bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of Abatacept to Treat Refractory Sarcoidosis
Condition: Sarcoidosis
MeSH terms: Sarcoidosis
Intervention: Abatacept
Intervention description: 10mg/kg IV (infusion directly into the vein of the arm) Day 1, week 2, week 4 and then every 4 week for 44 weeks.
Intervention MeSH terms: Abatacept
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
Healthy volunteers: No

Summary:

      The purpose of this study is to determine how safe and effective Abatacept is in treating
      patients who have progressive pulmonary sarcoidosis.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          -  Diagnosis of sarcoidosis for at least 1 year with lung disease

          -  Active disease despite current treatment

          -  On a stable dose of sarcoidosis treatment with oral steroids, methotrexate, or
             hydroxychloroquine, for at least 90 days

        Primary Exclusion Criteria:

          -  Previous treatment with Abatacept

          -  Currently receiving or received within the last 60 days the following: TNFα-inhibitors
             (infliximab, etanercept, adalimumab)

          -  Currently receiving or received within the last 30 days the following: cyclosporine,
             tacrolimus or leflunomide

          -  Previous treatment of IVIg within the last 6 months

          -  History of chronic infection that has been active within last 60 days, or herpes
             zoster within last 6 months, or any infection requiring hospitalization or intravenous
             medication within last 60 days or oral medication within the last 2 weeks

          -  History of congestive heart failure

          -  HIV
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 Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins
Condition: Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: Placebo; PF-04950615 (RN316); PF-04950615 (RN316)
Intervention description: An infusion lasting approximately 60 minutes; An infusion lasting approximately 60 minutes; An infusion lasting approximately 60 minutes
Intervention MeSH terms: Bococizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypercholesterolemia; dyslipidemia; high cholesterol; LDL; antibody; PCSK9; PF-04950615; RN316

Summary:

      PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this
      study to evaluate if it can lower LDL cholesterol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index (BMI) of 18.5 to 40 kg/m2

          -  On a stable maximum daily dose of a statin, defined as atorvastatin 80 mg or
             rosuvastatin 40 mg for a minimum of 45 days prior to Day 1.

          -  Lipids meet the following criteria twice during screening period:

          -  Fasting LDL C = or > 80 mg/dL;

          -  Fasting TG < 400 mg/dL.

        Exclusion Criteria:

          -  History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke,
             TIA, angioplasty) during the past year.

          -  Poorly controlled type 1 or type 2 diabetes mellitus.

          -  Poorly controlled hypertension.

          -  Fasting triglycerides > 400 mg/dL

          -  12 lead ECG demonstrating QTcFF >455 msec at screening.
Oral Immunotherapy (OIT) for Peanut Allergy
Condition: Peanut Hypersensitivity
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Intervention: Peanut OIT; Placebo
Intervention description: Peanut flour that is orally ingested in a graded fashion.; Oat flour used as a placebo that is orally ingested a graded fashion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 1 Year
Maximum age: 6 Years
Healthy volunteers: No
Keywords: Peanut Allergy

Summary:

      Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is
      to produce a new treatment that would benefit subjects who have peanut allergy by lowering
      the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune
      response in subjects who have peanut allergy (tolerance).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 1- 6 years all of either sex, any race, any ethnicity at the time of the initial
             visit

          -  The presence of IgE specific to peanuts (a positive skin prick test to peanuts
             (diameter of wheal >3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 7 kUA/L

          -  A history of significant clinical symptoms occurring within 60 minutes after ingesting
             peanuts

          -  Provide signed informed consent

        Exclusion Criteria:

          -  History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or
             neurological compromise (Cyanosis or oxygen saturation < 92% at any stage,
             hypotension, confusion, collapse, loss of consciousness; or incontinence)

          -  Currently participating in a study using an investigational new drug

          -  Participation in any interventional study for the treatment of food allergy in the
             past 12 months

          -  Subjects with a known wheat food allergy will be excluded because of cross
             contamination of oat with wheat

          -  Poor control or persistent activation of atopic dermatitis

          -  Moderate to severe persistent asthma

          -  Currently being treated with greater than medium daily doses of inhaled
             corticosteroids, as defined by the National Heart Lung and Blood Institute (NHLBI)
             guidelines

          -  Inability to discontinue antihistamines for skin testing and oral food challenges
             (OFCs)
Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Ganaxolone
Intervention description: oral suspension or capsules
Intervention MeSH terms: Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: PCDH19; ganaxolone; neurosteroid; CDKL5; LGS; CSWS

Summary:

      To evaluate the efficacy of open-label ganaxolone as adjunctive therapy for uncontrolled
      seizures in female children with PCDH19 mutation and other rare genetic epilepsies in an
      open-label proof-of-concept study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Have parent or legal guardian available and willing to give written informed consent.

          2. Male and female outpatients between 2 and 18 years of age years of age at time of
             consent.

          3. Have any of the following epilepsy syndromes: PCDH19; CDKL5; Dravet Syndrome; Lennox
             Gastaut Syndrome (LGS); Continuous Spikes and Waves during Sleep (CSWS)

          4. Have uncontrolled cluster seizures and/or non-clustered seizures.

          5. Subjects should be on a stable regimen of anti-epileptic medication, and generally in
             good health.

          6. Parent or guardian is able and willing to maintain an accurate and complete daily
             written seizure calendar.

          7. Able and willing to take study medication with food, two or three times daily.

        Key Exclusion Criteria

          1. Have had previous exposure to ganaxolone.

          2. Known sensitivity or allergy to any component in the study drug, progesterone, or
             other related steroid compounds.

          3. Exposure to any investigational drug or device < 90 days prior to screening, or plans
             to participate in another drug or device trial at any time during the study.

          4. Concurrent use of vigabatrin, tiagabine, or ezogabine is not permitted.

          5. Have any medical condition that, in the investigator's judgment, is considered to be
             clinically significant and could potentially affect subject safety or study outcome,
             including but not limited to: clinically significant cardiac, renal, pulmonary,
             gastrointestinal, hematologic or hepatic conditions; or a condition that affects the
             absorption, distribution, metabolism or excretion of drugs.

          6. Have active suicidal plan/intent, or have had active suicidal thoughts in the past 6
             months or a suicide attempt in the past 3 years.

          7. Have Alanine transferase (ALT; SGPT) or Aspartate transferase (AST; SGOT) levels > 3
             times upper limits of normal (ULN), or total bilirubin >1.5 time ULN at the screening
             and baseline visits.
Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer
Condition: Head and Neck Cancer; Head and Neck Neoplasms; Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: Enoblituzumab; Retifanlimab; Tebotelimab
Intervention description: Anti-B7-H3 antibody; Anti-PD-1 antibody; PD-1 X LAG-3 bispecific DART molecule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Enrollment into each cohort will occur independently in a non-randomized fashion, based on PD-L1 expression results. Patients may not crossover between cohorts.
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2 study of enoblituzumab combined with either retifanlimab or tebotelimab
      administered as first-line treatment to patients with recurrent or metastatic squamous cell
      carcinoma of the head and neck.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven, recurrent or metastatic squamous cell carcinoma of the head and
             neck (SCCHN) not curable by local therapy

          -  No prior systemic therapy for SCCHN in the recurrent or metastatic setting (with the
             exception of systemic therapy completed > 6 months prior if given as part of
             multimodal treatment for locally advanced disease)

          -  Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Patients
             may not have a primary tumor site of upper esophagus, salivary gland, or nasopharynx
             (any histology)

          -  Availability of formalin-fixed, paraffin embedded tumor specimen or contemporary
             biopsy for immunohistochemical evaluation of pharmacodynamic markers of interest

          -  Willing to consent for baseline and on-treatment biopsy.

          -  Performance status 0 or 1

          -  Life expectancy of 6 months or more

          -  Adequate end organ function

          -  At least one radiographically measurable lesion

          -  PD-L1 expression level that is either

               1. Positive (combined positive score [CPS] ≥ 1) for the retifanlimab cohort, or

               2. Negative (CPS < 1) for the tebotelimab cohort

          -  Results available from human papilloma virus p16 status for oropharyngeal cancer

          -  Acceptable laboratory results

        Exclusion Criteria:

          -  Disease suitable for local therapy administered with curative intent

          -  Progressive disease within 6 months of completion of curatively intended systemic
             treatment for locoregionally advanced SCCHN

          -  Radiation or other non-systemic therapy within 2 weeks prior to the first dose of
             study drug

          -  Prior therapy with an anti-B7-H3, anti-PD-1, anti-PD-L1, or anti-LAG-3 agent
Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
Intervention: Dasatinib; Imatinib
Intervention description: Dasatinib was supplied as 20- and 50-mg tablets.; Imatinib was supplied as 100- and 400-mg tablets.
Intervention MeSH terms: Imatinib Mesylate; Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 238.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study assesses the long-term safety and tolerability of dasatinib administered to
      patients with chronic myelogenous leukemia or Philadelphia chromosome positive acute
      lymphoblastic leukemia and experienced clinical benefit from treatment with dasatinib or
      imatinib in previous protocols.
    

Eligibility criteria:

        Key Inclusion Criteria

          -  Signed written informed consent

          -  Received treatment in protocols CA180-005, CA180-006, CA180-013, CA180-015 or
             CA180-017, or CA180-039

          -  Received clinical benefit with dasatinib or imatinib (study CA180017) in the opinion
             of the Investigator

          -  Men and women, ages 18 and older

        Key Exclusion Criteria

          -  A serious uncontrolled medical disorder or active infection that would impair the
             ability of the patient to receive protocol therapy

          -  Dementia or altered mental status that would prohibit the understanding or rendering
             of informed consent

          -  Patients currently taking drugs, including but not limited to quinidine, procainamide,
             disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins,
             clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide,
             ziprasidone, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine,
             domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, and lidoflazine,
             which are generally accepted to have a risk of causing Torsades de Pointes

          -  Patients taking medications known to be potent CYP3A4 inhibitors (ketoconazole,
             ritonavir) or inducers (rifampin, efavirenz)
Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Intervention: Cyclophosphamide; Methotrexate; Prednisone
Intervention description: Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule. In patients showing a partial response, but not a CR, the maximum period of therapy was 1 year.; Initial treatment consisted of MTX given orally at 10 mg/m2 in divided doses once weekly.; Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days.
Intervention MeSH terms: Prednisone; Cyclophosphamide; Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; T-cell large granular lymphocyte leukemia; LGL clone

Summary:

      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of methotrexate with or without
      cyclophosphamide in treating patients who have lymphocytic leukemia with neutropenia or
      anemia.
    

Eligibility criteria:

        Inclusion:

          -  Phenotypic studies from peripheral blood showing CD3+, CD57+ cells greater than
             400/mm3 or CD8+ cells greater than 650/mm3 within eight weeks prior to registration

          -  Evidence for clonal T-cell receptor gene rearrangement within one year prior to
             registration

          -  At least one of the following: Severe neutropenia less than 500/mm3, neutropenia
             associated with recurrent infections, symptomatic anemia, or transfusion-dependent
             anemia

          -  Bilirubin ≤ 2.0 mg/dl, SGOT(AST) ≤ 1.5 times normal, and Creatinine ≤ 2.0 mg/dl within
             4 weeks prior to registration

          -  ECOG performance status of 0-2

          -  At least 18 years of age

          -  Written informed consent

        Exclusion:

          -  Prior therapy with oral MTX or oral Cy

          -  Previous or concurrent malignancies except inactive non-melanoma skin cancer, in situ
             carcinoma of the cervix, or other cancer if the patient has been disease free for over
             5 years

          -  Pregnant or breast-feeding for female patients

          -  Serious medical illness, other than that treated by the study, which would limit
             survival to less than 2 years, or psychiatric condition which would prevent informed
             consent

        Note: to be eligible for step 2 of this study, patients were required to have no response
        after at least 4 months of methotrexate treatment.
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
Condition: Obesity
Intervention: JNJ-64565111 Dose Level 1; JNJ-64565111 Dose Level 2; JNJ-64565111 Dose Level 3; Liraglutide; Placebo
Intervention description: Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.; Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26.; Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26.; Participants will receive liraglutide at a starting dose of 0.6 mg then dose will be ramped up by 0.6 mg daily until reaching 3.0 mg. Participants will then continue on the 3.0 mg once-daily dosage until Week 26.; Participants will receive matching placebo SC once-weekly until Week 26.
Intervention MeSH terms: Liraglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 474.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo
      after 26 weeks of treatment on the percent change in body weight from baseline and to assess
      the safety and tolerability, in non-diabetic severely obese participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) greater than or equal to (>=) 35 to less than or equal to (<=)
             50 kilogram per square meter (kg/m^2) at the screening visit

          -  Stable weight (that is, change of <= 5 percent [%] within 12 weeks before screening
             based on medical history)

          -  Women must be either: (a) Postmenopausal, or (b) Permanently sterilized or otherwise
             be incapable of pregnancy, or (c) Heterosexually active and practicing a highly
             effective method of birth control, or (d) Not heterosexually active

          -  Woman of childbearing potential have a negative pregnancy test at screening

          -  Willing and able to adhere to specific the prohibitions and restrictions

        Exclusion Criteria:

          -  History of obesity with a known secondary cause (for example, Cushing's
             disease/syndrome)

          -  History of Type 1 diabetes mellitus, Type 2 diabetes mellitus (T2DM), diabetic
             ketoacidosis (DKA), pancreas or beta-cell transplantation, or diabetes secondary to
             pancreatitis or pancreatectomy

          -  Has a Hemoglobin A1c (HbA1c) of >= 6.5% or fasting plasma glucose (FPG) >= 126
             milligrams per deciliter (mg/dL) (>= 7.0 millimoles per liter [mmol/L]) at screening

          -  Screening calcitonin of >= 50 picograms per milliliter (pg/mL) personal history or
             family history of medullary thyroid cancer, or of multiple endocrine neoplasia
             syndrome type 2 (MEN 2), regardless of time prior to screening

          -  History of glucagonoma