bioihbjkbjnl/mcl2 huggingface dataset:
Intervention for Intrusive Negative Thinking
Condition: Intrusive Negative Thinking
Study type: Interventional

Summary: 
      Intrusive negative thinking styles such as rumination are typical of many psychiatric
      disorders, are difficult to treat, and predict poor treatment outcome. The investigators
      propose to evaluate a new intervention for negative thinking that capitalizes and builds on
      the preserved ability to attend to physical sensation. The investigators will examine changes
      in physiological mechanisms and symptoms.
    

Detailed description: 
      Intrusive negative cognitions are key features of many psychiatric disorders, are difficult
      to treat, and predict poor outcomes in conventional and neurobehavioral interventions. Here,
      we evaluate the extent to which a novel intervention capitalizing on a preserved
      neurocircuitry for attending to evolutionarily salient somatosensory stimuli can be used to
      train attentional mechanisms to override otherwise pre-potent negative cognitions. The
      initial period will involve open-label intervention refinement and mechanistic evaluation of
      mechanism; N=35 individuals with high levels of intrusive negative cognitions and dysphoria
      will be assessed pre/post intervention in the graded sensory training condition. Success will
      suggest a new intervention pathway for a traditionally treatment-resistant dimension of
      psychopathology. The second phase will be a randomized trial of 70 participants equally
      allocated to graded and non-graded training conditions.
    

Intervention name(s): Sensory attention training
Intervention type(s): Other
Intervention description(s): Participants will be instructed to attend to sensory stimuli and to press a button as quickly and accurately as possible while ruminating. Stimuli will consist of vibration via a wearable subwoofer or non-painful electrical muscle stimulation (10Hz biphasic current with a pulse width of 200us with rectangular 2" electrodes placed on the back near the shoulders) or vibratory stimulation with a vibroacoustic element placed on the back near the shoulders. Up to four sessions will be approximately 45 minutes, over the course of two weeks.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Rumination; Sensory processing; Non-pharmacological intervention; Depression; Anxiety; PTSD
Comparison of Two Technique for Assessment of Vocal Cord Movement by C-Mac Videolaryngoscope vs Airway Ultrasound.
Condition: Objective Vocal Cord Movement Assessment by C-Mac Videolaryngoscope Vs Airway Ultrasound in Ca Thyroid
MeSH terms: Thyroid Diseases
Study type: Interventional

Summary: 
      This study is planned to compare C-Mac video-laryngoscope and airway ultrasound as two novel
      techniques (causing least discomfort to the patients) for the detection of impaired
      vocal-cord movement after thyroid surgery.
    

Detailed description: 
      In this prospective study 100 patients posted for Thyroid surgery will be included, after
      explaining the procedure and written informed consent, all included patients in the study
      will be assessed for vocal cord mobility by C-Mac video laryngoscope (manufactured by KARL
      STORZ Video Laryngoscopes) followed by airway ultrasonography (USG). Linear transducer (7.5
      MHz) will be used for scanning the airway placed at the level of thyroid cartilage with 10-15
      degree cephalad tilt so to get proper acoustic window and for optimal visualization of
      laryngeal structures. C-Mac video laryngoscope will be required for virtual visualization of
      glottis apertures and vocal cord movement. All patients will be scanned pre-operatively by
      indirect laryngoscopy to see vocal cord mobility as a reference value. Immediately after
      extubation the patient will be scanned for vocal cord mobility by videolaryngoscope by first
      examiner, After oxygenation and stabilization of haemodynamic, ultrasound of airway will be
      performed to study the vocal cord movement by the other examiner (blinded to the laryngoscopy
      finding).Visibility of false vocal cords, true vocal cords and arytenoids will be given one
      point each for one side, maximal score will be 6. According to points the acoustic window
      scoring for glottis aperture will be graded as fair (score1-2), good(score3-4) and very
      good(score5-6) Findings of both the examiners will be collected by the primary investigator
      for data collection and analysis.
    

Intervention name(s): Active Comparator :C-Mac Videolaryngoscope; Experimental: Airway ultrasound,
Intervention type(s): Device; Device
Intervention description(s): Real time assessment of Glottic aperture at the time of extubation by videolaryngoscope; Airway ultrasound using portable ultrasound machine to assess vocal cords movement.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Diagnostic
Study Comparing In-laboratory Polysomnography Electrocardiogram (PSG ECG) to Simultaneously Recorded In-laboratory ECG on the CPC M1 Device
Condition: Sleep Disorder
MeSH terms: Sleep Wake Disorders
Study type: Interventional

Summary: 
      Research study that will test a portable device (CPC M1) that records: body movement; heart
      activity (ECG; snoring; and body position during sleep. The Food and Drug Administration
      (FDA) has not approved this device for use except in a research setting.

      The purposes of this study are to: a) determine if the ECG data collected using the CPC M1
      device is at least as good as the ECG data collected during a diagnostic, in-lab
      polysomnogram (PSG) (or sleep study) and b) determine if in-home monitoring with the device
      will provide similar results compared to an in-lab PSG.
    


Intervention name(s): CPC M1
Intervention type(s): Device
Intervention description(s): CPC M1
Other intervention name(s): in-laboratory vs. in-home recordings
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: scheduled for a polysomnogram (overnight sleep study)
Atorvastatin Study in Cardiovascular Disease Risk
Condition: Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Observational

Summary: 
      Treatment of hypercholesterolemia is based on the guidelines of ESC-EAS 2011 (European Heart
      Journal (2011) 32, 1769-1818, ESC / EAS Guidelines for the management of dyslipidaemias)
      These calculate the 10 year risk based on SCORE tables - Systematic COronary Risk Estimation
      and taking into account specific parameters in the patient's profile.
    

Detailed description: 
      The European Society of Cardiology initiated the development of a new risk calculation system
      (SCORE) using data from 12 European population monitoring studies (N = 205.178) with wide
      geographic distribution of countries with different cardiovascular risk. The SCORE data
      contains more than 3 million man-years of observation and 7934 fatal cardiovascular events.

        -  patient is classified into risk category (Very high-high-medium-low)

        -  a target for LDL-C was then placed on a risk basis and appropriate treatment proposed

        -  As a first option is to statin monotherapy to the maximum tolerated dose.

        -  Only in case of failure of the therapeutic target for LDL-C may be used active substance
           other therapeutic class or as alternative monotherapy or in combination with statin,
           Because European countries exhibit heterogeneity in genetics, lifestyle, living
           standards, health benefits, etc. have been divided into two groups, high risk
           (countries) and low risk (countries) and have been prepared in different tables SCORE
           (Systematic COronary Risk Estimation) For Greece, as in other countries has been further
           refinement of SCORE and trained specialists tables adapted to the Greek population
           (Statistical The most currently used treatment in Greece is atorvastatin, obtained from
           520,000 patients From far studies with atorvastatin have been well documented reductions
           in various lipid parameters and especially the LDL-C, which is the main objective in the
           treatment.

      But there is no evidence to suggest what is the dosage proved suitable in practice for the
      patient depending on the risk class belongs.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with dyslipidemia
NUtriGenomic Analysis in Twins
Condition: Metabolic Response to Dietary Modification
Study type: Interventional

Summary: 
      This is an intervention study in healthy adult twins with the aim to investigate the genetic
      determination of metabolic responses towards an isocaloric high carbohydrate, low fat diet
      versus an isocaloric low carbohydrate, high fat diet.
    

Detailed description: 
      The impact of carbohydrates, proteins and fatty acids as major components of daily nutrition
      on the development of metabolic illnesses is an objective of numerous clinical studies.
      However, the effect of an isocaloric diet on metabolism is less investigated and not well
      understood. This study aims to reveal genetic determinated metabolic responses to an
      isocaloric high carbohydrate, low fat diet versus an isocaloric low carbohydrate, high fat
      diet in healthy twins. This study generates information for further detailed nutrigenomic
      analysis. Twins receive an isocaloric diet rich in carbohydrates (55% carbohydrates, 15%
      protein, 30% fat) with dietary counselling for 5 weeks and afterwards with nutrients supplied
      for 6 days, followed by an isocaloric diet rich in saturated fat (40% carbohydrates, 15%
      protein, 45% fat) for 6 days with nutrients supplied and for 4 weeks with dietary counselling
      and again followed by another 6 days when nutrients were supplied. Anthropometry, blood tests
      and energy expenditure are performed after the period of diet rich in carbohydrates (Carb),
      after the first 6 days (HFshort) and at the end of the period of diet rich in fat (HFlong).
    

Intervention name(s): Isocaloric high carbohydrate diet intervention; Isocaloric high fat diet intervention
Intervention type(s): Other; Other
Intervention description(s): Time of 6 week, the last 6 days are standardized; Time of 6 weeks; the first and the last 6 days are standardized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Twins; High carbohydrat diet; High fat diet; Isocaloric; Nutrigenomics
Effects of Aleurone-enriched Products on Cardiovascular Risk Factors
Condition: Glucose and Lipid Metabolism; Incretin Hormones Plasma Levels; Inflammation, Oxidative Stress and Endothelial Function
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Very few studies have evaluated the effect of aleurone-enriched grains on cardiovascular risk
      factors. Price et al.(2010) have shown that 4-week supplementation of aleurone-enriched
      products (27 g/day of aleurone) increased betaine concentration in plasma whereas reduced
      homocysteine and LDL-cholesterol levels. Interestingly, aleurone had no effect on total
      antioxidant status or endothelial function, whereas an improvement of C-reactive protein was
      observed (Price RK et al, 2012). It is not known whether consumption of more than 27g/day of
      aleurone-enriched products with higher ferulic acid biodisponibility and longer time of
      treatment could influence these parameters in individuals with metabolic syndrome.
      Noteworthy, no studies have investigated the effect of aleurone-enriched products on fasting
      and postprandial glycemic homeostasis and lipid metabolism. In addition, mechanisms by which
      aleurone may act in vivo are still unknown.

      The aim of this study is to investigate whether 8 weeks supplementation with
      aleurone-enriched products may influence glucose and lipid metabolism, incretin hormones
      levels, satiety, inflammation, oxidative stress and endothelial function in overweight/obese
      subjects with high cardiovascular risk.
    


Intervention name(s): Aleurone; Control
Intervention type(s): Other; Other
Intervention description(s): Diet based in aleurone-enriched products for a period of 8 weeks.; Diet based on refined cereal products for a period of 8 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study of RO4917523 in Patients With Treatment Resistant Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, tolerability and efficacy of RO4917523, in comparison to
      placebo, in patients with treatment-resistant depression. Following a washout period from
      existing anti-depressant medication, cohorts of patients will be randomized to receive daily
      oral RO4917523 at up to five different doses (according to the safety and tolerability
      observed at the lower doses during the study), or placebo. The anticipated time on study
      treatment is 10 days (in an inpatient unit), and the target sample size is <100 individuals.
    


Intervention name(s): Placebo; RO4917523
Intervention type(s): Drug; Drug
Intervention description(s): po daily for 10 days; orally daily for 10 days, cohorts receiving up to 5 different doses (according to safety and tolerability)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine
Condition: Sedative Adverse Reaction
Study type: Interventional

Summary: 
      The aim of the study is to evaluate whether real-time binaural sound affects the dose of
      dexmedetomidine in patients undergoing sedation with dexmedetomidine after spinal anesthesia.
    

Detailed description: 
      Patients undergoing sedation with dexmedetomidine after spinal anesthesia are randomly
      assigned to binaural group, audio group, and control group. After spinal anesthesia, SedLine
      continuous monitoring is started. Real-time binaural sound applied music is played to the
      binaural group, normal music is played to the audio group, and headphones with no sound are
      applied to the control group. Observer's Assessment of Alertness/Sedation Scale (OAAS) and
      Patient State Index (PSi) are checked every minute after loading of dexmedetomidine at the
      rate of 1 μg/kg for 10 minutes (6 μg/kg/hr). Loading is stopped when the OAAS score is 3 or
      less. Then, dexmedetomidine is continuously infused at a rate of 0.6 μg/kg/hr, and OAAS is
      evaluated every 30 minutes. The infusion rate is lowered (-0.1 μg/kg/hr) if OAAS is lower
      than 3, and increased (+0.1 μg/kg/hr) if OAAS is higher than 3. The continuous infusion rate
      should not exceed 1 μg/kg/hr. The total dexmedetomidine dose corrected by the patient's
      predicted body weight and infusion time (μg/kg/hr) was compared between groups. In addition,
      the loading dose (μg/kg) and continuous infusion dose (μg/kg/hr), additional sedative use,
      blood pressure, heart rate, ECG changes, respiratory depression, and oxygen saturation were
      observed. The patient's satisfaction is evaluated after the surgery.
    

Intervention name(s): Real-time binaural sound; Music; Control
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Play music with a frequency difference (real-time binaural sound) in each ear through headphones during sedation.; Play the same music in both ears through headphones during sedation; Just wear headphones during sedation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Obesity and Brain: Genes and Environment
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The aim of this study is to investigate the effects of genetic and environmental risk factors
      on central nervous system (CNS) reward and satiety circuits in the etiology of obesity. The
      investigators will also investigate to what extent the alterations in CNS reward and satiety
      circuits are a cause or a consequence of the development of obesity.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from the Netherlands Twin Registry (NTR). All subjects are
        voluntary participants and have received surveys on lifestyle and health every 2 years. In
        addition, genome wide data are available in a large number of these individuals.
      
Keywords: Brain; Genes; Environment; Etiology; Reward; Satiety Response; Central Nervous System; Magnetic Resonance Imaging; Twins, Monozygotic; Overweight; Obesity
Level of Lacrimal Passage Obstruction
Condition: Lacrimal Apparatus Diseases
MeSH terms: Lacrimal Apparatus Diseases
Study type: Observational [Patient Registry]

Summary: 
      Detect anatomical level of acquired lacrimal passage obstructions among patients with
      epiphora. They were evaluated and divided into four groups Punctal, Canalicular, Nasolacrimal
      duct and Mixed groups according to level of obstruction
    

Detailed description: 
      In a 3 years period adult patients with obstructive epiphora were evaluated clinically by
      Probing /irrigation of lacrimal passages to detect anatomical level of obstruction.

      The main site of obstruction was the common canaliculus where 2/3 of patients had canalicular
      problems. The second common site of obstruction is nasolacrimal duct followed by the puncti.
    

Intervention name(s): Probing /irrigation of lacrimal passages
Intervention type(s): Diagnostic Test
Intervention description(s): Probing of the lacrimal passage was done using #00 Bowman's lacrimal probe which can reveal any narrowing (resistance) or obstruction (soft stop) of the canaliculi during its advancement from punctum towards the lacrimal sac.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients were divided into four main groups according to site of narrowing or obstruction
        Punctal group, Canalicular group, NLD group and Mixed group who had 2 or more levels of
        narrowing or obstruction
The Movement Imagery Ability in Patients With Familial Mediterranean Fever
Condition: Familial Mediterranean Fever
MeSH terms: Brucellosis; Familial Mediterranean Fever; Hereditary Autoinflammatory Diseases; Fever
Study type: Observational

Summary: 
      Motor imagery is the mental representation of movement without any doing body movement. A
      main function of imagery is to aid the self-regulation of thoughts, feelings, and behaviours.
      Studies have shown to be more effective for individuals displaying a higher level of imagery
      ability when using imagery to improve motor and motivational outcomes, including
      self-efficacy. The aim of this study is to measure the movement imagery ability in patients
      with Familial Mediterranean Fever and compare it with healthy individuals.
    

Detailed description: 
      Familial Mediterranean Fever (FMF) is an autosomal recessive disease characterized by
      recurrent and self-limited attacks of fever associated with abdominal, chest, and joint pain.
      Previous studies have shown that individuals with FMF are more limited in terms of physical
      function than the normal population, and depression and anxiety are more common in these
      individuals. Being a lifetime disease, quality of life, and mental health can be affected due
      to serious complications such as attack frequency, disease resistance, and sometimes
      amyloidosis. Mental imagery is the ability to imaging the movement without doing the physical
      execution of the movement. During the last years, mental imagery is used in clinical practice
      as a tool for the treatment of chronic pain. Pain differs in patients with rheumatic
      diseases. Stress is one of the predictors of pain in patients with FMF. Even if the frequency
      is variable when attacks happen they may affect patients physically and their mental health
      and the ability to cope. A main function of imagery is to aid the self-regulation of
      thoughts, feelings, and behaviors. To use imagery for motor and motivational outcomes firstly
      the imagery ability levels should be measured.
    

Intervention name(s): movement imagery ability
Intervention type(s): Behavioral
Intervention description(s): Determining the movement imagery ability: internal visual, external visual and kinesthetic imagery
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Familial Mediterranean Fever and Healthy Controls
      
Keywords: movement imagery ability; pain; catastrophizing; familial mediterranean fever
Effect of Functional Electrical Stimulation Versus TheraTogs on Treatment of Children With Hemiplegic Cerebral Palsy.
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      To compare the effect of functional electrical stimulation (FES) versus TheraTogs on Gait and
      Balance in children with hemiplegic CP.
    

Detailed description: 
      The aim of this study was to evaluate the effect of FES versus TheraTogs on Gait and Balance
      in children with hemiplegic CP. Thirty children with hemiplegic CP will be assigned randomly
      into two groups (A & B). Group A received FES by using the WalkAide foot drop stimulator
      while group B received TheraTogs. Patients' evaluation will be carried out before and after
      training to assess gait and balance performance.
    

Intervention name(s): Functional Electrical Stimulation; TheraTogs Orthotic Undergarment
Intervention type(s): Other; Other
Intervention description(s): Functional Electrical Stimulation Group received 1.5 hours of conventional physical therapy program /session - 3 sessions weekly - three successive months + 1/2 hour of the gait training program with functional electrical stimulation /session - 3 sessions weekly - three successive months.; TheraTogs Arm The participating children worn TheraTogs orthotic undergarment and strapping as preparatory stage without application of any exercise program with gradually increasing the worn time till reaching the 8 hours per day.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment