bioihbjkbjnl/mcl2 huggingface dataset:
MK0974 (Telcagepant) for Migraine Prophylaxis in Patients With Episodic Migraine (0974-049)
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Telcagepant 140 mg; Telcagepant 280 mg; 140 mg telcagepant placebo; 280 mg telcagepant placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 660.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to assess the safety and efficacy of MK0974 for preventing migraines in patients with
      episodic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is 18 years of age or older

          -  Patient has had a history of migraine with or without aura

          -  Patient is able to complete study questionnaire(s) and paper diary

        Exclusion Criteria:

          -  Patient is pregnant or breast-feeding, or is a female expecting to conceive within the
             projected duration of the study

          -  Patient has basilar or hemiplegic migraine headache, hepatitis or psychiatric
             conditions

          -  Patient was older than 50 years of age at migraine onset

          -  History of gastric or small intestinal surgery or has a disease that causes
             malabsorption

          -  Patient has heart attack, unstable angina, coronary artery bypass surgery or other
             revascularization procedure, stroke, or transient ischemic attack 3 months before
             starting the study

          -  Currently participating or has participated in a study with an investigational
             compound or device within 30 days of starting the study

          -  Currently participating in a study with MK-0974 or MK-3207
Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Intervention: placebo; oxytocin 24IU; oxytocin 48IU
Intervention description: intranasal placebo (48 international units); intranasal oxytocin (24 international units) and intranasal placebo (24 international units); intranasal oxytocin (48 international units)
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: Male
Minimum age: 13 Years
Maximum age: 29 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether the medication oxytocin is an effective and
      tolerable treatment in adolescent males with fragile X syndrome (FraX) for improving socially
      appropriate behaviors and reducing social anxiety.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Confirmed genetic diagnosis of Fragile X (FraX) (full mutation).

          2. Male (who have more serious effects due to the X chromosome nature of the disorder)

          3. Age 13-29 years.

          4. Parent of adolescent must be willing to sign informed consent.

          5. Intelligence Quotient (IQ) > 42.

        Exclusion Criteria:

          1. Cardiac risk factors.

          2. Medication exclusions: opiates or opiate antagonists, corticosteroids, typical or
             atypical antipsychotics.
A Pilot Study to Investigate the Effect of Cytotoxic Therapy and/or Radiotherapy on Cancer Related Sleep Disturbances in CLL and Breast Cancer Patients Experiencing Fatigue
Condition: Leukemia; CLL
MeSH terms: Leukemia; Dyssomnias; Parasomnias
Intervention: Lenalidomide
Intervention description: 5 mg daily for 56 days.
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; Lenalidomide; Actigraph; Sleep Test Study; Chronic Lymphocytic Leukemia; CC-5013; Revlimid

Summary:

      The goal of this clinical research study is to learn if treatments to kill cancer cells
      including lenalidomide and/or radiation therapy can help to control symptoms such as sleep
      problems and fatigue in patients with chronic lymphocytic leukemia (CLL) and/or breast
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Describe fatigue as being present every day for most of day for a minimum of 2 weeks
             and rate fatigue greater than or equal to 4 on a 0-10 scale, in which 0= no fatigue
             and 10=worst possible fatigue as assessed by MD Anderson symptom Inventory(MDASI).

          2. Have diagnoses of CLL and started on a new cytotoxic therapy or breast cancer
             receiving new cytotoxic or radiation therapy

          3. Patients will be eligible to participate in this study if they rate sleep disturbance
             greater than or equal to 4 on a 0-10 scale, in which 0= disturbed sleep is not present
             and 10 = disturbed sleep as bad as you can imagine as assessed by MDASI.

          4. Have a MDAS of 13 or less.

          5. Able to understand the description of the study and give written informed consent.

        Exclusion Criteria:

          1. Patients who are unable to complete the assessment measures or refuse to participate

          2. Patients with known history of brain metastasis.

          3. Patients with known history of sleep apnea.
E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Eculizumab
Intervention description: Each vial contains 30 mL of 10 mg/mL eculizumab; dose of 900 mg intravenous every 14 days.
Intervention MeSH terms: Eculizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Hemolytic Paroxysmal Nocturnal Hemoglobinuria; Eculizumab; PNH

Summary:

      The objective of this study was to assess the long-term safety and efficacy of eculizumab in
      hemolytic PNH patients who completed the 4-week screening and 12-week treatment period of the
      C07-001 study. In addition, pharmacokinetic and pharmacodynamic assessments of eculizumab
      were conducted.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have fully completed C07-001 study 12-week treatment period

        Exclusion Criteria:

          -  Patients who terminated early from the C07-001 study
A Sub-study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
Condition: Non-Alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: BMS-986036; Placebo
Intervention description: BMS-986036 20 mg QD; Placebo QD
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: First Line Therapy; NASH

Summary:

      The purpose of this sub-study of MB130-045 is to determine the pharmacokinetic effects,
      pharmacodynamic effects, efficacy and safety of BMS-986036 20 mg QD in subjects with
      Non-alcoholic Steatohepatitis (NASH)
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Male or female between 21 and 75 years old

          -  Body Mass Index (BMI) of 25 or more

        Exclusion Criteria:

          -  Chronic Liver disease other than NASH

          -  Uncontrolled diabetes

          -  Any major surgery within 6 weeks of screening

          -  Unable to self-administer under the skin injections

          -  Any bone trauma, fracture or bone surgery within 8 weeks of screening
Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
Condition: Dry Eye Syndromes; Keratoconjunctivitis Sicca
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Keratoconjunctivitis
Intervention: KPI-121; Placebo
Intervention description: KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.; Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Corticosteroid; Dry Eye; Hyperemia; Ocular Discomfort

Summary:

      The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25%
      ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented
      clinical diagnosis of dry eye disease. The product will be studied over 28 days, with 1-2
      drops instilled in each eye four times daily (QID).
    

Eligibility criteria:

        Inclusion Criteria:

        • Have a documented clinical diagnosis of dry eye disease in both eyes

        Exclusion Criteria:

          -  Known hypersensitivity/contraindication to study product(s) or components.

          -  History of glaucoma, IOP >21 mmHg at the screening or randomization visits, or being
             treated for glaucoma in either eye.

          -  Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in
             judgment of Investigator could confound study assessments or limit compliance;
             severe/serious systemic disease or uncontrolled medical condition that in judgment of
             Investigator could confound study assessments or limit compliance; or have been
             exposed to an investigational drug within the 30 days prior to screening.

          -  In the opinion of Investigator or study coordinator, be unwilling or unable to comply
             with study protocol or unable to successfully instill eye drops.
A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus, Type 2
Intervention: PF-04634817; Placebo
Intervention description: Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function; Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic nephropathy; type 2 diabetes; albuminuria; chemokine antagonist

Summary:

      The study hypothesis under test is that administration of a CCR2/5 antagonist to subjects
      with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a
      surrogate for improved glomerular filtration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of type 2 diabetes together with stages 2, 3a, 3b or 4 CKD, based
             on an eGFR of 20-75 mL/min/1.73m2.

          -  Evidence of persistent, overt albuminuria; defined as a UACR >=300 mg/g (>=33.9
             mg/mmol) or UPCR >=390 mg/g (44.1 mg/mmol), or equivalent, for 3 months or longer.

          -  Stable background therapy of RAAS inhibition (ie, an ACE inhibitor and/or an ARB,
             which may also include an aldosterone antagonist in double RAAS but not triple RAAS
             inhibitor therapy) for at least 3 months before screening and to be maintained for the
             duration of the study.

        Exclusion Criteria:

          -  Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.

          -  Subjects who are diagnosed with autosomal dominant polycystic kidney disease (ADPCKD),
             severe peripheral vascular disease (PVD) or obstructive uropathy.
Study of T-PRED(TM) Compared to Pred Forte(R)
Condition: Cataract
MeSH terms: Cataract
Intervention: T-PRED; Pred Forte
Intervention description: T-PRED sterile ophthalmic solution; Pred Forte sterile ophthalmic solution
Intervention MeSH terms: Prednisone; Prednisolone acetate; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study of T-PRED(TM) compared to Pred Forte(R)
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age

        Exclusion Criteria:

          -  No active or adverse disease
A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNFα Inhibitor Therapy
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: LY2127399; Placebo
Intervention description: LY2127399 will be administered as a single IV infusion over 30 minutes.; Placebo will be administered as a single IV infusion over 30 minutes.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to explore whether LY2127399 is effective in relieving signs and
      symptoms of rheumatoid arthritis (RA) in patients with a history of inadequate response or
      intolerance to at least 1 Tumor Necrosis Factor-Alpha (TNFα) inhibitor therapy. Examples of
      these TNFα inhibitor therapies that are currently on the market include Enbrel® (etanercept),
      Remicade® (infliximab), and Humira® (adalimumab).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have given written informed consent approval

          -  Women must not be at risk to become pregnant during study participation

          -  Diagnosis of Rheumatoid Arthritis

          -  Active Rheumatoid Arthritis

          -  Current, regular use of Methotrexate, at a stable dose

          -  Have been on at least 1 biologic tumor necrosis factor-alpha (TNFα) inhibitor therapy
             and either failed or were intolerant to treatment

          -  Other criteria to be reviewed by study doctor

        Exclusion Criteria:

          -  Use of excluded medications (reviewed by study doctor)

          -  Have medical findings which, in the opinion of the study doctor, put patient at an
             unacceptable risk for participation in the study

          -  Have had recent or ongoing infection which, in the opinion of the study doctor put
             patient at an unacceptable risk for participation

          -  Evidence of tuberculosis

          -  Have systemic inflammatory condition other than rheumatoid arthritis (RA), such as
             juvenile RA, seronegative spondyloarthropathy, Crohn's disease, ulcerative colitis, or
             psoriatic arthritis.

          -  Other criteria to be reviewed by study doctor
Atomoxetine and Huntington's Disease
Condition: Huntington Disease; Chorea
MeSH terms: Huntington Disease; Chorea
Intervention: atomoxetine; Matching Placebo
Intervention description: This study utilizes a crossover design. Accordingly, half of the participants receive 40 milligram twice a day atomoxetine at arm one while the remaining half receive this intervention at arm two.; This study utilizes a crossover design. Accordingly, half of the participants receive twice a day matching placebo at arm one while the remaining half receive this intervention at arm two.
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Huntington Disease; Chorea; Attention; ADHD; ADD; Strattera; Atomoxetine

Summary:

      The purpose of this research study is to evaluate the effect of atomoxetine (also known as
      Strattera) compared to placebo (inactive substance) on daily activities such as attention and
      focus, thinking ability and muscle movements in subjects with early Huntington Disease (HD)
      and attention deficit disorder (ADD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed Huntington's disease (HD) diagnosis

          -  Age 18 to 65

          -  Must have mild HD

          -  Must have complaints of poor attention

        Exclusion Criteria:

          -  Childhood history of attention deficit hyperactivity disorder (ADHD) symptoms

          -  Diagnosis of schizophrenia, bipolar affective disorder, dementia, delirium or severe
             anxiety

          -  Current use of a monoamine oxidase inhibitor (MAOI) medication

          -  Pregnancy

          -  Uncontrolled hypertension

          -  Tachycardia

          -  Cardiovascular or cerebrovascular disease

          -  History of a loss of consciousness for greater than (or equal to) 5 minutes

          -  Having any neurological disorder or insult other than Huntington disease
Lapatinib Ditosylate and Radiation Therapy in Treating Patients With Locally Advanced or Locally Recurrent Breast Cancer
Condition: Male Breast Cancer; Recurrent Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
MeSH terms: Breast Neoplasms; Breast Neoplasms, Male; Recurrence
Intervention: lapatinib ditosylate; radiation therapy; laboratory biomarker analysis
Intervention description: Given PO; Undergo radiation therapy; Correlative studies
Intervention MeSH terms: Lapatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well lapatinib ditosylate and radiation therapy work in
      treating patients with locally advanced or locally recurrent breast cancer. Lapatinib
      ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell
      growth. Radiation therapy uses high energy x rays to kill tumor cells. Giving lapatinib
      ditosylate together with radiation therapy may be an effective treatment for breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologically or cytologically confirmed locally advanced breast cancer
             that is refractory to chemotherapy or other therapeutic agents or with a history of
             breast cancer with new evidence of a local recurrence (defined as a chest wall or
             breast recurrence and/or nodal recurrence); the diagnosis will be made based on
             clinical and pathologic features

          -  Patients must be >18 years of age.

          -  Karnofsky Performance Status (KPS) score > 70

          -  Patts must have normal organ function as defined below:

               -  total bilirubin < 1.5 x institutional upper limit of normal

               -  AST(SGOT)/ALT(SGPT) < 2.5 x institutional upper limit of normal

               -  creatinine < 1.5 x institutional upper limit of normal

          -  Patients must have left-ventricular ejection fraction > 50% at baseline.

        Exclusion Criteria:

          -  Patients who have contraindications to radiotherapy, such as scleroderma,
             dermatomyositis, or severe cutaneous manifestations of systemic lupus erythematosus
             (SLE)

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to lapatinib

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, or psychiatric illness/social
             situations that would limit compliance with study requirements

          -  Women who are pregnant or lactating, as well as women of child-bearing potential who
             are unwilling or unable to use an acceptable method of birth control to avoid
             pregnancy for the duration of the study