bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Clinical Airway Assessments With a Gray Zone Approach
Condition: Difficult Laryngoscopy
Study type: Observational

Summary: 
      Failure of advanced airway security has been reported that it could lead lethal complication
      such as brain hypoxic damage. There have been controversial reports for the airway assessment
      tests which can predict difficult laryngoscopy. Therefore, we evaluated diagnostic validity
      of pre-existing airway assessment tests and scoring system using a gray zone approach in
      patients undergoing general anesthesia required endotracheal intubation.
    

Detailed description: 
      POGO(percentage of glottic opening)will be evaluated by an attachable fiberoptic scope (AV
      scope. CAREtec CO.Ltd, Kangwon-Do, South Korea)
    

Intervention name(s): Measurements of parameters related with physical examinations for difficult airway prediction
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing general anesthesia for any surgery at Samsung medical center
      
Keywords: Physical examinations, Percentage of glottic opening(POGO)
Cutaneous Silent Period Assessment in Primary Sjögren's Syndrome
Condition: Small Fiber Neuropathy; Primary Sjögren Syndrome
MeSH terms: Sjogren's Syndrome; Small Fiber Neuropathy; Syndrome
Study type: Observational

Summary: 
      Primary Sjögren's syndrome (pSS) is a chronic, immune-mediated inflammatory disease mainly
      characterized by exocrine gland involvement. Beyond the wide heterogeneity in clinical
      presentation, neurological manifestation is one of the important systemic involvement of pSS.
      The prevalence of neurological involvement varies widely from 10% to 60% in different series.

      Small fiber neuropathy (SFN) as a popular clinical entity in recent years targets nociceptive
      thinly myelinated A-delta and unmyelinated C-fiber nerves and is frequently associated with
      burning and allodynic pain. Previous studies have demonstrated that SFN is frequently seen in
      patients with pSS and has an important clinical importance because it cannot be detected by
      routine electrophysiological studies. Various methods can be used in the detection of SFN,
      and cutaneous silent period (CSP) measurement is gaining popularity recently due to its
      non-invasiveness and practical fashion.

      In this study, the investigators aimed to compare CSP parameters as an indicator of SFN in
      patients with pSS and in the healthy population and to reveal its relationship with clinical
      parameters.
    


Intervention name(s): cutaneous silent period (CSP) measurement
Intervention type(s): Diagnostic Test
Intervention description(s): CSP recordings are performed in the upper extremities using the same surface bar recording electrodes. Filters are set at 2 Hertz (Hz) to 10 kilo Hz, sensitivity is 200 microVolts (µV) and sweep speed is set at 200 milliseconds (ms). Stimulating electrode is placed on the index finger and recording bar electrode is placed on the abductor pollicis brevis (APB) muscle. During steady submaximal (50% of the maximal contraction) thumb abduction, 10 consecutive painful electrical stimuli of standard 80-milli Ampere (mA) intensity and 0.5-ms duration are applied to the index finger and responses are superimposed. CSP latency and duration are calculated and recorded. CSP latency is defined as the time between the stimulation and the onset of the silent period. CSP duration is calculated as the time interval between the beginning and end of the CSP.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population composed of two groups: the patient group including the participants
        diagnosed with pSS in accordance with the 2016 ACR/EULAR primary Sjögren's Syndrome
        classification criteria and the control group including the healthy participants.
      
Keywords: Small Fiber Neuropathy; Primary Sjögren Syndrome; Neuropathic Pain
A Study to Assess the Drug Absorption Into the Blood After Administration of 3 Doses of AZD5718
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to evaluate the AZD5718 pharmacokinetic (PK) doses in order to
      determine exposure in a new dose range and compare with previous results. This study will
      include 14 subjects in a single site in United Kingdom. Each subject will be involved in the
      study for 6 to 7 weeks.
    

Detailed description: 
      This study will be an open-label, randomized, 3-period, 3-treatment, crossover study
      performed in healthy subjects at a single study center.

      A total of 14 healthy male and female subjects (of no childbearing potential) will be
      randomized to ensure that at least 12 subjects are evaluable. Each subject will receive 3
      different treatments at least 4 days apart and will be dosed following an overnight fast of
      at least 10 hours. The following treatments will be given:

        -  Treatment A: AZD5718 Dose A tablet

        -  Treatment B: AZD5718 Dose B tablet

        -  Treatment C: AZD5718 Dose C tablet

      The study will comprise:

        -  A Screening Period of maximum 28 days.

        -  Three Treatment Periods during which subjects will be resident from the day before first
           dosing with AZD5718 (Day -1) in Treatment Period 1 until at least 48 hours after last
           dosing with AZD5718 in Treatment Period 3 for collection of PK and safety samples.
           Subjects will be discharged on Day 3 of Treatment Period 3.

        -  A Follow up Visit, 5 to 7 days after the last dose of investigational medicinal product
           (IMP).

      There will be a minimum washout period of 4 days between each dose administration.

      Each subject will be involved in the study for 6 to 7 weeks. This study will be conducted in
      male and female subjects aged 18 to 55 years.
    

Intervention name(s): Treatment A; Treatment B; Treatment C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subject will be given AZD5718 Dose A tablet once daily; Subjects will be given AZD5718 Dose B tablet once daily; Subjects will be given AZD5718 Dose C tablet once daily
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The following treatments will be given in crossover design:
Treatment A: AZD5718 Dose A tablet
Treatment B: AZD5718 Dose B tablet
Treatment C: AZD5718 Dose C tablet
There will be 6 arms consisting of all possible treatment sequences. The treatment sequence per arm will be:
Arm1: ABC Arm2: ACB Arm3: BAC Arm4: BCA Arm5: CAB Arm6: CBA
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics
Impact of Acupuncture on Vasomotor Rhinitis
Condition: Vasomotor Rhinitis; Acupuncture
MeSH terms: Rhinitis; Rhinitis, Vasomotor
Study type: Interventional
Phase: Phase 3

Summary: 
      Chronic rhinitis without an allergic or infectious aetiology (vasomotor rhinitis) is a common
      disease for which there are only poor therapeutic treatment options. The current placebo
      controlled partially double blinded pilot study evaluated the effects of acupuncture on the
      symptoms of vasomotor rhinitis.
    


Intervention name(s): Acupuncture; Sham-laser acupuncture
Intervention type(s): Device; Device
Intervention description(s): The treatment consisted of 5 sessions, all patients completed a recovery time after treatment of 30 min duration. The sessions were administered over a period of 5 weeks (one session per week). The acupuncture treatment was semi-standardised. It consisted of a basic pool of 6 body acupuncture points. Five additional acupuncture body points together with auricular points formed an individual pool. After needle insertion, the needle was manipulated until the subject obtained the de-Qi response (a deep aching or full feeling at the needle, [22]). After obtaining the de-Qi response, there was no further manipulation of the needle. Each session lasted 20 minutes.; The sham-laser acupuncture treatment consisted of 5 sessions, all patients completed a recovery time after treatment of 30 min duration. The sessions were administered over a period of 5 weeks (one session per week). Sham-laser acupuncture was applied at the same points as the acupuncture treatment. A deactivated laser pen (Seirin, 3B Scientific GmbH, Hamburg, Germany) that could only beam normal red light rather than laser was used. The total number of acupuncture points utilized was equal to the acupuncture group. Every point was treated for 30 sec with the total treatment time of 20 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: acupuncture; randomised controlled trial; placebo; sham laser; vasomotor rhinitis
Effects of Stress on Exposure Therapy
Condition: Specific Phobia
MeSH terms: Phobic Disorders
Study type: Interventional

Summary: 
      This study investigates whether stress can augment exposure therapy outcome in patients with
      specific phobia (spider phobia).
    

Detailed description: 
      Stress has been shown to modulate fear extinction. The present study is aimed at
      investigating whether stress (administered prior to exposure with the socially evaluated cold
      pressor test) augments exposure therapy outcome in patients with specific phobia (spider
      phobia). Furthermore, the effects of stress on the generalization of exposure-induced symptom
      reduction towards untreated fear stimuli (i.e. cockroaches) will be explored.

      Participants are randomly assigned to the cold or warm water condition of the socially
      evaluated cold pressor test (SECPT; Schwabe et al., 2008). Thereafter, participants of both
      conditions receive 45 minutes of in-vivo exposure to spiders. The effects of stress on
      exposure-based anxiety reductions toward spiders (treated fear stimulus) and cockroaches
      (untreated fear stimulus to assess generalization of treatment outcome) are assessed on the
      behavioral, subjective and physiological level at pretreatment, posttreatment (24 hours after
      exposure) and follow-up (4 weeks after exposure).
    

Intervention name(s): Cold water condition; Warm water condition
Intervention type(s): Other; Other
Intervention description(s): Cold water condition of the SECPT. Participants immerse their hand into ice-cold water (0-3°C). During the SECPT, participants are videotyped and monitored. After the SECPT, participants will receive 45 minutes of in-vivo exposure to spiders; Warm water condition of the SECPT. Participants immerse their hand into warm water (36-37°C). Participants are neither videotyped nor monitored during the whole procedure. After the SECPT, participants will receive 45 minutes of in-vivo exposure to spiders.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: anxiety disorders; spider phobia; stress; exposure therapy; generalization
Evaluation of the Effectiveness and Clinical Utility of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion in Youth and Adolescents Athletes.
Condition: Minor Traumatic Brain Injury (TBI)
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      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: 
        Up to 300 athletes from Nazareth Academy, Deerfield High School and the Deerfield young
        warriors program athletes, from both genders, aged 10-19 years
Single Transpulmonary Thermodilution and Continuous Monitoring of Central Venous Oxygen Saturation During Off-pump Coronary Surgery
Condition: Coronary Artery Disease; Hemodynamic Monitoring,; Goal Directed Therapy
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The aim of the present study was to evaluate the usefulness of an algorithm based on
      hemodynamic parameters obtained by single transpulmonary thermodilution (STD) combined with
      continuous monitoring of central venous oxygen saturation (ScvO2) for perioperative
      management of patients undergoing OPCAB.
    

Detailed description: 
      At the present time, there is an increasing tendency to perform off-pump coronary artery
      bypass grafting (OPCAB). However, OPCAB poses a variety of challenges from the point of view
      of the anesthesiologist and the intensivist. The aim of the present study was to evaluate the
      usefulness of an algorithm based on hemodynamic parameters obtained by single transpulmonary
      thermodilution (STD) combined with continuous monitoring of central venous oxygen saturation
      (ScvO2) for perioperative management of patients undergoing OPCAB.
    

Intervention name(s): Conventional monitoring; Advanced monitoring
Intervention type(s): Device; Device
Intervention description(s): In the CM group, therapy was guided by central venous pressure, mean arterial pressure (MAP) and heart rate (HR); In the AM group by the intrathoracic blood volume index, MAP, HR, central venous oxygen saturation (ScvO2) and cardiac index (CI). The measurements were performed before and during surgery, and at 2, 4 and 6 hrs post-operatively.
Other intervention name(s): Non actual; PiCCO-CeVOX
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: venous oxygen saturation; transpulmonary thermodilution
Cord Blood Transplantation in Patients With Advanced Lymphoid Malignancies
Condition: Patients With Advanced Lymphoid Malignancies in the Absence of an HLA Identical or Mismatch Donor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Indication: Patients with advanced lymphoid malignancies in the absence of an HLA identical
      or mismatch donor.

      Objectives: Overall survival at one year. Efficacy >60%, rejection rate <20%. Inclusion
      criteria: Age: 18-65 years old, no sibling or unrelated donor identified, low grade
      non-hodgkin lymphoma in third line (who already received at least one autologous
      transplantation); hodgkin lymphoma in early relapse (<1 year), who received at least one
      autologous transplantation and sensible to chemotherapy and CLL with 17p deletion or in
      relapse less than 2 year after a fludarabine nbased regimen or in relapse after one
      autologous transplantation.

      Stem cell source: Two cord blood units containing both together more than 3x107 frozen
      nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the
      patients.
    


Intervention name(s): Cord Blood Transplantation
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cord blood transplant; advanced lymphoid malignancies
Brain Machine Interface (BMI) in Subjects Living With Quadriplegia
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      In this study, investigators will show proof-of-concept that brain signals can be used in
      real-time, closed-loop mode to trigger stimulation for hand function. Subjects will undergo
      surgery to implant a unilateral subdural strip electrode (Resume II, Model 3587A) over the
      motor cortex. These electrodes implanted in the brain will enable bioelectrical data
      recording (sensing) from the brain to the implanted Activa PC+S. The cortical sensing data
      will be

        1. either processed in the Activa PC+S; or

        2. off-loaded via the Nexus D communication device (Medtronic) to a computer.
    


Intervention name(s): Medtronic Activa PC+S
Intervention type(s): Device
Intervention description(s): Upon consent, the good candidates will undergo surgical screening that includes a full neurological workup and baseline functional assessment. Subjects that demonstrate feasibility for control will undergo surgery for unilateral implantation of the Activa PC+S as well as the implantation of unilateral subdural strip electrodes (Resume II, model 3587A) over the motor cortex. After 24 hour observation in the hospital, subjects will participate in 24 distinct sessions or visits of testing over a 3-6 month period. During these visits, the sensing, decoding of the implanted device (Activa PC+S) as well as the external stimulation components (Bioness H200) and parameters will be tested and benchmarked. Subjects will participate for 24 sessions and continue to participate in the study until the end of life of the device, at which point the subject may elect to undergo an explant at that time.
Intervention model: Single Group Assignment
Intervention model description: Medtronic Activa PC + S is a multi-programmable primary cell neurostimulator that records bioelectric data and deliver electrical stimulation through leads implanted in the brain.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Usability Study of a Neuropsychological Intervention Program Based on Virtual Reality in Adults With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Nowadays, several strategies for treating neuropsychologic function loss in Parkinson disease
      (PD) have been proposed, such as physical activity performance and developing games to
      exercise the mind. However, few studies illustrate the incidence of these therapies in
      neuronal activity. This work aims to study the feasibility of a virtual reality-based program
      oriented to the cognitive functions' rehabilitation of PD patients. For this, the study was
      divided in intervention with the program, acquisition of signals, data processing and results
      analysis.

      The study highlights implementing new technologies to rehabilitate people with
      neurodegenerative diseases.
    

Detailed description: 
      Nowadays, several strategies for treating neuropsychologic function loss in Parkinson disease
      (PD) have been proposed, such as physical activity performance and developing games to
      exercise the mind. However, few studies illustrate the incidence of these therapies in
      neuronal activity. This work aims to study the feasibility of a virtual reality-based program
      oriented to the cognitive functions' rehabilitation of PD patients. For this, the study was
      divided in intervention with the program, acquisition of signals, data processing and results
      analysis. The alpha and beta bands power behaviour were determined by evaluating the
      electroencephalography (EEG) signals obtained during the execution of control tests and games
      of the "Hand Physics Lab" Software, from which five games related to attention, planning,
      sequencing, concentration, and coordination, were taken.

      The study highlights implementing new technologies to rehabilitate people with
      neurodegenerative diseases.
    

Intervention name(s): Intervention with virtual reality
Intervention type(s): Device
Intervention description(s): VR intervention with OCULUS QUEST2 (OCULUS VR, USA) consiste on a VR helmet positioned over subject head. The software consisted of a 3D environment with exercises of upper limbs and visual feedback for the treatment of cognitive and motor dysfunction. The therapist have real-time access to the activities in the 3D environment vby real-time video transmission of the helmet activity.
The program include a single session. Each session is monitored on safety aspects of the subjects with emphasis on possible side effects of virtual reality.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's disease; virtual reality; cognitive functions; alpha band; beta band; cerebral lobes; electroencephalography