linjc16/ctgov huggingface dataset:
Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)

Study Overview
=================
Brief Summary
-----------------
The main purpose of the study is to compare the mean AERP between treatment groups based on the hypothesis that in subjects with paroxysmal AF, Irbesartan prevents electrophysiological remodeling resulting in a prolonged atrial effective refractory period relative (AERP) to placebo.

Official Title
-----------------
Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recurrent PAF with indication for catheter ablation Exclusion Criteria: Struct. Cardiopathy Mitral valve disease VEF<40% Myocardiopathy LVH cardiac surgery AF reversible QT c>450 Recent MI/stroke, severe HTN Requirement of ACEI/ARBs Coronary synd., HTA, liver disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Irbesartan<br>* Tablets, Oral, 300 mg, once daily, 30 days.<br>* Other names: Avapro;|
| Placebo Comparator: B<br> | Drug: Placebo<br>* Tablets, Oral, 0 mg, once daily, 30 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irbesartan effect on duration of Atrial Effective Refractory Period (AERP) in paroxysmal AF (PAF) patients. |  | The measures are taken after 31 days of irbesartan treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irbesartan effect on A Function RP |  | The measures are taken after 31 days of irbesartan treatment | 
| Irbesartan effect on atrial conduction intervals after basal & extra-stimuli, in PAF patients |  | The measures are taken after 31 days of irbesartan treatment | 
| Refractoriness dispersion |  | The measures are taken after 31 days of irbesartan treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with Paroxysmal Atrial Fibrillation (PAF)
Effects of Dietary Fiber on Insulin Sensitivity

Study Overview
=================
Brief Summary
-----------------
This study will examine the effects of a dietary fiber on insulin sensitivity in overweight and obese women. The fiber will be added to snack foods and women will consume the foods for four weeks. In one four-week period, 15 g of fiber will be added, and 30 g will added in another period. In a third period, no fiber will be added to the snack foods. Insulin senstivity will be measured at the end of each treatment period.

Official Title
-----------------
Effects of Dieatry Fiber on Insulin Sensitivity in Pre- and Post-menopausal Women

Conditions
-----------------
Focus of the Study is Insulin Sensitivity

Intervention / Treatment
-----------------
* Dietary Supplement: Dietary Fiber


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Impaired fasting glucose Overweight and obese Exclusion Criteria: Diabetes, Presence of chronic diseases

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br>15 g of fiber per day will be added to snack foods | Dietary Supplement: Dietary Fiber<br>* Dietary fiber will be added to snack foods<br>|
| Experimental: High dose<br>30 g of fiber per day will be added to snack foods | Dietary Supplement: Dietary Fiber<br>* Dietary fiber will be added to snack foods<br>|
| Placebo Comparator: No fiber<br>Snack foods without fiber will be given | Dietary Supplement: Dietary Fiber<br>* Dietary fiber will be added to snack foods<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity | A frequently sampled intravenous blood glucose tolerance test will be performed. | 5-hr test, performed 3 times within a 20-week period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitocondrial function | A muscle biospy will be taken to assess mitochondrial function | 3 times, with a 20-week period | 
| Meal tolerance test | A high-fat meal will be given and blood will be drawn over a three-hr period | 3 times, within a 20-week period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin sensitivity, resistant starch
Effects of IV Chloride Content on Outcomes

Study Overview
=================
Brief Summary
-----------------
This observational study evaluates the impact of high and low chloride containing IV fluids on administrative and clinical outcomes. The study uses a large electronic health dataset and examines patients receiving fluid replacement and resuscitation. The hypothesis is that high chloride solutions are associated with adverse outcomes as measured by administrative data and by clinical parameters.

Official Title
-----------------
A Comparison of High and Low Chloride Containing IV Fluid Solutions in Patients Undergoing Major Surgery and/or ICU Admission

Conditions
-----------------
SIRS, Balanced Fluids, Plasmalyte

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults meeting SIRS criteria receiving at least 500 mL of fluid replacement on day of SIRS. Exclusion Criteria: Receipt of starches or other colloids

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 |
| --- | --- |
| High Chloride<br>Patients receiving .9% sodium choride for resuscitation | |
| Low chloride<br>Patients receiving Plasmalyte for resuscitation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Inpatient mortality. Expected Length of inpatient stay is approximately 7 days | Hospitalization, Expected Length of inpatient stay is approximately 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay |  | inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days | 
| Acute renal failure |  | inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days | 
| Infections |  | inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days | 
| dysrhythmias |  | inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days | 
| Electrolyte disorders |  | inpatient hospitalizationExpected Length of inpatient stay is approximately 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyperchloremic acidosis, balanced fluids, plasmalyte
Treatment to Quit Smoking

Study Overview
=================
Brief Summary
-----------------
This protocol evaluates the efficacy of combining pharmacologic treatments for smoking cessation, entailing the use of the nicotine skin patch with the nicotinic antagonist mecamylamine, with a specific behavioral therapy designed to inhibit the smoking urge.

Detailed Description
-----------------
Previous studies have found that nicotine/mecamylamine treatment more than doubles the long-term abstinence rates relative to nicotine replacement alone. Recent evidence supports the hypothesis that nicotine/mecamylamine treatment prior to smoking cessation partially blocks the rewarding effects of cigarette smoking and hence promotes extinction of the smoking habit, facilitating subsequent abstinence. The behavioral approach employed is also an extinction strategy and involves having smokers switch to de-nicotinized tobacco cigarettes for two weeks prior to quitting smoking. It is hypothesized that the use of de-nicotinized cigarettes might provide more complete extinction than provided by the partial pharmacologic blockade using nicotine/mecamylamine alone. The pharmacologic treatment was expected to increase compliance with the de-nicotinized cigarette smoking regimen, because subjects' usual brands of cigarettes will be less appealing than in the absence of nicotine/mecamylamine treatment. Together the brand-switching and nicotine/mecamylamine therapies were expected to reduce cravings and other withdrawal symptoms as well as increase long-term abstinence from smoking.

Official Title
-----------------
Combined Pharmacologic/Behavioral Treatment for Smoking Cessation

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Drug: Mecamylamine
* Drug: Nicotine Patch
* Behavioral: Cigarette brand switching


Participation Criteria
=================
Eligibility Criteria
-----------------
Smokers, Ages 18-65, wanted to quit smoking. Must be in good health Exclude cardiac disease, hypotensive or hypertensive, skin allergy, glaucoma, prostatic hypertrophy, pregnant women, drug or alcohol abuse, kidney disease.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mecamylamine|nan|
|Drug: Nicotine Patch|nan|
|Behavioral: Cigarette brand switching|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
-----------------
Nicotine, addiction, cigarette smoking
ESS as a Diagnosis Resource Aid of the Syndrome of Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to analyze the effectiveness of the Epworth's sleepiness scale as a recourse aid in the diagnosis of the syndrome of obstructive sleep apnea. 475 patients attended this study, that sought the CESF to probable diagnosis of some sleep disorder. The data were collected from records, wich are of questionnaires, including the ESE, prepared by the CESF professionals and responded, previously, by the own patients. The study compared the result obtained in the scale of Epworth with the data of polysomnography. The analysis of data was performed using the SPSS, based on descriptive and inferential statistics, being used the average considering the standard deviation, and, to the crossing of variables, was used the chi-square test of Pearson, considering as significant statistically values of p<0.05. The results showed that gender, age and BMI are predisposing factors to SOSA.

Official Title
-----------------
The Effectiveness of the Epworth´s Sleepiness Scale as a Resource Aid in the Diagnosis of the Syndrome of Obstructive Sleep Apnea

Conditions
-----------------
Sleep Apnea, Mixed Central and Obstructive Sleep Apnea, Sleep-Disordered Breathing

Intervention / Treatment
-----------------
* Other: Questionnaire and polysomnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Charts of whose admission of patients was from October 2005 to July 2007 Patients referred to the CESF for possible diagnosis of a sleep disorder Exclusion Criteria: incomplete data patients with concomitant diseases (heart disease, hormonal disease, chronic obstructive pulmonary disease and neurological patients) patients undergoing uvulopalatopharyngoplasty

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 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 |
| --- | --- |
| Obstructive Sleep Apnea<br>475 patients that sought the CESF to probable diagnosis of some sleep disorder, subsequently diagnosed with Obstructive Sleep Apnea. | Other: Questionnaire and polysomnography<br>* Comparison of polysomnography data records and previously made questionnaire, with the Epworth Sleepiness Scale.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epworth's sleepiness scale |  | March 2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnography |  | May 2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Evaluation, Obstructive sleep apnea, Polysomnography
Advair Pediatric Once-Daily

Study Overview
=================
Brief Summary
-----------------
To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of age with asthma.

Official Title
-----------------
A Stratified, Randomized, Double-blind, Placebo-controlled, Parallel-group, 12 Week Trial Evaluating the Safety and Efficacy of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg Once Daily Versus Fluticasone Propionate DISKUS 100mcg Once Daily and Placebo in Symptomatic Pediatric Subjects (4-11 Years) With Asthma

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

Intervention / Treatment
-----------------
* Drug: FP 100mcg
* Drug: FSC 100/50mcg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Out-patients Asthma diagnosis Reversibility Short-acting beta-agonist or asthma controlled medication use Exclusion Criteria: Life-threatening asthma Specified asthma medications Chickenpox Drug allergy Respiratory infections Tobacco use Clinical laboratory abnormalities Ophthalmologic conditions Investigation medications Affiliation with investigator site

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 11 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluticasone propionate/salmeterol combination<br>study drug | Drug: FSC 100/50mcg<br>* Once-daily dosing<br>|
| Experimental: Fluticasone propionate<br>study drug | Drug: FP 100mcg<br>* Once-daily dosing<br>|
| Experimental: Placebo<br>placebo | Drug: Placebo<br>* Once-daily dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at endpoint in daily PM PEF |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Various pulmonary function endpoints |  | 12 weeks |
ALK29-002: A Study of Baclofen Formulations in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.

Official Title
-----------------
A Phase 1, Single-Center, Open-Label Study of the Pharmacokinetics of Baclofen Formulations Administered to Healthy Adults

Conditions
-----------------
Alcohol Dependence

Intervention / Treatment
-----------------
* Drug: Baclofen IR
* Drug: Baclofen ER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18 and 65 years Body mass index of 19 to 30 kg/m2 at screening If subject is female and of childbearing potential, she must agree to use an acceptable method of contraception for the duration of the study Exclusion Criteria: Pregnancy and/or currently breastfeeding Clinical significant medical condition or observed abnormalities Acute gastrointestinal disorder or history of chronic gastrointestinal disease or surgery Participation in a clinical trial within 30 days before screening Known intolerance and/or hypersensitivity to baclofen or its excipients Use of alcohol-, caffeine-, or xanthine-containing products Clinically significant illness within 30 days of first study drug administration Dietary restrictions that conflict with required study meals

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IR am<br>30 mg, single dose, morning administration (immediate release [IR]) | Drug: Baclofen IR<br>* 30 mg; single dose<br>|
| Experimental: ER am<br>30 mg; single dose; morning administration (extended release [ER]) | Drug: Baclofen ER<br>* 30 mg; single dose<br>|
| Experimental: ER pm<br>30 mg; single dose; evening administration | Drug: Baclofen ER<br>* 30 mg; single dose<br>|
| Active Comparator: IR pm<br>30 mg; single dose; evening administration | Drug: Baclofen IR<br>* 30 mg; single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Cmax |  | 5 weeks | 
| Significant abnormal laboratory findings |  | 5 weeks | 
| Area under the plasma concentration curve (AUC) |  | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALK29, Alcohol Dependence, Pharmacokinetics
Safety and Efficacy Evaluation of iAPA-DC/CTL Combined Gemcitabine Therapy on Advanced Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the safety and efficacy of iAPA-DC/CTL combined gemcitabine therapy on advanced pancreatic cancer.

Conditions
-----------------
Carcinoma, Pancreatic Ductal

Intervention / Treatment
-----------------
* Other: iAPA-DC/CTL adoptive cellular immunotherapy
* Drug: Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced Pancreatic cancer patients with histological pathology confirmation Both gender, aged 18-70 year-old Bone marrow functioned well Renal function normal Liver function normal patients are voluntary, and willing to sign informed consent expected lifetime was at least 3 months Exclusion Criteria: With acute inflammation Accompanied with primary malignant tumor other than pancreas with autoimmune disease using corticosteroid or other suppress immune hormone treatment had transplant operation of vital organs active hepatitis HIV positive dysfunction in blood coagulation serious diseases in circulatory and respiratory systems pregnancy or breast-feeding women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: Gemcitabine<br>Standard Gemcitabine Therapy | Drug: Gemcitabine<br>* standard Gemcitabine therapy<br>|
| Experimental: cellular immunotherapy & Gemcitabine<br>iAPA-DC/CTL adoptive cellular immunotherapy combined Standard Gemcitabine Therapy | Other: iAPA-DC/CTL adoptive cellular immunotherapy<br>* twice DC cell infusion and CTL cell infusion for 6 times<br>Drug: Gemcitabine<br>* standard Gemcitabine therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month SR | 6 months survival rate | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | progression-Free Survival | 6 months | 
| OS | Over survival | 6 months | 
| ORR | Objective Response Rate | 2 months | 
| QOL | Quality of Life | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adoptive Cellular Immunotherapy, patient safety, therapeutic effect