bioihbjkbjnl/mcl2 huggingface dataset:
Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Exenatide Once Weekly; Placebo
Intervention description: Subcutaneous injection, 2 mg, administered once weekly.; Subcutaneous injection, matching volume of placebo, administered once weekly.
Intervention MeSH terms: Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 14752.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: exenatide once weekly; cardiovascular; Bydureon; Amylin

Summary:

      This study will compare the impact of including exenatide once weekly in addition to usual
      care vs. usual care without exenatide on major cardiovascular outcomes as measured by the
      primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction
      (MI), or nonfatal stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has type 2 diabetes mellitus

          -  Patient has an HbA1c of ≥ 6.5 % and ≤ 10.0% and is currently using one of the
             following treatment regimens: A) Treatment with 0-3 oral antihyperglycemic agents B)
             Insulin therapy, either alone or in combination with up to two oral agents

          -  Female patients must not be breast feeding and agree to use an effective method of
             contraception or must not otherwise be at risk of becoming pregnant.

        Exclusion Criteria:

          -  Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.

          -  Patient has ever been treated with an approved or investigational GLP-1 receptor
             agonist.

          -  Patient is enrolled in another experimental protocol which involves the use of an
             investigational drug or device, or an intervention that would interfere with the
             conduct of the trial.

          -  Patient has a planned or anticipated revascularization procedure.

          -  Pregnancy or planned pregnancy during the trial period.

          -  Patient has end-stage renal disease or an estimated glomerular filtration rate (eGFR)
             of <30 mL/min/1.73m2.

          -  Patient has a history of gastroparesis or pancreatitis.

          -  Personal or family history of medullary thyroid cancer or MEN2 (Multiple
             EndocrineNeoplasia Type 2) or calcitonin level of >40 ng/L at baseline.
Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Empagliflozin; Empagliflozin; Placebo
Intervention MeSH terms: Empagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 730.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin
      regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion
      (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period,
      an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week
      follow-up period.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female patient receiving insulin for the treatment of documented diagnosis of
             Type 1 Diabetes Mellitus (T1DM) for at least 1 year at the time of Visit 1

          -  Fasting C-peptide value of < 0.7 ng/mL (0.23 nmol/L) at Visit 2 measured by the
             central laboratory

          -  Use of, and be willing, based on the Investigator's judgement, to continue throughout
             the duration of the trial, either:

               -  Multiple Daily Injections (MDI) of insulin consisting of at least one basal
                  insulin injection and at least three daily bolus injections OR

               -  Continuous Subcutaneous Insulin Infusion (CSII) of any insulin type, with at
                  least 5 months experience of using CSII prior to Visit 1

          -  HbA1c >/= 7.5% and </= 10.0% at Visit 5 measured by the central laboratory

          -  Age >/= 18 years at Visit 1

        Additional inclusion criteria may apply

        Exclusion criteria:

          -  History of Type 2 Diabetes Mellitus (T2DM), maturity onset diabetes of the young
             (MODY), pancreatic surgery or chronic pancreatitis

          -  Pancreas, pancreatic islet cells or renal transplant recipient

          -  T1DM treatment with any other antihyperglycaemic drug (e.g. metformin,
             alpha-glucosidase inhibitors, Glucagon-like-peptide 1 (GLP-1) analogues,
             Sodium-Glucose Co-Transporter (SGLT-2) inhibitors, pramlintide, inhaled insulin,
             pre-mixed insulins etc.) except subcutaneous basal and bolus insulin within 3 months
             prior to Visit 1

          -  Occurrence of severe hypoglycaemia involving coma/unconsciousness and/or seizure that
             required hospitalisation or hypoglycaemia-related treatment by an emergency physician
             or paramedic within 3 months prior to Visit 1 and until randomisation

          -  Occurence of Diabetic Ketoacidosis (DKA) within 3 months prior to Visit 1 and until
             randomisation

        Additional exclusion criteria may apply
Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat (AbCONTOUR2)
Condition: Central Abdominal Bulging
Intervention: LIPO-202; Placebo
Intervention MeSH terms: Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 793.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a multi-center, randomized, double-blinded, placebo-controlled study evaluating the
      safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to
      subcutaneous fat in non-obese subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or non-pregnant female subjects

          -  Capable of providing written consent.

          -  BMI < 30 kg/m2

          -  Stable diet and exercise routine

          -  Central abdominal bulging that is evaluated by the clinician at least slight bulge,
             not flat

        Exclusion Criteria:

          -  Have had any treatment of the fat around your abdomen, including surgical procedures
             (tummy tuck, liposuction), injections for fat loss or treatments with devices to
             reduce fat in your abdomen.

          -  Plan on starting a weight loss or exercise program during the study.

          -  Known hypersensitivity to study drugs
A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Intervention: NBI-98854; Placebo
Intervention description: NBI-98854 40 mg capsules; NBI-98854 placebo capsules
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854
      administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects of childbearing potential must agree to use hormonal or two forms of
             nonhormonal contraception (dual contraception) consistently during the screening,
             treatment and follow-up periods of the study.

          2. Female subjects must not be pregnant.

          3. Have one of the following clinical diagnoses for at least 3 months prior to screening:
             Schizophrenia or Schizoaffective Disorder, or Mood Disorder.

          4. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to
             screening.

          5. Have moderate or severe TD.

          6. If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or
             mood disorder, be on stable doses.

          7. Be in good general health.

          8. Have adequate hearing, vision, and language skills to perform the procedures specified
             in the protocol.

          9. Have a negative drug screen for amphetamines,barbiturates, benzodiazepines,
             phencyclidine, cocaine, opiates, or cannabinoids

        Exclusion Criteria:

          1. Have an active, clinically significant unstable medical condition within 1 month prior
             to screening.

          2. Have a known history of substance dependence, or substance (drug) or alcohol abuse

          3. Have a significant risk of suicidal or violent behavior.

          4. Have a known history of neuroleptic malignant syndrome.

          5. Have a known history of long QT syndrome or cardiac tachy-arrhythmia.

          6. Have a cancer diagnosis within 3 years of screening (some exceptions allowed)

          7. Have received an investigational drug within 30 days prior to screening or plan to use
             an investigational drug (other than NBI-98854) during the study.

          8. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.

          9. Have an allergy, hypersensitivity, or intolerance to tetrabenazine.

         10. Have had previous exposure with NBI-98854 or had previously participated in an
             NBI-98854 clinical study.

         11. Are currently pregnant or breastfeeding.
A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: TD-4208; Tiotropium
Intervention description: Subjects receiving TD-4208 are blinded to one of two doses of 4208.; There is not a placebo, there is an active comparator (Tiotropium) arm.
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1060.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease, COPD

Summary:

      The purpose of this study is to measure the safety and tolerability of TD 4208, an
      investigational drug being developed to treat people with moderate to very severe COPD,
      compared to tiotropium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a male or female subject 40 years of age or older

        Exclusion Criteria:

          -  Females who are pregnant, lactating, breast-feeding or planning to become pregnant
             during the study
Study to Assess the Long-term Safety, Tolerability, Efficacy of Secukinumab in Pediatric Patients of Age 6 to <18 Years, With Moderate to Severe Plaque Psoriasis
Condition: Moderate to Severe Chronic Plaque-type Psoriasis
MeSH terms: Psoriasis
Intervention: secukinumab low dose; secukinumab high dose
Intervention description: dose depends on the weight group; dose depends on the weight group
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: pediatric; secukinumab; plaque psoriasis; AIN457A; Skin condition; skin disease; itching condition; psoriasis vulgaris; relapsing/remitting psoriasis; immune-mediated systemic disease; skin lesions; red skin lesions; scaly patches; papules; plaques; itching

Summary:

      This was an open-label, parallel-group, two-arm, multicenter study in pediatric subjects aged
      6 years to less than 18 years, at randomization, with moderate to severe chronic plaque
      psoriasis. 84 subjects (most with moderate severity) were enrolled. Subjects were stratified
      by weight and disease severity.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed assent and parental permission (age as per local law) obtained at
             screening before any assessment is performed.

          2. Must be 6 to less than 18 years of age at the time of randomization

          3. Moderate to Severe plaque psoriasis, defined as a PASI score ≥ 12, and IGA mod 2011
             score of ≥ 3, and BSA involvement of ≥10%, at randomization.

          4. Subject being regarded by the investigator to be a candidate for systemic therapy.

        Exclusion Criteria:

          1. Forms of psoriasis other than chronic plaque-type active at randomization

          2. Drug-induced psoriasis

          3. Ongoing use of prohibited treatments

          4. Female subjects of childbearing potential defined as all women physiologically capable
             of becoming pregnant, unless they are using effective methods of contraception during
             dosing and for 16 weeks after stopping study treatment

          5. Pregnant or nursing (lactating) females

          6. Subjects with total WBC count <2,500/μL, or platelets <100,000/μL or neutrophils
             <1,500/μL or hemoglobin <8.5 g/dL at screening

          7. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17
             or the IL-17 receptor
Opioid Prescription After Cesarean Trial
Condition: Pregnancy Related; Opioid Use; Pain
Intervention: 0 to 20 tablets of oxycodone 5mg; Fixed opioid prescription
Intervention description: Individualized opioid prescription protocol (IOPP) that includes shared decision making; 20 tablets of oxycodone 5mg
Intervention MeSH terms: Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized to either an individualized opioid prescription protocol (IOPP) that includes shared decision making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg.
Masking: Single (Outcomes Assessor)
Enrollment: 5521.0
Sex: Female
Healthy volunteers: No

Summary:

      Non-inferiority randomized trial of 5,500 women with a cesarean delivery randomized prior to
      discharge to either an individualized opioid prescription protocol (IOPP) that includes
      shared decision making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible)

          -  Singleton, twin or triplet gestation

        Exclusion Criteria:

          -  An opioid prescription filled during the current pregnancy

          -  Known history of opioid use disorder, by medical record review

          -  Contraindication to opioids (oxycodone)

          -  Contraindications to both acetaminophen and ibuprofen

          -  Significant surgical procedures (e.g., hysterectomy) prior to randomization as pain
             trajectory will be completely different

          -  Fetal or neonatal death prior to randomization

          -  Inability to randomize within 1 day before planned discharge from the hospital

          -  Inability to participate in shared decision making as assessed by research staff

          -  Language barrier (non-English or Spanish speaking)

          -  Participation in this trial in a previous pregnancy

          -  Participation in another intervention study that influences the primary outcome in
             this trial
Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy
Condition: Non-Small-Cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Canakinumab; Docetaxel; Placebo
Intervention description: Canakinumab, 200 mg, subcutaneous. The initial dose regimen was once every 3 weeks (on Day 1 of each 21-day cycle); Docetaxel 75mg/m^2, intravenous, administered on Day 1 of each 21-day cycle; Placebo, sub-cutaneous, admnistered at the RP3R defined in Part 1-safety run-in.
Intervention MeSH terms: Docetaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ACZ885; canakinumab; docetaxel; NSCLC; Non Small Cell Lung Cancer; Carcinoma; IL-1β; PD-(L)1; CANOPY; CANOPY-2; second or third line therapy; PD-(L)1 inhibitors; platinum-based chemotherapy

Summary:

      This study was designed to evaluate the role of canakinumab in combination with docetaxel in
      subjects with advanced non-small cell lung cancer (NSCLC) previously treated with PD-(L)1
      inhibitors and platinum-based chemotherapy.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Histologically confirmed advanced (stage IIIB) or metastatic NSCLC.

          -  Subject had received one prior platinum-based chemotherapy and one prior PD-(L)1
             inhibitor therapy for locally advanced or metastatic disease.

          -  Subject with ECOG performance status (PS) of 0 or 1.

          -  Subject with at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1
             in solid tumors criteria.

        Key Exclusion Criteria:

          -  Subject who previously received docetaxel, canakinumab (or another IL-1β inhibitor),
             or any systemic therapy for their locally advanced or metastatic NSCLC other than one
             platinum-based chemotherapy and one prior PD-(L)1 inhibitor.

          -  Subject with EGFRor ALK positive tumor.

          -  History of severe hypersensitivity reaction to monoclonal antibodies, taxanes or
             excipients of docetaxel or canakinumab.
The Hemophilia Inhibitor Prevention Trial
Condition: Hemophilia A Without Inhibitor
MeSH terms: Hemophilia A
Intervention: Eloctate Injectable Product; Emicizumab Injection [Hemlibra]
Intervention description: This is a factor VIII-Fc fusion protein.; This is a bispecific monoclonal antibody FVIII mimic.
Intervention MeSH terms: Antibodies, Bispecific
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a phase III open-label, randomized controlled trial comparing two drugs in the prevention of hemophilia inhibitor formation.
Masking: None (Open Label)
Enrollment: 1.0
Sex: Male
Minimum age: 4 Months
Maximum age: 4 Years
Healthy volunteers: No
Keywords: hemophilia A; eloctate; Emicizumab; inhibitor

Summary:

      This is a multi-center randomized phase III clinical trial, the Inhibitor Prevention Trial,
      in which Eloctate will be compared with Emicizumab, using adaptive design, to prevent
      inhibitors in patients with severe hemophilia A.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male children >= 4 months and up to 4 years of age.

          2. Severe hemophilia A (FVIII < 0.01 U/ml).

          3. No evidence of an inhibitor i.e. anti-FVIII < 0.6 B.U.

          4. No more than 3 FVIII exposures (Factor VIII concentrate, cryoprecipitate, or fresh
             frozen plasma), including circumcision.

        Exclusion Criteria:

          1. Acquired hemophilia or any bleeding disorder other than hemophilia A.

          2. Treatment with clotting factor or emicizumab previously.

          3. Use of an experimental drug(s).

          4. Surgery anticipated in the next 48 weeks.

          5. Life expectancy less than 5 years.

          6. Parent/caretaker unable or unwilling to keep a personal diary of bleeding frequency
             and study drug treatment, make monthly visits and blood draws at weeks 4, 12, 24, 36,
             and 48.

          7. Other illness, condition or reason in the opinion of the investigator that would make
             the patient unsuitable for the trial.
Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
Condition: Heart Failure; Type 2 Diabetes Mellitus; Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sotagliflozin; Placebo
Intervention description: Sotagliflozin was administered as a tablet(s), orally once daily.; Placebo was administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10584.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to compare the effect of sotagliflozin to placebo on
      total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and
      urgent visit for heart failure [HF] in participants with type 2 diabetes, cardiovascular risk
      factors, and moderate to severely impaired renal function.
    

Eligibility criteria:

        Inclusion criteria :

          -  Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) ≥7%.

          -  Estimated glomerular filtration rate (eGFR) ≥25 and ≤60 milliliter/minute
             (mL/min)/1.73 square meter (m^2).

          -  Age 18 years or older with at least one major cardiovascular risk factor or age 55
             years or older with at least two minor cardiovascular risk factors.

          -  Signed written informed consent.

        Exclusion criteria:

          -  Antihyperglycemic treatment has not been stable within 12 weeks prior to screening.

          -  Planned coronary procedure or surgery after randomization.

          -  Lower extremity complications (such as skin ulcer, infection, osteomyelitis, and
             gangrene) identified during screening and requiring treatment at randomization.

          -  Planning to start a sodium-glucose linked transporter-2 (SGLT2) inhibitor during the
             study.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.