bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 Study of Montelukast for the Treatment of Sickle Cell Anemia
Condition: Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)
MeSH terms: Anemia; Thalassemia; Anemia, Sickle Cell
Intervention: Montelukast added to Hydroxyurea; Placebo added to Hydroxyurea
Intervention MeSH terms: Hydroxyurea; Montelukast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      In this feasibility trial, the investigators will compare participants treated with
      montelukast and hydroxyurea to those treated with placebo and hydroxyurea for a total of 8
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1)Diagnosis of HbSS, or HbSβ-thalassemia0, confirmed by hemoglobin analysis

          -  2)Males and females age 16 years to 70 years old

          -  3)Greater than 2 episodes of pain in the last 12 months

          -  4)On a stable dose of hydroxyurea for at least 2 months and a stable hemoglobin

        Exclusion Criteria:

          1. Judged not likely to be study compliant by his/her hematologist

          2. History of adverse reaction to montelukast or any of the components of montelukast

          3. Have used medications known to interact with montelukast such as rifampin,
             phenobarbital, and gemfibrozil within 4 weeks of enrollment

          4. Currently being treated with a leukotriene antagonist (montelukast or zileuton) or
             have used montelukast/zileuton within the last 60 days

          5. Chronic blood transfusion therapy defined as regularly scheduled transfusions.

          6. Hemoglobin A greater than15% on hemoglobin analysis

          7. Individuals with a current physician diagnosis of asthma (within last 12 months) or
             requires continuous supplemental oxygen, or predicted or current use of asthma
             medications (inhaled corticosteroids, but participants taking bronchodilators will be
             allowed to participate).

          8. Current participation in another therapeutic trial for SCD

          9. Known current pregnancy

         10. Known history of HIV

         11. Serum creatinine greater than 3 times the site's upper limit of normal
Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: BI 695501 Autoinjector; BI 695501 Prefilled syringe
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is an open-label, phase II study of BI 695501 to assess handling experience of patients
      with Rheumatoid Arthritis using an autoinjector. The extension phase is to provide patients
      with additional exposure to BI 695501 and to enhance the safety database for this compound.
    

Eligibility criteria:

        Inclusion criteria:

          -  Moderately to severely active Rheumatoid arthritis (RA) for at least 6 months, which
             is not adequately controlled by non-biologics DMARDs.

          -  No contraindications to anti-Tumor necrosis factor (TNF) agents.

          -  Either biologics naive or biologics-experienced but with no experience of
             self-administration medication using autoinjector or pen.

          -  Patients must be able and willing to self-inject BI 695501. Further inclusion criteria
             apply.

        Exclusion criteria:

          -  Experience with self-administration of medication using an autoinjector or pen.

          -  American College of Rheumatology functional Class IV or wheelchair/ bed bound.

          -  Primary or secondary immunodeficiency.

          -  History of tuberculosis (TB). Further exclusion criteria apply.
Synera Venipuncture Pain
Condition: Pain; Phlebotomy; Palliative Care
Intervention: Synera (lidocaine 70mg/tetracaine 70mg)
Intervention description: All subjects will receive 2 patch applications during this study: one Synera, one placebo. The 2 patch applications must be done on separate days. Only 1 patch will be used per application. Arm 1 subjects will receive Synera patch for the 1st application, and placebo for the second. Arm 2 patients will receive placebo patch for the 1st application, and Synera patch for the second.
Intervention MeSH terms: Lidocaine; Tetracaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain control; Needle stick pain; Venipuncture pain

Summary:

      Synera, which is a heated topical patch containing both lidocaine and tetracaine, is intended
      to reduce the pain associated with venipuncture and superficial dermatologic procedures by
      numbing the skin. This study will test the effectiveness of the Synera lidocaine/tetracaine
      patch when administered for 30 ± 5 minutes to provide dermal anesthesia in adult oncology
      patients undergoing venipuncture as part of their care, for treatment or diagnostics
      (laboratory or imaging). Compared to the use of the placebo patch, this study hypothesizes
      that the difference of 1 cm on the 0-10 visual analogue scale (VAS) will be observed 30
      minutes after the use of the Synera patch. Pain intensity will be assessed by a 0-10 VAS
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with any tumor type where treatment is received through venipuncture or any
             procedure that is needle based or who require regular pharmacokinetic (PK) study.

          -  Is 18 years of age or older.

          -  Patients expected to undergo the first venipuncture procedure within 5 working days of
             enrollment.

          -  Male or female patients

          -  Has signed the most recent Patient Informed Consent Form

          -  Has signed a Patient Authorization Form (HIPPA)

        Exclusion Criteria:

          -  Patients with sensitivity to lidocaine, tetracaine, or any other component of the
             product

          -  Known sensitivity to any components of test materials (sulphites and adhesives)

          -  Patients with damaged or broken skin at the designated patch site

          -  Pregnant or breastfeeding women patients

          -  Use of any immediate-release single-agent opioid product (ie, morphine, oxycodone,
             hydrocodone, hydromorphone, oxymorphone, or tramadol) or combination products
             containing acetaminophen or ibuprofen with one of these agents within 4 hours of the
             patient's visit

          -  Previous irradiation to the site of the patch
Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: fludarabine; rituximab; VELCADE
Intervention description: fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle; rituximab 375mg/m2 on Day 1 of every 35-day cycle; 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 of every 35-day cycle
Intervention MeSH terms: Rituximab; Fludarabine; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, open-label, active-control, multicenter Phase 2 study of
      VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed
      advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the
      2 treatment arms (55 subjects per arm).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects 18 years or older

          -  Histologically proven diagnosis of follicular non-Hodgkin's lymphoma grades 1or 2
             according to the World Health Organization classification

          -  Subjects must have received at least 12 doses (375mg/m2 or appropriately adjusted
             dose) of rituximab for the treatment of this lymphoma as single agent rituximab or in
             rituximab-containing regimens as documented in the subject's medical record

          -  Documented relapse or progression following last antineoplastic treatment

          -  At least 1 measurable tumor mass (≥1.5 cm x ≥1.0 cm)

        Exclusion Criteria:

          -  Subjects with histological or clinical transformation to an aggressive lymphoma

               -  prior treatment with VELCADE or fludarabine.

               -  antineoplastic (including unconjugated therapeutic antibodies), experimental, or
                  radiation therapy within 3 weeks before randomization

               -  nitrosoureas within 6 weeks before randomization

               -  radioimmunoconjugates or toxin immunoconjugates within 10 weeks before
                  randomization

               -  major surgery within 3 weeks before randomization

               -  chronic use of corticosteroids, such as dexamethasone
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease
Condition: Stable Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Intervention: MEDI5884; Placebo
Intervention description: Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.; Participants will receive SC dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 133.0
Sex: All
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Coronary heart disease; Pharmacokinetic; Pharmacodynamics

Summary:

      A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in
      Adults With Stable Coronary Heart Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of stable coronary heart disease prior to screening

          -  Currently receiving high intensity statin(s)

        Exclusion Criteria:

          -  Unstable cardiovascular conditions

          -  Any planned arterial revascularizations

          -  Fasting Laboratory values at screening: Triglycerides > 500 mg/dl, Low Density
             Lipoprotein-Cholesterol > 100 mg/dL

          -  Any disease or condition or laboratory value that would place the participant at an
             unacceptable risk.
A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Intervention: OP0201; Placebo; Amoxicillin-clavulanate
Intervention description: OP0201 20mg per day in two divided doses for 10 days; Placebo 0mg per day in two divided doses for 10 days; Oral Amoxicillin-clavulanate in two divided doses for 10 days
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 103.0
Sex: All
Minimum age: 6 Months
Maximum age: 24 Months
Healthy volunteers: No

Summary:

      The purpose of this study is to develop a better understanding of the safety, tolerability
      and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the
      treatment of Acute Otitis Media (AOM) in infants and children.
    

Eligibility criteria:

        Inclusion Criteria includes but is not limited to:

          1. Male and female infants and children aged ≥6 months to ≤24 months

          2. Diagnosis of Acute Otitis Media (AOM) - moderate to severe bulging of the TM or mild
             bulging of TM and recent [less than 48 hours] onset of ear pain or intense erythema of
             the TM

          3. Score of 5 or more on the 5 question version of AOM-SOS scale1

          4. Written informed consent by the child's legal guardian and their willingness to ensure
             that study instructions are followed, all study-related visits are attended, that
             treatment administration is given, and Parent/Caregiver assessments are recorded
             according to the study protocol.

          5. Intact tympanic membrane (TM) in both ears (e.g., no perforation)

        Exclusion Criteria includes but is not limited to:

          1. Allergy to penicillin or cephalosporin

          2. History or presence of immunodeficiency disorders

          3. Antimicrobial therapy within the 3 days (i.e., 72 hours) prior to Day 1

          4. Craniofacial abnormalities (e.g., cleft palate or Down's Syndrome) that may interfere
             with Eustachian tube function

          5. Disorders with decreased mucociliary clearance or higher viscosity of the mucous
             (e.g., cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)

          6. Clinically relevant blockage of 1 or both nasal passages, as determined by the
             investigator's medical judgment
Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Ublituximab; Umbralisib; Ibrutinib; Venetoclax; Acalabrutinib Oral Capsule
Intervention description: recombinant chimeric anti-CD20 monoclonal antibody
administered as an IV infusion; Phosphoinositide-3-kinase (PI3K) delta inhibitor
Tablet form, to taken orally on a daily basis; Bruton Tyrosine Kinase (BTK) inhibitor
Tablet form, to taken orally on a daily basis; BCL-2 inhibitor
Tablet form, to be taken orally; Kinase inhibitor, capsule form, to be taken orally
Intervention MeSH terms: Venetoclax; Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: umbralisib; ublituximab; venetoclax; ibrutinib; CLL; acalabrutinib

Summary:

      Phase 2, two cohort trial evaluating the addition of ublituximab and umbralisib on the rate
      of minimal residual disease (MRD) negativity in participants with Chronic Lymphocytic
      Leukemia (CLL), who are currently on treatment with ibrutinib, alacabrutinib or venetoclax.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with Chronic Lymphocytic Leukemia (CLL) who have been on treatment for at
             least 6 months

          -  Minimal Residual Disease positive at screening

          -  Adequate organ system function as specified in the protocol

          -  Ability to follow protocol procedures.

        Exclusion Criteria:

          -  Participants receiving cancer therapy or any investigational drug within 21 days of
             Cycle 1, Day 1.

          -  Participants with a known histological transformation

          -  Active Hepatitis B or Hepatitis C.
Study Examining PrEP-001 in Healthy Subjects
Condition: Influenza A H3N2
MeSH terms: Influenza, Human
Intervention: PrEP-001; Placebo Comparator
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Phase 2 study, looking at the prophylactic efficacy, safety and tolerability to a repeated
      nasal dose of study drug after being infected with Influenza A/Perth/16/2009 (H3N2) virus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Young healthy adults as determined by medical history, physical examination, serology
             (HIV and Hepatitis B and C) and clinical laboratory tests.

          -  Female subjects were required to provide of a history of reliable contraceptive
             practice.

        Exclusion criteria:

          -  Subjects who have a significant history of any tobacco use at any time.

          -  Any history or evidence of any clinically significant cardiovascular, dermatological
             gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic,
             urological, neurological, psychiatric, renal disease.

          -  Abnormal ECG
Enhancing Prevention Capacity With Developmental Assets and Getting to Outcomes
Condition: Substance Abuse
MeSH terms: Substance-Related Disorders
Intervention: Assets Getting To Outcomes
Intervention description: Face to Face Training Assets Getting To Outcomes Manuals Technical Assistance
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 376.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Alcohol and other drug use among youth is costly for communities. More research is needed
      about how to best support community based prevention programs and how community prevention
      expertise can inform the research process. The National Institute on Drug Abuse has funded a
      5 year collaboration of the RAND Corporation, Search Institute and its training division,
      Vision Training Associates, Communities for Children and Youth, and the University of
      Southern Maine to implement and assess the impact on prevention coalitions, the combination
      of two complimentary, community-based interventions: Developmental Assets, which supports
      community mobilization and collaboration to promote positive youth development, and Getting
      To Outcomes (GTO), which enhances community capacity to complete critical prevention tasks
      (e.g., evaluation). The purpose of the project is to investigate: 1) How well is the
      Assets-GTO intervention delivered, how much is it used, and what coalitions think about it;
      2) The extent to which the Assets-GTO approach enhances the prevention capacity (knowledge,
      attitudes, and skills) of individual coalition members and the quality of prevention
      performance; and 3) Whether enhanced prevention capacity improves alcohol and drug outcomes
      among youth. Twelve community-based prevention coalitions in Maine (part of Communities for
      Children and Youth) will participate. Six coalitions-determined at random-will receive
      manuals, training, and on-site technical assistance consisting of bi-Weekly meetings between
      A-GTO 4 ME! and key coalition staff. The other six coalitions will continue practice as
      usual, but will receive an abbreviated version of the Assets-GTO intervention near the end of
      the project. A Community Research Workgroup made of coalition representatives will review all
      aspects of the study and interim findings and facilitate dissemination on A-GTO 4 ME! The
      project will demonstrate and evaluate strategies to strengthen the prevention capacity of
      community organizations that can be used broadly across many types of programs.
    

Eligibility criteria:

        Inclusion Criteria:

        Related to the programs of the 12 participating coalitions, the inclusion criterion is
        being an AOD-related universal, selective, or indicated prevention program or initiative.

        Exclusion Criteria:

        The exclusion criterion is being a case identification, treatment, or after-care program.
N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence
Condition: Methamphetamine Dependence
Intervention: Naltrexone plus N-Acetyl Cysteine; Placebo
Intervention description: daily; daily
Intervention MeSH terms: Acetylcysteine; Naltrexone; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Methamphetamine Dependence

Summary:

      The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine
      (NAC) in combination with naltrexone in methamphetamine dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          1. men and women age 18-65

          2. current DSM-IV methamphetamine dependence.

        Exclusion Criteria:

          1. unstable medical illness

          2. history of seizures

          3. myocardial infarction within 6 months

          4. current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential

          5. any thoughts of suicide

          6. lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any
             other DSM-IV psychotic disorder

          7. previous treatment with N-Acetyl Cysteine or naltrexone

          8. treatment with investigational medication or depot neuroleptics within 3 months, with
             fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study
             baseline

          9. abnormal liver function tests at screening

         10. diagnosis of asthma

         11. current use of opiates.