bioihbjkbjnl/mcl2 huggingface dataset:
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: Evolocumab
Intervention description: subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5035.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: High Cholesterol; Treatment for high cholesterol; Lowering cholesterol; Lowering high cholesterol; Hypercholesterolemia

Summary:

      The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and
      well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease
      (CVD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided informed consent before initiation of any study-specific
             activities/procedures

          -  Subject has completed FOURIER (Study 20110118) while still receiving assigned
             investigational product.

        Exclusion Criteria:

          -  Investigational product was permanently discontinued during FOURIER for any reason,
             including an adverse event or serious adverse event

          -  Subject is currently receiving treatment in another investigational device or drug
             study, or ended treatment on another investigational device or drug study(ies) within
             less than 4 weeks. Other investigational procedures while participating in this study
             are excluded

          -  Subject is not likely to be available to complete protocol-required study visits or
             procedures and/or to comply with required study procedures to the best of the
             subject's and investigator's knowledge

          -  Subject has a history or evidence of any other clinically significant disorder,
             condition, or disease that, in the opinion of the investigator or Amgen physician, if
             consulted, would pose a risk to subject safety or interfere with the study evaluation,
             procedures, or completion

          -  Subject has a known sensitivity to any of the active substances or excipients (eg,
             sodium acetate) to be administered during dosing

          -  Female subject is pregnant or breastfeeding or is planning to become pregnant or
             planning to breastfeed during treatment with evolocumab and within 15 weeks after the
             end of treatment with evolocumab

          -  Female subjects of childbearing potential who are not willing to use an acceptable
             method(s) of effective birth control during treatment with evolocumab and for an
             additional 15 weeks after the end of treatment with evolocumab are excluded
Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Metoprolol ER; Nebivolol
Intervention description: Metoprolol ER once daily, oral administration; Nebivolol once daily, oral administration
Intervention MeSH terms: Metoprolol; Nebivolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hypertension; Nebivolol; Beta blocker; Tolerability

Summary:

      The purpose of this study was to compare the tolerability of nebivolol to metoprolol ER in a
      general population of patients with mild to moderate hypertension receiving
      hydrochlorothiazide (HCTZ)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, ambulatory outpatients

          -  History of hypertension being treated with two medications, one of which must be HCTZ
             and the other of which must not be a beta-blocker or clonidine

          -  SBP of 135-155 mm Hg and/or DBP of >85 mm Hg at screening (Visit 1)

          -  SBP of 140-165 mm Hg and DBP > 90 mmHg at randomization (Visit 3)

        Exclusion Criteria:

          -  Treatment with a beta-blocker or clonidine within 6 months of screening (Visit 1)

          -  Clinically significant respiratory disease (e.g., bronchial asthma, reactive airways
             disease, chronic obstructive pulmonary disease)

          -  Coronary artery disease requiring treatment with a calcium channel blocker or nitrates

          -  Clinically significant cardiovascular disease (e.g., myocardial infarction,
             cerebrovascular event, significant arrhythmia) within 6 months of screening (Visit 1)

          -  History of severe mental illness (including Major Depressive Disorder, psychosis,
             dementia, bipolar disorder) within 6 months of screening (Visit 1)

          -  Use of antipsychotic medication (e.g., dopamine receptor antagonists, serotonin
             dopamine receptor antagonists) or antidepressants

          -  Diabetes mellitus, type I or II

          -  Participation in a previous investigational study of nebivolol at any time

          -  Receipt of treatment with an investigational study drug within 30 days of screening
             (Visit 1)

          -  History of hypersensitivity to nebivolol, metoprolol ER, other beta-blockers, HCTZ, or
             other sulfonamide-derived drugs
A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole Lauroxil; Paliperidone Palmitate
Intervention description: Intramuscular injection; study drug provided using a pre-filled syringe; Intramuscular injection
Intervention MeSH terms: Aripiprazole; Paliperidone Palmitate; Aripiprazole lauroxil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alkermes; schizophrenia; aripiprazole lauroxil; ARISTADA; ARISTADA INITIO

Summary:

      This study will evaluate the efficacy of initiating treatment of schizophrenia with ARISTADA
      INITIO plus 30 mg oral aripiprazole followed by a 2-month dose of AL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a diagnosis of schizophrenia

          -  Requires acute treatment for symptoms of schizophrenia

          -  Willing and able to be confined to an inpatient study unit for up to 3-4 weeks

          -  Has experienced at least one previous hospitalization for schizophrenia

          -  Has been able to achieve outpatient status for more than 3 months in the past year

          -  Has a body mass index (BMI) between 18.0 and 40.0 kg/m^2

          -  Resides in a stable living situation when not hospitalized

          -  Has an identified reliable caregiver (for example, family member)

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Poses a current suicide risk

          -  Pregnant, planning to become pregnant, or breastfeeding

          -  Initiated first antipsychotic treatment within the past 12 months

          -  Has received a long-acting injectable antipsychotic in the past 3 months

          -  Has participated in a clinical study involving any investigational product within the
             past 3 months, or is currently participating in a clinical study involving an
             investigational product.

          -  A positive urine drug test for drugs of abuse

          -  Additional criteria may apply
Effect of Vitamin D on Metabolic Profile in Overweight or Obese Women
Condition: Overweight; Obesity
MeSH terms: Overweight
Intervention: Placebo; vitamin D
Intervention description: dosage form:lactose dosage: 25 micrograms frequency: every day duration: 12weeks; dosage form:cholecalciferol dosage: 25 micrograms (1000 International Unit) frequency: every day duration: 12weeks
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 85.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vitamin D; Metabolic profile; Overweight; Obesity

Summary:

      The investigators investigated the effect of vitamin D3 supplementation on metabolic profile
      (anthropometric measures, blood pressure Lipids, lipoproteins and glycemic indices) in
      overweight or obese women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  18-50 years old

          -  Premenopause

          -  BMI ≥25

        Exclusion Criteria:

          -  Cardiovascular disease

          -  Liver disease

          -  Gastrointestinal disease

          -  Kidney disease

          -  Diabetes mellitus

          -  Osteoporosis

          -  Pregnancy

          -  Lactation
A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Weight Gain
Intervention: exenatide; insulin glargine
Intervention description: subcutaneous injection, 5mcg or 10mcg, twice a day; subcutaneous injection, titrated to target blood glucose level, once a day
Intervention MeSH terms: Insulin Glargine; Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 235.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: diabetes; exenatide; insulin glargine; Lilly; Amylin

Summary:

      This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral
      antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic
      control, as measured by hemoglobin A1c, with minimum weight gain, in patients with
      uncontrolled type 2 diabetes on OADs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes

          -  Currently being treated with the following: Dual or triple oral therapy - on a stable
             combination and dose for at least 3 months.

          -  HbA1c between 7.5% and 10.0%.

          -  BMI >27.

        Exclusion Criteria:

          -  Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy
             (excluding topical and inhaled preparations) or have received such therapy within 2
             weeks immediately prior to study.

          -  Have participated in an interventional medical, surgical, or pharmaceutical study (a
             study in which a medical or surgical treatment was given) within 30 days prior to
             entry into the study.

          -  Treatment with the following medications: *Insulin as outpatient therapy within last 3
             months; *Meglitinides, or acarbose within the last 3 months; *Regular use of any drugs
             that directly affect gastrointestinal motility; *Any previous (study) therapy with
             exenatide or glucagon-like peptide-1 (GLP-1) analogue; *Anti-obesity agent use within
             the last 3 months.

          -  Have received treatment within the last 30 days with a drug that has not received
             regulatory approval for any indication at the time of study entry.
Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone
Condition: Opioid-Induced Bowel Dysfunction
MeSH terms: Intestinal Diseases; Gastrointestinal Diseases; Opioid-Induced Constipation
Intervention: Lubiprostone; Placebo
Intervention description: 24 mcg capsules twice daily (BID); 0 mcg capsules twice daily (BID)
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 437.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone
      administration in patients with opioid-induced bowel dysfunction (OBD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consistent treatment for chronic, non-cancer-related pain with any full agonist opioid
             for at least 30 days prior to screening.

          -  Diagnosis of opioid-induced bowel dysfunction as confirmed during the screening
             period.

          -  If patient has a history of chronic constipation, condition must have been exacerbated
             by initiation of opioid treatment.

          -  Use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal
             motility (other than opioid therapy) must be discontinued during the study.

          -  If treated for clinical depression with selective serotonin reuptake inhibitors
             (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase
             (MAO) inhibitors, treatment must have been at a stable dose for at least 30 days prior
             to screening.

          -  Use of laxative and stool softeners (with the exception of approved rescue
             medications) must be discontinued while on study.

        Exclusion Criteria:

          -  Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of
             administration within 30 days of screening.

          -  Non-ambulatory patients, or those who are unable to eat/drink, take oral medications,
             or to hold down oral medications due to vomiting.

          -  Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma,
             and/or for the management of drug addiction.

          -  Patient has been treated for cancer in the past 5 years (with the exception of
             localized basal cell, squamous cell skin cancer, or in situ cancer that has been
             resected).

          -  Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.

          -  Female patients of childbearing potential who are unable/unwilling to use
             protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan to
             become pregnant or nurse during the study.
Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate
Condition: Healthy
MeSH terms: Flushing
Intervention: BG00012 (dimethyl fumarate); BG00012 placebo; ASA; ASA placebo
Intervention description: Each capsule contains 120 mg dimethyl fumarate (DMF). Fast titration involves taking one 120 mg capsule in the morning and one in the evening (240 mg daily) for one week, and then escalating to a dose of 480 mg daily (two capsules morning and evening) for the remainder of the study.Slow titration expands the dose escalation time to 4 weeks.; Placebo matching BG00012; 325 mg microcoated aspirin (ASA); Placebo matching aspirin
Intervention MeSH terms: Aspirin; Dimethyl Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 173.0
Sex: All
Minimum age: 25 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: BG00012; gastrointestinal events; flushing events; dose titration; pre-medication; aspirin

Summary:

      The primary objective of the study is to evaluate whether premedication with 325 mg
      microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the
      incidence and severity of flushing and GI events following oral administration of BG00012
      dosed at 240 mg twice a day (BID) in healthy volunteers. The secondary objective of this
      study is to evaluate the safety and tolerability of BG00012 when administered orally as a 240
      mg BID dose regimen with and without 325 mg ASA premedication or following a slow-titration
      dosing schedule in healthy volunteers.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must give written informed consent and any authorizations required by local law

          -  Must have a body mass index (BMI) of between 18.0 to 34.0 kg/m^2,inclusive.

          -  Ability to complete the tolerability scales by accurately using the hand-held subject
             reporting device

          -  Subjects of childbearing potential must be willing to practice effective contraception

        Key Exclusion Criteria:

          -  History of clinically significant diseases

          -  History of severe allergic or anaphylactic reactions

          -  Intolerance to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)

          -  Diarrhea, constipation, abdominal pain, flushing or nausea within 28 days prior to Day
             1

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Eplerenone; Placebo
Intervention description: Eplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily; Placebo once daily or every once daily
Intervention MeSH terms: Eplerenone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 221.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Double-blind; eplerenone; Japanese

Summary:

      A study to compare the efficacy and safety of eplerenone in Japanese chronic heart failure
      patients with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese chronic systolic heart failure patients with LVEF =<30% by echocardiography
             and NYHA II or more

          -  Patients who receive standard therapy (Angiotensin converting enzyme inhibitors,
             angiotensin receptor blockers, beta-blocker or diuretic)

        Exclusion Criteria:

          -  Patients with a myocardial infarction, stroke, cardiac surgery or percutaneous
             coronary intervention within 30 days prior to randomization.

          -  Patients with serum potassium >5.0 mmol/L or eGFR <30 ml/min/1.73 m2.
US Phase III Study of APD421 in PONV
Condition: PONV
Intervention: APD421- Amisulpride for IV injection; Placebo
Intervention description: APD421 ( Amisulpride) at 5mg given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia; Matching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia
Intervention MeSH terms: Amisulpride
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 364.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at
      moderate-to-high risk of PONV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients ≥ 18 years of age

          -  Patients undergoing elective surgery (open or laparoscopic technique) under general
             anaesthesia, expected to last at least one hour from induction of anaesthesia to wound
             closure and expected to require at least one overnight stay in hospital

        Exclusion Criteria:

          -  Patients scheduled for outpatient/day case surgery

          -  Patients scheduled to undergo intra-thoracic, transplant or central nervous system
             surgery

          -  Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal
             or epidural) block

          -  Patients who are expected to remain ventilated for a period after surgery

          -  Patients who are expected to need a naso- or orogastric tube in situ after surgery is
             completed
Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-659/TEZ/IVA; IVA
Intervention description: VX-659/TEZ/IVA FDC tablet.; IVA mono tablet.
Intervention MeSH terms: Ivacaftor; VX-659
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and
      pharmacodynamic effect of VX-659, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple
      combination (TC) in Cystic Fibrosis (CF) subjects with F/F or F/MF genotypes.

      The study was discontinued after completion of Part A due to Sponsor's discretion.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Homozygous or heterozygous for F508del mutation (F/F or F/MF genotypes)

          -  Forced expiratory volume in 1 second (FEV1) value ≥40% of predicted mean for age, sex,
             and height.

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary
             status.

          -  Solid organ or hematological transplantation.

        Other protocol defined Inclusion/Exclusion criteria may apply.