bioihbjkbjnl/mcl2 huggingface dataset:
Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)
Condition: Asthma
MeSH terms: Asthma
Intervention: Dupilumab SAR231893 (REGN668)
Intervention description: Pharmaceutical form: prefilled syringes
Route of administration: subcutaneous
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 393.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To describe the long-term safety of dupilumab in treatment of participants with moderate to
      severe asthma who completed the previous asthma clinical trial (TRAVERSE-LTS12551).
    

Eligibility criteria:

        Inclusion criteria:

          -  Participants with asthma who completed the treatment period in the previous dupilumab
             asthma clinical study LTS12551.

          -  Signed written informed consent.

        Exclusion criteria:

          -  Participants who experienced any systemic hypersensitivity reactions to the
             investigational medicinal product in the previous dupilumab asthma study LTS12551,
             which, in the opinion of the Investigator, could indicate that continued treatment
             with dupilumab might present an unreasonable risk for the participant.

          -  Clinically significant comorbidity/lung disease other than asthma.

          -  Participants with active autoimmune disease or participants who, as per Investigator's
             medical judgment, were suspected of having high risk for developing autoimmune
             disease.

          -  History of malignancy within 5 years before enrollment except completely treated in
             situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous
             or basal cell carcinoma of the skin.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Canagliflozin; Placebo; Sitagliptin
Intervention description: One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks (Main Study) or 26 weeks (High Glycemic Substudy); One matching placebo capsule orally once daily for 26 weeks (Main Study); One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 (Main Study)
Intervention MeSH terms: Sitagliptin Phosphate; Canagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 678.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 2; Canagliflozin; Placebo; Hemoglobin A1c; Type 2 diabetes mellitus

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2
      different doses of canagliflozin administered as monotherapy compared with placebo in
      patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have a diagnosis of T2DM

          -  Patients in the main study must have a Hemoglobin A1c (HbA1c) between >=7% and <=10%
             and a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)

          -  Patients in the High Glycemic Cohort Substudy must have an HbA1c between >10% and
             <=12% and a FPG <=350 mg/dL (19.44 mmol/L)

        Exclusion Criteria:

          -  History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta
             cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a
             severe hypoglycemic episode within 6 months before screening
A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)
Condition: Sleep Initiation and Maintenance Disorders; Mental Disorders; Dyssomnias; Sleep Disorders; Sleep Disorder, Intrinsic
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias; Dyssomnias; Sleep Disorders, Intrinsic; Mental Disorders
Intervention: Esmirtazapine; Placebo
Intervention description: One esmirtazapine 4.5 mg tablet once a day; One placebo tablet once a day
Intervention MeSH terms: Mirtazapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 460.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: placebo controlled; randomized; double blind

Summary:

      To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081,
      SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia.
      Primary efficacy variable is Total Sleep Time (TST).
    

Eligibility criteria:

        Inclusion Criteria:

          -  are at least 18 and less than 65 years;

          -  sign written informed consent after the scope and nature of the investigation have
             been explained;

          -  have shown capability to complete the LogPad questionnaires;

          -  have difficulty falling asleep, maintaining sleep or have early morning awakening;

        Exclusion Criteria:

          -  Significant medical or psychiatric illness causing sleep disturbances.

          -  Have a history of bipolar disorder or attempted suicide or have a family (immediate
             family) history of suicide.

          -  Have a sleep disorder such as sleep-related breathing disorder, restless leg syndrome,
             narcolepsy.

          -  Significant other medical illness such as acute or chronic pain, heart-, kidney-, or
             liver disease within the last year.

          -  Currently diagnosed or meet the criteria for Major Depressive Disorder (MDD) or have
             been treated for MDD in the last 2 years.

          -  Substance abuse, excessive use of alcohol (determined by the physician) or drug
             addiction within the last year.

          -  Are night workers or rotating shift workers or plan to travel through more than 3
             time-zones.

          -  Routinely nap during the day.

          -  Have a Body Mass Index (BMI) of 36 or more.
Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
Condition: Post-operative Pain
MeSH terms: Toothache; Pain, Postoperative
Intervention: Ibuprofen/acetaminophen; Ibuprofen/acetaminophen (higher dose); Nurofen Plus®; Panadeine® Extra; Placebo
Intervention description: One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet, single dose taken orally with 300 ml water; Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg, single dose taken orally with 300 ml water; Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®), single dose taken orally with 300 ml water; Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra), single dose taken orally with 300 ml water; Two placebo tablets, single dose taken orally with 300 ml water
Intervention MeSH terms: Acetaminophen; Ibuprofen; Codeine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 678.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Dental pain; Ibuprofen; Acetaminophen; Nurofen Plus®; Panadeine® Extra; Paracetamol

Summary:

      The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen
      plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg acetaminophen compared with Nurofen
      Plus® and Panadeine® Extra.
    

Eligibility criteria:

        Main Inclusion Criteria:

        Experiencing moderate to severe pain after extraction of impacted third molars

        Main Exclusion Criteria:

        Any ongoing painful condition other than that associated with the current third molar
        surgery that could significantly interfere with the subject's suitability Any condition
        that would render the subject unsuitable to receive an NSAID, acetaminophen or codeine
MOM Program 8-Year Follow-up
Condition: Child Development
Intervention: MOM Program home visiting; Control
Intervention description: Mixed professional home visiting program.; Control group will receive same assessment batteries at follow-up but did not receive the home visiting program.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 187.0
Sex: All
Minimum age: 94 Months
Maximum age: 98 Months
Healthy volunteers: No
Keywords: Evaluate developmental outcomes; Evaluate child cognitive, academic, and behavioral outcomes

Summary:

      Study measures will evaluate cognitive, academic, and behavioral outcomes for the children,
      school services received, and caregiver stress and depression. The main study outcome
      measures include cognitive status, school functioning, and behavior. Long-term outcomes will
      be studied in attempt to verify the 33 and 60 month significant differences found in school
      participation and behavior between the intervention and control groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Families from the original MOM RCT that participated in the 60 month evaluation

          -  Able to return to Philadelphia area for testing

          -  Parental/guardian informed consent and child assent

        Exclusion Criteria:

          -  Children unable to complete testing due to sensory, physical, or other deficits, as
             determined by clinical review by study psychologist

          -  Caregivers unwilling to authorize the release of school information

          -  Non-English speaking
A Study of the Safety and Efficacy of Golimumab in Patients With Active Psoriatic Arthritis
Condition: Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: golimumab; Placebo; golimumab; golimumab
Intervention description: 50 mg sc injs every 4 wks from wk 0 thru 5 yrs (unless early escape at wk 16); golimumab - if early escape, 100mg sc injection every 4 wks beginning wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100mg; SC injections ever 4 wks thru Wk 20 (unless early escape at wk 16); golimumab - if early escape, 50mg sc injection from wk 16 up to 5 yrs; golimumab -50mg sc injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg; 100 mg sc injections every 4 wks from wk 0 up to 5 yrs
Intervention MeSH terms: Golimumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 407.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; Spondyloarthritis; Spondyloarthropathy; subcutaneous injection

Summary:

      The purpose of this study is to evaluate the safety and efficacy (improvement of signs and
      symptoms) of subcutaneous (under the skin) injections of golimumab for the treatment of
      active psoriatic arthritis (PsA). Efficacy will be measured by reduction in the signs and
      symptoms of active PsA, including effects on joint pain and swelling, changes on x-ray
      related to joint damage, psoriasis skin lesions, physical function, and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Psoriatic arthritis (PsA) diagnosed > 6months prior

          -  Active PsA at the time of screening and at baseline visits, with >= 3 swollen joints
             and >= 3 tender joints

          -  Have at least 1 of the PsA subsets (DIP joint arthritis, polyarticular arthritis
             without rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or
             spondylitis with peripheral arthritis)

          -  Active plaque psoriasis with a lesion >= 2cm in diameter

          -  Active arthritis despite current disease modifying anti-rheumatic drug (DMARD) or
             nonsteroidal anti-inflammatory drug (NSAID) therapy

          -  Stable doses of methotrexate, low-dose corticosteroids, and NSAIDs are permitted.

        Exclusion Criteria:

          -  No prior treatment with biologic anti-TNF agents (infliximab, etanercept, adalimumab)

          -  No treatment with alefacept or efalizumab within 3 months prior to the first study
             drug injection

          -  No DMARDs other than methotrexate, or immunosuppressive drugs within 4 weeks prior to
             the first study drug injection.
Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy
Condition: Heterozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Placebo; Alirocumab
Intervention MeSH terms: Alirocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to evaluate the effect of alirocumab 150 mg every 2
      weeks (Q2W) in comparison with placebo on the frequency of low-density lipoprotein (LDL)
      apheresis treatments in participants with heterozygous familial hypercholesterolemia (HeFH)
      undergoing weekly or bi-weekly LDL apheresis therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women ≥18 years of age at the time of the screening visit

          2. Diagnosis of HeFH (Heterozygous familial hypercholesterolemia)

          3. Currently undergoing LDL (low-density lipoprotein) apheresis therapy QW (weekly) or
             Q2W (every 2 weeks) or at least 8 weeks prior to the screening visit

        Exclusion Criteria:

          1. Homozygous FH (familial hypercholesterolemia)

          2. Background medical LMT (lipid-modifying therapy) (if applicable) that has not been
             stable for at least 8 weeks prior to the screening visit

          3. LDL apheresis schedule/ apheresis settings that have not been stable for at least 8
             weeks prior to the screening visit

          4. An LDL apheresis schedule other than QW to Q2W

          5. Initiation of a new exercise program or exercise that has not remained stable within 8
             weeks prior to the screening visit (week -2)

          6. Initiation of a new diet or a diet that has not been stable within 8 weeks prior to
             the screening visit (week -2)

          7. Use of nutraceuticals or over-the-counter therapies known to affect lipids, at a
             dose/amount that has not been stable for at least 8 weeks prior to the screening visit
             (week -2), or between the screening and randomization visit

          8. Presence of any clinically significant uncontrolled endocrine disease known to
             influence serum lipids or lipoproteins

          9. Known history of a positive test for human immunodeficiency virus

         10. Use of any active investigational drugs within 1 month or 5 half-lives of screening,
             whichever is longer

         11. Patients who have been treated with at least 1 dose of alirocumab or any other
             anti-PCSK9 monoclonal antibody in any other clinical studies

         12. Pregnant or breastfeeding women
A Study of Alimta/Cisplatin/Gefitinib for Asian Non-smoking Participants With Non Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Cisplatin; Gefitinib; Gefitinib
Intervention description: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles.; 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles; 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, for maintenance in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy; 250 milligrams (mg) administered orally once a day, every day of 21-day cycles administered as a monotherapy
Intervention MeSH terms: Pemetrexed; Gefitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 236.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare two different approaches to treating non-small cell
      lung cancer (NSCLC) in East Asian never-smoker participants. Half of the participants will
      receive chemotherapy (pemetrexed/cisplatin) followed by an oral anti-cancer agent (gefitinib)
      and the other half of the participants will receive only the oral anti-cancer agent
      (gefitinib).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological diagnosis of NSCLC with locally advanced or metastatic disease that is of
             non-squamous histology.

          -  Participants must be "light ex-smokers" or "never-smokers".

               -  "Light ex-smokers" defined as having ceased smoking for greater than or equal to
                  5 years and not to have exceeded 10 pack-years.

               -  "Never-smokers" are defined as having smoked <100 cigarettes or equivalent during
                  his/her lifetime.

          -  Participants must be of East Asian ethnicity.

          -  No prior systemic therapy for lung cancer.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

        Exclusion Criteria:

          -  Presence of clinically significant (by physical exam) third-space fluid collections,
             for example, ascites or pleural effusions that cannot be controlled by drainage or
             other procedures prior to study entry.

          -  Any evidence of clinically active interstitial lung disease. Asymptomatic participants
             with chronic, stable, radiographic changes are eligible.

          -  Participants whose Epidermal Growth Factor Receptor (EGFR) mutation status is known
             prior to study entry will be excluded. Participants in which EGFR mutation testing has
             not been performed, or whose EGFR mutation status is unknown or inconclusive at study
             entry are eligible.
52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Metformin; Sulphonylurea; Saxagliptin
Intervention description: open-label metformin; Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks); Saxagliptin 5 mg tablets
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 891.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DPP-4 Inhibitors; HbA1c; incretins

Summary:

      Saxagliptin is a new investigational medication being developed for treatment of type 2
      diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in
      addition to metformin and compare to sulphonylurea in addition with metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes,

          -  Treatment with metformin alone on stable doses of 1500 mg or higher per day for at
             least 8 weeks prior to Visit 1,

          -  HbA1c >6.5% and ≤10.0%

        Exclusion Criteria:

          -  Type 1 diabetes,

          -  history of diabetic ketoacidosis or hyperosmolar non-ketonic coma,

          -  Insulin therapy within one year of enrolment (with the exception of insulin therapy
             during a hospitalization or use in gestational diabetes)