bioihbjkbjnl/mcl2 huggingface dataset:
Trans-spinal Direct Current Stimulation in Primary Orthostatic Tremor
Condition: Primary Orthostatic Tremor
MeSH terms: Tremor
Study type: Interventional

Summary: 
      To explore the effect of cathodal tsDCS vs sham tsDCS in primary orthostatic tremor. The
      investigators hypothesize that cathodal tsDCS but not sham tsDCS would be able to restore
      both motor and sensory pathways of the spinal cord leading to functional improvements.
    

Detailed description: 
      Regain of function and improvement of motor skills is a major challenge in motor disorders in
      which spinal cord functions play a key role. The growing development of non-invasive brain
      stimulations in the past decade led to significant progress in the understanding of neuronal
      abnormalities in patients with movement disorders that opens up new vistas for experimental
      treatments. However, these treatments are currently limited due to their high cost and lack
      of possibility to use in outpatients. Recently, trans-spinal direct current stimulation
      (tsDCS) has emerged as a novel tool to modulate non-invasively spinal cord excitability. This
      may be an excellent alternative to epidural stimulation, the sole technique available up to
      now to alter spinal functions in an invasive fashion. The overall goal of this study is to
      assess the potential of tsDCS to restore spinal cord functions in patients with primary
      orthostatic tremor (POT), a disorder with little or no current therapeutic resources and high
      disability for patients.

      Using a crossover, randomized, double-blinded approach, cathodal (2mA, 20 min) or sham tsDCS
      (with the active electrodes over the thoracic level and the reference electrode on the right
      shoulder) will be delivered to 15 patients with POT. The maximal time in upright position
      determined by a force platform, the cortical excitability assessed by transcranial magnetic
      stimulation (input / output curve of the tibialis anterior muscle and short-latency afferent
      inhibition) and EMG activities of lower extremity muscles will be measured before (PRE),
      immediately and 30 minutes after current offset (POST0 and POST30 respectively). Cathodal and
      sham tsDCS will be delivered in two different sessions with a washout period of at least 7
      days. The investigators anticipate that cathodal tsDCS but not sham tsDCS will be able to
      modulate both sensory and motor functions in POT and will, in turn, lead to functional
      improvement.
    

Intervention name(s): tsDCS
Intervention type(s): Device
Intervention description(s): 20 min of treatment applied at the thoracic level (active electrode) with reference placed on the right shoulder
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: spinal cord; tsDCS; 3D motion capture; EMG
Quality Control of CE-Certified Phonak Hearing Aids - Sonova2018_05
Condition: Hearing Loss, Sensorineural
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      Phonak Hearing Systems pass through different development and study stages. At an early
      stage, feasibility studies are conducted to investigate new algorithms, features and
      functions in an isolated manner. If the benefit is proven, their performance is then
      investigated regarding interdependency between all available algorithms, features and
      functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a
      result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing
      Systems undergo a final quality control in terms of clinical trials. This is a validation
      study, investigating optimized algorithms, features, functions and wearing comfort. This will
      be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based
      in Stäfa (Switzerland).
    

Detailed description: 
      In this study a comparison with a CE-labeled Phonak Receiver-in-the-canal (RIC) device
      (active comparator) and two CE-labeled competitor devices (RIC) is done. All study devices
      contain direct connectivity functionality which will be compared in terms of streamed Audio
      quality, streaming stability and Usability preferences of all available functions and
      features. This will be a clinical evaluation which will be conducted mono centric at Sonova
      AG Headquarters based in Stäfa (Switzerland).
    

Intervention name(s): Phonak Audéo B90-Direct; HearingAid_A; HearingAid_B
Intervention type(s): Device; Device; Device
Intervention description(s): The Phonak Audéo B90-Direct is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss.; HearingAid_A is the most recent Receiver-in-the-canal Hearing aid from manufacturer_A which will be fitted to the participants individual Hearing loss.; HearingAid_B is the most recent Receiver-in-the-canal Hearing aid from manufacturer_B which will be fitted to the participants individual Hearing loss.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of GSK2646264 in Cutaneous Lupus Erythematosus Subjects
Condition: Lupus Erythematosus, Cutaneous
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to examine safety, tolerability, pharmacokinetics, pharmacodynamics
      and clinical effect of repeat dosing of GSK2646264 in patients with subacute and chronic
      cutaneous lupus erythematosus (CLE) lesions and in acute CLE like lesions induced by
      photoprovocation (PV).

      Current study is two group study. In Group A, Patients with fewer than two active lesions
      will be enrolled and exposed to photoprovocation (PV) for 3 consecutive days. Patients that
      develop PV lesions at any time during this period, as determined by the local investigative
      team, will receive 1% strength GSK2646264 on 1 lesion and placebo on 1 lesion daily and
      either 1% strength GSK2646264 or placebo on an area of uninvolved skin, for skin
      pharmacokinetic (PK) of study drug, for 28 days.

      In Group B, Patients that have a minimum of 2 active existing CLE lesions as determined by
      the investigators will be enrolled into group B and have one lesion treated with 1%
      GSK2646264 and 1 lesion with placebo.

      A completed patient will be defined as a subject who receives at least 25 days of study drug
      and completes the end of treatment biopsy (at day 28) and assessment. Thereafter patients
      will be followed for 28 days in Group A only or until complete resolution of induced PV
      lesions, as determined by the investigator.
    


Intervention name(s): GSK2646264 1%; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A cream for topical application with a concentration of 1% GSK2646264.; Subjects will receive matching Placebo topically.
Intervention MeSH terms: GSK2646264
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cutaneous Lupus Erythematosus-CLE; Spleen Tyrosine Kinase-SYK; Photoprovocation-PV; GSK2646264
Effects of Red Bull® on the Effects of Training and Haemodynamic Parameters
Condition: Effects of; Food, Allergic
Study type: Interventional

Summary: 
      Background:

      The consumption of Energy Drinks (EDs) can acutely lead to negative side effects, such as
      raised blood pressure and impaired endothelial function. Nevertheless, they are sold
      worldwide and are often consumed before physical activity (PA). In contrast to the blood
      pressure elevating effect of EDs, PA leads to a reduction of blood pressure. The effect of ED
      consumption on blood pressure response during and after endurance training is currently
      unresolved.

      Methods:

      A total of 23 participants (eleven men, twelve women) were evaluated in the intervention
      study with a blinded Cross-Over Design. They consumed on two different days either 355 ml Red
      Bull (RB) or 355 ml Placebo (Pla) in randomised order. The peripheral (PBP) and central blood
      pressure (CBP) were measured before, during and after a 30-minute aerobic endurance training,
      by the Schiller BR-102 plus PWA device.
    

Detailed description: 
      Background:

      The consumption of Energy Drinks (EDs) can acutely lead to negative side effects, such as
      raised blood pressure and impaired endothelial function. Nevertheless, they are sold
      worldwide and are often consumed before physical activity (PA). In contrast to the blood
      pressure elevating effect of EDs, PA leads to a reduction of blood pressure. The effect of ED
      consumption on blood pressure response during and after endurance training is currently
      unresolved.

      Methods:

      A total of 23 participants (eleven men, twelve women) were evaluated in the intervention
      study with a blinded Cross-Over Design. They consumed on two different days either 355 ml Red
      Bull (RB) or 355 ml Placebo (Pla) in randomised order. The peripheral (PBP) and central blood
      pressure (CBP) were measured before, during and after a 30-minute aerobic endurance training,
      by the Schiller BR-102 plus PWA device.
    

Intervention name(s): Red Bull
Intervention type(s): Dietary Supplement
Intervention description(s): Drinking of Red Bull before exercise
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Myorelaxant Effect of Bee Venom(BV) Topical Skin Application in Patients With RDC/TMD Ia and Ib
Condition: Other Disorders of Muscle in Diseases Classified Elsewhere
MeSH terms: Muscular Diseases
Study type: Interventional

Summary: 
      Topical application of BV ointment in patients with Research Diagnostic
      Criteria/Temporomandibular Disorder 1a and 1b (RDC/TMD) in experimental group, compared to
      placebo (vaseline) in control group.Application was repeated 3 times a day, during 14 days.
      Surface electromyography (EMG) was used to measure masseter rest tonus and maximal voluntary
      contraction tonus. Pain intensity was also analysed in VAS scale. Effectiveness of BV was
      compared with placebo in masseter myofascial pain in patients with TMD
    

Detailed description: 
      The aim of the study was evaluation of myorelaxant action of bee venom(BV) ointment,
      comparing to placebo.Parallel group, randomized double blinded trial was performed, including
      79 patients with painful RDC/TMD 1a and 1b. Muscle tension was measured twice (TON1 and TON2)
      in rest muscle tonus (RMT) and maximal muscle contraction (MMC) on both sides right and left,
      with Easy Train Myo EMG (Version 3.1). Pain intensity was also analysed in VAS scale
    

Intervention name(s): Bee Venom Ointment; Vaseline Ointment
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 2 weeks; 2 weeks
Intervention MeSH terms: Petrolatum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: TMD; bee venom; muscle tension; muscle pain
Opioid Sparing Effect of Thoracic Epidural Analgesia for Open Upper Abdominal Surgery
Condition: Hepatoma; Pancreas Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional

Summary: 
      This prospective randomized controlled study is aimed to determine the advantages of thoracic
      epidural analgesia for open upper abdominal surgery in combination with multimodal analgesia
      compared with no thoracic epidural analgesia on postoperative pain control. The primary
      outcome is total opioid consumption in postoperative 72 hours. Secondary outcomes are the
      success of continuous epidural analgesia or complications of this technique, pain intensity,
      morbidity and mortality compare to no continuous epidural analgesia.
    

Detailed description: 
      Continuous epidural analgesia (CEA) for open upper abdominal surgery has been showed the
      analgesic analgesia for open abdominal surgery. However the technical difficulty,
      complications especially hypotension, pruritus of CEA impede the popularity of technique
      compared to intravenous patient-controlled analgesia (IV PCA) in multimodal analgesia. This
      study is aimed to study of the role of CEA and multimodal analgesia in open abdominal surgery
      compare to IV PCA.
    

Intervention name(s): Thoracic continuous epidural analgesia
Intervention type(s): Procedure
Intervention description(s): Continuous epidural catheter (Portex ™, Epidural Minipack , Smiths Medical), infused with 0.0625% bupivacaine (Marcaine™, Aspen Holdings) with morphine (morphine M&H™) 0.02 mg/ml 5 ml/h postoperative until POD3 morning Connected with The Sapphire ™ Infusion System Patient-Controlled-Analgesia (PCA) pump(fentanyl (fentanyl-Hameln™, Siam Bioscience): intravenous bolus mode only 15 ug/bolus, lockout interval 5 minutes, 4-hour limit 200 ug)
Postoprative analgesia: intravenous paracetamol (infulgan ™, Yuria-Pharm), tablet paracetamol (SaRa ™), Parecoxib (Dynastat ™, Pfizer), Etoricoxib (Arcoxia ™, MSD)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A: continuous epidural analgesia, Group B: no continuous epidural analsesia
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: open upper abdominal surgery; continuous epidural analgesia
Hydrocephalus iPad-App Based Intervention Study
Condition: Hydrocephalus; Hydrocephaly; Hydrocephalus in Children
MeSH terms: Hydrocephalus
Study type: Interventional

Summary: 
      This is a pilot study examining the feasibility and efficacy of using Apple iPad applications
      ("apps") during therapy interventions that target visual motor, visual attention, and
      visual-spatial reasoning skills in school age children who were previously treated surgically
      for hydrocephalus. Each subject will participate in an initial assessment and baseline MRI,
      followed by 6-weeks of iPad app-based interventions, and finally a follow-up assessment and a
      follow-up MRI.
    

Detailed description: 
      Long term visuospatial and visuomotor functional deficits are common in pediatric patients
      with surgically treated hydrocephalus. The deficits are often mild/moderate at early school
      age although the gap may widen as the children grow older, leading to increasing adverse
      impact on school performance and academic achievement. The proposed study will generate
      initial pilot data for the usage of iPad application based therapy intervention for the
      treatment of cognitive deficits common to pediatric hydrocephalus. It will help determine the
      optimal intensity and duration of training protocol adapted for the study. In addition, the
      sensitivity of neuroimaging (DTI) in response to the therapy will be assessed and validated
      as a biomarker that reflects the neuroanatomical alterations underpinning the outcome
      changes. This study will generate the crucial data to support the design of future Phase III
      clinical trial with the long term goal as changing the current standard of care in order to
      prevent neurocognitive and sensorimotor deficits before the injury to neural circuitry
      becomes irreversible.

      The participants who meet the inclusion criteria and do not opt-out of participation will be
      called by a study coordinator to ensure eligibility and to schedule the initial assessment
      date. Participation in this study will include 8-10 study visits. These visits include 2
      neuropsychological assessments, 2 MRI visits, and 6 weekly visits during intervention phase.
      MRI visit can be combined with the neuropsychological assessment visit if possible at both
      the pre- and post intervention time points.
    

Intervention name(s): iPad app-based intervention
Intervention type(s): Device
Intervention description(s): The 1-hour of home based intervention will break into three 20-min sessions, each including iPad apps targeting one of the three domains of deficits: visual attention, visual-spatial reasoning, and visual-motor skills.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Web Based Cardiac Rehabilitation Support in Coronary Artery Patients
Condition: Cardiac Rehabilitation; Healthy Lifestyle; Medication Adherence; Quality of Life; Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      This study was carried out as a randomized controlled experimental study to evaluate the
      effect of web-based cardiac rehabilitation support on the healthy lifestyle behaviors,
      medication adherence and quality of life in coronary heart patients.
    

Detailed description: 
      Hypothesis 1:

      H0: Web-based cardiac rehabilitation support has no effect on increasing the healthy
      lifestyle behaviors of patients with coronary artery disease.

      H1: Web-based cardiac rehabilitation support has an effect on increasing the healthy
      lifestyle behaviors of patients with coronary artery disease.

      Hypothesis 2:

      H0: Web-based cardiac rehabilitation support in patients with coronary artery disease has no
      effect on increasing the compliance of patients to drug therapy.

      H1: Web-based cardiac rehabilitation support in patients with coronary artery disease has an
      effect on increasing the compliance of patients to drug therapy.

      Hypothesis 3:

      H0: Web-based cardiac rehabilitation support has no effect on improving the quality of life
      of patients with coronary artery disease.

      H1: Web-based cardiac rehabilitation support has an effect on improving the quality of life
      of patients with coronary artery disease.
    

Intervention name(s): cardiac rehabilitation support program
Intervention type(s): Other
Intervention description(s): First of all, a preliminary interview was made with the patients in the experimental group, and their information needs were evaluated individually. Which trainings he should receive and his priorities were determined with the patient. After the training requirements were determined, the general introduction of the website was made and they were allowed to register. Experimental group patients received both training on the website and counseling over the phone for 12 weeks after they started working. A total of 3 phone calls were made with the patients in the first week, 4th and 8th weeks. The interviews lasted an average of 20 minutes. In each phone call, patients were informed and reminded. When patients needed, an average of 2-3 more phone calls were made and information was provided on the subjects they needed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Strawberries on Cardiovascular Disease Risk
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      It is important to identify and evaluate foods, such as strawberries, that can improve
      established and emerging cardiovascular risk factors, such as postprandial lipid and glycemic
      responses, and vascular health. Postprandial derangements may affect multiple metabolic
      pathways that lead to increased arterial stiffness. Research has demonstrated the potential
      of strawberries to ameliorate postprandial responses to a high fat/high glucose meal. Further
      research is needed to demonstrate this effect in better controlled clinical studies and
      explore whether metabolic effects lead to improved arterial health.

      The investigators propose to examine the effects of adding 40 g of freeze-dried strawberry
      powder to a high fat/high glucose meal on postprandial cardiovascular risk factor including
      lipids, insulin, glucose, and arterial stiffness and central blood pressure. The
      investigators hypothesize that the bioactive components of strawberry powder will attenuate
      postprandial lipemic and glycemic responses, as well as improve measures of arterial health.
    


Intervention name(s): Strawberry Meal; Control Meal
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): High-fat meal (50 g total fat) with 40 g freeze dried strawberry powder; High-fat meal (50 g total fat) with a matched placebo powder containing no strawberry bioactives
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Investigator Initiated Protocol for the: Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion and the Establishment of Normative Data in Youth and Adolescents Athletes
Condition: Normative; Concussed
Study type: Observational

Summary: 
      This study's objectives are:

        -  To prospectively examine changes in brain network activation (BNA™) from baseline to
           recovery (i.e., return to activity) in youth and adolescent athletes with concussion.

        -  To assess the clinical utility of changes in BNA to assist in clinical decision-making.

        -  To generate normative BNA data.
    

Detailed description: 
      Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing
      changes in brain activity associated with concussion. Event Related Potentials (ERPs), which
      are temporal reflections of the neural mass electrical activity of cells in specific regions
      of the brain that occur in response to stimuli, may offer such a method, as they provide both
      a noninvasive and portable measure of brain function. The ERPs provide excellent temporal
      information, but spatial resolution for ERPs has traditionally been limited. However, by
      using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is
      improved significantly. The paradigm for the current study will combine neurophysiological
      knowledge with mathematical signal processing and pattern recognition methods (BNA™) to
      temporally and spatially map brain function, connectivity and synchronization.

      The proposed study will provide additional evidence for the utility and contribution of the
      BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain
      functional connectivity associated with concussion) in concussion management.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        male and female athletes