linjc16/ctgov huggingface dataset:
Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium

Study Overview
=================
Brief Summary
-----------------
At present, all commercially available corneal organ culture media contain foetal calf serum (FCS) and sometimes other compounds extracted from animals. These compounds are necessary for corneal cell survival but are problematic because they theoretically have risk of anthropozoonosis transmission, especially for new variant of CJD and the variability between FCS batches influence graft quality. Our laboratory research allowed in vitro and ex vivo validation of a new medium free compound animal. We proved its superiority over conventional medium containing 2% FCS for endothelial cell survival during the storage time. The goal of this clinical trial is now to assess its superiority in patients.

Official Title
-----------------
Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium

Conditions
-----------------
Corneal Transplantation

Intervention / Treatment
-----------------
* Procedure: corneal graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients over 18 years of age Clinically proven corneal disease Registered on the French National waiting list (GLAC) Patient informed consent Patient who needs a 8.25mm of diameter perforating keratoplasty, either isolated or combined with lens surgery Low immune rejection risk (< 2 quadrants of neovascularization, no previous history of herpetic keratitis nor graft rejection) No previous history of glaucoma or elevated intra ocular pressure (>22 mm Exclusion Criteria: Patient is unlikely to comply with the requirements of the protocol

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Animal Compound Free Medium<br>Patients in this arm receive a corneal graft stored in organ culture in a animal compound free medium | Procedure: corneal graft<br> <br> |
| Active Comparator: organ culture medium containing 2% of fœtal calf serum<br>Patients in this arm receive a corneal graft stored in organ culture in a commercial organ culture medium containing 2% of fœtal calf serum | Procedure: corneal graft<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the primary outcome is the endothelial cell density (ECD) of the corneal grafts. |  | one year after graft | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Corneal Transplantation, corneal organ culture medium, free animal compound medium
Motor Control in Chronic Fatigue Syndrome and Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
This project is a comprehensive study, with main focus on motor control, comparing patients with chronic fatigue syndrome / myalgic encephalopathy (CFS/ME) and/or fibromyalgia syndrome (FMS). Focus of the present project will be on detailed movement analysis in a movement laboratory and involve functional tasks such as walking and standing. Investigations will also comprise muscle activity, reaction time and fine motor control.

Official Title
-----------------
Motor Control in Chronic Fatigue Syndrome and Fibromyalgia.

Conditions
-----------------
Fibromyalgia, Chronic Fatigue Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of chronic fatigue syndrome or fibromyalgia Exclusion Criteria: patients who already had been treated.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 49 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 fatigue syndrome<br> | |
| fibromyalgia<br> | |
| chronic fatigue syndrome + fibromyalgia<br> | |
| healthy sedentary control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| motor control |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Motor control, walking, physical activity, Muscle activity
Out of Hospital Cardiac Arrest: Trial Assessing the Survival Impact of Phone Advice

Study Overview
=================
Brief Summary
-----------------
Medical call center have no phone advice protocol within out of hospital cardiac arrest in France. The purpose of the present study is to compare a group of patients with protocol phone advice delivered by the dispatchers (CONTARM group) versus usual phone advice ( CONTHAB group). Comparison will be performed on survival to seven days. The hypothesis is that CONTARM group has an higher survival at seven days. A second goal is to measure the survival to 15 and 30 days. The trial is randomized, controlled and will include 2600 patients. The patients will be enrolled in 19 hospitals in France.

Official Title
-----------------
Out of Hospital Cardiac Arrest: Cluster Randomized Trial Assessing the Survival Impact of Phone Advice Delivered by Medical Call Center

Conditions
-----------------
Out of Hospital Cardiac Arrest

Intervention / Treatment
-----------------
* Other: Protocol phone advice
* Other: Usual phone advice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years old initial call to 15 out of hospital cardiac arrest patient proximity to witness Exclusion Criteria: first aid professionals on site rigor mortis location not allowing resuscitation inability to realize actions or misunderstanding no flow > 5 minutes

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: CONTARM<br>Protocol phone advice | Other: Protocol phone advice<br>* Protocol phone advice<br>|
| Other: CONTHAB<br>Usual phone advice | Other: Usual phone advice<br>* Usual phone advice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7 days survival | 7 days survival | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 15 and 30 days survival | 15 and 30 days survival | 15 and 30 days | 
| Assessment of compliance of phone advice | Listening of phone bands to measure compliance of phone advice protocol : good frequency of chest compression. Binary variable (Yes or Not) good depth of chest compression. Binary variable (Yes or Not) good patient positioning. Binary variable (Yes or No). | 7 days | 
| 30 days neurological status | Cerebral performance categories scale is counting with medical file | 30 days |
Cardiovascular Analysis of PEM

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine cardiopulmonary function in Chronic Fatigue Syndrome (CFS) patients and determine how it relates to the common symptom of Post-exertional malaise (PEM). Subjects will complete a maximal exercise test on 2 subsequent days. Total blood volume will be measured prior to each exercise test, and patient with hypovolemia on day 1, will be randomized to either a saline or sham infusion prior to the 2nd exercise test. A total of 80 CFS patients will be enrolled.

Official Title
-----------------
Cardiovascular Analysis of Post-exertional Malaise

Conditions
-----------------
Myalgic Encephalomyelitis, Chronic Fatigue Syndrome

Intervention / Treatment
-----------------
* Procedure: Saline Infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 25 to 60 Meet the 2015 IOM case definition for ME/CFS Exclusion Criteria: Patients with a medical cause for their fatigue Patients taking medications that would dampen cardiac response to exercise Patients with psychotic illness, bipolar disorder, or current major depressive disorder Patients with a history of anorexia or bulimia within 5 years of intake Patients with a history of alcohol or drug abuse within 2 years of intake

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saline Infusion<br> | Procedure: Saline Infusion<br>* Patient with hypovolemia on day 1 will be randomized to a saline or sham infusion prior to the Day 2 exercise test.<br>|
| Sham Comparator: Sham Infusion<br> | Procedure: Saline Infusion<br>* Patient with hypovolemia on day 1 will be randomized to a saline or sham infusion prior to the Day 2 exercise test.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPET testing | To assess VO2VT and peak VO2 | 2 days | 
| Total Blood Volume | To measure Total Blood Volume (TBV) before each exercise test | 2 days | 
| Hypovolemia | Patients with reduced Total Blood Volume on day #1 CPET will be randomized in a 1:1 fashion to either a one hour infusion of a liter of isotonic saline prior to day #2 CPET or a sham infusion | 1 day |
PHIL in the Treatment of Intracranial dAVF.

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, multicenter, single-arm study. Patients with Dural Arteriovenous Fistulas (dAVF) have a few choice for safe treatment. In this study, all patients with qualifying dAVFs will be treated with PHIL® Liquid Embolic material.

Official Title
-----------------
PHIL dAVF: Study of PHIL® Embolic System In The Treatment of Intracranial Dural Arteriovenous Fistulas

Conditions
-----------------
Arteriovenous Dural Fistula

Intervention / Treatment
-----------------
* Device: PHIL® Liquid Embolic System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 22 - 80 years. Subject is willing and capable of complying with all study protocol requirements, including specified follow-up period. Subject or authorized legal representative must provide written informed consent prior to initiation of any study procedures. Subject has an intracranial dAVF Exclusion Criteria: Subject having multiple dAVFs to be treated. Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated). Subject has known allergies to dimethylsulfoxide, iodine. Subject is currently participating in another clinical study Female subject is currently pregnant. Subject has co-morbid conditions that may limit survival to less than 24 months.

Ages Eligible for Study
-----------------
Minimum Age: 22 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dAVF treatment<br>PHIL® Liquid Embolic System | Device: PHIL® Liquid Embolic System<br>* The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects with neurological death or ipsilateral stroke | Reported incidences of death or ipsilateral stroke | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical events during the PHIL embolization procedure(s) | Reported incidences of technical events with PHIL device | During the procedure | 
| Device-related adverse events |  | 3-6 month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fistula, Intracranial, Dural, Arteriovenous, Liquid Embolic
Comparing Effect of Short Sleep Duration on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to evaluate the effect of sleep duration on weight loss of obese and overweight adult when they are in a weight loss plan (NovinDiet Protocol). The investigators aim is to compare the effects of short term sleep duration with normal sleep duration with respect to body weight (and abdominal adiposity).

Official Title
-----------------
Comparing the Effect of Short Sleep Duration on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program: A 12 Week Randomized Controlled Trial

Conditions
-----------------
Obesity, Overweight

Intervention / Treatment
-----------------
* Other: Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be female Must have < 7 hour sleep per night Must be 18-45 years of age. Must have Body mass index (BMI) between 27-35 kg/ m². Must be able to have moderate exercise. Must be interested to have weight loss. Exclusion Criteria: Participating in a research project involving weight loss or physical activity in the previous six months. Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months. Taking medication that could affect metabolism or change body weight. Report heart problems, chest pain, and cancer within the last five years. Smoking Menopause Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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: Short Sleep<br>Diet+ have 5 hour sleep at night (SS) | Other: Diet<br>* Intervention 'Diet+ short sleep versus normal sleep<br>|
| Experimental: Normal Sleep<br>Diet+ have 7-8 hour sleep at night (NS) | Other: Diet<br>* Intervention 'Diet+ short sleep versus normal sleep<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | kg | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index reduction | kg/m2 | 12 Weeks | 
| Fasting plasma glucose level | mmol/l | 12 Weeks | 
| lipid profiles | mmol/l | 12 Weeks | 
| Insulin resistance (HOMA) | score | 12 Weeks | 
| liver enzymes (SGOT, SGPT) | U/l | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep, Caloric Restriction, weight loss
Comparison Study of MDX-010 (CTLA-4) Alone and Combined With DTIC in the Treatment of Metastatic Melanoma

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to determine the safety and activity profile of multiple doses of MDX-010, and to determine the whether the addition of cytotoxic chemotherapy (decarbazine [DTIC]) can augment the effects of MDX-010 in patients with chemotherapy naïve metastatic melanoma with a tolerable toxicity profile.

Official Title
-----------------
A Randomized Study Comparing MDX-010 (CTLA-4) Alone or in Combination With DTIC in the Treatment of Patients With Chemotherapy Naїve Metastatic Melanoma.

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: MDX-010 (CTLA-4)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Clinical diagnosis of unresectable metastatic melanoma. No prior chemotherapy for melanoma, and no chemotherapy for other malignancies within 5 years and at least 4 weeks since treatment (surgery, radiation, or immunotherapy) for melanoma. Exclusion Criteria Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study: Any other prior malignancy, except for the following: adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the patient has been disease-free for >=5 years. Active autoimmune disease. Active infection requiring therapy, or chronic active HBV or HCV, or confirmed reactivity with HIV tests.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MDX-010 (CTLA-4)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Influence of ABCB1、CYP3A4、CYP3A5、POR Genetic Polymorphism and Other Factors on Tacrolimus Blood Concentration

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to identify factors that may influence tacrolimus (TAC) pharmacokinetics, and the impact of gene polymorphism (ABCB1, CYP3A4, CYP3A5, POR) on pharmacokinetics of TAC in Taiwanese.

Detailed Description
-----------------
TAC is one of the most important immunosuppressive agents for organ transplantation. In some patients the dose and concentration of TAC are difficult to adjust because of its narrow therapeutic index and variable pharmacokinetics. Many factors affect the pharmacokinetics of TAC. Literature suggests that ABCB1, CYP3A4, CYP3A5, POR gene polymorphisms may affect the pharmacokinetics of TAC. In addition, the distribution of TAC is affected by hematocrit and albumin concentrations. The pharmacokinetics of TAC may also be affected by total protein, total bilirubin, creatinine, AST, ALT, gender, age, drug interactions, and so on. This study intends to analyze the influence of various factors, including drugs, on the pharmacokinetics of TAC.

Official Title
-----------------
The Influence of ABCB1、CYP3A4、CYP3A5、POR Genetic Polymorphism and Other Factors on Tacrolimus Blood Concentration

Conditions
-----------------
Kidney Transplantation, Liver Transplantation

Intervention / Treatment
-----------------
* Other: Clinical and genetic factors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: kidney transplants or liver transplants 20 - 65 years old receiving tacrolimus as immunosuppressive drugs Exclusion Criteria: Human immunodeficiency virus-positive status Retransplantation or multiorgan transplantation non-Asian

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- |
| kidney or liver transplantation<br>Renal or liver transplant recipients with tacrolimus as immunosuppressive drugs. | Other: Clinical and genetic factors<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-normalized tacrolimus concentration |  | Within the first 6 months post-transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tacrolimus, pharmacokinetics, gene polymorphism, clinical factors
A Single Case Study of Hypermetabolism

Study Overview
=================
Brief Summary
-----------------
In the Metabolic Disorder clinic at The Hospital for Sick Children, the investigators identified a male, proband with possible Luft's disease. The investigators hypothesize that Luft's disease is caused by excess or dysregulation of brown/beige fat tissue. To address the hypothesis, the investigators would like to assess brown fat distribution and activity in this subject.

Detailed Description
-----------------
The subject will undergo a fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography (18F FDG PET/CT) at the Diagnostic Imaging unit of The Hospital for Sick Children.

Official Title
-----------------
A Single Case Study of Hypermetabolism

Conditions
-----------------
Hypermetabolism Due to Defect in Mitochondria, Luft Disease

Intervention / Treatment
-----------------
* Diagnostic Test: 18F FDG PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of hypermetabolism, possible Luft's disease. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One subject with possible Luft's disease<br>18F-FDG will be administered I.V., approximately 1 hour prior to PET/CT scan. | Diagnostic Test: 18F FDG PET/CT<br>* 18F FDG PET/CT imaging (fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brown/beige fat tissue distribution and activity. Measurement tool- 18F FDG PET/CT (fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography) | Areas of 18F-FDG uptake on PET colocalizing with regions of fat will be identified on CT (-250to -10 Hounsfield Units) and quantified by Standard Uptake Value (SUV). | 1 day |