bioihbjkbjnl/mcl2 huggingface dataset:
Decadron as Adjuvant in Femoral Nerve Blocks in Knee Arthroscopy
Condition: Knee Injury
MeSH terms: Knee Injuries
Intervention: Dexamethasone; Ropivacaine
Intervention description: Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.; Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
Intervention MeSH terms: Dexamethasone; Ropivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 77.0
Sex: All
Minimum age: 10 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: Dexamethasone; Ropivacaine; Knee arthroscopy; Femoral nerve blocks; Peripheral nerve blocks; Adjuvant; Pediatrics

Summary:

      If preservative-free dexamethasone 0.1 mg/kg (max dose 4 mg) is added to ropivacaine 0.5% 2
      mg/kg (max dose 100 mg), then post-PACU opioid consumption will be reduced by 33%.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children older than 10, and younger than 19 years of age undergoing unilateral
             arthroscopic surgery of the knee

          -  American Society of Anesthesiologists (ASA) Status I or II

          -  Patient's parent/guardian willing and able to give consent

          -  Patient willing to give assent

        Exclusion Criteria:

          -  Arthroscopic anterior cruciate ligament repair

          -  Systemic steroid use within the last 3 months

          -  Diabetes mellitus

          -  Females testing positive for pregnancy

          -  BMI > 98th percentile

          -  Positive pregnancy test

          -  Coagulopathy

          -  Renal or hepatic disease

          -  Pre-existing motor or sensory deficits in the lower extremities

          -  Predisposition for falls based on pre-existing sensory or motor deficits of the legs
             or inability to perform crutch training.

          -  Non-English speaking

          -  Systemic fungal infection

          -  Immunosuppressed patients
A Study of Subcutaneous C.E.R.A. for the Treatment of Anemia in Pre-Dialysis Patients.
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
Intervention description: Recommended starting dose 1.2 micrograms/kg sc monthly
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy, safety and tolerability of subcutaneous
      C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with
      chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible
      patients will receive C.E.R.A. by monthly subcutaneous injections, dependent on body weight
      (with a recommended starting dose of 1.2 micrograms/kg). The anticipated time on study
      treatment is 3-12 months, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  chronic renal anemia, with no need for dialysis expected in next 3 months;

          -  adequate iron status.

        Exclusion Criteria:

          -  previous epoetin therapy within 12 weeks prior to treatment;

          -  transfusion of red blood cells during 2 months prior to screening;

          -  significant acute or chronic bleeding such as overt gastrointestinal bleeding;

          -  hemolysis;

          -  folic acid and vitamin B 12 deficiency.
Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age
Condition: Fetal Growth Retardation
MeSH terms: Fetal Growth Retardation
Intervention: Genotonorm (Somatropin)
Intervention description: 0.40 mg/kg/week dived in 7 daily subcutaneous injections during 2 years
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 4 Years
Maximum age: 9 Years
Healthy volunteers: No

Summary:

      To estimate the percentage of children with serum IGF-1 > 2 standard deviation (compared to a
      child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12
      months after initiation of GH treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronological age between 4 and 9 years for a boy and 4 and 7 years for a girl.

          -  Measured Height < -2.5 Standard Deviation

        Exclusion Criteria:

          -  Pubertal signs ie: testis volume > or = 4 ml in boys and breast stage > or = B2
             (Tanner)

          -  Serious chronic disease (diabetes, renal insufficiency, heart failure, hepatic
             insufficiency, neoplasia)
Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain
Condition: Osteoarthritis Knee Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Duloxetine; Placebo
Intervention description: duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders; placebo every day (QD), by mouth (PO) for 13 weeks
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 256.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to determine if duloxetine reduces pain severity in
      patients with osteoarthritis knee pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients with osteoarthritis knee pain.

        Exclusion Criteria:

          -  Serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other
             medical or psychiatric condition that, in the opinion of the investigator, would
             compromise participation or be likely to lead to hospitalization during the course of
             the study.

          -  Previous exposure to duloxetine.
The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: bococizumab (PF-04950615); Placebo
Intervention description: 150 mg, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.; Placebo comparator, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.
Intervention MeSH terms: Bococizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10564.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: myocardial infarction; stroke; hyperlipidemia

Summary:

      This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to
      placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular
      death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization
      in high risk subjects who are receiving background lipid lowering therapy and have
      cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL
      (3.4 mmol/L).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be on background lipid lowering treatment.

          -  Must be at high risk of a CV event.

          -  Must have an LDL C >/=100 mg/dL (2.6 mmol/L) OR non HDL C >/=130 mg/dL (3.4 mmol/L).

        Exclusion Criteria:

          -  Planned coronary (PCI or CABG) or other arterial revascularization.

          -  New York Heart Association Class IV congestive heart failure or left ventricular
             ejection fraction < 25% by cardiac imaging.

          -  Chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by MDRD
             formula or with end state renal disease on dialysis.

          -  History of hemorrhagic stroke.

          -  Prior exposure to bococizumab or other investigational PCSK9 inhibitor.
Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines
Condition: Migraine
MeSH terms: Migraine Disorders; Headache
Intervention: Dexamethasone; Placebo
Intervention description: Dexamethasone 10mg IV; Placebo Dexamethasone 10mg IV
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: migraine, emergency department, dexamethasone; Migraine with or without aura or probable migraine without aura as defined by ICHD, 2nd edition

Summary:

      Migraines are a specific type of headache that frequently recur and are very painful.
      Although there are many medications that are effective against migraines, none of these
      medications cure 100% of migraines. Another problem with migraines is that although many
      times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3
      of the time migraines recur the next day. The purpose of this research project is to see if
      adding a medication called dexamethasone to standard ER therapy will help patients get better
      quicker and stay pain-free more often than if they receive placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Migraine with or without aura; probable migraine without aura

        Exclusion Criteria:

          -  Secondary headache

          -  Allergy, contraindication or intolerance to study medication
A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)
Condition: Pemphigus Vulgaris (PV)
MeSH terms: Pemphigus
Intervention: Mycophenolate Mofetil 2 g/Day; Mycophenolate Mofetil (MMF) 3 g/Day; Placebo
Intervention description: Mycophenolate mofetil 500 mg tablets; 4 tablets twice daily for 52 weeks; Mycophenolate mofetil 500 mg tablets; 6 tablets twice daily for 52 weeks; Placebo for MMF 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study was designed to assess the efficacy and safety of CellCept (1 g or 1.5 g orally
      twice daily for 52 weeks) in patients with pemphigus vulgaris receiving prednisone or other
      corticosteroids. During the study, patients had their corticosteroid dose gradually reduced
      if they responded to treatment. The anticipated time on study treatment was 12 months, and
      the target sample size was <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients 18 to 70 years of age

          -  Diagnosis of mild to moderate pemphigus vulgaris within the past 12 months, requiring
             high dose corticosteroids

        Exclusion Criteria:

          -  Female patients who are pregnant, breastfeeding, or lactating

          -  Regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG)
             treatment, or PE or IVIG treatment within 8 weeks prior to randomization

          -  CellCept or other immunosuppressive therapy, except corticosteroids, exceeding 2 weeks
             total duration and within 8 weeks prior to randomization

          -  Use of PV therapies other than those noted above, within 4 weeks prior to
             randomization

          -  Use of topical corticosteroids within 2 weeks prior to randomization
Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer
Condition: Gastric Ulcer
MeSH terms: Stomach Ulcer; Ulcer
Intervention: Esomeprazole; Ranitidine
Intervention MeSH terms: Esomeprazole; Ranitidine; Ranitidine bismuth citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 397.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: NSAID-associated gastric ulcer

Summary:

      The purpose of this study is to assess the efficacy of esomeprazole 20 mg dosed once daily
      and ranitidine 150 mg dosed twice daily through 4 weeks of treatment for the healing of
      gastric ulcers in patients receiving daily non-steroidal anti-inflammatory drug
      (NSAID)therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent.

          -  A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at
             least 2 months.

          -  Daily NSAID dose and type must have been stable for at least 2 weeks prior to the
             baseline endoscopy;orally;

        Exclusion Criteria:

          -  History of esophageal, gastric or duodenal surgery, except for simple closure of an
             ulcer.

          -  History of severe liver disease, including (but not limited to) cirrhosis and acute or
             chronic hepatitis.
Open-label Safety Extension Study of 15 and 20 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine (Lu AA21004)
Intervention description: 15 or 20 mg/day; tablets; orally
Intervention MeSH terms: Vortioxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioural Symptoms

Summary:

      To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of
      Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD)
    

Eligibility criteria:

        Inclusion Criteria:

        Patients who completed 8-week short-term treatment study, 13267A (NCT01140906), for Major
        Depressive Episode immediately prior to enrolment in this extension study

        Exclusion Criteria:

          -  Any current psychiatric disorder other than MDD as defined in the Diagnostic and
             Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV TR)

          -  Female patients of childbearing potential who are not using effective contraception

          -  Use of any psychoactive medication

          -  The patient, in the investigator's clinical judgment, has a significant risk of
             suicide.

        Other protocol-defined inclusion and exclusion criteria applied.
Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Remdesivir; RDV Placebo; Standard of Care
Intervention description: Administered as Intravenous (IV) infusion once daily; Administered as IV saline once daily; Standard of Care Treatment for COVID-19 Infection
Intervention MeSH terms: Remdesivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 249.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces
      the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in
      participants with severely reduced kidney function who are hospitalized for coronavirus
      disease 2019 (COVID-19).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) positive as determined by
             Polymerase Chain Reaction (PCR) or other commercially available or public health assay
             (eg, Nucleic Acid Amplification Test (NAAT) and antigen tests) in any respiratory
             specimen

          -  Hospitalized for COVID-19

          -  Weighing at least 40 kilograms (kg)

          -  Oxygen (O2) saturation ≤ 94% on room air or requiring O2 supplement or Radiographic
             evidence of pulmonary infiltrates for COVID-19

          -  Have either:

               -  a) Severely reduced kidney function (estimated Glomerular Filtration Rate (eGFR)
                  < 30 mL/min/1.73 m^2), including people with end-stage kidney disease (ESKD)
                  requiring chronic dialysis

               -  b) Ongoing acute kidney injury (AKI): defined as a 50% increase in serum
                  creatinine (SCr) within a 48-hour period that is sustained (ie, requires
                  confirmatory SCr) for ≥ 6 hours despite supportive care

          -  The interval between COVID-19 symptoms onset and randomization is no more than 10 days

        Key Exclusion Criteria:

          -  Received any investigational drug, RDV, or other antiviral treatment for COVID-19

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper
             limit of normal

          -  Invasive mechanical ventilation, noninvasive mechanical ventilation, extracorporeal
             membrane oxygenation (ECMO), or renal replacement therapy (RRT) for acute kidney
             injury (AKI)

          -  Positive serum pregnancy test at screening for women of childbearing potential or
             currently breastfeeding

          -  Known hypersensitivity to the study drug, metabolites, or formulation
             sulfobutylether-beta-cyclodextrin (SBECD)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply
Negative Pressure Wound Therapy: Are All Systems Alike?
Condition: Wounds
MeSH terms: Wounds and Injuries
Intervention: KCI -VAC; Versatile One (EZCare)
Intervention description: Negative pressure wound therapy device; Negative pressure wound therapy device
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Hypotheses: (1)Wound healing during hospital stay will be equal between systems, (2)RNs will
      perceive the Versatile One (EZCare) system as easier to use, (3)Costs related to dressing
      changes will be less with Versatile one (EZCare), (4)Hospital length of stay will be equal or
      shorter with the Versatile One (EzCare) system, (5) Nursing time using Versatile One (EZCare)
      will be less than or equal to VAC system, (6) Patients will report less pain during dressing
      changes with Versatile One (EZCare).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hospitalized adults requiring negative pressure dressings.

        Exclusion Criteria:

          -  Comatose

          -  Mentally obtunded

          -  Documented chronic psychiatric illness or any documented dementia significant enough
             to notably impair cognitive function

          -  Presence of Manufacturer's contraindications

          -  Malignancy in wound

          -  Untreated osteomyelitis

          -  Unexplored fistula

          -  Necrotic tissue

          -  Exposed blood vessels or organs

          -  Untreated malnutrition.
Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ozanimod; Interferon beta-1a; Placebo to ozanimod; Placebo to interferon beta-1a
Intervention description: Capsules for oral administration once a day; Administered by intramuscular injection once a week; Matching placebo capsules administered orally once a day; Placebo intramuscular injection once a week
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Ozanimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1346.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: MS; RMS; Multiple Sclerosis; Relapsing Multiple Sclerosis

Summary:

      The purpose of this study is to determine whether ozanimod is effective in the treatment of
      relapsing multiple sclerosis (RMS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria

          -  EDSS score between 0 and 5.0 at baseline

        Exclusion Criteria:

        • Primary progressive multiple sclerosis
Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)
Condition: Clostridium Infections; Diarrhea
MeSH terms: Clostridium Infections; Diarrhea
Intervention: Fidaxomicin; Vancomycin; Matching Placebo to Fidaxomicin
Intervention description: 200 mg oral capsules two times daily (q12h regimen); 125 mg capsules q6hr (4 times a day); Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)
Intervention MeSH terms: Vancomycin; Fidaxomicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 629.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: CDAD, Clostridium difficile, diarrhea; Clostridium difficile-Associated Diarrhea

Summary:

      This is a comparative study to investigate the safety and efficacy of fidaxomicin versus
      vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males/females with CDAD

          -  Females must use adequate contraception

          -  Signed informed consent

        Exclusion Criteria:

          -  Life-threatening CDAD

          -  Toxic megacolon

          -  Pregnant

          -  Concurrent use of diarrheal agents

          -  Participation in other trials