linjc16/ctgov huggingface dataset:
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia

Study Overview
=================
Brief Summary
-----------------
This study is being done to evaluate the long-term safety of tegaserod in women with symptoms of dyspepsia who have completed the core study. Tegaserod will be evaluated at 6 mg twice daily.

Official Title
-----------------
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia

Conditions
-----------------
Dyspepsia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, 18 years and older Fulfilled eligibility criteria in CHTF919D2301 (double blind study) and successfully completed the double-blind study Exclusion Criteria: - Early discontinuation from the double-blind study Other protocol-defined inclusion/exclusion criteria may apply

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term safety at 6 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term safety at 1 year. |  |  | 
| Quality of life : Nepean Dyspepsia Index, WPAI, patient perception of study medication-dyspepsia questionaire. |  |  | 
| Efficacy on satisfactory relief at month 6 and 12. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dyspepsia, gastrointestinal, tegaserod
Healthcare Decisions Post-Testing, Risk-reducing and Preventative Strategies Using LYNCH Genetic Testing Reducing, and Preventative Strategies Using LYNCH Genetic Testing

Study Overview
=================
Brief Summary
-----------------
Increase surveillance for LYNCH Syndrome

Detailed Description
-----------------
The purpose of this minimal risk, observational survey is to increase surveillance for Lynch Syndrome (hereditary non-polyposis colon cancer), Colorectal, and Endometrial cancer, also to determine targeted risk-reducing and preventative strategies.

Official Title
-----------------
Medical Provider Experience Assessment Healthcare Decisions Post-Testing, Risk-Reducing, and Preventative Strategies Using LYNCH Genetic Testing

Conditions
-----------------
Colon Cancer, Endometrial Cancer

Intervention / Treatment
-----------------
* Other: Genetic testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be a Medical Practitioner Medical Doctor (MD) Doctor of Osteopathic (DO) Physician Assistant (PA) Advanced Practice Registered Nurse (APRN) Nurse Practitioner (NP) Must have a current standard operating procedure that includes obtaining/reviewing medical history and family medical history. Exclusion Criteria: Government-funded insurance data cannot be included in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Genetic testing|LYNCH genetic testing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provider Structures and Processes | Plan of Care Changes due to LYNCH genetic testing. Provider based observational survey system on the health and well-being of patients and populations | 36 months |
Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient - a Study in France

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment.

Official Title
-----------------
Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient

Conditions
-----------------
Gastroesophageal Reflux Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 6 month history of GERD symptoms Treated with unchanged optimized PPI treatment for any GERD indication during the last 4 weeks before enrollment Remaining GERD symptoms despite optimized PPI treatment Able to read and write in French, and able to comply with study requirements Exclusion Criteria: Patients that have not experienced any GERD symptom improvement at all during PPI treatment Involvement in the planning or conduct of the study Involvement in any other observational study or in any clinical study at the time of this study or during the last 6 months Prior surgery of the upper GI tract

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 |
| --- | --- |
| 1<br>274 GERD patients, partial responders to PPI treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Productivity loss; Frequency and severity of GERD symptoms; Health care resource use |  | Collected at enrollment visit and at 3, 6, 9 and 12 month follow-up. (Health care resource use is collected by the physician at enrollment visit and 6 and 12 month follow-up) | 
| Utility values; Quality of Life |  | Collected at enrollment visit and at 6 and 12 month follow-up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, PPI, partial responders
A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).

Official Title
-----------------
A Randomized, Double Blind, Placebo-controlled Phase II Study of KPS-0373 in Patients With SCD

Conditions
-----------------
SCD

Intervention / Treatment
-----------------
* Drug: KPS-0373
* Drug: KPS-0373
* Drug: KPS-0373
* Drug: KPS-0373
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese SCD patients with mild to moderate ataxia Exclusion Criteria: Patients with secondary ataxia Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KPS-0373, lowest dose<br> | Drug: KPS-0373<br> <br> |
| Experimental: KPS-0373, 2nd lowest dose<br> | Drug: KPS-0373<br> <br> |
| Experimental: KPS-0373, 2nd highest dose<br> | Drug: KPS-0373<br> <br> |
| Experimental: KPS-0373, highest dose<br> | Drug: KPS-0373<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Scale for the assessment and rating of ataxia (SARA) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in patient improvement impression of activities of daily living |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinocerebellar degeneration (SCD), Thyrotropin-Releasing Hormone (TRH)
Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program

Study Overview
=================
Brief Summary
-----------------
This study is an early access program of 'Nexavar post-marketing surveillance (PMS) for renal cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and observational study for patients with unresectable or advanced RCC under real-life practice conditions. The objective of this study is to assess safety and effectiveness of Nexavar at some limited sites which joined to clinical trial of Nexavar, before available of it in the market. The enrollment period is 2 months, and patients who received Nexavar will be recruited and followed one year since starting Nexavar administration. The data of this study will be integrated into the Nexavar PMS and the data will not be analyzed and reported alone.

Official Title
-----------------
Special Drug Use Investigation of Nexavar (Unresectable or Advanced Renal Cell Carcinoma: Early Access Program)

Conditions
-----------------
Carcinoma, Renal Cell

Intervention / Treatment
-----------------
* Drug: Sorafenib (Nexavar, BAY43-9006)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received Nexavar for unresectable or advanced renal cell carcinoma Exclusion Criteria: Patients who are contraindicated based on the product label
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* Patients who have received Nexavar for unresectable or advanced RCC.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar |  | After Nexavar administration, up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease, clinical staging of RCC, Eastern Cooperative Oncology Group-Performance Status (ECOG-PS)] |  | After Nexavar administration, up to 1 year | 
| Effectiveness evaluation assessment [overall survival, response rate, stable disease rate, progression disease rate] by investigator-determined overall best response [according to the General rule for clinical and pathological studies on RCC] |  | After Nexavar administration, up to 1 year | 
| The status of therapy with Nexavar [duration of treatment, daily dose] |  | After Nexavar administration, up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nexavar, unresectable or advanced renal cell carcinoma
China STEMI-PCI Program

Study Overview
=================
Brief Summary
-----------------
Registration Performing in three stages Major aim: Much more and standard reperfusion therapy in STEMI patients

Official Title
-----------------
China STEMI-PCI Program

Conditions
-----------------
ST Segment Elevation Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Onset of STEMI within 12h Onset of STEMI within 12-36h needing primary PCI Exclusion Criteria: -
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 |
| --- | --- | --- |
| The reperfusion ratio |  | up to 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Door to Balloon time |  | up to 1 day | 
| BMS ratio |  | up to 1 day | 
| health economic evaluation |  | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
STEMI, reperfution, primary PCI
Pentoxifylline for Acute Alcoholic Hepatitis (AAH)

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH.

Detailed Description
-----------------
The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH. This study never moved forward due to funding issues.

Official Title
-----------------
A Pilot Study of Pentoxifylline-Therapy for Acute Alcoholic Hepatitis

Conditions
-----------------
Hepatitis, Alcoholic

Intervention / Treatment
-----------------
* Drug: pentoxifylline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatient with acute alcoholic hepatitis Model for End-Stage Liver Disease (MELD) of 15 or greater Recent alcohol abuse Exclusion Criteria: Recent infection Other life threatening disease Severe coagulopathy Another non-alcoholic cause of liver disease

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pentoxifylline/Placebo<br>All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days (20-40 treated, 1-20 placebo) with monthly follow up for 90 days. | Drug: pentoxifylline<br>* daily dosing<br>* Other names: no other names;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival at 28 Days |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute alcoholic hepatitis
Post-operative Hernias After Radical Cystectomy

Study Overview
=================
Brief Summary
-----------------
Post-operative hernias after cystectomy are frequent (our review of the literature with meta-analysis found an incidence of evisceration at 5%, median eventrations at 8% and peristomal hernias at 14%). These represent a non-negligible and partially morbidity. avoidable, subject to proper assessment of personal and surgical risk factors

Official Title
-----------------
Post-operative Hernias After Radical Cystectomy : Incidence and Risks Factors

Conditions
-----------------
Evisceration; Traumatic, Hernia

Intervention / Treatment
-----------------
* Procedure: Cystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: having undergone a cystectomy (for cancer or not), with or without reconstruction, between 01/01/2010 and 12/31/2020 Exclusion criteria: - refusing to participate

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- |
| Patients who undergo a cystectomy<br>Patients who undergo a cystectomy for cancer or not, since 2010 to 2020 | Procedure: Cystectomy<br>* Cystectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of post-operative hernias | Type of post-operative hernias : evisceration, median hernia, parastomal hernia | 1 day | 
| Define risk factors Type of risks factors | Define risk factors: sex, BMI, diabetes, ASA, duration surgery, delay, postoperative biology | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Median hernia, Parastomal hernia, Cystectomy
Endometrial Biopsy as Diagnostic Method for Endometriosis and Endometrioma

Study Overview
=================
Brief Summary
-----------------
Our aim was to evaluate the efficacy of examining endometrial biopsy specimens for nerve fibers as a diagnostic test for endometriosis and endometrioma in a double-blind comparison with diagnostic laparoscopy.

Official Title
-----------------
The Evaluation of Endometrial Biopsy in the Diagnosis of Endometriosis and Endometrioma: a Double Blind Study

Conditions
-----------------
Women in the Reproductive Age Group, Undergoing Laparoscopy for Pelvic Pain and/or Infertility, Not Currently Receiving Hormonal Treatment for at Least 3 Months Prior to Laparoscopy.

Intervention / Treatment
-----------------
* Procedure: Endometrial biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women in the reproductive age group undergoing laparoscopy for pelvic pain and/or infertility, and not currently receiving hormonal treatment for at least 3 months prior to laparoscopy will be included in the study

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control group<br> | Procedure: Endometrial biopsy<br>* For all the groups<br>|
| endometriosis group<br> | Procedure: Endometrial biopsy<br>* For all the groups<br>|
| endometrioma group<br> | Procedure: Endometrial biopsy<br>* For all the groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The density of nerve fibers in the endometrial biopsy sample. |  | 1 year |
Occurrence of Adverse Effects With Immune Checkpoint Inhibitors Between a Single and Double Dose Regimen

Study Overview
=================
Brief Summary
-----------------
This is a retrospective evaluation of the impact of a double dose regimen of immunotherapy use in cancer treatment compared to the single-dose regimen on the occurrence of clinically significant adverse events. The aim of this study is to provide evidence-based arguments to help clinicians to propose the best treatment regimen for each patient.

Official Title
-----------------
Comparison of the Occurrence of Adverse Effects With Immune Checkpoint Inhibitors Between a Single and Double Dose Regimen

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Any adult patient with anti-PD-1 or PD-L-1 immune checkpoint inhibitor as monotherapy Exclusion criteria: - age < 18

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 |
| --- | --- | --- |
| To compare the incidence of clinical significant toxicities | To compare the incidence of clinical significant toxicities reported for patients treated with a cancer immunotherapy on a simple dose regiment versus double dose regimen | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the incidence | To describe the incidence, type and severity of overall toxicities (serious and non-serious) reported with single and double dose cancer immunotherapy regimens | 18 months | 
| To identify risk factors for the development of severe toxicity | To identify risk factors for the development of severe toxicity | 18 months | 
| To describe the management and evolution of toxicities | To describe the management and evolution of toxicities | 18 months | 
| To describe the clinical oncologic response | To describe the clinical oncologic response | 18 months |