bioihbjkbjnl/mcl2 huggingface dataset:
Effect of a Pre Heparin Coated Dialysis Filter on Coagulation During Hemodialysis
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether the heparin-coated dialysis filter is
      superior to a conventional filter during hemodialysis in twelve stable, chronic hemodialysis
      (HD) patients.

      The antithrombogenic properties of the heparin-coated dialysis filter and of the conventional
      filter will be compared by means of statistical tests.
    

Detailed description: 
      In the present study twelve chronic hemodialysis (HD) patients will be included. Exclusion
      criteria are use of acetylsalicylic acid and/warfarin, clinical signs of infection and
      disseminated malignant disease. For each patient four HD sessions will be investigated;
      alternating with use of the pre-heparin-coated filter or the conventional filter. Dalteparin
      is reduced to 50% of the conventional dose and is given as one single bolus dose at start of
      HD.

      The venous drip chamber will be visually inspected for evaluation of clot score during each
      HD session. The filter will be visually inspected for clot score at the end of each session.

      Blood specimens will be drawn systematically during each HD session to evaluate platelet and
      coagulation activity as well as anti Factor Xa activity, haematology and urea/creatinine to
      evaluate dialysis effect.

      The antithrombogenic properties of the pre-heparin-coated filter and the conventional filter
      will be compared by means of statistical tests. The hypothesis is that the pre-heparin-coated
      filter induces significantly less clot score in the extracorporeal system during hemodialysis
      and also significantly less intravascular activation of the coagulation system compared to
      the conventional filter.
    

Intervention name(s): a pre-heparin-coated hemodialysis filter; Hepran
Intervention type(s): Device
Intervention description(s): Use of the pre-heparin-coated filter compared to the conventional filter in a cross over design
Other intervention name(s): HeprAN membrane; polyacrylonitrile; heparin-grafted membrane
Intervention MeSH terms: Heparin; Calcium heparin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemodialysis; Anticoagulation; Clotting; Coagulation; dalteparin; Clotting in the extracorporeal system during HD; Antithrombogenic property of Evodial HD filter; Anticoagulation during HD
Substrate Oxidation Does Not Affect Short Term Food Intake in Healthy Boys and Men
Condition: Food Intake Regulation; Substrate Oxidation
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of substrate oxidation, expressed by
      RER, on food intake regulation and net energy balance.
    

Detailed description: 
      The relationship between substrate oxidation as measured by respiratory exchange ratio (RER)
      and food intake is undefined. This study is examining the effects of three modulators of
      substrate oxidation (RER), a glucose preload, exercise and age food intake regulation and net
      energy balance in normal-weight boys (9-12 y) and men (20-30 y).

      Subjects (15 boys, 15 men) were measured in random order with treatments of beverages of
      either water or glucose followed by either moderate exercise or rest for 40 min. Measures
      included RER via indirect calorimetry, energy expenditure, subjective appetite, food intake
      measured at an ad libitum pizza meal and net energy balance as the sum of the calories of the
      glucose preload + calories from the pizza lunch minus energy expended at exercise or rest.
    

Intervention name(s): Glucose Preload and Exercise Intervention
Intervention type(s): Other
Intervention description(s): A glucose preload and exercise were administered to examine the modulate substrate oxidation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Glucose; Exercise; Metabolic flexibility; Substrate Oxidation; Food intake
A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2
      trial of Sprifermin administered intra-articularly in participants with primary
      osteoarthritis of the knee and Kellgren-Lawrence Grade 2 or 3. The trial was intended to
      investigate the efficacy and safety of different intra articular dosages of Sprifermin in
      these individuals.
    

Detailed description: 
      Participants were equally randomized to either one of 4 treatment arms or a placebo arm. The
      trial consists of a Screening period lasting up to 42 days, a two-year double-blind
      placebo-controlled (DBPC) treatment phase, which begins at randomization (Week 0) and ends at
      Year 2, and a 3-year extended follow-up phase.
    

Intervention name(s): Sprifermin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants received Sprifermin as intra-articular injection.; Participants received Placebo matched to sprifermin as intra-articular injection.
Other intervention name(s): Recombinant Human Fibroblast Growth Factor-18 (rhFGF-18)
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis of knee; Recombinant Human Fibroblast Growth Factor-18 (rhFGF-18); Sprifermin; Placebo
Spinal Cord Stimulation for the Treatment of Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This pilot clinical trial will evaluate the efficacy and safety of transcutaneous direct
      current stimulation (tsDCS) in major depressive disorder.
    

Detailed description: 
      This study aims to 1) determine the efficacy and safety of tsDCS in adult patients with MDD
      and 2) investigate interoceptive awareness, somatic symptoms, autonomic and metabolic
      regulation as potential mediators of antidepressant response to tsDCS. We predict that 1)
      Active tsDCS treatment will result in a greater decrease in depressive symptom severity
      compared to Sham tsDCS in adult patients with MDD, 2) active tsDCS will be safe and well
      tolerated in adult patients with MDD and 3) change in interoceptive awareness, somatic
      symptoms, and autonomic and metabolic parameters will be associated with change in depressive
      symptom severity. To accomplish these aims, we will conduct an 8-week, double blinded,
      randomized, sham controlled, parallel group, pilot clinical trial study design. A total of 20
      adult antidepressant-free MDD patients will be randomized to receive Active (n=10) or Sham
      (n=10) tsDCS protocols for 8 weeks in a 1:1 ratio. We will combine the use of a tsDCS device,
      psychometric instruments to diagnose MDD, and measures of depressive symptom severity,
      somatic symptoms, interoceptive awareness, autonomic function (blood pressure, heart rate),
      and potential metabolic markers as predictors of response.
    

Intervention name(s): Active transcutaneous spinal direct current stimulation; Sham transcutaneous spinal direct current stimulation
Intervention type(s): Device; Device
Intervention description(s): Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.; Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 8-week, double blinded, randomized, sham controlled, parallel group, pilot clinical trial study design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; transcutaneous spinal direct current stimulation; non-invasive; major depressive disorder
Platelet-Rich Plasma (PRP) for Treatment of Symptomatic Lumbar Facet Syndrome of the Spine
Condition: Platelet-Rich Plasma
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to investigate the feasibility of standardized autologous
      platelet rich plasma injections into osteoarthritic lumbar facet joints to treat back pain
      and improve patient function.
    


Intervention name(s): Autologous platelet rich plasma
Intervention type(s): Biological
Intervention description(s): 0.5 mL autologous platelet rich plasma into a symptomatic osteoarthritic lumbar facet to treat back pain caused by lumbar facet syndrome
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases
Condition: Hematological Neoplasms; Hematopoietic Stem Cell Transplantation
MeSH terms: Hematologic Neoplasms; Hematologic Diseases
Study type: Interventional

Summary: 
      To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients
      who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for
      malignant hematological diseases
    

Detailed description: 
      Primary Endpoints:

        1. Engraftment of donor cells

        2. Regimen related toxicities

      Secondary Endpoints:

        1. Disease-free survival

        2. Overall survival
    

Intervention name(s): Busulfex, Fludarabine, ALemtuzumab
Intervention type(s): Drug
Intervention description(s): Busulfex 3.2 mg/kg/day for 2 days infused over 3 hours, Days -6 and Day-5 Fludarabine 30 mg/m2/day for 5 days on Day -6 to D-2 Alemtuzumab 10 mg/day IV on Days -5 to -1
Intervention MeSH terms: Fludarabine; Alemtuzumab; Busulfan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allogenic stem cell transplant; Hematologic diseases
Reliability and Validity of the Finnish Version of the Prothesis Evaluation Questionnaire
Condition: Amputation Stump
Study type: Observational [Patient Registry]

Summary: 
      The present study assesses the reliability and validity of the Finnish version of Prothesis
      Evaluation Questionnaire. Major lower extremity amputees who use prosthesis are requited for
      the present study from the Helsinki and Uusimaa Hospital District and the Central Finland
      Health Care District.
    

Detailed description: 
      > 100 lower extremity prosthetic users with major lower extremity amputation are recruited
      for the present study. The aim is to assess the reliability and validity of the Finnish
      version of the Prothesis Evaluation Questionnaire (PEQ). The participants fill in a pre
      information form, the PEQ, the 15D health-related quality of life questionnaire, Houghton
      prothesis questionnaire, Locomotor Capabilities Index - 5, Prothesis Evaluation Questionnaire
      Mobility Section - 5. The psychometric abilities of the PEQ instrument are analyzed.
    

Intervention name(s): Prosthetic for major lower limb amputation
Intervention type(s): Other
Intervention description(s): Prosthetic for major lower limb amputee
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with major lower extremity amputation who has been prothetized.
      
Keywords: PEQ validation study, Finland
Impact of External Nasal Dilator on the Rhinogram
Condition: Nasal Obstruction
MeSH terms: Nasal Obstruction
Study type: Observational

Summary: 
      The aim of this study is to present new data for a better understanding of the anatomic
      correlation of these two notches.

      This study included 32 nasal cavities (16 individuals) with external nasal dilator strip
      (Breath Right®) and after decongestion (0.05% oxymetazoline chloride applied as an aerosol
      spray);
    

Detailed description: 
      Acoustic rhinometry is more accurate in the anterior portion of the nasal cavities, from the
      nostril to the nasal valve (NV), the most important site of nasal obstruction. Literature
      presents different opinions regarding the anatomical correlation of the two notches at the
      beginning of the rhinogram curve in normal adult Caucasian individuals.

      This prospective study included 32 nasal cavities under the following conditions: 1st - basal
      condition; 2nd - with external nasal dilator strip (ENDS) (Breath Right®); 3rd - after
      decongestion (0.05% oxymetazoline chloride applied as an aerosol spray); 4th - after
      decongestion with ENDS.
    

Intervention name(s): External Nasal Dilator Strip; 0.05% oxymetazoline chloride
Intervention type(s): Drug
Intervention description(s): External Nasal Dilator Strip placed above the upper lateral cartilage; 20 minutes after decongestion with 0.05% oxymetazoline chloride applied as an aerosol spray (two times); after decongestion with ENDS.
Other intervention name(s): Breath Right®
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        32 nasal cavities of 16 normal adult Caucasian individuals
      
Keywords: external nasal dilator strip; nasal valve; acoustic rhinometry
Pneumococcal Conjugate Vaccine Followup
Condition: Immune Tolerance
Study type: Interventional
Phase: Phase 2

Summary: 
      Recently, controversy has emerged regarding the role of the 23vPPV in infants due to
      potential immunological hypo-responsiveness (i.e. a poorer immune response to repeat
      vaccination). Although previous experience of 23vPPV in children in PNG has demonstrated
      protective efficacy against acute lower respiratory tract infection, the investigators feel
      it is a matter of urgency to determine if 23vPPV administration provides elevated antibody
      concentrations at 3 to 5 years of age, and to ensure the immunological safety of the 23vPPV
      in infants.

      Following consent and eligibility assessment, a baseline blood sample and nose swab will be
      taken, a 0.1ml dose of 23vPPV will be administered and a follow up blood sample and nose swab
      will be collected 28 days later. The investigators will also collect data on incidence of
      ALRI in all study participants by medical record review.
    


Intervention name(s): Prevenar + PPV; Infant PCV (Prevenar) + PPV at 9 months; No Prevenar + PPV at 9 months; Control
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5mL dose of Prevenar at 0-1-2 months, 0.5mL Pneumovax at 9 months and 0.1mL Pneumovax at 3-5 yrs; 0.5mL Prevenar at 1-2-3 months,0.5mL Pneumovax (PPV) at 9 months, 0.1mL Pneumovax at 3-5 yrs; no Prevenar, 0.5mL Pneumovax at 9 months, 0.1mL Pneumovax at 3-5 yrs; control, 0.1mL Pneumovax at 3-5yrs
Other intervention name(s): Prevenar; Pneumovax23
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pneumococcal,; pneumococcal polysaccharide vaccine,; challenge dose,; hyporesponsiveness,; Papua New Guinea
The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants
Condition: Preterm Infant; Music; Near-infrared Spectroscopy; Electroencephalogram
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Music has been consistently shown magic power in brain plasticity. Several study proved music
      can influence electronic activity of preterm infants' brain, while none study covered region
      oxygen metabolic. The investigators aim to discover the effects of music therapy on
      near-infrared spectroscopy and electroencephalogram in premature infants.
    

Detailed description: 
      Previous studies of music therapy have made some achievements for adult Parkinson's disease,
      schizophrenia, depression, anxiety, post-traumatic stress and pediatric autism spectrum
      disorders. For newborns, studies mainly focused on the effects of basic vital signs, feeding
      and pain score decreasing. So far, no studies evaluating the effect of music therapy on brain
      oxygen metabolic and electronic activity.
    

Intervention name(s): music
Intervention type(s): Other
Intervention description(s): music selected by musician
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Inhaled Corticosteroids in U-5 Children With Acute Respiratory Infection in Uganda: A Randomised Trial
Condition: Bacterial Pneumonia; Viral Pneumonia; Acute Asthma
MeSH terms: Pneumonia; Respiratory Tract Infections; Pneumonia, Bacterial; Pneumonia, Viral; Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to find out whether adjunct treatment with inhaled
      corticosteroids lead to faster improvement and reduce mortality of children under 5 years of
      age admitted to hospital with ALRI.
    

Detailed description: 
      Pneumonia is one of the common causes of serious illness in children under 5 years of age. It
      is one of the common causes of admission to hospital and the commonest cause of death in
      Ugandan children under 5 years of age. The signs of pneumonia also occur in children with
      asthma making it difficult to differentiate the two. Other researchers have found that one of
      two children under five years of age with pneumonia have asthma. Wheeze which is regarded as
      a sign of asthma is heard in only one of three children with asthma, implying that many
      children with asthma especially in the first few years of life are less likely to be
      diagnosed. They are also less likely to receive inhaled steroids, the recommended treatment
      for asthma. Failure to administer asthma medicines may contribute to delayed improvement and
      increase the risk of death. The study hypothesizes that use of inhaled corticosteroids in
      addition to standard treatment in children hospitalized with ALRI will be associated with
      reduced morbidity and mortality and that the improvement will be more marked in children
      diagnosed with asthma posthoc. Outcomes: Reduction in case fatality, Time to normalization of
      respiratory rate, Time to normalization of oxygen saturation, Duration of hospitalisation.
    

Intervention name(s): Inhaled corticosteroid; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Inhaled fluticasone 500mcg 12 hourly up to discharge or a maximum of 5 days; Placebo to be administered 12hourly
Other intervention name(s): Inhaled fluticasone propionate; Inhaler propellant
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Children U-5; ALRI; Inhaled Corticosteroids
The Impact of Acute Trans-resveratrol Administration on Whole Body Metabolism During Cognitive Demand.
Condition: Cognitive Change
Study type: Interventional

Summary: 
      Background: Increased cerebral vaso-dilation during cognitive demand is hypothesised to
      improve cognitive performance due to an improved micronutrient status. Despite previous
      research demonstrating that oral resveratrol can modulate cerebral haemodynamics, this has
      not translated into expected improvements to cognitive performance in young, healthy
      populations. As the brain is the most metabolic organ in the body, even subtle changes to
      fuel utilization and overall energy expenditure are detectable during cognitive demand. The
      measurement of both overall energy expenditure and fuel utilization may provide further
      insight to the effects of resveratrol and whether oral supplementation of this polyphenol can
      provide clear, cognitive benefits in a young, healthy sample.

      Objectives: The current study investigated the metabolic consequences of resveratrol on whole
      body metabolism and fuel oxidisation during cognitive performance.

      Methods: This repeated measures, double blind, placebo controlled, balanced design required
      participants (N=24 for metabolic activity & N=26 for cognitive outcomes) to complete a serial
      subtraction demand battery at baseline, 45 minutes, 2 and 3 hours following 500 mg, 250 mg
      trans-resveratrol or inert placebo, on three separate occasions whilst connected to an
      on-line gas analysis system.
    


Intervention name(s): Resveratrol; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Cognition; Resveratrol; Whole body metabolism
Effect of Preoperative Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain
Condition: Symptomatic Periapical Periodontitis
MeSH terms: Periodontitis; Periapical Periodontitis
Study type: Interventional

Summary: 
      The aim of this prospective, randomized, placebo controlled study is to evaluate the effect
      of a single preoperative dose of amoxicillin/clavulanic acid combination on post-operative
      pain and swelling in adult patient with symptomatic apical periodontitis.
    

Detailed description: 
      Medical and dental history will be obtained from all patients participating in this trial.
      Clinical and radiographic evaluation for each tooth included in this study will be recorded.

      Clinical diagnosis of symptomatic apical periodontitis is to be confirmed.

      Prior to initiation of root canal treatment, eligible participants will be randomly assigned
      to one of the following groups: experimental group (receiving 2 gm of amoxicillin/ clavulanic
      acid orally 30 minutes before the treatment) or control group (receiving a placebo 30 minutes
      before treatment).

      Root canal treatment will then be carried out in a single visit.

      Each patient will receive a 7-day diary to record postoperative pain and swelling. In case of
      pain, the participant will be instructed to take an analgesic. Post-operative pain will be
      measured as a primary outcome on 11-point scale (NRS) at the following time points: 6, 12,
      24, 48, 72 hours and 7 days. The occurrence of swelling will be reported by participant as a
      secondary outcome.
    

Intervention name(s): Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet; Oral placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 gm of amoxicillin/ clavulanic acid combination orally 30 minutes before root canal treatment; placebo 30 minutes before root canal treatment
Other intervention name(s): Augmentin
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment