bioihbjkbjnl/mcl2 huggingface dataset:
Tofacitnib for the Treatment of Alopecia Areata and Variants
Condition: Alopecia Areata (AA); Alopecia Totalis (AT); Alopecia Universalis (AU)
MeSH terms: Alopecia; Alopecia Areata
Intervention: Tofacitinib Administration
Intervention description: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus
      kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia
      areata and its variants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >= 18 years old

          -  Diagnosis of alopecia areata with >50% scalp involvement, alopecia totalis, or
             alopecia universalis

          -  Hair loss present for at least 6 months

          -  No treatment for alopecia areata in past 2 months

          -  No evidence of hair regrowth

          -  Females of childbearing potential must use birth control while taking the medication
             and there must be a negative pregnancy test documented prior to starting the
             medication

        Exclusion Criteria:

          -  Age <18 years old

          -  Patients have received treatment known to affect alopecia areata within 2 months of
             enrolling in the study

          -  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 with peptic ulcer disease

          -  Patients taking immunosuppressive medications, including but not limited to
             prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus,
             cyclosporine, or TNH-alpha inhibitors

          -  Women of childbearing potential who are unable or unwilling to use birth control while
             taking the medication

          -  Women who are pregnant or nursing
Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch
Condition: Diarrhea
MeSH terms: Diarrhea
Intervention: Heat-Labile Enterotoxin of E. coli (LT); Placebo
Intervention description: Travelers' Diarrhea Vaccine System; Travelers' Diarrhea Vaccine System
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 600.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prevention of Travelers' Diarrhea

Summary:

      The purpose of this study is to evaluate and compare the safety and immune responses
      following a two vaccination regimen by transcutaneous immunization with heat-labile
      enterotoxin of E. coli (LT) patches or Placebo, with or without alcohol swabbing
    

Eligibility criteria:

        Inclusion Criteria:

          1. A female or male 18-64 (inclusive) years of age;

          2. In good health as determined by medical history and screening exam;

          3. Females who are post-menopausal, surgically sterile, or have a negative serum/urine
             pregnancy test at Day 0 and agree not to become pregnant for the duration of study.

        Exclusion Criteria:

          1. Abnormalities at physical exam [as determined by the Toxicity Grading Scale (Grade
             1-4)];

          2. Laboratory abnormalities [as determined by the Toxicity Grading Scale (Grade 1 4)] at
             screening;

          3. Participated in research involving investigational product within 30 days before
             planned date of first vaccination;

          4. Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu,
             Berna Biotech, Ltd;

          5. Women who are pregnant or breastfeeding;

          6. Clinically significant underlying enteric, pulmonary, cardiac or renal disease;

          7. Current seizure disorder;

          8. Current use of immunosuppressive therapy (inhaled steroids are allowed);

          9. Known or suspected alcohol abuse or illicit drug use within the last year;

         10. Positive Serology for HIV-1, HIV-2, HbsAg, or HCV;

         11. Known allergies to any component of the vaccine including adhesives;

         12. An employee of the study site;

         13. An employee of Intercell (global) or an immediate family member;

         14. Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent
             appropriate dermatologic monitoring of the vaccination sites;

         15. Receipt of any routine vaccinations within 7 days prior to, or following, the date of
             planned study vaccinations.
Intravenous Allopurinol in Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Intervention: Allopurinol; Placebo
Intervention description: intravenous infusion of allopurinol (300mg); intravenous infusion of 50 ml dose of 5% dextrose
Intervention MeSH terms: Allopurinol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metabolism; congestive heart failure; allopurinol; Adenosine triphosphate (ATP)

Summary:

      This study tests the hypothesis that allopurinol, a xanthine oxidase inhibitor, improves
      heart metabolism in patients with heart failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  The patient is willing and able to provide informed consent

          -  Clinical diagnosis of chronic heart failure

          -  Ejection fraction (EF) < 40% by echocardiography, nuclear multigated acquisition
             (MUGA) or cath ventriculography

          -  No significant coronary disease at cardiac catheterization

          -  New York Heart Association (NYHA) Class I-IV symptoms

          -  Clinical stabilization for two weeks if following recent congestive heart failure
             (CHF) decompensation.

        Exclusion Criteria:

          -  Metallic implant prohibiting magnetic resonance (MR) evaluation

          -  Inability to lie flat for MR study

          -  Administration of additional investigational drugs

          -  Calculated creatinine clearance < 50 mL/min

          -  Allergy to allopurinol

          -  Current gout flare

          -  Currently taking oral allopurinol
A Study of Acute Myocardial Infarction Using FDY-5301
Condition: Acute Myocardial Infarction; STEMI
MeSH terms: Myocardial Infarction; Infarction
Intervention: FDY-5301; Placebo
Intervention description: FDY-5301 will be administered once, intravenously, by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day.; Placebo will be administered intravenously by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All subjects who fulfill all study eligibility criteria will be randomized to receive one of the 4 treatments.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: This is a double-blind study where all study staff and participants are blinded to whether the patient receives active drug or placebo.
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of
      three dose levels of FDY-5301 compared to placebo in STEMI patients undergoing PCI.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18-80 year old male subjects

          2. 18 to 80 year old female subjects who are not of child-bearing potential.

          3. Accepted for Primary PCI with diagnosis of first STEMI, based on clinical and ECG
             criteria (ST-elevation at the J-point in two contiguous leads with the cut-off points:
             ≥0.2 millivolt (mV) in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other
             leads), within 12 hours of symptom onset.

        Written informed consent prior to study participation (either by the subject or a legally
        authorized representative of the subject)

        Exclusion Criteria:

          1. Previous myocardial infarction

          2. Left bundle branch block (LBBB)

          3. Previous coronary artery bypass graft surgery (CABG)

          4. Major hemodynamic instability or uncontrolled ventricular arrhythmias

          5. Known contraindication to CMR

          6. Patients with known thyroid disease

          7. Subjects with past or current renal impairment requiring dialysis

          8. Pregnant or females of child bearing potential

          9. Body weight > 120 kg or Body Mass Index (BMI) > 35 kg/m2

         10. Use of investigational drugs or devices within 30 days prior to enrollment into the
             study.

         11. Life expectancy of less than 1 year due to non-cardiac pathology

         12. Any clinically significant abnormality identified at the time of screening that in the
             judgment of the Investigator or any sub-Investigator would preclude safe completion of
             the study
COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial
Condition: Infection Viral; Thromboses, Venous; COVID-19
MeSH terms: COVID-19; Virus Diseases; Thrombosis; Venous Thrombosis
Intervention: Enoxaparin Prefilled Syringe [Lovenox]
Intervention description: Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 m/gkg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL)
Intervention MeSH terms: Enoxaparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 0 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, dose-requirements, and exploratory
      efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in
      children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection
      (i.e., COVID-19).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Birth to <18 years of age; AND

          2. Positive nucleic acid test for SARS-CoV-2 within the past 7 days; AND

          3. Hospitalized, <72 hours post-admission; AND

          4. One or more signs and/or symptoms of COVID-19 illness within the past 72 hours, as
             follows:

               1. Cough; OR

               2. Fever (oral temperature >100.4°F/38°C); OR

               3. Chest pain; OR

               4. Shortness of breath; OR

               5. Myalgia; OR

               6. Acute unexplained loss of smell or taste; OR

               7. New/increased supplemental oxygen requirement; OR

               8. Acute respiratory failure requiring non-invasive or invasive ventilation; OR

               9. Encephalitis.

        Exclusion Criteria:

        An individual who meets any of the following criteria will be excluded from participation
        in this study:

          1. Receiving therapeutic anticoagulation for treatment of a thromboembolic event
             diagnosed within the past 12 weeks; OR

          2. Clinical-relevant bleeding (see criteria under Primary Outcome, below) within the past
             72 hours; OR

          3. Platelet count <50,000/µL within the past 24 hours; OR

          4. Prothrombin time (PT) ≥2 seconds above the upper limit of age-appropriate local
             reference range within the past 24 hours; OR

          5. Activated partial thromboplastin time (aPTT) ≥4 seconds above the upper limit of
             age-appropriate local reference range within the past 24 hours; OR

          6. Fibrinogen level <75 mg/dL; OR

          7. Severe renal impairment, as defined by estimated glomerular filtration rate (eGFR) <31
             mL/min/ 1.73 m2, as calculated by the Schwartz formula; OR

          8. Parent or legally authorized representative unwilling to provide informed consent for
             patient participation.
A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: ofatumumab with PRF; ofatumumab with AI
Intervention description: ofatumumab 20 mg subcutanious injection administered with pre-filled syringe (PRF); ofatumumab 20 mg subcutaneous injection administered with autoinjector (AI)
Intervention MeSH terms: Ofatumumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To address the primary objective of testing bioequivalence at dosing interval after Week 8 between Pre-filled Syringe (PFS) and Auto-Injector (AI), the primary analysis involves the two groups (PFS (abdomen) and AI (abdomen)). Further the pharmacokinetcs of ofatumumab will be compared between using the thigh or abdomen for injections.
Masking: None (Open Label)
Enrollment: 284.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Relapsing Multiple Sclerosis; Relapsing-remitting Multiple Sclerosis; Secondary progressive Multiple Sclerosis; Bioequivalence; Pharmacokinetics; Neurofilament light chain; Pre-filled Syringe; Auto-injector; adult; AI; PFS; OMB157

Summary:

      The primary purpose of this study is to demonstrate pharmacokinetic bioequivalence of
      ofatumumab injected by Pre-filled Syringe (PFS) versus Auto-Injector (AI) devices and thereby
      establish a bridge between the ongoing Phase 3 program and the to-be-marketed drug-device
      combinations
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of multiple sclerosis (MS)

          -  Relapsing MS: relapsing-remitting course (RRMS), or Secondary progressive (SPMS)
             course

          -  EDSS score of 0 to 5.5

          -  Documentation of at least: 1 relapse during the previous year OR 2 relapses during the
             previous 2 years prior to Screening OR a positive Gd-enhancing MRI scan during the
             year prior to randomization.

          -  Neurologically stable within 1 month prior to randomization

        Exclusion Criteria:

          -  Patients with primary progressive MS or SPMS without disease activity

          -  Disease duration of more than 10 years in patients with EDSS score of 2 or less

          -  Patients with an active chronic disease of the immune system other than MS

          -  Patients with active systemic bacterial, viral or fungal infections, or known to have
             AIDS or to test positive for HIV antibody at Screening

          -  Patients with neurological findings consistent with Progressive Multifocal
             Leukoencephalopathy (PML), or confirmed PML
Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Lenalidomide; Dexamethasone; Elotuzumab (BMS-901608)
Intervention MeSH terms: Dexamethasone; Lenalidomide; Elotuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone +
      Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM)
      in Japan.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Newly diagnosed with symptomatic Multiple Myeloma (MM)

          -  Have not received any prior systemic anti-myeloma therapy

          -  Have measurable disease

          -  Are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because
             of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy
             with SCT is NOT sufficient for entry onto CA204-116 for a subject < 65 years old.
             There must be a comorbidity that prevents SCT for a subject < 65 years old

        Exclusion Criteria:

          -  Non-secretory myeloma

          -  Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions

          -  Monoclonal Gammopathy of Undetermined Significance (MGUS)

          -  Active plasma cell leukemia

          -  Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
Treatment of Post-Traumatic Brain Injury (TBI) Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Sertraline; Placebo
Intervention description: Sertraline arm; Placebo
Intervention MeSH terms: Sertraline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sertraline; TBI; depression; SSRI; brain injury

Summary:

      Randomized clinical trial of sertraline vs. placebo for post-TBI depression
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  experienced a TBI with a documented loss of consciousness or other evidence of a TBI
             (i.e., evidence of pathology on neuro-imaging)

          -  at least 6 months post-injury

          -  English-speaking

          -  residential telephone service

          -  living within 1.5 hours of New York City

          -  able to comprehend or answer verbal or written questionnaires

          -  willing to provide consent to participate in a 12 week drug study to treat Major
             Depressive Disorder (MDD); current MDD as diagnosed using Structured Clinical
             Interview for Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)
             Disorders (SCID), and severity of MDD rated at least 18 on the HAM-D.

        Exclusion Criteria:

          -  currently taking antidepressant medication (including monamine oxidase inhibitors
             (MOAs) or tricyclic antidepressants (TCAs)

          -  unwilling to abstain from seeking new psychosocial or pharmacologic treatments during
             the course of the study

          -  currently in psychotherapy

          -  active suicidal plans and/or requiring hospitalization

          -  prior use of sertraline

          -  currently experiencing other serious medical illness

          -  currently pregnant or breast feeding

          -  mass brain lesions or other neurological diagnoses other than TBI

          -  history of current or past psychosis or mania

          -  current substance abuse

          -  history of clinically significant liver or renal disease
Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
Condition: Breast Neoplasm
MeSH terms: Breast Neoplasms
Intervention: epirubicin; cyclophosphamide; docetaxel; trastuzumab
Intervention description: epirubicin (100 mg/m^2) every 2 weeks for 4 cycles; cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; docetaxel (75 mg/m^2) every 2 weeks for 4 cycles; trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Trastuzumab; Epirubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neoadjuvant chemotherapy; HER2 positive breast cancer; stage II - III breast cancer

Summary:

      The purpose of this study is to evaluate the effectiveness and tolerability of the
      combination of the following medications given every two weeks in HER2 positive breast cancer
      patients:

        -  trastuzumab (Herceptin)

        -  epirubicin (Ellence)

        -  cyclophosphamide (Cytoxan)

        -  docetaxel (Taxotere)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-pregnant females =/> 18 years of age

          -  Non-inflammatory breast cancer stage IIA - IIIC or high risk node negative

          -  Core biopsy of breast demonstrating invasive cancer and documented ER/PgR receptor
             status

          -  Normal cardiac function and adequate hematologic function

          -  Human epidermal growth factor receptor 2 protein (HER2) positive

          -  No evidence of metastatic disease

          -  ECOG Performance Status 0 - 1

          -  Women of childbearing potential must agree to using effective contraception while on
             treatment and for at least 3 months post-treatment

        Exclusion Criteria:

          -  Treated with other investigational drugs within 30 days

          -  Uncontrolled intercurrent disease or active infection

          -  Known sensitivity to e. coli-derived proteins or polysorbate 80

          -  Psychiatric illness or social situation that would limit study compliance

          -  Pre-existing peripheral neuropathy > Grade 1

          -  Cancer within 5 years of screening with the exception of surgically cured
             nonmelanomatous skin cancer; in-situ carcinoma of the cervix; or in-situ carcinoma of
             the breast

          -  Bilateral synchronous breast cancer

          -  Inflammatory breast cancer

          -  Women who are pregnant or breast feeding