linjc16/ctgov huggingface dataset:
Ribavirin for Severe Acute and Chronic Hepatitis E Virus Infection.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the efficacy, safety and recurrence rate of two therapeutic strategies with ribavirin in patients with chronic hepatitis E and severe acute hepatitis E: fixed duration of treatment for 12 weeks vs variable duration depending on the viremia within 4 weeks of the start of treatment (12 vs 24 weeks). The purpose of the study is also improve the safety of treatment with Ribavirin by optimizing dose adjusted to renal function, plasma levels of drug and hemoglobin.

Official Title
-----------------
Randomized Study of Two Treatment Strategies With Ribavirin for Chronic Hepatitis E and Severe Acute Forms

Conditions
-----------------
Hepatitis E

Intervention / Treatment
-----------------
* Drug: Ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age equal or greater than 18 years. To comply with any of the following diagnoses: chronic Hepatitis E: HEV RNA detectable in patients with elevated transaminase levels for at least 6 months and / or HEV RNA detectable in two separated determinations by an interval of six months . severe acute Hepatitis E: alanine aminotransferase (ALT) levels greater than 10 times the normal limit, with HEV RNA positive, and signs of acute liver injury (International normalized ratio(INR> 1.5)); or with extrahepatic manifestations or liver failure in patients with previous liver disease. Signed informed consent Exclusion Criteria: Terminal illness with a expected life expectancy of less than 6 months Patients with contraindications for treatment with Ribavirin: pregnancy or lactation. Severe hepatic impairment or decompensated cirrhosis. hemoglobinopathies (thalassemia, sickle cell anemia). history of severe pre-existing cardiac disease, including unstable heart disease.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>Patients will receive ribavirin during 12 weeks | Drug: Ribavirin<br> <br> |
| Other: Group B<br>Patients will receive: ribavirin during 12 weeks if RNA (Ribonucleic acid) Hepatitis E virus (HEV) is undetectable at week 4 after treatment start (adjust to renal function) - ribavirin during 24 weeks if RNA (Ribonucleic acid) Hepatitis E virus (HEV) is detectable at week 4 after treatment start (adjust to renal function) | Drug: Ribavirin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response measured by HEV RNA | HEV RNA undetectable at 48 weeks after end of treatment | 48 weeks |
Vascular Changes Following Forearm Loop Arteriovenous Graft Placement

Study Overview
=================
Brief Summary
-----------------
This study will determine whether upper arm vessels increase in size following forearm loop arteriovenous graft placement and the timing of these changes.

Detailed Description
-----------------
The purpose of this study is to determine whether upper arm vessels increase in size following forearm loop arteriovenous graft placement, and if they do, characterize the timing of these changes.

Official Title
-----------------
The Natural History of Upper Arm Vessels Following Forearm Loop Arteriovenous

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 19 years Planned forearm loop arteriovenous graft placement for hemodialysis or forearm loop arteriovenous graft placed within the previous 7 days. Cephalic and/or basilic vein diameter greater than or equal to 2.5 mm at the antecubital fossa to the axilla prior to AVG placement Exclusion Criteria: Age less than 19 years Hemodialysis access other than forearm loop graft surgery placement Cephalic and/or basilic vein diameter less than 2.5 mm at any point from the antecubital fossa to the axilla Prior hemodialysis access surgery in the arm receiving the forearm loop graft

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Forearm Arteriovenous Loop Graft<br>Participants with planned forearm loop arteriovenous graft placement for hemodialysis or forearm loop arteriovenous graft placed within the previous 7 days will have the upper arm vessels assessed following forearm loop arteriovenous graft placement for size changes and timing of changes. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper arm vein diameter | 50% increase in upper arm vein diameter | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, Arteriovenous Graft
To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Non-Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting conditions.

Official Title
-----------------
A Relative Bioavailability of Clarithromycin 250 mg Tablets Under Non-Fasting Conditions

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA)
* Drug: Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 Years

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA) | Drug: Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA)<br> <br> |
| Active Comparator: 2<br>Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA) | Drug: Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 9 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic
A Phase II Evaluation of Telesurgery Systems

Study Overview
=================
Brief Summary
-----------------
This study evaluates a system of remote supervision of laparoscopic surgery. Laparoscopic surgery is performed through small holes in the abdomen called ports. A camera is passed through one port for visualization. Laparoscopic surgery requires an assistant to hold the camera and help the operating surgeon view the surgical field. The assistant camera holder may be a surgeon or a robotic arm. The robotic arm is usually controlled by the operating surgeon. In this study, a robotic arm holding the camera will be used, and will be controlled by a surgeon outside the operating room.

Detailed Description
-----------------
This study evaluates a system of remote supervision of laparoscopic surgery. Laparoscopic surgery is performed through small holes in the abdomen called ports. A camera is passed through one port for visualization. Laparoscopic surgery requires an assistant to hold the camera and help the operating surgeon view the surgical field. The assistant camera holder may be a surgeon or a robotic arm. The robotic arm is usually controlled by the operating surgeon. In this study, a robotic arm holding the camera will be used, and will be controlled by a surgeon outside the operating room.

Official Title
-----------------
A Phase II Evaluation of Telesurgery Systems

Conditions
-----------------
Laparoscopy

Intervention / Treatment
-----------------
* Procedure: Laparoscopic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Any patient undergoing laparoscopic surgery.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Laparoscopic surgery|nan|

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
-----------------
Laparoscopy, Telemedicine, Surgery, Endoscopy
A Multicentre Trial to Determine the Efficacy of AD 452 in RA Subjects.

Study Overview
=================
Brief Summary
-----------------
AD 452 is a new drug which is being developed for use in adult patients with RA. It is believed that AD 452 may modify the underlying disease of RA as well as improving RA symptoms, and in order to establish its efficacy and safety, AD 452 is being tested in a 3 month study. Patients enrolled in this study will already be taking methotrexate for their RA and they will remain on methotrexate throughout the study. An earlier clinical study in 98 subjects with RA on stable background therapy investigated the pharmacokinetics, safety and tolerability of AD 452 taken for one month. The drug was well tolerated and no significant drug related adverse events were reported.

Official Title
-----------------
Phase II Randomised, Double-Blind, Multicentre, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of 3 Strengths of AD 452 in Adults With Active RA Who Are Currently Taking Methotrexate.

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: AD 452


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/female age 18 -75 RA diagnosed for at least 6 months Taking methotrexate for at least 6 months Must have at least 4 swollen/tender joints Exclusion Criteria: Must not be pregnant/breastfeeding Must not have history of other inflammatory disorders Other conditions may lead to exclusion from the trial (e.g. Diabetes mellitus, malignant melanoma, HIV, active infection, hepatitis B/C, cardiac conduction disorders, hepatic/renal insufficiency, active depression/anxiety/psychosis/schizophrenia or convulsions.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: AD 452|nan|

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
-----------------
Rheumatoid Arthritis, RA, ACR20 endpoint, Tender/swollen joints, Improvement in pain, Health assessment questionnaire, Profile of mood states
Dose Response Trial of Pergolide for Cocaine Dependence - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of pergolide for treatment of cocaine dependence.

Official Title
-----------------
Dose Response Trial of Pergolide for Cocaine Dependence

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Pergolide


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pergolide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  |  | 
| Drug use |  |  | 
| Retention |  |  | 
| Cocaine withdrawal |  |  | 
| Compliance |  |  | 
| Effectiveness of medication for global improvements |  |  |
Predictors of Intrauterine Growth Restriction

Study Overview
=================
Brief Summary
-----------------
The main objectives of modern antenatal care programs are to identify high risk pregnancies then to predict any possibility of adverse pregnancy outcome as early as possible. The earliest attempts to achieve this goal were possible with the introduction of ultrasound in obstetrical practice in the 1950s. A breakthrough that enabled obstetricians to directly visualize the fetus, placenta and amniotic fluid. At first 2-dimensional (2D) imaging was employed whereby fetal biometry and placental location were detected. Later on, Doppler measurements & 3-dimensional (3D) representation became feasible further revolutionizing this area

Official Title
-----------------
Second Trimester Doppler Indices and Placental Vascularity as Predictors of Intrauterine Growth Restriction

Conditions
-----------------
Pre-Eclampsia

Intervention / Treatment
-----------------
* Procedure: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant female. Pregnant ± 22 to 26 weeks gestation Singleton pregnancy. Consenting to participate Exclusion Criteria: Intrauterine fetal death Diagnosed to have Any congenital anomalies Symmetrical IUGR Established fetal compromise that necessitates delivery
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: ultrasound|A 3D volume of the uterus will be acquired by transabdominal sonography. The sweep angle was set at 85º and the probe will be kept perpendicular to the placental plate. The placenta will be examined and the size of the volume box will be adapted in such a way that the placenta fitted into it completely. The volume will then stored for later offline analysis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of preeclampsia during pregnancy. | number of women developed preeclampsia | 5 months |
Blood for Immune Response to Provenge® in HRPC

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment regimen.

Detailed Description
-----------------
This study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment regimen. The trial only involves the collection of additional blood samples for the purposes of monitoring immune response. These samples will be taken at 7 time points before, during and after patients receive Provenge® (Sipuleucel-T). There will be no other study-specific procedures performed (other than the blood draws) nor any use of investigational agents in this study.

Official Title
-----------------
Blood Samples to Evaluate Immune Response to Provenge® (Sipuleucel-T) inHormone Refractory Metastatic Prostate Cancer Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who plan to receive standard of care Provenge® (Sipuleucel-T) at their primary physican's office. Exclusion Criteria: None
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 |
| --- | --- | --- |
| Immune Response | Standard of Care Drug Immune Response | Additional Blood Sample |
Non-interventional Study -Observe Treatment Efficacy in Maintaining Symptoms Control in Schizophrenia With Seroquel XR

Study Overview
=================
Brief Summary
-----------------
the primary purpose of the study is to observe symptoms control in schizophrenia for 6 months in patients treated with Seroquel XR. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
-----------------
Non-interventional Study to Observe Treatment Efficacy in Maintaining Symptoms Control in Patients With Schizophrenia, Treated With Seroquel XR

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will have a diagnosis of schizophrenia , as defined by DSM-IV-TR and their symptoms are controlled with Seroquel XR therapy started approximately 1 month before All eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme. Exclusion Criteria: All the patients who have a known hypersensitivity to Seroquel XR/quetiapine or any of its excipients will not be included in this study. As per valid Romanian SmPC, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Schizophrenia patients stabilized on Seroquel XR | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Psychiatric Rating Scale - BPRS |  | monthly/ at every clinic visit- 7 times | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression Severity of Illness - CGI -S |  | monthly/ at every clinic visit- 7 times | 
| Clinical Global Impression Improvement CGI -I |  | monthly/ at every clinic visit except first visit- 6 times | 
| Quality of Life Enjoyment & Satisfaction Questionnaire - Short Form ( Q - LES - Q - SF) |  | twice/first and last clinic visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia
Obstructive Sleep Apnoea and Adipose Tissue Dysfunction

Study Overview
=================
Brief Summary
-----------------
Dysfunctional adipose tissue predisposes to cardiovascular disease. Similarly, the risk of cardiovascular disease appears to be increased in subjects with obstructive sleep apnoea. Reduced adipose tissue oxygen availability has been described in obesity and may also be a mechanism in obstructive sleep apnoea. Hypoxia induces inflammation and fibrosis in adipose tissue which are factors contributing to cardiovascular risk. The investigators hypothesize that adipose tissue's oxygen uptake is reduced in subjects with obstructive sleep apnoea by comparing in vivo AT oxygenation and blood flow in tissue of control subjects.

Detailed Description
-----------------
Assessment includes a adipose tissue biopsy and measurement of oxygenation and blood flow by a Clarke type electrodes and non-invasive Doppler techniques.

Official Title
-----------------
Assessment of Hypoxia in Adipose Tissue of Subjects With Obstructive Sleep Apnoea

Conditions
-----------------
Obesity, Obstructive Sleep Apnoea, Hypoxia

Intervention / Treatment
-----------------
* Device: Continuous positive airway pressure devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men with or without obstructive sleep apnoea Exclusion Criteria: weight loss interventions steroid use active smoking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| men with obstructive sleep apnoea<br>Continuous positive airway pressure devices | Device: Continuous positive airway pressure devices<br>* overnight use of CPAP device<br>* Other names: CPAP;|
| control subjects<br>subjects with no obstructive sleep apnoea | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pO2 in adipose tissue by Clarke type electrode | Measurement of pO2 by Clarke type electrode | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood flow in adipose tissue by laser Doppler techniques | assessment of tissue blood flow by laser Doppler techniques | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, hypoxia, adipose tissue