bioihbjkbjnl/mcl2 huggingface dataset:
Atorvastatin Three Year Pediatric Study
Condition: Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: atorvastatin
Intervention description: Atorvastatin tablets or chewable tablets, 5, 10, 20, 40 mg strengths, once daily, for three years (an 80 mg maximum daily dose is delivered by taking two 40 mg strengths, once daily)
Intervention MeSH terms: Atorvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 272.0
Sex: All
Minimum age: 6 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: pediatric heterozygous familial hypercholesterolemia

Summary:

      The purpose of this study is to characterize three year descriptive growth and development
      (ie, height, weight, body mass index, Tanner Stage) and efficacy of cholesterol reduction in
      pediatric subjects with Heterozygous Familial Hypercholesterolemia receiving atorvastatin
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heterozygous familial hypercholesterolemia, ages 6-15, LDL greater than 4 mmol/l

        Exclusion Criteria:

          -  Active liver disease or hepatic dysfunction, or persistent elevations of serum
             transaminases exceeding three times the upper limit of normal (ULN).

        Female of childbearing potential who is not using adequate contraceptive measures or any
        female who is pregnant or breastfeeding. Any female who becomes pregnant during study
        participation will be immediately discontinued from treatment and counseled appropriately
        about the in utero exposure.

        Known hypersensitivities to HMG-CoA reductase inhibitors
A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis
Condition: Psoriasis
MeSH terms: Arthritis; Arthritis, Psoriatic; Psoriasis
Intervention: CP-690,550; CP-690, 550
Intervention description: 10 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.; 5 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.
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: 95.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: chronic; severe; moderate; treatment; safety; efficacy; CP-690; 550; Plaque psoriasis; Psoriasis Vulgaris; Psoriatic Arthritis; tofacitinib; Xeljanz

Summary:

      The main objective of this study is to evaluate the long term safety of CP-690,550 in
      patients being treated for moderate to severe plaque psoriasis and/or psoriatic arthritis.
      This study will also to compare the efficacy of two oral doses of CP-690,550 (5 mg BID and 10
      mg BID) after 16 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are 20 years or older and considered to be candidates for systemic or phototherapy.

        [Moderate to Severe Plaque Psoriasis]

          -  Diagnosed for at least 12 months.

          -  Have Psoriasis Area and Severity Index (PASI) score of 12 and plaque type psoriasis
             covering at least 10% of body surface area (BSA).

        [Psoriatic Arthritis]

          -  Diagnosed for at least 6 months.

          -  Meet the CASPAR (classification criteria for Psoriatic Arthritis) criteria at
             screening;

          -  Have active arthritis (≥3 tender/painful joints on motion and ≥3 swollen joints), and
             active plaque psoriasis with at least 2 cm in diameter.

        Exclusion Criteria:

          -  Non-plaque or drug induced forms of psoriasis

          -  Cannot discontinue current oral, injectable or topical therapy for psoriasis/psoriatic
             arthritis or cannot discontinue phototherapy (PUVA or UVB)

          -  any uncontrolled significant medical condition
Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery
Condition: Late Effects of Surgery; Staphylococcus Aureus; Surgical Site Infection
MeSH terms: Surgical Wound Infection
Intervention: daptomycin
Intervention description: Subjects enrolled in the intervention group will receive a single intravenous administration of daptomycin 8 mg/kg 30-60 minutes prior to surgery (incision). The 500 mg vial will be reconstituted with 10 mL of 0.9% normal saline (NS) and further diluted in 50 mL of 0.9% NS to be given over a 30 minute infusion.
Intervention MeSH terms: Daptomycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 19 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Daptomycin; Antibiotic Prophylaxis; Pharmacokinetics; Surgical Wound Infection; Staphylococcus aureus; Cardiopulmonary Bypass Surgery

Summary:

      This investigation is a prospective, open-label pharmacokinetic study of daptomycin
      prophylaxis in patients undergoing coronary artery bypass graft surgery without valvular
      replacement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hospitalized patients, awaiting scheduled elective coronary artery bypass graft (CABG)
             surgery without valve replacement surgery

          -  Age > 18 years and < 75 years

          -  BMI between 18.5 and 35.0 kg/meters-squared

          -  Crcl > 50 ml/minute calculated based on Cockcroft Gault equation

          -  No known active or suspected infection(s)

          -  Ability to complete the informed consent process

          -  Negative pregnancy test (for women of childbearing age)

        Exclusion Criteria:

          -  History of allergic reaction to daptomycin or components of daptomycin

          -  Receipt of daptomycin within 7 days prior to the surgery

          -  Elevated CPK levels (defined as > 3 times the upper limits of known normal)

          -  History of myopathy or complaints consistent with myopathy

          -  Current or planned use of mycophenolate mofetil, mycophenolic acid, or tobramycin
             during the subjects' current hospitalization (all of which are known to interact with
             daptomycin)

          -  Inability to complete the informed consent process because of problems with mental
             capacity

          -  Pregnancy and/or breast feeding
Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation
Condition: Irritable Bowel Syndrome With Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Lubiprostone; Placebo
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 590.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the efficacy and safety of administration of
      lubiprostone in patients with irritable bowel syndrome with constipation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age and older

          -  Stable fiber therapy

          -  Normal colonoscopy/sigmoidoscopy

          -  Able to refrain from use of medications known to treat or associated with constipation
             symptoms

          -  Experiences abdominal discomfort/pain associated with bowel movements

          -  Reports decreased bowel movement frequency and/or other symptoms associated with
             constipation

        Exclusion Criteria:

          -  Diarrhea-predominant or alternating (diarrhea and constipation cycling) irritable
             bowel syndrome (IBS), or constipation other than that associated with IBS

          -  Open gastrointestinal or abdominal surgery prior to IBS onset

          -  Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained
             weight loss or rectal bleeding

          -  Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric
             disorder, other systemic disease, or abnormal laboratory tests per investigator
             discretion

          -  If female, is currently pregnant or nursing, or plans to become pregnant or nurse
             during the clinical study
A Study of Ibuprofen (IBU) 250mg/APAP 500mg In The Treatment Of Post-Surgical Dental Pain
Condition: Pain
MeSH terms: Toothache
Intervention: FDC IBU/APAP 250 mg/500 mg; Placebo
Intervention description: FDC IBU/APAP 250 mg/500 mg; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Ibuprofen, acetaminophen, pain, molar extraction

Summary:

      This study is being conducted to determine the overall analgesic efficacy and safety of a
      fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to placebo in
      subjects who are experiencing post operative pain following surgical extraction of 3 or more
      third molar teeth. A review of any reported adverse events will also be completed.
    

Eligibility criteria:

        Inclusion Criteria

          1. Males and females 18 years to 40 years of age (inclusive).

          2. Outpatients who have undergone surgical extraction of 3 or more third molars, of which
             at least 2 must be a partial or complete bony mandibular impaction.

          3. Subject must have at least moderate pain on the 4 point categorical scale, confirmed
             by at least 50 mm on the 100 mm VAS PSR scale within approximately 5 hours (ie, less
             than or equal to 5 hours, 15 minutes) after surgery is completed.

          4. In general good health and have no contraindications to the study or rescue
             medication.

        Exclusion Criteria

          1. Presence or history of any significant hepatic, renal, endocrine, cardiovascular,
             neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic
             disorder determined by the Investigator to place the subject at increased risk,
             including the presence or history within 2 years of screening of the following medical
             conditions/disorders:

               -  Gastrointestinal ulcer or gastrointestinal bleeding;

               -  Paralytic ileus or other gastrointestinal obstructive disorders;

               -  Bleeding disorder.

          2. Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP,
             tramadol, other opioids, or to their combinations.

          3. Prior use of any type of analgesic or NSAID within five half lives of that drug or
             less before taking the first dose of investigational product, except for pre
             anesthetic medication and anesthesia for the procedure.

             .
Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)
Condition: Exercise Induced Asthma
MeSH terms: Asthma; Asthma, Exercise-Induced
Intervention: Montelukast sodium; Salmeterol xinafoate; Fluticasone propionate; Montelukast matching placebo; Salmeterol matching placebo
Intervention description: Montelukast 5 mg chewable tablet once daily; Salmeterol 50 mcg dry powder per actuation inhaled twice daily; Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily; Matching placebo to montelukast oral tablet administered once daily.; Matching placebo to salmeterol dry powder for inhalation administered twice daily
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 154.0
Sex: All
Minimum age: 6 Years
Maximum age: 14 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effect of four weeks of treatment with two
      investigational drugs (oral versus inhaled administration) plus an inhaled medication in the
      treatment of airway constriction brought on by exercise in participants with asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  6-14 year old children with a history of asthma for at least 12 months

          -  must demonstrate airway constriction brought on by exercise

        Exclusion Criteria:

          -  is taking any medications that are not allowed in the study
Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: USL261; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Epilepsy; seizure clusters; acute repetitive seizures; rescue treatment

Summary:

      This study is designed to evaluate the efficacy, safety, and tolerability of USL261 compared
      with that of intranasal (IN) placebo for the treatment of intermittent bouts of increased
      seizure activity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has been admitted to the institution's EMU for seizure characterization or
             pre-surgical evaluation, or such admission is planned within 28 days

          -  Subject body weight is ≥ 40 kg to ≤ 125 kg (inclusive)

          -  Subject has an established diagnosis of partial or generalized epilepsy

        Exclusion Criteria:

          -  Subject has history of status epilepticus in the 6 months prior to Screening

          -  Subject has a progressive neurological disorder such as brain tumor, demyelinating
             disease, or degenerative central nervous system (CNS) disease that is likely to
             progress in the next 12 months

          -  Subject has respiratory failure (or is at risk for respiratory failure) or other
             severe cardiorespiratory disease with New York Heart Association Class III or IV
             functional status, or requires supplemental oxygen

          -  Subject has acute narrow-angle glaucoma

          -  Subject is receiving chronic benzodiazepine treatment (defined as an average of ≥ 4
             administrations per week) and cannot safely withdraw from such treatment within the
             washout period prior to treatment
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
Condition: Macular Edema; Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Intervention: suprachoroidal CLS-TA; suprachoroidal sham; IVT aflibercept
Intervention description: suprachoroidal injection of CLS-TA; suprachoroidal sham procedure; 2 mg intravitreal injection of aflibercept
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Aflibercept; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 460.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RVO; ME; Central Subfield Thickness; OCT; Optical Coherence Tomography; Cystoid Macular Edema; Subretinal Fluid; Eylea; Aflibercept; Anti-VEGF; Suprachoroidal; Triamcinolone acetonide

Summary:

      This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12
      months duration in treatment naïve subjects with RVO.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a clinical diagnosis of RVO in the study eye

          -  Has a CST of ≥ 300 µm in the study eye

          -  Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye;

          -  Is naïve to local pharmacologic treatment for RVO in the study eye;

        Exclusion Criteria:

          -  Any active ocular disease or infection in the study eye other than RVO

          -  History of glaucoma, intraocular pressure > 21 mmHg or ocular hypertension requiring
             more than one medication

          -  Any uncontrolled systemic disease that, in the opinion of the Investigator, would
             preclude participation in the study

          -  Any evidence of neovascularization in the study eye
Long-Term Safety and Tolerability of Idebenone in Friedreich's Ataxia Patients (MICONOS Extension)
Condition: Freidreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: idebenone
Intervention description: Idebenone 1350 mg/d, patients < or equal 45 kg Idebenone 2250 mg/d, patients > 45 kg
Intervention MeSH terms: Idebenone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No
Keywords: FRDA; idebenone; FRDA disease

Summary:

      This is an Extension study of the MICONOS main randomised placebo-controlled trial
      (NCT00905268), and open to those patients completing the main study. The scientific aim of
      this extension study is to monitor safety and tolerability of idebenone over two years in
      patients with Friedreich's Ataxia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of 52 weeks in study SNT-III-001

          -  Body weight ≥ 25 kg

          -  Negative urine pregnancy test

          -  Eligibility to participate in the present extension study as confirmed by investigator

        Exclusion Criteria:

          -  Safety or tolerability issues arising during the course of SNT-III-001 which in the
             opinion of the investigator preclude further treatment with idebenone

          -  Clinically significant abnormalities of haematology or biochemistry including, but not
             limited to, elevations greater than 1.5 times the upper limit of SGOT, SGPT or
             creatinine

          -  Parallel participation in another clinical drug trial

          -  Pregnancy or breast-feeding

          -  Abuse of drugs or alcohol
Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Intervention: HEALOS and Leopard Cage; Leopard Cage and Autograft
Intervention description: Placement in interbody space; Placement in the interbody space
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: One or Two Level Degenerative Disc Disease

Summary:

      The purpose of this study is to determine the safety and effectiveness of HEALOS compared
      with autograft using the transforaminal lumbar interbody fusion (TLIF) method.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Persistent back and/or leg pain refractory to 6 months of non-surgical therapy

          -  Male or female 18 to 70 years of age (inclusive)

          -  Objective evidence of significant disc degeneration at one or two adjacent lumbar
             level(s) from L2/L3 to L5/S1

        Exclusion Criteria:

          -  Significant disc degeneration at more than two adjacent levels

          -  Greater than Grade II spondylolisthesis

          -  Prior fusion surgery of the lumbar spine (prior discectomies and intradiscal
             electrothermal therapy [IDET] are allowed)

          -  Insulin-dependent diabetes mellitus

          -  Pregnant or lactating, or wishes to become pregnant within the 24 month duration of
             the study
Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: high dose FDC; BI 10773 high dose; high dose FDC placebo; low dose FDC placebo; high dose FDC placebo; high dose FDC placebo; low dose FDC placebo; low dose FDC placebo; high dose BI 10773 placebo; low dose FDC; high dose FDC placebo; BI 10773 low dose; high dose BI 10773 placebo; high dose BI 10773 placebo; linagliptin; low dose FDC placebo; linagliptin placebo; BI 10773 low dose placebo; linagliptin placebo; low dose BI 10773 placebo; linagliptin placebo; high dose BI 10773 placebo; BI 10773 low dose placebo; low dose BI 10773 placebo; linagliptin placebo
Intervention description: once daily; once daily; once daily; once daily; once daily; once daily; once daily; once daily; once daily; once daily; once daily; low dose once daily; once daily; once daily; once daily; once daily; once daily; once daily; once daily; once daily; once daily; once daily; once daily; once daily; once daily
Intervention MeSH terms: Linagliptin; Empagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1405.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination
      (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to
      support approval by regulatory authorities.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of type 2 diabetes mellitus prior to informed consent

          2. Male and female patients on diet and exercise regimen who are drug-naïve (defined as
             absence of any oral antidiabetic therapy, glucagon like peptide-1 analog or insulin
             for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on
             the maximum tolerated dose or the maximum dose according to local label) unchanged for
             12 weeks prior to randomisation.

          3. Glycosylated hemoglobin (HbA1c) = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3
             mmol/mol) at Visit 1 (screening)

        Exclusion criteria:

          1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an
             overnight fast during placebo run-in and confirmed by a second measurement (not on the
             same day).

          2. Any other antidiabetic drug within 12 weeks prior to randomization (except metformin
             background therapy as defined via inclusion criterion 2)

          3. Acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation
             myocardial infarction and unstable angina pectoris), stroke or (transient ischemic
             attack) TIA within 3 months prior to informed consent