bioihbjkbjnl/mcl2 huggingface dataset:
Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)
Condition: Asthma
MeSH terms: Asthma
Intervention: montelukast sodium; Comparator: Usual Care
Intervention description: Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks; Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks
Intervention MeSH terms: Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 190.0
Sex: All
Minimum age: 6 Months
Maximum age: 2 Years
Healthy volunteers: No

Summary:

      Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who
      completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study.
      Additionally, patients with asthma who were 6 to 11 months of age and who had not
      participated in Protocol MK0476-176-01, could also enroll.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient successfully completed visit 5 of MK0476 Protocol 176 (NCT00943683)

        OR:

          -  Patient is in good, stable health

          -  Patient has been fed solid foods for at least 1 month

          -  Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring
             after 8 weeks of age; at least one within 6 months of the Prestudy Visit

          -  Patients had to be in need of a controller therapy according to criteria established
             in the Global Initiative for Asthma (GINA) guidelines

        Exclusion Criteria:

          -  Patient was hospitalized at the start of the study or had any major surgery 4 weeks
             prior

          -  Patient had an allergy to apples or applesauce
Empowering Patients to Better Manage Diabetes Through Self-Care
Condition: Type I or Type II Diabetes (Excludes Gestational Diabetes)
MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Pharmacist Counseling; Educational materials
Intervention description: Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items. Patients also received waiver of out-of-pocket expenses for diabetes care.; Patients received educational materials (handouts) in the mail. This was assumed to be of minimal effectiveness. Patients also received waiver of out-of-pocket expenses for diabetes care.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes

Summary:

      This study will look at the impact of health insurance benefits on self management of
      diabetes for people with this condition. Studies have shown that when people with diabetes
      manage their disease better, they stay healthier. Our goal in this study is to help those
      with diabetes better manage their disease (self-care). We will compare two types of health
      insurance benefits in this study. We want to see if one set of benefits improves self-care
      more than the other one.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diabetes (Type I or Type II)

          -  enrolled in health plan with participating employer

          -  age 18 or older

          -  willing and able to provide informed consent

        Exclusion Criteria:

          -  gestational diabetes
Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis
Condition: Osteopenia; Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Intervention: Denosumab
Intervention description: Administered by subcutaneous injection once every 6 months.
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4550.0
Sex: Female
Minimum age: 60 Years
Maximum age: 94 Years
Healthy volunteers: No
Keywords: postmenopausal osteoporosis; low bone density; fractures; low bone mass

Summary:

      The primary objective was to describe the safety and tolerability of up to 10 years or 7
      years denosumab administration as measured by adverse event monitoring, immunogenicity and
      safety laboratory parameters in participants who previously received denosumab or placebo,
      respectively.
    

Eligibility criteria:

        Postmenopausal women who have attended the 20030216 (NCT00089791) study month 36 visit will
        be eligible to participate if they meet the inclusion and exclusion criteria given below.

        Inclusion Criteria

          -  Subjects must sign the informed consent before any study specific procedures are
             performed and agree to receive denosumab 60 mg subcutaneous injection every 6 months

          -  Subjects must not have discontinued investigational product during the 20030216 study
             and must have attended the 20030216 study month 36 visit

          -  Subjects must be re-consented prior to (or at) the 24 month visit for participation
             beyond month 24.

        Exclusion Criteria

          -  Permanently non-ambulatory subjects (use of an assistive device eg, cane, walker, etc.
             is permitted)

          -  Missed 2 or more investigational product doses during the 20030216 study

          -  Any disorder that, in the opinion of the investigator, may compromise the ability of
             the subject to give written informed consent and/or comply with study procedures

          -  Developed sensitivity to mammalian cell derived drug products during the 20030216
             study

          -  Unable to tolerate calcium supplementation during the last 6 months of participation
             in the 20030216 study (between the month 30 and month 36 20030216 study visits)

          -  Currently receiving any investigational product other than denosumab or having
             received any investigational product during the 20030216 study

          -  Current use of the following osteoporosis agents: bisphosphonates, calcitonin,
             fluoride, parathyroid hormone, selective estrogen receptor modulators, systemic oral
             or transdermal estrogen (except vaginal preparations and estrogen creams which are
             acceptable), strontium, or tibolone

          -  For bone biopsy sub-study subjects only: known or suspected sensitivity or
             contraindication to tetracycline derivatives
ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium
Condition: Delirium
MeSH terms: Delirium
Intervention: haloperidol; Saline placebo
Intervention description: Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay.; control arem
Intervention MeSH terms: Haloperidol; Haloperidol decanoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Delirium; Mechanical ventilation; Intensive care; Haloperidol

Summary:

      The purpose of this study is to determine if treating delirious intensive care unit patients
      with haloperidol improves mortality.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All adult (>=18 years of age) mechanically ventilated patients admitted to the
             medical, surgical, trauma, or cardiothoracic ICUs of the UPMC main campus who are
             expected by the ICU clinical team to require >24 hours of mechanical ventilation

        Exclusion Criteria:

          -  Baseline QTc >480 milliseconds (ms); history of Parkinson's disease; pregnancy;
             history of schizophrenia or neurologic disease that would confound the delirium
             assessment; deafness or inability to understand English or Spanish; extubation prior
             to enrollment; previously enrolled in this study; patient, family, or attending
             physician refusal; death before enrollment; treatment with haloperidol within 2 days
             prior to ICU admission; and prisoners.
Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Background Metformin in Patient With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: BI 10773; BI 10773 Placebo; BI 10773 / BI 1356; BI 10773; BI 10773 / BI 1356; BI 10773 / BI 1356 Placebo; BI 10773; BI 10773; BI 10773; BI 10773 / BI 1356 Placebo; BI 10773 Placebo; BI 10773 / BI 1356 Placebo; BI 10773; BI 10773 / BI 1356 Placebo
Intervention description: Empagliflozin active; Empagliflozin placebo; Empagliflozin / Linagliptin 25/5 mg Dose FDC active; Empagliflozin active; Empagliflozin / Linagliptin 10/5 mg Dose FDC active; Empagliflozin / Linagliptin 10/5 mg Dose placebo FDC; Empagliflozin active; Empagliflozin active; Empagliflozin active; Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo; Empagliflozin placebo; Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo; Empagliflozin active; Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
Intervention MeSH terms: Empagliflozin; Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 708.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study is to investigate the efficacy, safety and tolerability of
      linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled T2DM
      patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. The primary
      objective of efficacy evaluation is planned after 24 weeks of treatment. The study is
      designed to show superiority of the combination of empagliflozin and linagliptin over
      empagliflozin alone.
    

Eligibility criteria:

        Inclusion criteria:

          1. Signed and dated ICF (Informed Consent Form)

          2. Male or female on diet and exercise regime and on stable background metformin > or
             equal to 1500 mg or maximun dose according to local label

          3. HBA1c (Glicoslated Hemoglobin) > or equal to 8% and < or equal to 10.5 % at Visit 1

          4. HbA1c > or equal to 7 and < or equal to 10.5 at Visit 4

          5. Age > or equal to 18 years

          6. BMI (Body Mass Index) < or equal to 45

        Exclusion criteria:

          1. Uncontrolled hyperglycemia during open label period and placebo add on "run-in" period

          2. Use of any other antidiabetic

          3. Renal function below 60 ml/min/1.73 m2

          4. Antiobesity drugs or aggresive diets

          5. Gastorintestinal surgeries

          6. Current systemic steroids or uncontrolled endocrine disorders other than Diabetes Type
             2

          7. Acute coronary syndrome and stroke within 3 months of informed consent

          8. Known allergies to DPP-IV (Dypeptidil Peptidase IV) or SGLT-2 (Sodium Glucose
             Transporter 2) inhibitors
A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Risperdal Consta; Placebo
Intervention description: 12.5, 25, 37.5 or 50mg intramuscular (IM) injection every 2 weeks; Matching placebo intramuscular (IM) injection every 2 weeks
Intervention MeSH terms: Risperidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 559.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Mood episodes; Bipolar 1 disorder; Intramuscular Injectable; risperidone; safety and efficacy

Summary:

      The purpose of this study is to determine if risperidone is effective and safe in the
      prevention of mood episodes in patients with bipolar 1 disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of bipolar 1 disorder, currently experiencing a mixed or manic episode or
             stable

          -  Two or more bipolar mood episodes in the last 2 years excluding current episode

          -  Negative pregnancy test

        Exclusion Criteria:

          -  History of > than 4 mood episodes a year during the last two years

          -  patients experiencing a depressive episode

          -  History of antisocial or borderline personality illness

          -  Has unstable or serious general medical illness

          -  Has received medications disallowed by study criteria.
A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Romosozumab; Placebo
Intervention description: Administered by subcutaneous injection once a month (QM); Administered by subcutaneous injections once a month
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 67.0
Sex: Female
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Osteoporosis.; Osteoporosis-Postmenopausal.; Bone Diseases-Metabolic.; Bone Diseases.; Musculoskeletal Diseases.

Summary:

      The primary objective is to evaluate the effect of treatment with romosozumab for 6 months
      compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as
      assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory postmenopausal Korean women, ≥ 55 to ≤ 90 years of age at enrollment.

          -  Postmenopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more
             consecutive months prior to screening.

          -  BMD T-score </= -2.50 at the lumbar spine, total hip or femoral neck.

          -  At least 2 vertebrae in the L1 through L4 region and at least one hip are evaluable by
             DXA.

          -  Other inclusion criteria may apply.

        Exclusion Criteria:

          -  Subjects with a BMD T-score </= -4.0 at the lumbar spine, total hip, or femoral neck.

          -  History of hip fracture.

          -  Bone disease other than osteoporosis/ or evidence of any other clinically significant
             disorder, condition/ or disease or significant laboratory abnormalities.

          -  Known sensitivity or intolerance calcium and vitamin D products.

          -  Other exclusion criteria may apply.
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries
Condition: Acute Blunt Soft Tissue Injuries/Contusions
MeSH terms: Wounds and Injuries; Soft Tissue Injuries; Contusions
Intervention: Diclofenac sodium; Placebo
Intervention description: Topical gel 1%- 4 times daily; Topical gel - 4 times daily
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Blunt soft tissue injury/contusion

Summary:

      The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied
      four times a day in subjects with acute blunt soft tissue injuries/contusions of the limbs
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18 years and over.

          -  Fresh impact injury (blunt, traumatic soft tissue injury or contusion) of the upper or
             the lower limbs, not requiring admittance to hospital, meeting baseline pain intensity
             level.Anticipated time between injury and treatment must be less than 3 hours.

        Exclusion Criteria:

          -  Pain medication was taken within the 6 hours that precede randomization.Any physical
             impairment that would influence the study's efficacy evaluations, in particular POM
             such as: peripheral or central neurological disease, significant back pain; in case of
             acute blunt soft tissue injuries of the lower limbs: symptomatic osteoarthritis of the
             hips, knees, or feet, or any other painful conditions of the lower extremities (e.g.,
             painful nail, wound, corn, or wart), in case of acute blunt soft tissue injuries of
             the upper limbs: no painful conditions of the upper extremities.
An Open Label Study for Participants With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: LY2127399
Intervention description: Administered Subcutaneously
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1086.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis

Summary:

      The primary purpose of this study is to help answer if LY2127399 is safe and effective during
      long-term treatment in participants with Rheumatoid Arthritis.

      This study is comprised of 2 periods:

      Period 1: Unblinded treatment for up to 240 weeks for participants who enroll from Study
      H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks
      for participants who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002).

      Period 2: 48-week post-treatment follow-up
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed 24 weeks of participation in Study H9B-MC-BCDO or Study H9B-MC-BCDV, or
             have completed 100 weeks of participation in Study H9B-MC-BCDM

          -  Woman must not be pregnant, breastfeeding, or become pregnant during the study

        Exclusion Criteria:

          -  Current presence of a serious disorder or illness
A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Moses laser enucleation of prostate
Intervention description: Using the moses settings with the Lumenis laser system to evaluate outcomes for enucleation of the prostate; hypothesis is that it leads to faster operative time
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: Male
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Holmium laser enucleation of the prostate (HOLEP) has proven to be efficacious and safe for
      the treatment of benign prostatic hypertrophy (BPH). New laser technologies such as the Moses
      Pulse laser system provide for improved energy delivery which may decrease blood loss and
      operative time. We seek to evaluate Moses technology for enucleation of the prostate in the
      setting of BPH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any man with clinical symptoms fo BPH requiring surgery who has a prostate sized at
             greater than 80 grams

        Exclusion Criteria:

          -  Anyone actively on anticoagulation perioperatively
Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Fostamatinib; Fostamatinib; Fostamatinib
Intervention description: Fostamatinib 100mg twice daily; Fostamatinib 150mg once daily; Fostamatinib 100mg once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1917.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; OSKIRA; Fostamatinib

Summary:

      The purpose of this study is to evaluate the long term safety and tolerability of
      fostamatinib in patients with rheumatoid arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002,
             D4300C00003 or D4300C00004) with fostamatinib

          -  Patients who have participated in a qualifying study and who have been classified as
             non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001,
             D4300C00002, D4300C00003).

        Exclusion Criteria:

          -  Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003
             and D4300C00004)

          -  Females who are pregnant or breast feeding

          -  Poorly controlled hypertension

          -  Significant liver function test abnormalities or physical symptoms of hepatotoxicity

          -  Significant infection

          -  Gastrointestinal intolerance

          -  Cancer