bioihbjkbjnl/mcl2 huggingface dataset:
24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients
Condition: Renal Transplant
Intervention: Everolimus; Tacrolimus; Mycophenolic acid (MPA)
Intervention description: Everolimus was supplied in boxes with 60 tablets. Available tablets: 1.0 mg, 0.5 mg and 0.25 mg.; Tacrolimus was administrated as Prograf® or Advagraf®, but could not be changed during study.; Myfortic® (MFS) was given as 720-1440 mg/day or 360-1440 mg/day. Cell-Cept® (MMF) was given as 1000-2000 mg/day or 500-2000 mg/day.
Intervention MeSH terms: Mycophenolic Acid; Everolimus; Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Renal transplant, everolimus, cardiovascular profile, CNI-free immunosuppression, left ventricular hypertrophy, biopsy proved acute rejection (BPAR)

Summary:

      The objective of the study is to compare the cardiovascular profile of an everolimus and
      mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic
      acid regimen in maintenance renal transplant patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Received kidney transplant > 6 months and < 3 years prior to study enrollment

          -  Receiving immunosuppressive regimen that includes tacrolimus and mycophenolic acid

          -  Between 18 and 70 years of age

          -  Willing to provide written informed consent

        Exclusion Criteria:

          -  Patients with an actual serum creatinine ≥ 2 mg/dl and/or eGFR≤ 40 ml/min and/or
             proteinuria≥ 500mg/day

          -  Patients who suffered from severe humoral and/or cellular rejection (≥ BANFF IIb,
             recurrent acute rejection or steroid resistant acute rejection in the previous years

          -  Patients who have severe hypercholesterolemia (>350 mg/dL; >9 mmol/L) or
             hypertriglyceridemia (>500 mg/dL; >8.5 mmol/L). Patients with controlled
             hyperlipidemia are acceptable.

          -  Diabetic patients

          -  Woman of child-bearing potential who is planning to become pregnant or is pregnant
             and/or lactating who is unwilling to use effective means of contraception

          -  Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the
             opinion of the site investigator, would interfere with study requirements

          -  Any other medical condition that, in the opinion of the site investigator based on
             recall or chart review would interfere with completing the study

          -  Receiving any investigational drug or have received any investigational drug within 30
             days prior to study enrollment
Effects of Oral Zinc Gluconate Among Acne Vulgaris Patients
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Zinc gluconate; Adapalene 0.003 MG/MG / Benzoyl Peroxide 0.025 MG/MG Topical Gel [Epiduo]; Placebo
Intervention description: oral zinc gluconate 200mg; Adapalene 0.3% + Benzoyl peroxide 2.5% gel applied once daily in the evening; contains cornstarch
Intervention MeSH terms: Zinc; Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 27 Years
Healthy volunteers: No
Keywords: acne vulgaris; zinc gluconate; inflammation; adapalene; benzoyl peroxide; Global Acne Grading System

Summary:

      Acne Vulgaris is one of the most common dermatologic diagnoses requiring long-term
      maintenance therapy. Promising results of oral zinc gluconate in improving acne vulgaris has
      been described.

      A randomized, double blind, placebo-controlled clinical trial was utilized for this study
      with the objective to assess the efficacy of oral zinc gluconate in the improvement of
      disease activity in acne vulgaris patients as measured by the inflammatory score and Global
      Acne Grading System (GAGS) score.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Filipino patients, aged 18-27 years old

          -  New patients diagnosed with Acne Vulgaris with a Global Acne Grading System score of
             at least 19

          -  Able to read and write in English or Tagalog

          -  Seen at the Dermatology out-patient clinic of East Avenue Medical Center

        Exclusion Criteria:

          -  Patients with other chronic dermatoses or systemic disease

          -  Taking oral supplements or medications within the past 4 weeks

          -  Patients who are pregnant or lactating
Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin Treatment
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart 30; metformin; glimepiride; insulin glargine
Intervention description: Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.; China: Tablets, 500 mg. Min. 1500 mg/day.
Japan: Tablets, 250 mg. Min 500 mg/day.; China: Tablets, 2 mg. Min. 4 mg/day.
Japan: Tablets, 1 mg. Min. 4 mg/day.; Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Insulin Aspart; Glimepiride; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 521.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood
      sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine
      once daily both in combination with metformin and glimepiride in Chinese and Japanese
      subjects with type 2 diabetes who have never received insulin before.

      The trial is conducted as a phase 4 trial in China and phase 3 in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes treated with a maximum of three different types of oral anti-diabetic
             drugs (OADs) (including traditional Chinese medicine which contains active ingredients
             of known OADs) for more than 6 months

          -  Unchanged total daily dose of at least 1500 mg (Chinese patients) or 500 mg (Japanese
             patients) metformin for the last two months

          -  Unchanged total daily dose of at least half maximum recommended total daily dose of
             any insulin secretagogue for the last two months

          -  Insulin naive

          -  HbA1c between 7.0% and 10.0%

          -  FPG (fasting plasma glucose) equal to or above 6.1 mmol/L (110mg/dL)

          -  Body Mass Index (BMI) below 40.0 kg/m^2

        Exclusion Criteria:

          -  Treatment with any thiazolidinedione (TZD) and GLP-1 (glucagon like peptide-1)
             receptor antagonists during the last 3 months before Visit 1 in this trial

          -  Any disease or condition which the Investigator feels would interfere with the trial

          -  Any contraindication to metformin or glimepiride (according to local labelling)
A Carotid Stenting Boston Scientific Surveillance Program
Condition: Carotid Artery Disease
MeSH terms: Carotid Artery Diseases
Intervention: Carotid WALLSTENT Monorail Endoprosthesis; FilterWire EZ™ System™
Intervention description: A carotid artery stent for use in subjects at high risk for adverse events from Carotid endarterectomy (CEA) due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.; Embolic protection device used in conjunction with the Carotid WALLSTENT Endoprosthesis.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1097.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cerebrovascular Disease; Carotid Stent; Stent; Carotid Endarterectomy (CEA)

Summary:

      CABANA is a multicenter U.S. surveillance registry that will be conducted to compile early
      clinical outcomes data for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in
      routine clinical practice and to assess the adequacy of the Boston Scientific Corporation
      (BSC) Carotid Stenting Training Program.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject at high risk for adverse events from carotid endarterectomy due to either
             anatomic or comorbid conditions who requires carotid revascularization in the
             treatment of ipsilateral or bilateral carotid artery disease.

          -  Subject with neurological symptoms and greater than or equal to 50% stenosis of the
             common, internal carotid artery and/or the bifurcation by ultrasound or angiogram OR

          -  Subjects without neurological symptoms and greater than or equal to 80% stenosis of
             the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram.

          -  Subject has a reference vessel diameter greater than or equal to 4.0 mm and less than
             or equal to 9.0 mm at the target lesion and a vessel diameter distal to the target
             lesion of greater than or equal to 3.5 mm and less than or equal to 5.5 mm as optimal
             "landing zone" for placement of the FilterWire EZ System.

          -  Subject is willing and able to comply with all follow-up requirements.

          -  Subject has provided a signed informed consent prior to participation in the Registry.

        Exclusion Criteria:

          -  Patients in whom anticoagulant and/or antiplatelet therapy is contraindicated

          -  Patients with severe vascular tortuosity or anatomy that would preclude the safe
             introduction of a guide catheter, sheath, embolic protection system or stent system

          -  Patients with uncorrected bleeding disorders

          -  Lesions in the ostium of the common carotid artery.
Prevention of Cigarette Smoking in Attention Deficit Hyperactivity Disorder (ADHD) Youth With Concerta
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: methylphenidate HCl (Concerta)
Intervention description: OROS MPH will be openly prescribed to a maximum of 1.5 mg/kg/day (maximum 126 mg/day). Doses will be titrated according to clinical assessment of efficacy and tolerability.
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 203.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: cigarette smoking; ADHD; adolescents; Concerta

Summary:

      This study will consist of a six-week open-label treatment period with an extended duration
      methylphenidate (OROS MPH) followed by subsequent monthly visits for 24 months in a large
      sample of youths aged 12-17 who meet Diagnostic and Statistical Manual of Mental Disorders,
      Fourth Edition (DSM-IV) criteria for ADHD.

      The researchers hypothesize that OROS MPH treatment will be associated with low rates of
      cigarette smoking in ADHD youth.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adolescent outpatients between 12 to 17 years of age (inclusive).

          2. Subjects with the DSM-IV diagnosis of ADHD, as manifested in the clinical evaluation
             and confirmed by structured interview.

          3. Subjects with sufficient current ADHD symptoms to warrant treatment, as measured by a
             Clinical Global Impression Severity Scale (CGI-S) score of greater than or equal to 4
             (moderately ill); OR subjects already on Concerta who are judged to be responders (CGI
             of 1 or 2) and who tolerate treatment well.

        Exclusion Criteria:

          1. Any serious or unstable medical illness including hepatic, renal, gastroenterologic,
             respiratory, cardiovascular (including ischemic heart disease, hypertension),
             endocrinologic, neurologic, immunologic, or hematologic disease.

          2. Clinically significant abnormal baseline laboratory values

          3. History of seizures

          4. Active tic disorder

          5. Pregnant or nursing females

          6. Mental retardation (intelligence quotient [IQ] < 75)

          7. Organic brain disorder

          8. Eating disorders

          9. Psychosis

         10. Current bipolar disorder (current episode)

         11. Current depression > mild (CGI-S > 3)

         12. Current anxiety > mild (CGI-S > 3)

         13. Substance abuse or dependence within the past 2 months

         14. Recent change in non-monoamine oxidase inhibitor (MAOI) antidepressants (< 3 months)

         15. Recent change in benzodiazepines (< 3 months)

         16. Concerta non-responder
Transcranial Direct Current Stimulation, Treatment of Childhood Drug-Resistant Lennox-Gastaut Syndrome, A Pilot Study
Condition: Lennox-Gastaut Syndrome
MeSH terms: Lennox Gastaut Syndrome; Syndrome
Intervention: tDCS
Intervention description: brain stimulation by cathodal electrode at motor cortex
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 6 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Transcranial direct current stimulation; Cathodal stimulation; Childhood Pharmacoresistant epilepsy; Lennox-Gastaut syndrome

Summary:

      Background: Lennox-Gastaut syndrome (LGS) is a severe childhood epileptic syndrome with high
      pharmacoresistance. The treatment outcomes are still unsatisfied. The investigator previous
      study of cathodal transcranial direct current stimulation (tDCS) in children with focal
      epilepsy showed significant reduction in epileptiform discharges. The investigator
      hypothesized that cathodal tDCS when applied over the primary motor cortex (M1) combined with
      pharmacologic treatment will be more effective for reducing seizure frequency in participants
      with LGS than pharmacologic treatment alone.

      Material and Method:

      Study participants were randomized to receive either:

        1. pharmacologic treatment with 5-consecutive days of 2 milliampere (mA) cathodal tDCS over
           M1 for 20 min or

        2. pharmacologic treatment plus sham tDCS. Measures of seizure frequency and epileptic
           discharges were performed before treatment and again immediately post-treatment and 1-,
           2-, 3-, and 4-week follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of LGS

          -  Failure of more than two first-line AEDs to control seizures

          -  Average seizure frequency of more than one per month for 18 months and no more than
             three consecutive seizure-free months during that interval

          -  Age between 6 and 15 years

        Exclusion Criteria:

          -  Drug addiction

          -  Pregnancy

          -  Skull defect

          -  Other serious neurological diseases and change in dosage of antiepileptic drugs or use
             of herbal remedies and other alternative therapies.
Study to Evaluate Long Term Immunogenicity up to 10 Years After the First Booster Immunization With Tick Borne Encephalitis Vaccine in Adults Who Received 1 of 3 Different Primary Vaccination Schedules
Condition: Tick Borne Encephalitis; Virus Diseases
MeSH terms: Virus Diseases; Encephalitis, Tick-Borne; Encephalitis
Intervention: Blood draw
Intervention description: Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Long term immunogenicity study

Summary:

      The aim of this study is to investigate the immunogenicity response in adults up to 10 years
      after one booster dose. Data collected from this study will allow for greater information to
      prescribers who administer TBE vaccine, so that they can appropriately time the
      administration of booster vaccinations to individuals who received different vaccination
      schedules and who live in tick borne encephalitis endemic regions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have completed prior study - V48P7E1.

        Exclusion Criteria:

          -  Subjects whose antibody responses to booster vaccine received in the parent study fell
             below protective levels, subjects who have been exposed to TBE or flavivirus vaccine,
             subjects with immunosuppression.
Evaluation of a Primary Type 2 Diabetes Prevention Programme
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: PREDIAS; Control
Intervention description: Group programme aiming at modification of lifestyle: lifestyle changes, 12 lesson a 90 minutes, delivered in a group setting, consists of analysis of barriers against lifestyle changes, behavior analysis of eating and exercise behavior, modification of unhealthy lifestyle and relapse prevention; Written Information about diabetes risks. Brochure about the value of a healthy lifestyle, calorie table, suggestions for healthy food and daily exercise
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 182.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: diabetes-prevention; lifestyle modification; behavior therapy; self-management

Summary:

      A type 2 diabetes prevention programme, named PREDIAS was developed. It consists of 12
      lessons delivered as group sessions. Die efficacy of PREDIAS was studied in a randomized
      controlled study with 12 month follow up. Control group received written information about
      diabetes risk. Primary outcome variable was weight reduction at 12 months follow up.
      Secondary variables were impact of the intervention on glycemic parameters, lipids, eating
      and exercise behavior and other metabolic risk factors
    

Eligibility criteria:

        Inclusion Criteria:

          -  impaired fasting glucose and/or

          -  impaired glucose tolerance

          -  overweight (BMI > 26 kg/m²)

        Exclusion Criteria:

          -  type 2 diabetes

          -  severe illness (cancer diagnosis, stroke or myocardial infarction in the last 12
             months)

          -  diagnosis of a current mental disease
Statin Therapy in Heart Failure: Potential Mechanisms of Benefit
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure
Intervention: atorvastatin; placebo
Intervention description: atorvastatin 10mg PO QD; matched placebo Qd x 3 months
Intervention MeSH terms: Atorvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Randomized Controlled Trial; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Sympathetic Nervous System; Ventricular Remodeling; Chemokines

Summary:

      The goal of the investigators' study is to further understand the potentially beneficial
      effects of statin therapy in patients with heart failure. It is hypothesized that statins
      will 1) increase the heart's pumping ability 2) improve functioning of the sympathetic
      nervous system and 3) decrease immune activation in heart failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age≥18 years old

          -  LVEF ≤ 35%, as documented by echocardiography, radionuclide ventriculography, gated
             SPECT, or contrast ventriculography within past 6 months

          -  Symptomatic HF (NYHA II-IV) or current NYHA I with history of symptomatic HF within
             the last year

          -  Stable doses of optimal HF medical therapy, unless documented contraindication.

        Exclusion Criteria:

          -  Ischemic etiology of HF, defined as the presence of at least one of the following four
             criteria; angiographic evidence of > 50% lesion in 1 or more of the 3 major epicardial
             vessels; history of myocardial infarction; history of revascularization procedure;
             evidence of significant perfusion defect in the setting of ischemic symptoms.

          -  Clinical indication for statin treatment - coronary artery, cerebrovascular, or
             peripheral vascular disease

          -  Major cardiovascular event or surgical procedure within past 8 weeks

          -  LDL<70 mg/dL

          -  HF secondary to congenital heart disease or uncorrected valvular disease

          -  Treatment with statin within past 2 months

          -  Pregnancy

          -  Contraindication to statin: moderate liver disease, AST/ALT > 150 U/ L, known
             hypersensitivity

          -  Likely to receive heart transplant within 3 months

          -  Known peripheral or autonomic neuropathy