linjc16/ctgov huggingface dataset:
Congestive Heart Failure Trends in the Elderly 1970-94

Study Overview
=================
Brief Summary
-----------------
To investigate trends in the incidence and survival rates of congestive heart failure (CHF) in two successive cohorts of elderly people (1970-74, 1990-94) in a health maintenance organization (HMO).

Detailed Description
-----------------
BACKGROUND: The study constituted part of a growing body of research designed to understand not only the secular trends in mortality, morbidity, survival, and disability levels for selected major chronic diseases among older persons in the United States, but also the implications of the findings for health care utilization. DESIGN NARRATIVE: The design was that of a retrospective study of successive cohorts of a well-defined and well-documented elderly population for the purpose of identifying and explaining trends in congestive heart failure (CHF) incidence, survival, comorbidities and health services utilization during the 25-year period 1970-1994. The study sample consisted of two successive period cohorts of elderly people, identified for each of two five-year periods, 1970-1974 and 1990-94. The study tested the following hypotheses: 1) incidence of CHF had decreased among the younger old (65-74 years of age); 2) incidence of CHF had increased among the older old (75 years of age or above); 3) one-year survival time had increased following onset of incident CHF; and 4) prevalence of hypertension had decreased and prevalence of myocardial infarction and other manifestations of coronary artery disease increased among incident cases of CHF. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive, Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
SARCOTHAL. Thalidomide in Skin Sarcoidosis

Study Overview
=================
Brief Summary
-----------------
Sarcoidosis is a multisystem disease involving most frequently the lung, the eyes, the lymph nodes and the skin. Skin lesions may be disfiguring and impair the quality of life. Thalidomide is a multi-target drug that has been shown to be of benefit in skin sarcoidosis in case reports. The objective is to assess the efficacy and tolerance of thalidomide in skin sarcoidosis.

Detailed Description
-----------------
The study consists in comparing thalidomide to placebo in skin sarcoidosis. Patients with sarcoidosis not necessitating a high-dose corticosteroid regimen, and assessable skin lesions, are eligible. They are randomized and receive either thalidomide or placebo for 3 months. Then they are given Thalidomide for a 3-month open-label period.

Official Title
-----------------
Randomized Controlled Trial of Thalidomide vs Placebo in Skin Sarcoidosis

Conditions
-----------------
Sarcoidosis

Intervention / Treatment
-----------------
* Drug: THALIDOMIDE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proven skin sarcoidosis Assessable target skin lesions Exclusion Criteria: Rapidly evolving sarcoidosis Patients necessitating a corticosteroid regimen of more than 15mg per day. Women not willing to undertake a contraceptive method. Neurologic impairment Past treatment with Thalidomide Renal impairment

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>THALIDOMIDE | Drug: THALIDOMIDE<br>* THALIDOMIDE<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of target skin lesions at 3 months. | Size of target skin lesions at 3 months. | during de study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months. | Physician global assessment at 3 months. Functional assessment of other organs. Side-effects at 3 months. | during the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Randomized controlled trial, Thalidomide vs placebo, skin sarcoidosis, Thalidomide
Acupuncture for Elevated Intraocular Pressure

Study Overview
=================
Brief Summary
-----------------
Glaucoma is the leading cause of irreversible blindness in the world, resulting from progressive axonal destruction of the optic nerve. Primary open-angle glaucoma is the most common form, and it is usually painless with insidious onset. Conventional treatment is focused on lowering intraocular pressure (IOP), the one risk factor that can be modified, which has been demonstrated to protect against further damage to the optic-nerve head. Acupuncture is an ancient treatment which has been found to be beneficial for many ailments, and may reduce IOP. We propose a pilot study to evaluate whether acupuncture is an effective and safe modality for reducing elevated IOP in patients with open angle glaucoma and primary ocular hypertension. Patients with elevated IOP on tonometric measurement (20mmHg < IOP < 30mmHg) will be treated twice-weekly with a standardized (as opposed to individualized) acupuncture treatment. Treatment will last for four-weeks (for a total of 8 treatments), and patients will be evaluated for IOP diurnal curves at 2 weeks (4 treatment), 4 weeks (end of treatment ) and then 4 weeks following the last treatment.

Official Title
-----------------
Acupuncture Treatment for Elevated Intraocular Pressure: A Pilot Study

Conditions
-----------------
Elevated Intraocular Pressure

Intervention / Treatment
-----------------
* Device: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients of either gender; age 21 years and older; intraocular pressure equal/greater than 20mmHg, equal/less than 30mmHg; ability to comply with study protocol Exclusion Criteria: patients with secondary or closed-angle glaucoma; patients with a history of laser or other surgical treatment of glaucoma; patients displaying symptoms of depression, anxiety or psychosis

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: acupuncture|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure curves. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of acupuncture treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture, intraocular pressure, glaucoma
Patients Preference for Oral or i.v. Therapy

Study Overview
=================
Brief Summary
-----------------
Until recently, bolus 5-flourouracil (FU) + folinic acid (FA) has been considered the standard chemotherapy for patients with colorectal cancer. Several studies have shown that Capecitabine is as effective as Mayo regimen. The Nordic FU/FA schedule was developed to be an active and tolerable bolus regimen. The Nordic regimen consists of a short (3 minutes) bolus injection of FU and 30 minutes later FA for 2 consecutive days each 2 weeks. In randomized studies efficacy is comparable to other FU/FA regimens. It is claimed that patients prefer oral therapy and in a randomized study comparing oral therapy (UFT/FA) and bolus FU/FA (Mayo) 84% preferred oral therapy. In the present randomized cross-over study patients were randomized for 3 courses of Nordic FU/FA followed by 2 courses of Capecitabine (or vice versa), and patients were asked for their preference.

Official Title
-----------------
A Randomized Crossover Trial Comparing Oral Capecitabine and Intravenous Fluorouracil + Folinic Acid (Nordic FU/FA Regimen) for Patient Preference in Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Capecitabine
* Drug: Fluorouracil + folinic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for treatment with a FU-regime WHO Performance Status 0-1 Life expectancy > 3 months Adequate haematological, renal and hepatic functions Adequate contraceptives Written informed consent Exclusion Criteria: Known CNS-metastases Prior treatment with chemotherapy Pregnant or breast feeding women Current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis other serious illness or medical conditions

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Capecitabine|nan|
|Drug: Fluorouracil + folinic acid|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
-----------------
Patients preference, Colorectal cancer, Capecitabine, Fluorouracil + folinic acid, Cross-over study
Casptesia Versus PICCO in Cardiac Surgical Patients in the ICU

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to assess the ability of a new smartphone PPV app to predict fluid responsiveness in cardiac surgical patients in the Intensive care unit (in the postoperative period)

Detailed Description
-----------------
Pulse pressure variation (PPV) remains a good predictor of fluid responsiveness in the ICU in ventilated and sedated patients. However, PPV can be time-consuming to calculate (manual determination), is not always displayed on monitoring screens nor reliable through visual assessment and needs additional often costly devices to be displayed. A new Android application (Captesia) automatically calculates the PPV utilizing a digital photograph of the arterial waveform from the monitor. The application determines the PPV by selecting peaks and troughs of the arterial curve.

Official Title
-----------------
Ability of a New PPV Smartphone Application to Predict Fluid Responsiveness in Cardiac Surgical Patients in the ICU

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Other: PPV from the capstesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults patients ( >18 years) Patients scheduled for cardiac surgery equipped with a femoral arterial catheter and the PICCO device Exclusion Criteria: Atrial fibrillation severe cardiac dysfunction

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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Agreement and precision between two methods to measure pulse pressure variation (PPV)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: group/cohort<br>operated patients from cardiac surgery. Once they arrived in the ICU, we will measure PPV with the capstesia and the PICCO device at baseline, and after a volume expansion of 500 ml of crystalloid. | Other: PPV from the capstesia<br>* we will challenge the application by doing 2 maneuvers: the first one is to increase the PEEP level from 5 to 15 cmH2O and the second one is the infusion of a mini-fluid challenge (100 ml) followed by the other 400 ml.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPV measure | PPV before with after 2 maneuvers which modify PPV (increase PEEP level and mini-fluid challenge) | baseline | 
| PPV measure | PPV before with after 2 maneuvers which modify PPV (increase PEEP level and mini-fluid challenge) | 1 minute after the end of volume expansion |
Schizophrenia and Genetic Counseling

Study Overview
=================
Brief Summary
-----------------
This research is designed to investigate the perceptions and opinions of individuals who either have schizophrenia or who have a family member with schizophrenia, in relation to genetic counseling. Data will be collected via a 15 minute online questionnaire. There is also an option for respondents to participate in a 45 minute interview if they wish. It is expected that the study will show that adequate information about genetic counseling is not provided to these individuals. It is also hoped that this research will help to make genetic counseling sessions more specific to people with schizophrenia in their family.

Detailed Description
-----------------
For more information please go to the following website: http://schizophreniageneticcounseling.blogspot.com

Official Title
-----------------
Schizophrenia and Genetic Counseling: A Survey of People With Schizophrenia and Their Relatives

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anyone diagnosed with schizophrenia OR who has family member diagnosed with schizophrenia Over 18 years old

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?
-----------------
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
-----------------
Genetic counseling, Genetic counselling, Genetics, Schizophrenia
Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping

Study Overview
=================
Brief Summary
-----------------
A randomized trial aimed at determining whether or not hemoclips are effective in preventing post-polypectomy bleeds on polyps that are 10mm in size or greater.

Official Title
-----------------
Risk of Post-Polypectomy Bleeding With Prophylactic Hemoclipping

Conditions
-----------------
Polypectomy, Post-polypectomy Bleeding, Elective Colonoscopy

Intervention / Treatment
-----------------
* Device: Hemoclip Placement
* Device: NO hemoclip placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting for elective colonoscopy Exclusion Criteria: Patients in which polypectomy can not be performed safely

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clip<br>A clip is been placed at the polypectomy site. | Device: Hemoclip Placement<br>* Placement of hemoclip at polypectomy site for polyps at least 1cm in size<br>* Other names: Clip;|
| Placebo Comparator: No Clip<br>A hemoclip is not placed at the site of the polypectomy. | Device: NO hemoclip placement<br>* No hemoclip placement (placebo / sham)<br>* Other names: No Clip;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Delayed Post Polypectomy Bleeding | rectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemoclip, colonoscopy, post-polypectomy bleed
ARIXTRA® Adherence in SVT Patients.

Study Overview
=================
Brief Summary
-----------------
Fondaparinux is an anticoagulant used in the prevention and treatment of thromboembolic disease. It has recently been approved in the European Union (EU) for the treatment of patients with isolated superficial vein thrombosis (SVT), i.e. without concomitant deep vein thrombosis (DVT), of the lower limbs. As part of EU approval, GlaxoSmithKline (GSK) committed to evaluate physicians' adherence to fondaparinux prescribing information regarding proper diagnosis and dosing for the treatment of SVT. The primary objective is to evaluate physicians' adherence to fondaparinux prescribing information for the treatment of patients with SVT without concomitant DVT. The study is designed as a non-interventional, retrospective chart review of patients prescribed fondaparinux to treat their SVT. The study will be conducted in several EU countries. ARIXTRA® is a registered trademark of the GlaxoSmithKline group of companies.

Official Title
-----------------
ARIXTRA® Physician Adherence to the Prescribing Information in Isolated Superficial Vein Thrombosis (SVT) Patients.

Conditions
-----------------
Thrombosis, Venous

Intervention / Treatment
-----------------
* Drug: Fondaparinux


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of SVT Prescribed fondaparinux for the treatment of SVT Age 18 years or older Exclusion Criteria: Patients should not have been involved in any clinical trial that could influence SVT treatment during the observational period.

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 |
| --- | --- |
| Superficial Vein Thrombosis (SVT)<br>A representative of geographical regions of patients with Superficial Vein Thrombosis (SVT) who live in several EU countries. | Drug: Fondaparinux<br>* Physician adherence study to Fondaparinux prescribing information for patients with Superficial Vein Thrombosis (SVT) of the lower limbs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be a measure of physician adherence. | adherence described as the percentage of patients for whom both an ultrasound (or other objective measure) was performed in order to rule out concomitant DVT prior to patients commencing fondaparinux | 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physician Adherence, superficial vein thrombosis, Fondaparinux
Buprenorphine Maintenance Dose Schedule and Treatment Setting - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess optimal dosage of buprenorphine on a thrice weekly schedule in a pilot clinical trial.

Official Title
-----------------
Buprenorphine Maintenance Dose Schedule and Treatment Setting: Pilot

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Maintenance treatment with daily medication | Drug: Buprenorphine<br>* Experimental Maintenance treatment with daily medication Experimental Maintenance treatment with thrice-weekly medication<br>|
| Experimental: 2<br>Maintenance treatment with thrice-weekly medication | Drug: Buprenorphine<br>* Experimental Maintenance treatment with daily medication Experimental Maintenance treatment with thrice-weekly medication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid and cocaine use |  | 26 weeks | 
| Social and psychological functioning |  | 26 weeks | 
| AIDS risk behavior |  | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opioid dependence