bioihbjkbjnl/mcl2 huggingface dataset:
Genome-wide Analysis of Lipid-lowering Efficacy and Drug Level of Simvastatin and Rosuvastatin
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Observational

Summary: 
      This study will perform a genome-wide association study (GWAS) of the lipid responses to
      rosuvastatin and simvastatin and plasma concentrations of these two statins in a homogeneous
      group of Han Chinese patients.
    

Detailed description: 
      A GWAS will be performed on about 360 Han Chinese patients with hypercholesterolaemia (which
      may be familial or non-familial) who have previously participated in a research project on
      the pharmacogenetics of statins and who have been treated with rosuvastatin and simvastatin
      to determine the genetic factors that may be related to the reduction in plasma low-density
      lipoprotein cholesterol (LDL-C) and plasma concentrations of these two statins. The lipid
      profiles were measured at baseline on no lipid-lowering treatment and after 4-6 week
      treatment of rosuvastatin 10 mg daily and after treatment with simvastatin 40 mg daily for at
      least 6 weeks with at least a 4-week washout period between the two treatments. Plasma
      concentrations of these two statins and their active metabolites about 12 hours after
      administration of statins have been measured by liquid chromatography-tandem mass
      spectrometry (LC-MS/MS).

      Genotyping for the whole-genome scan will be carried out on the Illumina OminiExpress
      beadchip (Illumina, San Diego, CA). The samples will be processed using the Illumina iScan
      platform at the Li Ka Shing Institute of Health Science, The Chinese University of Hong Kong
      (CUHK).
    

Intervention name(s): Rosuvastatin 10mg
Intervention type(s): Drug
Other intervention name(s): Simvastatin 40 mg
Intervention MeSH terms: Rosuvastatin Calcium; Simvastatin
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with hypercholesterolemia attending medical clinics in Hong Kong who were eligible
        for statin treatment according to local guidelines in Hong Kong and willing to give
        informed consent for DNA analysis.
      
Keywords: Statins; Pharmacogenomics
Global Coagulation Assessment in Cirrhosis and ACLF
Condition: Acute-On-Chronic Liver Failure; Cirrhosis, Liver
MeSH terms: Liver Cirrhosis; Liver Failure; End Stage Liver Disease; Acute-On-Chronic Liver Failure; Fibrosis
Study type: Observational

Summary: 
      Background: Patients with cirrhosis and acute-on-chronic liver failure (ACLF) may have
      bleeding complications which can lead to increased mortality. Standard coagulation tests
      (SCTs) like prothrombin time, platelet count and activated partial thromboplastin do not
      accurately depict in vivo coagulation profile. Point-of-care viscoelastic coagulation testing
      devices like thrombo-elastography (TEG) and Sonoclot may be better for guiding patient
      management.

      Methods: This prospective observational study compared and validated the point of care (POC)
      tests and SCTs in 70, 72 and 25 persons with ACLF, decompensated cirrhosis and healthy
      controls respectively.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients of ACLF, Cirrhosis of any etiology and Healthy controls were
        prospectively enrolled between January 2018 and August 2019.
      
Keywords: Sonoclot; Thromboelastography; RoTEM
An Investigation Into the Effects of Acute Exercise on Activities of Daily Living and Cognition in Older Adults
Condition: Physical Inactivity
Study type: Interventional

Summary: 
      Research has demonstrated the positive effects of chronic exercise on cognitive functioning
      and performance of Activities of Daily Living (ADLs). However, minimal research exists
      regarding the effects of acute exercise. To address this gap in the literature, the present
      study investigated the effect of an acute bout of exercise on executive functions, balance,
      and ADLs among healthy older adults. Based on the current literature, we expected
      participants in the exercise group to perform better on executive function tasks and ADLs
      compared to participants in the control group.
    


Intervention name(s): exercise
Intervention type(s): Behavioral
Intervention description(s): cycling exercise for 15min, with 5min warm up
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Control Trial: exercise or video control condition
Masking: Single (Participant)
Primary purpose: Basic Science
The Effect of Snacks on Glycaemic Regulation in Children
Condition: Blood Glucose; Energy Intake
Study type: Interventional

Summary: 
      Dairy products have a potential to be healthy snack foods for children. The purpose of this
      project is to investigate the short-term effects of Greek yogurt, a new popular dairy product
      on the regulation of glucose homeostasis, satiety and energy intake in normal weight and
      overweight/obese children.
    


Intervention name(s): dietary treatments
Intervention type(s): Other
Intervention description(s): commercially available food products
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of a Simulation Training Tool to Identify Lesions Requiring Further Screening for Melanoma
Condition: Skin Simulation Model; Mastery Learning Model to Simulation Training for Visual Screening for Melanoma and Skin Biopsy
MeSH terms: Melanoma
Study type: Interventional

Summary: 
      The investigators will design a curriculum for visual screening for melanoma and skin biopsy
      procedure, based on the mastery learning model, using simulators and web-based didactic
      instruction for medical students and internal medicine residents. This requires having a skin
      simulation model that presents a range of lesions from benign nevus to atypical nevus to
      melanoma in a distribution and density that mimics the clinical findings of those with 2 skin
      tones: fair-skin non- Hispanic white and Hispanic.
    


Intervention name(s): Simulation teaching session
Intervention type(s): Other
Intervention description(s): Simulation-based, mastery learning educational intervention in visual screening for melanoma
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Melanoma; Simulation Training; Medical Students
Therapeutic Plasmaexchange in Early Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Study type: Interventional
Phase: Phase 2

Summary: 
      Sepsis is defined by the occurrence of critical organ dysfunction in the context of
      infection. Unfortunately, its incidence appears to be rising, and the mortality of septic
      shock remains extraordinary high (> 60%). Death in sepsis arises from shock and multi organ
      dysfunction that are - at least in part - triggered by an inadequate response of the host's
      immune system to the infection. Given the injurious role of 1) this overwhelming immune
      response and 2) the consumption of protective plasmatic factors (e.g. vWF cleaving proteases,
      hemostatic factors etc.) while the disease is progressing the investigators hypothesize that
      early therapeutic plasma exchange (TPE) in the most severely ill individuals might improve
      hemodynamics, oxygenation and ultimately survival. This therapeutic strategy combines 2 major
      aspects in 1 procedure: 1. removal of harmful circulating molecules and 2. replacement of
      protective plasma proteins. The investigators designed the EXCHANGE trial to analyze in a
      randomized fashion the benefit of TPE as an add-on treatment to state of the art standard
      sepsis care. Only patients with early septic shock (< 24 hrs) and high catecholamine doses
      (norepinephrine > 0.4 ug/kg body weight/min) will be included. Those in the treatment group
      will receive 1 TPE within 2 hours following randomization. The primary outcome is
      norepinephrine dose 6 hrs after randomization. The recruitment period is 2 years and will be
      performed at the Hannover medical School University hospital in Germany. Secondary endpoints
      (including organ dysfunction as well as biochemical markers of inflammation and coagulation)
      will be assessed on day 1-8 and day 28 after TPE.

      The investigators hope to demonstrate a potential benefit of an additive treatment approach
      to improve the outcome of patients suffering from septic shock.
    


Intervention name(s): TPE
Intervention type(s): Device
Intervention description(s): singular Therapeutic Plasma Exchange using fresh frozen Plasma as replacement fluid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Septic shock; Therapeutic plasma exchange; Sepsis
Lead Mobilization & Bone Turnover in Pregnancy/Lactation
Condition: Lead Poisoning
MeSH terms: Poisoning; Lead Poisoning
Study type: Observational

Summary: 
      We are examining the role of maternal bone lead turnover during pregnancy and lactation as a
      potential source of lead exposure for the fetus and the infant (via breast milk). A cohort,
      ascertained at entry to care, consists of >1000 women to be followed through pregnancy. In
      the postpartum subjects are recruited for a nested case control study to assess the influence
      of lactation on maternal bone density, maternal blood lead and breast milk lead.
    


Observational model: Natural History
Time perspective: Prospective
Keywords: Pregnancy; Lead Exposure; Lactation; Bone Mineralization; Maternal-Fetal Exchange
Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
Condition: Endometrial Hyperplasia; Osteoporosis
MeSH terms: Osteoporosis; Endometrial Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether bazedoxifene/conjugated estrogens
      combinations are effective for the prevention of endometrial hyperplasia and for the
      prevention of osteoporosis in postmenopausal women.
    


Intervention name(s): Bazedoxifene/Conjugate Estrogens (CE); Raloxifene; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Raloxifene Hydrochloride; Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Menopause
Bioequivalence Study (Candesartan 16 mg and Amlodipine 5 mg) - A
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and pharmacokinetics of CKD-330
      (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of
      the two separate drugs in healthy male volunteers.
    


Intervention name(s): CKD-330 16/5mg - A; Candesartan 16mg and Amlodipine 5mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Amlodipine; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
HIV Reservoir Dynamics After Switching to Dolutegravir in Patients on a PI and 2 NRTI Based Regimen
Condition: HIV-1
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess changes in viral reservoir after changing IP/r to
      dolutegravir in HIV-1 infected patients maintaining undetectable viral load on Antiretroviral
      Therapy (ART).
    


Intervention name(s): Dolutegravir; PI; 2 NRTI; 2 NRTI
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): (Fosamprenavir, atazanavir, lopinavir or darunavir) boosted with 100 mg of ritonavir, or atazanavir (400 mg / d) not boosted with ritonavir,if the 2 NRTIs are abacavir + Lamivudine
Other intervention name(s): Fosamprenavir, atazanavir, lopinavir or darunavir; 2NRTI
Intervention MeSH terms: Lopinavir; Atazanavir Sulfate; Darunavir; Fosamprenavir; Dolutegravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of an investigational
      meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.
    


Intervention name(s): meningococcal B rLP2086 vaccine.; meningococcal B rLP2086 vaccine.; meningococcal B rLP2086 vaccine.; normal saline (placebo)
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): vaccine, 0.5 mL, 0 - 2 - 6 to 9 months; vaccine, 0.5 mL, 0 - 2 - 6 to 9 months; vaccine, 0.5 mL, 0 - 2 - 6 to 9 months; vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Use of Platelet Rich Plasma in the Management of Acute Hamstring Muscle Strain Injury
Condition: Acute Hamstring Muscle Strain Injury
MeSH terms: Wounds and Injuries; Sprains and Strains
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the therapeutic benefit of utilizing complex growth
      factor preparations (Platelet Rich Plasma (PRP) in the management of acute hamstring
      injuries.

      The hypothesis is that the time to return to sport is shorter in the patient group treated
      with Complex Growth Factor Preparations (PRP) in combination with exercise therapy in
      comparison with 2 control groups:

        -  the patient group treated with Platelet Poor Plasma (PPP) injections in combination with
           exercise therapy (control injection AND usual care).

        -  the patient group treated with exercise therapy (usual care)
    


Intervention name(s): Platelet Poor Plasma (PPP); Platelet Rich Plasma (PRP)
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Platelet rich plasma; Interventional; Randomized; Double-blind
Metformin Efficacy and Safety for Gastric Intestinal Metaplasia
Condition: Gastric Intestinal Metaplasia
MeSH terms: Metaplasia
Study type: Interventional
Phase: Phase 4

Summary: 
      Gastric intestinal metaplasia significantly increases the risk of gastric cancer. Metformin,
      a biguanide, which is widely used for treating diabetes mellitus, has recently been suggested
      to have a suppressive effect on tumorigenesis and cancer cell growth. The investigators
      devised a prospective randomized controlled trial to evaluate the chemopreventive effect of
      metformin against gastric intestinal metaplasia and the safety of this drug in non-diabetic
      gastric intestinal metaplasia patients.
    


Intervention name(s): Metformin; Folate
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be instructed to take one tablet(500mg) of metformin after breakfast every day, and to visit the hospital every 4 weeks for evaluation of the subjective symptoms and for receiving a new supply of medication.; Subjects will be instructed to take one tablet(5mg) of folate three times every day, and to visit the hospital every 4 weeks for evaluation of the subjective symptoms and for receiving a new supply of medication.
Other intervention name(s): Glucophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Response and Safety Following FMT for UC
Condition: Inflammatory Bowel Diseases; Fecal Microbiota Transplantation
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The study aims to evaluate the clinical efficacy and safety of fecal microbiota
      transplantation by automatic methods in the treatment of moderate to severe active ulcerative
      colitis. There are two groups according to FMT pathway ( through a naso-jejunal tube or
      transendoscopic enteral tubing). Patients were followed up until 2 weeks after the final FMT
      in hospital.
    


Intervention name(s): FMT through a naso-jejunal tube; FMT through TET
Intervention type(s): Other; Other
Intervention description(s): Prepared feces by automatic methods, then the purified fecal microbiota was delivered into the intestine through a naso-jejunal tube.; Prepared feces by automatic methods, then the purified fecal microbiota was delivered into the intestine through a transendoscopic enteral tubing (TET) which is fixed to the cecum with clips under endoscopic guidance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Vasomotor Symptoms in Korean Post Menopausal Women
Condition: Vasomotor Symptoms
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in
      Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and
      tolerability of Angeliq.
    


Intervention name(s): Angeliq (Drospirenone/17ß-estradiol, BAY86-4891); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.; Placebo treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval.
Intervention MeSH terms: Drospirenone; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vasomotor symptoms; Vasomotor System
Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study (ANSYSCAP)
Condition: Carotid Stenoses
MeSH terms: Carotid Stenosis
Study type: Observational

Summary: 
      A single center observational study. Observing the time between cerebrovascular symptoms and
      Carotid Endarterectomy (CEA) and patient outcome. An intervention at 17 of the 29 study
      months aimed at reducing the delay and increasing the patient safety. Main outcome is to
      measure the reduction in recurrent stroke with decreased delay to CEA.
    

Detailed description: 
      All patients with a carotid stenosis >50% according to the NASCET-criteria are included. The
      study does not affect the health care the patients receive. The time between symptom and
      surgery is compared to the outcome of the CEA after 45 days, 6 months, 1 year and 5 years. An
      intervention in the form of new practical local and regional guidelines in January 2009 (#17
      of the 29 study months) aimed at reducing the delay and increasing the patient safety.

      PRIMARY AIM:

      To study the risk of Ipsilateral stroke, any stroke, death, any cerebrovascular event, any
      cardiovascular event.

      Two primary analyses:

        1. Ipsilateral ischemic stroke within 90 Days of the presenting event. This analysis is
           aimed at the short term risk of pre-operative stroke. Survival analysis will be used.
           CEA will be used a censor, thus excluding all peri-operative and postoperative strokes.

        2. All primary endpoints within 5 years of the presenting event. This analysis is aimed att
           the long term risk of cardio-vascular morbidity and mortality.

      Secondary analyses:

      1) Same as first primary analysis, but including all stroke as endpoint, not only ipsilateral
      ischemic stroke.

      SECONDARY AIM:

      To attempt to validate different risk and score systems already published by other sources.
      Such as can ABCD2-score be used safely to chose between acute and fast normal screening for
      carotid stenosis?
    

Intervention name(s): New Guidelines
Intervention type(s): Other
Intervention description(s): New practical guidelines after half of the study aimed at reducing the delay and increasing the patient safety.
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients with a carotid stenosis >50%, preliminary eligable for CEA in the northern
        region of Sweden
      
Keywords: Carotid stenosis; Carotid endarterectomy
A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
Condition: Hypertension, Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare
      the pharmacokinetics and safety between a fixed dose combination of
      Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of
      Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects.
    


Intervention name(s): Fimasartan/Amlodipine combination drug, Rosuvastatin
Intervention type(s): Drug
Intervention MeSH terms: Amlodipine; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ventilation With Supraglottic Airway Devices
Condition: Laryngeal Masks Comparison
Study type: Observational

Summary: 
      Airo-Q Self Pressurized airway device with Blocker will be compared with Proseal LMA in
      anesthetized adult female patients undergoing elective surgeries to discuss the influence of
      different head and neck positions on the performance of both devices. Oropharyngeal leak
      pressure, peak inspiratory pressure, ventilation score and fiber-optic view will be assessed
      in neutral, flexion, extension and lateral positions in both groups.
    


Intervention name(s): Air-Q Self Pressurized Airway Device with Blocker; Proseal Laryngeal Mask Airway
Intervention type(s): Device; Device
Intervention description(s): used in low risk adult females undergoing elective surgeries; used in low risk adult female patients undergoing elective surgeries
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult female patients who will be admitted through outpatient clinic of Kasr alainy
        hospitals