bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Etanercept; Etanercept; Methotrexate
Intervention description: 10 mg twice weekly, subcutaneous injection for 52 weeks; 25 mg, twice weekly, subcutaneous injection for 52 weeks; up to 8 mg per week, oral dosing for 52 weeks
Intervention MeSH terms: Etanercept; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 550.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Arthritis

Summary:

      The purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared
      with methotrexate (up to 8 mg per week) on the slowing of joint destruction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be Japanese and live in Japan

          -  Must be age 20 to 75 years

          -  Diagnosed less than or equal to 10 years from time of first visit

        Exclusion Criteria:

          -  Anyone who has received etanercept or TNF-inhibitors such as infliximab or adalimumab
             in the past

          -  Patient with other rheumatic diseases or conditions that could predispose the patient
             to infection

          -  Pregnant or lactating women
A Study of Mycophenolate Mofetil (CellCept) in Lung Transplant Recipients
Condition: Lung Transplantation
Intervention: mycophenolate mofetil
Intervention description: 1.5 g PO BID from Days 2 to 30 post-transplantation, 1 g PO BID Days 31 to 90 post-transplantation
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single center study will assess the pharmacokinetics, efficacy and safety of
      mycophenolate mofetil in lung allograft recipients. Participants will be split into 2 groups
      according to the original disease: Group A (cystic fibrosis) and Group B (chronic obstructive
      pulmonary disease [COPD], emphysema, idiopathic pulmonary fibrosis, alpha-1 antitrypsin
      deficiency [A1AD]). All participants will receive mycophenolate mofetil orally, 1.5 grams (g)
      twice daily (BID) from Day 2 to 30 post transplantation, and 1 g BID from Day 31 to 90 post
      transplantation. Anticipated time on study treatment is 90 days, and target sample size is
      50-100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  primary single or bilateral lung allograft

          -  original disease cystic fibrosis, COPD, emphysema, idiopathic pulmonary fibrosis or
             A1AD

        Exclusion Criteria:

          -  lung allograft retransplantation

          -  multiple organ transplantation

          -  severe gastrointestinal disorder

          -  malignancies or history of malignancy
A Study of MK-3009 in Japanese Patients With Skin or Blood Stream Infections Caused by Methicillin-resistant Staphylococcus Aureus (MK-3009-002)
Condition: Staphylococcal Infection
MeSH terms: Infections; Communicable Diseases; Staphylococcal Infections
Intervention: Daptomycin 4 mg/kg; Comparator: vancomycin; Daptomycin 6 mg/kg
Intervention description: MK3009 (daptomycin) once daily by intravenous (IV) drip, 4 mg/kg for 7-14 days for skin and soft tissue infections (SSTI); vancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days; MK-3009 (daptomycin) once daily by intravenous drip, 6 mg/kg for 14-42 days for septicemia or right-sided infective endocarditis
Intervention MeSH terms: Vancomycin; Daptomycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The study investigates the efficacy and safety of MK-3009 in participants with skin
      infections, septicemia and right-sided infective endocarditis (RIE) caused by
      methicillin-resistant Staphylococcus aureus (MRSA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Both Sexes, Aged 20 Years Or Older

          -  Japanese Participants With Skin And Soft Tissue Infections, Septicemia, or RIE Known
             Or Suspected To Be Caused By MRSA

          -  Written Informed Consent

        Exclusion Criteria:

          -  Participants With Skin and Soft Tissue infections That Can Be Treated By Surgery Alone

          -  Participants With Pneumonia
Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Intervention: Elobixibat 10 mg
Intervention description: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 411.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation
      (CIC)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has completed double-blind treatment in either of the lead-in efficacy trials, 000079
             or 000080.

          -  The patient reports having understood and has signed the Informed Consent Form (ICF)
             and is willing to comply with all trial visits and assessments.

          -  The patient agrees to refrain from making any new, major lifestyle changes that may
             affect CIC symptoms (i.e., starting a new diet, changing an exercise plan) from the
             time of signing the ICF through to the last trial visit.

        Exclusion Criteria:

          -  The patient has been withdrawn/discontinued from the 000079 or 000080 trials.

          -  The patient is not willing to abide by the restrictions for intake of prohibited
             medication.

          -  Women of childbearing potential (defined, for the purpose of this trial, as all
             females post-puberty, not postmenopausal ≥2 years, or not surgically sterile) who have
             a positive urine pregnancy test at Visit 1, or who do not agree to use one of the
             following methods of birth control from the day of signing the ICF until 30 days after
             the final dose of trial drug are excluded:

               1. Transdermal patch

               2. Established use of oral, injected or implanted hormonal methods of contraception

               3. Placement of an intrauterine device (IUD) or intrauterine system (IUS).

               4. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or
                  cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.

               5. Male sterilisation (with the appropriate post-vasectomy documentation of the
                  absence of sperm in the ejaculate).

               6. True sexual abstinence: when this is in line with the preferred and usual
                  lifestyle of the patient.

          -  The patients is considered by the Investigator to be unsuitable to participate in the
             trial for any other reason.
SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Placebo
Intervention description: SGLT2 inhibitor (dapagliflozin); Placebo Comparator
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      In Protocol 2, the investigators will determine the role of pancreatic hormones (increase in
      plasma glucagon and decrease in plasma insulin concentration) in the stimulation of EGP
      following SGLT2 inhibition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  T2DM subjects

          -  18 - 70 yrs old

          -  BMI = 25-45 kg/m2

          -  Must be on a stable dose (more than 3 months) of monotherapy or combination therapy
             with metformin and/or a sulfonylurea

          -  HbA1c <10.0%

          -  Stable body weight (± 3 lbs) over preceding 3 months

          -  Do not participate in excessively heavy exercise

        Exclusion Criteria:

          -  Subjects taking drugs known to affect glucose metabolism (other than metformin and
             sulfonylurea)

          -  Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine
             >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg
Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
Condition: Active Polyarticular Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: Abatacept
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 219.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin)
      at Day 113 in children and adolescents with pJIA
    

Eligibility criteria:

        Inclusion Criteria:

          -  JIA subjects (male or female), ages 2-17 years with active disease who had an
             insufficient therapeutic response or intolerance to at least one non biologic DMARD or
             Tumor Necrosis Factor (TNFα) antagonists for at least 3 months prior to screening

          -  Subjects with TNFα inadequate response (or prior biologic) will be restricted to 30%
             of the population

          -  Subjects must have a history of at least 5 joints with active disease and must have
             currently active articular disease with ≥2 active joints and ≥2 joints with limitation
             of motion.

        Exclusion Criteria:

          -  Subjects with other rheumatic diseases or major chronic inflammatory/immunologic
             diseases, active uveitis, systemic JIA with active systemic features (within a period
             of 6 months prior to enrollment), persistent Oligoarthritis JIA, or failed 3 or more
             TNFα antagonists or other biological DMARDs will be excluded.

          -  Active systemic disease: (ie, extra-articular features of systemic JIA including
             fever, rash, organomegaly) within a period of 6 months prior to randomization.

          -  Subjects who have failed more than two TNFα antagonists or other biologic DMARDs
Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine
Condition: Migraine, With or Without Aura
MeSH terms: Migraine Disorders
Intervention: Ubrogepant; Placebo-matching Ubrogepant
Intervention description: 50 mg ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.; Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1672.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50
      and 100 mg) compared to placebo for the acute treatment of a single migraine attack.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least a 1-year history of migraine with or without aura consistent with a diagnosis
             according to the International Classification of Headache Disorders, 3rd edition, beta
             version

          -  Migraine onset before age 50

          -  History of migraines typically lasting between 4 and 72 hours if untreated or treated
             unsuccessfully and migraine episodes are separated by at least 48 hours of headache
             pain freedom

          -  History of 2 to 8 migraine attacks per month with moderate to severe headache pain in
             each of the previous 3 months.

        Exclusion Criteria:

          -  Difficulty distinguishing migraine headache from other headaches

          -  Has taken medication for acute treatment of headache (including acetaminophen,
             nonsteroidal anti-inflammatory drugs [NSAIDs], triptans, ergotamine, opioids, or
             combination analgesics) on 10 or more days per month in the previous 3 months

          -  Has a history of migraine aura with diplopia or impairment of level of consciousness,
             hemiplegic migraine, or retinal migraine

          -  Has a current diagnosis of new persistent daily headache, trigeminal autonomic
             cephalgia (eg, cluster headache), or painful cranial neuropathy

          -  Required hospital treatment of a migraine attack 3 or more times in the previous 6
             months

          -  Has a chronic non-headache pain condition requiring daily pain medication

          -  Has a history of malignancy in the prior 5 years, except for adequately treated basal
             cell or squamous cell skin cancer, or in situ cervical cancer

          -  Has a history of any prior gastrointestinal conditions (eg, diarrhea syndromes,
             inflammatory bowel disease) that may affect the absorption or metabolism of
             investigational product; participants with prior gastric bariatric interventions which
             have been reversed are not excluded

          -  Has a history of hepatitis within previous 6 months.
A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)
Condition: Hepatitis D, Chronic
MeSH terms: Hepatitis A; Hepatitis D; Hepatitis D, Chronic; Hepatitis
Intervention: Pegylated Interferon (PEG-IFN) alfa-2a
Intervention description: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks.
Intervention MeSH terms: Interferons
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon
      (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD).
      Treatment was followed by 24 weeks of treatment-free follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive hepatitis B surface antigen (HBsAg) for at least 6 months prior to screening

          -  Positive anti-delta for at least 3 months prior to screening

          -  Positive hepatitis D virus (HDV) ribonucleic acid (RNA)

          -  A liver biopsy obtained within the past 18 months for non-cirrhotic patients and 30
             months for cirrhotic patients demonstrating liver disease consistent with chronic
             hepatitis D (CHD)

          -  Negative urine or serum pregnancy test (for women of childbearing potential)
             documented within the 24-hour period prior to the first dose of test drug

        Exclusion Criteria:

          -  Antiviral therapy for CHD within the previous 6 months

          -  Positive hepatitis A, hepatitis C, or human immunodeficiency virus (HIV)

          -  Evidence of decompensated liver disease

          -  Other medical condition associated with chronic liver disease

          -  Women with ongoing pregnancy or who are breast feeding
Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
Condition: Impetigo
MeSH terms: Impetigo
Intervention: ozenoxacin placebo; retapamulin 1% ointment; ozenoxacin 1% cream
Intervention description: cream; ointment; 1% cream
Intervention MeSH terms: Retapamulin; Ozenoxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 465.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      This is multicenter, randomised, placebo controlled, parallel, blinded (double-blind for
      ozenoxacin versus placebo comparison and investigator blinded for retapamulin versus placebo
      comparison), superiority clinical study comparing ozenoxacin cream versus placebo and
      retapamulin ointment vs placebo, in patients with a clinical diagnosis of non-bullous or
      bullous impetigo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of bullous or non bullous impetigo. The patient has a total
             affected area comprised between 1-100 cm2 with surrounding erythema not extending more
             than 2 cm from the edge of any affected area. In case of multiple affected areas the
             total area will be the sum of each affected area and will not exceed 100 cm2.
             Additionally for patients < 12 years the total area will not exceed a maximum of 2% of
             the body surface area.

          -  Total Skin Infection Rating Scale (SIRS) score of at least 8, including pus/exudate
             score of at least 1

        Exclusion Criteria:

          -  Has a bacterial infection, which in the opinion of the investigator, could not be
             appropriately treated by a topical antibiotic.

          -  Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary
             temperature over 37.2 °C (99.0 °F)
Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody
Condition: Primary Hyperlipidemia and Mixed Dyslipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Evolocumab; Atorvastatin; Placebo to Evolocumab; Placebo to Atorvastatin
Intervention description: Administered by subcutaneous injection; Administered by mouth; Administered by subcutaneous injection; Administered by mouth
Intervention MeSH terms: Atorvastatin; Evolocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 89.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Raised cholesterol; Cholesterol; Elevated Cholesterol; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases

Summary:

      This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of
      evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fasting LDL-C at screening ≥ 100 mg/dL and ≤ 190 mg/dL

          -  Fasting triglycerides ≤ 150 mg/dL

          -  Body mass index (BMI) between 18.0 and 32.0 kg/m^2

          -  Framingham cardiac risk score 10% or less

        Exclusion Criteria:

          -  Treatment with a lipid-regulating drug or over the counter supplement in the last 3
             months prior to screening

          -  History of coronary heart disease (CHD) or CHD equivalent

          -  Uncontrolled hypertension

          -  Diabetes mellitus
Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: Proellex; Proellex; Placebo
Intervention description: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months; Two 25 mg mg capsules of Proellex® orally daily for up to four months; Two placebo capsules orally daily for up to four months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 77.0
Sex: Female
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: No
Keywords: Uterine Fibroids

Summary:

      Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex
      25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness
      between 50 mg versus placebo, and between 25mg and placebo will be analyzed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Speak, read and understand English or Spanish;

          -  Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation
             therapy (previous myomectomy is acceptable) for any cause and no surgical
             interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial
             embolization) are planned or anticipated during the study;

          -  One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;

          -  Menstrual cycle lasting from 24 to 36 days;

          -  History of excessive menstrual bleeding;

          -  Negative urine pregnancy test at screening.

        Exclusion Criteria:

          -  Six months or more (immediately prior to Screening Visit) without a menstrual period;

          -  Prior hysterectomy;

          -  Prior bilateral oophorectomy;

          -  Pregnant or lactating females or women who are attempting or expecting to become
             pregnant at any time during the study;

          -  Documented endometriosis, active pelvic inflammatory disease (PID), platelet
             dysfunction, or Von Willebrand's Disease;

          -  Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade
             including atypical squamous cells of undetermined significance (ASCUS) associated with
             Human Papilloma Virus (HPV);

          -  Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or
             any other organ system;

          -  Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or
             Chlamydia or previous history of auto-immune disease or positive serum antinuclear
             antibodies.