bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis
Condition: Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Intervention: Ixekizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing spondylitis

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in
      Chinese participants with radiographic axial spondyloarthritis (r-axSpA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have an established diagnosis of radiographic axial spondyloarthritis (r-xSpA) with
             sacroiliitis defined radiographically according to the modified New York criteria.

          -  Participants have a history of back pain ≥3 months with age at onset <45 years.

          -  Biologic naïve or have had prior treatment with 1 tumor necrosis factor (TNF)
             inhibitor.

          -  Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range
             for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.

          -  Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.

        Exclusion Criteria:

          -  Have total ankylosis of the spine.

          -  Have recently received a live vaccine within 12 weeks or have had a vaccination with
             Bacillus Calmette-Guerin (BCG) within the past year.

          -  Have an ongoing or serious infection within the last 12 weeks.

          -  Have a compromised immune system.

          -  Have any other serious and/or uncontrolled diseases.

          -  Have either a current diagnosis or a recent history of malignant disease.

          -  Have had major surgery within 8 weeks of baseline, or will require surgery during the
             study.

          -  Are pregnant or breastfeeding.
Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: Evolocumab; Placebo; Background Statin Therapy
Intervention description: Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.; Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.; Participants were required to be on a stable, high- to moderate-intensity statin background therapy consisting of an effective statin dose, ie, at least atorvastatin 20 mg daily or equivalent, and where locally approved, highly effective statin therapy (defined as at least atorvastatin 40 mg daily or equivalent) was recommended.
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1974.0
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:

      This study evaluated change over time in neurocognitive testing in patients receiving statin
      therapy in combination with evolocumab (AMG 145), compared with patients receiving statin
      therapy in combination with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Randomized into Study 20110118 (FOURIER; NCT01764633)

        Exclusion Criteria:

          -  Current or known past diagnosis of dementia or mild cognitive impairment (MCI)
Adjuvant Oophorectomy and Tamoxifen in Premenopausal Women With Hormone Receptor-Positive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Tamoxifen; Surgery: Oophorectomy
Intervention description: 20 mg po daily x 5 years; Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)
Intervention MeSH terms: Tamoxifen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 740.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Asian; Premenopausal; Women; Oophorectomy

Summary:

      This trial tests surgical oophorectomy (removal of ovaries) plus Tamoxifen, done at different
      times in the menstrual cycle, as adjuvant therapy for invasive breast cancer in 510
      premenopausal women with Hormone Receptor-positive Breast Cancer. This study is recruiting at
      hospitals in Philippines, Vietnam, and Morocco.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Open for accrual in Asia only

          -  Female age 18-50,

          -  premenopausal with regular cycles (>25-35 in length)

          -  fine-needle aspiration diagnosis

          -  Stage II-IIIA hormone receptor positive invasive breast cancer

          -  No prior radiation or chemotherapy

          -  Must be surgical candidate for bilateral oophorectomy
To Study Generic Diclofenac Sodium Topical Gel 1% in the Treatment of Osteoarthritis of the Knee (Degenerative Joint Disease Presented as Joint Pain, Stiffness, Swelling and Restricted Motion).
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Diclofenac Sodium gel, 1%; Voltaren® Gel; Placebo
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1164.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No

Summary:

      This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site
      Clinical Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel, 1% (Glenmark
      Pharmaceuticals Ltd) to Voltaren® Gel (Diclofenac Sodium topical gel) 1% (Novartis Consumer
      Health, Inc) in Patients with Osteoarthritis (OA) of the Knee
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of OA of
             the knee according to the American College of Rheumatology (ACR) criteria.

          2. OA Symptoms for at least 6 months prior to screening.

          3. Baseline Western Ontario McMaster Osteoarthritis (WOMAC) pain subscale of > 9 on a 20
             point scale for the target knee immediately prior to randomization.

        Exclusion Criteria:

          1. History of OA pain in the contralateral knee requiring medication within 1 year prior
             to screening.

          2. History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g.,
             colitis) or fibromyalgia.

          3. History of gastrointestinal bleeding or peptic ulcer disease.

          4. Known allergy to aspirin or nonsteroidal anti-inflammatory drug (NSAID).

          5. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or
             methotrexate prior to 30 days of screening.

          6. Concomitant use of systemic corticosteroids, topical corticosteroids, or
             immunosuppressive drugs or their use prior to 30 days of screening.
Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)
Condition: Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Intervention: ertapenem sodium (MK0826); Comparator: ceftriaxone sodium
Intervention description: a single daily dose of ertapenem sodium 1.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy if needed); a single daily dose of ceftriaxone 2.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy)
Intervention MeSH terms: Ceftriaxone; Ertapenem
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 271.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in
      treatment of complicated urinary tract infections with respect to the proportion of patients
      with a favorable microbiological response at 5-9 days post therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients with a suspected or documented complicated urinary tract infection

          -  Female patients must test negative for pregnancy and agree to use adequate birth
             control measures

          -  Nursing women must agree to defer breastfeeding until 5 days after completion of all
             study antibiotic therapy

        Exclusion Criteria:

          -  Patients with complete obstruction of any portion of the urinary tract

          -  Patients with rapidly progressive or terminal illness

          -  Renal transplant patients
Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)
Condition: Metastatic Castration-resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: olaparib; enzalutamide; abiraterone acetate; abiraterone acetate; enzalutamide
Intervention description: 300 mg (2x 150 mg tablets) twice daily; 160 mg (4 x 40 mg capsules) once daily; 1,000 mg (4 x 250 mg tablets) once daily; 1,000 mg (2 x 500 mg tablets) once daily; 160 mg (4 x 40 mg tablets) once daily
Intervention MeSH terms: Olaparib; Abiraterone Acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 387.0
Sex: Male
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: metastatic castration-resistant prostate cancer (mCRPC); homologous recombination repair (HRR)

Summary:

      The purpose of this study is to evaluate the efficacy and safety of olaparib versus
      enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate
      cancer who have failed prior treatment with a new hormonal agent and have homologous
      recombination repair gene mutations.
    

Eligibility criteria:

        Inclusion criteria

          1. Histologically confirmed diagnosis of prostate cancer.

          2. Documented evidence of metastatic castration resistant prostate cancer (mCRPC).

          3. Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate
             and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC .

          4. Ongoing therapy with LHRH analog or bilateral orchiectomy.

          5. Radiographic progression at study entry while on androgen deprivation therapy (or
             after bilateral orchiectomy).

          6. Qualifying HRR mutation in tumor tissue.

        Exclusion criteria

          1. Any previous treatment with PARP inhibitor, including olaparib.

          2. Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy,
             except if for non-prostate cancer indication and last dose > 5 years prior to
             randomization.

          3. Other malignancy (including MDS and MGUS) within the last 5 years except: adequately
             treated non-melanoma skin cancer or other solid tumors curatively treated with no
             evidence of disease for ≥5 years.

          4. Subjects with known brain metastases.
Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: TAS-118 plus Oxaliplatin; S-1 plus Cisplatin
Intervention MeSH terms: Oxaliplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 711.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Gastric Cancer; Gastrointestinal Diseases; Gastrointestinal Neoplasms; First Line Treatment; Antineoplastic Agents

Summary:

      The purpose of this trial is to evaluate the efficacy of TAS-118 plus Oxaliplatin compared
      with S-1 plus Cisplatin in overall survival in patients with advanced gastric cancer.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patients who are diagnosed as gastric cancer.

          -  No prior treatment for gastric cancer.

          -  Negative or unknown for HER2 testing.

          -  ECOG performance status of 0 or 1.

        Key Exclusion Criteria:

          -  Unmanageable diarrhea.

          -  Current peripheral sensory neuropathy or paresthesia.

          -  Pregnant or lactating female.
5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Pimecrolimus; Topical corticosteroids
Intervention description: Pimecrolimus cream 1 %; TCS
Intervention MeSH terms: Pimecrolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2418.0
Sex: All
Minimum age: 3 Months
Maximum age: 12 Months
Healthy volunteers: No
Keywords: Atopic dermatitis, children, infants, pimecrolimus

Summary:

      The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in
      the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than
      12 months of age compared to topical corticosteroids (TCS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 3 to < 12 months

          -  Diagnosis of AD fulfilling the diagnostic criteria of Seymour

          -  AD affecting at least 5% total body surface area

          -  Investigator's Global Assessment (IGA) score of 2 or 3, corresponding to
             mild-to-moderate disease at baseline

          -  Informed consent

        Exclusion Criteria:

          -  Phototherapy, systemic therapy (e.g., immunosuppressants, cytostatics), systemic
             corticosteroids within 4 weeks

          -  Topical tacrolimus or pimecrolimus within 2 weeks

          -  Topical therapy (e.g., tar, topical corticosteroids) within 3 days

          -  Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history
             of malignant disease

          -  Active acute viral skin infection (e.g. herpes simplex, herpes zoster, chicken pox),
             and/or clinically infected AD

          -  Failure to thrive (e.g., weight or height/length below the 5th percentile) or
             developmental abnormalities such as head circumference less than 5th and more than
             95th percentile

          -  Known hypersensitivity to any ingredient of pimecrolimus cream 1% or topical
             corticosteroids

          -  Clinical conditions other than AD that according to investigator can interfere with
             the evaluation
Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides
Condition: Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia
MeSH terms: Hypercholesterolemia; Dyslipidemias; Hypertriglyceridemia
Intervention: ABT-143; simvastatin
Intervention description: Once daily for 8 weeks; Once daily for 8 weeks simvastatin capsules 40 mg
Intervention MeSH terms: Simvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 474.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dyslipidemia; Hypercholesterolemia; Hypertriglyceridemia

Summary:

      The primary purpose of this study is to test the effect and safety of three different doses
      of ABT-143 compared to simvastatin in subjects with elevated levels of low density
      lipoprotein cholesterol ("bad cholesterol") and triglycerides.
    

Eligibility criteria:

        Inclusion Criteria

          -  Participants with hypercholesterolemia and hypertriglyceridemia.

          -  Participants had the following fasting lipid results following a greater than or equal
             to 12 hour fasting period (measured at the Screening Visit(s)):

               -  Triglycerides level greater than or equal to 150 milligrams/deciliter (mg/dL) and
                  less than 400 milligrams/deciliter, and

               -  Low-density lipoprotein cholesterol greater than or equal to 160
                  milligrams/deciliter and less than or equal to 240 milligrams/deciliter.

        Exclusion Criteria

          -  Participants with certain chronic or unstable medical conditions.

          -  Participants receiving coumarin anticoagulants, systemic cyclosporins, or certain
             other medications.

          -  Pregnant or lactating women, or women intending to become pregnant.

          -  Participants with diabetes mellitus that is poorly controlled.

          -  Participant was of Asian ancestry (having Filipino, Chinese, Japanese, Korean,
             Vietnamese, or Asian-Indian origin).
A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Bromfenac Ophthalmic Solution A; Bromfenac Ophthalmic Solution B; Placebo Comparator
Intervention description: sterile ophthalmic solution; sterile ophthalmic solution; sterile ophthalmic solution
Intervention MeSH terms: Bromfenac; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 840.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sign and symptoms of dry eye disease

Summary:

      A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry
      eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be of either gender and any race 18 years or older

        Exclusion Criteria:

          -  Have a local or systemic disease that could interfere with the assessment of safety or
             efficacy or that is likely to result in early discontinuation from the study
An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Nivolumab; Ipilimumab; Placebo
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 907.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In this study, all patients must have already completed first-line chemotherapy to treat
      extensive-stage disease small cell lung cancer. The purpose of this study is to show that
      nivolumab, or nivolumab plus ipilimumab followed by nivolumab by itself, will prolong overall
      survival when administered as consolidation treatment in patients that are stable or
      responding after chemotherapy. Patients receiving treatment will be compared with patients
      taking placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with histologically or cytologically confirmed extensive stage disease SCLC

          -  Ongoing response of stable disease or better following 4 cycles of platinum-based
             first line chemotherapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Subjects with symptomatic Central Nervous System (CNS) metastases

          -  Subjects receiving consolidative chest radiation

          -  Subjects with active, known, or suspected autoimmune disease are excluded

          -  All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1
             or baseline

        Other protocol-defined inclusion/exclusion criteria apply
A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)
Condition: Acute Respiratory Distress Syndrome; COVID-19
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Intervention: Brexanolone; Placebo
Intervention description: Administered as IV infusion.; Administered as IV infusion.
Intervention MeSH terms: Pregnanolone; Brexanolone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate the efficacy and safety of brexanolone in
      participants on ventilator support for acute respiratory distress syndrome (ARDS) due to
      COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant was confirmed positive for the novel coronavirus responsible for
             SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection as determined
             by polymerase chain reaction (PCR) at Screening

          -  Participant had a presumptive diagnosis of ARDS at Screening and partial pressure of
             arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) (ratio of partial pressure
             of arterial oxygen to fraction of inspired oxygen [PF ratio]) less than (<) 300 prior
             to randomization

          -  Participant was intubated and receiving mechanical ventilation prior to randomization

          -  Participants must had initiated mechanical ventilation within 48 hours prior to
             screening, or had an immediate clinical plan for such intervention at time of
             screening

          -  Participant was likely to survive, in the opinion of the investigator, for at least 72
             hours from the time of screening

        Exclusion Criteria:

          -  Participant had fulminant hepatic failure at Screening

          -  Participant had end stage renal disease at Screening

          -  Participant had a known allergy to progesterone, allopregnanolone, or any excipients
             in the brexanolone injection

          -  Participant was concurrently participating in another clinical trial for an
             investigational product or device at screening