linjc16/ctgov huggingface dataset:
The Use of Palliative Non Invasive Ventilation in Acute Respiratory Failure. OVNI Study.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is: to estimate the frequency of the use of non invasive ventilation to estimate the frequency of the use of palliative non invasive ventilation to evaluate the impact of non invasive ventilation to propose some recommendations

Detailed Description
-----------------
The purpose of this study is: to estimate the frequency of the use of non invasive ventilation to estimate the frequency of the use of palliative non invasive ventilation to evaluate the impact to propose some recommendations

Official Title
-----------------
Qualitative Outcomes After Palliative Noninvasive Mechanical Ventilation : OVNI Study

Conditions
-----------------
Acute Respiratory Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute respiratory failure hospitalization in ICU age >= 18 years Exclusion Criteria: Patients who have already participated to OVNI

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 |
| --- | --- | --- |
| Quality of life of patients receiving palliative noninvasive mechanical ventilation | Quality of life, assessed by short-form (SF)-36 health survey at day 90 after ICU discharge (average expected duration=7 days) | day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and Depression (evaluated by HADS) | Anxiety and depression at day 90 after ICU discharge (expected average duration=7 days), evaluated by Hospital Anxiety Depression Scale | day 90 | 
| Survival status | Survival status (0=alive, 1=deceased)at ICU discharge (average expected duration=7 days)and hospital discharge (average expected duration=14 days), day 90 after ICU discharge, day 180 after ICU discharge and 1 year after ICU discharge | patients will be followed during an average time of 14 days (mean hospitalization time) and until day 90 after ICU discharge | 
| Post traumatic stress disorder, evaluated by Impact of Event Scale(IES) questionnaire | PTSD evaluated by the Impact of Event Scale at day 90 after ICU discharge (average expected duration=7 days) | day 90 |
Possible Role of Roflumilast in Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
adding roflumilast to the standard therapy for diabetic nephropathy and studying the progression of many outcomes including urinary albumin to creatinine ratio, estimated GFR, biomarkers of diabetic nephropathy

Official Title
-----------------
Clinical Study Evaluating the Possible Efficacy and Safety of Roflumilast in Patients With Diabetic Nephropathy

Conditions
-----------------
Diabetic Nephropathies

Intervention / Treatment
-----------------
* Drug: Roflumilast
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic patients with persistent micro- or macroalbuminuria despite treatment with the maximum tolerated dose of ACE inhibitors for at least 8 weeks before the screening and randomization Type I or II diabetic patient with stage 2 CKD (eGFR = 60 - 89 ml/min) ,stage 3 CKD (eGFR = 30 - 59 ml/min) or stage 4 (eGFR 15-29 ml/min) Exclusion Criteria: moderate to severe hepatic disease (Child-Pugh B or C) severe renal disease (eGFR<15 ml/min) body-mass index below 25 kg/m2 concomitant use of strong cytochrome P450 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) known psychiatric illness, congestive heart disease patients with allergy for roflumilast pregnant and lactating women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: roflumilast arm<br> | Drug: Roflumilast<br>* adding one tablet of roflumilast 500 mcg to the standard ACEI (captopril) for diabetic nephropathy management<br>|
| Placebo Comparator: placebo arm<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in urinary albumin creatinine ratio (UACR) | measuring UACR pre and post experiment and substracting and dividing on baseline level | Baseline and 3 months | 
| Absolute change in Estimated glomerular filtration rate (eGFR) | substracting pre-treatment from post-treatment values of EGFR | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Urinary pro-inflammatory cytokine MCP-1 | substracting pre-treatment from post-treatment values of Change in Urinary pro-inflammatory cytokine MCP-1 | Baseline and 3 months | 
| Change in serum irisin level | substracting pre-treatment from post-treatment values of serum irisin level | Baseline and 3 months |
GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized study designed to compare genotype-guided dosing to usual care in patients with pancreas cancer and colorectal cancer who are UGT1A1 intermediate metabolizers (*1/*28) (heterozygotes) and usual UGT metabolizers (*1/*1). All patients will be assessed for UGT1A1 genotype at screening and those with intermediate or usual UGT1A1 genotypes (*1/*28, *1/*1) will be randomized to genotype-guided dosing versus usual care.

Official Title
-----------------
GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care

Conditions
-----------------
Colorectal Cancer, Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have histologically confirmed stage I-IV pancreas or stage III-IV colorectal cancer who are planning to undergo treatment. Prior treatment is allowed, specifically surgery and/or radiation and non-irinotecan containing regimens are allowed. Age ≥ 18 years. ECOG performance status ≤ 1. Patients must have adequate organ and marrow function as defined below: Measurable or non-measurable disease. Exclusion Criteria: Patients who received prior treatment with irinotecan are excluded. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician. Pregnant women are excluded from this study. Patients who are not planned for treatment of their cancer.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genocare Guided<br> | Drug: Irinotecan<br>* Usual dosing per package insert.<br>* Other names: Onyvide;|
| No Intervention: Usual Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events Frequency | To compare the frequency of cycle 1 grade 3-5 adverse effects in individuals with a *1/*28 or *1/*1 genotype who receive genotype-guided dosing and to those who are randomized to receive usual care. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | To evaluate overall survival between individuals randomized to receive genotype-guided dosing and those who are randomized to receive usual care. | 5 years |
Knowledge and Attitude in Perioperative Erythrocyte Transfusion in Medical Personnel in Siriraj Hospital

Study Overview
=================
Brief Summary
-----------------
This study is designed to explore the correlation between knowledge and attitude in perioperative erythrocyte transfusion in medical personnel.

Detailed Description
-----------------
Inappropriate erythrocyte transfusion is still have high incidence even lots of the transfusion guidelines and researches was launched. Unnecessary or delayed transfusion can cause morbidity and mortality. This study is descriptive research, questionnaire based survey conducted to explore the correlation between knowledge and attitude in perioperative erythrocyte transfusion in medical personnel in Siriraj Hospital.

Official Title
-----------------
Knowledge and Attitude in Perioperative Erythrocyte Transfusion in Medical Personnel of the Department of Anesthesiology and Department of Orthopedic Surgery in Siriraj Hospital

Conditions
-----------------
Transfusion-dependent Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-graduated medical personnel in Siriraj Hospital Exclusion Criteria: Post-graduated medical personnel in Siriraj Hospital who refuse to participate
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 |
| --- | --- | --- |
| Knowledge in perioperative erythocyte transfusion in medical personnel in Siriraj Hospital | We aim to explore the reason of high incidence of inappropriate transfusion by conduct the questionnaire, about knowledge and attitude in perioperative erythocyte transfusion in medical personnel in Siriraj Hospital. Knowledge part will measure followed by transfusion guideline of Hematology and Anesthesiology, Siriraj Hospital and attitude toward perioperative transfusion will collect and analyse | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attitude in perioperative erythocyte transfusion in medical personnel in Siriraj Hospital | We aim to explore the reason of high incidence of inappropriate transfusion by conduct the questionnaire, about knowledge and attitude in perioperative erythocyte transfusion in medical personnel in Siriraj Hospital. Knowledge part will measure followed by transfusion guideline of Hematology and Anesthesiology, Siriraj Hospital and attitude toward perioperative transfusion will collect and analyse | 10 minutes |
Platelet Function Analysis in Head Trauma: ASA/Plavix

Study Overview
=================
Brief Summary
-----------------
The investigators are assessing the platelet function analysis of those who sustained significant head trauma while on aspirin or plavix and to assess if any qualitative difference is obtained if platelets are administered.

Detailed Description
-----------------
The platelet function analyzer VerifyNow® P2Y12 uses ADP as agonists to induce platelet activation and ascertain the level of platelet function impaired by these medications. VerifyNow® Aspirin Assay utilizes arachidonic acid as the agonist to measure platelet function specifically along this pathway. Our research question for this study is as follows: Does the administration of desmopressin (DDAVP) and/or the transfusion of platelets in patients with head trauma reverse the platelet inhibition caused by Aspirin and/or Plavix? The investigators hypothesize that with the administration of platelets and/or DDAVP that there is a reversal of the inhibition.

Official Title
-----------------
Platelet Function Analysis in Head Trauma: ASA/CLOPIDOGREL

Conditions
-----------------
Head Injury Trauma Blunt

Intervention / Treatment
-----------------
* Biological: Platelets
* Drug: DDAVP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18yrs Must be a trauma patient with blunt head trauma. Must be on Aspirin and/or Plavix Subject or Legally Authorized Representative (LAR) (per Heath and Safety Code, Sections 24170 to 24179.5) must sign study consent within 4 hours from the first blood draw. (If this criterion is not met the initial blood draw must be destroyed and NOT run for study results). Exclusion Criteria: Hemoglobin ≤ 10 GM/DL Platelet Count ≤ 150 K/MCL Pregnant Females Subjects on Warfarin, Heparin or Enoxaparin

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Platelets/DDAVP<br>Fall on ASA/Plavix that sustained head trauma requiring administration of platelets and/or DDAVP | Biological: Platelets<br>* 1 unit of platelets<br>Drug: DDAVP<br>* Desmopressin 0.3mcg/kg IV x 1<br>|
| No Intervention: No Platelets<br>Those that sustain head trauma NOT requiring platelet transfusion. The investigators are evaluating platelet function in those not requiring platelet transfusion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet inhibition | We are measuring platelet inhibition using the verify now platelet function analyzer | 8 hours |
MRI Detection of Microbleeds in Glioma Patients

Study Overview
=================
Brief Summary
-----------------
Systematic retrospective medical chart and medical imaging file review of all patients receiving brain MRI for the follow-up of glioblastoma.

Official Title
-----------------
Detection of Microbleeds With MRI (SWI Sequences) in Glioma Patients

Conditions
-----------------
Glioblastoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients Diagnosed with brain glioblastoma Receiving treatment with cranial radiotherapy and/or chemotherapy Having at least one follow-up MRI conducted that used a susceptibility weighted imaging sequence Exclusion Criteria: Underage Absence of formal diagnosis of glioblastoma No available medical imaging file with MRI susceptibility weighted imaging sequence

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 |
| --- | --- | --- |
| Number of microbleeds diagnosed with MRI (susceptibility weighted imaging sequence) |  | At the time of each MRI conducted within 5 years after diagnosis |
A Registry of COPD Patients to be Used for Future Studies

Study Overview
=================
Brief Summary
-----------------
To develop a cohort of COPD participants to assist study staff in determining the most likely candidates for future studies.

Detailed Description
-----------------
To develop a cohort of COPD participants for study staff to determine the most likely candidates for future studies and to develop a repository of blood from subjects with COPD for future studies.

Official Title
-----------------
The Ohio State University COPD Registry

Conditions
-----------------
Chronic Obstructive Lung Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are 18 years of age and older who have been diagnosed with COPD by at least one of the following: clinical history-a documented history of COPD, emphysema, or chronic bronchitis; pulmonary function results (defined as an FEV1/FVC less than 0.7; radiographic results (high-resolution CT findings of emphysema Exclusion Criteria: in ability to give informed consent prisoners 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic obstructive lung disease<br>those with a condition | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This is a registry protocol to determine factors contributing to the development of chronic obstructive lung disease. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To develop a repository of blood from subjects with COPD for future studies. These studies may include evaluation of biologic markers of disease severity and progression. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD
Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution

Study Overview
=================
Brief Summary
-----------------
This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution.

Detailed Description
-----------------
This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution in patients with open-angle glaucoma. Study assessments will include IOP and medication use as well as safety parameters.

Official Title
-----------------
Prospective, Randomized Phase II Study Comparing Two Elution Rates of Glaukos Travoprost Intraocular Implants to Timolol Maleate Ophthalmic Solution, USP 0.5%

Conditions
-----------------
Glaucoma Open-angle

Intervention / Treatment
-----------------
* Drug: Travoprost Intraocular Implant, high elution
* Drug: Travoprost Intraocular Implant, low elution
* Drug: Timolol Maleate Ophthalmic Solution, 0.5%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Open angle glaucoma Exclusion Criteria: Uveitic, neovascular, or angle closure glaucoma; or glaucoma associated with vascular disorders. Functionally significant visual field loss, including severe nerve fiber bundle defects. Prior glaucoma surgery. Uncontrolled systemic disease, pregnant females or those planning a pregnancy. Other ocular status conditions, etc.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travoprost Intraocular Implant, high elution<br>This implant will be surgically implanted and elute travoprost, a prostaglandin. | Drug: Travoprost Intraocular Implant, high elution<br>* Surgical implant placed within the eye to elute travoprost.<br>|
| Experimental: Travoprost Intraocular Implant, low elution<br>This implant will be surgically implanted and elute travoprost, a prostaglandin. | Drug: Travoprost Intraocular Implant, low elution<br>* Surgical implant placed within the eye to elute travoprost<br>|
| Active Comparator: Timolol Maleate Ophthalmic Solution, 0.5%<br>Timolol, a beta blocker, will be dosed twice daily | Drug: Timolol Maleate Ophthalmic Solution, 0.5%<br>* Instillation of one drop of timolol in the study eye twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP (mmHg) Change From Baseline at Week 12 | Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline. | 12 weeks |
Identification in Obese Patients of the Mechanism Involved in Intramuscular Lipid Accumulation

Study Overview
=================
Brief Summary
-----------------
The study aims to determine in obese patients the implication of intramuscular lipid accumulation in relation with insulin resistance and defect in lipid oxidation.

Detailed Description
-----------------
Obese insulin sensitive and obese insulin resistant patients undergo a glucose tolerance test, indirect calorimetry during exercise and muscular biopsy.

Official Title
-----------------
Identification in Obese Patients of the Mechanisms Involved in Intramuscular Lipid Accumulation.

Conditions
-----------------
Obesity, Insulin Resistance, Hyperlipidemia

Intervention / Treatment
-----------------
* Other: Lipid accumulation analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese patients with a Body Mass Index (BMI) between 30 and 40 kg/m2 Patients who do not practice physical exercise (Voorips index < 9) Age between 40 and 70 years- Male gender Fast blood glucose <1,10 g/l and no hypoglycemic treatment Signed informed consent Social security affiliation Absence of anti VIH, anti hepatitis C antibodies, and HBS antigen Normal biological tests Non smoking persons Exclusion Criteria: Patients who refuse the anti-VIH, anti-hepatitis C antibodies, and HBS antigens tests Patients treated by anticoagulant, b blockers, lipopenic, or anti-inflammatory. Patients with a contraindication to muscular exercise (retinopathy, coronaropathy, nephropathy) and to muscular biopsy Allergy to local anaesthetic

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Insulin sensitive patients<br> | Other: Lipid accumulation analysis<br>* The lipid accumulation will be assessed with muscular biopsies.<br>|
| Other: Insulin resistant patients<br> | Other: Lipid accumulation analysis<br>* The lipid accumulation will be assessed with muscular biopsies.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid accumulation in skeletal muscle |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid accumulation in myotubes from obese patients |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obese, insulin sensitive, insulin resistant, myotubes, lipid accumulation