linjc16/ctgov huggingface dataset:
Vaginal Flora for Treatment of Bacterial Vaginosis

Study Overview
=================
Brief Summary
-----------------
Bacterial vaginosis (BV) is the most common vaginal infection in women. It is caused by a vaginal bacterial imbalance. Treatment with antibiotics is the standard of care but there is a high rate of recurrence. Almost half of women successfully treated suffer a recurrence within three months. Complications include risk factors for premature birth, increased transmission of sexually transmitted diseases and higher risk for carcinoma of cervix. The investigators proposed study is a cost effective treatment based on returning the normal microbial balance to the vagina. The investigators propose to transfer normal vaginal flora from healthy individuals to women with BV and thus restore normal vaginal flora and cure this disorder.

Official Title
-----------------
Vaginal Flora Transplantation for Recurrent Bacterial Vaginosis

Conditions
-----------------
Recurrent Bacterial Vaginitis

Intervention / Treatment
-----------------
* Biological: vaginal flora transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recurrent BV (4 or more incidences in the past year) recurrence of BV in less than 2 months of antibiotic treatment or need for prophylactic antibiotic 3/4 Amsel criteria and Nugent criteria greater or equal to 7 Exclusion Criteria: pregnancy or planned pregnancy during the study period other known diseases carriers of Hep B and C HIV or syphilis positive

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: recurrent bacterial vaginitis<br> | Biological: vaginal flora transplant<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relief of bacterial vaginosis | Clinical cure, i.e., absence of vaginal discharge and malodor | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory parameters | absence of all Amsel criteria and Nugent score<3. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bacterial vaginitis, vaginal flora, microbiome
MRI Findings of Encephalopathy Associated With Carbon Dioxide (CO2) Intoxication

Study Overview
=================
Brief Summary
-----------------
Carbon dioxide intoxication is a rare condition and only few case reports are found in the literature. There were six patients who suffered from carbon dioxide intoxication in our hospital about two years ago. Two of them are more severe with conscious change and brain MRI studies of the two patients were performed. Reviewing the literature, no any report has mentioned about the encephalopathy associated with carbon dioxide intoxication. We want to review the brain lesions on the diffusion weighted images and the laboratory data of the patients for further diagnostic help.

Conditions
-----------------
CO2 Intoxication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CO2 intoxication Exclusion Criteria: None CO2 intoxication
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carbon dioxide intoxication, Diffusion weighted images(DWI)
How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose

Study Overview
=================
Brief Summary
-----------------
This study is to find out if starting at low dose Avonex and slowly increasing to full dose will improve flu like symptoms as a side effect of Avonex treatment.

Official Title
-----------------
An Open-Label Study to Examine the Difference in Tolerability Associated With Titration Of Dose on Initiation of Avonex therapY (TODAY)

Conditions
-----------------
Relapsing Remitting Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Interferon beta-1a


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of clinically-definite relapsing-remitting multiple sclerosis Exclusion Criteria: Any Product Information-specified contraindications to interferon-beta therapy, or other medical factors which, in the opinion of the investigator, make the subject unsuitable for interferon-beta therapy Use of AVONEX, but not other interferon therapies, in the 3 months prior to randomisation into the study A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to randomisation. History of seizure in the 3 months prior to randomisation History of suicidal ideation or severe depression within the 3 months prior to randomisation. Other inclusion and exclusion criteria may apply per study protocol

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>titrated dose of Avonex | Drug: Interferon beta-1a<br>* injected, once a week<br>* Other names: Avonex;|
| Active Comparator: 2<br>full dose Avonex | Drug: Interferon beta-1a<br>* injected, once a week<br>* Other names: Avonex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the mean severity of episodes of FLS during the 4 week titration phase |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the mean severity and duration of FLS episodes in post-titration phase |  | throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Avonex, side effects, flu like symptoms
The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to determine whether the dual antiplatelet therapy (aspirin and clopidogrel) for 3 months after coronary implantation of zotarolimus-eluting stent is safe in terms of death, myocardial infarction, or stent thrombosis.

Official Title
-----------------
The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent in the Patients With Coronary Artery Disease (DATE Registry)

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

Intervention / Treatment
-----------------
* Drug: Aspirin, Clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinically significant de novo coronary artery disease Stenting only with Endeavor® stents The sum of stent length is less than 60 mm for one lesion. The sum of stent length in multiple lesions does not matter. Exclusion Criteria: Cardiogenic shock ST-elevation myocardial infarction within 48 hours of symptom onset Prior implantation of drug-eluting stents Left ventricular dysfunction (echocardiographic left ventricular ejection fraction < 25%) Stenting both branch of bifurcation lesion Left main trunk lesion Graft vessels Patients who have to receive clopidogrel due to other conditions Patients who have to receive warfarin, cilostazol or other antiplatelet therapy Patient with chronic renal failure (S-Cr > 2.0 mg/dl) Hypersensitivity to clopidogrel or aspirin Expectant survival less than 1 year Women who plan to become pregnant Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months) Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Aspirin, Clopidogrel<br>* Aspirin 100mg qd plus clopidogrel 75mg qd for 3 month after index procedure<br>* Other names: plavix;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angioplasty, Transluminal, Percutaneous Coronary, Stent thrombosis, Zotarolimus-eluting stent
Qualitative Analysis of Hospital Executives, Physician Administrators, and Hospital Legal Counsels' Perceptions of End-of-Life Care

Study Overview
=================
Brief Summary
-----------------
Interviewing hospital executives, physician administrators and hospital legal counsel who work in a hospital setting (academic, governmental, private or community hospital) about their perceptions concerning current and future end-of-life care provided in their facilities

Official Title
-----------------
Analysis of Hospital Executives, Physician Administrators, and Hospital Legal Counsels� Perceptions of End-of-Life Care

Conditions
-----------------
End of Life Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informant is a hospital executive, physician administrator or hospital legal counsel in a hospital setting (academic, governmental, private or community hospital) and is able to communicate perceptions verbally through use of English language. All participants will likely be nonveterans Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Hospital executives, physician administrators and hospital legal counsel | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceptions of hospital executive, physician administrator or hospital legal counsel in a hospital setting (academic, governmental, private or community hospital) |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
executive, administrator, perceptions, legal counsel, end of life
To Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutaneous Insulin.

Study Overview
=================
Brief Summary
-----------------
To examine the lung when people with diabetes take an inhaled form of insulin, compared to subcutaneous insulin.

Official Title
-----------------
A Phase 2, Exploratory Study to Examine the Effects of Inhaled Insulin, Compared With Subcutaneously Administered Insulin, on Airway Lining Fluid Composition in Subjects With Type 1 Diabetes Mellitus.

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: Inhaled insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 Diabetes Mellitus Normal lung function Exclusion Criteria: Smokers

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Inhaled insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess in patients with type 1 diabetes mellitus the effects, if any, on lung lining, fluid cell count and differential within subjects after 12 weeks of inhaled insulin therapy compared to 12 weeks of subcutaneous short-acting therapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (1) Albumin and fibrinogen concentrations, and airway appearance in the above subjects. (2) routine safety, tolerance, and efficacy in the above subjects. |  |  |
Heterosexual HIV Transmission Study (HATS). Prospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
PRIMARY: To identify factors associated with risk of HIV infection through heterosexual activity among urban, inner-city women. SECONDARY: To identify correlates of high-risk behaviors in order to provide a basis for future intervention studies.

Detailed Description
-----------------
At baseline and at 6-month intervals, participants are interviewed about their sexual behavior, drug and alcohol-related behaviors, and recent medical history, and are given a psychosocial assessment. They also undergo a physical exam, including pelvic exam and colposcopy, and have blood and urine specimens collected for HIV testing, drug screening, and STD evaluation. Additionally, participants are given pre- and post-test counseling and education, including information about social services. They are provided with basic gynecological care and either treatment or referral for medical problems.

Official Title
-----------------
Heterosexual HIV Transmission Study (HATS). Prospective Cohort Study

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

Intervention / Treatment
-----------------
* Behavioral: Pre- and post-test counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Participants must meet the following criteria: HIV-negative, sexually active women living in social and sexual proximity to men at high risk for acquiring HIV infection. Able to speak English, Spanish, or Creole. Living in the geographic area surrounding Kings County Hospital in Brooklyn, New York. (Hospital-based and community-based recruitment sites will be utilized.) Personal history of parenteral drug use by self-report or urine test. Heterosexual contact with men at high risk for HIV infection.

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?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Pre- and post-test counseling|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
-----------------
Sex Behavior
Management of Covid-19 Patients During Home Isolation

Study Overview
=================
Brief Summary
-----------------
This study will be concerned with managing patients of Covid-19 while being home isolated.

Official Title
-----------------
Management of Covid-19 Patients During Home Isolation

Conditions
-----------------
Covid 19

Intervention / Treatment
-----------------
* Device: Oxygen Therapy
* Procedure: Physical Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Covid-19 American Society of Anesthesiologists (ASA) class I >= 21 years old <= 40 years old Exclusion Criteria: ASA class II, class III or class IV

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 40 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxygen Therapy Group<br> | Device: Oxygen Therapy<br>* Patients receive oxygen therapy<br>|
| Experimental: Physical Therapy Group<br> | Procedure: Physical Therapy<br>* Patients receive physical therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Blood Gases (ABG): Partial Pressure of Oxygen and Carbon Dioxide |  | 48 hours | 
| Arterial Blood Gases (ABG): Acidity Potential Hydrogen (pH) |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital Signs (Temprature) |  | 24 hours | 
| Vital Signs (Respiratory Rate) |  | 24 hours | 
| Vital Signs (Oxygen Saturation) |  | 24 hours | 
| Vital Signs (Heart Rate) |  | 24 hours | 
| Vital Signs (Blood Pressure) |  | 24 hours |
Peroral Levosimendan in Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
The study will investigate the efficacy of oral levosimendan in patients with chronic New York Heart Association (NYHA) IIIb-IV heart failure (HF) using a composite end-point evaluating patient symptoms, morbidity and mortality. The patients are on treatment for at least 6 months.

Detailed Description
-----------------
The patients are randomised to 3 groups; higher or lower levosimendan dose group or placebo.

Official Title
-----------------
Effects of Peroral Levosimendan in the Prevention of Further Hospitalisations in Patients With Chronic Heart Failure. A Randomised, Phase II, Double-Blind, Placebo-Controlled, Multi-Centre, Parallel-Group Study

Conditions
-----------------
Chronic Heart Failure, Heart Diseases

Intervention / Treatment
-----------------
* Drug: levosimendan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed chronic heart failure Severe symptoms (NYHA IIIb-IV) Optimal on-going oral treatment for HF Left ventricular ejection fraction less than or equal to 30% Exclusion Criteria: Severe obstruction of ventricular outflow tracts Acute myocardial infarction within 30 days before screening Cardiac surgery or coronary angioplasty within 30 days before screening

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint measuring symptoms, morbidity, mortality |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
levosimendan, chronic heart failure, oral administration
Inert Gas Rebreathing in Ventilated Patients

Study Overview
=================
Brief Summary
-----------------
Measuring hemodynamic parameters in ventilated patients is important yet still complicated to perform. Inert gas rebreathing (IGR) showed promising results when being compared to other invasive as well as non-invasive techniques for the measurement of cardiac output. The aim of our study is to evaluate the feasibility of IGR in ventilated patients.

Official Title
-----------------
Feasibility of the Non-invasive Determination of Cardiac Output Using Inert Gas Rebreathing in Ventilated Patients

Conditions
-----------------
Sepsis, Respiratory Failure, Heart Failure, Renal Failure

Intervention / Treatment
-----------------
* Device: non-invasive determination of cardiac output


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 - 80 years mechanically ventilated patient existing PiCCO arterial line Exclusion Criteria: FiO2 > 60% (fraction of inspired oxygen) PEEP > 10 mmHg (positive end-expiratory pressure) SO2 < 90% (oxygen saturation ) Systolic blood pressure < 90 mmHg Heart rate > 150 bpm APRV (airway pressure release ventilation) ICD (implantable cardioverter defibrillator) / pace maker [ Anaesthetic Conserving Device (Anaconda) ]

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 |
| --- | --- |
| ventilated patients<br>ventilated patients in an internal medicine ICU with existing PiCCO invasive hemodynamic monitoring | Device: non-invasive determination of cardiac output<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac output | Determination of cardiac output using invasive pulse contour analysis (PiCCO) and non-invasive inert gas rebreathing (Innocor) | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac output, mechanical ventilation, inert gas rebreathing, pulse contour analysis