bioihbjkbjnl/mcl2 huggingface dataset:
Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk
Condition: Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Atorvastatin; Evolocumab; Placebo to Evolocumab
Intervention description: Administered orally once a day; Administered by subcutaneous injection; Administered by subcutaneous injection
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: 409.0
Sex: All
Minimum age: 20 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Japanese, high cholesterol, LDL-C, High Cardiovascular Risk

Summary:

      The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous
      evolocumab administered every 2 weeks and once a month, compared with placebo, on percent
      change from baseline in LDL-C when used in combination with statin therapy in adults with
      high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.
    

Eligibility criteria:

        Inclusion Criteria: Male or female, Japanese adult, 20-85 years of age; Subjects on stable
        dose of statin for greater than equal to 4 weeks; Fasting LDL-C greater than equal to 100
        mg/dL; Fasting triglycerides less than equal to 400 mg/dL; Subject is at high risk for
        cardiovascular events. Exclusion Criteria: New York heart Association (NYHA) III or IV -
        heart failure; Uncontrolled cardiac arrhythmia; Uncontrolled hypertension; Type 1 diabetes,
        poorly controlled type 2 diabetes; Uncontrolled hypothyroidism or hyperthyroidism
Adjunctive Ziprasidone in the Treatment of Bipolar I Depression
Condition: Bipolar Disorder; Depression, Bipolar
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Ziprasidone; Placebo
Intervention description: Oral capsule formulation to be administered every day for duration of patient's participation in the trial - 40 mg on Day 1; 40 mg twice a day (BID) on Day 2; Flexible BID dosing of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg or 160 mg total daily dose from Day 3 through Week 6. Dose increases of up to 40 mg/day can occur after subject has received previous lower dose for at least 1 day.; Matching placebo oral capsules to be administered as per the instructions for the ziprasidone arm
Intervention MeSH terms: Ziprasidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 298.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood
      stabilizer is safe and effective in the short term treatment of Bipolar I Depression.
      Ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on
      a therapeutic dose of one of these mood stabilizers for at least 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition
             (DSM-IV) criteria for Bipolar I disorder, most recent episode depressed, with or
             without rapid cycling and without psychotic features. Subjects receive therapeutic
             dose of lithium, valproate or lamotrigine for at least 4 weeks prior to randomization.

        Exclusion Criteria:

          -  Patients with ultra-fast rapid cycling (8 or more mood episodes per year)

          -  Significant heart disease including abnormalities in the heart's rhythm (QT
             prolongation)

          -  Psychotic symptoms (hallucinations and/or delusions).
Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis
Condition: Acute Rhinosinusitis
MeSH terms: Sinusitis
Intervention: BNO 1016; Placebo
Intervention description: sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; dosage: 480 mg per day (2 tablets t.i.d.) duration: 15 days; sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration 15 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 386.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: BNO 1016, acute rhinosinusitis

Summary:

      The purpose of this study is to determine whether the dry extract BNO 1016 is effective and
      safe in the treatment of acute rhinosinusitis in adults.
    

Eligibility criteria:

        Inclusion Criteria:

        Diagnosis of acute rhinosinusitis

          -  characterized by a major symptom score (MSS) ≥ 8 and ≤ 12 points (minimum 0, maximum
             15 points)

          -  individual score for facial pain/pressure ≥ 1 (mild) and ≤ 2 (moderate)

          -  confirmed by ultrasonography of paranasal sinuses

          -  with presence of symptoms ≤ 3 days prior to inclusion

        Exclusion Criteria:

          -  Chronic rhinosinusitis

          -  Polyposis nasi

          -  Anatomical deviations of the nasal septum that significantly impair nasal and
             paranasal ventilation/airflow

          -  Acute symptoms of a known allergic rhinitis

          -  Patients with asthma who have a history of exacerbations within 30 days prior to study
             inclusion

          -  Signs or symptoms of fulminant bacterial sinusitis

          -  Odontogenic sinusitis
To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis
Condition: Active Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Treatment I; Treatment II; Treatment III
Intervention description: Sunpharma1505 and Placebo; Sunpharma1505 and Placebo; Reference1505 and Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects
      with active rheumatoid arthritis who are experiencing a flare/exacerbation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects able and willing to give written informed consent and is available for entire
             study.

          2. Male or female ≥ 18 years old

          3. Willing and able to comply with the study protocol visits, assessments and accessible
             for follow up

          4. Known Diagnosed Rheumatoid arthritis

          5. Subjects of child bearing potential should be non-lactating and must be practicing an
             acceptable method of birth control as judged by the Investigator

        Exclusion Criteria:

          1. Subjects who are pregnant or intend to become pregnant during the study

          2. Subject with positive hepatitis panel and / or anti-hepatitis B core antibodies, and /
             or hepatitis C virus antibody [anti-HCV]), and / or a positive Human immunodeficiency
             virus (HIV) antibody.

          3. Known sensitivity to any component of the study drug or previous hypersensitivity
             reaction or other clinically significant reaction to IV medications, biologic therapy
             or IV radiocontrast agents.

          4. Active infection requiring systemic treatment

          5. Planned surgery during the study period or had undergone major surgery within the 60
             Days prior to the Screening visit.
Add-on to Micamlo BP Trial
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Telmisartan + amlodipine; hydrochlorothiazide; Telmisartan + amlodipine; Placebo
Intervention description: FDC tablet; tablet; FDC tablet; placebo matching hydrochlorothiazide tablet
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Telmisartan; Telmisartan amlodipine combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 309.0
Sex: All
Minimum age: 20 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      This is a multi-centre, randomised, double-blind, active-controlled, parallel-group
      comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg
      +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+
      amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the
      double-blind period in essential hypertensive patients who fail to respond adequately to
      telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a
      6-week open-label run-in period taking T80/A5 mg.
    

Eligibility criteria:

        Inclusion criteria:

          -  Essential hypertensive patients who have already taking 2 or 3 antihypertensive drugs
             and mean seated diastolic blood pressure (DBP) must be >=90 and <=114 mmHg and mean
             seated systolic blood pressure (SBP) must be =<200 mmHg

          -  Able to stop all current antihypertensive drugs (other than study medication) from
             Visit 1b through the end of the trial without risk to the patient based on the
             investigator's opinion

          -  Age 20 years or older

        Exclusion criteria:

          -  Patients with known or suspected secondary hypertension

          -  Patients with clinically relevant cardiac arrhythmia

          -  Congestive heart failure with New York Heart Association (NYHA) functional class
             III-IV

          -  Patients with recent cardiovascular events

          -  Patients with recent stroke events

          -  Patients with a history of sudden deterioration of renal function with angiotensin II
             receptor blockers or angiotensin converting enzyme inhibitors; or patients with
             post-renal transplant or post-nephrectomy

          -  Patients with hepatic and/or renal dysfunction

          -  Pre-menopausal women who are nursing or pregnant
A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Idelalisib; Rituximab; Placebo to match idelalisib
Intervention description: Idelalisib 150 mg tablet administered orally twice daily; Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter; Placebo to match idelalisib administered orally twice daily
Intervention MeSH terms: Rituximab; Idelalisib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CLL; CAL-101; GS 1101; PI3K; GS-US-312-0117; idelalisib

Summary:

      This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of
      idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor
      control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible
      patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either
      idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary
      study therapy but experience definitive CLL progression are eligible to receive active
      idelalisib therapy in the extension study, GS-US-312-0117.
    

Eligibility criteria:

        Inclusion:

          -  Adult subjects with previously treated recurrent CLL who have measurable
             lymphadenopathy

          -  Require therapy for CLL

          -  Have experienced CLL progression < 24 months since the completion of the last prior
             therapy

          -  Currently not sufficiently fit to receive cytotoxic therapy because of
             chemotherapy-induced bone marrow damage or comorbidities.
Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
Condition: Heart Failure; Type 2 Diabetes Mellitus; Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sotagliflozin; Placebo
Intervention description: Sotagliflozin was administered as a tablet(s), orally once daily.; Placebo was administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10584.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to compare the effect of sotagliflozin to placebo on
      total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and
      urgent visit for heart failure [HF] in participants with type 2 diabetes, cardiovascular risk
      factors, and moderate to severely impaired renal function.
    

Eligibility criteria:

        Inclusion criteria :

          -  Type 2 Diabetes Mellitus with glycosylated hemoglobin (HbA1c) ≥7%.

          -  Estimated glomerular filtration rate (eGFR) ≥25 and ≤60 milliliter/minute
             (mL/min)/1.73 square meter (m^2).

          -  Age 18 years or older with at least one major cardiovascular risk factor or age 55
             years or older with at least two minor cardiovascular risk factors.

          -  Signed written informed consent.

        Exclusion criteria:

          -  Antihyperglycemic treatment has not been stable within 12 weeks prior to screening.

          -  Planned coronary procedure or surgery after randomization.

          -  Lower extremity complications (such as skin ulcer, infection, osteomyelitis, and
             gangrene) identified during screening and requiring treatment at randomization.

          -  Planning to start a sodium-glucose linked transporter-2 (SGLT2) inhibitor during the
             study.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Phase III Study of ICI35,868 (Diprivan) With and Without EES0000645/A (SDS) on Gastrointestinal Endoscopy
Condition: Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy
Intervention: Intralipid; ICI35,868 (Diprivan); ICI35,868 (Diprivan) + EES0000645/A (SDS)
Intervention description: Treated by Anaesthesiologist. (Intralipid is being used as a placebo for Diprivan.); Treated by Anaesthesiologist; Treated by Endoscopist with EES0000645/A(SDS)
Intervention MeSH terms: Propofol; Soybean oil, phospholipid emulsion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 279.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: sedation, propofol, gastrointestinal endoscopy

Summary:

      This study is designed as a multi-centre, randomised, parallel-group, placebo-controlled,
      phase III confirmatory study. The study will be partially double-blinded: the comparison
      between Group 1 (placebo group) and Group 2 (ICI35,868 without EES0000645/A) will be carried
      out in double-blind, but the comparison between Group 1 (placebo group) and Group 3
      (ICI35,868 with EES0000645/A) will be carried out in single-blind.

      The efficacy and safety of ICI35,868 with and without EES0000645/A for the sedation to be
      moderate for a diagnostic gastrointestinal endoscopy and gastrointestinal endoscopic
      polypectomy will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

        1.Provision of written informed consent prior to any study-related procedures/examinations
        2.Aged 20 years and older 3.Subjects who are planned to undergo a non-emergent EGD or
        colonoscopy, including gastrointestinal endoscopic polypectomy that shall be completed
        within 1 hour (excluding the endoscopic submucosal dissection and ultrasonic endoscope,
        pernasal endoscope, etc.). Exclusion Criteria:

          1. involvement in the planning and/or conduct of the study (applies to both sponsor's
             employees and/or staffs at the study site)

          2. Subjects who underwent a endoscopic procedure under ICI35,868 (propofol)
             administration within 1 year.

          3. Participation in another clinical study with an investigational product within 4 weeks
             prior to randomisation.

          4. Baseline (Visit 1) of blood oxygen saturation (SpO2)<90% (room air)

          5. ASA III, IV, V and VI ; Subject with serious disease of cardiovascular, respiratory,
             renal, liver, pancreatic or endocrine function.
A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Sarilumab; Sulfasalazine; Leflunomide; Bucillamine; Tacrolimus; Mizoribine
Intervention description: Pharmaceutical form:solution; Pharmaceutical form: Tablet Route of administration: Oral; Pharmaceutical form: Tablet Route of administration: Oral; Pharmaceutical form: Tablet Route of administration: Oral; Pharmaceutical form: Capsule Route of administration: Oral; Pharmaceutical form: Tablet Route of administration: Oral
Intervention MeSH terms: Sulfasalazine; Mizoribine; Bucillamine; Tacrolimus; Leflunomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To document the long-term safety of sarilumab added to non-methotrexate (non-MTX)
      disease-modifying antirheumatic drugs (DMARDs) or as monotherapy.

      Secondary Objective:

      To document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy.
    

Eligibility criteria:

        Inclusion criteria:

        Diagnosis of rheumatoid arthritis (RA), according to the American College of
        Rheumatology/The European League Against Rheumatism (ACR/EULAR) 2010 Rheumatoid Arthritis
        Classification Criteria with >=3 months disease duration.

        Moderately to severely active RA defined as:

          -  At least 4 of 68 tender joints and 4 of 66 swollen joints at screening visit.

          -  High sensitivity C-Reactive Protein (hs-CRP) >=4 mg/L or Erythrocyte Sedimentation
             Rate (ESR) >=28 mm/hr at screening visit.

        For the combination stratum:

        Participants who had continuous treatment with non-biologic DMARDs other than MTX for at
        least 12 weeks prior to the randomization and on a stable dose for a minimum of 6 weeks
        prior to screening.

        For the monotherapy stratum:

        Participants who per investigator judgment were any of inappropriate, intolerant or
        inadequate to MTX treatment.

        Exclusion criteria:

        Participants <20 years of age. Prior treatment with tumor necrosis factor (TNF) antagonists
        or any other RA-directed biologic agents without the appropriate off-drug period prior to
        screening.

        Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R)
        antagonist therapies, including but not limited to tocilizumab or sarilumab.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI
Condition: Prostate Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: C-11 choline PET tracer; Gadobutrol; PET/MR scanner
Intervention description: C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.; Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.; C11-PET/MR and pelvic mpMRI scan for prostate cancer.
Intervention MeSH terms: Choline
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: high risk; prostate cancer; C11-choline; PET/MR; mpMRI

Summary:

      The purpose of this study is to find out if a PET/MR scan in combination with standard MRI
      and CT scans can improve the early detection and treatment of patients with prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Untreated patients with high-risk and very high-risk prostate cancer, who require
        clinical pelvic mpMRI, CT, and bone scan as standard clinical care for diagnosis and
        management of prostate cancer.

        Exclusion Criteria:

          1. Patients who already received primary treatment or neo-adjuvant therapy.

          2. Patients who refuse undergoing routine clinical imaging (i.e., pelvic mpMRI, CT, bone
             scan) for staging. Reimbursement of pelvic mpMRI in this study is denied. CT and bone
             scan may be done elsewhere outside of Mayo Clinic but should be of diagnostic quality.
             Research C-11 choline PET/MR will not substitute pelvic mpMRI, CT, or bone scan in
             this study.

          3. Patients cannot tolerate MRI (e.g., claustrophobia, severe back pain or spasm,
             involuntary movement [e.g., tremor, dystonia]).

          4. Patients have total hip arthroplasty (THA), which can cause substantial susceptibility
             artifact and degrade image quality of mpMRI.

          5. Patients have cardiac pacemaker, cochlear implants, neurostimulator, medical device
             which is unsafe at 3 Tesla, or foreign metallic body in the eyes or orbit.

          6. Patients have contraindication to gadolinium based MR contrast agents (e.g., renal
             failure, severe reaction to gadolinium based MR contrast agents). Epidermal growth
             factor receptor (eGFR) should be above 30 within 30 days the time of mpMRI.