linjc16/ctgov huggingface dataset:
Errors in the Use of Turbuhaler and Spiromax Devices Patients With Asthma

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the errors that may occur during inhalation of two devices in patients with asthma, as well as to study whether it relates to the degree of control of patient symptoms and the degree of compliance of medication symptoms. Finally, we also want to study the degree of patient satisfaction with each of the inhalers studied

Official Title
-----------------
Errors in the Use of Turbuhaler and Spiromax Devices Patients With Asthma

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

Intervention / Treatment
-----------------
* Device: TURBUHALER®
* Device: SPIROMAX®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of asthma with treatment indication with CI + LABA according to GINA 2015 guide and in dry powder device. Over 18 years. Patient in stable phase without having had exacerbations in the 3 months previous to the Inclusion in the study Exclusion Criteria: Presence of relevant respiratory disease other than asthma (including COPD). Refusal to participate in the study and sign informed consent or inability to To give informed consent. Patients who have previously been treated with inhaled dust devices dry.

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 asthma with an inhaled steroid<br>Patients with a diagnosis of asthma with indication of Treatment with an inhaled steroid (CI) | Device: TURBUHALER®<br> <br> |
| Patients with asthma with an inhaled Beta agonist<br>Patients with a diagnosis of asthma with indication of Treatment with an inhaled Beta agonist (LABA) | Device: SPIROMAX®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of inhaler management. | The effectiveness of inhaler management, It will be the comparison of the means of the number of errors detected between both devices. | two months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, devices
Intranasal Steroids and the Nasal Ocular Response

Study Overview
=================
Brief Summary
-----------------
Eye symptoms of tearing, redness and itch frequently occur in patients with allergic rhinitis or hayfever. The purpose of this study is to learn whether placing allergen (the substance that causes allergies) in the nose several days in a row will cause an increase in eye symptoms and whether receiving a nasal steroid spray will prevent these eye symptoms.

Official Title
-----------------
Intranasal Steroids Prevent Antigen-Induced Hyperresponsiveness of the Nasal Ocular Response

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

Intervention / Treatment
-----------------
* Drug: fluticasone furoate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Males and females between 18 and 45 years of age. History of grass and/or ragweed allergic rhinitis. Positive skin test to grass and/or ragweed antigen. Positive response to screening nasal challenge. Exclusion Criteria Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. Pregnant or lactating women. Upper respiratory infection within 14 days of study start.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluticasone furoate|corticosteroid nasal spray|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ocular symptoms |  | between days 1 and 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of eosinophils |  | between days 1 and 3 |
The Glycemic and Insulinemic Responses Elicited by Meals Containing Whole Grain Rye Bread or White Wheat Bread

Study Overview
=================
Brief Summary
-----------------
This is a postprandial study with healthy volunteers. The glycemic and insulinemic responses elicited by meals containing either whole grain rye bread or white wheat bread as such or combined with margarine and ham and vegetable soup are compared. Blood glucose concentrations are monitored from finger prick blood samples collected before the meal and at 15, 30, 45, 60, 90 and 120 min. Venous samples for insulin concentrations are taken at time-points 0, 30 and 60 min.

Official Title
-----------------
The Effects of Margarine and Ham or Vegetable Soup on the on the Glycemic and Insulinemic Responses Elicited by Whole Grain Rye Bread or White Wheat Bread

Conditions
-----------------
Blood Glucose Concentration

Intervention / Treatment
-----------------
* Other: Wheat bread
* Other: margarine
* Other: ham
* Other: soup
* Other: rye bread


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female BMI 18-27 kg/m2 Exclusion Criteria: pregnant or breastfeeding diabetes, gastrointestinal disease regular use of medication strict vegetarian or vegan diet food allergy recent blood donation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wheat bread<br>Bread-based meal | Other: Wheat bread<br> <br> |
| Experimental: Wheat bread with margarine and ham<br>Bread-based meal | Other: Wheat bread<br> <br> Other: margarine<br> <br> Other: ham<br> <br> |
| Experimental: Wheat bread with margarine, ham and soup<br>Bread-based meal | Other: Wheat bread<br> <br> Other: margarine<br> <br> Other: ham<br> <br> Other: soup<br> <br> |
| Experimental: Rye bread<br>Bread-based meal | Other: rye bread<br> <br> |
| Experimental: Rye bread with margarine and ham<br>Bread-based meal | Other: margarine<br> <br> Other: ham<br> <br> Other: rye bread<br> <br> |
| Experimental: Rye bread with margarine, ham and soup<br>Bread-based meal | Other: margarine<br> <br> Other: ham<br> <br> Other: soup<br> <br> Other: rye bread<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose concentration |  | 120 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum insulin concentration |  | 60 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carbohydrate, Glycemic response, insulin, whole grain, meal
Multiple-dose,Double-blind,Placebo-controlled Study of Sodium Oxybate in Patients With Essential Tremor

Study Overview
=================
Brief Summary
-----------------
To determine the relationship between drug plasma levels and safety, tolerability and efficacy in patients with essential tremors after dosing with Sodium oxybate

Official Title
-----------------
Multiple-dose, Double-blind, Placebo-controlled, Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Sodium Oxybate (Xyrem) in Subjects With Moderate to Severe Essential Tremor

Conditions
-----------------
Essential Tremor

Intervention / Treatment
-----------------
* Drug: Sodium Oxybate
* Drug: Sodium Oxybate
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of moderate or severe classic essential tremor (bilateral, largely symmetric postural or kinetic tremor involving hands and forearms. Willingness to abstain from ethanol and caffeine intake for at least 48 hours prior to Days 1 and 4 and on inpatient days Exclusion Criteria: Subjects with a clinically significant unstable medical abnormality, chronic disease or history or presence of significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, psychiatric, or metabolic disease or any other abnormality Subjects who are on sodium-restricted diets Subjects with a known history of sleep apnea

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Sodium Oxybate<br>* Dose 1<br>|
| Experimental: 2<br> | Drug: Sodium Oxybate<br>* Dose 2<br>|
| Placebo Comparator: 3<br> | Other: Placebo<br>* Dose 3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified FTM(Fahn-Tolosa-Marin) Essentials Tremor Rating Scale, Sum of All Essential Rating Tremor Scales Including Voice Tremor | The modified FTM sum of all essential rating tremor scales including voice tremor includes: the tremor rating taken for the left & right hands individually at rest, with posture (arms outstretched), with action (finger to nose). It also includes an evaluation of voice with scores for AAA & EEE sounds, an action evaluation of left & right hands pouring, bringing liquids to mouth, drawing large & small spirals. Scores for indiviuals items range from 0 (no tremor) to 4 (severe tremor). The sum ranges from 0 (no tremor) to 72 points (higher amplitude/more tremors). | Hour 1 |
Haemodynamics Variations of Transcutaneous Oxygen in Patient With Areterio-venous Leg Ulcers Under Venous Compression

Study Overview
=================
Brief Summary
-----------------
Arterio-venous leg ulcers are real problems when it comes to public health because it has a major cost and leads to social and professional handicap. The management of leg ulcers is not clear and can be venous compression or surgery. The aim of the study is to evaluate the variation of the transcutaneous oxygen with compression. The second aim is to see how tolerate is the compression and the quality of life.

Official Title
-----------------
Haemodynamics Variations of Transcutaneous Oxygen in Patient With Arterio-venous Leg Ulcers Under Venous Compression (COMPULCE Study)

Conditions
-----------------
Leg Ulcer, Compression; Vein

Intervention / Treatment
-----------------
* Device: venous compression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age eighteen or more leg arteio-venous ulcers Exclusion Criteria: age Under eighteen, Index pressure in the ankle Under 0.5
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: arterio venous leg ulcers<br> | Device: venous compression<br>* venous compression<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| haemodynamic variation of the transcutaneous oxygen | measurement of the transcutaneous oxygen during two different appointement using a transcutaneous monitor TCM4 | 1 month |
Durability of Nevirapine-Based Antiretroviral Regimen

Study Overview
=================
Brief Summary
-----------------
Although nevirapine is used as an alternative to efavirenz for initial regimen in developed countries, nevirapine has still been a key antiretroviral drug in many resource-limited countries including Thailand due to its accessibility and affordability. In addition, a component of stavudine and lamivudine is still widely used as a backbone in the antiretroviral regimen in this setting.To date, data on the durability of a regimen of stavudine, lamivudine and nevirapine are very limited, particularly from the resource-limited settings.

Official Title
-----------------
Durability of Stavudine, Lamivudine and Nevirapine Among Advanced HIV-1 Infected Patients With/Without Prior Co-Administration of Rifampicin: A 144-Week Prospective Study

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: nevirapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected individuals ≥15 years of age CD4 cell count <350 cells/mm3 Willing to participate and give consent form Exclusion Criteria: previous antiretroviral therapy pregnancy receiving a medication that has drug-drug interactions with NVP or RFP aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >5 times of upper limit of normal range

Ages Eligible for Study
-----------------
Minimum Age: 15 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

| Intervention/Treatment |
| --- |
|Drug: nevirapine|200 mg/day twice a day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with undetectable plasma HIV-1 viral load |  | 240 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, nevirapine, durability, AIDS, Treatment Naïve
Comparison of the Efficacy and Tolerability of T1210 and Olopatadine Hydrochloride 0.1% in the Treatment of Seasonal Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the efficacy and the safety of T1210 versus Olopatadine eye drops in the topical treatment of seasonal allergic conjunctivitis.

Conditions
-----------------
Seasonal Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: T1210
* Drug: Olopatadine hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Conjunctivitis allergic conjunctivitis Exclusion Criteria: Severe ocular allergy Vernal keratoconjunctivitis

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T1210<br> | Drug: T1210<br>* 2 drops T1210 once a day<br>|
| Active Comparator: Olopatadine hydrochloride<br> | Drug: Olopatadine hydrochloride<br>* 2 drops once a day Olopatadine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the score of tearing |  | Day 28 | 
| Change from baseline of the score of itching |  | Day 28 | 
| Change from baseline of the score of conjunctival hyperaemia |  | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global local tolerance assessment by the Investigator and the patient |  | Day 7 | 
| Global local tolerance assessment by the Investigator and the patient |  | Day 28 |
Study on the Frequency of de Novo Atrial Fibrillation in Septic Shock in Medical Intensive Care

Study Overview
=================
Brief Summary
-----------------
The aim of this pilot study is to determine, as exhaustively as possible thanks to the continuous and precise recording of heart rhythm, the frequency of de novo atrial fibrillation in septic shock, which is currently unknown, and to identify specific factors that could be associated with the condition. These will be investigated more precisely in a future study. This constitutes the first step in a reflection on the management of Cardiac Arrhythmia by Atrial fibrillation (ACFA) in septic shock in Medical Intensive Care, known as a major prognostic factor for morbimortality, but for which management is uncertain in the absence of reference data.

Official Title
-----------------
Prospective Study on the Frequency of de Novo Atrial Fibrillation in Septic Shock in Medical Intensive Care

Conditions
-----------------
Septic Shock, Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: Holter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients in septic shock (defined as hypotension that is not reversed by fluid resuscitation and requires the use of vasopressor agents) hospitalized in Medical intensive care Patients with national health insurance cover Age: at least 18 years with no upper limit Exclusion Criteria: Transferred from another intensive care unit for septic shock Adults under guardianship History of atrial fibrillation

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Septic shock<br> | Other: Holter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation diagnosed on a Holter recording |  | Over 7 days following the onset of septic shock, or until death or discharge, if one of these events occurs in the 7 days following the onset of the shock. |
Efficacy of Periodontal Treatment on Glycaemic Control in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy of periodontal treatment in diabetic patient. Patients will be randomized in the periodontal group or in the control group. The control group will received a periodontal treatment after the study.

Official Title
-----------------
Efficacy of Periodontal Treatment on Glycaemic Control in Diabetic Patients

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Other: periodontal manual treatment
* Other: no periodontal manual treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient suffering from a periodontitis patient with : 7,0% < Hemoglobin A1c < 9,5% Exclusion Criteria: If an hospitalization is planned within the next 4 months Patient suffering from chronic infectious pathology (HIV, hepatitis C virus, hepatitis B virus, mononucleosis) Renal insufficiency Contra indication for amoxicilline or clindamycin Antithrombotic treatment Liver disease
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: case<br>diabetic patients who will receive periodontal treatment blood sampling | Other: periodontal manual treatment<br>* periodontal manual treatment<br>|
| Experimental: control<br>diabetic patients without periodontal treatment (no periodontal treatment) blood sampling | Other: no periodontal manual treatment<br>* blood sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c blood level | efficacy of periodontal treatment on hemoglobin A1c | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetic patients, periodontal treatment, glycaemic control
Study of Postprandial Incretin Response in Women With Gestational Diabetes

Study Overview
=================
Brief Summary
-----------------
The researchers investigated nineteen pregnant women in third trimester and again postpartum. At the experimental days we performed a mealtest and drew blood for analyses of glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), insulin, C-peptide and glucagon. The researchers aimed to investigate whether women with gestational diabetes mellitus exhibit decreased postprandial GLP-1 responses, and if so, whether this deficiency ceases following delivery when normal glucose tolerance is reestablished.

Detailed Description
-----------------
The researchers investigated nineteen pregnant women in third trimester and again postpartum. At the experimental days we performed a mealtest and drew blood for analyses of glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), insulin, C-peptide and glucagon. The researchers aimed to investigate whether women with gestational diabetes mellitus exhibit decreased postprandial GLP-1 responses, and if so, whether this deficiency ceases following delivery when normal glucose tolerance is reestablished.

Official Title
-----------------
Reduced Postprandial GLP-1 Response in Gestational Diabetes Mellitus: a Fully Reversible Phenomenon

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

Intervention / Treatment
-----------------
* Other: Meal test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal haemoblobin Willingness to participate Exclusion Criteria: First degree relative with diabetes Diabetes before pregnancy Positive islet cell- and GAD-65 autoantibodies
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gestational Diabetes Mellitus<br>Women with Gestational Diabetes Mellitus | Other: Meal test<br>* Liquid meal test<br>|
| Normal Glucose Tolerance<br>Women with Normal Glucose Tolerance | Other: Meal test<br>* Liquid meal test<br>|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gestational diabetes mellitus, Meal test, Incretin hormones, Glucagon-like peptide-1 (GLP-1), Glucose-dependent insulinotropic polypeptide, Insulin, C-peptide, Glucagon