bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety of Apixaban in Acute Coronary Syndrome (ACS) Japanese Patients
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Apixaban; Apixaban; Placebo
Intervention description: Apixaban 2.5 mg tablet BID for 24 weeks; Apixaban 5.0 mg tablet BID for 24 weeks; Placebo tablet for 24 weeks
Intervention MeSH terms: Apixaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 151.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the bleeding safety (the composite endpoint of major
      and clinically relevant non-major bleeding) of 2 doses of apixaban (2.5 mg BID and 5.0 mg
      BID) or placebo in combination with standard therapy (aspirin and /or additional antiplatelet
      therapy) over a 24 week treatment period in selected subjects with recent (≤7 days) acute
      coronary syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recent (≤ 7 days) ACS

          -  Clinically stable, and receiving standard treatment (patients must be treated with
             aspirin ≤ 100 mg/day, with or without clopidogrel 75 mg/day or ticlopidine 200 mg/day)
             based on the physician's judgment)

        Exclusion Criteria:

          -  Scheduled/planned cardiac catheterization, PCI, CABG or other invasive procedure
             planned in the 24 weeks (within treatment period) following randomization

          -  Persistent severe hypertension, defined as systolic blood pressure of ≥180 mm Hg or
             diastolic pressure of ≥110 mm Hg

          -  Active bleeding or at high risk for bleeding (e.g., cirrhosis of the liver, any
             history of intracranial hemorrhage).
A Study of R1507 in Participants With Recurrent or Refractory Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma
Intervention: RG1507
Intervention description: Participants will receive R1507 IV infusion as 9 mg/kg once weekly or 27 mg/kg every 3 weeks, depending upon the cohort in which the participants are enrolled.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 317.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      The study was primarily designed to determine objective response, progression-free survival
      (PFS), and the safety and tolerability of R1507 in participants with recurrent or refractory
      Ewing's sarcoma, osteosarcoma, synovial sarcoma, rhabdomyosarcoma and other sarcomas
      including alveolar soft part sarcoma, desmoplastic small round cell tumor, extraskeletal
      myxoid chondrosarcoma, clear cell sarcoma, and myxoid liposarcoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  progressive, recurrent or refractory Ewing's sarcoma, or recurrent or refractory
             osteosarcoma, synovial sarcoma, rhabdomyosarcoma, or other sarcomas of the following
             sub-types: alveolar soft part sarcoma, desmoplastic small round cell tumor,
             extraskeletal myxoid chondrosarcoma, clear cell sarcoma and myxoid liposarcoma;

          -  Cohort 3 only: age must be >= 2 and <= 21 years

        Exclusion Criteria:

          -  clinically significant unrelated systemic illness which would compromise the
             participant's ability to tolerate the investigational agent, or interfere with the
             study procedures or results;

          -  known hypersensitivity to any of the components of R1507 or prior hypersensitivity
             reactions to monoclonal antibodies;

          -  treatment (within the past 2 weeks) with pharmacologic doses of corticosteroids or
             other immunosuppressive agents;

          -  current or prior therapy with insulin-like growth factor (IGF) inhibitor (monoclonal
             or specific kinase inhibitor);

          -  history of solid organ transplant;

          -  other malignant disease diagnosed within the previous 5 years, excluding
             intra-epithelial cervical neoplasia or non-melanoma skin cancer;

          -  active central nervous system disease
An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: BMS-986165; Placebo; Mycophenolate Mofetil
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Mycophenolic Acid; Deucravacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind Study
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of BMS-986165 compared
      with placebo with regard to measures of kidney function in participants with lupus nephritis
      (LN).
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Meets the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC)
             criteria for Systemic Lupus Erythematosus (SLE)

          -  Renal biopsy confirming a histologic diagnosis of active Lupus Nephritis (LN)
             International Scociety of Nephrology/Renal Pathology Society (ISN/RPS) Classes III,
             IV-S, or IV-G; or Class V

          -  Urine protein:creatinine ratio (UPCR) ≥1.5 mg/mg or UPCR ≥1 mg/mg assessed with a
             24-hour urine specimen

        Exclusion Criteria:

          -  Pure ISN/RPS Class V membranous LN

          -  Screening estimated glomerular filtration rate ≤30 mL/min/1.73 m^2

          -  Dialysis within 12 months before screening or plans for dialysis within 6 months after
             enrollment in the study

          -  End-stage renal disease

        Other protocol-defined inclusion/exclusion criteria apply
Nicotine Vaccination and Nicotinic Receptor Occupancy
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: NicVAX; [123I]5-IA-85380; Nicotine bitartrate
Intervention description: 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies; up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days; 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nicotine, SPECT, vaccine, receptor

Summary:

      This is a molecular imaging research study designed to examine how much nicotine gets into
      the brain before and after vaccination with NicVAX, a nicotine vaccine developed by Nabi
      Biopharmaceuticals. NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine
      designed as an aid to smoking cessation and long-term abstinence, as well as an aid to
      prevent relapses of a treated smoker.

      In this project we want to understand the degree to which NicVAX administration changes how
      much nicotine enters the brain in smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current smoker who smokes at least 10-25 cigarettes a day

          -  Good general health

        Exclusion Criteria:

          -  Subjects with a pacemaker or other ferromagnetic material in body.

          -  Prior exposure to NicVAX or any other nicotine vaccine.

          -  Use of systemic steroids or other immunosuppressive agent

          -  History of significant neurological, cardiovascular, hepatic, endocrine, renal, liver,
             psychiatric or thyroid illness

          -  Cancer or cancer treatment in last 5 years

          -  HIV infection

          -  Use of varenicline (Chantix), bupropion (Wellbutrin, Zyban), mecamylamine (Inversin),
             within 30 days prior to administration of NicVAX and for the duration of the study.

          -  Inability to fulfill all visits and examination procedures for approximately 20 weeks.
Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants
Condition: Alopecia Areata; Alopecia Totalis; Alopecia Universalis
MeSH terms: Alopecia; Alopecia Areata
Intervention: Tofacitinib ointment
Intervention description: Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alopecia

Summary:

      The purpose of the study is to investigate the use of topical tofacitinib to promote hair
      regrowth in patients with alopecia areata, alopecia totalis, and alopecia universalis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of AA with at least 2 patches of alopecia involving the scalp, AT or AU

          -  Stable hair loss present for 6 months or longer

          -  No treatment for alopecia areata in the past 1 month

          -  No evidence of spontaneous hair regrowth

        Exclusion Criteria:

          -  Patients have received treatment known to affect alopecia areata within 1 month of
             enrolling in the study

          -  Patients whose current episode of AT or AU is more than 5 years

          -  Patients with a history of malignancy (except history of successfully treated basal
             cell or squamous cell carcinoma of the skin)

          -  Patients known to be HIV or hepatitis B or C positive

          -  Patients with positive tuberculin skin test or positive QuantiFERON® TB test

          -  Patients with leukopenia or anemia

          -  Patients with renal or hepatic impairment

          -  Patients taking immunosuppressive medications, including but not limited to
             prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus,
             cyclosporine, or TNF-α inhibitors

          -  Women who are pregnant or nursing
Femoral Nerve Block for Femur Fracture Repair in Pediatrics
Condition: Traumatic Femur Fracture
MeSH terms: Fractures, Bone; Femoral Fractures
Intervention: Ropivicaine; Epinephrine
Intervention MeSH terms: Epinephrine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to prospectively compare post-operative pain relief in pediatric
      patients undergoing traumatic femur fracture repair who have received either a femoral nerve
      block with a lateral femoral cutaneous nerve block or a standard anesthetic for analgesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) physical status I or II

          -  Weight greater than or equal to 10kg

          -  Presenting for repair of traumatic femur fracture

        Exclusion Criteria:

          -  ASA physical status > II

          -  Co-morbid diseases (cardiac, pulmonary, neurological disease)

          -  Patients having concomitant procedures

          -  Abnormal neurovascular examination in the injured leg

          -  Presence of vascular compromise in the affected lower extremity

          -  Mechanism of sustained injury via crush injury

          -  Use of therapeutic dose anticoagulants or presence of a bleeding disorder
Vorapaxar Study for Maturation of AV Fistulae for Hemodialysis Access
Condition: AV Fistula
MeSH terms: Arteriovenous Fistula; Fistula
Intervention: Vorapaxar sulfate; Placebo
Intervention description: The study drug (12-week supply of study drug) will be dispensed to enrolled patients on the first day following surgery.; The placebo will match the study drug, vorapaxar sulfate, in appearance. A 12-week supply will be dispensed to enrolled patients on the first day following surgery.
Intervention MeSH terms: Vorapaxar
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The Objectives of this study are:

        1. To determine if vorapaxar safely improves arteriovenous (AV) fistula functional
           maturation when administered during the maturation process compared with placebo.

        2. To determine if vorapaxar safely improves AV fistula patency, allowing for secondary
           procedures to aid in fistula maturation compared with placebo.

        3. To determine if vorapaxar safely facilitates successful cannulation of AV fistulas for
           hemodialysis compared with placebo.

      This is a randomized placebo-controlled double-blind pilot trial. Study procedures will be
      conducted at Stanford University Medical Center, and standard-of-care (SOC) procedures will
      be conducted at Stanford and it's affiliated hospitals (Veteran's Affairs Palo Alto Health
      Care System and the Stanford Vascular Surgery Clinic at Valley Medical Center). The
      investigators expect to enroll 128 patients. Patients will be assigned to treatment groups
      with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation.
      Patients will be stratified based on fistula location (lower arm versus upper arm).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age >18

          2. Receiving or planning to receive maintenance hemodialysis

          3. Ability to sign informed consent

          4. 3 mm venous diameter within recipient vein

        Exclusion Criteria:

          1. History of stroke, transient ischemic attack or intracranial hemorrhage

          2. History of or high level of suspicion for, severe arterial insufficiency of the hand

          3. Indication or ongoing therapy with other antiplatelet agents, other than aspirin 81 mg
             daily

          4. Indication or ongoing therapy with anticoagulants, including warfarin, low molecular
             weight heparin, factor Xa inhibitors or direct thrombin and other inhibitors.
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: VOX; SOF/VEL
Intervention description: 100 mg tablet(s) administered orally once daily with food; 400/100 mg FDC tablet administered orally once daily with food
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of
      voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in
      adults with chronic non genotype 1 hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Individuals with chronic HCV infection

          -  HCV RNA ≥10^4 IU/mL at screening

          -  HCV genotypes 2, 3, 4, 5, or 6

          -  Cirrhosis determination; a liver biopsy may be required

          -  Screening laboratory values within defined thresholds

          -  Use of two contraception methods if female of childbearing potential or sexually
             active male

        Key Exclusion Criteria:

          -  Pregnant or nursing female

          -  Current or prior history of hepatic decompensation

          -  Hepatocellular carcinoma (HCC) or other clinically significant malignancy

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

          -  History of clinically significant illness or any other medical disorder that may
             interfere with the individual's treatment, assessment or compliance with the protocol

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Intervention: Antipyrine and Benzocaine otic solution; Antipyrine Otic Solution; Benzocaine Otic Solution; Placebo Otic solution
Intervention description: antipyrine 54 mg and benzocaine 14 mg; Antipyrine 54 mg and glycerine dehydrated to 1.0 mL; benzocaine 14 mg and glycerine dehydrated to 1.0 mL; Placebo otic solution will be glycerin that is dehydrated
Intervention MeSH terms: Antipyrine; Benzocaine; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 112.0
Sex: All
Minimum age: 2 Months
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The primary objective is to compare the effect of treatment with a combination of ear
      solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute
      otitis media.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical Diagnosis of Acute Otitis Media

          -  Moderate to severe pain

          -  Normally active and in good health as determined by the PI

          -  Parent or legal guardian consent

          -  Caregiver available to complete diaries during study

        Exclusion Criteria:

          -  History of or current Perforated tympanic membrane

          -  Tympanostomy tubes

          -  Acute or chronic otitis externa

          -  seborrheic dermatitis

          -  Received any otic topical or systemic antibiotic within 14 days of enrollment

          -  Receiving medication on a chronic basis for pain

          -  Known hypersensitivity to investigational product.

          -  clinical significant mental illness as determined by the PI

          -  Exposed to another investigational agent within 30 days before study entry. Any
             condition the PI believed will interfere with the ability to comply with all study
             procedures

          -  History of glucose 6-phosphate dehydrogenase deficiency

          -  History or currently anemic

          -  Congenital methemoglobinemia

          -  Recent history of acute gastroenteritis within 14 days of enrollment
Recombinant Human Papillomavirus Nonavalent Vaccine in Preventing Human Papilloma Virus in Younger Healthy Participants
Condition: Human Papillomavirus-Related Carcinoma
Intervention: Laboratory Biomarker Analysis; Recombinant Human Papillomavirus Nonavalent Vaccine
Intervention description: Correlative studies; Given IM
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 201.0
Sex: All
Minimum age: 9 Years
Maximum age: 11 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Human papillomavirus (HPV) is a common sexually-transmitted virus which causes infections
      that usually last only a few months, but sometimes can last a long time and cause cancers of
      the cervix, vagina, vulva, anus or oropharynx over many years among adults. This phase IIA
      trial studies how well does the nonavalent HPV vaccine (which can prevent nine different
      types of HPV) work when given in an alternative dosing schedule to heathy young research
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, medically well girls and boys

          -  Ability to understand and the willingness to sign a written informed consent document
             by the legal representative(s) of the participant

          -  Ability to understand and the willingness to sign a written assent document by the
             participant

        Exclusion Criteria:

          -  Previous vaccination against HPV

          -  The use of any investigational agent within 30 days preceding the first dose of the
             study vaccine or subsequent participation in another clinical trial at any time during
             the study period, in which the subject will be exposed to an investigational product

          -  Chronic administration of immunosuppressive agents or other immune-modifying drugs or
             chemotherapeutic agents within six months prior to the first vaccine dose; use of
             inhaled steroids, nasal sprays, and topical creams for small body areas is allowed

          -  Receiving active treatment for cancer or an autoimmune condition

          -  Confirmed or suspected immunosuppressive or immunodeficient condition

          -  Known bleeding disorders that preclude intramuscular injection (e.g., on
             anticoagulants or thrombocytopenia)

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             dysfunction, which in the opinion of the investigator precludes administration of the
             study vaccine

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition of GARDASIL 9 (recombinant human papillomavirus nonavalent vaccine),
             including yeast allergy

          -  Are pregnant