bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Abemaciclib (LY2835219) in Participants With Stage IV Squamous Non-small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer Stage IV
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Abemaciclib; Docetaxel
Intervention description: Administered orally; Administered IV
Intervention MeSH terms: Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 159.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: patient reported outcomes (PRO); patient focused outcomes (PFO); biomarkers; CDK 4 and 6

Summary:

      The main purpose of this study is to evaluate the effectiveness of the study drug known as
      abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung
      cancer (NSCLC) previously treated with platinum-based chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of stage IV NSCLC.

          -  Have progressed during or after platinum-based chemotherapy for advanced disease.

          -  Have not received prior treatment with docetaxel.

          -  Have availability of adequate formalin-fixed paraffin-embedded (FFPE) tumor derived
             material.

          -  Have adequate organ function including hematology, renal, and liver.

          -  Have good performance score (0-1).

          -  Have measurable disease per RECIST 1.1.

          -  Agree to use a reliable medically approved method of birth control.

        Exclusion Criteria:

          -  Have received prior treatment with any cyclin dependent kinase (CDK) 4 and 6 inhibitor
             or participated in a clinical trial with a CDK 4 and 6 inhibitor and the treatment
             administered is not known.

          -  Are currently receiving treatment in a clinical trial involving an investigational
             product or non-approved use of a drug or device.

          -  Have the presence of unstable central nervous system (CNS) metastasis.

          -  Have had major surgery (excluding biopsy) < 28 days of the initial dose of study drug.
Dose Response Study of EMA401 in Patients With Post-herpetic Neuralgia (PHN)
Condition: Post-herpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Intervention: EMA401; Placebo
Intervention description: EMA401; 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: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: post-herpetic neuralgia; neuropathic pain; angiotensin II type 2 receptor antagonist; dose ranging

Summary:

      This study was designed to characterize dose response, and evaluate safety and efficacy of
      three different doses of EMA401 compared to placebo in patients with post-herpetic neuralgia
      (PHN).
    

Eligibility criteria:

        Inclusion Criteria:

          -  At the time of Screening, must have had documented diagnosis of PHN (ICD-10 code
             B02.29), defined as pain in the region of the rash persisting for more than 6 months
             after onset of herpes zoster rash.

          -  Assessed as suffering from moderate to severe neuropathic pain across the Screening
             epoch (NRS ≥ 4).

          -  Patients must have had documented past and/or ongoing inadequate treatment response
             (having insufficient pain relief with treatment or inability to tolerate) to at least
             2 different prescribed therapies commonly used to treat and considered effective by
             the Investigator for the treatment of PHN.

          -  Patient must have been willing to complete daily eDiary

        Exclusion Criteria:

          -  History or had current diagnosis of electrocardiogram (ECG) abnormalities indicating
             significant risk of safety for patients participating in the study

          -  Had a major depressive episode within 6 months prior to Screening and/or a history of
             diagnosed recurrent major depressive disorder according to Diagnostic and Statistical
             Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant.

          -  Had evidence of significant renal insufficiency or pre-existing liver condition

          -  Had platelets ≤ 100 x 10^9/L, or neutrophil count < 1.2 x 10^9/L (or equivalent),
             hemoglobin ≤ 100 g/L for women or hemoglobin ≤ 110 g/L for men.

          -  Patients who had a known diagnosis of diabetes and are stable on medication with a
             hemoglobin A1c > 8%. Those who did not have a known diagnosis of diabetes with a
             hemoglobin A1c > 7%.
Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Chronic GVHD
Condition: Chronic Graft Versus Host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Intervention: Ponesimod
Intervention description: Oral film-coated tablets at the doses of 2, 3, 4, 5, 6, 7, 8, 9, 10, and 20 mg. One tablet of ponesimod at any dose will be taken orally once daily.
Intervention MeSH terms: Ponesimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: GVHD; ponesimod

Summary:

      Chronic graft versus host diseasre (GVHD) is a serious reaction that might occur in a person
      (the host) who has received cells or organs (graft) from another person because the graft
      attacks the host's cells. Currently there are no approved therapies for chronic GVHD in the
      USA, and patients with chroninc GVHD are treated with immunosuppressant drugs. T-lymphocytes
      (a type of white blood cells) are likely to play a role in the development of chronic GVHD.
      Due to the capacity of ponesimod to block the traffic of T-lymphocytes, ponesimod may be a
      new therapeutic approach to treat chroninc GVHD.

      The main objective of this study is to assess the effectiveness and safety of several doses
      of ponesimod in subjects with chronic GVHD who did not respond to standard available
      treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Symptomatic moderate or severe chronic GVHD patients in need of a change of systemic
             immunosuppressant (IS) therapy

          -  Women of child bearing potential must have a negative pregnancy test and use reliable
             methods of contraception

        Exclusion Criteria:

          -  Clinically significant medical conditions including active or uncontrolled infections,
             new or recurrent malignancy, serious cardiac, pulmonary, or renal disease, and
             uncontrolled diabetes.

          -  Karnofsky Performance Score < 60.

          -  Immunosuppressant therapies other than allowed background therapy

          -  Anti-arrhythmic and heart rate lowering drugs.

          -  Any other circumstances or conditions, which, in the opinion of the investigator, may
             affect full participation in the study or compliance with the protocol
Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study
Condition: Delirium; Fall Injury
MeSH terms: Delirium
Intervention: care.coach Avatar (HELP-Protocolized)
Intervention description: care.coach human-in-the-loop avatar system with software-directed protocols based on the Hospital Elder Life Program (HELP).
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 301.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: patient satisfaction; HCAHPS; loneliness; delirium; falls; HELP; hospitals; geriatrics; elder care

Summary:

      Through NINR project 1R44NR017842-01 which preceded the present study, the investigators
      enhanced the care.coach avatar platform to incorporate a robust suite of evidence-based
      protocols based on the Hospital Elder Life Program (HELP), and to leverage an integration
      with hospital-based electronic medical record (EMR) systems. In the present study, the
      investigators seek to validate the efficacy of the new avatar platform, as measured by
      reduction in falls, delirium, and patient sitter utilization. Also, the investigators seek to
      gather patient and outcomes data at a scale sufficient to begin developing machine learning
      algorithms for intelligent, automatic assignment of protocols to maximize patient engagement
      and clinical efficacy, and for intelligent, automatic screening of delirium to assist care
      teams in positive identification of delirium. Therefore, the present study comprises a
      two-year randomized between-groups comparison across multiple hospitals to compare outcomes
      with the new generation of care.coach avatars as the intervention versus usual care only as
      the control. Each study group will be geographically distributed across participating
      research sites: initially MediSys Health Network's Jamaica Hospital Medical Center in New
      York, with additional hospitals to join the study over the course of two years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  fall/delirium risk (may be based purely on age at the election of each site, e.g. 65+)

        Exclusion Criteria:

          -  aggression or combativeness with intent to harm self or others

          -  severe hearing impairment and simultaneous severe vision impairment, despite assistive
             devices

          -  no comprehension of either Spanish or English
Safety Study of Eteplirsen to Treat Early Stage Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy (DMD)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: eteplirsen
Intervention description: Eteplirsen 30 mg/kg will be administered as an IV infusion once a week for 96 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: Male
Minimum age: 4 Years
Maximum age: 6 Years
Healthy volunteers: No
Keywords: DMD; Duchenne muscular dystrophy; eteplirsen; Dystrophin; exon 51

Summary:

      This is an open-label study to assess the safety, tolerability, efficacy and pharmacokinetics
      of eteplirsen in patients with early stage Duchenne muscular dystrophy (DMD) who are amenable
      to exon 51 skipping.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male 4-6 years of age.

          -  Diagnosis of DMD, genotypically confirmed.

          -  Stable dose of oral corticosteroids for at least 12 weeks or has not received
             corticosteroids for at least 12 weeks.

          -  Intact right and left biceps muscles or two alternative upper arm muscle groups.

          -  Parent that is willing to provide consent and comply with study procedures.

        Exclusion Criteria:

          -  Use of any pharmacologic treatment (other than corticosteroids) within 12 weeks that
             may have an effect on muscle strength or function (e.g., growth hormone, anabolic
             steroids).

          -  Previous or current treatment with any other experimental treatments within 12 weeks
             or participation in any other clinical trial within 6 months.

          -  Major surgery within 3 months prior to the first dose of study drug, or planned
             surgery during this study which would interfere with the ability to perform study
             activities.

          -  Presence of other clinically significant illness.
Study to Investigate the Safety and Duration of Effect of Different Botulinum Toxin A (NT 201) Dose Groups Following the Treatment of Glabellar Frown Lines
Condition: Moderate to Severe Glabellar Frown Lines
Intervention: NT 201
Intervention description: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% unpreserved Sodium Chloride (NaCl).
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 241.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to investigate the safety and duration of effect following
      different doses of Botulinum Toxin A (NT 201) in the treatment of glabellar frown lines
      (GFL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participant 18 years or over.

          -  Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by
             investigator on the 4-point facial wrinkle scale (FWS).

          -  Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by participant
             on the 4-point FWS.

        Exclusion Criteria:

          -  Previous treatment with Botulinum neurotoxin (BoNT) of any serotype in the facial area
             within the last 12 months before injection.

          -  Previous treatment with any facial cosmetic procedure (example, chemical peeling,
             photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, tattooing of
             eyebrows) in the glabellar area within the last 12 months before injection.

          -  Previous treatment with any biodegradable filler in the glabellar area within the last
             12 months before injection.

          -  Inability to substantially reduce GFL by physically spreading them apart as assessed
             by the investigator.

          -  Excessively thick sebaceous skin or hypertrophic muscles in the upper third part of
             the face.

          -  Any surgery or scars in the glabellar area.

          -  Marked facial asymmetry.

          -  Eyelid ptosis.

          -  Marked brow ptosis and/or dermatochalasis.

          -  Ongoing severe or unstable medical conditions, example, systemic infection, or
             pulmonary disease, at the discretion of the investigator.
A Study Of AL101In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
Condition: Adenoid Cystic Carcinoma
MeSH terms: Carcinoma; Carcinoma, Adenoid Cystic
Intervention: AL101
Intervention description: AL101 is a small-molecule that inhibits gamma secretase, an enzyme which plays a key role in the activation of the Notch signaling pathway by releasing the Notch intracellular domain (NICD) of all four Notch receptors from the membrane.
In patients with aberrant Notch signaling, AL101 may inhibit Notch signaling and potentially impede tumor growth.The drug is administered intravenously
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open label
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, non comparative, open label, multicenter study of AL101 in patients with
      recurrent or metastatic ACC who harbor NOTCH 1,2,3,4 activating mutations.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Confirmed Adenoid Cystic Carcinoma with known NOTCH 1/2/3/4 activating mutation that
             is recurrent or metastatic, not amenable to potentially curative surgery or
             radiotherapy.

          2. Evidence of radiographic or clinical disease progression within 6-months of signing
             informed consent; newly diagnosed metastatic patients will be allowed.

          3. Patients must have Formalin-fixed, Paraffin-embedded tissue available .

          4. Must have at least 1 target lesion that is measurable for patients with nodal or
             visceral metastasis.

        Exclusion Criteria:

          1. Diagnosed with a malignancy other than ACC in the past 2 years.

          2. Uncontrolled, Active Infection

          3. Gastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel
             disease (IBD)]

          4. Symptomatic central nervous system (CNS) metastases.

          5. Unstable or severe uncontrolled medical condition

          6. Eastern Cooperative Oncology Group (ECOG) performance status ≥2.

          7. Abnormal organ and marrow function
Study of Ibrutinib in Combination With Rituximab in Previously Untreated Subjects With Follicular Lymphoma
Condition: Follicular Lymphoma; B-cell Lymphoma; Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell
Intervention: Ibrutinib; rituximab
Intervention description: All subjects will receive 560 mg of Ibrutinib orally.; All subjects will receive rituximab 375 mg/m2 intravenously
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pharmacyclics (PCYC); PCYC; Lymphoma; Follicular Lymphoma; FL; Rituximab; Ibrutinib; Rituxan; Non-Hodgkin's Lymphoma (NHL); NHL; B-cell Lymphoma

Summary:

      This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib
      combined with rituximab in previously untreated subjects with Follicular Lymphoma (FL).
    

Eligibility criteria:

        Key Inclusion criteria:

          1. Histologically documented FL (Grade 1, 2 and 3A)

          2. Not previously treated with prior anti-cancer therapy for FL

          3. Stage II, III or IV disease

          4. At least one measurable lesion ≥ 2 cm in longest diameter by CT and/or MRI scan

          5. Men and women ≥ 18 years of age

          6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

        Key Exclusion criteria:

          1. Medically apparent central nervous system lymphoma or leptomeningeal disease

          2. FL with evidence of large cell transformation

          3. Any prior history of other hematologic malignancy besides FL or myelodysplasia

          4. History of other malignancies, except

               1. Malignancy treated with curative intent and with no known active disease present
                  for ≥5 years before the first dose of study drug and felt to be at low risk for
                  recurrence by treating physician.

               2. Adequately treated non-melanoma skin cancer or lentigomaligna without evidence of
                  disease.

               3. Adequately treated carcinoma in situ without evidence of disease.

          5. Currently active, clinically significant cardiovascular disease or myocardial
             infarction within 6 months of screening

          6. Known anaphylaxis or Immunoglobulin E (IgE)-mediated hypersensitivity to murine
             proteins or to any component of rituximab (Rituxan®)

          7. Requires anti-coagulation with warfarin or a vitamin K antagonist.

          8. Requires treatment with strong cytochrome P450 (CYP) 3A inhibitors.

          9. Known bleeding diathesis or hemophilia
A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: ETC-1002; Placebo
Intervention description: Weeks 1-2, 60 milligrams per day (mg/day); Weeks 3-4, 120 mg/day; Weeks 5-6, 180 mg/day; Weeks 7-8, 240 mg/day; Placebo once daily for 8 weeks
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: lipid-lowering drugs; statin intolerance

Summary:

      This study will assess the Low-Density Lipoprotein-Cholesterol (LDL-C) lowering efficacy and
      safety of ETC-1002 versus placebo in participants with hypercholesterolemia and a history of
      statin intolerance.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  A history of statin intolerance that began during statin treatment and resolved within
             4 weeks of stopping the statin treatment

          -  For participants on current lipid-regulating drugs - LDL-C 100-220 milligrams per
             deciliter (mg/dL) and triglycerides <350 mg/dL (prior to wash-out of all
             lipid-regulating drugs and supplements)

          -  For participants not on current lipid-regulating drugs - LDL-C 115-270 mg/dL and
             fasting TG <400 mg/dL

        Key Exclusion Criteria:

          -  Acute significant cardiovascular disease

          -  Poorly controlled hypertension