linjc16/ctgov huggingface dataset:
An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots

Study Overview
=================
Brief Summary
-----------------
This study will assess the distribution of a microbicidal gel in the vagina and confirm the presence of bare spots. MRIs will be done with and without the addition of the MRI contrast Gadolinium to the microbicide in order to determine whether the bare spots are an artifact of the MRI technique.

Official Title
-----------------
An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots

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

Intervention / Treatment
-----------------
* Drug: HEC placebo gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 -45 year old women normal Pap smear not pregnant Exclusion Criteria: abnormal pelvic exam history of claustrophobia allergy to product formulation pregnant or breastfeeding

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

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

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HEC placebo gel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of bare spots with and without Gd. |  |  | 
| Quantification and location of bare spots. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Seronegativity, HIV
Investigation of Heart Failure Status Over Time Using Respiratory Parameters

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate respiratory indicators for clinically important changes in Heart Failure status over time.

Official Title
-----------------
Investigation of Heart Failure Status Over Time Using Respiratory Parameters

Conditions
-----------------
Heart Failure, Congestive, Sleep Apnea Syndromes

Intervention / Treatment
-----------------
* Device: ApneaLink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe Heart Failure (as determined by Echocardiogram or by treating physician) Exclusion Criteria: Malignant disease affecting gas exchange or respiratory parameters Medications compromising breathing with no adverse affects on heart failure Clinically significant (moderate to severe) asthma requiring therapy Chronic parenchymal lung disease (FEV1/FVC ratio = 65% or as determined by the treating physician) Severe pulmonary hypertension Heart failure due to alcohol abuse or chemotherapy Narcotic abuse/intravenous drug use (including HIV+ and hepatitis C) Alcohol consumption > 80g/day Patients receiving home Oxygen Methicillin- resistant Staphylococcus aureus infection Narcolepsy Cataplexy Enrolled in any concurrent study, that may confound the results of this study. Inability or refusal to sign the Patient Consent Form Inability or refusal to adhere to protocol requirements

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 |
| --- |
|Device: ApneaLink|A two channel sleep screening device for the assessment of Sleep Disordered Breathing.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Telecoaching of People With Type 2 Diabetes in Primary Care

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to analyze the effectiveness and the cost-effectiveness of telecoching in improving glyceamic control and other modifiable risk factors in patients with type 2 diabetes compared to usual care only.

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

Intervention / Treatment
-----------------
* Behavioral: telecoaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with type 2 diabetes between 18 and 75 years old on the day of the selection Exclusion Criteria: Debilitating coexisting medical condition (e.g. dialysis, mental illness, cancer) Residents of long term care facilities Pregnancy Incapable of telephone communication in Dutch

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: telecoaching<br> | Behavioral: telecoaching<br>* The COACH program trains patients to 'drive' the process of achieving and maintaining the target levels for their risk factors while working in association with their GP. The telephone coaching is aimed at improving self-efficacy by adhering to the prescribed therapy and making relevant behavior changes. The coaching model is a continuous five-stage coaching cycle: Stage 1. Finding out what the patient knows; Stage 2. Telling the patient what they should know; Stage 3. Assertiveness training; Stage 4. Setting an action plan; Stage 5. Reassessment at the next coaching session (monitoring). The coach monitors and registers: the biomedical risk factors, the lifestyle/behavioral risk factors and use of the recommended medications. Coaching is focused on eliminating the knowledge gap and motivating the patient to apply the appropriate lifestyle and medical therapy.<br>|
| No Intervention: control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the absolute change in HbA1c |  | baseline; 6 months and 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 Diabetes Mellitus, telenursing, RCT, economic analysis
BIO-PREDISC-TIA SWISS Cohort Study

Study Overview
=================
Brief Summary
-----------------
This research project aims at contributing to improve TIA diagnosis and management by using PREDISC scores and specific biomarkers thought to have elevated levels in TIA patients. A swift and accurate TIA diagnosis allows starting treatment of the patient adequately and shortly after the event. The shorter the time between the event and treatment onset, the better the outcome. This approach will be an important step forward in TIA diagnosis and management, similarly to acute coronary syndrome as discussed above.

Official Title
-----------------
BIOmarkers and PREDISC Diagnostic Evaluation for Patients With Suspected Transient Ischemic Attacks: the BIOPREDISC- TIA SWISS Cohort Study

Conditions
-----------------
Cerebrovascular Disease, Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected TIA (defined as the acute onset of focal neurological symptoms lasting <24 h and presumed to be caused by brain ischemia at the time of referral) within 48 h of symptoms onset. At least 18 years old. Having given their Informed Consent. Exclusion Criteria: · Patients with ocular TIA (Amaurosis fugax). Patients that still have neurological deficits at the moment of inclusion. Contraindication to perform MRI. For women: pregnancy.

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 |
| --- | --- | --- |
| Levels of specific biomarkers (Platelet Basic Protein (PBP), ceruloplasmin, microRNAs, exosomal particles) in patients with suspected TIA. | Diagnostic performance according to PREDISC scale | 1 year |
Evaluating Ureteral Length Using Computed Tomography (CT)

Study Overview
=================
Brief Summary
-----------------
Proper selection of ureteral stent length might help in reducing comorbidities associated with ureteral stenting, currently there is no standardized way of measuring ureteral length. Measurement of ureteral length according to Computed Tomography (CT) scan might provide useful information when selecting the length of a ureteral stent. Our aim in this study is to compare ureteral measurements using CT scan and measurement of actual ureteral length measured during ureteral stenting.

Official Title
-----------------
Evaluation of Ureteral Length Measurement by Computed Tomography (CT) to Actual Ureteral Length Measured by Ureteral Catheterization

Conditions
-----------------
Ureteral Calculi, Hydronephrosis, Ureteral Obstruction

Intervention / Treatment
-----------------
* Device: Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing planned procedure involving ureteroscopy or ureteral stenting Abdominal CT scan performed within 6 months prior to intervention Exclusion Criteria: Known iodine sensitivity Patients with fever or hemodynamic instability planned for urgent operation Severe immune compromized patients Severe thrombocytopenia < 50,000

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ureteral catheterization<br>During a planned procedure involving ureteroscopy or ureteral stenting, ureteral catheterization will be performed for the purpose of measuring exact ureteral length. Measurement results will be compared to measurements performed on CT scan (obtained before surgery). | Device: Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR<br>* During a planned procedure involving ureteroscopy or ureteral stenting, after retrograde pyelography and insertion of a safety wire, ureteral catheterization will be performed using Cook Urological Inc. open end ureteral catheter 5FR for the purpose of measuring exact ureteral length. Measurement results will be compared to measurements performed on CT scan (obtained before surgery).<br>* Other names: Karl Storz cystoscope 19-22F;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement between measurement of ureteral length (Centimeters) measured by CT and by ureteral catheterization |  | 1 year |
Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are: To evaluate the ability of the Methacetin Breath Test (MBT) to detect hepatic decompensation events To evaluate the relationship between liver Biopsy and clinical outcome and show that the MBT has a better predictive ability of clinical outcome than liver biopsy. To evaluate the ability of the MBT to predict each of the individual liver related complications.

Detailed Description
-----------------
Exalenz has previously gathered information in a previous study on patients with chronic liver disease including the methacetin breath test. Several years later, the company wishes to investigate this group of subjects and see retrospectively if the breath test was a predictor of complications related to their liver disease.

Official Title
-----------------
The Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation; a Retrospective Analysis

Conditions
-----------------
Chronic Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects that aere enrolled in the previous Exalenz trial HIS-EX-408 or PLT-BID-1108 Exclusion Criteria: None

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 |
| --- | --- |
| CLD from HIS-EX-408/PLT-BID-1108<br>Chronic liver disease subjects from previous Exalenz trial HIS-EX-408 and PLT-BID1108 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic Decompensation Event | Hepatic decompensation is defined as the occurrence of at least one of the following events in the time frame between the last 13C Methacetin Breath Test (MBT) to the time of data collection: Death (liver related) Transplantation (cadaveric and living donors) Ascites HE (Hepatic Encephalopathy) Newly diagnosed varices or variceal bleeding SBP (spontaneous bacterial peritonitis) HRS (Hepatorenal syndrome) HCC (hepatocellular carcinoma) Increase in CTP (Child Turcotte Pugh) Score by 3 points Increase in MELD score by 5 points | 5 years |
Predictors of Postoperative Left Ventricular Function in Patients Undergoing Mitral Valve Repair for Severe Degenerative Mitral Regurgitation

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate whether a predictive score (combination of several validated predictors) better predicts postoperative left ventricular function than any single predictor in patients undergoing mitral valve repair for degenerative mitral regurgitation. A single center, prospective cohort study

Conditions
-----------------
Severe Degenerative Mitral Regurgitation

Intervention / Treatment
-----------------
* Behavioral: mitral valve repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age 18- 85 years Patients with severe degenerative mitral regurgitation undergoing mitral valve repair at our institution Exclusion criteria: Functional or ischemic mitral regurgitation Presence of relevant (symptomatic) Coronary Artery Disease Inability of exercising on semi supine bicycle

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: mitral valve repair|Mitral valve repair in patients with degenerative mitral regurgitation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Curcumin on Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigator initiated study is to determine the efficacy of curcumin on disease activity of subjects with systemic lupus erythematous. Curcumin has been found to have anti-inflammatory effects and has been found to improve disease activity in lupus patients. In addition, subjects with rheumatoid arthritis as well as osteoarthritis have also found benefit for their disease activity.

Official Title
-----------------
Effect of Curcumin on Systemic Lupus Erythematosus

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: Curcumin supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 18 or older Diagnosed with Systemic Lupus Erythematous according to the 2012 Systemic Lupus International Collaborating Clinics Classification Criteria. SLEDAI score of 6 or higher Ability to take oral medication and be willing to adhere to the study drug regimen Exclusion Criteria: Inability to provide written consent for study participation Use of curcumin supplements within 30 days of enrollment of study Liver function disorders (AST/ALT > 2.5x upper limit of normal) Pregnancy or lactation Known allergic reactions to turmeric Subjects who are admitted for recent hospitalization within past 60 days Treatment with another investigational drug or other intervention within past 60 days Subjects with end stage renal disease on dialysis Subjects who lack the ability to provide consent

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin<br> | Drug: Curcumin supplement<br>* Intervention is 2 grams of curcumin supplement per day<br>|
| Placebo Comparator: Placebo<br> | Drug: Curcumin supplement<br>* Intervention is 2 grams of curcumin supplement per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SLEDAI | Number of participants with change in SLEDAI by 2 points by Day 90 | 90 days |
Treatment of Elderly Subjects With Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type

Study Overview
=================
Brief Summary
-----------------
This is a 10-week study with bifeprunox and placebo in elderly subjects with psychosis and behavioral disturbances associated with dementia of the alzheimer's type.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-controlled, Efficacy, Safety, and Tolerability Study of Bifeprunox in the Treatment of Elderly Subjects With Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type

Conditions
-----------------
Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type

Intervention / Treatment
-----------------
* Drug: bifeprunox
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of dementia of the Alzheimer's type Exclusion Criteria: History of seizure disorder Clinically significant electrocardiogram (ECG) Clinical or radiological evidence of stroke, vascular dementia or dementia due to substance abuse, or head trauma

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: bifeprunox<br>* One week titration with dose adjustments<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Psychiatric Rating Scale (BPRS) Total Score |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 10 weeks |
TIFACT Study - Tissue Factor Expression by Adipose Tissue in Extremely Obese Subjects.

Study Overview
=================
Brief Summary
-----------------
Tissue factor is the main activator of coagulation cascades. Excessive tissue factor expression is made responsible of thrombosis in a number of clinical situations including thrombosis in contact with atherosclerotic plaques. Recent work showed that tissue factor gene expression in adipose tissue was significantly increased in obese versus lean mice. The main objective of this study is to show that tissue factor expression is increased in human adipose tissue obtained from obese subjects and to identify its main tissular origin by comparing abdominal and subcutaneous adipose tissue. The secondary objectives are to identify the cell origin of tissue factor (adipocytes versus stromal cells) and to analyze the relation ship between blood tissue factor and (i) tissue factor expressed by adipose tissue, (ii) the amount of subcutaneous and profound adipose tissue, and (iii) coagulation activation markers.

Detailed Description
-----------------
Tissue factor is the main activator of coagulation cascades. Excessive tissue factor expression is made responsible of thrombosis in a number of clinical situations including thrombosis in contact with atherosclerotic plaques. Recent work showed that tissue factor gene expression in adipose tissue was significantly increased in obese versus lean mice. The main objective of this study is to show that tissue factor expression is increased in human adipose tissue obtained from obese subjects and to identify its main tissular origin by comparing abdominal and subcutaneous adipose tissue. The secondary objectives are to identify the cell origin of tissue factor (adipocytes versus stromal cells) and to analyze the relation ship between blood tissue factor and (i) tissue factor expressed by adipose tissue,

Official Title
-----------------
TIFACT Study - Tissue Factor Expression by Adipose Tissue in Extremely Obese Subjects. Relationship With Circulating Tissue Factor and Coagulation Activation Markers

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 35 Stable obesity Abdominal or pelvic surgery Agree to participate to the study Exclusion Criteria: malignancy, infectious or inflammatory disease, notably HIV infection pregnancy history of ischemic cardio or neurovascular event, lower limb arteritis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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
-----------------
Tissue factor, Obesity, Adipose tissue, Microparticles