bioihbjkbjnl/mcl2 huggingface dataset:
Coronary Artery Ectasia in Elective Coronary Angiography : Predictors, Outcomes and Management
Condition: Ectasia; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Coronary Aneurysm; Dilatation, Pathologic
Study type: Interventional

Summary: 
      Coronary artery ectasia (CAE) is the diffuse dilatation of coronary artery. It is defined as
      a dilatation with a diameter of 1.5 times the adjacent normal coronary artery . Its
      prevalence ranges from 1.2%-4.9% with male to female ratio of 3:1 .

      Coronary ectasia likely represents an exaggerated form of expansive vascular remodelling
      (i.e. excessive expansive remodelling) in response to atherosclerotic plaque growth .

      CAE is more common in males. Hypertension is a risk Factor. Interestingly, patients with DM
      have low incidence of CAE. This may be due to down regulation of MMP with negative
      remodelling in response to atherosclerosis . Smoking appears to be more common in patients
      with CAE than in those with coronary artery disease (CAD).

      The angiographic classification for CAE (described by Markis et al.) categorizes the severity
      based on the extent of coronary arterial involvement: Type 1: Diffuse ectasia of 2-3
      arteries; Type 2: Diffuse ectasia in one artery and localized in another; Type 3: Diffuse
      single arterial ectasia; Type 4: Localized or segmental ectasia .

      Stable angina is the most common presentation in patients with CAE . Patients with CAE
      without stenosis had positive results during treadmill exercise tests. ST-elevation
      myocardial infarction (MI) , non-ST elevation MI can occur from altered blood flow by distal
      embolization or occlusion of ectatic segment with thrombus.

      Medical management for CAE is a controversial area as there is lack of evidence based
      medicine, especially the role of antiplatelet versus anticoagulant agents. Aspirin was
      suggested in all patients because of coexistence of CAE with obstructive coronary lesions in
      the great majority of patients and the observed incidence of myocardial infarction, even in
      patients with isolated coronary ectasia .The role of dual anti platelet therapy has not been
      evaluated in prospective randomized studies. Based on the significant flow disturbances
      within the ectatic segments, chronic anticoagulation with warfarin as main therapy was
      suggested
    


Intervention name(s): Antiplatelet Agents; Anticoagulants
Intervention type(s): Drug; Drug
Intervention description(s): effect of dual antiplatelet in management of coronary artery ectasia; effect of oral anticoagulants in management of coronary artery ectasia
Intervention MeSH terms: Anticoagulants; Platelet Aggregation Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Total Knee Arthroplasty And Thromboembolism: A Comparison Between Two Surgical Techniques
Condition: Total Knee Replacement; Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Observational

Summary: 
      In patients undergoing total knee arthroplasty, thromboembolism is a common occurrence,
      especially following tourniquet deflation. The resulting cardiopulmonary emboli can
      potentially lead to hypoxemia, hypotension, hemodynamic collapse and post operative cognitive
      dysfunction due to emboli. The standard surgical technique involves placing an intramedullary
      rod in the femur to determine the angle and degree of resection from the end of the femur. A
      new surgical technique utilizes computer navigation system to perform the desired cuts in the
      appropriate position. The investigators hypothesize that the avoidance of intramedullary
      instrumentation in computer assisted total knee replacement will result in fewer
      thromboembolic events compared with the standard technique using manual instrumentation in
      the femur. The present study will test this hypothesis by quantifying the extent of
      thromboembolism during both surgical techniques.
    

Detailed description: 
      Currently, Transesophageal Echocardiography (TEE) is routinely used intraoperatively to
      monitor patients undergoing total knee arthroplasty for thromboembolic events. Video
      recording (without any patient identifiers) of the TEE loops before and after tourniquet
      release, offline analysis to quantify the extent of thromboembolism and the two surgical
      techniques will be compared. Patients are assigned to a particular technique according to
      some non-rigid criteria. This study has no impact on their selection into one group or the
      other. Participation in this study does not influence the choice/selection. We will simply
      record and analyze the echo loops in twenty patients already assigned to each surgical
      technique.
    

Intervention name(s): Measurement of total thrombolic load
Intervention type(s): Procedure
Intervention description(s): A video recording of the right atrium using TE echo will be used to quantitate the total thromboembolic load
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients scheduled for elective total knee replacement
      
Keywords: Total knee replacement; esophageal echocardiography
Change of Gut Microbiome in the Treatment of Graves' Disease
Condition: Graves' Disease
MeSH terms: Graves Disease
Study type: Observational

Summary: 
      Graves' disease is the main cause of hyperthyroidism. Graves' disease has a prevalence of
      0.5% in the general population. As a non-surgical treatment, antithyroid drug (ATD) and
      radioactive iodine treatment have been proposed and ATD is the first-line treatment in Korea.
      However, ATD has a rare but fatal side effect of agranulocytosis. Furthermore only half of
      its users maintain long-term remission and frequent recurrence is a problem to this disease.
      Therefore it is essential to distinguish between patients who respond well to ATD and those
      who resist it. The aim of this study is to verify the changes in gut microbiome in Graves'
      disease patients before and after six-month treatment with ATD. Patients first diagnosed with
      Graves' disease will participate in the study. The study design is a prospective longitudinal
      trial. The patients are asked to have their gut microbiome analyzed before and after the
      treatment of Graves' disease with ATD. Primary endpoint is the changes of analyzed gut
      microbiome before and after ATD treatment. Secondary outcome is to find species that can be
      used as a biomarker to differentiate the patients refractory to ATD.
    


Intervention name(s): Antithyroid Drug
Intervention type(s): Drug
Intervention description(s): Administration of antithyroid Drug for 6 months
Intervention MeSH terms: Antithyroid Agents
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients first diagnosed with Graves' disease, aged more than 19 years and lesser than 70
        years. Eligible for treatment of graves' disease with antithyroid drug. Consented for
        collection of stools in 6-month interval
      
Biospecimen description: 
      stool sample from study participants before and after 6-month antithyroid drug treatment
A Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the efficacy and safety of rebamipide liquid for chemoradiotherapy-induced
      oral mucositis in patients with head and neck cancer following administration of rebamipide
      and to determine the optimal dose of rebamipide.
    


Intervention name(s): Placebo; 2% Rebamipide liquid; 4% Rebamipide liquid
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Rebamipide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase II Study in Patients With Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a global Phase 2 study to evaluate the safety and effectiveness of an investigational
      study drug (called SHR0302) in adults with moderate to severe alopecia areata.
    

Detailed description: 
      The study is placebo-controlled, meaning that some patients entering the study will not
      receive active study drug but will receive tablets with no active ingredients (a placebo).
      This is a dose-ranging study, investigating 3 different dosing regimens. It will be
      double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will
      not know whether a patient is on active study drug (or the dose) or placebo.
    

Intervention name(s): SHR0302
Intervention type(s): Drug
Intervention description(s): Oral tablets taken once daily (QD)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Monitoring Functional Variation in the Breast During Menstrual Cycle by Using Diffuse Optical Spectroscopy
Condition: Accessory; Breast Tissue
Study type: Observational

Summary: 
      The purpose of this study is to do determine the changes in physiological and optical
      properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse
      Optical Spectroscopy. The Researcher can determine 1) how large variations in breast tissue
      components are 2) how predictable and repeatable these variations are 3) the effects of
      endogenous hormones on breast tissue physiology.
    

Detailed description: 
      Variations in breast physiology due to hormonal fluctuations during the menstrual cycle can
      correlate to quantitative changes in Diffuse Optical Spectroscopy functional parameters such
      as hemoglobin, lipid and water concentration and tissue scattering. Diffuse Optical
      Spectroscopy imaging can show increase blood flow in breast tissue after ovulation with a
      concomitant increase in mitotic activity, changes in hemoglobin concentration and in tissue
      scattering. Increases in fibroglandular breast tissue after ovulation have also been
      observed. Diffuse Optical Spectroscopy imaging can determine after time of ovulation has been
      detected during the two months of self-monitoring.
    

Intervention name(s): Diffuse Optical Spectroscopy
Intervention type(s): Device
Intervention description(s): Changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy
Other intervention name(s): Diffuse Optical Spectroscopy Imaging
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic, community sample
      
Keywords: breast tissue
Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial (STAAMP Trial)
Condition: Traumatic Hemorrhage
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if 1 gram of prehospital tranexamic acid given
      during emergency medical transport to a level 1 trauma center in patients at risk of
      hemorrhage is associated with lower 30 day mortality.
    

Detailed description: 
      Background: Traumatically injured patients continue to be plagued with uncontrolled
      hemorrhage resulting in significant morbidity and early mortality. A primary driving force
      for this unbridled hemorrhage is known to be the early coagulopathy which complicates severe
      injury. Trauma induced coagulopathy has been postulated to be an equilibrium imbalance
      between pro and anticoagulant factors, platelets, endothelium and fibrinolysis soon after
      injury. Recent evidence demonstrates that the early use of the antifibrinolytic agent
      tranexamic acid (TXA) after trauma center arrival results in improved survival in patients at
      risk for bleeding. Bringing this proven treatment to the prehospital arena and intervening
      earlier in those patients who would otherwise not be candidates for treatment has the real
      potential to further reduce or prevent the vicious hemorrhagic cascade, improve clinical
      outcomes and provide insight into the underlying mechanisms responsible for and which
      maximize its benefit.

      Objective/Hypothesis: The primary hypothesis will be that prehospital infusion of tranexamic
      acid in patients at risk for bleeding will reduce the incidence of 30 day mortality. The
      secondary hypotheses include that prehospital tranexamic acid will reduce the incidence of
      hyperfibrinolysis, acute lung injury, multiple organ failure, nosocomial infection,
      mortality, early seizures, pulmonary embolism and early resuscitation needs, reduce or
      prevent the early coagulopathy as demonstrated by improving presenting INR and rapid
      thromboelastography parameters, reduce the early inflammatory response, plasmin levels,
      leukocyte, platelet and complement activation, and determine the optimal dosing of tranexamic
      acid post-injury.
    

Intervention name(s): Tranexamic Acid; Saline control
Intervention type(s): Drug; Other
Intervention description(s): 1 gram of prehospital Tranexamic Acid; Saline Control
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tranexamic acid; randomized; hemorrhage; blinded
Bioequivalence of Azathioprine Suspension 10 mg/mL (Jayempi) Versus Azathioprine Tablet 50mg (Imurek®)
Condition: Therapeutic Equivalency
Study type: Interventional
Phase: Phase 1

Summary: 
      A single center, single dose, open-label, randomized, two period crossover study to assess
      the bioequivalence of an oral azathioprine suspension 10 mg/mL (Jayempi™) versus oral
      azathioprine tablet 50mg (Imurek®, Aspen Pharma Trading Limited, Dublin, Ireland.) in at
      least 30 healthy adult subjects under fasting conditions.
    

Detailed description: 
      This will be a single-dose, open-label, randomised, two-period crossover study with orally
      administered 1 x 5mL (50 mg) of Jayempi™ Oral Suspension 10mg/mL versus oral azathioprine
      tablet 50mg (Imurek®, Aspen Pharma Trading Limited, Dublin, Ireland) on two separate
      occasions conducted under fasting conditions in healthy male and female subjects at a single
      study centre.

      The study will comprise:

        -  Thiopurine methyltransferase (TPMT) testing;

        -  Screening period of maximum 28 days

        -  Two treatment periods (each of which will include a PK profile period of 12 hours)
           separated by a wash-out period of at least 3 calendar days (minimum number of days based
           on half-life of the analyte) and maximum of 14 calendar days between consecutive
           administrations of the IMP

        -  A post-study visit 7-10 days after the last dose of the last treatment period of the
           study.

      Subjects will be randomly assigned to treatment sequence, prior to the first administration
      of IMP.
    

Intervention name(s): Azathioprine 50Mg Tab; Azathioprine 10mg/mL oral suspension
Intervention type(s): Drug; Drug
Intervention description(s): tablet; oral suspension
Other intervention name(s): Imurek; Jayempi
Intervention MeSH terms: Azathioprine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Doripenem Intrapulmonary Pharmacokinetics in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being performed to measure the amount of the antibiotic doripenem (study drug)
      found in the fluid and cells of the lung and blood after receiving three doses of doripenem.
      The major objectives of this research are to see how much and for how long doripenem gets
      into the fluids and cells of the lungs of healthy adult subjects.
    

Detailed description: 
      The primary objective of this descriptive study is to determine and compare the plasma,
      epithelial lining fluid (ELF), and alveolar macrophages (AM) concentrations following
      multiple intravenous doses of doripenem in healthy, non-smoking adult subjects. In brief,
      each subject who qualifies for the study will be randomized to one of two dosing regimens:
      doripenem 500 mg or doripenem 1000 mg every 8 hours for a total of three intravenous doses.
      Each dose of doripenem will be administered as an intravenous infusion over 4 hours. Serial
      blood samples for determining plasma doripenem concentrations will be collected prior to and
      after the start of the intravenous infusion of the third doripenem dose. Each subject will
      undergo one standardized bronchoscopy with BAL in the outpatient bronchoscopy suite at one of
      four sampling times after the start of the intravenous infusion of the third doripenem dose.
      BAL collection will provide samples to determine drug concentration in ELF and AM. Safety
      will be assessed throughout the study by adverse event monitoring, clinical laboratory tests,
      and vital sign monitoring.
    

Intervention name(s): Doripenem; Doripenem
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous 500 mg every (q) 8 hours for 3 doses; Intravenous 1000 mg q 8 hours for 3 doses
Other intervention name(s): Doribax; Doribax
Intervention MeSH terms: Doripenem
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: doripenem; epithelial lining fluid; alveolar macrophages; pharmacokinetics; Healthy adult subjects
Intubation of a Pediatric Manikin in Difficult Airway by Novice Personnel: A Comparison of Glidescope and Airtraq
Condition: Intubation; Difficult; Edema of the Tongue
Study type: Interventional
Phase: Phase 4

Summary: 
      Background and aims: Glidescope and Airtraq were designed to facilitate intubation and to
      improve teaching intubation. The investigators want to find their efficacy in normal airway,
      tongue edema and face-to-face orotracheal intubation models by novice personal.

      Material and Methods: After Kocaeli Human Researches Ethics Committee approval, thirty six
      medical students who were on the beginning of their third year were enrolled in this study.
      After watching a video about the intubation of one of these devices, they attempted to
      intubate an adult manikin in three different airway models in a random order; first in normal
      airway, second, tongue edema and finally, in an entrapped manikin by face-to-face approach
      with Glidescope or Airtraq. Intubation attempts, insertion and intubation times, success
      rates, Cormack-Lehane grades, need of maneuvers of these devices were recorded.
    

Detailed description: 
      Trauma victims mostly had to be intubated at the scene of the area with the paramedics. In a
      suspect of a cervical trauma, patients must be intubated with the least movement.
      Videolaryngoscopic techniques had several advantages at this condition. We want to
      investigate which can be used easily by novice personnel.
    

Intervention name(s): Glidescope; Airtraq
Intervention type(s): Device; Device
Intervention description(s): Manikin was intubated by different novice personal with glidescope videolaryngoscope; Pediatric manikin was intubated by novice personal with airtraq
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL in 12 Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      -  To investigate absorption, metabolism and excretion of [14C]-DK-AH 269 CL after oral and
           intravenous administration in healthy volunteers

        -  To assess the safety and tolerability of DK-AH 269 CL after oral and intravenous
           administration to healthy volunteers
    


Intervention name(s): [14C]-DK-AH 269 CL, solution for infusion; [14C]-DK-AH 269 CL, drinking solution
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Relationship of Bone Mineral Density With Balance, Functional Ambulation and Falls in Stroke Patients
Condition: Stroke Patients
MeSH terms: Stroke
Study type: Observational

Summary: 
      The aim of this study is to investigate the relationship between bone mineral density and
      balance, functional ambulation and falls in hemiparetic patients with stroke in the subacute
      and chronic phases.
    

Detailed description: 
      Improving balance function is considered as an important method for reducing the risk of
      falling after stroke and protecting bone health. Bone mineral density, a measure of bone
      health, has been reported to decrease after stroke, consistent with increased bone resorption
      and decreased bone formation. The aim of this study is to investigate the relationship
      between bone mineral density and balance, functional ambulation and falls in hemiparetic
      patients with stroke in the subacute and chronic phases.
    

Intervention name(s): Bone mineral density
Intervention type(s): Diagnostic Test
Intervention description(s): Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA) method.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        44 patients
      
Keywords: stroke; osteoporosis
Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity
Condition: Pleural Metastases; Breast Cancer; Colon Cancer; Ovarian Cancer; Uterine Cancer; Renal Cell Cancer; Thymic Cancer
MeSH terms: Neoplasm Metastasis; Carcinoma, Renal Cell; Uterine Neoplasms; Thymus Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Cancers that have spread to the inner lining of the chest are classified as Stage IV and bear
      a poor prognosis. Surgery is rarely an option, with palliative chemotherapy and/or radiation
      therapy the only treatment options. This study intends to evaluate whether surgical removal
      of all visible tumor on the chest wall followed by bathing the chest cavity in heated
      chemotherapy solution will improve outcomes for these advanced cancers.
    


Intervention name(s): Surgical debulking and Intrathoracic Hyperthermic Chemotherapy
Intervention type(s): Procedure
Intervention description(s): Surgical debulking of intrathoracic metastases will be performed, followed by perfusion of the chest with heated Cisplatin for 60 minutes.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pleural metastases