bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.
Condition: Renal Transplantation
Intervention: Everolimus + Cyclosporine; Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS); Steroids
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Keywords: Everolimus, calcineurine inhibitor, renal transplantation in maintenance, chronic allograft nephropathy

Summary:

      Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine
      microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate
      Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in
      study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely
      discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine
      microemulsion + steroids).
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients who participated in and completed study CRAD001A2420

        Exclusion criteria:

          -  Premature study or study treatment discontinuation in CRAD001A2420 study.

          -  Acute rejection within the 3 months prior to inclusion

        Other protocol-defined inclusion/exclusion criteria may apply
Efficacy and Safety of Rivastigmine Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Rivastigmine transdermal patch; Placebo
Intervention description: Rivastigmine transdermal patch was provided in the following sizes and doses:
2.5 cm^2 (4.5 mg), 5 cm^2 (9 mg), 7.5 cm^2 (13.5 mg), and 10 cm^2 (18 mg). The caregiver applied one patch on the back of a patient, placed alternately from the right to the left side at approximately the same time each day.; Placebo transdermal patch was provided in the following sizes: 2.5 cm^2, 5 cm^2, 7.5 cm^2 and 10 cm^2. The caregiver applied one patch on the back of a patient, placed alternately from the right to the left side at approximately the same time each day.
Intervention MeSH terms: Rivastigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 859.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: rivastigmine，Alzheimer's Disease, transdermal patch

Summary:

      The purpose of this study was to investigate the 5cm^2 and 10cm^2 doses of rivastigmine
      transdermal patch in terms of efficacy and safety in patients with probable Alzheimer's
      Disease (MMSE [Mini Mental State Examination] 10-20). A 52-week extension phase evaluated the
      safety and tolerability of long-term treatment by rivastigmine transdermal patch in patients
      with probable Alzheimer's Disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria

          -  A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria

          -  An MMSE score of > or = 10 and < or = 20

        Exclusion Criteria:

          -  A current DSM-IV diagnosis of major depression

          -  Taken rivastigmine in the past

          -  A score of > 5 on the Modified Hachinski Ischemic Scale (MHIS) Other protocol-defined
             inclusion/exclusion criteria may apply

        Other protocol-defined inclusion/exclusion criteria may apply

        Extension Phase Eligibility Criteria

        Inclusion Criteria:

          -  Patients who have completed the Double-blind Treatment Phase on study medication

        Exclusion Criteria

          -  Patients who have any important protocol deviations until the completion of the
             Double-blind Treatment Phase
Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Rosuvastatin; Atorvastatin
Intervention description: Capsule/Tablet, oral, qd, 6 or 12 weeks; Capsule/Tablet, 10mg, oral, qd, 6 weeks
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 934.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HMG-CoA; LDL-C; CHD

Summary:

      This trial is to compare the efficacy, safety and tolerability of Rosuvastatin with
      Atorvastatin by assessing the change of LDL-C in patients with hypercholesterolemia and
      history of coronary heart disease (CHD) or risk equivalent, or a 10 year CHD risk of no less
      than 10%, following 6-week treatment and a possible 6 week extension treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treated for or diagnosed hypercholesterolemia or have had a high risk with
             hypercholesterolemia

          -  LDL-C between 3.36mmol/L and 6.5 mmol/L if not treated with statin or between
             2.6mmol/L and 4.14 mmol/L

          -  Fasting triglyceride less than 4.52mmol/L

        Exclusion Criteria:

          -  History of statin induced myopathy

          -  Unstable or uncontrolled cardiovascular diseases

          -  Familial dysbetalipoproteinemia
Comparison of the Effects of 2 Drugs on Lumbar Spine Volumetric BMD in Men With Glucocorticoid-Induced Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Teriparatide; Risedronate
Intervention description: 20 µg/day sc for 18 months; 35 mg/week po for 18 months
Intervention MeSH terms: Teriparatide; Risedronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: Male
Minimum age: 25 Years
Healthy volunteers: No
Keywords: Glucocorticoid Induced

Summary:

      The objective of this study is to test the hypothesis that teriparatide is superior to the
      active comparator in the change from baseline to 18 months of lumbar spine volumetric
      trabecular bone mineral density (BMD) in males with glucocorticoid-induced osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory men 25 years of age and older presenting to Visit 1 with a bone mineral
             density (BMD) of at least 1.5 standard deviation (SD) below the corresponding normal
             young adult men average BMD (T score of -1.5 or lower), as determined from the
             manufacturer's database at any of the following regions of interest: total hip,
             femoral neck, or lumbar spine

          -  Have received glucocorticoid therapy at an average dose of at least 5.0 milligrams
             (mg) per day of prednisone or its equivalent for a minimum of 3 consecutive months
             immediately preceding screening (Visit 1), as determined by medical history.

          -  A minimum of 2 lumbar vertebrae (L) in the L-1 through L-3 region must be evaluable by
             quantitative computerized tomography.

          -  Normal or clinically insignificant abnormal laboratory values (as determined by the
             investigator) including serum calcium, parathyroid hormone (PTH) (1 84), and 25
             hydroxyvitamin D concentrations, and alkaline phosphatase activity.

        Exclusion Criteria:

          -  Presence of a mild, moderate, or severe spinal fracture in both the twelfth thoracic
             vertebra (T-12) and first lumbar vertebra (L-1), as determined by the central reading
             facility using the semiquantitative technique.

          -  Abnormal albumin-corrected serum calcium levels

          -  History of unresolved skeletal diseases that affect bone metabolism other than
             glucocorticoid-induced osteoporosis

          -  History of malignant neoplasms in the 5 years prior to Visit 2, with the exception of
             superficial basal cell or squamous cell carcinomas of the skin that have been
             definitively treated. Increased baseline risk of osteosarcoma; this includes patients
             with Paget's disease of the bone, previous primary skeletal malignancy, or skeletal
             exposure to therapeutic irradiation.

          -  Abnormal thyroid function not corrected by therapy

          -  Past and/or current treatment with certain medications.
Long-term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Mth Schedule in Healthy Adults
Condition: Hepatitis B; Hepatitis A
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Twinrix™
Intervention description: Intramuscular injection, 3 doses
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: TWINRIX™ ADULT; Hepatitis A; Hepatitis B

Summary:

      The aim of this study is to evaluate the long-term persistence of hepatitis A and B
      antibodies at Years 11, 12, 13, 14 and 15 after subjects received their first dose of a 3
      dose primary vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol
      Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

      This protocol posting deals with objectives & outcome measures of the extension phase at Year
      11-15.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who had consented to participate in the long-term follow-up studies at the
             previous long-term blood sampling time points

          -  Written informed consent will have been obtained from each subject. before the blood
             sampling visit of each year.
Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Zoledronic Acid; Androgen Deprivation Therapy (ADT)
Intervention description: Zoledronic acid was provided by Novartis in vials containing 4 mg/5 mL liquid concentrate. Prior to administration, the liquid concentrate from one vial was to be further diluted with 100 mL of calcium-free infusion solution (0.9 % weight by volume sodium chloride solution or 5 % weight by volume glucose solution). If refrigerated, the solution had to be allowed to reach room temperature before administration.
After addition of the liquid concentrate to the infusion media, the infusion solution was to be used as soon as practicable to reduce the risk of microbiological hazard. If storage of the solution was necessary, it had to be refrigerated at temperatures between 2-8 degrees C and was to be used within 24 hours.
The infusion solution containing 4 mg zoledronic acid was to be administered every 4 weeks as an i.v. infusion over no less than 15 minutes.; Androgen deprivation therapy (ADT) was to be administered according to institutional protocols, in accordance with relevant prescribing information. The type and duration of androgen deprivation was at the discretion of the treating specialist, and could include orchiectomy where this would normally have been performed. Androgen deprivation therapy was provided by the investigational center, or obtained by the patient from usual sources. Anti-androgen monotherapy and intermittent ADT were excluded in the first 12 months of the study.
Intervention MeSH terms: Zoledronic Acid; Androgens
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 522.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: zoledronic acid; bone metastases; prostate cancer; hormone-sensitive

Summary:

      This study aims to determine whether early treatment with zoledronic acid, that is given
      during the early phase of advanced prostate cancer, will be more efficacious than delayed
      treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  prostate cancer

          -  at least one bone metastasis

          -  receiving or about to receive androgen deprivation therapy (ADT)

        Exclusion Criteria:

          -  previous ADT failure

          -  previous or current treatment with another bone-protecting agent, chemotherapy or
             targeted therapy

          -  abnormal renal function

        Other protocol-defined inclusion/exclusion criteria may apply.
Evaluate Safety as Mono or Combination Therapies With Anti-diabetes Mellitus Drugs in Japanese Subjects With Type 2 Diabetes Mellitus
Condition: Type2 Diabetes; High Blood Sugar
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Intervention: Dapagliflozin
Intervention description: Oral Dose 5 or 10 mg
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 728.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Phase3; Clinical trial; Type 2 Diabetes Mellitus

Summary:

      This is a long term, single arm, open label study to evaluate the safety and efficacy of
      dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in
      Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on
      diet and exercise or on other anti-diabetic treatment will be included in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  Men or women age ≥20 years old (Either gender needs to be 40% or higher of total
             number of treated subjects)

          -  diagnosed with type2 DM ; ≥6.5% and ≤10% at 1 week before treatment started

        Exclusion Criteria:

          -  Type 1 diabetes mellitus,

          -  FPG >240 mg/dL before treatment started

          -  Subjects who have history of unstable or rapidly progressing renal disease

          -  Subjects who have severe hepatic insufficiency and/or significant abnormal liver
             function

          -  Significant cardiovascular history
A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia
Condition: Chronic Kidney Disease; Dialysis; Hyperphosphatemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Intervention: MCI-196; Placebo
Intervention description: 3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind; 3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Dialysis; Hyperphosphatemia; Phosphate binder

Summary:

      This is a phase III multi-centre study in three periods: the first period is a phosphate
      binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the
      third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, and is >=18 years old

          -  Stable hemodialysis or peritoneal dialysis

          -  Subjects has Stable phosphate control

          -  Subjects on Stabilized phosphorus diet

          -  Subjects undergoing regular dialysis treatment

          -  Female and of child-bearing potential have a negative serum pregnancy test.

          -  Male subjects must agree to use appropriate contraception.

        Exclusion Criteria:

          -  Current clinically significant medical comorbidities, which may substantially
             compromise subject safety, or expose them to undue risk, or interfere significantly
             with study procedures and which, in the opinion of the Investigator, makes the subject
             unsuitable for inclusion in the study.

          -  serum albumin level < 3.0g/dL

          -  PTH level > 1000pg/mL

          -  Hemoglobin level < 8mg/dL

          -  A History of significant gastrointestinal motility problems

          -  Biliary obstruction or proven liver dysfunction

          -  A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2
             antibodies

          -  A clinically significant severe lactose intolerance or sensitivity

          -  A history of substance or alcohol abuse within the last year.

          -  Seizure disorders

          -  A history of drug or other allergy

          -  using cholestyramine, colestipol or colesevelam

          -  Schedule to receive a kidney transplant within the next 6 months

          -  Participation in a clinical study with any experimental medication in the last 30 days
             or an experimental biological product within the last 90 days prior to signing of
             informed consent
Olmesartan Medoxomil Versus Losartan in Patients With Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: olmesartan medoxomil; losartan potassium
Intervention description: olmesartan medoxomil oral tablets, once daily for up to 12 weeks; losartan oral tablets, once daily for up to 12 weeks
Intervention MeSH terms: Losartan; Olmesartan; Olmesartan Medoxomil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy and safety of oral administration of
      olmesartan medoxomil compared to losartan in subjects with mild to moderate hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diastolic BP 95 mm Hg - 114 mm Hg inclusive

          -  No participation in any clinical trial for the last 3 months

        Exclusion Criteria:

          -  Secondary hypertension

          -  Malignant hypertension

          -  Severe arterial hypertension

          -  Significant cardiovascular disease

          -  History or clinical evidence of cerebrovascular, gastrointestinal, hematological,
             hepatic disease, myocardial infarction, or severe liver disorder

          -  Clinical evidence of renal disease, poorly controlled diabetes, known malabsorption
             syndromes, psychiatric/emotional problems
Povidone-iodine Against Sodium Hypochlorite as Skin Antiseptics
Condition: Healthy Volunteers
Intervention: WHOLE GROUP OF 48 VOLUNTEERS
Intervention description: Two antiseptics (10% povidone iodine and 10% sodium hypochlorite) and one control were tested as skin antiseptics. The intervention consisted of preparing the skin with the antiseptic or the control. The areas were approximately 25 cm2 on the forearm for each antiseptic or control. The antiseptic or control were applied in an outward circular motion using a swab that was soaked with the solution. The solution was then kept on the skin for 60 seconds before the bacterial culture was conducted. All volunteers were instructed to continue the use of neutral soap and shampoo without antiseptics during the follow-up period.
Intervention MeSH terms: Povidone-Iodine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Antiseptics; Administration, cutaneous; Iodophors; Chlorine compounds; Anti-infecting agents, local

Summary:

      The investigators have few options for skin antisepsis. Alternatives for povidone-iodine,
      which is the most commonly used agent, are costly or ineffective. To have more options, this
      study is needed. The investigators want to know if there are difference between the use of
      10% sodium hypochlorite or 10% povidone-iodine for skin antisepsis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult volunteers.

        Exclusion Criteria:

          -  History of skin allergies or atopy, as well as reactions to soaps, iodine, chlorine,
             or latex
A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
Condition: Multiple Sclerosis; Walking Impairment
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: ADS-5102, 274 mg
Intervention description: Oral capsules
Intervention MeSH terms: Amantadine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 424.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study assessed the long-term safety and tolerability of ADS-5102 in subjects with MS and
      walking impairment who had completed the double-blind, placebo-controlled study of ADS-5102
      in subjects with MS (ADS-AMT-301).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed a current IRB-approved informed consent form

          -  Successful completion of a prior double blind study of ADS-5102 in patients with MS
             walking impairment.

        Exclusion Criteria:

          -  Based on the judgment of the investigator or Medical Monitor, participation in the
             study would jeopardize the safety of the subject.

          -  If female, is pregnant or lactating

          -  If a sexually active female, is not surgically sterile or at least 2 years
             post-menopausal, or does not agree to utilize a highly effective hormonal method of
             contraception (an IUD, or vasectomized male partner is also acceptable), in
             combination with a barrier method, from baseline through at least 4 weeks after the
             completion of study treatment. If a sexually active male, does not agree to utilize
             condoms from screening through at least 4 weeks after the completion of study
             treatment.

          -  Anticipated treatment with any amantadine formulation other than ADS-5102

          -  Planned participation in another interventional clinical trial