linjc16/ctgov huggingface dataset:
A Study to Evaluate the Safety of Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600g

Study Overview
=================
Brief Summary
-----------------
This is an open label, multicenter study designed to evaluate the safety and tolerability of efalizumab administered subcutaneously at weekly doses of 1.0 mg/kg in subjects with plaque psoriasis who previously participated in Study ACD2600g.

Official Title
-----------------
An Open Label, Multicenter Study to Evaluate the Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2600g

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Raptiva (efalizumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Previous participation in Study ACD2600g For women of childbearing potential, continued use of an acceptable method of contraception for the duration of the study Exclusion Criteria: Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to Efalizumab
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Raptiva (efalizumab)|nan|

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
-----------------
Moderate to severe plaque psoriasis
Effects of Chest Wall Elastance on Pulmonary Mechanics of Acute Respiratory Failure (ARF)

Study Overview
=================
Brief Summary
-----------------
Patients with chest wall elastance increasing could worsen lung function. Increasing of chest wall elastance plays a great role in lung mechanics, and could influence mechanical ventilation settings. Therefore, It could help the physicians to find appropriate indicators and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics changse in the patients with high chest wall elastance.

Detailed Description
-----------------
Mechanical ventilation(MV) is an important treatment for acute respiratory failure(ARF) patients, could improve hypoxemia, maintain lung volume and promote alveolar opening. However, because of barotrauma, volutrauma and biotrauma, MV could cause or aggravate acute lung injury not only in acute respiratory distress syndrome(ARDS) patients, but in patients with normal lung function1,2. Patients with chest wall elastance increasing could worsen lung function. Increasing of chest wall elastance plays a great role in lung mechanics, and could influence mechanical ventilation settings. Therefore, It could help the physicians to find appropriate indicators and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics changse in the patients with high chest wall elastance. The present study is set out to examine the effects of high chest wall elastance on changes of lung mechanics and the correlation of airway pressure(Paw) stress index and transpulmonary pressure(PL) stress index.

Official Title
-----------------
Physiological Effects of Chest Wall Elastance on Pulmonary Mechanics of Acute Respiratory Failure Patientstranspulmonary Pressure

Conditions
-----------------
Airway Pressure Stress Index, Transpulmonary Pressure Stress Index, Acute Respiratory Failure, Chest Wall Elastance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ARF mechanical ventilation cardiovascular stable Exclusion Criteria: age < 18y or > 85y pregnancy COPD or chronic pulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Changes of oxygenation and lung mechanics |  | up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Airway pressure stress index, Transpulmonary pressure stress index, Acute Respiratory Failure, Chest wall elastance, Lung stress
Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the Bladder

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to evaluate the applicability of non-invasive optical imaging for the measurement of brain function during investigation of the lower urinary tract.

Official Title
-----------------
Brain Imaging Plus Urodynamics to Investigate the Brain's Control of the Bladder

Conditions
-----------------
Urge Urinary Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ambulatory women over age 60, who are incontinent at least five times weekly for 3 months despite correction of potentially reversible causes. urinary incontinence (urge or predominantly urge) by clinical criteria. able to accurately complete a voiding diary, to perform a 24-hour pad test under direction. Exclusion Criteria: significant mental impairment [mini mental status exam (MMSE) ≤ 20) urethral obstruction history of bladder cancer spinal cord lesions multiple sclerosis pelvic radiation interstitial cystitis artificial sphincter implant expected to have changes in medications/doses during the trial medically unstable Patients with factors that could cause transient UI [e.g., current urinary tract infection (UTI), acute confusion] will be treated in concert with the subject's primary care provider and considered for enrollment if their UI persists. conditions that require endocarditis prophylaxis (such as heart valve problems or bacterial endocarditis)

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
urge incontinence
Long Term Treatment of Patients With Major Depressive Disorder With MK0869 (0869-065)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.

Detailed Description
-----------------
The duration of treatment is 20 months.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Multicenter Study of the Long-Term Efficacy of MK0869 in the Maintenance of Antidepressant Effect in Patients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: aprepitant
* Drug: Comparator: placebo (unspecified)


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with Major Depressive Disorder

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

| Intervention/Treatment |
| --- |
|Drug: aprepitant|nan|
|Drug: Comparator: placebo (unspecified)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total HAMD-17 score </= 10 after 10 weeks of treatment, time to relapse of depression over 6-10 months |  | after 10 weeks of treatment and over 6-10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-S score change from Week 10 at Month 6; HAMD-17 total score change from Week 10 at Month 6; an HAMA total score change from week 10 at Month 6. |  | Week 10 at Month 6 |
Pilot Study of Bone Biopsy and Aspirate in Women With Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is a feasibility study to demonstrate the team's ability to collect bone marrow aspirates and biopsies for research purposes from women with metastatic breast cancer.

Official Title
-----------------
Pilot Study of Bone Biopsy and Aspirate in Women With Metastatic Breast Cancer

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Bone marrow aspirates and biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with metastatic breast cancer (any site) age 21 or older Patients willing and able to provide informed consent & perform study procedures Patients may enroll with recently (with 2 months) progressive tumor burden Performance status of 0,1 or 2 Exclusion Criteria: Patients unable or unwilling to provide informed consent and or perform study procedures Patients with active, uncontrolled coagulopathy Patients on treatment dose anticoagulation or an International Normalised Ratio of 2 or greater if on warfarin Patients who are known to be pregnant are not eligible to participate in this study during the time of the pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Bone marrow aspirates and biopsy<br> | Procedure: Bone marrow aspirates and biopsy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient that agree to undergo 2 biopsy's strictly for research purposes. |  | At 3 months |
Hyperoxia and Pulmonary Complications After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The main objective is to demonstrate that hyperoxia in cardiac surgery increase the occurrence of post-operative pulmonary complications

Official Title
-----------------
Hyper-Cardia Study : Hyperoxia and Pulmonary Complications After Cardiac Surgery

Conditions
-----------------
Hyperoxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient (≥18 years old) Patient operated heart surgery with extra-corporal life support Hospitalization in Cardiology intensive and critical care unit Patient operated in HUS between 01/01/2015 and 31/12/2019 Subject consent, after information, to the reuse of its data for the purposes of this study Exclusion Criteria: Non-consent patient Hypoxemic patient Emergency surgery Patient with post-operative cardiac assist device Patient with guardianship

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective study of the average of per and postoperative PaO2 in cardiac surgery |  | iles analyzed retrospectily from January 1st, 2015 to December 31, 2019 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperoxia, Cardiac surgery, pulmonary complications, Lung collapse, Post-operative
Size Progression of Macular Degeneration After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to find out if in patients with non-exudative age-related macular degeneration (AMD), randomly assigned to cataract surgery, any AMD size progression or progression to exudative AMD could be detected 6 months after surgery.

Official Title
-----------------
Size Progression of Non-Exudative Age-Related Macular Degeneration After Cataract Surgery

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Procedure: Cataract Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cataract and non-exudative age-related macular degeneration Exclusion Criteria: Patients with retinal pathologies other than AMD, exudative AMD, progressive glaucoma, myopia > 10 diopters, panretinal laser treatment, former cataract or vitreoretinal surgery, were excluded.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group (CO)<br>Fifty-four patients with cataract and non-exudative age-related macular degeneration (AMD) were randomized into an early surgery group (ES=28) with immediate cataract surgery and a control group (CO=26) where surgery was performed after six months. | Procedure: Cataract Surgery<br>* Fifty-four patients with cataract and non-exudative age-related macular degeneration (AMD) were randomized into an early surgery group (ES=28) with immediate cataract surgery and a control group (CO=26) where surgery was performed after six months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AMD size (defined central region of interest) | To evaluate AMD size progression, absolute and relative differences in pixels of the ROI were cal-culated by equivalent tests. | at enrollment, after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional ophthalmic assessments | Cataract grade (LOCS-III), Visual acuity (distance/near), contrast acuity tests, Visual Function Index (VF-14) | at enrollment, after 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMD, Cataract surgery, Size of AMD, Influence of cataract surgery on AMD Size
Effect of Two Doses of Coenzyme Q10 on Seminal Fluid and Semen Antioxidant Status

Study Overview
=================
Brief Summary
-----------------
The study was conducted to assess the impact of two doses of coenzyme Q10 on seminal fluid parameters and antioxidant status in infertile men.

Detailed Description
-----------------
The aim of this study was to assess the impact of two doses of coenzyme Q10 on seminal fluid parameters and antioxidant status in infertile men with idiopathic oligoasthenoteratospermia.

Official Title
-----------------
The Effect of Two Doses of Coenzyme Q10 on Seminal Fluid Parameters and Antioxidant Status: A Randomised Controlled Trial

Conditions
-----------------
Male Infertility

Intervention / Treatment
-----------------
* Dietary Supplement: Coenzyme Q10 200
* Dietary Supplement: Coenzyme Q10 400


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of infertility of at least 12 months despite regular unprotected intercourse. Oligoasthenoteratospermia was diagnosed by semen analysis showing abnormal sperm concentration (<15 million/ml), progressive motility (<32%), total motility (<40%) and morphology (<30% WHO criteria) as defined by WHO manual for semen analysis 2010 Exclusion Criteria: Azoospermia, Varicocele, Genital tract infection, Cryptorchidism, Testicular trauma or scrotal surgery, Endocrine disorder, Systemic illness, Smoking The presence of female factor

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coenzyme Q10 200<br>Coenzyme Q10 200mg/day for 3 months | Dietary Supplement: Coenzyme Q10 200<br>* Coenzyme Q10 200 mg/day<br>|
| Active Comparator: Coenzyme Q10 400<br>Coenzyme Q10 400mg/day for 3 months | Dietary Supplement: Coenzyme Q10 400<br>* Coenzyme Q10 400 mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semen volume (WHO 2010 guidelines) | Semen volume in ml | 3 months | 
| Sperm concentration in semen (WHO 2010 guidelines) | Sperm concentration in million/ml | 3 months | 
| Sperm motility in semen (WHO 2010 guidelines) | Sperm motility (%) | 3 months | 
| Sperm morphology in semen (WHO 2010 guidelines) | Normal sperm morphology (%) | 3 months | 
| Seminal plasma TAC | Seminal plasma total antioxidant capacity in mmol/ml | 3 months | 
| Seminal plasma CAT | Seminal plasma catalase in U/ml | 3 months | 
| Seminal plasma SOD | Superoxide dismutase in U/ml | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Male infertility, Coenzyme Q10, Antioxidants
Air Pollution and Cardio-metabolic Health

Study Overview
=================
Brief Summary
-----------------
To investigate the effects of air pollution on surrogate cardio-metabolic outcomes in young healthy adults.

Detailed Description
-----------------
To investigate the effects of air pollution on surrogate cardio-metabolic outcomes in a panel study involving young healthy adults living in Beijing, China with extreme high ambient air pollution levels.

Official Title
-----------------
Effects of Air Pollution on Cardio-metabolic Outcomes Among Heathy Adults

Conditions
-----------------
Cardiovascular Outcomes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Living in Peking University Health Science Center neighborhood. Non smoker and no diseases. Exclusion Criteria: Advanced microvascular complications and active cardiovascular disease. Pregnancy or intent to get pregnant during the study period.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Systolic blood pressure and diastolic blood pressure | Four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic inflammatory | Systemic inflammation biomarkers, such as C-reactive protein etc. | Four months |
A Biobank for Diaphragm Muscular Fiber

Study Overview
=================
Brief Summary
-----------------
This non-interventional study focuses on mechanical ventilation used in intensive care unit to supplement ventilatory function in patients. Mechanical ventilation can paradoxically be at the origin of complications that can be life-threatening in patients. This muscular pathology is called ventilation-induced diaphragmatic dysfunction (DDIV). Diaphragmatic muscle collected during a digestive surgery for a benign or malignant tumor of the liver requiring surgical excision in contact with the diaphragm from the care will be conserved. The diaphragm biopsy from the care will be retained for biobanking to obtain myoblast in culture which will differentiate in Diaphragm fiber. Then these fibers will be submitted under mechanical stress condition similar to those imposed in vivo by mechanical ventilation to validate in human a model in vitro of diaphragm dysfunction induced by mechanical ventilation. Then the second part of the study will be to evaluate with this model, the efficiency of an antioxidant therapy.

Official Title
-----------------
Constitution of a Biobank to Optimize in Vitro an Antioxydant Treatment for Diaphragm Dysfunction Induced by Mechanical Ventilation

Conditions
-----------------
Diaphragm Dysfunction, Mechanical Ventilation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 30 and 65 years old patient treated by the digestive surgery department of Montpellier University Hospital for a benign or malignant tumor of the liver requiring surgical excision in contact with the diaphragm Non-smoker patient for more than 6 months patient clinically stable at the time of the study, ie not requiring any treatment Exclusion Criteria: Patients undergoing treatment with antibiotics or corticosteroids, or recently within the last 4 months Patients with a body mass index > 30 Patients with any criteria that may in themselves impair respiratory muscle function such as chronic obstructive pulmonary disease, heart failure, systemic infection, neuromuscular pathology, psychiatric pathology or metabolic disorder. Patients with coagulopathy or thrombocytopenia.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Myoblast differentiation capacity | Description: evaluation of ROS (reactive oxygen species) production by confocal microscopie of diaphragm fiber submitted in vitro by mechanical stress. | 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myoblast proliferation capacity | Description: Evaluation of diaphragm myoblast differenciation capacity in vitro under different concentration of antioxydant. | 24 month |