bioihbjkbjnl/mcl2 huggingface dataset:
A Dose Finding Study Of PF-00489791 In Patients With Mild To Moderate High Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Intervention: placebo; PF-00489791; PF-00489791; PF-00489791
Intervention description: placebo, oral, tablets, once daily, for 28 days; PF-00489791 20 mg titrated to 40 mg, oral, tablets, once daily, for 28 days; PF-00489791 4 mg, oral, tablets, once daily, for 28 days; PF-00489791 10 mg, oral, tablets, once daily, for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Clinical Trial; Randomized Controlled Trial; Humans; Cyclic Nucleotide Phosphodiesterases Type 5

Summary:

      The purpose of this study is to evaluate the safety and blood pressure lowering effect of
      different doses of PF-00489791 in patients with mild to moderate high blood pressure
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and/or Females of non-childbearing potential between 18 and 70 years of age

          2. History of mild to moderate hypertension

        Exclusion Criteria:

          1. Type 1 or 2 diabetes on prescribed medications

          2. Secondary, severe, or malignant hypertension

          3. History of a significant cardiovascular event within the last 12 months of enrollment
Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving
Condition: Smoking; Smoking Cessation
Intervention: Nicotine lower dose; Nicotine higher dose; Placebo
Intervention description: lower dose nicotine lozenge; higher dose nicotine lozenge; placebo
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nicotine; Nicotine craving

Summary:

      This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a
      cigarette compared to a matched placebo (a placebo is like sugar pill and contains no
      active).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy smokers who smoke more than 5 cigarettes per day

          -  Body mass index (BMI) within the range 19-35 kilogram (kg)/meter (m)^2

          -  Females of childbearing potential who are, in the opinion of the investigator,
             practicing a reliable method of contraception.

        Exclusion Criteria:

          -  Women who are pregnant or who have a positive urine pregnancy test.

          -  Participants with known or suspected intolerance or hypersensitivity to the study
             materials (or closely related compounds) or any of their stated ingredients.

          -  Clinical Study/Experimental Medication: Participation in another clinical study or
             receipt of an investigational drug within 30 days of the screening visit.

          -  Prior Concomitant Medication: Treatment with enzyme altering agents (e.g.
             carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the craving
             provocation visit; Use of any prescription psychoactive medication (such as but not
             limited to antidepressants, antipsychotics, anxiolytics) within 14 days of the craving
             provocation visit; Participant has used an over-the-counter (OTC) medication such as
             antihistamines, sedating agents, or any compound that would have a sedating effect
             within 24 hours of the craving provocation visit; Current use of any nicotine
             replacement therapy.

          -  Substance abuse: Recent history or current history (within the last 1 year) of alcohol
             or other substance abuse.
Pilot Study to Examine the Post-Dose Changes in Exhaled Nitric Oxide (eNO) Following Treatment With Fluticasone Propionate (FP)/Salmeterol (SAL) Combination Product Advair
Condition: Asthma
Intervention: fluticasone propionate/salmeterol (Flu/Sal) : 100mcg/50mcg, 250mcg/50mcg,500mcg/50 mcg
Intervention description: fluticasone propionate/salmeterol diskus
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To examine the post-dose changes in exhaled Nitric Oxide (eNO) following treatment with
      inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for
      Asthma (GINA) guidelines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  must be able to speak, read, and understand English

          -  exhaled Nitrous Oxide levels must be greater than or equal to 60 ppb at screening and
             greater than or equal to 55 ppb at Visits 2, 9, and 16

          -  must have history of at least 6 months of chronic, but stable asthma

          -  except for the presence of asthma, subjects must be in general good health

        Exclusion Criteria:

          -  past or present history of experiencing allergic reaction to medications used in this
             study

          -  subjects must not be receiving ongoing regular treatment with inhaled corticosteroids

          -  subjects must not have ragweed allergy

          -  subjects must have no recent history of respiratory infections for at least 1 month
             prior to screening and until the end of the study
Intravenous Immunoglobulin (IVIG) in Lung Transplantation
Condition: Hypogammaglobulinemia; Lung Transplantation
MeSH terms: Agammaglobulinemia
Intervention: IVIG; Placebo
Intervention description: 10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks; 0.1% Albumin in an equal volume to the investigational product
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hypogammaglobulinemia; Lung Transplantation

Summary:

      The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent
      bacterial infections in lung transplant patients with low serum levels of immunoglobulin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Lung transplant recipients > 3 months after transplant surgery

          -  Immunoglobulin G (IgG) < 500 mg/dL

          -  Stable medical regimen

        Exclusion Criteria:

          -  Acute rejection

          -  Active infection

          -  Contraindication to IVIG

          -  Pregnancy

          -  Recent thrombotic event
Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: fesoterodine fumarate; Placebo; fesoterodine fumarate
Intervention description: 8mg tablets OD for 12 weeks; Corresponding placebo tablets OD for 12 weeks; 4mg tablets OD for 12 weeks
Intervention MeSH terms: Fesoterodine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 951.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive
      bladder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day
             and urgency urinary incontinence >= 1 per day.

        Exclusion Criteria:

          -  Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or
             to peanut or soya or any of the excipients.

          -  Patient has a known neurological disease influencing bladder function.

          -  Patient has a complication of lower urinary tract pathology potentially responsible
             for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic
             organ prolapse.
A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Albuterol Spiromax®; ProAir® HFA; Placebo Inhaler
Intervention description: Albuterol Spiromax® delivers 90 mcg albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.; ProAir® HFA delivers 90 mcg of albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.; Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.
Intervention MeSH terms: Albuterol; Procaterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to
      help adult and adolescent subjects 12 years of age and older with persistent asthma to
      improve lung function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must provide written informed consent,

          -  Be between 12 years of age and older,

          -  Male or Female, females of non-child bearing potential or using reliable contraception

          -  Asthma for at least 6 months, FEV1 (forced expiratory volume in 1 second) between
             50-80% of predicted value, and reversibility greater than or equal to 15% following
             180 mcg albuterol

          -  Stable low dose of Inhaled Corticosteroids

          -  Non-smoker, 12 months smoking-free and <=10-pack years history

          -  Otherwise healthy

          -  Other criteria apply

        Exclusion Criteria:

          -  Pregnant

          -  Allergic to albuterol or severe milk protein allergy

          -  Must not be on another trial for 30days.

          -  Other criteria apply
A Study of Avastin (Bevacizumab) in Combination With Carboplatin-Based Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer.
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: bevacizumab [Avastin]; bevacizumab [Avastin]; Carboplatin-based chemotherapy
Intervention description: 7.5mg/kg iv on day 1 of each 3 week cycle; 15mg/kg iv on day 1 of each 3 week cycle; As prescribed
Intervention MeSH terms: Bevacizumab; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 303.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will explore the correlation of biomarkers with response rate, and the overall
      efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in
      patients with advanced or recurrent non-squamous non-small cell lung cancer. Patients will be
      randomized to one of 2 groups, to receive either Avastin 7.5mg/kg iv on day 1 of each 3 week
      cycle, or Avastin 15mg/kg iv on day 1 of each 3 week cycle; all patients will also receive
      treatment with carboplatin and either gemcitabine or paclitaxel for a maximum of 6 cycles.
      The anticipated time on study treatment is until disease progression, and the target sample
      size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  locally advanced metastatic or recurrent non-squamous non-small cell lung cancer
             (NSCLC);

          -  >=1 measurable tumor lesion;

          -  ECOG performance status 0-1.

        Exclusion Criteria:

          -  prior chemotherapy or treatment with another systemic anti-cancer agent;

          -  evidence of CNS metastases;

          -  history of grade 2 or higher hemoptysis;

          -  evidence of tumor invading or abutting major blood vessels;

          -  malignancies other than NSCLC within 5 years prior to randomization, other than
             adequately treated cancer in situ of cervix, basal or squamous cell skin cancer,
             localized prostate cancer or DCIS;

          -  clinically significant cardiovascular disease;

          -  current or recent use of aspirin (>325mg/day) or full dose anticoagulants or
             thrombolytic agents for therapeutic purposes.
Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant
Condition: Lymphoma, Large-Cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Intervention: Ofatumumab
Intervention description: 8 weekly intra-venous (i.v.) infusions, 1 x 300mg and 7 x 1000mg
Intervention MeSH terms: Ofatumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to determine the effect of ofatumumab in patients with Diffused
      Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous
      transplant
    

Eligibility criteria:

        Inclusion Criteria:

        Patients with DLBCL

          -  and relapse after complete remission or disease progression after partial remission
             who are ineligible for autologous stem cell transplantation

          -  and relapse after complete remission or disease progression after partial remission
             following autologous stem cell transplantation.
An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease; Inflammatory Bowel Disease
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
Intervention: AIN457
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
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Crohn's Disease; Crohns; Bowel disease; digestive disorders; auto immune; diarrhea; Inflammatory Bowel Disease (IBD); gastrointestinal diseases; digestive system diseases; Antibody; IL 17; anti IL-17; monoclonal antibody; Crohn's Disease (Chron's, CD)

Summary:

      This study will assess the safety and tolerability of AIN457 in patients with moderate to
      severe Crohn's disease who already participated and completed the core trial CAIN457A2202.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who participate and complete the core CAIN457A2202 study up to and including
             Visit 11 (end of study), may enter the extension study upon signing informed consent.

        Exclusion Criteria:

          -  Patients for whom continued treatment with AIN457 is not considered appropriate by the
             treating physician.

          -  Patients who were non-compliant or who demonstrated a major protocol violation in the
             core CAIN457A2202 study

          -  Patients who discontinued from the core CAIN457A2202 study before Visit 8 (day 43).

        Other protocol-defined inclusion/exclusion criteria may apply
An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Fingolimod
Intervention description: Fingolimod was supplied in capsules.
Intervention MeSH terms: Fingolimod Hydrochloride
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: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: FTY720; multiple sclerosis; MS

Summary:

      This study was an extension study of NCT00537082. This study was designed to evaluate the
      efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720)
      to relapsing multiple sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who completed 6 months of treatment with the study drug and the Month 6 visit
             in the core study NCT00537082.

          -  Females of childbearing potential who have a negative pregnancy test in the core study
             NCT00537082.

        Exclusion Criteria:

          -  Patients who permanently discontinued study drug treatment prior to the Month 6 visit
             in the core study NCT00537082.

        Other protocol-defined inclusion/exclusion criteria applied to the study.
Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)
Condition: Primary Mitochondrial Disease
MeSH terms: Mitochondrial Myopathies; Mitochondrial Diseases
Intervention: elamipretide
Intervention description: 40 mg, subcutaneous injections (in the abdomen) daily for the shortest of the following: 260 weeks; regulatory approval and commercial availability of elamipretide in the subject's respective country; or termination of the clinical development for elamipretide in subjects with PMD.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Primary Mitochondrial Disease; Stealth; elamipretide

Summary:

      This is a Phase 2 Open-Label extension study to evaluate the long term safety and
      tolerability of daily elamipretide injections in patients with genetically confirmed Primary
      Mitochondrial Disease who previously participated in the SPIMM-202 Clinical Trial
    

Eligibility criteria:

        Inclusion Criteria:

          -  Investigator determines the subject can, and subject agrees to, adhere to the trial
             requirements for the length of the trial including self-administration (by subject or
             trained caregiver) of the study drug

          -  Subject completed the End-of-Study Visit in SPIMM-202

        Exclusion Criteria:

          -  Subject has any prior or current medical condition that, in the judgment of the
             Investigator, would prevent the subject from safely participating in and/or completing
             all trial requirements

          -  Subject has received any investigational compound (excluding elamipretide) and/or has
             participated in another interventional clinical trial within 30 days prior to the
             SPIMM-203 Baseline Visit (excluding SPIMM-202) or is concurrently enrolled in any
             non-interventional research of any type judged to be scientifically or medically
             incompatible with the trial as deemed by the Investigator in consultation with the
             Sponsor

          -  Subject experienced an adverse reaction attributed to study drug resulting in
             permanent discontinuation of study drug in the SPIMM-202 trial.

          -  Female subjects who are pregnant, planning to become pregnant, or lactating

          -  Subject has undergone an in-patient hospitalization within the 1 month prior to the
             SPIMM-203 Baseline Visit
Inhaled Mometasone to Reduce Painful Episodes in Patients With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: Mometasone Furoate; Placebo
Intervention description: inhaled cortico-steroid (ICS) with a dosage of 220mcg once daily for 16 weeks; placebo training inhaler with the same instructions as the experimental group.
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Sickle Cell Disease; Pain Crisis; Painful Crisis; Sickle Pain

Summary:

      The proposed research is designed to test the global hypothesis that inhaled corticosteroids
      (ICS), a therapy developed to treat asthma, will prevent vasoocclusive painful episodes in
      adults with Sickle Cell Disease (SCD) who wheeze, but do not meet criteria for a diagnosis of
      asthma. The specific aims of this proposal are 1) Conduct a feasibility study - a randomized
      controlled trial of ICS for adults with SCD who do not meet criteria for a diagnosis of
      asthma but report recurrent cough or wheezing, 2) Measure the effects of ICS on biological
      correlates of pulmonary inflammation (as determined by exhaled nitric oxide) and vascular
      injury (as determined by sVCAM) in SCD, and 3) Compare properties of traditional and Bayesian
      adaptive clinical trial design for therapeutic trials in SCD in preparation for designing a
      definitive trial of ICS. These aims have the potential to 1) change the standard of care for
      individuals with SCD and recurrent cough or wheeze, 2) provide insight into the pathogenesis
      of non-asthmatic wheezing in SCD and its response to treatment, 3) explore the suitability of
      innovative clinical trial designs to overcome the challenges that have hindered therapeutic
      innovation for SCD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 15 or older

          -  Sever SCD phenotypes (Hb SS and Sβthalassemia0)

          -  A positive response to cough/wheeze questions

        Exclusion Criteria:

          -  Patient carries a physician diagnosis of asthma

          -  Patient is prescribed asthma medications

          -  Patient is currently having a painful crisis (as defined by validated pain diary
             questions)

          -  Patient has acute respiratory symptoms

          -  Known hypersensitivity to milk proteins

          -  Meets criteria for our operational diagnosis of asthma

          -  More than 15 ED visits for pain over the preceding 12 months

          -  Admitted or discharged from the hospital for SCD pain within the last 7 days