linjc16/ctgov huggingface dataset:
Effects of Obstructive Sleep Apnea and/or Cigarette Smoking on Endothelial Function

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that either obstructive sleep apnea (OSA) or cigarette smoking (CS) exposure would produce oxidative stress and inflammation leading to endothelial injury, and the combined exposure would be additive or synergistic.

Official Title
-----------------
Effects of Intermittent Hypoxia and/or Cigarette Smoking on Endothelial Injury in Vivo - Relevance to Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea, Smoking

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No acute illness No hospitalization in past 4 weeks Absence of medical comorbidity such as hypertension, ischemic heart disease, diabetes and hyperlipidemia, renal impairment, vasculitis or Raynaud's syndrome, peripheral vascular disease especially Buerger's disease, aortic disease (aortic aneurysm or dilatation), cancer, thrombocytopenia, coagulation disorder or other chronic medical illness Exclusion Criteria: Mentally incapacitated

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 |
| --- | --- |
| smoker, with high apnea-hypopnea index<br>subjects who smoke either in the past or currently, with confirmed moderate-severe OSA | |
| smoker, mild OSA or without OSA<br>subjects who smoke either in the past or currently, with mild OSA or without OSA | |
| nonsmoker, with high apnea-hypopnea index<br>subjects who never smoke, with confirmed moderate-severe OSA | |
| nonsmoker, with mild OSA or without OSA<br>subjects who never smoke, with mild OSA or without OSA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reactive hyperemia induced peripheral arterial tone (RH-RAT) index |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| circulatory metabolic and vascular inflammatory biomarkers |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endothelial function
Bleeding Risk in CVCs

Study Overview
=================
Brief Summary
-----------------
Since many of the patients in an intensive care unit suffer from disorders of hemostasis, bleeding is a main concern applying central venous catheters. Even if there are some data indicating elevated international normalized ratio may not increase the risk of bleeding no clear cut-off has been defined so far. An INR > 1.5 is generally considered to increase the risk of bleeding. Furthermore, many authors consider platelets below 50 x 109 /l as a contra-indication to CVC cannulation, since there are some data this may increase the risk of bleeding. Therefore platelet transfusion before venous puncture is suggested. In our clinical experience INR > 1.5 and platelets < 50 x 109 /l do not correlate with increased risk of bleeding. The aim of this study is to demonstrate, that coagulopathy, defined by INR and platelet count, is not decisive for bleeding.

Official Title
-----------------
Thrombocytes and International Normalized Ratio Are no Predictors for Bleeding in Application of Central Veneous Catheters

Conditions
-----------------
Bleeding

Intervention / Treatment
-----------------
* Procedure: central venous catheter application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients acquiring a central venous catheter Exclusion Criteria: Patients pre or post surgery Patients with bleeding due to other reason

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: central venous catheter application|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding within 24 hours after cvc application |  |  | 
| other complications within the first 24 hours |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  |  | 
| long-term complications |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
central venous catheter, international normalized ratio, thrombocytes, bleeding risk, all patients in need of central venous line, comparison of patients with normal hemostasis to such with disorders in hemostasis
Regulated Negative Pressure-Assisted Wound Therapy Device

Study Overview
=================
Brief Summary
-----------------
Regulated negative pressure-assisted wound therapy (RNPT) is regarded as a gold standard technology for treatment of various chronic and acute wounds. The investigators plan to evaluate the efficacy and ease of use of this device.

Conditions
-----------------
Negative-Pressure Wound Therapy

Intervention / Treatment
-----------------
* Device: Regulated Negative Pressure-Assisted Wound Therapy Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic or acute wounds Exclusion Criteria: Uncontrolled bleeding Neoplasms in wound Exposed blood vessels Exposed internal organs

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

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigated Wounds<br> | Device: Regulated Negative Pressure-Assisted Wound Therapy Device<br>* Negative pressure will be applied in the usual way that is normally applied in our Medical Center<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Measurement of change in wound size | Ten days |
Copeptin Changes After Food Intake

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether copeptin levels are affected by food intake.

Official Title
-----------------
Copeptin During a Standardized Oral Glucose Tolerance Test and a Mixed Meal Tolerance Test

Conditions
-----------------
Healthy Adults, Copeptin

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged over 18 years Exclusion Criteria: Intake of any kind of medication (except birth control pill) BMI >30 kg/m2 Evidence of any acute illness History of chronic illness Pregnancy Known galactosemia or maltose malabsorption Baseline glucose level >5.5 mmol/l Baseline sodium level <135 mmol/l or >145 mmol/l

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in copeptin levels after intake of a oral glucose tolerance test- and a mixed meal tolerance test liquid |  | 30, 60, 90, 120, 180 minutes after intake of the test liquids | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Copeptin, eating, glucose tolerance test, mixed meal test, physiological
Day to Day Variation in Fetal Heart Rate Variability

Study Overview
=================
Brief Summary
-----------------
This study evaluates the day-to-day variation in fetal heart rate variability based on non-invasive fetal-ECG (NI-FECG). Furthermore, the effect of fetal movements on fetal heart rate variability will be assessed.

Official Title
-----------------
Day to Day Variation in Fetal Heart Rate Variability Based on Fetal Electrocardiography (FECG), in a Standardized Setting: A Cohort Study

Conditions
-----------------
Fetal Growth Retardation

Intervention / Treatment
-----------------
* Diagnostic Test: fetal heart rate variability


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy singleton pregnant women with an expected healthy fetus Exclusion Criteria: fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor. Low birth weight or malformation diagnosed at birth.
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: fetal heart rate variability|An observational study. No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Root mean square of successive inter beat interval differences (RMSSD) | Time domain analysis | 1/8-2020 | 
| Standard deviation of normal to normal inter beat interval (SDNN) | Time domain analysis | 1/8-2020 | 
| High frequency power (HF-power) | Spectral analysis | 1/8-2020 | 
| Low frequency power (LF-power) | spectral analysis | 1/8-2020 | 
| Low frequency power/High frequency power (LF/HF) | Spectral analysis | 1/8-2020 |
Detection of Propofol in Exhaled Breath

Study Overview
=================
Brief Summary
-----------------
This study involves the use of an experimental device which will measure how much propofol is present in your exhaled breath during surgery compared to how much is in your blood. The study results will look at whether the device is as accurate as conventional methods for measuring propofol levels during surgery.

Official Title
-----------------
Propofol in Exhaled Breath: Real-time Detection by Surface Acoustic Wave Sensors.

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

Intervention / Treatment
-----------------
* Other: High-performance liquid chromatography Analysis
* Device: SMART Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be between 18 and 65 years old Healthy Male or Female BMI between 18.5 and 30.0 Have a planned surgery or other medical procedure requiring anesthesia Physical status ASA I, II, or III Exclusion Criteria: Known allergy to any component of propofol formulation components History of lung disease or tobacco use in the past 5 years Any finding not detailed above encountered on medical history or during screening physical and clinical laboratory examinations that, in the investigators judgment, might place the subject at unacceptable risk for injury during study participation

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol<br>Subjects will be given Propofol during routine surgery and then using the SMART Device the breath will be captured and compared to blood plasma using High-performance liquid chromatography Analysis. | Other: High-performance liquid chromatography Analysis<br>* Blood samples will be collected for HPLC analysis to compare with the breath samples.<br>Device: SMART Device<br>* Breath collection for GC-MS analysis to compare with Blood collection.<br>* Other names: SMART Breath Based Monitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of propofol concentrations in exhaled breath to those in plasma | Measure and compare propofol concentrations in exhaled breath to those in plasma in human patients anesthetized with propofol. Samples of the exhaled breath from patients will be monitored using the SAW Sensor and collected onto Tenax TA Tubes for analysis by Thermal Desorption GC/MS (using the method described by Grossher et al.) | Sampling will occur every 2 minutes after anesthetic induction up to 10 minutes and then every 5 minutes thereafter up to 1 hour. |
Reassessment of the Nutritional Status in Thai Orphans Living With HIV in a Family Style Community

Study Overview
=================
Brief Summary
-----------------
To reassess nutritional status of HIV-infected Thai children living in the family style community after receiving nutrition support program for 6 months.

Detailed Description
-----------------
The first assessment indicated that improving dietary intake, either energy or micronutrient intakes, to meet the recommended for HIV-infected children (CLHIV) would be able to improve growth of these children. We implemented the nutrition support program through the two strategies aiming to increase dietary intake for all children to meet the current World Health Organization (WHO) recommendations which the recommended energy requirements are increased by10% for asymptomatic CLHIV and increased by 20 to 50% for children who require catch up growth or experiencing opportunistic infections. The nutrition support program composed two strategies. Firstly is providing nutrition education to caregivers and also children. Secondly, revision food menus by caregivers with assisting from the nutritionists of the project. After this program have been implemented for 6 months, reassessment is needed to evaluate the changes of nutritional status and health outcomes in this children aiming to further providing support and applying to other settings.

Official Title
-----------------
Reassessment of the Nutritional Status in Thai Orphans Living With HIV in a Family Style Community: 6 Months After Nutrition Care Support by the Thai-Australian Collaboration HIV-Nutrition (TACHIN) Project

Conditions
-----------------
HIV Infection, HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children age 4-15 years old Confirmed HIV-1 diagnosis Reside at the community The guardian must be able and willing to provide written informed consent. Oral consent in the presence of witness is acceptable in the case of illiteracy Exclusion Criteria: non-HIV infected children Age 0-3 years

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 15 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 |
| --- | --- | --- |
| Growth parameters (weight and height), blood lipid levels and dietary intakes |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity, CD4, HIV-RNA and satisfaction of caregivers and children |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutritional status, Thai HIV-infected children
INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique

Study Overview
=================
Brief Summary
-----------------
Evaluate the efficacy of the Inspiron Sirolimus Eluting Stent on bifurcation coronary artery lesions, in order to preserve and not compromize the side branch using the provisional stent technique.

Official Title
-----------------
INSPIRON Sirolimus Eluting Stent Performance in Bifurcation Coronary Arteries Treated Using Provisional Technique

Conditions
-----------------
Bifurcation Lesion, Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Inspiron Sirolimus Eluting Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with coronary artery disease on bifurcation anatomy with indication of drug eluting stent implantation , on which the side branch is ≥ 2.5 mm diameter and ostial stenosis ≤50% (Medina 1-1-0, 1-0-0, 0-1-0). Exclusion Criteria: Acute Myocardial Infarction (STMI); Chronic occlusion; Cardiogenic shock; Ejection fraction ≤ 20%; Thrombocytopenia (≤ 50 mil); DAPT contraindication; Life expectancy of less than 12 months.

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 |
| --- | --- |
| Treatment<br>Bifurcation lesion treatment using provisional stent technique | Device: Inspiron Sirolimus Eluting Stent<br>* Bifurcation treatment using provisional stent technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Stenosis | % of stenosis on side branch after stent placement on main vessel | day 0 |
Cardiovascular Risk Assessment in Patients Treated With Caduet

Study Overview
=================
Brief Summary
-----------------
Compare the reduction in Framingham's predicted 10-year risk of a coronary event (6) in patients with hypertension and at least three other cardiovascular risk factors (including diabetic patients) seen in private practice and randomized to either Caduet or usual care.

Official Title
-----------------
Cardiovascular Risk Assessment In Patients With Hypertension And At Least Three Other Risk Factors, Treated With Caduet Compared To Usual Care: The Right Study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Procedure: Blood pressure measurements
* Procedure: Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Male or female, 18 years of age or over, 2.Patient with hypertension and at least three other CV risk factors, 3.Hypertension, treated or not, but not at the currently recommended goals (140/90 mmHg for most patients, 130/80 mmHg for patients with diabetes or nephropathy). In case of treated hypertension, patients should be on their current treatment for at least 4 weeks before randomisation, Exclusion Criteria: 1. Patient with a history of coronary heart disease, 2.Patients with a history of familial hypercholesterolemia, 3.Patient with malignant HTN, 4.Non-essential hypertension, 5.Known hypersensitivity to dihydropyridines, 6.Patients already receiving a dihydropyridine, 7.Known hypersensitivity to HMG-CoA-reductase inhibitors, 8.Patients currently receiving or who has received a HMG-CoA-reductase within the 3 months prior to selection, 9.Patients currently receiving or who has received a fibric acid, resins, ezetimibe, nicotinic acid and all other drug which is known to affect lipid levels, within 6 weeks prior to selection,

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood pressure measurements|nan|
|Procedure: Blood samples|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % reduction in Framingham's predicted 10-year risk of a coronary event between V1 and V3 in the Caduet group compared to the usual care group (6) (including diabetic patients) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. % patients changing risk category between V1 and V3 2. % reduction in Framingham's predicted 10-year risk of a coronary event (8) excluding diabetic patients 3. Clinical and biological safety during treatment period |  |  |
Cohort of Non-small Cell Lung Cancer With Mutation of the Nord Pas de Calais (CB(NPC)²)

Study Overview
=================
Brief Summary
-----------------
The investigators propose to create a database at the regional level, the principle is to include all patients in whom a mutation was detected from a single platform (Lille). The creation of this regional cohort, smaller than the national cohort of Biomarkers France, will perform a more comprehensive collection of clinical data, and molecular monitoring data of patients included. To increase the completeness of the collection of information, it will not be based on voluntary prescribing clinician but will be largely carried out by CRA dedicated to this activity.

Detailed Description
-----------------
This is a prospective and retrospective study of a population of patients with mutated non-small cell lung cancer in the Nord Pas de Calais. Retrospective cohort will involve patients with main molecular abnormalities, identifiable from molecular biology platform CRRC, except EGFR and KRAS treated from September 2011 to February 2013.

Official Title
-----------------
Cohort of Non-small Cell Lung Cancer With Mutation of the Nord Pas de Calais

Conditions
-----------------
Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥ 18 years old Patient with non-small cell lung cancer Detected in the Nord Pas de Calais Monitored in the Nord Pas de Calais Patient must have signed a non-opposition form to the use of medical data Exclusion Criteria: - No identified mutation

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 |
| --- | --- | --- |
| Correlation between clinical factors and mutation status | The clinical factors are age, smoking status, occupational and environmental exposure, personal and family background, TNM stage, performance status | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 3 years | 
| Overall survival |  | 3 years | 
| Number of patients included in a clinical trial dedicated to a certain type of non-small cell lung cancer with mutation |  | 3 years | 
| Number of cases per mutation type |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mutation