bioihbjkbjnl/mcl2 huggingface dataset:
Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Observational

Summary: 
      The aims of this study explore the relationships between cerebral vasospasm, apolipoprotein-E
      (apo-E) genotype, physiologic symptoms, and neurocognitive outcomes that may either intensify
      or ameliorate secondary injury, for children with a traumatic brain injury. Exploring the
      apo-E genotype will help us know if injury response is altered in certain children and will
      aid in developing interventional approaches.
    

Detailed description: 
      The purpose of this study is to advance knowledge of neurocognitive outcomes in pediatric
      traumatic brain injury (TBI) patients by exploring the relationships between physiologic
      factors of cerebral vasospasm, apolipoprotein E (apo-E) allele, biomarkers, and
      neurocognitive outcomes. This study is a funded project within Duke University School of
      Nursing National Institutes of Health/National Institute of Nursing Research (NIH/NINR) P30
      Center of Excellence Grant. This study will continue on with some of the work of a small
      intramural grant study determining the feasibility of conducting pediatric TBI research at
      DUHS. It will advance the measurement of vasospasm by translating the use of the Transcranial
      Doppler (TCD) ultrasound to neuromonitoring in children. To date, this will be the first
      pediatric study examining the relationship of cerebral vasospasm, apo-E, and biomarkers with
      neurocognitive outcomes. Unlike adult TBI patients, cerebral vasospasm, apo-E, and biomarker
      collections have yet to be examined in pediatric neurotrauma patients in the Duke University
      Health System. Although neurocognitive outcomes are a standard of care for TBI patients at
      Duke University Health System (DUHS), the data has yet to be examined within the realm of
      pediatric neurodiagnostic physiologic measures. By obtaining preliminary data in 35 patients,
      it will allow for the evaluation of multi-diagnostic measures in pediatric TBI patients, as
      well as provide data for future funding for a larger regionally-scale study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children
      
Biospecimen description: 
      Apolipoprotein E (apo-E) genotype/SNPs Endothelin 1 genotype/SNPs
    
Keywords: Pediatric; Traumatic Brain Injury; TBI; Apolipoprotein E; apo-E; Vasospasm; Genetics; Physiologic Mechanisms; Neurocognitive Outcomes; Endothelin 1
Effect of Different Skin Creams on TEWL
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Prospective, single center, clinical pilot study to test the hypothesis that lipid rich
      EpiCeram® is superior in improving skin barrier function compared to Aveeno Daily
      Moisturising Sheer Hydration Lotion®.
    

Detailed description: 
      Prospective, single center, clinical pilot study to test the hypothesis that lipid rich
      EpiCeram® is superior in improving skin barrier function compared to Aveeno Daily
      Moisturising Sheer Hydration Lotion®.

      Primary Objective: To compare skin barrier function, assessed by TEWL AUC, between
      non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer
      Hydration Lotion® or no emollient use for one week.

      Secondary Objectives: To assess lipid and protein profiles of skin tape strips from
      non-lesional skin, after a week of either EpiCeram®, Aveeno Daily Moisturising Sheer
      Hydration Lotion® or no treatment.

      Exploratory Objectives :

        -  To study whether the effects on TEWL on lesional and non-lesional skin persist 24 hours
           after cessation of therapy.

        -  To evaluate whether baseline food and environmental allergy sensitization (assessed via
           skin prick testing during screening) affects the outcomes. See protocol section 3.1 for
           allergen details.

        -  A central repository of blood samples will be stored for future use to assess plasma
           biomarkers to help characterize clinical outcome data.
    

Intervention name(s): EpiCeram; Aveeno Daily Moisturising Sheer Hydration Lotion®
Intervention type(s): Drug; Drug
Intervention description(s): To compare skin barrier function, assessed by TEWL AUC, between non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion®, and no emollient use over a period of one week.; To compare skin barrier function, assessed by TEWL AUC, between non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion®, and no emollient use over a period of one week.
Intervention MeSH terms: Decanoic acid
Intervention model: Single Group Assignment
Intervention model description: Prospective, single center, clinical pilot study to test the hypothesis that lipid rich EpiCeram® is superior in improving skin barrier function compared to Aveeno Daily Moisturising Sheer Hydration Lotion®.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dermatitis; emollient; Atopic Dermatitis
Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet as Well as Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets Under Fasting Conditions.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and
      assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under
      fasting conditions.
    


Intervention name(s): Empagliflozin; Empagliflozin; Empagliflozin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): high dose of empagliflozin after overnight fasting for at least 10 h; low dose empagliflozin after overnight fasting for at least 10 h; high dose of empagliflozin after a standardised high fat breakfast
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to confirm the efficacy of a single oral 900mg dose of
      nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer
      (ET) day.
    

Detailed description: 
      The study is a prospective, randomized, parallel group, double-blind, placebo-controlled
      study to confirm the efficacy and the safety of the oxytocin receptor antagonist, nolasiban,
      in 760 women undergoing fresh embryo transfer following in vitro fertilisation (IVF) or
      intra-cytoplasmic sperm injection (ICSI).
    

Intervention name(s): Nolasiban 900mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Nolasiban dispersible tablets for single oral administration; Placebo dispersible tablets for single oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IVF; ICSI
Immediate Effect Of Whole-Body Vibration And Walk in Osteoporosis/Osteopenia
Condition: Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      Introduction: Osteoporosis and Osteopenia are common bone disorders, characterized by low
      bone mass, signs of bone deterioration and are responsible for typical bone fragility.
      Physical activity is certainly a valid prevention tool because it contributes to a healthy
      energy balance, increasing muscle mass and providing beneficial effects in bone metabolism.
      Stress induced by more vigorous activities such as weight lifting, increases the risk of
      injury, particularly in the elderly. Therefore, alternative strategies with lower risk of
      injury are indicated such as whole body vibration and walk.

      Objective: Compare the effect whole body vibration and walking on muscular strength, balance
      and functional performance in the elderly with Osteoporosis and Osteopenia

      Methods: It is a clinical trial study, controlled, parallel, randomized and blind, which will
      follow the guidelines established in the Consolidated Standards of Reporting Trials
      (CONSORT). Participants will be randomly distributed in 2 groups: the experimental group (GI)
      that will hold the training in the vibrating platform and the control group (GC) that will
      perform the walk, settling 1 treatment session. All participants will be subjected to the
      initial and final assessment.
    


Intervention name(s): Training in the vibrating platform; Walk
Intervention type(s): Other; Other
Intervention description(s): 20-minute workout will be held, which will include: heating (5 minutes and stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling.; Will be held 30 minutes of training, which will include the heating (5 minutes of stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups: The experimental group (GI) that will hold the training in the vibrating platform and the control group (GC) that will perform the walk, settling 1 treatment session.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Osteoporosis; Muscle Strength; Postural Balance; Vibration; Walking
Epidural Neuroplasty for the Treatment of Herniated Lumbar Disk
Condition: Herniated Lumbar Disc
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether epidural neuroplasty has better efficacy
      than epidural steroid injection for the treatment of lumbar disc herniation.
    

Detailed description: 
      One hundred patients diagnosed as herniated lumbar disc will be recruited and divided into
      two groups. One group will be treated with Transforaminal steroid injection, the other with
      epidural neuroplasty. The VAS and ODI scores obtained at one month, three months and six
      months post-treatment will be analysed statistically.
    

Intervention name(s): Mechanical epidural neuroplasty; Transforaminal epidural compound betamethasone injection; Caudal epidural compound betamethasone injection; Epidural hyaluronidase injection
Intervention type(s): Device; Drug; Drug; Drug
Intervention description(s): Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented.; Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected.; steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty.; Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Herniated lumbar disc; Epidural neuroplasty; Epidural injection
Cortical Neuroplasticity by Muscle Pain of Pain-induced Plasticity
Condition: Nerve Growth Factor; Exercise; Motor Activity; Abnormality of SSEPs; Hyperalgesia
MeSH terms: Myalgia; Hyperalgesia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the sensory-motor cortical excitability response
      to delayed onset muscle soreness (DOMS) on Extensor Carpi Radialis (ECR) muscle during muscle
      hyperalgesia provoked by nerve growth factor (NGF).
    

Detailed description: 
      The purpose of this study is to assess changes in sensory-motor cortical excitability during
      experimental muscle hyperalgesia across several days provoked by injections of nerve growth
      factor (NGF) into the Extensor Carpi Radialis (ECR) muscle and delayed onset muscle soreness
      (DOMS) of the ECR muscle.

      It was hypothesized that muscle hyperalgesia across several days would result in:

      i) Increased sensory cortical excitability, based on somatosensory evoked potentials by means
      of electrical stimulation of the radial nerve, (increase of central-parietal evoked-potential
      P45 and decrease of frontal evoked-potential N30); ii) Increased corticomotor excitability of
      a ECR (increase map volume and number of active sites), assessed as motor evoked potentials
      induced by transcranial magnetic stimulation in primary motor cortex (M1); iii) Reduction of
      alpha oscillation based on nociceptive stimulus-evoked suppression of alpha activity in
      sensory regions (recording electrodes on contra-lateral parietal area);
    

Intervention name(s): Sterile solutions of recombinant human nerve growth factor (NGF)
Intervention type(s): Drug
Intervention description(s): The intramuscular injections of NGF cause muscle soreness.
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Virtual Reality Versus Proprioceptive Neuromuscular Facilitation on Postmastectomy Lymphedema
Condition: Postmastectomy Lymphedema
MeSH terms: Lymphedema; Breast Cancer Lymphedema
Study type: Interventional

Summary: 
      This study aimed to compare the therapeutic efficacy of VR and PNF on lymphedema and function
      in unilateral post-mastectomy lymphedema (UPML) patients. The patients were subdivided into
      two equal groups, 15 in each. Fifteen patients performed virtual reality-based exercises plus
      complete decongestive therapy, while the other fifteen patients performed proprioceptive
      neuromuscular facilitation plus complete decongestive therapy. The volume difference between
      normal and affected limbs was calculated before and after eight sessions of treatment for
      both groups by using the circumferential method. And the upper limb function was assessed
      before and after eight sessions of treatment for both groups by using the Arabic version of
      the Quick DASH scale.
    


Intervention name(s): virtual reality; proprioceptive neuromuscular facilitation; complete decogestive therapy
Intervention type(s): Other; Other; Other
Intervention description(s): wii video game based exercise; PNF with breathing; pneumatic compression, manual lymph drainage, skin care and home exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Online Learning of Veterinary Anatomy During COVID-19 Pandemic
Condition: COVID-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      This study aims to analyze the online learning of veterinary anatomy during COVID-19 pandemic
      lockdown.
    

Detailed description: 
      Analysis of the online learning of veterinary anatomy during COVID-19 pandemic lockdown.
    

Intervention name(s): survey
Intervention type(s): Other
Intervention description(s): online survey
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Veterinary Medical students who are studying anatomy online during the pandemic lockdown
      
Keywords: COVID-19; Anatomy; online learning
Effect of Totum-070 on Lipid Metabolism in Moderate Hypercholesterolemic Subjects
Condition: Hypercholesterolemia; Cardiovascular Risk Factor; Dyslipidemias; Overweight and Obesity; Atherosclerosis
MeSH terms: Atherosclerosis; Overweight; Hypercholesterolemia; Dyslipidemias
Study type: Interventional

Summary: 
      This clinical study aims to assess the efficacy of TOTUM-070, a mix of 5 plant extracts, on
      lipid metabolism in moderate hypercholesterolemic subjects. The hypothesis is that TOTUM-070,
      daily consumed, is superior to placebo for decrease of fasting blood LDL-cholesterol
      concentration (determined by ultracentrifugation method) after 24 weeks of consumption.
    


Intervention name(s): TOTUM-070; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 5-g dose of TOTUM-070 diet supplement, a mix of 5 plant extracts. Eight capsules per day to consume orally in two intakes; Placebo. Eight capsules per day to consume orally in two intakes
Other intervention name(s): Active product; Comparator product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Moderate Hypercholesterolemia; Dyslipidemia; Overweight; Obesity; Cardiovascular Risk Factor; Nutrition Healthcare; Plant Extracts; Metabolic diseases; Atherosclerosis; Hygiene and dietary recommendations
Results of a Program of Newborn Hearing Screening (NHS) in Cuiaba-Brazil
Condition: Showing the Results of a Program of NHS in Cuiaba_ Brazil
Study type: Observational

Summary: 
      The study aims to demonstrate the indices of quality of a Newborn Hearing Screening (NHS).
    

Detailed description: 
      The data refer to infants underwent newborn hearing screening by evoked otoacoustic emissions
      by transient stimulation, using the analyzer EOA Biologic. Examinations archived in the
      computer's service were analyzed for the amount of infants who passed or failed the
      screening, as well as the correlations with the same age and gender.
    

Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        There were two groups:

          1. high risk for hearing loss

          2. low risk for hearing loss
      
Keywords: hearing, newborn, screening
A Study of Blood-stage Controlled Human Plasmodium Falciparum Malaria Infection in Tanzania
Condition: Malaria; Plasmodium Falciparum
MeSH terms: Malaria
Study type: Interventional

Summary: 
      This will be a single-centre, open label trial to determine the safety and feasibility of
      CHMI model using Plasmodium falciparum-infected cryopreserved erythrocytes administered to
      healthy Tanzanian adults with varying prior exposure to P. falciparum.
    

Detailed description: 
      This study will be a single-centre controlled human malaria infection study using adults with
      varying degrees of prior exposure to P. falciparum. The study will take place at Bagamoyo
      Clinical Trail Facility of the Ifakara Health Institute, located in Bagamoyo town (about 60
      km north of Dar es Salaam).

      Twelve healthy male adults aged 18 to 35 years will be recruited into two cohorts of high and
      low previous exposure consisting of 6 volunteers each as determined by anti-schizont antibody
      levels. Up to 5 back-up volunteers will be also be recruited and may take the place of
      another volunteer should they withdraw or become ineligible prior to challenge.

      Participants will be infected via IV administration of Plasmodium falciparum-infected human
      erythrocytes of the chloroquine-susceptible 3D7 strain. Participants will then be closely
      monitored in a clinical trial facility for a maximum of 31 (28 days plus 3 days of treatment
      with anti-malarial drugs) days while undergoing frequent clinical and laboratory assessment.
      Volunteers who do not reach malaria treatment criteria as per protocol at day 28 (C+28) will
      be treated presumptively with antimalarial medications (ALU + a single low dose primaquine)
      under direct observation and will be discharged upon completion of treatment and on
      discretion of the study clinician.

      Identifying data will not be included on any trial documentation (other than signed consent)
      and participants will be referred to by the trial study ID number. The study will be funded
      primarily by EDCTP grant supporting the evaluation of Multi-Stage Malaria Vaccine.
    

Intervention name(s): P. falciparum infected erythrocytes
Intervention type(s): Biological
Intervention description(s): Chloroquine sensitive P. falciparum 3D7-infected red blood cells, thawed and prepared under strict aseptic conditions, will be used as a challenge agent.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Malaria Challenge; Controlled Human Malaria Challenge
Safety and Pharmacokinetic Interaction Study of Tadalafil and Dutasteride
Condition: Benign Prostate Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, two-arm, one-sequence, cross-over study to evaluate the safety and
      pharmacokinetic interaction after oral concomitant administration of tadalafil and
      dutasteride in healthy male volunteers.
    


Intervention name(s): Tadalafil; Dutasteride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tadalafil; Dutasteride
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)