linjc16/ctgov huggingface dataset:
A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions using a single dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

Detailed Description
-----------------
The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions using a single dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

Official Title
-----------------
A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions

Conditions
-----------------
Parkinson's Disease, Restless Leg Syndrome

Intervention / Treatment
-----------------
* Drug: Ropinirole Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to ropinirole or any other comparable product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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

| Intervention/Treatment |
| --- |
|Drug: Ropinirole Hydrochloride|Restless Leg Syndrome|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, seven day washout |
Study on Immediate Placement to Evaluate Astra Tech Osseospeed Implants in an Immediate Loading Protocol in Extraction Sockets and Healed Ridges

Study Overview
=================
Brief Summary
-----------------
This is a study to evaluate immediate implants.

Detailed Description
-----------------
Solitary replacement of teeth by implants in upper maxilla - immediate implants

Official Title
-----------------
An Open, Prospective, Controlled Study on Immediate Placement to Evaluate Clinical Outcome of Astra Tech Implants, Fixture Microthread Osseospeed in an Immediate Loading Protocol in Extraction Sockets and Healed Ridges

Conditions
-----------------
Dental Implants

Intervention / Treatment
-----------------
* Procedure: Immediate implants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Exclusion Criteria: Smoking Medical risk patients

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate implants<br> | Procedure: Immediate implants<br>* Immediate implants are used.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival after 1 week, 3 weeks, 8 weeks, 10 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years |  | after 1 week, 3 weeks, 8 weeks, 10 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years |
Interactions of Hepatitis C Viral (HCV) Dynamics and Immune Activation in HIV Coinfected Patients During HCV Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate T-cell mediated immune responses to HIV-1 and HCV and determine how these responses are affected by HCV treatment and correlates to response. Furthermore, to study Interferon-inducible protein-10 (IP-10) dynamics during HCV treatment, and correlate this to treatment outcome.

Official Title
-----------------
Hepatitis C Virus Dynamic and Immune Activation in HIV-1 Coinfected Patients Treated With Pegylated Interferon Alfa-2a and Ribavirin

Conditions
-----------------
Human Immunodeficiency Virus, Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: pegylated interferon-alpha (Pegasys)
* Drug: ribavirin (COPEGUS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 Hepatitis C coinfected adult patients Hepatitis C treatment naive Stable HIV-1 infection with or without cART > 300 CD4+ cell count Exclusion Criteria: Decompensated liver disease Ongoing depression Ongoing drug abuse Other contraindications for interferon or ribavirin treatment

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIV-1 HCV coinfected patients<br>HIV-1 HCV coinfected patients undergoing HCV therapy | Drug: pegylated interferon-alpha (Pegasys)<br>* Pegylated interferon-alpha 2a 180 micrograms s.c. weekly<br>* Other names: Pegasys (interferon);Drug: ribavirin (COPEGUS)<br>* ribavirin bid 800-1200 mg depending on HCV genotype and body weight<br>* Other names: COPEGUS (RIBAVIRIN);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response |  | 24 weeks end of treatment (EOT) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-cell mediated immune responses |  | baseline to 24 weeks EOT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1, Chronic hepatitis C, Immune activation, HCV kinetics, IP-10
OCS Liver PROTECT Continuation Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT Trial.

Official Title
-----------------
OCS Liver PROTECT Continuation Post-Approval Study

Conditions
-----------------
Liver Transplant

Intervention / Treatment
-----------------
* Device: OCS Liver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects transplanted in the OCS Liver PROTECT Trial

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| OCS Liver<br> | Device: OCS Liver<br>* Transplanted with a OCS preserved liver<br>|
| Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Graft Survival | Liver Graft Survival through 2 years (24 months) after transplantation. | 2 years |
The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.

Study Overview
=================
Brief Summary
-----------------
Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention of the stomach

Official Title
-----------------
The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.

Conditions
-----------------
Heartburn, Dyspepsia

Intervention / Treatment
-----------------
* Drug: Tegaserod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects at least 18 years of age. Subjects willing to undergo multiple nasogastric intubations. Patients with functional heartburn will need to meet ROME II criteria. Patients with symptoms consistent with dyspepsia (epigastric pain/discomfort characterized by bloating, postprandial fullness and early satiety) Exclusion Criteria: Subjects with clinically significant diarrhea or a diagnosis of diarrhea-predominant IBS. Subjects with a diagnosis of IBD, Barrett's esophagus, esophageal stricture or ring, or previous or current history of ulcer disease. Subjects with Diffuse Esophageal Spasm or Achalasia. Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if tegaserod 6 mg b.i.d modulates gastric sensitivity to mechanical distention of the stomach |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) Comparing effects at end of treatment compared to baseline: |  |  | 
| To verify that tegaserod modulates esophageal sensitivity to esophageal distention |  |  | 
| To determine if tegaserod improves individual dyspeptic symptoms of epigastric pain/discomfort |  |  | 
| To determine if tegaserod improves heartburn and/or regurgitation |  |  | 
| To determine if tegaserod is preferred by patients with functional heartburn & accompanying dyspepsia & gastric mechanical sensitivity over placebo |  |  | 
| Safety assessment |  |  | 
| To determine if there is a correlation between esophageal & gastric mechanosensitivity thresholds in this patient group, and to determine if tegaserod alters this relationshi |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
functional heartburn, dyspepsia, male, female, visceral sensitivity
Prevalence of Secondary Cardiac Damage in Rheumatic Fever Patients and Penicillin Secondary Prophylaxis

Study Overview
=================
Brief Summary
-----------------
According to American Heart Association criteria, patients who have had Rheumatic Fever (RF) should be treated with antibiotic prophylaxis. Continuous prophylaxis is recommended in patients with well-documented histories of RF and in those with evidence of rheumatic heart disease. There is a limited data regarding adherence of patients to treatment and efficacy of treatment. In this study, patients with RF who are older than 21 years will be collected from a computerized database of 'Maccabi Healthcare Services', one of the biggest Israeli Health Funds. Patients will be assigned to the study after obtaining informed consent. Previous adherence to antibiotic prophylaxis will be examined according to computerized database of drugs which were issued to the patient since RF diagnosis. Past history of cardiac involvement, including past Echocardiograms, will be collected from computerized database. In addition, the current cardiac state will be assessed by an experienced cardiologist, including a full new Echocardiogram examination.

Official Title
-----------------
Prevalence of Secondary Cardiac Damage in Rheumatic Fever Patients and Adherence to Penicillin Secondary Prophylaxis

Conditions
-----------------
Secondary Cardiac Damage in Rheumatic Fever

Intervention / Treatment
-----------------
* Diagnostic Test: Echocardiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients older than 21 years who were diagnosed with RF (before age 18 years) according to the computerized database. Exclusion Criteria: patients with other rheumatic disease diagnosed before RF diagnosis patients with other cardiac disease diagnosed before RF diagnosis patients with neoplastic disease diagnosed before RF diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Echocardiogram|Current cardiac state will be assessed by an experienced cardiologist, including a full new Echocardiogram examination|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac function including vulvar involvement | Cardiac morphology and function measured by echocardiography | 60 days |
Effects of Sympathy and Touch on Anxiety of Patients Undergoing Fiberoptic Bronchoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of verbal expression of sympathy and touch on anxiety of patients undergoing fiberoptic bronchoscopy

Official Title
-----------------
Effects of Sympathy and Touch on Anxiety of Patients Undergoing Fiberoptic Bronchoscopy

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Behavioral: verbal expression for compassion
* Behavioral: touch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients undergoing diagnostic fiberoptic bronchoscopy hospitalized patients Exclusion Criteria: patients who have undergone fiberoptic bronchoscopy not hospitalized patients cognitive impairment refusal to enroll

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: verbal expression for compassion<br>verbal expression for compassion | Behavioral: verbal expression for compassion<br>* The doctor going to perform bronchoscopy tells a short sentence to a patient. (Hello, I'm Dr.OO. During this test, I will keep an eye on you. Don't worry)<br>|
| Active Comparator: verbal expression and touch<br>verbal expression and touch | Behavioral: verbal expression for compassion<br>* The doctor going to perform bronchoscopy tells a short sentence to a patient. (Hello, I'm Dr.OO. During this test, I will keep an eye on you. Don't worry)<br>Behavioral: touch<br>* The doctor going to perform bronchoscopy puts a hand on the patient's shoulder<br>|
| No Intervention: control<br>control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of visual analogue scale (VAS) for anxiety |  | baseline (arrival at the test room), and follow-up (at least 10 min after baseline, right before undergoing bronchoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of patients after fiberoptic bronchoscopy |  | within 6 hours after bronchoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchoscopy, anxiety, touch, sympathy
Prognostic Value of Respiratory System Compliance Under VV-ECMO on 180-day Mortality in COVID-19 ARDS.

Study Overview
=================
Brief Summary
-----------------
Mortality of patients with COVID-19 associated acute respiratory distress syndrome (CARDS) treated with veno-venous extra-corporal membrane oxygenation (vv-ECMO) is increasing over time since the beginning of the COVID-19 pandemic. The objectives were to retrospectively describe over the first ten days after vv-ECMO implantation, the ventilatory management of CARDS and to assess the impact of static respiratory system compliance (CRS) on the first day of vv-ECMO on 180-day mortality.

Official Title
-----------------
Prognostic Value of Respiratory System Compliance Under VV-ECMO on 180-day Mortality in Patients With COVID-19 Associated Acute Respiratory Distress Syndrome (CARDS)

Conditions
-----------------
Ards, Mechanical Ventilation Pressure High, Extracorporeal Membrane Oxygenation

Intervention / Treatment
-----------------
* Other: No applicable


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ARDS secondary to COVID-19 pneumonia requiring ECMO-VV support, hospitalized in the intensive care units of the CHRU of Nancy, Marseille or Bordeaux between 01/03/2020 and 31/12/2021. Age > 18 years old Exclusion Criteria: Respiratory parameters not available on ten first day of VV ECMO implantation. Patient refusal to participate in the study

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No applicable|No applicable|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital status (dead or alive) | according to compliance during the first ten days of VV ECMO implantation | Days, 10. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of driving pressure | after VV-ECMO implantation | Days, 10 | 
| Evolution of tidal volume | after VV-ECMO implantation | Days, 10 | 
| Evolution of PEEP | after VV-ECMO implantation | days, 10 |
Cut-Off Progesterone Values Deleterious for In Vitro Fertilization and Fresh Embryo Transfer

Study Overview
=================
Brief Summary
-----------------
At which deleterious cut off value of progesterone on day of HCG (P-hCG) in our IVF program should fresh embryo transfer (ET) be cancelled?

Detailed Description
-----------------
There is still an ongoing debate on the effect of subtle increased P-hCG concentration on pregnancy outcome after fresh ET. No consensus on the cut-off value to define increased P-hCG seems to exist. It is accepted that high P advances endometrium, leading to asynchrony between the implanting embryo and the endometrium, and resulting in implantation failure. A freeze all embryos policy and postponement of ET in subsequent frozen-thawed cycle has been proposed.

Official Title
-----------------
Cut-Off Progesterone Values Deleterious for In Vitro Fertilization and Fresh Embryo Transfer

Conditions
-----------------
Progesterone, Fertilization in Vitro, Infertility, Pregnancy

Intervention / Treatment
-----------------
* Other: Progesterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fresh embryo transfer Progesterone value on day HCG (Human choriogonadotrophin hormone) Exclusion Criteria: Clinical indication for delaying embryo transfer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Progesterone|Progesterone level|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy |  | 6 weeks after embryo transfer procedure |
Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 in Male Patients With Premature Ejaculation

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the efficacy and safety of DA-8031 and to decide the optimal dose of DA-8031 in male patients with premature ejaculation after oral administration on-demand. The investigators hypothesized that newly-developed DA-8031 would effect in delaying ejaculation in patients with premature ejaculation (PE). Design: Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design

Official Title
-----------------
A Randomized, Double-blind, Double-dummy, Placebo-controlled, Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 After Oral Administration in Male Patients With Premature Ejaculation

Conditions
-----------------
Premature Ejaculation

Intervention / Treatment
-----------------
* Drug: DA-8031
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients aged with premature ejaculation for more than 6 months. PEDT score ≥ 11 Exclusion Criteria: IIEF-EF domain ≤ 21 Serum Creatinine ≥ 2.5 mg/dl AST, ALT > 3*Upper limit of normal Subjects with hypotension(SBP/DBP<90/50mmHg) or uncontrolled hypertension(SBP/DBP>180/100mmHg) Subjects with chronic depression, psychiatric or schizophrenia, Subjects with alcohol, drug or substance abuse

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>PO administration | Drug: Placebo<br>* Placebo of DA-8031, undistinguishable<br>|
| Experimental: DA-8031 dose 1<br>PO administration | Drug: DA-8031<br> <br> |
| Experimental: DA-8031 dose 2<br>PO administration | Drug: DA-8031<br> <br> |
| Experimental: DA-8031 dose 3<br>PO administration | Drug: DA-8031<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average IELT change |  | From 0 week(baseline) to 8 week(end of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PEP, PGI | PEP(Primary ejaculation profile), PGI(Patient-reported global impression) | 8 weeks |