bioihbjkbjnl/mcl2 huggingface dataset:
Biomarkers in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in TBI Patients
Condition: Traumatic Brain INjury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      The PreTBI II study aims to investigate the diagnostic potential of prehospital S100B and
      GFAP measurements in prediction of need for neurosurgical observation and/or intervention in
      moderate TBI patients, to rule-in high-risk patients. Ultimately to select patients who will
      benefit from neuro surgical expertise in specialized departments and thereby possibly better
      patient outcome. Hopefully also minimize treatment delay, secure optimal resource consumption
      and streamline patient courses by predicting the presence of neurotrauma.

      Hypotheses:

        1. A prehospital serum S100B level > 0,10 microgram/L and expectedly above a certain and
           currently unknown cut-off value indicates the need for neurosurgical observation and/or
           intervention in moderate TBI patients.

        2. A prehospital serum GFAP level above a certain and currently unknown cut-off value can
           significantly predict a need for urgent neurosurgical observation and/or intervention in
           moderate TBI patients.

        3. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and
           GFAP can significantly predict a need for urgent neurosurgical observation and/or
           intervention.

        4. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and
           GFAP can significantly predict hospital course and outcome of patients with moderate
           TBI.
    


Intervention name(s): Blood sampling
Intervention type(s): Other
Intervention description(s): Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All adult patients (≥18 years) suffering isolated head trauma and receiving an ambulance or
        anaesthetist-staffed critical care team dispatched by the Prehospital Emergency Medical
        Services (EMS) in the Central Denmark Region.
      
Biospecimen description: 
      Blood samples
    
Keywords: biomarker; point-of-care analysis
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with
      Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be
      randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4
      to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or
      3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment
      will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study
      treatment is 1 year, and the target sample size is 100-500 individuals.
    


Intervention name(s): Adefovir; Entecavir; Placebo; peginterferon alfa-2a [Pegasys]
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): From week -4 to week 2; From week -4 to week 2; From week -4 to week 2; 180 micrograms sc weekly, from week 1-48
Intervention MeSH terms: Peginterferon alfa-2a; Entecavir; Adefovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Viscosity of Fibre Predicts Cholesterol-lowering in Healthy Individuals
Condition: Lipidemia; Healthy
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the role of fibre viscosity (low, medium, high) in lowering cholesterol in
      healthy individuals
    


Intervention name(s): Viscous Fibre Blend; Psyllium; Wheat Bran
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): High viscosity viscous fiber blend sprinkled on wheat and maize bran cereals(Bran Buds®; Kellogg Company); Bran Buds cereal (white bran and maize bran) with psyllium (Bran Buds® with PSY; Kellogg Company); All Bran cereal (All Bran®; Kellogg Company)
Intervention MeSH terms: Psyllium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: dietary fibre; Viscosity; lipids; Healthy
Efficacy of PLEM100(Inbody®) in Children
Condition: Development, Child
Study type: Observational

Summary: 
      Evaluation of efficacy of PLEM100(Inbody®) in measuring the sedation level in pediatric
      patients
    

Detailed description: 
      The investigators plan to gather the basic data relevant to measurement of the level of
      consciousness/sedation in pediatric patients with developing brain by using PLEM100(Inbody®)

      PLEM100 (Inbody®) is a medical equipment to measure, based on phase lag entropy algorithm,
      the level of patient consciousness, which is expressed by PLE score ranging from 0 (burst
      suppression or deep sedated) to 100 (awake).

      In this study, pediatric patients aged from 3 to 6 years old who undergo total intravenous
      general anesthesia are chosen as target subjects. The investigators measure how PLE score
      changes during 1) anesthesia induction, 2) anesthesia maintenance, 3) emergence from
      anesthesia. Then, the PLE score would be validated by analyzing the correlation with the
      consciousness level expressed in University of Michigan Sedation Scale (UMSS).
    

Intervention name(s): PLE100(Inbody®)
Intervention type(s): Device
Intervention description(s): PLE100(Inbody®) monitoring in children to be operated under the total intravenous anesthesia (Propofol)
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients to be operated under general anesthesia, aged from 3 to 6 years
A Phase 1, First Time in Humans Study of NST-1024
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 1

Summary: 
      A first time in man study of NST-1024
    

Detailed description: 
      A Phase 1, First Time in Man Study to Evaluate the Safety, Tolerability, and Pharmacokinetics
      of NST-1024 in Healthy Subjects and Otherwise Healthy Subjects with Elevated Triglycerides.
      This will be a double-blind, randomised, placebo-controlled, single and multiple oral dose
      study conducted in 2 parts. In part A up to 6 cohorts of 8 healthy volunteers will receive
      single ascending doses of NST-1024 or matching placebo. I part B up to 4 cohorts of 10
      otherwise healthy volunteers, with elevated triglycerides will receive daily multiple
      ascending doses of NST-1024 for 14 days
    

Intervention name(s): NST-1024; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): NST-1024; Matching placebo to NST-1024
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells
Condition: Tracheal Stenosis; Laryngeal Stenosis; Mesenchymal Stem Cells
MeSH terms: Tracheal Stenosis; Laryngostenosis; Constriction, Pathologic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The trial evaluates the safety and efficacy of the olfactory mucosa-derived mesenchymal stem
      cells based therapy for the patients with chronic laryngeal and tracheal stenosis
    

Detailed description: 
      Trial evaluating the safety and efficacy of olfactory mucosa-derived mesenchymal stem cells
      based therapy for the patients with chronic laryngeal and tracheal stenosis.

      Mesenchymal stem cells are obtained from tissue biopsy of olfactory mucosa using explant
      method. Biomass of autologous mesenchymal stem cells in 10% human albumin solution is
      injected submucosally around and over the tissue after removal of a granuloma tissue during
      surgical intervention.
    

Intervention name(s): Olfactory mucosa-derived mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): Olfactory mucosa-derived mesenchymal stem cells
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mesenchymal stem cells; Tracheal Stenosis; Laryngeal Stenosis; cell therapy
The Efficacy of Pulsed Dye Laser in Dermatophytosis
Condition: Cutaneous Dermatophytosis; Pulsed Dye Laser
MeSH terms: Tinea; Dermatomycoses
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether Pulsed Dye Laser therapy are effective in
      the treatment of Cutaneous Dermatophytosis.
    

Detailed description: 
      This study was conducted to determine the efficacy of Pulse Dye Laser in skin fungal
      infection, if this study showed that Laser could be effective, this would be introduced as a
      new treatment modality.
    

Intervention name(s): pulsed dye (585nm) laser therapy
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasonic Evaluation of Carbon Dioxide Laser Effects on Patients With Genitourinary Syndrome
Condition: Genitourinary Syndrome of Menopause
MeSH terms: Syndrome
Study type: Observational

Summary: 
      The aim of the study was to evaluate the efficacy of vaginal Carbon Dioxide Laser treatment
      in patients with Genitourinary Syndrome of Menopause on the improvement of Vulvovaginal
      Atrophy (VVA) and stress urinary incontinence (SUI) by objective parameters and in particular
      to assess the ultrasound measurement of specific vaginal parameters in order to evaluate a
      new objective tool of assessment.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Menopausal patients that attended our clinic of menopausal disorders and performed Carbon
        Dioxide Laser therapy for genitourinary syndrome.

        In order to enroll patients with Genitourinary Syndrome of Menopause, the investigator used
        the Vaginal Health Index (VHI), Vulvar Health Index (VuHI), and Stress Urinary Incontinence
        (SUI) scales.

          -  The VHI score assesses vaginal health, with a cutoff of <15 on the index to diagnose
             patients with atrophy [ranging from "complete atrophy" (0) to "optimal vaginal health"
             (25)].

          -  The VuHI score assesses vulvar health, on a scale from normal (0) to severe (3). The
             overall score ranges from 0 to 24, and its cutoff for diagnosing atrophic vulva is >8
             on the index.

          -  Stress Urinary Incontinence (SUI) is characterized by sudden urine loss. Evaluated
             using the Stamey score, with ratings of no incontinence (0) to severe incontinence
             (3).
Safety, Tolerability, PK & PD Study of JTZ-951 in Anemic Subjects With End-stage Renal Disease
Condition: Anemia of Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK),
      and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days
      in anemic subjects with end-stage renal disease (ESRD) receiving hemodialysis.
    


Intervention name(s): JTZ-951; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive JTZ-951 or Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: anemia; chronic kidney disease; hemodialysis
Virtual Reality for Appendectomy Pain
Condition: Appendix Rupture; Pain; Pain, Postoperative
MeSH terms: Pain, Postoperative; Rupture
Study type: Interventional

Summary: 
      To determine the impact of VR-Biofeedback and VR-Distraction on pain and medication
      utilization in children and adolescents undergoing surgery for ruptured appendix.
    


Intervention name(s): VR-Biofeedback; VR-Distraction
Intervention type(s): Other; Other
Intervention description(s): Participants will be instructed to use the Mindful Aurora Application; Participants will be instructed to use one of four applications
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 60 participants assigned to one of two groups. VR- Distraction and VR-Biofeedback
Masking: None (Open Label)
Primary purpose: Other
Mindfulness Based Stress Reduction for Parents of Children With IBD
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Parents of children with chronic diseases often report increased level of stress and anxiety.
      The aim of the study is to assess the effect of mindfulness based stress reduction (MBSR)
      intervention on stress and anxiety of parents of children with inflammatory bowel diseases
      (IBD). The intervention is consisted of 8 group sessions managed by a certified psychologist.
      30 parents will participate. The efficacy of the intervention will be assessed by 3 validated
      questionnaires which will be filled by each participant prior to intervention, at the end of
      intervention and 3 months following interventions.
    

Detailed description: 
      Parents of children with chronic diseases often report increased level of stress and anxiety.
      Inflammatory bowel diseases (IBD), including crohn's disease and ulcerative colitis are
      chronic debilitating conditions with significant implications of both patients and parents.
      Thus, there is a necessity to address the stress and anxiety derived from parenting a child
      with IBD.

      Mindfulness is the psychological process of bringing one's attention to the internal and
      external experiences occurring in the present moment,which can be developed through the
      practice of meditation and other training. Clinical studies have documented both physical and
      mental health benefits of mindfulness in different patient categories as well as in healthy
      adults and children.

      The aim of the study is to assess the effect of mindfulness based stress reduction (MBSR)
      intervention on stress and anxiety of parents of children with inflammatory bowel diseases
      (IBD). The intervention is consisted of 8 group sessions managed by a certified psychologist.
      30 parents will participate in 4 separated courses. The efficacy of the intervention will be
      assessed by 3 validated questionnaires which will be filled by each participant prior to
      intervention, at the end of intervention and 3 months following interventions: Profile of
      mood states (POMS), The brief symptom inventory (BSI) and perceived stress scale (PSS).
      Differences in questionnaires' scores will be analyzed.
    

Intervention name(s): Mindfulness based stress reduction
Intervention type(s): Behavioral
Intervention description(s): Mindfulness based stress reduction consisted of 8 group sessions for parents of children with IBD
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation
Condition: Heart Disease
MeSH terms: Respiratory Aspiration; Heart Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a retrofit particle trap can reduce the
      adverse vascular responses to diesel exhaust inhalation
    

Detailed description: 
      18 subjects healthy male volunteers will be recruited at Umeå University. In a randomised,
      double blind 3 way crossover trial, subjects will be exposed to filtered air, diesel exhaust
      (300mcg/m3) or filtered diesel exhaust for 1 hour during intermittent exercise.

      2 hours following the exposure, thrombogenicity will be assessed using the Badimon chamber -
      an ex-vivo model of thrombosis formed under constant flow conditions.

      Forearm blood flow in response to infused intra-brachial vasodilators will be measured using
      venous occlusion plethysmography 6 hours after the exposure.

      Arterial stiffness will be measured using peripheral arterial applanation tonometry in the
      hour post-exposure.

      Blood samples will be collected at timepoints over the 24 hours after exposure.
    

Intervention name(s): Forearm Venous Occlusion Plethysmography
Intervention type(s): Procedure
Intervention description(s): Forearm venous occlusion plethysmography with intra-arterial infusion of Acetylcholine (5-20mcg/min), bradykinin (30-300mcg/min), sodium nitroprusside (2-8mcg/min) and Verapamil (2-10 mcg/min) into non-dominant brachial artery
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Air pollution; Diesel exhaust; Endothelial function; Vascular function; Particle trap; Thrombosis; effects; inhalation
Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy
      (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid
      seasonal allergic rhinoconjunctivitis.
    

Detailed description: 
      This was an open-label extension period of the previously randomized, multicenter,
      double-blind, placebo-controlled, parallel-group trial to demonstrate the benefit of pre- and
      co-seasonal combination therapy with anti-IgE (omalizumab) and specific immunotherapy
      (Depigoid) in patients with seasonal allergic asthma and co-morbid seasonal allergic
      rhinoconjunctivitis. During the open-label period, all patients received Depigoid monotherapy
      for two follow-up seasons every 4 weeks, 26 injections in total. The extension period was
      performed to evaluate the influence of omalizumab on the follow-up treatment with Depigoid in
      seasonal asthma.

      This study was a follow-up to the core IGE025ADE03 study, in which patients received
      omalizumab treatment. In this follow-up study, no patient received omalizumab.
    

Intervention name(s): Depigoid; Omalizumab; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL); anti-IgE (Omalizumab) given during the 2006 core study; Placebo given during the 2006 core study
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Advanced Glycation Endproducts on Satiety and Inflammation
Condition: Obesity; Type 2 Diabetes; Insulin Resistance; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Insulin Resistance; Inflammation
Study type: Interventional

Summary: 
      The purpose of the meal study is to investigate acute effects on satiety and inflammation of
      advanced glycation endproducts (AGE) in healthy overweight subjects. The AGE content of the
      meal is affected by food preparation methods: frying/grilling versus boiling/steaming.
    


Intervention name(s): Dietary meal intervention
Intervention type(s): Other
Intervention description(s): Test meals with different AGE content made by different cooking methods
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Advanced glycation endproducts; Satiety; Obesity; Inflammation; Insulin resistance
Effect of Gynostemma Pentaphyllum Tea in Insulin Sensitivity in Type 2 Diabetic Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance; Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the present study was to investigate the effects of Gynostemma Pentaphyllum tea on
      insulin sensitivity in drug-naïve type 2 diabetic patients.
    

Detailed description: 
      In Vietnam, traditional herbal medicines have played a major role in the management of
      diabetes for centuries. Gynostemma Pentaphyllum (GP) Makino (Family Cucurbitaceae) is a
      perennial creeping herb growing wild in the mountainous regions of Vietnam, China and some
      other Asian countries and was widely used in Southeast Asian countries as an herbal medicine
      and being beneficial for the prevention and treatment of diabetes. We have previously
      published the evidences that GP tea possessed anti-diabetic effect with good safety data in
      newly diagnosed T2D patients, and had effect on insulin sensitivity. In addition extract of
      GP had been shown to reduce both hyperglycemia and hyperlipidemia in diabetic Zucker Fatty
      rats. So the present study was to investigate the effects of Gynostemma Pentaphyllum tea in
      insulin sensitivity in type 2 diabetic patients.
    

Intervention name(s): Gynostemma Pentaphyllum tea; Placebo tea
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner; 6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner
Other intervention name(s): Gynostemma Pentaphyllum extract; Placebo extract
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Herbal medicine; Type 2 diabetes; Gynostemma pentaphyllum Tea; Insulin sensitivity;