linjc16/ctgov huggingface dataset:
Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The study is a prospective field evaluation to assess the effects of the chronic Intermittent Hypoxia exposure in 12 healthy humans. Precisely, the study was designed to : Set up a new model of Chronic Intermittent Hypoxia (CIH) applied to healthy human. This CIH is mimicking the CIH undergone by patients suffering from Sleep Apnea Syndrome. Evaluate the cardiovascular effect of CIH. Neuronal and humoral sympathetic control, blood pressure control, vascular resistance. Evaluate the Sleep quality, the ventilation under exposure and the long terms effect on ventilation control of CIH (central and peripheral chemoreflex). Investigates the biological aspects of CIH exposure.

Official Title
-----------------
Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects

Conditions
-----------------
Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Other: Chronic Intermittent Hypoxia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Exclusion Criteria: Any history or significant medical condition

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Chronic Intermittent Hypoxia|Chronic Intermittent Hypoxia mimicking the CIH undergone by patients suffering from Sleep Apnea Syndrome, is applied to Healthy subject during 8 hours a day (nights) for a 14 days period. The cycle of intermittent Hypoxia is 30 drop in SaO2 per hours with a 10% decrease in SaO2.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | Two Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuronal and humoral sympathetic control and vascular resistance. |  | Two weeks | 
| Sleep quality |  | Two Weeks | 
| The ventilation under exposure and the long terms effect on ventilation control of CIH (central and peripheral chemoreflex) |  | two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood pressure, Hypertension, sympathetic control, chemosensitivity, baroreflex
A Continuous Glucose Monitor Based Insulin Bolus Calculator (CGM-IBC) Study B

Study Overview
=================
Brief Summary
-----------------
This study examines the safety of an app-based insulin bolus calculator that utilizes glucose values from a continuous glucose monitor.

Detailed Description
-----------------
Individuals with type 1 diabetes and those with type 2 diabetes who are prescribed bolus insulin must decide on an insulin dose for any given meal. This dose is often based on what they are eating and their glucose value. Insulin bolus calculators may be helpful in recommending an insulin dose. This study examines the safety of an app-based insulin calculator manufactured by Welldoc (Columbia, MD). This app uses the glucose value and trend arrow, in certain circumstances, to recommend a bolus insulin dose. This study is a single arm trial where continuous glucose monitoring metrics such as time in range will be measured before and after the study participants are given the app.

Official Title
-----------------
Safety of a Real-time Continuous Glucose Monitor-based Insulin Bolus Calculator: The CGM-IBC Study B

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: BlueStar 10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or type 2 diabetes using the Dexcom G6 continuous glucose monitor Exclusion Criteria: Pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM insulin bolus calculator arm<br>Participants will use the CGM insulin bolus calculator arm | Device: BlueStar 10<br>* An app that coaches individuals with diabetes and supports insulin-dosing based on continuous glucose monitor data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of time a participant's glucose value is between 70 and 180 mg/dL will not be inferior to baseline. |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
continuous glucose monitor, insulin calculator
Non-interventional Retrospective Multicenter Study of Patients With Bronchial Asthma During a Routine Visit to Out of Patients' Clinics

Study Overview
=================
Brief Summary
-----------------
To assess asthma control in Russian patients according to the new criteria provided in the international guidelines and identify pharmacological approaches that provide a higher level of overall asthma control

Official Title
-----------------
Non-interventional Retrospective Multicenter Study of Patients With Bronchial Asthma During a Routine Visit to Out of Patients' Clinics

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients over 18 years of age Patients with asthma diagnosed in accordance with the Global Initiative for Asthma (GINA [xv]) within 6 months before inclusion into the study. Patients with no changes in their treatment within 2 months before inclusion into the study Patients who signed their informed consents to collection and further processing of data on their disease course Exclusion Criteria: Asthma patients with an exacerbation at the moment of inclusion. Patients on β-blockers. Patients with COPD, mucoviscidosis or bronchiectasis, Severe heart failure (NYHA functional class III-IV), Renal insufficiency, Cancer, Previous stroke. Pregnant women. Patients following a major surgery, Hepatic insufficiency.

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 |
| --- | --- |
| 1<br>Male and female over 18. Patients with asthma diagnosed in accordance with the Global Initiative for Asthma within 6 months before inclusion into the study and without changes in treatment for 2 months before inclusion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess asthma control in Russian patients acc. to the new criteria in the international guidelines (Standardizing Endpoints for Clinical Asthma Trials and Clinical Practice) and identify pharmacological approaches provided a higher level of control |  | 1 visit for 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the main demographic, clinical and pharmacoepidemiological characteristics of low-control patients. |  | 1 visit for 3 month | 
| To assess comparative value of the Asthma Control Questionnaire (ACT) and Asthma Control Questionnaire (ACQ) with regard to their use in clinical practice in Russia |  | 1 visit for 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Asthma in Children
Validation Study of Oral Teleconsultation

Study Overview
=================
Brief Summary
-----------------
In this study we want to evaluate the oral care pathway after an oral teleconsultation.

Detailed Description
-----------------
An oral teleconsultation was proposed to the 461 residents of the public hospital of Uzès. A specifically trained nurse recorded 4 videos (1 per quadrant) per mouth with an intra-oral camera using fluorescent light (Soprocare®) and keyed in information about the resident (general state, identification,…). These data were recorded and sent onto a central secured server, through a specific piece of software (e-DENT®). The dentists from the University Hospital of Montpellier were then able to analyse the videos remotely, make a diagnosis and organise each resident's oral care.

Official Title
-----------------
Validation Study of Oral Teleconsultation - Study EDENT2

Conditions
-----------------
Dental Care

Intervention / Treatment
-----------------
* Other: teleconsultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is aged at least 18 years Patients cared for in their host institution Exclusion Criteria: NA

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 |
| --- |
|Other: teleconsultation|Patients performing oral care required as a result of their diagnosis by teleconsultation in vulnerable populations (elderly, disabled adults).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic of caries | Teleconsultation will be made using a specific camera SoproCare®6, the company Acteon | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic of caries | Teleconsultation will be made using a specific camera SoproCare®6, the company Acteon | 6 months |
Active Vitamin D Effect on Left Ventricular Hypertrophy

Study Overview
=================
Brief Summary
-----------------
Left ventricular hypertrophy (LVH) predicts mortality at start of dialysis. Prevention of of LVH is important. It is not known whether secondary hyperparathyroidism might induce LVH. In the present study patients are randomised to 1.25 dihydroxycholecalciferol or no treatment to study the effect on LVH.

Official Title
-----------------
The Efficacy of 1,25 Dihydroxycholecalciferol on the Cardiovascular System in Patients With Renal Dysfunction

Conditions
-----------------
Chronic Kidney Disease, Secondary Hyperparathyroidism, Left Ventricular Hypertrophy

Intervention / Treatment
-----------------
* Drug: Alfacalcidiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic kidney disease (S-creatinin > 150 and < 600 mikroM) Secondary hyperparathyroidism (Between 3-8 times the upper limit of our PTH assay) Stable blood pressure during the last 6 months (less than (160/95) B-hemoglobin > 6 mmol/l EKG with sinus rhythm and no sign of Q-wave infarction Expected follow up 6 month Exclusion Criteria: Pregnancy Kidney transplantation Malignant disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Given alfacalcidiol. Dose adjusted after PTH level | Drug: Alfacalcidiol<br>* Alfacalcidiol are given to patientwith CKD 3-4 and secondary hyperparathyrodism. The PTH level is lowered to normal range. with increasing dose of alfacalcidiol and are followed for 6 month.<br>|
| No Intervention: 2<br>The untreated arm | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of dihydroxycholecalciferol on left ventricular hypertrophy |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the activity of the renin-angiotensin system |  | 6 month | 
| Changes in left ventricular function |  | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD 3-4
Study About Effect of Saxagliptin on Circulating Endothelial Progenitor Cells and Endothelial Function in Newly Diagnosed Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators aim to investigate whether saxagliptin modulate endothelial progenitor cells number and flow-mediated dilation in newly diagnosed, treatment-naive type 2 diabetic patients.

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: saxagliptin
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed type 2 diabetics (diagnosis were made according to the American Diabetes Association Guideline [19] ), treatment naive, age 30-75, hemoglobin A1c (HbA1c) ≥6.5%, fasting c-peptide >1.0ng/L Exclusion Criteria: pregnancy or lactation, smoker, acute disease or infection, chronic renal disease (estimated glomerular filtration rate <60 mL/min/1.73m2), live enzymes 3 times above the normal range, positive islet autoantibody, fasting c-peptide <1.0ng/L, severe hypertriglyceridemia (triglyceride >5.6mmol/L), cardiovascular events or surgery within 3 months, taking glucocorticoid, history of acute or chronic pancreatitis, pancreatic tumor, severe cardiac or pneumonic disease.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: saxagliptin group<br>saxagliptin group consumed saxagliptin 5mg per day for 12 week | Drug: saxagliptin<br>* 5mg per day for 12 weeks<br>|
| Active Comparator: metformin group<br>metformin group consumed metformin 1500mg per day for 12 week | Drug: Metformin<br>* 1500mg per day for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial progenitor cell |  | 12weeks | 
| flow-mediated dilation |  | 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 12weeks | 
| fasting blood glucose |  | 12weeks | 
| 2 hour postprandial blood glucose |  | 12weeks | 
| liver function test |  | 12weeks | 
| renal function test |  | 12weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
saxagliptin, endothelial progenitor cell, flow-mediated dilation
An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates

Study Overview
=================
Brief Summary
-----------------
This is a phase I open label multi-dose study to investigative the pharmacokinetics and safety of cefazolin in infants <121 days of age and < 28 weeks gestation with suspected sepsis. There will be two cohorts of 6 infants each: 1) >48 hours of age and ≤28 days and 2) >28 days of age and <121 days of age. The study requires administration of the study drug over 2 days followed by 1 week of safety monitoring. Six 200 µL pK samples will be obtained over the 2 days of drug administration. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of empirical antimicrobial therapy), and information from the study may benefit a large number of other infants in whom the drug is currently being administered despite the lack of PK data in this population.

Official Title
-----------------
An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates

Conditions
-----------------
Sepsis, Prematurity

Intervention / Treatment
-----------------
* Drug: cefazolin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: < 28 weeks gestation at birth > 48 hours and <121 days of age at the time of study drug administration One of the following: Suspected systemic infection Receiving cefazolin for prophylaxis Receiving cefazolin treatment of a systemic infection Exclusion Criteria: History of anaphylaxis attributed to a β-lactam Exposure to cefazolin in the month prior to study Serum creatinine > 1.7 mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 48 Hours
Maximum Age: 120 Days

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: Cefazolin<br>Dosage Number of Infants ≤28 days of age 25 mg/kg IV q12 6 29-120 days of age 25 mg/kg IV q8 6 | Drug: cefazolin<br>* Cefazolin dosing - administered for 48 hours Dosage ≤28 days of age 25 mg/kg IV q12 29-120 days of age 25 mg/kg IV q8<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cefazolin pharmacokinetics including half life, clearance, and volume of distribution |  | Dose 1 and Dose 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 7 days following last dose of cefazolin |
Fibre Specific Signalling in the Locomotor Myopathy of Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Skeletal muscle is composed of two fibre types which are intertwined. Skeletal muscle weakness, particularly of the walking muscles, is an important complication of Chronic Obstructive Pulmonary Disease (COPD) but so far the investigators do not know what mechanisms drive the process. All existing studies have investigated signalling pathways in the whole muscle so they have been forced to consider type I and type II fibres together. It is possible that disease selectively affects one fibre type, most likely type I fibres which are in fact lost in COPD patients. For this reason mechanisms of disease may have been overlooked by current studies. The applicants have acquired the technology which allows type I and type II fibres in a muscle specimen to be split (by laser capture microdissection) and so signalling pathways can be assessed separately in type II and type I fibres which is what this proposal sets out to do. The proposal therefore aims to capture well characterised clinical data from 60 COPD patients and 20 age matched controls, from whom a biopsy of the main walking muscle, the quadriceps, will be taken. In the samples the investigators will assess at a fibre specific level inflammatory signalling. Surplus material will be retained for subsequent fibre specific analysis.

Official Title
-----------------
Fibre Specific Signalling in the Locomotor Myopathy of COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 40 - 90 years inclusive. A clinical diagnosis of COPD based on spirometry (FEV1/FVC ratio < 70% on entry to the study with FEV1 < 80% predicted) Exclusion Criteria: History or current diagnosis of alpha 1-anti-trypsin deficiency, asthma, lung cancer, bronchiectasis or other significant respiratory disease (including treated TB in the past 10 years) Contraindication to biopsy for research purpose (e.g. use of anticoagulant in the 1 week prior to biopsy) Joint or neurological disease which on its own would preclude exercise

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- |
| Patients with COPD<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory signalling at a fibre specific level |  | 2 years |