bioihbjkbjnl/mcl2 huggingface dataset:
BAY79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: rFVIII-FS/pegylated liposomes (BAY79-4980); rFVIII-FS/WFI (BAY14-2222)
Intervention description: 35 IU/kg body weight intravenous 1x/week for 52 weeks This arm will be stopped by 30.04.10 the subjects will be offered to change to the active comparator arm; 25 IU/kg body weight intravenous 3x/week for 52 weeks
Intervention MeSH terms: Factor VIII
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 143.0
Sex: Male
Minimum age: 12 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hemophilia A; FVIII disease; rFVIII

Summary:

      A study to assess treatment with a new formulation of recombinant factor VIII reconstituted
      with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can
      prevent bleeds in subjects with severe haemophilia A.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males aged 12 to 70 years

          -  Subjects with severe hemophilia A (< 1% factor VIII [FVIII]:C)

          -  Subjects with equal or greater than 150 exposure days (EDs) with any FVIII in total

          -  Subjects who have been on-demand treatment with a minimum of 1 relevant bleed per
             month or have been on secondary prophylaxis treatment with not more than a 3x/week
             schedule

          -  Subjects with bleeding events and/or treatments during the last 6 months prior to
             study entry which are documented in the subjects medical records

          -  Subjects with no measurable inhibitor activity

          -  Subjects with no history of FVIII inhibitor antibody formation

          -  Written informed consent by subject and parent / legal representative, if < 18 years

        Exclusion Criteria:

          -  Subjects who are receiving primary prophylaxis

          -  Subjects on prophylaxis with documented requirements of > 75 IU/kg/week

          -  Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand
             disease)

          -  Subjects with abnormal renal function

          -  Subjects with elevated hepatic transaminases

          -  Subjects on treatment with immunomodulatory agents within the last 3 months prior to
             study entry or during the study

          -  Subjects with known hypersensitivity to the active substance, mouse or hamster
             protein, liposomes or polyethyleneglycol (PEG)

          -  Subjects who require any pre-medication for FVIII injections
Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: PF-02545920; Placebo
Intervention description: Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days; Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Schizophrenia; acute exacerbation; and PF-02545920

Summary:

      To assess the efficacy and safety of an investigational compound PF-02545920 for the
      treatment of schizophrenia. PF-02545920 will be more effective than placebo in reducing
      symptoms associated with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a current diagnosis of schizophrenia.

          2. Increase in symptoms over the past 2-4 weeks.

          3. Willing to remain inpatients for the duration of the trial.

        Exclusion Criteria:

          1. Evidence or history of clinically significant medical problems.

          2. Females of childbearing potential.

          3. A primary psychiatric diagnosis other than schizophrenia.

          4. A diagnosis of substance abuse or dependence in the last 6 months.
Family-Focused, Stress-Reduction Program to Improve the Health Care of Urban Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Project ASPIRE Home-Based Family Intervention; Project ASPIRE Enhanced Treatment As Usual
Intervention description: Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months; Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 43.0
Sex: All
Minimum age: 8 Years
Maximum age: 13 Years
Healthy volunteers: No

Summary:

      Stress and anxiety can negatively affect children with asthma. Reducing the stress of
      asthmatic children and their families may lead to improved asthma care and fewer asthma
      symptoms in the children. The purpose of this study is to develop and evaluate a
      family-focused asthma education program aimed at reducing stress levels and improving asthma
      care for urban children with asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of persistent asthma

          -  Poorly controlled asthma, as determined by emergency department visit,
             hospitalization, or steroid burst in the year prior to study entry

          -  Primary caregiver is under stress, as determined by a significantly elevated score on
             measures of stress

          -  Receives Medicaid or participates in Medicaid HMO

          -  Resides in the Atlanta metropolitan area

        Exclusion Criteria:

          -  Nonatopic, nonpsychiatric illness that requires daily medication

          -  Diagnosis of asthma in the year prior to study entry

          -  Homeless

          -  Caregiver is unable to complete study screening process

          -  Caregiver does not speak English
Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Once-daily aclidinium/formoterol; Twice-daily formoterol fumarate; Placebo to formoterol fumarate; Once-daily formoterol fumarate
Intervention description: Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning; Inhaled formoterol fumarate 12 µg twice-daily (BID); Inhaled placebo to formoterol fumarate once-daily in the evening; Inhaled formoterol fumarate 12 μg once-daily in the evening
Intervention MeSH terms: Formoterol Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 156.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Airflow Obstruction, Chronic; Chronic Airflow Obstruction; Chronic Obstructive Pulmonary Disease; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; COPD; COAD

Summary:

      This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of
      aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the
      evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs.
      formoterol fumarate twice daily. The study will assess pulmonary function and symptoms in
      patients with moderate to severe COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe COPD

          -  Smoking history of greater or equal to 10 pack-years

          -  Diagnosis of stable moderate to severe COPD as defined by the GOLD Guidelines

          -  Postbronchodilator FEV1 from 30% to 79% of predicted values, inclusive

          -  Postbronchodilator FEV1/FVC ratio < 0.70

        Exclusion Criteria:

          -  History or presence of asthma, allergic rhinitis, or exercise-induced bronchospasm

          -  Hospitalization for an acute COPD exacerbation in the 3 months prior to study entry

          -  Respiratory tract infection (including the upper respiratory tract) or COPD
             exacerbation in the 6 weeks prior to study entry

          -  Eosinophil count of at least 600 cells/mm3

          -  Long term oxygen therapy > 15 hours a day
Efficacy and Safety of Actiponin on Antiobesity in Obese Korean Subjects.
Condition: Obesity
MeSH terms: Obesity
Intervention: Actiponin; Placebo
Intervention description: The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.; Amount and calorie of placebo are same with Actiponin.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Actiponin; Obesity; Abdominal fat

Summary:

      Obesity is a major health issue worldwide; there is a constant raise in obesity related death
      each year. In vitro and animal studies elucidated Actiponin as a novel anti-obesity agent.
      However, the efficacy and safety of Actiponin supplementation on body weight regulation in
      humans are lacking.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI ≥ 25kg/m2 and WHR ≥ 0.90(men), WHR ≥ 0.85(women)

        Exclusion Criteria:

          -  Significant variation in weight(more 10%) in the past 3 months

          -  Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and
             patient with pacemaker

          -  History of disease that could interfere with the test products or impede theire
             absorption, such as gastrointestinal disease or gastrointestinal surgery

          -  Participation in any other clinical trials within past 2 months

          -  Abdominal hepatic liver function

          -  Renal disease, e.g. acute/chronic renal failure, nephritic syndrome

          -  Used antipsychosis drugs therapy within past 2 months

          -  Laboratory test, medical or psychological conditions deemed by the investigators to
             interfere with successful participation in the study

          -  Pregnancy or breast feeding

          -  History of alcohol or substance abuse

          -  Allergic or hypersensitive to any of the ingredients in the test products
A Study Evaluating the Efficacy of SAR 1118 (0.1%, 1.0%, 5.0%) Ophthalmic Solution in Subjects With Dry Eye Conducted in a Controlled Adverse Environment (CAE)
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Lifitegrast; Placebo
Intervention description: Ophthalmic Solution; Ophthalmic Solution
Intervention MeSH terms: Lifitegrast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 230.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dry Eye; ophthalmic delivery

Summary:

      The purpose of this study is to evaluate the efficacy of three different concentrations
      (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of
      dry eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed Informed Consent Form and HIPAA document

          -  Willing and able to comply with all study procedures

          -  Be at least 18 years of age

          -  Patient-reported history of dry eye in both eyes

          -  Demonstrate a positive response when exposed to the Controlled Adverse Environment
             model

          -  A negative urine pregnancy test if female of childbearing potential and must use
             adequate birth control throughout the study period

        Exclusion Criteria:

          -  Any ocular condition that, in the opinion of the Investigator, could affect study
             parameters including, but not limited to, active ocular infection, ocular
             inflammation, glaucoma, and/or diabetic retinopathy

          -  Unwilling to avoid wearing contact lenses for 7 days prior to and for duration of the
             study period

          -  Any blood donation or significant loss of blood within 56 days of Visit 1

          -  Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of
             acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.

          -  Use of any topical ophthalmic preparations (including tear substitutes) 72 hrs prior
             to screening assessments and through the entire study period

          -  Any significant illness that could interfere with study parameters

          -  History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal
             refractive surgery within 12 months prior to Visit 1, and/or any other ocular surgical
             procedure within 12 months prior to Visit 1; or any scheduled ocular surgical
             procedure during the study period.

          -  Known history of alcohol and/or drug abuse
Rituximab Plus Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: GM-CSF (Sargramostim); Rituximab
Intervention description: 250 mcg injection under the skin, three times a week for eight weeks.; 375 mg/m^2 administered intravenously once weekly for four weeks
Intervention MeSH terms: Rituximab; Molgramostim; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Chronic Lymphocytic Leukemia; Rituximab; Leukemia; Sargramostim; GM-CSF

Summary:

      The goal of this clinical research study is to learn if giving granulocyte-macrophage
      colony-stimulating factor (GM-CSF) together with rituximab can improve the ability of
      rituximab to shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). The safety of
      this combination treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Group 1. Diagnosis of previously treated B-CLL Rai III-IV or earlier stage disease
             with evidence of "active disease" as defined by the NCI-sponsored working group 1)
             weight loss of >10% in prior 6 months, 2) extreme fatigue, 3) fever or night sweats
             without evidence of infection, 4) worsening anemia or thrombocytopenia, 5) progressive
             lymphocytosis with a rapid lymphocyte doubling time, 6) marked hypogammaglobulinemia
             or paraproteinemia, 7) lymphadenopathy >5 cm in diameter.

          2. Group 2. Diagnosis of previously untreated B-CLL with Rai stage 0-II disease but high
             risk for progression based on B2-microglobulin >3.0 mg/mL, or with symptoms or
             significant fatigue.

          3. Group 3. Patients age 70 years of age and older with previously untreated B-CLL and
             Rai stage III-IV or earlier stage disease with indication for treatment who refused
             chemotherapy.

          4. Age 15 years or above.

          5. Adequate renal and hepatic functions (creatinine <2.5 mg/dL, bilirubin <2 mg/dL).
             Patients with renal or liver dysfunction due to organ infiltration by lymphocytes are
             eligible, as are patients with elevated bilirubin and history consistent with
             Gilbert's disease.

          6. Performance status <3 (Zubrod Scale).

          7. No active viral hepatitis

        Exclusion Criteria:

        1) None.
Phase II Iressa & Carbo/Gem in NSCLC
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Gefitinib; Gemcitabine; Carboplatin
Intervention description: oral tablet; intravenous injection; intravenous injection
Intervention MeSH terms: Carboplatin; Gemcitabine; Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small-Cell Lung Cancer; NSCLC; Lung Cancer

Summary:

      The primary objective is to demonstrate in chemotherapy naïve patients with advanced (Stage
      IIIB or IV) NSCLC and ECOG PS 2 non-inferiority in progression free survival (PFS) for ZD1839
      compared to gemcitabine/carboplatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced Non Small cell Lung Cell Lung cancer

          -  Never received chemotherapy

          -  Up and about 50% of waking hours

        Exclusion Criteria:

          -  Spread of lung cancer to the brain

          -  Low level of white blood cells

          -  Radiotherapy within 4 weeks

        Patients were entered to this study, initiated in 2004, before the significance of
        predictive factors such as smoking history, adenocarcinoma histology and mutation status
        was described.
Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: PF-04360365 0.1 mg/kg; PF-04360365 0.5 mg/kg; PF-04360365 1 mg/kg; Placebo; PF-04360365 3 mg/kg; PF-04360365 8.5 mg/kg
Intervention description: 0.1 mg/kg every 60 days (10 doses total); 0.5 mg/kg every 60 days (10 doses total); 1 mg/kg every 60 days (10 doses total); Placebo every 60 days (10 doses total); 3 mg/kg every 60 days (10 doses total); 8.5 mg/kg every 60 days (10 doses total)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 198.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Alzheimer's disease; antibody; amyloid

Summary:

      Purpose of the study is to determine whether multiple dose administration of PF-04360365 is
      safe and well tolerated in patient with mild to moderate Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females of non childbearing potential, age > or = 50

          -  Diagnosis of probable Alzheimer's disease, consistent with criterial from both:

               -  National Institute of Neurological and Communicable Disease and Stroke and
                  Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)

               -  Diagnostic and Statistical Manual of Mental Disorders (DSM IV)

          -  Mini-mental status exam score of 16-26 inclusive

          -  Rosen-Modified Hachinski Ischemia Score of < or = 4

        Exclusion Criteria:

          -  Diagnosis or history of other demential or neurodegenerative disorders

          -  Diagnosis or history of clinically significant cerebrovascular disease

          -  Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro
             hemorrhage, multiple white matter lacunes, extensive white matter abnormalities

          -  History of autoimmune disorders

          -  History of allergic or anaphylactic reactions
A Study of Galcanezumab (LY2951742) in Participants With Migraine Headache
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: Galcanezumab; Placebo
Intervention description: Administered SQ; Administered SQ
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 414.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate whether the study drug known as galcanezumab is
      safe and effective in the prevention of migraine headaches.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with a history of migraine of at least 1 year prior to enrollment.

          -  Migraine onset prior to age 50.

        Exclusion Criteria:

          -  Current enrollment in, or discontinuation within the last 30 days from, a clinical
             trial involving any investigational drug or device.

          -  Current use or any prior exposure to any CGRP antibody, any antibody to the CGRP
             receptor, or antibody to nerve growth factor (NGF).

          -  History of migraine subtypes including hemiplegic migraine, ophthalmoplegic migraine,
             and basilar-type migraine.

          -  Have a history or presence of other medical illness that indicates a medical problem
             that would preclude study participation.

          -  Failure to respond to more than two adequately dosed effective migraine prevention
             treatments.

          -  Evidence of significant active psychiatric disease, in the opinion of the
             investigator.

          -  Women who are pregnant or nursing.