linjc16/ctgov huggingface dataset:
Non-Positive Pressure Ventilation in Hypoxemic Patients

Study Overview
=================
Brief Summary
-----------------
The study is aimed to assess the possible benefit of non-positive pressure mechanical support in front of conventional ventilation in patients admitted to the intensive care unit (ICU) because of pure hypoxemic respiratory failure.

Detailed Description
-----------------
Pure hypoxemic patients admitted to intensive care unit in a teaching hospital have been randomized to be treated by conventional ventilatory support or non-positive mechanical ventilation support. Those patients who did not benefit from the experimental non-positive ventilatory support, were intubated and conventionally mechanically ventilated and discarded for analysis. The primary outcome was mortality rate in both groups, and secondary outcomes were length of stay, improvement of oxygenation, and reduced complications rates.

Official Title
-----------------
Non-Positive Pressure Ventilation in Hypoxemic Patients. A Randomized Study

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

Intervention / Treatment
-----------------
* Procedure: non positive pressure mechanical ventilatory support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dyspnea with respiratory rates higher than 35 p.m. pO2 < 65 mmHg paO2/FiO2 < 250 Exclusion Criteria: respiratory or cardiac arrest gastrointestinal bleeding hemodynamic instability face surgery upper airway obstruction inability for active cooperation need for airway protection exacerbation of COPD decrease of conscious level acute pulmonary cardiogenic oedema

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 |
| --- | --- |
| Experimental: non invasive ventilation approach<br>pure hypoxemic patients admitted to ICU treated by non-positive pressure mechanical ventilation | Procedure: non positive pressure mechanical ventilatory support<br> <br> |
| No Intervention: conventionally ventilated<br>pure hypoxemic patients treated by conventional ventilatory support | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rates |  | patient hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygenation improve |  | patient hospital discharge | 
| diminishing of tracheal intubation incidence |  | patient hospital discharge | 
| ICU and Post ICU hospital length of stay |  | patient hospital discharge |
Assessment of Therapeutic Education About Non Invasive Ventilation in Patients With Chronic Respiratory Failure (QoVNI)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the therapeutic education of patients with chronic respiratory failure who start to be treated with non invasive ventilation and during the first six months of ventilation.

Detailed Description
-----------------
Therapeutic education about non invasive ventilation in patients with chronic respiratory failure and alveolar hypoventilation is assessed during the first six months of ventilation thanks to a questionnaire. Moreover, the impact of this therapeutic education on non invasive ventilation compliance, blood gas, dyspnea and nocturnal desaturation is assessed.

Official Title
-----------------
Assessment of Therapeutic Education About Non Invasive Ventilation in Patients With Chronic Respiratory

Conditions
-----------------
Alveolar Hypoventilation

Intervention / Treatment
-----------------
* Other: Therapeutic education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic respiratory failure with alveolar hypoventilation required non invasive ventilation Adults and non-vulnerable subject Fluency in French Exclusion Criteria: Age under eighteen years old Patient with guardianship No french-speaking Severe cognitive abnormalities No criteria to introduce non invasive ventilation

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 |
| --- | --- |
| Alveolar hypoventilation<br> | Other: Therapeutic education<br>* Questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score efficacy of therapeutic education | calculation of the global mean score of the questionnaire dedicated to the knowledge about the ventilation device | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with the non invasive ventilation | number of hours of non invasive ventilation use per day | 6 months | 
| Dyspnea score | Dyspnea severity scoring between 0 and ten | 6 months |
Next Generation Ophthalmic Irrigating Solution Posterior Segment Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS PLUS for use during surgery for removal of epimacular membrane and vitrectomy.

Official Title
-----------------
Clinical Evaluation of the Safety of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Surgery for Removal of Epimacular Membrane and Vitrectomy

Conditions
-----------------
Eye Diseases

Intervention / Treatment
-----------------
* Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS)
* Other: BSS Plus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of any race and sex, with an epimacular membrane who would benefit from vitrectomy and membrane removal. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Under 18 years of age. Other protocol-defined exclusion criteria may apply.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NGOIS<br> | Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS)<br>* Volume sufficient to irrigate adequately during cataract surgery<br>|
| Active Comparator: BSS Plus<br> | Other: BSS Plus<br>* Volume sufficient to irrigate adequately during cataract surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected logMAR visual acuity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure (IOP) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epimacular membrane
Neutrophil-lymphocyte Ratio and Platelet-lymphocyte Ratio as Predictors for Adverse Events in EVAR

Study Overview
=================
Brief Summary
-----------------
This study investigated the association of chronic inflammatory markers with the clinical outcome after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm.

Detailed Description
-----------------
The study included 230 consecutive AAA patients, treated electively by EVAR from March 2016 to February 2019. The values of simple inflammatory markers,neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR), were measured pre- and postoperatively.Adverse events included any major adverse cardiovascular events (MACE), acute kidney injury and death from any cause.

Official Title
-----------------
Neutrophil-lymphocyte Ratio and Platelet-lymphocyte Ratio as Predictors for Adverse Events in Endovascular Aneurysm Repair for Abdominal Aorticaneurysm

Conditions
-----------------
Inflammation in EVAR

Intervention / Treatment
-----------------
* Other: NLR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AAA Elective EVAR Exclusion Criteria: Emergency Open surgery
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EVAR<br>Patinets with AAA, treated electively by EVAR. The values of simple inflammatory markers,neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR), were measured pre- and postoperatively. Adverse events included any major adverse cardiovascular events (MACE), acute kidney injury and death from any cause | Other: NLR<br>* neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR)<br>* Other names: PLR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NLR major cardiovascular events (MACE) | NLR indicator for major cardiovascular events (MACE) | Day 4 postopertively | 
| PLR major cardiovascular events (MACE) | PLR indicator for major cardiovascular events (MACE) | Day 4 postopertively | 
| NLR acute kidney injury (AKI) | NLR indicator for acute kidney injury (AKI) | Day 4 postopertively | 
| PLR acute kidney injury (AKI) | PLR indicator for acute kidney injury (AKI) | Day 4 postopertively | 
| NLR death | NLR indicator for death | Day 4 postopertively | 
| PLR death | PLR indicator for death | Day 4 postopertively |
Investigation of the Effects of Exercise on Gene Expression

Study Overview
=================
Brief Summary
-----------------
The investigators have previously shown that mild exercise training at the level of lactate threshold (LT) intensity (60 min/day, 5 days/week) improves peripheral insulin sensitivity and insulin-independent glucose disposal of glucose effectiveness, without changes in body weight and body fat (Nishida et al, Diabetes Care, 2001; Nishida et al, Diabetes, 2004). Thus these beneficial effects are likely related to a number of adaptations that occur in skeletal muscle as response to exercise. In the current study, the investigators hypothesised that a single bout of mild exercise performed at LT would be a physiological stimulator of skeletal muscle PGC-1alpha gene, and the repetition of this exercise stimulating PGC-1alpha gene (i.e., training) for 12 weeks would induce coordinated increases in a large number of metabolic genes, as well as other genes potentially important in the prevention of insulin resistance and metabolic syndrome.

Official Title
-----------------
Investigation on Gene Expression and Gene Marker Accompanied by a Single Bout of Exercise and Exercise Training

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

Intervention / Treatment
-----------------
* Other: exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men who were all in good health All individuals were free from diabetes and none were taking any medications All subjects were asked not to change their normal dietary habits, and not to engage in any strenuous physical activity Exclusion Criteria: People who undergone regular exercise for at least 2 years Smokers

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 32 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise<br>mild exercise training | Other: exercise training<br>* 60 min of low-intensity exercise, 5 days/week, 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal muscle PGC-1alpha gene expression and mitochondrial gene expression |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gene expression, skeletal muscle, Healthy men
Moxonidine in Patients Undergoing Vascular Surgery

Study Overview
=================
Brief Summary
-----------------
Investigating the perioperative effect of moxonidine. In a randomized double-blind fashion, patients undergoing vascular surgery will receive moxonidine 0.2 mg or placebo from the day before surgery until day 4 after surgery. Holter-EKG for 48 h, starting just before surgery. Repeated 12-lead EKG, measurements of Troponin I and BNP, clinical visitations, follow-up interviews at 6 and 12 months

Official Title
-----------------
The Effects of Small Doses of Moxonidine in Patients Undergoing Vascular Surgery

Conditions
-----------------
Cardiac Disease, Vascular Surgery

Intervention / Treatment
-----------------
* Drug: moxonidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: abdominal aortic or peripheral vascular surgery Exclusion Criteria: unstable angina, severe symptomatic heart failure (NYHA IV) systolic blood pressure at rest < 100 mmHg bradycardia (<50/min) higher grade AV heart block creatinine clearance < 30 ml/min pregnancy no 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?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br>moxonidine group | Drug: moxonidine<br>* moxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery<br>* Other names: Physiotens;|
| Placebo Comparator: II<br>placebo group | Drug: moxonidine<br>* moxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery<br>* Other names: Physiotens;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| over-all mortality |  | 30 days and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemia detected by Holter-ECG ST alterations or troponin T elevation |  | 7 days |
Enterprise Stent Aneurysm Treatment (ESAT) Study - France

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the morbidity, mortality, and efficacy of use of the Enterprise(TM) stent for the treatment of (ruptured or non-ruptured) intracranial aneurysms.

Detailed Description
-----------------
Per the opinion of the Commission for the Evaluation of Products and Services (CEPP) in France, renewal is contingent upon setup of a prospective morbidity, mortality, and efficacy study. The objective is to follow the stented Subjects for at least 1 year and evaluate the device and practices. This will be a multicenter study involving up to 15 interventional neuroradiologists in France. Subjects presenting with ruptured or non-ruptured aneurysms for whom simple or balloon assisted endovascular treatment is considered impossible or insufficient by the interventional neuroradiologist.

Official Title
-----------------
Prospective Multicenter Observational Study for the Evaluation of the Efficacy of the Cordis Enterprise(TM) Self-expanding Intracranial Stent: Enterprise Stent Aneurysm Treatment (ESAT) Study

Conditions
-----------------
Intracranial Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient implanted with one or more CODMAN ENTERPRISE™ stents and who present one or more ruptured or non-ruptured intracranial aneurysms assessed by angiography Agreement to take part in the study by the patient, or a representative of the patient in case of patient inability, after being informed by the investigator and have received information letter. Exclusion Criteria: Minors <18 years of age Patient implanted for the same aneurysm with a CODMAN ENTERPRISE™ stent in association with one or more stents from a different brand. Patient who does not accept to take part in the study.

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 |
| --- | --- |
| Non-ruptured aneurysms<br>Patients with intracranial aneurysm(s) requiring an endovascular treatment with a Codman ENTERPRISE stent who have one or more non-ruptured or late ruptured (>30days), intracranial aneurysm. | |
| Acute ruptured Aneurysms<br>Patients with intracranial aneurysm(s) requiring an endovascular treatment with a Codman ENTERPRISE stent who have a on or more acute ruptured (<30Days) aneurysms | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity and Mortality |  | Day 30 and 1 year post-procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aneurysm, stent, intracranial aneurysm, Ruptured Intracranial Aneurysm
The Cardiovascular Benefits of Reducing Personal Exposure to Air Pollution

Study Overview
=================
Brief Summary
-----------------
Exposure to air pollution is an important risk factor for cardiovascular morbidity and mortality, and is associated with increased blood pressure, reduced heart rate variability, endothelial dysfunction and myocardial ischaemia. The study objectives were to assess the potential cardiovascular benefits of reducing personal particulate air pollution exposure by wearing a facemask in healthy volunteers.

Official Title
-----------------
Beneficial Cardiovascular Effects of Reducing Exposure to Particulate Air Pollution With a Simple Facemask

Conditions
-----------------
Blood Pressure, Heart Rate Variability

Intervention / Treatment
-----------------
* Device: Face mask (Dust Respirator)
* Other: No Face mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: Current smokers Significant occupational exposure to air pollution Regular medication use (except oral contraceptive pill) Intercurrent illness
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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visit 1<br>2 hour city centre kerbside walk in Beijing China | Other: No Face mask<br>* Subjects will not wear a face mask to reduce their personal exposure to air pollution<br>|
| Experimental: Visit 2<br>2 hour city centre kerbside walk in Beijing China | Device: Face mask (Dust Respirator)<br>* Subjects to wear a simple face mask for 24 hours prior to the study day and the 24 hours of the study day. They will be instructed to wear the mask as much as possible when indoors and at all times when outdoors.<br>* Other names: 3M Dust Respirator 8812;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory blood pressure |  | During 24 hour study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  | During 24 hour study period | 
| Heart rate variability |  | During 24 hour study period | 
| Personal air pollution exposure |  | During 2 hour city centre walk | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Air pollution, Heart rate, Heart rate variability, Blood pressure, Face mask
Study of ENMD-2076 in Patients With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
Safety, tolerability, maximum tolerated dose and clinical benefit of ENMD-2076 administered over a range of doses in patients with relapsed or refractory multiple myeloma.

Detailed Description
-----------------
The study is designed to assess the safety, tolerability, maximum tolerated dose, and clinical benefit of treatment with ENMD-2076 administered orally once daily over a range of doses in patients with relapsed or refractory multiple myeloma.

Official Title
-----------------
A Phase 1 Study of ENMD-2076 in Patients With Relapsed or Refractory Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: ENMD-2076


Participation Criteria
=================
Eligibility Criteria
-----------------
Major Inclusion Criteria: Histological evidence of MM and evidence of relapse or refractory disease. Patients with non secretory myeloma or plasmacytoma only will be excluded. Patients must have failed thalidomide, lenalidomide, or velcade or be intolerant or ineligible to receive these agents. Age ≥18 years. ECOG performance status 0-2. Patients must have adequate organ and marrow function Major Exclusion Criteria: Prior cytotoxic chemotherapy or investigational agent within 28 days or autologous stem cell transplant within 6 months of receiving study drug ENMD-2076. Prior radiation therapy to > 25% of bone marrow forming bones (i.e., pelvis). Concomitant corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions. Have unstable angina pectoris or recent myocardial infarction (within 6 months. Have uncontrolled hypertension or congestive heart failure.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENMD-2076<br>Oral capsules, once daily in 28-day cycles | Drug: ENMD-2076<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose of ENMD-2076 |  | Within first 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlative studies of activity |  | throughout the study period | 
| Clinical Benefit |  | Each cycle of treatment |