linjc16/ctgov huggingface dataset:
Respiratory Events Among Premature Infants

Study Overview
=================
Brief Summary
-----------------
Assess the burden of disease associated with RSV infection with premature children in an outpatient setting.

Detailed Description
-----------------
The primary objective of this prospective study is to assess the burden of disease associated with RSV infection, as measured/determined by rates of outpatient medically attended LRI, emergency room visits and hospitalization among preterm infants (32-≤36 wGA) during RSV season, and its medical/health consequences, as measured by wheezing events, the infant's first RSV season, up to May 2009.

Official Title
-----------------
Respiratory Events Among Premature Infants (32-<36 w/GA) - Outcomes & Risk Tracking Study (The REPORT Study)

Conditions
-----------------
Respiratory Syncytial Virus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent from parent/guardian to participate in study Male or female preterm infants 32-≤36 wGA Infant is ≤ 6month old at the time of enrollment Parent/guardian has the ability and willingness to follow study protocol (during the first RSV season) as required by the protocol Exclusion Criteria: Receipt of any RSV prophylactic agent: palivizumab, IGIV, or motavizumab at any time prior to enrollment Participation in trials of investigational RSV prophylaxis or RSV therapeutic agents Presence of BPD or CHD (other than surgically treated PDA, ASD or VSD) Condition that limits life span to 6 months or less from the date of enrollment

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Stage 1 (Pilot Study) All infants enrolled in the pilot stage and completing baseline screening will be evaluated as the analyzable set. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of RSV positivity and rate of outpatient and/or inpatient LRI events as well as the rate of outpatient and inpatient wheezing events. |  | Seasonal: 2008-09 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate characteristics of infants in RSV risk factor and rate and reason of attrition. |  | Seasonal: 2008-09 |
Effects of Oxybutynin Topical Gel on Gastric Emptying

Study Overview
=================
Brief Summary
-----------------
This study explores the effect of oxybutynin topical gel on gastric emptying

Official Title
-----------------
Effect of Oxybutynin Chloride Topical Gel on Gastric Emptying, Using the Acetaminophen Absorption Test

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

Intervention / Treatment
-----------------
* Drug: Oxybutynin Chloride Gel
* Drug: Placebo Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult, healthy, post-menopausal females Exclusion Criteria: Patients for whom OTG or acetaminophen is contraindicated. Abnormality of the GI tract. Taking drugs that affect gastric motility.

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

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active OTG<br> | Drug: Oxybutynin Chloride Gel<br>* Once daily for 7 days, followed by single dose of acetaminophen<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo Gel<br>* Once daily for 7 days, followed by single dose of acetaminophen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of oxybutynin chloride topical gel administration on gastric emptying will be assessed by comparing the single dose relative bioavailability of acetaminophen |  | After 7 days of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteer
Short-term Effects of Good Metabolic Control on Cognitive Function, Wellbeing, and Metabolic Parameters in Adult Patients With Phenylketonuria

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate if in adult patients with phenylketonuria (PKU) without strict metabolic control during the last 12 months, strict metabolic control for 8 weeks results in an improvement of cognitive function.

Official Title
-----------------
Kurzfristiger Einfluss Einer Guten Stoffwechseleinstellung Auf Kognitive Funktion, Wohlbefinden Und Stoffwechselparameter Bei Erwachsenen Patienten Mit Phenylketonurie (Short-term Effects of Good Metabolic Control on Cognitive Function, Wellbeing, and Metabolic Parameters in Adult Patients With Phenylketonuria)

Conditions
-----------------
Phenylketonurias

Intervention / Treatment
-----------------
* Other: PHE-diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women with classical PKU Age ≥ 18 years Good metabolic control during childhood (at least until 12 years of age) Plasma Phe levels ≥ 15 mg/dl for ≥ 1 year Written informed consent prior to study participation Exclusion Criteria: Reduced cognitive function (unability to perform test battery) Drug and or alcohol abuse Treatment with BH4 Treatment with drugs known to affect cognitive function

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet<br> | Other: PHE-diet<br>* phenylalanine-restricted diet with phenylalanine free supplements for 8 weeks<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spatial working memory strategy index | cognitive function; scores range from 4 to 28, with lower scores representing better outcome | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction time | cognitive function; milliseconds, with faster times representing better outcome | 8 weeks | 
| Paired Associates Learning | cognitive function; scores range from 0 to 70, with lower scores indicating better outcome | 8 weeks | 
| Multitasking Test | cognitive function; scores range from 0 to 279, with lower scores indicating better outcome | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive function adults
Rapid Benzodiazepine Detoxification Using Flumazenil - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to verify the hypothesis that the benzodiazepine antagonist, flumazenil, will reduce acute benzodiazepine withdrawal.

Official Title
-----------------
Rapid Benzodiazepine Detoxification Using Flumazenil

Conditions
-----------------
Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Flumazenil


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
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 |
| --- |
|Drug: Flumazenil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Benzodiazepine withdrawal severity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Substance-Related Disorders
A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Sex Workers

Study Overview
=================
Brief Summary
-----------------
This study develops and tests a behavioural and structural intervention to prevent unprotected sex among young female sex workers. Half the participants will receive the intervention and half will receive the standard of care.

Official Title
-----------------
A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Women Engaging in High Risk Sexual Behavior

Conditions
-----------------
Sexually Transmitted Infection

Intervention / Treatment
-----------------
* Behavioral: ZETRA cognitive behavioral structural


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-uninfected women, aged 15-24 years, being sexually active and having engaged in any form of transactional sex at least once in the last 3 months, agreeing to participate in all intervention sessions and to all study procedures and interviews planned over 18 months of follow-up. Exclusion Criteria: presence of any physical or mental condition likely to cause inability to provide consent or hinder study participation; HIV infection

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 24 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: health literacy and technology skill building<br>ZETRA cognitive behavioral and structural | Behavioral: ZETRA cognitive behavioral structural<br>* ZETRA cognitive behavioral structural<br>|
| No Intervention: Standard Counselling<br>Standard of care prevention counselling | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unprotected Sex |  | 18 months |
1.5T Intraoperative MR Imaging in Craniopharyngiomas

Study Overview
=================
Brief Summary
-----------------
Purpose of this study is to investigate whether intraoperative imaging using a 1.5T MRI in craniopharyngioma surgery is useful in order to increase the rate of complete tumor removal.

Official Title
-----------------
Intraoperative Use of a MR Tomography System Combined With Neuronavigation - Analysis of the Craniopharyngioma Subgroup (Intraoperative Nutzung Eines Kernspintomographie-Systems in Direkter Kopplung Mit Einem Neuronavigations-System)

Conditions
-----------------
Craniopharyngioma

Intervention / Treatment
-----------------
* Other: Intraoperative imaging using 1.5T MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: complex craniopharyngioma > 1cm extension within 2 or more cranial fossae or ventricular system Patient or legal representative able to provide written informed consent Exclusion Criteria: tumor size< 1 cm Patients with any condition considered a contraindication to MRI Patients with any condition considered a contraindication for surgery Hypothalamic disturbances Hypothalamic edema

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 75 Years

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

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: Intraoperative imaging<br> | Other: Intraoperative imaging using 1.5T MRI<br>* Intraoperative imaging and determination of degree of resection / complete tumor removal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of additional tumor removal | Number of patients in whom non suspected tumor remants were indicated by intraoperative MRI and remnants could be removed completely thereafter. Results have to be confirmed in 1st follow up imaging. | up to 3-4 months following surgery | 
| Rate of achievement of intended extent of removal | It is examined whether the extent of tumor removal defined prior to surgery was achieved | up to three months following surgery | 
| Diagnostic reliability | false positive or negative interpretation of intraoperative imaging determined after follow-up imaging 3 - 4 months following surgery | within 3 -4 months following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complication | Rate of new deficits following surgery (excluding new endocrine deficits) | within 1st week following surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Craniopharyngioma, Surgery, Intraoperative imaging, Rate of total removal
Monitoring Hypertensive Patients's Cerebral Oxygen Saturation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether there is a significant decrease in cerebral oxygen saturation in hypertensive patients undergoing major abdominal surgery and their correlation with standard monitoring parameters.

Official Title
-----------------
Monitoring Cerebral Oxygen Saturation in Hypertensive Patients Undergoing Major Abdominal Surgery

Conditions
-----------------
Surgical Complications From General Anesthesia, Hypertension, Cerebral Ischemia, Cerebral Anoxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients have hypertension more than 3 year,whether well-controlled or uncontrolled, scheduled for major abdominal surgery for at least 2 h under general anesthesia American Society of Anesthesiologists（ASA）physical status : II   III Age > 30 Exclusion Criteria: pre-existing cerebral pathology for example episodes of cerebral ischemia or stroke; ASA physical status >IV hepatic failure renal failure preoperative Mini-Mental State Examination (MMSE) score less than 24 a history of cardiovascular surgery or craniotomy cardiac failure respiratory failure

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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 |
| --- | --- |
| hypertension disease<br>patients have hypertension disease, whether well-controlled or uncontrolled, more than 3 year | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decreases in cerebral oxygen saturation (rSO2) during the surgery |  | every 5 minutes throughout the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Mini-Mental State Exam (MMSE) perioperative period |  | Baseline, 4 day after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, cerebral oxygen saturation, near-infrared spectroscopy, cognitive function
Impact of Exercise on Retinal Microvascular Regulation Measured by Dynamic Vessel Analysis in Healthy Individuals

Study Overview
=================
Brief Summary
-----------------
Objective The investigators assessed the acute impact of physical exercise on retinal vessel regulation. This might be of clinical importance if retinal vessel regulation is examined with the very sensitive method of the dynamic vessel analyzer Design Forty middle aged (age range 18 to 31 years, mean age 24 years) healthy subjects (26 female / 14 male) had retinal examinations with static and dynamic vessel analysis prior and after (0.5h, 1.5h, 2.5h) intense exercise of 20 minutes.

Conditions
-----------------
Healthy Middle-aged Subjects, Age Range Was 18 to 31 Years, Caucasian Whites, Males and Females

Intervention / Treatment
-----------------
* Other: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy middle-aged subjects Exclusion Criteria: volunteers with systemic or ocular diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| exercise group<br> | Other: exercise<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retinal vessel diameter |  |  |
Secondary Ear Reconstructions Based on Nagata Method

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to provide a feasible surgical strategy based on Nagata method for patients who require secondary revision surgeries and to verify its long-term aesthetic outcomes. The main question it aims to answer is: • Whether ear reconstruction surgery based on Nagata method can improve the unsatisfactory outcomes of primary reconstruction surgery? Participants who had accepted secondary ear reconstruction based on Nagata method in our department will be required to received questionnaires in the follow-up and their photographs will be collected for reconstructed ear evaluation of its realness through convolutional neural network (CNN) models we previously developed.

Official Title
-----------------
Secondary Ear Reconstructions Based on Nagata Method for Unsatisfactory Outcomes After Microtia Surgeries

Conditions
-----------------
Secondary Ear Reconstructions Based on Nagata Method

Intervention / Treatment
-----------------
* Procedure: secondary ear reconstruction based on Nagata method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chest circumference larger than 60cm at the lowest sternum level; Willingness to participate long-term follow-ups; Ability to correctly understand the questionnaire(>8 years old). Exclusion Criteria: Patients with damaged superficial temporal artery (STA); Patients with poor condition of rib cartilage; Patients with active inflammation in auricular area; Patients who refuses surgical approach.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: secondary ear reconstruction based on Nagata method|Secondary auricular reconstructions based on Nagata method were conducted on patients who sought for secondary revision.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative and postoperative scores evaluated based on CNN | Preoperative and postoperative photographs were acquired for reconstructed ear evaluation of its realness and appearance improvement through convolutional neural network (CNN) models we previously developed. | change from baseline in appearance scores at 7 months after secondary surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Five-point Likert scale scores | Five-point Likert scale score will be collected to show patient-reported outcomes in the follow-up study through questionnaires to assess patients' postoperative satisfaction. This questionnaire includes overall appearance, size, projection and subunits of the ear and the postoperative status of donor site. 1 = poor and 5 = excellent. | at least 7 months after secondary surgery |
Sertraline and Naltrexone for Alcohol Dependence

Study Overview
=================
Brief Summary
-----------------
This study is a double-blind, placebo-controlled outpatient trial to improve, through the addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent individuals currently taking naltrexone (Revia).

Official Title
-----------------
Sertraline and Naltrexone for Alcohol Dependents

Conditions
-----------------
Alcoholism

Intervention / Treatment
-----------------
* Drug: naltrexone (Revia)
* Drug: sertraline (Zoloft)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets the criteria for alcohol dependence. Abstinent from alcohol for a period of at least 5 days and not greater than 30 days. Able to read English and complete study evaluations. A stable residence and a telephone to ensure that subjects can be located during the study. Exclusion Criteria: Currently meets criteria for substance abuse or dependence with the exception of nicotine dependence. Current use of disulfiram (Antabuse) or a MAO Inhibitor. Psychotic or otherwise severely psychiatrically disabled (i.e., depressed, suicidal, current mania). Major depression at the time of assessment. Previous treatment with naltrexone (Revia) for alcohol dependence. Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac disease. Abstinent longer than 30 days prior to admission to program. Hepatocellular disease or elevated bilirubin levels. Females who are pregnant, nursing, or not using a reliable method of birth control.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: naltrexone (Revia)|nan|
|Drug: sertraline (Zoloft)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |