linjc16/ctgov huggingface dataset:
Impact of ART Adherence on HIV Persistence and Inflammation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the relationship between anti-retroviral therapy (ART) adherence with levels of human immunodeficiency virus (HIV) reservoir and residual viremia in suppressed, HIV-infected individuals on chronic ART.

Detailed Description
-----------------
Understanding whether the size and dynamics of the HIV reservoir are associated with adherence, measured by an objective biomarker, could have significant clinical and therapeutic implications for ART and HIV cure. First, this aim will quantify levels of CA-RNA, CA-DNA, and plasma residual viremia in suppressed, HIV infected individuals and correlate them with levels of TFV-DP in DBS as a measure of cumulate drug exposure (adherence). Second, this study will evaluate the changes in the HIV reservoir in relation to changes in ART adherence over time.

Official Title
-----------------
Impact of ART Adherence on HIV Persistence and Inflammation

Conditions
-----------------
Human Immunodeficiency Virus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected males and females, Ages 18 years and older, Taking any TFV-based regimen, HIV suppression <20 copies/ml for at least 12 months; Not co-infected with HCV; Able and willing to give informed consent. Exclusion Criteria: Pregnancy. Refusal to participate.

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 |
| --- | --- |
| HIV suppressed individuals<br>HIV suppressed individuals on chronic ART, suboptimal adherence and exposure, measured through TFV-DP in DBS. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of tenofovir diphosphate in dried blood spots associated with the size of the HIV reservoir measured by the amount of CA-RNA and CA-DNA in PBMCs. | Evaluation of variations in ART cumulative adherence are associated with the size of the HIV reservoir and with the degree of chronic inflammation and immune activation in HIV-infected, virologically suppressed individuals. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of self-reported adherence (4-day, 30-day and 3-months using a visual analog scale) associated with the size of the HIV reservoir measured by CA-RNA and CA-DNA in PBMCs. | Evaluation of variations in ART self-reported adherence are associated with the size of the HIV reservoir and with the degree of chronic inflammation and immune activation in HIV-infected, virologically suppressed individuals. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anti-retroviral therapy
Comparison of Salivary and Serum Free Testosterone in Normal and Hypogonadal Men

Study Overview
=================
Brief Summary
-----------------
Low testosterone is a common male problem. The diagnosis of low testosterone often requires blood sampling and expensive testing. We want to know if measuring saliva testosterone can be used in place of blood sampling. Study participants will be asked to provide samples of blood and saliva for the measurement of testosterone. These results may lead to the development of a saliva test for testosterone.

Detailed Description
-----------------
Testosterone is required for normal male health that is known to decline in aging or other conditions. Physiologically active testosterone, also known as free testosterone, is present as a small percentage of the total blood level, mostly bound to sex hormone binding globulin and albumin. Estimation of serum free testosterone is difficult and costly, requiring equilibrium dialysis of a serum sample. These binding proteins are not normally present in saliva. It is hypothesized that the free fraction of testosterone in blood is in equilibrium with the extravascular space, notably saliva. The sponsor proposes to test this hypothesis by sampling saliva and serum and measuring testosterone. Serum free testosterone will be measured following equilibrium dialysis. To perform this study approximately 40 eugonadal and 20 hypogonadal males will be recruited.

Official Title
-----------------
Comparison of Salivary Testosterone With Serum Free Testosterone Done by Equilibrium Dialysis.

Conditions
-----------------
Known Androgen Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal male subjects aged 20-65 years Exclusion Criteria: Women Smokers, HIV positive, diabetes, hepatatis C positive, subjects currently taking testosterone who are unwilling to suspend use for teh duration of the trial, subjects taking aldactone or medicines that may interfere with the protocol

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal Males<br>Males with normal levels of serum testosterone | |
| Hypogonadal males<br>Males known to have low levels of serum testosterone | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood and saliva testosterone | Measures of blood and saliva testosterone | 1 year |
Randomized Study for Patients With Follicular Lymphoma Needing Treatment

Study Overview
=================
Brief Summary
-----------------
2 parallel studies. For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI For elderly patients (>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months

Detailed Description
-----------------
2 parallel studies. For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI For elderly patients (>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months

Official Title
-----------------
Randomized Study for Patients With Follicular Lymphoma Needing Treatment

Conditions
-----------------
Follicular Lymphoma

Intervention / Treatment
-----------------
* Procedure: CHVP + interferon
* Drug: fludarabine
* Procedure: CHOP + TBI and autotransplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: study 1 (young patients): being less than 61 years old with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node >7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass) study 2 (elderly patients): being older than 60 years with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node >7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass) Exclusion Criteria: contra-indication to anthracycline or interferon transformation into large cell lymphoma previous treatment localized stage without criteria of large tumor mass patients HIV+

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 |
| --- |
|Procedure: CHVP + interferon|nan|
|Drug: fludarabine|nan|
|Procedure: CHOP + TBI and autotransplant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Toxicity |  |  | 
| Response rates |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
follicular lymphoma, CHVP + interferon, fludarabine, autotransplant
Comparison of Inflight First Aid Performed by Cabin Crew Members and Medical Volunteers

Study Overview
=================
Brief Summary
-----------------
Since the number of air travelers, including the elderly and passengers with an underlying disease, is increasing every year, the number of inflight emergency patients is expected to increase as well. The investigators attempted to identify the incidence and types of inflight medical emergencies and analyze the first aid performed by cabin crew members or medical volunteers in flights by an Asian airline. The investigators also investigated the causes of inflight deaths and aircraft diversions.

Conditions
-----------------
Emergency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inflight medical emergencies from 2009 to 2013 Exclusion Criteria: Events that occurred before takeoff or after landing
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| An asian airline<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Types of inflight medical emergencies confirmed by reviewing cabin reports submitted by cabin crew and medical records submitted by medical volunteers | Types of inflight medical emergencies were created according to the initial symptoms of passengers (e.g. syncope, trauma) | 5 years (events during inflight, excluding events that occured before takeoff or after landing) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of inflight medical emergencies confirmed by reviewing cabin reports submitted by cabin crew and medical records submitted by medical volunteers | Incidence in inflight emergencies/million passengers | 5 years (events during inflight, excluding events that occured before takeoff or after landing) | 
| The causes of inflight deaths and aircraft diversions confirmed by reviewing cabin reports submitted by cabin crew and medical records submitted by medical volunteers | The causes of deaths and diversions were confirmed by types of inflight | 5 years (events during inflight, excluding events that occured before takeoff or after landing) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aircraft, Emergency, First aid, Cabin crew, Burn, Cardiac arrest
SEDPARK1: Safety and Efficacy Study With the Non-ergot Dopamine-agonist Piribedil in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The aim of the non-interventional Post Marketing Study is to investigate the use of the non-ergot dopamine agonist piribedil (trade name: CLARIUM) in mono- and combination therapy in patients with Morbus Parkinson. Tolerability and course of the disease or change of parkinsonian symptoms during stabilisation on, or change over from other dopamine agonists will be documented under routine conditions. Piribedil should be prescribed according to its marketing authorisation by the responsible neurologist.

Official Title
-----------------
Stabilization on, or Change-over to the Non-ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Parkinson Clinic Ambulances and Larger Private Practices.

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Piribedil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients 18 years and older. Indication: Morbus Parkinson. Treatment with piribedil for the first time. Monotherapy with piribedil. Combination therapy with L-Dopa (from the beginning or secondary) and/or in combination with other antiparkinsonian drugs. Exclusion 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

| Intervention/Treatment |
| --- |
|Drug: Piribedil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to monitor use in real practice including adverse events on piribedil |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Piribedil (trade name: CLARIUM), non-ergot dopamine agonist, Morbus Parkinson, Tolerability, Efficacy, Post Marketing Surveillance
RD13-01 for Patients With r/r CD7+ T-ALL/T-LBL

Study Overview
=================
Brief Summary
-----------------
This study is designed to explore the safety of RD13-01 for patients with CD7+ relapsed and/or refractory T cell acute lymphoblastic leukemia or lymphoblastic lymphoma. And to evaluate the efficacy and pharmacokinetics of RD13-01 in patients.

Official Title
-----------------
RD13-01 for Patients With r/r CD7+ T-ALL/T-LBL

Conditions
-----------------
T Acute Lymphoblastic Leukemia, T-lymphoblastic Lymphoma

Intervention / Treatment
-----------------
* Drug: RD13-01 cell infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 3 to 70 years. Diagnosis of r/r T-ALL/T-LBL. ECOG: 0-2. Life expectancy greater than 12 weeks. Cardiac left ventricle ejection fraction ≥50%. Informed consent explained to, understood by and signed by the patient/ guardian. Patient/guardian is given a copy of informed consent. Exclusion Criteria: Pregnant or lactating. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Viral (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive. Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs. Participated in other clinical studies within 2 weeks prior to screening. History of alcoholism, drug abuse or mental illness. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Ages Eligible for Study
-----------------
Minimum Age: 3 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RD13-01 cell infusion<br> | Drug: RD13-01 cell infusion<br>* Universal CAR-T cells targeting CD7<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity (DLT) |  | 4 weeks after infusion |
To Demonstrate the Relative Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets.

Official Title
-----------------
Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets

Conditions
-----------------
Immunosuppression, Rheumatism

Intervention / Treatment
-----------------
* Drug: Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)
* Drug: Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.) | Drug: Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.)<br> <br> |
| Active Comparator: 2<br>Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop) | Drug: Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 171 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunosuppressant and Antirheumatic
Study of Ambrisentan in Participants With Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to monitor the long-term safety of ambrisentan in adult participants with pulmonary hypertension. The available ambrisentan doses for this study are 2.5, 5, or 10 mg administered orally once daily. Investigators will be able to adjust ambrisentan dose as clinically indicated. A minimum of 4 weeks between dose adjustments is required. Participants receiving other therapies for pulmonary hypertension that are not contraindicated for concomitant use with ambrisentan are permitted to enroll in this study and continue to receive such therapies. Participants enrolled in this study will receive treatment with ambrisentan until such time as the investigator or participant chooses to stop ambrisentan treatment, ambrisentan becomes commercially available, or the sponsor stops the study.

Official Title
-----------------
ABS-LT: A Phase 3, Long-Term, Open Label, Multicenter Safety Study of Ambrisentan in Subjects With Pulmonary Hypertension

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Drug: Ambrisentan


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Men and women with pulmonary hypertension who are discontinuing a clinical study of ambrisentan due to study closure by the sponsor. Eligible participants are those participating in countries where ambrisentan is not yet commercially available. Participants participating in countries where ambrisentan is commercially available may be eligible if they do not qualify for treatment per the current prescribing information of that country. Key Exclusion Criteria: Participants who have discontinued an ambrisentan clinical study for any other reason than sponsor-initiated study closure are not eligible. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambrisentan<br>Participants will receive ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chooses to stop ambrisentan treatment, ambrisentan becomes commercially available, or the sponsor stops the study. | Drug: Ambrisentan<br>* Tablet administered orally once daily<br>* Other names: Volibris;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events (AEs) Associated With Long-Term Exposure to Ambrisentan |  | First dose date of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks) |
Viral Triggers in Pediatric Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether respiratory viral infections increase the risk of bronchiolitis obliterans syndrome (BOS), obliterative bronchiolitis (OB), death, or retransplantation in children who have received lung transplants.

Official Title
-----------------
Viral Triggers of Alloimmunity and Autoimmunity in Pediatric Lung Transplantation (CTOTC-03)

Conditions
-----------------
Lung Transplant, Bronchiolitis Obliterans, Obliterative Bronchiolitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent or legal guardian willing and able to provide informed consent Participant of first single or bilateral heart-lung transplant Exclusion Criteria: Recipient of multi-organ transplant (aside from heart-lung) Condition or characteristic which in the opinion of the investigator makes the participant unlikely to complete the study

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- |
| Pediatric lung transplantation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The earliest time to BOS or OB, retransplantation or death |  | Within 24 months of transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to each of the following events: BOS or OB, retransplantation or death |  | Within 24 months of transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung transplant, BOS, OB, Respiratory Viral Infection (RVI), Lung disease