bioihbjkbjnl/mcl2 huggingface dataset:
Study Of Ispinesib In Subjects With Breast Cancer
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms
Intervention: Ispinesib
Intervention description: Given intravenously at a dose of 18 milligram (mg)/ meter square (m^2).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer

Summary:

      The purpose of this research study is to find how breast cancer responds to the
      investigational drug, Ispinesib. An investigational drug is a drug that has not been approved
      by the Food and Drug Administration (FDA) and is available for research use only. In
      particular, this study will try is to find the answers to the following research questions:

        1. Does breast cancer respond to Ispinesib?

        2. What are the side effects of Ispinesib?

        3. How much Ispinesib is in the blood at specific times after it is taken?
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage IIIB or Stage IV breast cancer

          -  Previously received anthracycline and taxane therapy

        Exclusion criteria:

          -  Actively receiving anti-cancer therapy agent(s).
A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration
Condition: Choroid Neovascularization; Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: AGN 211745; AGN 211745; AGN 211745; Ranibizumab 500µg
Intervention description: AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2; AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2; AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2; Ranibizumab 500µg injections at Day 1, Month 1, Month 2
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 138.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This is a 24-month study to evaluate multiple doses of AGN211745 (previously known as
      Sirna-027) in treatment of subfoveal choroidal neovascularization associated with age-related
      macular degeneration
    

Eligibility criteria:

        Inclusion Criteria:

          -  50 years or older with "wet" AMD as determined by an ophthalmologist

          -  decrease in visual acuity (20/40 to 20/640) in at least one eye

        Exclusion Criteria:

          -  Uncontrolled systemic disease

          -  History of heart attack or stroke within one year of study entry

          -  Symptomatic coronary artery disease

          -  Cataracts that interfere with vision
Effect of Baclofen on Marijuana Withdrawal and Relapse
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Intervention: Baclofen; Marijuana; Placebo
Intervention description: Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200).; Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.
Intervention MeSH terms: Baclofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Baclofen; Marijuana Dependence; Marijuana Withdrawal

Summary:

      The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's
      direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current marijuana use: average of 3 marijuana cigarettes at least 4 times per week for
             the past 4 weeks

          -  Able to perform study procedures

          -  21-45 years of age

          -  Women practicing an effective form of birth control (condoms, diaphragm, birth control
             pill, IUD)

        Exclusion Criteria:

          -  Current, repeated illicit drug use (other than marijuana)

          -  Presence of significant medical illness(e.g., diabetes, cardiovascular disease,
             hypertension, examination, laboratory clinically significant laboratory abnormalities)

          -  History of heart disease

          -  Request for drug treatment

          -  Current parole or probation

          -  Pregnancy or current lactation

          -  Recent history of significant violent behavior

          -  Major current Axis I psychopathology(e.g., major depressive disorder, bipolar
             disorder, suicide risk, schizophrenia)

          -  Current use of any prescription or over-the-counter medication
Hyperbaric VO2max Study
Condition: Exercise Training
Intervention: Hyperoxic hyperbaric interval exercise training; Normoxic, normobaric, interval exercise training; Oxygen
Intervention description: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.; Six 30-min high-intensity interval training sessions completed 3-times a week.; Used in Hyperoxic hyperbaric interval exercise training intervention
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: interval training; hyperbaric oxygen; VO2 max; altitude; exercise performance; mitochondrial oxidative capacity; mitochondrial biogenesis

Summary:

      This study seeks to examine the effectiveness of training while in a hyperoxic-hyperbaric
      environment for exercise performance at altitude. Subjects will complete a short,
      high-intensity interval training (HIT) program inside the hyperbaric chamber.Before and after
      this training phase, all subjects will be tested for maximum aerobic capacity at a simulated
      high altitude of 15,000ft in a hypobaric chamber, as well as for molecular markers of
      mitochondrial oxidative capacity in a skeletal muscle biopsy.

      A group of individuals of similar characteristics completing this training program in a
      normoxic-normobaric environment will serve as a control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy, recreationally active or sedentary individuals

        Exclusion Criteria:

          -  VO2max < 35 ml/kg/min - male 30 ml/kg/min - female

          -  chronic cardiovascular or pulmonary diseases

          -  history of pneumothorax

          -  active smoker

          -  pregnant women

          -  non-english speaking

          -  not in full mental capacity

          -  blind

          -  sickle cell trait or disease
Use of Entresto Sacubitril/Valsartan for the Treatment of Peripheral Arterial Disease
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Intervention: Entresto; Placebo group
Intervention description: Oral pills; The placebo pills
Intervention MeSH terms: Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study proposes the use of Entresto (sacubitril/valsartan) to test the effects on pain
      free walking duration on patients with peripheral arterial disease, a condition caused by
      decreased blood flow to the muscles in the legs.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject with symptoms of intermittent claudication, such as exercise-induced pain,
             cramps, fatigue, or other equivalent discomfort, involving large muscle groups of the
             leg(s) (calf, thigh, buttocks), relieved by rest.

          2. Ankle-brachial index ≤ 0.90 acquired according to the American Heart Association
             guidelines.

          3. Highest ankle pressure reduced by at least 25 mm Hg after exercise compared to resting
             pressure (or loss of previously present Doppler signal for both the posterior tibial
             and anterior tibial arteries immediately after exercise if arteries were
             incompressible).

          4. Patients on medical treatment for PAD without significant improvement in intermittent
             claudication within the last 6 months.

        Exclusion Criteria:

          1. Age < 18 and > 80 years.

          2. Patients with physician diagnosed chronic kidney disease or heart failure stage II or
             IV or unstable angina.

          3. Echocardiographic evidence of cardiomyopathies and pulmonary hypertension.

          4. Patients that have received cancer treatment within the last year (except skin
             cancer).

          5. Severe limitations in mobility due to osteomuscular disorders present at time of
             interview.

          6. Dementia or other mental disorders that prevent patients from following a research
             protocol present at time of interview

          7. Patients engaged in an exercise rehabilitation program within the past 6 months.

          8. Patients schedule to undergo an arterial revascularization procedure during the study
             or have undergone one within the past 6 months.

          9. Inconsistent maximal walking distance on the treadmill test.
Study to Evaluate the Safety and Efficacy of CTP-656 in Patients With Cystic Fibrosis With CFTR Gating Mutations
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-561; Placebo; IVA
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of CTP-656 in patients with cystic fibrosis
      (CF) who have a cystic fibrosis transmembrane conductance regulator (CFTR) gating mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating
             mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R.

          -  Has been stable on Kalydeco therapy for at least 3 months prior to screening

          -  Has FEV1 ≥ 60% of predicted normal for age, sex, and height at screening and baseline
             (Day 1) assessments

          -  Weighs at least 40 kg at screening

          -  Patients of either gender and women of childbearing potential must be willing to use a
             medically highly effective form of birth control during the treatment period and 30
             days after the last dose of study treatment.

        Exclusion Criteria:

          -  Acute upper respiratory infection or lower respiratory infection, pulmonary
             exacerbation, or changes in therapy within 4 weeks of study treatment

          -  Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes

          -  History of hepatitis C or chronic active hepatitis B infection

          -  History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or
             allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2
             years prior to screening

          -  Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within
             2 years prior to Screening

          -  Abnormal liver function

          -  History of abnormal renal function

          -  History of prolonged QTcF > 450 msec for males or QTcF > 470 msec for females

          -  History of solid organ or hematological transplantation

          -  Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30
             days of screening

          -  Women who are pregnant or lactating, or have plans to become pregnant during the study
             or within 1 month following the last dose
Study of Naproxen Capsules to Treat Dental Pain
Condition: Dental Pain
MeSH terms: Toothache
Intervention: Naproxen Test; Naproxen Test; Naprosyn; Naprosyn; Placebo
Intervention description: 200-mg single dose; 400-mg (2 x 200-mg); single dose; single dose; single dose
Intervention MeSH terms: Naproxen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe
      and effective for the treatment of dental pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female between 18 and 50 years of age

          -  For women of child-bearing potential: a woman who is not pregnant and not nursing, and
             who is practicing an acceptable method of birth control

          -  Patient requires extraction of 2 or more third molars

          -  Patient must be willing to stay at the study site overnight

        Exclusion Criteria:

          -  Patient has hypersensitivity, allergy, or clinically significant intolerance to any
             medications to be used in the study, or related drugs

          -  Patient has a current disease or history of a disease that will impact the study or
             the patient's well-being

          -  Patient has used or intends to use any of the medications that are prohibited by the
             protocol

          -  Patient has a history of drug or alcohol abuse or dependence, or patient has a
             positive urine drug screen or alcohol breathalyzer test

          -  Patient has taken another investigational drug within 30 days prior to screening
Videophone Administered Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Intervention: Cognitive-behavioral therapy; Wait-list control
Intervention description: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks.; Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obsessive compulsive disorder

Summary:

      Although cognitive-behavioral therapy (CBT) is the most effective intervention for pediatric
      obsessive-compulsive disorder (OCD), many people do receive CBT initially. Given this,
      alternative ways of providing CBT need to be identified and tested. With this in mind, the
      proposed study examines the efficacy of a videophone based cognitive-behavioral intervention
      for youth with OCD. A total of 30 youth will be randomly assigned to either videophone
      administered CBT or an abbreviated wait-list control arm. Comprehensive assessments will be
      conducted by trained clinicians at relevant time-points to assess symptom severity and
      impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Principal diagnosis of OCD on the ADIS-IV-C/P and CY-BOCS Total Score ≥ 16

          -  No change in psychotropic medication (if applicable) for at least 8 weeks prior to
             study entry

          -  7 to 17 years old

          -  Availability of at least one parent to accompany the child to all assessment sessions
             and be present for videophone sessions

          -  Have a computer within their home

        Exclusion Criteria:

          -  History of and/or current psychosis, autism, bipolar disorder, or current suicidality

          -  Principal diagnosis other than OCD

          -  A positive diagnosis in the caregiver of mental retardation, psychosis, or other
             psychiatric disorders or conditions that would limit their ability to understand CBT
             (based on clinical interview)

          -  The child requires a higher level of psychiatric and/or medical care (e.g., inpatient
             hospitalization)

          -  Child receptive vocabulary < 80.
Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
Condition: Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: SOF; RBV
Intervention description: Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir
      (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV)
      infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  First generation Egyptian; must have been born in Egypt and can trace both maternal
             and paternal Egyptian ancestry

          -  Treatment-experienced or treatment-naive

          -  Chronic genotype 4 HCV infection

          -  Not co-infected with HIV

          -  Screening laboratory values within defined thresholds

          -  Use of highly effective contraception methods

          -  Must be able to comply with the dosing instructions for study drug administration and
             able to complete the study schedule of assessments

        Exclusion Criteria:

          -  History of any other clinically significant chronic liver disease

          -  Pregnant or nursing female or male with pregnant female partner

          -  History of clinically-significant illness or any other major medical disorder that may
             interfere with treatment, assessment, or compliance with the protocol

          -  Excessive alcohol ingestion or significant drug abuse
Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Intervention: 67.5 mg oral insulin crystals daily; 500mg oral insulin crystals every other week
Intervention description: human insulin crystals in capsules; human insulin crystals in capsules
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Isophane; Methamphetamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 3 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: oral insulin

Summary:

      The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to
      assess the effects of varying doses and schedules of oral insulin on immunological and
      metabolic markers in relatives at risk for type 1 diabetes (T1D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants in TrialNet Natural History/Pathway to Prevention Study (TN01); is
             relative of proband with type 1 diabetes

          -  Between ages 3-45 with normal Oral Glucose Tolerance Test (OGTT) or between ages 3-7
             with an abnormal OGTT

          -  Confirmed positive for insulin autoantibodies within previous six months

          -  Confirmed positive for one or more other autoantibodies on two separate occasions
             within the past six months

        Exclusion Criteria:

          -  Diagnosed with type 1 diabetes

          -  History of treatment with insulin or oral hypoglycemic agent

          -  History of therapy with immunosuppressive drugs or non-physiologic glucocorticoids
             within the past two years for a period of more than three months

          -  Ongoing use of medications known to influence glucose tolerance

          -  Pregnant or intending to become pregnant while on study or lactating