bioihbjkbjnl/mcl2 huggingface dataset:
Novel Use Of Hydroxyurea in an African Region With Malaria
Condition: Sickle Cell Anemia; Sickle Cell Disease; Malaria
MeSH terms: Malaria; Anemia, Sickle Cell
Intervention: Hydroxyurea; Placebo
Intervention MeSH terms: Hydroxyurea
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 208.0
Sex: All
Minimum age: 12 Months
Maximum age: 47 Months
Healthy volunteers: No
Keywords: Hydroxyurea

Summary:

      Multiple studies have shown that hydroxyurea has clinical efficacy in preventing acute
      painful episodes and reducing the need for blood transfusions in children with sickle cell
      anemia (SCA), but no study has been conducted in malaria endemic regions of sub-Saharan
      Africa, the areas with the most children with SCA.

      The primary goal of this study is to investigate the safety and efficacy of hydroxyurea for
      children with SCA in a malaria endemic region within sub-Saharan Africa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric subjects with documented sickle cell anemia (HbSS supported by hemoglobin
             electrophoresis or by peripheral blood smear showing sickled red blood cells)

          -  Age range of 1.00-3.99 years, inclusive, at the time of enrollment

          -  Weight at least 5.0 kg at the time of enrollment

          -  Willingness to comply with all study-related treatments, evaluations, and follow up

        Exclusion Criteria:

          -  Known chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis)

          -  Severe malnutrition determined by impaired growth parameters as defined by WHO (weight
             for length/height or weight-for-length/height > 3 z-scores below the median WHO growth
             standards)

          -  Pre-existing severe hematological toxicity:

               1. Hb <4.0 g/dL

               2. Hb <6.0 g/dL AND ARC <100 x 10E9/L

               3. Hb <7.0 g/dL AND ARC <80 x 10E9/L

               4. Platelets <80 x 10E9/L

               5. ANC <1.0 x 10E9/L

          -  Alanine transaminase (ALT) or creatinine >2 times the upper limit of normal for age

          -  Blood transfusion within 30 days prior to enrollment
Hutchinson Smoking Prevention Project
Condition: Smoking Among Youth
Intervention: Social-influences
Intervention description: grades 3-10, school-based social influences tobacco use prevention curriculum
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8388.0
Sex: All
Minimum age: 7 Years
Maximum age: 9 Years
Healthy volunteers: No
Keywords: smoking prevention; tobacco use prevention; adolescent tobacco use; prevention intervention

Summary:

      The Hutchinson Smoking Prevention Project is a 16-year, group-randomized trial to determine
      the extent to which a school-based (grades 3-10), theory-based, social-influences tobacco use
      prevention intervention can deter youth tobacco use throughout and beyond high school.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All students enrolled in third grade in one of two consecutive classes of third
             graders in an HSPP participating Washington school district (1984-85; 1985-86;
             1986-87).

        Exclusion Criteria:

          -  Enrolled but classified by participating school district as developmentally unable to
             learn.
A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea
Condition: Papulopustular Rosacea
MeSH terms: Rosacea
Intervention: FMX103 1.5%
Intervention description: FMX103 1.5% minocycline foam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 504.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective is to show that open-label extended treatment with FMX103 1.5%, for up
      to an additional 40 weeks, is safe and well tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have completed 12 weeks of treatment in either Study FX2016-11 or Study FX2016-12.

          2. Have not had a worsening of disease, determined by the Investigator's Global
             Assessment (IGA), at Visit 5/Week 12 (Final Visit) relative to the Day 0/Baseline
             assessment in Study FX2016-11 or Study FX2016-12.

        Exclusion Criteria:

          1. Have a new systemic disease or condition, including an ongoing AE that might interfere
             with the conduct of the study or the interpretation of results.

          2. Have developed a condition that would have been exclusionary for Study FX2016-11 or
             Study FX2016-12, including pseudomembranous colitis, antibiotic associated colitis,
             hepatitis, liver damage, renal impairment, drug addiction, or alcohol abuse.
The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms
Condition: Vasomotor Symptoms
Intervention: desvenlafaxine succinate sustained release; desvenlafaxine succinate sustained release; desvenlafaxine succinate sustained release; desvenlafaxine succinate sustained release; Placebo; desvenlafaxine succinate sustained release; desvenlafaxine succinate sustained release; desvenlafaxine succinate sustained release
Intervention description: Titration 100 mg; Titration 50 mg; Titration 25 mg, 50mg; Titration 25 mg; Tapering placebo; Tapering 50 mg, placebo; Tapering 50 mg, 25 mg; Tapering 50 mg QOD
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 500.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Desvenlafaxine succinate (DVS SR) is a serotonin and norepinephrine reuptake inhibitor
      (SNRI). It is a nonhormonal option for the treatment of Vasomotor Symptoms (VMS) associated
      with menopause. Nausea is the most common adverse event that is observed in clinical studies
      and is the main reason for discontinuation during the first week of therapy. Other adverse
      events (headache, nausea, and dizziness) associated with DVS SR have been noted to occur when
      subjects abruptly discontinue the medication. The purpose of this study is to evaluate
      several titration and tapering regimens of DVS SR to ensure a better tolerability profile at
      the start and completion of treatment. In addition, this study will provide a long
      posttreatment follow-up to assess any symptoms after treatment is discontinued.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy, postmenopausal woman who seeks treatment for hot flushes.

          -  Meets 1 of the following: At least 12 months of spontaneous amenorrhea; At least 6
             months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels
             > 40 mIU/mL; At least 6 weeks postsurgical bilateral oophorectomy (with or without
             hysterectomy). Hysterectomized without bilateral oophorectomy and with serum FSH
             levels >40 mIU/mL.

        Exclusion Criteria:

          -  History of a seizure disorder other than a single childhood febrile seizure.

          -  History or presence of clinically important hepatic or renal disease or other medical
             disease.

          -  Presence or recent history of major depressive disorder, bipolar disorder, psychotic
             disorder, or generalized anxiety disorder requiring therapy.
Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Placebo (for alirocumab); Alirocumab; Lipid-Modifying Therapy (LMT)
Intervention description: Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.; Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.; Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
Intervention MeSH terms: Alirocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2341.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9
      (proprotein convertase subtilisin/kexin type 9).

      Primary Objective of the study:

      To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk
      participants with hypercholesterolemia not adequately controlled with their current lipid
      modifying therapy (LMT).

      Secondary Objectives:

        -  To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C)
           levels after 24 weeks of treatment in comparison with placebo.

        -  To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time
           points.

        -  To evaluate the effects of alirocumab on other lipid parameters.
    

Eligibility criteria:

        Inclusion criteria:

        Either A or B below and who were not adequately controlled with their lipid-modifying
        therapy:

        A) Participants with heterozygous familial hypercholesterolemia (heFH) with or without
        established coronary heart disease (CHD) or CHD risk equivalents

        OR

        B) Participants with hypercholesterolemia together with established CHD or CHD risk
        equivalents.

        Exclusion criteria:

          -  Age < 18 years

          -  LDL-C <70 mg/dL (< 1.81 mmol/L)

          -  Fasting serum triglycerides > 400 mg/dL (>4.52 mmol/L)

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients With Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Benralizumab; Benralizumab Placebo; Seasonal influenza virus vaccine
Intervention description: Benralizumab SC administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).; Placebo administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).; Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
Intervention MeSH terms: Benralizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Male and female adolescent patients; severe asthma

Summary:

      This is a randomized, double-blind, parallel group, placebo-controlled study designed to
      investigate the potential effect of a fixed dose of benralizumab administered subcutaneously
      (SC) on antibody responses following seasonal influenza virus vaccination
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female and male patients aged 12 to 21 years, inclusive, at the time of Visit 1

          -  Weight of ≥40 kg

          -  Documented history of current treatment with Inhaled corticosteroids (ICS) and
             long-acting β2 agonists (LABA)

          -  Morning pre-bronchodilator forced expiratory volume in 1 second (FEV1) of >50%
             predicted at Visit 1 or Visit 2.

          -  Airway reversibility (FEV1 >12% and 200 ml) demonstrated at Visit 1 or Visit 2 using
             the Maximum Post-bronchodilator Procedure OR

          -  Airway reversibility documented in the previous 12 months prior to Visit 1

          -  An exacerbation, 1 or more, that required oral corticosteroids in the previous year OR

          -  Any condition assessed by patient recall over the previous 2-4 weeks

        Exclusion Criteria:

          -  Clinically important pulmonary disease other than asthma

          -  Known history of allergy or reaction to the Investigational Product formulation or
             influenza vaccine

          -  Receipt of an influenza vaccine within 90 days prior to randomization

          -  Poorly controlled asthma during the screening period that requires treatment with oral
             corticosteroids or a hospitalization/emergency room visit for the treatment of asthma

          -  Acute illness or evidence of significant active infection or known influenza infection
             during the current flu season
A Study to Evaluate Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ivacaftor; Placebo
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 3 Years
Maximum age: 5 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of ivacaftor treatment, as measured by lung clearance index (LCI),
      in subjects with cystic fibrosis (CF) who have a specified CF transmembrane conductance
      regulator (CFTR) gating mutation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female with confirmed diagnosis of CF.

          -  Must have 1 of the following CFTR gating mutations on at least 1 allele: G551D, G178R,
             S549N, S549R, G551S, G1244E, S1251N, S1255P, or G1349D.

          -  Hematology, serum chemistry, and coagulation at Screening with no clinically
             significant abnormalities or concomitant diagnosis that would interfere with the LCI
             and CT scan study assessments, as judged by the investigator.

        Exclusion Criteria:

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy (including antibiotics) for pulmonary disease within 4 weeks before Day 1

          -  Any clinically significant laboratory abnormalities at the Screening Visit that would
             interfere with the study assessments or pose an undue risk for the subject (in the
             opinion of the investigator)

          -  Abnormal liver function, at Screening, defined as ≥3 × upper limit of normal (ULN), of
             any 3 or more of the following: serum aspartate transaminase (AST), serum alanine
             transaminase (ALT), gamma-glutamyl transpeptidase (GGT), serum alkaline phosphatase
             (ALP), and total bilirubin

          -  History of solid organ or hematological transplantation

          -  Any clinically significant "non-CF-related" illness within 2 weeks before Day 1

          -  Use of any moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A
             within 2 weeks before Day 1

          -  Participation in a clinical study involving administration of either an
             investigational or a marketed drug within 30 days or 5 terminal half-lives (whichever
             is longer or as determined by the local requirements) before Screening
Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: ReFacto AF
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Hemophilia A; bleeding disorder

Summary:

      This study will examine the efficacy and safety of ReFacto AF in patients with severe and
      moderately severe hemophilia A undergoing elective major surgery when administered by either
      bolus injections (BI) or continuous infusion (CI).
    

Eligibility criteria:

        -  Male, at least 12 years old, with severe hemophilia A undergoing major elective major
             surgery requiring FVIII replacement for at least 6 days. Negative FVIII inhibitor test
             at screening and no past history of inhibitor.

          -  Previously treated with at least 150 exposure days to any Factor VIII product

          -  Normal hepatic and renal function tests and no other bleeding disorder
Intramuscular (IM) Olanzapine Versus IM Haloperidol Plus Lorazepam for Acute Agitation in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Agitation
MeSH terms: Psychomotor Agitation; Schizophrenia; Psychotic Disorders
Intervention: IM olanzapine; IM haloperidol plus lorazepam
Intervention description: 10mg olanzapine IM; IM 5 mg haloperidol plus IM 2 mg lorazepam
Intervention MeSH terms: Lorazepam; Haloperidol; Olanzapine; Haloperidol decanoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizophrenia; schizoaffective disorder; olanzapine; haloperidol; lorazepam; agitation

Summary:

      The aim of this study was to compare the efficacy and safety of intramuscular 10 mg
      olanzapine versus intramuscular 5 mg haloperidol plus lorazepam 2 mg in the treatment of
      acute agitated schizophrenic patients of Taiwanese populations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and non-pregnant, non-lactating women aged 18 to 65 years with a primary diagnosis
             of schizophrenia (DSM-IV)

          -  were hospitalized due to an acute relapse

          -  were clinically agitated with a minimum total score of ≧ 14 on the five items of the
             PANSS-EC and at least one individual item score of ≧ 4 using the 1-7 scoring system
             prior to first IM injection of study drug.

        Exclusion Criteria:

          -  female subjects who were either pregnant or breast-feeding;

          -  patients with acute, serious or unstable medical conditions;

          -  treatment with benzodiazepines within 4 hours prior to the first IM study drug
             administration;

          -  treatment with an injection depot neuroleptic within 1 injection interval prior to
             study drug administration;

          -  history of allergic reaction or intolerance to study medication(s);

          -  had a known diagnosis of dementia of any type, as defined in the DSM-IV.
Nitric Oxide Administration for Acute Respiratory Distress Syndrome
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Intervention: Nitric Oxide; No Intervention
Intervention description: Subjects will receive inhaled Nitric Oxide at a dose of 10 parts per million (ppm) for a 4 hour study period. Blood gases will be collected once an hour.; Subjects will receive no intervention (i.e., no nitric oxide treatment) for a 4 hour study period. Blood gases will be collected once an hour. During this time, all subjects will receive standard clinical care.
Intervention MeSH terms: Nitric Oxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 1 Month
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Acute Respiratory Distress Syndrome; ARDS; Nitric Oxide

Summary:

      This research project is an open-label, randomized study for the use of Nitric Oxide in
      pediatric patients with acute respiratory distress syndrome (ARDS). The study examines
      whether nitric oxide (NO) treatment impacts the the P:F ratio (arterial partial pressure of
      oxygen (PaO2) divided by fraction of inspired oxygen (FiO2) in patients with ARDS. The goal
      of the study is to evaluate whether the order of NO therapy will have any effect on response,
      and evaluate the characteristics of patients who respond to NO compared to those who do not.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is intubated and mechanically ventilated in the Pediatric Intensive Care Unit
             with a PaO2/FiO2 ratio less than or equal to 100, FiO2 greater than or equal to 0.60,
             PEEP greater than or equal to 10, and a Murray score greater than or equal to 2.5.

        Exclusion Criteria:

          -  Neonates (1 week to 28 days) and/or patients on extracorporeal membrane oxygenation
Chronic Versus Acute Dosing of Sodium Citrate for Swimming 200m
Condition: Alkalosis
MeSH terms: Alkalosis
Intervention: Sodium Citrate Dihydrate
Intervention description: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)
Intervention MeSH terms: Citric Acid; Sodium Citrate
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: Male
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: performance; speed; exertion

Summary:

      Ingestion of sodium citrate (Na-Cit), an alkalizing agent, increases extracellular pH via
      liver oxidation by decreasing [H+] and increasing bicarbonate concentration (HCO3-). Studies
      have confirmed that increasing extracellular pH promotes the efflux of La- and H+ from active
      muscles. This is due to an increase in activity of the pH sensitive monocarboxylate
      transporter as the gradient of intracellular versus extracellular H+ increases. Therefore,
      artificially inducing alkalosis prior to anaerobic exercise may reduce intracellular acidosis
      and increase the time to fatigue - defined as a decrease in force production with an
      increased perception of effort. The investigators will test the null hypothesis that sodium
      citrate ingestion (chronic and acute) will not have an effect on exercise performance
      compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 13-17

          -  Male

          -  Regional, provincial and national level swimmers

        Exclusion Criteria:

          -  Females

          -  Level of swimming below regional level standards

          -  Caffeine before trials

          -  Chronic health concerns

          -  Health problems before or during the course of the trial