linjc16/ctgov huggingface dataset:
Rifaximin for Prevention of Travellers' Diarrhea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

Detailed Description
-----------------
To determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.

Official Title
-----------------
A Randomized,Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Rifaximin for the Prevention of Travellers' Diarrhea

Conditions
-----------------
Diarrhea

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: travelling to Mexico within 72 hours of enrollment read and understand English in good health Exclusion Criteria: acute diarrhea within previous 7 days taken FQs (any drug in this class), macrolide, azalide, or trimethoprim-sulfamethoxazole within 7 days or enrollment or anytime during study. taken antidiarrheal medication within 24 hours of enrollment or anytime during study.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Rifaximin | Drug: Rifaximin<br> <br> |
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment | The efficacy of 14 days of rifaximin 600 mg once daily (QD) compared with placebo when taken by healthy subjects to prevent travelers' diarrhea (TD) resulting from all causes. | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TD, traveller's diarrhea, campylobacter, shigella, salmonella, E. coli, diarrhea
Adaptation Process of Patient-Reported Outcomes, an eVALuation Study

Study Overview
=================
Brief Summary
-----------------
Objectives: To identify the respective contributions of back-translations and of the expert committee in the process of cultural adaptation of patient reported outcome with an experimental design in the adaptation process : Four translations of a questionnaire will be produced: A simple translation by two translators, who serves as the basis for the three other translations A translation made with the use of a back-translation. A translation with review by an expert committee. A translation the use of a back-translation and review by an expert committee. Properties of each translation will be analyzed and compared

Official Title
-----------------
Adaptation Process of Patient-Reported Outcomes, an eVALuation Study

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

Intervention / Treatment
-----------------
* Other: Cross cultural adaptation of patient reported outcomes (PRO)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (other 18 years) Able to read, understand and answer the adapted questionnaire Having a medical condition targeted by the questionnaire

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 |
| --- | --- |
| Initial<br>Patients answering the initial translation | Other: Cross cultural adaptation of patient reported outcomes (PRO)<br>* Process used to adapt a questionnaire from one cultural setting to another<br>|
| Committee-only<br>Patients answering the translation modified by an expert committee | Other: Cross cultural adaptation of patient reported outcomes (PRO)<br>* Process used to adapt a questionnaire from one cultural setting to another<br>|
| BT-only<br>Patients answering the translation modified with the use of a back-translation | Other: Cross cultural adaptation of patient reported outcomes (PRO)<br>* Process used to adapt a questionnaire from one cultural setting to another<br>|
| Both<br>Patients answering the translation modified by an expert committee with the use of a back-translation | Other: Cross cultural adaptation of patient reported outcomes (PRO)<br>* Process used to adapt a questionnaire from one cultural setting to another<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heiQ questionnaire | Face/content validity, reliability, structural validity | baseline |
Treatment of Hypertension

Study Overview
=================
Brief Summary
-----------------
To determine whether the long-term treatment of essential hypertension without significant target organ disease materially influenced mortality and/or cardiovascular renal morbidity.

Detailed Description
-----------------
BACKGROUND: This grant-supported, cooperative, fixed-protocol clinical study was initiated in 1966 and followed a cooperative study of the treatment of renal hypertension initiated in 1960 to evaluate the relative efficacy of several recognized drug regimens for reduction of blood pressure. Six centers (USPHS hospitals) and a coordinating center were involved in the trial. DESIGN NARRATIVE: Randomized, double-blind, fixed sample. Three hundred and eighty nine eligible patients were assigned to drug therapy consisting of chlorothiazide plus Rauwolfia serpentina or to placebo. The study completion date listed in this record was inferred from last publication listed in the Citations section of this study record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases

Intervention / Treatment
-----------------
* Drug: chlorothiazide
* Drug: Rauwolfia alkaloids


Participation Criteria
=================
Eligibility Criteria
-----------------
Men and women, ages 21-55. Mild essential hypertension (diastolic blood pressure over 90 mm Hg.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: chlorothiazide|nan|
|Drug: Rauwolfia alkaloids|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Naltrexone and Patch for Smokers

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effects of naltrexone, alone and combined with nicotine patch, on responses of smokers to smoking cues after 10 hours of tobacco deprivation. Smokers who are not seeking treatment will be assigned to one of six conditions: They will receive either 50 mg of naltrexone or a placebo pill, and also will wear a nicotine patch that has 0, 21, or 42 mg of nicotine during the tobacco deprivation period. Both the day before the medication and deprivation and at the end of 10 hours of deprivation all will be exposed to lit cigarette cues in the laboratory. Effects of the medications will be assessed on withdrawal measures, urge to smoke, psychophysiological measures, and the topography of smoking three test cigarettes. Studies such as these can help to identify potential interventions for tobacco cessation or withdrawal, and thereby could result in less suffering and mortality.

Official Title
-----------------
Naltrexone and Nicotine Replacement Effects on Cue Reactivity of Smokers

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

Intervention / Treatment
-----------------
* Drug: Naltrexone Hydrochloride
* Drug: Transdermal Nicotine


Participation Criteria
=================
Eligibility Criteria
-----------------
Adults who have smoked at least 25 cigarettes per day for at least a year. They are not using any method to quit smoking and are not using naltrexone. Must weigh at least 100lbs with no medical contraindications for naltrexone or transdermal nicotine. No contraindicated medications, no recent opiate use or history

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: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Naltrexone Hydrochloride|nan|
|Drug: Transdermal Nicotine|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
-----------------
Naltrexone, Nicotine patch, Tobacco dependence
A Study of Tamiflu (Oseltamivir) Treatment in Laboratory-Confirmed Influenza.

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of Tamiflu in patients with clinically-diagnosed influenza occurring during an influenza outbreak within the community. Patients will be randomized to receive Tamiflu 75mg bid orally plus support therapy (NSAIDs and antibiotics) or support therapy alone. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Official Title
-----------------
A Randomized, Open Label Study to Evaluate the Effect of Tamiflu on Viral Shedding and on Serum and Cytoplasmic Inflammatory Cytokine Concentrations in Patients With Laboratory-confirmed Influenza

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Drug: oseltamivir [Tamiflu]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-64 years of age; ambulatory; influenza-like illness; positive rapid assay for detection of influenza antigen. Exclusion Criteria: presentation >36h after onset of symptoms; influenza-like symptoms outside an outbreak based on local surveillance activities; influenza vaccination between November 2006 and January 2007; receipt of antiviral therapy, systemic steroids or immunosuppressants within 2 weeks prior to study day 1.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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

| Intervention/Treatment |
| --- |
|Drug: oseltamivir [Tamiflu]|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral shedding; serum and intracellular concentrations of inflammatory cytokines (INFgamma, TNFalpha, IL-6, IL-12). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Duration of illness, health and functional status, extent and severity of symptoms, incidence of resistant viruses. Safety: AEs. |  |  |
A Phase 1 Feasbility Study Of Volume Intracardiac Echo In Assessment Of Patients With Structural And Valvular Heart Disease Undergoing Percutaneous Transcatheter Therapy

Study Overview
=================
Brief Summary
-----------------
This study will compare 3 dimensional intracardiac echo (ICE) with 2 dimensional ICE or transesophageal echo in patients with structural and valvular heart disease who are already scheduled to undergo a percutaneous intervention. Specifically those patients would be those scheduled for a PFO or ASD repair, mitral balloon valvuloplasty, diagnostic cardiac catheterization assessment of aortic stenosis and those undergoing transcatheter aortic valve replacement.

Official Title
-----------------
A Phase 1 Feasbility Study Of Volume Intracardiac Echo In Assessment Of Patients With Structural And Valvular Heart Disease Undergoing Percutaneous Transcatheter Therapy

Conditions
-----------------
Structural and Valvular Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in the study population referred to the cardiac catheterization laboratory for a percutaneous procedure to treat structural or valvular heart disease Exclusion Criteria: Class IV CHF, inadequate femoral access, coagulation abnormalities, intracariac thrombus or DVT

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 |
| --- | --- |
| Structural or Valvular Heart Disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of volume intracardiac echo imaging to 2 dimensional echo |  | Comparison study |
Acute Renal Injury Associated Contrast in Intensive Care Unit Patients

Study Overview
=================
Brief Summary
-----------------
Generally, a contrast medium is used when performing a CT scan or radiographic tests such as angiography because it heightens image clarity and can increase diagnosis accuracy. Despite these advantages, contrast media can cause allergic reactions in the body or a decline in renal function. Therefore, they should be handled carefully and explained sufficiently to the patient. For intensive care patients, the use of contrast agents has been revealed as a major cause of acute renal damage, and many studies have investigated this complication by examining incidence rates and prevention strategies. Hypothesis: Among intensive care patients, the group in which a contrast medium was used will have a higher risk of renal function decline compared with the group in which a contrast medium was not used, and, hence, the use of contrast media becomes a cause of renal function deterioration. Categorizing patients with renal function decline according to the new RIFLE criteria can have an association with the prognosis of intensive care patients, such as hospitalization period and death rate, which can promote faster intervention.

Conditions
-----------------
Acute Renal Injury

Intervention / Treatment
-----------------
* Other: contrast medium usage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For the 5 years from January 2008 to December 2012, patients in whom a contrast medium was used in the intensive care unit were examined. Exclusion Criteria: For the 5 years from January 2008 to December 2012, patients in whom a contrast medium was not used in the intensive care unit were examined.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| the medical records of those in whom a contrast medium<br> | Other: contrast medium usage<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of acute renal damage associated with contrast media in intensive care patients | The occurrence of acute renal damage was examined, and these patients were compared with the group that did not develop acute renal damage to investigate whether the use of contrast agents acts as an independent variable. In addition, the RIFLE (Risk, Injury, Failure, Loss, and End-stage kidney disease) categorization and the existing classification method were used to compare their predictive value for acute renal damage related to contrast media. | each time evaluation of contrast medium usage | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contrast, Intensive care unit, Acute kidney injury
Systematic Assessment of Self-help Tools for the Management of Chronic Tinnitus

Study Overview
=================
Brief Summary
-----------------
With this study we want to investigate the impact of self-help tools on the subjective tinnitus distress in chronic tinnitus patients. Furthermore, we want to investigate the influence of personal characteristics on the individual tinnitus improvement.

Detailed Description
-----------------
A smart-phone app running on iOS devices will be used to give self-help tips to the chronic tinnitus patients.

Official Title
-----------------
Systematische Untersuchung Zum Einfluss Von Selbsthilfe Auf Die Subjektive Belastung Bei Chronischem Tinnitus

Conditions
-----------------
Tinnitus, Subjective

Intervention / Treatment
-----------------
* Behavioral: TinnitusTipps


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic tinnitus, duration at least 6 monhts Exclusion Criteria: acute psychosis, depression, substance abuse psychopharmaca epilepsy or other disease of the central nervous system other tinnitus treatments in the last 3 months drug, medication or alcohol abuse in the last 12 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: TinnitusTipps|Self-helf tips for managing chronic tinnitus will be given via smartphones.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Tinnitus Handicap Inventory | Questionnaire | Before, after 4 months, and after 6 months | 
| Change of Tinnitus Numeric Rating Scale | Questionnaire | Before, after 4 months, and after 6 months | 
| Change Clinical Global Impression | Questionnaire | Before, after 4 months, and after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of WHO Quality of Life | Questionnaire | Before, after 4 months, and after 6 months |
A Study of the Trigeminal Cardio-Reflex in Endodontic and Other Dental Treatment

Study Overview
=================
Brief Summary
-----------------
This study sought to comprehend the relationship between syncope and dental related therapy. If the relationship between dental related therapies and syncope is proved, clinical dentists will be remained to monitor changes of patient's blood pressure during root canal procedure.

Detailed Description
-----------------
This study sought to comprehend the relationship between syncope and dental related therapy. If the relationship between dental related therapies and syncope is proved, clinical dentists will be remained to monitor changes of patient's blood pressure during root canal procedure. Previous Trigemino-Cardiac Reflex(TCR) related studies reported that stimulation of trigeminal nerve induces trigeminal nerve reflection, and then causes blood pressure rapidly decreasing. Finally, sudden blood pressure decreasing results in syncope. Clinical data has been collected and analyzed in the past four months, and the primary results showed significantly difference. This phenomenon may be probably observed in other dental treatments. Hence, the objective of this study is to remind clinical dentists to monitor patients' physical conditions when conducting root canal relevant treatments and to avoid situations such as syncope, and reduce medical disputes and benefit dentists and patient as a result. In the recent year, syncope often occurs during denture procedures. The value of this study will inform clinical dentist to notice risk of dental relative treatments. In addition, it will improve patients' safety.

Official Title
-----------------
A Study of the Trigeminal Cardio-Reflex in Endodontic and Other Dental Treatment

Conditions
-----------------
Pulpitis

Intervention / Treatment
-----------------
* Other: Observational Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who sign the informed consent forms Patients with Pulpitis Patients aged 20 or order Exclusion Criteria: Patients aged under 20

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

| Intervention/Treatment |
| --- |
|Other: Observational Study|Observational Study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Arterial Blood Pressure(MABP) lower than 20% |  | Through routine dental treatment completion, an average of 1 hour | 
| Heart Rate (HR): lower than 60 beats/ minute |  | Through routine dental treatment completion, an average of 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulpitis, Syncope, Trigeminal Cardio-Reflex