linjc16/ctgov huggingface dataset:
Prognostic Value of Biochemical Markers in Cerebrospinal Fluid for Functional Outcome of Spinal Cord Injured Patients

Study Overview
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Brief Summary
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The project is aimed to develop predictive indices of spinal cord injury severity through the analysis of cerebrospinal fluid of patient collected during acute injury.

Official Title
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Investigation on the Prognostic Value of Biochemical Markers in the Cerebrospinal Fluid for the Functional Outcome of Spinal Cord Injured Patients

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: Lumbar puncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of cervical and thoracic Spinal Cord Injury need to be submitted to spine surgical stabilization with posterior approach Exclusion Criteria: prior to recruitment, in the acute phase, treatment with steroid therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: lumbar puncture<br>That's not really an arm label because the only intervention on the patients is the lumbar puncture | Other: Lumbar puncture<br>* The only intervention is the lumbar puncture on the patients to obtain a Cerebrospinal Fluid sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creation of a model which analyze relationship among laboratory investigations and primary lesion, secondary damage and functional impairment | Correlation of the dosage of more than 20 tentative biomarkers with the biological effect of Cerebrospinal Fluid exposure on human cell lines, in order to directly test those effects. The Cerebrospinal Fluid will be encoded using technical procedures, divided into aliquots, quickly frozen and stored at 80°C. Biomarkers will be measured in the Cerebrospinal Fluid, related to: inflammatory and vascular reaction, by a cytokine panel including 12 different cytokines/chemochines; neurodegeneration and excitotoxicity, by a panel of 10 different biomarkers. | Three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injuries, Cerebrospinal Fluid
IN UTERO SMOKING AND PREMATURE CELLULAR SENESCENCE

Study Overview
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Brief Summary
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Actually, there is an increasing number of arguments for a premature origin of chronic adult's diseases, as the chronic obstructive pulmonary disease (COPD). Several factors interacting with the foetal or postnatal lung growth are associated with early and long-lasting respiratory functional changes susceptible to contribute very significantly to the arisen of a COPD in the adulthood. It is possible that these situations reflect phenomena of premature cellular senescence, recently involved in the physiopathology of the COPD. An in utero exposition to cigarette smoking is one of these situations, because it is known to induce, not only functional respiratory changes, but also multiple diseases in the child which could testify of cellular ageing phenomena. Our project aims to demonstrate that in utero smoking is associated with markers of premature cellular senescence in newborn children The study will be driven in human newborn child's, with comparison of the length of the telomeres in circulating lymphocytes (umbilical blood is collected), according to the exposure in in utero smoking and also according to the degree of hypotrophy. This study will be a pilot study completed by an animal experimental study.

Official Title
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IN UTERO SMOKING AND PREMATURE CELLULAR SENESCENCE

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Genetic: cord blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Born weight upper or equal to the 10th percentile and absence of smoking declared by the mother Born weight lower than the 10th percentile and absence of smoking declared by the mother Born weight upper or equal to the 10th percentile and smoking declared by the mother of at least 5 cigarettes a day Born weight lower than the 10th percentile and smoking declared by the mother of at least 5 cigarettes a day Exclusion Criteria: Gestationnel age 37 LIMITED COMPANIES Low(Weak) declaratory(declarative) maternal smoking (1 in 4 cigarettes a day) Pathologies associated by the newborn child (deformations, foetal suffering, infection maternofœtale, respiratory distress syndrome)

Ages Eligible for Study
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Maximum Age: 27 Days

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

Accepts Healthy Volunteers
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No

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: new borns<br> | Genetic: cord blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cord blood samples |  | 12months |
Database of Interstitial Lung Diseases

Study Overview
=================
Brief Summary
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The cause of most interstitial lung diseases (ILDs) is still unknown. Further research, for example to determine predisposing genetic factors, is therefore needed. A database with relevant clinical data and DNA/serum samples of ILD patients could facilitate future research on the cause of ILDs.

Detailed Description
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Protocol title: 'Registration of clinical data and DNA of patients with Interstitial Lung Disease (ILD)' Rationale: The etiopathogenesis of most Interstitial Lung Diseases (ILDs) is still unknown. Further research, e.g. to determine predisposing genetic factors, is therefore needed. A database with relevant clinical data and DNA/serum samples of ILD patients could facilitate future research on the etiopathogenesis of ILDs. Objective: Availability of relevant clinical data and DNA/serum samples of ILD patients in a database. Those data can be used for future research. Study design: A prospective observational study Study population: Patients diagnosed with ILD attending the pulmonology department in participating hospitals. Intervention: a blood sample is taken from each patient. Furthermore, additional information is collected from the medical file. Main study parameters/endpoints: DNA and serum sample, demographic variables, medical information, occupational history and hobbies. Nature and extent of the burden and risks associated with participation, group relatedness: two tubes of blood will be drawn from the patients. The risks of drawing blood from a vein are minimal.

Official Title
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Registration of Clinical Data and DNA/Serum of Patients With Interstitial Lung Diseases (ILD)

Conditions
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Interstitial Lung Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of an ILD, as stated by the American Thoracic Society (ATS)

Ages Eligible for Study
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Minimum Age: 18 Years

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

Accepts Healthy Volunteers
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No

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
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Lung disease, Interstitial, Sarcoidosis, Pulmonary fibrosis
Farming and Movement Evaluation Study (FAME)

Study Overview
=================
Brief Summary
-----------------
The long term goal of this research is to elucidate the cause(s) of Parkinson's disease, with a focus on environmental determinants. We propose to investigate the relationship between Parkinson's disease and exposure to pesticides and other factors by conducting a nested case-control study in the Agricultural Health Study.

Detailed Description
-----------------
The long term goal of this research is to elucidate the cause(s) of Parkinson's disease, with a focus on environmental determinants. We propose to investigate the relationship between Parkinson's disease and exposure to pesticides and other factors by conducting a nested case-control study in the Agricultural Health Study. The Agricultural Health Study is a cohort study of 52,000 licensed pesticide applicators and 32,000 of their spouses, conducted in North Carolina and Iowa. It is a joint effort of the National Cancer Institute, the National Institute of Environmental Health Sciences, and the US Environmental Protection Agency. The studies proposed here take full advantage of the Agricultural Health Study. We believe that this work could provide a critical and dramatic next step in furthering our knowledge of environmental determinants of PD, and thereby take us closer to our goal of finding its cause(s)

Official Title
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Pesticides and Risk in the Agricultural Health Study

Conditions
-----------------
Parkinson's Disease, Movement Disorders

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Subjects will be recruited from members of the Agricultural Health Study cohort.

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?
-----------------
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
-----------------
Parkinson's disease, Movement Disorders, Epidemiological Study
Estimation of Economic Consequences Linked With Different Care Management Pathways of Differentiated Thyroid Cancers

Study Overview
=================
Brief Summary
-----------------
The incidence of Thyroid Cancer (TC) has increased over the last thirty years, in France and worldwide. This increase is mainly due to good prognosis microPapillary TC (mPTC). Sixty percent of diagnosed cancers are considered as over-diagnosed, leading to an over-treatment of these cases. The increase of diagnosis of mPTC and its treatment inevitably leads to an increase of medical resources consumption and corresponding costs. The primary aim of this study is to estimate the cost related to different care management pathway of TC patient during a lifetime period using a multi-state Markov model. This is a retrospective, observational population based cohort study, using data from a cohort study of TC patients implemented by the ONCOMIP network which initially aimed to perform an audit of clinical practices for the management of TC, and from database of the French social health insurance of Midi-Pyrenees region to calculate observed costs of TC management during 24 months.

Official Title
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Estimation of Economic Consequences Linked With Different Care Management Pathways of Differentiated Thyroid Cancers : Involvement of Overtreatment

Conditions
-----------------
Thyroid Cancer

Intervention / Treatment
-----------------
* Procedure: care management pathways


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: all patients with a good prognosis of the TC diagnosed in 2014 whose medical file discussed in MultiDisciplinary Team Meeting (MDTM) in Midi-Pyrenees Exclusion Criteria: patients whose surgical management was carried out outside Midi Pyrenees are excluded and other morphological types are excluded (medullar, anaplastic, lymphomas, sarcomas)

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: care management pathways|different care management pathways, including thyroidectomy, iode 131, hormonal treatment and type of follow up|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost related to the different management pathways of TC patient | estimate the cost related to the different management pathways of TC patient during a lifetime period using a multi-state Markov model | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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health economics, care management pathways, overtreatment
Growth Response in Girls With Turner Syndrome

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of the trial is to evaluate growth response of two somatropin dose regimens in girls with Turner Syndrome.

Official Title
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Growth Response in Girls With Turner Syndrome During a Three-year GH Treatment Comparing Two Dose Regimens. Identification of Predictive Factors of Growth Response

Conditions
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Genetic Disorder, Turner Syndrome

Intervention / Treatment
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* Drug: somatropin
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Turner syndrome If age below 3 years, either body height below - 1 SD (standard deviation) with average growth velocity according to chronological age or body height below 0 SD with growth velocity below -1 SD according to chronological age If age above 3 years, body height below - 1 SD with average growth velocity according to chronological age Measured parental height available Written informed consent
Sexes Eligible for Study
-----------------
Female

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: Low dose<br> | Drug: somatropin<br>* 0.9 UI/kg/week. Subcutaneous injection for 3 years<br>|
| Experimental: High dose<br> | Drug: somatropin<br>* 1.8 UI/kg/week. Subcutaneous injection for 3 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height gain, SDS (Standard Deviation Score) |  |  | 
| Height gain in cm |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height |  |  | 
| Bone maturation |  |  |
A Videographic Study to Evaluate the Impact of a Pulsed Firing Technique on Staple Line Interventions in Laparoscopic Sleeve Gastrectomy

Study Overview
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Brief Summary
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Prospective, multi-center study will evaluate a pulsing technique with the ECHELON FLEX GST system for hemostasis at the staple line in laparoscopic sleeve gastrectomy procedures.

Detailed Description
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Prospective, multi-center study will evaluate a pulsing technique with the ECHELON FLEX GST system for hemostasis at the staple line in laparoscopic sleeve gastrectomy procedures. Data collected for the study consists of videography imaging and audio. Video recordings (no subject identifiers) will involve the use of two cameras providing: Synchronized Internal and external views of devices used, including the hands of the surgeon firing the endocutter; and Audio of the procedure to record the motor noise of the device while firing (audio will help identify the surgeon's pulsing technique during the procedure). Surgeon satisfaction with transection technique will also be collected. Videography will be evaluated for staple line hemostasis and need for surgical intervention at the staple line (defined in Criteria for Evaluation).

Official Title
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A Videographic Study to Evaluate the Impact of a Pulsed Firing Technique on Staple Line Interventions in Laparoscopic Sleeve Gastrectomy

Conditions
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Hemostasis

Intervention / Treatment
-----------------
* Device: Laparoscopic sleeve procedures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willingness to sign a Video, Audio and Digital Data Release consent for participation; and Scheduled for a laparoscopic sleeve gastrectomy procedure. Exclusion Criteria: Prophylactic use of buttressing material Other staple line reinforcement
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
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No

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Laparoscopic sleeve procedures|Laparoscopic sleeve procedures with powered stapler|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of oozing/bleeding at the staple line | Investigate whether use of a prescribed pulsing technique may provide potential reduction in the occurrence of oozing/bleeding at the staple line. | Intraoperative | 
| Occurence of sugical interventions required to achieve hemostasis at the staple line | Investigate whether use of a prescribed pulsing technique may provide potential reduction in the occurrence of surgical interventions required to achieve hemostasis at the staple line. | Intraoperative |
The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome

Study Overview
=================
Brief Summary
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This study will test the hypothesis that reducing the release of free fatty acids (FFA) from fat cells will restore insulin-mediated, endothelium-dependent vasodilation in people with the metabolic syndrome.

Detailed Description
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We hypothesize that acipimox, by decreasing plasma FFA concentrations, will augment endothelium-dependent vasodilation in conduit vessels and insulin-mediated vasodilation in forearm resistance arterioles in vivo, whole-body insulin sensitivity, and AKT (also known as Protein Kinase B) and endothelial nitric oxide synthase (eNOS) phosphorylation in skin biopsy specimens ex vivo, when compared with placebo.

Official Title
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The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome

Conditions
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Metabolic Syndrome

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


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Adults with metabolic syndrome, defined as the presence of 3 of 5 components of the syndrome as defined by the National Cholesterol Education Program including: abdominal obesity elevated fasting blood sugar (110 mg/dL< glucose < 126 mg/dL) low HDL elevated fasting blood triglycerides (> 150 mg/dL) hypertension (BP > 140/90 mm HG) Normal cardiovascular examination Exclusion Criteria: Diabetes mellitus Untreated hypercholesterolemia (LDL > 75th percentile for age) Cigarette smoking within 1 year Renal insufficiency (creatinine > 1.4 mg/dl) Blood dyscrasia Hepatic dysfunction (ALT > 2x normal) Evident coronary/peripheral atherosclerosis

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acipimox<br>Acipimox treatment QID for 7 days | Drug: acipimox<br>* 250 mg tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit<br>* Other names: Olbetam;|
| Placebo Comparator: Placebo<br>Placebo treatment QID for 7 days | Drug: Placebo<br>* 1 tablet orally every 6 hours for 7 days, with a dose at 7 am on the morning of the study visit<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow Mediated Vasodilation | Brachial artery response to a 5 minute blood pressure cuff-applied ischemic period | After 7 days of each treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
free fatty acids, insulin-mediated, endothelium-dependent vasodilation, metabolic syndrome