linjc16/ctgov huggingface dataset:
Control Cohort CTRL COH

Study Overview
=================
Brief Summary
-----------------
Autoimmune encephalitis (AE) and paraneoplastic neurological syndromes (PNS) are rare disease that could be difficult to diagnose. So it necessary to obtain numerous sample from different disease to develop more specific diagnosis kit It could be possible through the characterisation of new genetic biomarkers.

Official Title
-----------------
Control Cohort CTRL COH

Conditions
-----------------
Parkinson's Disease; Amyotrophic Lateral Sclerosis; Glioblastoma; Cancer Without Neurological Disease; Rheumatoid Polyarthritis

Intervention / Treatment
-----------------
* Biological: Collection of biological sample (blood and/or CSF)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with consent patient with following disease: Parkinson's disease, Amyotrophic lateral sclerosis, Glioblastoma, cancer without neurological disease (pulmonary cancer, breast cancer, ovarian cancer, melanoma, thymoma), rheumatoid arthritis. Exclusion Criteria: refusal consent patient with neurological disorder compatible with paraneoplastic neurological syndrome or auto-immune encephalitis patient under guardianship

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control cohort<br>Patient with following disease: Parkinson's disease, Amyotrophic lateral sclerosis, Glioblastoma, cancer without neurological disease (pulmonary cancer, breast cancer, ovarian cancer, melanoma, thymoma), rheumatoid arthritis. | Biological: Collection of biological sample (blood and/or CSF)<br>* Blood sample will be collected one time for each patient: 2 *4ml of blood on dry tube 2 *4ml of blood on EDTA tube If cerebrospinal fluid (CSF) has been drawn for diagnosis, remaining sample available will be stored in the control cohort (1 ml).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Samples (blood dry and EDTA tube and optional cerebro-spinal-fluid) | Numbers of samples collected and patients included in the cohort | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of genetic analysis | Number of new biomarkers (genetic) and specific HLA (human leucocyte antigen) | Data collecting: 3 years Data analysis: 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biological collection, control cohort,, new biomarkers
Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease

Study Overview
=================
Brief Summary
-----------------
To provide parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) to patients with liver disease (PNALD).

Detailed Description
-----------------
This is a compassionate use protocol for patients with PNALD who have failed traditional treatment to receive Omegaven through an IND. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.

Official Title
-----------------
Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease

Conditions
-----------------
Parenteral Nutrition-related Hepatitis

Intervention / Treatment
-----------------
* Drug: Omegaven


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient will be PN dependent and unable to meet nutritional needs solely by enteral nutrition. Patient will be <18 years of age. Direct bilirubin > 2.0mg/dl The patient must have failed standard therapies to prevent progression his/her liver disease. Exclusion Criteria: Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency). Patients who are allergic to eggs/shellfish Patients who have severe hemorrhagic disorders.

Ages Eligible for Study
-----------------
Maximum Age: 17 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
Interventional Model Description: This is a compassionate use protocol for patients with PNALD who have failed traditional treatment to receive Omegaven through an IND.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Overall Study<br>Use of Omegaven for patients with parenteral nutrition associated liver disease. | Drug: Omegaven<br>* Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day.<br>* Other names: IV Fish Oil Based Lipid Emulsion;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Progression as Measured by Serum Levels of Hepatic Enzymes | To evaluate whether established parenteral nutrition associated liver disease (PNALD) can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) as measured by normalization or decrease of serum levels of hepatic enzymes. | Up to 1 year |
The Effects of Labor Stages and Interventions on Hemodynamic Measures During & After Childbirth With Noninvasive Sensors

Study Overview
=================
Brief Summary
-----------------
The Effects of Labor Stages and Interventions on Hemodynamic Measures During and After Childbirth ( Epidural, Rupture Membranses Cesarean Sections and Preeclampsia) With Noninvasive Sensors.

Official Title
-----------------
The Effects of Labor Stages and Interventions on Hemodynamic Measures During and After Childbirth (Epidural, Rupture of Membranes, Cesarean Sections and Preeclampsia) With Noninvasive Sensors.

Conditions
-----------------
Rupture of Membranes; Premature, Cesarean Section; Infection, Preeclampsia

Intervention / Treatment
-----------------
* Device: biobeat sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant woman between 18-45 years old with non cardiovascular disease Exclusion Criteria: woman with a cardiovascular disease woman who don't agree to participate in the trial

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: biobeat sensor<br> | Device: biobeat sensor<br>* biobeat sensor is a noninvasive sensor of the the hymodynamic measures during the childbirth and after 24 hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biobeat sensor is a noninvasive sensor of the the hymodynamic measures during the childbirth | biobeat sensor is a noninvasive sensor of the the hymodynamic measures during the childbirth | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biobeat sensor is a noninvasive sensor of the the hymodynamic measures after 24 hours of the childbirth | biobeat sensor is a noninvasive sensor of the the hymodynamic measures after 24 hours of the childbirth | 24 hours |
Assessment of Nutritional Status in Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
The main theme of the cohort of systemic sclerosis (SSc) patients is the determination of nutritional status, its evolution and the evaluation of its management in patients with scleroderma. The main objectives are : To determine the incidence of malnutrition and its main determinants (disease characteristics, severity, eating habits, physical activity) in patients with scleroderma. For patients with undernutrition at inclusion or at 18 months follow-up: evaluate the impact of a standardized nutritional intervention (dietary advice, oral supplements, artificial, enteral or parenteral nutrition) on nutritional and disease parameters. Follow-up visits will take place every 6 months for 2 years. (M6, M12, M18 et M24). During each visit: a clinical examination, with anthropometric measurements, a 3-day dietary survey and a blood sample (10 ml), completion a multiple-choice of quality of life and physical activity evaluation. Paraclinical evaluation : echocardiography, lung function tests, screening for osteoporosis (M6 and M18). If undernutrition is detected during a follow-up visit, the subject will be referred to a specialized service.

Official Title
-----------------
Assessment of Nutritional Status in Systemic Sclerosis: Prospective Cohort Study in Montpellier University Hospital

Conditions
-----------------
Systemic Sclerosis

Intervention / Treatment
-----------------
* Other: Collection of data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All SSc patients aged 18 or more Patient followed at the Montpellier University Hospital Patients must fulfil the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria for SSc. Health insurance (affiliation to social security) Collection of non-opposition to participate in the study Exclusion Criteria: Patient under the protection of justice curatorship / guardianship; Patients who have already planned to move out of the region in the next two years, making the follow-up impossible.

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 |
| --- | --- |
| SSc patients<br> | Other: Collection of data<br>* different set of data will be collected over a 6 months period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of malnutrition | Incidence of malnutrition will be measured as a loss of more than 10% of body weight or a body mass index (BMI) less than 21 kg/m2 | 6 months | 
| Idetification of risk factors associated with malnutrition | Collection of data related to SSc disease burden | 6 months | 
| Success of the nutritional intervention | body weight gain > 5% | 6 months |
Post COVID-19 Functional Status in Egypt

Study Overview
=================
Brief Summary
-----------------
Since the outbreak of coronavirus disease - COVID-19 pandemic, most attention has focused on mode of transmission, clinical picture of the disease, treatment and prevention. In the coming weeks and months emphasis will gradually involve the post- acute care of COVID-19 survivors. It is anticipated that COVID-19 may have major impact on physical, cognitive, mental, social health status even in patients with mild disease. Moreover, pulmonary, radiologic, laboratory, sleep issues remain to be addressed

Official Title
-----------------
Assessment of Functional Recovery From COVID-19 Using the Proposed Post- COVID-19 Functional Status Score

Conditions
-----------------
COVID-19, Coronavirus Disease, SARS-CoV-2

Intervention / Treatment
-----------------
* Other: Post COVID-19 Functional Satus Scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All confirmed cases with COVID-19 Exclusion Criteria: Non COVID-19 cases
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Post COVID-19 Functional Satus Scale|scale from 0-64 assessing functional limitation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of functional limitations post COVID-19 | scale 0-64 points | 3-6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of psychologic changes | Hamilton scale, points | 3-6 months | 
| Sleep Disturbance and quality | ESS scale 0-20, points | 3-6 months | 
| Radiologic changes | Chest HRCT | 3-6 months | 
| Laboratory changes | Complete blood count, C - reactive protein, serum ferritin | 3-6 moths | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep disturbance, Functional score, Radiologic changes, Psychologic changes, Laboratory
Hydrogen Sulfide Detoxification and Butyrate Metabolism in Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the relation between sulphide detoxification and butyrate metabolism at the level of gene expression and enzyme activity in ulcerative colitis patients and healthy controls.

Official Title
-----------------
Impact of the Mucosal Detoxification Mechanism of Hydrogen Sulphide on the Oxidation Pathway of Butyrate in Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Ulcerative colitis patients: patients diagnosed with ulcerative colitis Exclusion Criteria: Healthy controls: no diagnosis of inflammatory bowel diseases Intake of antibiotics in the last month before the study

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy controls<br> | |
| Ulcerative colitis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Genetics of Hypertension and Its Intermediate Phenotypes

Study Overview
=================
Brief Summary
-----------------
To define the underlying genetics of hypertension in an Asian population by studying intermediate phenotypes.

Detailed Description
-----------------
BACKGROUND: Hypertension, an exceedingly common trait in most developed countries, imparts an increased risk of cardiovascular, cerebrovascular and renal diseases. Nevertheless, the primary determinants of elevated blood pressure in most patients are unknown. Recognizing that a sizable portion of variation in blood pressure is genetically determined, one line of research has focused on identifying genetic variants that contribute to the pathogenesis of hypertension. However, standard genetic linkage analysis using hypertension as a phenotype may lack power due to the multifactorial nature of the disorder. A way to overcome this challenge is to subdivide hypertensive subjects into more homogenous subgroups. DESIGN NARRATIVE: The overall goal, which is to define the underlying genetics of hypertension in an Asian population by studying intermediate phenotypes, can be divided into three parts. First, the rural Chinese population will be characterized by the collection of intermediate phenotype data on 600 unrelated individuals with high diastolic blood pressure and on 100 normotensive controls. Intermediate phenotypes include: 1) non-modulation of adrenal and renal vascular responses to angiotensin II with changes in sodium intake; 2) altered urinary kallikrein excretion; 3) low plasma renin activity response to volume depletion; 4) increased free cortisol excretion; and 5) insulin resistance. Second, candidate genes will be chosen according to the underlying physiology of the intermediate phenotypes, and variations in the coding sequences of these potentially relevant genes will be identified. Finally, polymorphisms identified in the candidate genes will be tested through case-control analyses defined by the intermediate phenotypes. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.

Official Title
-----------------
Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer

Conditions
-----------------
Head and Neck Neoplasms

Intervention / Treatment
-----------------
* Drug: tirapazamine (SR259075)
* Drug: cisplatin
* Procedure: Radiation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Stage III or IV disease (excluding T1N1, and T2N1). ECOG performance status less than or equal to 2. Absolute neutrophil count at least 1.5 X 10^9/L, platelet count at least 100 X 10^9/L, and hemoglobin > 9g/dL. Serum bilirubin < 1.25 times ULN and AST/ALT < 2.5 times ULN. Calculated creatinine clearance (Cockcroft-Gault) > 55 mL/min. Exclusion Criteria: Metastatic Disease

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: tirapazamine (SR259075)|nan|
|Drug: cisplatin|nan|
|Procedure: Radiation Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to locoregional failure. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
squamous cell carcinoma, oropharynx, oral cavity, larynx, hypopharynx
Resistance to Lamivudine in HBV Egyptian Patients

Study Overview
=================
Brief Summary
-----------------
On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients

Detailed Description
-----------------
Primarily: To study the correlations between the following parameters in adult Egyptian patients with chronic viral hepatitis B before treatment: ALT. HBeAg. HBV-DNA by quantitative PCR. Biopsy (if possible). Secondarily: After receiving lamivudine therapy we will identify the impact of these parameters on viral breakthrough at 1 year of therapy.

Official Title
-----------------
Pretreatment and On-treatment Indicators of Virologic Breakthrough in Chronic HBV Egyptian Patients Receiving Lamivudine Therapy

Conditions
-----------------
Chronic Hepatitis B Virus Treatment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients >18 years old Egyptian nationality Positive serology for HBsAg for more than 6 months Positive HBV viremia (above 2000IU/ml). Lamivudine monotherapy Exclusion Criteria: Anti-HBcIgM seropositivity Positive serology for HCV Positive serology for HDV Patients complicated with HCC

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic HBV Egyptian patients<br>chronic HBV patients receiving Lamivudine therapy in hepatology clinic in the National Hepatology & Tropical Medicine Research Institute in Egypt. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resistance to Lamivudine Therapy | Prevelance of Lamivudine resistance among HBV Egyptian cases pretreatment and on treatment parameters for Lamivudine therapy resistance | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis B virus, Lamivudine, Resistance to treatment