bioihbjkbjnl/mcl2 huggingface dataset:
Hypothermic Versus Normothermic Cardiac Bypass in Patients Undergoing CABG Surgery, Effect on Coagulation; Randomized Controlled Trial
Condition: CABG Surgery, Cold Blood Cardioplegia, Coagulation Profile and Platelet Function
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      On-pump CABG surgery deleteriously affects hematological and coagulation profiles of patients
      and this effect was accentuated by the use of cold bypass. PO altered platelet may count and
      function and prolonged clotting times correlates with amount of daily PO blood wound drainage
      and number of blood products units used, but prolonged aPTT is the best predictor for these
      events.
    

Detailed description: 
      Background: The use of cardiopulmonary bypass during cardiac surgery negatively affects the
      coagulation system. Hypothermia is also known to inhibit the coagulation profile. The aim of
      the study is to assess and compare the early postoperative (PO) haematological and
      coagulation profile of patients undergoing coronary artery bypass graft (CABG) surgery with
      Hypothermic (HT) versus normothermic (NT) bypass Methods: eighty-six patients were divided
      into two equal groups: NT group included patients received warm bypass and using warm blood
      cardioplegia from bypass and HT group included patients received cold bypass and using cold
      cardioplegia given by the anaesthesiologist. PO monitoring included the activated clotting
      time (ACT) prior to wound closure and 2-hr changes in the haemoglobin concentration (Hb),
      platelet count (PC), ADP-induced platelet aggregation (IPA), INR in relation to preoperative
      profile and amount of PO daily blood loss and number of transfused blood units. The primary
      outcome was the PO alternations in the coagulation and haematological profile. The secondary
      outcome was the amount of PO daily bleeding, number of transfused blood units and incidence
      of re-opening surgery due to bleeding.
    

Intervention name(s): Normothermic group
Intervention type(s): Procedure
Intervention description(s): Normothermic group (NT group) included patients will undergo CABG under warm bypass using warm blood cardioplegia (Normothermic CBP).
Hypothermic group (HT group) included patients will undergo CABG under cold bypass using cold blood cardioplegia (Hypothermic CBP).
Other intervention name(s): Hypothermic group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Hypothermia may alter coagulation profile of patients undergoing CABG surgery; thus, affecting patients' outcome.
Masking: Double (Participant, Care Provider)
Primary purpose: Diagnostic
The Predictive Value of Sidestream Dark Field Imaging in Diabetic Nephropathy
Condition: Microcirculation Detection in Diabetic Patients
MeSH terms: Diabetic Nephropathies
Study type: Observational [Patient Registry]

Summary: 
      Diabetic microangiopathy refers to the pathological changes of arterioles, capillaries and
      venules in diabetic patients. Due to the impacts including glycol-metabolism disorder,
      disturbance of lipid metabolism, cytokine, oxidative stress and hemodynamic changes, the
      structure and function of microvessels are damaged accordingly. Diabetic nephropathy (DN) is
      one of the most common and serious chronic microvascular complications of diabetes, and
      becomes a leading cause of end-stage renal failure(ESRF). Presently, urinary
      albumin/creatinine ratio (UACR) is a widely accepted and relatively reliable indicator for
      early diagnosis of DN, however, there are 2/3 DN patients with normal albuminuria have
      decreased glomerular filtration rate (glomerular filtration rate, GFR) and abnormal structure
      of the kidney, one the other hand, the presence of albuminuria is associated with other
      vascular dysfunction and kidney disease other than DN, therefore its accuracy is increasingly
      being challenged.

      Sidestream dark field(SDF) imagining technology, as an emerging way to visualize blood
      vessels, is evaluated in a semi-quantitative manner and provides an effective means to study
      structure and function of microcirculation. Different from biochemical markers like
      albuminuria, SDF provides a visual information about vessel structure, density, and quality
      of diffusion. At present the research of sublingual microcirculation by SDF technique is
      mainly applied to microcirculation monitoring in patients in the intensive care unit or
      laboratory animal models with acute hemorrhagic shock to assess the potential of being a tool
      of diagnosis and treatment prognostic indicator, no relevant research has been carried out to
      evaluate the predictive value of diabetic microangiopathy in literature so far.

      Herein, the investigators designed the study based on SDF imaging to collect scientific data,
      thus providing strong support for the early assessment and diagnosis of diabetic nephropathy
      and possibly guiding individual therapy in the future.
    


Intervention name(s): Sidestream dark field(SDF) imagining
Intervention type(s): Device
Intervention description(s): SDF imaging consists of a hand-held device that illuminates a region by surrounding a central light guide with concentrically placed light emitting diodes,which thus provide SDF illumination.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        We collected clinical data of 100 cases with T2DM who hospitalized in our treatment center
        from March 2019 to September 2020, and SDFI was taken properly.
      
Keywords: Type 2 Diabetes Mellitus; Sidestream dark field imaging; sublingual microcirculation
Tolerability and Efficacy of Rosuvastatin - Fenofibrate Combine Therapy in Korean Patients With Combined Hyperlipidemia
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 4

Summary: 
      Although the combination of statin and fenofibrate is one of the options for patients with
      combined hyperlipidemia, non-lipid effects of it has not been completely understood yet. In
      this study we compared the effects of rosuvastatin 10 mg/fenofibrate 160 mg combination and
      rosuvastatin 10 mg monotherapy on muscle and liver enzyme, homocysteine levels, kidney, blood
      glucose control, and blood cell counts.
    


Intervention name(s): Lipid modification; Lipid modification
Intervention type(s): Drug; Drug
Intervention description(s): rosuvastatin 10 mg/fenofibrate 160 mg per day; rosuvastatin 10 mg per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rosuvastatin, fenofibrate, creatine kinase, alanine aminotransferase
Effect of WF10 (TCDO) on HbA1c Values in Diabetic Foot Ulcer Patients
Condition: Diabetic Foot Ulcer (DFU); Uncontrolled Diabetes With Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      Study in adult Diabetes Mellitus patients with diabetic foot ulcers and elevated HbA1c who
      will receive standard wound treatment in combination with adjuvant therapy WF10 to compare
      the change of HbA1c levels at baseline and after treatment.
    

Detailed description: 
      Single-center, Prospective Open-labelled One Group Pretest Posttest Pilot Study
    

Intervention name(s): WF10
Intervention type(s): Drug
Intervention description(s): WF10, the chlorite-based drug is infused at a dose of 0.3 ml/Kg BW, after dilution in 300 mL physiological saline, over a period of 3 h. The drug is applied once a week for five subsequent weeks.
Other intervention name(s): Immunokine
Intervention model: Single Group Assignment
Intervention model description: T2DM patients with DFU and HbA1c > 8.5%
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DFU; WF10
Differin® Gel x12 Wks vs Tazorac® Cream x12 Wks vs Differin® x6 Wks Switched to Tazorac® x6 Wks for Treatment of Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the efficacy and safety of 12 weeks of treatment with Differin Gel, 0.1%
      compared to 12 weeks of treatment with Tazorac Cream, 0.1% and compared to 6 weeks treatment
      with Differin Gel, 0.1% followed by 6 weeks of treatment with Tazorac Cream
    

Detailed description: 
      Same as above.
    

Intervention name(s): Adapalene Gel, 0.1%; Tazarotene Cream, 0.1%; Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Apply once daily in the evening for 12 weeks; Apply once daily in the evening for 12 weeks; Apply adapalene Gel, 0.1% once daily in the evening for 6 weeks and Tazarotene Cream, 0.1% once daily in the evening for 6 weeks
Other intervention name(s): Differin® Gel, 0.1%; Tazorac® Cream, 0.1%; Differin® Gel, 0.1% and Tazorac® Cream, 0.1%
Intervention MeSH terms: Nicotinic Acids; Adapalene; Tazarotene
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children
Condition: Inguinal Hernia; Cryptorchidism
MeSH terms: Cryptorchidism; Hernia, Inguinal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the effects of caudal dexmedetomidine with
      intravenous dexmedetomidine on caudal levobupivacaine analgesia in children undergoing lower
      abdominal surgeries.
    

Detailed description: 
      Single shot caudal epidural block is one of the most widespread technique for pediatric pain
      management after infraumbilical surgical procedures.However, in a significant proportion of
      patients, despite good initial analgesia from a caudal block with local anesthetic, pain
      develops after the block resolves.

      Dexmedetomidine is used increasingly in pediatric anesthesia practice to prolong the duration
      of action of caudal block with a local anesthetic agent.But which route of administration of
      clonidine is the most beneficial remains unknown.

      The investigators performed prospective randomized double-blind study to compare the effects
      of caudal dexmedetomidine with intravenous dexmedetomidine on postoperative analgesia after
      caudal levobupivacaine for inguinal herniorrhaphy or orchidopexy surgery.

      90 children (ASAⅠorⅡ,aged 2-5 yr) undergoing unilateral orchiopexy or inguinal herniorrhaphy
      were included in this study. Anesthesia was induced with sevoflurane via a facemask, followed
      by placement of a laryngeal mask airway. Anesthesia was maintained with sevoflurane 2-3% in
      oxygen-air.Then,caudal block was applied. Patients were randomly assigned in three groups.
      Group Cau-DEX (n = 30): Caudal Levobupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and
      10 ml normal saline i.v.;Group IV-DEX(n = 30): Levobupivacaine 0.25% 1ml/kg and
      dexmedetomidine 1µg/kg(10 ml)i.v.;Group Placebo(n = 30): Levobupivacaine 0.25% and 10 ml
      normal saline intravenous.
    

Intervention name(s): Caudal Dexmedetomidine; Intravenous Dexmedetomidine; Placebo; sevoflurane
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg
Intravenous: 10 ml normal saline; Caudal: Levobupivacaine 0.25% 1ml/kg
Intravenous: dexmedetomidine 1µg/kg; Caudal: Levobupivacaine 0.25% 1ml/kg
Intravenous: 10 ml normal saline; Induction and maintain anaesthesia
Other intervention name(s): Precedex; Precedex; Levobupivacaine
Intervention MeSH terms: Dexmedetomidine; Sevoflurane; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Dexmedetomidine; Postoperative pain reaction; anesthesia; children
Study to Assess Bioequivalence of 30 and 120 mg Nifurtimox Tablets in Chronic Chagas' Patients
Condition: Chagas Disease
MeSH terms: Chagas Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the bioequivalence as well as safety and tolerability of a novel 30
      mg tablet of nifurtimox compared to the corresponding marketed 120 mg tablet in adult
      subjects suffering from chronic Chagas' disease when administered after a high-fat /
      high-calorie test meal. This study is a necessary step for the development of an age
      appropriate pediatric oral dosage form for the treatment of Chagas' disease in endemic
      countries according to the recommendations provided by current international guidelines (EMA
      Guideline on Clinical Development of Medicinal Products, EMA Note for Guidance on Oral Dosage
      Forms).
    


Intervention name(s): Nifurtimox (BAYa2502) (4 x 30 mg tablet); Nifurtimox (BAYa2502) (slurry of 4 x 30 mg tablets in tap water); Nifurtimox (BAYa2502) (120 mg tablet)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 120 mg single dose as four 30 mg tablets after a high fat, high calorie meal; 120 mg single dose as aqueous slurry in tap water produced from four 30 mg tablets; ingestion after a high fat, high calorie meal; 120 mg single dose as one 120 mg tablet after a high fat, high calorie meal
Intervention MeSH terms: Nifurtimox
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Why Are Patients With Absence Seizures Absent? A Brain Imaging Study
Condition: Childhood Absence Epilepsy
MeSH terms: Epilepsy; Epilepsy, Absence
Study type: Observational

Summary: 
      Our study examines which different brain regions are involved in child absence seizures and
      how they are related to attention and cognition.
    

Detailed description: 
      The fundamental mechanisms of altered brain function and impaired attention in childhood
      absence epilepsy (CAE) are not known. Absence seizures consist of brief 5-10 seconds episodes
      of unresponsiveness, associated with a 3-4 Hz "spike-wave" discharge on electroencephalogram
      (EEG). CAE affects 10-15% of children with epilepsy. In addition to the deficit during
      seizures, many children also suffer from milder attention impairment between absence
      episodes, which may not be due entirely to medications. Impaired attention during and between
      absence seizures has a major negative impact on patient quality of life due to deficits in
      school performance, potential for injuries, and social stigma.

      Recent studies suggest that impaired cognition in so-called "generalized" absence seizures
      may, in fact, depend on dysfunction in specific brain networks. Our central hypothesis is:
      abnormal function in focal brain regions, such as the anterior cingulate/medial prefrontal
      cortex and medial thalamus, causes impaired attention both during and between seizures in
      CAE. If confirmed, this may lead to innovative regional therapies targeted at improving
      impaired attention in CAE. Specifically, we hope to determine which specific cortical and
      sub-cortical networks are selectively involved when patients show impaired attention. Using
      simultaneous EEG and functional magnetic resonance imaging (fMRI), we will determine which
      brain regions are involved in absence seizures while using a continuous performance task
      (CPT) to test attention vigilance in the same patients. A few neuropsychology tests will then
      follow. Patients will be reimbursed $100 as well as all travel and parking expenses.

      For more information, please visit www.yalecae.com
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients diagnosed with absence epilepsy
      
Biospecimen description: 
      Saliva samples
    
Keywords: Absence; Epilepsy; Seizure; Brain
An Evaluation of a Gender Specific Insole to Provide Relief From Knee Pain Due to Osteoarthritis or General Anterior Knee Pain in Male Subjects When Used in Foot Wear Over a Period of Four Weeks
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The primary objective of this trial is to demonstrate the ability of a full length foam
      insole to provide relief from pain due to osteoarthritis of the knee or general knee pain
      when used in foot wear for a 4-week period of time.

      The secondary objectives comprise the evaluation of the insole's ability to provide
      appropriate shoe fit and comfort as well as relief from osteoarthritis/ general knee pain
      after short-term use. The safety and tolerability of the test articles in terms of adverse
      events (AE) will also be investigated.
    


Intervention name(s): BPI 1000013 (Dr Scholls Insole)
Intervention type(s): Device
Intervention description(s): Full length foam insole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP
Condition: Cholangitis
MeSH terms: Cholangitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Background and aims: The use of prophylactic antibiotics before endoscopic retrograde
      cholangiopancreatography (ERCP) is recommended by all major international gastroenterological
      societies, especially in the presence of an obstructed biliary system. Their use is intended
      to decrease or eliminate the incidence of complications following the procedure, namely
      cholangitis, cholecystitis, septicemia, and pancreatitis. However, there were a few reports
      concerning the dosage, duration and adopting antibiotics most suitable for this purpose. The
      aim of this prospective comparative study is to compare the occurrence rate of
      post-procedural complications, such as cholangitis, bacteremia and septicemia between
      intravenous moxifloxacin and ceftriaxone for the prophylactic use in patients with bile duct
      obstruction who will undergo therapeutic ERCP procedure.

      Methods: In this prospective study, a total of 160 patients (calculated by IBM SPSS Sample
      Power, version 3.0) with bile duct obstruction due to variable causes (bile duct stones,
      benign or malignant stricture, etc) will be enrolled and randomly allocated to intravenous
      moxifloxacin and ceftriaxone group, respectively (using simple randomization program).
      Intravenous moxifloxacin (400 mg/day, infused more than 60 min) or ceftriaxone (2 g/day,
      diluted in 40 cc of 5% dextrose water, infused more than 30 min) will be given 90 minutes
      before ERCP procedure, and will be given to a patient for more than 3 days if the patient
      develops symptoms and signs of cholangitis or septicemia.
    


Intervention name(s): Moxifloxacin; ceftriaxone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Moxifloxacin; Ceftriaxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bile duct obstruction; Cholangitis; Moxifloxacin; Ceftriaxone; Sepsis
CAEB071 Thorough QTc Study in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has been designed in compliance with the ICH-E14 guideline 2005 to evaluate the
      QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.
    


Intervention name(s): sotrastaurin; sotrastaurin; placebo to sotrastaurin; Avelox
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy volunteer; QT intervals; ECG; QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
Inspiratory Support Improves Preoxygenation in Healthy Subjects
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Preoxygenation optimizes oxygen content in the functional residual capacity (FRC). Adequate
      preoxygenation is defined by an expiratory oxygen fraction (FEO2) > 90%. Inspiratory support
      and positive end expiratory pressure (PEEP) can create a better reservoir, improve gas
      exchange and shorten the time needed for adequate preoxygenation. The goal of the study is to
      evaluate the efficacy and tolerability of different levels of inspiratory support and
      positive end expiratory pressure during preoxygenation in healthy subjects.
    

Detailed description: 
      We conducted a double blind prospective randomized trial on 20 healthy volunteers. Each
      subject went through three modes of preoxygenation in random order: normal breathing (SP),
      breathing under inspiratory support 4 cmH2O/PEEP 4 cmH2O (PSM-4) and inspiratory support 6
      cmH2O /PEEP 4 cmH2O (PSM-6). Each mode lasted for 3 min and parameters were recorded every 10
      s. We evaluated subject's tolerance, leaks and easiness of each mode of preoxygenation
      according to a simplified (1 to 4) scale. Two-way ANOVA was used to compare FEO2 while simple
      ANOVA was used for time to reach FEO2=90%.
    

Intervention name(s): VS; AI-4/PEEP-4; AI-6/PEEP-4
Intervention type(s): Other; Other; Other
Intervention description(s): Spontaneous breathing of 100% oxygen in a facemask for 3 minutes; Spontaneous breathing of 100% oxygen in a facemask with application of an inspiratory pressure of 4 cm H2O and a positive end-expiratory pressure of 4 cm H2O, for 3 minutes; Spontaneous breathing of 100% oxygen in a facemask with application of an inspiratory pressure of 6 cm H2O and a positive end-expiratory pressure of 4 cm H2O, for 3 minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Preoxygenation; Inspiratory; Support; Healthy; EndtidalO2
Antimicrobial Peptides in Periodontitis
Condition: Periodontal Disease : Chronic Periodontitis
MeSH terms: Periodontitis; Periodontal Diseases; Chronic Periodontitis
Study type: Interventional

Summary: 
      Periodontal diseases are complex chronic pathologies presenting a high prevalence worldwide.
      Etiopathological process involved in initiation and progression of these multifactorial
      diseases are not well understood, explaining the huge clinical forms variability and the
      complexity of the currently used classification of periodontal diseases. Recently, the
      implication of antimicrobial peptides (AMPs) have been suggested as potential track of
      explanation for periodontal diseases pathogeny. The here presented study explore the level of
      expression of genes coding those peptides by studying periodontal smears obtained from
      healthy and periodontitis patients.
    

Detailed description: 
      This study explore the level of expression of genes coding those peptides by studying
      Messenger RNA (mRNA) purified from periodontal smears obtained from healthy and periodontitis
      patients by "Masterpure©" protocol.After reverse transcription (RT-PCR), in-silico design of
      primers and specificity and efficiency calculation, Complementary DNA (cDNA) are quantified
      by a semi-quantitative method (delta-delta CT) vs a Housekeeping gene. Wilcoxon-Mann &
      Whitney tests and Chi² tests are performed to check the significativity of the results
      between groups.
    

Intervention name(s): periodontal smears
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic