linjc16/ctgov huggingface dataset:
Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea

Study Overview
=================
Brief Summary
-----------------
The study will compare durations of diarrhea among subjects who report to clinic for treatment and who receive either: standard rifaximin therapy at a dose of 200 mg three times a day for 3 days, OR a single 600 mg dose of rifaximin daily for 3 days.

Official Title
-----------------
Single Daily Dose Rifaximin vs. Standard Thrice Daily Dosing for the 3-Day Treatment of Travelers' Diarrhea

Conditions
-----------------
Travelers' Diarrhea

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: passage of 3 or more unformed stools in 24 hours plus an additional symptom of enteric disease such as abdominal cramps, nausea, vomiting, or fever; and investigator verification that an unformed stool has been submitted. is > 18 years of age has diarrhea (at least three unformed stools in 24 hrs) plus at least one additional sign or symptom of enteric illness has acute diarrhea less than 1 week's duration willingness to provide a diarrhea stool sample willingness to keep a daily diary for 5 days signed informed consent Exclusion Criteria: fever or bloody diarrhea has taken predictably effective antibiotics in the past week (e.g. quinolones, TMP/SMX, azalide or doxycycline) is pregnant now, likely to become pregnant, or breast-feeding has duration of diarrhea of greater than 1 weeks is allergic to Rifampin or Rifaximin has a history of significant underlying enteric, pulmonary, cardiac, renal disease, or any CNS disorder is more than moderately dehydrated

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>This is the approved treatment regimen for travelers' diarrhea (600 mg) | Drug: Rifaximin<br>* Rifaximin 200 mg TID for 3 days OR Rifaximin 600 mg Daily for 3 days<br>* Other names: Xifaxin;|
| Active Comparator: 2<br>This is the same dose as the standard dose, given once daily (200 mg) | Drug: Rifaximin<br>* Rifaximin 200 mg TID for 3 days OR Rifaximin 600 mg Daily for 3 days<br>* Other names: Xifaxin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from beginning therapy to passage of last unformed stool |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects as reported by the subjects on diaries |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diarrhea, travelers, Acute travelers' diarrhea
An Open-Label, Single-Center Study Evaluating the Effect of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in Patients Diagnosed With Dry Eye

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of acute and repeat dosing of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in a population of dry eye patients.

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Other: SYSTANE® Balance Lubricant Eye Drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have history of mild-moderate dry eye with use of (or desire to use) eye drops in past 6 months Exclusion Criteria: Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Balance.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYSTANE® Balance Lubricant Eye Drops<br>SYSTANE Balance Lubricant Eye Drops dosed (bilaterally) in the office during each visit. Between visits 2 and 3, patients will dose 4 times per day for the 7 day period. | Other: SYSTANE® Balance Lubricant Eye Drops<br>* Subjects will be dosed (bilaterally) in the office during each visit. Between visits 2 and 3, patients will dose 4 times per day for the 7 day period.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in video Ocular Protection Index 10 and 55 minutes following Systane Balance instillation at Days 1 and 7. |  | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blink pattern in subjects with mean Interblink Interval (IBI) < 3 seconds at Days 2 and 8 |  | 9 days | 
| Fluorescein staining at Visits 1 & 3 on the Ora staining scale |  | 9 days | 
| Ocular Symptomology at each visit |  | 9 days |
Evaluation of the AO Pediatric Classification for Long Bones Fractures Like a Guide for Treatment and Prognosis

Study Overview
=================
Brief Summary
-----------------
Is the AO Pediatric classification for long bones fractures reproductible? Is the AO Pediatric Classification for long bones fractures a treatment guide? The AO pediatric Classification for long bones fractures could be a prognosis factor?

Detailed Description
-----------------
PROPOUSE: To determinate the efectivity of the AO pediatric classification for long bones fractures. To evaluate the functionality of the AO pediatric classification for long bones fractures. To analyze if the AO pediatric classification for long bones fractures is a prognosis factor

Official Title
-----------------
Phase 2/3 Eficacy Study of the AO Pediatric Classification in Treatment and Prognosis of Long Bones Fractures

Conditions
-----------------
Fractures, Children

Intervention / Treatment
-----------------
* Procedure: clinical evaluation
* Procedure: observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients: Less than 16 years old. Open physis. Long bone fractures. X ray AP & lateral comparatives. Informed consent for parents or tutor. Don´t let the treatment during the time of study. Exclusion Criteria: Pathologic fractures. Fractures not included en the AO pediatric classification for long bones. Diseases that modifying the bone healing: Diabetes mellitus, osteogenesis imperfect, etc.

Ages Eligible for Study
-----------------
Maximum Age: 16 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Pediatric patients under 16 years old with long bones fractures | Procedure: clinical evaluation<br>* analyze the x ray from each patient and evaluate the treatment y development of bone healing.<br>* Other names: AO classification;Procedure: observational study<br>* evaluate the walk patron, bone healing and range of motion at 1,3,6,12 months<br>* Other names: AO clasification;|

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
-----------------
AO, Pediatric, Classification, Long Bones, fractures, bones
FTO Gene Variants and Diet in Obesity

Study Overview
=================
Brief Summary
-----------------
Studies have shown that the effect of fat mass and obesity-associated (FTO) gene on obesity is modulated by lifestyle factors. Hence, we aimed to determine whether two single nucleotide polymorphisms (SNPs) in the FTO gene are associated with obesity and to assess whether these associations were modified by lifestyle factors. The study included 200 obese and 200 non-obese individuals from Turkey. Our study suggests that the effect of the SNPs on obesity traits is likely to be influenced by lifestyle factors in this Turkish population.

Official Title
-----------------
Impact of FTO Gene Variants and Lifestyle Factors on Obesity Traits in a Turkish Population

Conditions
-----------------
Obesity, Diet Habit, Genetic Predisposition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: attending routine outpatient visits, aged 24 to 50 years, having a BMI ≥ 18.50 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study<br>obese (BMI ≥25.00 kg/m2, n=200) | |
| control<br>non-obese (BMI= 18.50-24.99 kg/m2, n=200) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic analysis of two SNPs at FTO gene | FTO SNPs rs9939609 and rs10163409 | up to 36 weeks | 
| Anthropometric measurements | Body mass index, waist circumference, hip circumference, body composition | up to 36 weeks | 
| Biochemical measurements | lipid profile, glucose, insulin, adiponectin | up to 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, gene-diet interaction, FTO gene variant
Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of interferon beta (Betaseron) in AIDS and advanced AIDS related complex (ARC) patients receiving a reduced-dose zidovudine (AZT) regimen.

Official Title
-----------------
Phase III Randomized Double-Blind Placebo Controlled Study To Evaluate the Safety and Efficacy of Betaseron in AIDS and Advanced ARC Patients Receiving a Reduced-Dose AZT Regimen

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

Intervention / Treatment
-----------------
* Drug: Interferon beta-1b
* Drug: Zidovudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Zidovudine (AZT). Patient must have: Uninterrupted therapy with reduced-dose AZT 500 - 600 mg/day for at least 3 weeks before entry. Acceptable hepatic and renal function. AMENDED to delete the following sentence: Hematologic intolerance to full-dose zidovudine (AZT) (1000 - 1200 mg/day). Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Concurrent, ineffectively controlled opportunistic infections. Extensive cutaneous and/or visceral Kaposi's sarcoma requiring systemic chemotherapy. Proteinuria of 2+ or greater. HIV encephalopathy. HIV wasting syndrome. New York Heart Classification III or IV. Uncontrolled angina pectoris. Evidence of clinically significant, multifocal uncontrolled cardiac dysrhythmias. Concurrent Medication: Excluded: Antiretrovirals other than zidovudine (AZT) or Betaseron. Chronic acyclovir therapy. Acetaminophen. Patients with the following are excluded: Intolerance (hematologic or otherwise) to zidovudine (AZT) at a dose of 100 mg orally every 4 hours. AMENDED to: Intolerance at a dose of 500 to 600 mg/day. Medical or psychiatric conditions that compromise the patient's ability to give informed consent or complete the study. Prior Medication: Excluded within 30 days of study entry: Cytotoxic chemotherapy. Prior therapy with alpha, beta, or gamma interferons. Active drug or alcohol abuse.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Interferon beta-1b|nan|
|Drug: Zidovudine|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
-----------------
Zidovudine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Interferon Type I
Cerebral Tissue Oxygenation in Very Low Birthweight Infants in the First 3 Days of Life

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the range of cerebral tissue oxygen saturation in healthy and sick very low birthweight infants during the first 72 hours of life.

Detailed Description
-----------------
In this observational trial we want to examine cerebral tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD as measured by near infrared spectroscopy during the first 72h of life in very low birthweight infants. Differences between relatively healthy and sick preterm infants will be explored. A focus is to find differences between those infants who develop germinal matrix hemorrhage and those who are at risk only but do not develop hemorrhage.

Official Title
-----------------
Cerebral Tissue Oxygen Saturation in Preterm Neonates Below 1500g Birth Weight During the First 72 Hours

Conditions
-----------------
Infant, Very Low Birth Weight

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Very low birthweight infants
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Very low birthweight infants<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral tissue oxygen saturation during first 72 hours of life |  | during first 72 hours of life |
Comparison of Patient Perceived Pain and Satisfaction Between Lightweight and Heavyweight Mesh for Laparoscopic Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
This study will be comparing the patients overall satisfaction of two different meshes used in laparoscopic inguinal hernia repairs.

Detailed Description
-----------------
This is a clinical trial comparing standard therapy in the use of either lightweight or heavy mesh for the repair of inguinal hernias. Both types of these meshes have been approved for surgical correction but subjective comparisons of patient overall satisfaction and perceived outcomes have not been measured. The investigators intend to measure certain subjective data in the form of a questionnaire will be issued to the patient preoperatively, one week, one month, six months, and one year after the surgery There is no recent literature comparing subjective data between two meshes called Ultra Pro and Surgi Pro. The biological effects of these meshes have identical properties as far as the healing process and inflammation as well as the low rate of infection. The main difference is the material that these meshes are composed of. The Ultra Pro is made of Prolene while the Surgi Pro is made of polypropylene. The risks are not increased anymore than that for normal surgical complications. They each have the same post operative risks including bleeding, infection and pain, but the investigators are investigating a possible subjective difference between these two separate meshes that are currently used.

Official Title
-----------------
Comparison of Patient Perceived Pain and Satisfaction Between Lightweight and Heavyweight Mesh for Laparoscopic Inguinal Hernia Repair

Conditions
-----------------
Inguinal Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over the age of 18 unilateral side to be repaired no major abdominal surgery previously Exclusion Criteria: under age 18 bilateral repairs undertaken

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| heavy weight mesh<br>Surgipro mesh is a heavier weighted mesh with less flexibility after surgery | |
| light weight mesh<br>UltraPro mesh is a lighter weighted mesh with theoretically less stiffness and more flexibility compared to heavier weighted meshes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | Subjective pain scale rating post surgical | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| return to activities of daily living | returning to their presurgical lifestyle | 1 year |
Evaluation of the Usefulness of a Treat and Extend Regimen Using Ranibizumab for Neovascular AMD.

Study Overview
=================
Brief Summary
-----------------
To evaluate the visual outcome, number of injections and visits, and the effect of mental status of a treat and extend regimen in managing neovascular age-related macular degeneration with intravitreal ranibizumab.

Detailed Description
-----------------
Treat and Extend Regimen (TER) may contribute to the improvement to a patients' mentality, since the treatment intervals are extended if there were no signs of recurrence. Therefore, we have planned to examine the psychological impact of TER using Hospital Anxiety and Depression Scale (HADS), in addition to the improvement of visual acuity and central retinal thickness.

Official Title
-----------------
Evaluation of the Usefulness of a Treat and Extend Regimen Using Ranibizumab for Neovascular Age-Related Macular Degeneration.

Conditions
-----------------
Neovascular Age-related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Intraviteal Ranibizumab 0.5mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent form Male or female of aged 50 years or older Typical AMD and PCV patients BCVA of 24 letters or over Exclusion Criteria: Total lesion area of >12 DA or >30.5 mm2 The existence of subretinal hemorrhage area constituting ≥50% of total lesion area The existence of scar or fibrosis area constituting ≥50% of total lesion area The existence of RPE tear Prior treatment for wet AMD History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD The pregnant or lactating woman

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraviteal Ranibizumab 0.5mg<br>Intraviteal Ranibizumab 0.5mg | Drug: Intraviteal Ranibizumab 0.5mg<br>* Intraviteal Ranibizumab 0.5mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central foveal thickness |  | One and two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neovascular age-related macular degeneration, Ranibizumab, Treat and extend
Critical Respiratory Events in Children Requiring Naloxone: Naloxone Use as Opioid Safety Measure

Study Overview
=================
Brief Summary
-----------------
Opioids are the mainstay of analgesia in hospitalized children but opioid therapy is associated with life-threatening respiratory depression requiring antagonism with naloxone. Hence, it is hypothesized that naloxone requirement can be used as a quality measure of opioid safety. A retrospective medical chart review of 95 patients, who received naloxone for life threatening events, from June 2006-2012, is planned, to identify significant factors associated with risk for opioid induced respiratory depression and formulation of preventive strategies.

Official Title
-----------------
Study of Hospital-wide Critical Respiratory Events Requiring Naloxone in a Pediatric Institution

Conditions
-----------------
Opioid Induced Respiratory Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any gender, age or race administered naloxone for opioid induced respiratory depression Exclusion Criteria: Any one who did not require naloxone for opioid induced respiratory depression

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients requiring naloxone for respiratory depression<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive: Medical history and Risk Factors for critical respiratory events requiring Naloxone in children | Data leading to the event and post-event descriptives will be collected | about 6 hours around the event | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
naloxone, children, opioid, respiratory depression, safety