linjc16/ctgov huggingface dataset:
Arterial Versus Venous Graft Recruitment by Intra-Aortic Balloon Pump

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the different performance of arterial and venous graft with intra-aortic balloon pump support following coronary artery bypass.

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: Transit-time flowmetry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing coronary artery bypass surgery Exclusion Criteria: Aortic insufficiency; Diffuse atherosclerosis impeding intra-aortic balloon pump introduction
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Transit-time flowmetry|Transit-time flowmetry during 1:1 IABP assistance and when IABP is turned off|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital mortality and morbidity |  | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transit-time flowmetry |  | three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery bypass graft, Intra-aortic balloon pump, transit-time flowmetry
A Study to Test the Effects of BMS-986036 on the Body in Healthy Japanese and Non-Japanese Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety, and tolerability of BMS-986036 and the effects the drug has on the body

Official Title
-----------------
A Randomized, Parallel, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986036 in Healthy Japanese and Non-Japanese Subjects

Conditions
-----------------
Metabolics

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: BMS-986036


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations Body mass index (BMI) of 25 to 40 kilogram / square meter (kg/m2), inclusive Additional criterion for Japanese subjects: Subjects must be first generation Japanese (born in Japan and not living outside of Japan for > 10 years, and both parents are ethnically Japanese) Exclusion Criteria Presence of any factors that would predispose the subject to infection (extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds) Any bone trauma (fracture) or bone surgery (hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration Known or suspected autoimmune disorder, excluding vitiligo Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Module A<br>BMS-986036 Arm | Drug: BMS-986036<br>* Specified dose on specified days<br>|
| Placebo Comparator: Module B<br>Placebo Arm | Drug: Placebo<br>* Specified dose on specified days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) | Safety | Up to 42 days | 
| Incidence of serious adverse events (SAEs) | Safety | Up to 42 days |
A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Rega

Study Overview
=================
Brief Summary
-----------------
To determine the effect of HIV-1 immunogen (Remune) on AIDS-free survival, defined as the time prior to development of an AIDS-defining condition or death.

Detailed Description
-----------------
Patients receive 10 units of HIV-1 immunogen in IFA or IFA alone every 12 weeks, then are followed for 104-148 weeks.

Official Title
-----------------
A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Regardless of Concomitant HIV Therapies

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

Intervention / Treatment
-----------------
* Biological: HIV-1 Immunogen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Antiretrovirals if on a stable dose for at least the past 3 months. Patients must have: HIV-1 infection with CD4 count 300-549 cells/mm3. No AIDS-defining condition. Been on a stable dose of antiretroviral for the past 3 months, if taking antiretrovirals. NOTE: KS is permitted if not requiring systemic therapy. Prior Medication: Allowed: Prior antiretrovirals. Exclusion Criteria Concurrent Medication: Excluded: Systemic chemotherapy for KS. Treatment for malignancy other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. Patients with the following prior conditions are excluded: History of any illness that would interfere with study. Acute infection requiring prescription therapy within the past month, other than genital herpes and oral or vaginal candidiasis. Prior Medication: Excluded: Prior HIV-1 Immunogen. Unwilling to use effective safe sex practices. Active substance abuse.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HIV-1 Immunogen|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
-----------------
HIV-1, Vaccines, Synthetic, Viral Vaccines, AIDS-Related Complex, AIDS Vaccines, Salk HIV Immunogen
A Phase 1 Study Of An Intravenously Administered Cyclin-Dependent Kinase Inhibitor In Patients With Advanced Cancer

Study Overview
=================
Brief Summary
-----------------
AG-024322 may work in cancer by stopping cancer cells from multiplying. AG-024322 is and intravenous drug from a new class of drugs call cyclin-dependent kinase (CDK inhibitors). This research study is the first time that AG-024322 will be given to people.

Detailed Description
-----------------
The study was prematurely discontinued due to the inability of the compound to adequately differentiate from other treatment options in the clinical endpoint and necessary product profile on April 13, 2007. Safety profile was not the reason that led to the discontinuation of the program.

Official Title
-----------------
A Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of AG-024322, An Inhibitor Of Cyclin-Dependent Kinase 1, 2 And 4, Administered Intravenously Daily For 5 Days Every 3 Weeks To Patients With Advanced Cancer

Conditions
-----------------
Neoplasms, Lymphoma, Non-Hodgkin

Intervention / Treatment
-----------------
* Drug: AG-024322


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced solid tumors or follicular of diffuse large cell non-Hodgkin's lymphoma, histologically or cytologically proven at diagnosis which is refractory to or intolerant of established therapy know to provide clinical benefit for their condition Adequate blood cell counts, kidney function and liver function and and ECOG score of 0 or 1. Exclusion Criteria: Prior high-dose chemotherapy requiring hemapoietic stem cell rescue Previous radiation therapy to >25% of the bone marrow Active or unstable cardiac disease or history of heart attack within 6 months

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AG-024322<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the safety of AG-024322 when taken by people who have cancer |  |  | 
| To find the AG-024322 dose that should be used in future clinical trials that will study effectiveness |  |  | 
| To assess how the human body handles blood concentrations of AG-024322 |  |  |
LGBT Internet Based Smoking Treatment - 1

Study Overview
=================
Brief Summary
-----------------
The overall goals of this line of research are to develop and evaluate innovative treatments for lesbian, gay, bisexual, and transgender (LGBT) cigarette smokers and to understand the processes related to smoking and relapse in this previously unstudied population of smokers. In this study, participants are randomly assigned to one of two Internet-based smoking cessation treatments: 1) a self-help intervention tailored LGBT smokers plus social support plus email-based counseling, or 2) a standard self-help condition alone, similar to other general smoking cessation treatments. Before starting the program, participants will complete measures of smoking, nicotine dependence, depression diagnosis, demographics, mood, motivation to change, and alcohol use. Smoking status will be determined at 1, 3, 6, and 12 months following the start of treatment. Data will be analyzed to compare the quit rates of the two Internet-based treatment groups. Also, we will complete exploratory analyses to determine those variables that best predict quitting for LGBT smokers.

Official Title
-----------------
LGBT Internet Based Smoking Treatment

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Tobacco Use Disorder
* Behavioral: Standard Web-based intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Must identify as a lesbian, gay male, bisexual male or female or a transgender individual. Must smoke most days during the preceding month. Must have a valid email address.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeted Internet Intervention<br>Web-based self help intervention developed to include specific cultural tailoring relevant to the LGBT community | Behavioral: Tobacco Use Disorder<br>* Web-based psychoeducational intervention culturally-tailored to the LGBT community including a social support component<br>|
| Active Comparator: Standard Intervention<br>Standard self-help internet-based intervention with no LGBT relevant information included | Behavioral: Standard Web-based intervention<br>* General psychoeducational Web-based smoking cessation intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| point-prevalence abstinence from tobacco use | Self-report of smoking status during the past seven days. | 7-day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking, tobacco
Neovascularization Patterns in Corneal Graft Rejection

Study Overview
=================
Brief Summary
-----------------
Corneal transplantation is the most commonly performed human tissue transplant worldwide. Over 40,000 corneal transplants occur in the US each year. . This study will determine specific corneal neovascularization (CN) patterns in human corneal allograft recipients to determine the characteristics that worsen the prognosis for graft survival. We will test the hypothesis that specific characteristics of CN are prognostic for corneal allograft rejection.

Detailed Description
-----------------
The investigators hope to enroll 240 subjects into the study. These patients will be enrolled prior to penetrating keratoplasty. They will be examined by the full protocol preoperatively, and postoperatively at 1 week, 1, 3, 6, 12, 18, and 24 months. During these visits slit lamp biomicroscopy will be used to study CN patterns, and take slit lamp photographs if there is any neovascularization detected, permitting us to develop algorithms of CN characteristics that are predictive for corneal allograft rejection and failure. The corneal tissue removed during these patients' surgeries will be evaluated histopathologically to identify inflammation and neovascularization to confirm and compare to what is seen clinically. There will be two short questionnaires conducted at each visit to assess stress levels.

Official Title
-----------------
Neovascularization Patterns in Corneal Graft Rejection

Conditions
-----------------
Corneal Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled for corneal transplant Exclusion Criteria: previous corneal transplant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| PKP<br>Subjects undergoing penetrating keratoplasty | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal graft rejection |  | 0 to 2 years after transplant |
Sources of Variability in Peak Expiratory Flow

Study Overview
=================
Brief Summary
-----------------
To provide information necessary for the development of standards for peak expiratory flow (PEF) test performance in populations studies.

Detailed Description
-----------------
BACKGROUND: While PEF has routinely been applied in the diagnosis and management of asthma, scientists were finding new applications for PEF as both a clinical and epidemiologic tool for following individuals with pulmonary diseases, studying the natural history of chronic obstructive pulmonary disease, and evaluating the impact of environmental exposures on lung function. Yet the standardization of the PEF measurement lagged behind its application. The little attention paid to the performance characteristics of the PEF maneuver contrasted sharply with the efforts to standardize measurement procedures for FEV1 and FVC. The American Thoracic Society devoted a great deal of attention to studying these measures and published guidelines for the standardization of their measurement. These guidelines included detailed protocols for calibrating equipment, administering the tests, determining reproducibility, and interpreting results. The research provided data on the optimal number of trials per test session, the difference between a PEF performed during a full forced expiratory effort and that resulting from a short blast, the impact of test supervision on test performance, and the reproducibility of the PEF measurement. DESIGN NARRATIVE: A baseline survey of ventilatory function was performed using spirometry. PEF was measured daily with a mini-Wright Peak Flow Meter over a period of several weeks in a study of 201 normals (staff, faculty and graduate students at the University of Massachusetts Lowell). Serial PEF data were collected on a group of mild asthmatics identified in a local occupational medicine clinic. Finally, performance characteristics were examined in serial PEF data from two existing occupational cohort studies. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Asthma, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease

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

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

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

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 |
| --- | --- | --- |
Direct Stimulation Of Spinal Nerve Roots To Determine Sensory And Motor Innervation Patterns

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect data while monitoring muscles and nerves during spine surgery. The data being collected and analyzed will be used to learn more about how the body's nerves and muscles are distributed and develop a map of human muscle innervation patterns.

Detailed Description
-----------------
In this large scale study it is proposed to examine root-to-muscle innervation directly, using the standard Intra-Operative Monitoring procedures during scheduled cervical and lumbar spinal surgeries. The study would directly map muscle and sensory distributions of nerve root innervations with no additional risk to patients.

Official Title
-----------------
Direct Stimulation Of Spinal Nerve Roots To Determine Sensory And Motor Innervation Patterns

Conditions
-----------------
Spine Surgery, Neuromuscular Mapping, Neurodiagnostics

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing either cervical or lumbar cord procedures at Lahey Clinic and during which the surgeon has requested intra-operative neurophysiologic monitoring. Surgery performed by a neurosurgeon Participant must be ≥ 18 years of age or ≤ 85 years of age Participant, or legally authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the Lahey Clinic IRB Exclusion Criteria: Past medical history significant for any of the following: Peripheral Neuropathy Patients with Diabetes Mellitus Neuromuscular disease that would interfere with intra-operative recordings The Investigator determines that the patient should not be included in the study for reason(s) not already specified

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Build a database of spinal nerve root innervation utilizing direct nerve root stimulation |  | Data collected during surgery and a 30 day post-op visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare clinical symptoms of the patient to the direct muscle activation via spinal nerve root stimulation |  | Data collected during surgery and a 30 day post-op visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuromuscular mapping, Spinal surgery, Neurodiagnostics, Segmental root innervation, Dermatomal innervation, Myotomal innervation, Nerve roots, Sensory, Signs and Symptoms
Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I Mania

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of children and adolescent patients with Bipolar I mania.

Official Title
-----------------
A 3-wk, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 3b Study of the Efficacy & Safety of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets in the Treatment of Children & Adolescents With Bipolar I Mania (Abbreviated)

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: quetiapine fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is able to provide written assent and the parents or legal guardian of the patient is able to provide written informed consent before beginning and study related procedures Patient has a documented clinical diagnosis of Bipolar I mania Patient's parent or legal guardian will be able to accompany the patient at each scheduled study visit Exclusion Criteria: Patients (female) must not be pregnant or lactating Patients with a known intolerance or lack of response to previous treatment with quetiapine Patients who have previously participated in this study

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 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: quetiapine fumarate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare efficacy of Quetiapine with placebo in the treatment of bipolar I mania as assessed by the YMRS total score, change from baseline to Day 21 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effect of Quetiapine with placebo in change from baseline to Day 21 percentage of patients with response, defined as a ≤ 12, evaluate safety and tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar I Mania