linjc16/ctgov huggingface dataset:
Alcohol Use and Relationships - III

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that individuals receiving the brief substance use intervention will have better substance use and intimate partner violence outcomes than individuals receiving the general health improvement intervention. All participants receive standard batterer intervention.

Official Title
-----------------
Impact of Brief Substance Use Intervention on Substance Use and Intimate Partner Violence

Conditions
-----------------
Intimate Partner Violence, Substance Use

Intervention / Treatment
-----------------
* Behavioral: Brief Alcohol Intervention plus Standard Batterer Intervention
* Behavioral: General Health Improvement Intervention plus Standard Batterer Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in Batterer Intervention Program in RI Hazardous Drinking Exclusion Criteria: drinks too much

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief Alcohol Intervention plus Standard Batterer intervention<br>Brief Alcohol Intervention plus 40 hours of Standard Batterer intervention | Behavioral: Brief Alcohol Intervention plus Standard Batterer Intervention<br>* Brief Alcohol Intervention plus 40 hours or Standard Batterer Intervention<br>|
| Placebo Comparator: General Health Improvement plus Standard batterer intervention<br>General Health Improvement Intervention plus 40 hours of Standard Batterer intervention | Behavioral: General Health Improvement Intervention plus Standard Batterer Intervention<br>* General Health Improvement Intervention plus 40 hours of Standard Batterer Intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lower levels of intimate partner violence | lower levels of any violence and severe intimate partner violence (psychological, physical, sexual, injuries) | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lower levels of substance use (alcohol and drug) |  | one year |
Fetal Programming of Obesity

Study Overview
=================
Brief Summary
-----------------
The overall goal of this project is to understand how a mother's health at conception may influence her child's growth and development.

Detailed Description
-----------------
The purpose of this study is to determine how the mother's health prior to or at the beginning of pregnancy may influence her child's growth and development. We plan to: 1) longitudinally and simultaneously assess a true measure of body composition (lean and fat mass) of the offspring, assess body composition of both parents, and obtain dietary intake data of the mother and offspring; 2) determine endocrine and metabolic profiles of the mother at baseline (pre-conception), during pregnancy and at birth (such as insulin, glucose, leptin); 3) determine the energy expenditure and physical activity of the mother and the child; 4) determine gene expression of the placenta and umbilical cord via gene microarray and real time PCR; and 5) focused on appropriate-for-gestational age (AGA) infants (the majority of infants born from normal and overweight mothers).Accordingly, this study will provide much needed comprehensive information on the possible effect of fetal programming on the development of pediatric obesity.

Conditions
-----------------
Healthy, Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy 21 years of age or older second pregnancy, singleton conceived without fertility treatments Exclusion Criteria: Preexisting medical conditions Sexually transmitted diseases Medical complications during pregnancy Medications during pregnancy known to influence fetal growth Smoking, alcohol drinking Excessive physical activity level which could affect the outcome of interest.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child body composition | lean and fat mass of the child | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child metabolism | monitor with a metabolic cart | 24 months | 
| Child development | Monitored from 2wks up to 24 months | 24 months | 
| Child dietary intake | Food records for each visit will be obtained | 24 months | 
| Placenta gene expression | via gene microarray and real time PCR | 9 months | 
| Placenta protein content | via gene microarray and real time PCR | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy, women, pregnancy
Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Non-invasive Ventilation (NAVA-NIV)

Study Overview
=================
Brief Summary
-----------------
Non-invasive ventilation (NIV) has been proposed to reduce the incidence of ventilatory dysfunction following mechanical ventilation weaning. However, the nasogastric tube reduces the airtightness of the facial mask used to perform non-invasive ventilation and induces air leaks. The presence of leaks at the patient-mask interface can increase the risk of patient-ventilator asynchrony, which in turn leads to increase patient discomfort. Neurally adjusted ventilatory assist (NAVA)could contribute to decreasing asynchrony. Its principle is to record the diaphragmatic electrical activity and to control the ventilator. The investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies in NIV

Official Title
-----------------
Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Non-invasive Ventilation (NAVA-NIV)

Conditions
-----------------
Weaning Period

Intervention / Treatment
-----------------
* Other: Device: Neurally Adjusted Ventilatory Assistance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with increased risk of post-extubation ventilatory dysfunction following invasive mechanical ventilation weaning. Exclusion Criteria: Contra-indication to non-invasive ventilation Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non invasive ventilation<br>Non-invasive ventilation after invasive mechanical ventilation weaning | Other: Device: Neurally Adjusted Ventilatory Assistance<br>* Device: Neurally Adjusted Ventilatory Assistance In ICU following extubation NIV was performed as follows: facial mask with PSV/NIV mode to define settings for NAVA ventilation facial use with NAVA/NIV mode<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triggering delay | Duration between the onset of neural inspiration and the onset of insufflation | Every inspiration, for 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycling off delay | Delay between the end of neural inspiration and the end of insufflation | Every inspiration, for 10 minutes |
Reperfusion Time in ST Segment Elevation Myocardial Infarction (STEMI)

Study Overview
=================
Brief Summary
-----------------
Reperfusion delay in STEMI has been shown to be excessive in our community. In order to improve delay a fast track (direct transfer in catheterization laboratory) has been implemented. The present study aims at evaluating the benefits of this procedure.

Detailed Description
-----------------
Reperfusion delay in STEMI has been shown to be excessive in our community. Admission in emergency room and waiting for transfer to catheterization laboratory seems to be the principal source of delay. In order to improve delays a fast track (direct transfer in catheterization laboratory) has been implemented for patients being diagnosed with STEMI by emergency physician out of hospital. The present study aims at evaluating the benefits of this procedure.

Official Title
-----------------
Evaluation of a Fast Track for Patients With STEMI

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: fast track


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of STEMI Exclusion Criteria: On site resuscitated patients

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: fast track|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Door to balloon time |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
STEMI, ST elevation myocardial infarction
Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam

Study Overview
=================
Brief Summary
-----------------
This is a study to investigate the pharmacokinetics of deferasirox

Official Title
-----------------
An Open-label, One-sequence Cross-over Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Deferasirox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good health No evidence of iron deficiency Weight between 50 and 100 kg Body Mass Index between 19 and 29 kg/m2 Exclusion Criteria: Use of certain drugs, herbal remedies or nutrients Other protocol-defined inclusion/exclusion criteria may apply

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of deferasirox on the pharmacokinetics of midazolam |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by adverse events (AEs) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interaction, healthy volunteers, deferasirox, midazolam
A Study of Clinical Outcomes for the NanoString® Technologies Prosigna™ Gene Signature Assay

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the impact of the result of the Prosigna Test (assay) on the therapeutic decision of adjuvant therapy (chemotherapy and hormone therapy) in patients suffering from early-stage breast cancer.

Detailed Description
-----------------
The secondary objectives will consist of: The evaluation of the confidence in the therapeutic indications of the practitioners before and after the test (assay) results, and by subgroups of cancers The evaluation of the rate of secondary effects of chemotherapy, The evaluation of the emotional state of patients faced with the therapeutic decision, of their degree of anxiety and of their functional status before and after the Prosigna test (assay) results

Official Title
-----------------
Prospective Study Evaluating the Clinical Impact of the Breast Cancer Intrinsic Subtype-Prosigna Test (Assay) in the Management of Early-stage Breast Cancers

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resected node-negative, estrogen-receptor-positive, HER2-negative early- stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0) Estrogen receptor status will be evaluated by Immunohistochemistry (IHC) and more than 1% of stained tumor cells will be considered positive. HER2 status will be evaluated by IHC (0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization. Postmenopausal women defined as: Natural Amenorrhea > 12 months, regardless of age Bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study) Radiological castration with amenorrhea > 3 months, regardless of age Hysterectomy and postmenopausal blood levels Able to give consent Eligible for treatment of breast cancer with adjuvant chemotherapy ECOG performance status of 0 or 1 Exclusion Criteria: Tumor size T3-T4 Non-invasive breast cancer (e.g., Paget's disease, DCIS) Tumors with nodes that are not N0, pN0 (i+), or pN0 (mol+) Tumors that are estrogen-receptor negative or HER2 positive Have metastatic disease Unable to give informed consent Unable to complete patient reported outcome surveys Have contraindications for adjuvant chemotherapy Age, performance status, significant comorbidities ECOG performance status > 1
Sexes Eligible for Study
-----------------
Female

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients whose choice of treatment is changed as a result of receiving the Prosigna test results. |  | 6 months |
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.

Study Overview
=================
Brief Summary
-----------------
Aloe vera is used for the treatment of inflammatory bowel disease (IBD), but no data are present in regard the gel formulation as topical therapy in active ulcerative colitis.

Detailed Description
-----------------
44 ulcerative colitis (UC) patients were enrolled and randomly allocated to treatment for 4 weeks with oral mesalazine (800 mg three times daily) and enema (60 ml aloe vera gel) 1/day (n = 22, Group A) or enema (60 ml placebo) (n = 22, Group B).

Official Title
-----------------
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL FOR ACHIVING REMISSION IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.

Conditions
-----------------
Aloe Vera Gel, Proctosigmoiditis, Remission, Trial, Ulcerative Colitis (UC)

Intervention / Treatment
-----------------
* Drug: Aloe vera gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 years, mild to moderate active ulcerative proctosigmoiditis, diagnosed for the first time and no therapy started before. The maximum extension of the disease was accepted of 40-60 cm from the anal verge or distal disease. Exclusion Criteria: an extension of disease above the sigma, renal impairment, pregnancy, lactation or established low compliance

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 22 patients were assigned to Group-A<br>22 patients were assigned to Group-A | Drug: Aloe vera gel<br> <br> |
| Placebo Comparator: 22 patients were assigned to Group-B<br>22 patients were assigned to Group-B | Drug: Aloe vera gel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endoscopic remission |  | 4 weeks |
The Product Surveillance Registry REVERSE Post Approval Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in the REVERSE and RAFT pivotal studies in real-world clinical practice.

Detailed Description
-----------------
The REVERSE PAS will estimate the 3-year survival probability of freedom from heart failure hospitalization and heart failure events in patients implanted with a Medtronic CRT-D device who meet the expanded indication criteria with a QRS duration ≤ 150 ms.

Official Title
-----------------
The REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE) Post Approval Study

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements Patient has or is intended to receive or be treated with a Medtronic CRT-D who meets the expanded CRT-D indication criteria with a QRS ≤ 150ms Patient within 30 days of implant Exclusion Criteria: Patient who is, or will be, inaccessible for follow-up Patient with exclusion criteria required by local law Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
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 |
| --- | --- | --- |
| Survival from Heart Failure Hospitalization and All-Cause Mortality | To estimate the 3-year survival probability of freedom from heart failure hospitalization or all-cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration ≤ 150ms. | 3 years | 
| Survival from Heart Failure Event and All-Cause Mortality | To estimate the 3-year survival probability of freedom from heart failure event or all- cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration ≤ 150ms. | 3 years |
Bile Duct Injury Digestif

Study Overview
=================
Brief Summary
-----------------
Data accumulated from medical record collected from January 2008 until December 2018

Official Title
-----------------
Full Data BDI Digestif RSCM

Conditions
-----------------
Surgery, Biliary Disease, Bile Duct Injury, Sepsis, Jaundice, Obstructive

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients with extrahepatic bile duct injury managed by digestive division of Cipto Mangunkusumo hospital Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Management of Post-Cholecystectomy Bile Duct Injuries without Operative Mortality at Jakarta Tertiary Hospital in Indonesia | Mortality Rate of Patients Performed Reconstructive Surgery for the Management of Bile Duct Injury Post-Cholecystectomy | january 2008 until december 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Management of Post-Cholecystectomy Bile Duct Injuries without Operative Mortality at Jakarta Tertiary Hospital in Indonesia | Most Frequent Anatomical Location of Bile Duct Injury Post-Cholecystectomy | january 2008 until december 2018 |
Is the Short Physical Performance Battery a Useful Outcome Measure in Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Patients with Chronic Obstructive Lung Disease (COPD) often develop muscle problems, particularly in their legs which makes them more limited in what they can do. The Short Physical Performance Battery (SPPB) is a simple test of standing balance, usual walking speed and ability to stand from a chair. The SPPB may be a useful measure to predict leg function. This study aims to evaluate whether the SPPB is comparable with current exercise tests used in COPD patients, and whether it is useful in predicting disability, death and health resource usage over time.

Official Title
-----------------
Is the Short Physical Performance Battery a Useful Outcome Measure in Patients With Chronic Obstructive Pulmonary Disease ?

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Pulmonary Emphysema, Bronchitis, Chronic, Lung Diseases, Disease Progression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of COPD Exclusion Criteria: Any patient in whom mobility and lower limb function have been significantly affected by a neuromuscular cause (eg. motor neurone disease), severe peripheral vascular disease or amputation Any patient whom is deemed unsafe to exercise Patients unable to complete the SPPB, walking tests and leg strength assessments.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Obstructive Pulmonary Disease<br>Patients with a diagnosis of COPD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalisation rate |  | 36 months | 
| Healthcare resource usage |  | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cohort Studies, Longitudinal Studies