bioihbjkbjnl/mcl2 huggingface dataset:
Medical Treatment for Gastroesophageal Reflux Disease (GERD) in Preterm Infants
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Metaclopramide; Ranitidine; placebo
Intervention MeSH terms: Metoclopramide; Ranitidine; Ranitidine bismuth citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 1 Month
Maximum age: 6 Months
Healthy volunteers: No

Summary:

      Study Question: In premature infants with apnea and/or bradycardia attributed to
      gastroesophageal reflux disease (GERD), does treatment with medications (acid blockers and
      motility agents), compared to placebo, reduce the frequency of apnea and bradycardia?

      Background: Many clinicians believe that apnea and bradycardia in preterm infants may be
      caused by gastroesophageal reflux (GER), however, studies have failed to demonstrate even a
      temporal association between episodes of GER and apnea. There have been no prospective
      randomized trials of treatment for GERD in preterm infants with apnea or other symptoms
      attributed to GER.

      Methods: A randomized, cross-over study will be performed. This cross-over design will
      provide the patient's clinician with unbiased information about the patient's response to
      treatment. The clinician can use this information in deciding whether or not to continue
      treatment after the two-week study period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premature infants < 37 weeks gestation at birth; currently less than 44 weeks
             postmenstrual age.

          -  Not currently receiving mechanical ventilation

          -  Clinical diagnosis of GER and apnea/bradycardia suspected by the clinicians to be
             related to the GER. (Supporting diagnostic test information, such as upper
             gastrointestinal series [UGI] studies and pH probes will be recorded but not required
             for study enrollment.)

          -  Attending physician plan to begin anti-reflux medications

          -  Infants may be included in the study if they are on continuous positive airway
             pressure (CPAP) or methylxanthines for treatment of apnea only if the clinicians are
             willing to maintain the same regimen for the two-week duration of the study.

          -  Stable feeding regimen

        Exclusion Criteria:

          -  History of congenital neurological defect

          -  Imminent discharge (within 2 weeks)

          -  Parent refusal
Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women
Condition: HIV-1 Infection
Intervention: E/C/F/TAF; E/C/F/TDF; ATV; RTV; FTC/TDF; B/F/TAF
Intervention description: 150/150/200/10 mg FDC tablet administered orally once daily with food; 150/150/200/300 mg FDC administered orally once daily with food; ATV 300 mg capsules administered orally once daily with food; RTV 100 mg tablets administered orally once daily with food; 200/300 mg tablet administered orally once daily with food; 50/200/25 mg FDC tablet administered orally once daily without regard to food
Intervention MeSH terms: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 472.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose
      combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus
      continuing on a regimen consisting of elvitegravir/cobicistat/emtricitabine/tenofovir
      alafenamide (E/C/F/TAF), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
      (E/C/F/TDF), or atazanavir (ATV) + ritonavir (RTV) + emtricitabine/tenofovir disoproxil
      fumarate (FTC/TDF) in virologically suppressed HIV-1 infected women.
    

Eligibility criteria:

        Key Inclusion Criteria

        Medically stable HIV-1 infected women who meet the following criteria:

          -  Completion of the Week 48 open-label extension (OLE) visit or any post Week 48 OLE
             visits in Gilead-sponsored study GS-US-236-0128, or Completion of the Week 96 visit or
             any post Week 96 visits in Gilead-sponsored study GS-US-292-0109 or completion of the
             Week 144 visit or any post Week 144 visits in Gilead sponsored studies GS-US-292-0104
             or GS-US-292-0111.

          -  Currently on a stable antiretroviral regimen consisting of E/C/F/TAF, E/C/F/TDF, or
             ATV+RTV+FTC/TDF continuously for ≥ 12 consecutive weeks preceding the Screening visit

          -  Documented plasma HIV-1 RNA levels < 50 copies/mL for ≥ 12 weeks preceding the
             Screening visit. After reaching HIV-1 RNA < 50 copies/mL, single values of HIV-1 RNA

             ≥ 50 copies/mL followed by re-suppression to < 50 copies/mL is allowed

          -  HIV-1 RNA <50 copies/mL at screening

          -  Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min (≥ 0.83 mL/sec) according to
             the Cockcroft-Gault formula at the Screening visit

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Condition: Serogroup B Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1); Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2); Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3); Infanrix Hexa; Menjugate; Prevenar
Intervention description: One dose of rMenB Lot concomitantly with the routinely administered infant vaccines; One dose of rMenB concomitantly with the routinely administered infant vaccines; One dose of rMenB concomitantly with the routinely administered infant vaccines; Routine vaccination; One dose of the routinely administered infant vaccines + MenC vaccine; Routine vaccination
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3630.0
Sex: All
Minimum age: 55 Days
Maximum age: 89 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: infant; Meningococcal disease; prevention; vaccination

Summary:

      The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to
      lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with
      routine infant vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy 2-month old infants (55-89 days, inclusive)

        Exclusion Criteria:

          -  Prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio,
             Haemophilus influenzae type b (Hib), and Pneumococcal antigens)

          -  Previous ascertained or suspected disease caused by N. meningitidis

          -  History of severe allergic reaction after previous vaccinations or hypersensitivity to
             any vaccine component;

          -  Any serious chronic or progressive disease

          -  Known or suspected impairment or alteration of the immune system
A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: PF-06438179; Infliximab
Intervention description: PF-06438179 will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.; Infliximab will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 650.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase 3; infliximab; rheumatoid arthritis

Summary:

      The study will assess the efficacy and safety of PF-06438179 and infliximab in combination
      with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate
      response to methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

        Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months.

        At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and
        baseline.

        HS-CRP equal or greater than 10 mg/L.

        Must have received methotrexate for at least 12 weeks and be on a stable dose for at least
        4 weeks.

        Exclusion Criteria:

        Evidence of untreated or inadequately treated latent or active TB.

        Evidence or history of moderate or severe heart failure (NYHA Class III/IV)

        Infection requiring hospitalization or parenteral antimicrobial therapy judged clinically
        significant by the investigator within 6 months prior to first dose of study drug.
Lubiprostone in Children With Functional Constipation
Condition: Constipation - Functional
MeSH terms: Constipation
Intervention: Lubiprostone; Placebo
Intervention description: 12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1; 0 mcg soft capsules of placebo for oral administration
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo controlled
Masking: Double (Participant, Investigator)
Masking description: While the care provider and outcomes assessor were also blinded, this was classified as a double-blind trial
Enrollment: 606.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Study to determine if children (6-17 years old) with functional constipation will respond to
      being treated with lubiprostone for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic
             Criteria for Childhood Functional Constipation

          -  At least 6 years of age but less than 18 years of age at the time of randomisation

          -  Only stable dose of selective serotonin re-uptake inhibitors (SSRIs),
             serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO)
             inhibitors are allowed if subject is taking antidepressants

        Exclusion Criteria:

          -  Any gastrointestinal (GI) condition, other than constipation and/or irritable bowel
             syndrome (IBS), affecting GI motility or defecation

          -  Untreated faecal impaction at the time of screening

          -  Medical/surgical condition that might interfere with the absorption, distribution,
             metabolism, or excretion of the study medication
A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: bevacizumab [Avastin]; Taxane-based chemotherapy
Intervention description: 10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle; As prescribed
Intervention MeSH terms: Bevacizumab; Taxane
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2296.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the safety and efficacy of a regimen of Avastin plus a
      taxane, with or without additional chemotherapy, as first-line treatment in patients with
      locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv
      every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are
      contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal
      doxorubicin) may be used. The anticipated time on study treatment is until disease
      progression, and the target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients, >=18 years of age;

          -  HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic
             disease; (HER-2 positive patients only if previously treated with Herceptin in the
             adjuvant setting;

          -  candidates for chemotherapy.

        Exclusion Criteria:

          -  previous chemotherapy for metastatic or locally recurrent breast cancer;

          -  concomitant hormonal therapy for metastatic or locally recurrent disease;

          -  concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2
             positive disease;

          -  previous radiotherapy for treatment of metastatic disease;

          -  evidence of CNS metastases.
Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy
Condition: Bipolar Disorder; Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Extended release quetiapine (quetiapine XR); Sertraline; adequate mood stabilizer
Intervention description: Flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
Quetiapine XR was initiated at 50 mg/day and titrated to 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, and flexible doses of 300 to 600 mg/d from day 5 to the end of the study.; Flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
Sertraline titration: 50 mg on day 1-3, 100 mg on day 4, and flexible doses of 50 to 200 mg/d from day 5 to the end of the study.; An adequate mood stabilizer treatment with lithium or valproate(defined as a serum concentration of 0.5-1.2 mEq/L or 50-100 microg/ml, respectively).
Intervention MeSH terms: Quetiapine Fumarate; Sertraline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar disorder; Bipolar depression; quetiapine; sertraline

Summary:

      Prospective, open-label, controlled (active comparator), randomized study of 8 weeks
      follow-up for the evaluation of the efficacy of extended release quetiapine (quetiapine XR)
      versus Sertraline in addition to previous mood stabilizer treatment (lithium or valproate at
      stable and clinically therapeutic blood levels) in the treatment of the adult bipolar
      depression. This multicentric study will be featured in two sites in Spain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult ambulatory patients diagnosed of bipolar disorder I or II, current depressive
             episode (DSM-IV-TR 4ª Ed: 296.5x or 296.89 codes)

          -  Have been treated with only one mood stabilizer (lithium or valproate) in optimal and
             stable doses during at least the previous 4 weeks to randomization

          -  Hamilton Depression Rating Scale (HDRS-17) total score ≥ 20 and Young Mania Rating
             Scale (YMRS) total score ≤ 14 at the screening and randomization visits - Informed
             consent signed

        Exclusion Criteria:

          -  Patients with any axis I or II Diagnostic and Statistical Manual of Mental Disorders,
             4th edition, text revision (DSM-IV-TR) diagnoses different from bipolar disorder I or
             II - Length of current depressive episode less than 2 weeks or more than 12 months

          -  Having been treated with more than one mood stabilizer or any mood stabilizer other
             than Lithium or valproate, any antidepressant, any antipsychotic or any CP450-3A
             inductor/inhibitor within the 7 days period prior to randomization
FUTURE 3 Study Extension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Bosentan
Intervention description: Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day
Intervention MeSH terms: Bosentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 3 Months
Maximum age: 12 Years
Healthy volunteers: No
Keywords: pediatric; pulmonary arterial hypertension; bosentan; Tracleer

Summary:

      The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety,
      tolerability and efficacy of the pediatric formulation of bosentan two versus three times a
      day in children with Pulmonary Arterial Hypertension (PAH).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients who completed the FUTURE 3 core study (AC-052-373) or prematurely
             discontinued due to PAH-progression, if bosentan was not permanently discontinued

          2. Patients who tolerated bosentan pediatric formulation and for whom bosentan is
             considered beneficial at the end of the FUTURE 3 core study (AC-052-373)

          3. Signed informed consent by the parents or the legal representatives prior to any
             study-mandated procedure.

        Exclusion Criteria:

          1. Known intolerance or hypersensitivity to bosentan or any of the excipients of the
             dispersible bosentan tablet

          2. Any clinically significant laboratory abnormality that precludes continuation of
             bosentan therapy

          3. Pregnancy

          4. AST and/or ALT values > 3 times the upper limit of normal range (ULN)

          5. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C

          6. Premature and permanent study drug discontinuation during the FUTURE 3 core study
             (AC-052-373)

          7. Any major violation of the FUTURE 3 core study (AC-052-373) protocol.
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
Condition: Esophagitis, Reflux; Esophagitis, Peptic
MeSH terms: Esophagitis; Esophagitis, Peptic
Intervention: Dexlansoprazole MR; Dexlansoprazole MR; Lansoprazole
Intervention description: Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.; Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.; Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 2038.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Erosive Esophagitis

Summary:

      The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD)
      treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in
      healing subjects with endoscopically proven erosive esophagitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have endoscopically confirmed erosive esophagitis as defined by the Los
             Angeles (LA) Classification Grading System (A-D)

        Exclusion Criteria:

          -  Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.)
             pylori.

          -  Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2)
             receptor antagonists or sucralfate, drugs with significant anticholinergic effects,
             misoprostol or prokinetics

          -  Use of antacids [except for study supplied Gelusil®]

          -  Need for continuous anticoagulant therapy (blood thinners)

          -  Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus

          -  History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of
             mucosal tissue near the lower esophageal sphincter)

          -  Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory
             condition.

          -  History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.

          -  Acute upper gastrointestinal hemorrhage within 4 weeks of the screening endoscopy
Asthma Exacerbation Study
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone Furoate/GW642444; Fluticasone furoate
Intervention description: Combination inhaled corticosteroid and long-acting beta2-agonist; Inhaled corticosteroid
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2020.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will establish the safety as well as demonstrate benefit of the addition of a LABA
      to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on
      both safety and efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of asthma

          -  Reversibility FEV1 of twelve percent or greater and two hundred milliliters and
             greater approximately ten to forty minutes following two to four inhalations of
             albuterol

          -  FEV1 of fifty to ninety percent of predicted

          -  Currently using inhaled corticosteroid therapy

          -  History of one or more asthma exacerbations requiring treatment with oral/systemic
             corticosteroids or emergency department visit or in-patient hospitalization in
             previous year

        Exclusion Criteria:

          -  History of life threatening asthma in previous 5 years (requiring intubation, and/or
             associated with hypercapnia, hypoxic seizure or respiratory arrest

          -  Respiratory infection or oral candidiasis

          -  - Uncontrolled disease or clinical abnormality

          -  Allergies

          -  Taking another investigational medication or prohibited medication