bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dulaglutide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 154.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatrics

Summary:

      The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and
      pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants
      with type 2 diabetes. The study duration is approximately 60 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes, treated with diet and exercise, with or without metformin and/or
             basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks
             prior to study screening.

          -  Have HbA1c >6.5% to ≤11% at screening visit. If newly diagnosed and not on medicine
             for diabetes, HbA1c must be between >6.5 % to ≤9%.

          -  Have a BMI (body mass index) >85 percentile for age, gender and body weight ≥50
             kilograms (110 pounds).

        Exclusion Criteria:

          -  Known type 1 diabetes, or positive GAD65 or IA2 antibodies, or history of diabetic
             ketoacidosis or hyperglycemic hyperosmolar syndrome.

          -  A history of, or at risk for pancreatitis.

          -  Self or family history of Multiple Endocrine Neoplasia (MEN) type 2A or B, thyroid
             C-cell hyperplasia or medullary thyroid cancer, or a blood calcitonin result ≥20
             picograms per milliliter (pg/ml) at screening.

          -  A systolic blood pressure of ≥160 millimeters of mercury (mmHg) or diastolic ≥100
             mmHg.

          -  Active or treated cancer.

          -  A blood disorder where an accurate HbA1c may not be obtainable.

          -  A female of childbearing age, sexually active and not on birth control.

          -  Pregnant or plan to be pregnant during the study, or breastfeeding.

          -  Taking any diabetic medication other than metformin or basal insulin and have not
             stopped it 3 months prior to the screening visit (6 weeks for bolus or mealtime
             insulin).

          -  Have taken oral steroids within the last 60 days or more than 20 days use within the
             past year or 1000 micrograms fluticasone propionate per day.

          -  Using prescription weight loss medications in the last 30 days, or plan to use.

          -  Taking psychiatric medications for depression or illness or attention deficit
             hyperactivity disorder (ADHD) if, the doses has changed within the last 3 months.
Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment
Condition: Mild Cognitive Impairment (MCI)
MeSH terms: Cognitive Dysfunction
Intervention: Behavioral Activation (BA); Supportive Therapy (ST)
Intervention description: BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.; ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 221.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Mild Cognitive Impairment; Memory

Summary:

      The goal of this study is to determine whether increasing participation in cognitive,
      physical, and/or social activities prevents cognitive decline in older African Americans
      (AAs) with Mild Cognitive Impairment (MCI). Patients with MCI are at increased risk for
      Alzheimer's Disease (AD); we propose that increasing participation in activities will prevent
      cognitive decline and may delay the onset of Alzheimer's Disease (AD). We will test this
      hypothesis by conducting a clinical trial in which older AAs with MCI (aged 65 years and
      older) will be randomized to Behavior Activation (BA) (a behavioral intervention that
      increases participation in daily activities) or Supportive Therapy (ST) (a person-centered
      psychotherapy that involves active listening and offering support focusing on participants'
      problems and concerns). We hypothesize that BA-treated subjects will have fewer declines in
      cognitive and functional abilities, fewer depressive and neuropsychiatric symptoms, and
      better quality of life than ST-treated subjects at 24 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 65 years and older

          -  Having a friend/relative willing to serve as a Knowledgeable Informant (KI)

          -  Diagnosis of aMCI-MD

          -  Self-identified as African American

        Exclusion Criteria:

          -  Psychiatric diagnosis, including dementia and major depression

          -  Sensory deficits that preclude neuropsychological testing

          -  Institutional residence

          -  Reduced life expectancy due to known terminal illness
Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: ALD403 (Eptinezumab); Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1121.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of
      migraine headache in chronic migraineurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females between 18 and 65 years of age, inclusive, who were diagnosed with
             migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months
             before screening.

          -  During the 28 day screening period, subjects must adequately complete the headache
             eDiary and must have headaches occurring on ≥ 15 to ≤ 26 days of which at least 8 must
             be migraine days.

          -  Headache eDiary was completed on at least 24 of the 28 days prior to randomization.

        Exclusion Criteria:

          -  Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low
             back pain, complex regional pain syndrome).

          -  Psychiatric conditions that are uncontrolled and/or untreated, including conditions
             that are not controlled for a minimum of 6 months prior to screening. Patients with a
             lifetime history of psychosis, mania, or dementia are excluded.

          -  Any use of botulinum toxin for migraine or for any other medical/cosmetic reasons
             requiring injections within 4 months prior to screening and during the screening
             period.

          -  History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic
             tension-type headache, hypnic headache, cluster headache, hemicrania continua, new
             daily persistent headache, or sporadic and familial hemiplegic migraine.

          -  Receipt of any monoclonal antibody treatment (within or outside a clinical trial)
             within 6 months before screening.

          -  Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway.
An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients
Condition: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder
MeSH terms: Neuromyelitis Optica
Intervention: eculizumab
Intervention MeSH terms: Eculizumab
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
Keywords: Long-term safety study; Extension trial; Eculizumab; Neuromyelitis Optica Spectrum Disorder; Devic's disease; Transverse Myelitis; Optic Neuritis; Relapse; NMO-IgG; CNS Autoimmune Disorders; Demyelinating Disorders

Summary:

      The purpose of this study is to determine whether eculizumab long-term use is safe and
      effective in patients with relapsing NMO.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Patient completed the ECU-NMO-301 trial

          2. Patient has given written informed consent

        Key Exclusion Criteria:

          1. Patients who have withdrawn from the ECU-NMO-301 trial as a result of an AE related to
             trial drug

          2. Female patients who are pregnant, breastfeeding, or intend to conceive during the
             course of the trial
An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
Condition: Brain Cancer
MeSH terms: Glioblastoma; Brain Neoplasms
Intervention: Nivolumab; Temozolomide; Radiotherapy
Intervention MeSH terms: Nivolumab; Temozolomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 560.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated
      (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every
      two weeks in addition to radiation therapy, and then every four weeks. They will be compared
      to patients receiving standard therapy with temozolomide in addition to radiation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and Females, age ≥ 18 years old

          -  Newly-diagnosed brain cancer or tumor called glioblastoma or GBM

          -  Tumor test result shows MGMT unmethylated type

          -  Karnofsky performance status of ≥ 70 (able to care for self)

        Exclusion Criteria:

          -  Prior treatment for GBM (other than surgical resection)

          -  Any known tumor outside of the brain

          -  Recurrent or secondary GBM

          -  Active known or suspected autoimmune disease

          -  Biopsy with less than 20% of tumor removed

        Other protocol-defined inclusion/exclusion criteria apply
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
Condition: Hypercholesterolemia; Atherosclerotic Cardiovascular Disease; Statin Adverse Reaction
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Hypercholesterolemia; Hyperlipidemias
Intervention: bempedoic acid; placebo
Intervention description: bempedoic acid 180 mg tablet; Matching placebo tablet
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 345.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hyperlipidemia; cholesterol; familial hypercholesterolemia; atherosclerotic cardiovascular disease; ASCVD; HeFH; LDL; statin intolerance

Summary:

      The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe
      versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Require lipid-modifying therapy for primary or secondary prevention of cardiovascular
             disease

          -  Fasting LDL-C ≥130 mg/dL for primary prevention or LDL-C ≥100 mg/dL for secondary
             prevention (history of HeFH and/or ASCVD)

          -  Be statin-intolerant (unable to tolerate 2 or more statins)

        Exclusion Criteria:

          -  Total fasting triglyceride ≥500 mg/dL

          -  Renal dysfunction or nephrotic syndrome or history of nephritis

          -  Body Mass Index (BMI) ≥50 kg/m2

          -  Significant cardiovascular disease or cardiovascular event in the past 3 months
An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: ALKS 9072, Low Dose; ALKS 9072, High Dose
Intervention description: Intramuscular injection, given monthly; Intramuscular injection, given monthly
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 291.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Schizophrenia

Summary:

      This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to
      continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects
      with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed the treatment period of Study ALK9072-003EXT

          -  Continues to require chronic treatment with an antipsychotic medication

          -  Continues to reside in a stable living situation

          -  Continues to have an identified reliable informant

        Exclusion Criteria:

          -  Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) finding
             during participation in Study ALK9072-003EXT that was clinically relevant and related
             to study drug

          -  Missed more than 1 scheduled study visit during participation in the preceding Study
             ALK9072-003EXT

          -  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, or has pending legal action which may impact
             compliance with study participation or procedures
Borage and Echium Seed Oils for Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Borage and Echium Seed Oils; Corn oil pills
Intervention description: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks.; Corn oils pills will be taken three times per day for six weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Asthma; Borage; Echium; Botanical

Summary:

      This study plans to look at whether borage and echium seed oils (natural oils from two
      plants) help decrease asthma symptoms and affect cells involved in inflammation. The
      investigators also want to look at how these plant oils decrease the generation of
      inflammatory cells in people with asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female 18 years to 65 years of age

          2. Stable physician diagnosed asthma with FEV1 of greater than 50% of predicted but less
             than 90% of predicted or less than 90% of known best and an asthma control
             questionnaire(ACQ) < 1.5.

        Exclusion Criteria:

          1. Pregnant or nursing

          2. Smoking history of > 10 pack years or active smoking within the past year.

          3. Due to possible effects on LT biosynthesis, use of the following asthma treatments
             within the preceding month will be exclusion criteria:

               -  LT modifying drugs (zileuton, montelukast, zafirlukast)

               -  theophylline

               -  oral steroids

               -  dietary supplements with fatty acids or other products that may interfere with LT
                  generation.

          4. Treatment within the previous three months with omalizumab (monoclonal antibody
             directed against IgE)

          5. Subjects will not be permitted to take non-steroidal anti-inflammatory drugs in the
             week prior to any measurements of ex vivo LT generation because of their effects on LT
             biosynthesis via inhibition of prostaglandin generation.

          6. A history of aspirin-sensitive asthma will be an exclusion criterion as the effects of
             GLA/SDA on prostanoid biosynthesis have not been adequately elucidated.

          7. Significant abnormalities in CBC, differential white cell count, renal function, and
             liver function, or urinalysis.

          8. No subjects will have any serious co-morbid medical condition.
A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas
Condition: Leiomyoma; Uterine Hemorrhage
MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage; Hemorrhage
Intervention: Ulipristal acetate (UPA); Placebo
Intervention description: Ulipristal acetate (UPA) tablet.; Matching placebo tablet.
Intervention MeSH terms: Ulipristal acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 432.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This study will evaluate the superiority of ulipristal acetate versus placebo for the
      treatment of abnormal uterine bleeding associated with uterine fibroids
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal women, 18-50 years, inclusive.

          -  Cyclic abnormal uterine bleeding (heavy or prolonged).

          -  Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in
             the first 8 days of menses.

          -  Minimum of one discrete leiomyoma observable by transvaginal ultrasound.

          -  Endometrial biopsy without evidence of malignancy or atypical or non-atypical
             hyperplasia.

        Exclusion Criteria:

          -  History of uterine surgery that would interfere with the study endpoints.

          -  Known coagulation disorder including bleeding disorder or clotting disorder.

          -  History of, or current uterine, cervix, ovarian, or breast cancer.

          -  Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP),
             or total bilirubin two times or greater than the upper limit of normal range.
Study of Rivoglitazone in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Pioglitazone; Placebo; Rivoglitazone; Rivoglitazone
Intervention description: 45 mg over-encapsulated tablet administered orally, once daily; Rivoglitazone-matching placebo administered as a tablet orally, once daily or a pioglitazone-matching placebo administered as an over-encapsulated tablet orally, once daily capsule; 1.0 mg tablet administered orally, once daily; 1.5 mg tablet administered orally, once daily
Intervention MeSH terms: Pioglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1912.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus

Summary:

      This is a 26-week study in subjects with type 2 diabetes currently sub-optimally controlled
      by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. The total
      duration of a subject's participation will be approximately 30 weeks, including a 2-week
      placebo run-in period, a 26-week double-blind treatment period, and a 2-week post-treatment
      follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of type 2 diabetes

          -  Male or female at least 18 years of age

          -  Hemoglobin A1C > 7% and less or equal to 8.5%

          -  Non-fasting C-peptide > 0.5 ng/mL

          -  Current monotherapy treatment with stable dose of approved non-Thiazolidinedione (TZD)
             antihyperglycemic medication for greater or equal to 3 months prior to screening or

          -  Untreated with any antihyperglycemic agent during 2 months prior to screening

        Exclusion Criteria:

          -  History of type 1 diabetes or ketoacidosis

          -  History of long-term therapy with insulin

          -  Body Mass Index (BMI) > 45 kg/m^2

          -  Known history of Congestive Heart Failure (CHF)

          -  Impaired hepatic function

          -  History of prior treatment failure with, or intolerance of, a TZD

          -  Contraindication to treatment with pioglitazone

          -  Treatment with fibrates

          -  If untreated with oral antihyperglycemic, considered to have failed diet and exercise
             modification as the sole treatment for type 2 diabetes