bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Plaque, Atherosclerotic
Intervention: Dalcetrapib (RO4607381); Placebo
Intervention description: 600mg po daily for 24 months; po daily for 24 months
Intervention MeSH terms: Dalcetrapib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic
      plaque in patients with coronary heart disease (CHD) including patients with other CHD risk
      factors. After a pre-randomisation period during which positron emission tomography computed
      tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either
      RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at
      intervals during the study. The anticipated time on study treatment is 2 years, and the
      target sample size is 100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-75 years of age;

          -  CHD, including patients with other CHD risk factors;

          -  treated appropriately for dyslipidemia;

          -  clinically stable.

        Exclusion Criteria:

          -  previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or
             vaccine;

          -  recent (within 3 months) clinically significant coronary events, transient ischemic
             attacks or cerebrovascular accident;

          -  severe anemia;

          -  uncontrolled hypertension;

          -  poorly controlled diabetes.
Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C
Condition: Diabetes; Diabetes Mellitus, Type 2; Cholesterolemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Bempedoic acid + Ezetimibe FDC Oral Tablet; Ezetimibe 10 mg Oral Tablet; Placebo Oral Tablet; Placebo oral capsule
Intervention description: Experimental therapy of bempedoic acid 180 mg + ezetimibe 10 mg FDC tablet; Ezetimibe 10 mg tablet, overencapsulated for blinding purposes; Placebo tablet, matched for the FDC product for blinding purposes; Placebo over-encapsulated for blinding purposes
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Ezetimibe
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetes; cholesterolemia; type 2 diabetes; LDL-C; T2D; diabetes mellitus

Summary:

      12 week study to assess the LDL-C lowering efficacy, other lipid and glycemic measures, and
      safety of bempedoic acid/ezetimibe FDC compared to ezetimibe and placebo in patients with
      type 2 diabetes (T2D) and elevated LDL-C
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes for 6 months or greater

          -  Currently taking stable diabetes medication for 3 months or greater

          -  HbA1c between 7-10%

          -  LDL-cholesterol greater than 70 mg/dL

          -  Women must not be pregnant, lactating, or planning to become pregnant within 30 days
             after last dose of study medication; and must be postmenopausal, surgically sterile,
             or willing to use 1 acceptable form of birth control during the study through 30 days
             after the last dose of study medication

        Exclusion Criteria:

          -  Body mass index > 40 kg/m2

          -  History of documented clinically significant cardiovascular disease

          -  Fasting triglycerides > 400 mg/dL

          -  History of Type 1 diabetes

          -  Uncontrolled hypothyroidism, liver dysfunction, renal dysfunction, gastrointestinal
             condition that may affect drug absorption, hematologic or coagulation disorder or
             active malignancy

          -  History of drug or alcohol abuse within 2 years
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: tirzepatide; Dulaglutide; Placebo
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Dulaglutide; Tirzepatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 318.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of the study drug tirzepatide in
      participants with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had type 2 diabetes (T2D) for ≥6 months according to the World Health
             Organization (WHO) classification.

          -  Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory.

          -  If on metformin, have been treated with stable doses of metformin for at least 3
             months.

          -  Have a body mass index (BMI) ≥23 and <50 kilograms per square meter.

        Exclusion Criteria:

          -  Have type 1 diabetes (T1D).

          -  Have used any glucose-lowering medication other than metformin within 3 months prior
             to study entry or during screening/lead-in period or have used any glucagon-like
             peptide-1 receptor agonists (GLP-1 RAs) at any time in the past.

          -  Have had any of the following cardiovascular conditions: acute myocardial infarction
             (MI), New York Heart Association Class III or Class IV heart failure, or
             cerebrovascular accident (stroke).

          -  Have acute or chronic hepatitis, signs and symptoms of any other liver disease other
             than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level
             >2.5 times the upper limit of the reference range, as determined by the central
             laboratory at study entry; participants with NAFLD are eligible for participation in
             this trial.

          -  Have had chronic or acute pancreatitis any time prior to study entry.

          -  Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square
             meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation.

          -  Have serum calcitonin ≥20 picograms per milliliter, as determined by the central
             laboratory at study entry.

          -  Have any condition that is a contraindication for use of the GLP-1 RA class (per
             country-specific labels) at study entry or develop such condition between study entry
             and randomization.
A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ALX-0061; Placebo; Methotrexate
Intervention description: Stable background dose of commercially available methotrexate (not provided by the Sponsor).
Intervention MeSH terms: Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 345.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061
      administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with
      active rheumatoid arthritis (RA) despite MTX therapy, compared with placebo.

      To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics
      (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061,
      based on safety and efficacy, for further clinical development.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of RA for at least 6 months prior to screening, and American College of
             Rheumatology (ACR) functional class I-III

          -  Subjects treated with and tolerating MTX

          -  Active RA

          -  Others as defined in the protocol

        Exclusion Criteria:

          -  Have been treated with disease-modifying antirheumatic drugs (DMARDs)/systemic
             immunosuppressives other than MTX.

          -  Have received approved or investigational biological or targeted synthetic DMARD
             therapies for RA less than 6 months prior to screening.

          -  Have a history of toxicity, non-tolerance, primary non-response or inadequate response
             to a biological therapy, or targeted synthetic DMARDs, for RA.

          -  Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.

          -  Others as defined in the protocol
Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults
Condition: Invasive Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV.; Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.; Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.; Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV.
Intervention description: Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus OMV.; Two injections of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.; One injection of saline solution placebo and one of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.; Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus a quarter dose of OMV.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 484.0
Sex: All
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Immunogenicity; Vaccine; Meningococcal; Seroresponse

Summary:

      This study will evaluate the safety and immunogenicity of combination vaccines as compared to
      the reference vaccines
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adolescents aged 10 through 25 years of age inclusive at the time of
             enrollment.

        Exclusion Criteria:

          -  History of any meningococcal vaccine administration;

          -  Current or previous, confirmed or suspected disease caused by N. meningitidis;

          -  Pregnant or nursing (breastfeeding) mothers;

          -  Females of childbearing age who have not used or do not plan to use acceptable birth
             control measures, for the duration of the study;

          -  Any serious, chronic, or progressive disease;

          -  Known or suspected impairment/alteration of the immune system;

          -  Receipt of blood, blood products and/or plasma derivatives, or a parenteral
             immunoglobulin preparation within the previous 90 days;

          -  History of severe allergic reactions after previous vaccinations or hypersensitivity
             to any vaccine component.
OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
Condition: Chronic Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Dexamethasone; Placebo Vehicle
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone
      insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the
      treatment of the signs and symptoms of chronic allergic conjunctivitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a positive history of ocular allergies and a positive skin test reaction to a
             perennial allergen and a seasonal allergen

          -  Has a positive bilateral CAC reaction to a perennial allergen within minutes of
             instillation

        Exclusion Criteria:

          -  History of ocular surgical intervention within the past 3 months

          -  Presence of an active ocular infection or positive history of an ocular herpetic
             infection at any visit

          -  Use any of the following disallowed medications during the period indicated
Long Term Extension Study Evaluating Safety, Tolerability and Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: ACC-001(3µg) + QS21; ACC-001(10µg) + QS21; ACC-001(30µg) + QS21
Intervention description: Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18; Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18; Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
Intervention MeSH terms: Saponin QA-21V1
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the long term safety, tolerability, and immunogenicity
      of ACC-001, an investigational active immunization product+, in subjects with mild to
      moderate Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects randomized under previous 3134K1-200 study (NCT00479557) and met all
             inclusion/and none of the exclusion criteria

          -  Screening brain MRI scan is consistent with the diagnosis of AD ' Mini-Mental State
             Examination (MMSE) score ≥10

        Exclusion Criteria:

          -  Significant Neurological Disease other than Alzheimer's disease

          -  Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study
             (NCT00479557)

          -  Clinically significant systemic illness
Chamomile for Chronic Primary Insomnia
Condition: Primary Insomnia; Chronic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Chamomile High Grade Extract; Placebo Tablet
Intervention description: three tablets each (equivalent to 7.5 g of dried herb) p.o. twice daily for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Matricaria; Chamomile; Herb; Insomnia

Summary:

      The purpose of this study is to determine if an herb called chamomile can help to treat
      insomnia (difficulty in going to sleep or getting enough sleep) by increasing the amount of
      time that you sleep and/or improving the quality of your sleep. The study will also be
      looking at the effect of chamomile on day time fatigue and functioning.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women aged 18 to 64 years;

          -  Must be able to give written informed consent;

          -  Have a diagnosis of primary insomnia per DSM-IV criteria, reporting < 6.5 hours sleep
             and/or >30 minutes to fall asleep (SOL) and/or wake after sleep onset (WASO) > 30
             minutes, three or more nights per week;

          -  Present sleep complaint for at least 6 months;

        Exclusion Criteria:

          -  Women who are pregnant, lactating or less than six months post-partum. Due to the fact
             that an assessment of reproductive performance and teratology tests have not been
             conducted we are excluding pregnant and lactating women;

          -  Patients with unstable medical conditions;

          -  DSM-IV Axis I or personality disorder diagnosis with the exception of patients with
             treated and stable unipolar depression or generalized anxiety disorder (such that the
             PRIME-MD scores are within normal range for these disorders);

          -  Difficulty in sleep initiation or maintenance associated with known medical diagnosis
             or conditions that may affect sleep, e.g., sleep apnea, restless leg syndrome, chronic
             pain;

          -  Evidence of lack of reliability or noncompliance as defined by missing a pretreatment
             appointment more than twice;

          -  Current diagnosis of substance abuse or dependence;

          -  Known allergy to chamomile or members of the ragweed family;

          -  Currently taking cyclosporine, warfarin or chronic sedative and anxiolytic
             medications;

          -  Prior use of insomnia medications is not exclusionary, but patients must be off of
             these medications at the screening visit and through out the study.
Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis
Condition: Lupus Nephritis; Lupus Erythematosus, Systemic
MeSH terms: Nephritis; Lupus Nephritis; Lupus Erythematosus, Systemic
Intervention: abatacept; cyclophosphamide; azathioprine; prednisone; abatacept placebo; azathioprine placebo
Intervention description: Intravenous infusion (500-1000 mg, dep on weight) at weeks 0, 2, and 4, then every 4 weeks until week 24; continue to week 48 only if partial response at 24 weeks; 500 mg intravenous infusion every 2 weeks for 12 weeks; 2 mg/kg/day orally from weeks 12-28; continue until week 52 if only partial response observed at week 24; 60 mg/day for 2 weeks, then taper to 10 mg/day by 12 weeks, then continue on stable dose; Intravenous infusion at weeks 0, 2, and 4, then every 4 weeks until week 24; continue to week 48 only if partial response at 24 weeks; Oral capsule, daily from weeks 28 to 52, only if complete response observed at week 24
Intervention MeSH terms: Prednisone; Cyclophosphamide; Abatacept; Azathioprine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 137.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: lupus; systemic lupus erythematosus; lupus nephritis; SLE; abatacept; CTLA4; CTLA4Ig; glomerulonephritis

Summary:

      This study is for individuals with lupus who have developed complications in their kidneys,
      or lupus nephritis. The study will determine whether adding the experimental medication
      abatacept to standard cyclophosphamide therapy is more effective in improving lupus nephritis
      than standard cyclophosphamide therapy by itself.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology
             (ACR) criteria

          -  Active lupus nephritis (defined by: kidney biopsy documentation within the last 12
             months using International Society of Nephrology/Renal Pathology Society (ISN/RPS)
             classification- proliferative nephritis, active urinary sediment, urine
             protein-to-creatinine ratio > 1, low complement C3)

          -  Positive antinuclear antibody (ANA) test result at time of study entry

        Exclusion Criteria:

          -  End stage renal disease

          -  Use of cyclophosphamide in the past year

          -  Neutropenia, thrombocytopenia, moderately severe anemia

          -  Active infection, including HIV, hepatitis B or C

          -  History of cancer, except carcinoma in situ and treated basal and squamous cell
             carcinomas

          -  Pregnant or breastfeeding