bioihbjkbjnl/mcl2 huggingface dataset:
The Development Of A Novel Biomarker For Early Identification Of The Individual's State Of Tolerance To Heat
Condition: Heat Stroke; Healthy
MeSH terms: Heat Stroke
Study type: Observational

Summary: 
      Today, the level of tolerance to heat is based on physiological strain indices, with no
      correlates to any relevant biomarker. We hypothesize that oxidative stress (OS) and the
      formation of reactive oxygen and nitrogen species (ROS, RNS), which are part of the underling
      pathophysiology related to hyperthermia, can be used to identify tolerance/intolerance to
      heat. The aim of the present project is to develop a simple assay, based on specific designed
      sensitive biomarkers of OS that can be detected in a small blood sample, and to possibly
      correlate each individual's state of tolerance to heat to the level of OS. These biomarkers
      specially designed and synthesized to form a novel probe (not present as such in biological
      organs). The method will be based on the incubation of the suggested biomarkers with the
      patient's blood sample and the measurement of the level and type of oxidative alteration of
      the markers. For this goal, post heat stroke patients, with different levels of tolerance to
      heat and subjects during a process of acclimation to heat will be studied. Such a method will
      add to our ability to better determine the level of tolerance to heat and not rely only on
      the measurements of temperature and heart rate during an exercise-heat stress.
    


Intervention name(s): heat tolerance test (HTT)
Intervention type(s): Other
Intervention description(s): An exercise-heat test,which consists of 120 min exposure to walking on a treadmill (5km/h; 2% grade) under conditions of 40oC and 50% rh.
Other intervention name(s): heat strain
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        young (18-28 years old) post heat stroke subjects, and matched healthy controls
      
Keywords: tolerance to heat
Efficacy and Safety of Lercanidipine and Valsartan in Patients With Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of fixed combination of
      lercanidipine (10 mg or 20 mg) and valsartan (80 mg or 160 mg), lercanidipine and valsartan
      alone in reducing blood pressure. The study will investigate the dose response relationship
      for the combinations and monotherapies.
    


Intervention name(s): Lercanidipine + Valsartan; Lercanidipine or Valsartan; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): L10/V80, L20/V80, L10/V160, L20/V160; L10, L20, V80, V160; Placebo of Lercanidipine and Valsartan
Intervention MeSH terms: Valsartan; Lercanidipine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hypertension; lercanidipine; valsartan
Study of Pomegranate Juice in the Modulation of Oxidative Stress Markers in Endurance-based Athletes
Condition: Oxidative Stress
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to evaluate modifications of plasma protein carbonyls and
      malondialdehyde levels in endurance-based athletes after three weeks of pomegranate juice
      consumption.
    


Intervention name(s): Pomegranate juice
Intervention type(s): Dietary Supplement
Intervention description(s): Intake of 200 ml of pomegranate juice or pomegranate juice dilution during 21 days after exercise.
Other intervention name(s): Zumo de Granada Vitalgrana
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antioxidants; Protein Carbonylation; Malondialdehyde; Punicaceae; Athletic Performance
Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.
Condition: Chronic Renal Failure
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Patients will be treated with hemodiafiltration (HDF) in postdilution mode, as a control
      therapy, during 9 weeks. During week 5 the 1st intervention treatment, predilution
      hemofiltration (HF) or predilution HDF, will be performed as a midweek session. After 4
      additional weeks of control therapy the other intervention treatment will be performed.
      Samples will be taken during week 4, 5 and 9: from inlet blood flow (0, 30, 60, 120 and 240
      min), from outlet blood flow and dialysate outflow (30, 60, 120 and 240 min).
    


Intervention name(s): Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration
Intervention type(s): Procedure
Intervention description(s): Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration is followed.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pilot MRI Study of Osteopathic Manipulative Treatment of Acute Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This is a pilot project intended to determine the feasibility of detecting soft tissue
      changes in response to osteopathic manipulative treatment (OMT). MRIs of the lumbar and
      pelvic regions of low back pain (LBP) patients will be taken once before and at two different
      time points after OMT. Images obtained will be quantitatively analyzed for changes in the
      volumes of back muscles and for changes (T2 signals) indicative of activity levels or
      pathological conditions. Electromyography (EMG) will be used as an independent measure of
      back muscle activity for comparison with MRI results.
    


Intervention name(s): osteopathic manipulative treatment
Intervention type(s): Other
Intervention description(s): Treatment will focus on the thoracolumbar junction, L5, the sacrum, and the pubes. Treatment will primarily utilize two techniques, muscle energy and ligamentous-articular release, but will be tailored to the findings of the individual patient.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to investigate the acute treatment efficacy, safety, and tolerability
      of atomoxetine on a once-daily dosing strategy (in the morning). It incorporates a 6-week
      acute treatment period and a 2-week discontinuation phase. The assessments in this study
      include a standard assessment of ADHD symptomatology using a Diagnostic and Statistical
      Manual of Mental Disorders, Fourth Edition™, investigator-administered rating scale.
    


Intervention name(s): atomoxetine; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Measuring Brain Activity of School Age Children
Condition: Perinatal Hypoxia; Dopamine; Neurobehavioral Manifestations
MeSH terms: Neurobehavioral Manifestations; Hypoxia
Study type: Observational

Summary: 
      This observational study will investigate whether differences in birth events and oxygen
      levels during the newborn period affects the brain activity of children during the middle
      childhood years.
    

Detailed description: 
      The investigators will conduct an observational study comparing two groups of children to
      determine whether differences in birth events and oxygen levels during the newborn period
      lead to structural and functional impairment within the brain's dopaminergic pathways and the
      cortical regions innervated by those pathways. The dopaminergic system is involved in
      modulating motor control and cognitive function.

      Using magnetic resonance diffusion tensor imaging, structural integrity of dopaminergic
      circuits will be quantified and compared in post-hypoxic former preterm children versus
      healthy control children born at term closely matched by age/sex/race.

      Functional activity during executive function tasks will be quantified and compared in
      post-hypoxic former preterm children versus healthy control children born at term using
      functional magnetic resonance imaging-blood oxygen level dependent (fMRI-BOLD). Assessment of
      motor function (grooved pegboard task) will also be performed.
    

Intervention name(s): Magnetic Resonance Imaging; Cognitive Performance Testing
Intervention type(s): Other; Other
Intervention description(s): MRI uses a strong magnetic field and radio waves to create detailed images of the brain while the person's head is positioned inside a round tunnel.; For the Grooved Pegboard task: After the MRI scan, children will be timed as they place pegs into holes with randomly positioned slots.
Other intervention name(s): T-1 MPRAGE; fMRI-BOLD; Grooved pegboard task
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study Group Children (n=11) will be drawn from a cohort currently maintained by the
        investigators.

        Healthy Control Children will be recruited using various strategies: (1) study flyers given
        to the parents of the prematurely born cohort children to pass along to parents of other
        children with ages similar to their own child. (2) study flyers posted in the hospital's
        primary care pediatric clinics asking interested children/families to contact us to learn
        more about the study; (3) study flyers distributed by professional colleagues/pediatric
        physicians to potential candidate children/families meeting study inclusion criteria.
      
Biospecimen description: 
      MRI neuroimages
    
Keywords: Hypoxia, Brain; Neural networks; Magnetic Resonance Imaging
Impact of Severe Hepatic Impairment on Pharmacokinetics of Cenicriviroc and Its Metabolites
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability
      profiles of cenicriviroc (CVC) and its metabolites (M-I and M-II) in participants with
      severely impaired hepatic function compared with matched healthy participants following
      single-dose administration
    


Intervention name(s): Cenicriviroc
Intervention type(s): Drug
Intervention description(s): 1 tablet; single-dose oral administration
Other intervention name(s): CVC
Intervention MeSH terms: Cenicriviroc
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver insufficiency; Hepatic Impairment; Cenicriviroc; Pharmacokinetics
Using Cumulase for Denudation of Cycles With ≤ 8 Cumulus-oocytes Complexes
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The cumulus-corona-oocyte complex (COCs) surrounds each oocyte and must be removed prior to
      intracytoplasmic sperm injection (ICSI). This is traditionally achieved with a bovine-derived
      hyaluronidase followed by mechanical denudation through pipetting. A human recombinant
      hyaluronidase (Cumulase) has been developed to circumvent the problems and concerns
      associated with the animal origin and lack of purity of the bovine-derived form of the
      enzyme. whether cumulase offers a higher chance for success after ICSI for women with 8 COCs
      or lower remains an open question.
    


Intervention name(s): Cumulase denudation
Intervention type(s): Other
Intervention description(s): Testing the effect of cumulase for women with poor oocyte yield due to poor ovarian reserve
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Ultra Rapid Culture Independent Detection of High-Priority Carbapenem Resistant Enterobacteriaceae Directly From Blood
Condition: Bacteremia; Enterobacteriaceae Infections
MeSH terms: Bacteremia; Enterobacteriaceae Infections
Study type: Observational

Summary: 
      The purpose of this study is to develop a new and very rapid diagnostic test for identifying
      a certain type of bacteria called Enterobacteriaceae in blood. Rapid identification of
      bacteria will assist in decreasing the use of antibiotics and help more patients survive
      bacterial infections of the blood.
    

Detailed description: 
      It is our overall goal to develop a new diagnostic technology that will facilitate
      antibacterial stewardship to reduce selective pressure and improve patient outcomes. The
      Institute of Medicine has identified antibiotic resistance as one of the key microbial
      threats to health in the United States and has prioritized decreasing inappropriate use of
      antimicrobials as the primary solution to address this threat. The emergence of carbapenem
      resistance among Enterobacteriaceae (CRE) in the United States represents a recent and severe
      byproduct of excessive antimicrobial use with a high mortality rate in bacteremia. A major
      barrier toward decreasing use of antimicrobials is lack of sensitive and accurate rapid
      diagnostic tests for identifying bacterial etiologies of infection.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hospitalized patients with bacterial blood infections.
      
Keywords: Carbapenem-resistant Enterobacteriaceae; Accelerate ID/AST
Effect of Consuming Oat Bran Mixed in Water Before a Meal on Glycemic Responses in Healthy Humans - a Pilot Study
Condition: Glucose Intolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      Viscous dietary fibers including oat β-glucan are one of the most effective classes of
      functional food ingredients for reducing postprandial blood glucose. The mechanism of action
      is thought to be via an increase in viscosity of the stomach contents that delays gastric
      emptying and reduces mixing of food with digestive enzymes, which, in turn, retards glucose
      absorption. Previous studies suggest that taking viscous fibers separate from a meal may not
      be effective in reducing postprandial glycemia. The purpose of this study is to re-assess the
      effect of consuming a preload of a commercially available oat-bran (4.5, 13.6 or 27.3 g)
      containing 22% of high molecular weight oat β-glucan (O22) mixed in water before a test-meal
      of white bread on glycemic responses in 10 healthy humans.
    


Intervention name(s): 0 grams oat bran; 4.5 grams oat bran; 13.6 grams oat bran; 27.3 grams oat bran
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 200 milliliters water plus 0 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread; 200 milliliters water plus 4.5 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread; 200 milliliters water plus 13.6 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread; 200 milliliters water plus 27.3 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Humans; Glycemic response; Oat beta-glucan
Affective Responses in Neurological Rehabilitation
Condition: Neurological Incidents; Stroke; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      Using a single blind within-subject design, 16 patients with neurological disorders were
      randomly exposed to two different treatments: physical therapy and robotic assisted gait
      training. Both before and after the treatments, a self-report Mood Survey Scale (MSS) was
      used to assess the effects on the treatment on distinct affective states. The subscales of
      the MSS were tested for pre-post changes and different effects between treatments with
      non-parametric tests.
    


Intervention name(s): Physical therapy and robotic assisted gait training
Intervention type(s): Procedure
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with neurological disorders
Macrophage Activation Markers During Sofosbuvir-based Treatment Regimes of Chronic Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Observational

Summary: 
      The purpose of the study is to investigate how the liver is affected with regard to
      inflammation and fibrosis during Sofosbuvir based treatment regimes of chronic hepatitis C.

      In order to examine how the liver heals, we want to use blood samples to check for the
      occurrence of special liver inflammation cells (CD163 and CD206). To assess to which extent
      fibrosis disappear during treatment, we want to examine the liver with FibroScan (a type of
      ultrasound examination) and also preferably with extraction of a small tissue sample. We want
      to examine how the liver function as inflammation and scar tissue decrease, especially
      concerning the liver's ability to produce proteins. Furthermore, we want to examine with a
      gastroscopy, if the circulation of blood in the liver is improved after successful treatment
      with the expected result that potential varicose veins in the esophagus vanish.
    


Intervention name(s): Galactose; Gastroscopy; Liver biopsy; Fibroscan; Liver vein catheterization; Sofosbuvir
Intervention type(s): Drug; Procedure; Procedure; Procedure; Procedure; Drug
Intervention description(s): A test to investigate the liver's ability to metabolize galactose to glucose by injecting galactose followed by measurements of blood glucose and the quantification of galactose in the urine.
Other intervention name(s): GEC
Intervention MeSH terms: Sofosbuvir; Liver Extracts
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with chronic hepatitis C initiating sofosbuvir-based direct-acting antiviral
        treatment.
      
Keywords: Sofosbuvir; Direct acting anti-viral treatment; liver cirrhosis
Study of Therapeutic Effect of Electret Static Physiotherapy Film on Acute Soft Tissue Closed Injury
Condition: Soft Tissue Injuries
MeSH terms: Wounds and Injuries; Soft Tissue Injuries
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the efficacy and safety of electret static
      physiotherapy film developed by Beijing Youshilin science and Technology Development Co.,
      Ltd., to treat acute soft tissue injury by sticking to the affected area
    

Detailed description: 
      Design of randomized, open, parallel controlled non inferiority clinical trial.A total of 60
      patients were included in the trial, including 30 subjects in the experimental group and 30
      subjects in the control group. The experimental disease was acute soft tissue closed injury.
    

Intervention name(s): Electret electrostatic physiotherapyFilm; Fracture healing film
Intervention type(s): Drug; Drug
Intervention description(s): Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm; Patients with acute soft tissue injury treated with Fracture healing film
Other intervention name(s): polypropylene; Teflon,2011-2640661
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, open, parallel controlled, non inferiority clinical trial design was used in this trial.Objective to evaluate the safety and effectiveness of electret static physiotherapy film in Beijing Youshilin science and Technology Development Co., Ltd.The patients were followed up after receiving the electret static physiotherapy film, and the treatment and complication rate of the patients were observed after the electret static physiotherapy film was attached to the patient.The data were compared between the experimental group and the control group.
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine When Administered in Children Who Previously Participated in Study 115345
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals'
      investigational vaccine GSK2321138A in children who previously participated in study 115345
      (FLU D-QIV-004 PRI) (NCT01439360).
    


Intervention name(s): Fluarix Quadrivalent
Intervention type(s): Biological
Intervention description(s): 1 or 2 doses administered intramuscularly (IM) in deltoid region depending on the priming status
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: GSK Biologicals quadrivalent influenza vaccine; Influenza; Children; Safety; Immunogenicity
Study of Efficacy of Sodium Valproate in Therapy of Bronchial Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether antiepileptic drug sodium valproate is
      effective in the treatment of chronic asthma.
    

Detailed description: 
      Effective therapy of asthma still remains quite serious problem. According GINA definition,
      asthma is an inflammatory disorder. Consequently, modern pharmacotherapy of asthma provides
      wide use of anti-inflammatory drugs. But asthma also is a paroxysmal disorder: many
      specialists and even some guidelines underline paroxysmal clinical picture of asthma. Besides
      this, according to some authors, neurogenic inflammation may play important role in asthma
      mechanism. But some other neurogenic inflammatory paroxysmal disorders exist, and they are
      migraine and trigeminal neuralgia. Some antiepileptic drugs, like carbamazepine and
      valproate, are very effective in therapy of migraine and trigeminal neuralgia - more than in
      80% of cases. If bronchial asthma also is paroxysmal inflammatory disease, like migraine and
      trigeminal neuralgia, it is possible that some antiepileptic drugs also are very effective in
      asthma therapy.

      We performed a double-blind, placebo-controlled 3-month trial for evaluation of sodium
      valproate efficacy in therapy of bronchial asthma. Sodium Valproate is antiepileptic drug of
      new generation, initially produced by Sanofi Pharma. Comparison: Patients received
      investigational drug in addition to their usual routine antiasthmatic treatment, compared to
      patients received placebo in addition to their usual routine antiasthmatic treatment.
    

Intervention name(s): Sodium Valproate
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bronchial asthma; Sodium valproate; Antiepileptic drug; Efficacy