linjc16/ctgov huggingface dataset:
Reduction of Environmental Tobacco Smoke (ETS) Exposure at Home: the BIBE Study

Study Overview
=================
Brief Summary
-----------------
Main objective: to determine the effectiveness of a brief opportunist educational performance directed to the parents who smoke -- inside the context of programmed visits of paediatrics in primary care -- to reduce the exposure of the babies to secondhand smoke (SHS) Secondary objectives: Smoking reduction / quitting of the mother and/or the father To determine the relationship between the level exposure to SHS and main related variables

Official Title
-----------------
Effectiveness of a Brief Intervention Opportunistic Targeting Parents Who Smoke to Reduce Exposure to Secondhand Smoke in Babies: STUDY BIBE

Conditions
-----------------
Tobacco Smoke Pollution

Intervention / Treatment
-----------------
* Behavioral: Brief intervention based in clinical practice guide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Smoking parents with babies minor 1 year-old Exclusion Criteria: Parents reporting diagnosis of major psychiatric illnesses Parents reporting active addictive substances consumption Parents in active smoking cessation treatment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br>Usual care | Behavioral: Brief intervention based in clinical practice guide<br>* Minimal counseling at smoking parents with babies minor 1 year-old<br>* Other names: Usual care;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of exposure to SHS in the babies by means of questionnaire and nicotine hair analysis. |  | 6 months at the beginning of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental smoking quitting or reduction by questionnaire and CO monitoring to whom self declared abstinent. Health related variables of babies and parents by follow-up questionnaire |  | 6 months at the beginning of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tobacco Smoke Pollution/prevention and control, Parent-Child Relations, Environmental Tobacco Smoke (ETS)
Prospective Study to Quantify the Change in Weight at a Pneumonia

Study Overview
=================
Brief Summary
-----------------
This study is based on the change in weight of hospitalized patients knowing that the diagnosis of malnutrition based on the presence of at least one clinical or laboratory test which anthropometric measures (Evaluation of diagnostic protein energy malnutrition in hospitalized adults ANAES , Guidelines Department, September 2003; HAS Strategy supported in cases of wasting energy and protein in the elderly April 2007). The goal of this study is to find the correlation between hospitalization and weight loss, significant risk factors for malnutrition in a situation of community-acquired pneumonia infection.

Official Title
-----------------
Prospective Study to Quantify the Change in Weight at a Pneumonia

Conditions
-----------------
Hospitalisation for Pneumonia

Intervention / Treatment
-----------------
* Other: weighing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cough Fever > 38.5 ° C Tachycardia > 100 / Min Chest pain lateralized Absence of infection high respiratory tract Global Impression of Severity Fireplace auscultatory signs (rattle crackling) Exclusion Criteria: Pregnant women Dialysis patients Any patient with home oxygen or under a home care for BPCO stage 3 or 4 Patients transferred from intensive care Patients with severe sepsis and requiring a filler Enteral or parenteral nutrition

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 pneumonia<br> | Other: weighing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight history | The weight of the patient, and weight's history. | Few minutes | 
| Standard biology | C-reactive protein, Albumine, Transthyretin, Oxygen | Few hours | 
| Severity of pneumonia | Fine's score or CURB 65 | Few minutes | 
| The functional status | ADL score ; activities daily living | Few minutes |
Evaluation of Target Organs Damage in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
Evaluation of target organs damage in hypertensive patients with no known cardiovascular (CV) or renal disease, stratified according to level of blood pressure control

Official Title
-----------------
Evaluation of Target Organs Damage in Hypertensive Patients Followed in General Practice With no Known Cardiovascular (CV) or Renal Disease, Stratified According to Blood Pressure Control

Conditions
-----------------
Target Organs Damage, Hypertensive, no Known Cardiovascular, no Known Renal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of essential hypertension (treated or untreated); HT not discovered on the day of the consultation; no documented clinical cardiovascular or renal disease. Exclusion Criteria: -

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 |
| --- | --- | --- |
| To evaluate the frequency of evaluation of preclinical target organs damage in hypertensive patients with no known cardiovascular or renal disease, by taking blood pressure (controlled or uncontrolled HT*) into account |  | once / 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the patient profile (socio-demographic, risk factors, comorbidities, global CV risk level estimated by the doctor and calculated retrospectively [according to ESH 2007]) associated with screening for target organs damage |  |  | 
| To describe the modalities of patient follow-up and management |  |  | 
| To compare the frequency of evaluation of target organs damage as a function of the modalities of management of CV risk factors at the time of the consultation. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Target organs damage, hypertensive patients
Influence of Different Zirconia Surface Treatments on Biofilm Formation

Study Overview
=================
Brief Summary
-----------------
The aim is to test the influence of surface finish on biofilm formation on the transmucosal part of zirconia implants in an in vivo study. Sixteen test person will therefore receive an orthodontic apparatus containing the specimens with the respective surfaces and carry them for 2x 24h. The primary outcome is the spectormetrical quantification (OD value) of biofilm on the specimens that have been carried by the test person over 24h. Biofilm will be analysed using scanning electron microscopy.

Official Title
-----------------
Influence of Different Zirconia Surface Treatments on Biofilm Formation

Conditions
-----------------
Surface Finish

Intervention / Treatment
-----------------
* Other: Implant neck surface


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No systematic antibiotic therapy during the last 3 months Good oral health and compliance (PI and BI <20%) No sign of parodontal disease or other inflammatory changes in the mouth Non-smoker Exclusion Criteria: Disease that requires antibiotic therapy Pressure marks due to the orthodontic apparatus that can not be eliminated Other unexpected complications that could be related to the orthodontic apparatus

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Zirconia structure<br>The participants will carry an orthodontic device containing 4 discs of differently structured zirconia and titanium to test the biofilm formation in order to determine the ideal structure for the neck area of zirconia dental implants. | Other: Implant neck surface<br>* The biofilm formation is tested on discs manufactured of zirconia with different surfaces in vivo using orthodontic devices that the participants carry over 24h<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safranin Staining | The biofilm on the discs is quantified using safranin staining and evaluated with the measurement of optical density using a photospectrometer | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SEM | The morphology of the biofilm is analyzed using scanning electron microscopy | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental implant, zirconia, biofilm
CoverEdge Algorithm Programming Study

Study Overview
=================
Brief Summary
-----------------
This is a prospective, on-label, multi-center, non-randomized, exploratory, single-arm study to characterize the effects of programming features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator (SCS) System using the CoverEdge™ surgical lead.

Official Title
-----------------
Study to Characterize the Effects of Programming Features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator System Using the CoverEdge™ Surgical Leads

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Device: Precision Spectra™ SCS system programming features


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject implanted, on-label, with a commercially approved Boston Scientific Spectra neurostimulation system and at least one CoverEdge or CoverEdge X surgical lead, per local directions for use (DFU). Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form. Subject is 18 years of age or older when written informed consent is obtained. Exclusion Criteria: Subject meets any contraindication in Boston Scientific (BSC) neurostimulation system local DFU. Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Precision Spectra™ SCS system programming features|Precision Spectra™ SCS system programming features using the CoverEdge surgical lead.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire | Change in paresthesia distribution based on programming parameters | minimum 25 days post IPG implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stimulation, implantable, pulse generator, back pain, chronic pain, leg pain
Exercise Training in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
Exercise training is the key component of respiratory rehabilitation.The success of long-term program resides in the integration between exercise prescription and patients'compliance with home training. This can be difficult for patients, especially in terms of understanding the exercise intensity. This study is designed to evaluate different methods of exercise training at home, to help understanding and maintaining the walking intensity in COPD patients. Outcome: exercise performance, daily physical activity and respiratory function.

Official Title
-----------------
Different Methods of Home Exercise Training in COPD Patients

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Behavioral: Home exercise training
* Behavioral: NO Exercise Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients. All patients are at stable state, free from an exacerbation from at least 3 months. Exclusion Criteria: COPD patients with a recent history of cardiovascular disease and other diseases that would interfere with exercise performance.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Exercise Training Group A1<br>Patients assigned to this arm maintain the prescribed walking speed during the training with a metronome | Behavioral: Home exercise training<br>* 20-30 min/day for at least 4 days/week<br>* Other names: Pulmonary Rehabilitation;|
| Experimental: Home Exercise Training Group A2<br>Patients assigned to this arm cover a fixed distance in a given period of time. | Behavioral: Home exercise training<br>* 20-30 min/day for at least 4 days/week<br>* Other names: Pulmonary Rehabilitation;|
| No Intervention: Control<br> | Behavioral: NO Exercise Training<br>* No intervention<br>* Other names: No intervention;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Capacity |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, home exercise training
Teneligliptin Versus Linagliptin in Diabetes Mellitus Type Two Patients

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and safety of Teneligliptin and Linagliptin in the type 2 Diabetes Mellitus patients.

Detailed Description
-----------------
A randomized, open label, parallel-group, non-inferiority, active-controlled, phase IV study

Official Title
-----------------
A Randomized, Open Label, Parallel-group, Non-inferiority, Active-controlled, Phase Ⅳ Study to Evaluate the Efficacy and Safety of Teneligliptin Versus Linagliptin in Type 2 Diabetes Mellitus Patients

Conditions
-----------------
Type2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Teneligliptin
* Drug: Linagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are 19 years or older on screening Patients with type 2 diabetes mellitus Patients with 7.0% ≤ HbA1c ≤ 11.0% at the screening visit Patients with Fasting Plasma Glucose <15mmol/L(270mg/dL) on screening Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 19 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: teneligliptin<br>teneligliptin 20mg qd | Drug: Teneligliptin<br>* teneligliptin 20mg qd<br>|
| Active Comparator: linagliptin<br>linagliptin 5mg qd | Drug: Linagliptin<br>* linagliptin 5mg qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 12week |
Drug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if the concomitant administration of either ketoconazole or fluconazole with BMS-708163 will affect the PK of BMS-708163 and to assess safety and tolerability of BMS-708163

Official Title
-----------------
A Study of the Effect of Concomitant Administration of Ketoconazole or Fluconazole on the Pharmacokinetics of BMS-708163 in Healthy Subjects

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: BMS-708163
* Drug: BMS-708163 + Ketoconazole
* Drug: Ketoconazole
* Drug: Fluconazole
* Drug: BMS-708163 + Fluconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and postmenopausal female subjects 18-55 yrs old inclusive Exclusion: Premenopausal women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BMS-708163 / Ketoconazole<br> | Drug: BMS-708163<br>* Capsule, Oral, 50 mg, once, Day 1<br>Drug: BMS-708163 + Ketoconazole<br>* (BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day Day 12 (Ketoconazole) - Tablet, Oral, 400 mg, daily, 1 day<br>Drug: Ketoconazole<br>* Tablet, Oral, 400 mg, daily, 16 days<br>|
| Active Comparator: BMS-708163 / Fluconazole<br> | Drug: BMS-708163<br>* Capsule, Oral, 50 mg, once, Day 1<br>Drug: Fluconazole<br>* Tablet, Oral, 1 day 400 mg then 3 days 200 mg<br>Drug: BMS-708163 + Fluconazole<br>* (BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day (Day 12) (Fluconazole) - Tablet, Oral, 200 mg, daily, 13 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK profile of BMS-708163 |  | Within 14 days after dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of BMS-708163 when administered alone and with either ketoconazole or fluconazole |  | During the entire study period |
Angiotensin-Converting Enzyme Polymorphism and Acute Renal Failure (ECAREA)

Study Overview
=================
Brief Summary
-----------------
Associations between angiotensin-converting enzyme gene polymorphism and occurrence and outcome of ARDS, and with respiratory complications post cardiopulmonary bypass have already been demonstrated. Based on physiological effects of angiotensin II, we hypothesized that the I allele of the angiotensin-converting enzyme Insertion/Deletion polymorphism may be associated with a higher risk of acute renal failure in critically ill patients.

Detailed Description
-----------------
Associations between angiotensin-converting enzyme gene polymorphism and occurrence and outcome of ARDS, and with respiratory complications post cardiopulmonary bypass have already been demonstrated. Based on physiological effects of angiotensin II, we hypothesized that the I allele of the angiotensin-converting enzyme Insertion/Deletion polymorphism may be associated with a higher risk of acute renal failure in critically ill patients.

Official Title
-----------------
Evaluation of the Impact of the Angiotensin-Converting Enzyme Insertion/Deletion Polymorphism on the Development of Acute Renal Failure in Critically Ill Patients

Conditions
-----------------
Kidney Failure, Acute, Critical Illness

Intervention / Treatment
-----------------
* Procedure: Blood sampling for PCR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 yrs ICU stay > 48 hours Exclusion Criteria: Age < 18 yrs Creatinine > 180 µmol/L Absence of consent

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

| Intervention/Treatment |
| --- |
|Procedure: Blood sampling for PCR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ARF |  | During ICU stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | ICU and Hospital mortality | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney failure, Acute, Genetic Polymorphism, Angiotensin-converting enzyme