linjc16/ctgov huggingface dataset:
TBTC Study 23C: Pharmacokinetics of Intermittent Rifabutin and Isoniazid With Daily Efavirenz

Study Overview
=================
Brief Summary
-----------------
The aim of this trial is to study the efavirenz-rifabutin interaction. Thus, this trial will enroll patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg daily. Enrollment in TB Trials Consortium Study 23 is not a requirement for participation in this study. Primary Objective: To compare the pharmacokinetics of rifabutin at 600 mg twice a week in combination with efavirenz 600 mg daily to the pharmacokinetics of rifabutin 300 mg twice a week without efavirenz.

Official Title
-----------------
TBTC Study 23C: Intensive Pharmacokinetic Study of Intermittent Rifabutin and Isoniazid With Daily Efavirenz in Combination With Two Nucleoside Analogs for Treatment of HIV and Tuberculosis Co-infections

Conditions
-----------------
HIV Infections, Tuberculosis

Intervention / Treatment
-----------------
* Drug: Rifabutin
* Drug: Efavirenz


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg daily.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rifabutin|nan|
|Drug: Efavirenz|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare PK of rifabutin 600mg twice weekly with efavirenz 600mg daily to PK of rifabutin 300mg twice weekly without efavirenz |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| *Describe PK of rifabutin 600mg twice weekly in combination with efavirenz 600mg daily with 2 NRTI's |  |  | 
| *Describe PK of efavirenz in this regimen |  |  | 
| *Assess safety of concomitant rifabutin and efavirenz in HIV-TB |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tuberculosis, TB
Intraoperative Use of the BP Device for Detecting Positive Margins During Lumpectomy Procedure

Study Overview
=================
Brief Summary
-----------------
This protocol was designed for testing the intraoperative use of the Dune device. This multicenter study will take place in Israel at 12 sites.

Detailed Description
-----------------
Use of the device will take place during a partial mastectomy procedure (lumpectomy).The patient will be randomized to enter the device or control arm.

Official Title
-----------------
MAST Study Protocol

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: Dune Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Women diagnosed with carcinoma of the breast Undergoing lumpectomy (local wide excision) procedure. Over 18 years of age Signed ICF Exclusion criteria Neoadjuvant systemic therapy Previous radiation in the operated breast Prior surgical procedure in the same quadrant Implants in the operated breast Pregnancy Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Dune Device|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IDC, DCIS, ILC
Minimum Dose CT Post Lung Biopsy

Study Overview
=================
Brief Summary
-----------------
The aim is to evaluate whether Minimum Dose CT (MnDCT) is useful in the management of patients post Lung Biopsy

Detailed Description
-----------------
Patients post Lung Biopsy have a chest X-ray (CXR) and a MnDCT post lung biopsy. Both studies are compared for the detection of a pneumothorax

Official Title
-----------------
Can Minimum Dose CT Post Lung Biopsy Predict Patient Outcome?

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Device: CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Patients having a lung biopsy Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CT|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Pneumothorax |  |  |
Harnessing Online Peer Education Online Support Intervention for COVID-19 (HOPE COVID-19)

Study Overview
=================
Brief Summary
-----------------
The Harnessing Online Peer Education COVID-19 (HOPE COVID-19) intervention will assess whether a peer-led online support community can improve behavioral health outcomes related to COVID-19.

Detailed Description
-----------------
The Harnessing Online Peer Education COVID-19 (HOPE COVID-19) intervention will assess whether a peer-led online support community can improve behavioral health outcomes related to COVID-19. Participants in the intervention group will be assigned to peer leaders trained in the HOPE intervention methods.

Official Title
-----------------
HOPE Intervention for COVID-19

Conditions
-----------------
COVID-19 Vaccination

Intervention / Treatment
-----------------
* Behavioral: HOPE intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-30 years old English speakers only U.S. Resident Part of phase 1a or 1b of COVID-19 vaccine rollout (Healthcare personnel, education, and frontline essential workers, verified through LinkedIn profile) Uses social media and/or online communities greater than twice per week Has, or is willing to accept a friend request and group invite from our Facebook social media page Have not received a COVID-19 vaccine and do not have medical conditions or other circumstances preventing them from receiving one Exclusion Criteria: -

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HOPE Intervention<br>HOPE peer-led intervention | Behavioral: HOPE intervention<br>* Online peer support community of peers trained in behavior change science<br>|
| No Intervention: Control<br>Control group- online community without peer leaders | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Requests for a COVID-19 Vaccine Resource Sheet | Whether or not the participant requested that our study team send them an electronic resource sheet on the COVID-19 vaccine and where they can get vaccinated. | 1 time request during the 4-week study |
Buprenorphine Maintenance for Opioid Addicts - 3

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate buprenorphine in a medical maintenance model three times a week.

Official Title
-----------------
Buprenorphine Maintenance for Opioid Addicts

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Retention |  |  | 
| Withdrawal symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opioid-Related Disorders
Hydration and Contrast-Induced Nephropathy in Primary Angioplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether hydration with sodium bicarbonate is more effective than hydration with sodium chloride to prevent contrast induced nephropathy in patients undergoing Primary Coronary Intervention for Acute ST Elevation Myocardial Infarction.

Official Title
-----------------
Hydration and Contrast-Induced Nephropathy in Primary Angioplasty. A Randomized, Placebo Controlled, Trial.

Conditions
-----------------
Contrast Induced Nephropathy

Intervention / Treatment
-----------------
* Drug: sodium bicarbonate solution
* Drug: Isotonic saline
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with Acute ST Elevation Myocardial Infarction submitted to Primary Intervention Exclusion Criteria: refusal to consent previous contrast exposure within 72 hours
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 |
| --- | --- |
| Active Comparator: 1<br>Sodium Bicarbonate (154 mEq/L in dextrose and H2O) 3 mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after the procedure | Drug: sodium bicarbonate solution<br>* 154 mEq/L in dextrose and H2O<br>|
| Active Comparator: 2<br>Isotonic Saline (0.9% sodium chloride) 1 mL/kg/h for 12 hours after the procedure | Drug: Isotonic saline<br>* 0.9% sodium chloride<br>|
| Placebo Comparator: 3<br>Placebo | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration or a relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration |  | within 5 days after contrast exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contrast Induced Nephropathy
Carotid Atherosclerotic Disease Following Childhood Scalp Irradiation

Study Overview
=================
Brief Summary
-----------------
Background: During the first half of the 20th century, scalp irradiation was a standard treatment for induction of epilation in children suffering from Tinea Capitis. These children are now more than 50 years old and the aim was to investigate the possible association between their childhood low dose irradiation exposure and development of carotid atherosclerotic disease in adulthood. Methods: The study included 145 individuals treated by irradiation in their childhood, and 150 matched control subjects with no history of irradiation. B-mode ultrasound imaging and US Doppler were used to measure carotid and femoral stenosis and Intima-Media Thickness (IMT). Blood samples were taken for lipid profile and homocysteine evaluation.

Official Title
-----------------
Carotid Atherosclerotic Disease Following Childhood Scalp Irradiation

Conditions
-----------------
Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 or older childhood scalp irradiation or mach controls writen informed consent Exclusion Criteria: inability to give written informed consent

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 |
| --- | --- |
| 1<br>145 individuals treated by irradiation in their childhood | |
| 2<br>150 matched control subjects with no history of irradiation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effects of Exercise Therapy on Ventricular and Endothelial Function in Patients After Coronary Artery Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was (1) to compare the peak exercise capacity and left ventricular diastolic function between patients with and without diabetes and (2) to investigate the interrelation among peak oxygen consumption, left ventricular diastolic function, blood sugar, and lipid profile.

Official Title
-----------------
Effects of Exercise Therapy on Ventricular and Endothelial Function in Patients After Coronary Artery Bypass Surgery

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

Intervention / Treatment
-----------------
* Other: exercise capacity test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: well-controlled diabetes no history of myocardial infarction stable post coronary artery bypass surgery for at least 3 months Exclusion Criteria: heart failure, valvular disease, abnormal kidney or liver function, cerebrovascular disease, primary pulmonary disease, other systemic or acute illness that may impede the testing or training

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| DM group<br> | Other: exercise capacity test<br> <br> |
| non-DM group<br> | Other: exercise capacity test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular diastolic function | echocardiographic parameters | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow-mediated dilation | flow-mediated dilation on right brachial artery | 1 week | 
| exercise capacity | oxygen consumption | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery bypass graft, Diabetes mellitus, type 2
Non-curative ESDs: Assessing the Rates and Risk Factors for Residual Neoplasia

Study Overview
=================
Brief Summary
-----------------
Short and long outcomes of ESD are well described, particularly in Eastern series. However, the outcome of non-curative ESDs is scarcely reported in the west (particularly among non-gastric or submucosal lesions). Therefore, the aim of this project is to describe the European experience with non-curative ESDs, analysing all the consecutive ESDs performed in several reference centers, assessing the presence of residual lesion in the endoscopic follow-up or in the surgical specimen.

Official Title
-----------------
Multi-center Survey on Non-curative ESDs: Assessing the Rates and Risk Factors for Residual Neoplasia

Conditions
-----------------
Gastric Neoplasm, Esophageal Neoplasms, Colorectal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients submitted to ESD due to neoplastic lesions of the gastrointestinal tract Exclusion Criteria: Patients without endoscopic follow-up or surgery will be excluded from the analysis

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Residual neoplasia | Presence of residual neoplasia after non-curative ESD | 2010-2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic therapy, Endoscopic submucosal dissection
Evaluation of Obstructive Sleep Apnea as a Risk Factor for Pulmonary Embolism

Study Overview
=================
Brief Summary
-----------------
we evaluate the presence of OSA in patients that have a computed tomography (CT) of the chest to rule out pulmonary embolism (PE) to determine if OSA constitutes an independent risk factor for PE.

Official Title
-----------------
Evaluation of Obstructive Sleep Apnea as a Risk Factor for Pulmonary Embolism

Conditions
-----------------
Obstructive Sleep Apnea, Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female patients age 18 years and older with suspected PE

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive Sleep Apnea, Pulmonary Embolism, male and female patients suspected of having a pulmonary embolism.
Pulmonary Vasculature and Right Heart Dysfunction in Chronic Obstructive Pulmonay Disease

Study Overview
=================
Brief Summary
-----------------
The pulmonary vasculopathy and right heart dysfunction in COPD are drawing increasing attention these days. Recent researches show that pulmonary vasculopathy and right heart dysfunction relate to greater severity in COPD. Applying appropriate modalities for early detection of pulmonary vasculopathy and right heart dysfunction is of great importance. What's more, the interaction mechanism between pulmonary vasculature, right heart and COPD still needs to be further studied. The aim of our study is to develop an assessment system of pulmonary vasculopathy and right heart dysfunction in COPD patients and elucidate their impact on COPD course and outcome.

Official Title
-----------------
Pulmonary Vasculature and Right Heart Dysfunction in Chronic Obstructive Pulmonay Disease

Conditions
-----------------
COPD, Pulmonary Vascular Disorder, Right Ventricular Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable COPD patients Exclusion Criteria: patents with other respiratory diseases and pulmonary hypertension other than group 3 PH; psychopath, addict or patients not able to coordinate; patients in pregnancy or breastfeeding; patients with limited life expectancy; patients with contraindiction for MRI or PET; patients having cerebrovascular events in 3 months; unstable COPD patients

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| All-cause mortality | survival rate in % | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD exacerbations | total times | 3 year | 
| GOLD degree | Ⅰ-Ⅳ according to the pulmonary function | 3 year | 
| NYHA degree | Ⅰ-Ⅳ according to the symptom | 3 year |