bioihbjkbjnl/mcl2 huggingface dataset:
Bispectral Index Under Propofol Anesthesia in Children : a Study Between TIVA and TCI
Condition: Anesthesia
Study type: Interventional

Summary: 
      In children, only a few studies have compared different modes of propofol infusion during a
      total intravenous anesthesia (TIVA) with propofol and remifentanil. The aim of this study is
      to compare Bispectral Index (BIS) profiles (percentage of time spent at adequate BIS values)
      between four modes of propofol infusion: titration of the infusion rate on clinical signs
      (TIVA0), titration of the infusion rate on the BIS (TIVABIS), target controlled infusion
      (TCI) guided by the BIS either with the Kataria model (TCI KBIS) or the Schnider model (TCI
      SBIS).

      Methods: Children will be prospectively randomized into the 4 groups. In the TIVA0 group the
      anesthesiologist is blinded to the BIS. In each group, the percentage of time with adequate
      BIS values (45-55), the bias and imprecision will be calculated.
    


Intervention name(s): Propofol : TCI Schnider; Propofol : TCI Kataria; Propofol : TIVA; EEG Monitoring; Remifentanil
Intervention type(s): Drug; Drug; Drug; Device; Drug
Intervention description(s): Target controlled infusion using schnider model for propofol; Target controlled infusion using Kataria model for propofol; Total intravenous anesthesia without use of a pharmokinetic model; Maintaining a bispectral index between 45 and 55; Remifentanil at discretion of the anesthesiologist
Other intervention name(s): BISPECTRAL INDEX
Intervention MeSH terms: Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Total intravenous anesthesia; Target Controlled Infusion; Propofol; Bispectral index; Children
Study of Effectiveness of Different Lifestyle Interventions for Health and Wellbeing
Condition: Metabolic Syndrome Risk Factors; Overweight; Psychological Stress
MeSH terms: Overweight; Metabolic Syndrome; Stress, Psychological
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effectiveness and applicability of different
      interventions designed for enhancing overall wellbeing. Lifestyle changes, as well as
      psychological and physiological health variables are assessed. The interventions are based on
      the principles of cognitive behavioural therapy, and delivered either face-to-face, via
      mobile phone application, or Internet.
    

Detailed description: 
      The study focuses on targeting overweight, stress, and impaired overall wellbeing with new
      cost-effective intervention methods. The intervention methods are based on the principles of
      cognitive behavioural therapy (CBT) and further acceptance-commitment therapy (ACT). The
      interventions are delivered either face-to-face, via mobile application, or via Internet. The
      purpose of each intervention is to improve the subjects lifestyles and activate them towards
      beneficial changes in their everyday life. The psychological and physiological effects of
      interventions are measured with various invasive and non-invasive methods. The study gives
      new insight into effectiveness and acceptability of up-to-date psychological intervention
      methods, and new knowledge of different ways to deliver interventions for improving wellbeing
      of an individual.
    

Intervention name(s): Wellbeing intervention (ACT); Wellbeing intervention (Internet); No intervention
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The intervention is based on principles of acceptance-commitment therapy (ACT). It aims to increase psychological flexibility through different exercises that are developed for improving skills of being present, dealing with thoughts and feelings, as well as support clarifying individual values and value-based actions. In addition exercises for relaxation, physical activity, and mindful eating are provided. The content of intervention for face-to-face and mobile groups is similar but delivery method is different.; The intervention is Duodecim Virtual Health Check and Coaching where the subject gets feedback based on his/her health information and is provided with different weekly tasks regarding lifestyle changes. The tasks are developed based on principles of cognitive behaviour therapy (CBT).; No intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Cognitive Behavior Therapy; Acceptance Commitment Therapy; Psychological Stress; Metabolic Syndrome; Overweight; Life Style
6 Minute Propulsion Test Sensitivity to Increased Aerobic Capacity
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Observational

Summary: 
      The goals of this project are to 1)determine the responsiveness of the 6 Minute Push Test
      (6MPT) and 2) explore the relationship between 6MPT distance and measures of handicap,
      wheelchair satisfaction, depression, and self-reported avoidance of environmental features.
    

Detailed description: 
      The 6 minute walk test is a widely used assessment of aerobic capacity, function, and
      functional change in the ambulatory population. A similar clinical and research outcome
      instrument that is responsive to changes in aerobic capacity and function are lacking for
      persons with spinal cord injury (SCI). A 6 minute push test, adapted from the 6 minute walk
      test may fill the void. The primary aim of this project is to assess if distance traveled in
      6 minutes of wheelchair propulsion changes after an increase in aerobic capacity. We
      hypothesize that participants will push farther in 6 minutes after their aerobic capacity
      increases. The secondary aim is to explore the correlation between 6MPT distance and
      handicap, depression, wheelchair satisfaction, and self-reported avoidance of environmental
      features. We hypothesize increasing 6MPTdistance will be correlated with decreasing
      depression, decreasing handicap, decreasing self-reported avoidance of environmental
      features, and increasing wheelchair satisfaction. This is a low risk, high benefit study.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample of persons with spinal cord injury
      
Keywords: aerobic capacity
Physical Therapy in Shoulder Impingement Syndrome
Condition: Subacromial Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effects of low-level laser therapy (LLLT) and
      therapeutic ultrasound combined with home-based exercise in comparison with home-based
      exercise alone in patients with subacromial impingement syndrome (SIS). Participants are
      going to evaluate before training, and at the 1-month follow-up and 3-month follow-up using
      the visual analog scale (VAS) scores for pain during activity, at rest, and at night, and the
      Shoulder Pain and Disability Index (SPADI).
    

Detailed description: 
      SIS is an important cause of pain and disability and affects activities of daily living.
      Therefore, a major goal of SIS treatment is to reduce pain and improve upper extremity
      function. In this prospective, randomized controlled, single-blind, interventional trial, a
      total of 60 patients with SIS who met the eligibility criteria are going to enrolled in the
      study. Eligible participants are going to randomly assign to one of the three groups by an
      independent blinded researcher, using a computer-generated random numbers and allocation
      ratio of 1:1:1: the LLLT group (LG, n = 20), the ultrasound therapy group (UG, n = 20), and
      the control group (CG, n = 20). Participants are going to evaluate before training, and at
      the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for
      pain during activity, at rest, and at night, and the Shoulder Pain and Disability Index
      (SPADI).
    

Intervention name(s): Low-level laser therapy; Therapeutic ultrasound; Home-based exercise
Intervention type(s): Device; Device; Other
Intervention description(s): Gallium-aluminum-arsenide diode laser device; Therapeutic pulsed ultrasound with a frequency of 1 MHz; Home-based exercises 3 days a week; each exercise comprises one set with 5 repetitions over 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis
Condition: Group A Streptococcal Infection
MeSH terms: Pharyngitis; Streptococcal Infections
Study type: Observational

Summary: 
      The objective of this pilot study is to acquire images using the Strepic® device, a clinical
      prototype that has been designed specifically as a viable, low-cost, commercially realizable
      autofluorescence-based diagnostic test, using (1) fluorescence and (2) white light image
      data, as well as other clinical data points. By acquiring and analyzing the images of
      pharyngeal bacterial fluorescence and white light patterns in patients with Group A
      Streptococcus (GAS)-associated pharyngitis and comparing them with those observed in non-GAS
      pharyngitis, it is believed an algorithm can be developed such that the device will improve
      the ability of clinicians to quickly and accurately identify GAS infections.
    


Intervention name(s): Strepic® Device
Intervention type(s): Device
Intervention description(s): The Strepic® device is a qualitative point-of-care diagnostic test for the detection of GAS pharyngitis. The test uses direct visualization of the pharynx with a light source of specified wavelengths, causing excitation of endogenous fluorophores that emit a characteristic colored light pattern. White light images may give additional diagnostic accuracy through use of an artificial intelligence analysis of a large set of images of GAS and non-GAS pharyngitis.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting to participating U.S. emergency departments or clinics with complaint
        of pharyngitis will be screened.
Prone Positioning for Brain-injured Patients With Severe ARDS (ProBrain)
Condition: Cerebral Blood Flow
Study type: Observational

Summary: 
      Prone position (PP) is a key component to treat hypoxemia in patients with severe acute
      respiratory distress syndrome (ARDS). However, most studies evaluating PP effects in patients
      with ARDS exclude those with brain-injuries without providing any medical evidence. This
      prospectice observational study aimed to investigate if prone positioning leads to
      significant modification of cerebral perfusion in brain-injured patients with ARDS.
    


Intervention name(s): Transcranial Doppler (TCD)
Intervention type(s): Other
Intervention description(s): TCD ultrasonography is based on the principle of the Doppler effect. According to this principle, ultrasound waves emitted from the Doppler probe are transmitted through the skull and reflected by moving red blood cells within the intracerebral vessels. The difference in the frequency between the emitted and reflected waves, referred to as the "Doppler shift frequency," is directly proportional to the speed of the moving red blood cells (blood flow).
Cerebral blood flow (in cm/s) of the middle cerebral artery will be measured with TCD in blood-injured ARDS patients before and one hour after prone positioning (normal ranges: 48 to 72 cm/s).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        - Brain-injured patients with ARDS requirering prone positioning
      
Keywords: Prone Position; Acute Respiratory Distress Syndrome; Intracranial Pressure
Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache
Condition: Cervicogenic Headaches
MeSH terms: Post-Traumatic Headache; Headache
Study type: Interventional

Summary: 
      The purpose of this research is to compare two different approaches for treating patients
      with cervicogenic headaches: non-thrust mobilization and exercise versus thrust manipulation
      and dry needling. Physical therapists commonly use all of these techniques to treat
      cervicogenic headaches. This study is attempting to find out if one treatment strategy is
      more effective than the other.
    

Detailed description: 
      Patients with cervicogenic headaches will be randomized to receive 1-2 treatment sessions per
      week for 4 weeks (up to 8 sessions total) of either: (1) Dry Needling and HVLA thrust
      manipulation group, or the (2) Exercise and non-thrust mobilization group
    

Intervention name(s): Dry Needling,Thrust Manipulation; Exercise,Non-thrust Mobilization
Intervention type(s): Other; Other
Intervention description(s): HVLA thrust manipulation to upper cervical and upper thoracic regions. Dry needling to cervicothoracic and craniofacial regions. Up to 8 treatment sessions over 4 weeks.; Non-thrust mobilization and exercise to upper cervical and upper thoracic regions. Up to 8 treatment sessions over 4 weeks.
Other intervention name(s): Spinal Manipulation; Dry Needling; Exercise; Non-thrust Mobilization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Randomized Study For Minimally Invasive Splinted Implants
Condition: Jaw, Edentulous
MeSH terms: Jaw, Edentulous
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the effect of a integrated system for inserting two
      splinted minimally-invasive implants, to retain mandibular over dentures, on the quality of
      life of edentulous patients.
    


Intervention name(s): Integrated system to insert two splinted (bar) mini dental implants for mandibular overdenture; Denture
Intervention type(s): Device; Other
Other intervention name(s): Easy2Fix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mini-Dental Implant; Implant-Supported Dental Prosthesis; Minimally Invasive Surgical procedures; Overdentures; Aged
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
Condition: HIV Infections; Cytopenias
MeSH terms: HIV Infections; Anemia
Study type: Interventional

Summary: 
      To determine the safety and efficacy of erythropoietin (r-HUEPO) administered to AIDS
      patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.
    


Intervention name(s): Epoetin alfa
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Masking: Double
Primary purpose: Treatment
Keywords: Recombinant Proteins; Erythropoietin; Acquired Immunodeficiency Syndrome; Anemia; Zidovudine
The Drug-drug Interaction of SP2086 and Simvastatin
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the potential interaction between SP2086 and
      Simvastatin after the multiple oral doses treatment in healthy adult volunteers.
    

Detailed description: 
      This is an open-label (volunteers will know the names of treatments they are assigned)
      single-center and cross-over study of SP2086 and Simvastatin in healthy adult volunteers. All
      subject were randomized into two groups, and the drugs will be administered according to the
      AB and BA sequences. The A sequence was that SP2086 was taken at 40mg qd on Day1-Day 10;
      Simvastatin will be administered orally (by mouth) as 200mg on Day 6-Day10.The B sequence was
      that Simvastatin was taken at 40mg qd on Day6-Day10. There were 5 days washout period between
      A and B. The total time of this trial was 27 days.
    

Intervention name(s): SP2086; Simvastatin
Intervention type(s): Drug; Drug
Intervention description(s): The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.; The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SP2086; Simvastatin; drug-drug interaction
Safety, Immunogenicity, and Immune Persistence Study of an Inactivated Hepatitis A Vaccine
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      A double-blind, randomized and controlled clinical trial was conducted in healthy children
      aged from 1 to 8 years to evaluate the immunogenicity and safety of three consecutive lots of
      a preservative-free inactivated hepatitis A vaccine (Healive®).

      Participants who completed their primary vaccination were invited to participate in the
      follow-up phase. Written informed consents were obtained from them. The follow-up study was
      open-label. These subjects were visited in the next 11 years for blood sampling and
      assessment of immune persistence induced by vaccination.
    

Detailed description: 
      The investigated vaccine is an inactivated, adjuvanted and preservative-free hepatitis A
      vaccine. Each dose contained 250 U HAV antigen in 0.5 milliliter.

      Total 400 subjects were enrolled and assigned into four groups, each receiving one of the
      three lots of Healive® or an established control vaccine at month 0 and 6. Anti-HAV titers
      were determined at month 1, 6 and 7. Anti-HAV titer over 20 mIU/ml is defined as
      seroprotection.

      After the full immunization schedule, written informed consents were obtained from subjects
      who would like to participate in the follow-up study. Blood samples of these subjects were
      collected at month 18, 30, 42, 54, 66, 112,138 after the first injection to evaluate the
      seroconversion rates (SCRs) and geometric mean concentrations (GMCs) of antibody against
      hepatitis A virus. Serological results of the follow-up study were then used to explore
      suitable statistical model for predicting the persistence of hepatitis A vaccine-induced
      antibodies.
    

Intervention name(s): Healive® Lot 1; Healive® Lot 2; Healive® Lot 3; Havrix
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart; Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart; Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart; Inactivated hepatitis A vaccine manufactured by GlaxoSmithKline Biologicals; two-dose regimen with 6 months apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: inactivated hepatitis A vaccine; Healive; safety; immunogenicity; immune persistence
A Study to Evaluate Safety and Efficacy of Oral Febuxostat in Patients With Gout
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, open label, randomized, allopurinol-controlled, parallel-design study.
      Approximately 120 subjects will be randomly assigned in 1:1 ratio to receive febuxostat, or
      allopurinol for subjects with gout.
    


Intervention name(s): febuxostat; Allopurinol
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Adenuric, Uloric, Feburic
Intervention MeSH terms: Allopurinol; Febuxostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: xanthine oxidase inhibitor; Uric acid lowering drug
Effect of Physical Activity on Depressive Symptoms With a 5 Month Follow-up
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The main objective of this study is to evaluate the effect of a 12 weeks adapted physical
      activity program (active walking) on depression by analyzing the dynamics of emotional and
      cognitive functioning. The secondary objectives are to test the effects of a physical
      activity on functional performance and to highlight psychological mechanisms.
    

Detailed description: 
      Primary outcomes:

      Self evaluations concerning global self-esteem, a perception of competence and satisfaction
      in the physical self and four sub-domains that are perceived physical endurance, perceived
      competence in sports, perceived physical force and perceived physical appearance, are
      performed.

      Assessment of depressive symptomatology is also realised including momentary levels of
      depression, anxiety, rumination, efficacy of coping strategies and quality of life.

      Secondary outcomes:

      Assessment of postural control
    

Intervention name(s): Physical activity program
Intervention type(s): Other
Intervention description(s): One hour sessions of active walking occurring three times a week during three months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Major depressive disorder; Follow-up study; Ecological momentary assessment; Physical activity; Depression; Self-esteem; Anxiety; Rumination; Quality of life
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children
Condition: ADHD; Attention Deficit Hyperactivity Disorder; Neurodevelopmental Disorders
MeSH terms: Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      Organizational, time management and planning (OTMP) skills deficits are impairing features of
      developmental disorders, such as Attention Deficit Hyperactive Disorder (ADHD), which
      compromise school performance and family relations. The manualized Organizational Skills
      Training program (OST) was designed to target children's specific OTMP deficits. However, the
      brain mechanisms of treatment-induced changes remain unknown. The current study combines a
      training intervention (OST) with non-invasive MRI imaging in a pre-/post-design in a
      randomized two-arm (treatment vs. waitlist) trial to address this question.
    


Intervention name(s): Organizational Skills Training; Waitlist
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Will undergo two magnetic resonance imaging (MRI) sessions: one within 2 weeks prior to OST treatment and one within 2 weeks of completion of the OST treatment.; Will undergo two magnetic resonance imaging (MRI) sessions separated by a 12 week wait period. Will then undergo OST treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment