linjc16/ctgov huggingface dataset:
Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via Cylex

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Rituximab, in the same doses as used in rheumatoid arthritis patients, will benefit pemphigus patients. It also tests immune function via the Cylex assay in pemphigus patients before and after treatment with RItuximab.

Official Title
-----------------
Treatment of Moderate to Severe Patients With Pemphigus With the Monoclonal Anti CD20 Antibody Rituximab at a Protocol of 1000mgX2 and Assessment of Their Immune Status Via the Cylex Test

Conditions
-----------------
Pemphigus

Intervention / Treatment
-----------------
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Pemphigus patients with moderate-severe disease Exclusion Criteria: Pregnancy or lactation Woman of reproductive age not using birth control measures. Prior severe allergy or anaphylaxis with a human monoclonal antibody Heart failure Unstable angina or ischemic heart disease Uncontrolled arrhythmia HIV positive Active hepatitis B infection or positive for hepatitis C virus (HCV) antibodies. Severe dementia or a psychiatric illness Active acute infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab<br> | Drug: Rituximab<br>* intravenous (IV) Rituximab 1 gramX2, every (q) 2 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete or partial remission off treatment (based on the consensus statement for pemphigus) |  | 6 months after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pemphigus, Rituximab, Cylex
Molecular Urine Tests for Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Prostate cancer is the second leading cause of cancer related deaths among men in the United States.1 Although still controversial, there is growing evidence that early detection will reduce prostate cancer mortality. Currently the most useful biomarker to aid in early detection is measurement of serum prostate specific antigen (PSA) levels. Despite the value of PSA it has substantial limitations. To overcome the limitations of total PSA testing, there is emerging evidence demonstrating that relevant cancer biomarker can be detected in urine. Patients who present to the urology clinic for a radical prostatectomy will be asked to enter this study. After obtaining informed consent, the following exam and specimen collection scheduled will be followed: Visit 1 (pre-op): Digital Rectal Exam (DRE) - Voided urine collection & serum collection Visit 2 (time of prostatectomy): Under anesthesia- catheterized urine collection and serum collection Visit 3 (approximately 8 days post-prostatectomy): Catheterized urine collection Visit 4 (approximately 3 months post-prostatectomy): Voided urine collection and serum collection Some patients will not have the serum collection at visits 1, 2, and 4. The patients will be notified as to whether or not their blood will be drawn during the visits. Pre-operative Digital Rectal Exam, urinary catheterization and blood draws are part of standard of care in this patient population with localized prostate cancer. The catheter will be inserted during the time of surgery preparation in the operating room and removed during the post operative clinic appointment.

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those scheduled to undergo radical prostatectomy for the treatment of prostate cancer. Exclusion Criteria: minors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, PCA3
Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP) in the  Real-life  : Result of the French Experience in 72 Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to review the charts of the first 100 patients included in the french compassionate program including patients with Immune Thrombopenia receiving romiplostim.

Detailed Description
-----------------
Inclusion Criteria: Subject has a diagnosis of ITP according to the American Society of Hematology guidelines (George et al., 1996). Subject is equal to or greater than 18 years of age. Before any study-specific procedure, the appropriate written informed consent must be obtained. Subject receiving romiplostim in the compassionate program Available follow-up of one-year Exclusion Criteria: •Secondary ITP e.g: thrombopenia related to hepatitis C, HIV, Chronic Lymphocytic Leukemia... The goal of this study is to review retrospectively the charts of the 100 first patients including in this program in France during the period of January 2008 and July 2008.

Conditions
-----------------
Thrombopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion Criteria: Subject has a diagnosis of ITP according to the American Society of Hematology guidelines (George et al., 1996). Subject is equal to or greater than 18 years of age. Before any study-specific procedure, the appropriate written informed consent must be obtained. Exclusion Criteria: Exclusion Criteria: Secondary ITP

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immune Thrombopenia, Thrombocytopenia, romiplostim, compassionate program
The Effect of Exercise on Blood Glucose Levels in Patients With Type 1 Diabetes: A Comparison of 3 Long-acting Insulins

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this research is to assess the impact of three basal (long-acting) insulin treatments on blood glucose levels in people with type 1 diabetes when performing physical exercise.

Official Title
-----------------
An Assessment of the Impact of Performing Physical Exercise on the Maximum Plasma Glucose Decline in Subjects With Type 1 Diabetes Managed on a Basal Bolus Insulin Regimen: A Comparison of 3 Basal Insulin Treatments - Insulin Detemir, Insulin Glargine and NPH Insulin

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: insulin glargine
* Drug: insulin NPH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 Diabetes Current basal-bolus insulin therapy HbA1c < 10% BMI < 32 kg/m2 Exclusion Criteria: Proliferative Retinopathy / Maculopathy Recurrent major hypoglycaemias Impaired hepatic or renal function Cardiac Problems Uncontrolled hypertension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin detemir|nan|
|Drug: insulin glargine|nan|
|Drug: insulin NPH|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference between plasma glucose concentrations immediately pre-exercise and the minimum plasma glucose concentrations (nadir) in the period 0-150 min following exercise |  | following 4 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose pre-exercise & post-exercise |  |  | 
| Hypoglycaemia episodes (major and minor episodes) during exercise, afterwards & from end of study until 07:30 the following morning |  |  | 
| Plasma glucose profile post-exercise |  |  | 
| Incidence of adverse events during the trial |  |  |
Effect of Information on Service Delivery in Rural India

Study Overview
=================
Brief Summary
-----------------
A lack of public awareness about entitled health and social services may contribute to poor delivery of services in developing countries. We sought to determine the impact of educating villagers about entitled services.

Detailed Description
-----------------
105 gram panchayats (village clusters) were randomized to receive information about their guaranteed health, education, and village governance rights. We then selected households within each treatment and control village to assess whether the information had made an impact.

Conditions
-----------------
Delivery of Services to Rural Populations in India

Intervention / Treatment
-----------------
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gram panchayats in Uttar Pradesh
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Education|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visits by nurse midwife |  |  | 
| prenatal exams, tetanus vaccinations, & iron tablets received by pregnant women |  |  | 
| infant vaccinations |  |  | 
| educational scholarships and fees for children |  |  | 
| occurrence of village council meetings |  |  | 
| development work in villages |  |  |
A Case Control Study to Investigate the Possible Association Between Atrial Fibrillation and Endothelium Dysfunction by Using Flow-Mediated Vasodilation Method

Study Overview
=================
Brief Summary
-----------------
Endothelial function is closely related to the hemostasis , vascular tone, and organ perfusion in cardiovascular system, and its dysfunction would cause overactivation of the coagulative system to induce thrombus formation. So we study the relationship between the endothelial function and atrial fibrillation.

Conditions
-----------------
Atrial Fibrillation, Endothelial Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lone AF patients and normal controls Exclusion Criteria: DM, hypertension, hyperlipidemia, smoking, pregnancy,

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparing Paroxetine and Duloxetine on Cardiovascular Measures

Study Overview
=================
Brief Summary
-----------------
This double-blind placebo-controlled trial is designed to test and to compare the cardiovascular profile of paroxetine controlled release (CR) with duloxetine in outpatients with depressive symptoms.

Detailed Description
-----------------
This double-blind placebo-controlled study will test the hypothesis that greater reduction in heart rate variability will be associated with duloxetine than paroxetine in outpatients with major depressive disorder. We will also examine the relationship between changes in heart rate variability to the magnitude of serotonin and norepinephrine transporter occupancy produced by each drug.

Official Title
-----------------
A Study of the Effects of Paroxetine vs. Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control

Conditions
-----------------
Depressive Symptoms

Intervention / Treatment
-----------------
* Drug: paroxetine versus duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Depressive symptoms Ages 20-60 In good medical health and not pregnant Exclusion Criteria: Bipolar disorder Schizophrenia or other psychotic disorder Alcohol or other substance abuse within the last 3 months Cognitive impairment History of attempted suicide in the past 2 months and who score 4 or more on the suicide item of the MADRS

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paroxetine versus duloxetine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R-R interval change with deep breathing |  |  | 
| Respiratory sinus arrhythmia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale (MADRS) |  |  | 
| Hospital Anxiety and Depression Scale |  |  | 
| Spielberger State-Trait Anxiety Inventory |  |  | 
| Connor-Davidson Resilience Scale |  |  | 
| Norepinephrine receptor occupancy |  |  | 
| Serotonin receptor occupancy |  |  |
Rituximab for the Treatment of Severe Ocular Manifestations of Behcet's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find if Rituximab can improve severe ocular lesions of Behcet's Disease.

Detailed Description
-----------------
To test in a single blind randomized control study the efficacy of Rituximab versus combination of pulse cyclophosphamide and azathioprine. Both group receiving 0.5 mg/kg/daily prednisolone.

Official Title
-----------------
Effect of Rituximab in the Treatment of Resistant Ocular Inflammatory Lesions of Behcet's Disease (Pilot Study)

Conditions
-----------------
Behcet's Syndrome

Intervention / Treatment
-----------------
* Drug: Rituximab
* Drug: Cytotoxic Combination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Behcet's Disease fulfilling the new International Criteria for Behcet's Disease Having active ocular lesions (posterior and/or retinal vasculitis) Resistant to cytotoxic drugs + prednisolone 0.5 mg/kg Exclusion Criteria: Visual acuity less than 1/10 on Snellen chart Antecedent of allergic reaction to any component of the therapeutic regimen

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rituximab | Drug: Rituximab<br>* Infusion of Rituximab, 1500 mg, two times with 15 days interval. Patients receive also Methotrexate (15 mg weekly) and Prednisolone (0.5 mg/daily).<br>* Other names: Rituxan;|
| Active Comparator: 2<br>Cytotoxics combination | Drug: Cytotoxic Combination<br>* Pulse cyclophosphamide 1000 mg in perfusion, once monthly monthly. Azathioprine 3 mg/kg/body weight daily + prednisolone 0.5 mg/kg/daily.<br>* Other names: Cytoxan;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory index for posterior uveitis |  | 6 months | 
| Inflammatory index for retinal vasculitis, especially for edema |  | 6 months | 
| Total Adjusted Disease Activity Index (TADAI) |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ocular lesions, Visual Acuity, Retinal Vasculitis
Robot-Aided Neurorehabilitation of the Upper Extremities

Study Overview
=================
Brief Summary
-----------------
Task-oriented repetitive movement can improve movement performance in patients with neurological or orthopedic lesions. The application of robotics can serve to assist, enhance, evaluate, and document neurological and orthopedic rehabilitation of movements. Arm therapy is used in neurological rehabilitation for patients with paralyzed upper extremities due to lesions of the central or peripheral nervous system, e.g. after stroke or spinal cord injury. The goal of the therapy is to recover motor function, improve movement coordination, learn new motion strategies (trick movements), and/or prevent secondary complications such as muscle atrophy, osteoporosis, and spasticity.

Conditions
-----------------
Robot-aided Arm Therapy, Brain Injury, Motor Relearning Programme, Activities of Daily Living

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with neurological disability of the upper limb with qualification for arm training, e.g. after stroke and spinal cord injury Exclusion Criteria: limitations of the join mobility osteoporosis cardiovascular disease injury of the upper limb decubitus psychic diseases (like schizophrenia, dementia, depression) Body weight > 120kg pacemaker.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients<br> | |
| healthy subjects<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The acceptanece of the arm rehabilitation robot therapy and the influence to the motivation through the visual feedback. |  | A measure lasts approx. 90 minutes. Every participant once. |
Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX in Healthy Indian Children (V210-056)

Study Overview
=================
Brief Summary
-----------------
To observe the safety and tolerability of the administration of VARIVAX in varicella history negative Indian children 12 months to 12 years of age.

Official Title
-----------------
Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX (V210)in Healthy Indian Children

Conditions
-----------------
Varicella

Intervention / Treatment
-----------------
* Biological: Varicella Virus Vaccine Live (Oka-Merck)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Children, Between 12 Months And 12 Years Of Age Parent Or Legal Guardian Should Be Willing And Able To Sign The Informed Consent Form Prior To Entry Into The Study Exclusion Criteria: Any Immune Impairment Or Deficiency, Neoplastic Disease, Or Depressed Immunity, Including That Resulting From Corticosteroid Or Other Immunosuppressive Therapy Any Immunoglobulin Or Blood Products 5 Months Prior To Or Expected Within 3 Months After Enrollment In This Study Any Medical Condition Which, In The Opinion Of The Investigator May Interfere With The Evaluation Of Teh Study Objectives Any Other Inactivated Vaccine Administered Within 14 Days Before Or Expected Within 42 Days After Administration Of The Study Vaccination Any Other Live Vaccine Administered Within 30 Days Before Or Expected Within 42 Days After Administration Of The Study Vaccination Female Subjects Who Are Pregnant Or Nursing History Of Anaphylactic Or Other Immediate Allergic Reactions Hypersensitivity To Any Of The Components Of The Vaccine Administered Under This Protocol Such As Gelatin Or Neomycin Past History Of Varicella Previous Vaccination With Any Varicella Vaccine In Either Monovalent Or Combination Form Recent Household, Daycare, Or School Exposure(In The Last 4 Weeks) To Varicella

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Open label | Biological: Varicella Virus Vaccine Live (Oka-Merck)<br>* VARIVAX(TM) (Refrigerated) [Varicella Virus Vaccine Live (Oka/Merck), Refrigerator-Stable Formulation.] Subjects enrolled in the study received one 0.5 mL subcutaneous dose of VARIVAX(TM). Frequency is single dose.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects with VZV specific antibody titre>= 5gp ELISA units/ml 6 weeks post-vaccination |  | 6 weeks post-vaccination |