bioihbjkbjnl/mcl2 huggingface dataset:
Pediatric ACTION3 (Identify, Treat, Control): Effectiveness of Adding Montelukast in Pediatric Subjects With Uncontrolled Asthma (0476-385)
Condition: Asthma
MeSH terms: Asthma
Intervention: montelukast sodium
Intervention description: Montelukast 4-5 mg for 12 weeks, oral tablet
Intervention MeSH terms: Montelukast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 445.0
Sex: All
Minimum age: 2 Years
Maximum age: 14 Years
Healthy volunteers: No

Summary:

      a study to describe patient and physician satisfaction with montelukast therapy for the
      control of asthma used either as monotherapy or in combination with inhaled corticosteroids
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient Is Diagnosed With Asthma For At Least 6 Months

          -  Patient's Peak Expiratory Flow (PEF) Is 80% Of Predicted Value (Appendix 10)

          -  Patient Is Currently Untreated, Or Patient Is A User Of Short-Acting 2-Agonist On An
             As-Needed Basis, Or Patient Is A User Of Ics At Any Dosage

          -  Physician And/Or Patient Are Dissatisfied With Current Controller Therapy, Or Patient
             Is Reluctant To Take Ics Therapy, Or Patient Is Insufficiently Controlled Due To
             Non-Adherence With Current Therapy Through The Preceding 6 Weeks

        Exclusion Criteria:

          -  As Per Canadian Guidelines, Patient Is On A Laba Alone (Formoterol (Oxeze), Salmeterol
             (Serevent)) Or A Combination Product (Advair Or Symbicort)

          -  Patient Is Well Controlled, Adherent And Satisfied With Current Controller Therapy
Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer
Condition: Foot Dermatoses
MeSH terms: Onychomycosis; Skin Diseases; Foot Dermatoses
Intervention: Loceryl NL; Ciclopirox NL
Intervention description: Topical over the entire toenail plate of all affected toenails, once weekly in the evening (at bed time) after filing down the affected toenails.; Topical over the entire toenail plate of all affected toenails and surrounding skin, once daily in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed
Intervention MeSH terms: Ciclopirox; Amorolfine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intra-individual study
Masking: Single (Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Onychomycosis

Summary:

      The main objective of this study is to compare subject's compliance and satisfaction for two
      modes of treatment of toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl
      NL) and Ciclopirox Nail Lacquer (Ciclopirox NL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to
             dermatophytes and/or yeast (including Candida) on at least one toenail of each foot at
             screening visit,

          -  Subject with less than 80% of the nail surface area with disease involvement and
             without matrix involvement, no dermatophytoma, streaks (spikes) or subungual
             hyperkeratosis > 2mm,

          -  Subjects with positive mycological results (direct microscopy and culture) for
             dermatophytes and/or yeasts (including Candida) at baseline,

          -  Subjects with same number of affected toenails on both feet or no more than one
             additional affected toenail on one of the feet,

        Exclusion Criteria:

          -  Subject with a surgical, medical condition or clinically important abnormal physical
             findings, which, in the judgement of the investigator, might interfere with
             interpretation of the objectives of the study (i.e. lack of autonomy),

          -  Subjects with post-traumatic nail, lichen planus, eczema, psoriasis, or other
             abnormalities of the nail unit, which could affect/influence the subject's compliance
             of the investigational products, or mask the effects of treatment (cure),

          -  Subjects with known immunodeficiency, radiation therapy, immune suppressive drugs.
Toward Zero Prescribed Opioids for Outpatient General Surgery
Condition: Opioid Misuse and Addiction; Pain
MeSH terms: Opioid-Related Disorders
Intervention: Oxycodone; Zero Opioid Protocol
Intervention description: Investigators provided set opioid prescriptions for 10 pills each patient.; Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control.
Intervention MeSH terms: Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Control group, opioid sparing arm, and zero opioid arm
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Investigators have created an opioid reduction "package" which includes patient education,
      non-narcotic pain control instructions, and limited (or no) opioid pain prescriptions
      provided at discharge in an attempt to reduce the number of opioid consumption after
      outpatient general surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Opioid naïve patients

          -  Age > 18

          -  Being scheduled for an outpatient elective inguinal hernia repair or cholecystectomy

        Exclusion Criteria:

          -  Urgent/emergent status

          -  Previous cholecystostomy tube placement
A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: rituximab [MabThera/Rituxan]; Methotrexate
Intervention description: 1000mg iv on days 1 and 15; 10-25mg/week po or parenteral
Intervention MeSH terms: Rituximab; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the safety and efficacy of MabThera in combination with
      methotrexate in patients with rheumatoid arthritis who have had an inadequate response or
      intolerance to one or more anti-TNF agents. Patients will receive MabThera 1000mg i.v. on
      days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with
      methylprednisolone 100mg i.v. prior to infusion of MabThera. The anticipated time on study
      treatment is 3-12 months, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  active rheumatoid arthritis;

          -  receiving outpatient treatment;

          -  an inadequate response, or intolerance, to >=1 anti-TNF agent.

        Exclusion Criteria:

          -  other rheumatic autoimmune disease or inflammatory joint disease;

          -  concurrent treatment with any anti-TNF-alpha therapy;

          -  joint or osseous surgery during 8 weeks prior to recruitment.
Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure
Condition: Partial Epilepsies
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: Lacosamide
Intervention description: Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.
Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.
Taper phase if needed: 3 to 4 weeks
Intervention MeSH terms: Lacosamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epilepsy treatment.; Anti-epileptic drugs; Seizures

Summary:

      To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of
      400 mg/day, or to a clinically effective lower dose for an individual patient, improves the
      tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients
      with partial onset epilepsy.

      Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a diagnosis of partial-onset epilepsy with or without secondary
             generalization

          -  Currently taking 1 to 3 concomitant marketed antiepileptic drugs

          -  18 years and older at study entry

        Exclusion Criteria:

          -  Previous use of lacosamide

          -  Hypersensitivity to any component of lacosamide

          -  Patients with partial onset seizures not clearly identifiable

          -  History of generalized epilepsy

          -  History of status epilepticus within last 12 months

          -  Uncountable seizures due to clustering within last 12 weeks

          -  Non epileptic events, including pseudoseizures, conversion disorder that could be
             confused with seizures

          -  History of drug or alcohol abuse

          -  History of suicide attempt

          -  Progressive cerebral disease

          -  Concomitant treatment of felbamate

          -  Prior or concomitant vigabatrin use

          -  Under legal protection
Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures
Condition: Vertebral Compression Fracture
MeSH terms: Fractures, Bone; Spinal Fractures; Fractures, Compression
Intervention: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)
Intervention description: A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 50 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: osteoporosis; vertebral compression fractures

Summary:

      Balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression
      fractures has been shown to be successful in providing acute pain relief, enabling improved
      function, and restoring of vertebral body height. However, limited prospective data exists in
      the investigation of unipedicular balloon kyphoplasty as a sufficient alternative to
      bipedicular balloon kyphoplasty. The purpose of this prospective randomized study was to
      compare the clinical and radiographic outcomes of unipedicular and bipedicular balloon
      kyphoplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females older than 50 years of age with acute vertebral compression fractures
             causing significant pain and functional limitations in their daily activities.

        Exclusion Criteria:

          -  primary tumors of bone or evidence of metastasis at the index vertebrae

          -  pre-existing chronic pain or functional disability unrelated to a vertebral
             compression fracture which would confound the data analysis

          -  fracture secondary to a traumatic event

          -  inability to fully visualize both pedicles of the fractured vertebrae on
             intraoperative fluoroscopy
Growth and Development Study of Alglucosidase Alfa
Condition: Pompe Disease; Glycogen Storage Disease Type II (GSD-II); Acid Maltase Deficiency Disease
MeSH terms: Glycogen Storage Disease Type II; Glycogen Storage Disease; Deficiency Diseases
Intervention: alglucosidase alfa
Intervention description: Dose: 20 mg/kg every 2 weeks; Route of administration: Intravenous infusion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Maximum age: 24 Months
Healthy volunteers: No
Keywords: Glycogenesis 2

Summary:

      Pompe disease (also known as glycogen storage disease Type II) is a rare autosomal recessive
      metabolic muscle disease caused by the deficiency of acid α glucosidase (GAA), an enzyme that
      degrades lysosomal glycogen. As opposed to the exclusively cytoplasmic accumulation of
      glycogen that occurs in other glycogen storage disorders, Pompe disease is characterized by
      organelle bound (lysosomal) and extra-lysosomal accumulation of glycogen in many body
      tissues, ultimately leading to multisystemic pathology. The overall objective of this study
      was to evaluate the long-term growth and development of participants with infantile-onset
      Pompe disease with alglucosidase alfa before 1 year of age. Participants were to be followed
      for a 10-year period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant or participant's legal guardian must have provided signed, informed
             consent prior to performing any study-related procedures.

          -  The participant must have had a confirmed diagnosis of Pompe disease as determined by
             deficient endogenous GAA activity or GAA mutation analysis.

          -  The participant must be less than (<) 1 year of age at time of study enrollment (and
             received alglucosidase alfa treatment before 1 year of age), or the participant must
             be between 1 year and 24 months of age and must have had initiated alglucosidase alfa
             treatment prior to turning 1 year of age.

        Exclusion Criteria:

          -  The participant was participating in another clinical study using alglucosidase alfa
             or any investigational therapy.
Impact of Chronic Kidney Disease on Clopidogrel Effects in Diabetes Mellitus
Condition: Chronic Kidney Disease (CKD); Type 2 Diabetes Mellitus (T2DM); Coronary Artery Disease (CAD)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Clopidogrel; Clopidogrel active metabolite
Intervention description: Both CKD and Non-CKD patients will be administered a 600-mg LD of clopidogrel followed by a single 75-mg MD administered after 24 hours.; In both CKD and Non-CKD patients, blood samples collected at baseline only (before clopidogrel LD administration) will be incubated with escalating concentrations of clopidogrel active metabolite (1, 3 and 10 μM)
Intervention MeSH terms: Clopidogrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pharmacodynamics (PD); pharmacokinetic (PK); clopidogrel

Summary:

      Patients with diabetes mellitus (DM) and chronic kidney disease (CKD) are at increased risk
      of atherothrombotic events. Clopidogrel is the most widely used platelet P2Y12 receptor
      inhibitor in patients with coronary artery disease (CAD). However, despite its benefits, many
      patients still experience recurrent atherothrombotic events. The proposed study will test the
      central hypothesis that in DM patients the presence of CKD reduces clopidogrel-mediated P2Y12
      inhibitory effects through synergistic mechanisms, which include upregulation of the P2Y12
      signaling pathway and impaired clopidogrel metabolism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 DM, defined according to ADA definition, on treatment with oral hypoglycemic
             agents and/or insulin

          -  Angiographically documented CAD

          -  On treatment with low-dose aspirin (81mg/day) for ≥30 days as part of standard of
             care.

        Exclusion Criteria:

          -  Use of any antiplatelet therapy (except aspirin) in prior 30 days

          -  Use of parenteral or oral anticoagulation

          -  Active bleeding

          -  High risk of bleeding

          -  Clinical indication to be on a P2Y12 receptor inhibitor

          -  End-stage renal disease on hemodialysis

          -  Any active malignancy

          -  Platelet count < 100x106/µl

          -  Hemoglobin <9 g/dl

          -  Severe known liver disease

          -  Hemodynamic instability

          -  Known allergy to clopidogrel

          -  Pregnant / lactating females (women of childbearing age must use reliable birth
             control).
Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: Dapsone 7.5 % gel
Intervention description: Dapsone gel 7.5% applied once daily to truncal acne
Intervention MeSH terms: Dapsone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the
      trunk
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects of any race and at least 12 years of age.

          -  Female subjects of childbearing potential must have a negative urine pregnancy test at
             Baseline and practice a reliable method of contraception throughout the study.

          -  Truncal acne IGA score of 3.

          -  Able to understand the requirements of study and sign Informed Consent/HIPAA forms.

        Exclusion Criteria:

          -  Female subjects who are pregnant , breast feeding or are of childbearing potential who
             are not willing to use a reliable method birth control.

          -  Subjects who have an allergy or sensitivity to any component of the test medication.

          -  Subjects who have not complied with the proper wash out periods for prohibited
             medications.

          -  Evidence of recent drug or alcohol abuse.

          -  Skin disease /disorder that might interfere with the diagnosis or evaluation of
             truncal acne.

          -  Exposure to an investigational drug within 30 days of the Baseline visit.

          -  Medical condition that contraindicates the subject's participation in the study.

          -  History of poor cooperation, non-compliance with medical treatment or unreliability.
Glargine Dosing in Hospitalized Patients With Type 2 Diabetes and Renal Insufficiency
Condition: Type 2 Diabetes; Renal Insufficiency
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: 0.5 units/kg daily insulin; 0.25 units/kg daily insulin
Intervention description: Participants randomized to receive this intervention will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.; Participants randomized to receive this intervention will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible participants are randomized to one of the two dosing groups using a 1:1 allocation
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glargine; glulisine; type 2 diabetes; renal insufficiency

Summary:

      It is imperative to devise easy to follow, yet appropriate, guidelines for insulin use in
      renal-impaired patients. This will be done by comparing two regimens: 1) glargine once daily
      plus mealtime glulisine based on weight alone and 2) a predetermined dosing reduction
      algorithm with glargine/glulisine based on weight with reduction for decreased estimated GFR
      by MDRD as follows: < 30 ml/min/1.73m2 or on dialysis reduce dose by 50% from weight based
      calculation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 Diabetes Mellitus of mor than 1year

          -  GFR less than 30 ml/min/1.73m2 or dialysis

          -  Age greater than 18years

          -  Entry blood glucose (fasting or random) greater than 180mg%

        Exclusion Criteria:

          -  Type 1 Diabetes Mellitus

          -  New onset hyperglycemia

          -  Pregnant

          -  Solid organ transplant within 1 year

          -  Steroids prednisone greater than 7.5mg/day or equivalent

          -  Hospital LOS predicted less than 2 days

          -  Severe liver disease

          -  Known hypopituitarism or adrenal insufficiency

          -  Patients in the ICU

          -  Patients with hypoglycemic unawareness

          -  Outpatient insulin dose less than 0.6 units/kg