bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: ezetimibe (+) simvastatin; Comparator : rosuvastatin calcium; Comparator: Placebo (unspecified); Comparator: Placebo (unspecified)
Intervention description: ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks.; rosuvastatin 10mg. The treatment duration will be 6 weeks.; rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks.; ezetimibe/simvastatin 10/20mg Placebo. The treatment duration will be 6 weeks.
Intervention MeSH terms: Rosuvastatin Calcium; Simvastatin; Ezetimibe; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 618.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: High Cholesterol

Summary:

      This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin
      versus rosuvastatin in participants with high cholesterol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is currently taking a statin medication for the treatment of high
             cholesterol

          -  Participant has an LDL-C level that is greater than or equal to 100 mg/dl and less
             than or equal to 190 mg/dl

        Exclusion Criteria:

          -  Women who are pregnant or nursing, or women who intend to become pregnant

          -  Participant has any condition, situation, or is currently taking any medication that
             might pose a risk to the participant or interfere with participation in the study
Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: rMenB+OMV; rMenB+OMV; rMenB+OMV
Intervention description: 2 doses of vaccine 2 months apart; 2 doses of vaccine 2 months apart; 2 doses of vaccine 2 months apart
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 239.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; vaccination; complement deficiency; asplenia; splenic dysfunction

Summary:

      The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered
      to subjects from 2 to 17 years of age with increased risk of meningococcal disease because
      either of primary or secondary complement deficiencies or of asplenia or splenic dysfunction.
      A group of healthy age-matched subjects will be enrolled to serve as a descriptive control
      for immunogenicity and safety.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion criterion applicable to All Groups

          -  Subjects aged 2 to 17 years (inclusive) at enrollment

          -  weighing at least 13 Kg at the time of enrollment

        Inclusion criterion applicable to Group A - Subjects at risk of meningococcal disease
        because of primary or secondary complement deficiencies

        Inclusion criterion applicable to Group B

        - Subjects at risk of meningococcal disease because of functional or anatomic asplenia

        Inclusion criterion applicable to Group C - healthy subjects

        Exclusion Criteria:

        Exclusion criteria applicable to All Groups (A, B and C)

          -  History of any previous immunization with a meningococcal B vaccine

          -  History of severe allergic reaction after previous vaccinations, or hypersensitivity
             to any component of the vaccine

          -  Known HIV infection

          -  History of any progressive or severe neurologic disorder or seizure disorder

          -  Contraindication to intramuscular injection or blood drawn

          -  Females who are pregnant, planning a pregnancy or nursing (breastfeeding)

          -  Females of childbearing potential who have not used or do not plan to use acceptable
             birth control measures

          -  History or any illness/condition that, in the opinion of the investigator, might
             interfere with the results of the study or pose additional risk to the subjects

        Exclusion criterion applicable to Groups A and B

        - Previous known or suspected disease caused by N. meningitidis in the last year.

        Exclusion criteria applicable to Group C

          -  Previous known or suspected disease caused by N. meningitidis

          -  Known or suspected impairment/alteration of the immune system
A 6-Month Extension Study of OTO-104 in Meniere's Disease
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Intervention: OTO-104
Intervention description: Single intratympanic injection of 12 mg OTO-104
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 189.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label extension study of a single intratympanic injection of OTO-104 given
      every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study
      104-201102 (Phase 2b study of OTO-104) or 104-201506 (Phase 3 study of OTO-104) in order to
      be eligible for this open-label extension study.
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject has completed the OTO-104 Phase 2b (104-201102) or Phase 3 (104-201506)
             clinical study.

          -  Subject has a diagnosis of definite unilateral Meniere's disease by 1995 AAO-HNS
             criteria

        Exclusion Criteria includes, but is not limited to:

          -  Subject is pregnant or lactating.

          -  Subject has a history of immunodeficiency disease.

          -  Subject has experienced an adverse reaction to intratympanic injection of steroids.
Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Infliximab; Infliximab and methotrexate
Intervention description: Infliximab 5 mg/kg body weight intravenous infusion given every 6 weeks; Infliximab 5 mg/kg body weight intravenous infusion (given every 8 weeks) plus methotrexate 7.5 mg orally (once weekly)
Intervention MeSH terms: Infliximab; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Participants from an ongoing observational study (P05319) who have a limited (adequate but
      less than optimal) response to infliximab will be randomized to either increase the frequency
      of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to
      their current treatment plan. While receiving infliximab study treatment(s), patients in this
      study will attend regularly scheduled office visits for various clinical tests for safety and
      effectiveness evaluations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a diagnosis of moderate to severe plaque-type psoriasis and have
             had participated in Study P05319.

          -  Subjects must have demonstrated an adequate but suboptimal response to infliximab in
             Study P05319

          -  Subjects must be at least 18 years old

          -  Subjects must be candidates for phototherapy or systemic treatment for psoriasis.

          -  Subjects must not be pregnant and must meet contraceptive requirements

          -  Subjects must meet tuberculosis screening criteria

          -  Subjects must meet laboratory and medical history screening requirements

        Exclusion Criteria:

          -  Subjects for whom infliximab or methotrexate is contraindicated or not recommended.

          -  Subjects already using certain investigational, biological, or immunosuppressive drugs

          -  Subjects with certain comorbid conditions

          -  Subjects who currently have or have a history of certain infections

          -  Subjects who have recently received live virus or bacterial vaccinations

          -  Subjects who are in a situation or have any condition that, in the opinion of the
             investigator, may interfere with optimal participation in the study.
A Safety and Efficacy Study of Dexamethasone Versus Laser Photocoagulation in Participants With Diabetic Macular Edema
Condition: Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Dexamethasone; Laser Photocoagulation
Intervention description: Dexamethasone 700 μg intravitreal injection in the study eye on Day 1, Months 5, and 10.; Laser photocoagulation on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 284.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of 700 μg dexamethasone versus laser
      photocoagulation in participants with diabetic macular edema (DME).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of diabetes mellitus (type 1 or type 2)

          -  Presence of macular edema

        Exclusion Criteria:

          -  Anticipated need for ocular surgery in the study eye during the study

          -  Laser photocoagulation in the study eye within 3 months

          -  Cataract surgery within 3 months
A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-659/TEZ/IVA; IVA; Placebo
Intervention description: Participants received VX-659/TEZ/IVA orally once daily in the morning.; Participants received IVA orally once daily in the evening.; Participants received placebo matched VX-659/TEZ/IVA orally once daily in the morning and placebo matched to IVA orally once daily in the evening.
Intervention MeSH terms: Ivacaftor; VX-659
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 385.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor
      (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for
      F508del and a minimal function mutation (F/MF subjects).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Heterozygous for F508del and an MF mutation (as defined in the protocol)

          -  Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for
             age, sex, and height

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

          -  Solid organ or hematological transplantation

        Other protocol defined Inclusion/Exclusion criteria may apply
Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir
Condition: HIV Infections; AIDS Virus; Human Immunodeficiency Virus; Acquired Immunodeficiency Syndrome Virus
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Intervention: darunavir (DRV, TMC114); darunavir (DRV, TMC114)
Intervention description: 800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks; 800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
Intervention MeSH terms: Darunavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; Monotherapy; Darunavir; Protease inhibitor; Early pre-treated; Undetectable; Treatment Experienced

Summary:

      The purpose of the study is to compare the efficacy, safety and tolerability of
      darunavir/ritonavir 800/100 mg once a day (O.D.) as a monotherapy versus a triple combination
      therapy containing 2 nucleosides and darunavir/ritonavir in 250 HIV-1 infected patients who
      have been on Highly Active Antiretroviral Therapy (HAART) and have plasma viral load below 50
      copies/ml for at least 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with documented HIV-1 infection

          -  Patients currently receiving HAART for at least 24 weeks

          -  Plasma viral load < 50 copies/mL for at least 24 weeks prior to screening (two results
             must be documented)

          -  Patients taking the same antiretroviral combination for at least 8 weeks before
             screening

          -  Patients and physician's preference to change the current HAART regimen for reasons of
             simplification and/or toxicity

          -  CD4 > 100/mm3 at the start of HAART and > 200/mm3 at screening.

        Exclusion Criteria:

          -  No history of virological failure defined as two consecutive plasma HIV-1 RNA > 500
             copies/mL while on previous or current antiretroviral therapy

          -  No history of any primary PI mutations as defined by the IAS-USA guidelines 2006

          -  No patients co-infected with hepatitis B

          -  No pregnant or breastfeeding women

          -  No active clinically significant disease or life threatening disease or findings
             during screening of medical history or physical examination that, in the
             investigator's opinion, would compromise the patient's safety or outcome of the study.
Efficacy and Safety of Indacaterol in Adults (40 Years and Above) With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol 150 µg; Indacaterol 300 μg; Placebo to indacaterol
Intervention description: Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).; Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).; Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 563.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; indacaterol; long-acting β2-agonist; adults

Summary:

      This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or
      over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults aged ≥ 40 years

          -  Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as
             classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
             Guidelines, 2007) and:

               1. Smoking history of at least 10 pack years

               2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30%
                  of the predicted normal value

               3. Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

        Exclusion Criteria:

          -  Patients who have received systemic corticosteroids for a COPD exacerbation in the 6
             weeks prior to screening or during the run-in period

          -  Patients requiring long-term oxygen therapy (> 15 hours a day) for chronic hypoxemia

          -  Patients who have had a respiratory tract infection within 6 weeks prior to screening

          -  Patients with concomitant pulmonary disease

          -  Patients with a history of asthma

          -  Patients with diabetes Type I or uncontrolled diabetes Type II

          -  Any patient with lung cancer or a history of lung cancer

          -  Any patient with active cancer or a history of cancer with less than 5 years
             disease-free survival time

          -  Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured
             at screening is prolonged

          -  Patients who have been vaccinated with live attenuated vaccines within 30 days prior
             to screening or during the run-in period

          -  Patients unable to successfully use a dry powder inhaler device or perform spirometry
             measurements

        Other protocol-defined inclusion/exclusion criteria applied to the study.
A Study Evaluating the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm
Condition: Unruptured Wide-neck Intracranial Aneurysms
MeSH terms: Intracranial Aneurysm; Aneurysm
Intervention: PulseRider® Aneurysm Neck Reconstruction Device
Intervention description: Neck Reconstruction Device
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Unruptured; intracranial aneurysms; Endovascular

Summary:

      This is a prospective, multi-center, non-randomized clinical evaluation utilizing the
      PulseRider® Aneurysm Neck Reconstruction Device.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject with wide neck intracranial aneurysm located at a bifurcation

          2. The subject is between 18 and 80 years of age the time of consent

          3. Informed consent is obtained and the subject signs the IRB approved consent prior to
             beginning any study procedures

          4. In the opinion of the treating physician, placement of the PulseRider® device is
             technically feasible and clinically indicated

        Exclusion Criteria:

          1. Unstable neurological deficit (condition worsening within the last 90 days)

          2. Subarachnoid Hemorrhage (SAH) within the last 60 days

          3. Irreversible bleeding disorder

          4. Patient has another intracranial aneurysm that in the Investigator's opinion, may
             require treatment within the 1 year follow up period

          5. A history of contrast allergy that cannot be medically controlled

          6. Known allergy to nickel

          7. Relative contraindication to angiography

          8. Woman of child-bearing potential who cannot provide a negative pregnancy test

          9. Current involvement in a study for another investigational product

         10. Patient and / or family considering a move from this geographical location at the time
             of consent

         11. Categorized as a vulnerable population and require special treatment with respect to
             safeguards of well-being (e.g. cognitively impaired, veteran, prisoner, etc.)
Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Intervention: Placebo; DHEA; DHEA
Intervention description: Placebo vaginal suppository; Vaginal suppository containing 0.25% (3.25 mg) DHEA; Vaginal suppository containing 0.5% (6.5 mg) DHEA
Intervention MeSH terms: Dehydroepiandrosterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 450.0
Sex: Female
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Vulvar/vaginal atrophy; Atrophic Vaginitis; Dehydroepiandrosterone; DHEA; Prasterone; Vaginorm; Menopause; Intrarosa

Summary:

      The purpose of this Phase III trial is to evaluate the efficacy of intravaginal
      dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women (non-hysterectomized or hysterectomized)

          -  Women between 40 and 75 years of age

          -  Willing to participate in the study and sign an informed consent

          -  Women who have self-identified symptom(s) of vaginal atrophy

          -  For non-hysterectomized women, willing to have endometrial biopsy at baseline and end
             of study

        Exclusion Criteria:

          -  Undiagnosed abnormal genital bleeding

          -  Hypertension equal to or above 140/90 mm Hg

          -  The administration of any investigational drug within 30 days of screening visit

          -  Endometrial hyperplasia, cancer or endometrial histology showing proliferative,
             secretory or menstrual type characteristics at histologic evaluation of endometrial
             biopsy performed at screening