bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of BAF312 in Dermatomyositis
Condition: Active Dermatomyositis
MeSH terms: Dermatomyositis
Intervention: BAF312; Placebo
Intervention description: BAF312 was provided as film-coated tablets in strengths of 0.25, 0,5, 1 and 2 mg for oral administration.; Matching placebo to BAF312 as tablets for oral administration.
Intervention MeSH terms: Siponimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Dermatomyositis

Summary:

      This study investigated the dose response relationship for the efficacy and safety of BAF312
      compared to placebo in active DM patients over a treatment period of 6+6 months and to
      determine the minimum dose required for a maximal clinical effect. The study was composed of
      2 periods: a double-blind period 1 with BAF312 administered at different daily doses (0.5, 2,
      10 mg and placebo) and a fixed-dose Period 2 in which BAF312 was administered at the dose of
      2 mg daily .
    

Eligibility criteria:

        Key Inclusion Criteria:

        Written informed consent must be obtained before any assessment is performed.

          -  Patients who have been defined as "definite" or "probable" based on the criteria of
             Bohan and Peter (Bohan and Peter 1975) for dermatomyositis at least 3 months before
             screening

          -  Patients must have active disease as defined by muscle weakness

          -  Patients may be on a stable dose of corticosteroid (up/equal to 20 mg once daily
             prednisone equivalent)

          -  Patients currently treated with oral or subcutaneous MTX must have been a stable dose
             of no more/equal to than 25 mg per week

          -  Patients currently treated with Azathioprine must have been a stable maintenance dose
             of no more/equal to 3 mg/kg/day

          -  Negative cancer screening conducted in the 12 months prior to screening visit

        Key Exclusion Criteria

          -  Dermatomyositis patients having overlap myositis or any other type of myositis
             including paraneoplastic myositis, drug-induced myopathy, necrotizing myositis

          -  Preexisting severe cardiac or pulmonary conditions, malignancy of any organ system or
             significant eye diseases.

          -  Uncontrolled diabetes mellitus or diabetes complicated with organ involvement.

          -  Pregnant or nursing (lactating) women
Asimadoline for the Treatment of Post-Operative Ileus
Condition: Post-Operative Ileus
MeSH terms: Ileus
Intervention: Asimadoline; Placebo
Intervention description: Asimadoline was provided in coated tablets of 1.0 mg strength. Subjects were given 3 tablets of study drug 90 minutes prior to their operation and then 3 tablets b.i.d. for up to 10 post-operative doses. Subjects randomized to receive 3.0 mg of asimadoline received three 1.0 mg asimadoline tablets at each scheduled dose, while those randomized to receive 1.0 mg of asimadoline received two placebo tablets and one 1.0 mg asimadoline tablet at each scheduled dose.; Placebo was provided in coated tablets identical in appearance to asimadoline tablets. Subjects were given 3 tablets of placebo 90 minutes prior to their operation and then 3 placebo tablets b.i.d. for up to 10 post-operative doses.
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: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of asimadoline in patients
      who have undergone a laparoscopic segmental colectomy and determine whether it reduces the
      time to recovery of bowel function compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females aged 18-80

          -  Must be scheduled to undergo a laparoscopic/hand-assisted laparoscopic segmental
             colectomy

          -  Must sign an ICF

          -  Females of childbearing potential must have a negative pregnancy test at screening

        Exclusion Criteria:

          -  Subjects with evidence of a biochemical or structural abnormality of the GI tract or
             other co-morbid illness that may impact the ability to interpret the safety and
             efficacy data

          -  Pregnant or breastfeeding females

          -  Use of investigational drugs in previous 30 days

          -  Refusal to discontinue prohibited concomitant medications

          -  Chronic use of prescription narcotics over the previous 6 months
Intranasal Insulin for Weight Management During Smoking Cessation
Condition: Tobacco Abstinence Syndrome
Intervention: Intranasal Insulin; Placebo
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This FDA-approved (IND# 120700) study will evaluate efficacy of intranasal insulin in
      reducing snack intake and reducing postprandial free fatty acid levels in abstinent smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  smokers (>10 cig/day) for the past 1 year

          -  normosmic olfactory function

        Exclusion Criteria:

          -  previous/current use of insulin

          -  current Diagnostic and Statistical Manual-IV-Revised (DSM-IV-R) Axis I disorder

          -  current pregnancy (or lactation)

          -  lifetime history of endocrine disease

          -  excessive alcohol use (>25 standard units of alcohol/week)

          -  current use of illicit drugs

          -  current use of a smoking cessation aid (NRT, Chantix or Wellbutrin), or a psychotropic
             agent

          -  local infections, inflammation, structural abnormalities, or other nasal pathology

          -  current use of any medications administered intranasally, including intranasal
             steroids
Effect of Simethicone on Eustachian Tube Dysfunction
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Intervention: Simethicone; Placebo
Intervention description: single 125 mg chewable tablet; chewable calcium tablet
Intervention MeSH terms: Simethicone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Eustachian tube; otitis; middle-ear pressure; simethicone

Summary:

      This study is designed to measure the effects of a chewable Simethicone tablet taken by mouth
      on middle-ear pressure in adults with a common cold and evidence of abnormal middle-ear
      pressure. In children and adults, middle-ear diseases such as otitis media (the buildup of
      fluid within the middle ear) and a form of temporary hearing loss occur if the Eustachian
      tube does not open, does not open often enough or is always open. Simethicone, available
      over-the-counter under several brand names including Gas-X, may help break up the bubbles
      that may block the opening of the Eustachian tube in the back of the nose during a cold,
      allowing air to pass between the nose and middle ear. This study requires a single visit to
      the Middle Ear Physiology Laboratory in the Oakland section of Pittsburgh. If eligible for
      the study, Eustachian tube function testing will be done; the Simethicone tablet or placebo
      (a tablet that looks and tastes like the Simethicone tablet but has no active ingredient)
      will be given and Eustachian tube function testing repeated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 50 years

          -  Healthy subjects other than current upper respiratory tract infection ("cold")

          -  Jackson Score of 6 on screening

          -  Subject reports symptom onset within 4 days of entry visit

          -  Unilateral or bilateral middle-ear pressure <-50 mmH2O

        Exclusion Criteria:

          -  Otoscopic diagnosis of unilateral or bilateral otitis media

          -  Presence of tympanostomy tubes or tympanic membrane perforations bilaterally

          -  Asthma or any chronic medical disease or condition

          -  Use of an "over the counter" medicine within 24 hours of study or prescription within
             4 weeks of the study day (except birth control)

          -  Use of an experimental drug within 3 months of study

          -  An unusual or allergic reaction to simethicone, food dyes, or preservatives

          -  Pregnancy or breast feeding

          -  Ear surgery other than tympanostomy tube insertion
Ziprasidone in the Psychosis Prodrome
Condition: Psychosis Prodrome
MeSH terms: Psychotic Disorders; Mental Disorders
Intervention: ziprasidone; placebo
Intervention description: 20-160 mg/d; placebo
Intervention MeSH terms: Ziprasidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 16 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: psychosis; schizophrenia; prodrome; ziprasidone; placebo

Summary:

      This study aims to determine whether ziprasidone is superior to placebo over 24 weeks for
      patients with the psychosis prodrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Structured Interview for Psychosis-risk Syndromes criteria for Clinical High Risk for
             Psychosis

          -  clinically referred

        Exclusion Criteria:

          -  prolonged corrected QT interval

          -  history of syncope
Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
Condition: Rectal Carcinoma
MeSH terms: Carcinoma; Rectal Neoplasms
Intervention: 5FU; Radiation; Surgery of resectable lesions; Irinotecan
Intervention MeSH terms: Fluorouracil; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rectal; rectum; cancer; carcinoma

Summary:

      Determine if genotype-directed neoadjuvant chemoradiation, using information from the
      thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging
      in high risk patients compared to historical controls.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven adenocarcinoma of the rectum

          -  Lesion evaluated by surgeon and found to be resectable

          -  Stage T3 or T4 disease on radiography or ultrasound

          -  Karnofsky Performance Status at >60

          -  Laboratory criteria:

               -  Absolute neutrophil count >= 1.5 K

               -  Platelets >= 100 K

               -  Total Bilirubin <= 2.0;

               -  SGOT and Alkaline Phosphatase <= 2 x upper limit of normal

               -  Creatinine < 2.0

          -  Informed consent signed

          -  Patients with distant metastatic disease will be eligible if they satisfy all other
             conditions.

        Exclusion Criteria:

          -  Pregnant women, children < 18 years, or patients unable to give informed consent

          -  Patients with a past history of pelvic radiotherapy.

          -  Patients with prior malignancy in the past 5 years except: skin cancer or in-situ
             cervical cancer. However, patients with synchronous adenocarcinomas are eligible
             provided either (a) the synchronous adenocarcinoma was in a removed pedunculated polyp
             and did not invade the stalk or (b) the synchronous adenocarcinoma was in a removed
             polyp that lay within the surgical field (extent of resection would not be changed) or
             (c) the synchronous adenocarcinoma is smaller than the index rectal cancer and lies
             completely within the radiation field (clinically favorable second lesion and the
             extend of radiation and surgery would not be changed).

          -  Patients with known allergy to 5-fluorouracil or irinotecan
Sildenafil for Swimming-Induced Pulmonary Edema (SIPE) Prevention
Condition: Edema, Pulmonary; Immersion; Diving
MeSH terms: Pulmonary Edema; Edema
Intervention: Sildenafil Citrate; Placebo Oral Tablet
Intervention description: Oral sildenafil, 50 mg; Placebo
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double blind, randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Placebo controlled
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This trial is testing the effectiveness of a single oral dose of sildenafil (50 mg) taken 1
      hour before a provocative event on the subsequent development of swimming-induced pulmonary
      edema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteers between 18 and 45 years

          -  History of swimming-induced pulmonary edema

        Exclusion Criteria:

          -  Pregnant women

          -  Significant heart valve disease

          -  Cardiomyopathy

          -  Uncontrolled hypertension

          -  Coronary artery disease

          -  Obstructive lung disease

          -  VO2max <25 mL/kg as estimated by the University of Houston Non-Exercise Test

          -  Previous adverse reaction to sildenafil

          -  Use of antihypertensives or other drugs that are known to interact adversely with
             sildenafil (e.g. nitrates, alpha adrenergic blockers)
Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: rituximab
Intervention description: treatment with rituximab
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: active disease despite concomitant methotrexate

Summary:

      Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers
      will assess changes in the immune response that occur as a result of treatment with
      rituximab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active rheumatoid arthritis

          -  Use of concomitant methotrexate

        Exclusion Criteria:

          -  Use of disease-modifying anti-rheumatic drugs (DMARDs)/biologics other than
             methotrexate

          -  Serious medical conditions that would preclude the use of the treating agent
A Follow-up Assessment of Resistance to ABT-333 in Hepatitis C Virus (HCV)-Infected Subjects Who Have Received ABT-333 in ABT-333 Studies
Condition: HCV Infection
MeSH terms: Hepatitis C
Intervention: Blood sample collection only; ABT-333
Intervention description: Approximately monthly collection of blood samples.; Previous treatment in prior ABT-333 studies.
Phase: Phase 2
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HCV Infection

Summary:

      The purpose of this follow-up study is to evaluate the frequency and persistence of specific
      viral mutations in response to treatment with ABT-333 (dasabuvir).
    

Eligibility criteria:

        Inclusion Criteria:

        - Main Selection Criteria: Subject received ABT-333 or matching placebo in a prior clinical
        study involving ABT-333.

        Exclusion Criteria:

        - The investigator considers the subject unsuitable for the study for any reasons inclusive
        of, but not limited to, failure to comply with study procedures in prior ABT-333 clinical
        study.
Nepafenac 0.3% Two Study
Condition: Cataract
MeSH terms: Cataract
Intervention: Nepafenac Ophthalmic Suspension, 0.3%; Nepafenac Ophthalmic Suspension, 0.1%; Nepafenac Vehicle 0.3%
Intervention description: Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.; Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.; Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.
Intervention MeSH terms: Nepafenac
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1342.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cataract; inflammation; pain; inflammatory cells; aqueous flare

Summary:

      The purpose of this study was to assess the safety and efficacy of Nepafenac Ophthalmic
      Suspension, 0.3% for the prevention and treatment of inflammation (swelling and redness) and
      pain in the eye after cataract extraction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Planned cataract extraction by phacoemulsification with the implantation of a
             posterior chamber intraocular lens;

          -  Patients who, in the opinion of the Investigator, would have improvement in
             best-corrected visual acuity after surgery;

          -  Able to understand and sign an informed consent;

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Use of topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within
             7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100
             mg) prior to surgery and through study exit;

          -  Use of topical ocular, inhaled or systemic steroids within 14 days prior to surgery
             and through study exit;

          -  History of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis,
             uveitis, iridocyclitis, rubeosis iridis) in the operative eye;

          -  Diabetic retinopathy in the operative eye;

          -  Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory
             drugs (NSAIDs), or to any component of the test article;

          -  Other protocol-defined exclusion criteria may apply.
Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: K-877-ER (Dose A); K-877-ER (Dose B); K-877-IR
Intervention description: Dose A Oral Administration; Dose B Oral Administration; K-877-IR Oral Administration
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to evaluate the efficacy of K-877 extended release (ER) once daily (QD) compared to
      K-877 immediate release (IR) twice daily (BID).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide written informed consent before any study-specific evaluation is
             performed

          -  At screening, have a mean fasting TG level of ≥180 mg/dL and <550 mg/dL; at subsequent
             Qualification Period visits confirm fasting TG level of ≥200 mg/dL and <500 mg/dL

          -  Able to meet all inclusion criteria outlined in clinical study protocol

        Exclusion Criteria:

          -  Require lipid-altering treatments other than study drugs, statins, ezetimibe, or PCSK9
             inhibitors during the study

          -  Known hypersensitivity or intolerance to fibrates or peroxisome proliferator-activated
             receptor alpha agonists

          -  Meet any other exclusion criteria outlined in clinical study protocol
A Comparison of Dendritic Cell Content and T-Cell Phenotype Between Granulocyte Colony-Stimulating Factor (G-CSF) or G-CSF + Granulocyte Macrophage (GM)-CSF
Condition: Hematologic Diseases
MeSH terms: Hematologic Diseases
Intervention: G-CSF; GM-CSF
Intervention description: G-CSF, solution given subcutaneously twice per day, total dosage varies by weight.; GM-CSF, solution given subcutaneously twice per day, total dosage varies by weight.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hematologic Diseases

Summary:

      This is a study involving patients who are undergoing allogeneic peripheral blood stem cell
      transplantation. Both donors and recipients are being sought for this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All normal donors for patients undergoing allogeneic peripheral blood stem cell (PBSC)
             for hematologic diseases will be invited to participate in this research trial.

          -  All patients must meet criteria for transplantation.

          -  Final eligibility will be determined by the health professionals conducting this
             clinical trial.

        Exclusion Criteria:

          -  Donors for patients undergoing selected or manipulated PBSC grafts are not eligible.

          -  Donors who are pregnant or lactating females and donors with a known hypersensitivity
             to either G-CSF or GM-CSF will be excluded from this study.

          -  Final eligibility will be determined by the health professionals conducting this
             clinical trial.