bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: BI 10773; Glimepiride; Placebo; Placebo
Intervention description: Medium dose once daily; 1-4 mg once daily; Placebo matching BI 10773; Placebo matching Glimepiride
Intervention MeSH terms: Glimepiride; Empagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1549.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for
      BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2
      diabetes mellitus and insufficient glycaemic control.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis typ 2 diabetes mellitus

          -  Male and female on diet and exercise regimen, pre-treated with metformin 12 weeks
             prior to randomisation

          -  HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1

          -  18 years or more

          -  BMI equal or less than 45Kg/m2

        Exclusion criteria:

          -  Uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight
             fast during placebo run-in

          -  Any other antidiabetic drug within 12 weeks prior to randomisation except metformin

          -  Acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or
             transient ischemic attack within 12 weeks of informed consent

          -  Indication of liver disease

          -  Moderate to severe renal impairment

          -  Bariatric surgery within past 2 years

          -  Medical history of cancer or treatment for cancer within last 5 years

          -  Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell

          -  Contraindications hypersensitivity to concomitant drugs

          -  Treatment with anti-obesity drugs
Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
Condition: Liver Diseases
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Pioglitazone; Vitamin E; Matching placebo
Intervention description: 30 mg daily; 800 IU daily; Daily
Intervention MeSH terms: Vitamin E; Pioglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 247.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non alcoholic steatohepatitis; Steatohepatitis

Summary:

      The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead
      to an improvement in liver histology in non-diabetic adult patients with non-alcoholic
      steatohepatitis (NASH).
    

Eligibility criteria:

        -  Histologic evidence of NASH based on a liver biopsy obtained within 6 months of
             randomization.

          -  Age 18 years or older
Extension Study of Asenapine [P06107 (NCT01244815)] for Pediatric Bipolar Disorder (P05898)
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Asenapine; Rescue medication
Intervention description: One flavored asenapine sublingual tablet (containing either 2.5, 5 or 10 mg asenapine) twice daily (BID), starting at 2.5 mg on Day 1 for three consecutive days. Normally on Day 4, the dose will increase to 5 mg BID beginning with the evening dose. Normally on Day 7, the dose will increase to 10 mg BID beginning with the evening dose. The dose may be up-titrated earlier than Days 4 and 7 at the investigator's discretion. Beginning on Day 8 (or after at least 1 day on 10 mg BID), asenapine dosing will be flexible (2.5, 5, or 10 mg BID) until up to Week 50.; For participants whose symptoms worsen or are not adequately controlled on assigned treatment, rescue medication may be administered during the trial in the following circumstances. For the control of agitation, anxiety, insomnia, restlessness, or akathisia and extrapyramidal symptoms (EPS) some benzodiazepines (i.e., lorazepam [up to 4 mg/day] or an equivalent dose of short-acting benzodiazepines) and EPS medications (i.e., anticholinergics) are allowed. Benadryl (diphenhydramine) and beta blockers are also permitted, provided that they are not taken within 8 hours of efficacy assessments.
Intervention MeSH terms: Asenapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 322.0
Sex: All
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This study will investigate the safety and tolerability of a flexible dosing regimen of
      asenapine for the long-term treatment of manic or mixed episodes associated with bipolar
      disorder I in children and adolescents who completed study P06107.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed study P06107 and demonstrated acceptable degree of compliance with
             medication, visits and other study requirements

          -  Must be male or a female who is not of childbearing potential and is not sexually
             active or is using a medically accepted method of contraception; or female who is not
             pregnant, or not lactating.

          -  Must have a caregiver or responsible person living with the participant who agrees to
             provide support to ensure compliance with treatment, visits, and protocol procedures

        Exclusion Criteria:

          -  Positive pregnancy test or intention to become pregnant during the study

          -  At imminent risk of self-harm or harm to others

          -  Under involuntary inpatient commitment

          -  Known serological evidence of human immunodeficiency virus (HIV) antibody
A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: ALKS 9072, Low; ALKS 9072, High
Intervention description: IM injection, given monthly; IM injection, given monthly
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 478.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS
      9070) during long-term treatment of subjects with stable schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

        (Subjects who participated in ALK9072-003)

          -  Completed the ALK9072-003 Day 85 visit

          -  Continues to require treatment with an antipsychotic medication

        (New Subjects)

          -  On a stable dose of oral antipsychotic medication

          -  Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual of
             Mental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable

          -  Has been able to achieve outpatient status for more than 3 months prior to screening

          -  Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)

          -  Resides in a stable living situation

        Exclusion Criteria:

        (Subjects who participated in ALK9072-003)

          -  Abnormal clinical laboratory, vital sign, or electrocardiogram (ECG) finding during
             participation in study ALK9072-003 that was clinically relevant and related to study
             drug

          -  Missed more than 1 scheduled study visit during participation in study ALK9072-003

          -  Has a significant or unstable medical condition that would preclude safe completion of
             the current study

          -  Subject is pregnant or breastfeeding

          -  Subject expects to be incarcerated in the next 12 months, or has pending legal action
             which may impact compliance with study participation or procedures

        (New Subjects)

          -  History of poor or inadequate clinical response to treatment with aripiprazole

          -  History of treatment resistance

          -  Diagnosis of current substance dependence (including alcohol)

          -  Pregnant, lactating, or breastfeeding

          -  Has received any long-acting intramuscular antipsychotic medication within 60 days
             prior to screening

          -  Currently under involuntary hospitalization

          -  Current or expected incarceration

        Additional inclusion/exclusion criteria may apply
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
Condition: Hyperparathyroidism, Secondary
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Etelcalcetide
Intervention description: Administered by bolus injection into the venous line of the dialysis circuit at the end of hemodialysis treatment, and prior to or during rinse-back with each hemodialysis session (ie, 3 times per week).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 891.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism

Summary:

      This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG
      416) for the treatment of SHPT in adults with CKD on hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject understands the study procedures and agrees to participate in the study by
             giving written informed consent.

          -  Subject must complete the treatment and follow-up period, or have been discontinued
             for rising intact parathyroid hormone (iPTH), from an AMG 416 phase 3 parent study
             prior to the start of dosing in this study: 20120229 (NCT01785849), 20120230
             (NCT01788046), or 20120359 (NCT01932970).

          -  Subject agrees to not participate in another study of an investigational agent during
             the study.

          -  Other Inclusion Criteria may apply

        Exclusion Criteria:

          -  Currently receiving treatment in another investigational device or drug study.

          -  Currently receiving other investigational procedures while participating in this
             study.

          -  Subject has known sensitivity to any of the products or components to be administered
             during dosing.

          -  Subject has an unstable medical condition based on medical history, physical
             examination, and routine laboratory tests, or is otherwise unstable in the judgment of
             the Investigator.

        Other Exclusion Criteria may apply
A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Olanzapine; Paliperidone ER; Placebo
Intervention description: Once daily in dose range of 5 to 20 mg/day for 15 weeks, then until recurrence; Once daily in dose range of 3 to 12 mg/day for 15 weeks, then until recurrence; Once daily until recurrence (only after initial 15 weeks on paliperidone ER)
Intervention MeSH terms: Olanzapine; Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 768.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar Disorder; Mania; Depression; Manic-Depressive Disorder

Summary:

      The purpose of this study is to evaluate the effectiveness and safety of oral
      extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence
      of mood symptoms in patients with Bipolar I Disorder who initially respond to treatment of an
      acute manic or mixed episode with paliperidone ER. Olanzapine was included as an active
      control arm, although the study is not designed to allow for a direct comparison of
      olanzapine with paliperidone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition)
             criteria for Bipolar I Disorder Most Recent Episode Manic or Mixed (with or without
             psychotic features)

          -  have a history of at least 2 previously documented mood episodes associated with
             Bipolar I Disorder (1 of which must be a manic or mixed episode) that required medical
             treatment within the past 3 years

          -  a total score of at least 20 on the YMRS at screening and at Day 1 of the study.

        Exclusion Criteria:

          -  Meet DSM-IV criteria for any type of episode associated with bipolar disorder other
             than Bipolar I Disorder Most Recent Episode Manic or Mixed

          -  Meet DSM-IV criteria for rapid cycling

          -  Meet DSM-IV criteria for schizoaffective disorder

          -  Known or suspected borderline or antisocial personality disorder

          -  be, in the opinion of the investigator, at significant immediate risk for suicidal or
             violent behavior during the course of the study based on current status or prior
             history (e.g., suicide attempts during previous episodes).
A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis
Condition: Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Intervention: Tenapanor; Placebo; Sevelamer Carbonate
Intervention description: Active Drug; Inactive Drug; Active control
Intervention MeSH terms: Sevelamer
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1559.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This Phase 3, 26-week, open label study with a 12-week, placebo-controlled, randomized
      withdrawal period followed by an open label long term safety extension will evaluate the
      safety and efficacy of tenapanor to treat hyperphosphatemia in end-stage renal disease (ESRD)
      on hemodialysis and peritoneal dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females must be non-pregnant, non-lactating, and either be post-menopausal for at
             least 12 months, have documentation of irreversible surgical sterilization, or confirm
             the use of one of the acceptable contraceptive methods

          -  Males must agree to avoid fathering a child and agree to use an appropriate method of
             contraception

          -  Chronic maintenance hemodialysis 3x a week for at least 3 months

          -  Chronic maintenance peritoneal dialysis for a minimum of 6 months

          -  Kt/V ≥ 1.2 at most recent measurement prior to screening

          -  Prescribed and taking at least 3 doses of phosphate binder per day

          -  Serum phosphorus levels should be between 4.0 and 8.0 mg/dL at screening

          -  Unchanged dose of vitamin D or calcimimetics for the last 4 weeks prior to screening

          -  For enrollment in the study after at least 2 weeks of wash-out, subjects must have
             serum phosphorus levels of at least 6.0 mg/dL but not more than 10.0 mg/dL and have
             had an increase of at least 1.5 mg/dL versus pre-wash out value after 2 or 3 weeks
             wash-out of phosphate binders

        Exclusion Criteria:

          -  Severe hyperphosphatemia defined as serum phosphorus greater than 10.0 mg/dL on
             phosphate-binders at any time point during clinical routine monitoring for the 3
             preceding months before screening visit

          -  Serum/plasma parathyroid hormone >1200 pg/mL

          -  Clinical signs of hypovolemia at enrollment

          -  History of IBD or IBS-D

          -  Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD
             or plans to relocate to another center during the study period

          -  Positive serology with evidence of significant hepatic impairment or WBC elevation
             according to the Investigator

          -  Life expectancy <6 months

          -  Previous exposure to tenapanor
Aromasin Vs Arimidex Study As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: exemestane; anastrozole
Intervention description: take orally one tablet per day of exemestane 25 mg and one tablet per day of anastrozole placebo daily after meal; take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal
Intervention MeSH terms: Anastrozole; Exemestane
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 298.0
Sex: Female
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To verify the non-inferiority of exemestane compared to anastrozole in time to tumor
      progression (TTP), the primary efficacy endpoint, in postmenopausal women with
      advanced/recurrent breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histologically or cytologically confirmed breast cancer at original diagnosis. At
             study entry, the patient must have metastatic progressive or locally recurrent
             inoperable breast cancer.

        Exclusion Criteria:

          -  Having received any hormonal therapy (e.g., Tamoxifen, LHRH-agonists) ovariectomy or
             any chemotherapy for advanced/recurrent breast cancer
Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Lurbinectedin (PM01183); Pegylated liposomal doxorubicin (PLD); Topotecan
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Topotecan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 442.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the
      activity and safety of PM01183 versus PLD or topotecan as control arm in patients with
      platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the
      experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >/= 18 years

          -  Confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary
             peritoneal cancer.

          -  Platinum-resistant disease (PFI: 1-6 months after last platinum-containing
             chemotherapy).

          -  Evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
             v.1.1 criteria

          -  No more than three prior systemic chemotherapy regimens

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) (ECOG PS) ≤ 2

          -  Adequate hematological, renal, metabolic and hepatic function

        Exclusion Criteria:

          -  Concomitant diseases/conditions: cardiac disease, immunodeficiency, chronic active
             hepatitis or cirrhosis, uncontrolled infection, bowel obstruction, any other major
             illness

          -  Prior treatment with PM01183, trabectedin, or with both PLD and topotecan.

          -  Requirement of permanent or frequent (i.e., once per week) external drainages within
             two weeks prior to randomization
A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain
Condition: Chronic Pain; Low Back Pain; Analgesia
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Intervention: ALO-02; Placebo
Intervention description: 20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily; oral placebo, divided into symmetric doses and administered twice daily
Intervention MeSH terms: Naltrexone; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 410.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: oxycodone; naltrexone; chronic pain; low back pain

Summary:

      The primary objective of the study is to determine the analgesic efficacy and safety of
      ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to
      severe chronic low back pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate-to-severe chronic low back pain present for at least 3 months.

          -  Require a continuous around-the-clock opioid analgesic for an extended period of time.

          -  Refrain from taking other opioid and non-opioid medications during the study.

        Exclusion Criteria:

          -  Active or within a past 2 years a history of lumbosacral radiculopathy or chronic low
             back pain due to other underlying disorders such as spinal stenosis with neurologic
             impairment, cancer, infection, or post-surgical intervention.

          -  Documented diagnosis of ongoing pain due to other chronic pain conditions which may
             interfere with assessment of chronic low back pain.

          -  Active or ongoing or history of alcohol or drug abuse.