bioihbjkbjnl/mcl2 huggingface dataset:
Decrease Emergence Agitation and Provide Pain Relief for Children Undergoing Tonsillectomy & Adenoidectomy
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Emergence Delirium
Intervention: dexmedetomidine; fentanyl
Intervention description: 2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion; 1 microgram/kilogram as a bolus
Intervention MeSH terms: Fentanyl; Dexmedetomidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 122.0
Sex: All
Minimum age: 2 Years
Maximum age: 10 Years
Healthy volunteers: No
Keywords: obstructive sleep apnea; tonsillectomy; adenoidectomy

Summary:

      Pediatric tonsillectomy (with or without adenoidectomy) is a brief but painful surgery
      carried out in children who very often also present with obstructive sleep apnea. To provide
      pain relief, i.e. analgesia, current practice relies on opioids , e.g., morphine or fentanyl.
      These narcotics are known to depress respiration and to increase the incidence of
      post-operative nausea and vomiting. These side effects are worrisome in this patient cohort.
      An alternative medication, dexmedetomidine, may have an opiate sparing effect and has a high
      safety profile in adults as well as in sedation in children. The purpose of this study is to
      determine if intravenous dexmedetomidine given as an infusion during general anesthesia for
      tonsillectomy or adenotonsillectomy reduces the incidence and severity of emergence
      agitation, improves analgesia and reduces nausea and vomiting in the 60 minutes following
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ages 2-10 ASA rating of I-III undergoing general anesthesia tonsillectomy with and
             without adenoidectomy

        Exclusion Criteria:

          -  diagnosis of anxiety disorder or chronic pain syndrome chronic disabilities or
             developmental delays are currently on psychotherapeutic or sedating medication are on
             chronic pain medication or opiate any known adverse effect to the study drug any known
             cardiac abnormalities
Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Ipilimumab
Intervention MeSH terms: Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 831.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will
      extend the lives of subjects with unresectable or metastatic melanoma more than giving
      Ipilimumab at a dose of 3 mg/kg
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Unresectable Stage III or Stage IV melanoma

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Brain metastases with symptoms or requiring treatment

          -  History of autoimmune disease
An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer
Condition: Advanced Cancer
Intervention: Nivolumab; Placebo
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 794.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to determine whether Nivolumab will improve disease-free
      survival compared with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with Stage II/III carcinoma of the esophagus or gastroesophageal junction

          -  Completed pre-operative chemo radiotherapy followed by surgery

          -  Diagnosed with residual pathologic disease after being surgically rendered free of
             disease with negative margins following complete resection

        Exclusion Criteria:

          -  Diagnosed with cervical esophageal carcinoma

          -  Diagnosed with Stage IV resectable disease

          -  Did not receive concurrent chemoradiotherapy prior to surgery

          -  Participants who have received a live/attenuated vaccine within 30 days of the first
             treatment

        Other protocol defined Inclusion/exclusion criteria could apply
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
Condition: Hypercholesterolemia; Atherosclerotic Cardiovascular Disease; Statin Adverse Reaction
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Hypercholesterolemia; Hyperlipidemias
Intervention: bempedoic acid; placebo
Intervention description: bempedoic acid 180 mg tablet; Matching placebo tablet
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 345.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hyperlipidemia; cholesterol; familial hypercholesterolemia; atherosclerotic cardiovascular disease; ASCVD; HeFH; LDL; statin intolerance

Summary:

      The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe
      versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Require lipid-modifying therapy for primary or secondary prevention of cardiovascular
             disease

          -  Fasting LDL-C ≥130 mg/dL for primary prevention or LDL-C ≥100 mg/dL for secondary
             prevention (history of HeFH and/or ASCVD)

          -  Be statin-intolerant (unable to tolerate 2 or more statins)

        Exclusion Criteria:

          -  Total fasting triglyceride ≥500 mg/dL

          -  Renal dysfunction or nephrotic syndrome or history of nephritis

          -  Body Mass Index (BMI) ≥50 kg/m2

          -  Significant cardiovascular disease or cardiovascular event in the past 3 months
Multi-Targeted Cardiac Risk Intervention in Type 2 Diabetes
Condition: Diabetes; Hypertension; Dyslipidemia
MeSH terms: Diabetes Mellitus; Dyslipidemias
Intervention: MEDIC
Intervention description: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Group Intervention; Pharmacotherapy; Behavioral Modification; Diabetes

Summary:

      Our study intends to test the efficacy of pharmacist-led group interventions on a weekly
      basis for 4-weeks, then on a monthly basis for 5 additional months to achieve concomitant
      reductions in hemoglobin A1c, lipids and blood pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetes mellitus,

          -  >18 years old,

          -  with a documented HbA1c more than 7.0%,

          -  an LDL cholesterol >100 mg/dl AND a blood pressure >130/80 mm Hg documented at least
             once in the medical records within the last 6 months, and

          -  willing to comply with the study interventions will be eligible for the study.

        Exclusion Criteria:

          -  pregnancy,

          -  unable to attend the group sessions,

          -  disease conditions such as psychiatric instability (acutely suicidal, psychotic) or
             organic brain injury that preclude them from performing diabetes self-care,

          -  enrolled in the Providence VAMC's Telehealth program
Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m
Condition: Whole Cell Pertussis; Haemophilus Influenzae Type b; Hepatitis B; Diphtheria; Tetanus; Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin
MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis; Tetany
Intervention: Tritanrix-HepB/Hib-MenAC; Mencevax ACWY; Tritanrix-HepB/Hiberix; Meningitec
Intervention description: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine; GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine; Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine; Wyeth's MenC CRM197 conjugated vaccine, Meningitec
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 617.0
Sex: All
Minimum age: 427 Days
Maximum age: 730 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prophylaxis diphtheria; Hib & meningococcal serogroup A & C disease

Summary:

      The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a
      booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15
      to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Antibody
      persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity
      of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to
      subjects not boosted with a MenA conjugate and/or MenC containing vaccine.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male or female between and including 15 and 24 months of age

          -  Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack
             No. 100480)

        Exclusion criteria:

          -  Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus
             influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not
             foreseen in the protocol, after the date of the study conclusion visit of the primary
             vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480).

          -  History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib
             and/or meningococcal serogroup A or C disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition.

          -  A family history of congenital or hereditary immunodeficiency.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures including febrile seizures (at least
             two events) in infancy.
A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Intervention: Solifenacin succinate suspension
Intervention description: Oral suspension
Intervention MeSH terms: Solifenacin Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Overactive bladder (OAB); Solifenacin succinate suspension; Phase 3; Pediatric

Summary:

      This was a 40-week study to investigate how safe and effective solifenacin solution was in
      treating children or adolescents with symptoms of overactive bladder (OAB), who completed
      study 905-CL-076 (NCT01565707).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has met the inclusion criteria of study 905-CL-076 and completed study
             905-CL-076

        Exclusion Criteria:

          -  Subject has failed the exclusion criteria of study 905-CL-076
A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CP-690,550; CP-690,550; CP-690,550; CP-690,550; Placebo; CP-690,550; Placebo; CP-690,550
Intervention description: Oral tablets administered at 5 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.; Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.; Oral tablets administered at 10 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.; Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.; Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.; Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.; Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.; Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 800.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: double-blind placebo-controlled investigational drug oral therapy safety and efficacy hand and feet x-rays

Summary:

      This study is designed to provide safety and efficacy data to support the development of
      CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of
      methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate

        Exclusion Criteria:

          -  Pregnancy, severe acute or chronic medical conditions, including serious infections or
             clinically significant laboratory abnormalities.
12-week Open-label Evaluation of Efficacy and Safety of Indacaterol
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol; Long-acting beta2-agonist
Intervention description: Indacaterol 150 µg once-daily via single-dose dry powder inhaler; Long-acting beta2-agonist (LABA) bronchodilator monotherapy via inhaler twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: indacaterol; COPD; Long-acting beta2-agonist (LABA)

Summary:

      In this 12-week study, patients were randomized to either open-label indacaterol or standard
      of care for Chronic Obstructive Pulmonary Disease (COPD) treatment; efficacy and safety were
      assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as
             classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
             Guidelines, 2007) and:

          -  Post-bronchodilator forced expiratory volume in 1 second (FEV1) <80% and ≥30% of the
             predicted normal value

          -  Post-bronchodilator FEV1/FVC (Forced Vital Capacity) <70%

          -  Current COPD bronchodilator treatment that includes a LABA bronchodilator or a fixed
             dose combination of LABA and Inhaled Corticosteroid (ICS)

        Exclusion Criteria:

          -  Patients with a history of asthma

          -  Patients who are currently being treated for COPD with tiotropium (Spiriva®)

          -  Patients with diabetes Type I or uncontrolled diabetes Type II

          -  Patients with a history of certain cardiovascular comorbid conditions

        Other protocol-defined inclusion/exclusion criteria may apply
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding
Condition: Anemia
MeSH terms: Uterine Hemorrhage; Anemia; Hemorrhage
Intervention: Ferric Carboxymaltose (FCM); Ferrous Sulfate tablets
Intervention description: Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered; 325 mg tablets TID on Days 0 through Day 42
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 456.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anemia; heavy uterine bleeding; menorrhagia; Anemia secondary to heavy uterine bleeding

Summary:

      This study compares of the safety and efficacy of intravenous iron vs oral iron in the
      treatment of anemia secondary to heavy uterine bleeding
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects >/= 18 years of age

          -  History of Heavy uterine bleeding

          -  Hgb </= 11

          -  Practicing acceptable birth control

          -  Demonstrate ability to understand and comply with protocol

        Exclusion Criteria:

          -  Known Hypersensitivity to oral or IV iron

          -  Anemia other than iron deficiency anemia

          -  Iron storage disorders

          -  Initiation of treatment that may effect degree of heavy uterine bleeding

          -  Anticipated need for surgery

          -  Severe psychiatric disorder

          -  Active infection

          -  Positive Pregnancy test

          -  Known Hep B or C or Active Hepatitis

          -  Received investigational Drug within 30 days

          -  Alcohol or drug abuse
Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Fulvestrant; BKM120; BKM120 matching placebo
Intervention description: Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter); BKM120 100 mg once daily; BKM120 matching placebo, once daily
Intervention MeSH terms: Fulvestrant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1147.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; Hormone receptor positive; HER2-negative; Metastatic; Locally advanced; PI3K; Fulvestrant; Refractory; Aromatase inhibitor

Summary:

      This study was a multi-center, randomized, double-blind, placebo controlled Phase III study
      to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus
      fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive
      (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally
      advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase
      inhibitor (AI) treatment.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Locally advanced or metastatic breast cancer

          -  HER2-negative and hormone receptor-positive status (common breast cancer
             classification tests)

          -  Postmenopausal woman

          -  A tumor sample must be shipped to a Novartis designated laboratory for identification
             of biomarkers (PI3K activation status)

          -  Progression or recurrence of breast cancer while on or after aromatase inhibitor
             treatment

          -  Measurable disease or non measurable disease bone lesions in the absence of measurable
             disease as per RECIST 1.1

          -  Adequate bone marrow and organ function defined by laboratory values

        Key Exclusion Criteria:

          -  Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant

          -  More than one prior chemotherapy line for metastatic disease

          -  Symptomatic brain metastases

          -  Increasing or chronic treatment (> 5 days) with corticosteroids or another
             immunosuppressive agent

          -  Active heart (cardiac) disease as defined in the protocol

          -  Certain scores on an anxiety and depression mood questionnaires