linjc16/ctgov huggingface dataset:
Study of Liberty Program on Women's Health and Intimate Partner Violence

Study Overview
=================
Brief Summary
-----------------
Previous studies indicated high frequency of abuse in families and its consequences. Considering the importance of interventions such as educational interventions, in order to increase women's abilities to prevent abusive behaviors, the current research aims to determine the impact of an Liberty program on prevention of violence against women and propose solutions for less damages and consequences.

Official Title
-----------------
Study of Liberty Program on Women's Health and Intimate Partner Violence: Multinational, Open, Randomised, Controlled Clinical Study

Conditions
-----------------
Violence Against Women

Intervention / Treatment
-----------------
* Behavioral: Liberty Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be married, Be under the aegis of Foundation at least for a year, Have at least one child. Exclusion Criteria: Not participating in two educational sessions, Not being interested in continuing the cooperation.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liberty Group<br>Weekly intensive support group for women with children who have suffered or are still suffering from domestic abuse (DA). | Behavioral: Liberty Program<br> <br> |
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life measured by SF 36 Scale |  | Change from baseline in SF 36 Scale at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Esteem measured by Rosenberg Self-Esteem Questionnaire |  | Change from Baseline in Rosenberg Self-Esteem Questionnaire at 6 months |
Prediction Accuracy for Langeal Mask Unique TM Size in Pediatric Patient

Study Overview
=================
Brief Summary
-----------------
the study aimed to know the accuracy for laryngeal mask unique TM size to Malay pediatric race according to weight measurement recommended by manufacturer

Detailed Description
-----------------
sixty-six pediatric subjects aged between 1 - 10 years old underwent general anesthesia using laryngeal mask Unique TM. Laryngeal mask inserted using the size based on subject's weight. Effectivity was confirmed if there is no air sound from patient's mouth, airway seal pressure ≥20 cmH2O, maximum inspiration pressure was ≤ 20 cmH2O, difference in expiration and inspiration tidal volume less than 5%, and there is no cuff appear in mouth.

Official Title
-----------------
Prediction Accuracy for Langeal Mask Unique TM Size in Melayu Pediatric Population According to Weight Meissurement

Conditions
-----------------
General Anaesthesia

Intervention / Treatment
-----------------
* Device: laryngeal mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 1 -10 years old Malay race scheduled for general anesthesia procedure with laryngeal mask Exclusion Criteria: - disagree to be included in the study

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 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 |
| --- | --- |
| laryngeal mask size<br>laryngeal mask size determines according to weight measurement | Device: laryngeal mask<br>* the size of laryngeal mask given to the patient was based on patient's weight measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful insertion of laryngeal mask | observe the sign of successful insertion of laryngeal mask | 3 minutes |
Effect of BMS-914392 on Pharmacokinetics of Metoprolol

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the effects of BMS-914392 administration on the pharmacokinetics of a single-dose of metoprolol in healthy subjects.

Detailed Description
-----------------
Protocol designed to evaluate the potential for a drug-drug-interaction

Official Title
-----------------
Effect of BMS-914392 on the Pharmacokinetics of Metoprolol and on Heart Rate After Co-administration of BMS-914392 and Metoprolol in Healthy Subjects

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: metoprolol
* Drug: BMS-914392


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations. Subjects genotyped as Intermediate, Extensive or Ultra-rapid CYP2D6 metabolizers Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy Exclusion Criteria: Any significant acute or chronic medical illness. Current or recent (within 3 months of study drug administration) gastrointestinal disease. Current or history of neurological diseases or psychiatric disorders, cardiovascular diseases, and bronchospastic diseases. CYP2D6 poor metabolizers based on genotype

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: metoprolol<br>Treatment A | Drug: metoprolol<br>* Tablets, Oral, 200 mg, once, 1 day<br>|
| Experimental: BMS-914392 + metoprolol<br>Treatment B | Drug: metoprolol<br>* Tablets, Oral, 200 mg, once, 1 day<br>Drug: BMS-914392<br>* Tablets, Oral, 60 mg, once daily, 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of single dose of metoprolol derived from serial measurements of metoprolol plasma concentrations |  | Pre-dose and 0.5 Hr, 1 Hr, 1.5 Hr, 2 Hr, 3 Hr, 4 Hr, 6 Hr, 8 Hr, 12 Hr, 24 Hr, and 36 Hr after dosing of metoprolol alone or in combination with BMS-914392 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of multiple doses of BMS-914392 on PR, QRS, RR, and QTc intervals derived from serial electrocardiograms (ECGs) |  | Pre-dose and 0.5 Hr, 1 Hr, 1.5 Hr, 2 Hr, 3 Hr, 4 Hr , 6 Hr, 8 Hr, 12 Hr, 24 Hr after dosing with metoprolol alone or in combination with BMS-914392 | 
| Number of subjects with adverse events as a measure of safety and tolerability of BMS-914392 |  | Daily |
A Novel Echocardiography Modality to Assess Left Ventricular Dyssynchrony

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that the relation between mechanical and hemodynamic left ventricular dyssynchrony might better predict response to Cardiac Resynchronization Device(CRT) than currently existing echo indices.

Detailed Description
-----------------
Cardiac resynchronization therapy is emerging to be a highly effective treatment option for selected patients with symptomatic congestive heart failure on optimal medical therapy and evidence of left ventricular (LV) conduction delay and contraction dyssynchrony. It can improve quality of life and results in better survival in this selected group of patients. However, patients have different responses to CRT, and up to 30% of those implanted show no response at all. Ongoing trials, whether prospective or retrospective, have been trying to define best predictors of response to CRT and to measure ventricular dyssynchrony. Despite this, no single echo criterion to date can predict successful CRT over current guidelines. In this study, we propose to compare LV muscle mechanical dyssynchrony assessment by speckle tracking to hemodynamic dyssynchrony assessment by 4D segmental ejection fraction (EF), a novel modality brought recently by University of Missouri Echocardiography laboratory.

Official Title
-----------------
A Novel Echocardiography Modality to Assess Left Ventricular Dyssynchrony: Hemodynamic Assessment by 4D Segmental Ejection Fraction

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac Resynchronization Therapy(CRT) device implanted in the last 5 years. Exclusion Criteria: Acute decompensated congestive heart failure. chronic permanent atrial fibrillation

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 |
| --- | --- |
| CRT device<br>Patients with Cardiac Resynchronization Therapy(CRT) device implanted in the last 5 years will be studied by the new echo modality.Study doesn't involve acute device implantation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4D echo is the best modality to measure systolic dyssynchrony index |  | Two years |
E-cigarettes, Nicotine Inhaler, and Blood Vessel Function

Study Overview
=================
Brief Summary
-----------------
Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, nicotine inhaler, and sham-control on endothelial function, oxidative stress and sympathetic nerve activity

Detailed Description
-----------------
Participants will have an acute exposure on 4 occasions1) e-cigarette with nicotine, 2) e-cigarette without nicotine, 3) nicotine inhaler, 4) sham control and undergo ECG recording for heart rate variability, endothelial function measurement using ultrasound (FMD) and blood tests for oxidative stress markers.

Official Title
-----------------
The Effects of Electronic Cigarettes on Endothelial Function and Oxidative Stress

Conditions
-----------------
Nicotine Dependence

Intervention / Treatment
-----------------
* Other: e-cig with nicotine
* Other: e-cig without nicotine
* Other: nicotine inhaler
* Other: sham control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Exclusion Criteria: Cardiac disease Respiratory disease Diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine: use e-cig with nicotine<br>One time exposure to e-cig with nicotine | Other: e-cig with nicotine<br>* use an e-cig with nicotine for 30 minutes<br>|
| Experimental: no nicotine: use e-cig without nicotine<br>One time exposure to e-cig without nicotine | Other: e-cig without nicotine<br>* use an e-cig without nicotine for 30 minutes<br>|
| Experimental: Nicotine inhaler: use a nictoine inhaler<br>One time exposure to nicotine inhaler | Other: nicotine inhaler<br>* use a nicotine inhaler for 30 minutes<br>|
| Sham Comparator: Sham control<br>Use an empty e-cigarette | Other: sham control<br>* use an empty e-cigarette for 30 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow Mediated dilatation (FMD) | FMD is a measure of endothelial function | 10 minutes after exposure | 
| Heart rate variability (HRV) | HRV is a measure of cardiac sympathetic tone | 10 minutes after exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paraoxonase (PON) | PON is a measure of oxidative stress |  30 minutes after exposure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nicotine, sympathetic nerve activity, oxidative stress
Diaphragmatic Movement Before and After Stellate Ganglion Block : A Ultrasonographic Study

Study Overview
=================
Brief Summary
-----------------
The temporary diaphrgmatic dysfunction will occur after stellate ganglion block(SGB) and will be easily detected by M-mode ultrasonography

Conditions
-----------------
Head Pain, Neck Pain, Shoulder Pain, Arm Pain, Neural Sensory Hearing Loss

Intervention / Treatment
-----------------
* Procedure: M-mode ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class I-II patients who have head and neck pain or shoulder pain or sudden sensory neural hearing loss Exclusion Criteria: coagulopathy, pulmonary disease, neuropathy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- |
|Procedure: M-mode ultrasonography|Evaluation of diaphragmatic movement using M-mode ultrasonography before and after stellate ganglion block with 1% lidocaine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amplitude of diaphragm movement before and after SGB during quiet breathing, deep breathing and voluntary sniff, inspiratory time and expiratory time, oxygen saturation |  | The ultrasonographic evaluation will take place just before and 30 minutes after stellate ganglion block. |
Prevalence and Genetic Alternation of Autoimmune Polyglandular Syndrome Type II in Taiwan

Study Overview
=================
Brief Summary
-----------------
Autoimmune polyendocrine syndrome (APS) is an autoimmune disease involving at least two endocrine organ. It is classified into type I and type II diseases. Among them, APS type II is more common. It is diagnosed when two of the three following diseases are diagnosed in the same patient, including type 1 diabetes mellitus, autoimmune thyroid disease, and primary adrenal insufficiency. In this study, we will observe the epidemiology, clinical characteristics, and genetic variants of APS II in Taiwan.

Official Title
-----------------
Prevalence and Genetic Alternation of Autoimmune Polyglandular Syndrome Type II in Taiwan

Conditions
-----------------
Autoimmune Polyendocrine Syndrome Type II

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients visited NTUH during 2006-2021, and had at least two of the three diseases: type 1 DM, primary adrenal insufficiency, and autoimmune thyroid disease. Exclusion Criteria: Patients aged less than 20 years old

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 |
| --- | --- |
| Autoimmune polyendocrine syndrome type II<br>patients with autoimmune polyendocrine syndrome type II | Other: no intervention<br>* No intervention, only observation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of endocrine organs involved | We will observe the rate of each endocrine organ involved, including adrenal gland, thyroid, and pancreas | 2022/1/1   2026/12/31 |
Open International Study on Quality of Life in Irritable Bowel Syndrome (IBS) Patients Before and After 8 Weeks Treatment With Mebeverine/Pinaverium Bromide

Study Overview
=================
Brief Summary
-----------------
A study to evaluate, by country and overall, the changes from baseline of the irritable bowel syndrome quality of life (IBS QoL) total score after 4 and 8 weeks of treatment with Duspatalin® or Dicetel® in IBS patients.

Official Title
-----------------
Open International Study on Quality of Life in IBS Patients Before and After 8 Weeks Treatment With Mebeverine/Pinaverium Bromide

Conditions
-----------------
Irritable Bowel Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Irritable bowel syndrome patients diagnosed by Rome III criteria (18 years or older) Exclusion Criteria: Pregnancy and lactation Specific contraindications to mebeverine hydrochloride or pinaverium bromide

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 |
| --- | --- |
| One patient group<br>Patients suffering from irritable bowel syndrome | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Irritable Bowel syndrome (IBS) quality of life (QoL) measure (IBS-QoL) to assess the impairment of QoL in IBS patients |  | From baseline up to the week 8 visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in abdominal pain |  | From baseline up to the week 8 visit | 
| Change in bloating |  | From baseline up to the week 8 visit | 
| Change in feeling of abdominal distension |  | From baseline up to the week 8 visit | 
| Change in stool frequency |  | From baseline up to the week 8 visit | 
| Change in stool form |  | From baseline up to the week 8 visit | 
| Change in straining of evacuation |  | From baseline up to the week 8 visit | 
| Change in urgency of evacuation |  | From baseline up to the week 8 visit | 
| Change in feeling of incomplete evacuation |  | From baseline up to the week 8 visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal pain, Diarrhea, Mebeverine hydrochloride, Constipation, Pinaverium bromide, Irritable bowel syndrome, Bloating, Quality of life
Out-of-hospital Cardiac Arrest Epidemiology and Outcomes in Kaunas 2016-2021

Study Overview
=================
Brief Summary
-----------------
Out-of-hospital cardiac arrest rate is common problem, because of high mortality rate. It is not clear incidence rate, epidemiology and outcomes in Lithuania and Kaunas city included.

Detailed Description
-----------------
This data reported according to UTSTEIN guidelines could be compared with other countries from the region although not much data is available, but it will be a baseline for future references about processes in patient management, demographics, incidence rate and OHCA outcomes.

Official Title
-----------------
Out-of-hospital Cardiac Arrest Epidemiology and Outcomes in Kaunas 2016-2021

Conditions
-----------------
Out-Of-Hospital Cardiac Arrest

Intervention / Treatment
-----------------
* Other: Dispatcher protocol change


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OHCA patients of all ages more than 18 years-old with resuscitation commenced or continued by EMS personnel were included. Exclusion Criteria: obviously dead patients, were excluded

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 |
| --- | --- |
| Subgroup 2016-2018<br>Subgroup before change of dispatcher protocol | |
| Subgroup 2019-2021<br>Subgroup after change of dispatcher protocol | Other: Dispatcher protocol change<br>* In the beginning of 2019 dispatcher protocol was changed to shorten the time of death detection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The detection of death will be shorter |  | 31 Dec 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The survival rate will increase |  | 31 Dec 2021 |
To Assess Compliance With a Once-daily Regimen of Lamivudine, Efavirenz and Didanosine

Study Overview
=================
Brief Summary
-----------------
To assess compliance of once daily dosing to assess their benefits in terms of potency and safety as well as their impact on adherence and quality of life.

Official Title
-----------------
A Randomized, Multi-center, Open Label Study in Well Controlled Treatment-experienced HIV- Infected Patients to Assess Compliance With a Once-daily Regimen

Conditions
-----------------
AIDS

Intervention / Treatment
-----------------
* Behavioral: Compliance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 or older, required lab results, currently taking no more than two of the proposed once daily arm medications with medications administered twice daily and women of child bearing potential. Exclusion Criteria: virological failure, serious medical condition, known toxicities to any of the once daily arm medications, lab abnormalities, women who are pregnant/breastfeeding

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Compliance|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine over 24 weeks the levels of adherence in two groups of HIV-infected subjects randomized to receive either a once daily 3-drug regimen or to continue a minimum 3-drug regimen requiring more frequent dosing. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that once daily therapy is not-inferioir to continued multiple dosing in terms of proportion of patients with treatment failure. |  |  |