bioihbjkbjnl/mcl2 huggingface dataset:
Which Parameters of Short-term Blood Pressure Variability Best Predict Early Outcomes in Acute Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Observational

Summary: 
      Previous studies on the association between blood pressure variation (BPV) in acute ischemic
      stroke and functional outcomes yield conflicting result. The obscured definition and
      measurement of BPV engenders considerable confounding factors, making it difficult to
      interpret. We aim to investigate the predictive role of 24-hour BPV on early outcomes in
      acute non-cardiogenic ischemic stroke.
    

Detailed description: 
      This is a perspective registered cohort study. Patients with acute non-cardiogenic ischemic
      stroke are included into the study. During the first 24 hours after admission, the 24 hours
      blood pressure monitoring is to be taken and used to calculate various parameters of
      hour-to-hour blood pressure variability, including standard deviation(SD), coefficient of
      variation (CV), variation independent of mean(VIM) and average real variability (ARV) of
      systolic blood pressure (SBP) and diastolic blood pressure (DBP). The demographic and
      clinical data are also recorded. This is an observational sturdy, thus the caring physician
      make clinical decisions according to individual patient's condition. The endpoints are
      defined as early neurological deterioration, functional outcome(modified Rankin scale<3 as
      good outcome) at discharge and 3 months.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        acute ischemic stroke patients with 72 hour after onset
      
Biospecimen description: 
      fasting glucose, creatine, BNP, CRP,BUN,cholesterol, LDL,HDL
    
Keywords: stroke, blood pressure, prognosis
Study to Assess VB-201 in Patients With Psoriasis
Condition: Active Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the efficacy, safety and tolerability of VB-201 as
      compared with placebo on measures of disease activity in patients with psoriasis.
    


Intervention name(s): VB-201; VB-201; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Single daily dose of oral VB-201 20 mg; Single daily dose or oral VB-201 80 mg; Single daily dose of oral placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis
A Double-blind Randomized Clinical Trial on the Efficacy of Magnetic Sacral Roots Stimulation for the Treatment of NE
Condition: Nocturnal Enuresis
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of daily sacral root magnetic stimulation
      for 10 sessions in patients with nocturnal enuresis.Eligible patients were randomized to
      receive either real or sham repetitive sacral root magnetic stimulation (rSMS; 15 Hz with a
      total of 1500 pulses/session) for 10 sessions. Evaluation was performed before starting
      treatment, immediately after the 5th and 10th treatment session, and 1 month later, using
      frequency of enuresis/week, visual analogue scale (VAS) and Quality of life. Cortical
      excitability of upper and lower limbs were done before and after the end of sessions.
    

Detailed description: 
      The purpose of this study is to assess the efficacy of daily sacral root magnetic stimulation
      for 10 sessions in patients with nocturnal enuresis. Eligible patients were randomized to
      receive either real or sham repetitive sacral root magnetic stimulation (rSMS; 15 Hz with a
      total of 1500 pulses/session) for 10 sessions. Evaluation was performed before starting
      treatment, immediately after the 5th and 10th treatment session, and 1 month later, using
      frequency of enuresis/week, visual analogue scale (VAS) and Quality of life. Cortical
      excitability of upper and lower limbs were done before and after the end of sessions.
    

Intervention name(s): rSMS in treatment of Nocturnal Enuresis
Intervention type(s): Device
Intervention description(s): Real rSMS (15 Hz at 50% of maximum stimulator output (10 seconds on and 30 seconds off) with a total of 1500 pulses and the hand of the coil upword. The stimulation was repeated for 10 sessions, 5 sessions per week and 2 days off. Sham rSMS received stimulation using the same coil, the same session frequency, in the same setting, but the coil was tilted 90.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Bioavailability Study of LY2452473 and Tadalafil
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compares LY2452473 taken orally as a 5 milligram (mg) capsule at the same time as
      a 5 mg tadalafil tablet with three different combination tablets (LY900010) of 5 mg LY2452473
      and 5 mg tadalafil taken orally. The study will evaluate the amount of LY2452473 and
      tadalafil circulating in the blood for each treatment. Side effects will be documented. This
      study is approximately 34 days not including screening.
    


Intervention name(s): LY2452473; Tadalafil; LY900010
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Other intervention name(s): LY450190; Cialis
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: testosterone; energy; libido; erectile function; weak muscles
Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment
Condition: Insomnia Chronic
MeSH terms: Dementia; Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The longstanding view has been that insomnia, and other forms of sleep disturbance, emerge as
      a consequence of dementia and are the result of progressive neuronal damage. However, there
      is growing evidence that the direction of causation may go both ways, with sleep disturbance
      potentially increasing vulnerability to dementia. Longitudinal studies have found that sleep
      disturbance often precedes and increases risk for dementia by several years. The purpose of
      this study is to examine whether treatment of insomnia with cognitive behavioral therapy
      (CBT-I) is associated with a decrease in dementia biomarkers found in cerebrospinal fluid
      (CSF). Fifteen adults age 30-50 with chronic insomnia will undergo overnight polysomnography
      and CSF sampling in the morning. This will be followed by 8 weeks of treatment with CBT-I and
      then repeat CSF sampling.
    


Intervention name(s): cognitive behavioral treatment of insomnia
Intervention type(s): Behavioral
Intervention description(s): A behavioral modification program consisting of 8 clinic sessions focused on sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis
Condition: Mild to Moderately Active Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      Green tea consists of several components, with most research focusing on the polyphenol
      fraction. The polyphenol fraction(-)-epigallocatechin-3-gallate (EGCG)has been studied
      extensively as an anti-inflammatory agent as well as a preventative agent for cancer. It has
      been shown to effectively reduce the inflammation associated with animal models of
      inflammatory bowel disease. This clinical trial will determine the ability of EGCG, in the
      form of Polyphenon E®, to treat patients with mild to moderately severe ulcerative colitis.
    


Intervention name(s): Polyphenon E®; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsules; Oral tablet: placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulcerative colitis; EGCG; Green tea polyphenols; Inflammatory bowel disease; Colitis; IBD; Green tea
Effect of Prewarming During Induction of General Anesthesia Combined With Warmed Intravenous Fluid on Core Temperature.
Condition: Urologic Diseases
MeSH terms: Urologic Diseases
Study type: Interventional

Summary: 
      Hypothermia occurs frequently during general anesthesia. This study is to evaluate the
      efficacy of 10 minutes of prewarming during induction of general anesthesia during urologic
      surgery.
    

Detailed description: 
      Hypothermia is of continuous issue in patients undergoing general anesthesia. During urologic
      operation (transurethral resection of bladder and prostate), bladder irrigation worsens
      hypothermia. Hence, various methods including prewarming of the patient are used to maintain
      core temperature during operation.

      Prewarming is found to be effective in maintaining core temperature perioperatively by
      increasing peripheral tissue heat content. However, applying more than 30 minutes of
      prewarming may be impractical as a clinical routine practice. Hence, developing simple and
      effective method to prevent hypothermia is expected.

      Here, the investigators planned to examine the effect of active warming (10 minutes of
      warming during induction of general anesthesia and prewarmed intravenous fluid
      intraoperatively) on hypothermia in patients undergoing urologic operation under general
      anesthesia.
    

Intervention name(s): warming during induction of anesthesia; Prewarmed intravenous fluid administration
Intervention type(s): Procedure; Procedure
Intervention description(s): Warming group patients are applied air-forced warming device (bair-hugger 43'C) with blanket (warm touch, COVIDIEN, full body blanket) during induction of anesthesia in the operation room.; Prewarmed intravenous fluid is connected.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Study of RG1662 in Individuals With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This multi-center, randomized double-blind, placebo-controlled study will assess the safety
      and tolerability of RG1662 in individuals with Down Syndrome. Eligible subjects will be
      randomized in cohorts to receive either multiple oral doses of RG1662 or placebo. Anticipated
      time on study treatment is 38 days.
    


Intervention name(s): Placebo; RG1662
Intervention type(s): Drug; Drug
Intervention description(s): multiple oral doses; Cohorts receiving multiple oral doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care
Condition: Depth of Anaesthesia; EEG; Anesthesia Emergence Delirium
MeSH terms: Emergence Delirium
Study type: Interventional

Summary: 
      Electroencephalographic recordings (EEG) present an opportunity to monitor changes in human
      brain electrical activity during changing states of consciousness during general anesthesia.

      The investigators aim to determine if EEG-guided anaesthesia using the Masimo Sedline Root
      monitor will result in different anaesthetic requirements, different anaesthetic depth, and
      emergence characteristics in children under 16 years of age.

      200 children under 16 years undergoing routine general anaesthesia under sevoflurane will be
      randomized to either EEG monitoring or routine care. We will compare the anaesthetic
      requirements, the patient state index, number of episodes of burst suppression and the
      incidence and severity of emergence delrium between the two groups.
    

Detailed description: 
      Electroencephalographic recordings (EEG) present an opportunity to monitor changes in human
      brain electrical activity during changing states of consciousness during general anesthesia.

      At present, monitoring of the brain under anaesthesia is not routinely employed. Since every
      patient is different and the way their brain response to anaesthetic drugs is different, it
      is important to adjust the patients' anaesthetic depth according to their brains' response,
      rather than only relying on routine cardiorespiratory parameters. This is important
      particularly for children, whose physiological responses and electroencephalographic
      recordings (EEG) differ from that of adults.

      200 children under 16 years undergoing routine sevoflurane general anaesthesia will be
      randomized to either EEG-guided anaesthesia or routine care. The investigators will compare
      the anaesthetic requirements, the patient state index, number of episodes of burst
      suppression and the incidence and severity of emergence delrium between the two groups.
    

Intervention name(s): Sedline EEG sensor placement; Sedline EEG monitoring
Intervention type(s): Device; Device
Intervention description(s): Patients will have Sedline EEG sensor placed before or immediately after induction.; Anaesthesia depth will be guided by EEG characteristics in addition to routine clinical parameters
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised Controlled Trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
A Study of the Function of Hormones Present In Taste Buds
Condition: Diabetes; Obesity; Pre-Diabetes; Metabolic Syndrome
MeSH terms: Diabetes Mellitus; Metabolic Syndrome; Prediabetic State
Study type: Observational

Summary: 
      The purpose of this study is to find out whether the hormones in the taste buds are affected
      by tasting and eating food, and also whether these hormone levels are affected by an increase
      in body weight or type 2 diabetes.
    

Detailed description: 
      Cephalic phase of insulin secretion is regulated by autonomic and endocrine responses to
      food-related sensory stimulation such as sight, smell, and taste. Human taste perception
      comprises of at least five distinct qualities: bitterness, saltiness, sourness, sweetness,
      and umami, the sensation elicited by glutamate, commonly found in protein (meat, fish, and
      legumes) and flavor enhancer such as monosodium glutamate (MSG).

      Both the sweet and umami taste stimuli had been shown to illicit cephalic-phase insulin
      release in rats. Oral sensory stimulation in human with modified sham feeding (MSF where food
      is smelled, chewed, but not swallowed) had been shown to enhance insulin release during the
      cephalic phase, lower postprandial glucose level, and improve glucose tolerance in healthy
      subjects. The loss of pre-absorptive insulin response has been shown to impair glucose
      tolerance. Furthermore, patients with type 2 diabetes and their first degree relatives had
      been shown to have impairment of sweet taste.

      Recently, glucagon-like peptide-1 (GLP-1) and peptide YY (PYY) have been found in the taste
      cells located in the taste buds of mice (unpublished data). These new findings raise several
      interesting questions of whether strict tasting of food without ingestion may stimulate
      secretion of GLP-1 and PYY from the taste cells, whether their secretion is involved in the
      afferent input of the cranial nerves, and whether this secretion is impaired in obesity and
      in patients with pre-diabetes or type 2 diabetes. We also want to investigate whether
      different tastants, such as sweet versus umami, and different food contents such as percent
      fat versus carbohydrate compositions, would elicit different hormonal responses.
    

Time perspective: Prospective
Keywords: Hypoglycemia; Blood Sugar; Blood Glucose Level; Insulin Sensitivity; Metabolism; Type 2 Diabetes; Healthy
Effects of Ketogenic Diet on Body Composition and Performance in Soccer Players
Condition: Athletic Performance
Study type: Interventional

Summary: 
      A ketogenic diet (KD) is a nutritional approach, usually adopted for weight loss, that
      restricts daily carbohydrates under 30 g/day. KD showed contradictory results on sport
      performance, whilst no data are available on team sports. The investigators will investigate
      the influence of a KD on different parameters in soccer players
    

Detailed description: 
      Sixteen semi-professional soccer players will be randomly assigned to a ketogenic diet (KD
      n=8) or to a western diet (WD n=8). Diets contain the same amount of protein (1.8g/Kg body
      weight/day). Body weight and body composition will be measured by dual energy x-ray
      absorptiometry (DXA) and bioelectrical impedance analysis (BIA). Resting energy expenditure
      (REE), respiratory exchange ratio (RER), cross sectional area (CSA) and isometric muscle
      strength of quadriceps, counter movement jump (CMJ) and yoyo intermittent recovery test will
      be measured.
    

Intervention name(s): Western diet; ketogenic diet
Intervention type(s): Other; Other
Intervention description(s): Subjects in this intervention will follow a normal western diet; Subjects in this group will follow a low carbohydrate ketogenic diet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It is single blind, parallel arms study
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: ketogenic diet; western diet; soccer; sport performance; muscle mass; body composition
Modeling Variation of the Objective Mental Workload for Tasks Requiring Different Cognitive Functions.
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      This study focuses on the identification of objective mental workload (through
      ElectroEncephaloGraphy) during tasks involving different cognitive functions.
    

Detailed description: 
      In a medical context based on the solicitation of various cognitive functions, it is
      essential to be able to modulate the level of difficulty of the task, to maintain a constant
      level of mental workload while preserving the playful aspect of the activity. This must be
      sufficient to maintain the person's involvement without inducing too high a mental workload.

      However, currently, there is no standardized model of variation of mental workload for
      cognitive tasks that could be used to modulate the difficulty. The present study is therefore
      part of this context and concerns the identification of the mental workload during tasks
      requiring cognitive functions such as memory or attention.

      Further this study will allow to adapt in real time the difficulty of virtual tasks to the
      mental workload of people. In other words, to have a universal brain decoder of the mental
      workload.
    

Intervention name(s): Cognitive tasks
Intervention type(s): Other
Intervention description(s): Electroencephalographic signals registration during different levels of difficulty of three tasks requiring very distinct cognitive functions: the updating of verbal memory, visuospatial span and mental motor inhibition.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Bronchodilator Effect of RPL554 Administered in Addition to Tiotropium/Olodaterol in Patients With COPD
Condition: COPD
Study type: Interventional
Phase: Phase 2

Summary: 
      The study investigates the effect of 3 days of twice daily treatment of two different doses
      of RPL554 (a phosphodiesterase [PDE]3/4 inhibitor) or placebo, each administered in addition
      to once daily tiotropium/olodaterol (Respimat) in patients with moderate to severe chronic
      obstructive pulmonary disease (COPD). Patients will receive each of the three treatment
      combinations in a randomized sequence using a crossover design
    

Detailed description: 
      RPL554 is a dual inhibitor of phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) which
      are known to have a role in modulating the inflammatory airway response in respiratory
      diseases, including COPD. PDE3 inhibitors act as bronchodilators whilst PDE4 inhibitors have
      anti-inflammatory properties and there is also evidence to suggest that combined inhibition
      of PDE3 and PDE4 can have additive or synergistic anti-inflammatory and bronchodilator. The
      two doses of RPL554 (1.5 mg and 6 mg)have been selected based on the results from prior
      studies investigating single and multiple ascending doses in healthy subjects, single doses
      in asthmatics, single/multiple ascending doses in COPD patients, and 3 days of dosing in COPD
      patients. These doses were demonstrated to be both effective as a bronchodilator and well
      tolerated.

      The purpose of the study is to investigate if RPL554 has an additive bronchodilator effect
      when administered in combination with a commonly used anticholinergic/β-agonist combination
      medication, tiotropium/olodaterol (Respimat), in this patient population measured by the peak
      forced expiratory volume in one second (FEV1), and forced vital capacity (FVC).
    

Intervention name(s): RPL554 Suspension; Placebo; Tiotropium/olodaterol (Respimat)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A PDE3/4 inhibitor; A placebo solution; An anticholinergic/β-agonist combination medication
Intervention MeSH terms: Tiotropium Bromide; Olodaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; Bronchodilation; FEV1
miRNA Profile in Aneurysmal Subarachnoid Haemorrhage
Condition: Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      The investigators aim to investigate and understand the circulating miRNA profiles after
      acute aneurysmal subarachnoid haemorrhage and underlying pathological significance.
    

Detailed description: 
      1. The investigators aim to investigate the miRNA classifier for delayed cerebral
           infarction after aneurysmal subarachnoid haemorrhage;

        2. The investigators aim to investigate the corresponding circulating and CSF miRNA
           profiles.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  Acute aneurysmal subarachnoid hemorrhage patients with and without delayed cerebral
             infarction

          -  Healthy volunteers
      
Biospecimen description: 
      Serum
    
Keywords: Subarachnoid Haemorrhage