linjc16/ctgov huggingface dataset:
Endotracheal Tube Cuff Pressure Measurement

Study Overview
=================
Brief Summary
-----------------
The effect of endotracheal cuff pressure measurement technique for preventing ventilatory associated pneumonia.

Detailed Description
-----------------
Aim of this study is to evaluate the effect of endotracheal cuff pressure measurement technique for preventing ventilatory associated pneumonia of severe traumatic brain injured patients in a tertiary level intensive care unit.

Official Title
-----------------
Comparison of Two Different Measurement of Endotracheal Tube Cuff Pressure for Ventilatory Associated Pnemonia in Severe Brain Injured Patients

Conditions
-----------------
Ventilator Associated Pneumonia, Morality, Trauma, Brain, Endotracheal Aspiration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ASA classification of 1 - 2- 3 patients Patients required mechanical ventilation support for more than 48 hours Patients diagnosed with Traumatic brain injury Exclusion Criteria: Official patient relatives who rejected to give informed consent for the study Patients diagnosed with aspiration pneumonia during ICU follow up Patients diagnosed with Acute Respiratory Distress Syndrome Patients diagnosed with cavitary lung lesion Primary lung cancer Metastatic lung cancer Congenitally immune deficiency Leukopenia Neutropenia Tracheostomized patients Post cardiopulmonary arrest patients Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Duration | Follow up duration in ICU | 30 days | 
| Ventilation | Mechanically ventilated period | 30 days | 
| Score | Clinical Pulmonary Infection Score Change from baseline at 48.hour, 72.hour and 96.hour | 48.hour - 72.hour - 96.hour | 
| CRP | C Reactive Protein measurement change from Baseline at 48.hour, 72.hour and 96.hour | 48.hour - 72.hour - 96.hour | 
| Oxygenation | Fractional Inspiratory Oxygen levels change from baseline at 48.hour, 72.hour and 96.hour | 48.hour - 72.hour - 96.hour | 
| PEEP | Positive End Expiratory Pressure levels change from baseline at 48.hour, 72.hour and 96.hour during ventilatory support | 48.hour - 72.hour - 96.hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tracheal aspirate | Tracheal aspirate sample for culture | 0.hour - 48.hour - 72.hour - 96.hour | 
| Bacterial distribution | Bacterial distribution of tracheal aspirate culture | 0.hour - 48.hour - 72.hour - 96.hour | 
| Mortality | Total mortality ratio during study period | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pneumonia, cuff pressure, brain injury
Molecular Subtyping for Prognosis Evaluation in Resected Pancreatic Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Pancreatic adenocarcinoma (PAAD) patients following surgeries are prone to relapse shortly, while it is not well understood by current biomarkers. Given the potential associations of human leukocyte antigen class I (HLA-I) genotype with oncogenic mutational profile and immunotherapy efficacy, we aimed to assess whether differential HLA-I genotype could predict the postoperative outcomes in resected PAAD patients.

Official Title
-----------------
Molecular Subtyping Based on Specific HLA-I Genotypes for Prognosis Evaluation in Resected Pancreatic Adenocarcinoma: A Retrospective Observational Cohort Study

Conditions
-----------------
Pancreatic Cancer Resectable

Intervention / Treatment
-----------------
* Device: Multigene panel for next-generation sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radically resected pancreatic adenocarcinoma (stage I-III) Resected tumor tissues and matched blood cells available Signed informed consent Exclusion Criteria: Pancreatic cancer except pancreatic adenocarcinoma Non-radical resection

Ages Eligible for Study
-----------------
Minimum Age: 34 Years
Maximum Age: 84 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Multigene panel for next-generation sequencing|HLA-I genotyping based on next-generation sequencing for prognosis evaluation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (DFS) | Comparison of DFS between patients with specific HLA-I genotypes or not | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
human leukocyte antigen class I, supertypes, recurrence
Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay ,UVA Protection Factor Assay (UVAPF), Minimal Persistent Pigment-Darkening Dose (MPPD)

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY 987517)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRLSHF(Self History Form) Signed and dated Informed Consent Form Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: BAY 987517<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY 987517)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Number-SR15-63-Z13-084).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Pyrophosphate and Arterial Calcification in Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Arterial calcifications start at early stages of chronic kidney disease (CKD) and are associated to cardiovascular mortality. Pyrophosphate (PPi) is an endogenous compound, which stops the mineralization process in bones and is expected to act at ectopic sites. In uremic rats, low PPi plasma levels are associated with high calcium content in the aorta and peritoneal administration of PPi blocks this process. People on maintenance dialysis or kidney transplant recipients have low plasma levels of PPi and show high scores of arterial calcification. The purpose is to determine the role of low PPi in the development of arterial calcifications in patients with CKD stage 3 or 4. To that aim, 252 patients with eGFR between 59 et 20 ml/min/1,73 m2 will be recruited and will be examined at baseline and three years later.

Official Title
-----------------
Pyrophosphate: a New Biomarker to Predict Arterial Calcification in Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Other: Collect blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: eGFR between 59 et 20 ml/min/1,73 m2 twice at three month interval Exclusion Criteria: kidney transplantation acute inflammatory disease or active cancer

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Myocardial CT<br>The investigator will collect the usual clinical history and data. Risk factors and cardiovascular events are identified. A blood sample dedicated to the study and necessary for routine care is taken. The pulse wave velocity and systolic pressure index are measured. A myocardial CT scan coupled with a computed tomography is performed. The patient collects stools at his home, simply conditions them and sends them by mail to the centre, which stores them. | Other: Collect blood sample<br>* A blood sample dedicated to the study and necessary for routine care is taken. The pulse wave velocity and systolic pressure index are measured. A myocardial CT scan coupled with a computed tomography is performed. The patient collects stools at his home, simply conditions them and sends them by mail to the centre, which stores them.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of PPI | To show that low plasma levels of PPi at baseline is associated with a high progression of arterial calcification at three years after adjustment for confounding variables | 3 years |
Central Apnea in Patients Receiving Ticagrelor

Study Overview
=================
Brief Summary
-----------------
all patients with a left ventricular ejection fraction superior or equal to 50% less than 2 years after an acute coronary event and receiving ticagrelor will undergo a sleep polygraphy

Detailed Description
-----------------
all patients with a left ventricular ejection fraction superior or equal to 50% less than 2 years after an acute coronary event and receiving ticagrelor will undergo a sleep polygraphy the main objective of the study will be to look for central sleep apnea

Official Title
-----------------
Central Apnea in Patients Receiving Ticagrelor

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: sleep polygraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient receiving ticagrelor 10 days to 2 years after an acute coronary syndrome Exclusion Criteria: left ventricular ejection fraction < 50% patients refusal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: sleep polygraphy|sleep polygraphy (one night) in all included patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central apnea index | mean central apnea index: apnea hypopnea index (AHI) is the scale commonly used to assess sleep disordered breathing.This scale includes central and obstructive apnea and hypopnea. The main outcome will be the central apnea index: number of central apnea per hour | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global apnea hypopnea index | number of apnea and hypopnea per our | baseline |
Adrenergic Cholinergic Enteric Measures/Mapping

Study Overview
=================
Brief Summary
-----------------
Patients seen who had autonomic and enteric profiling (Adrenergic, Cholinergic, Enteric Measures/Mapping=ACEM_ from 2012-2019 at the University of Louisville.

Detailed Description
-----------------
Patients seen who had autonomic and enteric profiling (Adrenergic Cholinergic Enteric Measures/Mapping=ACEM) from 2012-2019 at the U of Louisville. Results of the physiologic measures of ACEM had the results recorded. ACEM is compared to standardized gastric emptying values as the primary measure. ACEM is also compared to metabolic measures of weight, height and thus BMI as a secondary measure. ACEM is aloes compared with standardized gastrointestinal symptoms by a traditional patient recorded outcome as another secondary measure. Other sites may be added if they have identical IRB and/or data sharing agreements with the University of Louisville.

Official Title
-----------------
Adrenergic Cholinergic Enteric Measures/Mapping

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with the symptoms suggestive of autonomic and/or enteric disorders. Exclusion Criteria: Anatomic obstruction of the GI tract Pregnancy Inability of patient or guardian to sign informed consent, if needed Psychiatric disorders precluding assessment and treatment of the patient's GI condition.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Body Mass Index | We calculate Body Mass Index (BMI) using the following formula: weight (kg) / [height (m)] squared BMI is weight in kilograms divided by height in meters squared. | 10 years |
The Effectiveness of Two Osteoporosis Drugs on Prosthetic Bone Mineral Density (BMD) Loss After Total Hip Arthroplasty(THA)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether alendronate and alfacalcidol are effective on prosthetic or lumbar spine BMD after total hip arthroplasty.

Official Title
-----------------
A Comparison of Alendronate vs. Alfacalcidol Medication for the Preservation of Bone Mineral Density Around the Femoral Implant and in the Lumbar Spine After a Total Hip Arthroplasty

Conditions
-----------------
Bone Density, Arthroplasty, Replacement, Hip

Intervention / Treatment
-----------------
* Drug: alendronate, alfacalcidol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: osteoarthritis of the hip patients after total hip arthroplasty Exclusion Criteria: diseases related to bone metabolism patients taking drugs which affect bone metabolism

Ages Eligible for Study
-----------------
Minimum Age: 44 Years
Maximum Age: 82 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: Alendronate medication<br> | Drug: alendronate, alfacalcidol<br>* Alendronate: 5mg per day, Tablet, Duration is 48 weeks. Alfacalcidol: 1μg per day, Tablet, Duration is 48 weeks.<br>|
| Active Comparator: Alfacalcidol medication<br> | Drug: alendronate, alfacalcidol<br>* Alendronate: 5mg per day, Tablet, Duration is 48 weeks. Alfacalcidol: 1μg per day, Tablet, Duration is 48 weeks.<br>|
| No Intervention: Non-medication<br> | Drug: alendronate, alfacalcidol<br>* Alendronate: 5mg per day, Tablet, Duration is 48 weeks. Alfacalcidol: 1μg per day, Tablet, Duration is 48 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DEXA QDR 2000, Hologic Co. |  | 1, 12, 24 and 48 weeks after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bisphosphonate, vitamin D3, Total Hip arthroplasty
Ulna Length in Black Children

Study Overview
=================
Brief Summary
-----------------
Height measurement is unreliable when neuromuscular weakness or spinal deformity is present. The aim of this study was to accurately predict pulmonary function from a limb segment (ulna) measurement that is precise and reproducible. Equations are available in caucasian children but are not available in children of sub-saharian or caribbean ethnicity, which was the aim of the study. To this end, 350 black children referred for pulmonary function testing for asthma follow-up will be included.

Detailed Description
-----------------
Ulna (dominant and non-dominant arm), height measurement in 350 asthmatic children of sub-saharian or caribbean ethnicity (both parents). Repeatability analysis (ulna and height) for the first fifty children. Recording of pulmonary function tests results (spirometry, resistance measurements)

Official Title
-----------------
Prediction of Childhood Pulmonary Function Using Ulna Length in Children of Sub-saharian or Caribbean Ethnicity

Conditions
-----------------
Ulna Length in Otherwise Healthy Children (With the Exception of Mild to Moderate Asthma)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 3 to 18 years old, two parents of sub-saharian or caribbean origin, referred for asthma suspicion or follow-up. Exclusion Criteria: chronic disease excepting asthma, prematurity (<36 GW), steroid (>3/year), high dosage of inhaled steroid

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulna length |  | 12 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ulna; healthy children; height predicted
Sex-Differential Health Interventions In Low-Birth-Weight Infants

Study Overview
=================
Brief Summary
-----------------
Our group has consistently found that the major interventions to reduce morbidity and mortality in low-income countries have sex-differential effects. These interventions include BCG vaccine, oral polio vaccination (OPV), and vitamin A supplementation (VAS). Low-birth-weight (LBW) children constitute the largest high-risk group in low-income countries. According to current policy, they receive OPV at birth. Current evidence suggests that a policy of providing BCG with OPV for girls and VAS instead of OPV for boys at birth may improve survival in LBW neonates. This will be tested in a large randomized trial. We experienced an unexpected cluster of deaths among boys in the VAS arm, which could be due to chance, but we decided to stop randomizing boys to OPV or VAS. Very recent evidence has suggested that low-birth-weight boys may benefit from BCG at birth as well. Hence, we have obtained ethical permission to continue the trial with randomization of boys to OPV or OPV plus BCG.

Official Title
-----------------
Sex-Differential Health Interventions In Low-Birth-Weight Infants

Conditions
-----------------
Mortality, Morbidity, Growth, Neonatal Mortality

Intervention / Treatment
-----------------
* Biological: OPV
* Biological: OPV plus BCG
* Biological: OPV
* Biological: OPV plus BCG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low-birth-weight infants (<2500 g) Exclusion Criteria: Already received BCG/OPV Overtly sick or have malformations at the time of enrolment Clinical signs of vitamin A deficiency (very unlikely)

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Boys 1<br>OPV as usual | Biological: OPV<br> <br> |
| Experimental: Boys 2<br>OPV plus BCG | Biological: OPV plus BCG<br> <br> |
| Active Comparator: Girls 1<br>OPV as usual | Biological: OPV<br> <br> |
| Experimental: Girls 2<br>OPV plus BCG | Biological: OPV plus BCG<br> <br> |

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall severe morbidity as measured by number of hospitalizations |  |  | 
| Morbidity due to rotavirus and malaria |  |  | 
| Growth |  |  | 
| BCG scar formation and PPD delayed type hypersensitivity (DTH) response |  |  | 
| Changes in cytokine profile |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BCG vaccine, Oral polio vaccine, Vitamin A supplementation, Low-birth-weigth, Sex-differential, Prevention, Immunological parameters