linjc16/ctgov huggingface dataset:
Natural History of Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
To examine the natural history of mortality due to coronary heart disease in post-myocardial infarction patients from the Beta-Blocker Heart Attack Trial (BHAT) and the Aspirin Myocardial Infarction Study (AMIS).

Detailed Description
-----------------
BACKGROUND: In January 1990, the National Heart, Lung, and Blood Institute issued a Program Announcement establishing a Small Grants Program to provide limited support to extend analyses of research data generated by clinical trials, population research, and demonstration and education studies. This study used data collected in two completed clinical trials, the BHAT and AMIS. DESIGN NARRATIVE: Study endpoints included all-cause mortality, cause-specific mortality such as sudden death, recurrent and non-fatal myocardial infarction, and incident congestive heart failure. Univariate and multivariate analyses of baseline data variables from BHAT were conducted to determine which were predictive of study endpoints. Baseline variables included sociodemograhic characteristics, medical history, medication use, physical examination finds, and electrocardiographic characteristics. Baseline characteristics found to be predictive of study endpoints in the BHAT placebo group were examined in the AMIS placebo group. Long- and short-term prognoses for patients suffering a transmural myocardial infarction were compared for those suffering a subendocardial infarction. 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, Coronary Disease, Myocardial Infarction, Heart Diseases, Death, Sudden, Cardiac, Heart Failure, Congestive, Heart Failure

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

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons

Study Overview
=================
Brief Summary
-----------------
To examine the continued safety and tolerability of four doses of vesnarinone in HIV-infected patients who have completed a short-term study (less than 12 months on continuous treatment) of the drug.

Detailed Description
-----------------
Patients who have completed a limited duration study (less than 12 months of continuous treatment) of vesnarinone on protocols FDA 234A or FDA 234B and who have no current signs or symptoms of AIDS-defining illnesses may roll over to this study and continue receiving their regimen of vesnarinone for 12 months beyond their original participation.

Official Title
-----------------
A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Vesnarinone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria. Acyclovir for acute treatment of herpes. Exclusion Criteria Concurrent Medication: Excluded: Antiretroviral agents, including ddI, ddC, AZT, and d4T. Immunosuppressive agents. Investigational HIV drugs/therapies including vaccines. Interferon or other immunomodulating agents. Corticosteroids (other than topical). Megestrol acetate. Agents known to cause neutropenia. Ganciclovir. Cytotoxic chemotherapy. Concurrent Treatment: Excluded: Radiation therapy. Patients with the following prior conditions are excluded: Poor compliance (less than 80 percent of drug taken) on the Phase I protocol (FDA 234A or FDA 234B). Missed more than one clinic visit on the Phase I protocol. Prior Medication: Excluded: Acyclovir as prophylaxis for herpes within 48 hours prior to study entry. Patients meet the following criteria: Successful completion of short-term therapy with vesnarinone on FDA 234A or FDA 234B. Active illicit drug abuse.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vesnarinone|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
-----------------
vesnarinone, Acquired Immunodeficiency Syndrome, Antiviral Agents
Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy and toxicity of the combination of mitoxantrone hydrochloride ( Novantrone ) and etoposide in the treatment of patients with HIV associated lymphomas.

Official Title
-----------------
Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas

Conditions
-----------------
Lymphoma, Non-Hodgkin, HIV Infections

Intervention / Treatment
-----------------
* Drug: Mitoxantrone hydrochloride
* Drug: Etoposide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have the following: Positive HIV antibody, positive HIV culture or antigen capture, or prior diagnosis of AIDS by the CDC criteria. Diagnosis by pathological examination of large cell or immunoblastic lymphoma within measurable or evaluable disease. Pneumocystis carinii pneumonia (PCP) prophylaxis during the course of the study. Signed written informed consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks. Stage IE Central Nervous System lymphomas. Patients with the following are excluded: More than one previous treatment for lymphoma. Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks. Conditions that preclude obtaining an informed consent. Not accessible for scheduled treatment visits or follow-up. Stage IE Central Nervous System (CNS) lymphomas. Prior Medication: Excluded within 2 weeks of study entry: Zidovudine. Excluded: Doxorubicin dosing = or > 300 mg/m2. Prior Treatment: Excluded: Received more than one previous treatment regimen for lymphoma. Required: Prophylactic treatment for Pneumocystis carinii pneumonia (PCP) prophylaxis.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mitoxantrone hydrochloride|nan|
|Drug: Etoposide|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
-----------------
Mitoxantrone, Lymphoma, Large-Cell, Etoposide, Acquired Immunodeficiency Syndrome
In-hospital Initiation of PCSK9 Inhibitor in Patients With Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been shown to improve cardiovascular outcomes when added to conventional statin therapy. This study aims to investigate the efficacy and safety of in-hospital initiation of PCSK9 inhibitor among patients with acute myocardial infarction(AMI) based on real-world experience. A total of 7556 AMI patients from the biobank database between January 2016 and December 2020 were screened for eligibility. After excluding those without revascularization or Statin based therapy, the remaining 5802 Statin users, 801 Statin plus Ezetimibe users and 170 Statin plus Evolocumab users (including 95 users without and 75 users with Ezetimibe), were selected for this study. Then, 1st and 3rd-month follow-up data were collected and analysed, including in-hospital mortality, readmission rate and lipid profiles

Official Title
-----------------
In-hospital Initiation of PCSK9 Inhibitor and Short-term Lipid Profile Alteration, as Well as In-hospital Mortality and Readmission Rate in Patients With Acute Myocardial Infarction

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Drug: Evolocumab 140 MG/ML


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed admission diagnosis of AMI and were defined based on the universal definition criteria by the American Cardiology College Exclusion Criteria: (1) severe noncardiac disease with an expected survival of less than 1 year and unwillingness to participate; (2) patients over the age of 80 years or living far away from the hospital's catchment area.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Statin Group<br>AMI patients with Statin therapy. | |
| Ezetimibe Group<br>AMI patients with Statin plus Ezetimibe therapy. | |
| PCSK9i Group<br>AMI patients with Statin plus PCSK9i therapy. | Drug: Evolocumab 140 MG/ML<br>* 140 mg per two weeks, subcutaneous injection<br>|
| Triple Group<br>AMI patients with Statin plus Ezetimibe plus PCSK9i therapy | Drug: Evolocumab 140 MG/ML<br>* 140 mg per two weeks, subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission rate |  | 1 YEAR |
Pleth Variability Index and Hypotension

Study Overview
=================
Brief Summary
-----------------
Correct assessment of a patient's volume status is the most important goal for an anesthetist. However, most of the variables used for fluid response evaluation are invasive and technically challenging.Pulse oximeter is a non-invasive, standardized and widely used monitoring method in many countries. Our aim in this study is to investigate the usefulness of the noninvasive pleth variability index to predict hypotension in orthopedic hip fracture patients who underwent spinal anesthesia.

Official Title
-----------------
Hypotension Relationship With Pleth Variability Index In Hip Fracture Patients Who Underwent Spinal Anesthesia

Conditions
-----------------
Hypotension, Pleth Variability Index

Intervention / Treatment
-----------------
* Device: pleth variability index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 65 years old Patients to undergo spinal anesthesia Exclusion Criteria: Patients under 65 years old Patients to undergo general anesthesia or only sedation Patients with cardiac arrhythmia Patients with low ventricular ejection fraction Heart valve disease patients

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: pleth variability index|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detecting pleth variability index-hypotension relationship |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pleth variability index response to fluid management |  | one year | 
| Make a differential diagnosis of hypotension with pleth variability index |  | one year | 
| Correlation between arterial hemoglobin and pleth variability index hemoglobin |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypotension, Pleth variability index, Hip Fracture, Spinal anesthesia
To Assess the Efficacy and Safety of Vildagliptin as Add-on Therapy to Sulfonylurea in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy

Study Overview
=================
Brief Summary
-----------------
This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is designed as a multicenter, randomized, double-blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of vildagliptin as add-on therapy to a sulfonylurea in patients with type 2 diabetes inadequately controlled with sulfonylurea monotherapy.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With Vildagliptin to Placebo as Add-on Therapy to Sulfonylurea in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of type 2 diabetes and treated with a stable dose of sulfonylurea Patients on diet and exercise who have not reached target blood glucose levels Outpatients Exclusion Criteria: Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes Significant cardiovascular complications as defined by the protocol Significant diabetic complications as defined by the protocol Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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: Vildagliptin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to endpoint on HbA1c at 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to endpoint on fasting plasma glucose at 12 weeks |  |  | 
| Change from baseline to endpoint in HOMA B at 12 weeks |  |  | 
| Change from baseline to endpoint in HOMA IR at 12 weeks |  |  | 
| Change from baseline to endpoint on fasting lipids at 12 weeks |  |  | 
| Adverse events profile after 12 weeks of treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, Vildagliptin, HbA1c
Survey on the Effect of Health Related Quality of Life (QOL) Associated With Compliance of Carbocisteine in Asthma Patients

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to investigate the influence on HR-QOL (SF-36 v2) resulting from the compliance of MUCODYNE Tablets or MUCODYNE DS (Dry Syrup) 50% in asthma patients whose control levels are partly controlled or uncontrolled.

Detailed Description
-----------------
Period: 2012-2013 Observation Time: 0 week, 4 week Matters investigated: QOL determination using SF-36 v2 Medication compliance (VAS scale) Gender, age, diagnosis, asthma subtype, severity, duration of disease, level of asthma control, concomitant drugs, comorbidities, smoking, alcohol, work

Official Title
-----------------
Survey on the Effect of Health Related QOL Associated With Compliance of Carbocisteine in Asthma Patients Study (SEARCH Study)

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients ≥ 20 years of age Outpatients Patients with mild or moderate persistent asthma Patients with phlegm Patients whose levels of asthma control are partly controlled or uncontrolled Patients who are planned to treat MUCODYNE Patients who voluntarily submitted written consent forms upon participation in this study Exclusion Criteria: Patients with a history of adverse reactions to carbocisteine Patients with serious cardiac, hepatic, renal, pulmonary, or hematological disease Patients with the possibility of pregnancy or suspected pregnancy Patients with complication of malignancy Current smoker Patients with definitive diagnosis for COPD Other patients whom investigators or subinvestigators considered inappropriate to participate in this study

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| SEARCH Study Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of SF-36 |  | 4 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HR-QOL condition of asthma patients with phlegm |  | 0 week | 
| Medication compliance: measured by patient response to visual analog scale |  | 4 week | 
| Relation between a medication compliance measured by patient response to visual analog scale and change of HR-QOL from baseline at 4 weeks |  | 0 week, 4 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, SF-36, HRQOL
Platelet Rich Plasma Following Hysteroscopic Adhesolysis

Study Overview
=================
Brief Summary
-----------------
Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial

Official Title
-----------------
Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial

Conditions
-----------------
Intra-uterine Adhesions

Intervention / Treatment
-----------------
* Procedure: Platelet Rich Plasma
* Procedure: intra-uterine balloon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18-40 years Grade III intra-uterine adhesions Exclusion Criteria: Age < 18 or > 40 years. Hb < 11 g/dL, platelets < 150.000/mm3. Patient taking anticoagulant. Patient taking NSAID in the 10 days before procedure. Any significant comorbidity or psychiatric disorder that would compromise patient's consent. Active cervical or uterine infection. Undiagnosed genital bleeding. pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet Rich Plasma<br>PRP | Procedure: Platelet Rich Plasma<br>* Platelet Rich Plasma<br>Procedure: intra-uterine balloon<br>* intra-uterine balloon<br>|
| Active Comparator: intra-uterine balloon<br> | Procedure: intra-uterine balloon<br>* intra-uterine balloon<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adhesion recurrence | recurrence of severe intra-uterine adhesions | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of menses | Number of days of menstrual cycle following operation | 3 months | 
| Amount of menses | Number of sanitary pads changed during each menstrual cycle | 3 months |
Evaluation of Sloan-Charts for Assessment of Disease Progress in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Impairment of visual deficits, in particular contrast acuity and contrast impairment are frequent symptoms in MS. However, visual function is not appropriately covered by the standard tools for clinical assessment, namely, the EDSS and the MSFC. The primary aim of this study is to investigate, whether in MS patients contrast acuity and sensitivity change over a period of two years. Secondary aims are the correlation of visual contrast parameters with structural retinal changes and quality of life.

Official Title
-----------------
Evaluation of Low Contrast Sloan Visual Charts as Method for the Assessment of Disease Progression in Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically Isolated Syndrome or definite MS (relapsing-remitting or secondary progressive course) Written Informed Consent Exclusion Criteria: Relapse within the last 30 Days Significant Cognitive Impairment Severely Decreased Visual Acuity Preexisting Severe Retinal Pathology

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Multiple Sclerosis Patients<br>Patients with Clinically Isolated Syndrome or definite Multiple Sclerosis (either relapsing-remitting or secondary progressive) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Contrast Acuity |  | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structural and Functional Changes of Optic Pathway |  | 24 Months | 
| Clinical Neurological Assessment |  | 24 Months | 
| Quality of Life |  | 24 Months | 
| Contrast Sensitivity |  | 24 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Visual Contrast Acuity, Visual Contrast Sensitivity, Sloan Charts