bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: BMS-986165; Placebo for BMS-986165
Intervention MeSH terms: Deucravacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 268.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated
      with BMS-986165
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Male and female, ages 18 to 70 years

          -  Diagnosis of plaque psoriasis for 6 months

          -  Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
             test, must not be pregnant, lactating, breastfeeding or planning pregnancy

          -  Males who are sexually active with WOCBP must agree to follow instructions for
             method(s) of contraception for the duration of treatment plus 5 half-lives of the
             study drug plus 90 days.

        Exclusion Criteria:

          -  Any significant acute or chronic medical illness

          -  Blood transfusion within 4 weeks of study drug administration

          -  Inability to tolerate oral medication

          -  Positive hepatitis-B (HBV) surface antigen

          -  Positive hepatitis-C (HCV) antibody

          -  Any history or risk for tuberculosis (TB)

          -  Any major illness/condition or evidence of an unstable clinical condition

          -  Chest X-ray findings suspicious of infection at screening

          -  has received ustekinumab, secukinumab or ixekizumab within 6 months of first
             administration of study medication

          -  Has received anti-Tumor Necrosis Factor (TNF) inhibitor(s) within 2 months of first
             administration of study medication

          -  Has received Rituximab within 6 months of first administration of study medication

          -  Topical medications/treatments for psoriasis within 2 weeks of the first
             administration of any study medication

          -  Any systemic medications/treatments for psoriasis within 4 weeks of the first
             administration of any study medication

        Other protocol defined inclusion/exclusion criteria could apply
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
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
A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: ZPL-3893787; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This was a randomized, double blind, placebo controlled, parallel group study in 129 subjects
      with moderate to severe psoriasis with a PASI score of at least 10. Following run-in,
      subjects were randomized and received either oral 30 mg ZPL-3893787 once daily or placebo
      once daily for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A documented history of moderate to severe plaque psoriasis for at least 6 months
             prior to screening.

          -  Male or female, aged ≥18 years.

          -  Psoriasis Area and Severity Index (PASI) ≥10 at both Screening and Day 0.

          -  An Investigator's Global Assessment (IGA) score ≥ 3 at both Screening and Day 0.

          -  Psoriasis affecting ≥10% body surface area (BSA) at Screening and Day 0.

        Exclusion Criteria:

          -  Current diagnosis of Pustular, Guttate, Erythrodermic, exfoliative or only nail
             psoriasis or a diagnosis of inverse psoriasis without having plaque psoriasis.

          -  Concurrent skin disease (e.g. acne) of such severity in the study area that it could
             interfere with the study evaluation or presence of skin comorbidities that may
             interfere with study assessments.

          -  Active skin infections (e.g. impetigo, abscesses) or any other clinically apparent
             infections.

          -  Biologic treatments for psoriasis (e.g. Enbrel, Humira, Stelara, Cosentyx) within 3
             months of the start of the Run-In.

          -  Phototherapy (e.g. UVA, UVB, PUVA) within 4 weeks of the start of the Run-In.

          -  Oral calcineurin inhibitors and immunosuppressants (e.g. cyclosporine, azathioprine,
             methotrexate) within 4 weeks of the start of the Run-In.

          -  Systemic corticosteroids within 4 weeks of the start of the Run-In.

          -  Oral antihistamines and leukotriene inhibitors and tricyclic antidepressants within 1
             week of the start of the Run-In.

          -  Topical steroids (any potency), topical calcineurin inhibitors (tacrolimus,
             pimecrolimus), salicylic acid and urea containing treatments and coaltar preparations,
             topical and oral retinoids and vitamin D derivatives, within 1 week of the start of
             the Run-In.
Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Intervention: lurbinectedin (PM01183)
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Study to assess the potential effects of lurbinectedin (PM01183) at a therapeutic dose on the
      duration of the QTc interval, measured by electrocardiograms (ECGs), to characterize the
      PM01183 plasma concentration/QTc relationship, and to explore related ECG parameters in
      patients with selected solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntarily signed and dated informed consent

          -  Normal cardiac conduction and function (centrally read)

          -  Blood pressure between 90 and 150 mmHg systolic, inclusive, and not higher than 90
             mmHg diastolic.

          -  Specific serum electrolyte levels

        Exclusion Criteria:

          -  Age > 65 years

          -  Performance status = 2 [Eastern Cooperative Oncology Group (ECOG)]

          -  Heart rhythm disturbances

          -  Significant ischemic coronary disease, heart failure, myocardial infarction, or
             unstable angina within the last six months.

          -  Prior exposure to anthracyclines at a cumulative dose of doxorubicin (or equivalent) >
             450 mg/m²
Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia
Condition: Leukemia; Acute Disease; Acute Myeloid Leukemia; Nonlymphocytic Leukemia; Myelodysplastic Syndromes
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Acute Disease
Intervention: vosaroxin
Intervention description: Vosaroxin was administered by slow intravenous (IV) infusion or via syringe pump within 10 minutes.Patients could have completed up to 4 treatment cycles consisting of 1 or 2 induction treatment cycles and up to 2 consolidation treatment cycles. For Schedule A, an induction cycle was a minimum of 21 days during which patients received vosaroxin on Days 1, 8, and 15, followed by weekly observations until hematologic recovery for patients with aplastic marrow after the postinduction bone marrow assessment. For Schedules B and C, an induction cycle was a minimum of 15 days, during which patients received vosaroxin on Days 1 and 8 (Schedule B), or Days 1 and 4 (Schedule C), followed by the same weekly observations until hematologic recovery as for Schedule A.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 113.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Leukemia; Myeloid; Elderly; Hematologic; Blood; Cancer; Malignancy; SNS-595; Sunesis; Hematologic Diseases; Myelodysplastic Syndromes; Older; voreloxin; reveal-1

Summary:

      This study will evaluate the overall remission rate of treatment with vosaroxin (formerly
      voreloxin) Injection in patients at least 60 years of age with previously untreated AML
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. At least 60 years of age and diagnosis of previously untreated AML (either de novo or
             from an antecedent hematologic disorder or therapy related AML)

          2. At least 20% blasts by BM biopsy or aspirate

          3. ECOG performance status of 0,1,or 2

          4. Adequate cardiac, renal and liver function

        Key Exclusion Criteria:

          1. Uncontrolled DIC

          2. Active central nervous system involvement by AML

          3. Requiring hemodialysis or peritoneal dialysis

          4. Some prior history of heart attack or stroke (depending on how long ago the event
             occurred)
Multiple Doses of AT-1501-A201 in Adults With ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Intervention: AT-1501
Intervention description: AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ALS; Lou Gehrig's Disease; motor neuron disease; motor neuron degeneration; AT-1501; humanized blocking antibody to CD40LG; CD40L inhibitor; monoclonal antibody

Summary:

      This is a Phase 2a, multi-center, open label, multiple dose study of AT-1501, a humanized
      monoclonal antibody antagonist to CD40 ligand (CD40L). Approximately 54 adults with
      Amyotrophic Lateral Sclerosis (ALS) will be enrolled into the study in the United States and
      Canada at approximately 13 ALS treatment sites.

      Participants will be enrolled into one of four ascending doses.
    

Eligibility criteria:

        Inclusion Criteria:

          1. ALS diagnosed as possible, laboratory supported probable, probable, or definite as
             defined by revised El Escorial criteria

          2. ALS Functional Rating Scale - Revised (ALSFRS-R) Aggregate score of 37 or greater

          3. No more than 24 months from diagnosis

        Exclusion Criteria:

          1. Any other central or peripheral nervous system disease that may interfere with the
             evaluation of ALS or its progression

          2. Presence of a tracheostomy, or use of permanent assistive ventilation (ventilatory
             support for 23 hours per day or more)

          3. History of malignancy within the previous 5 years, except for localized non-melanoma
             skin cancers

          4. Abnormal function of the immune system resulting from:

               -  Clinical conditions affecting the immune system (e.g. HIV infection,
                  agammaglobulinemia),

               -  Systemic administration of corticosteroids (PO/IV/IM) at a dose equivalent to 20
                  mg/day of prednisone for more than 14 consecutive days within 90 days prior to
                  screening,

               -  Administration of anti-neoplastic and/or immunomodulating agents (e.g. Tumor
                  necrosis factor alpha (TNF α) antagonists or anti-B cell antibodies) or
                  radiotherapy within 1 year prior to screening.

          5. Recipient of Stem Cell or Gene Therapy

          6. Positive test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV.

          7. History of deep venous thrombosis or pulmonary embolism

          8. History of active substance abuse within the past 2 years

          9. History of stroke, poorly controlled or significant cardiovascular disease, diabetes
A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration
Condition: Geographic Atrophy; Macular Degeneration
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: 400 µg Brimonidine Implant; Sham
Intervention description: 400 µg brimonidine implant in the study eye using Brimo DDS® applicator on Day 1, and every 3 months through Month 21.; Sham treatment with needleless applicator (no implant) to the study eye on Day 1, and every 3 months through Month 21.
Intervention MeSH terms: Brimonidine Tartrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 310.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and efficacy of the brimonidine intravitreal implant in
      participants with geographic atrophy due to age-related macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Geographic atrophy due to age-related macular degeneration in the study eye

          -  Visual acuity better than or equal to 20/125 Snellen equivalent in the study eye and
             20/200 Snellen equivalent in the fellow eye.

        Exclusion Criteria:

          -  Cataract surgery or Laser-Assisted in situ Keratomileusis (LASIK) in the study eye in
             the last 3 months

          -  Infections in either eye in the last 3 months
N-acetylcysteine for Tobacco Use Disorder
Condition: Nicotine Dependence; Smoking
MeSH terms: Tobacco Use Disorder
Intervention: N-acetylcysteine (NAC); Placebo
Intervention description: NAC or matched placebo will be given to study participants for 8 weeks.; Matched placebo (2 capsules taken in the morning and evening) will be taken by study participants for eight weeks. All participants will receive brief smoking cessation counseling and support.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nicotine; tobacco; smoking; cessation; N-acetylcysteine; NAC; pharmacotherapy; relapse; tobacco use disorder

Summary:

      The purpose of this study is to assess the effects of administering N-Acetylcysteine (NAC) to
      assist in initial cessation and/or relapse prevention in adult cigarette smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-65

          2. Daily smoker for ≥6 months, smoking approximately ≥5 cigarettes per day on average in
             the past month or must meet the criteria for nicotine dependence

          3. Be interested in quitting smoking (defined as a 2 or above on a 10-point Likert scale
             assessing readiness and interest in quitting (1=not at all ready/interested,
             10=extremely ready/interested)

          4. Willing to engage in a 3-day quit attempt as part of study procedures

          5. Willing to abstain from cannabis use during study procedures (since inhaled cannabis
             will affect breath carbon monoxide readings).

          6. If female, agreement to use birth control (any form) to avoid pregnancy during study
             procedures

        Exclusion Criteria:

          1. Any serious or unstable medical/psychiatric disorder (including severe substance use
             disorders, other than tobacco use disorder) in the past month that may interfere with
             study performance based on PI judgment

          2. Current pregnancy or breastfeeding

          3. Current use of medications with smoking cessation efficacy

          4. Known hypersensitivity to NAC

          5. Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous
             if taken with NAC) within 14 days of study participation