linjc16/ctgov huggingface dataset:
Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Official Title
-----------------
Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

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

Intervention / Treatment
-----------------
* Drug: adalimumab
* Drug: placebo for adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of moderate to severe chronic plaque psoriasis Active psoriasis, despite topical therapies Exclusion Criteria: Other active skin diseases or skin infections Prior exposure to any anti-TNF therapy Subject has other active skin diseases Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies) Poorly controlled medical conditions History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease History of cancer or lymphoproliferative disease History of active TB or listeriosis, or persistent chronic or active infections Known to have immune deficiency or is immunocompromised Clinically significant abnormal laboratory test results Erythrodermic psoriasis or generalized pustular psoriasis

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 |
| --- | --- |
| Active Comparator: A<br> | Drug: adalimumab<br>* OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded 40 mg eow through Week 48, withdrawal and observation for 360 days after last dose<br>* Other names: Humira;|
| Placebo Comparator: B<br> | Drug: placebo for adalimumab<br>* OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded placebo eow through Week 48, withdrawal and observation for 360 days after last dose<br>* Other names: placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index |  | Week 12-Week 24 | 
| Adverse Events |  | Throughout Study Participation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index |  | Week 12, Week 24 through 360 days after last dose | 
| Physician's Global Assessment |  | Week 12, Week 24 through 360 days after last dose |
Clinical Investigation and Molecular Forms of Family Disease of Varicose

Study Overview
=================
Brief Summary
-----------------
The existence of a family factor in the genesis of varicose veins is certain, but few studies have addressed reliably instead of the genetic factor in clinical and molecular level. The investigator initiated an original study to identify one or more genetic abnormalities predisposing to varicose disease, based on a combined approach of genetic linkage and of exome sequencing. The clinical research phase is an essential prerequisite to the identification of genetic mutations; it is to identify large affected families and ensure an extremely rigorous and accurate phenotyping of individuals over several generations. A first clinical work has identified and / or phenotype 8 families with a genetically informative family suggesting autosomal dominant inheritance. Linkage analysis suggested several candidate chromosomal regions without allowing the identification of a gene. This project aims to resume and expand the Family clinical investigations and apply the techniques of genome analysis points, including exome sequencing on the most informative families to identify the genes and mechanisms responsible of this disease and improve the prevention and the treatment of varicose veins.

Official Title
-----------------
Genetic Study of Varicose Disease by Sequencing Exome

Conditions
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Varicose Veins

Intervention / Treatment
-----------------
* Other: blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient consultant the Medicine Vascular Surgery for varicose veins of the lower limbs as part of a manifesto family context Varices Presence in at least one family member Written consent Exclusion Criteria: Patients who are unable to sign or who refuse to sign an informed consent Subjects aged less than 25 years, due to the low penetrance of varicose disease that age. Secondary veins at a post-thrombotic disease (suspected by the examination and confirmed by Doppler ultrasonography of the deep venous system) Venous angiodysplasia or secondary varicose arteriovenous fistulas.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: blood sample|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genetic abnormalities segregating with the presence of varicose veins in the informative families recruited. |  | year 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genotype/phenotype relationship | improving knowledge of the genotype / phenotype based on genes identified in different families. | year 4 |
How Much The Self-Reported Physical Activity Change in Patients With Physical Disabilities Hospitalized for Rehabilitation in A Physical Medicine and Rehabilitation Clinic

Study Overview
=================
Brief Summary
-----------------
Disability was defined by WHOas a restriction or lack of ability to perform daily activity, but this definition was later changedto problems in functioning in the WHO classification of Functioning, Disability and Health (ICF). Osteoarthritis, back pain, neck pain, rheumatologic diseases, neurologic disorders (stroke, spinal cord injury, multiple sclerosis, Parkinson diseases) can cause physical disabilities.Recent studies have shown that; high levels ofdisability is related with low levels of physical activity.Individuals with disability are commonly hospitalized ininpatients clinicsfor rehabilitation, which aims to achieveoptimal functional level ofpatients within their own limitations.A rehabilitation program can be an excellent opportunity to integrate post-rehabilitation physical activity into their lifestyle.This study aimed to examine the short term effect of inpatient rehabilitation program on self -reported physical activity both participants with physical disabilities due to musculoskeletal, and neurological disorders

Official Title
-----------------
How Much The Self-Reported Physical Activity Change in Patients With Physical Disabilities Hospitalized for Rehabilitation in A Physical Medicine and Rehabilitation Clinic

Conditions
-----------------
Disability Physical, Impairment, Physical Activity, Rehabilitation, Televisit

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Patients with physical disabilities, due to neurologic or musculoskeletal diseases and hospitalized in PMR clinic for rehabilitation between Patients over 18 years of age with cognitive functions able to fill the forms and patients with medical stabilization for neurological diseases. Exclusion Criteria: Patients under 18 years of age, Patients with additional hearing, visual and mental disabilities Patients with metabolic instability for neurological diseases, history of malignancyand pulmonary and cardiac failure, Patients with recurrent hospitalization in the PMRclinic

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASIPD | SELF-REPORTED PHYSİCAL ACTİVİTY | 15 MİNUTES |
Study on COPD Corticosteroid-induced Hyperglycemia on Clinical Outcome in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
Hyperglycemia is a common complication of corticosteroid (cortisone) therapy. It is estimated that more than a third of patients with chronic pulmonary disease (COPD) exacerbation (16). Despite its frequency, the impact of corticosteroid-induced diabetes on clinical outcome and mortality is not known. A computerized search of biomedical journal literature from MEDLINE, PubMed, and Ovid from 1966 to 2006 provided very little information on the prevalence and outcome of corticosteroid-induced diabetes in patients with COPD. Therefore, the present study aims to evaluate the impact of corticosteroid-induced diabetes on clinical outcome in patients with COPD exacerbation. We will perform a retrospective chart review of all patients admitted to the hospital with COPD exacerbation from 1/01/05 to 06/30/06 at Grady Memorial Hospital. Medical records of all patients with COPD exacerbation treated with corticosteroids will be analyzed. Data on demographics, laboratory values, mortality rate, rate of hypoglycemic events, length of stay, as well as disposition at discharge will be analyzed.

Detailed Description
-----------------
Hypotheses: We hypothesize that COPD patients with corticosteroid-induced hyperglycemia experience higher morbidity (infections, ventilator associated pneumonia, length of stay, acute renal failure) and mortality compared to COPD patients with normal glucose levels. Specific Aim: To determine the impact of corticosteroid-induced hyperglycemia on clinical outcome (length of stay, disposition, APACHE score, need for ventilatory support and ICU admission, mortality) in patients with COPD exacerbation.

Official Title
-----------------
The Impact of Corticosteroid-induced Hyperglycemia on Clinical Outcome (Length of Stay, Disposition, APACHE Score, Need for Ventilatory Support and ICU Admission, Mortality) in Patients With COPD Exacerbation

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted with COPD exacerbation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of the study is to determine the mortality rate of COPD patients with corticosteroid-induce hyperglycemia. |  | once all charts have been reviews | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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COPD, Diabetes, Respiratory Disorders
Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the long term safety and preliminary efficacy of intramedullary transplantation of HuCNS-SC cells in subjects with thoracic spinal cord trauma.

Detailed Description
-----------------
The investigation is a multi-year observational study following the completion of the open-label, single dose Phase I/II study involving transplantation of allogeneic HuCNS-SC cells into 12 subjects with thoracic spinal cord injury. Subjects will be monitored at routine intervals for safety and preliminary efficacy for four years. The LTFU study will commence following the one year post-transplantation termination visit of the Phase I/II investigation.

Official Title
-----------------
Long-term Follow-up (LTFU) Study of the Phase I/II Safety and Preliminary Efficacy Investigation of Intramedullary Spinal Cord Transplantation of HuCNS-SC® in Subjects With Thoracic (T2-T11) Spinal Cord Trauma

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have undergone HuCNS-SC transplantation as a subject in the Phase I/II trial Must agree to comply in good faith with all conditions of the study and to attend all required study visits Exclusion Criteria: Subjects have received or are receiving off-protocol immunosuppressive medications Subjects who, after completion of Phase I/II trial (Protocol # CL-N02-SC), have entered or are about to enter any other investigational study.

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 |
| --- | --- |
| No treatment<br>Observation | Other: Observation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Spinal Injury Association (ASIA) Impairment Scale Improvement | Evidence of improvement in ASIA impairment scale as confirmed by neurological examination | Four years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Cord Injury, HuCNS-SC cells, Human Neural Stem Cells, Neural Stem Cells, Stem Cells
Assessing the Occupation Burden in COPD

Study Overview
=================
Brief Summary
-----------------
To assess the population burden of occupational exposures in the prevalence and progression of chronic obstructive pulmonary disease (COPD).

Detailed Description
-----------------
BACKGROUND: Chronic obstructive pulmonary disease is the only one of the top four or five leading causes of death in the U.S. with worsening epidemiological trends. Cigarette smoking accounts for approximately 85 percent-90 percent of cases, but the other 10 percent-15 percent of the attributable risk still represents a substantial fraction of this disease that remains unexplained. Recently, several studies, in various countries, have addressed whether certain occupational exposures (primarily those relating to dusts, vapors, gases, and/or fumes) are potential risk factors for COPD. Most of these studies have shown elevated odds ratios or relative risks, although not always to a statistically significant level. DESIGN NARRATIVE: A population sample of the continental United States of those aged 55-75, supplemented by an enriched sample in geographic hot spots identified by the National Institute for Occupational Safety and Health (NIOSH) through respiratory diseases mapping. Structured telephone interviews assessed demographics, health status, smoking exposures, and occupational histories. High risk jobs were coded using a job matrix system independent of subject report of specific exposures. Two hundred thirty-four of those with COPD, with over-sampling of those with greater severity, were followed at 12-14 months to assess health status and health services utilization, as well as decrements in quality of life. 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
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Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease

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

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 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 |
| --- | --- | --- |
Study of microRNAs as a Diagnostic Tool for HCV-related Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
The aim of this work is to study the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma.

Detailed Description
-----------------
Early diagnosis of hepatocellular carcinoma can significantly improve the overall survival of HCC patients, currently available diagnostic markers are still inadequate and limited by their low sensitivity and specificity. For instance, the gold standard marker, alpha-fetoprotein (AFP), has a false negative rate up to 40% for early stage of HCC. It is worthy to mention that the level of AFP was reported in a normal range of 25% of patients with advanced HCC. These discrepancies suggest the need of discovering new reliable diagnostic markers for patients with HCC. miRNAs are small endogenous, non-coding, ssRNA that are 21-30 nucleotides in length. As for the relationship between miRNA and HCC several studies have demonstrated that the aberrant expression of specific miRNA can be detected in HCC cells and tissues. miRNAs expression profile analysis has allowed the characterization of 'identity' associated with each type of human cancer and this 'identity' is correlated with carcinogenesis, tumor progression, and response to tumor treatment.

Official Title
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Study of microRNAs as a Diagnostic Tool for HCV-related Hepatocellular Carcinoma

Conditions
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miRna in HCC

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: RNA extraction and quantitative Real-Time PCR analysis Diagnosis of HCV will be based on detection of anti-HCV antibodies Diagnosis of liver cirrhosis will be based on ultrasonography, biochemically and elastography when available Diagnosis of HCC will be based on ultrasonography, the typical criteria in triphasic multislice CT scan Exclusion Criteria: HBV or autoimmune or metabolic liver disease serological evidence of human immunodeficiency virus (HIV) infection malignancy in other organs After intervention in treatment of hepatocellular carcinoma

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group1<br>20 patients with chronic HCV | |
| GroupII<br>20 patient with chronic HCV related liver cirrhosis | |
| GroupIII<br>40 patients with chronic HCV related liver cirrhosis complicated by hepatocellular cacinoma | |
| group IV<br>20 healthy blood donors will also be included as a control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the role of circulating miRNAs in diagnosis of HCV related hepatocellular carcinoma. | cilculating miRNAs in serum samples of HCV related HCC, HCV related liver cirrhosis , chronic HCV and healthy control group | basline |
Microperimetry and Optical Coherence Tomography (OCT) in Idiopathic Macular Hole

Study Overview
=================
Brief Summary
-----------------
To evaluate the correlations between anatomical and functional changes studied with microperimetry (MPM) and spectral-domain OCT (SD-OCT) in patients after successful repair of idiopathic macular hole (MH).

Official Title
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Long-term Anatomical and Functional Outcomes of Idiopathic Macular Hole Surgery. The Yield of Spectral-domain OCT Combined With Microperimetry.

Conditions
-----------------
Macular Hole

Intervention / Treatment
-----------------
* Other: Microperimetry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Closure of the hole seen on the OCT at 1 year postoperative Exclusion Criteria: Patients with an axial length over 26 mm, diabetes, macular diseases, glaucoma, or postoperative retinal detachment were excluded

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 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 |
| --- | --- |
| Macular Hole<br> | Other: Microperimetry<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular sensitivity | To describre mean retinal sensitivity in the 12 and 4 central degrees of the retina in 23 patients one-year after macular hole surgery and thus to correlate macular sensitivities and retinal anatomic features in SD-OCT | 12 months |