linjc16/ctgov huggingface dataset:
Positioning and Gastric Aspiration in Ventilated Premature Infants

Study Overview
=================
Brief Summary
-----------------
Gastro-esophageal reflux and aspiration is a common problem in premature infants receiving mechanical ventilation. Pepsin measured in tracheal aspirate (TA) emerged as a specific marker for aspiration. The objective of this study is to examine if TA pepsin will change when ventilated premature infants are positioned in two different positions; on their back vs. on their right side.

Official Title
-----------------
Positioning and Gastric Aspiration in Ventilated Premature Infants

Conditions
-----------------
Respiratory Aspiration of Gastric Contents

Intervention / Treatment
-----------------
* Behavioral: Right side position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born between 28 and 32 weeks gestational age postnatal age > 72 hours tracheally intubated and receiving conventional mechanical ventilation feeding enterally more than 20 ml per day. Exclusion Criteria: neurological insult in the form of perinatal asphyxia (pH <7, base deficit more than 12, Apgar score at < 3 at 5 minutes of life), intracranial hemorrhage grades 3 or 4 at 72 hours of age or periventricular leucomalacia major congenital anomalies, or gastrointestinal anomalies such as tracheoesophageal fistula, or necrotizing enterocolitis , receiving xanthine derivatives, H2 blockers, prokinetics, proton pump inhibitors or sedation

Ages Eligible for Study
-----------------
Minimum Age: 3 Days
Maximum Age: 28 Days

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

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

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 |
| --- | --- |
| Experimental: Right side position<br>Premature infants on mechanical ventilation are kept on their right side | Behavioral: Right side position<br>* Enrolled infants are positioned on their back or right side. Tracheal aspirate is assessed for pepsin concentration as an index of aspiration.<br>|
| No Intervention: Supine position<br>Premature infants on mechanical ventilation are kept on their back | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pepsin concentration in tracheal aspirate |  | 6 hours after intervention |
Fabry : National Initiative of Screening

Study Overview
=================
Brief Summary
-----------------
Fabry disease is a genetic disease due to an enzymatic deficit. A screening of this disease allows patients to benefit from an enzyme replacement therapy and prevent the occurrence of life threatening manifestations such as an ischemic stroke. The purpose of the study is to determinate the prevalence of Fabry disease in a population of male patients hospitalized for an ischemic stroke. This study, with a screening of Fabry disease, allows the patients to make a precise diagnosis of their ischemic stroke and to facilitate the screening of the other members at the facility.

Official Title
-----------------
National, Multicenter, Prospective Study of Screening of Fabry Disease in a Population of Men Over 28 Days Old and Less Than 55 Years, Hospitalized for an Ischemic Stroke.

Conditions
-----------------
Ischemic Stroke Hospitalized

Intervention / Treatment
-----------------
* Procedure: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized ischemic stroke Written and signed informed consent from patient or legal representative Exclusion Criteria: Patients belonging to a family which has a Fabry disease's diagnosis confirmed

Ages Eligible for Study
-----------------
Minimum Age: 28 Days
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood sample|Ischemic stroke hospitalized|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fabry disease's screening (Positive microdosage confirmed by a macrodosage) |  | Positive microdosage confirmed by a macrodosage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe and compare the characteristics of patients affected by Fabry disease and patients who are not affected Identify clinical and neuroradiological predictive elements of Fabry disease |  | patients affected by Fabry disease | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fabry disease, Screening, Ischemic stroke
Acute Abdomen in Adults- a Prospective Study on Emergency Department Admissions

Study Overview
=================
Brief Summary
-----------------
This is a non-randomized, prospective, population-based, single-center study designed to evaluate conditions resulting emergency admission in patients with abdominal pain. Furthermore, we are interested in how many patients are discharged with non-specific abdominal pain but later readmitted and diagnosed with a specific diagnosis.

Detailed Description
-----------------
1000 adult patients with acute abdominal pain will be recruited at Tampere University Hospital Emergency department. The patients will fill in a questionaire about the symptoms and their duration. A urine sample will be collected for polyamine molecule analysis with an electronic nose. At later stage of the study, a serum sample for coeliac tests will be collected. Patient outcome will be obtained during the hospital stay, at one-month after discharge and at one year.

Official Title
-----------------
Acute Abdomen in Adults- a Prospective Study on Causes of Abdominal Pain Leading to Emergency Department Admission in Tampere University Hospital

Conditions
-----------------
Abdominal Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients with abdominal pain. Exclusion Criteria: Under the age of 18 years

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with specific diagnose | Population based analysis of incidence of diseases | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients misdiagnosed in emergency department and requiring readmission |  | One month | 
| Number of participants with treatment related adverse events |  | One month | 
| Diagnostic accuracy of polyamine molecule analysis |  | One month | 
| Number of patients with undiagnosed coeliac disease |  | One month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abdominal pain, adult, emergency department, electronic nose, celiac disease
Case Series Comparing Drains to TissuGlu® in a Donor Site DIEP Flap Breast Reconstruction Procedure

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and effectiveness of a lysine-derived urethane adhesive (TissuGlu® Surgical Adhesive) as a less invasive alternative to surgical drains in the abdominal donor site for deep inferior epigastric perforator (DIEP) flap reconstruction.

Official Title
-----------------
Post-Market, Investigator Initiated, Retrospective, Audited Observational Case Series Comparing SWC With Drains to SWC With TissuGlu® and no Drains in a Donor Site DIEP Flap Breast Reconstruction Procedure in 58 Patients

Conditions
-----------------
Deep Inferior Epigastric Perforator Flap Reconstruction

Intervention / Treatment
-----------------
* Device: TissuGlu Surgical Adhesive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be 18 years of age or older be in good general health (with no conditions that would, in the opinion of the surgeon, exclude them from a drain-free donor site approach) have a body mass index (BMI) < 28 have received a DIEP flap breast reconstruction procedure Exclusion Criteria: current smoker have a body mass index (BMI) > 28 taking active SSRI medication prescriptions

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 |
| --- | --- |
| Control<br>donor site DIEP flap breast reconstruction procedure with standard wound closure with drains | |
| TissuGlu Surgical Adhesive<br>donor site DIEP flap breast reconstruction procedure with standard wound closure with TissuGlu Surgical Adhesive and no drains | Device: TissuGlu Surgical Adhesive<br>* lysine-derived urethane adhesive<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of post-operative clinical interventions related to wound fluid management at the donor site | number of interventions | 6 weeks post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total wound drainage | drain volume + aspiration volume | 6 weeks post-operatively | 
| cumulative drain volume | volume | 6 weeks post-operatively | 
| aspiration volume | volume | 6 weeks post-operatively | 
| cumulative days of invasive treatment | days with drains in + days in which an aspiration was performed | 6 weeks post-operatively | 
| days to drain removal | days | 6 weeks post-operatively |
Comparative Analysis of Cerebral Oximetry and Mean Arterial Pressures at the Cerebral Level in the Beach Chair Position

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the changes measured by Somanetics Invos cerebral oximeter to the mean arterial pressure at brain level in patients having elective shoulder replacement surgery. The Somanetics Invos System measures and monitors the oxygen saturation (rS02) of blood in the brain tissues to help prevent brain injury or other complications. The investigators hypothesize that maintaining normocarbia and systemic mean arterial pressure at or above 70mmHg during general anesthesia in the beach chair position will decrease the number of cerebral deoxygenation events during the procedure.

Conditions
-----------------
Cerebral Perfusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be undergoing elective shoulder replacement surgery Subjects must have an ASA class of I or II Subject is able and willing to sign the informed consent Subject is 18 years of age or older at time of consent Subject is not pregnant Subject is not a prisoner Exclusion Criteria: Subject has a mental condition that may interfere with the subject's ability to give informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with Subject's cognitive abilities, senile dementia, and Alzheimer's Disease) Subject is younger than 18 years of age at consent Subject is pregnant Subject is a prisoner

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Direct Aortic vs Subclavian Access for TAVI: a Review of the Outcomes in the UK

Study Overview
=================
Brief Summary
-----------------
A retrospective analysis of outcomes of all patients who received TAVI via the subclavian or direct aortic approach between January 2011 and January 2016

Official Title
-----------------
Direct Aortic vs Subclavian Access for TAVI: a Review of the Outcomes in the UK

Conditions
-----------------
Aortic Stenosis

Intervention / Treatment
-----------------
* Procedure: TAVI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recieve TAVI via subclavian or direct aortic apporach in the UK Exclusion Criteria: Nil
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAVI via Subclavian approach<br>Any TAVI procedure using any valve type performed via the subclavian approach | Procedure: TAVI<br> <br> |
| TAVI via Direct Aortic approach<br>Any TAVI procedure using any valve type performed via the direct aortic approach | Procedure: TAVI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE |  | Up to 5 years (average 3 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Complications |  | 30 dyas post procedure |
Effects of Grape Juice With Breakfast on Glycemia and Cognitive Function in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
Assess the impact of 100% grape juice with a meal on postprandial glycemic response and subsequent appetite, food intake and cognitive function.

Detailed Description
-----------------
Investigators earlier studies and published literature suggest that the phenolic content and strong flavor intensity of 100% Concord grape juice hold potential beneficial effects on blood sugar levels. Investigators aim to better understand the consumption of 100% grape juice with a meal modifies appetite and glycemia acutely and over the day using a 24 hour glucose monitor.

Official Title
-----------------
Effects of Grape Juice With Breakfast on Glycemia and Cognitive Function in Healthy Adults

Conditions
-----------------
Glycemic Response, Appetitive Behavior

Intervention / Treatment
-----------------
* Other: Concord Grape Juice
* Other: Low flavonoid low essence beverage
* Other: Low flavonoid beverage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 25.0-34.9 kg/m2 Willingness to eat all test foods Low consumer of tea and coffee, willingness to refrain from both during the 48 hours prior to test days and on the test day Fasting blood glucose below 6.1mmol/l via capillary finger-stick blood sample using a SureStep glucometer (Lifescan, Milpitas, CA) Exclusion Criteria: Taking medications known to affect glycemia, lipid metabolism or appetite Body weight fluctuation of >5kg in the past 3 months Taking vitamin or other supplements Smokers Acute or Chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Concord Grape Juice<br>Concord Grape Juice | Other: Concord Grape Juice<br>* Concord Grape Juice<br>|
| Sham Comparator: Low flavonoid low essence beverage<br>Low flavonoid low essence beverage | Other: Low flavonoid low essence beverage<br>* Low flavonoid low essence beverage<br>|
| Sham Comparator: Low flavonoid beverage<br>Low flavonoid beverage | Other: Low flavonoid beverage<br>* Low flavonoid beverage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in blood glucose over 24 hours | samples taken every 5 minutes for 24 hours by a continuous glucose monitor | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite | Questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly on same day as grape juice intervention | 24 hours |
The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers

Study Overview
=================
Brief Summary
-----------------
Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion (Zyban). We compare cue-induced reactivity to smoking videos in smokers who were successfully treated with Bupropion to smokers who are still smoking. We measured the brain's metabolic activity in response to smoking and neutral cues in Positron Emission Tomography using FDG.

Detailed Description
-----------------
Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion (Zyban)for 2 months. We compare cue-induced reactivity to smoking videos in smokers who were successfully treated with Bupropion to smokers who are still smoking. We measured the brain's metabolic activity after exposure to videotapes showing smoking and neutral scenes in Positron Emission Tomography using FDG. There were 2 scanning sessions, one with a smoking videotape and one with a neutral video separated by a week. So far we have compared the brain's metabolic activity in 6 abstinent smokers and 6 still smokers.

Official Title
-----------------
The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers.

Conditions
-----------------
Nicotine Dependence

Intervention / Treatment
-----------------
* Drug: Bupropion (Zyban)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cigarette smokers (over 1 pack a day) Age 20-65, male-females Exclusion Criteria: Dependence on other substances Psychiatric diagnosis Neurological disorder Obesity Young persons Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bupropion (Zyban)|1 tablet a day increasing to 2 tablets a day after a week|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain metabolic activity (FDG) in response to craving and neutral cues. |  | 30-40 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective ratings of craving |  | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
craving, nicotine, imaging, FDG, PET, smoking, Bupropion
Observational Study of Allergic Rhinitis in Children

Study Overview
=================
Brief Summary
-----------------
Observational, cross-sectional, prospective, multicentric study in France with private paediatricians to describe the management of allergic rhinitis in children.

Detailed Description
-----------------
Data collected about diagnostic, comorbidities, clinical history, management of allergic rhinitis using a patient paper case report form. There is only one visit per patient and investigators can include up to 10 patients.

Official Title
-----------------
Observational Study of Allergic Rhinitis in Children

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Other: Management of allergic rhinitis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Under 18 years of age With allergic rhinitis Who's representative of the parental authority did not object to his child's participation after oral and written information and who agrees to participate Exclusion Criteria: Child or adolescent opposed to participate or collect his personal data

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Management of allergic rhinitis|Collection of patient data in real-life|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of children over 2 years of age with allergic rhinitis eligible for allergic immunotherapy | Descriptive analysis : evaluation with data collected in the case report form about allergic rhinitis | 1 year |