bioihbjkbjnl/mcl2 huggingface dataset:
Fungal Prophylaxis With Isavuconazole for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HCT)
Condition: Hematologic Malignancy; Myeloproliferative Disorder
MeSH terms: Hematologic Neoplasms; Myeloproliferative Disorders
Intervention: Isavuconazole
Intervention description: Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose.
Intervention MeSH terms: Isavuconazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to study the effects of isavuconazole in preventing fungal
      infections in patients who have had a hematopoietic stem cell transplant (HCT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of greater than or equal to 18 years of age of either sex and of any race.

          -  Have received first peripheral blood, marrow or cord blood transplant from a family or
             unrelated donor for hematologic malignancy or myeloproliferative disorder.

        Exclusion Criteria:

          -  Proven or probable aspergillosis or other mold infection or deep mycoses including
             hepatosplenic candidiasis less than 60 days from first dose of ISA.

          -  History of allergy or intolerance to ISA.

          -  Clinically significant elevation of liver function tests prior to the first day of
             dosing (FDD) that at the discretion of the treating physician would preclude the
             administration of an azole antifungal.

          -  Familial short QT syndrome.
Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: PF-06865571; PF-05221304; Placebo
Intervention description: Tablet; Tablet; Tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Dose-ranging of combination doses
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind, Double-dummy, Placebo controlled
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study will evaluate the effect of coadministration of a range of doses of DGAT2i with 1
      dose of ACCi, on hepatic steatosis and the ability of DGAT2i to mitigate ACCi-induced
      elevations in serum triglycerides. The study has a 2-part design with sequential conduct of
      Part 1 and Part 2 with each part conducted in distinct/separate cohorts of participants. The
      overall study design, objectives/endpoints, eligibility criteria for both parts is envisioned
      to be identical, however, data from Part 1 will be used to determine whether to conduct Part
      2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI ≥25 and ≤ 40 kg/m2

          -  concomitant medical conditions associated with NAFLD

        Exclusion Criteria:

          -  Evidence of other causes of liver disease such as Alcoholic steatohepatitis,
             (de)compensated cirrhosis, active viral hepatitis

          -  Any condition possibly affecting drug absorption

          -  Unstable liver function tests

          -  Recent cardiovascular event(s),

          -  Malignancies
A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Etrasimod 1 mg; Etrasimod 2 mg; Etrasimod matching placebo
Intervention description: Etrasimod 1 mg tablet taken by mouth, once daily; Etrasimod 2 mg tablet taken by mouth, once daily.; Etrasimod matching placebo tablet by mouth, once daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Moderate-to-severe atopic dermatitis; Etrasimod; APD334

Summary:

      The purpose of this study is to determine whether etrasimod is a safe and effective treatment
      for moderate-to-severe atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion criteria:

          -  Participants with chronic atopic dermatitis, defined by Hanifin and Rajka criteria,
             that has been present for at least 1 year prior to the Screening Visit

          -  Participants with Eczema Area and Severity Index (EASI) ≥ 12 at the Screening Visit
             and ≥ 16 at the Baseline Visit

          -  Participants with validated Investigator's Global Assessment (vIGA) score ≥ 3 (on the
             0 to 4 vIGA scale, in which 3 = moderate and 4 = severe) involvement at the Screening
             and Baseline visits

        Exclusion Criteria:

          -  Presence of skin comorbidities that would interfere with study assessments of the
             underlying disease.
Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus
Condition: Lupus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: BMS-931699; Placebo matching BMS-931699
Intervention MeSH terms: Antibodies
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 730.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic
      lupus erythematosus in male and female adults. Patients who qualify will be randomized to
      either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the
      initial 24 weeks of treatment and who are responding to therapy will have the option to
      continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and
      safety will be assessed over the course of the study through laboratory values, various
      rating scales accepted in systemic lupus erythematosus studies and patient self reporting.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Male or female aged between 18 to 70 (included)

          -  Diagnosed with active systemic lupus erythematosus by a doctor

          -  Disease must be in patient's joints or on the skin at a minimum

          -  Taking other medications is allowed but some are excluded

        Exclusion Criteria:

          -  Diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis

          -  Diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus
Colchicine and CRP in Atrial Fibrillation and AF Ablation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Colchicine, 0.6 mg PO BID; Matching placebo
Intervention description: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo; Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug
Intervention MeSH terms: Colchicine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: atrial fibrillation; catheter ablation; colchicine; c reactive protein; CRP

Summary:

      Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the
      rise in CRP which occurs following atrial fibrillation ablation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Group 1: Persistent or chronic AF presenting for evaluation in cardiology offices.
             Diagnosis of AF will be made based on the 12 -lead surface ECG.

          -  Group 2: Paroxysmal AF scheduled to go AF ablation presenting to the electrophysiology
             laboratory for the procedure in sinus rhythm..

          -  Group 3:Chronic AF scheduled to go clinically indicated AF ablation, and presenting in
             the electrophysiology laboratory in atrial fibrillation .

        Exclusion Criteria:

          1. Abnormal liver function with elevated enzymes> 1.5 times the normal.

          2. Abnormal kidney function with glomerular filtration rate < 50 ml/min

          3. Increased levels of creatine kinase or known myopathy

          4. Neutropenia

          5. Known GI disorders

          6. Women of childbearing age who have not had surgical sterilization and are not using
             oral contraceptives, or who's spouse has not had surgical sterilization will be
             excluded due to the length of the trial and the possibility that they could become
             pregnant after entry.

          7. Pregnant and lactating women

          8. Lactose intolerance

          9. Known sensitivity, allergy, or contraindication to colchicine use
Candin Safety & Efficacy Study for the Treatment of Warts
Condition: Warts; Human Papilloma Virus
MeSH terms: Warts; Papilloma
Intervention: Candida albicans Skin Test Antigen
Intervention description: 0.3 ml injected intralesionally monthly. Number of injections: until wart lesion is resolved or up to 6 injections.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Treatment; common wart lesions; (verruca vulgaris)

Summary:

      The primary objective of this study is to determine the safety of Candin® (Candida albicans
      Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common
      warts (Verruca vulgaris).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have at least 3 and not more than 10 common warts not located on the palms or
             digits

          -  Positive DTH response to Candin® required

        Exclusion Criteria:

          -  No previous medical treatment for warts other than OTC

          -  No immunocompromising medical conditions or medicines allowed

          -  No preexisting inflammatory conditions at treatment site allowed
Use of a Novel Drug in People With Non-alcoholic Steatohepatitis (NASH) or Non-alcoholic Fatty Liver Disease (NAFLD)
Condition: Non-alcoholic Fatty Liver Disease (NAFLD); Non-alcoholic Steatohepatitis (NASH)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: AZ compound; Placebo
Intervention description: AZ compound 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg).; Placebo 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Does the novel drug decrease liver fat in subjects with NASH or NAFLD as compared to placebo
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 21-75

          -  Body Mass Index (BMI) >19 kg/m^2

          -  Subjects with biopsy/MRE proven NASH [MRE liver fat ≥ 5%, with elevated liver enzymes
             ALT <5x upper limit normal (ULN)].

          -  Subjects with NAFLD and MRE shows F0 or greater fibrosis

          -  Subjects with history suggestive of NAFLD/NASH

          -  Total bilirubin must be < 1.5 x ULN and INR must be < 1.3 at baseline screening.

          -  TSH and CPK will be within normal limits (WNL) at screening.

          -  Subjects with type 2 diabetes who are on stable doses of medications (except
             pioglitazone) to control hyperglycemia and have baseline HbA1c of 10% or lower.

          -  Hemoglobin must be greater than or equal to 12.0 in males and 11.0 in females.

        Exclusion Criteria:

          -  Medications that may affect glucose metabolism such as corticosteroids, opiates,
             barbiturates, and anticoagulants.

          -  Subjects with anemia, and symptoms suggestive of undiagnosed illness, overt hepatic
             disease, stroke, Alzheimer's disease, autoimmune hepatitis, alcoholism or increased
             alcohol consumption over the American Diabetes Association (ADA) guidelines.

          -  Any disorder that may potentially impact the outcome measures.

          -  Pregnant women and children.

          -  Subjects planning weight loss or in any weight loss program.

          -  Subjects taking TZD's, Atazanavir, Indinavir, Ketoconazole, Valproic acid, Silybum
             marianum and Valeriana officinalis.
Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Patients With Hormone Receptor-Positive Breast Cancer and Resistance to Non-Steroidal Aromatase Inhibitors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: BMS-754807; letrozole
Intervention description: Tablet, Oral, 100 mg, Daily, Until disease progression or unacceptable toxicity; Tablets, Oral, 2.5 mg, Daily, Until disease progression or unacceptable toxicity
Intervention MeSH terms: Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate oral doses of BMS-754807 in combination with
      letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic
      hormone receptor positive breast cancer subjects who have progressed with prior non-steroidal
      aromatase inhibitor treatment.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Postmenopausal women with hormone receptor-positive and HER-2 negative breast cancer

          -  Disease progression following non-steroidal aromatase inhibitor treatment

        Exclusion Criteria:

          -  Known symptomatic brain metastasis

          -  Medical condition requiring chronic steroids

          -  History of Type 1 or 2 Diabetes

          -  Uncontrolled or significant cardiovascular (CV) disease

          -  Concomitant second malignancies
A Study to Assess Dystrophin Levels in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD) Who Have Been Treated With Ataluren
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Ataluren
Intervention description: Ataluren will be administered as per the dose and schedule specified in the arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Healthy volunteers: No

Summary:

      This study is designed to generate additional data on the effect of ataluren for producing
      dystrophin protein in nonsense mutation nmDMD participants. This study will evaluate
      dystrophin levels from participants with nmDMD who currently have been receiving ataluren for
      ≥9 months.

      The study will have a single visit (Visit 1).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of signed and dated informed consent/assent document(s) indicating that the
             participant (and/or his parent/legal guardian) has been informed of all pertinent
             aspects of the trial.

          -  Ambulatory (10 meters walk/run in less than [<] 30 seconds) and functional grade on
             the Brooke Upper Extremity Scale of a 1 or a 2.

          -  Currently being treated with ataluren 10, 10, 20 mg/kg for >=9 months, with no gap in
             treatment of greater than (>) 1 month, in an ongoing PTC-sponsored nmDMD clinical
             trial prior to study entry.

          -  Phenotypic evidence of duchenne muscular dystrophy (DMD) based on the onset of
             characteristic clinical symptoms or signs (for example, proximal muscle weakness,
             waddling gait, and Gowers' maneuver) by 6 years of age and an elevated serum creatine
             kinase (CK). Medical documentation of phenotypic evidence of DMD needs to be provided
             upon request by the medical monitor.

          -  Willing to undergo muscle biopsy.

        Exclusion Criteria:

          -  Known contra-indication to muscle biopsy (such as bleeding or clotting disorders).

          -  Exposure to another investigational drug within 2 months prior to study enrollment or
             ongoing participation in any non-ataluren interventional clinical trial.

          -  Requirement for daytime ventilator assistance or any use of invasive mechanical
             ventilation via tracheostomy. Note: Evening non-invasive mechanical ventilation such
             as use of bilevel positive airway pressure (Bi-PAP) therapy is allowed.

          -  Prior or ongoing medical condition (for example, concomitant illness, psychiatric
             condition, behavioral disorder), medical history, physical findings or laboratory
             abnormality that, in the investigator's opinion, could adversely affect the safety of
             the participant, makes it unlikely that the course of treatment or follow-up would be
             completed, or could impair the assessment of study results.
A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Condition: Peripheral T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Intervention: SP-02L (darinaparsin for injection)
Intervention description: Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This study is a phase 2 multinational, multicenter, single-arm, open-label, non-randomized
      study to evaluate the efficacy and safety of SP-02L monotherapy in relapsed or refractory
      patients with peripheral T-cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a Japanese, Korean, Taiwanese, or Chinese ethnic background of each
             country/region

          -  Patients aged ≥20 years on the date of informed consent

          -  Patients with histologically confirmed diagnosis of one of the following:

               -  Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)

               -  Angioimmunoblastic T-cell Lymphoma (AITL)

               -  Anaplastic large cell lymphoma (ALCL), (ALK-positive/negative)

          -  Relapsed or refractory patients with a treatment history of at least one regimen with
             antitumor agents for the above disease

          -  Have at least 1 measurable lesion

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

          -  Patients with a life expectancy of at least 3 months as determined by the investigator
Cognitive Enhancement Through Transcranial Laser Therapy
Condition: Healthy Participants; Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Intervention: LLLT; Placebo
Intervention description: The treatment will consist of applying light of a specific wavelength (1064 nm) using a laser diode supplied by Cell Gen Therapeutics, LLC (CG-5000 laser, HD Laser Center, Dallas, TX, USA).; The treatment will consist of applying light of a specific wavelength (1064 nm) using a laser diode supplied by Cell Gen Therapeutics, LLC (CG-5000 laser, HD Laser Center, Dallas, TX, USA). However, the placebo group will receive approximately 1/12th of the cumulative energy density as the treatment group.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 91.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a mechanism-driven translational project to test the efficacy of transcranial
      low-level light/laser therapy (LLLT), for enhancing cognitive function in middle-aged and
      older adults and participants with Mild Cognitive Impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and postmenopausal women, aged 45 and older

          -  Participants with Mild Cognitive Impairment

        Exclusion Criteria:

          -  neurological disease (e.g., large vessel stroke, seizure disorder, Parkinson's
             disease, Alzheimer's disease, clinically significant traumatic brain injury with loss
             of consciousness > 30 minutes, multiple sclerosis, or brain infection/meningitis

          -  baseline IQ < 85 placing them below the average range of intellectual functioning

          -  major psychiatric illness (e.g., schizophrenia, bipolar disorder) or substance abuse
             (diagnosed abuse and/or previous hospitalization for substance abuse)

          -  severe cardiovascular disease (e.g., pacemaker), chronic obstructive pulmonary
             disease, liver or kidney disease, inflammatory illness