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{
"NCT_ID" : "NCT01580813",
"Brief_Title" : "Evaluating the Effects of a Study Medication on Exercise Function in Type 2 Diabetes",
"Official_title" : "Effects of Serum Fatty Acid Lowering on Insulin Sensitivity, Cardiovascular Function, And Exercise Capacity in Non-Insulin Dependent Diabetes",
"Conditions" : ["Type 2 Diabetes"],
"Interventions" : ["Drug: Placebo", "Drug: Acipimox"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-06-05",
"Study_Completion_Date(Actual)" : "2015-06-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-05-24",
"First_Submitted_that_Met_QC_Criteria" : 2021-11-05",
"First_Posted(Estimated)" : 2012-04-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-04-17",
"Last_Update_Posted(Estimated)" : 2021-12-03",
"Last_Verified" : 2021-11"
}
}}
|
#Study Description
Brief Summary
People who are overweight or who have type 2 diabetes mellitus (T2DM) have higher levels of certain fats in their blood. The blood vessels and heart of most of these individuals do not work normally and people with T2DM also have an impaired ability to perform exercise. The purpose of this study is to use the free fatty acid lowering drug, acipimox, to temporarily decrease the level of fat in the bloodstream of people with T2DM and observe the physiological changes to blood vessel function and exercise capacity and insulin sensitivity. This will help the investigators to understand ways of improving blood vessel function and the ability to exercise effectively in people who are overweight or have T2DM.
#Intervention
- DRUG : Acipimox
- Subjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit.
- Other Names :
- Olbetam
- DRUG : Placebo
- Subjects will take a placebo pill 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit.
|
#Eligibility Criteria:
Inclusion Criteria:
* Sedentary adults not participating in a regular exercise program (<= one bout of scheduled exercise per week)
* Subjects must have Type 2 Diabetes
* Subjects must be otherwise healthy
* Ages of 30 <= age <= 60 years
* BMI of 25 <= age <= 39 and stable weight for 3 months prior to the start of the study
* Diabetes controlled by diet +/- insulin secretagogues (sulfonylureas or glinides), metformin, or glucose absorption blockers (acarbose).
* Total glycosylated hemoglobin levels (HbA1C) <=9% (fair control) on current therapy.
Exclusion Criteria:
* Any comorbid condition which could limit exercise performance including Chronic Obstructive Pulmonary Disease (COPD) or asthma
* Concurrent enrollment in an interventional study.
* Any tobacco use either current or within the last year
* Clinically evident distal symmetrical neuropathy, determined by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, light touch, ankle jerks), will be excluded.
* Autonomic dysfunction (>20 mm fall in upright BP without a change in heart rate) will be excluded.
* Evidence of ischemic heart disease by history or abnormal resting or exercise electrocardiogram (EKG) (> 1 mm ST segment depression) on screening exercise test.
* Angina or any other cardiovascular, pulmonary or musculoskeletal symptoms
* Presence of systolic blood pressure >190 at rest or >250 with exercise or diastolic pressure >95 at rest or >105 with exercise
* Proteinuria (urine protein >200 mg/dl) or a creatinine > 2 mg/dl, suggestive of severe renal disease
* Proliferative retinopathy
* Insulin, incretin, or glitazone treatment
* Niacin treatment
* History of peptic ulcers
* A history of hereditary angioedema
* C1 esterase deficiency
* Women who are pregnant or breastfeeding
* Use of fibrate drugs
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT01580813
| 134,633 |
{
"NCT_ID" : "NCT06289166",
"Brief_Title" : "Safety and Efficacy of STSP-0601 in Adult Patients with Hemophilia a or B with Inhibitor",
"Official_title" : "A Multi-center, Open-label, Phase Ⅱb Trial to Evaluate the Safety and Efficacy of STSP-0601 for Injection in Patients with Hemophilia with Inhibitor",
"Conditions" : ["Hemophilia"],
"Interventions" : ["Drug: STSP-0601 for Injection"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SEQUENTIAL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2024-03-18",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-10-17",
"Study_Completion_Date(Actual)" : "2024-10-17},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-02-23",
"First_Posted(Estimated)" : 2024-03-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-02-23",
"Last_Update_Posted(Estimated)" : 2025-01-22",
"Last_Verified" : 2025-01"
}
}}
|
#Study Description
Brief Summary
This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor.
#Intervention
- DRUG : STSP-0601 for Injection
- A Multiple-dose Design to Evaluate the Safety, Tolerability and Efficacy of STSP-0601 for Injection in hemophilia A or B patients with inhibitor.
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 <=age<=70 years,male.
* Hemophilia A or B patients. (No less than 3 patients with hemophilia B)
* Peak historical inhibitor titer >= 5 BU and apositive inhibitor test when enrolled.
* Establish proper venous access.
* There were at least 3 bleeding events that requiring treatment occurred in the past 6 months before screening (Only applicable to the on-demand treatment stage).
* Agree to use adequate contraception to avoid pregnancy. Agree not to donate sperm or eggs.
* Provide signed informed consent.
Exclusion Criteria:
* Have any coagulation disorder other than hemophilia.
* Plan to receive prophylactic treatment of coagulation factor during the trail.
* Patients plan to receive Emicizumab during the trial.
* Patients received anticoagulant or antifibrinolytic therapy 7 days before enrollment or plan to receive these drugs during the trial.Patients received anticoagulation therapy (such as coagulation factor replacement therapy, prothrombin complex, plasma, etc.) 7 days before enrollment.
* Have a history of arterial and/or venous thrombotic events.
* Platelet <100×109/L.
* Hemoglobin<90g/L.
* Severe liver or kidney disease.
* Severe bleeding event occurred within 4 weeks before enrollment.
* Accepted major operation or blood transfusion within 4 weeks before enrollment.
* Have a known allergy to STSP-0601.
* Pregnant, lactating, or blood pregnancy test positive female subjects
* Participate in other clinical research within 4 weeks before enrollment(except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails).
* Within 1 day prior to enrollment, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days prior to enrollment, prothrombin complex, FVIII, and FIX were used. Within 4 weeks prior to enrollment, treatment with amisulumab was received.
* Patients not suitable for the trail according to the judgment of the investigators.
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
|
NCT06289166
| 12,666 |
{
"NCT_ID" : "NCT02608736",
"Brief_Title" : "Chemoprevention of Head and Neck Squamous Cell Carcinoma (HNSCC) With Valproic Acid",
"Official_title" : "Phase 0 Clinical Trial With Valproic Acid as a Chemopreventive Agent in Patients With Head and Neck Squamous Cell Carcinoma Previously Treated",
"Conditions" : ["Head and Neck Squamous Cell Carcinoma"],
"Interventions" : ["Drug: Valproic Acid", "Drug: Placebo"],
"Location_Countries" : ["Brazil"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["EARLY_PHASE1"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-12",
"Study_Completion_Date(Actual)" : "2017-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-11-16",
"First_Posted(Estimated)" : 2015-11-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-11-17",
"Last_Update_Posted(Estimated)" : 2018-02-01",
"Last_Verified" : 2016-09"
}
}}
|
#Study Description
Brief Summary
This study evaluates the addition of valproic acid as a chemopreventive drug in head and neck squamous cell carcinoma (HNSCC) patients that do not have signs of recurrence or residual disease. The participants will be randomized 1:1 (valproic acid : placebo). The primary outcome is to document histone acetylation and DNA methyltransferase expression (DNMT) in saliva collected from participants when comparing valproic acid arm with placebo arm.
Detailed Description
Chemoprevention is an attractive strategy to reduce the incidence of squamous cell carcinoma of the head and neck, although past trials have not demonstrated its feasibility.
Valproic acid (VA) is a modifier of epigenetic events as it is an histone deacetylase inhibitor and causes DNMT degradation. The histone deacetylase inhibitors (e.g. VA) encompasses a new class of anti-tumor drugs, that can affect multiple pathways related to tumor initiation and progression due to histone and non-histone protein acetylation and DNMT degradation. VA promote histone acetylation when orally administered with a dose of 20-40 mg/kg, per day or 1000/1500 mg, per day.
Initially the authors will study saliva from participants documenting if there is saliva histone acetylation and if a difference in DNMT expression in saliva exists when comparing valproic acid arm to placebo arm (biological validation) after giving placebo or valproic acid for three months.
This will be the initial step of a bigger project. If authors prove that there will be a difference in histone acetylation and/or DNMT expression between groups they will launch a randomized, double blind, placebo control clinical trial (phase 3 clinical trial), to evaluate VA action as a chemopreventive agent in HNSCC patients who usually carries a high chance to develop recurrence (stages III/IV) or second primary malignancies (stages I/II/III/IV).
#Intervention
- DRUG : Valproic Acid
- Half of the participants will receive valproic acid orally for three months. Saliva and blood will be sampled in the study entry. The participants will be followed with blood tests every month for three cycles. After the third cycle, saliva and blood will be sampled once more. Finally, histone acetylation and DNMT expression will be studied comparing the samples collected in different timelines and comparing them to saliva collected in placebo arm.
- Other Names :
- Divalproex, Depakene, Depacon, Depakote
- DRUG : Placebo
- The other half of the participants will receive placebo for three months. Saliva and blood will be sampled in the study entry. The participants will be followed with blood tests every month for three cycles. After the third cycle, saliva and blood will be sampled once more. Finally, histone acetylation and DNMT expression will be studied comparing the samples collected in different timelines and comparing them to saliva collected in valproic acid arm.
- Other Names :
- Inert, not active
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients that signed the formal consent;
* Previous history of head and neck squamous cell carcinoma with no more than three years of follow-up;
* History of squamous cell carcinoma in the following sub-sites: oral cavity, oropharynx, larynx and hypopharynx;
* Absence of active malignant disease (HNSCC) with at least three months of follow-up (without signs of residual disease, recurrence or second primary invasive tumors);
* Normal liver, hematologic and renal function.
* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0, 1 or 2;
* Smoking history (current smokers or former smokers). Former users were defined as patients who had quit smoking at least one year prior to diagnosis and smoked more than 100 cigarettes in their lifetime.
Exclusion Criteria:
* Any active malignancy;
* History of invasive malignancies (other than HNSCC) diagnosed within the last 2 years (controlled non-melanoma skin cancer are an exception);
* History of hepatitis B, hepatitis C, HIV, chronic liver disease or chronic pancreatic disease;
* Any comorbid medical or psychiatric disorder that it is not well controlled;
* Patients under immunosuppression or under systemic corticosteroid therapy to treat any active autoimmune disease;
* Patients that still have documented toxicities greater than grade 1 (CTCEA NCI v4.0) due to the previously treated HNSCC;
* Patients that are pregnant or breast-feeding;
* Patients that are in routine use of the following medications due to drug interaction: phenytoin, carbamazepine, barbiturates, chlorpromazine, diazepam, clonazepam, lamotrigine, primidone, amitriptyline, nortriptyline, ethosuximide, warfarin, tolbutamide or topiramate;
* Any medical condition or mental disorder that can potentially increase their risk during the trial (e.g. epilepsy, active infection, schizophrenia);
* Patients that are already under valproic acid use due to neurological or psychiatric disorders;
* Patients that are allergic/intolerant to valproic acid;
* Patients with alcoholism history within the past year or that was under alcoholism treatment in the same period;
* Institutionalized 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
|
NCT02608736
| 129,312 |
{
"NCT_ID" : "NCT06289504",
"Brief_Title" : "A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight",
"Official_title" : "An Open-label, One-sequence Cross-over, Single-centre Trial, Investigating the Influence of CagriSema on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Atorvastatin in Participants With Overweight or Obesity",
"Conditions" : ["Obesity"],
"Interventions" : ["Drug: Atorvastatin", "Drug: Warfarin", "Drug: Semaglutide", "Drug: Cagrilintide"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "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)" : "2024-10-16",
"Study_Completion_Date(Actual)" : "2024-11-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-02-25",
"First_Posted(Estimated)" : 2024-03-04"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-02-25",
"Last_Update_Posted(Estimated)" : 2025-05-11",
"Last_Verified" : 2025-05"
}
}}
|
#Study Description
Brief Summary
This study will look at how CagriSema affects the blood levels of atorvastatin and warfarin. The study will look at the levels of warfarin and atorvastatin in the blood before the participant starts taking CagriSema and if this changes after the participant has taken CagriSema. The study will also investigate the effect of warfarin before and after the participant takes CagriSema and assess if the injection site affects the level of CagriSema in the blood. The study will last for about 8 months.
#Intervention
- DRUG : Cagrilintide
- Cagrilintide will be administered subcutaneously once weekly.
- DRUG : Semaglutide
- Semaglutide will be administered subcutaneously once weekly.
- DRUG : Atorvastatin
- Atorvastatin will be administered as a single dose orally 2 times during the study.
- DRUG : Warfarin
- Warfarin will be administered as a single dose orally 2 times during the study.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female.
* Aged 18 <= age <= 65 years (both inclusive) at the time of signing informed consent.
* Body Mass Index (BMI) between 27.0 and 39.9 kilograms per square meter (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
Exclusion Criteria:
* Previous dosing in a study with an amylin analogue.
* Presence or history of pathological bleeding tendencies, recent serious bleeding, recent myopathy or rhabdomyolysis, malignant hypertension and any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions including type 1 or type 2 diabetes mellitus.
* Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator.
* Glycated haemoglobin (HbA1c) greater than or equal to (>=) 6.5 % (48 millimoles per mole [mmol/mol]) at screening.
* Activated partial thromboplastin time (APTT) less than (<) 22.1 seconds (lower normal limit [LNL]-0%) or APTT greater than (>) 28.1 seconds (upper limit of normal [UNL) +0%) at screening.
* Prothrombin time < 70% (LNL-0%) or prothrombin time > 130% (UNL-0%) at screening.
* Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic cytochrome P450 (CYP) pathways, such as perikon (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae within 14 days (or within 5 half-lives of the medicinal product, whichever is longest) of screening, with the exception of use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of paracetamol and highly effective contraceptives.
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
|
NCT06289504
| 61,858 |
{
"NCT_ID" : "NCT03895073",
"Brief_Title" : "HEart fAiluRe evaluaTion Questionnaire",
"Official_title" : "Observation Study for the Assessment of the 'Four-point' Questionnaire by Severo and His Associates and Its Weighting in the Greek Population to Provide a Powerful Tool for Categorizing the Severity of the Symptoms of Heart Failure",
"Conditions" : ["Heart Failure", "Heart Failure NYHA Class III", "Heart Failure NYHA Class II", "Heart Failure NYHA Class I", "Heart Failure NYHA Class IV"],
"Interventions" : ["Other: healthy volunteers"],
"Location_Countries" : ["Greece"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-09-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-02-25",
"Study_Completion_Date(Actual)" : "2019-02-25},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-03-27",
"First_Posted(Estimated)" : 2019-03-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-03-28",
"Last_Update_Posted(Estimated)" : 2019-03-29",
"Last_Verified" : 2019-03"
}
}}
|
#Study Description
Brief Summary
The 'four-point' questionnaire by Severo and his associates was weighted in 2011 in the Portuguese population and aims to characterize the severity of the symptoms of heart failure by providing a way to minimize the reliability of the NYHA classification. The questionnaire consists of four closed questions, three possible single-choice answers, coded 0, 1 or 2, and has been translated into Greek in accordance with the internationally-based methodology, with forward-backward translation.
Detailed Description
In clinical practice, the most commonly used classifications of the severity of CA⸱ are the New York Heart Association functional classification (NYHA), which is based on symptoms and exercise capacity11 and has been used in the majority of clinical trials combined with the fraction left ventricular ejection and ACC / AHA (American College of Cardiology Foundation / American Heart Association), which describes the disease according to structural lesions and symptoms.
With NYHA calibration, patients can be classified into four classes (I, II, III, IV) according to conclusions drawn from the medical history and / or observations of their physical activity and in some cases from cardiac function measurements . An attempt has been made to increase the objectivity of the method through a more comprehensive assessment, which will also be based on clinical measurements from electrocardiograms, stress tests, x-rays, echocardiograms, etc. There is a very high variability among clinicians' ratings on classifying patients in classes based on the NYHA functional classification as the class is selected according to the physician's personal assessment of the patient's physical condition. This increases the subjectivity of the particular sorting system. Studies have shown that there is agreement on NYHA calibration between different doctors for the same patient, of 55%, which leads to the conclusion that the use of this scale as the endpoint in clinical research is questionable and inadequate.
Patient self-assessments are more reliable with respect to the subjectivity of assessing the severity of symptoms. This is why maximizing the interest of the scientific community, clinicians and pharmaceutical companies in developing more subjective methods of measuring health status. 30% of all new drugs developed use patient-reported outcomes (PROs) as primary or intermediate endpoints.
The different data collection methods and sampling techniques are methods and methodologies that allow for the reduction of the amount of data to be collected, considering data only as some elements of a subset of the cases under consideration. The questionnaire is a form that includes a series of structured questions, in which the respondent is asked to respond in writing and in a specific order. Questionnaires collect data asking people to answer exactly the same set of questions. They are usually used in a research strategy to collect descriptive and explanatory data about views, behaviors, features, attitudes, etc. The questionnaire is the means of communication between the researcher and the respondents, directly or indirectly, depending on the method of data collection. The structure of the questionnaire, due to its qualities, is the most critical and delicate task, crucial to the success of a statistical survey.
#Intervention
- OTHER : healthy volunteers
- the questionnaire has been assessed by both groups, healthy and heart failure
- Other Names :
- healthy vs heart failure
|
#Eligibility Criteria:
Inclusion Criteria:
* NYHA classification
* informed consent
* compliant with study procedures
Exclusion Criteria:
* no informed consent
Sex :
ALL
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
|
NCT03895073
| 13,986 |
{
"NCT_ID" : "NCT06063642",
"Brief_Title" : "Neurofeedback for Internet Gaming Addiction",
"Official_title" : "Real-time Functional Magnetic Resonance Imaging Neurofeedback Treatment for Young Adults With Internet Gaming Addiction",
"Conditions" : ["Internet Gaming Disorder"],
"Interventions" : ["Device: Neurofeedback training", "Device: Sham feedback training"],
"Location_Countries" : ["Macau"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-10-15",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-02-20",
"Study_Completion_Date(Actual)" : "2024-03-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-05-31",
"First_Posted(Estimated)" : 2023-10-02"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-09-29",
"Last_Update_Posted(Estimated)" : 2024-07-30",
"Last_Verified" : 2023-09"
}
}}
|
#Study Description
Brief Summary
The primary aim of this study is to evaluate the therapeutic potential of real-time functional magnetic resonance imaging (MRI) neurofeedback in alleviating internet gaming disorder (IGD) symptoms by training individuals with such symptoms to down-regulate the activity in their reward-processing-related midbrain regions.
#Intervention
- DEVICE : Neurofeedback training
- Neurofeedback training is a type of non-invasive brain modulation technique that enables individuals to self-regulate brain activity patterns by providing them feedback on specific activity measures. Effective self-regulation is often linked to changes in cognition, behavior, and clinical symptoms.
- DEVICE : Sham feedback training
- A controlled form of neurofeedback training that provides feedback irrelevant to the targeted mental process.
|
#Eligibility Criteria:
Inclusion Criteria:
* Meet at least five of the Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) criteria for IGD and score 38 or above on the Internet Addiction Test (IAT)
* First language is Chinese (Mandarin)
* Right-handed
* Have played the mobile game 'King of Glory' for more than 3 years
* Ability to give informed consent
* Normal or corrected-to-normal vision
Exclusion Criteria:
* Any primary diagnosis of a current psychological or neurological disorder
* Any history of psychological or neurological disorder
* Any MRI contraindication
* Currently on a psychotropic medication
* Any history of substance dependence
* Any history of brain injury or surgery
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 28 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06063642
| 164,231 |
{
"NCT_ID" : "NCT06473636",
"Brief_Title" : "Mindfulness Training Improves Emotions Among Female Abdominal Cancer Patients",
"Official_title" : "Mindfulness Training Improves Depression Among Female Abdominal Cancer Patients Through Improving Cognitive Emotion Regulation and Emotional State",
"Conditions" : ["Mindfulness Training"],
"Interventions" : ["Behavioral: Mindfulness training"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2024-08-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-12-30",
"Study_Completion_Date(Actual)" : "2024-12-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-06-19",
"First_Posted(Estimated)" : 2024-06-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-06-19",
"Last_Update_Posted(Estimated)" : 2025-05-07",
"Last_Verified" : 2025-05"
}
}}
|
#Study Description
Brief Summary
We first explored the effect of mindfulness training on depression in patients with abdominal cancer. Then the effects of cognitive emotion regulation and emotional state in the training effect were examined. Sixty patients with abdominal cancer were recruited from a hospital and divided into two groups: the mindfulness group (n=30) who received a four-week mindfulness training program, and the control group (n=30) who received only one mindfulness lecture. All participants were assessed using the Mindful Attention Awareness Scale, Cognitive Emotion Regulation Strategy Questionnaire, Positive and Negative Affect Scale, and depression subscale of the Patient Health Questionnaire before and after the mindfulness training program.
Detailed Description
Participants Sixty patients with abdominal cancer from a hospital were recruited. All patients were divided into a mindfulness group (n=30) who received a four-week mindfulness training program and a control group (n=30) who received only one mindfulness lecture over four weeks. No age difference was found between the mindfulness group (M=53.87, SD=10.31, ranging from 35 to 75) and the control group (M=52.73, SD=7.27, ranging from 42 to 69), t(58) =0.49, p=0.625. The participants were all women and none of them reported a history of neurological or psychiatric illness.
Ethics approval statement All procedures involving human participants in this study were conducted in strict accordance with the ethical standards of the Ethical Committee at a medical university, as well as the 1964 Helsinki Declaration and its subsequent amendments, or any comparable ethical standards. All participants gave informed consent before participating. Furthermore, following the completion of the study, the control group could also undergo the same mindfulness training program if they volunteered.
Measurements Mindful Attention Awareness Scale. It contains 15 items in a single dimension. All of the items are rated on a 7-point Likert scale from 1 ('strongly agree') to 7 ('strongly disagree'). Higher scores reflect a higher level of trait mindfulness and awareness of the present moment. The Cronbach\'s α was 0.89 and the two-week test-retest reliability was 0.87 in the Chinese sample. The Cronbach\'s α coefficient of the scale in the present study was 0.87.
The Patient Health Questionnaire. Its depression subscale consists of 9 items. All of the items are rated on a 4-point Likert scale from 1 ('strongly disagree') to 4 ('strongly agree'). Higher scores indicate a greater level of depression. The Cronbach\'s α was 0.86 and the two-week test-retest reliability was 0.86 in the Chinese sample. The Cronbach\'s α coefficient of the scale in the present study was 0.87.
The Cognitive Emotion Regulation Questionnaire. It consists of 36 items and nine subscales. These subscales assess various strategies employed in cognitive emotion regulation, such as self-blame, blaming others, acceptance, refocus on planning, positive refocusing, rumination or focus on thought, positive reappraisal, putting into perspective, and catastrophizing. Each item is rated on a 5-point Likert scale ranging from 1 (\"strongly disagree\") to 5 (\"strongly agree\"). Higher scores on each subscale indicate a greater likelihood of utilizing that particular cognitive emotion regulation strategy in the face of negative events. Adaptive cognitive emotion regulation strategy is assessed using the sum of scores on the acceptance, putting into perspective, refocus on planning, positive refocusing, and positive reappraisal subscales. Non-adaptive cognitive emotion regulation strategy is assessed using the sum of scores on the self-blame, blaming others, rumination or focus on thought, and catastrophizing subscales. In the Chinese samples, the Cronbach\'s α coefficients for these subscales ranged from 0.48 to 0.89. The Cronbach\'s α coefficients of the adaptive and non-adaptive cognitive emotion regulation strategies subscales in the present study were 0.84 and 0.74 respectively.
The Positive and Negative Affect Scale. It contains 20 items and consists of two self-report subscales including positive emotions and negative emotions. All of the items are rated on a 5-point Likert scale from 1 ('strongly disagree') to 5 ('strongly agree'). The higher the score, the stronger the emotions in a certain dimension. The Cronbach\'s α for positive and negative emotions were 0.85 and 0.83 respectively in the Chinese sample. The Cronbach\'s α coefficients of the positive and negative emotions subscales in the present study were 0.84 and 0.78 respectively.
Procedure There are three phases in the present study, i.e., the pre-training test phase (T1), the training phase, and the post-training test phase (T2). In the two test phases, all participants completed all the questionnaires including the Mindful Attention Awareness Scale, the Patient Health Questionnaire-depression subscale, the Cognitive Emotion Regulation Questionnaire, and the Positive and Negative Affect Scales.
The mindfulness training program consisted of four 45-minute lessons, conducted once a week. After each lesson, participants were required to complete daily homework, which included the mindfulness exercises learned during that week for at least 30 minutes. The control group only attended a mindfulness lecture during the four weeks.
The mindfulness training program was based on Kabat-Zinn\'s Mindfulness-Based Stress Reduction5 and Williams\' Mindfulness-Based Cognitive Therapy. Additionally, specific contents of cancer-related mindfulness training were incorporated into this program, such as Anti-cancer Self-healing Power: 8 Lessons in Mindfulness-based Stress Reduction. The contents of the mindfulness training program included:
Session 1: Establishing a connection with the body. Mindfulness activities consisted of eating one raisin mindfully and mindfulness cobble practice.
Session 2: Observing thoughts as they are. Mindfulness activities included the body scan and awareness of breathing meditation.
Session 3: Cultivating mindful attention. Mindfulness activities involved awareness of breathing meditation and mindfulness compassion meditation.
Session 4: Applying mindfulness in daily life. Mindfulness activities included embracing yourself, 3-min breathing space and mindfulness stretching exercises.
Statistical analysis To investigate the impact of mindfulness training on mental states, we conducted a 2 (Group: mindfulness group and control group) × 2 (Test time: T1 and T2) repeated measures ANOVA on each scale score. If a significant interaction effect or main effect was observed, post hoc analysis with Bonferroni correction was performed. To examine the role of cognitive emotion regulation strategy in improving emotional symptoms, we constructed multiple mediation models based on previous studies. First, we calculated the improvements in all measurements by subtracting the scores at T1 from the scores at T2 (i.e., improvement=T2-T1). Next, we examined bivariate correlations between each two improvements. Finally, we treated mindfulness training (0=control group, 1=training group) as the independent variable, the improvement in depressive symptoms as the dependent variable, and the improvements in cognitive emotion regulation strategy and positive/negative emotions as the mediators. We utilized the PROCESS v4.1 macro for SPSS (Model 6) to test the mediation effects.
#Intervention
- BEHAVIORAL : Mindfulness training
- The mindfulness training program consisted of four 45-minute lessons, conducted once a week. After each lesson, participants were required to complete daily homework, which included the mindfulness exercises learned during that week for at least 30 minutes. The mindfulness training program was based on Kabat-Zinn's Mindfulness-Based Stress Reduction and Williams' Mindfulness-Based Cognitive Therapy. Additionally, specific contents of cancer-related mindfulness training were incorporated into this program, such as Anti-cancer Self-healing Power: 8 Lessons in Mindfulness-based Stress Reduction.
|
#Eligibility Criteria:
Inclusion Criteria:
* patients with abdominal cancer; female; > 19 years
Exclusion Criteria:
* a history of neurological or psychiatric illness; intellectual or speech disorders
Sex :
FEMALE
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT06473636
| 136,330 |
{
"NCT_ID" : "NCT04273464",
"Brief_Title" : "Breast Reconstruction With Autologous Tissue: Microsurgery or Fat Grafting?",
"Official_title" : "Secondary Breast Reconstruction in Irradiated Patients - Prospective Trial Comparing DIEP to Brava Expansion + Fat Transplantation",
"Conditions" : ["Breast Cancer", "Mammaplasty"],
"Interventions" : ["Procedure: DIEP-group", "Procedure: Brava-group"],
"Location_Countries" : ["Norway"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-08",
"Study_Completion_Date(Actual)" : "2022-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-10-29",
"First_Posted(Estimated)" : 2020-02-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-02-17",
"Last_Update_Posted(Estimated)" : 2022-12-07",
"Last_Verified" : 2022-12"
}
}}
|
#Study Description
Brief Summary
Methods for breast reconstruction after mastectomy vary from rather simple techniques using expanders and implants, local flaps alone or in combination with implants, to more complex methods using autologous tissue.Transverse rectus abdominis muscle (TRAM) flap has since 1983 become golden standard in autologous breast reconstruction. The deep inferior epigastric perforator (DIEP)-flap, the very last improvement of TRAM flap, has been used in breast reconstruction after mastectomy and radiation therapy as the method of choice at the Department for Plastic Surgery at Hospital of Telemark since 2000.Transplantation of fat tissue by lipoinjections is an alternative method for partial breast reconstruction. In recent years, fat transplantation techniques have gained interest even for patients after mastectomy, as donor site morbidity and operative trauma seem to be less than when free flaps are used. Best results are obtained if the skin around mastectomy scar is pretreated with external expansion. The results of breast reconstruction with fat transplantation are promising, but have not been compared to microsurgical reconstruction of the breast in a scientific manner. The present project is designed to address clinical questions regarding efficiency and patient satisfaction of the two methods.
Detailed Description
When used for breast reconstruction on irradiated patients, breast implants can result in 50% or higher rate of complications included capsular contracture and implant rupture. For this reasons secondary breast reconstruction in irradiated patients is preferably done with autologous tissue.Reconstruction methods employing microvascular transfer of autologous tissue are time consuming having a long learning curve for surgeons. The present project aims to evaluate fat transplantation in combination with external tissue expansion (Brava method) as an alternative to microsurgical complexe methods.
Hypothesis: Early complication/ drop out occur more frequently in fat transplantated patients.
Methods: External tissue expanders (Brava, Brava, LLC 14221 SW 142nd St, Miami, FL 33186) will be used 3 weeks prior to reconstruction in order to enhance the volume and survival of fat cells. The investigators expect that each patient in the fat transplantation group will need 4-6 transplantation sessions of about 1.5 to 2 hours each to achieve satisfactory volume and shape of the breast. The investigators expect 1-2 operative sessions of respectively 5-7 and 2-3 hours duration in the DIEP group. The risk of reoperation (second operation during the first postoperative week) in the DIEP group is 5-10 %.
Patients in the fat transplantation group experiencing poor compliance or early complications as well as patients with unsatisfactory results will be offered alternative methods of reconstruction such as superior or inferior gluteal perforator flap (SGAP or IGAP), Latissimus dorsi pedicled flap alone or in combination with implant. In some cases even simple implant reconstruction could be offered assuming that the quality of previously irradiated skin has been improved by fat transplants .
Study design: Prospective cohort study
Hypothesis: Reconstruction with BRAVA and fat transplantation is a good alternative to reconstruction with DIEP flap.
Study variables: MRI-based volume estimates, anthropometric measurements, VAS scale (Breast-Q - questionnaire measuring patient-related outcome) and Telemark breast score evaluation through independent investigators
Statistics: Power analysis determine that 25 patients are required in each group in this study considering 80 % power with 95 % significance and 40 % difference with regard to patient satisfaction and early complications.
Follow-up: 6 months after DIEP reconstruction and 3 months after the second session of fat transplantation.
Primary endpoint: assessment of early complications in both study groups
Secondary endpoint: patient satisfaction with shape and symmetry of the breast, Satisfaction with psychosocial, psychological and sexual well-being, satisfaction with process of care, shape of the body and postoperative scars (Breast-Q).
#Intervention
- PROCEDURE : Brava-group
- Breast reconstruction by external tissue expansion and multiple fat transplantations(Brava group); Breast reconstruction with microsurgical DIEP-flap transfer.
- PROCEDURE : DIEP-group
- Microsurgical reconstruction by DIEPO method
|
#Eligibility Criteria:
Inclusion Criteria:
* Women who have consented to participate in the study and underwent mastectomy and radiation therapy.
* Mammography of the remaining breast performed within 3 months before surgery
* At least 1 year after completion of radiotherapy
* BMI between 22 and 32 -
Exclusion Criteria:
* Patients with recurrent or metastatic breast cancer
* Patients with pacemakers or metal clips after any surgery
* Patients with heart, kidney or liver failure or other medical conditions such as severe hypertension, COPD, autoimmune disorders, SLE or poorly regulated diabetes
* Patients with claustrophobia
* Patients with severe drug abuse
* Patients with silicone allergy
* Patients with bleeding disorders
* Patients who smoke or have smoked in the last two months
Sex :
FEMALE
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
|
NCT04273464
| 179,262 |
{
"NCT_ID" : "NCT05676814",
"Brief_Title" : "Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients",
"Official_title" : "Pecto-intercostal Fascial Block With Perineural Adjuvants for Postoperative Analgesia Following Sternotomy in Patients Undergoing Cardiac Surgery",
"Conditions" : ["Analgesia", "Sternotomy"],
"Interventions" : ["Drug: PIFB with adjuvants", "Drug: Pecto-intercostal Fascial Block (PIFB)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-03-24",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-06-23",
"Study_Completion_Date(Actual)" : "2023-06-24},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-12-22",
"First_Submitted_that_Met_QC_Criteria" : 2024-05-13",
"First_Posted(Estimated)" : 2023-01-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-12-22",
"Last_Update_Posted(Estimated)" : 2024-06-11",
"Last_Verified" : 2024-04"
}
}}
|
#Study Description
Brief Summary
The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed with local anesthetic solution with or without perineural adjuvants in patients following cardiac surgery involving sternotomy. The study team hypothesizes that the patients receiving PIFB with bupivacaine with epinephrine, clonidine, and dexamethasone will have lower dynamic pain over the first 36 hours compared to those receiving PIFB with just bupivacaine and epinephrine.
Detailed Description
This will be a randomized, triple-blinded, prospective, feasibility trial. Written informed consent will be obtained from all study participants prior to randomization. Patients scheduled to undergo cardiac surgery involving sternotomy at Atrium Health Wake Forest Baptist will be screened for eligibility. These patients will be approached for enrollment by research staff either during their preoperative assessment clinic visit prior to their surgery date, or when admitted as inpatients and scheduled for surgery. Subjects chosen to participate will be randomized into one or other arm and PIFB will be performed after skin closure and before transport from the operating room to the ICU. For patients who are randomized at enrollment but later excluded due to exclusion criteria prior to block placement, their randomization assignment will be replaced at the end of the initial recruitment.
#Intervention
- DRUG : Pecto-intercostal Fascial Block (PIFB)
- PIFB done with bupivacaine and epinephrine
- DRUG : PIFB with adjuvants
- PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults between undergoing cardiac surgery involving sternotomy
Exclusion Criteria:
* Patients with any contraindications to regional anesthesia, such as history of allergy to amide local anesthetics or any of the perineural adjuvants
* existing neurologic deficit in the chest wall;
* remaining intubated at the six hour point after block placement
* weight under 50kg
* undergoing emergency surgical procedures or urgent return to the operating room
* active endocarditis or mediastinitis
* moderate to severe right ventricular function before or after cardiopulmonary bypass
* reliance on mechanical circulatory support devices, such as intra-aortic balloon pump or Impella
* reliance on extracorporeal membrane oxygenation
* localized or systemic infection
* chronic use of high dose opioid analgesics (defined as daily use greater than 30 oral morphine milligram equivalents (OMME) for over one month prior to surgery)
* those who are pregnant
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
|
NCT05676814
| 124,375 |
{
"NCT_ID" : "NCT00651313",
"Brief_Title" : "Efficacy and Safety Study of Lidocaine Vaginal Gel for Recurrent Dysmenorrhea (Painful Periods)",
"Official_title" : "A Phase II, Double-Blind, Crossover Study to Assess the Efficacy and Safety of 10% (150mg) Lidocaine Vaginal Gel Administered to Women With Recurrent Dysmenorrhea",
"Conditions" : ["Dysmenorrhea"],
"Interventions" : ["Drug: Placebo", "Drug: Lidocaine"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2007-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2008-06",
"Study_Completion_Date(Actual)" : "2008-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-03-28",
"First_Submitted_that_Met_QC_Criteria" : 2011-06-07",
"First_Posted(Estimated)" : 2008-04-02"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-04-01",
"Last_Update_Posted(Estimated)" : 2012-02-17",
"Last_Verified" : 2012-02"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether lidocaine vaginal gel is safe and effective for preventing or reducing the severity of dysmenorrhea (painful menstrual periods) compared to placebo (inactive gel).
Detailed Description
The primary objective of this study is to evaluate the efficacy of 10% (150 mg) lidocaine gel compared with placebo in reducing the severity and onset of primary dysmenorrhea in women with recurrent dysmenorrhea.
The secondary objectives of this study are the following:
* to assess the safety of 10% (150 mg) lidocaine gel compared with placebo
* to evaluate electrocardiograms (ECGs) for potentially significant QT changes at approximate peak lidocaine plasma concentration after 4 days of dosing with 10% (150 mg) lidocaine gel.
#Intervention
- DRUG : Lidocaine
- Lidocaine vaginal gel 10% (150mg) administered once daily for 4 days
- DRUG : Placebo
- Placebo vaginal gel administered once daily for 4 days
|
#Eligibility Criteria:
Inclusion Criteria:
* Experiences primary dysmenorrhea requiring pain medication for moderate-to-severe pain (as measured by a 4-point categorical rating scale) by the subject's own report for at least four of the previous six menstrual cycles.
* Has a history of primary dysmenorrhea with onset within 4 years of menarche.
* Has regular menstrual cycles (i.e. onset of menses predictable within 1 - 2 days each month) for the 3 month period preceding enrollment. If a subject has had regular cycles for the past 12 months but had a single cycle that was not regular within the 3 month period preceding enrollment, the subject may be enrolled at investigator discretion after consultation with sponsor.
* Taking the same strength and type of hormonal contraception on a monthly cycle for at least the previous 6 months prior to screening and plans to remain on this hormonal contraception for the duration of participation in the study or is on an acceptable method of birth control including surgical sterilization (i.e. bilateral tubal ligation, partner vasectomy), double-barrier methods, and total abstinence (at the discretion of the investigator in cases where age, career, lifestyle, or sexual orientation of the patient ensures compliance).
* Is a tampon user and/or must be willing to use tampons throughout the study dosing period.
* Age 18 <= age <= 40 (inclusive).
* Has a Body Mass Index (BMI) <= 35 kg/m2.
* Able to understand and willing to complete the efficacy evaluations.
* Able to speak and understand English, and must give written informed consent for the study.
Exclusion Criteria:
* Unable, in the opinion of the Investigator, to comply fully with any of the study requirements.
* Experiencing pelvic pain other than that thought to be associated with primary dysmenorrhea, such as chronic pelvic pain occurring at times other than exclusively during menses and/or dyspareunia.
* Experiencing dysmenorrhea symptoms that are effects of or thought to be effects of (at least in part) secondary causes of dysmenorrhea, such as uterine fibroids, endometriosis, and/or currently symptomatic ovarian cysts.
* Experienced dysmenorrhea that did not require, in the opinion of the subject, the use of analgesic medication during four of the previous six menstrual episodes.
* Has dysmenorrhea refractory to treatment with commonly used analgesic medications for the treatment of menstrual pain (e.g., ibuprofen or naproxen sodium).
* Use of any Class I antiarrhythmic drug.
* Currently using contraceptive injection, implant, or extended cycle OC (hormonal contraceptive cycles consisting of 28 days or more of active hormones).
* Pregnant or breastfeeding.
* Participated in a clinical trial in the 30 days from the time of last dosing in the prior study to the time of providing consent for this study.
* Previously randomized into this study.
* A history of allergic hypersensitivity or significant intolerance (including angioedema, urticaria, bronchospasm, and rhinitis) related to treatment with any medications used in this study.
* A history of past or ongoing clinically significant disease, illness, or disorder that, in the opinion of the Investigator, makes the subject unsuitable for study participation including active vaginal, vulvar, and cervical lesions.
* Laboratory abnormalities that, in the opinion of the Investigator, could contraindicate study participation such as liver function tests > 1.5 times the upper limit of normal (At the Investigator's discretion, laboratory tests may be repeated once for verification.)
* A history of, within the past 4 years, or ongoing significant psychiatric illness that, in the opinion of the Investigator, makes the subject unsuitable for study participation.
* A history of chronic analgesic or tranquilizer use or drug abuse including alcohol within the 6 months before providing consent for this study.
* Regular use of any concomitant medications that might confound efficacy and/or safety assessments, in the opinion of the Investigator, including, but not limited to, the following: psychotropic drugs, antidepressants, sedative-hypnotics, sedating antihistamines, or tranquilizers for 24 hours or five half-lives prior to providing informed consent until 24 hours after the final treatment cycle. Selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), and St. John's Wort are permitted for indications other than pain if the subject has been on a stable dose for at least 2 weeks before providing consent for this study and agrees to remain on a stable dose throughout the course of the study.
* Unwilling to use only those medications that are allowed in the study for the treatment of their dysmenorrhea, i.e., study drug and rescue medication.
* Any ongoing vaginal infection requiring intravaginal treatment.
* A history of toxic shock syndrome (TSS).
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00651313
| 133,767 |
{
"NCT_ID" : "NCT01020968",
"Brief_Title" : "Use of Ixmyelocel-T (Formerly Catheter-based Cardiac Repair Cell [CRC]) Treatment in Patients With Heart Failure Due to Dilated Cardiomyopathy",
"Official_title" : "Catheter-based Transendocardial Delivery of Autologous Bone Marrow-Derived Cells in Patients With Heart Failure Due to Dilated Cardiomyopathy",
"Conditions" : ["Dilated Cardiomyopathy"],
"Interventions" : ["Other: Vehicle Control", "Biological: Ixmyelocel-T"],
"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)" : "2009-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-01-11",
"Study_Completion_Date(Actual)" : "2013-12-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-11-25",
"First_Posted(Estimated)" : 2009-11-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-11-25",
"Last_Update_Posted(Estimated)" : 2021-05-27",
"Last_Verified" : 2021-05"
}
}}
|
#Study Description
Brief Summary
This study is designed to assess the safety profile and the efficacy of cardiac repair cells (CRCs) administered via catheter in treating patients with dilated cardiomyopathy (DCM).
Detailed Description
Heart failure remains a major public health problem, affecting 5 million patients in the US, with 550,000 new diagnoses made each year (Hunt SA; et al., 2005). Heart failure is the leading cause of hospitalization in persons over 65 years of age with cost exceeding $29 billion annually. Prognosis is very poor once a patient has been hospitalized with heart failure. The mortality risk after heart failure hospitalization is 11.3% at 30 days, 33.1% at 1 year and well over 50% within 5 years (Hunt SA; et al., 2005). These numbers emphasize the need to develop and implement more effective treatments to manage heart failure.
Aastrom is targeting a subset of heart failure patient population, namely those diagnosed with dilated cardiomyopathy. The World Health Organization (WHO) defines dilated cardiomyopathy (DCM) as a cardiac condition wherein a ventricular chamber exhibits increased diastolic and systolic volume and a low (\<40%) ejection fraction (Manolio TA; et al., 1992; Towbin JA; et al., 2006). DCM is reported to affect 108,000 to 150,000 patients in the United States (Richardson P; et al., 1996; Towbin JA; et al., 2006).
This study is a prospective, stratified, randomized, open-label, controlled, multi-center study to assess the safety profile and the efficacy of CRCs administered via catheter in treating patients with DCM. Two strata will be used: ischemic (IDCM) and non-ischemic (NIDCM). Within each stratum, patients will be randomized to receive either CRC treatment or control in a 2:1 ratio (8 patients per CRC treatment group and 4 patients per control group). It will enroll a total of 24 patients at 2 sites in the U.S.
#Intervention
- BIOLOGICAL : Ixmyelocel-T
- CRCs will be administered via catheter-based injection to the endocardial surface of the left ventricle.
- OTHER : Vehicle Control
- will receive approximately 12-20 intramyocardial injections of 0.4 mL each of vehicle control into the left ventricle.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of ischemic or non-ischemic dilated cardiomyopathy according to WHO criteria. Ischemic: DCM in a patient with a history of myocardial infarction or evidence of clinically significant (>= 70% narrowing of a major epicardial artery) coronary artery disease. Non-ischemic: Dilation and impaired contraction of left ventricle or both ventricles of idiopathic, familial/genetic, viral and/or immune, toxic origin, or associated with recognized cardiovascular disease in which the degree of myocardial dysfunction is not explained by normal loading conditions or the extent of ischemic damage.
* No other cardiac surgery or percutaneous cardiac interventions likely to produce clinical improvement, as determined by an interventional cardiologist (for PTCA) and a cardiothoracic surgeon (for CABG). This condition is satisfied in patients w/chronic ischemic disease who have previously been successfully revascularized but have failed to show clinical improvement. All patients who are candidates for revascularization are ineligible for participation.
* LVEF <= 30% by echocardiogram within 30 days prior to randomization.
* Symptomatic heart failure in NYHA class III or IV.
* Able to comply with scheduled visits in cardiac out-patient clinic.
* Able to tolerate study procedures, including bone marrow aspiration, cardiac CT, metabolic stress test,6 minute walk test.
* Males and females, 18 <= age <= 86 years.
* Life expectancy of 6 months or more in the opinion of the investigator.
* Able to give informed consent.
* Normal organ and marrow function (Leukocytes >= 3,000/microgram, Absolute neutrophil count >= 1,500/microgram, Platelets >= 140,000/microgram, AST(SGOT)/ALT (SGPT) <= 2.5 X institutional standards range and Creatinine <= 2.5 mg/dL).
* Controlled blood pressure (systolic blood pressure <= 140; diastolic blood pressure <= 90 mmHg) and established anti-hypertensive therapy as necessary prior to entry into the study.
* Stable, standard medical therapy for DCM for at least 1 month with NO new medications to treat the disease introduced in the last 3 months. Standard medical therapy includes: Placement of AICD unless contraindicated (refusal of AICD not considered valid contraindication), use of ACE inhibitors and/or AT-1 receptor blockers as well as loop diuretics unless contraindicated and, depending on the type of heart failure associated with the disease, standard therapy may also include use of vasodilators, beta blockers, digoxin, and aldosterone or other medications.
* Pre-existing conditions are adequately controlled in the opinion of the investigator.
* Fertile patients must agree to use an appropriate form of contraception while participating in the study.
Exclusion Criteria:
* Severe primary valvular heart disease including, but not limited to, aortic valve stenosis and insufficiency.
* Known history of COPD defined as Gold stage IIB (FEV1/FVC<70% with 30%<=FEV1<50% predicted, with or without chronic symptoms of cough, sputum production, dyspnea) or more severe or restrictive pulmonary disease.
* Known history of primary pulmonary hypertension.
* VAD implantation.
* Myocardial infarction within 4 weeks prior to randomization.
* History of life-threatening ventricular arrhythmia, except if an AICD is implanted.
* Unstable angina, characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged duration.
* Patients at high risk for complications due to injection procedure (e.g. patients who have severe peripheral atherosclerotic disease that does not allow advancement of the catheter; patients who have a prosthetic aortic or mitral valve; patients who have a LV thrombus or aneurysm; patients who have an aortic dissection or aneurysm, etc.).
* Patients w/poorly controlled diabetes mellitus (HbAlc>9.0%).
* Patients receiving treatment with hematopoietic growth factors (e.g. EPO, G-CSF).
* Patients who require uninterruptible anticoagulation therapy (e.g. warfarin)that cannot be stopped for 72 hours prior to bone marrow aspiration and intramyocardial injections; OR patients receiving anti-platelet therapy (e.g. clopidogrel) that cannot be stopped for 7 days prior to bone marrow aspiration and transendocardial injections, unless contraindicated.
* Known cancer and undergoing treatment including chemotherapy and radiation.
* Patients requiring continuous, systemic, high dose corticosteroid therapy (more than 7.5 mg/day) within 1 month before aspiration or 6 months after injection procedure.
* End stage renal disease requiring dialysis.
* Patients pregnant or lactating; positive for hCG
* History of alcohol consumption regularly exceeding the equivalent of 2 drinks/day (1 drink = 5 oz of wine or 12 oz [360mL] of beer or 1.5 oz [45mL]) of hard liquor or history of illicit drug use w/in 6 months of screening.
* Known allergies to protein products (horse or bovine serum, or porcine trypsin) used in the ex-vivo cell production process.
* BMI of 40 Kg/m2 or greater.
* Patients receiving experimental medications or participating in another clinical study within 30 days of screening.
* HIV or syphilis, positive at time of screening.
* Active Hepatitis B or Hepatitis C infection at the time of screening.
* Patient determined unsuitable for cellular therapy, in the opinion of the investigator or sponsor.
* Patients receiving anti-angiogenic drugs (e.g. anti-VEGF).
* Known allergy or sensitivity to contrast agents used in imaging procedures.
* Minimum LV wall thickness of less than 6mm as determined by ECHO.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 86 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01020968
| 120,151 |
{
"NCT_ID" : "NCT01911845",
"Brief_Title" : "An Open-label, Single Arm, Phase 2 Study to Evaluate ABT-450/r/ABT-267 and ABT-333 With Ribavirin (RBV) in Adults With Genotype 1 HCV Infection Taking Methadone or Buprenorphine",
"Official_title" : "An Open-label, Single-Arm, Phase 2 Study to Evaluate the Combination of ABT-450/r/ABT-267 and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Hepatitis C Virus (HCV) Infection Taking Methadone or Buprenorphine",
"Conditions" : ["Chronic Hepatitis C Infection", "Chronic Hepatitis C"],
"Interventions" : ["Drug: ABT-450/r/ABT-267", "Drug: ABT-333", "Drug: Ribavirin (RBV)"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-12",
"Study_Completion_Date(Actual)" : "2014-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-05-13",
"First_Submitted_that_Met_QC_Criteria" : 2014-12-23",
"First_Posted(Estimated)" : 2013-07-30"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-07-29",
"Last_Update_Posted(Estimated)" : 2018-05-30",
"Last_Verified" : 2015-08"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults taking methadone or buprenorphine ± naloxone.
Detailed Description
This study consisted of 2 periods: a 12-week treatment period and a 48-week post-treatment period (for all participants who received study drugs). All participants who received at least 1 dose of study drug were to be followed for 48 weeks post-treatment to monitor for safety, HCV RNA, the emergence and/or persistence of resistant viral variants, and assessment of patient-reported outcome (PRO) instruments.
#Intervention
- DRUG : ABT-450/r/ABT-267
- Tablet; ABT-450 coformulated with ritonavir and ABT-267
- Other Names :
- ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir
- DRUG : ABT-333
- Tablet
- Other Names :
- dasabuvir
- DRUG : Ribavirin (RBV)
- Tablet
|
#Eligibility Criteria:
Inclusion Criteria:
* Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile.
* Chronic HCV infection prior to study enrollment.
* Screening laboratory result indicating HCV genotype 1-infection.
* Subject must be treatment naive or previous pegylated interferon/ribavirin treatment experienced.
* Subjects must be on a stable opioid replacement therapy of methadone or buprenorphine ± naloxone for at least 6 months prior to screening.
Exclusion Criteria:
* Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening.
* Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir.
* Females who are pregnant or plan to become pregnant, or breastfeeding, or males whose partners are pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug.
* Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis, e.g., a Metavir Score of >3 or Ishak score of > 4.
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
|
NCT01911845
| 264,712 |
{
"NCT_ID" : "NCT04274660",
"Brief_Title" : "Evaluation of Diabetes and WELLbeing Programme",
"Official_title" : "Evaluation of the Diabetes and WELLbeing (DWELL) Programme for People With Type 2 Diabetes",
"Conditions" : ["Type 2 Diabetes", "Type 2 Diabetes Treated With Insulin"],
"Interventions" : ["Behavioral: DWELL (Diabetes and WELLbeing) Programme"],
"Location_Countries" : ["United Kingdom", "France", "Belgium", "Netherlands"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "FACTORIAL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-09-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-12-31",
"Study_Completion_Date(Actual)" : "2022-12-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-02-05",
"First_Posted(Estimated)" : 2020-02-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-02-17",
"Last_Update_Posted(Estimated)" : 2024-02-14",
"Last_Verified" : 2023-02"
}
}}
|
#Study Description
Brief Summary
This study evaluates the impact of 'DWELL' - a 12-week psycho-social education programme designed to help people with type 2 diabetes to better self-manage their condition. Up to 600 patients will participate in the programme, while a non-intervention group will receive routine care for their diabetes
Detailed Description
The DWELL (Diabetes and WELLbeing) 12-week programme has been designed to incorporate specific elements of diabetes education and is underpinned by motivational interviewing to ensure it is tailored to individuals. Each of the four elements of the programme - education, nutrition, physical activity and wellbeing - have been carefully selected based on previous research into diabetes education. The Canterbury Christ Church University (CCCU) DWELL Team are responsible for the evaluation of DWELL, which will explore whether the combination of the programme elements is effective in improving self-management. Additionally, a process evaluation and cost effectiveness analysis will be conducted alongside participant outcomes
The programme will be delivered at five sites (two in the UK, one in Belgium, one in France, one in the Netherlands). The CCCU DWELL research team will be responsible for quality assurance, management and analysis of data, sample size assessment and reporting of adverse events. Each delivery site is responsible for adhering to their own Standard Operating Procedures.
#Intervention
- BEHAVIORAL : DWELL (Diabetes and WELLbeing) Programme
- 12-week psychoeducational programme
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of type 2 diabetes
* Over the age of 18
Exclusion Criteria:
* Under the age of 18
* Pregnant women
* Individuals who do not have the mental capacity to participate
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
|
NCT04274660
| 48,984 |
{
"NCT_ID" : "NCT04366674",
"Brief_Title" : "Mordified Restoration of Tensor Veli Palatini in Cleft Palate Repair",
"Official_title" : "The Possible Effect of Modified Restoration of Tensor Veli Palatini on Audiological and Otological Outcome in Cleft Palate Repair.",
"Conditions" : ["Cleft Palate"],
"Interventions" : ["Procedure: cleft palate repair"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-01-31",
"Study_Completion_Date(Actual)" : "2019-06-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-04-26",
"First_Posted(Estimated)" : 2020-04-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-04-26",
"Last_Update_Posted(Estimated)" : 2020-04-29",
"Last_Verified" : 2020-04"
}
}}
|
#Study Description
Brief Summary
to study the benefical audiological and/or otological effect by mordified restoration of tensor veli palatini in cleft palate repair compared to traditional Langenbeck's repair and merely levator veli palatini restoration.
Detailed Description
71 patients with cleft palate received surgery were divided into 3 groups. Group 1: patients who received Langenbeck surgery without specific restoration of levator veli palatini or tensor veli palatini. Group 2: patients who received palate surgery with special levator veli palatini restoration. Group 3: patients who received palate surgery with modified tensor veli palatini restoration. The conductive auditory brainstem response and 226 Hz tympanometry were used to test the audiological and otological status of the three groups. Preoperative and postoperative results were compared intragroup and intergroup.
#Intervention
- PROCEDURE : cleft palate repair
- restoration of tensor veli palatini for the purpose of the muscle function recovery.
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of cleft palate.
* Primary palate repair.
Exclusion Criteria:
* Severe general disease
* Confirmed hereditary hearing loss or neuropathic hearing loss.
* Received any kind of audiological or otological therapy before.
* Patients and/or his/her don't want to continue the clinical trial.
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 60 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04366674
| 38,044 |
{
"NCT_ID" : "NCT03797911",
"Brief_Title" : "Efficacy of Resistive Capacitive Monopolar Radiofrequency in the Physiotherapeutic Treatment of Chronic Pelvic Pain: RCT",
"Official_title" : "Efficacy of Resistive Capacitive Monopolar Radiofrequency in the Physiotherapeutic Treatment of Chronic Pelvic Pain: Randomized Clinical Trial.",
"Conditions" : ["Pelvic Pain", "Pelvic Pain Syndrome", "Chronic Pain", "Chronic Pain Syndrome", "Chronic Pelvic Inflammatory Disease", "Physical Therapy"],
"Interventions" : ["Combination Product: Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education", "Combination Product: Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education"],
"Location_Countries" : ["Spain"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-03-23",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-04-16",
"Study_Completion_Date(Actual)" : "2021-04-23},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-12-12",
"First_Posted(Estimated)" : 2019-01-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-01-08",
"Last_Update_Posted(Estimated)" : 2021-12-28",
"Last_Verified" : 2021-12"
}
}}
|
#Study Description
Brief Summary
This study evaluates if the application of resistive capacitive monopolar radiofrequency therapy associated with physiotherapeutic techniques and pain education provides benefits with respect to physiotherapy and pain education techniques alone in the management of patients with chronic pelvic pain.
Detailed Description
It is evident that physiotherapeutic techniques and pain education are a first-line treatment for patients suffering from chronic pelvic pain. But there is no scientific evidence that resistive capacitive monopolar radiofrequency can be another treatment option for these patients, although at the clinical level there is evidence of its beneficial effects.
#Intervention
- COMBINATION_PRODUCT : Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education
- Activated resistive capacitive monopolar radiofrequency is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education.
- COMBINATION_PRODUCT : Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education
- Disactivated resistive capacitive monopolar radiofrequency inactived is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education.
|
#Eligibility Criteria:
Inclusion Criteria:
* Have an age equal to or greater than 18 years
* Having chronic pelvic pain of six or more months of evolution.
Exclusion Criteria:
* Failure to grant informed consent.
* Have fibromyalgia.
* Present a pacemaker or other type of electronic implant.
* Suffer systemic diseases (infectious, vascular, endocrine, metabolic or neoplastic conditions).
* Previous treatment with chemotherapy and / or radiotherapy in the pelvic area.
* Suffering from neuromuscular diseases (amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis or spinal muscular atrophy).
* Have myelopathy and osteomyelitis.
* Have neurological and / or metabolic pathology that alters the response capacity: diabetes, parkinson's disease, senile dementia ...
* Have an alteration of the central nervous system (traumatic or spinal vascular injury)
* Suffer oncological processes with sacral involvement.
* Have a severe mental disorder.
* Have vulvodynia
* Be pregnant.
* Have undergone surgery in the last 3 months in the pelvic area.
* Have hypersensitivity of the skin, hyposensitivity and / or rejection of manual contact.
* Inability to correctly complete the questionnaires or understand the study protocol.
* Having initiated other pelvic physiotherapy treatments during the study intervention.
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
|
NCT03797911
| 236,584 |
{
"NCT_ID" : "NCT00514787",
"Brief_Title" : "Be SMART NIS, Moderate to Servere Asthma Patient Observation",
"Official_title" : "Be SMART NIS, Moderate to Servere Asthma Patient Observation",
"Conditions" : ["Asthma"],
"Location_Countries" : ["Austria"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-08-09",
"First_Posted(Estimated)" : 2007-08-10"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-08-09",
"Last_Update_Posted(Estimated)" : 2009-03-27",
"Last_Verified" : 2009-03"
}
}}
|
#Study Description
Brief Summary
Screen for moderate to severe asthma patients with suboptimal asthma control (as defined by GINA-Guidelines). Document current asthma control status. Re-evaluate asthma therapy and document new therapy if applicable.
|
#Eligibility Criteria:
Inclusion Criteria:
* Moderate to severe asthma with suboptimal control
Exclusion Criteria:
* Intermittent or mild asthma, patient with good asthma control
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00514787
| 217,851 |
{
"NCT_ID" : "NCT02199106",
"Brief_Title" : "Effectiveness of Neuronavigated Continuous Theta Burst Stimulation of the Left Heschl's Gyrus in Chronic Tinnitus",
"Official_title" : "Effectiveness of Neuronavigated Continuous Theta Burst Stimulation of the Left Heschl's Gyrus in Chronic Tinnitus",
"Conditions" : ["Chronic Tinnitus"],
"Interventions" : ["Device: Left temporal placebo cTBS", "Device: Left temporal verum cTBS"],
"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)" : "2009-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-03",
"Study_Completion_Date(Actual)" : "2011-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-07-22",
"First_Posted(Estimated)" : 2014-07-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-07-23",
"Last_Update_Posted(Estimated)" : 2014-07-24",
"Last_Verified" : 2014-07"
}
}}
|
#Study Description
Brief Summary
Neuronavigated continuous theta burst stimulation of the left Heschl's gyrus is used to modulate auditory cortex activity and plasticity contributing to the perception and distress of chronic tinnitus.
Detailed Description
Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. One significant modulator of tinnitus is stress. Tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. Repetitive transcranial magnetic stimulation (rTMS) is also effective in treatment of tinnitus with moderate effect size. Pilot data were positive for low-frequency rTMS applied to the temporal and temporoparietal areas. Continuous theta burst stimulation (cTBS) is a new protocol of rTMS with a possible superior effect in contrast to low-frequency rTMS. Also anatomical neuronavigation might increase the efficacy of rTMS due to exact targeting of the primary auditory cortex. Thus, the aim of this study is the evaluation of the clinical efficacy of neuronavigated left-sided cTBS in chronic tinnitus in a randomised sham-controlled two-arm design.
#Intervention
- DEVICE : Left temporal verum cTBS
- Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session)
Arms: Left temporal verum cTBS
- Other Names :
- MC-B70, MagPro,MagOption, Medtronic, Germany
- DEVICE : Left temporal placebo cTBS
- Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session); coil tilted by 45° over both wings
Arms: Left temporal placebo cTBS
- Other Names :
- MC-B70, MagPro,MagOption, Medtronic, Germany
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of bothersome, subjective chronic tinnitus
* Duration of tinnitus more than 6 months
Exclusion Criteria:
* Objective tinnitus
* Treatable cause of the tinnitus
* Involvement in other treatments for tinnitus at the same time
* Clinically relevant psychiatric comorbidity
* Clinically relevant unstable internal or neurological comorbidity
* History of or evidence of significant brain malformation or neoplasm, head injury
* Cerebral vascular events
* Neurodegenerative disorder affecting the brain or prior brain surgery
* Metal objects in and around body that can not be removed
* Pregnancy
* Alcohol or drug abuse
* acute or chronic inflammation of the middle ear, Meniere diseases, sudden idiopathic hearing loss, fluctuating hearing
* history of seizures
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
|
NCT02199106
| 194,776 |
{
"NCT_ID" : "NCT04780451",
"Brief_Title" : "Omega-3 Supplementation Combined With Endurance Training Improve Running Economy in Recreational Runners.",
"Official_title" : "12 Weeks of Omega-3 Supplementation Combined With Endurance Training Improve Running Economy in Recreational Runners. The Potential Role of the Myokines-NO Pathway.",
"Conditions" : ["Effect of Omega-3 Supplementation on Exercise Performance and Muscle Tissue Functions"],
"Interventions" : ["Dietary Supplement: Omega-3 supplementation in recreational runners"],
"Location_Countries" : ["Poland"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-09-16",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-12-20",
"Study_Completion_Date(Actual)" : "2021-03-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-03-02",
"First_Posted(Estimated)" : 2021-03-03"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-03-02",
"Last_Update_Posted(Estimated)" : 2021-03-03",
"Last_Verified" : 2021-02"
}
}}
|
#Study Description
Brief Summary
Recreational male runners participated in 12 weeks training and omega-3 supplementation programme. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed.
Detailed Description
40 healthy, recreational male runners participated in 12 weeks training and supplementation programme. The training protocol was built based on undulatory load manipulation 3:1, which was suggested to be effective to prevent overtraining and stress due to oscillations between volume/intensity. Throughout the study all participants took 4 identical-looking capsules per day (2 in the morning and 2 in the evening) containing either omega-3 fatty acids or medium chain triglycerides as placebo in total amount of 4g of fat per day. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed. Additionally, blood was collected to determine the concentrations of selected proteins (including eNOS, irisin, adiponectin) that may be associated with potential changes in participants' oxygen uptake during the treadmill test.
#Intervention
- DIETARY_SUPPLEMENT : Omega-3 supplementation in recreational runners
- Male recreational runners participated in 12 weeks of endurance training combined with omega-3 fatty acids supplementation. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed.
|
#Eligibility Criteria:
Inclusion Criteria:
* non smoking
* no chronic diseases
* no supplements and medicines
* personal best in 10km run between 35 and 59 min at the turn of 2016 and 2020 y
Exclusion Criteria:
*
Sex :
MALE
Ages :
- Minimum Age : 29 Years
- Maximum Age : 42 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04780451
| 274,329 |
{
"NCT_ID" : "NCT04138810",
"Brief_Title" : "Postoperative Virtual Clinical Encounters",
"Official_title" : "Assessment of Video-conference Technology for Post-operative Follow up in a Urogynecologic Population",
"Conditions" : ["Pelvic Organ Prolapse"],
"Interventions" : ["Other: VCE", "Other: Survey"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "OTHER",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-07-17",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-07-01",
"Study_Completion_Date(Actual)" : "2019-07-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-10-23",
"First_Submitted_that_Met_QC_Criteria" : 2020-08-11",
"First_Posted(Estimated)" : 2019-10-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-10-23",
"Last_Update_Posted(Estimated)" : 2020-08-24",
"Last_Verified" : 2020-08"
}
}}
|
#Study Description
Brief Summary
Postoperative follow up is necessary following any surgical procedure and has been conducted in the same manner since the field of surgery began. The study will determine feasibility and patient satisfaction of innovative postoperative virtual clinical encounters utilizing mobile video conference technology for women undergoing pelvic reconstructive surgery through a randomized controlled trial.
Detailed Description
This will be a prospective randomized control study comparing postoperative virtual clinical encounters versus traditional in-office postoperative visits in women undergoing pelvic reconstructive surgery. The postoperative experiences of both groups will be assessed via surveys. Virtual Clinical Encounter Group: - Receive video-conference call from office nurse 48-72 hours post discharge from hospital - Receive video-conference call from fellow and/or attending physician approximately 30 days (4-6 weeks) from surgery -- Complete telephone survey one day later - Have in-office postoperative visit with fellow and/or attending physician approximately 90 days (10-12 weeks) from surgery -- Fill out surveys after office visit Traditional Office Group: - Receive telephone call from office nurse 48-72 hours post discharge from hospital - Have in-office postoperative visit with fellow and/or attending physician approximately 30 days (4-6 weeks) from surgery -- Complete telephone survey one day later - Have in-office postoperative visit with fellow and/or attending physician approximately 90 days (10-12 weeks) from surgery -- Fill out surveys after office visit
#Intervention
- OTHER : VCE
- Videoconference conducted according to a standard script which reviews the following key aspects of post-operative care: bowel functions, voiding functions, presence of vaginal bleeding, pain control, diet status, ambulatory status and any additional concerns. Standard post-operative instructions and precautions are reviewed as well.
- OTHER : Survey
- Measure of satisfaction regarding post-op visit.
|
#Eligibility Criteria:
Inclusion Criteria:
* Undergoing surgery for pelvic organ prolapse
* Age greater than 18
* Access to a smartphone
* Access to high speed internet access (via 4G or 3G on their smartphone or high speed Wi-Fi)
* Signed up for MyPennMedicine web portal
* Ability to download MyChart mobile application
* Pennsylvania Hospital Subject: NJ or PA resident, HUP & Presbyterian Hospital Subject: PA resident
Exclusion Criteria:
* Pregnancy
* Inability to read, speak or understand English
* Isolated midurethral sling procedure
* Extraperitoneal vaginal colpopexy with Uphold mesh
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04138810
| 9,268 |
{
"NCT_ID" : "NCT04218435",
"Brief_Title" : "Impact of Sacubitril/Valsartan on Quality of Life and Mortality of CKD vs Non-CKD in Heart Failure Patients",
"Official_title" : "Impact of Sacubitril/Valsartan on Quality of Life and Mortality of CKD vs Non-CKD in Heart Failure Patients",
"Conditions" : ["Heart Failure NYHA Class IV", "Heart Failure NYHA Class II"],
"Interventions" : ["Drug: Sacubitril / Valsartan Oral Tablet"],
"Location_Countries" : ["Pakistan"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-10-25",
"Study_Completion_Date(Actual)" : "2020-12-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-12-27",
"First_Posted(Estimated)" : 2020-01-06"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-01-02",
"Last_Update_Posted(Estimated)" : 2021-02-01",
"Last_Verified" : 2019-10"
}
}}
|
#Study Description
Brief Summary
The two primary goals of it's management are preventing further disease progression(mortality,hospitalizations and deterioration of left ventricular function)and alleviating patient suffering
Detailed Description
Heart failure (HF) is emerging as an epidemic in 3rd world countries. Despite significant therapeutic advances, patients with chronic heart failure remain at high risk for HF progression and death. The two primary goals of its management are preventing further disease progression(mortality, hospitalizations and deterioration of left ventricular function)and alleviating patient suffering.Sacubitril /valsartan (previously known as LCZ696) is a first-in-class medicine that contains a neprilysin (NEP )inhibitor(sacubitril) and an angiotensin II receptor blocker (valsartan). NEP is an endopeptidase that metabolizes different vasoactive peptides including natriuretic peptides, bradykinin and Ang -II. In consequence, its inhibition increases mainly the levels of both natriuretic peptides (promoting diuresis, natriuresis and vasodilation) and Ang- II whose effects are blocked by the angiotensin receptor blocker, valsartan (reducing vasoconstriction and aldosterone release).
#Intervention
- DRUG : Sacubitril / Valsartan Oral Tablet
- Sacubitril/Valsartan is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.
Sacubitril/Valsartan is usually administered in conjunction with another heart failure therapies, in place of an ACE inhibitor or other ARB.
- Other Names :
- Sacvin
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with heart failure (NYHA class II-IV).
* LV EF(less than or equal to 40%).
* eGFR (more than 30 ml/min /1.73m2).
Exclusion Criteria:
* Symptomatic hypotension.
* eGFR<30 ml/min/1.73m2 .
* Serum potassium >5.2mmol/L
* Angioedema
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
|
NCT04218435
| 82,798 |
{
"NCT_ID" : "NCT05147727",
"Brief_Title" : "Drug-drug Interaction Study Between Fluconazole and Famitinib in Healthy Subjects",
"Official_title" : "A Single-center, Open-label, Fixed-sequence Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics and Safety of Famitinib in Healthy Subjects",
"Conditions" : ["Tumor"],
"Interventions" : ["Drug: Fluconazole、Famitinib"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "BASIC_SCIENCE",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-03-14",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-05-02",
"Study_Completion_Date(Actual)" : "2022-05-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-12-06",
"First_Posted(Estimated)" : 2021-12-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-12-06",
"Last_Update_Posted(Estimated)" : 2022-12-23",
"Last_Verified" : 2022-12"
}
}}
|
#Study Description
Brief Summary
An open-label, fixed-sequence, drug-drug interaction study to evaluate the effects of fluconazole on the pharmacokinetics and safety of famitinib in healthy subjects.
#Intervention
- DRUG : Fluconazole、Famitinib
- Fluconazole, once daily on Days 12 to 24; Famitinib, once daily on Days 1 and 15
|
#Eligibility Criteria:
Inclusion Criteria:
* With my consent and informed consent, I am willing and able to complete the study in accordance with the requirements of the experimental protocol;
* Healthy male or female aged 18 <= age <= 45 years (including threshold) on the date of signing the informed consent form;
* Male body weight >= 50 kg, female body weight >= 45 kg, body mass index (BMI) in the range of 19.0 <= age <= 26.0 kg / m2 (including the critical value);
* Physical examination, vital signs, laboratory measurements (blood routine, blood biochemistry, urine routine test, coagulation function, etc.), 12-lead ECG, abdominal B-ultrasound, chest X-ray, etc. are normal or abnormal, but the researcher has no clinical significance according to NCI CTCAE 5.0 standard;
* Fertile subjects had no family planning and had to take acceptable contraceptive measures and no plans to donate eggs and sperm within 3 months from the date of signing informed consent to the last medication; the serum pregnancy test of fertile women within 24 hours before the first administration of the study drug should be negative.
Exclusion Criteria:
* Those who have previously suffered from primary diseases of important organs, including but not limited to neuropsychiatric, cardiovascular, digestive tract, respiratory system, urinary, endocrine, blood, immune and other diseases, which are judged by the researchers to be unsuitable for the trial;
* Subjects who have received any previous operation affecting gastrointestinal absorption;
* Subjects who had received any surgery within 6 months before screening, or planned to undergo surgery during the study period;
* Those who lost blood or donated more than 400 ml or received blood transfusion within 3 months before screening;
* HBsAg positive, HCVAb positive, HIV antibody positive, syphilis antibody positive;
* History of drug use in the past 5 years or drug abuse, or drug screening positive;
* Smoking and alcohol addict and unable to stop smoking during the test period; those with positive alcohol screening; those with positive nicotine screening;
* Subjects who have swallowing resistance or obstacle that will affect the drug absorption;
* Allergic constitution, including severe drug allergy or drug allergy history; known allergy to fluconazole and famitinib or its excipients;
* Those who have participated in other clinical trials and taken the study drug within 3 months before taking the study drug for the first time;
* Inducers or inhibitors of CYP3A4 were taken within 4 weeks before the first administration of study drug;
* Taking any prescription drug, over-the-counter drug, traditional Chinese medicine or food supplement within 2 weeks before taking the study drug for the first time;
* Ingestion of grapefruit containing products, fruit juice, food or beverage containing methylxanthine or alcohol within 48 hours before taking the study drug for the first time; taking strenuous exercise; or having other factors affecting the absorption, distribution, metabolism and excretion of drugs;
* Lactating women;
* The researchers considered that the subjects had any other factors that were not suitable for the trial.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05147727
| 24,300 |
{
"NCT_ID" : "NCT06542965",
"Brief_Title" : "Bloodstream Infection of Carbapenem-Resistant Proteus Mirabilis",
"Official_title" : "Clinical Characteristics, Risk Factors and Resistance Mechanisms for Bloodstream Infection of Carbapenem-Resistant Proteus Mirabilis",
"Conditions" : ["Proteus Mirabilis Infection", "Bacteremia", "Carbapenem Resistant Bacterial Infection"],
"Interventions" : ["Other: Non-Interventional Research"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-12-31",
"Study_Completion_Date(Actual)" : "2023-01-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-07-31",
"First_Posted(Estimated)" : 2024-08-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-08-03",
"Last_Update_Posted(Estimated)" : 2024-08-07",
"Last_Verified" : 2024-08"
}
}}
|
#Study Description
Brief Summary
This study aims to determine the clinical characteristics, risk factors, and resistance mechanisms of patients with carbapenem-resistant P. mirabilis bacteremia.Patients with P. mirabilis growth in blood culture samples sent to bacteriology laboratory between 2018 and 2021 were retrospectively analyzed. Patients meeting the inclusion criteria were divided into carbapenem-resistant and carbapenem- susceptible groups. The investigators recorded demographic data, clinical features, and laboratory findings. Resistance genes were investigated in carbapenem-resistant isolates using PCR.
Detailed Description
Patients with P. mirabilis growth in blood culture who met the study criteria were divided into two groups as carbapenem susceptible and resistant according to carbapenem antibiogram results. Patients with carbapenem-resistant P. mirabilis (CRPM) growth in blood culture were included in the case group and patients with carbapenem- susceptible P. mirabilis (CSPM) growth in blood culture were included in the control group.
Demographic characteristics of the patients, concomitant chronic diseases, Charlson comorbidity index (CCI), hospital and intensive care unit (ICU) hospitalization and number of days in the last year, history and type of invasive intervention in the last three months (surgical-invasive), history of antibiotic use in the last three months and types of antibiotics used (Penicillin, cephalosporin, quinolone, carbapenem, tigecycline, colistin, aminoglycoside), hospitalization unit, total length of hospitalization, sample collection unit, growth result and antibiogram, clinical and laboratory data of the day of growth, sepsis and septic shock evaluated according to systemic inflammatory response syndrome (SIRS) criteria, 30-day mortality and patient outcome information were recorded.
Carbapenemase-producing gene regions were investigated by Polymerase Chain Reaction (PCR) in accessible samples of patients with carbapenem-resistant P. mirabilis growth in blood cultures.
#Intervention
- OTHER : Non-Interventional Research
- Non-Interventional Research
|
#Eligibility Criteria:
Inclusion Criteria:
* Inpatients aged 18 years and older
* P. mirabilis growth in blood cultures
Exclusion Criteria:
* Samples taken in emergency departments, outpatient clinics, day treatment units
* Recurrent growths of the same patient
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
|
NCT06542965
| 23,247 |
{
"NCT_ID" : "NCT04155593",
"Brief_Title" : "In-office Assessment of Voiding Function Following Botox Injection for Overactive Bladder",
"Official_title" : "In-office Assessment of Voiding Function Following Botox Injection for Overactive Bladder; Does Measuring Post Void Residual Impact Management",
"Conditions" : ["Overactive Bladder"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-11-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-03-25",
"Study_Completion_Date(Actual)" : "2020-07-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-11-05",
"First_Posted(Estimated)" : 2019-11-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-11-06",
"Last_Update_Posted(Estimated)" : 2020-09-02",
"Last_Verified" : 2019-11"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to describe the rates of elevated post void residual (PVR) (defined as \>200mL) in Cincinnati Urogynecology Associates patients following Botox injection, as well as to document how many patients required treatment with clean intermittent self-catheterization (CISC).
Detailed Description
Approximately 16% of all women have symptoms of overactive bladder (OAB), whereas 30% of the elderly population are affected. Patients who do not respond to, or cannot tolerate, first and second line therapy with behavioral modifications and pharmacotherapy are offered additional treatment options. Third line therapy involves injection of onabotulinumtoxinA (Botox©, Allergen) into the bladder detrusor muscle.
Botox was approved for use for the diagnosis of OAB in 2013. Cincinnati Urogynecology Associates (CUA), TriHealth Inc. has incorporated intravesical Botox injections into the management algorithm for refractory OAB, since 2014. Currently, patients who fail to improve after a trial of first and second line therapy are offered treatment with Botox.
The standard practice is to request patients return to the office for a routine PVR measurement using straight catheterization within approximately two-four weeks following their Botox injection. This is done regardless if patients are exhibiting symptoms of urinary retention. Patients with an elevated PVR are treated with CISC if they are symptomatic.
Nevertheless, many studies suggest that patients are accurately able to self-identify symptoms of urinary retention, and treating asymptomatic urinary retention may not be necessary.
The investigators aim to describe how many patients with PVR \>200mL had symptoms following intravesical injection of Botox for OAB.
|
#Eligibility Criteria:
Inclusion Criteria:
* OnabotulinumtoxinA injections in the bladder for overactive bladder
* Completed a post injection appointment at which time PVR was collected (approximately 10 to 28 days following Botox injection)
* Age >18
* English speaking
Exclusion Criteria:
* OnabotulinumtoxinA injection for any other cause than overactive bladder
* Patients requiring self-catheterization at baseline
* Failure to complete a postoperative appointment within 4 weeks of Botox injection
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04155593
| 220,884 |
{
"NCT_ID" : "NCT06519630",
"Brief_Title" : "REHABOTICS: Integrated Rehabilitation System for People With Motor Disabilities",
"Official_title" : "REHABOTICS: Integrated Rehabilitation System for People With Motor Disabilities",
"Conditions" : ["Stroke", "Spasticity, Muscle", "Upper Extremity Dysfunction"],
"Interventions" : ["Other: Traditional Physiotherapy", "Device: Rehabotics Physiotherapy"],
"Location_Countries" : ["Greece"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-11-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-11-03",
"Study_Completion_Date(Actual)" : "2023-11-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-07-09",
"First_Posted(Estimated)" : 2024-07-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-07-19",
"Last_Update_Posted(Estimated)" : 2024-07-25",
"Last_Verified" : 2024-07"
}
}}
|
#Study Description
Brief Summary
The goal of the Rehabotics project is the development of a comprehensive rehabilitation system to provide highly individualized treatment of upper limb function in patients with motor disorders due to acquired brain damage (eg stroke) or neurodegenerative disease (eg sclerosis), having as central pillar the integration of robotic systems and support functions. A key part of the proposed system is the development and evaluation of an innovative robotic extraskeletal device that will be applied in the form of a glove to the diseased limb of the neurological patient.
The proposed robotic system:
1. will measure various motor and kinematic parameters of the extremity in order to assess the patient's condition and progress, and
2. will offer a specialized rehabilitation program (therapeutic exercises, retraining of functional movements and support of daily activities) through an interactive virtual environment provided by the Rehabotics platform.
The aim is to provide an environment for the provision of a high level of treatment and support services to patients with hand mobility disorders which will take place both in the clinical environment and in the patient's home through telemedicine applications.
To demonstrate the efficiency of the proposed system, Rehabotics will be applied on post-stoke patients for rehabilitation while also using a control group receiving traditional physiotherapy.
#Intervention
- DEVICE : Rehabotics Physiotherapy
- The intervention will be consisted of sessions for participants in the intervention group which includes a repetition of each of the four Sollerman AR Games named, Wallet, Key, Jar, Screwdriver and one repetition of Balloon Pop. Participants will interact with the AR Box and Block Test (BBT) and the serious games under controlled conditions. A clinician will be present throughout the whole session providing help if participants encounter any difficulties. Following the games, the clinician will initiate a stretching program using the Active Exoskeletal Aid, performing 3 sets of 10 repetitions on the finger flexors of the patient's hand. Each rehabilitation session will last 30 minutes and will be conducted three times a week. Similarly, the traditional physiotherapy training program will be prescribed for the control group and will be consisted of sessions lasting 30 minutes per day, three days per week. Both programs duration will be five weeks.
- OTHER : Traditional Physiotherapy
- Similarly, the hand functional training program prescribed for the control group consisted of sessions lasting 30 minutes per day, three days per week. Both programs lasted for five weeks and were designed by two clinical experts.
|
#Eligibility Criteria:
Inclusion Criteria:
* stroke pathology,
* Ashworth Scale <= 3,
* 6 months maximum time since the incident
Exclusion Criteria:
* Presence of neurological pathologies that affect hand motion (Parkinson's disease)
* Musculoskeletal deficits that affect normal finger range of motion (e.g. finger fractures, joint stiffness/pain, arthritis that affect joint motion)
* Ashworth Scale > 3,
* Over 6 months since the incident
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT06519630
| 55,591 |
{
"NCT_ID" : "NCT03557645",
"Brief_Title" : "Ventilator Hyperinflation and Hemodynamics",
"Official_title" : "Hemodynamic Repercussions of Ventilator Hyperinflation Using Volume-controlled Ventilation: a Randomized Controlled Trial",
"Conditions" : ["Respiratory Failure", "Respiratory Disorders"],
"Interventions" : ["Device: VHI With Inspiratory Pause", "Device: Baseline Mechanical Ventilation", "Device: VHI Without Inspiratory Pause"],
"Location_Countries" : ["Brazil"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-11-05",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-09-20",
"Study_Completion_Date(Actual)" : "2018-09-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-05-13",
"First_Posted(Estimated)" : 2018-06-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-06-04",
"Last_Update_Posted(Estimated)" : 2020-08-14",
"Last_Verified" : 2020-08"
}
}}
|
#Study Description
Brief Summary
Ventilator hyperinflation (VHI) has been shown to be effective in improving respiratory mechanics, secretion removal, and gas exchange in mechanically ventilated patients; however, the literature is scarce concerning its safety and adverse effects. Thus, the aim of this study is to compare the hemodynamic repercussions of VHI in volume-controlled mode. In a randomized, controlled and crossover design, 24 mechanically ventilated patients will undergo 2 modes of ventilator hyperinflation (with and without an inspiratory pause) and a control intervention. Cardiac output, cardiac index, mean arterial pressure, pulmonary vascular resistance, systolic volume and other hemodynamic variables will be recorded during the interventions.
Detailed Description
Background: ventilator hyperinflation (VHI) has been shown to be effective in improving respiratory mechanics, secretion removal, and gas exchange in mechanically ventilated patients; however, the literature is scarce concerning its safety and adverse effects. Thus, the aim of this study is to compare the hemodynamic repercussions of VHI in volume-controlled mode.
Methods: in a randomized, controlled and crossover design, 24 mechanically ventilated patients will undergo 2 modes of ventilator hyperinflation (with and without an inspiratory pause of 2 seconds) and a control intervention. For the VHI interventions, the inspiratory flow will be set at 20 Lpm, and tidal volume will be increased until a peak pressure of 40cmH2O is achieved. During the control intervention, the patients will remain in volume-control ventilation with an inspiratory flow = 60Lpm and tidal volume = 6mL/IBW. The interval between interventions (washout) will be of 10 minutes or more, according to the time needed to recover the cardiac index to baseline values (maximum difference of 10%). Cardiac output, cardiac index, mean arterial pressure, pulmonary vascular resistance, systolic volume and other hemodynamic variables will be recorded during the interventions by using impedance cardiography.
#Intervention
- DEVICE : Baseline Mechanical Ventilation
- The subjects will be kept in Volume Control Continuous Mandatory Ventilation (VC-CMV).
- DEVICE : VHI With Inspiratory Pause
- Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory pause.
- DEVICE : VHI Without Inspiratory Pause
- Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) without an inspiratory pause.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients under mechanical ventilation for more than 48h
Exclusion Criteria:
* mucus hypersecretion (defined as the need for suctioning < 2-h intervals),
* absence of respiratory drive,
* atelectasis,
* severe bronchospasm,
* positive end expiratory pressure > 10cmH2O,
* PaO2-FiO2 relationship < 150,
* mean arterial pressure < 60mmHg,
* inotrope requirement equivalent to >15 ml/h total of adrenaline and noradrenalin,
* intracranial pressure > 20mmHg
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
|
NCT03557645
| 263,160 |
{
"NCT_ID" : "NCT04850378",
"Brief_Title" : "Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome",
"Official_title" : "Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome",
"Conditions" : ["Nephrotic Syndrome", "Thromboembolic Disease"],
"Interventions" : ["Drug: Apixaban", "Drug: Dalteparin"],
"Location_Countries" : ["Denmark"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-03-25",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-05-01",
"Study_Completion_Date(Actual)" : "2024-05-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-04-09",
"First_Posted(Estimated)" : 2021-04-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-04-14",
"Last_Update_Posted(Estimated)" : 2025-04-11",
"Last_Verified" : 2024-05"
}
}}
|
#Study Description
Brief Summary
The study aims to describe the biochemical coagulation profile and investigate the effect of Low molecular weight heparin and Apixaban on this profile in patients with nephrotic syndrome.
Detailed Description
The initial part of the study is a prospective cross-sectional study which will describe the biochemical coagulation profile in nephrotic patients. It will include 60 patients with nephrotic syndrome and data from 50 anonymous blood donors matched in age and gender for comparison.
The second part of the study is an open-label, controlled, non-randomized, interventional clinical trial consisting of 3 groups of patients with nephrotic syndrome or atrial fibrillation treated with either Dalteparin or Apixaban. The study participant is expected to be in stable condition after 4 full days of treatment. For administrative reasons, the final biochemical tests are performed on day 4, 5, 6 or 7 described as day 4 in this protocol.
* Group A: Up to 50 patients with nephrotic syndrome treated with injection Dalteparin 200 Units/kg subcutaneous once a day for 4 days
* Group B: 10 patients with nephrotic syndrome and membranous nephropathy treated with Apixaban 5 mg twice daily for 4 days.
* Group C: 10 patients with atrial fibrillation and no kidney disease treated with Apixaban 5 mg twice daily for 4 days.
Patients participating in the initial part of the study will be included in det second part (Group A) if they meet the inclusion criteria. If the patient is diagnosed with membranous nephropathy it is possible to be included in the initial part as well as the second part (Group A and B).
#Intervention
- DRUG : Dalteparin
- Drug: Dalteparin 200 units/kg once a day for 4-7 days.
- Other Names :
- Fragmin
- DRUG : Apixaban
- Drug: Apixaban 5 mg twice a day for 4-7 days.
- Other Names :
- Eliquis
|
#Eligibility Criteria:
Inclusion Criteria: Nephrotic patients - no intervention
* Age 18 <= age <= 79 years
* Estimated Glomerular Filtration Rate (eGFR) > 49 mL/min/1.73 m2
* P-albumin < 30 g/L
* U-Albumin excretion > 2.2 g/day
* Known glomerular disease including membranous nephropathy, which may cause nephrotic syndrome or diagnostically unresolved nephrotic syndrome with a planed kidney biopsy.
Inclusion Criteria: Nephrotic patients treated with Dalteparin
* Age 18 <= age <= 79 years
* eGFR > 49 mL/min/1.73 m2
* P-albumin < 25 g/L
* U-Albumin excretion > 2.2 g/day
* Known glomerular disease including membranous nephropathy, which may cause nephrotic syndrome or diagnostically unresolved nephrotic syndrome with a planed kidney biopsy.
Inclusion Criteria: Nephrotic patients treated with Apixaban
* Age 18 <= age <= 79 years
* eGFR > 49 mL/min/1.73 m2
* P-albumin < 25 g/L
* U-Albumin excretion > 2.2 g/day
* Membranous Nephropathy
Inclusion Criteria: Patients with atrial fibrillation treated with Apixaban
* Age 18 <= age <= 79 years
* eGFR > 49 mL/min/1.73 m2
* P-albumin > 36 g/L
* U-Albumin excretion < 300 mg/day
* Atrial Fibrillation
Exclusion Criteria:
* Contraindication to Apixaban
* Contraindication to Dalteparin
* Known allergy or intolerance to Apixaban
* Known allergy or intolerance to Dalteparin
* Treatment with anticoagulation for other reasons.
* Treatment with cyclooxygenase-1-inhibitors or Adenosine Diphosphate (ADP) receptor inhibitors.
* Known acquired or congenital coagulation defect non related to nephrotic syndrome or thromboembolic disease within 3 months.
* Known diabetes mellitus.
* Lack of compliance, comorbidity or other conditions that, in the patients unfit to participate in the trial.
* Pregnancy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04850378
| 257,750 |
{
"NCT_ID" : "NCT06126562",
"Brief_Title" : "A Pharmacokinetic Study of Lanifibranor in Healthy Adult Chinese Subjects",
"Official_title" : "A Phase I Clinical Study to Evaluate the Pharmacokinetic Profile and Safety of Lanifibranor After Single Dose and Multiple Doses in Healthy Adult Chinese Subjects",
"Conditions" : ["Pharmacokinetic"],
"Interventions" : ["Drug: Lanifibranor"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-10-31",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-11-28",
"Study_Completion_Date(Actual)" : "2023-12-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-11-07",
"First_Posted(Estimated)" : 2023-11-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-11-07",
"Last_Update_Posted(Estimated)" : 2024-01-02",
"Last_Verified" : 2023-12"
}
}}
|
#Study Description
Brief Summary
This will be a randomized, open-label parallel design and single centre study conducted at the 1st hospital affiliated to Jilin University. Approximately 24 healthy Chinese volunteers, male and female will be recruited and divided into two equal groups (12 subjects per dose). The primary objective of this study is to evaluate the pharmacokinetic profile of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects. The secondary objective is to evaluate the safety of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects.
#Intervention
- DRUG : Lanifibranor
- Lanifibranor is a pan-peroxisome proliferator-activated receptor (PPAR) agonist.
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged 18 <= age <= 45 years (both inclusive) at the time of signing the informed consent form (ICF), regardless of gender;
* Male subjects body weight >= 50 kg and female subjects body weight >= 45 kg, with a body mass index (BMI) of 18 <= age <= 28 kg/m2 (both inclusive);
* No clinically significant findings in medical history, physical examination, 12-lead ECG, vital signs, laboratory tests, etc.;
* Normal clinical laboratory test values at screening and baseline (Day 1) or judged as not clinically significant by the investigator and/or sponsor;
* Alanine aminotransferase <= 1.1 × upper limit of normal (ULN), aspartate aminotransferase <= 1.2 × ULN; normal renal function, estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m2 at screening.
* Subjects need to understood the study, agree to voluntarily participate in the study, to comply with the study requirements, and provide written informed consent;
* Female subjects of childbearing potential must agree to use 2 highly effective methods of contraception, barrier contraception, during the study and within 30 days after one of which must be the study treatment. Female subjects must have a negative serum pregnancy test at screening and baseline (Day 1).
* Male subjects and their female partners of childbearing potential must agree to use 2 highly effective methods of contraception (as defined above), one of which must be a barrier method, during the study and for 90 days after receiving the study drug.
Exclusion Criteria:
* History or evidence of respiratory, circulatory, endocrine, urinary, digestive, immunological, reproductive, hematological, neurological, or psychiatric disorders, especially any history that may affect drug absorption, distribution, metabolism, and excretion.
* Subjects who are positive for any of the following: hepatitis B virus surface antigen (HBs-Ag), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus antibody (anti-HIV), and treponema pallidum antibody (anti-TP).
* Subjects with any of the following conditions within 6 months prior to screening: Unstable body weight, Women with irregular menstruation or ovulation, including but not limited to women with Stein-Leventhal syndrome and perimenopausal women with abnormal ovulation, History of osteoporosis or fracture, History of oedema peripheral at any site, History of gallbladder disease, including but not limited to cholelithiasis, and cholecystitis, History of hypoglycemia or events highly suspicious of hypoglycaemia.
* Current tissue dysplasia or history of malignancy (including lymphoma and leukemia) within the past 5 years, except for successfully cured non-metastatic basal cell carcinoma or squamous cell carcinoma or localized cervical carcinoma in situ.
* Pregnant, lactating women, or women planning to become pregnant during the study or within 30 days of study drug administration.
* Treatment with another study drug or device within 3 months before study drug administration; or less than 5 half-lives from treatment with another study drug or device at screening, whichever is longer.
* Known hypersensitivity or intolerance to lanifibranor or any of the excipients, and allergic constitution.
* Consumption of more than 28 units of ethanol per week, or a history of alcohol abuse, at any time within 6 months prior to study drug administration.
* Smoking more than 5 cigarettes per day or consuming an equivalent amount of nicotine or nicotine-containing products within 6 months before screening, or an inability to discontinue the use of any tobacco products during the study.
* Taking prescription drugs (excluding oral and other contraceptives [e.g., long-acting formulations, transdermal contraceptives, and intrauterine devices]), including nonsteroidal anti-inflammatory drugs, sucralfate, drugs known to decrease metabolism or increase bioavailability, traditional Chinese medicine preparations, melatonin, or other nutritional supplements, within 14 days or 5 half-lives (whichever is longer) before study drug administration, or taking over-the-counter drugs, vitamins, or supplements (including cod-liver oil) within 7 days before study drug administration.
* Consuming products containing alcohol, caffeine, or xanthines, Seville oranges, and grapefruit or grapefruit juice within 72 hours prior to study drug administration.
* Engagement in strenuous activity (e.g., exercise) within 96 h (4 days) before admission to the clinical research unit (CRU) and throughout the study.
* Donation of more than 500 mL of blood or significant blood loss within 90 days prior to admission to the CRU.
* History or evidence of poor venous access or hemorrhagic disorder.
* History of drug use, drug abuse, or positive urine drug test.
* Any condition that, as determined by the investigator, may pose a safety risk to the subject during the study or may interfere with the study's conduct, or the investigator believes that the subject may not be able to complete the study or comply with its requirements.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06126562
| 40,397 |
{
"NCT_ID" : "NCT00125073",
"Brief_Title" : "Postoperative Dietary Counseling After Bariatric Surgery",
"Official_title" : "Postoperative Dietary Counseling After Bariatric Surgery",
"Conditions" : ["Obesity"],
"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)" : "2005-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2005-08",
"Study_Completion_Date(Actual)" : "2005-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2005-07-28",
"First_Posted(Estimated)" : 2005-07-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2005-07-28",
"Last_Update_Posted(Estimated)" : 2010-06-28",
"Last_Verified" : 2010-06"
}
}}
|
#Study Description
Brief Summary
This study aims to assess the changes in physical characteristics, food intake, eating behavior, vomiting, and dumping in 100 patients who undergo bariatric surgery. Patients are put into one of two conditions; they will either receive standard postoperative care or biweekly counseling sessions with a dietician that will help them with the postoperative diet. Patients who receive dietary counseling are anticipated to experience greater weight loss and report less consumption of sugar and fat as compared to patients who do not receive dietary counseling. Moreover, patients who receive dietary counseling are predicted to report less frequent nausea, vomiting, and gastric dumping, as compared to patients who do not receive postoperative dietary counseling. This is predicted to result as a consequence of increased dietary adherence evidenced by the former group.
Detailed Description
This study aims to assess the changes in physical characteristics, food intake, eating behavior, vomiting, and dumping in 100 patients who undergo bariatric surgery. Patients are put into one of two conditions; they will either receive standard postoperative care or biweekly counseling sessions with a dietician that will help them with the postoperative diet. Patients who receive dietary counseling are anticipated to experience greater weight loss and report less consumption of sugar and fat as compared to patients who do not receive dietary counseling. Moreover, patients who receive dietary counseling are predicted to report less frequent nausea, vomiting, and gastric dumping, as compared to patients who do not receive postoperative dietary counseling. This is predicted to result as a consequence of increased dietary adherence evidenced by the former group.
#Intervention
- BEHAVIORAL : Postoperative nutritional counseling
|
#Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI): 40 to 60 kg(squared) or greater than or equal to 35kg(squared) in the presence of co-morbid medical condition.
* Subjects must live within 30 minutes of the University of Pennsylvania and drive or have ready access to public transportation.
* Subjects must be able to ambulate without assistance.
* Subjects will be free of contraindications to bariatric surgery and will have been approved for surgery by both the medical staff and their insurance carrier.
* Subjects must be able to communicate with the investigator, be legally competent, and provide written informed consent.
Exclusion Criteria:
* Evidence of significant psychiatric distress that impairs daily functioning, as suggested by a Beck Depression Inventory-II (BDI-II) greater than or equal to 25. (Individuals with BDI-II scores greater than or equal to 25 will be referred for appropriate help, as per the requirements of the law in the state of Pennsylvania.)
* Any current substance abuse or dependence disorder.
* Concurrent psychiatric treatment for any DSM-IV condition
* Persons who binge eat and report purging behavior (i.e., vomiting, laxative or diuretic abuse, etc.) will be excluded from the study and referred to an eating disorders specialist.
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
|
NCT00125073
| 11,534 |
{
"NCT_ID" : "NCT02628041",
"Brief_Title" : "HDR Brachytherapy vs. LDR Brachytherapy Monotherapy in Localized Prostate Cancer",
"Official_title" : "A Phase II Randomized Trial Evaluating Acute and Late Toxicity of High-Dose Rate Brachytherapy and Low-Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer",
"Conditions" : ["Prostate Cancer"],
"Interventions" : ["Radiation: Permanent Iodine-125 seed implant", "Radiation: High-Dose-rate Prostate Brachytherapy"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-12",
"Study_Completion_Date(Actual)" : "2021-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-12-07",
"First_Posted(Estimated)" : 2015-12-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-12-10",
"Last_Update_Posted(Estimated)" : 2021-02-09",
"Last_Verified" : 2021-02"
}
}}
|
#Study Description
Brief Summary
High-dose rate brachytherapy (HDRB) used as monotherapy is emerging as an alternative to Low-Dose Rate brachytherapy (LDRB) with excellent PSA-progression free survival as high as 90-100% for favorable prostate cancer at a median follow-up of 3-5 years.
HDRB has many advantages over LDRB such as prospective dosimetry not impacted by setup errors, organ motion and prostate swelling during treatment delivery. In addition, HDRB causes less acute and late urinary toxicity compared with LDRB. Acute urinary retention can lead to prolonged catheterization, pericatheter urine leakage, urinary tract infection and Trans-Urethral Resection of the Prostate resulting in diminished quality of life (QOL) and increased psychological distress.
The goal of the investigators' phase II randomized study is to evaluate the differences in QOL in the urinary domain between patients with favourable intermediate risk or extensive low-risk prostate cancer treated with LDRB and HDRB at 3 months using the Expanded Prostate Cancer Index Composite (EPIC) QOL scores. The 3 months cut-off endpoint has been chosen since HDRB-induced urinary toxicity subsides at 12 weeks compared to 12 months with LDRB. Secondary objectives include: bowel and sexual domain EPIC scores and International Prostate Symptom Score. The absolute PSA nadir and a prostate biopsy at 36 months will be reported to assess local control.
Detailed Description
Primary Endpoint:
• To evaluate the differences in QOL in the urinary domain between patients treated with Low-Dose Rate Brachytherapy (LDRB) and High-Dose Rate Brachytherapy (HDRB) at 3 months.
Secondary Endpoints:
* To compare LDRB vs. HDR as related to the Expanded Prostate Cancer Index Composite (EPIC) score in the bowel and sexual domain at baseline, 1, 3, 6, 12, and 24 months.
* To evaluate differences in urinary function using the IPSS which, will be filled in by the patient at baseline, 1, 3, 6, 12 and 24 months after the procedure.
* To report acute and long-term urinary, sexual and gastro-intestinal toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 at each patient's visit.
* To report the dose to the bladder neck defined as 5 mm around the Foley catheter from the bottom of the Foley balloon to the prostatic urethra with a volume of at least 2 cc.
* To assess local control by performing prostate rebiopsy after radiotherapy at 36 months to assess treatment outcome.
* The absolute Prostate Specific Antigen ( PSA) nadir value will be reported as a secondary objective by PSA measurements every 6 months after the procedure.
#Intervention
- RADIATION : Permanent Iodine-125 seed implant
- Permanent Iodine seed implant is performed under general or epidural anesthesia with the patient is positioned in the lithotomy position.
A Foley catheter is inserted in the bladder. Under transrectal ultrasound guidance, the prostates is scanned and the dosimetry is generated. Catheters are inserted in the prostate and the seeds are injected using the Nucletron automatic after loader according to the dosimetry plan.
The catheters are removed at the end of the procedure.
- RADIATION : High-Dose-rate Prostate Brachytherapy
- High-Dose-Rate Prostate brachytherapy is performed under general or epidural anesthesia, the patient is positioned in the lithotomy position.
A Foley catheter is inserted in the bladder. Under transrectal ultrasound guidance, catheters are inserted in the prostate to assure adequate coverage. The patient is returned in dorsal decubitus and a CT scan or Ultrasound scan is performed. A inverse-planning dosimetry plan is generated to deliver 19 Gy to the target volume. The patient is treated and then the implant is removed and anesthesia is reversed.
- Other Names :
- HDR implant
|
#Eligibility Criteria:
Inclusion Criteria:
*Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months.
Patients on active surveillance with evidence of disease progression are eligible to the protocol as long as they meet the eligibility criteria and have a recent prostate biopsy (within 9 months).
* Low-risk disease defined as: Clinical stage T1-T2 and Gleason 6 and PSA<=20 ng/mL.
* Intermediate-risk disease defined as: Clinical stage T1-T2 and Gleason 7 (3+4) and PSA <= 20 ng/mL and <= 60% of positive cores.
* Lymph node evaluation by either CT or MRI is optional and is left at the discretion of the treating physician.
* No alpha reductase inhibitors use within 2 weeks of randomization. A washout period of 2 weeks is required prior to randomization.
* Eastern Cooperative Oncology Group status 0 <= age <= 1
* No hormonal therapy is accepted.
* Prostate volume by Trans-rectal Ultrasound (TRUS) <= 60 cc.
* Internation Prostate Symptom Score (IPSS) <= 20 (alpha blockers allowed)
Exclusion Criteria:
* Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumours curatively treated with no evidence of disease for >= 5 years.
* Prior or current bleeding diathesis
* Previous androgen deprivation therapy within 6 months of the registration.
* Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior Transurethral resection of the prostate (TURP), prior cryosurgery of the prostate.
* Evidence of metastatic disease (radiology investigations at the discretion of the treating physician).
* Any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision).
* Gleason score 7 (4+3), clinical stage>= T3a, PSA > 20 and > 60% of positive cores.
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
|
NCT02628041
| 99,299 |
{
"NCT_ID" : "NCT03496688",
"Brief_Title" : "Comparative Results of Six Biomaterials Used in Two-stage Maxillary Sinus",
"Official_title" : "Comparative Histological and Histomorphometric Results of Six Biomaterials Used in Two-stage Maxillary Sinus Augmentation Model After 6-month-healing",
"Conditions" : ["Atrophy", "Jaw, Edentulous, Partially", "Sinus Floor Augmentation", "Bone Substitutes", "Bone Regeneration"],
"Interventions" : ["Procedure: Sinus floor augmentation"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-01-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-01-04",
"Study_Completion_Date(Actual)" : "2017-09-11},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-03-29",
"First_Posted(Estimated)" : 2018-04-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-04-05",
"Last_Update_Posted(Estimated)" : 2018-04-12",
"Last_Verified" : 2018-04"
}
}}
|
#Study Description
Brief Summary
Objectives: The aim of the study was to compare histological and histomorphometric results of six bone substitute materials used as graft in two-stage maxillary sinus augmentation model, after 6-month-healing.
Detailed Description
Materials and Methods:
A two-stage sinus augmentation was carried out in six patients using mineralized solvent-dehydrated bone allograft (MCBA), freeze-dried mineralized bone allograft (FDBA), anor-ganic bovine bone (ABB), equine-derived bone (EB); synthetic micromacroporous biphasic calcium-phosphate block consisting of 70% beta-tricalcium phosphate and 30% hydroxyap-atite (HA-β-TCP 30/70), or bioapatite-collagen (BC).
#Intervention
- PROCEDURE : Sinus floor augmentation
|
#Eligibility Criteria:
Inclusion Criteria: patients healthy, absence of systemic pathologies (ASA class I), non-smokers, good oral hygiene, not pregnant or lactating, absence of painful symptoms and associated inflammatory or osteolytic pathologies, maxillary partial edentulism involving the premolar/molar areas, residual bone height between the sinus floor and alveolar ridge ranging from 2 to 4 mm, as measured on computerized tomography (CT) scan.
*
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Minimum Age : 33 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03496688
| 223,165 |
{
"NCT_ID" : "NCT00768274",
"Brief_Title" : "Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol",
"Official_title" : "A Safety, Pharmacokinetic, and Pharmacodynamic Assessment of 28-Day Oral Dosing of RVX000222 in Healthy Subjects and Subjects With Low High Density Lipoprotein (HDL)",
"Conditions" : ["Dyslipidemia", "Atherosclerosis", "Acute Coronary Syndrome", "Cardiovascular Disease"],
"Interventions" : ["Drug: Placebo", "Drug: RVX000222"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2008-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-08",
"Study_Completion_Date(Actual)" : "2009-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2008-10-07",
"First_Posted(Estimated)" : 2008-10-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2008-10-07",
"Last_Update_Posted(Estimated)" : 2022-11-04",
"Last_Verified" : 2016-07"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to investigate an oral formulation of RVX000222 for safety, pharmacokinetic and efficacy in healthy subjects.
Detailed Description
One-third of the US population, almost 80 million adults, have cardiovascular disease and mortality associated with heart disease which still remains a leading cause of death around the world. The major risk factors for cardiovascular disease associated with atherosclerosis is dyslipidemia, characterized by high levels of low density lipoprotein (LDL) and/or low levels of high density lipoprotein (HDL).
HDL has a well established role in atherosclerosis and cardiovascular disease protection. HDL mediates the removal of cholesterol from the atherosclerotic plaques for elimination from the body. The major component of HDL consists of apolipoprotein A-I (ApoA I). Recent intervention studies with synthetic HDL particles and recombinant ApoA-I have shown that HDL has the capacity to reverse coronary atherosclerosis.
RVX000222 is a member of a novel class of small molecules that are candidates for the treatment of dyslipidemia by increasing plasma levels of ApoA-I and HDL.
#Intervention
- DRUG : RVX000222
- RVX000222 twice daily (b.i.d.) for 28 days
- Other Names :
- RVX-208, apabetalone
- DRUG : Placebo
- Placebo twice daily (b.i.d.) for 28 days
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects who meet the following criteria may be enrolled:
1. Be men or women between 18 and 65 years, inclusive
2. Weigh between 60 kg and 110 kg, inclusive, and have a BMI >=25 kg/m2.
3. Healthy volunteers with normal or low HDL
4. If female, non-pregnant (as determined by a negative serum pregnancy test at Screening), non-lactating, and not of childbearing-potential or willing to practice an acceptable form of birth control. If male, be willing to practice an acceptable form of birth control.
Exclusion Criteria:
* Subjects who meet any of the following criteria will not be enrolled:
1. Have presently, or have a history of, clinically significant disease, including cardiovascular, gastrointestinal, renal, hepatic, pulmonary, endocrine, hematologic, vascular, immunologic, metabolic, neurological, or collagen disease, as judged by the Investigator.
2. Have active cholecystitis or gallbladder symptoms within 60 days prior to Check-in (subjects who have had a cholecystectomy are not excluded from this study).
3. Have had a clinically significant illness, in the opinion of the Investigator, within 30 days prior to Check-in.
4. Have hypertension that is currently being treated, or uncontrolled hypertension
5. Have a serum creatinine >1.5 mg/dL, hemoglobin <11.2 g/dL, or white blood cell count <4000/μL.
6. Have positive test results for HIV, hepatitis A, B, or C.
7. Have a positive result on drug screen testing.
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
|
NCT00768274
| 37,065 |
{
"NCT_ID" : "NCT04896515",
"Brief_Title" : "INTENT-Muscle (A Sub-study of INTENT)",
"Official_title" : "Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults: A Randomised Pilot Trial - Muscle (a Sub-study of INTENT)",
"Conditions" : ["Critically Ill"],
"Interventions" : ["Dietary Supplement: Supplemental parenteral nutrition"],
"Location_Countries" : ["Australia", "New Zealand"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2021-06-21",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-02-27",
"Study_Completion_Date(Actual)" : "2023-02-27},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2021-04-15",
"First_Posted(Estimated)" : 2021-05-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2021-05-18",
"Last_Update_Posted(Estimated)" : 2024-05-24",
"Last_Verified" : 2024-05"
}
}}
|
#Study Description
Brief Summary
The currently recruiting randomised controlled trial 'Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults' (INTENT, NCT03292237) is the first multi-centre trial to compare an intensive, individualised nutrition intervention to standard care for the duration of hospital admission in critically ill patients. INTENT-Muscle, is an observational longitudinal study nested within INTENT. The aim of INTENT-Muscle is to compare longitudinal changes in muscle health (assessed by bioimpedance and muscle ultrasound) in critically ill patients randomised to each arm of INTENT.
Detailed Description
Background: Critically ill patients may experience debilitating loss of muscle mass and strength, leading to substantial functional impairments both during and long after hospitalisation. Little is known about what therapies may attenuate deterioration of muscle health (muscle mass and muscle quality) in this setting but nutrition is thought to be important, based on the physiological response to critical illness.
The currently recruiting randomised controlled trial (RCT) 'Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults' (ClinicalTrials.gov Identifier: NCT03292237) is the first multi-centre trial to provide an individualised nutrition intervention for the duration of hospital admission in critically ill patients. Combining the most promising and novel bedside techniques for objectively measuring muscle health (bioimpedance technology and ultrasound) with a whole hospital nutrition intervention has never been done before, and will provide crucial data to understand the relationship between nutrition delivery and changes in muscularity from ICU admission to hospital discharge.
Aim: To explore changes in muscle health in response to an individualised nutrition intervention and in association with clinical and functional outcomes, using clinically applicable bedside techniques.
Secondary aims:
In both arms of INTENT to:
1. Compare longitudinal changes in bioimpedance variables (fat-free mass, normally hydrated lean tissue, extracellular/intracellular ratio, and variables from Cole modelling) to hospital discharge (or day 28)
2. Compare longitudinal changes in ultrasound variables (mid-upper arm and quadriceps muscle thickness, rectus femoris cross-sectional area, and rectus femoris echogenicity) to hospital discharge (or day 28)
3. Compare clinical and functional outcomes in patients identified as having low muscularity (assessed by ultrasound) at ICU admission
4. Investigate the relationship between bioimpedance and ultrasound variables with clinical and functional outcomes at baseline and over the hospital admission (collected as part of INTENT)
Hypothesis: In critically ill patients receiving individualised nutrition care for the duration of hospital admission (censored at study day 28), declines in phase angle and muscle health will be attenuated compared to patients receiving standard nutritional care.
#Intervention
- DIETARY_SUPPLEMENT : Supplemental parenteral nutrition
- Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)
|
#Eligibility Criteria:
Inclusion Criteria:
* Randomised to the INTENT trial at a participating sub-study site
Exclusion Criteria:
* Patients will be excluded from the sub-study if they have any of the following:
* A pacemaker or electronic implantable device
* Missing limb(s)
* Unable to get adequate separation in the limbs (e.g. severe obesity)
* Inaccessible site(s) for electrode placement (e.g. major burns, trauma)
* Broken skin at the site(s) of electrode placement
* The treating clinician does not believe the study to be in the best interest of the patient
* Person responsible/Medical treatment decision maker is of non-English speaking background (therefore cannot provide informed consent) Note Before: If the Person responsible/medical treatment decision maker is of English speaking background but the patient is not (and the Person responsible/Medical treatment decision maker speaks the same language as the patient) you may continue assessing the patient for eligibility to INTENT-Muscle as the Person Responsible/Medical treatment decision maker can translate the Patient Information and Consent Form (PICF) and consent discussion with the patient in order to obtain continuing 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
|
NCT04896515
| 196,769 |
{
"NCT_ID" : "NCT01256099",
"Brief_Title" : "Internet-CBT for Insomnia",
"Official_title" : "Guided Internet-treatment for Insomnia. Treatment Effects, Health Economics and Interaction With Depression",
"Conditions" : ["Insomnia", "Depression"],
"Interventions" : ["Behavioral: Therapist Guided Internet-CBT for depression", "Behavioral: Brief Internet-CBT for insomnia, without support", "Behavioral: Therapist guided Internet-CBT for insomnia"],
"Location_Countries" : ["Sweden"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-02",
"Study_Completion_Date(Actual)" : "2015-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-10-12",
"First_Posted(Estimated)" : 2010-12-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-12-07",
"Last_Update_Posted(Estimated)" : 2015-04-03",
"Last_Verified" : 2015-04"
}
}}
|
#Study Description
Brief Summary
This study includes two sub-trials.
In trial 1 patients suffering from insomnia but not meeting the criteria for depression are randomised to either therapist guided Internet-based CBT for insomnia or to a control group with a non-guided, brief self-help program that acts as a placebo control. The primary purpose is to evaluate reduction in Insomnia severity (compared to placebo) after treatment and at follow-ups at 6-month, 1 year and 3 years. Secondary purpose is to evaluate the costeffectiveness of the treatment and to evaluate if the insomnia treatment has a preventive effect on future depressive episodes. Recruitment is done through mass media and includes all regions of Sweden. Initial assessment based on questionnaires and telephone interviews.
Trial 2 includes patients suffering from both Insomnia and depression. Randomization is done between either CBT for insomnia or CBT for depression (both Internet-based) to evaluate each respective treatment's effect on both insomnia and depression. The patients need for further treatment after the initial one will be measured and used as a secondary outcome. Recruitment is done through mass media but only citizens in the Stockholm area are included since the initial assessment are based on both questionnaires and telephone interviews as well as a visit at a psychiatrist located at the Internet psychiatry clinic in Stockholm.
Both trials will include health economic data and analysis. For the longer follow-up periods (1 and 3 years), registers will be used to analyse consumption of sleep medication and antidepressants as well as general health care utilization.
#Intervention
- BEHAVIORAL : Therapist guided Internet-CBT for insomnia
- An 8 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia
- BEHAVIORAL : Brief Internet-CBT for insomnia, without support
- No support and less text, not including the CBT-methods that are presumed to be most effective to reduce Insomnia symptoms
- BEHAVIORAL : Therapist Guided Internet-CBT for depression
- An 9 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression. Information and methods regarding sleep difficulties removed
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical level of Insomnia (more than 10 on ISI)
* Meets criteria for Insomnia according to DSM-IV-TR
* Enough language skills
* Only Trial 2: Meets criteria for Major Depressive Disorder according to DSM-IV-TR
Exclusion Criteria:
* Sleep disorders requiring other treatment
* High consumption of alcohol/drugs that affect sleep
* Started to use or changed the dose of antidepressant drug during the last 2 months
* Somatic or psychiatric conditions requiring acute care
* Working night shifts
* Only Trial 1: Meets criteria for Major Depressive Disorder according to DSM-IV-TR
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
|
NCT01256099
| 202,283 |
{
"NCT_ID" : "NCT04214977",
"Brief_Title" : "Spinal Anesthesia Versus General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position",
"Official_title" : "Spinal Anesthesia Versus General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position: A Controlled Clinical Trial",
"Conditions" : ["Anesthesia", "Anorectal Surgery"],
"Interventions" : ["Procedure: General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position", "Procedure: Spinal Anesthesia for Anorectal Surgeries in Prone Position"],
"Location_Countries" : ["Jordan"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-04-25",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-08-14",
"Study_Completion_Date(Actual)" : "2019-08-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-12-28",
"First_Posted(Estimated)" : 2020-01-02"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-12-28",
"Last_Update_Posted(Estimated)" : 2020-01-03",
"Last_Verified" : 2019-12"
}
}}
|
#Study Description
Brief Summary
Anorectal surgeries are of the commonest elective surgeries that are performed worldwide under different types of anaesthesia. The aim of this prospective interventional study was to compare the use of general anaesthesia (GA) using a laryngeal mask airway (LMA) with spinal anesthesia (SA) in anorectal surgeries.
Detailed Description
Anorectal surgeries are of the most frequently performed procedures worldwide. These procedures are commonly performed in prone position as it offers sufficient exposure and provides enough surgical space. Choosing the suitable anesthetic technique will help in reducing perioperative complications in patients undergoing surgical procedures in prone position, by taking into consideration changes in cardiovascular and pulmonary physiology, airway management, and proper positioning for the prevention of direct and indirect pressure injuries. The aim of this prospective interventional controlled study was to compare the use of general anesthesia (GA) using a laryngeal mask airway (LMA) with spinal anesthesia (SA) in anorectal surgeries.
#Intervention
- PROCEDURE : Spinal Anesthesia for Anorectal Surgeries in Prone Position
- Spinal anesthesia in sitting position was done under complete aseptic technique through a standard midline approach. One and a half millilitres of 0.5% bupivacaine (7.5 mg) was injected through a 25 Gauge pencil-point needle into the subarachnoid space at L3-L4 or L4-L5 interspace. All patients were kept in a head-up position for 3 minutes. The patient was then asked to turn him- or herself into the prone position on the surgical table with the help of the surgical and anesthetic teams.
- PROCEDURE : General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position
- General anesthesia was induced using fentanyl 2 mcg/kg and Propofol 2-3 mg/kg. Any stomach contents were then suctioned through an oro-gastric tube to reduce the risk of regurgitation. Proper (weight-based) classic laryngeal mask airway was then blindly inserted. laryngeal mask airway was then properly fixed to the face and anesthesia was maintained with isoflurane 1-2% in 50% Oxygen/air mixture.
|
#Eligibility Criteria:
Inclusion Criteria:
* patients undergoing elective anorectal surgery (perianal fistula surgery, haemorrhoidectomy, perianal abscess, pilonidal sinus, anal fissure or evaluation under anaesthesia).
* patients older than 16-years old.
* patients who have ASA score I-III.
* Patients whose BMI is less than 35 kg/m2.
Exclusion Criteria:
* any patient who refused to participate in the study.
* patients with surgeries for anal or rectal tumors.
* any patient with expected surgery's duration more than 90 minutes
* patients with uncontrolled respiratory conditions
* any patient whose preoperative assessment was suggestive of possibility of difficult airway.
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04214977
| 271,836 |
{
"NCT_ID" : "NCT01730859",
"Brief_Title" : "The Effect of Ankle Taping and Balance Exercises on Postural Stability",
"Official_title" : "The Effect of Ankle Taping and Balance Exercises on Postural Stability Indices in Healthy Women",
"Conditions" : ["Disturbance; Balance, Labyrinth", "Proprioceptive Disorders"],
"Interventions" : ["Other: Balance exercise and ankle taping"],
"Location_Countries" : ["Iran, Islamic Republic of"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2011-10",
"Study_Completion_Date(Actual)" : "2011-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-11-10",
"First_Posted(Estimated)" : 2012-11-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-11-15",
"Last_Update_Posted(Estimated)" : 2012-11-22",
"Last_Verified" : 2012-11"
}
}}
|
#Study Description
Brief Summary
Both taping and balance exercises have effects on dynamic balance, so this study compared ankle taping and balance exercise on postural stability indices in healthy women. we hypothesized that both balance exercise and taping would increase stability indices but the effects of balance exercise was more greater than taping.
Detailed Description
The ability to control the body in the space is a complex interaction between musculoskeletal and neural systems. This set is called postural control system. Postural control involves the control of body position in space for the dual purposes of postural stability and postural orientation. Balance process is divided into four-stage by Sullivan and Markos: mobility, stability, controlled mobility, and skill. Several types of exercise have been proposed to improve proprioception. Bout and Gahery stated that balance exercises improve neuromuscular relations and reduces the proprioception errors. They believe that those who have more proprioception difficulty may benefit more from exercise therapy.Taping is another technique to enhance proprioception. Improvement in proprioception leads to better function and reduction of disability. Kinesiotaping is being used to prevent injuries and to help curing the injury. It can also improve efficiency in sport, improve lymph and venous circulation, decrease edema, stimulate the mechanoreceptors and increase awareness of subject about the ankle position, reduces the pain and improves muscle performance
#Intervention
- OTHER : Balance exercise and ankle taping
- Balance Exercises: The first group performed balance exercise which last for six weeks, 3 times a week, and 40 minutes each session. Each session started by several minutes of slow walking and progressive stretching of ankle, knee and hip muscles which was gradually increased in time and repetition. After that, balance exercises were performed.
Ankle taping: In second group Ankle joint taping continued for 6 weeks and was renewed three times a week.
- Other Names :
- Balance Exercises, Ankle taping
|
#Eligibility Criteria:
Inclusion Criteria:
* having no pain in ankle joint, not having sport activity in the period of this study, healthy sensory motor function in lower limb, no history of neuromuscular disease, vertigo or any uncorrected visual problems, any kind of ankle injury or lower limb surgery, taking sedative medication, cardiovascular, neurologic, and pulmonary disease, balance problems, rheumatoid disease, psychological disease, body mass index between 17 to25.
Exclusion Criteria:
* ankle pain, allergy to tape, and not completing all interventional sessions.
Sex :
FEMALE
Ages :
- Minimum Age : 19 Years
- Maximum Age : 22 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01730859
| 171,829 |
{
"NCT_ID" : "NCT04465097",
"Brief_Title" : "Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer",
"Official_title" : "Neoadjuvant Tucidinostat and Exemestane in Estrogen Receptor-Positive Early Breast Cancer （NeoTEE）",
"Conditions" : ["Breast Cancer"],
"Interventions" : ["Drug: Ovarian function suppression", "Drug: Tucidinostat", "Drug: Exemestane"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-07-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-10-01",
"Study_Completion_Date(Actual)" : "2023-10-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-06-30",
"First_Posted(Estimated)" : 2020-07-09"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-07-07",
"Last_Update_Posted(Estimated)" : 2023-10-17",
"Last_Verified" : 2023-10"
}
}}
|
#Study Description
Brief Summary
This study is to evaluate the efficacy of tucidinostat combined with exemestane as neoadjuvant strategy in estrogen receptor-positive early breast cancer patients and explore the genetic model which can predict neoadjuvant endocrine therapeutic results.
Detailed Description
This study is to evaluate the efficacy of tucidinostat combined with exemestane as neoadjuvant strategy in estrogen receptor-positive early breast cancer patients.This study will recruit 30 patients. The 30 patients will receive 25 mg exemestane QD for 26 weeks. Tucidinostat will be prescribed 30 mg BIW from week 3 to week 26. During neoadjuvant treatment biopsy, CEUS and MRI will be perfomed according to protocol to evaluate the therapeutic results. Genetic testing will also be performed before and after neoadjuvant treatment to explore the predictive value. MRI evaluated ORR is primary end point. CEUS evaluated ORR, pCR, AE and RCB are secondary end point.
#Intervention
- DRUG : Tucidinostat
- Tucidinostat: 30 mg BIW (Monday and Thursday) from week 3 to week 26
- Other Names :
- Chidamide, Epidaza
- DRUG : Exemestane
- Exemestane: 25 mg QD from week 1 to week 26.
- DRUG : Ovarian function suppression
- If the patient is premenopausal, leuprorelin 3.75mg or goserelin 3.6 mg will be injected every 28 days.
|
#Eligibility Criteria:
Inclusion Criteria:
* Written informed consent must be signed；
* Eastern Cooperative Oncology Group Performance Status: 0~1;
* Histological confirmation of estrogen receptor (ER) positive and HER 2 negative invasive breast cancer;
* Age >=18 years；
* No distant metastatic disease；
* The disease condition is stage II or stage III;
* Laboratory exam criteria for enrollment: HGB>=10g/dl, WBC>=4,000/mm3, PLT>=100,000/mm3, GOT, GPT, ALP<=2 times ULN, TBIL, CCr<=1.5 times ULN.
Exclusion Criteria:
* Patients who are pregnant or lactating at the time of randomization or refuse to contraception.
* Patients who received organ transplantation (include bone marrow autologous transplantation and stem cell transplantation).
* Patients who have other malignant diseases within 5 years, except for cured skin basal cell carcinoma, flat cell carcinoma or cervical carcinoma in situ
* Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study.
* Patients with sever hepatic, renal,cardiovascular, respiratory, digestive diseases or uncontrolled diabetes.
* Patients who had myocardial infarction in the past 12 months.
* Patients who participate in other clinical trail.
* Patients who allergy to goserelin, leuprorelin, tucidinostat or aromatase inhibitor.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04465097
| 240,181 |
{
"NCT_ID" : "NCT01008085",
"Brief_Title" : "STENTYS Self-expanding Versus Balloon-expandable Stent in Acute Myocardial Infarction (AMI)",
"Official_title" : "Randomized Comparison Between the STENTYS Self-expanding Coronary Stent and a Balloon-expandable Stent in Acute Myocardial Infarction - APPOSITION II",
"Conditions" : ["STEMI"],
"Interventions" : ["Device: Stentys coronary stent", "Device: Balloon-expandable stent"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2010-06",
"Study_Completion_Date(Actual)" : "2010-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-11-04",
"First_Posted(Estimated)" : 2009-11-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-11-04",
"Last_Update_Posted(Estimated)" : 2011-01-24",
"Last_Verified" : 2011-01"
}
}}
|
#Study Description
Brief Summary
Study hypothesis: the Stentys self-expandable Stent results into a better alignment of the struts to the vessel wall than a balloon-expandable stent within a few days after the procedure in acute myocardial infarction patients.
Detailed Description
Stent strut malapposition and stent underexpansion are a common phenomenon in AMI as a result of the changing anatomy after an AMI has occurred (thrombus dissolution, resolution of spasm) with the traditional balloon-expandable stent treatment. A self-expanding stent might lead to better stent strut apposition as it follows the contours of the vessel wall due to its self-expanding properties. This might result into better long term clinical outcomes like lower thrombosis rates.
#Intervention
- DEVICE : Stentys coronary stent
- Self-expanding Nitinol stent
- Other Names :
- Self-expanding stent
- DEVICE : Balloon-expandable stent
- VISION/Driver
- Other Names :
- VISION/Driver
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject 18 years.
* Acute Myocardial Infarction defined as presence of at least two of the three items below:
1. Detection of rise of cardiac biomarkers with a least one value above the 99th percentile of the upper reference limit (URL)
2. Symptoms of ischaemia (chest pain) >20 minutes
3. ECG changes indicative of new ischaemia: new ST-T changes (ST deviation >=0.2mV precordial leads and/or >=0.1mV limb leads) or new LBBB)
* Reperfusion expected to be achieved within 12 hours from the onset of symptoms
* Subject understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
* Subject is willing to comply with specified follow-up evaluation and can be contacted by telephone.
* Acceptable candidate for coronary artery bypass graft (CABG) surgery.
* Male or non-pregnant female subject.
Angiographic Inclusion Criteria:
* Reference vessel diameter >2.5mm and <4.0mm by visual estimate.
* Target lesion <30mm in length by visual estimate
Exclusion Criteria:
* Currently enrolled in another investigational device or drug study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
* Coronary or cardiac intervention or major surgery of any kind within 30 days prior to the procedure.
* Target vessel supplied by by-pass vessel
* Patients on anticoagulation therapy (Coumadin)
* Patient received thrombolytic therapy.
* Myocardial infarction due to stent thrombosis, or infarct lesion at the side of a previously implanted stent
* Cardiogenic shock
* Any previous stent placement within 10mm (proximal or distal) of the target lesion.
* Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study.
* Concurrent medical condition with a life expectancy of less than 6 months.
* Left ventricular ejection fraction (LVEF) <30% at the most recent evaluation.
* Cerebrovascular accident or transient ischemic attack in the last 6 months.
* Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, or sensitivity to contrast media, which cannot be adequately pre-medicated.
* Known serum creatinine level >2.5mg/dl or presence or history of renal failure
Angiographic Exclusion Criteria:
* Unprotected left main coronary artery disease (obstruction greater than 50% in the left main coronary artery that is not protected by at least one non-obstructed bypass graft to the left anterior descending (LAD) or left circumflex (LCX) artery or a branch thereof).
* Target vessel is excessively tortuous (two bends >90˚ to reach the target lesion).
* Lesion location that is aorto-ostial or within 5mm of the origin of the LAD or LCX.
* Target lesion is severely calcified.
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
|
NCT01008085
| 208,261 |
{
"NCT_ID" : "NCT04088552",
"Brief_Title" : "Preventing Chronic Disease: ActuaYa",
"Official_title" : "Preventing Chronic Disease (HIV, Diabetes, Hypertension, Obesity) Among Older Hispanic Women in Broward",
"Conditions" : ["Healthy Aging"],
"Interventions" : ["Behavioral: ActuaYa Educational Sessions", "Other: Go4Life-Physical Activity/Exercise Program 'Workout to Go' 5"],
"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)" : "2020-03-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-09-29",
"Study_Completion_Date(Actual)" : "2021-09-29},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-09-11",
"First_Posted(Estimated)" : 2019-09-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-09-11",
"Last_Update_Posted(Estimated)" : 2021-10-20",
"Last_Verified" : 2021-10"
}
}}
|
#Study Description
Brief Summary
The purpose of the study is to help older Hispanic women to increase physical activity, reach a healthy body weight, increase self-esteem and mood and increase knowledge about chronic diseases such as hypertension, diabetes, and HIV.
#Intervention
- OTHER : Go4Life-Physical Activity/Exercise Program 'Workout to Go' 5
- The Go4Life-Physical Activity/Exercise Program 'Workout to Go' 5 Program is an exercise regimen provided to participants. Participants will be provided a booklet with exercise routines that requires minimal equipment and can be performed anywhere for approximately 30 minutes per session. Recommendation on staying active by increasing daily steps through walking will also be recommended as part of the regimen.
- BEHAVIORAL : ActuaYa Educational Sessions
- The ActuaYa Educational Sessions will be delivered by a facilitator in 3 separate sessions with each session lasting 2.5 hours for a total of 7.5 hours administered for the study duration. Each session will be conducted in separate groups of 6-10 participants. Session 1 will discuss the impact of chronic disease in the older Hispanic community. Session 2 will discuss the communication and negotiation with the family and partner. Session 3 will discuss saying goodbye and having a plan for a healthy lifestyle.
|
#Eligibility Criteria:
Inclusion Criteria
* Must self-identify as a Hispanic woman
* Must be aged >= 50 years
* Must not already be engaging in exercise for >150 minutes per week
* Must be able to ambulate without the use of assistive devices
* Must have an intelligent phone iOS or Android
* Must be willing and able to participate in the informed consent process.
Exclusion Criteria
* Participants that do not meet the above-mentioned criteria.
* In the opinion of the investigator, have any clinical condition that would make the participant unsuitable to participate.
* Participants who are currently participating in another investigational study.
* Participants that need a medical clearance for exercise based on the American College of Sports Medicine exercise participation algorithm.
Sex :
FEMALE
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04088552
| 200,551 |
{
"NCT_ID" : "NCT01405430",
"Brief_Title" : "Exploration of Circulating VE-cadherin in Metastatic Colorectal Adenocarcinoma Patients Treated With Bevacizumab",
"Official_title" : "Exploration of New Biologic Factors' Predictive Value , Especially Circulating VE-cadherin in Metastatic Colorectal Adenocarcinoma Patients Treated With Bevacizumab",
"Conditions" : ["Colorectal Cancer", "Metastasis"],
"Interventions" : ["Biological: Bevacizumab + blood samples"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"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)" : "2014-05",
"Study_Completion_Date(Actual)" : "2014-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-07-26",
"First_Posted(Estimated)" : 2011-07-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-07-27",
"Last_Update_Posted(Estimated)" : 2015-06-29",
"Last_Verified" : 2015-06"
}
}}
|
#Study Description
Brief Summary
It is a prospective, non-randomized, monocentric study. The purpose of the study is to assess the predictive value of VE-cadherin on the objective tumor response.
Biological factors will be correlated to clinical outcome measures.
100 patients treated with bevacizumab for a metastatic colorectal adenocarcinoma will be enrolled.
Patients will be followed every 10 weeks until progression in spite of bevacizumab or until they stop bevacizumab because of toxicity.
Bevacizumab will be administered according to investigators appreciation.
Blood samples will be collected at enrollment, at second bevacizumab's administration and every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or until one year at most in case that patients still receive bevacizumab.
#Intervention
- BIOLOGICAL : Bevacizumab + blood samples
- Bevacizumab will be administered according to investigators appreciation.
Blood samples will be collected at enrollment, at second bevacizumab's administration and every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or until one year at most in case that patients still receive bevacizumab.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient with a metastatic colorectal cancer proved histologically and treated with bevacizumab in first line.
* At least one extra-osseous, non-irradiated, measurable site (>= 10 mm with spiral CT).
* No prior radiotherapy treatment unless treatment is over for at least 4 weeks.
* Adult patients.
* PS <= 2.
* Life expectancy greater than 3 months.
* Mandatory affiliation with a healthy security insurance.
* Signed written informed consent.
Exclusion Criteria:
* Prior chemotherapy for the metastatic cancer.
* Prior bevacizumab treatment.
* Other current cancer or previous cancer detected in the last 5 years that can be linked to the current disease.
* Patient deprived of freedom.
* Pregnant or lactating women.
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
|
NCT01405430
| 80,077 |
{
"NCT_ID" : "NCT02034721",
"Brief_Title" : "Protein and Recovery From Exercise-induced Muscle Damage",
"Official_title" : "Influence of Protein-amino Acid Supplementation on Recovery From Exercise-induced Muscle Damage in NASCAR Pit Crew Athletes",
"Conditions" : ["Muscle Damage", "Inflammation"],
"Interventions" : ["Dietary Supplement: Protein supplement", "Dietary Supplement: Placebo"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-02",
"Study_Completion_Date(Actual)" : "2014-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-01-10",
"First_Posted(Estimated)" : 2014-01-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-01-10",
"Last_Update_Posted(Estimated)" : 2016-12-13",
"Last_Verified" : 2015-01"
}
}}
|
#Study Description
Brief Summary
Intense, eccentric resistance exercise causes muscle damage, soreness, inflammation, and a loss of muscle function. Protein-amino acid supplementation before, during, and following damaging resistance exercise may reduce muscle damage and accelerate recovery. This study will determine if supplementation with Herbalife 24 Rebuild Strength (compared to placebo) before, during, and after a 90-minute bout of eccentric exercise attenuates exercise-induced muscle damage, inflammation, and delayed onset of muscle soreness (DOMS), speeds recovery of muscle function, and maintains immune function in NASCAR pit crew athletes (Hendrick Motor Sports).
Detailed Description
Intense, eccentric resistance exercise produces high mechanical forces leading to muscle damage, soreness, inflammation, and a loss of muscle function (J Sci Med Sport 2010;13:178-181). Limited evidence suggests that protein-amino acid supplementation before, during, and following damaging resistance exercise reduces muscle damage and accelerates recovery in resistance trained subjects (J Int Soc Sports Nutr 2012;9:20; Int J Sport Nutr Exerc Metab 2010;20:236-44; Appl Physiol Nutr Metab 2008;33:483-8).
Herbalife 24 Rebuild Strength is a protein-amino acid supplement recommended for use after resistance exercise to help rebuild muscle, speed recovery, support immune function, and promote muscle repair. (http://performancenutrition.herbalife.com/en/products/ rebuild-strength). A serving of Rebuild Strength (50.5 grams) contains 190 kilocalories, 24 grams of protein, 18 grams of carbohydrate, 1 gram of fat, and vitamins and minerals (C, E, B1, B6, B12, pantothenic acid, calcium, iron, magnesium, chromium, sodium, potassium, all at 10% to 150% Daily Value levels). The 24 grams of protein per serving include whey and casein proteins, L-glutamine (3,000 mg), and branched-chain amino acids (BCAA) (4,000 mg). (See nutrition label at the website).
Purpose: To determine if supplementation with Herbalife 24 Rebuild Strength (compared to placebo) before, during, and after a 90-minute bout of eccentric exercise can attenuate exercise-induced muscle damage, inflammation, and delayed onset of muscle soreness (DOMS), speed recovery of muscle function, and maintain innate immune function in NASCAR pit crew athletes (Hendrick Motor Sports).
Research design:
Subjects will be randomized to Rebuild Strength or placebo supplements (double blind administration in the same colored bottles, with the code held by Herbalife until the study is completed).
Testing Sequence:
1. Subjects will come to the HMS training facility in an overnight fasted state (no food or beverage other than water for the previous 8 hours) and provide a DOMS rating and a blood sample. Height, weight, and percent body fat (skinfolds) will also be obtained.
2. Rebuild Strength subjects will consume 2 scoops (50.5 grams of product with 24 grams protein) in water 15-20 min prior to the 90-min eccentric exercise bout. Subjects in the placebo group will consume 2 scoops of the same supplement but without protein or amino acids (with carbohydrate added to keep energy intake the same between groups). Supplements will be prepared by Herbalife and coded 'A' and 'B', with this double blind code maintained until the study has been completed.
3. Muscle function testing will follow supplementation: vertical jump, kneeling medicine ball toss, and the 30-second Wingate test (see description below).
4. Subjects will engage in 90-min eccentric exercise (see description below), with 1 scoop of Rebuild Strength (12 grams protein) or placebo ingested after 45 min exercise.
5. Immediately following exercise, subjects will ingest 2 scoops Rebuild Strength (24 grams protein) or placebo, provide a DOMS rating and a blood sample, and then take the same three muscle function tests. Total protein intake before, during, and immediately after the 90-min eccentric exercise bout will be 60 grams. All subjects will refrain from any food or beverage intake (except for water) for one hour after taking the final supplement dose.
6. Subjects will return at 7 am in an overnight fasted state three days in a row after the eccentric exercise bout, and will provide a DOMS rating and a blood sample followed by ingestion of 2 scoops Rebuild Strength or placebo, and then the three muscle function tests. Subjects will engage in normal training during the 3-day recovery period. The blood samples will be analyzed for markers of muscle damage, inflammation, and immune function.
Eccentric Exercise Bout:
HMS pit crew members engage in eccentric exercise bouts on a regular basis, and are very familiar with the exercises that will be utilized in this study to induce muscle damage and soreness. The 90-minute eccentric exercise bout will consist of 17 different exercises:
1. Hammer incline presses with eccentric focus (3 sets, 5 reps).
2. Bench presses with resistance bands (3 sets, 20 seconds to fatigue).
3. Supine medicine ball (9.1 kg) explosive catch and throws (20 seconds, 3 sets).
4. Bent (90○) arm hangs to fatigue (3 sets).
5. Eccentric lat pulls (8 reps, 3 sets).
6. Partner rowing eccentric pulls (8 reps per arm, 3 sets).
7. Eccentric triceps extensions (8 reps per arm, 3 sets).
8. Eccentric bicep curls (8 reps, 3 sets).
9. Explosive tuck jumps (20 seconds, 3 sets).
10. Eccentric back extensions (8 reps, 3 sets).
11. Eccentric hamstring curls (8 reps, 3 sets).
12. 20 second sprints on inclined treadmills with no electrical power (3 sets).
13. Split squats (15 reps each leg, 2 sets).
14. Walk 0.40 km with dumbbells, with shoulder shrugs every three steps.
15. Isometric abdominal curl with medicine ball (9.1 kg) twisting side to side for 20 seconds (3 sets).
16. Abdominal crunches for 20 seconds (3 sets).
17. Plank position (elbows and toes) for 45 seconds (2 sets).
#Intervention
- DIETARY_SUPPLEMENT : Protein supplement
- 24 g protein before, 12 g during, and 24 g after eccentric exercise
- Other Names :
- Herbalife Rebuild Strength
- DIETARY_SUPPLEMENT : Placebo
- Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* NASCAR pit crew members/recruits from Hendrick Motorsports
* Agree to avoid use of other protein supplements during the 4-day study
Exclusion Criteria:
* Heart problem or told by an MD not to engage in vigorous exercise
* History of allergies to milk or soy products
Sex :
MALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02034721
| 106,530 |
{
"NCT_ID" : "NCT00093756",
"Brief_Title" : "Bortezomib, Paclitaxel, Carboplatin and Radiation Therapy for Non-Small Cell Lung Cancer",
"Official_title" : "Phase I/II Study of PS-341 in Combination With Paclitaxel, Carboplatin, and Concurrent Thoracic Radiation Therapy for Non-small Cell Lung Cancer (NSCLC)",
"Conditions" : ["Recurrent Non-small Cell Lung Cancer", "Stage IIIA Non-small Cell Lung Cancer", "Stage IIIB Non-small Cell Lung Cancer"],
"Interventions" : ["Radiation: 3-dimensional conformal radiation therapy", "Drug: paclitaxel", "Drug: carboplatin", "Drug: bortezomib"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1", "PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2004-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-01",
"Study_Completion_Date(Actual)" : "2013-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2004-10-06",
"First_Submitted_that_Met_QC_Criteria" : 2014-12-03",
"First_Posted(Estimated)" : 2004-10-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2004-10-07",
"Last_Update_Posted(Estimated)" : 2017-12-07",
"Last_Verified" : 2017-11"
}
}}
|
#Study Description
Brief Summary
This phase I/II trial (phase I closed to accrual as of 09/29/2009) is studying the side effects and best dose of bortezomib, paclitaxel, and carboplatin when given with radiation therapy and to see how well they work in treating patients with stage IIIA or stage IIIB non-small cell lung cancer that cannot be removed by surgery. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may increase the effectiveness of paclitaxel and carboplatin by making tumor cells more sensitive to the drugs. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving bortezomib, paclitaxel, and carboplatin together with radiation therapy may kill more tumor cells.
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of bortezomib, paclitaxel, and carboplatin when administered with fractionated radiotherapy in patients with unresectable stage IIIA or IIIB non-small cell lung cancer. (Phase I) (closed to accrual as of 09/29/2009) II. Determine the 1-year survival of patients treated with this regimen. (Phase II)
SECONDARY OBJECTIVES:
I. Determine the tolerability of this regimen in these patients. (Phase II) II. Determine the response rate, progression-free survival, and overall survival of patients treated with this regimen. (Phase II) III. Correlate p27 expression in tumor tissue with survival, time to progression, and response in patients treated with this regimen. (Phase II)
OUTLINE: This is a multicenter, phase I (closed to accrual as of 09/29/2009), dose-escalation study of bortezomib, paclitaxel, and carboplatin followed by a phase II study.
PHASE I: (closed to accrual as of 09/29/2009) Patients receive bortezomib IV on days 1, 4, 8, and 11. Patients also receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 2. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19. Treatment repeats every 3 weeks up to 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bortezomib, paclitaxel, and carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PHASE II: Patients receive bortezomib, paclitaxel, and carboplatin as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. Patients are followed up periodically for up to 5 years from the time of registration.
#Intervention
- RADIATION : 3-dimensional conformal radiation therapy
- DRUG : bortezomib
- Given IV
- DRUG : paclitaxel
- Given IV
- DRUG : carboplatin
- Given IV
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
* Locally advanced stage IIIA or IIIB disease that is considered unresectable
* No stage IV disease
* Requires radiotherapy
* Performance status (PS) - Eastern Cooperative Oncology Group (ECOG) 0 <= age <= 1
* At least 12 weeks
* Absolute neutrophil count >= 1,500/mm^3
* Platelet count >= 100,000/mm^3
* Bilirubin <= 1.5 times upper limit of normal (ULN)
* aspartate aminotransferase (AST) <= 3 times ULN
* Creatinine <= 1.5 times ULN
* No New York Heart Association class III or IV heart disease
* Forced expiratory volume (FEV) FEV_1 >= 1 L OR 35% of predicted
* Weight loss < 10% within the past 3 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No peripheral neuropathy >= grade 2
* No other severe underlying disease that would preclude study participation
* No uncontrolled infection
* No unhealed wound within the past 2 weeks
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas (carcinoma in situ), or localized prostate cancer
* No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
* No prior systemic chemotherapy for NSCLC*
* No prior radiotherapy to the chest
* More than 2 weeks since prior major surgery
Contraindications
* Any of the following:
* Pregnant wome
* Nursing women
* Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.) as this regimen may be harmful to a developing fetus or nursing child NOTE: This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
* Any of the following prior therapies:
* Prior radiation therapy to the chest
* Prior systemic chemotherapy for NSCLC (phase II portion)
* New York Heart Association classification III or IV (see Appendix II).
* Any other severe underlying diseases which are, in the judgment of the investigator, inappropriate for entry into this study.
* uncontrolled infection.
* Major surgery or unhealed wound <= 2 weeks prior to registration.
* Prior history of malignancy <= 5 years, except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas (carcinoma in situ), or localized prostate cancer.
* Peripheral neuropathy >=grade 2
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
|
NCT00093756
| 256,508 |
{
"NCT_ID" : "NCT06301529",
"Brief_Title" : "The Efficacy and Tolerability of Canagliflozin in Healthy Individual",
"Official_title" : "The Efficacy and Tolerability of Canagliflozin in Healthy Individuals Comparing Dosing Protocols of Canagliflozin for Use as a Gerotherapeutic",
"Conditions" : ["Healthy Aging"],
"Interventions" : ["Drug: Invokana Pill"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "OTHER",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2024-02-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-06-29",
"Study_Completion_Date(Actual)" : "2024-06-29},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2024-03-04",
"First_Posted(Estimated)" : 2024-03-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2024-03-04",
"Last_Update_Posted(Estimated)" : 2024-07-19",
"Last_Verified" : 2024-07"
}
}}
|
#Study Description
Brief Summary
The primary objective is to measure the effects that canagliflozin intervention has on reducing average glucose in healthy individuals.
The secondary objective is to assess the tolerability and side effects and urinary glucose excretion following the pulsatile dosing protocol.
Detailed Description
This study is designed to mitigate the effects of glucose with intermittent oral Canagliflozin for healthy, non-diabetic volunteers of any sex who enroll in the study. Participants will provide informed consent via AgelessRx electronic medical record. If eligible, prescriptions will be provided online through the AgelessRx website (www.agelessrx.com). Participants will be randomized into two arms: Arm A will take 100 mg of canagliflozin each day for a total of 7 doses, while Arm B will take 150 mg of canagliflozin every other day for a total of 4 doses. Participants in Arm B will also be provided a pill cutter to use throughout the trial on the 300mg tablet.
All participants will begin the trial on the day that they apply a continuous glucose monitor (considered Day 0) and will be asked to take daily blood pressure reading. After one week of baseline readings, both arms will start their canagliflozin dosing protocols.
Participants will be asked to complete 7 total surveys to outline side effects and tolerability, one each day starting after their canagliflozin consumption.
Participants will be asked to complete a dietary intake journal through Day 0 -Day 14. Lifesum (https://lifesum.com/) should be used to track Carbohydrate/Protein/Fat consumption. Participants will share their dietary intake journal twice over their participation (Day 7 \& Day 14).
#Intervention
- DRUG : Invokana Pill
- 100 mg and 150 mg doses, taken every day and every-other day, respectively.
- Other Names :
- Canagliflozin
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 <= age <= 85
* Any sex
* Any ethnicity
* Interest in taking Canagliflozin
* Approved by the AgelessRx Medical team to take Canagliflozin
* Willing and technically able to use and operate a continuous glucose monitor
* Own a CGM-compatible phone
* Relatively good health with only well-managed chronic diseases (hypertension, coronary artery disease, type II diabetes, etc.) clinically stable
* Adequate cognitive function to be able to give informed consent
Exclusion Criteria:
* Diabetes of any type
* Taking metformin or any other glucose-lowering medication
* Other diabetes medication
* Active malignancy of any kind
* Clinically relevant renal or kidney disease or dysfunction
* History of eating disorder
* Any diuretic
* Taking any medication, or having any medical condition, that might interfere with the action of canagliflozin or the CGM sensor
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06301529
| 48,555 |
{
"NCT_ID" : "NCT01296750",
"Brief_Title" : "Late Compared to Early Physiotherapy Following Knee Dislocation",
"Official_title" : "A Randomized Clinical Trial Comparing Late Versus Early Physiotherapy Start Times Following Multi Ligament Reconstruction for Knee Dislocation (Co-LEAP)",
"Conditions" : ["Traumatic Knee Dislocation"],
"Interventions" : ["Other: Early Physiotherapy start"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-06",
"Study_Completion_Date(Actual)" : "2018-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2011-02-14",
"First_Posted(Estimated)" : 2011-02-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-02-14",
"Last_Update_Posted(Estimated)" : 2021-01-20",
"Last_Verified" : 2020-01"
}
}}
|
#Study Description
Brief Summary
A knee dislocation is an unusual and extremely serious injury and is defined as complete displacement of the tibia with respect to the femur, usually with disruption of 3 or more of the stabilizing ligaments. When the knee dislocates, there is often significant damage to the soft-tissues envelope surrounding the joint, including adjacent neurovascular structures. Not surprisingly, this injury is a profoundly debilitating, life-altering event, with the potential to necessitate career change in athletes and laborers alike. Current evidence indicates that operative management for these injuries is more effective at returning patients to pre-morbid range of motion (ROM) and activity than conservative management. Post operative rehabilitation programs for these patients must balance the need for stability of their surgical repair and knee ROM and functionality. Experimental data suggests that post-operative immobilization offers greater protection of the surgical reconstruction, whereas immediate, aggressive physiotherapy may be more effective at preventing arthrofibrosis stiffness. The investigators are proposing a randomized clinical trial comparing early physiotherapy (day one post op) versus immobilization for three weeks then initiation of physiotherapy. The physiotherapy progams will be identicalbe in all aspects except for progam initiation.
#Intervention
- OTHER : Early Physiotherapy start
- Physiotherapy starting at one day post op
|
#Eligibility Criteria:
Inclusion Criteria:
* Ambulation without aids in pre-morbid condition
* Multi-ligament knee injury with or without associated peri-articular fracture
* Operative management within three weeks of the injury
Exclusion Criteria:
* Poly-trauma with life-threatening injuries preventing rehabilitation
* Patients unable to comply with intensive rehabilitation
* Patients unable or unlikely to maintain follow-up
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01296750
| 154,555 |
{
"NCT_ID" : "NCT05422391",
"Brief_Title" : "The Acute Effects of Caloric Restriction on Anthropometrics, Metabolism, and Cardiovascular Health in Overweight Adults",
"Official_title" : "Evaluating the Short-Term Effects of 3 Days of Caloric Restriction/Intermittent Fasting Using the Plexus(R) Program on Anthropometrics, Metabolism, Markers of Cardiovascular Health in Overweight/Obese Men and Women",
"Conditions" : ["Obesity", "Overweight", "Intermittent Fasting"],
"Interventions" : ["Dietary Supplement: 3 day caloric restriction/metabolic reset"],
"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)" : "2022-06-07",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-09-07",
"Study_Completion_Date(Actual)" : "2022-11-17},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-05-17",
"First_Posted(Estimated)" : 2022-06-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-06-13",
"Last_Update_Posted(Estimated)" : 2022-12-13",
"Last_Verified" : 2022-12"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to document the efficacy of a 3 day intermittent fasting/caloric restriction (IF/CR) using the Plexus® 3 day reset program on body weight as well as regulatory parameters of metabolism and metabolic flexibility. This study will provide data on the acute efficacy regarding the program but also identify the potential underlying physiological mechanisms through which the dietary intervention may elicit improvements, and the participant experience of the program. Collectively, this will provide a window into the possible adaptations with a longer-term dietary intervention.
Detailed Description
According to the US Centers for Disease Control, more than 42% of adults are classified as obese, and approximately 74% of US adults are classified as overweight (body mass index of 25.0 to \< 30 kg/m2) or obese (\>30 kg/m2) (Ow/Ob). The costs on human health are profound, increasing the risk of heart disease, stroke, type 2 diabetes, and certain cancers, and ultimately increasing morbidity associated with these chronic diseases. Obesity and the negative sequelae inflict staggering economic costs, estimated at $147 billion, and that was in 2008. Therefore, understanding and developing interventions that can help address Ow/Ob can reduce the risk of chronic disease, reduce healthcare costs, and likely improve quality of life.
One such intervention has been through altering diet and/or physical activity. However, prior systematic review and meta-analysis suggests that when comparing diet alone vs. exercise alone, dietary interventions result in \~3-fold greater weight loss (11 vs 3 Δkg). While the additional benefits of exercise are not be discounted, engaging dietary approaches can be a highly effective way to promote weight loss. Caloric restriction (CR) has long been touted as an effective method of inducing weight loss, although there are also issues with adherence and maintenance with such an approach. This study is seeking to understand the acute metabolic changes with engaging in a 3-day caloric restriction, which would typically be part of an intermittent fasting dietary regimen.
Specific Aim 1. Document the efficacy of the 3 day IF/CR on inducing short term weight loss, the nature of the weight loss changes (body composition), changes in anthropometrics (waist and hip circumference), changes in resting metabolic rate and changes in metabolic flexibility (relative utilization of fats versus carbohydrates).
Specific Aim 2. Explore the physiological responses to the 3 day IF/CR with the Plexus 3 day reset program through analysis of blood plasma for levels of insulin, glucose, lipid profile (total cholesterol, high- and low-density cholesterol (HDL/LDL)), pro- and anti-inflammatory mediators (Tumor Necrosis Factor-alpha, TNFa and Cortisol, respectively), ketones, thyroid stimulating hormone (TSH), and hormones related to hunger and satiety and thus energy intake (protein YY (PYY), neuropeptide Y (NPY), Ghrelin, and Leptin).
Specific Aim 3. Ascertain any possible changes in clinically relevant parameters such as heart rate, heart rate variability (HRV), blood pressure (central and peripheral), and vascular stiffness (augmentation index, AIx).
Hypothesis: The investigators hypothesize that the nutritional intervention will induce weight loss, changes in anthropometrics/body composition (i.e. decreased body water), resting metabolic rate, and alterations in metabolic flexibility. These measures will be explained, at least, in part, by alterations in specific blood biomarkers. The investigators also hypothesize that the 3 day IF/CR will result in improved indicators of cardiovascular health.
#Intervention
- DIETARY_SUPPLEMENT : 3 day caloric restriction/metabolic reset
- Participants will consume \~500 kcal/day, using commercially available products (Plexus(r)), for 3 days, measuring physiological relevant parameters pre-and post-intervention.
|
#Eligibility Criteria:
Inclusion Criteria:
* Overweight or obese (body mass index, BMI > 27.5 kg/m2)
* Weight stable (± 4.4 lb) for > 6 months prior
* 25 <= age <= 65 of age
* Participants will be expected to be otherwise relatively healthy without uncontrolled chronic disease (e.g. cardiovascular, metabolic, or pulmonary) and 2 or fewer positive risk factors for cardiovascular disease (CVD) (e.g. high blood pressure, high cholesterol, etc) as described by the American College of Sports Medicine (ACSM)/American Heart Association (AHA) Criteria.
* Cleared by Physician
Exclusion Criteria:
* Subjects who present with more than 2 CVD risk factors (AHA/ACSM criteria) or have uncontrolled/overt cardiovascular, pulmonary, or metabolic disease (Diabetes Mellitus)
* Not cleared by their physician.
* Recent blood donation (<8 weeks)
* Those who have cancer or are being treated for cancer.
* Women who are currently pregnant, breastfeeding, attempting to conceive, or amenorrheic (not associated with menopause).
* Anyone who presents with food allergies to coconuts, dairy, soy, stevia, or nuts will also be excluded.
* Those with eating disorders should not partake in this study.
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05422391
| 251,995 |
{
"NCT_ID" : "NCT00052338",
"Brief_Title" : "Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer",
"Official_title" : "A Phase I Study Of PS-341 In Combination With Gemcitabine And Carbloplatin In Selected Stage IIIB Or IV Non-Small Cell Lung Cancer",
"Conditions" : ["Malignant Pleural Effusion", "Recurrent Non-small Cell Lung Cancer", "Stage IIIB Non-small Cell Lung Cancer", "Stage IV Non-small Cell Lung Cancer"],
"Interventions" : ["Drug: bortezomib", "Other: laboratory biomarker analysis", "Drug: gemcitabine hydrochloride", "Drug: carboplatin"],
"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)" : "2002-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2004-05",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2003-01-24",
"First_Posted(Estimated)" : 2003-01-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2003-01-26",
"Last_Update_Posted(Estimated)" : 2013-01-23",
"Last_Verified" : 2013-01"
}
}}
|
#Study Description
Brief Summary
Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and bortezomib may kill more tumor cells
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the safety and feasibility of combining bortezomib with gemcitabine and carboplatin in patients with advanced or recurrent non-small cell lung cancer.
II. Determine the maximum tolerated dose of bortezomib administered in combination with gemcitabine and carboplatin in these patients.
III. Correlate results from laboratory studies on patient tissue and serum specimens with potential predictors of response in patients treated with this regimen.
IV. Determine, preliminarily, the response of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of bortezomib.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8, carboplatin IV over 15-30 minutes on day 1, followed 1 hour later by bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with a clinical or radiographic response may continue receiving bortezomib beyond 6 courses.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 10 additional patients with chemotherapy-naive disease receive treatment as above with the MTD of bortezomib.
Patients are followed for survival.
#Intervention
- DRUG : gemcitabine hydrochloride
- Given IV
- Other Names :
- dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
- DRUG : carboplatin
- Given IV
- Other Names :
- Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
- DRUG : bortezomib
- Given IV
- Other Names :
- LDP 341, MLN341, VELCADE
- OTHER : laboratory biomarker analysis
- Correlative studies
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed non-small cell lung cancer
* Selected stage IIIB (malignant pleural effusion) or stage IV disease
* Recurrent disease after first-line therapy allowed
* Patients who received prior platinum-based chemotherapy must have no disease progression during or within 3 months after completion of therapy
* Patients who are enrolled at the maximum tolerated dose must have chemotherapy-naïve disease
* Evaluable disease
* Asymptomatic brain metastases allowed if treated with surgical resection or radiotherapy, neurologically stable, and off steroids for at least 4 weeks
* Performance status - Karnofsky 60 <= age <= 100%
* More than 3 months
* Absolute neutrophil count at least 1,500/mm^3
* Platelet count at least 100,000/mm^3
* Bilirubin no greater than 1.5 mg/dL
* AST no greater than 2.5 times upper limit of normal
* Creatinine normal
* Creatinine clearance at least 50 mL/min
* 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
* No peripheral neuropathy grade 2 or greater
* No prior allergic reactions to compounds of similar chemical or biological composition to bortezomib or other agents used in this study
* No concurrent ongoing or active infection
* No other concurrent uncontrolled illness
* No psychiatric illness or social situation that would preclude study compliance
* No concurrent routine filgrastim (G-CSF)
* See Disease Characteristics
* No more than 1 prior chemotherapy regimen
* At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
* No prior gemcitabine
* See Disease Characteristics
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered
* See Disease Characteristics
* More than 30 days since prior investigational drugs
* No prior bortezomib
* No concurrent anticonvulsant therapy
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational or commercial agents or therapies with intent to treat malignancy
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
|
NCT00052338
| 124,243 |
{
"NCT_ID" : "NCT03639246",
"Brief_Title" : "Efficacy and Safety Study of AVB-S6-500 in Patients With Platinum-Resistant Recurrent Ovarian Cancer",
"Official_title" : "A Phase 1b/2 Randomized, Controlled Study of AVB-S6-500 in Combination With Pegylated Liposomal Doxorubicin (PLD) or Paclitaxel (Pac) in Patients With Platinum-resistant Recurrent Ovarian Cancer",
"Conditions" : ["Ovarian Cancer"],
"Interventions" : ["Drug: AVB-S6-500", "Drug: Pegylated liposomal doxorubicin (PLD)", "Other: Placebo", "Drug: Paclitaxel (Pac)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-12-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-01-08",
"Study_Completion_Date(Actual)" : "2022-12-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-08-17",
"First_Posted(Estimated)" : 2018-08-21"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-08-17",
"Last_Update_Posted(Estimated)" : 2023-02-13",
"Last_Verified" : 2023-02"
}
}}
|
#Study Description
Brief Summary
This is a Phase 1b/2 study of AVB-S6-500 in combination with pegylated liposomal doxorubicin (PLD) or paclitaxel (Pac) in patients with platinum resistant recurrent ovarian cancer. The phase 1b portion of the study is open label and patients will receive either AVB-S6-500+PLD or AVB-S6-500+ Pac. The Phase 2 portion of the study is randomized, double-blind, placebo-controlled study to compare efficacy and tolerability of AVB-S6-500 in combination with PLD or Pac versus placebo plus PLD or Pac.
Detailed Description
While this study was planned as two-part study consisting of a Phase 1b and a Phase 2 portion, the sponsor decided not to proceed with the Phase 2 portion.
The Phase 1b portion of the study was a multicenter, 2-group, open-label design to evaluate the safety and tolerability of AVB-S6-500 combined with PLD or Pac in subjects with platinum-resistant recurrent ovarian cancer. The decision to enroll in the Phase 2 portion of the study was to be driven by the recommendation of a safe and tolerable dose of AVB-S6-500 in combination with each chemotherapy backbone; however, enrollment into the Phase 2 portion was not initiated per Sponsor decision. Given that sufficient data were obtained in the Phase 1b portion AVB-S6-500 + Pac group, the decision was made to pursue a randomized Phase 3 to further study the benefit of this combination versus paclitaxel alone in patients with platinum resistant ovarian cancer.
#Intervention
- DRUG : AVB-S6-500
- AVB-S6-500 is experimental drug
- DRUG : Paclitaxel (Pac)
- Paclitaxel is active comparator
- Other Names :
- Taxol
- DRUG : Pegylated liposomal doxorubicin (PLD)
- PLD is active comparator
- Other Names :
- Doxil
- OTHER : Placebo
- Placebo comparator
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* Histologically confirmed and documented recurrent ovarian, fallopian tube, and peritoneal cancer.
* Platinum resistant disease, defined as progression within <= 6 months from completion of most recent regimen and calculated from the date of the last administered dose of platinum therapy
* Must have available archived tumor tissue OR if archived tissue is not available, willing to provide a fresh tumor biopsy
* Must have radiologic imaging with a computerized tomography (CT) scan or magnetic resonance imaging (MRI) within 4 weeks of first dose of study drug
* Received at least 1 but not more than 3 therapy regimens, not including maintenance or adjuvant therapy
* Must have ovarian cancer that is measurable according to RECIST 1.1
* ECOG performance status of 0 <= age <= 1
* Normal gastrointestinal (GI), bone marrow, liver and kidney function
* At least 28 days between termination of prior anti-cancer or hormonal therapy and administration of AVB-S6 <= age <= 500
Exclusion Criteria:
* Primary platinum-refractory disease (defined as progression during the first platinum regimen or within 4 weeks of completion of the first platinum regimen)
* Currently being treated with concurrent anti-cancer therapy or any other interventional treatment or trial
* Received prior therapy with Pac or PLD in the recurrent setting, depending on physician-chosen chemotherapy for this study
* Significant cardiac disease history
* Has other prior or concurrent malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
* Symptomatic CNS metastasis or metastases
* Serious active infection requiring IV antibiotics and/or hospitalization at study entry
* Has known previous or current human immune deficiency (HIV) syndrome, hepatitis B, or hepatitis C
* Has had paracentesis for ascites within 3 months
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03639246
| 252,801 |
{
"NCT_ID" : "NCT01871844",
"Brief_Title" : "ITF2984 Repeated Doses Study in Healthy Volunteers",
"Official_title" : "A Within Group, Randomised, Phase I, Repeated Doses, Placebo and Octreotide Controlled Study in Healthy Volunteers to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Incremental Doses of ITF2984",
"Conditions" : ["Healthy Male Volunteers"],
"Interventions" : ["Drug: Placebo", "Drug: octreotide 50 mcg tid", "Drug: ITF2984 (500, 1000, 2000 mcg bid for 7 days)"],
"Location_Countries" : ["United Kingdom", "Italy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-09",
"Study_Completion_Date(Actual)" : "2013-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-05-22",
"First_Posted(Estimated)" : 2013-06-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-06-04",
"Last_Update_Posted(Estimated)" : 2013-06-07",
"Last_Verified" : 2013-06"
}
}}
|
#Study Description
Brief Summary
This was a within group, randomised, repeated dose, placebo- and octreotide controlled study in a target population of 45 healthy male subjects. Subjects were required to attend the clinical for screening procedures between 3 and 28 days before dosing commenced. The study was conducted in 4 groups of subjects; Groups 1 to 3 were a double-blinded, randomised design, each consisting of 12 subjects. Group 4 was an open-label design and consisted of 9 subjects. There was a minimum interval of 96 h between dosing of Groups 1, 2 and 3 to allow for interim analyses of PK and safety/tolerability data for dose escalation purposes. Group 4 (the active control group) was still to proceed if the decision was taken to prematurely stop dosing with ITF2984 (somatostatin analogue) following review of the PK and safety data presented at the interim decision meeting; dosing of this group was conducted independently from Groups 1 to 3. On Days 1 to 6, subjects in Groups 1 to 3 were to receive 2 doses of investigational medicinal product (IMP) approximately 12 h apart; subjects in Group 4 were to receive 3 doses of IMP approximately 8 h apart. For all groups, subjects were scheduled to receive their final dose of IMP on the morning of Day 7.
In addition, subjects were to receive exogenous test administrations(stimulation test) on Day -1, Day 1 and Day 7 at the same time on each day (ie for Day -1, 23.5 h before the first dose of IMP, and for Days 1 and 7, 0.5 h after the first dose of IMP on the respective day). Blood samples for PD and PK analyses were taken at specified time points after each dosing.
Subjects remained on site for 10 days (ie 36 h after the final dose of IMP on Day 7) providing that discharge conditions had been met, and returned to the clinic between 5 and 10 days after the last IMP administration for a follow-up visit.
#Intervention
- DRUG : ITF2984 (500, 1000, 2000 mcg bid for 7 days)
- Other Names :
- somatostatin analogue
- DRUG : octreotide 50 mcg tid
- DRUG : Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy Caucasian male volunteers between 18 and 50 years, inclusive.
* Body mass index (BMI) of 18 to 25 kg/m2 inclusive.
* Was willing and able to communicate and participate in the entire study.
* Had an understanding, ability and willingness to fully comply with study procedures and restrictions.
* Was willing and able to provide written, personally signed and dated informed consent to participate in the study, in accordance with the ICH GCP Guidelines and applicable regulations, before completing any study-related procedures.
* Agreed to comply with the applicable contraceptive requirements from admission to 90 days after the last dose.
* Had a satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, ECG or laboratory evaluation (haematology, biochemistry, urinalysis) as assessed by the investigator.
Exclusion Criteria:
* Current or recurrent disease (eg cardiovascular, respiratory, endocrine, renal, liver, GI, malignancy or other conditions) that could have affected the action, absorption or disposition of the IMP, or could have affected clinical or laboratory assessments.
* Current or relevant previous history of physical or psychiatric illness, any medical disorder that may have required treatment or made the subject unlikely to fully complete the study, or any condition that presented undue risk from the IMP or study procedures.
* Significant illness, as judged by the investigator, within 2 weeks of the first dose of IMP.
* Current use (defined as use within 14 days of first IMP dose) of any medication, including prescription, over-the-counter, herbal or homeopathic preparations (other than 4 g per day of paracetamol).
* Subjects who had received prohibited medication
* Known or suspected intolerance or hypersensitivity to the IMP, closely related compounds or any of the stated ingredients.
* History of alcohol or other substance abuse within the last year. A positive result for alcohol or drugs of abuse.
* Male subjects who consumed more than 21 units of alcohol per week or 3 units per day (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
* A positive human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) test.
* Use of tobacco in any form (eg smoking or chewing) or other nicotine-containing products in any form (eg gum, patch). Ex-users had to report that they had stopped using tobacco for at least 90 days before receiving the first dose of IMP. A breath carbon monoxide (CO) reading of greater than 10 ppm at screening.
* Donation of blood or blood products (eg plasma or platelets) of greater than 400 mL within 90 days before receiving IMP.
* Use of another IMP within 90 days before receiving the first dose of IMP, or active enrolment in another drug or vaccine clinical study.
* Subjects who had previously been enrolled in this study.
* Clinically significant abnormal biochemistry, haematology or urinalysis result as judged by the investigator.
* Presence or history of allergy requiring treatment. Hayfever was allowed as long as it was inactive.
* Failure to satisfy the investigator of fitness to participate for any other reason.
Sex :
MALE
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
|
NCT01871844
| 68,148 |
{
"NCT_ID" : "NCT05431985",
"Brief_Title" : "Cross-cultural Validation of a Screening Scale for the Misuse of Opioid Analgesics in Primary Care",
"Official_title" : "Cross-cultural Validation of a Screening Scale for the Misuse of Opioid Analgesics in Primary Care",
"Conditions" : ["Chronic Pain", "Addiction Opiate"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-03-01",
"Study_Completion_Date(Actual)" : "2019-07-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-06-17",
"First_Posted(Estimated)" : 2022-06-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-06-23",
"Last_Update_Posted(Estimated)" : 2022-06-24",
"Last_Verified" : 2022-06"
}
}}
|
#Study Description
Brief Summary
Objective: Analgesic Opioids misuse among patients with chronic pain ranges from 0% to 50%. The general practitioner is the first prescriber of opioid analgesics Our objective was to validate in primary care the POMI (Prescription Opioid Misuse Index) to identify the misuse of AOs.
Study Setting: Patients with chronic pain, taking AOs for at least 3 months, and followed in general practice.
Study design: Psychometric study
Data Collection/Extraction methods: Eligible patients followed in general practice responded to the POMI: Test phase. They then responded after 2 weeks: the retest. The gold standard used was the DSM-V.
Detailed Description
Chronic pain represents a major problem in terms of individual, quality of life, and collective impact: cost generated by delays in treatment and care. The prevalence of chronic pain among the general population varies from 10.1 to 55.2%. In the front line, general practitioners (GP) are at the heart of treating pain : pain represent 43% of the reasons for the consultation, 24% of these being for chronic pain. More than half of these patients had exclusive care through their GP. The others are followed up in a pain assessment and treatment center.
In 2015, nearly one in five French people (17,1%) of French people have taken opioid treatment. The risk of opioid use disorder secondary to opioid analgesics among patients suffering from chronic pain varies from 0% to 50%. American recommendations advocate periodic surveillance of this opioid use disorder depending on the patient's risk factors, when chronic opioid analgesics are prescribed. The French 'Limoges' recommendations also mention a systematic search for signs of psychological dependence during treatment and state that treatment with strong opioids should be stopped in the event of misuse, abuse or addiction. They recommend, on each examination, the investigation for signs of misuse or psychological dependence (characterised by craving) as ways of monitoring that strong opioids are being correctly used in chronic osteo-articular pain.
Identifying the misuse is a way of optimising their benefit/risk ratio
The difficulty in establishing the prevalence of misuse is due to a lack of standardization of studies and the lack of consensus in the use of assessment tools. Several tools are available internationally. The only diagnostic criteria available are those of the DSM-5 (Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders) or the ICD-10 which overestimate this prevalence notably by the presence of frequent tolerance and withdrawal criteria for these patients, in the absence of misuse or addiction. Today, no screening scale has been validated in France for primary care, but recently, the authors have validated the POMI scale in French to screen the patients specifically followed in pain clinic and presenting a misuse behavior of their opioid analgesic treatment. In 2015, treatment initiation was carried out by a GP in 59.1% of cases for weak opioid and 62.9% of cases for strong opioids and by a hospital doctor for 20.1% and 21% respectively7. Currently, no scale was validated in primary care. A scale validated in French would make it possible to standardize these screening practices and secure prescription both from the point of view of the doctor and of the patient. Furthermore, this absence of a validated tool in French is proving to be an obstacle to the development of true pharmaco-epidemiological studies on the prevalence of the opioids misuse. The originality of this study is to assess the clinical relevance of the french transcultural validation of the POMI scale in primary care in order to ensure an appropriate and relevant use by all health professionals and to allow large-scale screening for the misuse behavior of analgesic opioids.
The aim of the study was a validation of the French version of the Prescription Opioid Misuse Index - POMI patients with chronic pain in general practitioners setting.
Secondary objective
* To study the profile of participants with misuse of opioid analgesics.
* To compare the results of this study with the previous study on patients followed in pain clinic.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 and over,
* Patients with chronic pain for at least 6 months,
* Patients with a prescription from the GP of at least one Opioid analgesic drug taken daily for at least the previous 3 months,
* Patients registered with the French insurance system.
Exclusion Criteria:
* Discontinuation of opioid prescriptions on the test phase day (no Retest possible),
* Patients in the process of withdrawal (risk of having been withdrawn during the Retest phase),
* Patients unable to complete the questionnaire alone,
* Patients who are monitored by a pain clinic or addiction centre,
* Patients with ongoing cancer,
* Patients refusing to participate.
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
|
NCT05431985
| 207,624 |
{
"NCT_ID" : "NCT00928343",
"Brief_Title" : "First-in-Human Single Ascending Subcutaneous (s.c.) Dose and Single Oral Dose of GLPG0187",
"Official_title" : "Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending Subcutaneous and Oral Doses of GLPG0187 in Healthy Subjects.",
"Conditions" : ["Healthy"],
"Interventions" : ["Drug: Placebo", "Drug: GLPG0187"],
"Location_Countries" : ["Belgium"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2009-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-11",
"Study_Completion_Date(Actual)" : "2009-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2009-06-23",
"First_Posted(Estimated)" : 2009-06-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2009-06-24",
"Last_Update_Posted(Estimated)" : 2010-01-15",
"Last_Verified" : 2010-01"
}
}}
|
#Study Description
Brief Summary
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) subcutaneous and single oral dose of GLPG0187 compared to placebo.
Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0187 after single subcutaneous and oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.
#Intervention
- DRUG : GLPG0187
- Single ascending subcutaneous doses (subcutaneous solution), and single oral dose (oral solution)
- DRUG : Placebo
- Matching subcutaneous or oral placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy male, age 18 <= age <= 50 years
* BMI between 18 <= age <= 30 kg/m², inclusive
Exclusion Criteria:
* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse
Sex :
MALE
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
|
NCT00928343
| 174,073 |
{
"NCT_ID" : "NCT00576485",
"Brief_Title" : "Spherical Aberration and Contrast Sensitivity in IOLs",
"Official_title" : "Spherical Aberration and Contrast Sensitivity in Eyes Implanted With Aspheric and Spherical Intraocular Lenses: Clinical Comparative Study",
"Conditions" : ["Cataract", "Signs and Symptoms", "Pseudophakia", "Lens Diseases"],
"Interventions" : ["Procedure: Cataract surgery and intraocular lens implantation"],
"Location_Countries" : ["Brazil"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE4"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-02",
"Study_Completion_Date(Actual)" : "2007-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-12-18",
"First_Posted(Estimated)" : 2007-12-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-12-18",
"Last_Update_Posted(Estimated)" : 2008-10-20",
"Last_Verified" : 2007-12"
}
}}
|
#Study Description
Brief Summary
Purpose: To determine whether implantation of an intraocular lens (IOL) with a modified anterior aspheric surface results in reduced spherical aberration and improved contrast sensitivity after cataract surgery.
Design: Prospective, comparative, interventional case series.
Methods: In an intraindividual randomized prospective study of 25 patients with bilateral cataract, an IOL with a modified anterior surface (Tecnis Z9001, AMO- Group 1) was compared with biconvex lens with spherical surfaces (ClariFlex®, AMO- Group 2). Ocular aberrations for a 5.0 mm pupil and 6.0 mm pupil were measured with Hartmann-Shack aberrometer. Quality of vision was measured by visual acuity and contrast sensitivity under mesopic and photopic conditions. All patients were followed for 3 months.
Detailed Description
With improvement in the quality of life and the resulting expansion of the elderly population, the prevalence of cataract cases will continue to rise. The population is on average older, and the environment has become more demanding for older people, who therefore need to regain excellent quality of vision. Advances in both IOL and phacoemulsification technology have enable cataract surgery to evolve from a procedure concerned with the safe removal of the cataract to a procedure refined to achieve the best possible postoperative refractive result.
Snellen visual acuity insufficiently describes the quality of the eye's optics before and after cataract surgery. 1-3 Multiple scientific studies have demonstrated that contrast sensitivity represents a robust indicator of functional vision. 4-7 The contrast sensitivity function, measured under varying conditions of luminance and glare, establishes the limits of visual perception across the spectrum of spatial frequencies.
Studies have demonstrated a nearly linear decline in image quality with age, suggesting a significant increase in the optical aberrations in the eye over time. 8-9 Advances in wavefront technology have opened a new door to the measurement of ocular aberrations. 9-10 Also, this technology allowed the development of a new type of IOL designed to compensate for the positive spherical aberration of the cornea, which is one of the most important aberrations contributing to visual deterioration of the pseudophakic eye. 11-14 Based on these findings, the approach to compensate for increasing spherical aberration in older eyes is to develop an IOL that introduces negative spherical aberration into the system. Such an IOL, the Tecnis Z9001® IOL (Model Z9001, Advanced Medical Optics, Santa Ana, CA), has been developed by AMO. This is a polysiloxane foldable 3-piece IOL, with anterior aspheric surface (negative spherical aberration) designed to decrease the total amount of ocular spherical aberration after cataract surgery.7
The purpose was to determine whether implantation of an intraocular lens (IOL) with a modified anterior aspheric surface results in reduced spherical aberration and improved contrast sensitivity after cataract surgery.
Patients and Methods
This double-blind prospective randomized study included patients with age-related cataract, no indication of existing ocular pathology, unsatisfactory correction with glasses and less than 2.50 diopters (D) of topography cylinder. Patients were offered the opportunity to be part of a clinical trial in which they would be allocated to have cataract surgery with implantation of aspherical or spherical IOL. Patients were randomized to receive a Tecnis Z9001 aspheric IOL in one eye and a ClariFlex spheric IOL in the fellow eye. To protect patient safety, after the first eye surgery, they were asked whether they wished to have the same lens type implanted in the second eye. Written informed consent was obtained from all patients before surgery and the study was approved by the local ethics committee. Exclusion criteria were previous ocular surgery, central endothelial cell count less than 1800 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopic eyes, retinal abnormalities, diabetes mellitus, steroid or immunosuppressive treatment, and connective tissue diseases.
The selected lenses used in this study were the Tecnis Z9001® (Model Z9001, Advanced Medical Optics, Santa Ana, CA) and the ClariFlexTM (Advanced medical Optics, Santa Ana, CA) (Table 1). Eyes in Group 1 (n=25) received the Tecnis Z9001® (Model Z9001) and eyes in Group 2 (n=25) received the ClariFlexTM (Table 1).
The Holladay formula was used to calculate the IOL power when there was a short axial length (\< 22.0 mm) and the SRK/T formula was used when there was an average axial length (≥ 22.0 mm). The A-constant used was 119.1 for the Tecnis Z9001 IOL and 118.0 for the ClariFlex IOL. Axial length was measured with the IOL Master (Carl Zeiss Meditec AG), and the targeted postoperative refractive error was 0.0.
Preoperative and postoperative evaluation included uncorrected distance visual acuity (UCDVA), best corrected visual acuity (BCVA), spherical equivalent (SE), slitlamp biomicroscopy, applanation tonometry, fundus examination, B-scan biometry, specular microscope and corneal topography. Topography was performed in all patients using the EyeSys unit (Version 3.03; EyeSys Technologies, Houston, Texas). The corneal endothelial cell count was also recorded for all eyes (noncontact specular microscope, NonCon Robo, Konan). The visual acuity measurements were recorded with logMAR UCDVA and BCVA. Clinical data were collected preoperatively and 1 and 3 months postoperatively for each eye.
All patients were operated in the same fashion by the same surgeon. All patients received topical anesthesia by lidocaine 2% gel before surgery. A 2.75 mm self-sealing clear cornea incision was made on the temporal side. Viscoelastic solution of sodium hyaluronate 3% and chondroitin sulfate 4% (Viscoat®) was used to reform and stabilize the surgical planes and protect the endothelium. A 5.00 to 5.25 mm continuous curvilinear capsulorhexis was initially performed with a 26-gauge needle and completed with forceps. The nucleous was removed without intraoperative complications such as posterior capsule rupture. Phacoemulsification was performed using the Infinite (Alcon Surgical) or Sovereign machine (Allergan Surgical). All IOLs were inserted in the capsular bag with the injector system. The viscoelastic material was completely removed at the end of the procedure. No sutures were used in any case. After 1 week the patient had the fellow eye operated. Postoperative medication included moxifloxacin (Vigamox®) or gatifloxacin (Zymar®) 4 times a day for 2 weeks, 0.1% diclofenaco sodium (Voltaren) 3 times a day for 4 weeks and steroid (Predfort) eyedrops 4 times a day for 6 weeks. Postoperative follow-up was 1 day, 1 and 3 months.
Postoperative evaluations were performed at 1 day, 1 month, and 3 months. At 1 month and 3 months, visual acuity, refraction, contrast sensitivity (CSV-1000 HGT, Vector Vision Inc.), and wavefront analysis with the Zywave aberrometer (Bauch \& Lomb, Rochester, New York) were performed.
Contrast sensitivity was measured using the CSV-1000 HGT testing instrument (Vector Vision Inc.), which presents a translucent chart divided into 4 cycles with spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd). The background illumination of the translucent chart does not depend on room lighting; rather, it is provided by a fluorescent luminance source of the instrument and is automatically calibrated to 85 candelas/m2. All measurements were obtained under mesopic (5 cd/m2) and photopic (85 cd/m2) conditions. Each cycle contains 17 round patches that are 1.5 inches in diameter. The first patch has a high-contrast grating and presents the sample. The test patches are arranged in 2 rows with 8 levels of contrast. The levels decreased from left to right along the row in a logarithmic fashion in 0.17 log units for steps 1 through 3 and 0.15 log units for steps 3 through 8. The examinations were performed unilaterally at a distance of 2.5 m with best corrected visual acuity (BCVA) and an undilated pupil. All measurements were conducted under the same conditions by an examiner who was unaware of the type of IOL implanted.
Wavefront analysis was performed by the Zywave aberrometer. The Zywave aberrometer uses the Hartmann-Shack method of analysis of the outgoing wavefront that measures up to fifth-order Zernike aberrations, including coma, trefoil, and spherical aberrations.
For statistical analysis of visual acuity, logarithm of minimum angle of resolution (logMAR) acuity values were used. Similarly, the recorded contrast sensitivity values were transformed into log values as described by Vector Vision. All data analyses were performed using SPSSX statistical programs (SPSS Inc, Chicago, IL). The 2 IOLs were compared between eyes intraindividually. The analysis was based on a non-normal distribution of the data. The nonparametric Mann-Whitney U test was used to compare data between the 2 IOL groups. A P value less than 0.05 was considered statistically significant.
#Intervention
- PROCEDURE : Cataract surgery and intraocular lens implantation
- Cataract surgery and implantation of an intraocular lens
|
#Eligibility Criteria:
Inclusion Criteria:
* Age-related cataract
* No indication of existing ocular pathology
* Unsatisfactory correction with glasses and
* Less than 2.50 diopters (D) of topography cylinder.
Exclusion Criteria:
* Previous ocular surgery
* Central endothelial cell count less than 1800 cells/mm2
* Glaucoma or intraocular pressure greater than 21 mmHg
* Amblyopic eyes
* Retinal abnormalities
* Diabetes mellitus
* Steroid or immunosuppressive treatment, and
* Connective tissue diseases
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00576485
| 205,041 |
{
"NCT_ID" : "NCT03882697",
"Brief_Title" : "Ability of Cardio Q for Prediction of Hypotension",
"Official_title" : "Ability of Cardio Q for Prediction of Hypotension After Postural Change in Robot-Assisted Laparoscopic Radical Prostatectomy",
"Conditions" : ["Prostate Cancer"],
"Location_Countries" : ["Korea, Republic of"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-09-24",
"Study_Completion_Date(Actual)" : "2020-09-24},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-02-12",
"First_Posted(Estimated)" : 2019-03-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-03-19",
"Last_Update_Posted(Estimated)" : 2020-12-21",
"Last_Verified" : 2020-12"
}
}}
|
#Study Description
Brief Summary
Evaluation the ability of each indicator of Cardio Q in predicting hypotension after position changes in robot-assisted laparoscopic radical prostatectomy
Detailed Description
Hypotension is common in patients who undergo general anesthesia. Hypotension may cause hypoperfusion in the organs of the body, resulting in ischemia and increased mortality within one year. Hypotension may occur at any time during general anesthesia but may also occur with changes in posture. In robot-assisted laparoscopic radical prostatectomy, hypotension often occurs when posture is changed from a Trendelenburg position to a supine position. However there is no data regarding which hemodynamic parameters can predict hypotension induced by position change.
Excessive administration of the fluid in steep Trendelenburg position may lead to fluid overload and lead to complications such as pulmonary edema. Thus, the predictors are should be identified to manage patients without fluid overload. Therefore, the aim of this study is to investigate the parameters of Cardio Q which are useful for predicting hypotension after position change.
|
#Eligibility Criteria:
Inclusion Criteria:
Patients undergoing robot-assisted laparoscopic radical prostatectomy ASA 1 <= age <= 3
Exclusion Criteria:
Patients that
* Unstable angina, left ventricular ejection fraction <40%
* Severe vascular disease
* Insertion type : pacemaker / defibrillator
* Autonomic nervous system diseases
* When esophageal varices are present
* If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)
Sex :
MALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03882697
| 239,629 |
{
"NCT_ID" : "NCT04319497",
"Brief_Title" : "Subjective and Objective Refraction in Pseudophakic Patients",
"Official_title" : "Agreement and Variability of Subjective Refraction, Autorefraction, and Wavefront Aberrometry in Pseudophakic Patients",
"Conditions" : ["Pseudophakia"],
"Interventions" : ["Device: Autorefraction", "Device: Subjective refraction", "Device: Wavefront aberrometry"],
"Location_Countries" : ["Austria"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "DIAGNOSTIC",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-03-20",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-08-20",
"Study_Completion_Date(Actual)" : "2014-08-20},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-03-19",
"First_Posted(Estimated)" : 2020-03-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-03-20",
"Last_Update_Posted(Estimated)" : 2020-03-24",
"Last_Verified" : 2020-03"
}
}}
|
#Study Description
Brief Summary
Targeting of post-cataract refraction depends mainly on the prediction of the post-operative lens position, but also on the post-operative refraction itself. Hence, aim of this study is to evaluate the agreement and variability of subjective refraction performed by two independent examiners, autorefraction, and wavefront aberrometry in pseudophakic patients after uneventful cataract surgery.
Detailed Description
One of the main goals of modern cataract surgery, beside removing the cataractous lens, is to achieve the patient's desired post-operative refraction. Targeting this post-operative refraction depends mainly on the prediction of the post-operative lens position and the post-operative refraction itself. Reason for the contributing effect of post-operative refraction in the error-propagation analyses is that refraction in phakic patients was shown to have only moderate reproducibility.
In the past, different studies evaluated refraction methods. However, there is no study that included reproducibility of subjective refraction in pseudophakic patients and compares it with objective refraction methods (autorefraction, wavefront aberrometry).
100 eyes of 100 patients, which underwent uneventful cataract surgery, will be included in the study. Refraction of one eye of each patient will be tested using subjective refraction by two different examiners, autorefraction, and wavefront aberrometry at two separate occasions.
#Intervention
- DEVICE : Subjective refraction
- Subjective refraction measurements will be performed by two testers for all the patients included
- DEVICE : Autorefraction
- Five autorefraction measurements will be performed for all the patients included
- DEVICE : Wavefront aberrometry
- Five wavefront measurements will be performed for all the patients included
|
#Eligibility Criteria:
Inclusion Criteria:
* Minimum age: 21 years
* Cataract surgery (at least 8 weeks post-surgery)
* written informed consent
Exclusion Criteria:
* Complications during or after cataract surgery
* Ophthalmic diseases, that might interfere with measurements (macular degeneration, glaucoma, diabetic retinopathia)
* Ophthalmic surgery other than cataract surgery
* Clinically significant posterior capsule opacification
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 105 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT04319497
| 239,931 |
{
"NCT_ID" : "NCT01955954",
"Brief_Title" : "Using the Canary Breathing System for Panic Disorder Patients",
"Official_title" : "Investigation of the Canary Breathing System for Treating the Symptoms of Panic Disorder",
"Conditions" : ["Panic Disorder"],
"Interventions" : ["Device: Canary Breathing System"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-05",
"Study_Completion_Date(Actual)" : "2016-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-09-30",
"First_Submitted_that_Met_QC_Criteria" : 2018-01-10",
"First_Posted(Estimated)" : 2013-10-08"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-10-07",
"Last_Update_Posted(Estimated)" : 2018-02-06",
"Last_Verified" : 2018-01"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to test the effectiveness of the Canary Breathing System (CBS) in treating the symptoms of panic disorder.
Detailed Description
Panic disorder (PD) is associated with hyperventilation. The efficacy of a brief respiratory feedback program for PD has been previously established. The aim of the present study was to expand these results by testing a similar program with more clinically representative patients and settings. The intervention is delivered via home use following initial training by a clinician and provides remote monitoring of client adherence and progress by the clinician. Outcomes were assessed post-treatment and at 2- and 12-month follow-up.
#Intervention
- DEVICE : Canary Breathing System
- The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns.
|
#Eligibility Criteria:
Inclusion Criteria:
* Primary diagnosis of Panic Disorder
* Subjects between 18 and 60 years (inclusive on day of enrollment)
* Subjects with a Clinician's Global Impression of > or = to 4.
* If on psychotropic medication, on a stable dose for a minimum of 3 months prior to enrollment
* If on psychotropic medication, an agreement to stay on their stable dose from study entry until the 2-month follow-up.
Exclusion Criteria:
* Pregnancy
* Current enrollment in another drug or device study
* Current enrollment in another drug or device study that is not at least 30 days past the final follow-up
* Currently undergoing cognitive behavioral therapy (or equivalent)
* Refractory to either a breathing training program or cognitive behavioral therapy (or equivalent) in the 3 months prior to enrollment
* Evidence of organic mental disorder
* Severe suicidality
* Presence of any psychotic disorder
* Bipolar disorder that is present for < 5 years; a major depressive, manic or hypomanic episode in the last 12 months; failure to take and maintain a stable dose of medication in treatment of bipolar disorder in the last 12 months
* Current alcohol or drug dependence
* Cardiovascular or pulmonary disease
* Epilepsy or seizures
* Undergoing additional psychologic treatment at any point from study enrollment to 2-month follow-up to treat panic disorder
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
|
NCT01955954
| 270,936 |
{
"NCT_ID" : "NCT01766817",
"Brief_Title" : "Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis",
"Official_title" : "Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis",
"Conditions" : ["Idiopathic Pulmonary Fibrosis"],
"Interventions" : ["Drug: BMS-986020", "Drug: Placebo matching with BMS-986020"],
"Location_Countries" : ["Colombia", "United States", "Mexico", "Australia", "Chile", "Peru"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-01-31",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-02-29",
"Study_Completion_Date(Actual)" : "2016-02-29},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-01-10",
"First_Submitted_that_Met_QC_Criteria" : 2019-05-02",
"First_Posted(Estimated)" : 2013-01-11"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-01-10",
"Last_Update_Posted(Estimated)" : 2020-08-11",
"Last_Verified" : 2020-08"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to determine if study drug (BMS-986020) dose of 600 mg once daily or 600 mg twice daily for 26 weeks compared with placebo will reduce the decline in forced vital capacity (FVC) and will be well tolerated in subjects with idiopathic pulmonary fibrosis (IPF).
#Intervention
- DRUG : BMS-986020
- DRUG : Placebo matching with BMS-986020
|
#Eligibility Criteria:
Inclusion Criteria:
* Are between the ages of 40 and 90 years, inclusive, at randomization.
* Have clinical symptoms consistent with IPF.
* Have first received a diagnosis of IPF less than 6 years before randomization. The date of diagnosis is defined as the date of the first available imaging or surgical lung biopsy consistent with IPF/UIP.
* Have a diagnosis of usual interstitial pulmonary fibrosis (UIP) or IPF by HRCT or surgical lung biopsy (SLB).
* Extent of fibrotic changes (honeycombing, reticular changes) greater than the extent of emphysema on HRCT scan.
* Have no features supporting an alternative diagnosis on transbronchial biopsy, BAL, or SLB, if performed.
* Have percent predicted post-bronchodilator FVC between 45% and 90%, inclusive, at screening.
* Have a change in post-bronchodilator FVC (measured in liters) between screening and day 1 that is less than a 10% relative difference, calculated as: the absolute value of 100% * (screening FVC (L) - day 1 FVC (L)) / screening FVC (L).
* Have carbon monoxide diffusing capacity (DLCO) between 30% and 80% (adjusted for hemoglobin and altitude), inclusive, at screening.
* Have no evidence of improvement in measures of IPF disease severity over the preceding year, in the investigator's opinion.
* Be able to walk 150 meters or more at screening.
* Demonstrate an exertional decrease in oxygen saturation of 2 percentage points or greater at screening (may be performed with supplemental oxygen titrating to keep oxygen saturation levels >88%).
* Are able to understand and sign a written informed consent form.
* Are able to understand the importance of adherence to study treatment and the study protocol and are willing to comply with all study requirements, including the concomitant medication restrictions, throughout the study.
* Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must use acceptable method(s) of contraception. The individual methods of contraception and duration should be determined in consultation with the investigator. WOCBP must follow instructions for birth control when the half-life of the investigational drug is less than 24 hours, contraception should be continued for a period of 30 days after the last dose of investigational product.
1. Women must have a negative urine pregnancy test within 24 hours prior to the start of investigational product.
2. Women must not be breastfeeding.
3. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men that are sexually active with WOCBP must follow instructions for birth control when the half-life of the investigational drug is less than 24 hours, contraception should be continued for a period of 90 days after the last dose of investigational product.
4. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and azoospermic men do not require contraception.
Exclusion Criteria:
Target Disease Exclusions
* Has significant clinical worsening of IPF between screening and day 1 (during the screening process), in the opinion of the investigator.
* Has forced expiratory volume in 1 second (FEV1)/FVC ratio less than 0.8 after administration of bronchodilator at screening.
* Has bronchodilator response, defined by an absolute increase of 12% or greater and an increase of 200 mL in FEV1 or FVC or both after bronchodilator use compared with the values before bronchodilator use at screening.
Medical History and Concurrent Diseases
* Has a history of clinically significant environmental exposure known to cause pulmonary fibrosis, including, but not limited to, drugs (such as amiodarone), asbestos, beryllium, radiation, and domestic birds.
* Has a known explanation for interstitial lung disease, including, but not limited to, radiation, drug toxicity, sarcoidosis, hypersensitivity, pneumonitis, bronchiolitis, obliterans, organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer.
* Has a clinical diagnosis of any connective tissue disease, including, but not limited to, scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, rheumatoid arthritis, and undifferentiated connective tissue disease.
* Currently has clinically significant asthma or chronic obstructive pulmonary disease.
* Has clinical evidence of active infection, including, but not limited to, bronchitis, pneumonia, sinusitis, urinary tract infection, and cellulitis.
* Has any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 2 years. This does not include minor surgical procedures for localized cancer (e.g., basal cell carcinoma).
* Has any condition other than IPF that, in the opinion of the investigator, is likely to result in the death of the subject within the next 2 years.
* Has a history of end-stage liver disease.
* Has a history of end-stage renal disease requiring dialysis.
* Has a history of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months, including, but not limited to, the following: i. Unstable angina pectoris or myocardial infarction ii. Congestive heart failure requiring hospitalization iii. Uncontrolled clinically significant arrhythmias
* Has any condition that, in the opinion of the investigator, might be significantly exacerbated by the known side effects associated with the administration of BMS-986020.
* Has a history of alcohol or substance abuse in the past 2 years.
* Has a family or personal history of long QT syndrome and/or Torsades de Pointes (polymorphic ventricular tachycardia).
* Has used any of the excluded medications per Appendix 1 of the Protocol, which includes, but is not limited to:
* current treatment with pirfenidone or nintedanib
* use of over-the-counter medications and herbal preparations, within 4 weeks before study drug administration except those medications cleared by the BMS medical monitor
* For subjects taking statins, there are restrictions on the maximum allowable doses for statins listed below. If subjects are currently taking statins and their doses are higher than those mentioned below, please reduce the dose to the maximum allowable dose.
Additionally, if subjects are on statins and ready to start dosing, these subjects should limit statin doses by maximal allowable dose or lower for at least 5 days prior to the first BMS-986020 dosing. Shorter durations may be considered in select cases after discussion with the medical monitor.
Maximum allowable dose for statins:
* Simvastatin 20 mg QD
* Pitavastatin 2 mg QD
* Atorvastatin 40 mg QD
* Pravastatin 40 mg QD
* Rosuvastatin 20 mg QD
* Lovastatin 40 mg QD
* Fluvastatin 40 mg QD
* Prednisone is allowed up to a maximum of 15 mg po daily
* Pirfenidone or nintedanib dosing for a maximum of 3 months in the prior 12 months is permitted with a 4 week washout period prior to dosing with BMS-986020.
Physical and Laboratory Test Findings
* Has any of the following liver-function test criteria above the specified limits: total bilirubin >1.5 x ULN, excluding subjects with Gilbert's syndrome; aspartate or alanine aminotransferase (AST/SGOT or ALT/SGPT) greater than 3 x ULN; alkaline phosphatase greater than 2.5 x ULN.
* Has creatinine clearance less than 30 mL/minute, calculated using the Cockcroft-Gault formula.
* Has ECG result with a QT interval by Fridericia's correction (QTcF) of 500 msec or greater or an uncorrected QT of 500 msec or greater at screening. Note: For subjects with a machine read QT interval of >500 msec, if their heart rate is > 100 bpm, the machine read QT interval (either corrected or not) may not be accurate. If the investigator is uncertain about the QT abnormality, it is recommended that ECGs be over-read by a cardiologist. The manually read QT interval by a cardiologist should be used for assessment of eligibility whenever possible.
Allergies and Adverse Drug Reaction Has had prior use of BMS-986020 or has known hypersensitivity to any of the components of study treatment.
Other Exclusion Criteria
* Is not a suitable candidate for enrollment or is unlikely to comply with the requirements of this study, in the opinion of the investigator.
* Has smoked cigarettes within 4 weeks or screening or is unwilling to avoid tobacco products throughout the study.
* Is expected to receive a lung transplant within 1 year from randomization or, for subjects at sites in the United States, is on a lung-transplant waiting list at screening.
* Prisoners or subjects who are involuntarily incarcerated.
* Subjects who are compulsorily detained for treatment either of a psychiatric or physical (e.g., infectious disease) illness.
* Inability to comply with restrictions and prohibited activities/treatments as listed in Section 3.3 of the Protocol.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT01766817
| 141,699 |
{
"NCT_ID" : "NCT00002000",
"Brief_Title" : "A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients",
"Official_title" : "A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients",
"Conditions" : ["Herpes Simplex", "HIV Infections"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 1999-11-02",
"First_Posted(Estimated)" : 2001-08-31"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2001-08-30",
"Last_Update_Posted(Estimated)" : 2005-06-24",
"Last_Verified" : 1996-04"
}
}}
|
#Study Description
Brief Summary
To evaluate the safety and efficacy of oral valacyclovir hydrochloride (256U87) vs. acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients (CD4 greater than or equal to 100).
Detailed Description
Efficacy variables include the length of the episode, the time to lesion healing, the duration and severity of pain/discomfort, the duration of viral shedding, the proportion of patients with aborted episodes, the proportion of patients requiring extended therapy.
#Intervention
- DRUG : Valacyclovir hydrochloride
- DRUG : Acyclovir
|
#Eligibility Criteria:
Inclusion Criteria
Patients must have the following:
* HIV-infected individual (CD4 = or > 100) with a history of recurrent anogenital herpes.
* Signed the consent form or present a signed parental consent form if below 18 years.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Hepatic impairments as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. Impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine. History of hypersensitivity to acyclovir. Malabsorption or vomiting that would, in the investigators opinion, potentially limit the retention and absorption of oral therapy.
Patients with the following are excluded:
* Hepatic impairment as evidenced by a three-fold increase from the upper limit of normal in alanine or aspartate transaminase. Impairment of renal function as evidenced by any elevation above the upper limit of normal for serum creatinine.
* History of hypersensitivity to acyclovir. Malabsorption or vomiting that would, in the investigator's opinion, potentially limit the retention and absorption of oral therapy.
Prior Medication:
Excluded:
* Systemic antiherpes or immunomodulatory therapy within 30 days prior to entry.
Sex :
ALL
Ages :
- Minimum Age : 13 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00002000
| 256,840 |
{
"NCT_ID" : "NCT00099489",
"Brief_Title" : "Safety and Efficacy of Avonex in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)",
"Official_title" : "A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of AVONEX When Used in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)",
"Conditions" : ["Chronic Inflammatory Demyelinating Polyradiculoneuropathy"],
"Location_Countries" : ["United Kingdom", "United States", "Canada", "Australia"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2004-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2006-02",
"Study_Completion_Date(Actual)" : "2006-02},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2004-12-15",
"First_Posted(Estimated)" : 2004-12-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2004-12-15",
"Last_Update_Posted(Estimated)" : 2010-03-05",
"Last_Verified" : 2010-03"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether AVONEX (Interferon Beta-1a), when compared to placebo, reduces the total dose of IVIg that is administered after Visit 5 and through Visit 9 (Week 32, End of Study).
Detailed Description
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) is an acquired peripheral neuropathy of unknown origin. The etiology is not well understood but is presumed to be immunological. Evidence for this comes from observed similarities to Guillain-Barre syndrome and from the favorable response with immunomodulatory treatments.
CIDP is a peripheral nervous system demyelinating neuropathy that is sometimes a corollary disorder to the central nervous system demyelination of multiple sclerosis (MS. The precise mechanisms underlying the pathogenesis are uncertain, but a number of those mechanisms support a potential role for immunomodulatory treatments such as interferon beta (e.g., Biogen Idec Inc.'s AVONEX).
The rationale for the use of AVONEX in CIDP derives from observations on the pathogenesis of the condition and its similarities to MS, the mechanism of action of AVONEX, clinical trials that have been performed in CIDP that support a role for IFN-beta, and the unmet need that currently exists because of availability and safety issues with existing therapies.
This Phase 2b study is a dose-ranging study designed to provide scientific evidence regarding the safety and efficacy of AVONEX in CIDP. In addition, the study aims to demonstrate the responsiveness and clinical relevance of changes in the MRC sum score and ODSS in CIDP patients.
#Intervention
- DRUG : Interferon Beta-1a
|
#Eligibility Criteria:
Inclusion Criteria:
* Written informed consent prior to any testing under this protocol
* Must be between 18 and 75 years
* Have a diagnosis of CIDP as determined by a board-certified or board-eligible neurologist, or equivalent, for at least 6 months, including fulfilling modified INCAT neurophysiological criteria for CIDP,CIDP motor deficit responsive to IVIg and alternative EP data that justifies subject inclusion, and/or supportive pathologic or laboratory data that supports the diagnosis of CIDP
* Documentation in the medical record prior to screening that the CIDP had been associated with loss of muscle strength, such that the MRC sum score was less than or equal to 58.
* Documentation in the medical record that the patient benefited fom IVIg treatment (patient had a 2-point change or equivalent in 60-point MRC sum score)
* Tested for IgM monoclonal gammopathy and found to have tested negative for IgM monoclonal gammopathy or if positive for IgM monoclonal gammopathy, then are MAG antibody-negative and proven to be IVI g responsive per protocol.
* Must have been clinically stable while on a constant regimen of IVIg (every 2-weeks, 3-weeks, 4-weeks or 5-weeks) in the 3 months prior to screening.
Exclusion Criteria*:
* Associated systemic disorder that might cause neuropathy.
* History of, or abnormal laboratory results indicative of any significant major disease or known drug hypersensitivity that, in the opinion of the investigator, would preclude the administration if IFN-beta or participation in this study.
* Subjects with diabetes mellitus will not be eligible, unless they satisfy both of the following requirements: a) their diabetes is well-controlled, with no retinopathy or nephropathy, having been identified during the ongoing care of their diabetes; and b) they have a normal sensory nerve action potential (SNAP) amplitude recorded in the sural nerve on at least one side of the body identified during electrophysiology (EP) testing documented in their medical record.
* Abnormal screening or baseline blood tests that the investigator deems clinically significant
* History of a seizure disorder prior to baseline (Visit 1, Week 0).
* History of suicidal ideation within 3 months prior to Baseline Visit (Week 0) or an episode of severe depression within 3 months prior to Baseline Visit (Week 0).
* Pure motor syndrome fulfilling criteria for multifocal motor neuropathy with conduction block.
* Pure sensory CIDP, or any other variant of CIDP without motor involvement
* Serious local infection or systemic infection within the 6 months prior to Screening.
* Use of IFN-beta at any time, use of plasma exchange, plasmapheresis, or any other immunosuppressant (with the exception of oral or non-systemic corticosteroids) within 6 months prior to Screening.
* History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen, and/or aspirin that would preclude use of at least one of these during the study.
* For female subjects, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception, as defined by the Investigator, during the study.
* Female subjects considering becoming pregnant while in the study
* Female subjects who are currently pregnant or breast-feeding.
* This list is not exhaustive and there may be additional exclusions
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
|
NCT00099489
| 41,606 |
{
"NCT_ID" : "NCT05204329",
"Brief_Title" : "Safety of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease",
"Official_title" : "Safety of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease",
"Conditions" : ["Mesenchymal Stromal Cells", "Cornea", "Corneal Defect", "Corneal Epithelium Defect"],
"Interventions" : ["Biological: MSC Secretome Eye Drops"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["EARLY_PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "SEQUENTIAL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2024-01-24",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-11-08",
"Study_Completion_Date(Actual)" : "2024-11-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-01-11",
"First_Posted(Estimated)" : 2022-01-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-01-11",
"Last_Update_Posted(Estimated)" : 2024-12-16",
"Last_Verified" : 2024-12"
}
}}
|
#Study Description
Brief Summary
This study is a longitudinal assessment using a classic dose-escalation study design to assess the safety and maximal tolerated dose (MTD) of topical MSC Secretome eye drops. The study will be conducted at Illinois Eye and Ear Infirmary located at University of Illinois at Chicago. The study will use anterior segment Optical Coherence Tomography (OCT)/Scheimpflug Imaging, esthesiometry, and visual analogue scale (VAS) to assess treatment tolerability.
Detailed Description
The 'Safety of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease' study is designed to evaluate the safety and maximal tolerated dose (MTD) of topical MSC Secretome eye drops in patients with chronic ocular surface disease through a dose-escalation study under a 28-day topical application protocol, and also obtain a preliminary observation on the following:
1. Incidence of treatment emergent adverse events (TEAE) assessed at 28 days following treatment initiation
2. Proportion of patients with improved corneal epithelial barrier at 28 days compared to baseline
3. Final visual acuity, corneal epithelial thickness, corneal stromal haze, corneal sensation, and treatment tolerability
The objective is to determine the dose of MSC Secretome through a first-in-human study through a dose-escalation strategy targeting a toxicity rate of 33% or less.
#Intervention
- BIOLOGICAL : MSC Secretome Eye Drops
- MSC Secretome eye drop will be dispensed.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients 18 years or older
* Chronic corneal epithelial disease with fluorescein staining score >= 6 by NEI grading scale
* Reduced corneal sensation (<= 4 cm measured by Cochet Bonnet esthesiometry) in at least one corneal quadrant
* A stable ocular surface with no objective clinical evidence of significant (> 50%) improvement/worsening of the epithelial disease in the last 30 days
* Epithelial disease refractory to conventional non-surgical treatments (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops; anti-inflammatory therapy)
Exclusion Criteria:
* Any active or suspected ocular infection (bacterial, viral, fungal or protozoal).
* Evidence of corneal ulceration with stromal loss > 10%
* Presence of an epithelial defect >=1.0 mm in the largest diameter in the affected eye
* Presence of any size epithelial defect that has been persistent for more than 30 days
* Patients unable to discontinue or intermittently remove therapeutic contact lens in the study eye (to apply drops) during the 4-week study period
* History of any ocular surgery (including laser or refractive surgical procedures) in the affected eye within the 3 months prior to study enrollment
* History of chemical injury within the last 6 months prior to study enrollment Known hypersensitivity to one of the components of the study or procedural medications (e.g.,fluorescein)
* History of drug, medication or alcohol abuse or addiction
* Use of any investigational agent within 4 weeks of screening visit
* History of previous enrollment in the MSC Secretome Study at a lower dose
* Participation in another clinical study at the same time as the present study
* Participants who are pregnant at the time of study enrollment
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
|
NCT05204329
| 3,890 |
{
"NCT_ID" : "NCT05862428",
"Brief_Title" : "Rectal Misoprostol in Women Undergoing Total Abdominal Hysterectomy for Intraoperative Blood Loss Reduction",
"Official_title" : "Rectal Misoprostol in Women Undergoing Total Abdominal Hysterectomy for Intraoperative Blood Loss Reduction",
"Conditions" : ["Intraoperative Blood Loss"],
"Interventions" : ["Drug: Rectal misoprostol"],
"Location_Countries" : ["Thailand"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-02-18",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2022-09-26",
"Study_Completion_Date(Actual)" : "2022-09-26},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2023-04-23",
"First_Posted(Estimated)" : 2023-05-17"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2023-05-07",
"Last_Update_Posted(Estimated)" : 2023-05-17",
"Last_Verified" : 2023-05"
}
}}
|
#Study Description
Brief Summary
Comparing of the intraoperative blood loss between group rectal misoprostol group and control group
Detailed Description
This open-labeled randomized controlled trial was conducted at the Department of Obstetrics and Gynecology, Queen Savang Vadhana Memorial Hospital, Chonburi, Thailand, from February 2022 to September 2022, after approval of the Institution of Review Board of Queen Savang Vadhana Memorial Hospital (IRB No. 001/2565).
Fifty six (56) women with diagnosis of benign uterine disease who were scheduled to perform total abdominal hysterectomy with or without bilateral salpingo-oophorectomy between February 2022 to September 2022 at Queen Savang Vadhana Memorial Hospital were enrolled in this study.
The participants were randomly allocated into two groups, study and control group. The randomization list was kept in a sealed opaque envelope. Study group received two tablets of 200 mcg misoprostol; The drug was inserted rectally 1 hour before operation. Few drops of normal saline were used to dissolve tablets before insertion. Control group that did not receive the drug. The drug was administered by a nurse at Gynecologic ward. The primary outcome was intraoperative blood loss that recorded by measuring amount of blood on the surgical gauzes and swabs by standardized scales and another was recorded from blood in suction container. The secondary outcome was hemoglobin differentiation, rate of blood transfusion and adverse events of misoprostol usage.
#Intervention
- DRUG : Rectal misoprostol
- This intervention group receive Misoprostol transrectally before undergoing total abdominal hysterectomy
|
#Eligibility Criteria:
Inclusion Criteria:
Female undergoing total abdominal hysterectomy (elective case) with
* No history of bleeding tendency
* No history of anticoagulant drug used within 7 days before surgery
* No contraindications of Misoprostol drug used
* No history of allergic to misoprostol
Exclusion Criteria:
* Can not communicate with Thai language
* Malignancy case
* Emergency case
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05862428
| 273,538 |
{
"NCT_ID" : "NCT03282266",
"Brief_Title" : "Safety and Efficacy of Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension",
"Official_title" : "A Randomised, Single-blind, Sham Operation-controlled Study to Evaluate the Safety and Efficacy of the Pulmonary Artery Denervation for the Treatment of Pulmonary Arterial Hypertension",
"Conditions" : ["Pulmonary Arterial Hypertension"],
"Interventions" : ["Procedure: PADN", "Procedure: Sham operation"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-01-18",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-06-22",
"Study_Completion_Date(Actual)" : "2021-12-22},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-09-12",
"First_Posted(Estimated)" : 2017-09-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-09-12",
"Last_Update_Posted(Estimated)" : 2022-03-29",
"Last_Verified" : 2022-03"
}
}}
|
#Study Description
Brief Summary
The objective of this randomized control trial is to gain clinical insight on the use of pulmonary artery denervation (PADN) for the treatment of pulmonary arterial hypertension (PAH). The primary objective is to assess effectiveness and safety of PADN for the treatment of PAH.
Detailed Description
The current study is designed as a multicenter, randomized and prospective study aiming to compare the change in 6-minute walk distance (6MWD) of PADN on PAH patients. Based on the previous studies, the 6MWD was 13±24 m after 6-month treatment using target drugs. And our previous data showed that 6MWD at 6-month after PADN procedure was 65±85 m. As a result, a total of 128 patients with Group I PAH are randomized at a ratio of 1:1 to either PADN procedure plus phosphodiesterase-5 inhibitors (PDE5i) group (PADN group) or sham-PADN procedure plus PDE5i group (Sham group) using a randomization schedule blocked by site. The combination therapy of PDE5i with additional other PAH-specific target drugs is not recommended for all patients and is left at physician's discretion in both groups.
#Intervention
- PROCEDURE : PADN
- PADN was performed at three sites at the conjunctional area between the distal main trunk and the ostial left branch. The following ablation parameters were programmed at each point: a temperature of 45 ℃-50 ℃, energy ≤15 W, and a time of 120 seconds. The procedure would cease for 10 seconds if the patient felt intolerable chest pain during the procedure. The EKG and pressure lines (including cardiac output) were monitored and continuously recorded throughout the procedure.
- Other Names :
- pulmonary artery denervation
- PROCEDURE : Sham operation
- The radiofrequency ablation catheter placed, no ablations for patients in the sham PADN group.
|
#Eligibility Criteria:
Inclusion Criteria:
Provision of informed consent prior to any study specific procedures; Men and women 18 years and older; Group I PAH, defined as a mPAP>=25mmHg, PCWP<15mmHg and PVR[The PVR =(mPAP-PCWP)/CO]>3.0 Woods unit.
Exclusion Criteria:
General exclusion criteria:
Pregnancy and breast feeding mother; Estimated life expectancy < 12 months; Scheduled major surgery in the next 6 months; Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk; Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days.
Procedural exclusion criteria:
WHO group II, III, IV, V PH Severe Renal dysfunction (Ccr<30 ml/min) Blood platelet count<100,000/L Expected life span<6-month Systematical inflammation Malignant cancer(s) Tricuspid valve stenosis, Supra-pulmonary valve stenosis Allergic to studied drugs or metal materials.
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
|
NCT03282266
| 31,551 |
{
"NCT_ID" : "NCT02670044",
"Brief_Title" : "A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy",
"Official_title" : "A Phase IB Multi-Arm Study With Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy",
"Conditions" : ["Leukemia, Myeloid, Acute"],
"Interventions" : ["Drug: Idasanutlin", "Drug: Cobimetinib", "Drug: Venetoclax"],
"Location_Countries" : ["United States", "Canada", "Italy", "France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-03-09",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-12-10",
"Study_Completion_Date(Actual)" : "2020-12-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-01-28",
"First_Posted(Estimated)" : 2016-02-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-01-28",
"Last_Update_Posted(Estimated)" : 2022-01-03",
"Last_Verified" : 2021-12"
}
}}
|
#Study Description
Brief Summary
The primary objective for this study is to assess the safety and tolerability as well as preliminary efficacy of venetoclax in combination with cobimetinib, and venetoclax in combination with idasanutlin in patients with relapsed or refractory acute myeloid leukemia (R/R) AML who are not eligible for cytotoxic therapy.
#Intervention
- DRUG : Cobimetinib
- Cobimetinib will be administered orally as per schedule in Arm description.
- DRUG : Idasanutlin
- Idasanutlin will be administered orally as per schedule in Arm description.
- DRUG : Venetoclax
- Venetoclax will be administered orally as per schedule in Arm description.
|
#Eligibility Criteria:
Inclusion Criteria:
* Histological confirmation of relapsed or refractory AML after prior anti-leukemic therapy by WHO classification
* Ineligible for cytotoxic therapy defined by the following:
a. Age (>=) 75 years or b. age 18- 74 years with at least one of the following comorbidities: i. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3 ii. Cardiac history of congestive heart failure requiring treatment or ejection fraction (<=) 50% or chronic stable angina iii. Diffusing capacity of the lungs for carbon monoxide (<=) 65% or forced expiratory volume in the first second of expiration (<=) 65% iv. Creatinine clearance (>=) 30 mL/min to< 45 mL/min v. any other comorbidity that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the Medical Monitor before screening and study enrollment.
* Life expectancy of at least 12 weeks
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 <= age <= 2
* Adequate liver and renal function
Exclusion Criteria:
* Patients with acute promyelocytic leukemia (French-American-British [FAB] class M3 AML)
* Known active central nervous system (CNS) involvement with AML at study entry
* ECOG Performance Status (>=) 3 in patients who are (>=) 75 years or ECOG Performance Status of 4, regardless of age
* Prior exposure to Bcl-2 inhibitors, murine double minute 2 (MDM2) antagonists or prior exposure to experimental treatment targeting Raf, mitogen-activated protein kinase (MEK), or the mitogen-activated protein kinase (MAPK) RAS/RAF/MEK/ERK MAPK pathway
* Positive for hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) and known history of HIV, malignancy, active infection and cardiovascular diseases (CVs)
* Received strong cytochrome (CYP) 3A inhibitors, moderate CYP3A inhibitors, strong CYP3A inducers and moderate CYP3A inducers within 7 days prior to initiation of study treatment
* History of symptomatic Clostridium difficile infection within 1 month prior to dosing
Additional arm specific exclusion criteria:
Dose Escalation Arm A (Venetoclax and Cobimetinib):
* History or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration
* Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower
Arm B (Venetoclax and Idasanutlin):
* Received the following within 7 days prior to the initiation of study treatment: Strong CYP2C8 inhibitors or CYP2C8 substrates, OATP1B1/3 substrates
* Received the following within 14 days prior to the initiation of study treatment: Strong CYP2C8 inducers
* History of liver cirrhosis by radiologic, clinical or laboratory data, or biopsy despite normal liver function tests
* Received treatment with oral or parenteral anticoagulants/anti-platelet agents within 7 days prior to initiation of study treatment.
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
|
NCT02670044
| 67,435 |
{
"NCT_ID" : "NCT01611922",
"Brief_Title" : "Optimization of Assessment and Grading for Lid Wiper Epitheliopathy",
"Official_title" : "Optimization of Assessment and Grading for Lid Wiper Epitheliopathy",
"Conditions" : ["Dry Eye"],
"Interventions" : ["Device: Contact lenses", "Other: Ophthalmic dye"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2012-05",
"Study_Completion_Date(Actual)" : "2012-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-05-31",
"First_Posted(Estimated)" : 2012-06-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-06-04",
"Last_Update_Posted(Estimated)" : 2012-06-05",
"Last_Verified" : 2012-06"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to assess eyelid margin staining, termed 'lid wiper epitheliopathy' (LWE), in three populations. The hypothesis is LWE will be more prevalent in symptomatic contact lens wearers than non-symptomatic contact lens wearers and least prevalent in asymptomatic non-contact lens wearers.
#Intervention
- OTHER : Ophthalmic dye
- Topically instilled for the purpose of assessing lid margin staining
- Other Names :
- Lissamine Green, Sodium Fluorescein
- DEVICE : Contact lenses
- Silicone hydrogel contact lenses per subject's habitual brand and power, worn for a minimum of 8 hours on the day of assessment, after which lenses will be removed and dye will be instilled.
|
#Eligibility Criteria:
Inclusion Criteria:
* Has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Has had an ocular examination in the last two years;
* Has clear corneas and no active ocular disease;
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Has any ocular disease;
* Has a systemic condition that may affect a study outcome variable;
* Is using any systemic or topical medications that may affect ocular health;
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
* Has undergone corneal refractive surgery;
* Currently wears contact lenses on an extended wear basis (overnight);
* Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
* Other protocol-defined exclusion criteria may apply.
Sex :
ALL
Ages :
- Minimum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01611922
| 84,654 |
{
"NCT_ID" : "NCT00388336",
"Brief_Title" : "PROCRIT (Epoetin Alfa) 60,000 Units Administered Once Every Two Weeks in Anemic Cancer Patients Who Are Not Receiving Chemotherapy or Radiation Therapy",
"Official_title" : "A Pilot Study to Evaluate the Response Rate of PROCRIT� (Epoetin Alfa) at 60,000 Units Every Two Weeks in Anemic Cancer Patients Not Receiving Chemotherapy Or Radiation Therapy",
"Conditions" : ["Anemia", "Neoplasms"],
"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)" : "2004-02",
"Study_Completion_Date(Actual)" : "2005-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2006-10-13",
"First_Posted(Estimated)" : 2006-10-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2006-10-13",
"Last_Update_Posted(Estimated)" : 2011-05-18",
"Last_Verified" : 2010-04"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of Epoetin alfa administered at 60,000 Units every two weeks in cancer patients who are not receiving chemotherapy or radiation therapy.
Detailed Description
This was an open-label (doctors and patients knew which drug was being administered), non-randomized (patients were assigned to treatment), multi-center pilot study with the objective to investigate the effectiveness of PROCRIT (Epoetin alfa) on hematopoietic response (effect on red blood cells) when administered at 60,000 Units subcutaneously (under the skin) every two weeks in anemic patients with cancer who were not receiving chemotherapy or radiation therapy.
Treatment with study drug was for a maximum of 12 weeks followed by a 4-week observation period after the last dose of the study drug had been administered.
Safety and efficacy evaluations were performed at specified intervals throughout the study and included assessment of laboratory tests (Complete Blood Count \[CBC\], Serum Chemistry \[including hemoglobin level\]), vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events. All patients enrolled in this study received pharmacologic ferrous sulfate 325 mg by mouth once a day or an equivalent formulation, as tolerated, unless it was determined by the physician that the patient should not receive it. All patient's received injections of PROCRIT (Epoetin alfa) 60,000 Units under the skin once every two weeks. If after 4 weeks of treatment, the patient's hemoglobin level did not increase by \>= 1 g/dL, the Epoetin alfa dose was increased to 80,000 Units every 2 weeks. Study drug was administered for a maximum of 12 weeks followed by a 4-week observation period after the last dose of study drug. Epoetin alfa doses were reduced or held as needed depending on the patients' hemoglobin level.
#Intervention
- DRUG : Epoetin Alfa
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically confirmed diagnosis of non-myeloid malignancy
* Baseline hemoglobin value of <= 11 g/dL unrelated to transfusion
* Patients must not be receiving or planning to receive chemotherapy or radiotherapy within the 16-week study period. However, patients receiving hormonal therapy or non-myelosuppressive therapies are allowable
* Female patients with reproductive potential must have a negative serum pregnancy test at screening.
Exclusion Criteria:
* Patients must not have uncontrolled hypertension or a history (within 6 months) of uncontrolled cardiac arrhythmias, pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
* No transfusion within 28 days prior to first dose
* No planned chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry
* No prior treatment with Epoetin alfa or any other erythropoietic agent within the previous two months.
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
|
NCT00388336
| 129,981 |
{
"NCT_ID" : "NCT03556592",
"Brief_Title" : "Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4",
"Official_title" : "An Open-label, Multi Centre Drug-drug Interaction Trial to Investigate the Effects of Tralokinumab on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Subjects With Moderate-to-severe Atopic Dermatitis",
"Conditions" : ["Atopic Dermatitis"],
"Interventions" : ["Drug: Caffeine", "Drug: Warfarin", "Drug: Tralokinumab", "Drug: Omeprazole", "Drug: Metoprolol", "Drug: Midazolam Hydrochloride"],
"Location_Countries" : ["United States", "Netherlands", "France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2018-08-13",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-03-16",
"Study_Completion_Date(Actual)" : "2020-06-20},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2018-05-30",
"First_Posted(Estimated)" : 2018-06-14"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-06-13",
"Last_Update_Posted(Estimated)" : 2025-02-24",
"Last_Verified" : 2020-10"
}
}}
|
#Study Description
Brief Summary
The purpose of this trial is to investigate if tralokinumab changes the metabolism of selected CYP substrates in adults with moderate-to-severe AD after:
* 14 weeks of treatment with tralokinumab
* a single dose of tralokinumab
#Intervention
- DRUG : Tralokinumab
- Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.
- DRUG : Caffeine
- 1x 100 mg tablet
- DRUG : Warfarin
- 2x 5 mg tablets
- DRUG : Omeprazole
- 1x 20 mg capsule
- DRUG : Metoprolol
- 1x 100 mg tablet
- DRUG : Midazolam Hydrochloride
- 1 mL of 2 mg/mL oral solution/syrup
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 and above.
* Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.
* History of AD for >=1 year.
* Subjects who have a recent history of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable.
* AD involvement of >=10% body surface area at screening and baseline.
* Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.
* Willingness to abstain from consumption of any 1 or more of the following items in the periods specified:
* ±7 days within each cocktail dosing visit: foods/beverages that affect the CYP system:
* Grapefruit or grapefruit juice, Seville oranges or orange juice, starfruit, pomegranate and cranberry juices, red wine, red grape extract.
* Cruciferous vegetables (for example broccoli).
* Chargrilled meat.
* ±48 hours within each cocktail dosing visit: caffeinated beverages and foods/drugs that contain caffeine.
Exclusion Criteria:
* Administration, within 14 days or 5 half-lives (whichever is longer) prior to Day -7, of any medication that is a known inducer or inhibitor of 1 or more of the following CYP enzymes: CYP3A, CYP2C19, CYP2C9, CYD2D6, and CYP1A2.
* Subjects who are poor metabolisers of CYP2C9, CYP2C19, or CYP2D6, based on genotyping.
* Any contraindication to 1 or more of the following drugs, according to the applicable labelling: caffeine, warfarin, omeprazole, metoprolol, or midazolam.
* Consumption of any 1 or more of the following items in the periods specified:
* ±7 days within each cocktail dosing visit: foods/beverages that affect the CYP system:
* Grapefruit or grapefruit juice, Seville oranges or orange juice, starfruit, pomegranate and cranberry juices, red wine, red grape extract.
* Cruciferous vegetables (for example broccoli).
* Chargrilled meat.
* ±48 hours within each cocktail dosing visit: caffeinated beverages and foods/drugs that contain caffeine.
* Nausea or diarrhoea 1 week prior to Day -7.
* Active dermatologic conditions that may confound the diagnosis of AD.
* Use of tanning beds or phototherapy within 5 weeks prior to Day -7.
* Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 3 weeks prior to Day -7.
* Treatment with topical corticosteroids, topical calcineurin inhibitors, or topical phosphodiesterase 4 inhibitors within 1 week prior to Day -7.
* Receipt of any marketed biological therapy or investigational biologic agent (including immunoglobulin, anti-IgE, or dupilumab):
* Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to Day -7, or until lymphocyte count returns to normal, whichever is longer.
* Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to Day -7.
* Active skin infection within 1 week prior to Day -7.
* Clinically significant infection within 4 weeks prior to Day -7.
* A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
* Tuberculosis requiring treatment within 12 months prior to screening.
* Known primary immunodeficiency 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:
No
|
NCT03556592
| 65,725 |
{
"NCT_ID" : "NCT03155308",
"Brief_Title" : "Validation of the NICE Classification Using Pentax Chromoendoscopy",
"Official_title" : "Validation of the NICE Classification Using Pentax Chromoendoscopy (I-scan and Optical Enhancement System",
"Conditions" : ["Colorectal Polyp"],
"Interventions" : ["Device: Pentax chromoendoscopy (i-scan and Optical Enhancement)"],
"Location_Countries" : ["Ecuador"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-04-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-05-01",
"Study_Completion_Date(Actual)" : "2018-07-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-05-14",
"First_Posted(Estimated)" : 2017-05-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-05-14",
"Last_Update_Posted(Estimated)" : 2019-02-26",
"Last_Verified" : 2019-02"
}
}}
|
#Study Description
Brief Summary
Colorectal cancer (CRC) is the most frequent gastrointestinal tumor and the second cause of cancer related death. Colonoscopy is currently the recommended method for detection of polyps and cancers in the colon. Removal of all adenomatous polyps during colonoscopy has become worldwide a standard procedure as it has been demonstrated to significantly reduce colorectal cancer incidence and mortality. It is routine practice to remove all the detected polyps for pathological evaluation, due to the low accuracy (59% to 84%) to differentiate non-neoplastic from neoplastic colorectal lesions with white-light endoscopy. The development of electronic or virtual chromoendoscopy (CE) has aimed to reliably predict histology of colorectal lesions based on endoscopic features. This technology differentiates between neoplastic and non-neoplastic lesions base on the analysis of the neo-angiogenesis and the mucosal pit pattern. Optical endoscopic diagnosis allows the real-time evaluation of polyp histology during colonoscopy and to determine the appropriate therapeutic strategy. This is important in clinical practice, since adenomas or superficial invasive submucosal carcinoma lesions can be curatively treated by endoscopic removal, unlike deeply invasive carcinomas, which requires surgery. The Narrow-band imaging (NBI) international colorectal endoscopic (NICE) classification is validated classification system proposed as a valid tool for not only differentiating hyperplastic from adenomatous polyps, but also predicting submucosal deep (SM-d) carcinomas. It was developed based on NBI technology, leaving uncertainty on its applicability to other systems. It was previously evaluated the application of the NICE classification to Fujinon spectral Imaging Color Enhancement (FICE) technology founding suboptimal results (accuracy 77%, sensitivity 77% and specificity 75%) and moderate inter-observer agreement (kappa: 0.51).
Detailed Description
NBI technology uses a physical filter in order to exploit the capacity of hemoglobin to selectively absorb blue light. It is considered to be less useful in areas with a large lumen, such as the stomach and colon, as a result of insufficient light for wide-range observation of the full extent of the tissue surface, and because the images are dark. I-scan is a virtual chromoendoscopy, based on the principle of digital post-processing and consists of three different image algorithms. Mode 1 is for detection of lesions. This algorithm is used for surface enhancement (SE) and enhances light-dark contrast by obtaining luminance intensity data for each pixel and apply an algorithm that allows detailed observation of the mucosal surface structure and lesion borders without altering the brightness of the endoscopic picture. Mode 2 is for characterization of lesions. This algorithm combines SE and tone enhancement (TE). TE dissects and analyses the individual red-green-blue components of a normal endoscopic image in real time and then alters the color frequencies of each component and recombines the components to a single, new color image without visible delay for the examiner. It is used to enhance minute mucosal changes and vessel structures. Mode 3 adds contrast enhancement (CE) to the endoscopic image (in addition to SE and TE) and is for demarcation of lesions. It digitally adds blue color to dark areas within the endoscopic image. Recently an image-enhanced endoscopic technology using a pre-processor band-limited light called Optical Enhancement system (OE system™), was developed by HOYA Co. (Tokyo, Japan) and is now equipped with the latest endoscopy system (Pentax Video Processor EPK-i7010; HOYA Co.). This new technology combines digital signal processing with optical filters that overcomes the limit of the spectral characteristics of the illumination light. Previous i-scan technology uses white light alone as an illumination light and digital post-processing of the reflection afterwards creates images yielding the virtual chromoendoscopic image. Although accumulating evidence has shown the usefulness of i-scan in the clinical setting, emission of white light alone causes a potential limitation for the current i-scan technology to obtain higher contrast images of microvascular pattern on the mucosal surface as shown by Narrow Band Imaging (NBI). The basic concept of OE is to overcome the darkness of NBI, which results in less usefulness for detectability in wide-range observation in the full-extended gastrointestinal lumen. The new innovated optical filters achieve higher illumination intensity and overall transmittance by connecting the peaks of the hemoglobin absorption spectrum (415 nm, 540 nm and 570 nm) creating a continuous wavelength spectrum. There are two modes with different OE filters. Mode 1 is designed mainly to improve visualization of microvessels with a sufficient amount of light, and Mode 2 is designed to improve contrast of white-light observation by bringing the color tone of the overall image closer to that of natural color (white color tone). Due to the underlying differences between the NBI and Pentax technologies (i-scan and OE system), it remains uncertain whether the NICE classification may be translated to this technology. The aim of this study is to validate the NICE classification by applying i-scan and OE system with high-definition without optical magnification, to evaluate colorectal lesions.
MATERIALS AND METHODS
Study design: It will be a non-interventional, prospective, non-randomized, non-controlled and simple blind study, performed in the Ecuadorian Institute of Digestive Disease (IECED), OmniHospital Academic Tertiary Center Ecuador, with patients included from April 2017 to October 2017. The study protocol and consent form has been approved by the institutional review board and will be conducted according to the declaration of Helsinki. Written informed consent will be obtained from all subjects before the examination.
Study Population: Consecutive adult patients between 18 and 80 years of age, referred for elective outpatient colonoscopy and in whom polypectomy or biopsy is performed will be enrolled. Exclusion criteria will be pregnancy, suspected colonic obstruction or history of previous obstruction, gastrointestinal bleeding, history colorectal surgery, inflammatory bowel disease, hereditary polyposis syndrome, diverticulitis, history of radiation therapy to abdomen or pelvis, history of severe cardiovascular, pulmonary, liver or renal disease, severe coagulation disorders or use of anticoagulants. Patients with polyps but in whom histopathology has not been evaluated or with a poor bowel preparation (Boston Bowel Preparation Scale ≤6) will be excluded from the analysis but included in the intention to treat.
Intervention: endoscopic technique The procedures will be performed under propofol intravenous sedation, in left later or supine position. For bowel preparation, the participants will have to ingest 4 liters of polyethylene glycol solution in the evening the day before the procedure. The effectiveness of the bowel cleansing will be evaluated using the Boston Bowel Preparation Scale. Three colonoscopists (C.R.M., M.V., M.S.A.), with extensive experience in colonoscopy with i-scan and OE (\>1000 cases) and familiar with the NICE classification, will perform the procedures using Pentax high definition colonoscopes without optical magnification (EC-3890Zi, PENTAX Medical, HOYA Co.) and EPK-i7010 processor with the ability to display i-scan and OE system™ images. The endoscopy images will be analyzed on a 27-inch, flat panel, high definition LCD monitors (Radiance™ ultra SC-WU27-G1520 model). All lesions initially detected by white light endoscopy will be intensively washed using a water ejection pump before recording the procedure and then the endoscopic features on the surface will be evaluated using the 3 i-scan modes and the 2 OE modes without magnification. The lesion size data (1-5/6-9/\>10 mm), location (cecum/ right/ transverse/ left/ sigmoid colon/ rectum) and macroscopic shape of the lesions based on the Paris classification will be recorded. The size will be estimated with biopsy forceps (2.2 mm closed; Radial Jaw 4, Boston Scientific, Marlborough, Massachusetts, USA) or polypectomy snare (13mm open; Captivator, Boston Scientific, Marlborough, Massachusetts, USA). Finally all lesions will be classified in real-time into 3 types based on NICE classification (NICE 1, hyperplastic polyps; NICE 2, adenoma and superficial submucosal carcinoma; NICE 3, SM-d invasive carcinoma). A level of confidence (high or low) will be assign in each stage. A high confidence prediction will be considered when the endoscopist is 90% certain of the diagnosis and this condition will be consider when polyps have ≥1 features associated with one NICE type and no features associated to the others NICE type. If there are uncertainty regarding the features or if there are features from different NICE types the prediction will have low confidence. Polyp's images will be photographically and videotape recorded. Each high-definition video will consist of 30 to 60 seconds of white-light endoscopy followed by i-scan 1,2,3 and OE mode 1 and 2. For the purpose of this study, magnification was not allowed during recording. All polyps will be resected or biopsied for histopathological examination used as the criterion standard for the analysis. Two experienced pathologists, blind to the endoscopic diagnosis, will assess the histology according to the revised Vienna classification. Lesions identified histopathologically as serrated adenomas/ polyps or traditional serrated adenoma will be excluded from the analysis but included in the intention to treat, due to the lack of fully established evidence of NICE classification utility for the diagnosis of these lesions.
In a second phase, endoscopists with less experience (\<1000 procedures) using i-scan and OE will be selected. After a formal instruction on the NICE classification based on theoretical background and a series of i-scan/OE-polyp images, each of them will have to reviewed all the videos and applied the NICE classification in order to predict the histology. Each of the three criteria of the NICE system (colour/vessel/surface pattern) will be individually scored as well as the overall level of confidence (high/low).
Statistical analysis
Base line characteristics will be expressed as percentage or mean +/- standard deviation. It will be calculated the accuracy, sensitivity, specificity, negative and positive predictive values with the 95% of Confidence Interval (95% CI), for each component of the classification and for the overall prediction by using the classification. Using multilevel logistic regression, the sensitivity and specificity of the different criteria, will be compared. Diagnostic values of the criteria used in combination (combination of 'at least 1 criterion being positive' versus 'all combined criteria being positive') will be assessed and compared. The criterion standard for validation of predictions will be the lesions histology. Presence of adenomatous feature at each criterion will be defined as a positive result. The sample size was calculated assuming that 80% of predictions will be made with high confidence, and that the real accuracy will be 90%. A data set containing 30 random-selected videos will be presented after 2 months to the three main investigators (C.R.M, M.V, M.S.A.) in order to assess intra and inter-observer reproducibility. The endoscopists will have classified again the polyps according to the three types on the NICE classification. To examine inter and intra observer agreement, kappa values will be calculated. Kappa coefficients below 0.4 indicate 'poor agreement,' values between 0.4 and 0.8 represent 'moderate to good agreement,' and values greater than 0.8 indicate 'excellent agreement.' A P value of less than 0.05 will be considered to be statistically significant. All the statistical analysis will be performed using SPSS software suite v.22.
#Intervention
- DEVICE : Pentax chromoendoscopy (i-scan and Optical Enhancement)
- All lesions will be evaluated using the 3 i-scan modes and the 2 OE modes without magnification. The lesion size data, location and macroscopic shape of the lesions based on the Paris classification will be recorded. Finally all lesions will be classified in real-time into 3 types based on NICE classification (NICE 1, hyperplastic polyps; NICE 2, adenoma and superficial submucosal carcinoma; NICE 3, SM-d invasive carcinoma). A level of confidence (high or low) will be assign in each stage. Polyp's images will be photographically and videotape recorded. All polyps will be resected or biopsied for histopathological examination used as the criterion standard for the analysis.
|
#Eligibility Criteria:
Inclusion Criteria: Consecutive adult patients between 18 and 80 years, referred for elective outpatient colonoscopy and in whom polypectomy or biopsy is performed will be enrolled.
Exclusion Criteria: pregnancy, suspected colonic obstruction or history of previous obstruction, gastrointestinal bleeding, history colorectal surgery, inflammatory bowel disease, hereditary polyposis syndrome, diverticulitis, history of radiation therapy to abdomen or pelvis, history of severe cardiovascular, pulmonary, liver or renal disease, severe coagulation disorders or use of anticoagulants.
Patients with polyps but in whom histopathology has not been evaluated or with a poor bowel preparation (Boston Bowel Preparation Scale <=6) will be excluded from the analysis but included in the intention to treat.
Sex :
ALL
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
|
NCT03155308
| 123,855 |
{
"NCT_ID" : "NCT03378076",
"Brief_Title" : "Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA",
"Official_title" : "A Randomized, Open-label, Parallel Group Study in Patients With Bilateral Knee Osteoarthritis Comparing the Systemic Exposure of Triamcinolone Acetonide Following Administration Into Both Knees of Either Extended-release FX006 or Immediate-release TAcs (Triamcinolone Acetonide Suspension)",
"Conditions" : ["Bilateral Knee Osteoarthritis"],
"Interventions" : ["Drug: FX006 32 mg", "Drug: TAcs 40 mg"],
"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)" : "2017-12-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-03-14",
"Study_Completion_Date(Actual)" : "2018-03-14},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-12-08",
"First_Submitted_that_Met_QC_Criteria" : 2019-04-11",
"First_Posted(Estimated)" : 2017-12-19"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-12-17",
"Last_Update_Posted(Estimated)" : 2024-01-24",
"Last_Verified" : 2024-01"
}
}}
|
#Study Description
Brief Summary
This is a randomized, open-label, parallel group study to compare systemic exposure of triamcinolone acetonide following administration into both knees of either FX006 or TAcs.
Detailed Description
This is a randomized, open label, parallel group study that will be conducted in male and female patients ≥ 40 years of age with bilateral knee OA.
Approximately 24 patients will be randomized to one of two treatment groups (1:1) and treated with IA injections to both knees of either:
* extended-release FX006 64 mg total dose (approximately 12 patients) or
* immediate-release TAcs 80 mg total dose (approximately 12 patients) Each patient will be screened to confirm the diagnosis of OA and eligibility based on the inclusion/exclusion requirements and will be randomized to treatment on Day 1. Following screening, pharmacokinetics (PK) and safety will be evaluated at 6 out-patient visits scheduled on Study Days 1 \[calendar day of injection\], 2, 8, 15, 29, and 43.
#Intervention
- DRUG : FX006 32 mg
- Drug: Extended-release 32 mg FX006 IA injection into each knee (total 64 mg dose)
- Other Names :
- Zilretta
- DRUG : TAcs 40 mg
- Drug: Immediate-release 40mg TAcs IA injection into each knee (total 80 mg dose)
- Other Names :
- Kenalog®-40 Injection, Triamcinolone Acetonide Crystalline Suspension (TAcs), TCA-IR 40
|
#Eligibility Criteria:
Inclusion Criteria:
* Written consent to participate in the study
* Male or female greater than or equal to 40 years
* Symptoms consistent with OA in both knees for greater than or equal to 6 months prior to Screening (patient reported is acceptable)
* Currently meets ACR Criteria (clinical and radiological) for OA in both knees
* Knee pain in both knees for greater than 15 days over the last month (as reported by the patient)
* Body mass index (BMI) less than or equal to 40 kg/m2
* Morning serum cortisol result within normal range at Screening (5 <= age <= 23 mcg/dL or 138 <= age <= 635 nmol/dL)
* Ambulatory and in good general health
* Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions.
* Willing to abstain from use of protocol-restricted medications during the study
Exclusion Criteria:
* Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
* History of infection in either knee joint
* Clinical signs and symptoms of active knee infection or crystal disease in either knee within 1 month of Screening
* Unstable joint (such as a torn anterior cruciate ligament) in either knee within 12 months of Screening
* Presence of surgical hardware or other foreign body in either knee
* Surgery or arthroscopy of either knee within 12 months of Screening
* IA treatment of any joint with any of the following agents within six (6) months of Screening: any corticosteroid preparation (investigational or marketed, including FX006), any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed).
* IA treatment in either knee with hyaluronic acid (investigational or marketed) within 6 months of Screening
* Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening
* Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
* Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study
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
|
NCT03378076
| 2,747 |
{
"NCT_ID" : "NCT02668419",
"Brief_Title" : "Electrical Stimulation Improves Exercise Tolerance in Patients With Advanced Heart Failure on Continuous Dobutamine Use",
"Official_title" : "Neuromuscular Electrical Stimulation Improves Exercise Tolerance in Patients With Advanced Heart Failure on Continuous Dobutamine Use - A Randomized Controlled Trial",
"Conditions" : ["Heart Failure", "Ventricular Dysfunction, Left"],
"Interventions" : ["Other: Physical Therapy Session", "Device: Neuromuscular Electrical Stimulator"],
"Location_Countries" : ["Brazil"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-12",
"Study_Completion_Date(Actual)" : "2014-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-01-19",
"First_Posted(Estimated)" : 2016-01-29"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-01-28",
"Last_Update_Posted(Estimated)" : 2016-01-29",
"Last_Verified" : 2016-01"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether neuromuscular electrical stimulation can improve exercise tolerance for patients with heart failure and continuous dobutamine use in a hospital.
#Intervention
- DEVICE : Neuromuscular Electrical Stimulator
- Quadriceps and calf muscles of both legs were simultaneously stimulated using self adhesive surface rectangular electrodes. During all session period, the patients were maintained in the supine Fowler 45º position. Stimulation parameters were set up as follows: biphasic current of 40 Hz, 400-µs pulse duration, mode 'on-time' 10s and 'off-time' 20s and maximal amplitude of 60 mA. The stimulation intensity was progressively increased according to the patient tolerance until a muscular contraction was observed. Stimulation was performed twice a day; the session duration was 60 min.
- Other Names :
- NMES, Functional Electrical Stimulation (FES)
- OTHER : Physical Therapy Session
- each session consisted of breathing exercises and global active exercises of the upper and lower limbs in bed. The treatment was applied twice a day during the hospitalization period. The protocol was interrupted if the patient had signs or symptoms suggestive of poor tolerance to exercise: 1) cyanosis, pallor, dizziness, nausea or pre-syncope; 2) chest pain; 3) bradycardia; 4) a drop in systolic blood pressure \>15 mmHg in comparison to baseline; 5) an excessive rise in systolic blood pressure defined as \>200 mmHg; 6) a rise in diastolic blood pressure during exercise \>110 mmHg; 7) fatigue rated ≥6/10 on the perceived exertion Borg scale (PEB); and/or 8) electrocardiographic signs of cardiac ischemia or ventricular arrhythmias.
|
#Eligibility Criteria:
Inclusion Criteria:
* Advanced heart failure (Stage D - Left ventricle ejection fraction <30%)
* New York Heart Association class III-IV
* Standard medical therapy for heart failure management
* Continuous inotropic infusion
Exclusion Criteria:
* Unstable angina pectoris
* Recent (6 months) acute coronary syndrome
* Arrythmias
* Chronic renal failure
* Diabetes Mellitus
* Peripheral vascular diseases
* Inability to walk
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02668419
| 130,523 |
{
"NCT_ID" : "NCT01928823",
"Brief_Title" : "Augmentation of Psychotherapy With D-Cycloserine in Agoraphobia",
"Official_title" : "Augmentation of Exposure Therapy With D-Cycloserine in Patients With Agoraphobia With or Without Panic Disorder",
"Conditions" : ["Agoraphobia"],
"Interventions" : ["Drug: D-Cycloserine", "Behavioral: CBT"],
"Location_Countries" : ["Germany"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "QUADRUPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2011-11",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2014-05",
"Study_Completion_Date(Actual)" : "2014-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2013-07-26",
"First_Posted(Estimated)" : 2013-08-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-08-22",
"Last_Update_Posted(Estimated)" : 2014-05-19",
"Last_Verified" : 2014-05"
}
}}
|
#Study Description
Brief Summary
Since decades, D-Cycloserine (DCS, drug class: Oxazolidinone) is proven to be an effective antibiotic agent in the treatment of tuberculosis. Furthermore it takes action in the central nervous system as an partial agonist on NMDA receptors. Because of glutamate mediated neuronal long-term potentiation in long-term memory DCS has an augmenting effect on emotional learning, as it occurs in exposure therapy of anxiety disorders. In this context we use DCS in addition to exposure therapy as a part of cognitive behavioral therapy (CBT) in patients suffering from agoraphobia with or without panic disorder. Thereby DCS is applicated oral as a capsule of 50mg, on three consecutive therapy sessions.
Detailed Description
The present study is a multicenter study with two participating institutions: The 'Klinik für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin' and the 'ZPHU - Zentrum für Psychotherapie am Institut für Psychologie, Humboldt-Universität zu Berlin'. It is a randomized, placebo-controlled and double blind study with agoraphobic patients receiving a manualized cognitive behavioral therapy. The randomization and blindness refers to medication with an antibiotic called D-Cycloserine: One group receives D-Cycloserine after exposure sessions and the other group is treated with a placebo. The aim is to find out, whether or not D-Cycloserine augments psychotherapy outcome when administered after an exposure. Altogether, 78 patients will be treated. Before therapy, all patients receive a clinical examination to ensure that no contraindications for participating (like cardiac defects or serious central nervous system diseases) are present. In the following diagnostic sessions therapists conduct standardized assessments and after four diagnostic sessions therapy starts. All patients receive six therapy sessions, whereof three consist of exposures. When exposures are successful, D-Cycloserine or Placebo is administered afterwards. At the last therapy session another clinical examination to control several parameters is conducted. One month after therapy, two follow-up sessions with assessments take place.
#Intervention
- BEHAVIORAL : CBT
- 12 sessions of CBT (cognitive behavioral therapy) with psychoeducation and in-vivo exposure
- DRUG : D-Cycloserine
- Administered for three times (50mg, oral) directly after exposure
- Other Names :
- "Seromycin' by Eli Lilly and Company
|
#Eligibility Criteria:
Inclusion Criteria:
* written consent (as per AMG §40 (1) 3b)
* diagnosis of agoraphobia; severity of the disorder due to the CGI should at least be 'moderately ill'
* age: 18 <= age <= 75 years
* negative pregnancy test for premenopausal women and safe contraception (Pearlindex < 1) during the study
* accessibility (geographical vicinity) for treatment and follow-up
* Compliance of the patient
Exclusion Criteria:
* Known overreaction after taking of D-Cycloserine
* Actual pharmacotherapy with ethionamides and/ or isoniazide
* Judicial or regulatory hospitalization in a mental institution (as per AMG §40 (1) 4)
* Severe psychiatric disorder like schizophrenia, addiction or dementia
* acute suicidal tendency
* epilepsy or other diseases concerning the CNS (e.g. brain tumor, encephalitis)
* internal disease like severe hypertension, cardiac insufficiency, cardiac arrhythmia, severe dysfunction of liver or kidney, insulin-dependent diabetes mellitus or disorders of the hematopoiesis
* lactation
* changes in a psychopharmacotherapy or discontinuation of a pretreatment with psychoactive drugs less than 4 weeks previous to the begin of the study
* disturbance of the day and night rhythm
* disorder-specific psychotherapy
* participation in another AMG-study during the last month previous to the inclusion in the study or during the participation in this study
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
|
NCT01928823
| 149,503 |
{
"NCT_ID" : "NCT03292055",
"Brief_Title" : "Food Frequency Questionnaire (FFQ) for Coronary Heart Disease (CHD) Patients",
"Official_title" : "Evaluation of the Psychometric Properties of a Food Frequency Questionnaire Developed for Patients With Coronary Heart Disease in Northern China",
"Conditions" : ["Coronary Heart Disease"],
"Location_Countries" : ["China"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-01-13",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2017-12-15",
"Study_Completion_Date(Actual)" : "2017-12-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-09-19",
"First_Posted(Estimated)" : 2017-09-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-09-22",
"Last_Update_Posted(Estimated)" : 2018-01-25",
"Last_Verified" : 2018-01"
}
}}
|
#Study Description
Brief Summary
This study aims to evaluate the psychometric properties of a newly developed FFQ specified for northern Chinese CHD and their high risk patients (CHD-FFQ). The psychometric properties include test-retest reliability, content validity, convergent validity, discriminant validity, concurrent validity and predictive validity. Particularly, this study will measure the physiological indicators, including plasma lipid profile (i.e. TG, TC, HDL-C, LDL-C), BG, BP and BMI twice at baseline and the end. The level of these physiological indicators will be compared with the fat intake measured by the CHD-FFQ, i.e. the baseline intake to test its convergent validity. It is also expected to predict the diet-related progression of CHD risks among high-risk individuals, i.e. patients with two or more CHD risk factors as following: raised fasting blood glucose (BG) level, increased blood pressure (BP), increased triglycerides (TG), decreased HDL-Cholesterol (HDL-C), increased LDL-Cholesterol (LDL-C), smoking and central obesity (International Diabetes Federation, 2015). In addition, this study will provide the FFQ's concurrent validity in assessing the intake of energy and nutrients against the CDC-FFQ. Moreover, whether the FFQ could detect the known differences in energy intake between men and women will be established for its discriminant validity.
|
#Eligibility Criteria:
Inclusion Criteria:
* >= 18 years;
* Have no CHD at enrollment;
* At high risk of CHD with at least two of the following risk factors:
* current smoking: current smokers are defined as individuals who smoked regularly during the last 12 months
* central obesity: for Chinese, central obesity is defined as waist circumstance above 90cm for male and 80cm for female, or with BMI above 30kg/m²
* raised BP (systolic BP [SBP] >= 130 mmHg or diastolic BP [DBP] >=85 mmHg or under antihypertensive treatment)
* raised fasting BG (FBG) (100mg/dL [5.6mmol/L]) or under treatment with insulin or oral hypoglycemic agents
* elevated TG (150mg/dL [1.7mmol/L])
* elevated TC (>= 240 mg/dL [5.18 mmol/L])
* raised LDL-C (>= 160 mg/dL [4.15 mmol/L])
* decreased HDL-C (<40 mg/dL [1.03 mmol/L] for males, and <50 mg/dL [1.29 mmol/L] for females)
* undergoing hyperlipidemia treatment
Exclusion Criteria:
* Impaired bilateral hearing
* Impaired mental status (according to their medical record)
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
|
NCT03292055
| 156,730 |
{
"NCT_ID" : "NCT01074463",
"Brief_Title" : "Pramipexole Dihydrochloride 0.25 mg Tablets Under Non-Fasting Conditions",
"Official_title" : "A Relative Bioavailability Study of 0.25 mg Pramipexole Dihydrochloride Tablets Under Non-Fasting Conditions",
"Conditions" : ["Healthy"],
"Interventions" : ["Drug: Pramipexole Dihydrochloride"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE1"],
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "CROSSOVER",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-02",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2005-03",
"Study_Completion_Date(Actual)" : "2005-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-02-22",
"First_Submitted_that_Met_QC_Criteria" : 2010-04-08",
"First_Posted(Estimated)" : 2010-02-24"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2010-02-23",
"Last_Update_Posted(Estimated)" : 2010-04-30",
"Last_Verified" : 2010-04"
}
}}
|
#Study Description
Brief Summary
The object of this study was to compare the relative bioavailability (rate and extent of absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc. following a single oral dose in healthy adults under non-fasting conditions.
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods
#Intervention
- DRUG : Pramipexole Dihydrochloride
- 0.25 mg Tablet
- DRUG : Pramipexole Dihydrochloride
- 0.25 mg Tablet
- Other Names :
- Mirapex®
|
#Eligibility Criteria:
Inclusion Criteria:
* All volunteers selected for this study will be healthy men and women 18 <= age <= 45 of age, inclusive.
* The weight range will not exceed + 20% for height and body frame as per 'Desirable Weights for Adults - 1983 Metropolitan Height and Weight Table'
* Each volunteer will complete the screening process within 28 days prior to Period 1 dosing.
* Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
* If female: and of child bearing potential is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), is postmenopausal for at least 1 year, or is surgically sterile.
Exclusion Criteria:
* Volunteers with a recent history of drug or alcohol addiction or abuse.
* Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
* Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
* Volunteers demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
* Volunteers demonstrating a positive drug abuse screen when screened for this study.
* Female volunteers demonstrating a positive pregnancy screen.
* Female volunteers who are currently breastfeeding.
* Volunteers with a history of allergic response(s) to pramipexole or related drugs.
* Volunteers with a history of clinically significant allergies including drug allergies.
* Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
* Volunteers who currently use tobacco products.
* Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
* Volunteers who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for 4 weeks after completing the study.
* Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for 4 weeks after completing the study.
* Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing.
* Volunteer who report taking any systemic prescription medication in the 14 days prior to Period I dosing. Diltiazem (Cardizem®), triamterene (Dyrenium®), verapamil (Calan®, Covera-HS®), quinidine, and quinine are prohibited throughout the entire study.
* Volunteers using OTC medication 7 days prior to dosing including vitamins, cough and cold preparations. Cimetidine (Tagamet®), ranitidine (Zantac®), probenecid (Pro-Bionate®), and any OTC antihistamine products (such as diphenhydramine, chlorpheniramine) are absolutely prohibited throughout the entire study.
* Volunteers who consume food containing poppy seeds in the 48 hours before dosing of each period.
* Volunteers who consume grapefruit or related products 14 days prior to Period I dosing.
* Female volunteers who report the use of oral contraceptives or injectable contraceptives.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01074463
| 258,795 |
{
"NCT_ID" : "NCT00455403",
"Brief_Title" : "Atheroma Reduction With Chloroquine in Patients With the Metabolic Syndrome (ARCH-MS)",
"Official_title" : "Genotoxic Stress, Atherosclerosis, and Metabolic Syndrome- Aim 3",
"Conditions" : ["Metabolic Syndrome X", "Overweight", "Hypertension", "Dyslipidemias", "Prediabetic State"],
"Interventions" : ["Drug: Placebo Comparator", "Drug: Chloroquine"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2006-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2009-12",
"Study_Completion_Date(Actual)" : "2009-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-03-30",
"First_Submitted_that_Met_QC_Criteria" : 2021-06-03",
"First_Posted(Estimated)" : 2007-04-03"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-03-30",
"Last_Update_Posted(Estimated)" : 2021-12-15",
"Last_Verified" : 2021-12"
}
}}
|
#Study Description
Brief Summary
Metabolic syndrome consists of a group of co-occuring conditions that increase an individual's risk of developing heart disease, stroke, and diabetes. The purpose of this study is to evaluate the long-term effectiveness of chloroquine, a protein-activation medication, at reducing the progression of atherosclerosis in patients with the metabolic syndrome.
Sub-study: Vascular endothelial growth factor(VEGF)and Cardiometabolic Risk, The purpose is to determine if the association of VEGF with atherosclerosis indicates that it should be a marker of the disorder.
Detailed Description
Metabolic syndrome is one of the most common disorders in industrialized countries. It consists of abnormal serum lipids, glucose intolerance, elevated blood pressure, and central obesity in the setting of insulin resistance. The syndrome substantially increases the risk of developing diabetes and vascular disease, but there is no clear unifying approach to treat this disorder. In animals, activation of the protein ataxia telangiectasia mutated (ATM) using the antimalarial drug chloroquine improves features of metabolic syndrome and decreases atherosclerosis, a build-up of fatty plaque within arteries. The purpose of this study is to examine the effect of long-term treatment with low doses of chloroquine on atherosclerosis in people with metabolic syndrome.
At a baseline study visit, participants will undergo an ultrasound of the neck to evaluate carotid artery intima-media thickness (IMT) and MRI to evaluate plaque composition. In addition, blood will be collected for laboratory testing and blood pressure will be measured. Participants will then be randomly assigned to receive either placebo or chloroquine. Study visits will occur every 3 months for 1 year. At each visit, blood pressure will be measured and blood will be collected. At Months 6 and 12, a repeat ultrasound will be performed. At month 12 a repeat carotid MRI is performed. Participants will attend one follow-up visit at Month 24 and will undergo a final ultrasound.
Sub-Study: VEGF and Cardiometabolic Risk, (This is an observational, case-study of existing baseline plasma and carotid intimal-medial thickness measurements) VEGF is also closely linked to vascular disease. From cell culture and animal models it is known that VEGF is increased in atherosclerotic lesions. It is controversial whether that relationship is causative or reparative. Both pro- and anti-VEGF therapies have been proposed for atherosclerosis. However, the association of VEGF with atherosclerosis indicates that it should be a marker of the disorder, which is the hypothesis we wish to test. No previous studies of circulating VEGF have been published.
Other markers may be related to vascular disease or VEGF in this dataset. Tumor necrosis factor (TNF)-alpha results in increased expression of VEGF and may be correlated positively with VEGF. By Erenna Technology testing, cardiac troponin I can be measured at levels much lower than current clinical assays and is expected to be elevated in ischemia but not necessarily in the stable vascular disease anticipated in our subjects. High sensitivity C-reactive protein (hsCRP)has been proposed as a marker for vascular disease that merits drug treatment in its own right and may also be correlated with VEGF and vascular disease. However, currently the relationship between hsCRP and vascular disease is not completely clear.
For this preliminary VEGF study observational data from the baseline only will be studied. Baseline testing includes carotid artery intimal-medial thickness, carotid MRI, lipid panel, complete blood count, comprehensive metabolic chemistry panel, Thyroid-stimulating hormone (TSH) and glucose tolerance test with plasma insulin and glucose responses. Plasma collected at baseline (approximately 1 ml) will be transferred to Singulex on dry ice. Samples will be coded but will not contain patient identifiers. Erenna Technology assays will be done for VEGF-A, cardiac troponin I,TNF-alpha, interleukin-6, interleukin-17A, and other cytokines at Singulex. This method utilizes single-photon counting of visible light to improve assay sensitivity. Separately, Washington University's Core Lab for Clinical Studies (CLCS) will determine hsCRP.
#Intervention
- DRUG : Chloroquine
- One tablet of 80 mg of chloroquine on a daily basis for 12 months followed by 12 months off drug with 1 visit at month 24
- Other Names :
- Arlen
- DRUG : Placebo Comparator
- Chloroquine Placebo tablet daily for 12 months followed by 12 months off drug with 1 visit at month 24
- Other Names :
- placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of metabolic syndrome, as determined by at least three of the following five criteria:
1. Elevated fasting triglyceride level greater than 150 mg/dL
2. Low HDL cholesterol levels: less than 50 mg/dL for women and less than 40 mg/dL for men
3. Hypertension (greater than or equal to 130/85 mm Hg and less than or equal to 160/100 mm Hg) untreated; or hypertension controlled (less than or equal to 150/90 mm Hg) on a stable medication regimen for 4 weeks prior to baseline visit.
4. Increased waist circumference: greater than 35 inches in women and greater than 40 inches in men
5. Elevated fasting glucose level greater than or equal to 100 mg/dL and less than or equal to 126 mg/dL
* Willing to use acceptable form of birth control
* Subjects may be on a stable doses of a statin drug for at least 3 months
* Subjects may be on a stable doses of L-thyroxine for at least 3 months
Exclusion Criteria:
* Prior travel treatment with chloroquine or hydroxychloroquine as follows:
1. Any exposure in the past 2 years
2. More than 30 days of therapy if exposure was between 2 and 5 years ago
3. More than 90 days of therapy if exposure was between 5 and 10 years ago
4. More than 6 months of therapy if exposure was 10 <= age <= 20 ago
5. More than 1 year of therapy if exposure was 20 <= age <= 30 ago
6. No limit if last exposure was more than 30 years ago (e.g., during the Vietnam conflict)
* Morbid obesity (body mass index [BMI] greater than 45)
* Coronary artery disease or other vascular disease
* History of stroke
* Significant kidney disease (estimated glomerular filtration rate (eGFR)less than 60 mL/min/1.73 m2)
* Diabetes
* Seizure disorder
* History of psoriasis
* Blood disorders, including anemia (i.e., hemoglobin levels less than 13 g/dL in men and less than 12 g/dL in women)
* Current malignancy or active treatment for recurrence prevention, example tamoxifen. Cancer considered to be cured, either as a result of surgery or other treatment is not exclusionary.
* Asthma requiring daily beta agonist therapy or intermittent oral steroids is exclusionary. Inhaled steroids are acceptable. Obstructive sleep apnea will be allowed if Continuous Positive Airway Pressure (CPAP) or other therapy has been stable for 6 months. Other active respiratory diseases are excluded.
* Liver disease, or liver function test results greater than twice the normal value
* Active infection, including HIV
* Serious illness requiring ongoing medical care or medication
* Treatment with atypical anti-psychotic medication. Treatment with any other medication for psychiatric illness, unless on a stable dose for 6 weeks prior to enrollment. Patients with unstable psychiatric disorders are excluded per the decision of the study MD regardless of medication history.
* Receiving any of the following lipid lowering medications: niacin, fibrates, or fish oils greater than 1 gram
* Uncontrolled hypertension (blood pressure greater than or equal to 150/90) at baseline visit.
* Need for daily over the counter medications, or currently taking cimetidine or greater than 1000 IU vitamin E daily and unwilling to reduce or discontinue the use of vitamin E or discontinue cimetidine for the duration of the study. Patients taking greater than 1000 IU of vitamin E should reduce the dose 30 days prior to randomization.
* Pregnant, breastfeeding, or intending to become pregnant
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Retinal disease
* Auditory disease or hearing loss; patients with total, irreversible hearing loss can be enrolled
* Participation in another clinical trial within past 30 days prior to screening and 60 days prior to randomization. Questionnaire or observational studies are not exclusionary.
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
|
NCT00455403
| 184,779 |
{
"NCT_ID" : "NCT03041207",
"Brief_Title" : "Decreasing Antibiotic Use in Infants With Suspected Ventilator-associated Infection",
"Official_title" : "Decreasing Antibiotic Use in Infants With Suspected Ventilator-associated Infection",
"Conditions" : ["Ventilator Associated Pneumonia", "Nosocomial Infections in Children", "Microbial Colonization"],
"Interventions" : ["Behavioral: Development and implementation of an antibiotic guideline"],
"Location_Countries" : ["United States", "Canada"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-03-20",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-04-30",
"Study_Completion_Date(Actual)" : "2019-04-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-01-31",
"First_Posted(Estimated)" : 2017-02-02"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-01-31",
"Last_Update_Posted(Estimated)" : 2019-07-17",
"Last_Verified" : 2019-07"
}
}}
|
#Study Description
Brief Summary
This is a prospective study with three specific aims: (1) To convene a consensus conference to develop a guideline for antibiotic use in infants (age \< 3 yrs) with suspected ventilator-associated infection; (2) To evaluate outcomes before and after implementation of the antibiotic guideline; (3) To evaluate changes in the tracheal microbiome over the course of mechanical ventilation
Detailed Description
In 2011 the Centers for Disease Control (CDC) estimated antibiotic-resistant infections resulted in $20 billion in excess healthcare costs and more than 100,000 unnecessary deaths in the U.S. alone. Ventilator-associated infections (VAI) are the most commonly diagnosed hospital-acquired infections in the pediatric intensive care unit (PICU) and account for more than half of all antibiotic use. We believe the diagnosis is often in error and that much of the antibiotic use is unnecessary. Initiating broad-spectrum antibiotics is routine when VAI or other infection is suspected in the child on mechanical ventilation, but our data show when all other cultures are negative at 48-72 hours antibiotics are frequently still continued based on identification of bacteria in respiratory secretion cultures. The investigators have previously shown, however, that identification of bacteria in respiratory secretion cultures is common in asymptomatic children and continuing antibiotics on the basis of a 'positive' respiratory secretion culture is not associated with a shorter hospital stay or improved survival.
Antibiotics are not benign. Antibiotics are expensive, have disproportionate adverse effects in younger children, often require placement of catheters that are themselves potential sources of infection, and their overuse has been associated with increasing resistance worldwide. Antibiotic exposure in young children has been associated with increased risk for obesity, types 1 and 2 diabetes, inflammatory bowel diseases, celiac disease, allergies, and asthma. Mouse studies have found that early antibiotic exposure disrupts the development of the early-life gut bacterial composition (microbiome), leading to metabolic perturbations that affect fat deposition and may alter normal immunologic development.
There is no diagnostic test for VAI and distinguishing tracheal bacterial colonization from actual infection is not straightforward. The normal lung is essentially sterile but placement of an endotracheal tube (ETT) compromises the lung's ability to clear aspirated secretions and allows a direct route for bacterial contamination from the mouth and throat. The resultant tracheal bacterial composition (the 'microbiome') is largely unstudied but preliminary research suggests it consists of small numbers of a wide diversity of bacteria originating from the mouth. Loss of this bacterial diversity in conjunction with proliferation of pathological bacteria is thought to herald the conversion from colonization to infection.
The investigators believe that a positive respiratory culture alone in the absence of other indicators of infection is insufficient justification for continuing antibiotics and, consequently, much of the antibiotic use in VAI is both unnecessary and potentially harmful. To critically evaluate this belief and potentially decrease the use of unnecessary antibiotics we propose the following:
Aim 1: To develop a guideline to assess the likelihood of VAI and discontinue antibiotics when the risk is judged to be low Hypothesis 1.1: Using an iterative process PICU doctors can reach consensus on criteria to assess the likelihood of VAI and discontinue antibiotics when the risk of VAI is judged to be low
Aim 2: To assess the efficacy and safety of discontinuing antibiotics in children judged to have a low risk of VAI Hypothesis 2.1: Discontinuing antibiotics at 48-72 hours in children judged to have a low risk of VAI will result in fewer total days on antibiotics with no difference in survival, numbers of subsequent infection episodes, duration of need for mechanical ventilation and length of stay in the PICU compared to care prior to the implementation of the guideline.
Aim 3: To describe the longitudinal changes in the tracheal bacterial composition (the 'microbiome') in children on mechanical ventilation Hypothesis 3.1: Loss of diversity in the tracheal microbiome will predate clinical signs and symptoms of VAI.
Hypothesis 3.2: Emergence of a dominant bacterial pathogen in the tracheal microbiome will be associated with clinical signs and symptoms of VAI.
Decreasing unnecessary antibiotic use has important implications for public health. Pediatric intensive care medicine is running out of effective antibiotics while also exposing our children to antibiotic risks, many of which are only now beginning to be understood. Avoidance of unnecessary antibiotic exposure in young children is critical and would be facilitated by a rational guideline for assessment of the risk and appropriate treatment for suspected VAI. As VAI is the most common reason for antibiotic use in the PICU, it is an obvious target for more careful antibiotic stewardship. Better understanding of the normal tracheal microbiome after placement of an endotracheal tube would also inform future decisions regarding appropriate antibiotic use when VAI is suspected. The most effective means of decreasing antibiotic resistance is avoidance of unnecessary use.
#Intervention
- BEHAVIORAL : Development and implementation of an antibiotic guideline
- A consensus conference will develop and then implement a guideline for stopping vs. continuing antibiotics in infants with suspected ventilator-associated infection
|
#Eligibility Criteria:
Inclusion Criteria:
* Age newborn -- 3 years in the Pediatric ICU
* on invasive mechanical ventilation > 48 hours
* evaluation for ventilator-associated infection that includes respiratory secretion cultures and microscopic evaluation of the gram-stained specimen
* antibiotics initiated for suspected ventilator-associated or other infection
Exclusion Criteria:
* Immune compromise --Other positive cultures (blood, urine, etc.) for which antibiotic continuation is appropriate
Sex :
ALL
Ages :
- Maximum Age : 3 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT03041207
| 214,176 |
{
"NCT_ID" : "NCT01285661",
"Brief_Title" : "Optimal Duration of Anticoagulation in Deep Venous Thrombosis",
"Official_title" : "Identification of the Optimal Duration of Anticoagulation in Patients With Deep Venous Thrombosis of the Lower Extremities With the Use of Residual Vein Thrombosis in Combination With D-Dimer",
"Conditions" : ["Deep Vein Thrombosis of Lower Limb", "Lower Extremity Deep Venous Thrombosis Recurrent"],
"Interventions" : ["Drug: Sodium warfarin"],
"Location_Countries" : ["Italy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE3"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2010-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2015-10",
"Study_Completion_Date(Actual)" : "2015-10},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2010-04-30",
"First_Posted(Estimated)" : 2011-01-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2011-01-26",
"Last_Update_Posted(Estimated)" : 2016-07-19",
"Last_Verified" : 2016-07"
}
}}
|
#Study Description
Brief Summary
Prospective cohort study aimed at optimizing the duration of anticoagulant treatment in patients at their first episode of proximal deep venous thrombosis (DVT) of the lower extremities, whose pathogenesis is either unknown (idiopathic DVT) or associated with minimal risk factors for thrombosis, with the help of an algorithm which incorporates both ultrasonography and D-dimer information. All patients will be followed-up until 1) the achievement of a major end-point; 2) the date of lost to to followup; 3) the date of death; 4) the date of study stop. The purpose of this study is to demonstrate the safety of withholding anticoagulation from a subgroup of patients with proximal DVT whose veins have recanalized and present with a repeatedly negative D-dimer (at baseline, after 1 and 3 months). The approach will be deemed to be safe if the annual rate of recurrent VTE in patients who will have their anticoagulation discontinued is lower than 5%.
Detailed Description
After giving informed consent, patients will receive an ultrasound investigation of the proximal-vein system (common femoral vein at groin, popliteal vein up to its trifurcation):
* Patients with residual thrombosis (defined as a diameter of at least 4 mm in at least one spot) will have their anticoagulation continued. A repeat ultrasound is scheduled after 6, 12, 18, 24 and 36 months. In patients with persistently residual thrombosis anticoagulation will not be discontinued, while those whose veins have recanalized will have a decision making process based on the behaviour of D-dimer (see below).
* Patients whose veins have recanalized (either at the recruitment or later on) will receive the D-dimer determination before discontinuing anticoagulation. In those with negative D-dimer anticoagulation will be discontinued. These patients will have two further determinations of D-dimer (after 1 and 3 months, respectively). While patients with persistently negative D-dimer will no longer receive anticoagulation, those in whom D-dimer becomes positive will have their anticoagulation resumed and no longer discontinued.
* All patients will be followed up to completion of 4 years since recruitment. For the purpose of this study each quantitative D-dimer is allowed. The criterion for D-dimer interpretation will rely on the cut-off that is recommended by manufacturers for diagnostic purposes.
D-dimer.For the purpose of this study each quantitative D-dimer is allowed. The criterion for D-dimer interpretation will rely on the cut-off that is recommended by manufacturers for diagnostic purposes.
Sample size 1000 years of observation without anticoagulation are required to demonstrate (power 90%, type I error 0.05, two sided) that with this approach the annual rate of recurrent VTE is lower than 5%. Approximately 600 patients with proximal DVT satisfying the eligibility criteria are required to obtain 1000 years of observation without anticoagulation.
#Intervention
- DRUG : Sodium warfarin
- Patients with early vein recanalization, as shown by ultrasonography, and repeatedly negative D-dimer will have anticoagulation discontinued. They will be followed-up for up to 4 years after recruitment in order to assess the rate of recurrent symptomatic VTE. In all other patients anticoagulation will not be discontinued.
- Other Names :
- Vitamin K antagonists, Oral anticoagulants
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with proximal DVT that is idiopathic or secondary to minor factors for thrombosis, with or without contemporary manifestations of PE, who have completed an uneventful 3 to 24-month period of anticoagulation and are available for an overall 48-month follow-up at the study centre.
Exclusion Criteria:
* previous thromboembolism
* recent (less than 3 months) major trauma or surgery
* active cancer
* immobilization resulting from chronic irreversible medical diseases
* need for indefinite anticoagulation for medical reasons other than VTE
* impossibility to attend the follow-up visits or to have D-dimer determinations
* already known major thrombophilia: carriage of deficiencies of natural anticoagulants, lupus-like anticoagulants, homozygosis for factor V Leiden or prothrombin mutation, heterozygosis for both abnormalities
* short (less than 1 year) life expectancy
* pregnancy
* age younger than 18
* refusal of 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
|
NCT01285661
| 235,796 |
{
"NCT_ID" : "NCT01726517",
"Brief_Title" : "Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects",
"Official_title" : "A Phase 2, Randomized, Open-Label Study of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin in Subjects With Chronic Genotype 1 HCV Infection",
"Conditions" : ["Chronic Hepatitis C Virus"],
"Interventions" : ["Drug: LDV/SOF", "Drug: RBV"],
"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)" : "2012-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2013-07",
"Study_Completion_Date(Actual)" : "2014-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2012-11-10",
"First_Submitted_that_Met_QC_Criteria" : 2014-11-07",
"First_Posted(Estimated)" : 2012-11-15"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2012-11-10",
"Last_Update_Posted(Estimated)" : 2018-11-16",
"Last_Verified" : 2014-11"
}
}}
|
#Study Description
Brief Summary
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.
#Intervention
- DRUG : LDV/SOF
- LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
- Other Names :
- Harvoni®
- DRUG : RBV
- RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years, with chronic genotype 1 HCV infection
* HCV RNA equal to or greater than 10,000 IU/mL at screening
* Cirrhosis determination; a liver biopsy may be required
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria:
* Pregnant or nursing female or male with pregnant female partner
* Current or prior history of clinical hepatic decompensation
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
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
|
NCT01726517
| 103,355 |
{
"NCT_ID" : "NCT04002245",
"Brief_Title" : "A Pilot Study Efficiency of Techniques of 'Snail ' and 'Go-back' Application of an Alcoholic Antiseptic on Healthy Skin Before the Placement of a Intra-vascular Device,",
"Official_title" : "A Pilot Study, Non-comparative Efficiency of Techniques of 'Snail ' and 'Go-back' Application of an Alcoholic Antiseptic on Healthy Skin Before the Placement of a Intra-vascular Device,",
"Conditions" : ["Health Care Utilization"],
"Interventions" : ["Procedure: antiseptic application"],
"Location_Countries" : ["France"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-04-08",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-06-19",
"Study_Completion_Date(Actual)" : "2019-06-19},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-06-26",
"First_Posted(Estimated)" : 2019-06-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-06-26",
"Last_Update_Posted(Estimated)" : 2019-07-02",
"Last_Verified" : 2019-06"
}
}}
|
#Study Description
Brief Summary
Given the lack of scientific data on the effect of the antiseptic application technique on reducing the number of microorganisms present during application, this pilot study will provide data on the initial level of microorganisms in this population of healthy volunteers and on the difference before and after antiseptic application according to both techniques. These data will be useful to then calculate the study size suitable for a formal comparative study.
Detailed Description
During their care, many patients benefit from invasive procedures. These treatments involve a break-in of the healthy skin which, without the application of preventive measures, can be at the origin of an infection starting from the micro-organisms present on the skin.
Cutaneous antisepsis, which objective is to reduce or even eliminate commensal and transient flora microorganisms, is an essential preventive measure during an invasive act on healthy skin. The choice of antiseptic most suitable in this context has been the subject of numerous publications and recommendations (including: French Society of Hospital Hygiene - SF2H- 2016). But there is no consensus on application technique.
In France, there is two application techniques : the 'snail' and the 'back and forth' techniques. These two techniques have never been compared in clinical trials. This study will bring preliminary evidence on empirical practices, in order to complement the recommendations of good antiseptic practices and ultimately reduce infections.
This brings us to the following question: what are the effects of the application of an alcoholic antiseptic by 'back and forth' and 'snail' techniques on healthy skin? We'll conduced a monocentric non-comparative, randomized, matched pilot study, to provide data on the initial level of microorganisms in this population of healthy volunteers and on the difference before and after antiseptic application according to both techniques. These data will be useful to then calculate the study size suitable for a formal comparative study between application techniques.
#Intervention
- PROCEDURE : antiseptic application
- The application of the antiseptic on the healthy and visibly clean skin of the bend of the elbow will be carried out for all participant
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteer
* Nursing student (NS)
* Signed consent
* Major (18 years and over)
Exclusion Criteria:
* Allergy to the antiseptic used in the study
* Contamination visible at the bend of the elbow
* Impossibility to carry out the procedure on one of the arms
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
|
NCT04002245
| 267,455 |
{
"NCT_ID" : "NCT02026037",
"Brief_Title" : "Reducing PTSD in Hospitalized Burn Patients",
"Official_title" : "A Brief Intervention to Reduce PTSD in Acutely Burned Hospital Patients",
"Conditions" : ["Posttraumatic Stress Disorder"],
"Interventions" : ["Behavioral: Brief Treatment for Acutely Burned Patients (BTBP)"],
"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)" : "2013-04",
"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" : 2013-12-31",
"First_Posted(Estimated)" : 2014-01-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2013-12-31",
"Last_Update_Posted(Estimated)" : 2017-09-21",
"Last_Verified" : 2017-09"
}
}}
|
#Study Description
Brief Summary
The investigators propose to develop and pilot-test a short-term cognitive-behavioral treatment (CBT) for hospitalized survivors of acute burns, in order to reduce posttraumatic symptoms before they consolidate into long-term posttraumatic stress disorder (PTSD). This is important because approximately one third of burn survivors develop PTSD after discharge. PTSD is associated with extended psychological suffering and a greater need for medical services in the future. Although there are treatments for chronic PTSD, there are far fewer interventions available to treat acute posttraumatic symptoms before they develop into this disorder, and none to date has focused on adult burn survivors. The little research available on other forms of trauma suggests that interventions developed to treat PTSD may be helpful in preventing PTSD when used in the first weeks following a trauma.
The investigators will develop a six-session intervention package for use with patients at the Los Angeles County + University of Southern California Burn Center. The intervention will translate CBT principles that have been validated with trauma survivors, but will be adapted to hospitalized burn patients. After manual development, we will pilot-test this treatment on 15 patients who are medically stable, and not critically ill, intubated, or delirious. Treatment will consist of three 50-minute CBT sessions per week, involving mindfulness-focused relaxation training, graduated exposure to memories of the burn, psychoeducation, and cognitive restructuring. Assessment will include standardized tests of posttraumatic stress, anxiety, and depression, administered at the initiation and termination of treatment, and at one-month follow-up. Also assessed will be number of hospital days to discharge and participant satisfaction with treatment. We will evaluate the overall feasibility of conducting a study on PTSD prevention in burn survivors, as measured by initial recruitment success, subsequent dropout rates at the end of treatment and at the one-month follow-up, and participant satisfaction. These data will then be used to support a subsequent application for funding of a larger-scale randomized clinical trial (RCT) study.
#Intervention
- BEHAVIORAL : Brief Treatment for Acutely Burned Patients (BTBP)
- Brief Treatment for Acutely Burned Patients (BTBP) adapts CBT principles that have been validated with non-burn trauma survivors to the treatment of hospitalized burn patients. BTBP consists of three 1 to 1½ hour sessions per week for two weeks, as well as two sessions for family members or partners/spouses.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male & female patients at the LAC+USC Medical Center Burn Center
* 18 years or older
* English-speaking, able to read & write English
* Expected by the treatment team to require at least 2 weeks of hospitalization
* Willing to participate
Exclusion Criteria:
* Patients who are critically ill; intubated; unable to converse; or delirious
* Cognitively impaired or mentally retarded
* Severely depressed or suicidal
* Psychotic; manic or hypomanic due to a bipolar affective disorder
* Currently demonstrating withdrawal from alcohol or other substances
* Patients whose physical pain level requires medications that would cognitive impair him or her to the point of diminished or impaired functioning
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
|
NCT02026037
| 199,041 |
{
"NCT_ID" : "NCT05323812",
"Brief_Title" : "ASURE: Alzheimer Study Using oRal Edaravone",
"Official_title" : "A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of TW001 in Alzheimer Patients",
"Conditions" : ["Alzheimer Disease"],
"Interventions" : ["Drug: TW001", "Drug: Placebo"],
"Location_Countries" : ["Netherlands", "Croatia"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2023-03-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2024-12-30",
"Study_Completion_Date(Actual)" : "2024-12-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-03-16",
"First_Posted(Estimated)" : 2022-04-12"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-04-11",
"Last_Update_Posted(Estimated)" : 2025-04-23",
"Last_Verified" : 2024-09"
}
}}
|
#Study Description
Brief Summary
This is a multi-center, Phase IIa, randomized, double-blind, placebo-controlled study in patients with Alzheimer's Disease (AD).
Detailed Description
This is an exploratory, double-blind, randomized, placebo-controlled phase IIa proof of concept study to evaluate the safety, pharmacodynamics and pharmacokinetics of TW001 in patients with mild AD. Patients will be randomized 1:1 to TW001 and placebo. Treatments will be given in a fasted state once daily for 90 days. The total duration of the clinical trial will be approximately 4 months per patient.
#Intervention
- DRUG : TW001
- daily dose of 100 mg TW001/placebo
- Other Names :
- Edaravone
- DRUG : Placebo
- daily dose of 100 mg TW001/placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 55 <= age <= 80 years (both inclusive), male or female.
* Body mass index between 18.5 to 33.0 kg/m2 (both inclusive).
* Should meet the criteria for early clinical stage Alzheimer's Disease (AD) according to the National Institute on Aging and Alzheimer's Association (NIA-AA) criteria research framework:
1. Gradual and progressive change in memory function reported by patient or informant over more than 6 months,
2. Clinical syndrome of Mild Cognitive Impairment (MCI) due to AD or mild AD dementia,
3. An Mini-Mental State Exam (MMSE) score >= 20 at screening,
4. Biomarker classification according to the Amyloid/Tau/Neurodegeneration (ATN) as A+T+N+ or A+T+N- based upon:
(i) Cerebrospinal fluid (CSF) profile consistent with AD (an Aβ42 concentration of <1000 pg/mL AND phosphorylated tau (p-tau) >19 pg/mL, or a ratio of p-tau/Aβ42 of >=0.020) taken during the screening period prior to the day of the first dose of study medication, or
(ii) Documented evidence of a CSF profile consistent with AD obtained with the previous 12 months, or
(iii) Documented amyloid positron emission tomography (PET) scan evidence acquired within the previous 12 months.
* A reliable and competent trial partner/caregiver who can assist and witness dosing and is willing to accompany the patient to all visits. The trial partner/caregiver should understand the nature of the trial and adhere to trial requirements (e.g., visit schedules, evaluations) and confirm this by co-signing the informed consent of the patient or signing of a separate informed consent of the partner/caregiver according to the local requirements.
* If a patient is taking medication, supplements or vitamins that may have an influence on oxidative stress, cognition and/or EEG, the dose must be stable at screening for at least one month, and the patient must be willing to remain on the same treatment and dose for the duration of the trial.
* A male patient abstains from sexual intercourse, or is vasectomized (> 6 months), or will use a condom with spermicide during sexual intercourse during the trial and for three months after participation in the trial and will abstain from sperm donation during the trial and for three months after participation in the trial.
* A female patient should not be of reproductive potential:
A female patient who is not of reproductive potential is defined as one who:
1. Has reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone [FSH] levels in the postmenopausal range as determined by the local laboratory, or 12 months of spontaneous amenorrhea);
2. Is 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or
3. Has undergone bilateral tubal ligation. Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (e.g., anorexia nervosa).
* Capable of providing informed consent and complying with trial procedures.
Exclusion Criteria:
* A known history of stroke that is clinically important in the investigator's opinion.
* Evidence of a clinically relevant neurological disorder other than AD at screening, including but not limited to: vascular dementia, Parkinson's disease, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, progressive supranuclear palsy, dementia with Lewy bodies, other types of dementia, neurosyphilis or head trauma with loss of consciousness that led to persistent cognitive deficits.
* A history of seizures or epilepsy within the last 5 years before screening.
* Evidence of a clinically relevant or unstable psychiatric disorder, based on the 5th edition after text revision of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5TM) criteria, including schizophrenia or other psychotic disorder, bipolar disorder, major depression, or delirium. Major depression in remission is not exclusionary.
* Renal impairment as indicated by a creatinine clearance of less than 50 mL/min as calculated by the Cockcroft Gault equation.
* Patient has a history of any of the following conditions:
1. Clinically significant hepatic disease,
2. AST or ALT levels of >= 2 times upper limit of normal (ULN),
3. Biliary tract disease,
4. Patient has a positive screening test for HIV, hepatitis B or C.
* Presence of any of the following clinical conditions:
1. Unstable cardiac, pulmonary, endocrine, hematologic or active infectious disease,
2. Unstable psychiatric illness defined as psychosis, untreated major depression within 90 days of the screening visit,
3. A history of cancer within the past 3 years prior to screening other than treated squamous cell carcinoma, basal cell carcinoma and melanoma in situ, or in-situ prostate cancer or in-situ breast cancer which have been fully removed and are considered cured
* History or signs/symptoms of lumbar spine/disc disease including but not limited to scoliosis, herniation, or any other contraindication to lumbar puncture.
* History of known sensitivity or intolerability to edaravone, related substances of edaravone, or to any of the excipients.
* Current substance or alcohol dependence.
* Exposure to any investigational drug within 30 days of the screening visit.
Sex :
ALL
Ages :
- Minimum Age : 55 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05323812
| 252,709 |
{
"NCT_ID" : "NCT05636449",
"Brief_Title" : "Suprainguinal Fascia Iliaca Block vs. Periarticular Injection for Total Knee Arthroplasty",
"Official_title" : "Ultrasound Guided Suprainguinal Fascia Iliaca Block vs. Periarticular Injection for Total Knee Arthroplasty: Prospective Randomized Study",
"Conditions" : ["Analgesia"],
"Interventions" : ["Other: Group Suprainguinal fascia iliaca block", "Other: Group Periarticular Infiltration"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-11-25",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-05-15",
"Study_Completion_Date(Actual)" : "2023-05-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-11-15",
"First_Posted(Estimated)" : 2022-12-05"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-11-23",
"Last_Update_Posted(Estimated)" : 2023-06-18",
"Last_Verified" : 2023-06"
}
}}
|
#Study Description
Brief Summary
Total knee replacement (total knee arthroplasty) is performed to resurface a knee damaged by arthritis and relieve pain in patients with severely damaged knee joints.
Total knee arthroplasty (TKA) is associated with severe postoperative pain, and the management of postoperative pain continues to evolve with the advancement of surgical techniques and pharmacological treatments.
Femoral, lateral femoral cutaneous nerve and obturator nerve block is provided with suprainguinal fascia iliaca plan block, which is used for postoperative analgesia, especially in hip surgeries. In this way, the investigators think it can be used as a part of multimodal analgesia in total knee arthroplasty surgery.
#Intervention
- OTHER : Group Suprainguinal fascia iliaca block
- After the operation is completed, the fascia iliaca will be separated from the iliacus muscle. With ultrasound guidance, the local anesthetic injection will be made between the fascia and the muscle.
- OTHER : Group Periarticular Infiltration
- A total volume of 80 ml local anesthetic will be applied to the medial and lateral capsule, the medial and lateral meniscus margins, the deep part of the medial ligament, the medial and lateral synovial space, and the patellar ligament and quadriceps tendon.
|
#Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiologist's physiologic state I-III patients
* Total knee arthroplasty
Exclusion Criteria:
* BMI>35
* liver, kidney, and advanced heart failure,
* routine use of analgesics and
* having used analgesics in the last 24 hours,
* having neuropathic pain,
* refusal to participate in the study
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
|
NCT05636449
| 194,027 |
{
"NCT_ID" : "NCT00563745",
"Brief_Title" : "Telemedicine for Patients With Chronic Respiratory Insufficiency",
"Official_title" : "Randomised Trial on Telemedicine to Save Health Care Requests for Patients With Severe Chronic Respiratory Failure.",
"Conditions" : ["Chronic Respiratory Failure"],
"Interventions" : ["Device: telemedicine program"],
"Location_Countries" : ["Italy"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2004-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2005-04",
"Study_Completion_Date(Actual)" : "2007-04},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-11-21",
"First_Posted(Estimated)" : 2007-11-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-11-23",
"Last_Update_Posted(Estimated)" : 2015-03-06",
"Last_Verified" : 2015-03"
}
}}
|
#Study Description
Brief Summary
In unstable patients needing oxygen and/or home mechanical ventilation, a nurse-centred TM programme (supported by continuous availability of a call centre and a pulsed oxygen system) is cost/effective saving health care resources.
Detailed Description
Background: Integrated care and strict follow up have been recommended for frail patients with chronic respiratory failure (CRF) discharged at home.
Objectives: To evaluate impact and costs on health care resources of a telemedicine programme (TM) for severe patients discharged at home with oxygen and/or home mechanical ventilation (HMV) with a high risk of hospital readmission.
Design: Prospective randomised controlled trial. Setting: Respiratory Rehabilitation Unit S. Maugeri Foundation between May 2004 and March 2007.
Participants: 240 CRF patients will be randomised into an intervention group (TM) and a control Group, which received current usual care (educational plan, 3 months outpatient visits).
Interventions: one year TM with continuous (h 24) on call accessibility to a nurse and/or a pulmonologist, a web-based call centre and a pulse oxymetry tracing.
Main outcome measures: survival, admissions to emergency room (ER), hospitalisations, urgent general practitioner (GP) calls, home relapses; probability to remain free from the above events will be also compared among groups. TM and health Care System costs as customer satisfaction will be also collected.
#Intervention
- DEVICE : telemedicine program
- One year TM with continuous (h 24) on call accessibility to a nurse and/or a pulmonologist, a web-based call centre and a pulse oxymetry tracing will be provided.
- Other Names :
- home care
|
#Eligibility Criteria:
Inclusion Criteria:
* CRF patients discharged from Respiratory Unit with home MV
Exclusion Criteria:
* Severe co morbid conditions, i.e. lung cancer or other advanced malignancies, and extremely severe neurological disorders (with impaired cognitive status, ability to understand medical instructions, dementia or severe psychiatric illness)
* Logistical limitations due to extremely poor social conditions, such as illiteracy or no telephone access at home
* Being admitted to a nursing home
* Lack of caregiver when ventilated invasively (i.e. tracheal cannula with sounds uncertain) to allow a contact between care team and family
* Refusal to give informed consent
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00563745
| 262,913 |
{
"NCT_ID" : "NCT03033940",
"Brief_Title" : "Total Knee Arthroplasty Videofluoroscopy",
"Official_title" : "Kinematics Analysis: Comparison Between the Cruciate Retaining, Fixed Bearing Primary Total Knee Arthroplasty ATTUNE TM Knee System and the Fixed Bearing PFC Sigma Curved Total Knee Arthroplasty",
"Conditions" : ["Total Knee Anthroplasty"],
"Interventions" : ["Radiation: Observational use of fluoroscopy"],
"Location_Countries" : ["Switzerland"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-12",
"Study_Completion_Date(Actual)" : "2018-12},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-01-25",
"First_Posted(Estimated)" : 2017-01-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2017-01-25",
"Last_Update_Posted(Estimated)" : 2019-12-20",
"Last_Verified" : 2019-12"
}
}}
|
#Study Description
Brief Summary
The primary objective is to quantify and compare the three-dimensional kinematics of the cruciate retaining (CR), fixed bearing ATTUNETM TKA to the kinematics of the PFC Sigma Curved CR Fixed Bearing TKA (both DePuy Synthes, Johnson and Johnson) during daily activities.
The secondary objective is to describe the kinematics in terms of range of motion, patterns of anterior-posterior motion of the nearest medial and lateral points ('posterior femoral rollback') and tibio-femoral internal/external rotation as well as the kinetics during daily activities, such as level gait, a deep knee bend (only ATTUNETM subjects), sitting down onto a chair, standing up from a chair and stair descent by means of video-fluoroscopy.
Furthermore, the encoded data will be handed over to DePuy Synthes (Johnson and Johnson) and to the Center for Orthopaedic Engineering of the University of Denver, where it will be used within a musculoskeletal model with the aim of simulating tibiofemoral contact mechanics and changes in the musculoskeletal system due to the TKA.
#Intervention
- RADIATION : Observational use of fluoroscopy
|
#Eligibility Criteria:
Inclusion Criteria:
* Unilateral TKA (ATTUNETM/Sigma) due to osteoarthritis
* BMI <= 33
* Good clinical outcome, KOOS > 70
* No or very low pain VAS < 2
* At least one year post-op
* Standardized general health survey score (SF-12) within the normal range for people in their age group
Exclusion Criteria:
* Actual significant problem on lower extremities
* Misaligned TKA
* Any other arthroplasty at the lower extremities
* Patient incapable to understand and sign informed consent
* Incapable of performing the motion tasks
* 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:
Yes
|
NCT03033940
| 64,820 |
{
"NCT_ID" : "NCT00024791",
"Brief_Title" : "Eye-Hand Coordination in Children With Spastic Diplegia",
"Official_title" : "Neurophysiology of Motor Disorders in Spastic Diplegia",
"Conditions" : ["Diplegia, Spastic"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2001-09",
"Study_Completion_Date(Actual)" : "2005-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2001-09-27",
"First_Posted(Estimated)" : 2001-09-28"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2001-09-27",
"Last_Update_Posted(Estimated)" : 2008-03-04",
"Last_Verified" : 2005-09"
}
}}
|
#Study Description
Brief Summary
This study will examine how the brain controls eye-hand coordination (visuomotor skills) in children with spastic diplegia and will determine whether impairment of this skill is related to the learning difficulties in school that some of these children experience. Spastic diplegia is a form of cerebral palsy that affects the legs more than the hands. The brain injury causing the leg problem in this disease may also cause difficulty with eye-hand coordination.
Healthy normal volunteers and children with spastic diplegia between 6 and 12 years of age may be eligible for this study. Candidates will be screened with a review of medical and school records, psychological testing, neurological and physical examinations, and assessment of muscle function in the arms and legs.
Participants may undergo one or more of the following procedures:
Neuropsychological testing (1 to 2 hours) - involves sitting at a computer and answering questions, such as whether the letters on the screen make up a real word.
Magnetic resonance imaging (MRI) (45 minutes) - uses a strong magnetic field and radio waves to provide images of the brain. The child lies on a table in a narrow cylindrical machine while the scans are obtained. Both the child and parent wear earplugs to muffle the loud noise the radio waves make while the images are formed.
Electroencephalography (EEG) and electromyography (EMG) (1 to 2 hours) - EEG uses electrodes to record the electrical activity of the brain. The electrodes are in a special cap that is worn on the head during the procedure. EMG records electrical activity from muscles. Electrodes are placed on the skin over certain muscles. During the test, the child makes simple repetitive movements, such as finger tapping. The cap and the electrodes on the skin are removed at the end of the test.
Detailed Description
The goal of this Career Transition Award is to acquire research training in clinical and neurophysiologic dimensions of motor disorders in cerebral palsy. Dr. Mark Hallett of the Human Motor Control Section, NINDS, will act as the principal mentor for this training award. Cerebral palsy is a group of syndromes with non-progressive motor impairment resulting from a static injury to the developing brain. The processes of growth and development further complicate the motor syndromes of cerebral palsy leading to a changing clinical picture. Mirror movements in children with spastic hemiplegia are prominent in the affected hand under 10 years of age, but are more symmetric and less noticeable after this age. Investigators speculate that callosal maturation is responsible for these changes. Understanding the affect of development on motor manifestations of cerebral palsy is critical to develop effective rehabilitative strategies at each stage of life. Many children with cerebral palsy make significant contributions to society as adults, but these achievements are possible only by overcoming physical and educational impediments with effective therapeutic interventions. Research into therapeutic strategies can decrease the possibility of performing inappropriate or irreversible interventions. A major obstacle to research in this group of patients is difficulty in distinguishing between motor syndromes. Neurophysiology can help to distinguish between the specific hypertonic patterns and their contribution to the child's functional disability. The focus of the research proposed in this award is to use neurophysiologic methods to enhance our understanding of the motor disabilities of spastic diplegia and to explore the affect of development on these disorders. One set of studies, coinciding with training in the physiology of motor control, explores the more basic physiologic aspects of motor syndromes in spastic diplegia. These studies will assess diplegic children with the goal of clarifying the physiologic nature of these motor disorders and their relationship to functional status of the patients. A second set of studies examines motor skills in spastic diplegia children at different ages with the goal of defining the affect of callosal development on the motor syndromes of cerebral palsy.
|
#Eligibility Criteria:
INCLUSION CRITERIA FOR SPECIFIC AIM #1:
Children 12 <= age <= 14 of age will be eligible for the study as neuromotor function in healthy children is close to adult levels at this age.
Diplegic children must have been born before 36 weeks gestation with a birth weight appropriate for their gestational age.
Clinical examination for these children must show bilateral spasticity with more severe involvement of the legs than of the arms.
Healthy subjects must be free from all neurologic and psychiatric disorders with normal scores on the Connor's attention deficit hyperactivity disorder (ADHD) checklist and the Child Behavior Check List (CBCL).
Neurological history and examination must be normal.
EXCLUSION CRITERIA FOR SPECIFIC AIM #1:
Patients with sapstic diplegia who were born at term will be excluded from the study as these form a separate diagnostic cohort.
Children with a history of a severe (grade III or IV) intraventricular hemorrhage, or periventricular hemorrhagic infarction will be excluded.
Diplegic children who have a genetic or congenital disorder (such as congenital cytomegalovirus or rubella infection) will be excluded.
Children with obviously asymmetric findings (hemiplegia) or quadriplegia (arms and legs affected equally) will also be excluded.
Healthy children will be excluded from the study if they have ADHD, obsessive compulsive symptoms, tics or any other neurologic or psychiatric disorders.
Subjects who have siblings with an undiagnosed cause of developmental delay or abnormalities of the corpus callosum will be excluded from the study.
Subjects with albinism or a personal or family history of sensorineural hearing loss have an increased incidence of incidental callosal abnormalities and for this reason will be excluded.
Diplegic subjects with a personal history of seizures and any subject with a family history of first degree relatives with seizures will be excluded from the transcranial magnetic stimulation portion of the study.
INCLUSION CRITERIA FOR SPECIFIC AIM #2:
Spastic diplegia patients and age matched healthy controls aged 7 <= age <= 14 years will be recruited using the same methods outlined in Specific Aim #1. Data from eligible 13 years patients and healthy controls studied in Specific Aim #1 will be included in the data analysis of this specific aim.
Spastic diplegia patients will be matched on the extent and severity of periventricular leucomalacia (PVL) on their clinical MRIs. We will study the group of patients with pathology extending from occipital to frontal regions, as this appears to be most common in diplegic children.
Healthy subjects must be free from all neurologic and psychiatric disorders with normal scores on the Connor's attention deficit hyperactivity disorder (ADHD) checklist and the Child Behavior Check List (CBCL).
Neurological history and examination must be normal.
EXCLUSION CRITERIA FOR SPECIFIC AIM #2:
These will be the same as those outlined in Specific Aim #1 for both spastic diplegia patients and healthy controls.
In addition, diplegic children with MRI lesions other than PVL (porencephaly, schizencephaly) will be excluded.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00024791
| 41,090 |
{
"NCT_ID" : "NCT05654519",
"Brief_Title" : "Comparison of Pericapsular Nerve Group Block and Quadratus Lumborum Block",
"Official_title" : "Comparison of Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve Block and Quadratus Lumborum Block for Total Hip Arthroplasty",
"Conditions" : ["Total Hip Surgery", "Pericapsular Nerve", "Quadratus Lumborum"],
"Interventions" : ["Drug: PENG/LFCN and QL Blocks"],
"Location_Countries" : ["Turkey"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2022-01-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-04-10",
"Study_Completion_Date(Actual)" : "2023-04-21},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2022-11-30",
"First_Posted(Estimated)" : 2022-12-16"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2022-12-08",
"Last_Update_Posted(Estimated)" : 2024-12-20",
"Last_Verified" : 2023-04"
}
}}
|
#Study Description
Brief Summary
Adequate pain management following total hip arthroplasty (THA) is a key component for patient satisfaction and early ambulation. However, due to the complexity of the innervation of the hip joint, the most appropriate anaesthetic and analgesic technique for THA remains unclear. A femoral nerve block is commonly performed and well established but is associated with motor weakness. Recently, the pericapsular nerve group (PENG) block has been introduced as an effective choice which targets the articular branches of the hip. The quadratus lumborum block (QLB) is a relatively new regional block that has been reported to provide effective analgesia for THA.
The main objective of this study is to compare the effectiveness of the ultrasound-guided PENG block technique compared to QLB block in terms of efficacy of pain control and the safety profile after total hip arthroplasty under spinal anesthesia.
Detailed Description
The patients will be randomly classified into two equal groups (40 patients each). Group allocation will be done by computer generated random numbers and closed opaque sealed envelopes. The study will be designed to be double blind as all patients and outcomes assessor will be blinded to group assignment.
Patients will be randomized to one of three equal groups:
Group I (n= 40 patients): Patients in this group will receive an ipsilateral single shot of QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.
Group II(n= 40 patients): patients in this group will receive an ipsilateral single-shot of PENG block (25 ml of plain bupivacaine 0.25%) and LFCN block (5 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.
#Intervention
- DRUG : PENG/LFCN and QL Blocks
- Bupivacaine 0.25% injection
|
#Eligibility Criteria:
Inclusion Criteria:
Physical status according to American Society of Anesthesiologists (ASA ) I-III
Exclusion Criteria:
* Younger than 40 years and older than 85
* Patients undergoing general anesthesia
* Allergy or intolerance to one of the study medications
* Infection of the skin at the site of the needle puncture,
* Patients who do not accept the procedure
* History of bleeding diathesis
* ASA IV,
* Chronic gabapentin/pregabalin,opioid use
* Hepatic or renal insufficiency
* Previous operation on the same hip
* BMI >40
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT05654519
| 191,335 |
{
"NCT_ID" : "NCT02104921",
"Brief_Title" : "Innovative Ultrasound Technology in Neuromuscular Disease",
"Conditions" : ["Amyotrophic Lateral Sclerosis", "Muscular Dystrophy", "Radiculopathy", "Myopathy", "Polyneuropathy and Mononeuropathies", "Trauma Injury", "Orthopedic Disorder"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2013-12-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-03-01",
"Study_Completion_Date(Actual)" : "2020-03-01},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-03-31",
"First_Posted(Estimated)" : 2014-04-07"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-04-02",
"Last_Update_Posted(Estimated)" : 2022-03-11",
"Last_Verified" : 2022-03"
}
}}
|
#Study Description
Brief Summary
This study is utilizing ultrasound measurement to measure neuromuscular disease status in adult patients. The hypothesis is the by quantifying ultrasound data, it is possible that ultrasound can be utilized as a tool to determine if a disease is responding to therapy or progressing.
|
#Eligibility Criteria:
Inclusion Criteria:
* History of a well-defined, localized or generalized neuromuscular condition producing weakness or muscle atrophy, including disuse atrophy.
Exclusion Criteria:
* Multiple generalized neuromuscular conditions.
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:
Yes
|
NCT02104921
| 175,203 |
{
"NCT_ID" : "NCT00532363",
"Brief_Title" : "Obesity and Asthma:a Specific Phenotype",
"Official_title" : "Obesity-related Pseudo-asthma (ORPA): Description of a Novel Clinical Entity",
"Conditions" : ["Obesity", "Asthma"],
"Location_Countries" : ["Canada"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2005-09",
"Study_Completion_Date(Actual)" : "2010-09},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2007-09-18",
"First_Posted(Estimated)" : 2007-09-20"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2007-09-18",
"Last_Update_Posted(Estimated)" : 2012-02-22",
"Last_Verified" : 2012-02"
}
}}
|
#Study Description
Brief Summary
Clinicians frequently observed that obese women referred for severe asthma do not respond to treatment. These patients, despite the presence of wheezing, often have normal expiratory flows and normal or 'borderline' airway responsiveness.
It is therefore possible that this mode of presentation reflect a pseudo-asthmatic state for which clinical definition and characteristics and optimal management remain to be determined.
The aim of this study was to study the pulmonary physiological and airway inflammatory characteristics and response to treatment of obese women considered to have clinically severe asthma in order to demonstrate that some of these patients have a phenotype that is not that of asthma.
Detailed Description
Twenty-five obese women (BMI over 30) and 25 non-obese women (18\>BMI\<25) considered to have severe asthma by their physician and requiring corticosteroids to control their asthma will have the following investigation:
* Respiratory questionnaires focussing on the nature and time-course of symptoms, asthma control criteria, medication use.
* Physical examination, including measures of BMI, waist, hips and ratio waist/hips
* Blood test for Complete Blood Count, blood glucose, total IgE levels and markers of systemic inflammation (C-Reactive Protein, fibrinogen...)
* Spirometry and bronchodilator response.
* Induced sputum analysis and Exhaled Breath Condensate pH to assess airway inflammation.
* Skin prick tests with a battery of common airborne allergens
* Measurement of lung volumes and airway resistance + MIP and MEP.
* Methacholine challenge (up to 16 mg/ml) with Borg scores for breathlessness and chest tightness.
|
#Eligibility Criteria:
Inclusion Criteria:
* Will be women aged 18 years and over
* Will be in good health apart from asthma or obesity as determined by history and physical examination (No other condition that could influence the proposed tests).
* All will be non smokers or ex-smokers for more than six months with a smoking history of no more than 10 pack- years (i.e., one pack per day or its equivalent for 10 years.)
* Subjects will have a physician's made diagnosis of severe asthma and treated with corticosteroids.
Exclusion Criteria:
* Subjects who are, in the opinion of the investigator, mentally or legally incapacitated thus preventing informed consent from being obtained.
* Subjects having a co-existing illness that precludes them from the trial.
* Pregnancy or lactation
* Contraindication to the prednisone treatment.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT00532363
| 87,498 |
{
"NCT_ID" : "NCT03729219",
"Brief_Title" : "Prevention of Diarrheal Disease Due to Infection With Enterotoxigenic E. Coli (ETEC)",
"Official_title" : "A Randomized, Placebo-controlled Phase II b(OEV 123) Study to Evaluate Safety, Immunogenicity, Diagnostic Methodology, and Estimate Vaccine Efficacy of an Oral Enterotoxigenic Escherichia Coli(ETEC) Vaccine(ETVAX) for Prevention of Clinically Significant ETEC Diarrhea in Healthy Adult Travelers Visiting West Africa",
"Conditions" : ["Diarrhea"],
"Interventions" : ["Biological: E. coli ETVAX", "Other: Placebo"],
"Location_Countries" : ["Finland"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "PREVENTION",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2017-06-12",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-04-15",
"Study_Completion_Date(Actual)" : "2019-04-15},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2017-10-16",
"First_Posted(Estimated)" : 2018-11-02"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2018-11-01",
"Last_Update_Posted(Estimated)" : 2019-11-08",
"Last_Verified" : 2019-11"
}
}}
|
#Study Description
Brief Summary
This is a Phase II b, double-blind, randomized, placebo-controlled study in healthy adults (age 18-65 years) to evaluate the safety, immunogenicity, different diagnostic tools and efficacy of ETVAX. Participants will travel to Grand Popo, Africa for 12 days. Prior travelling participants will be vaccinated with two doses of vaccine or placebo. Vaccine Preventable Outcome will be identified and then characterized as to incidence, duration, severity and frequency of Moderate or Severe Travellers diarrhea. Health related information and assessments will be recorded during the travel.
Detailed Description
This is a Phase II b, double-blind, randomized, placebo-controlled study in healthy adults (age 18-65 years) to evaluate the safety, immunogenicity, different diagnostic tools and efficacy of two doses of ETVAX. Study participants will be recruited among students, and personnel at the University of Helsinki and Helsinki University Hospital and among those responding to recruitment advertisements. To be eligible, the participants have to commit themselves to comply with the study protocol which involves in addition to vaccination, study visits and sampling, and commitment to travel to Grand Popo, Benin and stay there for 12 days. After providing written informed consent, eligible participants will be randomized (ratio 1:1, and block randomization in groups of 6) and immunized with two doses of vaccine or placebo, given 14±7 days apart while in Finland. The last dose of vaccine will be administered at least one week before departure (and no more than 30 days prior to travel) to Benin. Eligible participants will pay four pre-travel visits (V0 + V 1-3) to Aava Travel Clinic / University of Helsinki prior to travel. They will be asked to fill in pre-travel questionnaire latest at visit 1 (Q1) and fill in an Adverse Event Form (AEF1 and AEF2) after each dose, and give blood and fecal samples and saliva before travel. The participants will go together to Benin in groups of 25-35 individuals at a time.
In Benin, the participants will be seen within 48 hours of arrival to the study site in Grand Popo. Once the participants arrive at the study site in Grand Popo, they will be provided with practical information and contact details of the study personnel. They will receive the health card (HC1) and a stool collection kit with instructions.
Diarrhea reporting, stool collection, and stool submission procedures will be reviewed with the study participants. One routine visit at day 4 is planned for review of the participant's health status and collection of a routine stool sample. Other visits will take place when and if the participant gets Travelers Diarrhea (TD) episodes for collection of study specific stool samples and health related information and assessments. If more than one diarrhea episode occurs, 48 diarrhea and symptom (TD defined symptoms) free hours must have passed between the episodes for the new episode to be counted as a separate one. One or two days prior to departure from the Grand Popo site, all participants will have a final review of their HC1s. Health Card ( HC2) will be given. After 1-6 days back in Finland the participant has to give blood and a routine stool sample and they fill in Questionnaire 2 (Q2), HC2 will be reviewed. Approx. 30 days after return to Finland the last stool and blood sample will be collected and the post-travel questionnaire (Q3) filled and HC2 reviewed. Participants who get urinary tract infection will fill in Urinary questionnaire 4 (QU4) form at the time of infection. This follow-up is valid until V5.
#Intervention
- BIOLOGICAL : E. coli ETVAX
- Oral suspension Sterile water is added to dmLT . Vaccine is poured to the effervescent solution and needed amount of dmLT is added.
- OTHER : Placebo
- Oral suspension
|
#Eligibility Criteria:
Inclusion criteria:
* Male or female age >=18 and <= 65 years
* General good health at the time of first vaccination
* Female participants of childbearing potential must not be pregnant
* Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study
* Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained
* Availability for the study duration, including all planned follow-up visits
* Intake of atovaquone + proguanil (Malarone) as anti-malaria prophylax according to prescription guidelines mandatory before, during and after travel to Benin
Exclusion Criteria:
* Presence of a significant medical or psychiatric condition, which in the opinion of the investigator precludes participation in the study
* Known or suspected history of drug, chemical or alcohol abuse, as deemed by the investigator/physician; AUDIT > 13 points
* Known recent history of impaired immune function which, according to the judgement of the investigator could influence the immune response
* Intends to receive any other investigational vaccine during the study period, or within two weeks prior to study vaccination
* Intends to donate blood at any time during the study.
* An acute or chronic medical condition that, in the opinion of the investigator/physician, would render ingestion of the investigational products unsafe or would interfere with the evaluation of responses. This includes, but is not limited to gastrointestinal diseases and autoimmune diseases requiring treatment
* Any history of psychosis or bipolar disorder or on-going significant mental disorder
* Regular (daily) use of laxatives or agents which lower stomach acidity (antacids, proton pump inhibitors) less than one week before visit V1
* Use of any oral or parenteral medication known to affect the immune function (e.g., corticosteroids and others) within 30 days preceding the first vaccination or planned use during the active study period
* Traveled to ETEC-endemic areas within the last year or visit for > two months in ETEC endemic areas during the last 10 years
* Receipt of Dukoral or other ETEC or cholera vaccines within 3 years or planned receipt of such vaccine except ETVAX during the study
* Antibiotic therapy within two weeks prior to the vaccination
* History of diarrhea in the 7 days prior to vaccination (defined as >= 3 unformed loose stools in 24 hours)
* Any other criteria which, in the investigator's opinion, would compromise the ability of the traveler to participate in the study, the safety of the study, or the results of 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:
Yes
|
NCT03729219
| 137,337 |
{
"NCT_ID" : "NCT02176239",
"Brief_Title" : "Monitoring of 5% Treatment Naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) Patients Using the CareExchange® System: A Pilot Study Using 5% Gammaplex® IVIg in the Home Setting",
"Official_title" : "Monitoring of 5% Treatment Naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) Patients Using the CareExchange® System: A Pilot Study Using 5% Gammaplex® IVIg in the Home Setting",
"Conditions" : ["Primary Immunodeficiency Disease (PIDD)"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2014-06",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2019-08",
"Study_Completion_Date(Actual)" : "2019-08},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2014-06-24",
"First_Posted(Estimated)" : 2014-06-27"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2014-06-26",
"Last_Update_Posted(Estimated)" : 2019-08-07",
"Last_Verified" : 2019-08"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to demonstrate the utility of measuring outcomes in 5% treatment naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) patients using infusion nurse and patient measured physical, quality of life (QOL), respiratory, and disability assessments using CareExchange in the home setting.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of any form of Primary Immunodeficiency Disease
* Males and Females
* >= 15 and <= 85 years
* 5% treatment Naïve IVIg for the treatment of PIDD
* Ability to have Gammaplex® IVIg prescribed under the discretion of the patient's treating physician in accordance with standard treatment practices for the entire duration of the study
* Ability and willingness to provide informed consent and comply with study requirements and procedures
* Ability to read and write English
* Understanding of study procedures and ability to comply with study procedures for the entire length of the study
* Eligible for infusion services by AxelaCare Health Solutions, LLC, in collaboration with the subject's prescribing physician and insurance provider
Exclusion Criteria:
* The presence of any medical condition that the investigator and/or prescribing physician deems incompatible with participation in this trial.
* Prisoners, and other wards of the state
* Determined to have non-competency of data collection requirements (physical assessments and use of an iPAD™) by either the home infusion nurse and/or Caregiver.
* Receiving Subcutaneous Immunoglobulin (SCIg) Therapy during study participation.
Sex :
ALL
Ages :
- Minimum Age : 15 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02176239
| 54,886 |
{
"NCT_ID" : "NCT04104685",
"Brief_Title" : "A Study to Compare FCD105 Foam to Minocycline 3% Foam, Adapalene 0.3% Foam and Vehicle Foam.",
"Official_title" : "A Prospective, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of a Combination of 3% Minocycline and 0.3% Adapalene Topical Foam Formulation for the Treatment of Moderate-to-Severe Acne (Study FX2016 40)",
"Conditions" : ["Acne Vulgaris"],
"Interventions" : ["Combination Product: FCD105", "Drug: 3% Minocycline Foam", "Drug: 0.3% Adapalene Foam", "Other: Vehicle Foam"],
"Location_Countries" : ["United States"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "DOUBLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-09-18",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2020-02-28",
"Study_Completion_Date(Actual)" : "2020-03-03},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-09-24",
"First_Posted(Estimated)" : 2019-09-26"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-09-24",
"Last_Update_Posted(Estimated)" : 2021-02-05",
"Last_Verified" : 2021-02"
}
}}
|
#Study Description
Brief Summary
A study comparing FCD105 to 3% minocycline foam, 0.3% adapalene foam and vehicle foam in patients ≥ 12 years old for the treatment of moderate-to-severe acne.
#Intervention
- COMBINATION_PRODUCT : FCD105
- Experimental combination
- DRUG : 3% Minocycline Foam
- Active Comparator
- DRUG : 0.3% Adapalene Foam
- Active Comparator
- OTHER : Vehicle Foam
- Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Has facial acne vulgaris with all of the following:
1. 20 to 50 inflammatory lesions (papules and/or pustules) on the face.
2. 25 to 100 non-inflammatory lesions (open and closed comedones) on the face.
3. IGA score of moderate (3) to severe (4).
* No more than two active nodules on the face.
* Willing to use only the supplied non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study
Exclusion Criteria:
* Female who is pregnant or lactating, or is planning a pregnancy during the study.
* Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face that could interfere with the clinical evaluations.
* Facial hair (eg, beard, mustache, etc.) that could interfere with the clinical evaluations.
* Sunburn on the face.
* Severe systemic disease as assessed by the Investigator that might interfere with the conduct of the study or the interpretation of the results.
* Subjects who have a documented history of any of the following:
1. Allergy to tetracycline-class antibiotics or to any ingredient in the study drug.
2. Pseudomembranous colitis or antibiotic-associated colitis.
3. Hepatitis or clinically significant liver damage or clinically significant renal impairment.
4. Known or suspected premalignant or malignant disease (excluding successfully treated skin cancers).
* Subjects who have used the following medications:
Within 1 week prior to randomization:
* Medicated facial cleansers on the face.
* Topical acne treatments on the face (other than those listed below).
Within 4 weeks prior to randomization:
* Topical retinoids on the face.
* Topical anti-inflammatories and/or corticosteroids on the face.
* Topical corticosteroids on body areas other than the face for more than 15 consecutive days and on more than 10% of the body surface area. In body folds, such as axillary and inguinal regions, only mild topical steroids are allowed for short term use (<=15 consecutive days).
* Systemic antibiotics.
* Systemic acne treatments.
Within 12 weeks prior to randomization:
* Systemic retinoids.
* Systemic corticosteroids (Note: Intranasal and inhaled corticosteroids may be used throughout the study if the subject is on a stable dose).
* Use of sauna during the 2 weeks prior to randomization.
* Epilation of the face within 2 weeks prior to randomization.
* Folliculitis on the face.
* Documented history of depression that is not, in the opinion of the Investigator, currently adequately controlled with medication
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04104685
| 207,892 |
{
"NCT_ID" : "NCT02594046",
"Brief_Title" : "The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia",
"Official_title" : "The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia",
"Conditions" : ["Androgenic Alopecia"],
"Interventions" : ["Other: stem cell component extract"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "SUPPORTIVE_CARE",
"Allocation" : "RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "TRIPLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2015-07-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-02-28",
"Study_Completion_Date(Actual)" : "2016-05-28},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2015-10-30",
"First_Posted(Estimated)" : 2015-11-01"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2015-10-30",
"Last_Update_Posted(Estimated)" : 2017-04-05",
"Last_Verified" : 2017-04"
}
}}
|
#Study Description
Brief Summary
This randomized, placebo-controlled, double-blind study evaluates the efficacy and tolerability of the allogeneic human adipose derived stem cell component extract on androgenic alopecia in relatively healthy adults. A total of 38 subjects received 1.2 g of allogeneic human adipose derived stem cell component extract per month or a placebo for 16 weeks.
Detailed Description
This randomized, placebo-controlled, double-blind study evaluates the efficacy and tolerability of the allogeneic human adipose derived stem cell component extract on androgenic alopecia in relatively healthy adults. A total of 38 subjects received 1.2 g of allogeneic human adipose derived stem cell component extract per month or a placebo for 16 weeks. Hair count and thickness will be primary outcomes.
#Intervention
- OTHER : stem cell component extract
- The Allogeneic Human adipose derived stem cell component extract
- Other Names :
- Tiara hair toninc
|
#Eligibility Criteria:
Inclusion Criteria:
* androgenic alopecia basic and specific(BASP) classification: M2, C2, U1, V1, or F1 or higher
Exclusion Criteria:
* patient of scalp disease
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 59 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02594046
| 110,268 |
{
"NCT_ID" : "NCT02714868",
"Brief_Title" : "Evaluation of Project TEAM (Teens Making Environmental and Activity Modifications)",
"Official_title" : "Evaluation of Project TEAM (Teens Making Environmental and Activity Modifications) - Effectiveness, Social Validity and Feasibility",
"Conditions" : ["Transition-age Youth", "Developmental Disabilities", "Cerebral Palsy", "Autism", "Intellectual Disability"],
"Interventions" : ["Behavioral: Project TEAM", "Behavioral: Matched Comparison"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NON_RANDOMIZED",
"Interventional_Model" : "PARALLEL",
"Masking" : "SINGLE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2012-10",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2016-09",
"Study_Completion_Date(Actual)" : "2017-07-31},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-03-11",
"First_Submitted_that_Met_QC_Criteria" : 2019-11-21",
"First_Posted(Estimated)" : 2016-03-22"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-03-16",
"Last_Update_Posted(Estimated)" : 2019-11-25",
"Last_Verified" : 2019-11"
}
}}
|
#Study Description
Brief Summary
The purpose of this study is to determine the extent to which Project TEAM (Teens making Environment and Activity Modifications) is an effective, socially valid, and feasible intervention that prepares youth with developmental disabilities ages 14-21 to respond to environmental barriers and increases participation in school, work, and the community. Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals. Project TEAM outcomes are to: increase youths' knowledge of environmental factors and modification strategies; reduce the impact of environmental barriers on participation; increase self-efficacy and self-determination; and increase participation in a personal activity goal in the area of education, employment, or community life. This project builds on a participatory action research partnership with disability community stakeholders to address the following research questions: (1) To what extent do youth with disabilities participating in Project TEAM achieve intervention outcomes? (2) What are the characteristics of youth with disabilities who most benefit from Project TEAM? (3) To what extent are goals, procedures, and outcomes of Project TEAM important and acceptable (socially valid) to youth with disabilities?.
Detailed Description
Disparities in school, work, and community participation impact the 15% of youth in the United States estimated to have a developmental disability. A growing body of literature suggests disparities in participation are due to barriers in the physical and social environment. Practitioners and advocates have developed skill and advocacy interventions in an attempt to increase the participation of youth with disabilities. Yet none of these interventions focus specifically on acquiring the problem-solving skills needed to identify environmental barriers and generate modification strategies to resolve barriers to participation. Research indicates that there is a vital need to develop manualized, theory-based interventions that empower youth with developmental disabilities to identify and advocate for environments that support their participation in school, work, and the community.
The purpose of this study is to determine the extent to which Project TEAM is an effective, socially valid, and feasible intervention that prepares youth with developmental disabilities ages 14-21 to respond to environmental barriers and increases participation in school, work and the community. Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals. Project TEAM outcomes are to: increase youths' knowledge of environmental factors and modification strategies; reduce the impact of environmental barriers on participation; increase self-efficacy and self-determination; and increase participation in a personal activity goal in the area of education, employment, or community life. Pilot research showed that Project TEAM participants (N=20) had a significant increase in knowledge of environmental barriers and modification strategies (t(19) = -6.37, p=.00), and 57% increased their participation in one activity.
This project builds on a Participatory Action Research (PAR) partnership with disability community stakeholders to address the following research questions: 1) To what extent do youth with disabilities participating in Project TEAM achieve intervention outcomes? 2) What are the characteristics of youth with disabilities who most benefit from Project TEAM? 3) To what extent are goals, procedures, and outcomes of Project TEAM important and acceptable (socially valid) to youth with disabilities? This project uses a multi-site, quasi-experimental repeated measures design with matched controls to evaluate Project TEAM. Sixty-four youth ages 14-21 with developmental disabilities will participate in Project TEAM and complete outcome measures at three time points: 2 weeks pre-intervention, 2 weeks post- intervention, and follow-up 6 weeks post-intervention. A control group of 64 youth, matched to intervention participant characteristics using a three tiered approach, will complete outcome measures at time points that correspond with the intervention group. Outcome measures assess goal attainment (Goal Attainment Scaling), knowledge and application of skills acquired during intervention (Project TEAM Knowledge Test), changes in participation and impact of barriers on participation (Participation and Environment Measure- Child \&Youth), self-efficacy (Generalized Self Efficacy Scale), and self-determination (AIR Self-Determination Scale). Characteristics that may influence the extent to which youth benefit from Project TEAM will be assessed using a battery of descriptive measures. Outcomes will be analyzed within and across groups to evaluate the effectiveness of Project TEAM. Feasibility and adherence to the proposed design will be evaluated using a process evaluation.
To evaluate social validity, a Youth Research Panel (YRP) of 6 youth with disabilities ages 14-21 and a Consumer Research Specialist will administer a satisfaction survey and focus group interview to Project TEAM participants. Parents (n= 64) will also participate in on-line focus groups to evaluate the feasibility and usefulness of Project TEAM. The YRP and other members of the research team will use an action/reflection process to interpret data and revise Project TEAM to maximize outcomes for future implementation. The YRP will disseminate information about Project TEAM to local and national capacity- building organizations targeted to youth with disabilities. The PI will also disseminate findings to professionals and the disability community via a website, presentations, and peer- reviewed journals.
#Intervention
- BEHAVIORAL : Project TEAM
- Project TEAM is a manualized, group-based intervention designed to be co-facilitated by an experienced leader with a disability (disability advocate) and a licensed service provider (such as an occupational therapist, social worker, or educator). Project TEAM includes eight group sessions and two experiential learning field trips for each participant. Weekly phone calls with peer mentors with disabilities support achievement of each participant's personal activity goal.
- BEHAVIORAL : Matched Comparison
- Participants set goal to try a new activity in the community
|
#Eligibility Criteria:
Inclusion Criteria:
* 1) A developmental disability as defined by the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (Public Law No.106 <= age <= 402) 9(example diagnoses include autism, intellectual disability, and cerebral palsy), 2) Age 14 <= age <= 21 at time of enrollment, 3) Communicate in English verbally or using other means as needed, 4) Able to attend to a task for 10 minutes and follow a two-step direction with support, 5) Able to categorize objects and concepts, and 6) Self-identify as a youth with a disability as reported on a modified functional strengths and challenges questionnaire
Exclusion Criteria:
* Learning disabilities without any other co-occuring diagnosis.
* living outside of the university recruitment regions
Sex :
ALL
Ages :
- Minimum Age : 14 Years
- Maximum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02714868
| 119,879 |
{
"NCT_ID" : "NCT06966739",
"Brief_Title" : "Multispectral Optoacustic Imaging in Patients With Myositis",
"Official_title" : "Multispectral Optoacustic Imaging in Patients With Myositis",
"Conditions" : ["Myositis"],
"Interventions" : ["Other: MSOT of musculature"],
"Location_Countries" : ["Germany"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2025-03-03",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2025-05-06",
"Study_Completion_Date(Actual)" : "2025-05-07},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2025-03-12",
"First_Posted(Estimated)" : 2025-05-13"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2025-05-07",
"Last_Update_Posted(Estimated)" : 2025-05-13",
"Last_Verified" : 2025-05"
}
}}
|
#Study Description
Brief Summary
Myositis syndromes are a relatively rare group of diseases in which acquired inflammation of the muscles occurs. According to clinical, histological and immunopathological criteria, autoimmune (dermatomyositis, polymyositis, immune-mediated necrotizing myopathy, anti-synthetase syndrome, inclusion body myositis), pathogen-related and so-called special forms (e.g. checkpoint-inhibitor-related) of myositis can be distinguished.
A typical symptom of the disease is progressive muscle weakness. In addition, especially a possible extramuscular organ manifestation can lead to increased morbidity.
The initiation of appropriate drug therapy and regular follow-ups to measure the success of the therapy are of crucial importance. Magnetic Resonance Imaging (MRI) and sonography are imaging methods that have proven effective for this purpose to date.
The former can be used to detect changes such as fatty remodeling, edema or inflammatory changes using T1- and T2-weighted images and Short-Tau-Inversion-Recovery (STIR). However, the duration of the examination, the lack of space and the high costs are certainly a limitation of the examination. Furthermore, patients with corresponding contraindications, such as a pacemaker.
Sonography of the musculature is therefore also important. In particular, changes in the muscle parenchyma in the sense of increasing echogenicity can be detected in this context. Moreover, regional atrophy can also be detected in this modality. However, myosonography is more of a screening procedure for neuromuscular diseases than it is suitable for monitoring progression and therapy.
Another option is the method of multispectral optoacoustic imaging (MSOT), in which ultrasound is combined with optical imaging using laser beams.
Depending on the wavelength, different chromophores such as hemoglobin or melanin (wavelength in the visible range of light) or lipids and proteins (wavelength in the near-infrared range, long-wave light) can be imaged.
Optoacoustic imaging thus provides information about morphological as well as molecular and functional conditions.
The advantages of this imaging have already been established in the context of various neuromuscular diseases:
For example, a significant increase in collagen concentration was shown in patients with Duchenne muscular dystrophy compared to a healthy control group as a possible marker of fibrosis. A significant correlate was also found in the clinical neurological examination. Particularly striking here was an indirect correlation between the 6-minute walk test and the collagen concentration.
The aforementioned imaging can also offer advantages for patients with neuromuscular diseases, particularly with regard to therapy monitoring.
Objective and quantitative measurement of disease progression is essential here. Optoacoustic imaging allows functional and molecular parameters in particular to be differentiated. This enables early and objective quantitative measurement of possible tissue loss, which can ultimately influence further therapy.
The aim of the present study is to carry out functional and molecular imaging using optoacoustic imaging to evaluate possible functional and molecular parameters, which may prove to be suitable markers for monitoring progression.
The aim of the study is to investigate whether the examination technique could be suitable for monitoring the progression of myositis.
All patients with a neuromuscular disease of the NMZ will be included in this trial.
#Intervention
- OTHER : MSOT of musculature
- All measurements using multispectral optoacustic tomography (MSOT) are performed on the paraspinal muscles as well as the trapezius, rectus abdominus and the proximal and distal limb muscles in a right vs. left comparison (leg proximal: quadriceps and ischiocrural muscle, leg distal triceps surae muscle, tibialis anterior muscle; arm proximal: M. biceps, distal: forearm flexors).
|
#Eligibility Criteria:
Inclusion Criteria:
* patients with myositis undergoing treatment at the integrated muscle center (imz) of the University Hospital of Gießen
Exclusion Criteria:
* contraindications against an optoacoustic examination
* pregnancy
* ingestion of photosensitizers within the last 72 hours
* current phototherapy
* known photosensitive disorder
Sex :
ALL
Ages :
- Minimum Age : 18 Hours
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT06966739
| 259,178 |
{
"NCT_ID" : "NCT02842736",
"Brief_Title" : "A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding",
"Conditions" : ["Menorrhagia"],
"Interventions" : ["Device: Cerene(R) Cryotherapy Device"],
"Location_Countries" : ["United States", "Mexico", "Canada"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["NA"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2016-04",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2018-04",
"Study_Completion_Date(Actual)" : "2020-05},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2016-07-21",
"First_Submitted_that_Met_QC_Criteria" : 2019-06-04",
"First_Posted(Estimated)" : 2016-07-25"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2016-07-22",
"Last_Update_Posted(Estimated)" : 2021-01-05",
"Last_Verified" : 2020-12"
}
}}
|
#Study Description
Brief Summary
The purpose of the study is to evaluate the safety and effectiveness of the Cerene Cryotherapy Device in reducing menstrual bleeding in women with heavy menstrual bleeding (menorrhagia) due to benign causes for whom child bearing is complete.
#Intervention
- DEVICE : Cerene(R) Cryotherapy Device
|
#Eligibility Criteria:
Inclusion Criteria:
* Refractory heavy menstrual bleeding with no definable organic cause
* Female subject age 25 <= age <= 50, inclusive
* Sounded length of uterine cavity no greater than 10 cm and endometrial cavity no greater than 6.5 cm
* Sufficient myometrial thickness
* Documented excessive menstrual blood loss within 3 months of informed consent
* Premenopausal confirmed by follicle stimulating hormone (FSH) measurement
* Agrees to use a reliable form of contraception following ablation treatment
* Provides written informed consent using a form that has been approved by the reviewing ethics committee
* Agrees to follow-up exams and data collection requirements
* Demonstrates an understanding of how to record menstrual blood loss using a menstrual pictogram
* Has predictable, cyclic menstrual cycles
Exclusion Criteria:
* Pregnant or has a desire to conceive
* Endometrial hyperplasia as confirmed by histology
* Active endometritis
* Active pelvic inflammatory disease
* Active sexually transmitted disease (STD)
* Presence of bacteremia, sepsis, or other active systemic infection
* Active infection of the genitals, vagina, cervix, or uterus
* Known/suspected abdominal, pelvic, or gynecological malignancy within the past 5 years
* Known clotting defects or bleeding disorders
* Abnormal cytology on Human papillomavirus (HPV) testing not treated according to local standards.
* Prior uterine surgery that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section).
* Previous low transverse cesarean section where the myometrial wall thickness is insufficient
* Previous endometrial ablation procedure
* Clinically significant adenomyosis indicated by subject complaints, imaging, or clinician's judgment
* Presence of an implantable contraceptive device
* Currently on medications that could thin the myometrial muscle
* Currently on anticoagulants
* Abnormal or obstructed cavity
* Currently using an intrauterine device (IUD) and unwilling to remove the IUD
* Post-partum <= 6-months
* Considering participation in a research study of an investigational drug or device that would begin during the course of this investigational study
* Any general health or mental, or other situation or condition which, in the opinion of the Investigator, could represent an increased risk for the subject or impact the subject's ability to comply with protocol requirements
Sex :
FEMALE
Ages :
- Minimum Age : 25 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT02842736
| 131,932 |
{
"NCT_ID" : "NCT04165850",
"Brief_Title" : "Open Label Study to Evaluate Ciprofloxacin/Celecoxib Combination in Patients With ALS",
"Official_title" : "Open Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Ciprofloxacin/Celecoxib Combination in Patients With ALS",
"Conditions" : ["Amyotrophic Lateral Sclerosis", "ALS"],
"Interventions" : ["Drug: Fixed dose combination Ciprofloxacin/Celecoxib"],
"Location_Countries" : ["Israel"],
"Study_Design" : {
"Study_Type" : "INTERVENTIONAL",
"Phase" : ["PHASE2"],
"Primary_Purpose" : "TREATMENT",
"Allocation" : "NA",
"Interventional_Model" : "SINGLE_GROUP",
"Masking" : "NONE"
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2019-11-25",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2021-01-19",
"Study_Completion_Date(Actual)" : "2021-01-19},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2019-11-13",
"First_Posted(Estimated)" : 2019-11-18"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2019-11-13",
"Last_Update_Posted(Estimated)" : 2021-03-03",
"Last_Verified" : 2019-11"
}
}}
|
#Study Description
Brief Summary
This is an open label, off label study, to provide interested ALS patients with Ciprofloxacin/Celecoxib fixed dose combination, while assessing safety and tolerability and routine disease progression measures (ALSFRS-R and Vital Capacity).
Detailed Description
Patients will be prescribed a fixed dose combination of Ciprofloxacin and Celecoxib to be taken thrice daily, and will be monitored for safety and tolerability. Additionally, routine disease progression measures will be assessed.
#Intervention
- DRUG : Fixed dose combination Ciprofloxacin/Celecoxib
- Fixed dose Ciprofloxacin and Celecoxib capsule to be taken thrice daily, total dose 909mg/day
- Other Names :
- PrimeC
|
#Eligibility Criteria:
Inclusion Criteria:
* Able to comprehend and willing to sign an Informed Consent Form (ICF)
* Males or females between the ages of 18 and 75 years, inclusive
* Diagnosis of familial or sporadic ALS (defined as meeting the laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology El Escorial criteria)
* Disease duration after first symptom less than 3 years prior to baseline
* Patients may be treated in parallel with Riluzole and/or Edaravone; 30 days of stable use prior to enrollment is required
* Upright forced vital capacity (FVC) >= 50% of predicted for age, height, weight and sex at screening
* Patient is able to swallow tablets/ capsules
* A caregiver (if one is needed)
* Female patients must be post-menopausal (>= 1 year) OR sterilized, OR if of childbearing potential (i.e., females who have had their first period unless they are anatomically or physiologically incapable to become pregnant), must have a negative pregnancy test, and agree to use contraceptive drugs or devices (e.g., diaphragm plus spermicide, or oral contraceptives) for the duration of the study and 10 weeks after the last treatment dose AND require male partners to use a condom during sexual intercourse
Exclusion Criteria:
* A past history of adverse reaction/hypersensitivity to either NSAIDs, celecoxib or fluoroquinolones, ciprofloxacin
* Any known clinically significant abnormal gastric mucosal erosion, ulcer or tumor or/and GI disorder
* Known history of clinically significant impairment of renal function (creatinine >= 1.5)
* Known or suspected congestive heart and/or coronary heart disease, previous history of myocardial infarction, uncontrolled arterial hypertension, or rhythm abnormalities requiring permanent treatment
* Known history of QT/QTc prolongation, Torsade de pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT syndrome) and the use of concomitant medications that prolong the QT/QTc interval
* Known or suspected diagnosis or family history of epilepsy
* Presence at screening of any medically significant cardiac, pulmonary, musculoskeletal, or psychiatric illness that might interfere with the patient's ability to comply with study procedures or that might confound the interpretation of clinical safety data, including, but not limited to:
1. Mean systolic blood pressure >180 mm Hg; mean diastolic blood pressure >100 mm Hg (measurements taken after few min rest) that persist on 3 successive measurements taken at least 2 minutes apart
2. NYHA Class II or greater congestive heart failure
3. Chronic obstructive pulmonary disease or asthma requiring daily use of bronchodilator medications
4. Poorly controlled or brittle diabetes mellitus
5. Cognitive impairment, related to ALS or otherwise, sufficient to impair patient's ability to understand and/or comply with study procedures and provide informed consent
* Patient who is treated with chronic aspirin or NSAIDs, and is at risk if stopped. Clopidogrel is allowed and can replace Aspirin.
* Female who is pregnant or breastfeeding or with intention of becoming pregnant during the course of the study
* Any impairment or social circumstance that, in the opinion of the Investigator, would render the patient not suitable to participate in the study
* Patient, patient's parent(s), or patient's legal guardian(s) is/are unable to understand the nature, scope, and possible consequences of the study
* Patient is participating in (or plans to participate in) any other investigational drug trial, or plans to be exposed to any other investigational agent, device and/or procedure, from 30 days prior to Screening through study completion
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
|
NCT04165850
| 146,867 |
{
"NCT_ID" : "NCT04249401",
"Brief_Title" : "Study to Gather Information About the Safety of Oral Anticoagulation Drugs and How Well These Drugs Work in Real World for Patients With Non-valvular Atrial Fibrillation (Irregularly Heart Beats Which is Not Caused by a Heart Valve Problem)",
"Official_title" : "Real-world Evidence for Non-valvular Atrial Fibrillation Patients Treated With Oral Anticoagulation in the Nordics",
"Conditions" : ["Atrial Fibrillation"],
"Interventions" : ["Drug: Warfarin", "Drug: Dabigatran", "Drug: Apixaban", "Drug: Rivaroxaban (Xarelto)"],
"Location_Countries" : ["Sweden"],
"Study_Design" : {
"Study_Type" : "OBSERVATIONAL",
},
"Recruitment_Information" : {
"Study_Start_Date(Actual)" : "2020-03-01",
"Primary_Completion_Date(Actual)(Final_data_collection_date_for_primary_outcome_measure)" : "2023-09-30",
"Study_Completion_Date(Actual)" : "2023-09-30},
"Study_Record_Dates" : {
""Study_Registration_Dates" : {
"First_Submitted" : 2020-01-17",
"First_Posted(Estimated)" : 2020-01-31"
},
"Study_Record_Updates" : {
"Last_Updated_that_Met_QC_Criteria" : 2020-01-29",
"Last_Update_Posted(Estimated)" : 2024-08-01",
"Last_Verified" : 2024-07"
}
}}
|
#Study Description
Brief Summary
Oral anticoagulant (OAC) treatment with either vitamin K antagonists (VKAs) or non-vitamin K antagonist oral anticoagulants (NOACs) is essential in patients with atrial fibrillation for the prevention of stroke or systemic embolism (SE) a condition that happens when a blood clot forms elsewhere in the body and travels through the blood stream to plug another vessel. While there are significant number of real-world publications on the use and outcomes of NOACs for stroke prevention, evidence from routine clinical practice on the use and outcomes of reduced doses of NOACs is scarce. By evaluating routine clinical practice data from national registers in Denmark, Finland, Norway and Sweden, researchers want to gather information about the safety and how well reduced doses of NOACs work in patients with irregularly heartbeats which are not caused by a heart valve problem (non-valvular atrial fibrillation, NVAF). As a primary aim of this study, treatment with low doses of NOACs (Xarelto \[generic name rivaroxaban\], Eliquis \[generic name apixaban\] or Pradaxa \[generic name dabigatran\]) will be compared with VKAs (warfarin) in Nordic patients with NVAF to assess the occurrence of stroke and systemic embolism \[effectiveness\]) and intracranial hemorrhage a type of bleeding that occurs inside the skull \[safety\]).
#Intervention
- DRUG : Rivaroxaban (Xarelto)
- NOAC, reduced dose
- DRUG : Apixaban
- NOAC, reduced dose
- DRUG : Dabigatran
- NOAC, reduced dose
- DRUG : Warfarin
- VKA
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with a qualifying oral OAC dispensed during the study period
* A primary diagnosis indicative of atrial fibrillation during the baseline period
Exclusion Criteria:
* Age < 18 years at index date
* Died on index date
* A diagnosis of valvular disease, pregnancy, transient cause of atrial fibrillation or venous thromboembolism in the baseline period or on the index date
* Hip or knee replacement surgery in the 60 days prior to or on the index date
* A dispensed prescription of heparin or fondaparinux in the 60 days prior to or on the index date
* A diagnosis of end-stage kidney disease or renal replacement therapy in the baseline period or on the index date
* More than one dispensed OAC (any dose of rivaroxaban, apixaban, dabigatran, edoxaban, or warfarin) on the index date
* A dispensed prescription of an OAC (any dose of rivaroxaban, apixaban, dabigatran, edoxaban, or warfarin) during the baseline period
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
|
NCT04249401
| 121,958 |
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