linjc16/ctgov huggingface dataset:
Nicorandil Study to Reduce Cardiac Death After Percutaneous Coronary Intervention (PCI) in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
Survival after invasive coronary revascularization is worse in patients with chronic kidney disease than in those without it. The investigators aimed to examine whether oral administration of nicorandil, a hybrid of nitrate and adenosine triphosphate-sensitive potassium channel opener, could improve the survival of end-stage renal disease patients with coronary artery disease by inhibiting cardiac death after coronary revascularization.

Official Title
-----------------
Oral Nicorandil to Reduce Cardiac Death After Coronary Revascularization in Hemodialysis Patients: A Randomized Trial

Conditions
-----------------
Acute Myocardial Infarction, Congestive Heart Failure

Intervention / Treatment
-----------------
* Drug: Nicorandil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemodialysis patients with coronary artery disease who had undergone a successful first PCI with bare-metal stents between July 1, 2001 and December 31, 2003. Exclusion Criteria: Subjects with moderate or worse cardiac valvular disease or old myocardial infarction at the point of first PCI.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicorandil<br> | Drug: Nicorandil<br>* Oral administration of nicorandil (15 mg/day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death (sudden cardiac death, deaths due to acute myocardial infarction or congestive heart failure) |  | Jan 1, 2002 to Dec 31, 2006 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | Jan 1, 2002 to Dec 31, 2006 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sudden cardiac death
Ultrasound Guided Quadratus Lumborum Block Compared to Caudal Bupivacaine/ Neostigmine in Pediatric Lower Abdominal Surgeries

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the postoperative pain control in children undergoing lower abdominal surgeries receiving QL block with those receiving caudal bupivacaine/ neostigmine.

Official Title
-----------------
Ultrasound Guided Quadratus Lumborum Block Compared to Caudal Bupivacaine/ Neostigmine in Pediatric Lower Abdominal Surgeries, a Randomized Controlled Trial

Conditions
-----------------
Postoperative Analgesia

Intervention / Treatment
-----------------
* Drug: bupivacaine/ neostigmine.
* Drug: bupivacaine/ neostigmine.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients American Society of Anesthesiologists physical status (ASA) I or II. Consent from parents or legal guardian(s). Lower abdominal surgeries. Exclusion Criteria: Parents' refusal or legal guardian's refusal. Infection at the injection site. Known allergy to bupivacaine and/or neostigmine. Contraindications to regional anesthesia (including coagulopathy and local infection). Anatomical anomalies at the site of the block.

Ages Eligible for Study
-----------------
Maximum Age: 15 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1(QL group)<br> | Drug: bupivacaine/ neostigmine.<br>* will receive bilateral ultrasound guided QLB<br>|
| Active Comparator: Group 2 (CB group)<br> | Drug: bupivacaine/ neostigmine.<br>* will receive ultrasound guided CB.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total amount of paracetamol doses (mg) | The total amount of paracetamol doses (mg) | 24 hours postoperatively |
Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation Patients

Study Overview
=================
Brief Summary
-----------------
Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.

Detailed Description
-----------------
Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour. Objective(s): The primary objective of this study is to evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3 by attempting to demonstrate a mean error for FTRR < 1.0 BPM during spontaneous breathing.

Official Title
-----------------
Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation

Conditions
-----------------
Respiratory Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is at least 18 years old; The subject has given written informed consent to participate in the study; The subject is both willing and able to comply with study procedures. Exclusion Criteria: The subject has a history of or current atrial fibrillation; The subject has a documented history of frequent premature ventricular contractions (PVCs), defined as >3 per 30 seconds; The subject has an implanted pacemaker; The subject has had any relevant injury at the sensor location site (self-reported); The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination); The subject is currently or trying to get pregnant (self-reported); and/or The subject has another health condition which in the opinion of the principal investigator makes subject unsuitable for testing.

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 |
| --- | --- |
| subjects with respiratory disease<br>This study is a comparative, single-center study. This is a minimal risk study using a non-significant risk device. A minimum of 60 and maximum of 70 subjects will be enrolled in the study. Subject participation will last approximately 1 hour(s). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3 | Measure respiratory rates | 40 minutes |
Dipole Density Mapping of Right and Left Atrial Supraventricular Tachycardia

Study Overview
=================
Brief Summary
-----------------
Use of dipole density mapping to identify activation in complex supraventricular tachycardias

Official Title
-----------------
Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia

Conditions
-----------------
Supraventricular Tachycardia

Intervention / Treatment
-----------------
* Device: Mapping with the Acutus Medical System followed by Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18 to 75 years scheduled for ablation of atypical atrial flutter or paroxysmal atrial fibrillation able and willing to give informed consent Exclusion Criteria: implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped, permanent pacemaker or ICD leads in the chamber being mapped, and/or hypercoagulopathy or an inability to tolerate anticoagulation . myocardial infarction within the prior two months cardiac surgery within the prior three months intracardiac thrombus clinically significant tricuspid valve regurgitation or stenosis any cerebral ischemic event in the prior six months pregnant or nursing currently enrolled in any other clinical investigation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dipole Density Mapping<br> | Device: Mapping with the Acutus Medical System followed by Ablation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with device-related complications |  | 7 days | 
| The number of patients for which activation maps can be created |  | 7 days |
Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that fenofibrate/omega will improve insulin resistance compared with fenofibrate

Conditions
-----------------
Hypertriglyceridemia

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: fenofibrate/omega
* Drug: fenofibrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypertriglyceridemia Exclusion Criteria: moderate or severe hypertension, uncontrolled diabetes (HbA1c > 9%), nephrotic syndrome, hypothyroidism, coronary artery disease, or peripheral vascular disease

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 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 |
| --- | --- |
| Placebo Comparator: placebo<br>placebo | Drug: placebo<br> <br> |
| Active Comparator: fenofibrate/omega<br>fenofibrate/omega | Drug: fenofibrate/omega<br> <br> |
| Active Comparator: fenofibrate<br>fenofibrate | Drug: fenofibrate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow-mediated dilation |  | 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance |  | 8 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin resistance
Resistance to HIV Infection

Study Overview
=================
Brief Summary
-----------------
The immune systems of some individuals may be capable of resisting HIV infection. These individuals do not appear to be infected with HIV despite multiple sexual encounters with HIV infected partners. This study will examine the immune systems of these individuals to determine what factors are responsible for their ability to resist HIV infection. Study hypothesis: Some long-term, multiply-exposed seronegative persons have relative resistance to HIV infection maintained by T cell responses.

Detailed Description
-----------------
Rare individuals appear naturally resistant to overt HIV-1 infection despite repeated sexual exposures. These individuals, referred to as exposed seronegatives (ES), represent a unique population in which to evaluate mechanisms by which HIV-1 replication is either controlled or aborted. The purpose of the study is to analyze HIV-specific immune responses, both cellular and humoral, that exist in seronegative individuals who have experienced multiple exposures to HIV by sexual contact. This study will follow participants for 2 years. Participants will have 25 study visits during the study. Assessments will include HIV tests, viral load measurements, CD4 counts, pregnancy tests, and physical exams.

Official Title
-----------------
Evaluation of HIV-Specific Immunological and Virological Responses of HIV-1 Multiply-Exposed Seronegative Individuals

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good general health HIV uninfected Repeated exposures to HIV through unprotected sexual intercourse within the 2 years prior to study entry Live in the greater Seattle area Plan to stay in the greater Seattle area for the 2 years after study entry Exclusion Criteria: Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Seronegativity
A Phase I Pharmacologic Study of CYC116, an Oral Aurora Kinase Inhibitor, in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is a phase I study of an investigational cancer drug, CYC116, in patients with advanced solid tumors.

Detailed Description
-----------------
Phase I study of an investigational cancer drug, CYC116, an Aurora kinase inhibitor, in patients with advanced solid tumors.

Official Title
-----------------
A Phase I Pharmacologic Study of CYC116, an Oral Aurora Kinase Inhibitor, in Patients With Advanced Solid Tumors

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: CYC116


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Incurable advanced solid tumors that did not respond to conventional therapy or for which no effective therapy exists Age >=18 years Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy ≥ 3 months Evaluable disease Adequate bone marrow function Adequate renal function Adequate liver function At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities Able to swallow capsules At least 3 weeks from major surgery Agree to practice effective contraception Exclusion Criteria: Previously untreated CNS metastasis or progressive CNS metastasis documented by MRI scan performed at 4 weeks or longer after the last treatment for CNS metastasis Currently receiving radiotherapy, biological therapy, or any other investigational agents Uncontrolled intercurrent illness Pregnant or lactating women Known to be HIV-positive Known active hepatitis B and/or hepatitis C infection

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: CYC116<br>CYC116 dose escalation first-in-human evaluation | Drug: CYC116<br>* Dose escalation of CYC116<br>* Other names: Aurora kinase inhibitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | Safety and tolerability; SAEs and AEs | over the course of study |
Anorectal Microbicide Project(AMP): Rectal Health, Behaviors and Microbicide Acceptability

Study Overview
=================
Brief Summary
-----------------
Observational, cross-sectional, single-visit study of 896 men and women in Los Angeles, CA and Baltimore, MD including a computer-assisted interview focusing on the behavioral repertoire surrounding RAI, symptoms, and health seeking behaviors and a multidimensional assessment of behaviors, anorectal examination, and testing for sexually transmitted infections (STIs).

Official Title
-----------------
Rectal Health, Behaviors and Microbicide Acceptability

Conditions
-----------------
Rectal Health, Rectal Behaviors, Anorectal Symptomatology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women are eligible who meet all of the following criteria: At least 18 years of age Willing to be tested for STIs including HIV Willing to undergo an anal exam Mentally competent to understand study procedures and give informed consent. For the NO-RAI groups: No RAI in the past year for the non-RAI men and women For the practicing RAI groups: Males: report RAI in the past 30 days Females: report RAI in the past 12 months Exclusion Criteria: Less than 18 years of age Unwilling to be tested for STIs (and HIV) Unwilling to undergo an anal exam Unwilling to complete study questionnaire Not mentally competent to understand study procedures and give informed consent.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Tear-based, Lab-developed Test for Breast Cancer for Women With Dense Breast Tissue

Study Overview
=================
Brief Summary
-----------------
Investigation of a tear-based, lab-developed biological test for breast cancer, as a supplemental tool to current screening recommendations for women with dense breast tissue will explore if a tear-based biological test can be used as a support tool in the breast cancer screening protocol for women with dense breast tissue. The test was designed and validated by Namida Lab, Inc., a high complexity Clinical Laboratory Improvement Amendments (CLIA) certified lab.

Official Title
-----------------
Investigation of a Tear-based, Lab-developed Biological Test for Breast Cancer, as a Supplemental Tool to Current Screening Recommendations for Women With Dense Breast Tissue.

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

Intervention / Treatment
-----------------
* Diagnostic Test: Schirmer Strip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Categorized as having heterogeneously dense or extremely dense tissue 18 years of age or older Able to understand the informed consent process Willing to comply with all study procedures Exclusion Criteria: Have an active eye infection Categorized as having fibro glandular densities or fatty breast tissue Currently diagnosed or are receiving treatment for breast cancer Under 18 years of age

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dense Breast<br>Women mammographically categorized as having either heterogeneously dense or extremely dense breast tissue. | Diagnostic Test: Schirmer Strip<br>* A tear-based screening assay for breast cancer developed and validated by Namida Lab, Inc., a high complexity CLIA-certified lab. It consists of two parts: tear sample collection using a Schirmer Strip and a clinical lab-developed test that measures protein biomarkers for breast cancer screening.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy Measure | Degree of closeness of categorization by a tear-based biological test scores to imaging techniques | 3 months |
Extended Study of Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301EXT is an open-label, nonrandomized, phase 1 extension study of PSMA ADC administered IV in subjects with progressive CMPC that has progressed after prior taxane therapy. Subjects who have participated in PSMA ADC 1301 and who, in the opinion of the PI, are likely to benefit from continued treatment with PSMA ADC will be enrolled in PSMA ADC 1301EXT.

Official Title
-----------------
Extended 39-Week Study of PSMA ADC Following the Initial 12-Week Dose-escalation Study in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: PSMA ADC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have completed the PSMA ADC 1301 study and who, in the opinion of the investigator, have derived benefit from treatment with PSMA ADC. A diagnosis of progressive, castration-resistant, metastatic prostate cancer. Prior chemotherapy regimens, one of which contains taxane. Eastern Cooperative Oncology Group status of 0 or 1 Exclusion Criteria: Clinically significant cardiac disease or severe debilitation pulmonary disease Evidence of an active infection requiring ongoing antibiotic therapy History of drug and/or alcohol abuse

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: PSMA ADC<br>* PSMA ADC administered IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with Adverse Events | Safety and tolerability of PSMA ADC as measured by all adverse events, hematology, blood chemistry, and urine values, vital signs, electrocardiogram, and physical exam. | 39 weeks |