linjc16/ctgov huggingface dataset:
Impact of Gamma-OH on Sleep in ICU Patients

Study Overview
=================
Brief Summary
-----------------
The Main objective of the trial is to assess sleep quality with Gamma-OH® in patients difficult to wean from mechanical ventilation in the ICU.

Official Title
-----------------
Impact of Gamma-OH on Sleep in ICU Patients Difficult to Wean From Mechanical Ventilation

Conditions
-----------------
Weaning From Mechanical Ventilation

Intervention / Treatment
-----------------
* Drug: Gamma Hydroxybutyrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intubated at least 24 hours difficult weaning from mechanical ventilation according to international guidelines, i.e. who failed at least one spontaneous breathing trial. Patients will be included after to obtain inform consent. Exclusion Criteria: neuromuscular disease central nervous disease psychiatric disease severe obesity

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: One arm with Gamma-OH® treatment<br>Gamma-OH® will be administered intravenously at a dose of 20 mg/kg/h for 6 hours between 10 p.m. to 4 a.m. | Drug: Gamma Hydroxybutyrate<br>* Gamma-OH® will be administered intravenously at a dose of 20 mg/kg/h for 6 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients having poor sleep with Gamma-OH | Primary end point will be analyzed from sleep recordings performed during a single night with Gamma-OH®. | Hour24 |
Determinants of Bladder Cancer Recurrence Study (The DETER Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn how different lifestyle factors, such as cigarette smoking and body weight, change after a diagnosis of bladder cancer, and how they influence who gets a bladder cancer recurrence and who does not.

Official Title
-----------------
Determinants of Bladder Cancer Recurrence Study (The DETER Study)

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Behavioral: questionnaires
* Other: Saliva and/or urine sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥18 years old AND Histologically-confirmed non-muscle invasive bladder cancer (NMIBC) Exclusion Criteria: Patients are ineligible for the study if they have/had: Histologically-confirmed NMIBC diagnosed >36 months prior to enrollment Cystectomy prior to enrollment Any condition, which in the opinion of the primary MSK clinician or investigators precludes their ability to provide informed consent or comply with study procedures Non English-speaking

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 |
| --- | --- |
| patients with bladder cancer<br> | Behavioral: questionnaires<br>* The study questionnaires (baseline and 2 follow-ups) will capture information on how modifiable factors, including the patients' smoking habits and body weight, have changed since last contact. RSA will conduct this interview at a time convenient to the patient either during a scheduled clinic visit or by telephone.<br>Other: Saliva and/or urine sample<br>* Patients will contribute approximately 5 mL of saliva at baseline, and at the time of their follow-up questionnaires. If the patient declines to contribute a saliva specimen, they can contribute approximately 10mL of urine. Urine is routinely collected from bladder cancer patients for clinically-related tests. We will also collect urine from every participant for whom the sample is not depleted by clinical tests at the end of the day. Saliva/urine specimens will be tested for cotinine which is regarded as the gold standard to detect recent smoking exposure and is widely used to identify active smokers in epidemiologic studies.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence | will be defined as the presence of pathologically-confirmed NMIBC lesion >8 weeks after diagnosis | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
15-047, MSK Tobacco Cessation Program, smoking exposure
Surveillance of Rotavirus Gastroenteritis in Children <5 Years

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor diarrheal disease and observe changes after the introduction of the rota vaccine.

Detailed Description
-----------------
Monitoring of diarrheal disease and observe changes after the introduction of the rota vaccine Comparing the epidemiology in Jewish and Bedouin population before and after the introduction of the rota vaccine into the national immunization program

Official Title
-----------------
Surveillance of Rotavirus Gastroenteritis Among Children <5 Years of Age Visiting the Pediatric Emergency Room in Southern Israel

Conditions
-----------------
Gastroenteritis, Rotavirus Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children < 5 years with Gastro enteritis Visiting the ER Residents of southern Israel Signed informed concent - Exclusion Criteria: Not all of the above

Ages Eligible for Study
-----------------
Maximum Age: 5 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 |
| --- | --- |
| 2<br>Jewish and Bedouin children < 5 years of age in southern Israel | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| epidemiology of rota virus disease in southern Israel before and after the rota virus vaccine introduction | To assess the proportion of rotavirus gastroenteritis among children <5 years of age visiting the pediatric ER in southern Israel. To assess the hospitalization rate due to rotavirus. | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare rotavirus gastroenteritis among children <5 years of age from Jewish and Bedouin populations. | To compare rotavirus gastroenteritis among children <5 years of age from Jewish and Bedouin populations. | 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surveillance Rotavirus Gastroenteritis Children, < 5 years of age, southern Israel, Signed informed concent
Effects of Sevoflurane in Subanesthetic Concentrations on the Forearm Perfusion

Study Overview
=================
Brief Summary
-----------------
Sevoflurane preconditioning and cardiovascular protection against ischemia/reperfusion injury. Study hypothesis: The volatile anesthetic sevoflurane at subanesthetic concentrations achieves endothelial protection against ischemia/reperfusion injury and reduces inflammatory markers in the circulation

Detailed Description
-----------------
Healthy volunteers are included in the study to investigate endothelial function and platelet activation after preconditioning by sevoflurane in subanesthetic concentrations. Forearm perfusion, endothelial function and leukocyte/thrombocyte activation after tourniquet-induced ischemia/reperfusion injury of the forearm are measured using healthy volunteers in a cross-over design.

Official Title
-----------------
Effects of Sevoflurane in Subanesthetic Concentrations on the Forearm Perfusion, Leukocyte/Thrombocyte Activation, and Endothelial Function After Tourniquet-Induced Ischemia/Reperfusion Injury in the Forearm of Volunteers

Conditions
-----------------
Ischemia/Reperfusion Injury

Intervention / Treatment
-----------------
* Drug: Sevoflurane (Preconditioning)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: male Non-smoker No asthma NPO Volunteer Exclusion criteria: Female Chronic medication Asthma Smoking

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sevoflurane (Preconditioning)|Inhalation of sub-anesthetic doses of sevoflurane|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| marker expression on blood cells |  | December 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ischemia/Reperfusion, Organ Protection, Anesthetics
Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software (Europe)

Study Overview
=================
Brief Summary
-----------------
This Clinical Study will be conducted as a comparative study focusing on usability and efficiency by comparing alarm burden pre- and post-implementation of an Alarm Advisor software.

Detailed Description
-----------------
In a first phase of data collection (pre-implementation) all alarms of an intensive care unit population are recorded. In an interim period an Alarm Advisor software will be introduced to the unit. In a second phase (post-implementation) the same set of alarm data will be recorded. The Alarm Advisor Software can identify alarms based on criteria set by the medical staff and provide hints to reduce alarms and alarm nuisance (e.g. by proposing adjustments of alarm limits). The effect of reduction of recurring nuisance alarms through the implementation of the Alarm Advisor shall be evaluated.

Official Title
-----------------
Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software (Europe)

Conditions
-----------------
Clinical Alarms

Intervention / Treatment
-----------------
* Other: Alarm Advisor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the intensive care unit during the study period Exclusion Criteria: none

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 |
| --- | --- |
| Pre Phase (no Alarm Advisor)<br>No Software installed | |
| Post Phase (Alarm Advisor installed)<br>Software implemented and staff trained (Interventional Phase) | Other: Alarm Advisor<br>* Providing advice on alarm limits as part of routine medical care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Alarms | Number of Different Alarms on Intensive Care | six to eight months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alarms, Alarm Fatigue, Alarm Nuisance, Alarm Reduction, Patient Monitoring, Intensive Care
Translation of the Sydney Swallow Questionnaire and Validation of the German Version

Study Overview
=================
Brief Summary
-----------------
Translation of a validated questionnaire (SSQ) from english to german and validation of the german version. The SSQ consists of 17 well-structured questions for the assessment and quantification of patient reported difficulties in swallowing function. The tool is specifically designed to evaluate important aspects of swallowing function The questions cover the symptoms related to combinations of variables like the anatomic region, type of dysfunction, and the consistency of swallowed bolus.

Official Title
-----------------
Sydney Swallow Questionnaire: Translation of a Questionnaire Relating to the Function of Swallowing and Validation of the German Version

Conditions
-----------------
Dysphagia

Intervention / Treatment
-----------------
* Procedure: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - patients with diagnosed dysphagia of any causes sufficient proficiency in german voluntary participation Exclusion criteria: - insufficient knowledge of the german language cognitive limitations reduced general state of health

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Questionnaire|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients able to understand and fill out the german translation of the questionnaire | Establishment of a questionnaire in german to determine patients' swallowing functions. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dysphagia, Swallowing functions, Questionnaire in German
Prevalence of Oral Mucosal Alterations in Mucocutaneous Ocular Disorders

Study Overview
=================
Brief Summary
-----------------
The patients will be selected from the pool of the Clinics (Rheumatology, Ophthalmology and Dermatology) of Faculty of Medicine and (Diagnostic center and Oral Medicine) of Faculty of Dentistry -Cairo University. For each eligible participant, a full history will be obtained followed by thorough clinical examination.

Official Title
-----------------
Prevalence of Oral Mucosal Alterations in a Sample of Egyptian Patients With Mucocutaneous Ocular Disorders: A Hospital Based Cross Sectional Study

Conditions
-----------------
Oral Disease, Muco-Cutaneo-Ocular Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients diagnosed with one of the mucocutaneous disorder. Patient who will agree to participate in the study. Patients who will accept to sign the informed consent. Exclusion Criteria: Patients not physically able to participate in survey or clinical oral examination.
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identifying and recording oral mucosal alterations | clinical examination according to World Health Organization guidelines | 10 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identifying the oral health-related quality of life: OHIP-14 | using Oral Health Impact Profile-14 (OHIP-14) Slade G. and Spencer A.: Development and evolution of the oral health impact profile. Community Dent Health, 11 (1): 3-11, 1994 Response categories for the five-point scale are: Very often, Fairly often, Occasionally, Hardly ever and Never. | 10 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral health status, oral findings, oral manifestations, patient with mucocutaneous ocular disorders, mucocutaneous ocular disorders
Role of Dopamine Transporter in Glucose Control

Study Overview
=================
Brief Summary
-----------------
Healthy subjects will be enrolled in this study. Each subject will be scanned twice with F18-FP-CIT PET which is commercially available. F18-FP-CIT reflects dopamine transporter availability of striatum. Before each PET scan, subject will be injected either glucose or normal saline. Therefore, PET scan will reflect the changes of dopamine transporter availability after the injection of glucose.

Official Title
-----------------
Role of Dopamine Transporter in Glucose Loading of Healthy Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Glucose injection/Normal saline injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects Exclusion Criteria: known neurologic disorder known drug addiction known endocrine disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy subjects<br>All subjects will be injected twice for each visit (normal saline or glucose) | Other: Glucose injection/Normal saline injection<br>* Before each PET scan, subject will be injected either glucose or normal saline.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific binding ratio of dopamine transporter availabilitiy measured from PET scans | Specific binding ratio of dopamine transporter availabilitiy measured from PET scans | less than 1 month |
VATS Versus Thoracotomy for Pulmonary Hydatid Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the efficacy and safety of minimally invasive surgery and compare the outcomes with patients undergoing thoracotomy in treatment of Pulmonary Hydatid Cyst. Disease : pulmonary hydatid cyst. Intervention: Group 1 : VATS approach. Group 2 : thoracotomy approach.

Detailed Description
-----------------
After being informed about the study and the approach, all patients giving written informed consent to determine eligibility for study entry.

Official Title
-----------------
VATS Versus Thoracotomy for Pulmonary Hydatid Disease

Conditions
-----------------
Pulmonary Hydatid Cyst

Intervention / Treatment
-----------------
* Procedure: VATS approach
* Procedure: Thoracotomy approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - all patients underwent surgery for pulmonary hydatid cyst Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 81 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: Parallel Assignment
Interventional Model Description: study the effect of a treatment and evaluate outcome postoperative
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VATS approach<br>patients treated by VATS technique. | Procedure: VATS approach<br>* video-assisted thoracic surgery approach<br>|
| Active Comparator: Thoracotomy approach<br>patients treated by Thoracotomy technique | Procedure: Thoracotomy approach<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | evaluate the complication at 30 days | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary hydatid cyst, video-assisted thoracic surgery, thoracotomy
Genetic Polymorphism and Israeli Top-level Swimmers' Performance and Expertise

Study Overview
=================
Brief Summary
-----------------
In a study conducted in our laboratory few years ago, we genotyped 22 genes in 2 athletic groups (endurance and sprinters) and in age and gender matched nonathletic controls. Few of these genes were found to be associated with athletic performance and area of specificity. Since then a few more genes have been found that are related to athletic performance, and we intend to study various genes related to 3 genetic cascade: genes associated with body fluid balance and homeostasis, genes associated with muscle strength, and genes associated with bioenergy. The results of this study compared with athletic level will provide deeper insight into the genetic mechanisms involved in performance.

Conditions
-----------------
Genetic Polymorphism Connected to Top-level Swimmers

Intervention / Treatment
-----------------
* Other: Extraction of whole blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Top-level swimmers Other swimmers Exclusion Criteria: All others

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 40 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 |
| --- | --- |
| I. Top-level swimmers<br> | Other: Extraction of whole blood<br>* Extraction of DNA from whole blood<br>|
| II. Control<br>Other swimmers | Other: Extraction of whole blood<br>* Extraction of DNA from whole blood<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of genes associated with swimming performance |  | One year |