bioihbjkbjnl/mcl2 huggingface dataset:
A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Canagliflozin 100 mg; Placebo
Intervention description: Participants will receive 100 mg immediate-release, over-encapsulated tablets (as a capsule) orally once daily.; Participants will receive matching placebo capsules orally once daily.
Intervention MeSH terms: Canagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 476.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the superiority of the effectiveness of
      canagliflozin 100 milligram (mg) daily versus placebo in participants with symptomatic heart
      failure (HF) in improving the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) Total
      Symptom Score (TSS).
    

Eligibility criteria:

        Inclusion Criteria:

        - Have clinically stable symptomatic heart failure (HF) (heart failure with reduced
        ejection fraction [HFrEF] and heart failure with preserved ejection fraction [HFpEF]): (A)
        For HFrEF: (a) ejection fraction (EF) less than or equal to (<=) 40 percent (%) and (b) a
        primary diagnosis of HF OR 2 medical visits (including virtual) with a HF diagnosis code in
        any position in the past 18 months (B) For HFpEF: (a) EF greater than (>) 40%; (b) a
        primary diagnosis of HF OR 2 medical visits (including virtual) with a HF diagnosis code in
        any position in the past 18 months, AND; (C) on a loop diuretic or spironolactone or
        eplerenone (mineralocorticoid receptor antagonists), in the past 18 months

          -  Have a baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) score of less than or
             equal to (<=) 80 prior to randomization

          -  Be able to read and understand English

          -  Possess and have sole use (example: not shared with other users) of smartphone
             compatible with the Fitbit device

          -  Willing/able to wear the Fitbit device on a regular basis for the 9-month study period

        Exclusion Criteria:

          -  Currently taking a sodium-glucose co-transporter 2 inhibitor (SGLT2i) or within the
             last 3 months

          -  History of diabetic ketoacidosis or have type 1 diabetes mellitus (T1DM)

          -  Have acute decompensated HF (exacerbation of symptomatic HF) requiring intravenous
             diuretics, inotropes, or vasodilators within the last 4 weeks

          -  Have stage 4 or 5 Chronic Kidney Disease (that is, estimated glomerular filtration
             rate [eGFR] <30 milliliter per minute [ml/min] on dialysis) from the most recent
             assessment

          -  Have a diagnosis of hypotension within 30 days
Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder
Condition: Bipolar I Disorder
Intervention: Cariprazine
Intervention description: Cariprazine was supplied in capsules.
Intervention MeSH terms: Cariprazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 403.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Mania; Acute mania; Bipolar I disorder

Summary:

      The objective of this study is to evaluate the long-term safety, tolerability, and
      pharmacokinetics of cariprazine in patients with bipolar I disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have provided informed consent prior to any study specific procedures.

          -  Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders,
             Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed
             by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition (SCID).

          -  Patients who experienced a manic or mixed episode that required treatment within the
             past 12 months.

          -  Patients with normal physical examination, laboratory, vital signs, and
             electrocardiogram (ECG).

        Exclusion Criteria:

          -  Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I
             disorder.
Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Ezogabine: USAN Retigabine (International Nonproprietary Name)
Intervention description: Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patient receives between 600 and 1200 mg of retigabine per day. The duration will be until the trial concludes or the patient leaves the trial.
Intervention MeSH terms: Ezogabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Epilepsy; Partial Seizures; Potassium Channels; Anticonvulsant; Complex Partial Seizures; Epilepsies, Partial; RTG115098

Summary:

      The purpose of this study is to evaluate the safety and tolerability of long-term therapy
      with retigabine administered as adjunctive therapy in adult epilepsy patients with
      partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of
      long-term treatment with retigabine and patient quality of life will also be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has successfully completed the Maintenance and Transition phases of Study
             VRX-RET-E22-301 for the treatment of partial-onset seizures

          -  Patient is expected to benefit from participation in the study in the opinion of the
             Investigator.

        Exclusion Criteria:

          -  Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-301 study or
             is experiencing an ongoing serious adverse event.

          -  Patient is receiving any investigational drug or using any experimental device in
             addition to Retigabine for treatment of epilepsy or any other medical condition.

          -  Patient has any other condition that would prevent compliance with the study
             procedures or proper reporting of adverse events.
Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain
Condition: Post-operative Dental Pain
MeSH terms: Toothache
Intervention: Test acetaminophen; Commercial acetaminophen; Commercial ibuprofen; Placebo
Intervention description: single dose of 2 Test acetaminophen 500 mg tablets; single dose of 2 acetaminophen 500 mg caplets; Single dose of 2 ibuprofen 200 mg Liquid-filled Capsules; 2 placebo caplets
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Post-operative dental pain following third molar extraction.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 664.0
Sex: All
Minimum age: 17 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      To evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as
      two Test Acetaminophen 500 mg tablets (Test ACM) compared with 1000 mg acetaminophen
      administered as two commercial acetaminophen 500 mg caplets (ACM) and 400 mg ibuprofen
      administered as two commercial ibuprofen 200 mg liquid-filled capsules (IBU) in the dental
      pain model following third-molar extractions.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 17 to 50 years old

          2. Weigh 100 lbs. or greater and have a body mass index (BMI) of 18 to 30 (inclusive)

          3. Dental extraction of three or four third molars

          4. Meets post-surgical pain criteria

          5. Females of childbearing age must be willing to use acceptable method of birth control

        Exclusion Criteria:

          1. Currently pregnant or planning to be pregnant or nursing a baby

          2. Known allergy to acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs)
             including aspirin, as well as hydrocodone or other opioids

          3. Inability to swallow whole large tablets or capsules

          4. Have other conditions that the investigator feels may impact subject's safety and/or
             the integrity of the study

          5. Use of pain medications 5 or more times per week

          6. Have a history of chronic tranquilizer use, heavy drinking, or substance abuse in the
             last 5 years

          7. History of endoscopically documented peptic ulcer disease or bleeding disorder in the
             last 2 years

          8. Have a positive urine drug screen
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: SOF/VEL
Intervention description: 400/100 mg FDC tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy, safety, and tolerability of
      treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in
      participants with chronic hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

        Key Exclusion Criteria:

          -  Any other chronic liver disease

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

          -  Clinical hepatic decompensation

          -  Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A
             inhibitor

        Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY900014; Insulin Lispro; Insulin Glargine; Insulin Degludec
Intervention description: Administered SC; Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 628.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in
      combination with insulin glargine or insulin degludec, is safe and effective in participants
      with type 2 diabetes (T2D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have T2D based on the disease diagnostic criteria World Health
             Organization (WHO) classification.

          -  Participants must have been treated for at least 90 days prior to screening with
             either basal insulin + at least 1 prandial injection of bolus insulin or premixed
             analog/human insulin regimens at least twice daily.

          -  Participants must be treated no more than 3 oral anti-hyperglycemic medications
             (OAMs).

          -  Participants must have a HbA1c ≥7.0% and ≤11.0%.

          -  Participants must have body mass index (BMI) of ≤35.0 kilograms per meter squared
             (kg/m2).

        Exclusion Criteria:

          -  Participants must not have been diagnosed, at any time, with type 1 diabetes (T1D) or
             latent autoimmune diabetes in adults.

          -  Participants must not have had any episode of severe hypoglycemia within the 6 months
             prior to screening.

          -  Participants must not have had 1 or more episodes of diabetic ketoacidosis or
             hyperglycemic hyperosmolar state within the 6 months prior to screening.

          -  Participants must not have used thiazolidinediones, glucagon-like peptide 1 (GLP-1)
             receptor agonist, or pramlintide within 90 days prior to screening.
VIR-7831 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: VIR-7831; Placebo; Remdesivir
Intervention description: VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1.; Commercially available 0.9% sodium chloride solution; Antiviral agent
Intervention MeSH terms: Remdesivir; Sotrovimab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 367.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; COVID 19; Coronaviridae Infections; Coronavirus Infections; RNA Virus Infections; Virus Diseases; Nidovirales Infections; SARS-CoV-2; SARS Coronavirus; ACTIV-3; ACTIV3; TICO

Summary:

      This study looks at the safety and effectiveness of VIR-7831 in treating COVID-19 in people
      who have been hospitalized with the infection. Participants in the study will be treated with
      either VIR-7831 plus current standard of care (SOC), or with placebo plus current SOC. This
      is ACTIV-3/TICO Treatment Trial H2.
    

Eligibility criteria:

        Inclusion Criteria: Refer to the master protocol (NCT04501978)

        Exclusion Criteria: Refer to the master protocol (NCT04501978)

        Additional Exclusion Criteria:

          1. Pregnant women

          2. Nursing mothers

        In addition, prior to the initial futility assessment which is performed when approximately
        150 participants have been enrolled on VIR-7831 and 150 on placebo, patients on highflow
        oxygen or non-invasive ventilation (category 5 of the pulmonary ordinal outcome) will be
        excluded. These patients may be eligible for the trial if the initial futility assessment
        is passed by this agent.
A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: M207 Microneedle System
Intervention description: M207 Microneedle System 3.8 mg
Intervention MeSH terms: Oxazolidinones; Zolmitriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single dose, open-label treatment
Masking: None (Open Label)
Masking description: Open-label
Enrollment: 342.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: migraine; migraine headache; acute migraine; acute migraine headache

Summary:

      This is an open-label, twelve-month safety study. There is a screening period followed by a
      run-in period to record migraine activity. Qualified subjects will receive study medication
      for up to twelve months for the treatment of multiple migraine attacks. Using the electronic
      diary (eDiary) to confirm they are experiencing a qualified migraine, subjects will
      self-administer the patches and respond to questions in the eDiary post treatment
      administration.
    

Eligibility criteria:

        Main Inclusion Criteria:

          1. Women or men 18 to 75 years of age

          2. Greater than 1 year history of episodic, migraine (with or without aura) with onset
             prior to 50 years of age.

          3. Migraine history during the prior 6 months must include:

               1. at least 2 migraines per month

               2. no more than 8 migraines per month

               3. no more than 15 headache days per month

          4. Women of child-bearing potential must not be pregnant, must agree to avoid pregnancy
             and use an acceptable double-barrier method of birth control during the trial.

          5. Willing and able to treat a minimum of 2 migraines per month with study medication and
             consistently complete eDiary for up to 12 months.

        Main Exclusion Criteria:

          1. Contraindication to triptans

          2. Use of selective serotonin reuptake inhibitors (drugs like Prozac®) or serotonin or
             norepinephrine reuptake inhibitors (drugs like Effexor®) or anti-coagulants (drugs
             like Coumadin®)

          3. Known allergy or sensitivity to zolmitriptan or its derivatives or formulations

          4. Known allergy or sensitivity to adhesives and/or titanium

          5. Women who are pregnant, breast-feeding or plan a pregnancy during this study

          6. Three or more of the following cardiovascular risk factors:

               -  Current tobacco use

               -  Hypertension or receiving anti-hypertensive medication for hypertension

               -  Hyperlipidemia or on prescribed anti-cholesterol treatment

               -  Family history of premature coronary artery disease

               -  Diabetes mellitus

          7. History or current abuse or dependence on alcohol or drugs
A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
Condition: Glioblastoma; Gliosarcoma
MeSH terms: Glioblastoma; Gliosarcoma
Intervention: Temozolomide; Depatuxizumab mafodotin; Radiation; Placebo for ABT-414
Intervention description: Oral Capsule; Intravenous (IV) Infusion; IV Infusion (IV)
Intervention MeSH terms: Temozolomide; ABT-414
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Sub-study was open-label.
Enrollment: 691.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Newly Diagnosed Glioblastoma; Epithelial Growth Factor Receptor (EGFR); Temozolomide; ABT-414; Radiology Therapy Oncology Group; Antibody Drug Conjugate; Brain Tumor; Brain Tumor Group; EGFRvIII; EGFR Amplified; First Line Therapy; Brain Cancer

Summary:

      This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and
      temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall
      survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal
      growth factor receptor (EGFR) amplification.

      In addition, there is a Phase 1, open-label, multicenter sub-study to assess the
      pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed
      EGFR-amplified GBM who have mild or moderate hepatic impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a clinical diagnosis of glioblastoma (GBM).

          -  Must have a confirmed epidermal growth factor receptor amplification in tumor tissue.

          -  Must have a Karnofsky Performance Status (KPS) >= 70 at assessment <= 14 days prior to
             randomization (N/A to the sub-study).

          -  Must have recovered from effects of surgery, postoperative infection and other
             complications of surgery.

          -  Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the
             participant must have adequate bone marrow and renal function and have
             mild-to-moderate hepatic impairment).

        Exclusion Criteria:

          -  Multifocal, recurrent or metastatic GBM or gliomatosis cerebri (For the sub-study, the
             participant can have multifocal GBM and glimatosis cerebri but can't have recurrent or
             metastatic GBM).

          -  Prior chemo therapy or radiosensitizer for head and neck cancer.

          -  Prior radiotherapy to the head or neck in overlap of radiation fields.

          -  Prior therapy for glioblastoma or other invasive malignancy.

          -  Prior, concomitant or planned treatment with Novo Tumor Treatment Fields (Novo-TTF),
             EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or
             intracavity anti-neoplastic therapy.
A Study of Ibuprofen (IBU) 250mg/APAP 500mg In The Treatment Of Post-Surgical Dental Pain
Condition: Pain
MeSH terms: Toothache
Intervention: FDC IBU/APAP 250 mg/500 mg; Placebo
Intervention description: FDC IBU/APAP 250 mg/500 mg; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Ibuprofen, acetaminophen, pain, molar extraction

Summary:

      This study is being conducted to determine the overall analgesic efficacy and safety of a
      fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to placebo in
      subjects who are experiencing post operative pain following surgical extraction of 3 or more
      third molar teeth. A review of any reported adverse events will also be completed.
    

Eligibility criteria:

        Inclusion Criteria

          1. Males and females 18 years to 40 years of age (inclusive).

          2. Outpatients who have undergone surgical extraction of 3 or more third molars, of which
             at least 2 must be a partial or complete bony mandibular impaction.

          3. Subject must have at least moderate pain on the 4 point categorical scale, confirmed
             by at least 50 mm on the 100 mm VAS PSR scale within approximately 5 hours (ie, less
             than or equal to 5 hours, 15 minutes) after surgery is completed.

          4. In general good health and have no contraindications to the study or rescue
             medication.

        Exclusion Criteria

          1. Presence or history of any significant hepatic, renal, endocrine, cardiovascular,
             neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic
             disorder determined by the Investigator to place the subject at increased risk,
             including the presence or history within 2 years of screening of the following medical
             conditions/disorders:

               -  Gastrointestinal ulcer or gastrointestinal bleeding;

               -  Paralytic ileus or other gastrointestinal obstructive disorders;

               -  Bleeding disorder.

          2. Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP,
             tramadol, other opioids, or to their combinations.

          3. Prior use of any type of analgesic or NSAID within five half lives of that drug or
             less before taking the first dose of investigational product, except for pre
             anesthetic medication and anesthesia for the procedure.

             .