linjc16/ctgov huggingface dataset:
Investigating Lysosomal Storage Diseases in Minority Groups

Study Overview
=================
Brief Summary
-----------------
Although lysosomal storage disorders, such as Fabry disease, Gaucher disease, and Pompe disease, represent serious challenges in the healthcare system, no study has yet investigated the prevalence of these diseases in the US. Frequently, patients show progressive worsening of symptoms for several years before they get diagnosed. Since many of these diseases can be managed therapeutically, it is important to identify and treat patients in order to avoid organ damage. The investigators aim to undertake a screening study that identifies undiagnosed patients with lysosomal storage disorders and determine the prevalence of these diseases with special focus on underrepresented minority groups.

Conditions
-----------------
Lysosomal Storage Disorders, Gaucher Disease, Fabry Disease, Pompe Disease, Niemann-Pick Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is greater than or equal to 1 day of age and less than or equal to 100 years of age Subject is managed by a physician in the Washington, D.C metro area Subject is getting blood work as part of standard clinical care and there is at least 60 uL blood remained in a tube after all clinical tests were run Exclusion Criteria: Absolute contraindication for blood drawing Subject cannot be traced back by the referring physician upon a positive screening result

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 100 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 |
| --- | --- | --- |
| Number of patients identified with lysosomal storage disorders |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LSD, Lysosomal storage disorders, Gaucher disease, Fabry disease, Pompe disease, Niemann-Pick disease
A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The patients about to undergo liver transplantation will be randomized to one of the following two group: Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3 months(12 weeks

Official Title
-----------------
A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With Steroids in Patients Undergoing Liver Transplantation and a Pharmacokinetics Study.

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Drug: Tacrolimus modified-release
* Drug: Prograf


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent with the date of the patient must be obtained. Patient between 18-70 years of age receiving the primary liver. Female patients must have a negative pregnancy test prior to the enrolment. Female patients of child bearing potential must agree to practice effective birth control during the study Exclusion Criteria: Liver re-transplantation patients or received an organ transplantation other than a liver. Living-related liver transplantation patient. Patient has received an AB0 incompatible donor liver. Patient who needs antibody induction therapy. Patient with sever infection requiring treatment. Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy, liver cancer not included.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>In combination with steroids | Drug: Tacrolimus modified-release<br>* oral<br>* Other names: MR4;|
| Active Comparator: 2<br>In combination with steroids | Drug: Prograf<br>* oral<br>* Other names: FK506;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event rate of patients with acute rejections |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of and time to acute rejections |  | 12 Weeks | 
| Overall frequency of acute rejections |  | 12 Weeks | 
| Rate of patient and graft survival following transplantation. |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver Transplantation, Tacrolimus, Methylprednisolone, Prednisolone
Marijuana for HIV-Related Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
To evaluate whether smoked marijuana reduces pain in people with HIV-related peripheral neuropathy.

Detailed Description
-----------------
The study will include subjects with peripheral neuropathy caused either by HIV-disease or antiretroviral medication for the treatment of HIV. A neurologist will conduct a neurological and pain evaluation to determine eligibility for the study. Subjects who meet all eligibility criteria will be admitted to the General Clinical Research Center at San Francisco General Hospital for seven days. Subjects will be randomized (like a toss of a coin) to smoke marijuana or a placebo (cigarettes with no THC).

Official Title
-----------------
Effects of Marijuana on Neuropathic Pain in HIV-Related Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study.

Conditions
-----------------
Peripheral Nervous System Diseases, HIV Infections

Intervention / Treatment
-----------------
* Drug: Smoked Marijuana


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: HIV positive. Be 18 years or older. Diagnosis of HIV-related painful neuropathy. Stable antiretroviral therapy or no antiretroviral therapy for at least 8 weeks. Prior use of marijuana, at least 6 occasions in their lifetime prior to enrollment. EXCLUSION CRITERIA: (Not allowed) Current use of smoked tobacco products. Current methadone treatment. Use of smoked marijuana within 30 days of enrollment. Diagnosis of diabetes mellitus. Currently receiving treatment with corticosteroids. Use of INH, dapsone or metronidazole within 8 weeks prior to enrollment. Severe heart disease, uncontrolled high blood pressure or lung disease. Women who are pregnant or breastfeeding.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Smoked Marijuana|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of HIV-related neuropathic pain as recorded on a 100mm Visual Analog Scale. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of experimentally-induced pain. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuropathy, treatment experienced, complementary therapies, Peripheral Neuropathy, HIV-Related Peripheral Neuropathy, HIV
Epicardial Adipose Tissue and Arterial Stiffness in People Living With Diabetes (METAB-CV-PWV)

Study Overview
=================
Brief Summary
-----------------
The present study is a retrospective and prospective current care cohort that will allow us to evaluate the relationship between epicardial fat volume and increased arterial stiffness in a person living with diabetes.

Detailed Description
-----------------
Epicardial adipose tissue is considered as the cardiac visceral fat and is associated with increased cardiovascular risk, for example in diabetes. Thus, the mechanisms involved seem to be related to myocardial lipotoxicity; atherosclerosis in connection with inflammation and secretion of proinflammatory factors such as cytokines but also insulin resistance. In this context, the investigators hypothesize that epicardiac adipose tissue volume will be higher in patients with increased arterial stiffness than in those without. In this study, the investigators will then try to verify the existence of a relationship between pericardial adipose tissue volume and increased arterial stiffness in people living with diabetes. To do this, the investigators will analyze the results of measurements of pericardial fat volume, coronary calcium score, and pulse wave velocity in diabetic patients.

Official Title
-----------------
Tissu Adipeux épicardique et rigidité artérielle Chez Les Personnes Vivant Avec un diabète

Conditions
-----------------
Diabetic Patients

Intervention / Treatment
-----------------
* Procedure: CT scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be eligible for participation in the study if: They are informed and have not objected to participating in the research. They have type 1 or 2 diabetes. They perform a coronary calcium score measurement by CT scan and a pulse wave velocity assessment during their routine care practice.

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: CT scan|coronary calcium score measurement by CT scan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epicardial fat volume | Epicardial fat volume will be determined using cardiac CT scan without contrast injection. | the inclusion visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabet, arterial stiffness, pericardial adipose tissue
Determination of COVID-19 Related Virus in Central Nervous System

Study Overview
=================
Brief Summary
-----------------
Coronavirus disease 2019 (COVID-19) is a highly infectious pandemic disease caused by SARS-CoV-2 virus. Central Nervous System (CNS) complications associated with COVID-19 might be secondary sequelae due to exuberant systemic innate-mediated hyper-inflammation, which may impair neurovascular endothelial function, disrupt blood brain barrier (BBB), activates CNS innate immune signaling pathways, and induces parainfectious autoimmunity, potentially contributing to the CNS manifestations. Although the predominant clinical manifestation of SARS-CoV-2 is characterized by dyspnea, unremitting fever and hypoxemic respiratory failure, neurologic manifestations do occur in most hospitalized SARS-CoV-2 patients and include non-specific encephalopathy, psychosis, meningitis/encephalitis, myelitis, cerebrovascular events, Guillain-Barre' syndrome, and cranial or peripheral neuropathies, such as anosmia and ageusia. To date, data about primary CNS involvement due to neurotropism and direct neuroinvasion are still lacking.

Detailed Description
-----------------
Determination of SARS-CoV-2 presence in central nervous system

Official Title
-----------------
Determination of SARS-Cov-2 Virus in Central Nervous System

Conditions
-----------------
COVID-19 Testing, CNS Disease, CNS Infection

Intervention / Treatment
-----------------
* Diagnostic Test: Determination of SARS-CoV2 presence in CNS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients Patients candidate for CNS surgery Patients who have been tested for nasopharyngeal swab for SARS-CoV-2 Patients who have been tested for serology test for anti SARS-CoV-2 immunoglobulinG (IgG) and immunoglobulinM (IgM) antibodies Patients able to sign informed consent Exclusion Criteria: Patients not meeting inclusion criteria

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 |
| --- | --- |
| Adult neurosurgical patients<br>Adult, both sex, neurosurgical patients candidate for intracranial surgery, able to sign informed consent. | Diagnostic Test: Determination of SARS-CoV2 presence in CNS<br>* Brain tissue sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of SARS-CoV-2 presence in the CNS | Brain tissue sampling analysis | Surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-Cov-2, CNS infection, Coronavirus, Brain
A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Multi-center, Open Label, Extension Study to Evaluate the Long-term Safety and Tolerability of GK Activator (2) in Type 2 Diabetic Patients From Studies BM18248 or BM18249

Conditions
-----------------
Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Drug: GK Activator (2)
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetic patients who have completed studies BM18248 or BM18249; patients considered by the investigator to be suitable for long term treatment with GK Activator (2). Exclusion Criteria: type 1 diabetes mellitus; women who are pregnant, breast-feeding or not using adequate contraceptive methods.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: GK Activator (2)<br>* Escalating doses bid<br>Drug: Metformin<br>* As prescribed, in patients who were in study BM18249<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs, laboratory parameters, ECG. |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from original baseline in HbA1c, FPG, lipid profile. |  | Throughout study |
Role of Anti Mullerian Hormone for Ovarian Reserve Determination of Preoperative and Postoperative Endometrioma Patients

Study Overview
=================
Brief Summary
-----------------
Ovarian reserve influenced by many factor but especially cysts like endometrioma. Anti mullerian hormone is recent marker for ovarian reserve. The investigators are searching ovarian reserve pre and post operatively by using antimullerian hormone of endometrioma patient who are operated for their cysts.

Detailed Description
-----------------
long term results of the postoperative follow up for the endometrioma patients

Official Title
-----------------
Role of Anti Mullerian Hormone for Ovarian Reserve Determination of Preoperative and Postoperative Endometrioma Patients

Conditions
-----------------
Endometrioma, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ultrasonographical symptomatic and benign cysts which has surgery indication. Exclusion Criteria: Over 42 years old, systemic endocrine disorder, history of ovarian surgery

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 42 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endmetrioma surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term postoperative ovarian reserve outcomes of endometrioma patients by examining antimullerian hormone. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovarian reserve, Antimullerian hormone
Serological Test for the Diagnosis of TB

Study Overview
=================
Brief Summary
-----------------
TB remains a health problem in France with about 5,000 new cases per year. Development of new screening tests is a priority for TB. The main objective of the study is to evaluate performances of innovative blood tests to identify active tuberculosis in adults patients living in low-prevalence country. Adult patients with possible TB from will be tested for the presence of antibodies directed against M. tuberculosis selected antigens. Positive and negative predictive values will be established based on TB culture results.

Official Title
-----------------
Performances of Immunoassays Based on the Detection of Antibodies Directed Against Mycobacterium Tuberculosis Antigen for the Diagnosis of Active Tuberculosis in Adults

Conditions
-----------------
Active Tuberculosis

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signs of possible Tuberculosis (TB); testing for TB in routine practice (microbiology) Exclusion Criteria: Immunosuppression

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 |
| --- |
|Other: No intervention|Evaluation of performance of immunoassays based on the detection of antibodies directed against Mycobacterium tuberculosis antigen|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and negative predictive values for the diagnosis of active TB |  | 48 months |
Peripheral Venous Stent System in the Treatment of Iliac Vein Stenosis or Occlusion

Study Overview
=================
Brief Summary
-----------------
Clinical study on safety and efficacy of Zylox peripheral venous stent system in the treatment of iliac vein stenosis or occlusion.

Detailed Description
-----------------
The purpose of this study was to evaluate the safety and efficacy of Zylox peripheral venous stent system in the treatment of iliac vein stenosis or occlusive lesions compare with conventional venous stent.

Official Title
-----------------
Safety and Efficacy of Peripheral Venous Stent System in the Treatment of Patients With Iliac Vein Stenosis or Occlusion: a Prospective, Multicentre, Randomized Controlled Clinical Trial.

Conditions
-----------------
Iliac Vein Stenosis, Iliac Vein Occlusion

Intervention / Treatment
-----------------
* Device: Zylox Peripheral Venous Stent
* Device: Zilver Vena Venous Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged from 18 to 75 years old, male or female Subject's target lesions were stenosis and/or occlusion CEAP≥C3 Subjects were able to understand the purpose of the study, demonstrate full compliance with the program and sign informed consent Exclusion Criteria: Pregnant woman or who's pregnancy test is positive Lactation period woman or woman/man with fertility plan

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zylox Peripheral Venous Stent Implantation<br>Percutaneous stent placement in the iliofemoral veins | Device: Zylox Peripheral Venous Stent<br>* Self-expanding stent implantation during the index procedure.<br>|
| Active Comparator: Zilver Vena Venous Stent Implantation<br>Percutaneous stent placement in the iliofemoral veins | Device: Zilver Vena Venous Stent<br>* Self-expanding stent implantation during the index procedure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vascular patency rate at 12 months after operation | Target vascular patency rate | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of major adverse events | Related to death of clinical trials | 12 months | 
| Adverse Event | Adverse medical events,whether or not related to the medical device | Preoperative、Intraoperative、up to 1 month、3 month、6 month、12 month、2 years、3 years、5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral venous stent system, Iliac vein patency rate