bioihbjkbjnl/mcl2 huggingface dataset:
Impaired HDL and Coronary Artery Disease in Anabolic Androgenic Steroid Users
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      Anabolic androgenic steroids (AASs) have been associated with coronary artery disease (CAD).
      The illicit use of these substances also leads to a remarkable decrease in high-density
      lipoprotein (HDL) plasma concentration, which could be a key factor in the atherosclerotic
      process. The investigators tested the functionality of HDL by cholesterol efflux and
      antioxidant capacity and its association with CAD in young men.
    

Detailed description: 
      Twenty strength-trained AAS users (AASU) age 29±5 yr, 20 age-matched strength-trained AAS
      nonusers (AASNU), and 10 sedentary controls (SC) were enrolled.

      HDL concentration and functionality by measuring the 14C-cholesterol efflux mediated by HDL
      and the ability of HDL in inhibiting LDL oxidation were evaluated.

      Coronary artery was evaluated with coronary computed tomography angiography.
    

Intervention name(s): Coronary Computed Tomography Angiography; Macrophage cholesterol efflux mediated by HDL
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): To assess coronary artery plaque and calcification, all participants underwent coronary computed tomography angiography according to the guidelines of the Society of Cardiovascular Computed Tomography (SCCT). All CT scans were acquired in a 320-row detector scanner (AquillionOneTM - Toshiba Medical Systems Corporation, Otawara, Japan) with 0.5-mm thick slices. Acquisition protocol included coronary artery calcium scoring (CACS) and coronary CTA. CACS protocol utilized a 370-ms tube rotation, 120-kV tube voltage, 300-mA tube current, and 320x0.5-mm collimation with 3-mm slice thickness reconstructed images, one heart beat acquisition during diastole.; Macrophages were incubated with DMEM (Low Glucose, Gibco, Grand Island, New York, USA) containing 1 mg fatty acid free albumin (FAFA) (Sigma-Aldrich, Steinheim, Germany) plus 50 μg acetylated LDL/mL and 0.3 μCi 14C-cholesterol/mL (Amersham Biosciences, UK) for 48h. After washing with PBS/FAFA, cells were incubated in the presence or absence of HDL (50 µg/mL) for 8h. The amount of radioactivity present in the medium at the end of the HDL incubation period will indicate albumin-mediated cholesterol efflux with albumin alone and total efflux with albumin + HDL. Thus, specific HDL-mediated efflux will be calculated, subtracting the albumin-mediated efflux from total efflux
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Anabolic androgenic steroids users and nonusers were recreational weightlifters or amateur
        bodybuilding athletes who were recruited from gymnasiums.

        Sedentary control group was recruited from community sample.
      
Keywords: Coronary artery disease; HDL; anabolic steroids
Clinical Outcome of Liver Transplant Patients With Tacrolimus-based Immunosuppression
Condition: Liver Transplantation
Study type: Observational

Summary: 
      Genetic polymorphism and numerous clinical factors could influence tacrolimus
      pharmacokinetics, which led to large inter-and intra-individual variability.Since its narrow
      therapeutic range,predicting therapeutic outcome and individualized dosage remains to be a
      challenge. The study's objective is to identify the genetic and clinical factors that can
      influence clinical outcome in liver transplant.
    

Detailed description: 
      A great number of studies had found significant correlation between tacrolimus
      pharmacokinetics and gene polymorphism. However, previous studies on the correlation between
      genetic factors and clinical outcome were controversial. Furthermore, most studies focused on
      single genetic polymorphism and clinical outcome, and very limited studies took multiple
      genetic factors and clinical factors into account.

      This is a retrospective study. Eligible patients were those who had signed informed consent
      for genetic study in previous research projects ( IRB approval number：201512005RINC and
      201612023RIND ). The present study will collect laboratory data, concurrent medications, and
      therapeutic drug monitoring (TDM) data. Patient survival, graft survival, acute rejection and
      tacrolimus-associated adverse events will be assessed.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who underwent living donor liver transplantation (LDLT) during 2008 to 2017 in
        National Taiwan University Hospital and received tacrolimus-based immunosuppression.
      
Keywords: tacrolimus; liver transplant; gene polymorphism; immunosuppressant
A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients who are Hepatitis C Negative (HCV negative) and are on the waiting list for a lung
      transplant at NYULH who consent to participate in this study will receive a lung transplant
      from a deceased donor that is HCV positive. Patients will initiate treatment for HCV with the
      pan-genotypic agent, Mavyret, on the day of surgery and will complete the full 8-week
      treatment course. Patients will be monitored post-transplant for the development of viremia,
      and for the time course of clearance of viremia among those who develop viremia.
    


Intervention name(s): Mavyret
Intervention type(s): Drug
Intervention description(s): Patients will be on 8 weeks of Mavyret
Other intervention name(s): pibrentasvir; glecaprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preliminary Study of Pharmacokinetics of Ginkgolides Meglumine Injection.
Condition: Ischemic Stroke
MeSH terms: Ischemic Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      To explore the rule of absorption, distribution, metabolism and elimination after intravenous
      administration of Ginkgolides Meglumine Injection healthy subjects. The plasma drug profiles
      will be important to assess the potential clinical drug-drug interactions.
    

Detailed description: 
      Ginkgolides Meglumine Injection was jointly developed by China Pharmaceutical University and
      Jiangsu Kanion Pharmaceutical Co., Ltd. Its pharmacal ingredients are ginkgo lactones A ,
      ginkgo lactone B, ginkgo lactone K, etc; Excipients for meglumine, citric acid, sodium
      chloride. It is used to treat stroke (mild-to-moderate cerebral infarction) in recovery
      phlegm and Syndrome of Intermingled Phlegm and Blood Stasis.

      The aim of this study is to explore the rule of absorption, distribution, metabolism and
      elimination after intravenous administration of Ginkgolides Meglumine Injection healthy
      subjects. The plasma drug profiles will be important to assess the potential clinical
      drug-drug interactions.

      Biological sample including blood and urine for PK is collected during the study. In the
      first stage, the biological sample of two subjects will be collected at different time
      points. In the second stage, the biological sample of another two subjects will be collected
      at the time points which are adjusted according to the results of the first stage.
    

Intervention name(s): Ginkgolides Meglumine Injection
Intervention type(s): Drug
Intervention description(s): 25 mg, ivdrip, once.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ischemic stroke; safety; Pharmacokinetics; Ginkgolides Meglumine Injection
Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000
      mg/m2/day by mouth [po], day 1 pm-day 15 am every 3 weeks [q3w]), oxaliplatin (130 mg/m2
      intravenously [iv], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with
      advanced and/or metastatic colorectal cancer.
    

Detailed description: 
      This study will evaluate the efficacy, safety and pharmacokinetics of Capecitabine (2000
      mg/m2/day po, day 1 pm-day 15 am q3w), Oxaliplatin (130 mg/m2 iv, day 1 q3w) and Bevacizumab
      (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.
    

Intervention name(s): Bevacizumab; Oxaliplatin; Capecitabine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks); 130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks); 2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)
Intervention MeSH terms: Bevacizumab; Capecitabine; Oxaliplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced and/or metastatic colorectal cancer
Effects of Tea Catechin Extracts on Oxidative Damage
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to clarify the effects of tea catechin extracts on the frequency
      changes of micronuclei in peripheral lymphocytes compared with other oxidative stress markers
      in late middle aged healthy volunteers
    

Detailed description: 
      Experimental studies have revealed that tea catechin extracts induce preventive effects on
      oxidative stress, but there have been few clinical trials conducted to verify the effects.
      Also, there have been few clinical markers indicating oxidative damage, and therefore, more
      accurate and reliable markers have been expected. The study is designed for evaluating the
      effects of tea catechin extracts on the frequency changes of micronuclei in peripheral
      lymphocytes as the indicator of oxidative damage, compared with other oxidative stress
      markers in late middle aged healthy volunteers.
    

Intervention name(s): catechin extracts
Intervention type(s): Dietary Supplement
Intervention description(s): comparison with placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: catechin; oxidative stress; chromosome damage; aged
Virological and Clinical Anti-Hepatitis B Virus (HBV) Efficacy of Tenofovir and Emtricitabine in Patients With HIV/HBV co-Infection
Condition: HIV Infections; Hepatitis B
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis B; Coinfection; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized multicentre trial of emtricitabine (FTC) versus tenofovir (TDF)/FTC in
      antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A).

      Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A
      is being conducted. (Substudy A1)
    

Detailed description: 
      This is a randomized multicentre trial of FTC vs TDF/FTC in antiretroviral naive subjects
      with HIV/HBV co-infection over 48 weeks (Clinical Trial A).

      Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A
      is being conducted. (Substudy A1)

      Primary Objectives:

        -  To compare the proportion of subjects with HBV DNA levels below the limit of detection
           (<400 copies/ml) by week 48 in each treatment group

      Secondary Objectives:

        -  To evaluate the emergence of HBV resistance at 48 weeks

        -  To compare the proportion of patients with undetectable HBV DNA at weeks 12 and 24 in
           each treatment group

        -  To compare the proportion of patients who achieve HBeAg and HBsAg seroconversion at
           weeks 12, 24 and 48 during the study

        -  To compare changes in ALT from baseline and the rate of hepatic cytolysis (ALT>5x ULN)

        -  To compare suppression of HIV-1 RNA and changes in CD4/CD8 counts over 48 weeks

        -  To compare the effect of therapy on histological changes in the liver and the presence
           of ccc-DNA

      Enrollment:

        -  24 patients in Clinical trial A (of whom 16 enter substudy A1).

      Clinical Trial A:

        -  Patients with HIV/HBV co-infection who are naive to HIV/HBV therapy, have detectable HBV
           viraemia and are willing to start antiretroviral therapy.

      Inclusion Criteria:

        -  Written informed consent

        -  Documented HIV infection

        -  Age 18 - 70 years

        -  HBV DNA > 106 copies/ml

      Randomization:

        -  Arm 1: Zidovudine (AZT), emtricitabine (FTC), efavirenz (EFV)

        -  Arm 2: Tenofovir (TDF), emtricitabine (FTC), efavirenz (EFV)
    

Intervention name(s): tenofovir; emtricitabine; zidovudine; efavirenz
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Tenofovir; Emtricitabine; Zidovudine; Efavirenz
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1; HBV; treatment; tenofovir; emtricitabine; Treatment Naive; HIV-1 infection; Hepatitis B virus infection
Diabetes in Minor Stroke/TIA, Glucose Tolerance and Haemostasis, a Long-term-follow-up Study and Intervention With Yoga
Condition: Stroke; TIA
MeSH terms: Stroke
Study type: Observational

Summary: 
      In acute stroke patients about 20 % have known diabetes. There is a doubled risk of recurrent
      stroke in diabetic patients. It has been shown that antiplatelet drugs are not as effective
      in diabetic patients as in non-diabetic patients. In acute stroke patients around 80 % have
      impaired glucose tolerance, which will improve after one month till about 60 %.

      This study includes acute patients with minor stroke or TIA. They are followed up at one and
      six months and then at every six months for at least four years. The investigators perform an
      OGTT and haemostatic tests within the first days after onset and then at one month. Blood
      pressure, metabolic parameters, bodyweight, physical activity and diet are collected at each
      visit. The investigators give the patients information about lifestyle changes as needed.

      As part of the study there is an interventional study, Medicine Yoga, an open randomized
      controlled study. Patients are randomized to 16 sessions of Yoga under professional
      instructions and a CD for home training or controls.

      The aims of this study are to investigate glucose tolerance in acute stroke and TIA patients,
      and its relation to the different haemostatic variables. The importance of glucose tolerance,
      haemostatic variables and other risk factors (blood pressure, lipids, BMI,) on cardiovascular
      events will be investigated and the possibility to affect these risk factors by lifestyle
      changes and Yoga. The effect of different antiplatelet drugs will be investigated in relation
      to glucose tolerance.
    

Detailed description: 
      144 patients with minor stroke and TIA has been included in the study between 2010 and 2012.
      They have been follow for four years.

      Two papers have been published on the results of the study. Lundström A, von Arbin M, Laska A
      C, Jörneskog G, Wallen NH. Glucose intolerance and insulin resistance as predictors of low
      platelet response to clopidogrel in patients with minor ischemic stroke or TIA. Platelets.
      2013 Mar 25.341-49.

      Lundström A, Wallén H, von Arbin M, Jörneskog G, Gigante B, Höeg Embrower K, Laurencikas E,
      Laska AC. Clopidogrel Resistance after Minor Ischemic Stroke or Transient Ischemic Attack is
      Associated with Radiological Cerebral Small-Vessel Disease. J Stroke Cerebrovasc Dis. 2015
      Aug 21. pii: S1052-3057(15)00349-3
    

Intervention name(s): Diabetes in stroke/TIA
Intervention type(s): Other
Intervention description(s): Mostly no intervention. A small Group of the patients recieved Yoga
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Acute stroke and TIA patients screened from the stroke unit at Danderyd Hospital,
        Stockholm, Sweden
Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP Study)
Condition: Anxiety Disorders; Depressive Disorders
MeSH terms: Anxiety Disorders; Depressive Disorder
Study type: Interventional

Summary: 
      This study is to examine the superiority of the combined treatments of transdiagnostic
      cognitive-behavior therapy (Unified Protocol; UP) and Treatment-As-Usual in comparison with
      the waiting-list with Treatment-As-Usual in the reduction of depressive and anxiety symptoms
      among depressive and anxiety disorders.
    

Detailed description: 
      Participants with depressive or anxiety disorders will be randomized to either Unified
      Protocol with Treatment-As-Usual or Wail-list with Treatment-As-Usual. Intervention period
      will be 20-week and the follow-up period will be 43 week from registration.
    

Intervention name(s): Unified Protocol with Treatment As Usual; Treatment As Usual
Intervention type(s): Behavioral; Other
Intervention description(s): Unified Protocol(UP) is a transdiagnostic cognitive-behavioral therapy for depressive and anxiety disorders, which is developed by Dr. Barlow and his colleagues at Boston university.
UP is weekly, face to face, individual psychotherapy consisting of 9 to 20 sessions. Average session number is 16 sessions. Contents of the treatment includes motivational enhancement, psychoeducation of treatment rationale and emotion, emotion awareness training, cognitive reappraisal, avoidance and emotion driven behaviors, interoceptive exposure and emotion exposure.; Most of the TAU will be drug therapy or nonsystematic supportive psychotherapy.
Other intervention name(s): Cognitive Behavioral Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Antifungal Potential of Moringa Olifera Against Otomycosis
Condition: Otomycosis
MeSH terms: Otomycosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      patients with Otomycosis were recognized by an ENT specialist. 20 patients were distributed
      randomly into two groups. The first group will be treated with Nystatin ear drops twice
      daily. The second group will be treated with Moringa ear drops. patients will be examined
      endoscopically by the ENT specialist. patient's swabs will be isolated and analyzed by ELISA.
    

Detailed description: 
      Inclusion criteria:

      (1) Otomycosis .

      Exclusion criteria:

        1. tympanic membrane perforation;

        2. concurrent immune suppression,

        3. and concurrent bacterial infection.
    

Intervention name(s): Moringa oleifera leaf 10mg/100ml; Ear Drop
Intervention type(s): Drug; Drug
Intervention description(s): ear drops; plain ear drop formulation without moringa
Other intervention name(s): ear drops
Intervention MeSH terms: Carbamide Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: moringa extract ear drops
Masking: None (Open Label)
Primary purpose: Treatment
Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets
Condition: Primary Hypophosphatemic Rickets
MeSH terms: Rickets; Rickets, Hypophosphatemic; Familial Hypophosphatemic Rickets
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy and safety of oral phosphate (Z-521)
      in subjects with primary hypophosphatemic rickets.
    


Intervention name(s): Z-521
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
House Dust Mite SLIT in Elderly Patients
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      The safety and efficacy of specific sublingual immunotherapy for house dust mite allergens in
      patients over 60 years of age with allergic rhinitis and a confirmed allergy to house dust
      mites were the focus of the stu First, 111 patients, ages 60-75 years, with allergic rhinitis
      and with a confirmed allergy to D. pteronyssinus and D. farinae by the use of skin prick
      tests, serum-specific IgE and nasal provocation tests were included. Patients were
      individually randomised to groups: active or placebo using a double-blind method. A total of
      51 subjects in the sublingual allergen-specific immunotherapy (SLIT) group (Staloral 300R,
      Stallergens, France) and 57 in the placebo group were monitored for three years. The patients
      had to record on a diary card whenever they used anti-allergic medications.
    


Intervention name(s): immunotherapy Staloral
Intervention type(s): Drug
Intervention description(s): Staloral (R) 300 is a sublingual solution of allergen extracts for allergen immunotherapy. During a 16 day incrementally increasing dose period, patients took daily increasing doses period, patients took 1-8 drops of the 100 IR/ml extract during the first 8 days. Then, on days 9-16, patients took 1-8 drops of the 300 IR/ml extract. Next, patients received maintenance treatment consisting of five applications of eight drops (equivalent to 0.5 mL) of 300 IR/mL extract five times a week. The mean duration of the treatment was 28.2 months (range: 3-36 months).
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: immunotherapy; elderly