" : ["Hemodialysis"],
"Interventions" : ["Other: Yoga-resistance exercise"],
"Location_Countries" : ["Vietnam"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-07-13",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-10-13",
"Study_Completion_Date(Actual)" : "2023-10-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-08-30",
"First_Posted(Estimated)" : 2022-09-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-09-07",
"Last_Update_Posted(Estimated)" : 2023-11-14",
"Last_Verified" : 2023-07"
}
}}
|
#Study Description
Brief Summary
Objective: Intra-dialytic exercises are strongly believed to have benefits and have become a crucial therapeutic modality for managing hemodialysis patients. The effects of each type of exercise and yoga on hemodialysis patients' physical and psychological health have been studied extensively. However, the effects of combining yoga and resistance training exercises remain unclear in this population. The aims of this study are: (1) to create a feasible intradialytic yoga-resistance exercise (YRE) program for hemodialysis patients; and (2) to investigate its effects on muscle strength, fatigue, depression, and sleep quality in hemodialysis patients.
Methods: Seventy-two participants will be randomly assigned to a 12-week YRE group or a wait-list control group. The YRE group will perform exercises (breathing exercises, flexibility, resistance exercises, relaxation with meditation) in the first two hours of each hemodialysis session, three times weekly. The outcome measures are the following: socio-demographic characteristics; fatigue (measured by the Functional Assessment of Chronic Illness Therapy-Fatigue); depression (the Patient Health Questionnaire); sleep quality (Pittsburgh Sleep Quality Index); muscle strength (a hydraulic hand dynamometer, hand-held dynamometer, and one-minute sit-to-stand test). The outcomes will be assessed at baseline, week 6, and week 12. The independent t-test will be applied to compare the differences in outcome scores between groups at different time points. Using a generalized estimating equation method to analyze the effects of the intervention on the outcome variables.
Results: The expected results are: (1) The combined YRE program is feasible and safe for hemodialysis patients. (2) After 12 weeks, the intervention group will show significant improvement in muscle strength, fatigue, depression, and sleep quality compared to the control group.
Detailed Description
Study design: a randomized controlled trial.
Setting: This study will be conducted at the dialysis department of the Bach Mai hospital which is a national-level hospital in Hanoi, Vietnam.
Sample size: The sample size was calculated using G\*Power software 3.1.9.7 (Faul et al., 2007) with α = 0.05, the 1-beta error probability of 0.80, and the effect size for the main outcome of the leg muscle strength was 0.66 (Rosa et al., 2018). A sample size of 30 participants for each group was calculated. Anticipating a 20% attrition rate, a total number of 36 participants is assigned to each group.
Recruitment process: The potentially eligible participants will be referred by the head nurse or the nephrologists at the Dialysis Department of Bach Mai hospital. The researcher will assess the potential participants' eligibility via their medical records and cognitive and physical function assessment as well as reconfirm with their nephrologists. The researcher will explain the study's purpose, procedures, potential benefits, and risks of participating in this study to patients and their families.
Randomization \& allocation concealment: The randomization procedure will be performed by a nurse lecturer who does not participate in the study recruitment and data collection.
To prevent intervention diffusion, the participants will be randomly assigned to the intervention group or the control group according to their hemodialysis (HD) schedules.
Intervention: The protocol of the combined YRE program will be generated based on findings obtained from a literature review. It consists of four parts as follows: breathing exercises, flexibility, strength exercises and relaxation. It will be carried out about 30 minutes to 45 minutes in the first two hours of each HD session after connecting the patient to the dialysis machine for 30 minutes, three times weekly for 12 weeks.
Due to the facility conditions and fall prevention purposes, all types of exercise in the combined YRE program will be done when in the supine position.
The intensity of the resistance training: During the first two weeks of training, the participants will perform two sets of 8-12 repetitions for each type of strength exercise with the yellow or red elastic band depending on the participant's tolerance. Three sets of each exercise will apply from the third week until the end. The rest interval between sets and exercises is one to two minutes. The training intensity will be adjusted at week 3, week 7, and week 11 according to the increase in muscle strength. The intensity of each strength exercise will be increased gradually by changing the different colors of elastic bands. The intensity of strength exercise that each patient can tolerate will be adjusted to the rate of perceived exertion (RPE) of 'somewhat hard' (13-14 on the Borg scale) (Borg, 1982).
Validation of the combined YRE program: This protocol will be validated the suitability by a panel of experts before implementing in the feasibility study. The experts include one physiotherapist; one nephrologist, one hemodialysis nurse, and one yoga teacher.
Interventionist: the researcher and another HD nurse (at least five years' experiences experience in working with HD patients).
Intervention delivering: A pre-training information session will be given to all participants one week before the intervention at the dialysis unit by the interventionists. The first two weeks, participants will be familiarized with the intervention. In the following weeks, the participants will practice exercises under the interventionist's supervision.
Monitor for safety, adverse events: All potentially eligible participants will be confirmed by their nephrologists for exercise capacity before recruiting for this study. The blood pressure, heart rate, and SpO2 will be monitored before and after training. The interventionists will supervise the patient's exercise and monitor for exercise-related side effects such as nausea or vomiting; a sudden headache, dizziness, or a feeling of lightheadedness; a sudden weakness in your arms or legs; hypotension. Stop exercise and medical consultation will be recommended if any of these problems occur. Moreover, other side-effects of exercise such as muscle soreness, joint problems, or injuries should also be documented.
Data collection: Data collection will be done at the baseline, week 6, and week 12 on a midweek non-dialysis day. The data collector (A nephrology nurse) will be blinded to the study group assignment. It takes about 30 minutes.
Feasibility \& Safe of the YRE: The feasibility of the recruitment process, The attrition rate The adherence rate, Length of time for intervention implementation, Adverse events associated with the intervention.
Instruments The study questionnaires include questions on demographics (age, gender, marital status, education, occupation), The Functional Assessment of Cancer Therapy-Fatigue (FACIT-F), Patient Health Questionnaire (PHQ-9), and sleep quality (Pittsburgh Sleep Quality Index). Disease characteristics, including body height (cm), weight after dialysis (kg), body mass index (BMI, kg/m2), HD vintage (years), HD access site, and Charlson comorbidity index will be collected from the participants' medical records. The physical measurements include muscle strength measures of upper limbs and lower limbs, and one-minute STS test.
Data analysis: Using independent t-test and chi-square tests to test the homogeneity of two groups at baseline. The independent t-test will be applied to compare the differences on outcome's scores between groups in different time points. A generalized estimating equations method will be used to analyze the effect of the intervention on the outcome variables.
Ethical consideration: Ethical approvals will be obtained from the Ethical Committee of Hanoi Medical University, Vietnam.
#Intervention
- OTHER : Yoga-resistance exercise
- Breathing exercise (5 minutes), flexibility (5 minutes), resistance exercise (20 minutes), relaxation \& meditation (10 minutes).
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with ESRD
* Undergoing maintenance hemodialysis treatment for more than three months,
* Age between 45 years and 65 years,
* Under the permission of their nephrologist,
* Able to communicate in Vietnamese.
Exclusion Criteria:
* Unstable cardiac status such as angina, heart failure stage >= 3, myocardial infarction in the last six months, uncontrolled arrhythmia, uncontrolled hypertension with systolic blood pressure >= 200 mmHg or diastolic blood pressure >= 120 mmHg, symptomatic tachyarrhythmia or bradyarrhythmias, cardiovascular stent implantation, pacemaker installation,
* Artificial joint replacement; amputations or prostheses in upper and lower extremities,
* Suspected or known dissecting aneurysm,
* Uncontrolled diabetes (blood sugar 2 hours after eating < 7 or > 14 mmol),
* Hospitalization during the previous month, except for vascular access repair,
* Currently or in previous month (>= three times/week) involved in any exercise program (e.g. yoga, aerobic, taichi...),
* Arteriovenous fistula dysfunction or new central venous catheter/ arteriovenous fistula access (less than 3 months)
* Severe cognitive impairment (screened by the nephrologist)
* Currently taking an antidepressant
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05535114
| 152,681 |
{
"NCT_ID" : "NCT03029260",
"Brief_Title" : "Effects of Nervous System Mobilization",
"Official_title" : "Effect of Nervous System Mobilization on Heat, Cold and Mechanical Pain Thresholds and Lower Limb Flexibility",
"Conditions" : ["Healthy Individuals"],
"Interventions" : ["Other: Neural mobilization - gliding", "Other: Neural mobilization - tension."],
"Location_Countries" : ["Portugal"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-07",
"Study_Completion_Date(Actual)" : "2017-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-01-19",
"First_Posted(Estimated)" : 2017-01-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-01-20",
"Last_Update_Posted(Estimated)" : 2018-04-05",
"Last_Verified" : 2018-04"
}
}}
|
#Study Description
Brief Summary
This study aims to compare the effect of tension neural mobilization versus sliding neural mobilization of the peroneal nerve on the heat and cold threshold, on pressure pain threshold and on flexibility both in the dominant lower limb (subjected to mobilization) and the non-dominant lower limb (not subjected to mobilization) in healthy young participants.
Detailed Description
Sixty young and healthy participants will be randomly allocated to receive tension neural mobilization (n=30) or sliding neural mobilization (n=30). Data on heat threshold, cold threshold, pressure pain threshold and lower limb flexibility will be collected before the intervention, immediately after the intervention and at least 24h after the intervention.
#Intervention
- OTHER : Neural mobilization - tension.
- Neural mobilization in tension consists of using combinations of joint movement known to maximize the tension and lengthening of peripheral nervous structures.
The intervention will be delivered in one session only.
- OTHER : Neural mobilization - gliding
- Gliding neural mobilization consists of using combinations of joint movement known to maximize the movement of the peripheral nerves in relation to adjacent structures.
The intervention will be delivered in one session only.
|
#Eligibility Criteria:
Inclusion Criteria:
* naïve to nervous system mobilization;
Exclusion Criteria:
* Any surgery or trauma in the previous 6 months; neurological, cardiorespiratory or rheumatic pathology; cancer.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03029260
| 79,124 |
{
"NCT_ID" : "NCT01752179",
"Brief_Title" : "Kinesio Taping Technique and Trigger Point",
"Official_title" : "The Effect of Kinesio Taping Technique on Trigger Point of Piriformis Muscle",
"Conditions" : ["Piriformis Syndrome"],
"Interventions" : ["Procedure: kinesio Tape : Width 5cm ,Length 35cm Y shape"],
"Location_Countries" : ["Iran, Islamic Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-02",
"Study_Completion_Date(Actual)" : "2013-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-11-17",
"First_Posted(Estimated)" : 2012-12-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-12-15",
"Last_Update_Posted(Estimated)" : 2013-03-01",
"Last_Verified" : 2013-02"
}
}}
|
#Study Description
Brief Summary
Kinesio taping is a novel method which recently has emerged as a viable option to treat of various musculoskeletal and neuromuscular deficits. The application of tape to injured soft tissues and joints provides support and protection for these structures. Many different techniques are used for injury prevention, treatment, rehabilitation, proprioception and sport. Elastic adhesive tape may be used to unload Myofacial Trigger Points (MTrPs), A trigger point can be located in fascia, ligaments, muscles, and tendons; however, MTrPs are also found in skeletal muscles and/or their fascia. An MTrP is a hyperirritable spot, associated with a taut band of a skeletal muscle that is painful on compression or stretch, and that can give rise to a typical referred pain pattern as well as autonomic phenomena. The use of tape along muscle to unload affected soft tissue seems to be effective in the treatment of trigger points by inhibiting overactive muscle, changing the orientation of fascia and a proprioceptive effect. The purpose of study was to determine the efficacy of Kinesio taping application on trigger point of piriformis muscle.
Detailed Description
Piriformis syndrome is a peripheral neuritis of the sciatic nerve caused by an abnormal condition of the piriformis muscle. Some investigators consider it as a form of Myofacial pain syndrome which defined as the presence of exquisite tenderness at a nodule in a palpable taut band of muscle. Trigger points are able to produce referred pain, either spontaneously or on digital compression. Although myofascial trigger points are a widely recognized phenomenon in clinical practice, there remains much to be elucidated with regards to their pathophysiology. Conservative pharmacotherapy with nonsteroidal anti-inflammatory drugs (NSAID), muscle relaxants, and physical therapy modalities such as heat therapy, cold therapy, ultrasound, electrical current and stretching were traditionally used in the treatment of trigger points.
The utilization of Kinesio taping regarding to the proposed mechanisms including 1) restoring correct muscle function by supporting weakened muscles, (2) reducing congestion by improving the flow of blood and lymphatic fluid, (3) decreasing pain by stimulating neurological system, and (4) correcting misaligned joints by retrieving muscle spasm (5) enhancing proprioception through increased stimulation to cutaneous mechanoreceptors can be helpful in restoring muscle function in patients with Myofacial trigger points . However, there are not many controlled studies that have analyzed the effects of the Kinesio taping in their treatment. Therefore, the purpose of study was to determine the efficacy of KT application as an easy and appropriate method on trigger point of piriformis muscle.
#Intervention
- PROCEDURE : kinesio Tape : Width 5cm ,Length 35cm Y shape
- In the experimental group, Kinesio taping application of piriformis according to Kenzo Kase in 2003 is modified by using unloading technique (Macdolanld, 2004). Size and Shape of Tape is Width 5cm ,Length 35cm Y shape.
Taping method include :
1. stretches the piriformis muscle in side lying position ,the affected leg is upper most with hip in flexion, adduction and internal rotation.
2. puts the base of tape over the contralateral of sacrum with no tension.
3. attaches the superior tail on the buttock over the upper part of piriformis and ends at the greater trochanter of the femur.
4. attaches the lower tail by lifting up the soft tissue and ends at the greater trochanter of the femur.
This is an origin to insertion application.
|
#Eligibility Criteria:
Inclusion Criteria:
* Having trigger point and tenderness in piriformis muscle.
* Having at least three positive physical examination tests from FAIR, Freiberg Lasegue and Beaty test.
Exclusion Criteria:
* spinal surgery
* spinal or pelvic fracture
* disc herniation,
* facet arthropathy
* sacroiliitis
* osteoarthritis or fracture of the lower extremities
* systemic disease, such as arthritis or tuberculosis
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01752179
| 160,042 |
{
"NCT_ID" : "NCT01945138",
"Brief_Title" : "Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation",
"Official_title" : "Efficacy and Feasibility of Fully Automated Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation",
"Conditions" : ["Chronic Pancreatitis", "Diabetes Mellitus"],
"Interventions" : ["Device: Closed Loop Insulin"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-06",
"Study_Completion_Date(Actual)" : "2015-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-08-19",
"First_Submitted_that_Met_QC_Criteria" : 2015-12-09",
"First_Posted(Estimated)" : 2013-09-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-09-13",
"Last_Update_Posted(Estimated)" : 2017-07-31",
"Last_Verified" : 2017-06"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of closed loop insulin pump therapy to control blood sugar following total pancreatectomy and islet auto-transplantation (TPIAT).
Detailed Description
OBJECTIVES AND HYPOTHESES The main objective of this study is to determine if a closed loop insulin system can successfully achieve tighter blood sugar control than the current multiple daily injection regimen. The investigators hypothesize that the average blood glucose will be lower in the closed loop group than the control group, there will be less glucose variability in the closed loop group than the control group, and there will be less total time spent in hyperglycemia and hypoglycemia in the closed loop group than in the control group. The investigators also will investigate insulin requirements and islet function in the first 6 months post-transplant in the closed loop group The investigators hypothesize that the insulin requirements will be lower and the C-peptide levels higher in the closed loop group than in the control group.
#Intervention
- DEVICE : Closed Loop Insulin
- The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
- Other Names :
- Medtronic ePID 2.0 system, Medtronic Paradigm REAL-Time Insulin Pump (MMT-722), Enlite Glucose Sensor (MMT-7008X), MiniLink REAL-Time Transmitter (MMT-7703XNA), ComLink Device (MMT-7304)
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing total pancreatectomy and islet auto-transplantation.
* Patients ages 21 <= age <= 64 old
Exclusion Criteria:
* Preexisting diabetes
* Use of acetaminophen during study period, which interferes with CGM sensor function
* Any medical condition requiring corticosteroids
* Severe Psychiatric disease or developmental delays, that might interfere with the ability to provide informed consent
* Any other medical condition which in the opinion of the investigators impairs the person's ability to safely participate in the trial
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT01945138
| 128,233 |
{
"NCT_ID" : "NCT00878462",
"Brief_Title" : "An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED)",
"Official_title" : "A Randomized, Crossover Study Evaluating the Acceptability of Unflavored Asenapine and Raspberry Flavored Asenapine in Stable Subjects With A Psychotic Disorder",
"Conditions" : ["Psychosis"],
"Interventions" : ["Drug: Asenapine WHITE raspberry flavor (Treatment A)", "Drug: Asenapine WHITE UNFLAVORED (Treatment C)", "Drug: Asenapine RED raspberry flavor (Treatment B)"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-06-29",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2005-10-15",
"Study_Completion_Date(Actual)" : "2005-10-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-04-08",
"First_Posted(Estimated)" : 2009-04-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-04-08",
"Last_Update_Posted(Estimated)" : 2024-08-15",
"Last_Verified" : 2022-02"
}
}}
|
#Study Description
Brief Summary
This trial was a randomized trial to determine a patient's acceptability of unflavored antipsychotic medication compared to raspberry flavored antipsychotic medication. Patients received 6 total doses of study drug (2 doses of each asenapine formulation) over 3 consecutive days: 2 different formulations each day, 1 in the morning and 1 in the evening. The formulations were: white unflavored, white raspberry flavored, and red raspberry flavored. Patients were given a questionnaire following each dose of study medication (one questionnaire twice per day for 3 days) to measure how acceptable each formulation was.
Detailed Description
Study drug was administered according to a random selected sequence schedule with 2 constraints: Subjects did not receive consecutive doses of the same formulation, and each formulation was given once in the morning and once in the evening over the course of the 3-day treatment period.
#Intervention
- DRUG : Asenapine WHITE raspberry flavor (Treatment A)
- Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets
- Other Names :
- Saphris, Org 5222, SCH 900274
- DRUG : Asenapine RED raspberry flavor (Treatment B)
- Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets
- Other Names :
- Saphris, Org 5222, SCH 900274
- DRUG : Asenapine WHITE UNFLAVORED (Treatment C)
- Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets
- Other Names :
- Saphris, Org 5222, SCH 900274
|
#Eligibility Criteria:
Inclusion Criteria:
* are at least 18 years and of legal minimum age for trial participation;
* are a male, or a female who is not of childbearing potential
* are free from an acute exacerbation of psychosis for at least 3 months;
* have a current DSM-IV diagnosis of schizophrenia (paranoid, disorganized, catatonic, or undifferentiated subtype), or schizoaffective disorder; delusional disorder, major depressive disorder, or bipolar disorder, for whom chronic antipsychotic therapy is indicated;
* correctly identify 3 out of 4 basic flavors (bitter, sweet, salty, or sour) on a neutral taste paradigm;
* are receiving oral antipsychotic medication.
Exclusion Criteria:
* an uncontrolled, unstable clinically significant medical condition
* clinically significant abnormal laboratory, vital sign, PE, or ECGs findings at Screening;
* previously experienced NMRB (also known as vasovagal reflex) or sensitivity for fainting;
* a positive serum pregnancy test at screening, or the intention to become pregnant within the next 30 days;
* a history of seizures;
* a history of neuromalignant syndrome;
* a current (past 6 months) substance abuse or dependence according to DSM-IV-TR criteria (excluding nicotine);
* an imminent risk of self-harm or harm to others;
* currently receiving a depot antipsychotic, such as fluphenazine decanoate, haloperidol decanoate, or Risperdal Consta, within at least 1 dosing cycle of Day-5;
* any impairment in taste functioning;
* receiving lithium or topiramate;
* judged by the principal investigator (PI) to be unable to reliably respond to the questionnaire based on clinically significant cognitive impairment.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00878462
| 40,044 |
{
"NCT_ID" : "NCT03683511",
"Brief_Title" : "Nomograms for Optimization of Amikacin First Dose in Critically Ill Patients Using a Population Pharmacokinetics Model",
"Official_title" : "Population Pharmacokinetics Modeling : a Priori Optimization of Amikacin First Dose in Critically Ill Patients Using a Nomogram",
"Conditions" : ["Pharmacokinetics"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-04-21",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-06-30",
"Study_Completion_Date(Actual)" : "2016-06-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-09-13",
"First_Posted(Estimated)" : 2018-09-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-09-21",
"Last_Update_Posted(Estimated)" : 2018-09-25",
"Last_Verified" : 2018-09"
}
}}
|
#Study Description
Brief Summary
The aim of this study is to elaborate nomograms to optimize amikacine first dosing in critically ill patients, using a population pharmacokinetics model elaborated with multicentric data.
Detailed Description
French guidelines recommend for probabilistic therapy to reach an amikacin concentration 1 hour after beginning the infusion ≥ 60 mg/L. This target is rarely achieved in the ICU despite a 30 mg/kg recommended dosage. Using data collected prospectively in critically ill patients of Nîmes (France) (1) and Nantes (France), we will elaborate a population pharmacokinetic model on the non-parametric software Pmetrics and on the parametric software Monolix. We will calculate probability of target attainment of Monte-Carlo simulations, using the non-parametric model. Nomograms to determine optimal first dose of amikacin in critically ill patients, according to a few variables previously identified, will be produced.
|
#Eligibility Criteria:
Inclusion Criteria:
* patients treated with amikacin for sepsis in one of the participating ICU will be included.
Exclusion Criteria:
* patients with aminoglycoside allergy, history of myasthenia, pregnancy, under guardianship.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03683511
| 227,638 |
{
"NCT_ID" : "NCT02459782",
"Brief_Title" : "Ultrasound Guided Peribulbar Anaesthesia - A Novel Dual Quadrant Injection Technique",
"Official_title" : "Ultrasound Guided Peribulbar Anaesthesia: a Real-time Ultrasound Guided Technique With a Novel Dual Quadrant Injection",
"Conditions" : ["Eye Diseases"],
"Interventions" : ["Procedure: Ultrasound guided Dual Quadrant Peribulbar Anaesthesia"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-03",
"Study_Completion_Date(Actual)" : "2012-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-03-20",
"First_Posted(Estimated)" : 2015-06-02"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-05-28",
"Last_Update_Posted(Estimated)" : 2015-06-02",
"Last_Verified" : 2015-05"
}
}}
|
#Study Description
Brief Summary
Peribulbar anaesthesia for ocular surgery depends on the spread of local anaesthetic throught the orbit to be successful and has a relatively high failure rate. This study will examine a novel ultrasound guided approach to peribulbar anaesthesia which should extend the depostion of local anaesthetic by using a dual quadrant injection technique. The study will assess the feasibility of this technique, how successful it is and whether any obvious safety issues arise with its use.
Detailed Description
Peribulbar anesthesia is widely used for anterior and posterior chamber ophthalmic procedures. It is a blind technique which is traditionally carried out by inserting a needle in the infero-lateral aspect of the orbit below the globe and injecting a volume of 8 - 12 mL of local anesthetic in the periorbital space. The goal of this inejction is to achieve akinesia and anesthesia of the eye sufficient for surgery. The technique has a relatively high failure rate of up to 30%. A failure or insufficient block requires a second or rarely a third peribulbar injection to achieve success. Ultrasound can be used to guide needles in the human body and has been successfully used in many anatomic locations for anaesthesia. This study will assess whether ultrasound can guide the block needle in ophthalmic anesthesia to deliver local anesthetic via a single entry into two discrete locations within the periorbital space - the first in the infero-lateral quadrant and the second in the infero-medial quadrant. If this can be done the investigators may achieve a higher success rate for this block with a lower volume potentially improving the quality of the block and its safety.
#Intervention
- PROCEDURE : Ultrasound guided Dual Quadrant Peribulbar Anaesthesia
- Landmark Guided single injection vs Ultrasound guided dual quadrant injection
|
#Eligibility Criteria:
Inclusion Criteria:
* ASA score less than III and ability to provide a written informed consent
* 22 patients presenting for opthalmic surgery
Exclusion Criteria:
* Coagulation disorder or anticoagulated with INR > 1.5
* Platelet count < 75 X 10*9/L
* Significant Myopia (axial length > 28mm)
* Patients unable to lie supine for 2 hours
* Patients with recent gas or silicone injections in/around the eye
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02459782
| 1,776 |
{
"NCT_ID" : "NCT04382560",
"Brief_Title" : "Coping Strategies and Responsiveness to a Brief Online Intervention During COVID-19 Pandemic",
"Official_title" : "Resting Heart Rate Variability as a Predictor of Coping Strategies and Responsiveness to a Brief Online Intervention During Forced Quarantine",
"Conditions" : ["Behavior, Social", "Autonomic Imbalance"],
"Interventions" : ["Other: Deep Breathing training", "Other: Compassion focused intervention"],
"Location_Countries" : ["Italy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-05-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-05-31",
"Study_Completion_Date(Actual)" : "2020-05-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-05-05",
"First_Posted(Estimated)" : 2020-05-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-05-07",
"Last_Update_Posted(Estimated)" : 2021-04-01",
"Last_Verified" : 2021-03"
}
}}
|
#Study Description
Brief Summary
The present study investigates the efficacy of a brief and cost-effective video-intervention that combines bottom-up elements of deep breathing and third-wave cognitive behavioral therapy techniques (i.e., mindfulness and compassion) on coping strategies during the COVID-19 pandemic.
#Intervention
- OTHER : Deep Breathing training
- The intervention will comprise a psychoeducational part on the theorethical background underlying this technique and a pratical session in which partecipant will be instructed to inhale air with his/her nose and exhale with his/her mouth for a period of 3 seconds of inhalation and 7 seconds of exhalation (i.e., 6 cycles of breaths per minute;). During the session, the participant will be encouraged to put one hand over his/her chest and the other over the abdomen in order to see the difference between normal breathing and deep breathing. To help the subjects in the training, an online pacer will give the rhythm of respiration and will be used as visual feedback.
- OTHER : Compassion focused intervention
- The short compassion focused intervention will begin with a short psychoeducation on the evolved nature and difficulties of the human mind, such as tendencies for negativity bias, negative rumination, and self-criticism. Participants will then be offered insights into how humans can work with their 'tricky brains' using body-based and psychological-based practices aimed at increasing a grounding and soothing compassionate attitude towards ourselves and others. In particular, participants will be instructed to pratice a mindfulness technique designed to help them to become more aware of their present moment-to-moment and more compassionate towards their own emotions. They will then be guided to create an image conveying warmth and compassion to them. Lastly, participants will be guided to bring the image to mind and then write write a brief 'self-compassionate letter' to themselves from that point of view.
|
#Eligibility Criteria:
Inclusion Criteria:
* Being healthy
* Previous participation (maximum elapsed time: 2.0 years) in a study conducted by the same research group and incorporating cardiac autonomic assessment at rest
Exclusion Criteria:
* Self-reported development of cardiovascular disease since previous assessment
* Use of psychotropic medications or medications affecting the autonomic nervous system
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04382560
| 48,770 |
{
"NCT_ID" : "NCT05639946",
"Brief_Title" : "Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial",
"Official_title" : "Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial",
"Conditions" : ["Spinal Cord Injuries", "Neuropathic Pain"],
"Interventions" : ["Drug: Placebo", "Drug: brivaracetam"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-08-12",
"Study_Completion_Date(Actual)" : "2024-10-16},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-11-23",
"First_Posted(Estimated)" : 2022-12-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-12-05",
"Last_Update_Posted(Estimated)" : 2025-02-28",
"Last_Verified" : 2025-02"
}
}}
|
#Study Description
Brief Summary
Spinal cord injury (SCI) is associated with severe neuropathic pain that is often refractory to pharmacological intervention. Preliminary data suggest brivaracetam is a mechanism-based pharmacological intervention for neuropathic pain in SCI. Based on this and other reports in the literature, SCI-related neuropathic pain is hypothesized to occur largely because of upregulation of synaptic vesicle protein 2A (SV2A) within the substantia gelatinosa of the injured spinal cord. Furthermore, compared to placebo, brivaracetam treatment is hypothesized to reduce severe below-level SCI neuropathic pain and increases parietal operculum (partsOP1/OP4) connectivity strength measured by resting-state functional Magnetic Resonance Imaging (rsfMRI). Circulating miRNA-485 levels may be associated with change in pain intensity due to brivaracetam treatment. The study aims to determine the efficacy of brivaracetam treatment for SCI-related neuropathic pain.
#Intervention
- DRUG : brivaracetam
- Drug dosage will be individually titrated for each participant with a goal of 100mg BID according to the following dose escalation protocol that we use clinically: 50mg BID for 2 weeks, followed by 50mg TID for 2 weeks, followed by 100mg BID for 48 days as tolerated. Participants will be allowed to reduce the dose of brivaracetam if they experience unacceptable side effects defined as increased somnolence according to routine clinical practice with other drugs in this class used for pain.
- DRUG : Placebo
- Participants will receive placebo drug
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 years or older
* Injured for > 3 months
* Completed inpatient rehabilitation and living in the community
* Chronic sublesional neuropathic pain defined as persistent pain (VAS grade 3 <= age <= 10) for three months or more
* For people of child-bearing potential: currently practicing an effective form of two types of birth control (defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly).
Exclusion Criteria:
* Progressive myelopathy secondary to posttraumatic cord tethering or syringomyelia
* Active use of drugs known to interact with brivaracetam: rifampin, carbamazepine, sodium oxybate, buprenorphine, propoxyphene, levetiracetam, and phenytoin.
* Brain injury or cognitive impairment limiting the ability to follow directions or provide informed consent
* Pregnancy or lactation
* Epilepsy or active treatment for seizure disorder
* Past or current suicidality
* Active treatment for psychiatric disease
* Drug addiction
* Moderate or heavy alcohol intake (up to four alcoholic drinks for men and three for women in any single day, and a maximum of 14 drinks for men and 7 drinks for women per week)
* Hepatic cirrhosis, Child-Pugh grades A, B, and C
* Impaired renal function (GFR<60ml/minute)
* Contraindications to brivaracetam or pyrrolidine derivatives including allergy
* Active clinically significant disease (e.g., renal, hepatic, neurological, cardiovascular, pulmonary, endocrine, psychiatric, hematologic, urologic, or other acute or chronic illness) that, in the opinion of the investigator, would make the patient an unsuitable candidate for this trial.
* History of malabsorption or other gastrointestinal (GI) disease that may significantly alter the absorption of brivaracetam
* Use of any investigational drug 30 days prior to enrollment in this study
* Enrollment in another clinical trial.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05639946
| 252,671 |
{
"NCT_ID" : "NCT01918202",
"Brief_Title" : "A Study To Evaluate The PDE10 Enzyme Occupancy Following A Single Dose Of PF-02545920 In Healthy Male Volunteers",
"Official_title" : "A Phase 1, Open-label Adaptive Design Study To Evaluate Pde10 Enzyme Occupancy As Measured By Positron Emission Tomography (Pet) Following Single Oral Dose Administration Of Pf-02545920 In Healthy Male Subjects",
"Conditions" : ["Healthy"],
"Interventions" : ["Drug: PF-02545920", "Drug: 20 mg PF-02545920"],
"Location_Countries" : ["Sweden"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-09",
"Study_Completion_Date(Actual)" : "2014-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-08-05",
"First_Posted(Estimated)" : 2013-08-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-08-05",
"Last_Update_Posted(Estimated)" : 2014-11-10",
"Last_Verified" : 2014-11"
}
}}
|
#Study Description
Brief Summary
This Phase 1 study will evaluate PDE10 enzyme occupancy using Positron Emission Tomography after a single dose of PF-02545920 in Healthy male volunteers.
#Intervention
- DRUG : 20 mg PF-02545920
- Subject will receive a single dose of 20 mg PF-02545920.
- DRUG : PF-02545920
- The dose will be selected based on the results obtained for Cohort 1. Dose options range from 30 mg to 10 mg, 5 mg, 2mg, 1 mg.
This cohort is optional.
- DRUG : PF-02545920
- The dose will be selected based on the results obtained for Cohort 1 and cohort 2.
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy male volunteers
Exclusion Criteria:
* History of orthostatic hypotension
* History of prior radiation exposure for research purposes, or radiation therapy
Sex :
MALE
Ages :
- Minimum Age : 21 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01918202
| 175,517 |
{
"NCT_ID" : "NCT00079131",
"Brief_Title" : "Oblimersen in Treating Patients With Merkel Cell Carcinoma",
"Official_title" : "A Phase II Study of G3139 (Genasense ™) in Patients With Merkel Cell Carcinoma",
"Conditions" : ["Recurrent Neuroendocrine Carcinoma of the Skin", "Stage I Neuroendocrine Carcinoma of the Skin", "Stage II Neuroendocrine Carcinoma of the Skin", "Stage III Neuroendocrine Carcinoma of the Skin", "Stage IV Neuroendocrine Carcinoma of the Skin"],
"Interventions" : ["Other: laboratory biomarker analysis", "Other: pharmacological study", "Biological: oblimersen sodium"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2004-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2007-01",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2004-03-08",
"First_Posted(Estimated)" : 2004-03-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2004-03-08",
"Last_Update_Posted(Estimated)" : 2013-06-04",
"Last_Verified" : 2013-06"
}
}}
|
#Study Description
Brief Summary
This phase II trial is studying how well oblimersen works in treating patients with Merkel cell cancer. Biological therapies, such as oblimersen, may interfere with the growth of tumor cells and slow the growth of Merkel cell carcinoma (skin cancer).
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the overall response rate in patients with Merkel cell carcinoma treated with oblimersen.
SECONDARY OBJECTIVES:
I. Determine the time to progression in patients treated with this drug. II. Determine the response duration in patients treated with this drug. III. Determine the safety and tolerability of this drug in these patients. IV. Determine the pharmacodynamic effects of this drug on bcl-2 expression and apoptosis in tumor biopsy specimens from these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oblimersen IV continuously on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
#Intervention
- BIOLOGICAL : oblimersen sodium
- Given IV
- Other Names :
- augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense
- OTHER : pharmacological study
- Correlative studies
- Other Names :
- pharmacological studies
- OTHER : laboratory biomarker analysis
- Correlative studies
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed Merkel cell carcinoma
* Metastatic OR regionally recurrent disease
* Localized disease not amenable to curative therapy (surgery or radiotherapy) also allowed
* Measurable disease
* At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* No known brain metastases
* Previously resected or irradiated brain metastases allowed if stable for at least the past 3 months and no evidence of neurological compromise exists
* Performance status - Karnofsky 60 <= age <= 100%
* Absolute neutrophil count >= 1,500/mm^3
* Platelet count >= 100,000/mm^3
* WBC >= 3,000/mm^3
* AST/ALT =< 2.5 times upper limit of normal
* Bilirubin normal
* INR =< 1.5
* Creatinine normal
* Creatinine clearance >= 60 mL/min
* No atrial fibrillation unless stable for at least the past 6 months
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Adequate venous access
* No peripheral neuropathy > grade 1
* No active or ongoing infection
* No other concurrent uncontrolled illness
* No prior grade 3 or 4 anaphylactic reaction to phosphorothioate oligonucleotide
* No psychiatric illness or social situation that would preclude study compliance
* More than 3 weeks since prior chemotherapy and recovered
* More than 3 weeks since prior radiotherapy and recovered
* No prior radiotherapy to 25% or more of bone marrow
* More than 3 weeks since prior investigational therapy and recovered
* No prior oblimersen
* No other concurrent investigational agents
* No concurrent anticoagulation except 1 mg of warfarin for mediport patency
* No concurrent combination antiretroviral therapy for HIV-positive patients
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00079131
| 20,367 |
{
"NCT_ID" : "NCT05826808",
"Brief_Title" : "Effect of Moderate Altitude (>1000 m.a.s.l.) on Sleep Examinations (Polysomnography).",
"Official_title" : "The Different Diagnostic Values of Polysomnographies at Low and at Moderate Altitude - A Randomized Crossover Trial",
"Conditions" : ["Healthy"],
"Interventions" : ["Diagnostic Test: Polysomnography"],
"Location_Countries" : ["Switzerland"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "DIAGNOSTIC",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-06-30",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-03-16",
"Study_Completion_Date(Actual)" : "2024-03-16},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-03-15",
"First_Posted(Estimated)" : 2023-04-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-04-12",
"Last_Update_Posted(Estimated)" : 2025-04-23",
"Last_Verified" : 2025-04"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to investigate the effect of moderate altitude (\>1000 m.a.s.l.) on sleep examinations (polysomnography).
Detailed Description
Polysomnographies will be done for each participant for 2 consecutive nights at the sleep laboratory in Chur (CH; 600 m.a.s.l.) as well as for 2 consecutive nights at the participants home elevations (CH; \>1000 m.a.s.l.). Between the measurements at those two different altitudes there will be a two-week washout period at \>1000 m.a.s.l.. The sequence of altitude exposure will be randomized.
#Intervention
- DIAGNOSTIC_TEST : Polysomnography
- The polysomnographic recordings include electroencephalogram (EEG), electrooculogram (EOG), electromyogram (EMG), electrocardiogram (ECG), pulse oximetry, transcutaneous capnography, nasal airflow and thoracic and abdominal respiratory effort.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy (no current medical condition or intake of regular medication, except negligible medical issues or accidents not interfering with the current health status or physical performance.)
* Living above 1000 m.a.s.l. since at least 1 year
* No overnight stay at altitudes <1000 m.a.s.l. in the previous 4 weeks
* 18 <= age <= 70 years
* Body mass index 18,5 <= age <= 30 kg/m2
* informed consent
Exclusion Criteria:
* Active diseases or health related conditions that require treatment (sleep disorders (mainly sleep apnea), chronic rhinitis, cardiovascular and lung diseases)
* Use of drugs that affect the respiratory center drive (sedatives, sleep inducing drugs, opioids), stimulants or illegal drugs
* Regular consumption of recreational drugs (alcohol and nicotine included)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05826808
| 123,942 |
{
"NCT_ID" : "NCT05922319",
"Brief_Title" : "Effects of Training Dose on Computerized Cognitive Training in Patients With Cognitive Impairment",
"Official_title" : "Effects of Training Dose on Computerized Cognitive Training in People With Cognitive Impairment: A Large-population Retrospective Study",
"Conditions" : ["Cognitive Impairment, Mild", "Dementia"],
"Interventions" : ["Other: Computerized cognitive training with different training doses"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-07-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-08-30",
"Study_Completion_Date(Actual)" : "2023-08-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-04-02",
"First_Posted(Estimated)" : 2023-06-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-06-26",
"Last_Update_Posted(Estimated)" : 2024-05-21",
"Last_Verified" : 2023-06"
}
}}
|
#Study Description
Brief Summary
The goal of this observational study is to explore the optimal dose of computerized cognitive training in patients with cognitive impairment. The main questions it aims to answer are:
* Is there an optimal dose of computerized cognitive training for patients with cognitive impairment?
* Is the optimal dose different in patients in different age populations? Participants enrolled in the study took a reported computerized cognitive training program and the training data were analyzed for exploring the optimal dose.
The researchers will compare the different dose groups to see if there is an optimal dose for the highest improvement in cognitive abilities.
The researchers will additionally compare two age groups (aged younger than 60y or aged 60y and older) to see if the optimal doses in the two groups are different.
Detailed Description
Background: Computerized Cognitive Training (CCT) is a form of digital therapeutics that uses computerized cognitive tasks to train patients with cognitive impairment caused by various neurological or psychiatric diseases. CCT has been shown to slow the progression of cognitive impairment in early-stage dementia, particularly in working memory. However, there is a lack of research on the optimal training dose for people with cognitive impairment. Previous meta-analyses have explored the types, delivery methods, and training dose of cognitive training in healthy older adults and those with dementia risk factors, but not in those with cognitive impairment.
Objectives: The study aimed to explore the dose-response relationship of CCT and estimate the optimal daily and weekly dose for people with cognitive impairment.
Participants and methods: the study is a retrospective cohort study and will enroll 21845 patients with cognitive impairment. The exposures in the study are different doses of cognitive training in a week and the outcome is the improvement in cognitive abilities in a week. The weeks with the same training dose of different patients will be classified into one group of exposure. The mixed effects model will be used to estimate the optimal dose.
#Intervention
- OTHER : Computerized cognitive training with different training doses
- The training dose was defined as training frequency (number of training days per week) and average training duration per training day. The daily dose was divided into 13 categories with an interval of 5 minutes and the training frequency has 7 categories according to the number of training days per week.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with cognitive impairment.
* Patients who took computerized cognitive training in 2017 <= age <= 2022.
* age >= 40 years
* Training duration >= 2 weeks
Exclusion Criteria:
* with moderate to severe dementia, cancer, unstable systemic diseases, or psychiatric diseases
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05922319
| 190,811 |
{
"NCT_ID" : "NCT02059031",
"Brief_Title" : "A Study to Assess The Relative Bioavailability of New Tablet Formulations of GSK1265744 in Healthy Adult Subjects",
"Official_title" : "A Two Part, Single-center, Randomized, Open-label, Crossover Study to Assess The Relative Bioavailability of New Tablet Formulations of GSK1265744 in Healthy Adult Subjects",
"Conditions" : ["Infection, Human Immunodeficiency Virus"],
"Interventions" : ["Drug: GSK1265744 Reference formulation", "Drug: GSK1265744 New formulation 2", "Drug: GSK1265744 New formulation 1"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-06",
"Study_Completion_Date(Actual)" : "2014-06},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-02-06",
"First_Posted(Estimated)" : 2014-02-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-02-06",
"Last_Update_Posted(Estimated)" : 2014-07-16",
"Last_Verified" : 2014-07"
}
}}
|
#Study Description
Brief Summary
This study will evaluate two new GSK1265744 sodium salt tablet formulations and provide data for selection of one of these tablet formulations for use in Phase 3. This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects. Part A is a randomized, open-label, 3-way balanced cross-over design in 24 subjects to assess the oral bioavailability of two GSK1265744 sodium salt tablet formulations relative to the current GSK1265744 sodium salt formulation being used in the phase IIb studies under fasting conditions. Part A treatment periods will be separated by a 14 day washout. After completion of Part A, preliminary PK data will be analyzed and a decision will be made based on pre-specified criteria, as to which formulation will be used to conduct Part B. Fifteen subjects who will have participated in Part A will participate in Part B and receive the selected formulation with a moderate fat meal. All treatments will be administered as single 30 mg doses of GSK1265744. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 10 - 14 days after the last dose of study drug.
#Intervention
- DRUG : GSK1265744 Reference formulation
- GSK1265744 (micronized) reference formulation is available as 30 mg tablet to be orally administered with 240 mL of water
- DRUG : GSK1265744 New formulation 1
- GSK1265744 (micronized) New formulation 1 is available as 30 mg tablet to be orally administered with 240 mL of water
- DRUG : GSK1265744 New formulation 2
- GSK1265744 (un-micronized) New formulation 2 is available as 30 mg tablet to be orally administered with 240 mL of water
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and females aged between 18 and 65 years inclusive, at the time of signing the informed consent.
* Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
* Body weight >= 50 kilogram (kg) and body mass index (BMI) within the range 18.5 <= age <= 31.0 kg/meter^2 (inclusive).
* A female subject is eligible to participate if she is of: non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy [for this definition, 'documented' refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records]; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 milli-international units per milliliter (MIU/mL) and estradiol < 40 picogram (pg)/ml (<147 picomole per liter [pmol/L]) is confirmatory]; child-bearing potential with negative pregnancy test as determined by a serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing AND; agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the final study visit; OR has only same-sex partners, when this is her preferred and usual lifestyle.
* Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in protocol. This criterion must be followed from the time of the first dose of study medication until 14 days post-last dose of study medication.
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <= 1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Exclusion Criteria:
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation.
* A history of regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
* A positive pre-study drug/alcohol screen.
* A positive test for human immunodeficiency virus (HIV) antibody.
* The subject's systolic blood pressure is outside the range of 90 <= age <= 140 millimeter of mercury (mmHg), or diastolic blood pressure is outside the range of 45 <= age <= 90 mmHg.
* History of clinically significant cardiovascular disease including: exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination) - Heart rate of <45 and >100 beats per minute for males and <50 and >100 beats per minute for females; QRS duration >120 milliseconds (msec); QT duration corrected for heart rate by Bazett's formula (QTc B) >450 milliseconds. Evidence of previous myocardial infarction (pathologic Q waves, S-T segment changes (except early repolarization); History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PCTA) or any clinically significant cardiac disease; Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [2nd degree (type II) or higher], Wolf Parkinson White [WPW] syndrome); Sinus pauses > 3 seconds. Any significant arrhythmia which, in the opinion of the principal Investigator and GSK Medical Monitor, will interfere with the safety for the individual subject. Non-sustained (>=3 consecutive ventricular ectopic beats) or sustained ventricular tachycardia.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02059031
| 10,813 |
{
"NCT_ID" : "NCT04691258",
"Brief_Title" : "Back Squat Exercise Treatment for Low Back Pain: Clinical Trial",
"Official_title" : "Back Squat Exercise for Low Back Pain: Avoiding Butt Wink vc Full Range Clinical Trial.",
"Conditions" : ["Low Back Pain", "Muscle Strength", "Visceral Obesity", "Spine Disease", "Spine Degeneration", "Postural Low Back Pain", "Spine Deformity"],
"Interventions" : ["Behavioral: Active Comparator: Restricted Group", "Behavioral: Experimental: Complete Group"],
"Location_Countries" : ["Brazil"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-11-30",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-03-30",
"Study_Completion_Date(Actual)" : "2021-04-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-11-26",
"First_Posted(Estimated)" : 2020-12-31"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-12-30",
"Last_Update_Posted(Estimated)" : 2021-10-04",
"Last_Verified" : 2021-09"
}
}}
|
#Study Description
Brief Summary
Summary: Low back pain is the leading cause of deficiency and loss of productivity worldwide. No evidence of any particular exercise was more effective than another for treating nonspecific low back pain. Objective: To evaluate the efficacy of two resistance training protocols, with different techniques for performing lower limbs exercises, in improving vertebral posture and reducing symptoms of low back pain. Methods: Randomized parallel clinical trial with two arms: Restricted Group (GR) performed all squat and Stiff exercises with neutral vertebral posture and the Complete Group (CG) performed the same exercises prioritizing the complete range of motion. Both groups had a 12-week intervention with 36 resistance training sessions. This study was conducted between November 2020 and April 2021 in Goiás (Brazil). Thirty-two participants aged 18 to 69 years with nonspecific low back pain were recruited in the extension project of the Faculty of Physical Education and Dance of the Federal University of Goiás (UFG), at the Hospital das Clínicas - UFG and at the Campos Samambaia Health Center. To ensure blindness, participants did not know why the technique of movement between them was different. The movement technique was monitored by one teacher per participant throughout the training and cannot be altered by participants at risk of compromising the results. Spinal posture was evaluated by three-dimensional reconstruction and posture quantification using dynamic posture software and pain symptoms were evaluated by the Brief Pain Inventory and Rolland Morris Questionnaire. Statistical analysis was performed in the Software SPSS and MATLAB. The Shapiro-Wilk and Bartlett tests were used to confirm the normal distribution and similar variances in the distribution of the data. The other quantitative and qualitative variables were analyzed by nonparametric statistical methods. Quantitative data with normal distribution were reported by means of means and standard deviation, minimum and maximum values, and the other data by median, interquartile range, minimum and maximum values. The pre-intervention conditions of the groups were compared by independent t-test. Two-way ANOVAs (groups X time) were used for group intervention effect comparisons for quantitative data variables with normal distribution. Significance level of 5%. The size of the effect of the results will be calculated using cohen's test.
Detailed Description
Back Squat Exercise for Low Back Pain: Avoiding Butt Wink vs Full Range Clinical Trial.
Background The deterioration of muscle strength of the back was the most important factor to decrease the range of motion of the spine and were related to the worsening of quality of life. Back pain is the leading cause of deficiency and loss of productivity worldwide. Resistance training has become increasingly a great ally in the benefit of health and especially in the functional capacity of the human being, and reduction of injuries.
Squat is one of the most popular exercises in resistance training, widely used to achieve health, rehabilitation, performance and aesthetic goals.
Vertebral posture has been much questioned in the scientific literature whether or not it may undergo changes in its curvature associated with high overloads during the execution of the squat, believing that this may cause or increase back pain. Further studies are needed before abandoning the current standards of the squat technique that defend a neutral position of the lumbar spine during a deep squat.
OWEN et al. (2020), concluded that no evidence of any particular form of exercise was more effective than others for treating back pain. Therefore, the aim of the present study is to evaluate the efficacy of two resistance training protocols, with different techniques for performing squat exercise, in improving vertebral posture and reducing low back pain.
Methodology
Participants, Randomization and Blindness
This study is a randomized clinical trial involving 32 participants aged 18 to 69 years, all with symptoms of low back pain, controlled by participant, in the effectiveness of the movement technique with a teacher for each exercise.
The participants were recruited in the Faculty of Physical Education and Dance, Federal University of Goiás (UFG), at the Clinical Hospital and Samambaia Campus Health Center.
Research participants must watched 85% of the classes during the 12 weeks of exercise/intervention treatment.
For randomization, they were distributed in a ratio of 1:1, in order of the registration number and parallel intervention. The intervention groups were: 1) Restricted Group (RG) and 2) Complete Group (CG). All perform the same exercises, the only difference between the groups was the technique of movement of the Squats and Stiff.
To ensure blindness, participants not knew why the technique of movement between them was different. The movement technique was monitored with one teacher per participant throughout the training and cannot be altered by participants at risk of compromising the results.
For the participants of the research, a first meeting was scheduled to present and clarify the research and schedule the evaluations.
Ethical procedures All participants signed the Free and Informed Consent Form in two ways according to the Ethics Committee on Human and Animal Research of UFG, opinion number 2,458,324.
Evaluation of vertebral posture with videogrammetry
Retroreflective stickers (flat, rectangular \[12x8 mm\]) were positioned on the back of the participants to identify anatomical accidents (Figure 3). Markers were positioned at the point of intersection between the medial edge and the spine of the scapula (Scapula Trigone), on the left and right side; in the lower angle of the left and right scapula (SI) ; in the posterior superior iliac spine (PSIS); in the spinous processes of the second sacral vertebra (S2), fourth lumbar vertebra (L4), twelfth, sixth and first thoracic vertebrae (T12, T6 and T1). In addition to these, pairs of markers, which were used as reference points during the analysis, were positioned bilaterally and at the time of the spinous processes of L4, T12, T6 and T1, following the alignment of the PSIS. After identifying these points, the line defined by the spinous processes of the vertebrae was filled with markers regularly positioned approximately every 2.5 cm.
To record the back of these volunteers, three OptiTrack Flex 13 cameras with 100Hz acquisition frequency were used and were regulated before postural recording. The measurement of the geometric curvature of the spine was performed with the method described in Campos et al., 2015). The method consists of automatic tracking and three-dimensional reconstruction of retroreflective markers with video cameras. The movement of markers on the back of volunteers is tracked and analyzed.
The processing of images to measure the spatial position of the markers was performed in the Dynamic Posture software (CAMPOS, 2010) developed in Matlab® (The MathWorks, Natick, Massachusetts,USA). In each frame of each video collected, for all cameras, the bidimensionais coordinates of the centroid of the markers were calculated from their respective barycenter (GRUEN, 1997). The calibration of the system was performed through the point s register with a known location, which allowed the three-dimensional reconstruction using the method of linear transformation direct (ABDEL-AZIZ; KARARA, 1971). The system global reference of the laboratory was defined as: vertical axis Z (para up), horizontal back-row axis X(forward) and Y horizontal lateral axis (to left).
During locomotion the trunk presents a regular oscillatory behavior along the vertical axis, with one cycle per step, reaching a maximum peak during each simple support phase and a minimum peak during the double support phases of the lower limbs. Thus, the beginning and end of each step were defined at the moments when the minimum vertical oscillation peaks of the column markers occurred (we calculated the average of the Z coordinate of all column markers). Thus, every two minimum peaks we had a complete stride. Through a function based on finite differences, all minimum peaks of vertical trunk oscillation were identified and consequently passed. We emphasize that we did not claim to identify the events and phases of each pass with this procedure. It was only identified the stride as a whole.
After three-dimensional reconstruction, for locomotion, the data were smoothed with a spline filter adjusted so that the residues were below 1 mm. Each stride cycle was normalized at 101 points in time, representing positions from 0 to 100% of the complete movement cycle. In the analysis of the locomotion of each participant, an average cycle of 10 stride cycles was used, called in this standard cycle work of the stride. For static posture analysis, each marker had its position represented by the average three-dimensional position in a stretch of one second (100 frames).
At each moment in which the posture was recorded, the 3D s of all spinal markers between S2 and T1 were described in a local reference system in the trunk (CAMPOS et al., 2015) with or from T12. The vector with origin in L4 and end in T6 defined the orientation of the longitudinal axis z (upward). An auxiliary vector y' was defined with origin at the midpoint of the reference points to the right of L4 and T6 and with an end at the midpoint of the reference points to the left of L4 and T6. The vector product between y' and z defined the local sagittal axis of trunk x (forward) and the vector product between z and x defined the local transverse axis of trunk y (left).
The method proposed in Brenzikofer et al. (2000), is adopted to measure the geometric shape of the column. By means of the minimum squares method, a polynomial adjustment was made on the position of the markers projected in the sagittal and frontal plane. The lower and upper extremities of the polynomial curve were discarded in the analyses because they could present in very robust adjustments. Eighth-degree polynomials defined by the X²red, chi-square-reduced test (VUOLO, 1992) were used. The geometric curvature of the column vertebral, K(z), was calculated (Figure 4 - left; Figure 3) with the first and second derivatives, P'(z)and P'(z),by means of equation (1): K(z)= P'(z) / \[1 + P'(z)2 \]3/2.
Geometric curvature can be interpreted as being the inverse of the radius of the circumference that adjusts and touches the curve at each height of the longitudinal axis of the column. The unit of measurement of geometric curvature is 'm-1'. In the sagittal plane, v positive curvature allocated previous (kyphosis) and posterior negative (lordosis) concavities. In the frontal plane, positive values indicated left bending and negative for the right.
For the analysis of locomotion, both in the sagittal and frontal plane, the mean posture of the standard cycle of the stride was calculated, called the neutral curve (CAMPOS et al., 2015). We also analyzed the Oscillatory Component, defined by the difference between the postures presented at each instant of the standard stride cycle and the Neutral Curve.
In the analysis of static posture and neutral gait curve, para the sagittal plane, the peak of absolute curvature in the lumbar region (z \< 0 cm) was identified as a representative variable of lumbar lordosis and the peak of absolute curvature in the thoracic region (z \> 0 cm), as a representative variable of thoracic kyphosis. Also in the sagittal plane, the sagittal geometric curvature at the level of L4, T12 and T6 was analyzed. Frontal geometric curvature was analyzed at the level of L4, T12 and T6 as well as the absolute peak of lateral flexion (higher absolute value of curvature) in the lumbar and thoracic regions.
In the analysis of the Oscillatory Component, in the sagittal and frontal plane, for the lumbar and thoracic regions, the place where the greatest range of motion presented in the standard cycle was identified. The range of motion was analyzed.
The trunk inclination was calculated similarly to CAMPOS et al. (2015). The local longitudinal axis of the z trunk was projected in the sagittal plane of the laboratory (normal to Y) in such a way that 0º indicated that the trunk was completely vertical, and 90º indicated that the trunk was inclined to previously, completely horizontal. The local longitudinal axis z of the trunk was also projected in the frontal plane of the laboratory (normal to X) in such a way that 0º indicated that the trunk was completely vertical and 90º indicated that the trunk was tilted to the left, completely horizontal. The cross-sectional and local axis of the trunk was projected in the transverse plane of the laboratory (normal to Z) in such a way that 0º indicated that the trunk was completely aligned with the Y axis and positive values indicated that the trunk was rotated to the left and negative to the right.
Six angular variables were calculated for the two regions of the spine studied (lumbar and thoracic). For the calculation of lumbar angles (Figure 3), a local system was constructed in this region. The vector with origin in S2 and end in T12 defined the orientation of the lumbar longitudinal axis (upward). A lumbar auxiliary vector was defined with origin in the right superior superior iliac spine and extremity in the left upper superior iliac spine. The vector product between the auxiliary vector and the longitudinal lumbar axis defined the lumbar sagittal axis. The vector product between the longitudinal lumbar axis and the sagittal lumbar axis defined the transverse lumbar axis. The lower lumbar segment was defined as the straight segment starting at S2 and end in L4. The upper lumbar segment was defined as the straight segment with beginning at L4 and end in T12. The upper transverse lumbar segment was defined as the straight segment starting at the bilateral point on the right side of T12 and the lower transverse lumbar segment was defined as the straight segment with beginning in the right upper inferior iliac spine and extremity in the upper superior iliac spine. The lower and upper lumbar segments were projected in the sagittal and frontal planes, defining respectively the sagittal lumbar angle(α)and frontal lumbar angle(β)(Figure 3a and 3b). The transverse lumbar angle (θ) was defined by the projection ofthe transverse lumbar segments (Figure 3c).
For the thoracic region, the same procedures used for the lumbar region angles were adopted, replacing in the formulas S2, L4, T12 and the respective bilateral scans with markers of T12, T6, T1 and the respective bilateral ones. Thus, theSagittal Thoracic Angle, TheFrontal Thoracic Angle andTransverse Thoracic Angle were calculated.
Interventions
The participants were frequently trained three times a week, being 2x for lower limbs (Smith Machine Squat, Free Squat, Unilateral Squat and Deadlift with Rigid Legs, on the 3rd and 6th and 1x for upper limbs, (Lat Pulldown, Low Rowing Machine, Inverted Crucifix with Dumbbells, Complete and Inverse Abdominal, Supine with Bar and Supine with Bar).
The selected exercises were the same for the two protocols, but what differentiated one group from the other was the technique of movement of squat and ground lifting exercises with rigid legs. The evaluations were made in two moments, at baseline and at the end of the intervention, after 12 weeks.
In exercise, the ground survey with rigid legs was also controlled by neutral vertebral posture for the participants, and the CG prioritize or range of motion. Foot positioning was also controlled in the Stiff Legged Deadlift exercise in the two protocols respectively in the positions explained for the squat. For the CG the orientation was to go down as much as possible seeking the best posture I could without.
During the execution of both protocols, the knees exceed ed the foot line so that the positioning of the trunk was as straight as possible and did not provide the greatest range of motion of the knees.
The intensity of the exercises see you adjusting load according to the volitive tolerance for 10 to 12 maximum repetitions. The loads and repetitions achieved in each series of each exercise per training session of each participant were noted to control the evolution of the training load. The rest interval was only one minute timed between all series. The cadence of repetitions was 2 seconds in concentric contraction and 4 seconds in eccentric contraction. All 36 training sessions were followed from 14:30 to 16:30 with guidance and supervision of a teacher graduated in Physical Education and Physiotherapy, who perform so this research and one more teacher and three trainees.
Adhesive markers were fixed on the ground, which were measured with goniometer and measuring tape at the squat site, to control the positioning of the feet in the two protocols in all training sessions.
#Intervention
- BEHAVIORAL : Experimental: Complete Group
- The participants performed the squat and Stiff exercises with the maximum range of motion. In the squats, the knees were completely flirted, even if the participant could not perform the movement with neutral vertebral posture. The heels were also not supported to the ground in some participants due to lack of flexibility. It was instructed that the participants tried to perform the Squats and Stiff keeping the lumbar lordosis neutral, with the best posture they could in all training sessions, but all should perform the exercise with as much range of motion as possible.
The positioning of the feet was also carefully controlled, there was no hip rotation and the distance between the lateral edges of the heels was defined as the distance between the upper iliac spines (EIAS). The direction of the knees was oriented pointing in the direction of the tip of the feet parallel throughout the cycle of the movement.
- BEHAVIORAL : Active Comparator: Restricted Group
- The conventional movement technique of the squat exercise was used, in which the participants performed with the range of motion restricted to the neutral vertebral posture, approximately 90º of movement of the knee joint. may increase the range of motion if the lumbar posture did not rectify.
The positioning of the feet in this group was carefully controlled, the participants performed the exercise with the joints of the hips abducted and rotated laterally. Having markings on the ground as a reference, the feet went rotated at 21º and the lateral edge of the heels were moved away from each other, approximately with the biacromial distance. The direction of the knees was oriented pointing in the direction of the tip of the feet throughout the cycle of the movement, aligned to the lateral rotation of the hip. In the first training session, with the aid of a goniometer and metric tape, adhesive marks were placed on the floor to ensure this positioning of the support base.
|
#Eligibility Criteria:
Inclusion Criteria:
Adults and older adults with back pain and able to practice regular physical exercise.
Exclusion Criteria:
* Recent myocardial infarction (less than three months)
* Recent (less than three months) or disabling stroke
* Congestive heart failure
* Chronic kidney failure
* Decompensated Diabetes
* Any other disease or limitation that could compromise the performance of physical exercise protocols.
* Participants who perform other resistance exercise activities
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 69 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04691258
| 88,725 |
{
"NCT_ID" : "NCT06969768",
"Brief_Title" : "Proteogenomics for Follicular Cell-derived Thyroid Cancer: Development of a Classification and Prognosis Prediction Model",
"Official_title" : "Integrative Multi-Omics Refines the Molecular Subtypes of Thyroid Cancers and Enhances Cancer-Progression Prediction",
"Conditions" : ["Thyroid Cancer"],
"Location_Countries" : ["Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-02-21",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-02-21",
"Study_Completion_Date(Actual)" : "2024-02-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2025-04-30",
"First_Posted(Estimated)" : 2025-05-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2025-05-12",
"Last_Update_Posted(Estimated)" : 2025-05-14",
"Last_Verified" : 2025-05"
}
}}
|
#Study Description
Brief Summary
This study aims to refine the molecular classification of thyroid cancer (TC) using a multi-omics approach. By identifying a novel gene set and applying decision-tree modeling, the study seeks to improve diagnostic accuracy and predict tumor progression in BRAFV600E-like and RAS-like TC subtypes. Protein biomarkers were validated via immunohistochemistry (IHC), with findings confirmed across external datasets.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with a confirmed clinical diagnosis of thyroid cancer
* Availability of surgically resected thyroid tissue suitable for omics analysis
Exclusion Criteria:
* Patients who have received chemotherapy for other malignancies
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT06969768
| 113,402 |
{
"NCT_ID" : "NCT04297917",
"Brief_Title" : "First in Human Study of ChAdOx1-HBV",
"Official_title" : "A Phase 1 Monotherapy Study to Evaluate the Safety, Tolerability & Immunogenicity of Vaccination With Candidate Chimpanzee Adenovirus-vectored HepB Virus Vaccine ChAdOx1 HBV in Healthy Participants & Participants With Chronic HepB Infection",
"Conditions" : ["Hepatitis B", "Healthy"],
"Interventions" : ["Biological: ChAdOx1-HBV"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SEQUENTIAL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-02-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-05-26",
"Study_Completion_Date(Actual)" : "2022-05-26},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-02-28",
"First_Posted(Estimated)" : 2020-03-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-03-03",
"Last_Update_Posted(Estimated)" : 2022-07-25",
"Last_Verified" : 2022-03"
}
}}
|
#Study Description
Brief Summary
This is a Phase 1, first in human study of ChAdOx1-HBV. The study will be conducted in 40 healthy participants and 12 participants with CHB and virally suppressed with oral antiviral medication. This will be an open-label, non randomised dose escalation study comparing the safety, tolerability and immunogenicity of 2 different doses of ChAdOx1 HBV vaccine. T cell responses in healthy participants who have received a prior two-dose series of AZD1222 will be compared with those who have received either the Pfizer COVID 19 vaccine or the Moderna mRNA COVID 19 vaccine.
Detailed Description
This is a first in man human study of a therapeutic vaccine for chronic hepatitis B infection(ChAdOx1-1HBV). The vaccine will be given to participants in a dose escalation strategy (two doses). Five healthy participants will be administered the low dose first (cohort 1). Dose escalation will only be initiated in the next 5 healthy participants (cohort 2) following Safety Monitoring Committee (SMC) review.
Six CHB participants will be administered the low dose (cohort 3) before the dose escalation is initiated in the remaining 6 CHB participants (cohort 4).
Thirty healthy participants (15 who have received two doses of AZD1222 \[cohort 5\] and 15 who have received at least two prior doses of Pfizer/Moderna mRNA COVID 19 vaccine \[cohort 6\]) will be dosed in parallel with the high dose used in cohorts 2 and 4.
Each participant will receive 1 dose of the vaccine (intramuscular injection). Participants (Volunteers \& patients) in cohorts 1 to 4 will attend up to 9 study visits and cohorts 5 \& 6 will attend up to 4 visits in total. The last visit will be 24 weeks after vaccination for cohorts 1 to 4 and 12 weeks for cohorts 5 \& 6.
#Intervention
- BIOLOGICAL : ChAdOx1-HBV
- chimpanzee adenovirus-vectored hepatitis B virus vaccine
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult males or females aged >=18 to <=65 years at screening
* Body Mass Index <=30 kg/m2
* Able to provide informed consent indicating they understand the purpose of, and procedures required, for the study and are willing to participate
* If female, willing not to become pregnant up to 8 weeks after last dose of study vaccine, not breast feeding
* If female: Not pregnant, and one of the following:
* Of non-childbearing potential (i.e. women who have had a hysterectomy or tubal ligation or are post menopausal, as defined by no menses in >=1 year)
* Sexual abstinence, only if the participant refrains from heterosexual intercourse during the entire study period and it is the usual lifestyle of the participant
* Of childbearing potential but agrees to practice highly effective contraception for 4 weeks prior to study vaccine and 8 weeks after study vaccine. Highly effective methods of contraception include one or more of the following:
Male partner who is sterile (medically effective vasectomy) prior to the female participant's entry into the study and is the sole sexual partner for the female participant, Hormonal (oral, intravaginal, transdermal, implantable or injectable), An intrauterine hormone releasing system, An intrauterine device and Bilateral tubal occlusion
Healthy participants (cohorts 1 and 2):
* Considered to be healthy with no current conditions that may significantly impair participant safety or influence study results, in the opinion of the Investigator
Participants with well controlled CHB (cohorts 3 and 4):
* Documented evidence of chronic HBV infection (e.g. HBsAg positive >=6 months with detectable HBsAg levels at screening)
* Receipt of only either entecavir or tenofovir for at least 12 months before screening
* Virally suppressed (HBV DNA <40 IU/mL for >=6 months)
* HBsAg <4000IU/mL
Participants with well controlled CHB (cohorts 3 and 4):
* Documented evidence of chronic HBV infection (e.g. HBsAg positive >=6 months with detectable HBsAg levels at screening) 8. Receipt of only either entecavir or tenofovir for at least 12 months before screening 9. Virally suppressed (HBV DNA <40 IU/mL for >=6 months) 10. HBsAg <10000 IU/mL
Healthy participants (cohort 5):
* Considered to be healthy with no current conditions that may significantly impair participant safety or influence study results, in the opinion of the Investigator 12. Adult males or females aged >=40 to <=60 years at screening 13. Completed second dose of COVID-19 AZD1222 vaccine 10 to 18 weeks before enrolment
Healthy participants (cohort 6):
* Considered to be healthy with no current conditions that may significantly impair participant safety or influence study results, in the opinion of the Investigator
* Adult males or females aged >=40 to <=60 years at screening
* Received the latest dose of Completed of either Pfizer (Comirnaty®) or Moderna (Spikevax) mRNA COVID 19 vaccine 6 to 30 weeks before enrolment
Exclusion Criteria:
* Presence of any significant acute or chronic, uncontrolled medical/ psychiatric illness
* Hepatitis C virus antibody positive.
* Human immunodeficiency virus antibody positive
* History or evidence of autoimmune disease or known immunodeficiency of any cause
* Prolonged therapy with immunomodulators (e.g. corticosteroids) or biologics (e.g. monoclonal antibodies, interferon) within 3 months of screening
* Receipt of immunoglobulin or other blood products within 3 months prior to screening
* Receipt of any investigational drug or vaccine within 3 months prior to screening
* Cohorts 1 <= age <= 4: Receipt of any adenoviral vaccine within 3 months prior to administration of ChAdOx1-HBV on Day 0, or plan to receive an adenoviral-based vaccine within 3 months after Day 0
Cohorts 5 and 6: Receipt of any adenoviral vaccine (other than AZD1222 per inclusion criterion 13) within 3 months prior to administration of ChAdOx1-HBV on Day 0, or plan to receive an adenoviral-based vaccine within 3 months after Day 0
* Receipt of any live vaccines within 30 days prior to screening
* Receipt of any inactivated vaccines within 14 days prior to screening
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
* Any history of anaphylaxis in reaction to vaccination
* Malignancy within 5 years prior to screening with the exception of specific cancers that are cured by surgical resection (e.g. except basal cell skin carcinoma of the skin and cervical carcinoma). Participants under evaluation for possible malignancy are not eligible
* Current alcohol or substance abuse judged by the Investigator to potentially interfere with participant safety and compliance
* Significant cardiac disease or unstable uncontrolled cardiac disease
* Any laboratory test at screening which is abnormal and which is deemed by the Investigator to be clinically significant
* Any other finding that, in the opinion of the Investigator, deems the participant unsuitable for the study Additionally, for healthy participants (cohorts 1, 2, 5 and 6)
* HBsAg positive Additionally, for participants with well controlled CHB (cohorts 3 and 4)
* Co infection with hepatitis delta
* Documented cirrhosis or advanced fibrosis indicated by a liver biopsy within 6 months prior to screening.
In the absence of an appropriate liver biopsy, either 1 of the following:
* Screening Fibroscan with a result >9 kPa within <=6 months of screening or
* Screening FibroTest >0.48 and aspartate aminotransferase (AST) to platelet ratio index of >1 In the event of discordant results between non-invasive methods, the Fibroscan result will take precedence.
* Alanine transaminase (ALT) >3 × upper limit of normal, international normalised ratio (INR) >1.5 unless the participant was stable on an anticoagulant regimen affecting INR, albumin <35 g/L, total bilirubin >2 mg/dL, platelet count <100,000/mL
* A history of liver decompensation (e.g. ascites, encephalopathy or variceal haemorrhage)
* Prior or current hepatocellular carcinoma
* Chronic liver disease of a non HBV aetiology
* Any herbal supplements and or other medicines with potential liver toxicity within the previous 3 months prior to enrolment into this study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04297917
| 105,352 |
{
"NCT_ID" : "NCT02516982",
"Brief_Title" : "mHealth for Antenatal Mental Health",
"Official_title" : "Tablet Computers for Implementing NICE Antenatal Mental Health Guidelines - Feasibility Study",
"Conditions" : ["Depression", "Pregnancy"],
"Interventions" : ["Other: Whooley Questions", "Other: Momentary questions", "Other: Edinburgh Postnatal Depression Scale", "Other: Contextual questions"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-02",
"Study_Completion_Date(Actual)" : "2018-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-07-20",
"First_Submitted_that_Met_QC_Criteria" : 2019-09-20",
"First_Posted(Estimated)" : 2015-08-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-08-04",
"Last_Update_Posted(Estimated)" : 2019-09-23",
"Last_Verified" : 2019-09"
}
}}
|
#Study Description
Brief Summary
The aim of this study is to determine the feasibility of using mobile technology for:
1. Implementing the recommendations of the Antenatal and postnatal mental health: clinical management and service guidance NICE guideline for recognising depression (i.e., Whooley questions followed by a validated screening instrument such as the Edinburgh Postnatal Depression Scale) during pregnancy using iPad Air tablets in the waiting area of general practices, midwifery services, or hospitals during antenatal clinics; and
2. Using a bespoke app running on pregnant women's own smartphones to monitor mood and symptoms of depression throughout pregnancy.
Detailed Description
As part of our first aim, we will assess the psychometric properties of the Whooley questions, by comparing the answers given to these questions against the scores obtained on the Edinburgh Postnatal Depression Scale, and we will manipulate the survey questionnaire layout of the Whooley Questions and the Edinburgh Postnatal Depression Scale in order to ensure that this survey design choice does not affect data quality. As part of our second aim, we will compare two prospective sampling protocols on patient compliance and engagement with the app.
We will use a parallel, randomised control trial study design. Participation in each part of the study (i.e., iPads in antenatal clinics, or app running on own handset) will be independent from each other. Those participants consenting to get involved in the part of the study assessing the use of iPads in antenatal clinics will be randomly assigned to complete (i) an app version of the Whooley questions and the Edinburgh Postnatal Depression Scale in which the questionnaires are presented using a scrolling layout (i.e., App screening - Scrolling), or (ii) an app version of the Whooley questions and the Edinburgh Postnatal Depression Scale in which the questionnaires are presented using a paging layout (i.e., App screening - Paging).
Participants consenting to get involved in the part of the study assessing the use of an app running on participants' own devices will be randomly allocated to one of two sampling protocols: (i) a prospective sampling protocol of 6 months consisting of the Edinburgh Postnatal Depression Scale and 5 momentary questions related to mood; or (ii) a prospective sampling protocol of 6 months consisting of the Edinburgh Postnatal Depression Scale.
We will utilise a block randomisation procedure (with blocks of 4) to generate our allocation sequence. Random numbers will be generated using Stata 13.0. Researchers conducting participant recruitment will not be involved in this randomisation procedure in order to avoid recruitment bias.
#Intervention
- OTHER : Whooley Questions
- The Whooley questions are a case-finding instrument for depression in primary care. This 2-question instrument screens for depressed mood and anhedonia that have been present during the past month. Respondents are required to answer Yes or No to each of these questions. An affirmative answer to any of them should be followed by further assessment, including the use of a validated screening instrument or referral to a general practitioner or a mental health practitioner.
- OTHER : Edinburgh Postnatal Depression Scale
- The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-administered survey that screens for symptoms such as feelings of guilt, sleep disturbance, reduced energy levels, anhedonia and suicidal ideation that have been present during the 7 days preceding its administration. Each question is scored on a 4-point scale ranging from 0 to 3 points. Overall scores between 10 and 12 points suggest increased risk for depression; scores of 13 points or above indicate that the diagnostic criteria for major depression disorder have probably been met. In addition, item 10 deals with suicidal thoughts. The EPDS is a valid and reliable tool for identifying women at risk of depression, both during pregnancy and postpartum, and is sensitive to changes in the severity of depression over time.
- OTHER : Momentary questions
- These will consist of 5 questions on a 5-point pictorial scales, assessing participants' mood, sleep, energy, enjoyment and worry.
- OTHER : Contextual questions
- Two questions asking for participants' location and activity at the time they were asked to complete the momentary questions.
|
#Eligibility Criteria:
Inclusion Criteria:
* Pregnant women attending antenatal clinics
Exclusion Criteria:
* Diagnosis of any common mental health disorder (i.e., depression or anxiety disorders) as specified in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition
* Receiving treatment for any common mental health disorder
* Recent personal history of any common mental health disorder (i.e., within the past 12 months)
* Not comfortable reading and writing in English
Participants enrolled in the study assessing an app for the monitoring of mood and symptoms of depression need to own an iPhone or any Android-compatible smartphone.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02516982
| 18,272 |
{
"NCT_ID" : "NCT00968838",
"Brief_Title" : "A Study for Leukemia Patients With Life-Threatening Infections",
"Official_title" : "Comparative Study of Radiated and Unradiated Leukocyte Transfusions for Patients With Life-threatening Infections: A Collaborative Study by the Leukemia Department and Laboratory Medicine",
"Conditions" : ["Leukemia"],
"Interventions" : ["Procedure: White Blood Cell Transfusion"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-08",
"Study_Completion_Date(Actual)" : "2011-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-08-27",
"First_Submitted_that_Met_QC_Criteria" : 2013-11-01",
"First_Posted(Estimated)" : 2009-08-31"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-08-28",
"Last_Update_Posted(Estimated)" : 2013-11-26",
"Last_Verified" : 2013-11"
}
}}
|
#Study Description
Brief Summary
The goal of this clinical research study is to compare the effectiveness of a white blood cell transfusion with radiated cells to a white blood cell transfusion with cells that have not been radiated. The safety of this procedure will also be studied.
Detailed Description
Radiated White Blood Cell Transfusions:
White blood cell transfusions from a volunteer donor may contain blood cells that your body can react with to produce a disorder called transfusion-associated graft versus host disease. This means that some of the injected white blood cells can reproduce in your body and react with your own tissues and create side effects. To avoid this, the blood is radiated (changed through radiation) to kill all the cells that can divide. But this radiation also may destroy some of the infection-fighting capacity of the white blood cell transfusion, this may decrease the effectiveness of these white blood cell transfusions. Radiating white blood cells is the standard procedure that has been used to treat serious, life-threatening infections.
Non-Radiated White Blood Cell Transfusions:
If the white blood cells are not radiated, it may increase the effectiveness of these white cell transfusions. This may help the white blood cells to make more infection-fighting white blood cells. But, the cells that are also responsible for the transfusion-associated graft versus host disease will not be killed. This increases the risk that you could have this complication.
Study Groups:
If you agree to take part in this study, and if you are one of the first 40 patients, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You or your physician will not know the results of this randomization. If you are in Group 1, you will have a non-radiated white blood cell transfusion. If you are in Group 2, you will have a standard white blood cell transfusion (with radiation). If you are less than 50 years old, you will receive 4 transfusions of radiated white cells. If you continue to show signs and symptoms of infection you will receive additional white cell transfusions based on the group you were randomized to.
If you are after the first 40 patients, you will be placed in a group that the study doctor thinks will most benefit you. It is important to note that this study is designed as a 'adaptive randomization' which means that as the outcome for each individual is observed, the next patient receives the product which is most likely to be beneficial and least likely to be harmful.
White Blood Cell Transfusion:
Before the transfusion, a nurse will take your temperature, breathing rate and blood pressure. During the transfusion a nurse will watch you closely. Side effects sometimes occur during and soon after the transfusion. You may be given a drug to help or reduce any side effects.
If you are in Group 2, you will receive 4 standard white blood cell transfusions (with radiation).
If you still have an infection after 4 transfusions and the doctor thinks it is necessary, you will have additional transfusions. You will continue to have transfusions until the doctor feels the infection has been controlled. If you experience graft-versus-host disease (GVHD), this will be up to your doctor's discretion.
If you need a white blood cell transfusion for a new infection or for an infection that comes back, you will receive the same type of transfusion as you received before.
If you were discharged from the hospital and your doctor would like for you to continue receiving white blood cell transfusions, you will be able to receive them as an outpatient.
Each transfusion will take from 1 hour to several hours depending on how you tolerate the treatment. Each transfusion will be given daily or as close to daily as possible.
Before every infusion, blood (about 1 tablespoon) will be drawn to measure the number of white blood cells in your blood.
Length of Study:
You will receive transfusions until your doctor feels the infection has been controlled.
This is an investigational study. White blood cell transfusions are considered standard procedure for the treatment of serious, life threatening infections.
Up to 150 patients will take part in this study. All will be enrolled at The University of Texas (UT) MD Anderson Cancer Center.
#Intervention
- PROCEDURE : White Blood Cell Transfusion
- 4 Transfusions, each taking approximately 1 hour:
Patients \<50 years of age receive 4 standard transfusions before they are randomized to receive further radiated or non radiated transfusions.
Patients \>50 years of age are randomized to receive either radiated or non radiated transfusions.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of hematologic malignancy admitted to the Leukemia service.
* Severe neutropenia defined as Absolute neutrophil count (ANC) less than or equal to 1000.
* Persistent fever and/or signs of life threatening infection despite 48 hours on antibiotics.
* Sign a written informed consent form.
* Greater than 18 years.
Exclusion Criteria:
1) None
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00968838
| 187,977 |
{
"NCT_ID" : "NCT04738279",
"Brief_Title" : "The CASCADE HF Soft Launch and Calibration Phase I and II",
"Official_title" : "A Study to Determine the Efficacy of Continuous Ambulatory Wearable Technology and a Cascading Alert System in Reducing 30d Readmission in High Risk Heart Failure Patients",
"Conditions" : ["Heart Failure"],
"Interventions" : ["Other: Affective Analysis of Participant Response to Continuous Remote Patient Monitoring", "Device: Non-Invasive Continuous Remote Patient Monitoring"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2", "PHASE3"],
"Primary_Purpose" : "OTHER",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SEQUENTIAL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-12-14",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-10-30",
"Study_Completion_Date(Actual)" : "2021-10-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-01-27",
"First_Submitted_that_Met_QC_Criteria" : 2023-02-14",
"First_Posted(Estimated)" : 2021-02-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-01-29",
"Last_Update_Posted(Estimated)" : 2023-10-03",
"Last_Verified" : 2023-10"
}
}}
|
#Study Description
Brief Summary
Invasive telemonitoring has shown promising results in reducing readmissions and health service utilization, and improving patient outcomes; however, such evidence is lacking for non-invasive telemonitoring. Our proposal is to deploy a wearable solution that predicts physiological perturbation comparable to invasive devices and to perform continuous remote patient monitoring; this will be connected to a structured, cascading, escalation pathway involving home health nurses, advanced practitioner providers, specialists, and surgeons, and has the potential to transform care management in the post-discharge period, where patients are the most vulnerable for readmission.
#Intervention
- DEVICE : Non-Invasive Continuous Remote Patient Monitoring
- Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway
- OTHER : Affective Analysis of Participant Response to Continuous Remote Patient Monitoring
- Survey and qualitative interviewing of participants
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient is an inpatient at NorthShore University HealthSystem
* Patient is on the heart failure consult list
* Patient has a history of heart failure
* Patient received at least one dose of IV diuretics at index hospitalization
* Patient is discharging with NorthShore Home Health services
* Symptoms corresponding to New York Heart Association function class II-IV
* Patient has heart failure with reduced left ventricular ejection fraction (LVEF)<40%, or HF with mid-ranged ejection fraction (LVEF 40 <= age <= 50%), or HF with preserved ejection fraction (LVEF>=50%)
* Patient is in the top 50% risk of readmission across NorthShore University HealthSystem's CAPE 30-day readmission model
* Patient is at least 18 years
* Patient is fluent in English
* Patient agrees to protocol-required procedures
Exclusion Criteria:
* Patient has cognitive or physical limitations that, in the opinion of the investigator, limit the patient's ability to maintain patch, phone
* Patient has allergy to hydrocolloid adhesives
* Patient has present skin damage preventing them from wearing a study device
* Patient has renal dysfunction requiring dialysis
* Pregnancy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04738279
| 177,856 |
{
"NCT_ID" : "NCT02014038",
"Brief_Title" : "Ultrarunners Longitudinal TRAcking Study (ULTRA)",
"Official_title" : "Ultrarunners Longitudinal TRAcking Study (ULTRA)",
"Conditions" : ["Arthritis", "Osteoporosis", "Injuries"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-12",
"Study_Completion_Date(Actual)" : "2016-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-12-06",
"First_Posted(Estimated)" : 2013-12-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-12-11",
"Last_Update_Posted(Estimated)" : 2023-04-13",
"Last_Verified" : 2023-04"
}
}}
|
#Study Description
Brief Summary
Health status information and physical activity level will be collected longitudinally on a large group of individuals who are ultramarathon runners at the time of enrollment to determine if very high levels of physical activity alter health risks compared with sedentary or moderately active lifestyles.
Detailed Description
The intent of this research is to longitudinally study the health of individuals who have run at least one ultramarathon (50K distance or greater) prior to enrollment.Longitudinal data will be collected through periodic (every 1-2 years) survey completion by enrolled subjects over the course of up to 20 years. All surveys will be collected through a secure web-based system used by Stanford University Qualtrics). Minor formatting adjustments will be required when placing into the on-line questionnaire format.
We anticipate that the follow-up surveys will be adjusted prior to use, so they will be submitted to the Institutional Review board as addendum or in continuing review. As indicated elsewhere, subjects will be recruited through an email exchange (referred to as the 'Ultralist'), various ultramarathon-related web sites and blogs, and ultramarathon-related magazines. Initial recruitment will continue for up to 12 months or until we have reached our desired sample size. Recruitment material (attached) will include a link to the initial survey. For follow-up surveys, subjects will initially be sent an email (using the address they have provided with the initial survey) that contains a link to the survey and request that they complete the survey. Attempt to contact non-responders will be, in this order, through a second email, phone call, letter to their home, email to identified surrogate, phone call to identified surrogate, and letter to identified surrogate. Publicly available death records will be examined for cases where follow-up cannot be achieved.
|
#Eligibility Criteria:
Inclusion Criteria:Healthy adults, able to provide consent, able to do survey online, must have completed one ULTRA marathon prior to participating in this study.
Exclusion Criteria:Not meeting the inclusion criteria
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02014038
| 124,181 |
{
"NCT_ID" : "NCT05384782",
"Brief_Title" : "Computational Decision Support in Epilepsy Using Retrospective EEG",
"Official_title" : "Retrospective Analysis of Resting-State EEG in the Diagnosis of Epilepsy to Validate a Computational Biomarker for Seizure Susceptibility",
"Conditions" : ["Epilepsy"],
"Location_Countries" : ["United Kingdom"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-12-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-12-31",
"Study_Completion_Date(Actual)" : "2022-03-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-05-04",
"First_Posted(Estimated)" : 2022-05-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-05-18",
"Last_Update_Posted(Estimated)" : 2022-05-20",
"Last_Verified" : 2022-05"
}
}}
|
#Study Description
Brief Summary
The primary aim is to validate a set of computational biomarkers as potential decision support in epilepsy on a large cohort of study participants that were diagnosed with epilepsy and controls that ended up with another diagnosis (such as syncope or non-epileptic seizures). The goal is to examine if the methodology works robustly on this large cohort, and can theoretically contribute to the reduction of misdiagnosis rates.
The secondary aim is to examine whether the computational biomarkers could contribute to reducing the waiting time and the number of clinical appointments needed before a final diagnosis is made.
Detailed Description
Mathematical models provide a powerful and useful tool with which to identify and understand biological mechanisms that may lead to the risk of having seizures as well as how they generate, propagate and terminate (Wendling, 2005). Mathematical models that combine experimental and clinical detail at diverse scales have revealed the importance of many microscopic and macroscopic mechanisms in the generation of seizure-like activity, ranging from genetic and molecular mechanisms to changes in the excitability of neural populations leading to the generation of pathological oscillations (for review see Woldman \& Terry (2015); Soltesz \& Staley (2008)). Due to the increased availability of data recordings (EEG, MRI, MEG, CT, PET), there has been a significant increase in research studies that aim to identify novel biomarkers from these recordings with potential clinical value, using various different techniques (e.g. time-series analysis, computational modelling, machine learning).
By combining mathematical and computational techniques, we have identified properties in the resting-state EEG (eyes closed, relaxed) of people with epilepsy that differ from those of controls as well as their first-degree relatives (Chowdhury et al., 2014). Developing these approaches and applying them to routine recordings from individuals with epilepsy against a control cohort (Schmidt et al., 2016) revealed levels of diagnostic accuracy similar to current general (i.e. non-specialist) neurology practices (60% sensitivity, 87% specificity, N=68). Crucially, our method correctly classified several subjects using their first EEG, whereas clinical diagnosis was confirmed only after prolonged telemetric recordings over many months.
Since our methods and analysis depend on short segments of resting-state EEG only, its accuracy and efficacy do not rely on capturing epileptiform abnormalities, in contrast to the current use of EEG in diagnosing epilepsy. Since many EEGs return negative, clinicians are often faced with the problem of deciding on whether to opt for longer recordings of EEG or ambulatory or video EEG, which is currently the final method in the diagnostic cascade. This is time-consuming, expensive and relies on the availability and expertise of trained EEG-readers. By optimally interrogating short segments of background activity with mathematical and computational analysis, our methods, in the short term, provide additional evidence that could guide clinicians in future diagnostic steps.
|
#Eligibility Criteria:
Inclusion Criteria:
Subject was suspected of having had a seizure or epilepsy (fits, faints or funny turns), and as part of the diagnostic process one or more EEGs was recorded The subject ended up with a confirmed diagnosis of epilepsy or of the differential diagnosis such as syncope, or psychogenic seizures (diagnosis must have been at least 1 year ago, and not changed since)
For each subject identified we would like to have all the available EEG files within the centre, with the following metadata:
Primary meta-data (crucial):
Age at the subject at time of each available EEG Treatment status at the time of each available EEG (including drug-load) Gender of the individual Ethnicity of the individual Confirmed diagnosis: details on the exact diagnosis made (syndrome and or condition)
Secondary meta-data (optional):
Aim of each available EEG at the time Information on whether any other conditions are present such as Alzheimer's disease, schizophrenia, Intellectual Disability If available: information on when the diagnosis was made If available: interpretation of each available EEG
Specifics for the EEG recordings:
Montage (10 <= age <= 20 preferred) Number of channels (minimum 19 channels) Referencing method (common average preferred) Format of the file (EDF preferred) Consistent channel labels for all EEGs provided from each centre Information concerning the time of day during the recording Information on the sampling frequency Faulty channels (not more than 2 preferred, all should be indicated though) Pre-processing details (information as to whether any filters were used, for example)
Exclusion Criteria:
Subject was not suspected of having had a seizure or epilepsy Unavailable information concerning the final diagnosis of the subject (epilepsy or other) Incomplete or unreliable meta-data, such as the age, gender and treatment-status at the time of the EEG recording (primary meta-data) Recordings which do not comply with inclusion criteria
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05384782
| 4 |
{
"NCT_ID" : "NCT02803372",
"Brief_Title" : "Circulatory Management and Acute Kidney Injury in Patients Undergoing Partial Nephrectomy",
"Official_title" : "Impact of Circulatory Management Based on LiDCOrapid Hemodynamic Monitoring on the Incidence of Acute Kidney Injury in Patients Undergoing Partial Nephrectomy: A Randomized Controlled Trial",
"Conditions" : ["Acute Kidney Injury"],
"Interventions" : ["Other: Routine circulatory management", "Other: Goal-directed circulatory management"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-12",
"Study_Completion_Date(Actual)" : "2017-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-06-06",
"First_Posted(Estimated)" : 2016-06-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-06-13",
"Last_Update_Posted(Estimated)" : 2018-01-03",
"Last_Verified" : 2017-12"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to investigate whether circulatory management based on LiDCOrapid hemodynamic monitoring can reduce the incidence of acute kidney injury in patients undergoing partial nephrectomy when compared with routine circulatory management based on blood pressure and urine output monitoring
Detailed Description
Previous studies found that the incidence of acute kidney injury afer partial nephrectomy is higher than 30%. In addition to nephron loss induced by renal parenchyma resection, ischemia/reperfusion injury produced by clamping/unclamping of renal arteries is also an important reason. However, studies investigating the effect of circulatory management on the incidence of acute kidney injury after partial nephrectomy are limited.
It has been shown that perioperative hemodynamic optimization protected renal function in surgical patients. And in patients undergoing renal transplantation, adequate hydration and optimal perfusion enhances early graft function. The investigators hypothesize that hydration and circulatory management to guarantee optimal renal perfusion may decrease the occurrence of acute kidney injury after partial nephrectomy. The purpose of this study is to investigate whether circulatory management based on LiDCOrapid hemodynamic monitoring can reduce the incidence of acute kidney injury in patients undergoing partial nephrectomy when compared with routine circulatory management based on blood pressure and urine output monitoring.
#Intervention
- OTHER : Goal-directed circulatory management
- In addition to routine monitoring, invasive LiDCOrapid is used to monitor MAP, SVV and CI. Intraoperative circulatory management is performed according to the goal-directed principal, i.e., to maintain MAP \> 95 mmHg, SVV \< 6%, and CI 3.0-4.0 L/min/m2, started from renal artery clamping and maintained until the end of surgery. Crystalloid solution is firstly infused to maintain SVV at the target level, dobutamine and/or noradrenaline are then infused to maintain MAP and CI at the target levels.
- OTHER : Routine circulatory management
- Routine monitoring is performed, which include invasive blood pressure and urine output. Intraoperative circulatory management is performed according to routine practice, i.e., to maintain blood pressure within 20% from baseline level and urine output \> 0.5 ml/kg/h by infusing crystalloid solution and administering vasoactive drugs when considered necessary.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age > 18 years;
* Planning to undergo partial nephrectomy;
Exclusion Criteria:
* Patients with renal function damage (chronic kidney disease stage 3 <= age <= 5) before surgery;
* Patients with arrhythmia or aortic valve diseases (moderate or higher degree stenosis/regurgitation);
* Patients who has participated in other trials.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02803372
| 73,646 |
{
"NCT_ID" : "NCT03363308",
"Brief_Title" : "Effects of a Health Workforce Capacity Building and Quality Improvement Intervention in Kinshasa",
"Official_title" : "Effects of a Health Workforce Capacity Building and Quality Improvement Intervention on Intrapartum Stillbirth, Early Newborn Mortality and Post-pregnancy Family Planning in Kinshasa: a Cluster Randomized Evaluation",
"Conditions" : ["Maternal Death", "Infant Death", "Stillbirth"],
"Interventions" : ["Behavioral: training for health care workers supplmented by QI teams"],
"Location_Countries" : ["Congo, The Democratic Republic of the"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-11-16",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-06-30",
"Study_Completion_Date(Actual)" : "2020-06-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-11-30",
"First_Posted(Estimated)" : 2017-12-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-11-30",
"Last_Update_Posted(Estimated)" : 2020-07-24",
"Last_Verified" : 2020-07"
}
}}
|
#Study Description
Brief Summary
The aim of the study is to evaluate a health workforce capacity building and quality improvement intervention focused on integrated day-of-birth and post-pregnancy care at 16 hospitals in Kinshasa, Democratic Republic of Congo. The intervention package consists of a low-dose, high-frequency (LDHF) training of health workers, support for quality improvement teams, and provision of critical equipment, supplies and drugs within a quality improvement (QI) framework.
Detailed Description
The health workforce capacity building and quality improvement intervention will be implemented in two phases: eight facilities will receive the intervention in phase 1 and the remaining eight facilities will receive the intervention in phase 2.
Objective 1: For objective 2 on facility-based health outcomes, the study design is a cluster-randomized evaluation in phase 1. The intervention's effects will be assessed by comparing an intervention group and a control group of facilities. These will be selected from 16 Kinshasa health facilities. Intervention and control facilities' monthly reported health outcomes will be compared in a 12-month baseline period and 12-month period during and after the intervention implementation (Phase 1) in a difference-in-difference analysis. In Phase 2, all facilities will have their monthly service statistics and health outcomes reviewed for trends in improvement.
Overall, in Phase 1, eight intervention sites will be matched to eight sites serving as controls. In Phase 2, the eight Phase 1 control sites will then receive the same package as the intervention sites in Phase 1. Sites will be stratified by case load, low and high (over 90 births per month), and funding (public or private funding). Within each stratum, prior to start of the intervention, there will be random selection to intervention and control groups to allow for baseline comparability between groups.
#Intervention
- BEHAVIORAL : training for health care workers supplmented by QI teams
- Jhpiego will deliver maternal and newborn health and family planning (MNH+FP) training using evidence-based low-dose, high-frequency (LDHF) learning approaches and support hospital staff-led quality improvement efforts to increase the coverage of facility-based high-impact interventions, including care of the mother and newborn on the day of birth and through the first week postpartum and post abortion services.
- Other Names :
- Practice coordinator training after training session, Practice sessions using anatomic models, SMS reminder messages and quizzes, Routine calls between mentors and providers, Health information officer training, Data collection and use training, Supply of simulators, equipment, kits and other, Develop quality improvement teams and review of action plans, Routine calls between project staff and mentors
|
#Eligibility Criteria:
Inclusion Criteria:
* Health providers:
* Currently on the roster of maternity ward providers working at one of the 16 selected facilities at the time of the training module.
* Willing to attend a Jhpiego clinical training workshop and offer consent as study participant.
* Age >= 18 years.
Exclusion Criteria:
* there are no exclusion criteria
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03363308
| 188,315 |
{
"NCT_ID" : "NCT05695664",
"Brief_Title" : "Postoperative Analgesic Effects of Ibuprofen Versus Ketorolac in Patients Undergoing in Orthopedic Surgery",
"Official_title" : "Comparison of the Postoperative Analgesic Effects of Ibuprofen Versus Ketorolac in Patients Undergoing Orthopedic Surgery",
"Conditions" : ["Intravenous Drug Usage", "Ibuprofen", "Ketorolac", "Knee Arthroscopy", "Postoperative Pain"],
"Interventions" : ["Drug: Ibuprofen 800 mg", "Drug: Ketorolac Injection"],
"Location_Countries" : ["Pakistan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["EARLY_PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-08-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-01-31",
"Study_Completion_Date(Actual)" : "2022-01-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-01-12",
"First_Posted(Estimated)" : 2023-01-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-01-20",
"Last_Update_Posted(Estimated)" : 2023-01-25",
"Last_Verified" : 2023-01"
}
}}
|
#Study Description
Brief Summary
Objectives: To compare the postoperative analgesic effects of ibuprofen versus ketorolac in patients undergoing orthopedic surgery at Combined Military Hospital, Rawalpindi.
Study design: Randomized controlled trial Setting: Department of Anasthesiology, Combined military Hospital, Rawalpindi Duration of study:6 months (01st August 2021 to 31st January 2022) Material and methods: After ethical approval, 100 patients in randomly divided two equal groups (A and B) were selected. In group A, 800 mg IV ibuprofen while in group B, 30 mg IV ketorolac was given within 30 min of skin closure after orthopedic surgery. The pain was assessed via visual analogue scale postoperatively. The SPSS version 25 was used for analysis of data. P value ≤ 0.05 was considered as significant.
Detailed Description
INTRODUCTION Healthcare seeks to decrease postoperative pain to ensure better and faster postoperative mobilization.1 Postoperative pain pathways identify populations at risk for 30-day readmissions and emergency department visits that are not due to post discharge complications.2 Chronic pain is acknowledged as a disease per se, and addressing pain control expectations before discharge could reduce surgical readmissions.3 However, despite advances in perioperative protocols, pain remains a very frequent clinical symptom seen by orthopedic surgeons and a major reason for patients to seek medical assistance. Moreover, pain management after orthopedic procedures remains suboptimal for many patients.4 For instance, 37% of orthopedic patients reported their pain to be severe at its highest intensity, where postoperative pain remains a problem that requires consensus and joint efforts.5 Several modalities are available to alleviate the postoperative period, which range from nerve blocks to the use of various classes of drugs. Opioids have been widely used for pain relief. However, this class of drug is associated with a wide range of side effects, including a potential for developing drug dependence and addiction. On the other hand, non-steroidal anti-inflammatory drugs (NSAIDs), have been used widely for pain relief. NSAIDs are widely available as compared to opioids. NSAIDs also have several side effects, but a study has proven NSAIDs to be safe for controlling acute postoperative pain if they are used appropriately.6 Several studies have compared the different drugs belonging to the NSAID class in terms of their efficacy as postoperative analgesia. A study found no difference in pain and satisfaction between two groups of patients receiving either IV ketorolac or IV Ibuprofen as part of postoperative analgesia following urogynecological surgeries.7 However, patients who underwent laparotomies had less pain with Keterolac.8 In another study carried out on patients undergoing knee arthroscopies, preemptive use of Ibuprofen 800 mg was associated with less postoperative pain.9 Uribe et al. compared the postoperative analgesic effects of ibuprofen and ketorolac and discovered a difference in rescue analgesic use (55% vs. 83.9%), time to first rescue analgesic use (77.62 ± 33.03 vs. 55.78 ± 35.37 hours), and analgesic requirement in PACU (5.53 ± 5.89 vs. 19.92 ± 15.63 mg, p value 0.05).10 Postoperative pain is one of the principal concerns of surgeons and anesthesiologists, which leads to prolonged hospitalization and an increased analgesic requirement. Both factors expose the patient to hospital acquired infection and the untoward side effects of analgesics. As a result, a balanced or multimodal analgesia with adjuvant medications is required. It is important that, as anesthesiologists, we understand the effective method for pain suppression during orthopedic procedures. Therefore, this study is aimed at filling this knowledge gap. Data from this study would add information and serve as a baseline for the development of management guidelines for pain management.
METHODS AND MATERIALS After obtaining approval from the Ethical Committee / Institutional Review Board (IRB) (document no. 156/05/21), patients undergoing orthopedic surgeries were enrolled in the Department of Anesthesiology and Orthopedics at the Combined Military Hospital, Rawalpindi. The sample size for this randomized controlled trial (RCT) was 100 patients (50 patients in each group), which was calculated from a previous study by taking the frequencies of rescue analgesic use as (55% vs. 83.9%). 11 The power of the test was 90% with a 5% level of significance. The research lasted six months, from August 1, 2021, to January 31, 2022. All patients gave their informed written consent. The patients of either gender with an age range of 40-80 years and an ASA grade of 2 who were undergoing orthopedic surgeries for fractures of the radius, ulna, and wrist were included in the study. Patients with a history of adverse reactions to ibuprofen or ketorolac, a history of epilepsy, bronchial asthma, coronary artery disease, renal or hepatic impairments, or use of antiarrhythmic or analgesic medications in the last seven days were excluded. Age, gender, obesity (BMI \> 27 kg/m2), history of smoking (10 or more cigarettes per day for at least 5 years or 5 or more cigarettes per day for at least 10 years), diabetes, and hypertension were registered before pre-operative evaluation of the patients to assess their fitness for anesthesia. The patients were labeled as diabetics when they were on anti-diabetic medication for at least 6 months or when there was lab evidence of HBA1c \>6.5%, fasting blood sugar of \>126 mg/dL, or a random blood sugar level of \>200 mg/dL. Patients were classified as hypertensive if they had been taking anti-hypertensive medication for at least 6 months or if clinical evidence of blood pressure greater than 140/90 was found on at least two separate occasions at least two hours apart. All patients were randomly divided into two equal groups (A and B) by using the sealed envelope technique. All surgeries were done under standard general anesthesia. Patients were induced with propofol (2 mg/kg) and premedicated with fentanyl. Endotracheal intubation was facilitated by the muscle relaxant atracurium 0.5 mg/kg. Anesthesia was maintained with 50% O2, 50% air, 1 MAC isoflurane, and atracurium. The patients were mechanically ventilated to keep ETCO2 between 35 and 40 mmHg. In Group A, patients received an intravenous injection of 800 mg of Ibuprofen, while intravenous ketorolac (30 mg) was given to patients in Group B, approximately 30 minutes before the skin closure. All patients were extubated and transferred to the post-anesthesia care unit (PACU). The durations of the surgical procedure and anesthesia were documented. Another anesthesiologist on duty was deputed for follow-up with the patients. The patients were kept blind to the type of analgesic drug they received. The postoperative pain was measured by VAS at 3, 6, and 12 hours postoperatively. The VAS ranged from 0 to 10, with 0 representing no pain and 10 representing the maximum bearable pain. When the VAS score was \> 4, the injection Tramadol 30 mg was given intravenously as a rescue analgesic. The frequency of patients requiring rescue analgesia, the time to start rescue analgesia, and the total dose of drug during the 12-hour postoperative period were noted in each group.
Statistical analysis: The data was analyzed by IBM, SPSS Version 20 registered for Microsoft Windows. The mean, standard deviation, and frequency/percentages were calculated for quantitative and qualitative data, respectively. Chi square and independent sample t-tests were used to compare postoperative analgesic parameters between both groups. The p value of \<0.05 was taken as statistically significant.
#Intervention
- DRUG : Ibuprofen 800 mg
- Intravenous injection of ibuprofen 800 mg
- DRUG : Ketorolac Injection
- Intravenous injection of Ketorolac 30 mg
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients of either gender undergo orthopedic surgery were included in the study.
* ASA <= 2
* Age 40 <= age <= 80 years.
* Fracture Radius , Ulna, and wrist
Exclusion Criteria:
* Patients with history of adverse response from ketorolac and ibuprofen was not taken into the study.
* Patients with history of epilepsy.
* Patients with history of cardiac conduction defects.
* Patients on antiarrhythmic drugs or analgesics.
* Patients with H/O stroke, renal impairment, chronic obstructive pulmonary disease, asthma, chronic liver disease, hypothyroidism and CCF were excluded.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05695664
| 107,401 |
{
"NCT_ID" : "NCT02464163",
"Brief_Title" : "Trial to Evaluate the Immunogenicity and Safety of Panblok® (H7 rHA) in Healthy Adults Aged 18 and Older",
"Official_title" : "Phase 1/2 Adaptive Design Trial to Evaluate the Immunogenicity and Safety of Panblok (H7 rHA) at Three Dose Levels Adjuvanted With a Stable Oil-in-Water Emulsion Compared With Unadjuvanted H7 rHA in Healthy Adults Aged 18 and Older",
"Conditions" : ["Influenza"],
"Interventions" : ["Biological: rHA adjuvant", "Biological: Panblok"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-08",
"Study_Completion_Date(Actual)" : "2016-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-06-01",
"First_Submitted_that_Met_QC_Criteria" : 2017-09-26",
"First_Posted(Estimated)" : 2015-06-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-06-04",
"Last_Update_Posted(Estimated)" : 2017-10-26",
"Last_Verified" : 2017-09"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Anhui/1/2013 (H7N9) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an unadjuvanted rHA formulation.
Detailed Description
All currently licensed influenza vaccines in the United States are produced in embryonated hen's eggs. There are several well-recognized disadvantages to the use of eggs as the substrate for influenza vaccine. Eggs require specialized manufacturing facilities and could be difficult to scale up rapidly in response to an emerging need such as a pandemic. It is usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs, a process that can be time consuming, is not always successful, and can select receptor variants that may have suboptimal immunogenicity. In addition, agricultural diseases that affect chicken flocks, and that might be an important issue in a pandemic due to an avian influenza virus strain, could easily disrupt the supply of eggs for vaccine manufacturing. Therefore, development of alternative substrates for influenza vaccine production has been identified as a high-priority objective.
One potential alternative method for production of influenza vaccine is expression of the influenza virus hemagglutinin (HA) using recombinant DNA techniques. This alternative avoids dependence on eggs and is very efficient because of the high levels of protein expression under the control of the baculovirus polyhedrin promoter.
#Intervention
- BIOLOGICAL : Panblok
- Intramuscular injection
- Other Names :
- recombinant hemagglutinin, rHA
- BIOLOGICAL : rHA adjuvant
- Intramuscular injection
- Other Names :
- SE
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults, regardless of gender, aged 18 years and above
* Able to give written informed consent to participate.
* Body temperature <100.0ºF.
* The subject must be in reasonably good health as determined by targeted physical examination, when necessary, based on medical history.
* Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test within 24 hours preceding receipt of first and second vaccine doses.
* Women are considered not of child-bearing potential if they are:
* Surgically sterile
* Menopausal, defined as no natural menses for >=12 months
* Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits and remote contacts.
Exclusion Criteria:
* Persons who previously received an H5N1 or H7N9 influenza vaccine or who plan to receive an H5N1or H7N9 influenza vaccine while participating in the study.
* Persons who plan to receive a seasonal influenza vaccine earlier than Day 42 of participation in this study, i.e. before the post-vaccination serology sample is obtained.
* Persons with an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of immune responses.
* Persons taking medications or treatments that may adversely affect the immune system, e.g. cytotoxic agents, immunosuppressive doses of corticosteroids, anti-TNFα agents.
* Persons with an active neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) or a history of any hematological malignancy. For this criterion, 'active' is defined as having received treatment within the past 5 years.
* Persons with a history of documented autoimmune disease.
* Women currently pregnant, nursing mothers or women planning a pregnancy between enrollment and 42 days after randomization.
* Persons who have had a prior serious reaction to any influenza vaccine.
* Persons with a known history of Guillain-Barré Syndrome (GBS).
* Persons with a history of anaphylactic-type reaction to injected vaccines.
* Persons with a history of illicit drug use or alcohol abuse that may compromise the subject's ability to comply with the protocol.
* Persons who received a seasonal influenza vaccine < 6 months prior to enrollment (may delay enrollment).
* Persons who received any licensed inactivated or recombinant (non-live) vaccine within 2 weeks prior to enrollment or any licensed live vaccine within 1 month prior to enrollment (may delay enrollment) (See separate exclusion criteria #1 and #12 for seasonal and H5N1 influenza vaccines.)
* Persons who have had an acute illness or fever (>38º C or >100º F) within three days prior to study enrollment (enrollment may be delayed for full recovery, if acceptable to investigator).
* Persons currently participating or planning to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, or medication) or have received an experimental agent within 1 month prior to enrollment in this study, or who expect to receive another experimental agent during participation, or intend to donate blood during the 42-day primary study period.
* Persons who received immunoglobulin or another blood product within the 3 months prior to enrollment in this study. Persons who expect to receive immunoglobulin or another blood product during the 42-day primary period of this study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02464163
| 56,802 |
{
"NCT_ID" : "NCT00467883",
"Brief_Title" : "Pilot Study of High Dose Liposomal Amphotericin B Efficacy in Initial Zygomycosis Treatment",
"Official_title" : "AMBIZYGO: Efficacy of High Dose [10 mg/kg/j] Liposomal Amphotericin B (Ambisome)Efficacy in Initial Zygomycosis Treatment:Phase II Trial",
"Conditions" : ["Zygomycosis"],
"Interventions" : ["Drug: Liposomal Amphotericin B"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-06",
"Study_Completion_Date(Actual)" : "2013-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-04-30",
"First_Posted(Estimated)" : 2007-05-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-04-30",
"Last_Update_Posted(Estimated)" : 2014-07-18",
"Last_Verified" : 2014-07"
}
}}
|
#Study Description
Brief Summary
Evaluation after 4 weeks of treatment or at end of treatment if it occurs before. Efficacy will be defined as objective responses; complete and partial response.
Detailed Description
Primary objective: Efficacy of 4 weeks of liposomal amphotericin B (AmBisome®) at high dose \[10 mg/kg/j\] or at maximal tolerable dose in initial zygomycosis treatment. Evaluation after 4 weeks of treatment or at end of treatment if it occurs before. Efficacy will be defined as objective responses; complete and partial response.
Secondary objectives: Efficacy, tolerance and survival after 15 days of treatment, cumulative dose of AmBisome® necessary to obtain objective response, efficacy in operated and non operated patients, tolerance after 4 and 12 weeks treatment, survival, and relapse rate at 6 months of 4 weeks of liposomal amphotericin B (AmBisome®) at high dose \[10 mg/kg/j\] or at maximal tolerable dose.
Scheme : prospective, multicentric, non comparative therapeutic pilot study.
Inclusion criteria: Presence on a tissue biopsy of large non septated hyphae compatible with zygomycete or presence of a zygomycete in culture associated with clinical or radiological abnormalities compatible with fungal invasive infection.
Exclusion criteria: Life expectancy below 72 hours, pregnancy, breast feeding, polyene hypersensitivity, absence of histologic or mycologic zygomycosis documentation, absence of informed consent, previous treatment with polyene or other antifungal active on zygomycete (posaconazole, itraconazole) over 5 days during the month previous inclusion.
Treatment : AmBisome® 10 mg/kg/j monotherapy during at least 15 days, then AmBisome® at maximal tolerable dose during 15 days associated with early optimal surgical treatment. After the first treatment month, following treatment is decided by referent physician.
#Intervention
- DRUG : Liposomal Amphotericin B
- high dosage
- Other Names :
- high dosage
|
#Eligibility Criteria:
Inclusion Criteria:
* Presence on a tissue biopsy of large non septated hyphae compatible with zygomycete
* Presence of a zygomycete in culture associated with clinical or radiological abnormalities compatible with fungal invasive infection.
Exclusion Criteria:
* Life expectancy below 72 hours,
* Pregnancy, breast feeding,
* Polyene hypersensitivity,
* Absence of histologic or mycologic zygomycosis documentation,
* Absence of informed consent,
* Previous treatment with polyene or other antifungal active on zygomycete (posaconazole, itraconazole) over 5 days during the month previous inclusion
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00467883
| 261,209 |
{
"NCT_ID" : "NCT01222468",
"Brief_Title" : "Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons",
"Official_title" : "A Randomized Double-Blinded Crossover Trial Assessing the Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons",
"Conditions" : ["Muscle Spasticity as a Result of Spinal Cord Injury"],
"Interventions" : ["Drug: nabilone 0.5 mg", "Drug: placebo"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-02",
"Study_Completion_Date(Actual)" : "2015-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-10-14",
"First_Posted(Estimated)" : 2010-10-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-10-15",
"Last_Update_Posted(Estimated)" : 2015-02-25",
"Last_Verified" : 2015-02"
}
}}
|
#Study Description
Brief Summary
This study is being conducted to study the effect of nabilone (a synthetic cannabinoid)on spasticity in spinal cord injured persons.The study will be a phase 2, randomized, placebo-controlled crossover study. Each eligible subject will participate for 26 weeks.Subjects will be randomized to receive either nabilone or placebo during phase 1 of the study. Study drug will be titrated up from 0.5mg daily to a maximum of 3.0 mg daily over the first 11-week phase. Following a 4-week washout period, subjects will be crossed-over to the opposite arm for another 11 week treatment period (phase 2).
#Intervention
- DRUG : nabilone 0.5 mg
- nabilone 0.5 mg tablets od titrated to a maximum daily dose of 3mg po over an 11-week phase
- Other Names :
- Cesamet
- DRUG : placebo
- placebo 0.5 mg po daily, dose titrated to a maximum daily dose of 3.0mg po over an 11-week phase
|
#Eligibility Criteria:
Inclusion Criteria:
* Spinal Cord Injury
* 12 months post -injury
* C2-T12, ASIA A-D, stable level of injury
* moderate to severe spasticity or moderate to severe neuropathic pain
* no cognitive impairment
* spasticity medications unchanged for at least 30 days or inadequate pain control at a stabilized dose of either gabapentin or pregabalin for at least 30 days
* no botulinum toxin injections x 6 months
Exclusion Criteria:
* significant cardiovascular disease
* major illness in another body area
* history of psychological disorders or predisposition to psychosis
* sensitivity to cannabinoids
* severe liver disfunction
* history of drug dependancy
* fixed tendon contractures
* used cannabis in the past 30 days
* unwilling to refrain from smoking cannabis during the study
* pregnant or nursing mother
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01222468
| 114,922 |
{
"NCT_ID" : "NCT01696656",
"Brief_Title" : "Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency",
"Official_title" : "Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency",
"Conditions" : ["Intestinal Insufficiency", "Short Bowel Syndrome"],
"Interventions" : ["Drug: Drug prescription pattern"],
"Location_Countries" : ["Brazil"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-09",
"Study_Completion_Date(Actual)" : "2012-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-09-27",
"First_Posted(Estimated)" : 2012-10-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-09-28",
"Last_Update_Posted(Estimated)" : 2012-10-01",
"Last_Verified" : 2012-09"
}
}}
|
#Study Description
Brief Summary
Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and symptom-relieving agents may be required. Prescriptional pattern of these drugs will be analyzed in a clinical cohort.
Detailed Description
Intestinal insufficiency due to short bowel syndrome is a chronic, disabling condition with significant morbidity and mortality.Standard care includes home parenteral/enteral nutrition as well as intestinal transplantation, however multiple drugs, vitamins, antibiotics and symptom-relieving agents may be required. Little attention has been given to the indications and dosage schedules of such drugs, many of which are employed as off-label prescriptions because of lack of official guidelines.
Prescriptional patterns of these drugs will be analyzed in a clinical cohort of home parenteral/enteral nutrition patients, registered at the outpatient service of Hospital das Clinicas, Sao Paulo, Brazil.
#Intervention
- DRUG : Drug prescription pattern
- Type, dosage, administration route and frequency of prescription of all adjuvant pharmacologic agents will be transcribed from hospital records
- Other Names :
- Gastrointestinal drugs, Antibiotics, Vitamins, Minerals, General drugs
|
#Eligibility Criteria:
Inclusion Criteria: Home nutritional support longer than 12 months,full records and return visits available at the hospital system.
*
Exclusion Criteria: Critical illness, death, discontinuation of nutritional therapy, registered for intestinal transplantation, additional gastrointestinal operations for short bowel syndrome (valves, lengthening) or for other conditions (gallbladder disease, intestinal obstruction, necrosis, infection).
*
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01696656
| 213,113 |
{
"NCT_ID" : "NCT01132586",
"Brief_Title" : "Lenalidomide, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia",
"Official_title" : "Phase I Study of Lenalidomide and Conventional Chemotherapy in Acute Myeloid Leukemia",
"Conditions" : ["Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome", "Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11", "Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11", "Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1", "Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL", "Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA", "Alkylating Agent-Related Acute Myeloid Leukemia", "de Novo Myelodysplastic Syndrome", "Previously Treated Myelodysplastic Syndrome", "Recurrent Adult Acute Myeloid Leukemia", "Secondary Acute Myeloid Leukemia", "Secondary Myelodysplastic Syndrome", "Untreated Adult Acute Myeloid Leukemia"],
"Interventions" : ["Other: Laboratory Biomarker Analysis", "Drug: Cytarabine", "Other: Pharmacological Study", "Drug: Idarubicin", "Drug: Lenalidomide"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-01",
"Study_Completion_Date(Actual)" : "2014-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-05-26",
"First_Posted(Estimated)" : 2010-05-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-05-26",
"Last_Update_Posted(Estimated)" : 2014-12-23",
"Last_Verified" : 2014-11"
}
}}
|
#Study Description
Brief Summary
This phase I trial studies the side effects and best dose of lenalidomide when given together with cytarabine and idarubicin in treating patients with acute myeloid leukemia. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cytarabine and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cytarabine and idarubicin may kill more cancer cells.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of lenalidomide in combination with conventional chemotherapy in two separate cohorts of patients with 1) relapsed or refractory acute myeloid leukemia (AML) and 2) age \>= 60 with untreated AML and recommend starting doses for phase II studies of this combination of agents.
SECONDARY OBJECTIVES:
I. To define the qualitative and quantitative toxicities of these combinations of agents in regard to organ specificity, time course, predictability, and reversibility.
II. To document the therapeutic response of these combinations of agents in patients with poor risk AML.
III. To conduct pharmacodynamic studies to investigate the potential mechanism of lenalidomide activity in this trial.
OUTLINE: This is a dose-escalation study of lenalidomide.
INDUCTION:
COHORT I: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21, cytarabine intravenously (IV) continuously over 96 hours on days 5-8, and idarubicin IV over 1 hour on days 5-7.
COHORT II: Patients receive lenalidomide PO QD on days 1-21, cytarabine IV continuously over 24 hours on days 5-11, and idarubicin as above.
Patients with residual disease on day 18 undergo a second course of induction therapy.
CONSOLIDATION:
COHORT I: Patients receive lenalidomide PO QD on days 1-14, idarubicin IV over 1 hour on days 5-6, cytarabine IV continuously on days 5-7. Treatment continues for 1 course in the absence of disease progression or unacceptable toxicity.
COHORT II: Patients 2 receive 4 courses of consolidation therapy comprising lenalidomide PO QD on days 1-14 and cytarabine IV every 12 hours on days 5, 7, and 9. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
#Intervention
- DRUG : Lenalidomide
- Given PO
- Other Names :
- CC-5013, CC5013, CDC 501, IMiD-1
- DRUG : Cytarabine
- Given IV
- Other Names :
- CHX-3311, U-19920
- DRUG : Idarubicin
- Given IV
- Other Names :
- Idamycin, IMI-30, SC-33428, Zavedos
- OTHER : Pharmacological Study
- Correlative studies
- Other Names :
- pharmacological studies
- OTHER : Laboratory Biomarker Analysis
- Correlative studies
|
#Eligibility Criteria:
Inclusion Criteria:
* Cohort 1: Patients must be age >= 18 and < 65 with relapsed or refractory AML or high risk myelodysplastic syndrome (MDS); high risk MDS is defined as international prognosis scoring system (IPSS) score of 1.5 or higher; eligible patients will have a score of 1.5 or higher at any time from diagnosis to screening
* Cohort 2: Patients must be age >= 18 with previously untreated AML; favorable risk AML patients < 60 years are excluded; these are defined as core binding factor (CBF) AML patients and characterized by cytogenetic or molecular evidence of CBF leukemia; untreated AML patients < 60 years must be negative on screening for CBF leukemia by cytogenetic or molecular analysis (Note: Prior therapy for MDS is permitted)
* Patients with secondary AML or therapy-related disease (transformed [t]-AML/MDS) are eligible
* If the patient has co-morbid medical illness, life expectancy attributed to this must be greater than 6 months
* Eastern Cooperative Oncology Group (ECOG) performance status =< 2
* Total bilirubin < 2.0 mg/dL
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 times upper limit of normal
* Creatinine < 2.0 mg/dL AND creatinine clearance (calculated) >= 50 mL/min
* Left ventricular ejection fraction (LVEF) >= 40%
* Patients who have previously received lenalidomide, idarubicin, and/or cytarabine are eligible provided that the combination of the 3 agents has never before been administered, and that no lenalidomide has been administered for at least 6 months
* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a minimum sensitivity of at least 25 mIU/mL within 10 <= age <= 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; these methods of birth control must be used for the duration of study participation and for 28 days after lenalidomide discontinuation; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
* Ability to understand and willingness to sign the written informed consent document
Exclusion Criteria:
* Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Patients who have taken lenalidomide within the last 6 months
* Patients receiving any other investigational agents or patients that have received other investigational agents within 14 days of enrollment
* Patients with active central nervous system disease or with granulocytic sarcoma as sole site of disease
* Patients with history of medically serious allergic reactions or non-hematologic toxicities attributed to the agents in this trial such as lenalidomide or thalidomide or compounds of similar chemical or biologic composition that are not easily managed, or patients with a history of cerebellar toxicity to cytarabine
* Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; patients with medical comorbidities that will preclude safety evaluation of the combination should not be enrolled
* Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study
* Pregnant women or women who are breastfeeding; additional pregnancy testing before, during, and after lenalidomide treatment is required, as well as requirements for contraception before, during, and after lenalidomide treatment
* Patients with advanced malignant solid tumors are excluded; patients with active additional hematologic malignancies are excluded
* Patients with a history of neurologic toxicity with cytarabine are excluded
* As infection is a common feature of AML, patients with active infection are permitted to enroll provided that the infection is under control; patients with uncontrolled infection shall not be enrolled until infection is treated and brought under control
* Known human immunodeficiency virus (HIV)-positive patients are ineligible; appropriate studies will be undertaken in HIV + patients once safety of the combination has been demonstrated
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
|
NCT01132586
| 81,412 |
{
"NCT_ID" : "NCT05287620",
"Brief_Title" : "Objective, Passive Assessment of LRRK2 Carriers",
"Official_title" : "Objective, Passive Assessment of LRRK2 Carriers",
"Conditions" : ["Parkinson Disease"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-04-27",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-05-07",
"Study_Completion_Date(Actual)" : "2024-05-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-03-09",
"First_Posted(Estimated)" : 2022-03-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-03-09",
"Last_Update_Posted(Estimated)" : 2024-06-28",
"Last_Verified" : 2024-06"
}
}}
|
#Study Description
Brief Summary
The goal of this project is to identify objective, sensitive, and convenient measures for assessing early signs of Parkinson's disease in an at-risk population at home. We will do so by using a wireless sensor and analyzing the radio signals that bounce off patients' bodies, while patients go about their normal life without needing to wear sensors, answer questionnaires, or actively perform any tests.
#Intervention
- DEVICE : Emerald device
- The Emerald device is a wireless sensor that can track the motion, breathing, and sleep of participants without touching or requiring any interaction with the participants, allowing them to go about their normal lives. The Emerald device operates by transmitting and receiving low power radio signals that reflect off of the participant and return back to the device. The power of these signals is 1,000 times lower than what a typical Wi-Fi device transmits. The ability of the device to monitor gait, breathing, sleep, and other metrics has been validated and documented. Studies of the Emerald device in individuals with Parkinson's disease, Alzheimer's disease, and rare diseases have demonstrated the feasibility of monitoring at home and the ability to characterize gait, breathing, and sleep in these populations specifically. In this study, the Emerald device will be used to characterize the mobility, breathing and sleep of the participant.
|
#Eligibility Criteria:
Inclusion Criteria:
* At least 50 years
* Able and willing to provide informed consent
* English fluency
* U.S. resident
* LRRK2 G2019S gene carrier, determined by participation in VALOR-PD
* Mild parkinsonian signs, determined by modified Movement Disorder Society-Unifeid Parkinson's Disease Rating Scale (MDS-UPDRS) score from the most recent VALOR-PD visit
* Have WiFi in their residence
* Access to a smartphone or tablet
Exclusion Criteria:
* Inability to complete study activities, as determined by the study team
* Any medical or psychiatric condition that, in the study team's judgement, would preclude participation
* Self-reported or VALOR-PD investigator determined Parkinson's disease
* Any movement disorder (e.g. essential tremor)
* Currently taking neuroleptics or other drugs known to cause parkinsonism
* Pregnancy
* Non-ambulatory status
* More than one ambulatory pet in the household*
* More than two individuals in the household (not including participant)*
* these criteria can be waived at the discretion of the investigators
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05287620
| 4,820 |
{
"NCT_ID" : "NCT04388787",
"Brief_Title" : "Investigating the Effect of Stochastic Resonance Vibration on Gait and Balance and Upper Extremity Function in Children With Cerebral Palsy",
"Official_title" : "Investigating the Effect of Stochastic Resonance Vibration on Gait and Balance and Upper Extremity Function in Children With Cerebral Palsy",
"Conditions" : ["Cerebral Palsy"],
"Interventions" : ["Device: Stochastic resonance (SR) wraps"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-07-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-11-14",
"Study_Completion_Date(Actual)" : "2020-11-14},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-05-13",
"First_Submitted_that_Met_QC_Criteria" : 2022-01-11",
"First_Posted(Estimated)" : 2020-05-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-05-13",
"Last_Update_Posted(Estimated)" : 2022-01-18",
"Last_Verified" : 2022-01"
}
}}
|
#Study Description
Brief Summary
The purpose of this research study is to determine the effects of wearable vibration devices for children with cerebral palsy and impaired arm function.
Detailed Description
Vibration devices have been used by some patients with cerebral palsy during therapy sessions. Researchers believe they have the potential to be even more useful for everyday use, and are doing this study to learn more about what they can do.
Participate in this study will be asked to complete assessments that test arm motion, muscle tone, motor control, and sensory function. They will then be asked to wear a wristband on each wrist and on their shoulder. These wristbands contain vibrators that can vibrate at different levels. The vibrations are caused by a low-level of sound waves that people may barely be able to hear. While wearing the vibration devices on the wrist and shoulder, participants will be asked to perform two tasks. The first task is called the box and blocks test, which consists of transferring wooden blocks from one box to another. The second test is called the Shriners upper extremity evaluation (SHUEE). In this test participants will perform a series of fine motor tasks with their hands. The SHUEE test will be video recorded for scoring by a study therapist at a later time on how much and how well participants use their impaired arm to perform the tasks. Participants will be asked to complete the box and blocks test and the SHUEE test 3 times. Participation in this study will be one single visit and last approximately an hour to an hour and a half.
#Intervention
- DEVICE : Stochastic resonance (SR) wraps
- SR wraps will be applied to the one or both wrists depending on whether the impairment is unilateral or bilateral. Two additional actuators will be secured around the shoulder. The threshold for detection of SR will be determined by the examiner prior to initiating the test condition. The intensity of the stimulation is adjustable with a scroll bar on the app and ranges from a 0 - 100. The examiner will gradually increase the stimulus intensity until the participant reports being able to feel it. This will set the participant's detection threshold.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with cerebral palsy
* 3 years to 18 years
* Able to reliably express pain, discomfort or fear as reported by the parent/guardian
* Manual ability classification scale (MACS) levels I, II or III
Exclusion Criteria:
* Any unstable medical condition. An unstable medical condition is a state of imminent threat to life such as shock, acute asthma, respiratory distress, severe infection and sepsis. Any patient in a clinic or therapy center presenting with signs and symptoms of an unstable medical condition will be directed to emergency medical services
* Any medical condition preventing active rehabilitation reported by the parent/guardian such as:
o Thromboembolic disease, acute progressive neurological disorder, cardiovascular or pulmonary contraindications, aggressive behavior, severe cognitive deficits, joint instabilities and compromised bone health, recent or non-consolidated fractures, osteoporosis
* Subjects with cardiac pacemakers, electronic pumps or any other implanted medical devices
* Skin lesions affecting the areas where the device straps will be attached to the body
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04388787
| 246,733 |
{
"NCT_ID" : "NCT04253353",
"Brief_Title" : "A Drug-Drug Interaction Study To Estimate The Effect Of Tafamidis On Rosuvastatin Pharmacokinetics",
"Official_title" : "A PHASE 1, OPEN LABEL, TWO-PERIOD, TWO-TREATMENT, FIXED-SEQUENCE STUDY TO ESTIMATE THE EFFECT OF A MULTIPLE ORAL DOSE OF TAFAMIDIS ON ROSUVASTATIN PHARMACOKINETICS IN HEALTHY PARTICIPANTS",
"Conditions" : ["Healthy Volunteers"],
"Interventions" : ["Drug: tafamidis", "Drug: rosuvastatin"],
"Location_Countries" : ["Belgium"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "NA",
"Interventional_Model" : "SEQUENTIAL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-02-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-08-10",
"Study_Completion_Date(Actual)" : "2020-08-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-01-31",
"First_Posted(Estimated)" : 2020-02-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-01-31",
"Last_Update_Posted(Estimated)" : 2020-09-10",
"Last_Verified" : 2020-09"
}
}}
|
#Study Description
Brief Summary
Each subject will be given a single oral dose of rosuvastatin on Day 1 in Period 1. In Period 2, after a washout period of at least 5 days, each subject will receive oral doses of tafamidis twice daily (BID) on days 1 and 2, followed by tafamidis once daily (QD) on days 3 to 9 with an oral dose of rosuvastatin on Day 7. Rosuvastatin exposures will be compared between Periods 1 and 2 to estimate the effect of tafamidis on rosuvastatin PK in healthy subjects.
#Intervention
- DRUG : tafamidis
- 61 mg capsule
- Other Names :
- Vyndaqel
- DRUG : rosuvastatin
- 10 mg tablet
- Other Names :
- Crestor
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female participants must be 18 <= age <= 60 of age, inclusive, at the time of signing the informed consent document (ICD)
* Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiovascular tests
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* History of hypersensitivity to rosuvastatin., asymptomatic, seasonal allergies at the time of dosing).
* Use of CYP2C19 inhibitors (eg, fluconazole, fluoxetine, fluvoxamine, ticlopidine omeprazole, voriconazole, cimetidine, esomeprazole, and felbamate) or inducers (eg, rifampin, ritonavir, efavirenz, enzalutamide, phenytoin, and St. John's Wort) within 28 days or 5 half-lives (whichever is longer) prior to dosing.
* Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or other inducers (eg, phenytoin, carbamazepine) within 28 days or 5 half-lives (whichever is longer) prior to dosing
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
|
NCT04253353
| 245,812 |
{
"NCT_ID" : "NCT02838004",
"Brief_Title" : "Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens",
"Official_title" : "An Open Label, Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus",
"Conditions" : ["Cataract", "Presbyopia"],
"Interventions" : ["Device: IOL MINI WELL READY"],
"Location_Countries" : ["Germany"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-10",
"Study_Completion_Date(Actual)" : "2017-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-07-12",
"First_Posted(Estimated)" : 2016-07-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-07-15",
"Last_Update_Posted(Estimated)" : 2020-01-14",
"Last_Verified" : 2020-01"
}
}}
|
#Study Description
Brief Summary
This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.
Detailed Description
To evaluate if the positive results (to assure a good visual acuity at all distances and a good quality of life in terms of glasses independence and absence of undesired events), obtained experimentally using the IOL MINI WELL READY, can be confirmed in the practical surgical routine with a population belonging to different EU countries
#Intervention
- DEVICE : IOL MINI WELL READY
- IOL MINI WELL READY
|
#Eligibility Criteria:
Inclusion Criteria:
* Any gender and age above 18 years.
* Refractive lens exchange (RLE) or cataract surgery.
* Healthy corneas, not treated surgically.
* Patients willing to have surgery in both eyes in a short period of time (within 2 weeks).
* Patients request to receive the IOL MINI WELL READY implant
Exclusion Criteria:
* Previous corneal surgery (i.e. pterygium, refractive surgery).
* Eye diseases determining a probable postoperative visual acuity < 20/40.
* Pseudoexfoliation.
* Abnormal pupil size and position.
* Use of contact lens 30 days before the preoperative visit.
* Corneal warpage.
* Predicted postoperative corneal astigmatism higher than 1 D.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02838004
| 119,213 |
{
"NCT_ID" : "NCT05086822",
"Brief_Title" : "A Study of Irinotecan Hydrochloride Liposome in Advanced Solid Tumors",
"Official_title" : "A Phase Ia Study on Tolerability and Pharmacokinetics of Irinotecan Hydrochloride Liposome Alone in Patients With Advanced Solid Tumors",
"Conditions" : ["Advanced Solid Tumors"],
"Interventions" : ["Drug: Irinotecan liposome"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-09-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-08-28",
"Study_Completion_Date(Actual)" : "2017-08-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-09-29",
"First_Posted(Estimated)" : 2021-10-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-10-12",
"Last_Update_Posted(Estimated)" : 2021-10-21",
"Last_Verified" : 2021-09"
}
}}
|
#Study Description
Brief Summary
This is an open label, dose-escalation and expansion, single centre, phase Ia study . In this study, the tolerability, safety, pharmacokinetics and efficacy of irinotecan hydrochloride liposome injection were studied in patients with advanced solid tumors, to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan hydrochloride liposome.
#Intervention
- DRUG : Irinotecan liposome
- Irinotecan liposome
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed solid tumors documented as advanced or metastatic disease;
* Subjects must be considered relapsed or refractory to standard therapies, have been intolerant to standard therapies, or have refused standard therapy;
* ECOG: 0 <= age <= 1;
* Adequate organ and bone marrow function;
* sign an informed consent.
Exclusion Criteria:
* Patients with brain malignant tumor, lymphoma or other malignant hematologic diseases;
* Active CNS metastasis;
* Clinically significant GI disorders;
* Significant cardiovascular disease;
* Active infection or uncontrolled fever;
* Pregnant or breast feeding patients;
* Allergic to a drug ingredient or component;
* The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05086822
| 55,428 |
{
"NCT_ID" : "NCT06154460",
"Brief_Title" : "The Effects of Different Surgical Stabilization Methods in Recurrent Anterior Shoulder Instability",
"Official_title" : "Comparison of Different Surgical Stabilization Methods for Recurrent Anterior Shoulder Instability in Terms of Pain, Proprioceptive Sense, Functional Status, and Muscle Activation",
"Conditions" : ["Surgery", "Anterior Shoulder Instability"],
"Interventions" : ["Procedure: Reimplissage Surgery", "Procedure: Capsular Reconstruction", "Procedure: Laterjet Surgery"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-12-18",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-05-10",
"Study_Completion_Date(Actual)" : "2024-06-29},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-11-02",
"First_Posted(Estimated)" : 2023-12-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-11-23",
"Last_Update_Posted(Estimated)" : 2024-08-09",
"Last_Verified" : 2024-08"
}
}}
|
#Study Description
Brief Summary
Shoulder instability is the inability to retain the humeral head in the glenoid fossa. The incidence of instability is 8.2 to 23.9 per 100,000 person-years with an estimated prevalence of 1.7%. The most common shoulder instability with a rate of 98% is anterior dislocation, in which the humeral head is displaced anterior to the glenoid. Conservative and surgical treatments of instability are available. There are many controversial issues related to these methods in the literature. For example; an atrophy and functional loss in the infraspinatus after reimplissage, atrophy and loss of proprioception in the muscles around the shoulder after capsular repair, and loss of proprioception after the laterjet procedure have been reported.Therefore, the aim of this study was to compare different surgical stabilization methods in terms of pain, proprioceptive sensation, functional status and muscle activation in recurrent anterior shoulder instability, which is very common in adults.
Detailed Description
Shoulder instability is the inability to retain the humeral head in the glenoid fossa. The incidence of instability is 8.2 to 23.9 per 100,000 person-years with an estimated prevalence of 1.7%. The most common shoulder instability with a rate of 98% is anterior dislocation, in which the humeral head is displaced anterior to the glenoid. It is more common in young males. While damage is limited to the capsule and labrum in most instabilities seen in young people, rotator cuff tear is also observed in 89% of those over 40 years of age. Trauma is the main cause of shoulder instability. While 96% of shoulder instabilities develop as a result of a blow to the arm in abduction or external rotation of the shoulder with excessive flexion, approximately 4% occur without trauma. Anterior instability occurs when the shoulder is forced into abduction and external rotation by impact, and posterior instability occurs when the shoulder in slight flexion and adduction is hit. The glenohumeral joint is an unstable joint because the depth and size of the glenoid fossa are not fully compatible with the humerus and as a result, the range of motion is wider compared to other joints in the body. While articular surface congruence, articular version, glenoid labrum, capsule and ligaments constitute static factors in ensuring stability; rotator cuff, biceps tendon, intra-articular negative pressure and muscles that form scapulothoracic movements (Trapezoid, Serratus Anterior, Rhomboids, Latissimus Dorsi) constitute dynamic factors. Insufficiency of one or more of these structures causes instability. Conservative and surgical treatments of instability are available. Conservative treatment includes nonoperative methods. These methods consist of electrophysical agents, heat-light agents, exercise and manual treatment methods and proceed through a certain protocol according to the patient's condition and symptoms. In cases where medical and physical therapies are not sufficient, surgical treatment procedures are initiated.
Reimplisasagge, capsular reconstruction and laterjet methods are commonly used in surgical treatments. Reimplissagge operation, which means 'to fill', is an open procedure designed to limit the engagement of Hill-Sachs deformity by passing the infraspinatus into the Hill-Sachs defect. The possibility of loss of internal and external rotation as a result of infraspinatus tendon transfer after reimplissage is a matter of debate. Allografts or autografts are used for capsular reconstruction, which is another surgical method. In the procedure performed with capsular repair and grafts, the capsule is strengthened and stabilization is attempted. The laterjet procedure is an operation in which the coracoid process is transferred to the glenoid rim with a screw.
There are many controversial issues related to these methods in the literature. For example; an atrophy and functional loss in the infraspinatus after reimplissage, atrophy and loss of proprioception in the muscles around the shoulder after capsular repair, and loss of proprioception after the laterjet procedure have been reported. Therefore, the aim of our study was to compare these commonly applied methods in terms of pain, proprioceptive sensation, functional status and muscle activation and the hypothesis of the study was as follows; Hypothesis of the Study: Laterjet, reimplissage and capsular reconstruction surgical procedures in recurrent anterior shoulder instabilities affect pain, proprioceptive sensation, functional status and muscle activation differently.
#Intervention
- PROCEDURE : Laterjet Surgery
- The laterjet procedure is an operation in which the coracoid process is transferred to the glenoid rim with a screw.
- Other Names :
- LS
- PROCEDURE : Reimplissage Surgery
- Reimplissagge operation, which means 'to fill', is an open procedure designed to limit the engagement of Hill-Sachs deformity by passing the infraspinatus into the Hill-Sachs defect.
- Other Names :
- RS
- PROCEDURE : Capsular Reconstruction
- Allografts or autografts are used for capsular reconstruction. In the procedure performed with capsular repair and grafts, the capsule is strengthened and stabilization is attempted
- Other Names :
- CR
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 years or older,
* At least 4 months after surgery,
* Not having any diagnosed neurological problem
Exclusion Criteria:
* Having an additional diagnosis that would cast doubt on the assessments (rheumatoid arthritis, cancer, neurological disorders, fibromyalgia, psychiatric disorders, etc.),
* Pregnancy status or suspicion
* Having undergone a different surgery such as a fracture with instability.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06154460
| 51,668 |
{
"NCT_ID" : "NCT01932619",
"Brief_Title" : "The Influence of Storage Container and Defrost Process on Components in Breast Milk",
"Official_title" : "The Influence of Storage Container and Defrost Process on Components in Breast Milk",
"Conditions" : ["Human Milk"],
"Location_Countries" : ["Taiwan"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-04",
"Study_Completion_Date(Actual)" : "2013-04},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-08-21",
"First_Posted(Estimated)" : 2013-08-30"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-08-27",
"Last_Update_Posted(Estimated)" : 2013-08-30",
"Last_Verified" : 2013-08"
}
}}
|
#Study Description
Brief Summary
Breast milk is best food for neonates and preterm infants. However many handling would be done if direct breastfeeding is not feasible, and it may result in nutrients change in human milk. We investigate the influence of storage in different containers and different thawing or heating methods on human milk nutrients.
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy mothers lactating during first year of their babies and have sufficient milk to donate
Exclusion Criteria:
* mothers who have insufficient milk for their babies
* mothers have major disease or on specific diet or drug which would affect breast milk composition
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:
Yes
|
NCT01932619
| 189,431 |
{
"NCT_ID" : "NCT03553199",
"Brief_Title" : "Study on a New Endoscopic Platform for the ESD of Colorectal Lesions: Tissue Retraction System",
"Official_title" : "Pilot Study on a New Endoscopic Platform for the ESD of Colorectal Lesions: Tissue Retraction System",
"Conditions" : ["Tissue Retraction System"],
"Interventions" : ["Device: TRS, Tissue Retraction System"],
"Location_Countries" : ["Italy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-05-28",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-12-31",
"Study_Completion_Date(Actual)" : "2020-12-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-05-29",
"First_Posted(Estimated)" : 2018-06-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-06-11",
"Last_Update_Posted(Estimated)" : 2021-03-18",
"Last_Verified" : 2021-03"
}
}}
|
#Study Description
Brief Summary
Endoscopic submucosal dissection (ESD) is an endoscopic technique that allows the removal of lesions of the gastrointestinal tract. The European Society of Gastrointestinal Endoscopy (ESGE) suggests to consider ESD for the removal of colorectal lesions that cannot be removed enbloc with standard polypectomy or endoscopic mucosal resection (EMR) and for lesions that are \> 20 mm in diameter, with a high probability of having a limited submucosal invasion.
ESD is a technically difficult and time-consuming procedure that is very difficult to learn and to perform, but it allows higher enbloc resection rates compared to other endoscopic techniques and is less invasive than surgery requiring less length of hospital stay.
Recently, several new techniques and devices have been developed to facilitate ESD and to overcome difficulties related to challenging situations. The main difficulties are related to the instability of the operating field, due to the physiologic peristalsis, and to the loss of traction, due to the single operating channel.
Detailed Description
Tissue Retraction System (TRS, Boston scientific) is a new endoscopic platform, that consists of an expandable and dynamically-controlled intra-luminal chamber, mounted on a flexible overtube, and two associated specifically designed retractor graspers. The system is front-loaded over the colonoscope and introduced into the colon. When the target area is reached, the retractor system is deployed creating an expanded, optimally reconfigured and stable operating field around the target lesion. Then endoscopic removal of the lesion is performed using available endoscopic instruments (injection needles, knives, snares, etc) through the operating channel of the colonoscope with assistance of two retractor graspers. Each accessory within the TRS can be moved forward and backward, left or right, rotated 360 degrees, and can be advanced out and pulled in, regardless of the TRS.
The investigators hypothesize that the TRS can improve visualization of lesions and stabilize the work environment by allowing retraction and tissue resection during ESD.
TRS is a new device not yet commercially available, thus no study has been already performed in humans to evaluate its feasibility and safety to speed up the ESD of left colon and rectum lesions.
The investigator's proposal is to perform a pilot study to evaluate the feasibility, the efficacy and the safety in patients undergoing ESD of colorectal lesions with the assistance of the TRS.
#Intervention
- DEVICE : TRS, Tissue Retraction System
- Tissue Retraction System
|
#Eligibility Criteria:
Inclusion Criteria:
* left colon and rectal lesions matching the criteria of ESD removal: depressed/flat elevated morphology and irregular or nongranular surface pattern, larger than 20 mm; lesions that cannot be optimally and radically removed with standard polypectomy or EMR
* age >=18 years
* ability to sign the informed consent
Exclusion Criteria:
* deep submucosal invasion diagnosed by distorted pit (Kudo's type V) and/or capillary (Sano's type III) patterns [5];
* poor general condition (American Society of Anesthesiologists score >= 3);
* coagulation disorders;
* pregnancy and breastfeeding;
* inability to sign the informed consent.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03553199
| 192,873 |
{
"NCT_ID" : "NCT06247566",
"Brief_Title" : "68Ga-Pentixafor PET/CT for Guiding Surgical Treatment of Primary Aldosteronism With Bilateral Adrenal Lesions",
"Official_title" : "CXCR4-targeted 68Ga-Pentixafor PET/CT for Guiding Surgical Treatment of Primary Aldosteronism With Bilateral Adrenal Lesions: Preliminary Results From a Single-center Retrospective Study",
"Conditions" : ["Primary Aldosteronism With Bilateral Adrenal Lesions"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-11-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-07-01",
"Study_Completion_Date(Actual)" : "2023-07-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-01-31",
"First_Posted(Estimated)" : 2024-02-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-01-31",
"Last_Update_Posted(Estimated)" : 2024-02-09",
"Last_Verified" : 2024-02"
}
}}
|
#Study Description
Brief Summary
Screening potential candidates who may benefit from surgery remains challenging for patients diagnosed with primary aldosteronism (PA) accompanied by bilateral adrenal lesions. Although adrenal venous sampling is currently the gold standard, it is a technically cumbersome, challenging, and difficult-to-interpret invasive procedure that requires a cutting-edge facility and radiologists with a high level of expertise, which restricts its widespread use. The present study aimed to assess the comprehensive effect of 68Ga-pentixafor positron emission tomography/computer tomography (PET/CT) on guiding surgical treatments for PA patients with bilateral adrenal lesions.
Detailed Description
Primary aldosteronism (PA) is characterized by the overproduction of renin-independent aldosterone, which results in increased blood volume, potassium excretion, and sodium storage in the body, as well as the inhibition of renin-angiotensin system activity. Clinically, the condition frequently presents as hypertension and hypokalemia. Patients with PA are at a much higher risk of experiencing cardiovascular and cerebrovascular complications than those with primary hypertension matched by blood pressure. PA is classified into two subtypes: unilateral aldosterone hypersecretion (most often aldosterone-producing adenoma (APA)) and contralateral aldosterone non-secretion or bilateral aldosterone hypersecretion (most often idiopathic hyperaldosteronism (IHA)). Differentiating PA subtypes is crucial, as patients with unilateral adrenal hypersecretion of aldosterone may be cured by the surgical removal of the adrenal lesion. Moreover, mineralocorticoid-receptor antagonists (MRAs) are the choice therapy for patients with bilateral hypersecretion.
Computed tomography (CT) is a useful tool for identifying and analyzing abnormalities in the adrenal gland and is one of the main methods used to distinguish between unilateral and bilateral adrenal lesions. CT images with abnormalities on only one side of the adrenal gland in young PA patients (aged \<35 years) suggest that abnormal hypersecretion of aldosterone is caused by the unilateral adrenal lesion. However, PA patients with bilateral adrenal lesions on CT do not necessarily exhibit excessive aldosterone secretion. Aldosterone hypersecretion may occur in only one side of the gland. However, because CT does not provide enough information about the secretory activity of a detected nodule, it is difficult to distinguish the side of the adrenal lesion that secretes excessive aldosterone. In recent years, adrenal vein sampling (AVS) - which determines lesions with functional aldosterone secretion - has been considered the gold standard for identifying PA subtypes with bilateral adrenal lesions. However, the feasibility of AVS remains controversial because of its substantial cost, invasiveness with potential risks, and complicated technique with a relatively high rate of failure. Therefore, in regions where AVS is infeasible, experienced physicians may recommend MRAs treatment directly, or the suspected aldosterone-producing lesions may be removed based on the severity of the disease and adrenal CT features. In the latter setting, larger lesions or the side of lesions with radiological features of classic cortical adenoma are often removed, but these lesions may be non-functional. Therefore, this empirical method has a high risk of failure in disease control. Hence, considerable efforts have been made to identify a cost-effective, convenient, and non-invasive substitution for AVS. The utilization of functional imaging techniques is promising for detecting aldosterone-secreting adrenal lesions. For instance, the performance of 11C-metomidate positron emission tomography/computer tomography (PET/CT) is comparable to that of AVS. However, the short half-life of 11C-metomidate and higher requirements for equipment limits its widespread application in clinical practice.
The C-X-C chemokine receptor 4 (CXCR4) - a G protein-coupled transmembrane receptor - is highly expressed in aldosterone-producing tissue16. Its expression is strongly correlated with the expression of aldosterone synthase CYP11B2 (cytochrome P450, family, subfamily b, polypeptide 2). The utilization of 68Ga-pentixafor, a radiolabeled CXCR4 ligand, enables the visualization of tissues exhibiting elevated CXCR4 expression on PET/CT by specifically binding to CXCR4 receptors on the cell membrane 18. Evidence has shown that the utilization of 68Ga-pentixafor PET/CT in patients with adrenal lesions reveals a notable disparity in the uptake value of the tracer between the adrenal lesion side generating excessive aldosterone and non-functional adrenal adenomas (NFA). Previous study also showed that 68Ga-pentixafor PET/CT has diagnostic significance in PA subtypes. We found that the maximum standardized uptake value (SUVmax) of IHA lesions and NFA was significantly lower than that of APA. However, studies on the value of PET/CT in patients with PA coupled with bilateral adrenal lesions are scanty. Herein, we employed 68Ga-pentixafor PET/CT imaging to evaluate PA patients with bilateral adrenal lesions who may receive surgical benefits and tracked their prognosis to examine the significance of 68Ga-pentixafor PET/CT in guiding the treatment strategy.
|
#Eligibility Criteria:
Inclusion Criteria:
patients with bilateral adrenal lesions who were diagnosed as PA
Exclusion Criteria:
* patients diagnosed with other types of secondary hypertension
* patients had comorbidities
* Patients with incomplete follow-up data
* Patients who successfully underwent AVS
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT06247566
| 22,688 |
{
"NCT_ID" : "NCT05079178",
"Brief_Title" : "Newborns in Level III Services in Alsace From Mothers With COVID-19",
"Official_title" : "Retrospective Clinical Study of the Care and Follow-up in the First Month of Life of Newborns in Level III Services in Alsace From Mothers With COVID-19",
"Conditions" : ["COVID-19"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-06-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-10-31",
"Study_Completion_Date(Actual)" : "2021-10-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-10-14",
"First_Posted(Estimated)" : 2021-10-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-10-14",
"Last_Update_Posted(Estimated)" : 2021-11-18",
"Last_Verified" : 2021-10"
}
}}
|
#Study Description
Brief Summary
Very little is known about the impact on the newborn of late pre-partum maternal SARS-CoV-2 infection.
Care without separation of the mother and her newborn with continued breastfeeding has been advocated in France and by the WHO but is being debated in some countries.
Assessment of the development of newborns in their first month of life with this strategy associated with close and secure follow-up.
Importance of reporting the potential benefits / risks of this treatment to guide the care of newborns in a persistent epidemic context in a particularly affected region.
|
#Eligibility Criteria:
Inclusion criteria:
* Newborns born between March 1 and June 30, 2020 to COVID 19
* From positive mothers in Strasbourg University Hospital or Mulhouse Hospital.
* Parents' non-opposition to the analysis of hospitalization data for children contained in the medical file
Exclusion criteria:
* Parents' opposition to the analysis of hospitalization data for children contained in the medical file
Sex :
ALL
Ages :
- Minimum Age : 1 Day
- Maximum Age : 1 Year
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT05079178
| 225,619 |
{
"NCT_ID" : "NCT00731913",
"Brief_Title" : "A Comparison of Monosyn and Monocryl Sutures in Surgical Wounds",
"Official_title" : "A Randomized, Prospective Trial Evaluating Surgeon-Preference in Selection of Absorbable Suture Material",
"Conditions" : ["Wounds"],
"Interventions" : ["Other: Absorable, monofilament sutures: Monosyn and Monocryl"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-03",
"Study_Completion_Date(Actual)" : "2008-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-08-07",
"First_Posted(Estimated)" : 2008-08-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-08-08",
"Last_Update_Posted(Estimated)" : 2015-03-19",
"Last_Verified" : 2015-03"
}
}}
|
#Study Description
Brief Summary
To better understand surgeon preference when using synthetic, absorbable, monofilament suture by comparing two similar appearing FDA-approved sutures, Monosyn (Aesculap) and Monocryl (Ethicon).
Detailed Description
Physicians have used suture to close wounds for at least 4,000 years. Archaeological records from ancient Egypt show that Egyptians used linen and animal sinew to close wounds. In ancient India, physicians used the pincers of beetles or ants to staple wounds shut. They then cut the insects' bodies off, leaving their jaws (staples) in place. Other natural materials used to close wounds include flax, hair, grass, cotton, silk, pig bristles, and animal gut.
The fundamental principles of wound closure have changed little over 4,000 years. Successful closure of wound involves surgical techniques coupled with knowledge of the physical characteristics and handling of the suture and needle. The selection of proper suture material in closing any surgical defect is important in wound healing, minimizing infection, and achieving optimal cosmetic and functional results.
A great deal of progress has been made since Egyptian times with regard to suture materials and manufacturing processes. Today, sutures are available with a wide variety of characteristics, configuration, manipulability, coefficient of friction, solubility, strength, and immunogenic properties. Yet, sutures are currently rather crudely classified based on a numeric scale according to diameter and tensile strength; descending from 10 to 1, and then descending again from 1-0 to 12-0. This study aims to explore the factors that are important to a surgeon when choosing sutures via evaluating surgeon preference for two types of synthetic, absorbable, monofilament sutures: Monosyn and Monocryl. We hope to initiate a more nuanced exploration of how suture characteristics influence surgeon preference, beyond filament type and size, and how makers of suture may better report and represent these factors.
#Intervention
- OTHER : Absorable, monofilament sutures: Monosyn and Monocryl
- Subjects were randomized to Monosyn vs. Monocryl suture arms. The designated skin lesion was removed surgically. The surgical repair of the defect was performed by dividing the wound in half by a single Prolene suture. The appropriate suture was opened by the Study Coordinator and passed sterilely to the surgical technician. The surgical technician loaded the suture, and passed it in a blinded fashion to the physician who closed the appropriate half of the surgical defect. One half of the wound was closed with one suture and the other half was closed with the other suture. Each patient served as their own control, as both sutures were used in each study patient.
- Other Names :
- Monofilament, absorbable sutures
|
#Eligibility Criteria:
Inclusion Criteria:
* Specific eligibility requirements included surgical defects that are linear, without curvature, 3.0 cm in length or greater and extending into the subcutis or fascia.
* All surgical defects were required to be closed primarily (that is without flaps or grafts) and had equal skin integrity on both halves of their surgical defects.
* All subjects were capable of providing written informed consent.
Exclusion Criteria:
* Unable to provide written informed consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00731913
| 129,241 |
{
"NCT_ID" : "NCT02737215",
"Brief_Title" : "Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea",
"Official_title" : "Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea: a Multicenter Study",
"Conditions" : ["Atrial Fibrillation", "Obstructive Sleep Apnea", "Coronary Artery Bypass Grafting"],
"Interventions" : ["Device: CPAP"],
"Location_Countries" : ["Brazil"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-05-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-12",
"Study_Completion_Date(Actual)" : "2019-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-04-10",
"First_Posted(Estimated)" : 2016-04-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-04-10",
"Last_Update_Posted(Estimated)" : 2021-12-09",
"Last_Verified" : 2021-12"
}
}}
|
#Study Description
Brief Summary
Background. Atrial fibrillation is one of the most common complications in the postoperative period of coronary artery bypass grafting (CABG) surgery and usually associated with increased length of hospital stay and higher hospital costs. Among the main mechanisms involved, excessive sympathetic activation, oxidative stress and inflammation are fundamental elements in the pathophysiology of obstructive sleep apnea. Objectives. To evaluate the effects of continuous positive airway pressure (CPAP) in reduction of atrial fibrillation after CABG in patients with obstructive sleep apnea. Methodological procedures: A multicenter randomized controlled study to compare the incidence of atrial fibrillation between the intervention group and the control group, both monitored seven days with Holter.
#Intervention
- DEVICE : CPAP
- patients will receive CPAP therapy with Auto-CPAP
|
#Eligibility Criteria:
Inclusion Criteria:
* apnea-hypopnea index > 15 events/hour
Exclusion Criteria:
* ejection fraction < 45%
* chronic atrial fibrillation
* periprocedural instability (haemodynamic, neurological)
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT02737215
| 216,859 |
{
"NCT_ID" : "NCT01448265",
"Brief_Title" : "Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter",
"Official_title" : "Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter",
"Conditions" : ["Atrial Fibrillation"],
"Interventions" : ["Procedure: Cryoballoon ablation."],
"Location_Countries" : ["Germany"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-07",
"Study_Completion_Date(Actual)" : "2013-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-09-30",
"First_Posted(Estimated)" : 2011-10-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-10-06",
"Last_Update_Posted(Estimated)" : 2013-07-25",
"Last_Verified" : 2013-07"
}
}}
|
#Study Description
Brief Summary
Background: Atrial fibrillation (AF) is the most frequent sustained cardiac arrhythmia, impairs quality of life and increases stroke risk and mortality. Recent clinical experience with the Arctic Front™ cryoballoon ablation catheter system (Medtronic) suggests that it can be used to isolate the pulmonary veins (PVs) safely and effectively in patients with AF, thereby eliminating the recurrence of AF.
Hypothesis: Our hypotheses are (1) that visualization of real-time pulmonary vein conduction during cryoballoon ablation of atrial fibrillation using a novel spiral circumferential mapping catheter (Achieve™) is feasible and safe, and (2) that procedure and fluoroscopy times decrease with experience.
Objective: The purpose of this study is to assess safety, feasibility, and a learning curve associated with cryoballoon catheter ablation using a novel circular mapping catheter (Achieve™, Medtronic) inserted through the lumen of the cryoballoon in patients with symptomatic paroxysmal atrial fibrillation.
The primary goal is to evaluate successful pulmonary vein isolation using the Achieve™ mapping catheter. The reduction of procedure and fluoroscopy times during the first 40 patients treated with this approach will be analyzed to evaluate a potential learning curve upon introduction of the technique.
Detailed Description
A total of 40 patients scheduled for a first ablation of paroxysmal AF will be included. All study subjects will undergo cryoablation using the 28 mm Arctic Front™ Cryoablation Catheter. A double transseptal approach will be followed in all study patients, allowing for use of regular guide wire and circular mapping catheter, respectively, if required.
Use of the 20 mm Achieve™ circular mapping catheter is preferred. The 15 mm AchieveTM catheter may be used at the physician's discretion. If stable balloon positions cannot be obtained, the Achieve™ catheter will be replaced by a regular guide wire and pulmonary vein isolation will be assessed by a circular mapping catheter (Lasso™; Biosense Webster) introduced through a second transseptal puncture. Cryoablations will be applied for 5 minutes each. Premature terminations will be allowed at the physician's discretion but should be avoided to allow for detection of late pulmonary vein isolation during cryoenergy application. Cryoballoon catheter manipulations (e.g., pull down maneuver) may be performed during energy application. During ablation of septal pulmonary veins, electrical phrenic nerve stimulation will be performed to exclude phrenic nerve palsy. If additional single point ablations are required to achieve electrical isolation of pulmonary veins, a linear cryocatheter (Freezor™ Max; Medtronic) will be used.
#Intervention
- PROCEDURE : Cryoballoon ablation.
- Cryoballoon ablation using a novel circular mapping catheter.
|
#Eligibility Criteria:
Inclusion Criteria:
* Documented paroxysmal atrial fibrillation
* >=18 and <=75 years
* Failure of one or more antiarrhythmic drugs
* Referral for a pulmonary vein isolation catheter ablation procedure to treat atrial fibrillation
Exclusion Criteria:
* Previous ablation of atrial fibrillation
* Documented left atrial thrombus
* Irregular pulmonary vein anatomy according to transesophageal echocardiography
* Atrial fibrillation secondary to reversible cause
* Amiodarone therapy in the previous 6 months
* Cardiac surgery within the prior 6 months
* Myocardial infarction within the previous 2 months
* Ejection fraction < 40%
* NYHA class III or IV
* Moderate to severe valvular heart disease
* Previous valve replacement
* Pacemaker or implantable cardioverter defibrillator placement in the prior 3 months
* History of stroke or TIA within the previous 12 months
* Left atrial size >= 50 mm
* Contraindication for anticoagulation medication
* Life expectancy of less than 12 months
* Pregnancy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01448265
| 34,674 |
{
"NCT_ID" : "NCT02895607",
"Brief_Title" : "Evaluation of Outpatient Surgery in the Anterior Cruciate Ligament Reconstructions With Hamstring Hospital",
"Official_title" : "Prospective Evaluation of Outpatient Surgery in the Anterior Cruciate Ligament Reconstructions With Hamstring Hospital",
"Conditions" : ["Anterior Cruciate Ligament"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-05",
"Study_Completion_Date(Actual)" : "2015-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-09-01",
"First_Posted(Estimated)" : 2016-09-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-09-08",
"Last_Update_Posted(Estimated)" : 2018-08-10",
"Last_Verified" : 2016-09"
}
}}
|
#Study Description
Brief Summary
Care in ambulatory surgery (CA) is growing in France, despite lagging behind other countries in North or US Europe. Arthroscopic knee surgery is a minimally invasive surgery eligible for CA. Currently 71.8% of knee arthroscopy are made in this context. However ligamentoplasties anterior cruciate are still carried out predominantly in conventional hospitalization (HC) with a median of 3 to 5.5 days of stay.
Two recent prospective studies French single-operator shows the feasibility of reconstruction of the anterior cruciate ligament (ACL) in ambulatory: no serious events were recorded, the risks are comparable to those of a HC.
However, this support requires a structure and a coordinated network between different medical and paramedical (surgeons, anesthetists, nurse frame, City nurse, doctor, physiotherapist).
The objective of the study is to evaluate (i.e. EPP or 'feasibility') ACL reconstruction in CA in hospitals, multi-operator.
Detailed Description
II. objectives
at. primary objective
Rating (or 'feasibility') of a management protocol HDJ of ACL reconstruction in a hospital structure on a multi-operator series.
Evaluation criteria (absence of EG)?
b. secondary objectives
i. Evaluation of the acceptance rates of ambulatory care patients eligible
ii. Evaluation of the rate and type of complication in our series
iii. Evaluation of early postoperative results (postoperative pain, analgesic consumption, sleep, satisfaction)
IV. Methodology and duration of the research
This is a consecutive series single-center multi-operator prospective regarding the evaluation of surgical practice cited in goal.
The inclusion of patients will take place over a period of 4 months.
The management of ACL reconstruction in outpatient will be proposed in consultation with the surgeon.
After an explanation of the course of treatment a fact sheet on the protocol will be provided to the patient and his doctor to the patient to decide its support AC or HC.
Clinical data will be collected by telephone the first 4 days and in consultation with J45. The revision sheet is provided.
Patients are aware of the use of their data for medical research through oral information provided by the doctor at the signing by the patient's consent related to the surgery.
The data collected as part of the research are anonymous and unidentifiable (for each subject is assigned a number); the name of the surgeon is also anonymized.
#Intervention
- PROCEDURE : Ambulatory care among eligible patients
- The management of Anterior Cruciate Ligament (ACL) Reconstruction reconstruction in outpatient will be proposed in consultation with the surgeon.
After an explanation of the course of treatment a fact sheet on the protocol will be provided to the patient and his doctor to the patient to decide its support in CA (ambulatory surgery) or HC (conventional hospitalization).
|
#Eligibility Criteria:
Inclusion Criteria:
* Isolated ACL tear
* First arthroscopic reconstruction at DIDT
Exclusion Criteria:
* Age > 60 years
* ASA score greater than 2
* Geographical remoteness
* Social isolation
* medical condition requiring supervision by HC (phlebitis history, coagulation disorders ...)
* psychiatric pathology
Sex :
ALL
Ages :
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02895607
| 210,357 |
{
"NCT_ID" : "NCT00760006",
"Brief_Title" : "Preventing Complications in Cleft Palate Repair With Antibiotics",
"Official_title" : "Efficacy of Preoperative Prophylactic Antibiotics in Preventing Complications in the Primary Repair of Cleft Palates",
"Conditions" : ["Cleft Palates"],
"Interventions" : ["Other: saline solution", "Drug: Unasyn"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-08",
"Study_Completion_Date(Actual)" : "2015-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-09-24",
"First_Submitted_that_Met_QC_Criteria" : 2018-01-04",
"First_Posted(Estimated)" : 2008-09-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-09-24",
"Last_Update_Posted(Estimated)" : 2018-02-01",
"Last_Verified" : 2018-01"
}
}}
|
#Study Description
Brief Summary
The primary objective of this study is to determine the efficacy of administering a single dose of preoperative antibiotics to prevent complications in patients undergoing primary closure of a cleft secondary palate. Secondary objective of this study is to evaluate the effects of preoperative antibiotics administered on post operative outcome following primary closure of cleft secondary palate. The study aims to assess the efficacy of prophylactic antibiotics in cleft surgery to
* decrease the incidence of surgical sight infections
* speed the progression of postoperative healing
* improve the final quality of wound healing achieved
* decrease the rate of palatal fistula formation
Detailed Description
During the initial clinical visit, the clinical diagnosis of a cleft secondary palate or submucous cleft will be made. Other associated clinical findings such as unilateral/bilateral cleft lip, unilateral/bilateral cleft primary palate, Veau cleft palate classification, and associated syndromic diagnosis will be recorded. The severity of the cleft palate will be documented by measuring the width of the cleft and the hard-soft palate juncture. The patients will proceed through the standardized cleft treatment protocol as mandated by their specific anatomic findings. These include possible naso-alveolar molding, lip-adhesion procedures, and cleft lip repair procedures. The patients will be followed regularly in clinic and will undergo a palatoplasty procedure to repair their cleft secondary palate when clinically indicated, typically between the age of 9 and 14 months. Patients who present for treatment late will be operated on when clinically appropriate, as determined by the plastic surgeon. A Furlow palatoplasty procedure is the typical palatoplasty procedure performed by the primary investigator, but other procedures such a Von Langenbeck pushback palatoplasty may be performed as dictated by the clinical scenario.
Subjects will be randomized via aid from statisticians in the Clinical and Translational Science Institute (CTSI) here at the University of Pittsburgh. This will enable the research pharmacist at Children's Hospital of Pittsburgh, to send either the antibiotic or the saline placebo to the operating room in a blinded manner. All subjects enrolled in the study will receive a single dose of antibiotic or saline solution (placebo control) intravenously, as the IV will already be in place as standard of card for surgery. Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure. The FDA approved antibiotic used for this study is Unasyn. Unasyn is a first-line measure, used by ENT surgeons at Children's Hospital of Pittsburgh for antibiotic treatment of virtually all ear, nose and throat infections. The use of Unasyn for this study is off-label as with the majority of antibiotics used with children. Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm. This constitutes the focus of the study, and is the only variation from standard treatment.
Patients will be admitted to the hospital, and will be discharged home when they are in no respiratory distress, have adequate pain control, and are able to tolerate adequate PO intake. This is generally on post-operative day 2. All patients will be prescribed pain medications. Parents will be provided with, and counseled how to properly use arm splints for 14 days postoperatively. They will also be taught how to feed the child with syringe feeds. These measures prevent the child from traumatizing the suture lines with bottles, hands and foreign bodies.
Screening procedures will consist of a medical history and physical examination by a Pediatric Plastic Surgeon to determine what type of cleft palate repair is necessary. This is the same standard exam and medical/surgical work-up that any patient would receive if they were treated by the Cleft-Craniofacial Clinic in Children's Hospital of Pittsburgh of UPMC and not enrolled in this study. This aspect of care will not vary from routine treatment. All patients will be seen in weekly postoperative follow-up in the Cleft-Craniofacial Center. Documentation of these postoperative visits will include notation of signs of surgical sight infections, such as continued fevers, erythema, swelling, discharge, dehiscence, pain, and the presence of nonviable tissue. The progression of wound healing will be quantified on a scale of 1 to 4. Wounds will be classified as Stage 1 healing when there is complete union of the mucosa, and no irregularities or separation. Stage 2 healing will be documented for wounds with minor incisional irregularities or incomplete healing. Stage 3 healing will be documented when the wound exhibits worrisome mucosal viability, partial dehiscence of the oral mucosal closure, erythema, purulent drainage, or exposure of the alloderm patch. Stage 4 healing will include patients with a palatal fistula. Any patients with clinical signs and symptoms of thrush, a fungal infection of the mouth and esophagus, will have cultures of the lesions sent to confirm the diagnosis. These patients will be immediately started on a seven day course of oral fluconazole, with an initial dose of 6mg/kg, followed by daily dose of 3mg/kg, as recommended by Dr. Andrew Nowalk, MD. Patients will be seen in clinic weekly until they have reached stage 1 healing, or until the presence of a palatal fistula is documented. We anticipate a minimum of less than 2 months to a maximum of 1 year for follow-up will be necessary to document either stage 1 healing or the presence of a palatal fistula in nearly all cases. The primary endpoints measured will be 1) the incidence of surgical sight infections, 2) the incidence of palatal fistula 3) the average time needed to achieve stage 1 healing, 4) the incidence of cases with healing delayed more than one standard deviation from the average, 5) the incidence of thrush, a fungal infection of the mouth and esophagus, and 6) the incidence of allergic/drug reactions to the study drug. Surveillance for other factors such as hospital length of stay, postoperative bleeding events, postoperative respiratory distress, and diagnosis of a sepsis will be recorded as secondary endpoints.
Data collection will include patient characteristics such as, but not limited to, Veau cleft classification, width of the cleft defect, presence of associated cleft lip or primary palate, presence of syndromic diagnosis, and use of alloderm for repair augmentation, and the administration of intraoperative steroids. The two study groups will be compared on the basis of these characteristics to determine if statistically significant differences exist between the two groups. Endpoint data will be collected as discussed above, and the outcomes for the placebo and antibiotic group will be compared.
#Intervention
- DRUG : Unasyn
- Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure. The FDA approved antibiotic used for this study is Unasyn. Unasyn is a first-line measure, used by ENT surgeons at Children's Hospital of Pittsburgh for antibiotic treatment of virtually all ear, nose and throat infections. The use of Unasyn for this study is off-label as with the majority of antibiotics used with children. Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm
- Other Names :
- ampicillin, sulbactam
- OTHER : saline solution
- Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm.
- Other Names :
- Salt solution
|
#Eligibility Criteria:
Inclusion Criteria:
* Children diagnosed as having cleft palates undergoing palatoplasty between the ages of 3 months and 18 years will be included in this study. Palatoplasty is the current standard of care in the sequence of treatment for cleft secondary palates. Pediatric plastic surgeons work primarily with children, and have undergone extensive training during their residencies and pediatric surgical fellowships to do so. Children will be evaluated initially at the Cleft-Craniofacial Center at the Children's Hospital of Pittsburgh of UPMC, which is set up to accommodate children of all ages and their families. Approximately 300 children will be required to contribute to a meaningful analysis.
Exclusion Criteria:
* All patients requiring prophylactic antibiotics for spontaneous bacterial endocarditis, with documented allergic reactions to the ampicillin-sulbactam, and with known immunodeficiencies or immunodeficiency associated syndromes, such as the 22q chromosomal deletion, will be excluded from study participation.
* Selection will be based on the parent's willingness to allow their child to participate in the study.
* Children already receiving antibiotics at the time of their surgery will be evaluated distinctly, though they will not be included in the antibiotic or the placebo groups
Sex :
ALL
Ages :
- Minimum Age : 3 Months
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00760006
| 193,477 |
{
"NCT_ID" : "NCT05359549",
"Brief_Title" : "Dental Implant Treatment for Two Adjacent Teeth in the Maxillary Aesthetic Region: an Evaluation After 10 Years",
"Official_title" : "Dental Implant Treatment for Two Adjacent Teeth in the Maxillary Aesthetic Region: an Evaluation After 10 Years",
"Conditions" : ["Missing Teeth"],
"Interventions" : ["Device: Two endosseous dental implants (NobelReplace Groovy®) were placed 10 years ago"],
"Location_Countries" : ["Netherlands"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-10-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-05-01",
"Study_Completion_Date(Actual)" : "2023-05-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-03-29",
"First_Posted(Estimated)" : 2022-05-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-04-28",
"Last_Update_Posted(Estimated)" : 2025-03-30",
"Last_Verified" : 2023-10"
}
}}
|
#Study Description
Brief Summary
* Background Replacement of two missing adjacent teeth is considered a difficult treatment in implant dentistry and even more challenging if located in the anterior region due to aesthetic demands. As well peri-implant bone contour as soft tissue volume is compromised at start of the treatment and difficult to restore. The question is if this reconstruction will be stable in the longterm. Full-scale evaluation of adjacent implant placement with crown rehabilitation in the aesthetic region with a follow-up of at least 10 years is underreported in this field of implant dentistry.
* Main research question The aim of this observational study was to analyze peri-implant bone changes, mucosa levels, aesthetic ratings and patient-reported satisfaction with the maxillary aesthetic region following implant placement with crown restoration after a 10-years follow-up period.
* Design (including population, confounders/outcomes) The study design is an observational study of a group of patients with two missing adjacent teeth in the maxillary aesthetic region which was treated 10 years ago with dental implant placement and an implant-supported restorations.
Outcomes: primary outcome is the change in marginal peri-implant bone level 10 years after placing the definitive restoration. Secondary outcome measures will be implant and restoration survival and changes in interproximal peri-implant mucosa, midfacial peri-implant mucosal level , aesthetic outcome assessed by means of an objective index and patients' satisfaction using a questionnaire.
• Expected results Stable peri-implant bone levels, stable peri-implant soft tissue levels, high implant and restoration survival rate and satisfied patients.
Detailed Description
The study design is an observational study of a group of 25 patients with two missing adjacent teeth in the maxillary aesthetic region which was treated 10 years ago with dental implant placement and an implant-supported restorations.
* Inclusion criteria:
* Patients, having two missing teeth in the maxillary aesthetic region, referred to the department of Oral and Maxillofacial Surgery 10 years ago and treated with dental implant placement and implant-supported restorations. At the time of treatment:
* The patient was 18 years or older;
* The failing teeth were an incisor (central or lateral), cuspid or first bicuspid in the maxilla; the adjacent teeth are natural teeth;
* Sufficient healthy and vital bone to insert a dental implant with a minimum length of 10 mm and at least 3.5 mm in diameter with initial stability \> 45 Ncm
* The implant site was free from infection;
* Adequate oral hygiene (modified plaque index and modified sulcus bleeding index ≤ 1);
* Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration;
* The patient was capable of understanding and giving informed consent.
* Exclusion criteria at the time of treatment:
* Medical and general contraindications for the surgical procedures;
* Presence of an active and uncontrolled periodontal disease;
* Bruxism;
* Smoking
* A history of local radiotherapy to the head and neck region. All patients were 10 years ago referred to the Department of Oral and Maxillofacial Surgery (University of Groningen, University Medical Hospital) because of having two failing teeth in the maxillary aesthetic region and were treated with dental implant placement and implant-supported restorations. Patients will have a regular routine control visit (as part of regular follow-up of these patients). All data to be collected are part of the routine visit and collected regularly at earlier routine visits, except for the questionnaire. The questionnaire contains a limited number of questions with respect to satisfaction with the aesthetic result. If patients are willing to participate (to use their research data and to fill in the questionnaire), they will be asked to give informed consent by signing a form. After signing, they will be included in the 10-years evaluation as participant. The forms will be collected in the CRF and in the medical record it will be noted that patient has signed the informed consent. Data will be collected during the routine control visit; patients will not have an extra visit for data collection.
#Intervention
- DEVICE : Two endosseous dental implants (NobelReplace Groovy®) were placed 10 years ago
- All patients were 10 years ago referred to the Department of Oral and Maxillofacial Surgery (University of Groningen, University Medical Hospital) because of having two failing teeth in the maxillary aesthetic region and were treated with dental implant placement and implant-supported restorations. Patients will have a regular routine control visit (as part of regular follow-up of these patients)
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients, having two missing teeth in the maxillary aesthetic region, referred to the department of Oral and Maxillofacial Surgery 10 years ago and treated with dental implant placement and implant-supported restorations. At the time of treatment:
* The patient was >= 18 years;
* The failing teeth were an incisor (central or lateral), cuspid or first bicuspid in the maxilla; the adjacent teeth are natural teeth;
* Sufficient healthy and vital bone to insert a dental implant with a minimum length of 10 mm and at least 3.5 mm in diameter with initial stability > 45 Ncm
* The implant site was free from infection;
* Adequate oral hygiene (modified plaque index and modified sulcus bleeding index <= 1);
* Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration;
* The patient was capable of understanding and giving informed consent.
Exclusion Criteria:
*
* Medical and general contraindications for the surgical procedures;
* Presence of an active and uncontrolled periodontal disease;
* Bruxism;
* Smoking
* A history of local radiotherapy to the head and neck region.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05359549
| 135,761 |
{
"NCT_ID" : "NCT05090774",
"Brief_Title" : "Integrating Fall Prevention Balance Exercises Into a Program for Older Adults With Peripheral Artery Disease (PAD): A Mixed Methods Feasibility Study",
"Official_title" : "Integrating Fall Prevention Balance Exercises Into a Program for Older Adults With Peripheral Artery Disease (PAD): A Mixed Methods Feasibility Study",
"Conditions" : ["Fall", "Fall Injury", "Peripheral Artery Disease", "Peripheral Arterial Disease"],
"Interventions" : ["Behavioral: Adapted Otago Exercise Program (OEP)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-10-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-03-01",
"Study_Completion_Date(Actual)" : "2023-03-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-10-06",
"First_Posted(Estimated)" : 2021-10-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-10-12",
"Last_Update_Posted(Estimated)" : 2023-04-07",
"Last_Verified" : 2023-04"
}
}}
|
#Study Description
Brief Summary
The overarching objective of this study is to improve fall prevention efforts in community-dwelling older adults with peripheral artery disease (PAD) to reduce falls. To accomplish this, the investigators will conduct a feasibility study and pilot the addition of a balance exercise component to existing supervised exercise therapy (SET) programs for PAD. This intervention may be an effective way to help older adults with PAD self-manage their leg pain and walking impairments as well as fall risk. The long-term goal of this research is to reduce morbidity and mortality associated with falls in older adults with symptomatic PAD through the development and evaluation of a balance intervention component implemented within existing exercise programs. Findings from this research may also be translated to the implementation of disease management programs for other chronic conditions associated with fall risk. The rationale for this research is to determine improve disease-specific, comprehensive and fall prevention strategies for older adults with PAD.
Detailed Description
Falls are a growing public health concern as the proportion of aging adults will continue to increase in the coming years and the prevalence of falls is high. Older adults with PAD have previously demonstrated impaired static balance, higher prevalence of history of stumbling/unsteadiness (41%) and falling (26%), and abnormal balance using computerized dynamic posturography compared to non-PAD controls. Adults with symptomatic PAD also demonstrate LE weakness and gait deficiencies due to impaired muscle power and biomechanics. While still unspecified, muscle weakness and ischemic neuropathy could partially explain the etiology for impaired balance in those with PAD. Other potential associations with increased fall risk in PAD may include claudication, limited physical activity, and poor LE function. Through expansion of disease-specific knowledge related to fall prevention interventions in older adults with PAD, healthcare providers may find that targeted balance screening and interventions to improve balance and strength are essential to disease management and the prevention of disability. The proposed study is innovative as it is the first balance intervention study in PAD and uses an explanatory sequential mixed methods design. Given the known associations between PAD and balance, in addition to morbidity and mortality associated with falls in the general population of older adults, the contribution of this knowledge is unique in that it will improve understanding of interventional study designs, leading to future revisions in prevention strategies for this sub-group.
Findings from a recent systematic review of fall prevention interventions for community-dwelling older adults with chronic conditions suggest that the stage of intervention development primarily lies within efficacy-based RCTs that focus on internal validity, which limits the generalizability of these intervention effects for varying contexts. Most of these interventional studies did not report detail related to adoption and maintenance, such as recruitment of participants from the target populations and intervention adoption by staff, which are critical to understanding how to implement these interventions in clinical settings. There was also a lack of qualitative research methods use across the studies, which limits the understanding of participants' acceptability and perceived intervention effects. Most of these trials were conducted in controlled research setting environments adjacent to, but not integrated within, clinical practice settings without staff involvement, which impacts the adoption of these programs. While all of the studies in the review included targeted, individuals, and moderately challenging balance exercises (some with additional strength and aerobic training components), the dosing of balance exercises was not sufficient to meet the exercise duration recommendations over the intervention period. Due to the stage of development, it is challenging to evaluate the long-term implementation and public impact of these interventions with delivery performed by clinicians and community partners who have direct contact with this target population. Despite the inextricable relationships between fall risk and PAD, self- management interventions for fall risk and PAD are currently not integrated into PAD treatment. Often, interventions for self-management of chronic conditions and fall prevention are delivered separately. Given the complexity, time, and effort required for PAD self-management programs, a separate stand- alone program for fall prevention exercises is unlikely due to its added burden on patients. Thus, there is a need to explore the feasibility of integrating evidence- based fall prevention exercises into existing PAD programs. Some researchers have investigated the integration of rehabilitation programs and fall prevention in patients with chronic obstructive pulmonary disease, where balance exercises were delivered as part of either outpatient and inpatient pulmonary rehab. Although balance training has not been implemented as a standard treatment for PAD subgroups, there is potential for its addition to established PAD programs. Many older adults with PAD participate in outpatient supervised exercise therapy (SET) walking programs, which are the most effective non-invasive method to mitigate claudication and improve walking function in adults with PAD. In addition to mitigating fall risk, the combined balance training within SET programs also has potential to improve patient outcomes. Balance training could be an adjunct to the SET standard of care, which is designed to improve claudication symptoms and address walking function. Although intermittent treadmill walking is the optimal mode to maximize benefits from exercise training for PAD, it is often contraindicated or refused due to poor balance. As walking demands adequate balance, LE strength, and endurance, individuals with poor postural control may benefit from improving their balance prior to or during the initiation of walking exercise to manage their vascular disease. Thus, the simultaneous learning and mastering of balance exercises to reduce fall risk may enable successful participation in treadmill walking, thus maximizing the benefits gained from SET.
#Intervention
- BEHAVIORAL : Adapted Otago Exercise Program (OEP)
- A modified version of the 8- week evidence-based Otago Exercise Program (OEP), adapted for integration into supervised exercise therapy (SET). The OEP exercises will include 12 static and dynamic standing balance movements (knee bends, backwards walking, walking and turning, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, heel-toe walking backwards, sit to stand, stair walking). The OEP also contains additional behavior change techniques embedded within the intervention protocol (i.e. feedback on behavior, self-monitoring of behavior, biofeedback).
|
#Eligibility Criteria:
Inclusion Criteria:
* Enrolled in supervised exercise therapy (SET)
* One or more fall risk factors as determined by CDC STEADI fall risk screener
* One or more falls in the last year
* Unsteadiness when standing or walking
* Worries about falling
* Have symptomatic peripheral artery disease (PAD) with objective diagnosis (ABI less than or equal to 0.90 or previous revascularization)
Exclusion Criteria:
* Formal diagnosis of neurocognitive impairment or <3 on Callahan 6-Item Screener
* Current uncontrolled vestibular dysfunction (e.g. Meniere's Disease, benign paroxysmal positional vertigo)
* Participants who self-report the following symptoms will require clearance from a primary provider (as guided by the Exercise and
Screening for You Questionnaire):
* Pain, tightness or pressure in chest during physical activity (walking, climbing stairs, household chores, similar activities) that have not been checked and/ or treated by a healthcare provider
* Current dizziness that have not been checked and/ or treated by a healthcare provider
* Current, frequent falls that have not been checked and/ or treated by a healthcare provider
* Other clinically significant disease that is, in the opinion of the study team, not stabilized or may otherwise confound the results of the study
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05090774
| 37,103 |
{
"NCT_ID" : "NCT03976037",
"Brief_Title" : "Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb",
"Official_title" : "Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb for Labor Induction at Term: a Randomized Controlled Trial",
"Conditions" : ["Induction of Labor"],
"Interventions" : ["Drug: Misoprostol"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["EARLY_PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-06-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-01-20",
"Study_Completion_Date(Actual)" : "2021-02-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-05-31",
"First_Posted(Estimated)" : 2019-06-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-06-04",
"Last_Update_Posted(Estimated)" : 2021-02-26",
"Last_Verified" : 2021-02"
}
}}
|
#Study Description
Brief Summary
Combined misoprostol and Foley bulb catheter has been shown to be an effective induction method. However, optimal route of administration for misoprostol has not been established.
Therefore, the purpose of this study is to compare the effectiveness and safety of combination buccal miso-foley to combination vaginal miso-foley for third trimester cervical ripening and induction of labor.
Detailed Description
This randomized controlled trial of consenting women undergoing induction of labor with combined misoprostol and Foley catheter seeks to efficacy of vaginal versus buccal misoprostol route of administration.
This project will include 216 women presenting at Christiana Care Health System. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter combined with misoprostol. Following admission, women will be randomized into either vaginal or buccal misoprostol.
Women will be randomized with equal probability to the intervention group using block randomization stratified by party.
Patients will receive 25 micrograms of misoprostol along with the insertion of a16F Foley catheter. Misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. The remainder of labor management will be at the discretion of each woman's obstetric provider.
Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review
#Intervention
- DRUG : Misoprostol
- Women randomized to either vaginal or buccal misoprostol-cervical Foley group will have both misoprostol and a cervical Foley placed. Patients will receive 25 micrograms of vaginal or buccal misoprostol along with the insertion of a16F Foley catheter with stylet. The Foley balloon catheter will be filled with 30cc balloon inserted digitally or by direct visualization with a speculum. The Foley bulb will be placed just above the level of the internal os and inflated with 30cc of sterile water.
vaginal or Buccal misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. If the patient is contracting more than 3 times per 10 minutes after 6 hours, oxytocin protocol is initiated.
- Other Names :
- cytotec
|
#Eligibility Criteria:
Inclusion Criteria:
* >=18 years
* full term (>=37 weeks) gestations determined by routine obstetrical guidelines
* singleton gestation in cephalic presentation
* Both nulliparous and multiparous women
* Intact membranes
* Cervical dilation <=2cm
Exclusion Criteria:
* Any contraindication to a vaginal delivery or to misoprostol
* fetal demise
* Multifetal gestation
* prior uterine surgery, previous cesarean section
* Tachysystole was defined as at least 6 contractions in 10 minutes for 2 consecutive 10-minute periods
* women with HIV, and women with medical conditions requiring an assisted second stage
* Additional exclusion criteria were as follows: category 3 fetal heart rate tracing, hemolysis elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia, growth restriction <10th percentile (based on Hadlock growth curves) with reversal of flow in umbilical artery Doppler studies, and growth restriction <5th percentile with elevated, absent, or reversal of flow in umbilical artery Doppler studies
As described in previous research (Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016;128(6):1357 <= age <= 1364)
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03976037
| 197,920 |
{
"NCT_ID" : "NCT03723122",
"Brief_Title" : "Efficacy of a Dyadic Cancer-related Communication Reinforcement Intervention",
"Official_title" : "Cancer-related Communication Between Patients and Their Caregivers: A Randomized Controlled Trial Assessing the Efficacy of a Dyadic Communication Reinforcement Intervention (DCRI)",
"Conditions" : ["Cancer", "Communication Programs"],
"Interventions" : ["Behavioral: Dyadic Communication Reinforcement Intervention"],
"Location_Countries" : ["Belgium"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-07-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-08-24",
"Study_Completion_Date(Actual)" : "2018-12-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-10-23",
"First_Posted(Estimated)" : 2018-10-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-10-26",
"Last_Update_Posted(Estimated)" : 2018-12-04",
"Last_Verified" : 2018-12"
}
}}
|
#Study Description
Brief Summary
Background: To face cancer-related stress, patients and caregivers activate individual and dyadic coping responses. Opened communication, adequate involvement, reciprocal supportive roles, self-disclosure and responsiveness enhance dyadic coping. Nevertheless, little is known about the optimal content of dyadic interventions designed to improve dyadic communication.
Methods: A randomized controlled trail was designed to assess the efficacy of a dyadic intervention centered on a cancer-related communication reinforcement. Patient-caregiver dyads are randomly assigned to either an intervention group or a waiting list group. Patients and caregivers complete self-reported scales that assessed emotional distress, individual coping, cancer-related dyadic communication frequency, satisfaction, self-efficacy and coping at baseline and post-treatment (intervention group), or 6 weeks after baseline (waiting list group). This dyadic communication reinforcement intervention (DCRI) consists of a weekly 4-session intervention. This intervention includes specific communication tasks aiming the improvement of some cancer-related dyadic communication competencies such as concerns disclosure and request for support.
Discussion: DCRI would lead to improvements in cancer-related dyadic communication self-efficacy, cancer-related dyadic communication satisfaction and dyadic coping.
Detailed Description
1. Aim of the trial: A randomized longitudinal study assessing the efficacy of a dyadic communication reinforcement intervention (DCRI) between cancer patients and their caregivers. Efficacy of the DCRI will be assessed by the analysis of changes over time in both patients and caregivers self-reported questionnaires/scales measures.
2. Participants: Patients and caregivers are recruited from oncology clinics at Erasme Hospital and Jules Bordet Institute (Brussels, Belgium). Recruitment and all study procedures were approved by a central ethics committee (Erasme - ULB Ethics Committee) and all participants are providing written informed consent.
3. Study Design: Participants are randomly assigned to the experimental group, consisting of the DCRI, or to the control group, consisting of a waiting list. Dyads in the waiting list can complete the DCRI after the last assessment if they want to. Investigator, psychologist in charge of the intervention and participants are blinded for this randomization. Dyads completed a follow-up assessment (T2), either 2 weeks after the DCRI in the experimental group or 6 weeks after baseline in the control condition. All assessment time were completed either at the outpatient clinic or at home.
4. DCRI content: DCRI aims communication reinforcement by a weekly 4-sessions program. DCRI is manualized and is conducted by an experienced psychologist (same psychologist for all participating dyads). Sessions focus on reciprocal cancer-related stress communication between patients and their caregivers using a specific communication task that promotes self-disclosure and request for support. All sessions are divided into four times: (1) session introduction, (2) first communication task, (3) second communication task and (4) session conclusion.
(1)Session introduction: Firstly, psychologist assesses if any significant moment occurred before the actual session and let dyad members talk about it if they want. Secondly, psychologist addresses some theoretical information about the session subject. First and second session subject is about personal cancer-concerns disclosure and close one supportive response to this disclosure. Third and fourth session subject is about personal request for support to face a cancer-related stress and close one response to this request for support. In the first and second session, psychologist therefore discusses the importance of sharing stress appraisal, stress describing, thoughts and emotions expressing and how to be supportive in responding. In the third and fourth session, psychologist discusses the importance of the personal needs communication and the clarity of the request for support to be well understood by the partner.
(2 \& 3) First and second communication task: This communication task is divided into an audio-recorded communication exercise and the debriefing of this communication exercise. In each session, there are therefore two communication tasks (two exercises and two debriefing). An exercise lasts 5 minutes and psychologist stays with the dyad but does not intervene during it. This exercise consists in patient and caregivers embody a specific role: 'discloser' and 'listener'. Each role is associated with specific instructions. Exercise (and therefore task) is performed twice a session to let patient and caregiver experiment each of these roles. In the first and second session, the discloser has to express a personal cancer-related stress to the listener. The listener has to listen and respond supportively to this expressed cancer-related stress. In the third and fourth session, the discloser has to ask for help about a personal cancer-related stress to the listener. The listener has to listen and respond to this request for support. The exercise debriefing consists in the listening, in session, of the exercise record. After the listening, psychologist asks to the listener what kind of the discloser communicational behavior help him to understand the expressed cancer-related stress. Psychologist asks also to the discloser what kind of the listener communicational behavior help him to feel supported. After that, psychologist reinforces each positive communication strategy used by the discloser and the listener.
(4) Session conclusion: Psychologist summarizes the two communication tasks and notes all positive communication strategies used by the patient and the caregiver in self-disclosing/responding (first and second session) or request for support/responding to request for support.
5. Assessment procedure: Patients and caregivers are assessed by self-reported measures at baseline (T1) (after enrollment) and 2 weeks after the intervention (in the experimental group) or 6 weeks after baseline (T2) (in the control group). Patients and caregivers complete exactly the same self-reported questionnaires and scales. Patients had a medical information questionnaire in addition at baseline and study personnel rated their performance status, based on the Karnofsky Performance Status Scale, at T1 and T2. Other specific oncologic information was collected by medical record review.
At T1, demographic questionnaire assesses gender, age, cultural background, education level, native speaking, professional situation, familial situation (children) and psychiatric history. At T1, dyadic information questionnaire assesses relationship type, relationship length, living situation and contact frequency between patients and caregivers.
Patients and caregivers complete following self-reported scales in T1 and T2: (1) Cancer-related dyadic communication frequency, (2) cancer-related dyadic communication satisfaction, (3) cancer-related communication self-efficacy, (4) Dyadic Coping Inventory, (5) Hospital Anxiety and Depression Scale and (6) Ways of Coping Checklist.
6. Statistical Analysis: Statistical analysis consisted in a comparative analysis of groups at baseline using parametric and nonparametric tests as appropriate (Student's t test, Mann-Withney U test or Chi-squared test). Patients and caregivers outcomes at baseline and after the DCRI, or after the waiting period, were compared using repeated measures analysis of variance (MANOVA). Time and group-by-time effects were processed using MANOVA. Effect size will be report with eta-squared (η²) given by MANOVA. All tests were two-tailed, and the alpha was set at 0.05. All analyzes were performed using SPSS®, version 25.
7. Data Quality Control: There are 6 study collaborators: (1) recruitment manager, (2) investigation coordinator, (3) assessor, (4) psychologist in charge of the intervention, (5) data manager and (6 \& 7) two data assistants.
1. Recruitment manager manages the recruitment process. Every recruitment steps have been approved by institution ethics committee. Patients phone numbers meeting inclusion criteria are provided by the medical staff to the recruitment manager only. These phone numbers are destroyed after the recruitment phase. Recruitment manager calls each patient to give them basic information about the study. If they are interested in, recruitment manager calls the designated caregiver with the patient consent. If the caregiver agrees too, recruitment manager makes an appointment to provide a written informed consent.
2. Investigation assistant provides the randomization number for each participating dyad to the data manager. He books all DCRI session for the psychologist in the good time lapses (regarding the group).
3. Assessor assists participants in questionnaires and scales if they need it and he rates each patient by a Karnofsky score. A numerical copy is made for each assessment. This copy is put on a encrypted hard drive disk. Paper version is given in person to data manager. Paper versions are stored in a secure location.
4. Psychologist conducts the DCRI
5. Data manager manages randomization number, securing data storage, data encoding and encoding checking.
6. Data assistants encode data provide by the questionnaires and scales. They only have a participant ID and no randomization information. Double encoding, checked by the data manager, reduces encoding error.
This 7-persons functioning guarantees complete masking procedure from recruitment to encoding.
#Intervention
- BEHAVIORAL : Dyadic Communication Reinforcement Intervention
- Psycho-educative and behavioral intervention centered on cancer-related dyadic communication
|
#Eligibility Criteria:
Inclusion Criteria:
* To read and speak French
* To be aged 18 years or more
* To be diagnosed with any cancer type with a life expectancy of >= 6 months or be the caregiver of patients meeting this inclusion criteria
* To benefit from a folfox, folfiri, folfirinox or folfiri+bevacizumab-type chemotherapy with a life expectancy of >= 6 months or be the caregiver of patients meeting this inclusion criteria
Exclusion Criteria:
* Not be treated for a psychiatric disorder
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03723122
| 27,507 |
{
"NCT_ID" : "NCT04846335",
"Brief_Title" : "Familiar Fatal Insomnia: Preventive Treatment With Doxycycline in Subject With Disease Risk",
"Official_title" : "Familiar Fatal Insomnia: Preventive Treatment With Doxycycline in Subject With Disease Risk",
"Conditions" : ["Familial Fatal Insomnia"],
"Interventions" : ["Drug: Doxycycline Hcl", "Drug: Placebo"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-04-28",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-04-12",
"Study_Completion_Date(Actual)" : "2024-11-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-04-12",
"First_Posted(Estimated)" : 2021-04-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-04-12",
"Last_Update_Posted(Estimated)" : 2024-12-05",
"Last_Verified" : 2021-04"
}
}}
|
#Study Description
Brief Summary
The neurodegenerative disorders is a class o pathologies including very common diseases as Alzheimer or Parkinson or very rare as fatal familial insomnia (FFI), the progression of the disease with no therapeutic remedy is the common tract of these disorders. The aim of this project is to carry out a preventive treatment in subjects with genetic risk to develop FFI to avoid the establishment of the disease. FFI is a rare genetic neurodegenerative disease characterized by disrupted sleep, autonomic hyperactivation and motor abnormalities with fatal exitus. FFI is inherited in an autosomal dominant fashion and is linked to the D178N mutation in the prion protein gene (PRNP) in association with a methionine at the polymorphic codon 129 (D178N/M129). About thirty FFI pedigrees have been described worldwide, the mfirst case being reported in 1986 in northern Italy. This patient turned out to belong to large kindred, which spans 7 generations dating back to the eighteenth century. Many people belonging to this geneaology still live in the Veneto region of Italy, and they are part of an association. The genetic screening of 85 subjects belonging to this family permitted to identify the mutation carriers. Since the disease is aggressive and the affected people usually died within thirteen months from the onset, the possibility of an efficacious therapy when the disease become evident is unrealistic. This condition indicates in a preventive approach the better condition to affect the disease. Experimental studies and clinical observation indicated the antibiotic doxycycline (DOXY) as a potential candidate for a treatment in FFI subjects. The age with maximal risk to get the disease is between 50 and 55 years old. Thus the carriers that were born between 1958 and 1969 will be recruited for a preventive treatment with DOXY for ten years, at the end of this period or before we can establish if DOXY can be useful to avoid the development of FFI.
#Intervention
- DRUG : Doxycycline Hcl
- tablets of DOXY hydrocloride (Bassado)
- DRUG : Placebo
- tablets of placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* subjects aged 44 <= age <= 53;
* no conditions known to be contraindications to the use of tetracyclines;
* written informed consent.
Exclusion Criteria:
* end stage liver,
* heart and renal disease,
* active malignancy,
* female subjects who are pregnant or lactating
Sex :
ALL
Ages :
- Minimum Age : 44 Years
- Maximum Age : 53 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04846335
| 83,575 |
{
"NCT_ID" : "NCT04475029",
"Brief_Title" : "Methadone in Cystectomy Patients",
"Official_title" : "Clinical Effectiveness and Safety of Intraoperative Methadone in Patients",
"Conditions" : ["Pain, Postoperative", "Postoperative Complications", "Pathologic Processes", "Bladder Cancer", "Pain", "Signs and Symptoms", "Neurologic Manifestations", "Neurologic Symptoms", "Side Effect of Drug"],
"Interventions" : ["Drug: Methadone", "Drug: Morphine"],
"Location_Countries" : ["Denmark"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-07-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-08-15",
"Study_Completion_Date(Actual)" : "2023-08-17},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-07-09",
"First_Posted(Estimated)" : 2020-07-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-07-16",
"Last_Update_Posted(Estimated)" : 2023-09-13",
"Last_Verified" : 2023-04"
}
}}
|
#Study Description
Brief Summary
The role of a single-dose intraoperative methadone on postoperative pain and opioid consumption in patients undergoing Surgeon Accuracy Robot Assistant cystectomy. A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone in patients undergoing robotassisted cystectomy.
Detailed Description
During early recovery after surgery, intravenous opioids are typically administered to control the pain, either as intermittent bolus administration by nursing staff or by a patient-controlled analgesia device. Unfortunately, repeated doses or boluses of shorter-acting opioids, such as morphine, oxycodone and fentanyl, result in fluctuating blood concentrations, with the inherent risk of only relatively brief periods of adequate pain relief. Moreover, the use of shorter-acting opioids increases the risk of opioid-associated side effects, such as sedation, nausea and vomiting. An alternative approach to the postoperative use of shorter-acting opioids is therefore called for.
In this respect, methadone is an opioid with unique pharmalogical properties that may be advantageous when applied intraoperatively. A single-dose of this long acting opioid could provide a stable analgesia and potentially reduce the need for shorter-acting opioids
Method:
110 patients will be included in an investigator-initiated, prospective, randomised, double-blind, controlled trial with two arms: intervention arm (methadone 0.15 mg/kg ideal body weight). Control arm (morphine 0.15 mg/kg ideal body weight). The study will be GCP-monitored, and is approved by the Danish Health and Medicines Authority (2020041652) and the Central Denmark Region Committees on Health Research Ethics (1-10-72-275-19).
Hypothesis We hypothesize that a single-dose of intravenous intraoperative methadone is efficient and safe for the treatment of postoperative pain after cystectomy.
Objectives The primary objective is to determine whether a single-dose of intravenous methadone reduces postoperative opioid consumption when compared to morphine. The secondary objectives are to compare the effect and safety of intravenous methadone and morphine on postoperative pain, side effects, patient satisfaction and length of stay.
#Intervention
- DRUG : Methadone
- One intravenous administration of methadone (0.15 mg/kg treatment weight (height(cm)-100)) one hour prior to expected extubation.
- DRUG : Morphine
- One intravenous administration of morphine (0.15 mg/kg treatment weight (height(cm)-100)) one hour prior to expected extubation.
|
#Eligibility Criteria:
Inclusion Criteria:
* All patients (>=18 years) scheduled for elective robot assisted cystectomy.
Exclusion Criteria:
* American Society of Anesthesiologists (ASA) physical status IV or V
* Prolonged QTc-interval assessed by electrocardiogram (> 440 milliseconds)
* Existing treatment with a high risk of QTc-interval prolongation
* Allergy to study drugs
* Preoperative daily use of opioids
* Inability to provide informed consent
* Severe respiratory insufficiency (oxygen treatment at home)
* Heart failure (ejection fraction < 30%)
* Acute abdominal pain
* Signs of severe liver dysfunction (cirrhosis, inflammation/hepatitis or liver malignancy)
* Severe kidney insufficiency (estimated Glomerular Filtration Rate < 30 ml/min)
* Treatment with rifampicin
* Phaeochromocytoma
* Treatment with MAO-inhibitor during the last 14 days
* Pregnancy
* Nursing mothers
* Intraoperative conversion to open surgery (secondary inclusion criterion)
* Epidural analgesia in relation to surgical procedure
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 110 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04475029
| 50,901 |
{
"NCT_ID" : "NCT04185415",
"Brief_Title" : "A Study to Test the Safety and Tolerability of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP)",
"Official_title" : "A Participant-Blind, Investigator-Blind, Placebo-Controlled, Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP)",
"Conditions" : ["Progressive Supranuclear Palsy"],
"Interventions" : ["Drug: bepranemab", "Drug: Placebo"],
"Location_Countries" : ["Germany", "United Kingdom", "Belgium", "Spain"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-12-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-11-17",
"Study_Completion_Date(Actual)" : "2021-11-17},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-12-02",
"First_Posted(Estimated)" : 2019-12-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-12-02",
"Last_Update_Posted(Estimated)" : 2023-12-01",
"Last_Verified" : 2023-11"
}
}}
|
#Study Description
Brief Summary
The purpose of the study is to assess the safety and tolerability of UCB0107 in study participants with Progressive Supranuclear Palsy (PSP).
#Intervention
- DRUG : bepranemab
- bepranemab will be administered in a predefined dosage.
* Pharmaceutical Form: Solution for infusion
* Route of Administration: Intravenous
- Other Names :
- UCB0107
- DRUG : Placebo
- * Pharmaceutical Form: Solution for infusion
* Concentration: 0.9% w/v sodium chloride aqueous solution
* Route of Administration: Intravenous
|
#Eligibility Criteria:
Inclusion Criteria:
* Participant must be >=40 years at the time of signing the informed consent
* Participants meet the criteria for possible or probable Progressive Supranuclear Palsy (PSP) Richardson's Syndrome according the Movement Disorder Society (MDS)-PSP criteria
* Participant is able to walk at least 5 steps with minimal or no assistance (stabilization of one arm or use of cane/walker)
* Participant has reliable caregiver support during the whole study period or the participant is able to independently follow the study protocol
* Participant is stable on all treatments for at least 2 weeks prior to the Baseline Visit
* Participant has a body mass index (BMI) within the range 16.0 to 32.0 kg/m^2 (inclusive)
* Participants can be male or female
* Participant (and caregiver or legal representative, if applicable) is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent form (ICF) and in this protocol. Informed consent must be obtained before initiating any study procedures
Exclusion Criteria:
* Ongoing, recurrent, severe headaches, including migraines
* Evidence of any clinically significant neurological disorder (including any clinically significant abnormalities on the screening magnetic resonance imaging) other than Progressive Supranuclear Palsy (PSP)
* Participant has a lifetime history of suicide attempt, or has suicidal ideation with at least some intent to act in the past 12 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the 'Screening/Baseline' version of the Columbia-suicide severity rating scale (C-SSRS) at Screening
* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or medical monitor, contraindicates participation in the study
* The following liver enzyme test results:
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) are >2.0x upper limit of normal (ULN)
* Bilirubin >1.5x ULN (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35 %)
* The mean QT interval value (corrected by Fredericia's formula for the heart rate, QTcF) of the 3 Screening ECGs is >450 msec for male participants or >470 msec for female participants or QTcF is >480 msec in participants with bundle branch block
* Abnormalities in lumbar spine previously known or determined by a Screening lumbar x-ray (if conducted) that may jeopardize the execution of the lumbar puncture
* Participant was previously treated with tau-protein targeting drugs and/or tau-protein targeting antibodies or vaccines.
* Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to the first dose
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04185415
| 209,038 |
{
"NCT_ID" : "NCT06179043",
"Brief_Title" : "Impact of Front-of-package Warning Labels on Perceived Weight Stigmatization",
"Official_title" : "Examining the Impact of Different Types of Front-of-package Warning Labels for Sugar-sweetened Beverages on Perceived Weight Stigmatization Among a Sample of US Adults",
"Conditions" : ["Weight Stigma"],
"Interventions" : ["Behavioral: Graphic health warning labels", "Behavioral: Control labels", "Behavioral: Nutrient warning labels", "Behavioral: Text-only health warning labels"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "FACTORIAL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2024-01-18",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-01-26",
"Study_Completion_Date(Actual)" : "2024-01-26},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-12-11",
"First_Posted(Estimated)" : 2023-12-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-12-11",
"Last_Update_Posted(Estimated)" : 2024-02-13",
"Last_Verified" : 2024-01"
}
}}
|
#Study Description
Brief Summary
The goal of this experiment is to examine the effects of three different types of front-of-package warning labels for sugar-sweetened beverages on perceived weight stigmatization, as well as the effect of making such labels more weight-neutral. The main questions this experiment aims to answer are:
* Are certain types of front-of-package warning labels perceived as more stigmatizing than others?
* Are more weight-neutral versions of front-of-package warning labels perceived as less stigmatizing than their regular versions?
* Is there a trade-off between label effectiveness in discouraging product consumption and perceived weight stigmatization?
Additionally, this experiment also aims to answer the following questions:
* Does exposure to certain types of front-of-package warning labels lead to changes in participants' weight bias?
* Are changes in participants' weight bias as a result of label exposure mediated by attribution of personal responsibility for body weight, pathogen disgust, or perceived social consensus?
Detailed Description
Participants will be randomly assigned to see one of four types of labels: control labels, nutrient warning labels, text-only health warning labels, or graphic health warning labels. Participants will then see an image depicting different types of fictional sugar-sweetened beverages carrying the label type that they were assigned to. Participants will see this image twice, in random order, each time differing in whether the label is weight-neutral or not (i.e., whether the label references calories/obesity or not). Each time, participants will answer survey questions about the label. Last, participants will answer survey questions measuring their weight bias and potential mediating variables.
#Intervention
- BEHAVIORAL : Nutrient warning labels
- In random order, participants in this arm will see an image of fictional sugar-sweetened beverages carrying:
* Labels that read 'high in sugars' and 'high in calories'
* A label that reads 'high in sugars'
- BEHAVIORAL : Text-only health warning labels
- In random order, participants in this arm will see an image of fictional sugar-sweetened beverages carrying:
* A label that reads 'Drinking beverages with added sugars contributes to obesity, type 2 diabetes and tooth decay'
* A label that reads 'Drinking beverages with added sugars contributes type 2 diabetes and tooth decay'
- BEHAVIORAL : Graphic health warning labels
- In random order, participants in this arm will see an image of fictional sugar-sweetened beverages carrying:
* A label that reads 'Drinking beverages with added sugars contributes to obesity, type 2 diabetes and tooth decay' and contains graphics illustrating obesity, type 2 diabetes, and tooth decay
* A label that reads 'Drinking beverages with added sugars contributes type 2 diabetes and tooth decay' and contains graphics illustrating type 2 diabetes and tooth decay
- BEHAVIORAL : Control labels
- In random order, participants in this arm will see an image of fictional sugar-sweetened beverages carrying:
* A neutral bar code label
* A neutral quick response (QR) code label (not scannable)
|
#Eligibility Criteria:
Inclusion criteria:
* At least 21 years.
* Residing in the US.
Exclusion Criteria:
*Involved in any pre-testing.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06179043
| 124,224 |
{
"NCT_ID" : "NCT01685775",
"Brief_Title" : "Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy",
"Official_title" : "Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy: a Randomized Clinical Trial",
"Conditions" : ["Calculus of Gallbladder With or Without Cholecystitis", "Laparoscopic Cholecystectomy"],
"Interventions" : ["Procedure: Needlescopic with 3 trocars", "Procedure: Transvaginal/transumbilical"],
"Location_Countries" : ["Germany"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-07",
"Study_Completion_Date(Actual)" : "2012-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-09-04",
"First_Posted(Estimated)" : 2012-09-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-09-11",
"Last_Update_Posted(Estimated)" : 2013-10-16",
"Last_Verified" : 2013-10"
}
}}
|
#Study Description
Brief Summary
Laparoscopic surgery has become the golden standard for the removal of the gallbladder. Recently, developments have been made so that operations can be performed through a natural orifice instead of the abdominal wall, thus minimizing the trauma of a procedure. This study compares the transvaginal/transumbilical cholecystectomy with the laparoscopic operation using 2-3mm instruments in female patients. It also examines the benefits and disadvantages related to postoperative pain, cosmetic aspects, and potential physiological alterations to the transvaginal approach that affect sexual intercourse.
Detailed Description
The amount of trauma inflicted, especially in abdominal operations, depends largely on target organ access. Great efforts have been made to minimize access trauma. The further development of laparoscopy led to the miniaturization of surgical instruments and otherwise the use of natural orifices, like the stomach, rectum or vagina. The cholecystectomy is currently performed needlescopicly with 2-3 mm trocars and in transumbilically assisted transvaginal technique. The aim of this randomized study is to compare these two techniques in female patients that are in need of an elective cholecystectomy. The patients will be randomized on a 1:1 ratio into two treatment groups. In the needlescopic group the investigators will use two 2-3 mm working trocars and one 10 mm optic trocar, also to extract the gallbladder. In the transvaginal/transumbilical group the investigators will perform the Zornig technique using a 5 mm trocar in the umbilicus and a 10 mm trocar together with a 5 mm seizing forceps through the posterior vaginal vault. The primary endpoint of this trial is to measure the intensity of pain in motion measured from the day of the operation until postoperative day 2. Four different measurements of pain will be used. Furthermore the investigators examine perioperative complications as security parameters. The trial is supported in part by the German Ministry of Research and Education (CHIR-Net grant, BMBF No. 01-GH-0605).
#Intervention
- PROCEDURE : Transvaginal/transumbilical
- PROCEDURE : Needlescopic with 3 trocars
|
#Eligibility Criteria:
Inclusion Criteria:
* Gender: Female
* Minimum Age: 18 Years
* Maximum Age: 80 Years
* indication for elective cholecystectomy on account of symptomatic cholecystolithiasis
* age >=18 years and <=80 years
* legal competence
Exclusion Criteria:
* Acute cholecystitis or locally complicated disease (gallbladder empyema, choledocholithiasis, pancreatitis, etc.)
* liver cirrhosis (Child Pugh A, B, C)
* severe comorbidity, class IV or V as defined by the American Society for Anesthesiologists (ASA)
* intact hymen
* acute vaginal infection
* lacking visibility of the uterine orifice
* endometriosis
* malignoma
* obesity with a Body Mass Index (BMI) > 40 kg/m2
* chronic abuse of analgesics or alcohol
* neuromuscular disease that could interfere treatment or measures of pain
* history of major abdominal surgery with a high risk of intraperitoneal adhesions (minor operations such as an appendectomy, inguinal hernia repair, minor gynaecological surgery, etc. will not be considered exclusion criteria)
* gravidity or breastfeeding
* allergy against analgesics
* patients who are dependent on or employed by the trial sponsor or physicians
* institutionalisation for legal reasons
* participation in other clinical studies that could interfere with the present trial
* no written informed consent signed
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01685775
| 140,620 |
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