bioihbjkbjnl/mcl2 huggingface dataset:
Sensory Versus Motor Level Neuromuscular Electrical Stimulation
Condition: Stroke, Ischemic
MeSH terms: Ischemic Stroke
Study type: Interventional

Summary: 
      Dysphagia is a serious cause of morbidity and mortality in stroke survivors. Electrical
      stimulation is often included as part of the treatment plan for dysphagia, and can be applied
      at a sensory or motor level intensity. However, evidence to support these different modes of
      stimulation is lacking. This study compared the effectiveness of sensory and motor level
      stimulation on post-stroke dysphagia.
    

Detailed description: 
      Objective: Dysphagia is a serious cause of morbidity and mortality in stroke survivors.
      Electrical stimulation is often included as part of the treatment plan for dysphagia, and can
      be applied at a sensory or motor level intensity. However, evidence to support sensory versus
      motor stimulation is lacking. This study compares the effect of sensory and motor stimulation
      on post-stroke dysphagia.

      Design: Randomized controlled trial

      Setting: Inpatient rehabilitation facility.

      Participants: Participants (50-75 years of age) who had dysphagia caused by a stroke within 6
      months prior to enrollment were included. Participants were excluded if they had a
      contraindication for electrical stimulation, previous stroke, psychiatric disorder,
      contraindications for MBS, or pre-stroke swallowing disorders.

      Interventions: Each patient received ten, 45-minute anterior neck sensory or motor level
      electrical stimulation sessions in addition to standard speech therapy. Motor stimulation was
      administered as a stimulus intensity sufficient to produce muscle contractions. Sensory
      stimulation was defined as the threshold when the patient feels a tingling sensation on their
      skin (approximately 4-5mA).

      Main Outcome Measures: Swallow FIM, National Outcome Measurement System (NOMS), Dysphagia
      Outcome Severity Scale (DOSS), and change in modified diet.
    

Intervention name(s): Neuromuscular electrical stimulation
Intervention type(s): Device
Intervention description(s): Motor stimulation was administered at an intensity sufficient to produce muscle contractions. Sensory stimulation was defined as the threshold when the patient feels a tingling sensation on their skin.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dysphagia; Swallow; Stimulation
Pneumatic Dilatation or Surgical Myotomy for Achalasia
Condition: Achalasia
MeSH terms: Esophageal Achalasia
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with newly diagnosed achalasia have been submitted to either treatment with
      pneumatic dilatation or surgical myotomy. Minimal follow up five years.
    

Detailed description: 
      Patients with newly diagnosed achalasia have been submitted to either treatment with
      pneumatic dilatation or surgical myotomy. Minimal follow up five years.

      During follow up patients have been interviewed with regular intervals, by use validated
      questionnaires. The level of symptom control has been assessed as well as the scoring
      cumulative incidence of treatment failures.

      Health Related Quality of Life (HRQL) has been regularly checked.
    

Intervention name(s): Pneumatic dilatation; Laparoscopic myotomy
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      For the primary goals, we hypothesize that 1) the oral tobacco product will be more
      efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2)
      among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette
      smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal
      nicotine use will be observed during and beyond the treatment period.

      For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal
      symptoms from cigarette abstinence; and 2) the toxicant exposure and toxicity will be reduced
      dramatically when smokers switch from cigarettes to each of these products; however, this
      reduction will be greater with the use of medicinal nicotine.
    

Detailed description: 
      This second study under "Oral Tobacco as a Harm Reduction Product" grant is a clinical trial.
      Subjects will be randomized to the brand of smokeless tobacco that is determined to be most
      effective in Study 1 or to nicotine gum for 12 weeks to compare complete substitution for
      smoking. The secondary aims are to determine the effects of the products on biomarkers of
      exposure and toxicity. Other secondary aim includes examining the effects of the two products
      on withdrawal symptoms. Two sites will be used for these studies: University of Minnesota and
      Oregon Research Institute (ORI).
    

Intervention name(s): Oral tobacco; Nicotine Gum
Intervention type(s): Other; Drug
Intervention description(s): Snus; 4 mg Nicotine gum
Other intervention name(s): Camel Snus; Nicorette
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oral Tobacco Products; Snus; Smoking Substitution; Harm Reduction; Biomarkers of Tobacco Exposure
Trans-theoretical Model Based Home Visiting on Medication Behavior
Condition: Hypertension; Medication Adherence
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This study was a single-blinded, two-armed, randomized controlled trial comparing a
      medication self-management intervention to usual care for hypertensive elderly in the
      residential care facility.

      To explore the effect of stage-matched tailored education on disease management for
      hypertensive elderly. Patient were randomly assigned to either a 6-month trans-theoretical
      model-based medication management intervention group or a treatment-as-usual group. we would
      like to improve its adherence to the medicine prescribed by their own physician through five
      sessions of face-to-face interview which focused on anti-hypertensive medication-related
      information, the importance of medication refills, motivation, self-management and self-check
      skills.
    

Detailed description: 
      This study was a single-blinded, two-armed, randomized controlled trial comparing a
      medication self-management intervention to usual care for hypertensive elderly in the
      residential care facility. From October 2018 to November 2018, convenience sampling was used
      to recruit 120 participants from one of the most extensive facilities in Zhengzhou, China.
      Individuals aged 65 years of age or older diagnosed had stage I or stage II hypertension
      (140-159/90-99 mm Hg or 160-180/100-110 mm Hg, respectively), as confirmed by the
      professional physician and prescribed anti-hypertensive medication by the physician for at
      least six months and with an estimated life expectancy of no less than six months were
      included.The intervention included five educational sessions focused on anti-hypertensive
      medication-related information, the importance of medication refills, motivation,
      self-management and self-check skills.
    

Intervention name(s): behavior management for anti-hypertensive medication; placebo group
Intervention type(s): Behavioral; Other
Intervention description(s): five sessions of educational interview and home visiting to improve medication-related self-management skills; treatment as usual
Intervention MeSH terms: Antihypertensive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Satiety Response of Short Chain Fructooligosaccharide
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Populations that report high fiber consumption demonstrate lower rates of obesity. Enhanced
      satiety may play a key role in this relationship. The colonic fermentation of fibers is
      theorized to influence satiety and food intake. Short chain fructooligosaccharide (scFOS) are
      rapidly fermentable fibers that can easily be added to foods to impact these parameters.

      The objective of this study was to evaluate the satiety response of scFOS and its ability to
      decrease food intake.
    

Detailed description: 
      Intervention study with fiber added to beverages and acute effects on satiety measured.
    

Intervention name(s): Short chain fructo-oligosaccharide (scFOS) 5 g; Placebo; Short chain fructooligosaccharide (scFOS) 8 g
Intervention type(s): Dietary Supplement; Other; Dietary Supplement
Intervention description(s): Dietary Supplement: scFOS 5 g
Novel fiber administered in two 5 g doses--the first in a beverage and the second in a solid chew.; Treatment without scFOS fiber; Novel fiber administered in two 8 g doses--the first in a beverage and the second in a solid chew.
Other intervention name(s): fructo-oligosaccharide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory
Condition: Stress, Psychological; Stress, Physiological; Anxiety; Pain Perception
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The goal of this study is to assess the utility of virtual reality technology to aid in the
      mental health of patients with cardiac disease, specifically looking at decreasing anxiety
      and perceptions of pain from stressful procedures in the pediatric electrophysiology
      laboratory.
    

Detailed description: 
      The investigators will perform a pilot study of 40 patients who are randomized to either
      standard of care preparation for an electrophysiology procedure (control arm) vs. Virtual
      Reality preparation (VR arm). Participants in control arm will have standard preparation for
      a procedure including discussion of the procedure with the provider the day before the
      procedure with all questions answered at that time. VR arm participants will have access to
      the Virtual Reality tour and gear 1 week prior to the procedure. VR arm participants will be
      instructed to watch the Virtual Reality tour at least three times prior to the procedure but
      will be encouraged to watch as often as the participants would like. The Virtual Reality
      equipment will measure how often participants complete the tour. All participants will
      undergo anxiety measures a total of four times: once at time of recruitment, day of procedure
      and then 1 week and 4 weeks post procedure. Participants will have cortisol salivary swabs
      performed 1 week before procedure (before VR use), pre-op visit, day of procedure, and
      immediately following procedure. Heart rate and blood pressure will be measured on day of
      procedure.
    

Intervention name(s): Use of Virtual Reality App
Intervention type(s): Behavioral
Intervention description(s): The VR app will consist of relaxation techniques as well as a virtual tour of the hospital (pre-op area, IV placement, cath lab, and post-op area).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virtual Reality; Stress Inoculation; Procedure
Virtual Reality Effect in Geriatric Individuals
Condition: Pain; Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study aimed to determine the effect of a virtual reality experience on pain, depression
      and functional adequacy in geriatric individuals living in a nursing home.

      A virtual reality video with dance moves has been applied to the experimental group
      participants. Each video takes 3 minutes, and the elderly person has been put into practice
      at least 30 minutes after having breakfast in 3-minute periods and at least 30 minutes after
      dinner. In the morning and evening, 15 minutes, 2 times a day, a total of 9 days were applied
      for 3 weeks. The application lasted a total of 3 weeks. Scales were applied 1 week after the
      virtual reality application was completed and 1 month after the experimental group. The
      scales were filled in the control group at the same time.
    

Detailed description: 
      It is recommended that the future studies be conducted with larger samples on pain,
      depression, life quality and functionality.
    

Intervention name(s): virtual reality game
Intervention type(s): Other
Intervention description(s): routine
Other intervention name(s): routine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: geriatric pain; geriatric depression
Brain Connectivity in Age-Related Macular Degeneration
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      This study is to determine how cognitive deficits (e.g.,verbal fluency deficit) in patients
      with Age-Related Macular Degeneration (AMD) relate to specific aspects of brain and function.
      The study team will assess whether the "brain signatures" associated with specific cognitive
      deficits differ in older adults with and without AMD.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will include 300 participants: 150 subjects with AMD plus 150 age, gender, and
        education-matched adults without AMD. All participants will receive baseline and 2 year
        neurocognitive tests and a subset will provide structural and "resting stage"functional
        magnetic resonance images (MRIs) at each time point.
Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults
Condition: Oxygen Consumption
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Albuterol is the most commonly used β agonist to treat reversible lower airway obstruction.
      Albuterol contains a racemic mixture of two enantiomers. Levalbuterol contains the single R
      form enantiomer. Levalbuterol is frequently prescribed to limit cardiovascular toxicity. The
      investigators sought to examine the changes in oxygen consumption (V'O2) and Heart Rate (HR)
      following administration of albuterol and
    

Detailed description: 
      Inhaled β2 adrenoceptor agonists are frequently used to treat reversible lower airway
      obstruction, or to assist with mucociliary clearance. Albuterol remains the most commonly
      used β agonist and contains a racemic mixture of two enantiomers. The R enantiomer is the
      active moiety responsible for the bronchodilation, while the S enantiomer was initially
      thought to be inactive, although recent studies suggest otherwise. Levalbuterol contains the
      single R form enantiomer, and in clinical practice it is frequently prescribed not only
      because of its bronchodilator benefits, but to limit cardiovascular toxicity. Adverse
      cardiovascular effects remain the main dose-limiting factor for β2 agonists. The primary
      objective of the investigators study is to compare the change in oxygen consumption following
      albuterol to that of levalbuterol, in healthy adult volunteers. The investigators
      hypothesized there would be no clinically significant difference in V'O2 between the two
      drugs, if equal doses of the R-enantiomer were administered. Secondary objectives were to
      compare the changes in heart rate and other vital signs between the two drugs.
    

Intervention name(s): Albuterol; Levalbuterol
Intervention type(s): Drug; Drug
Intervention description(s): Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.; Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Beta Agonists; Asthma; Albuterol; Levalbuterol
Pilot Study of the GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children
Condition: Diabetes Mellitus, Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Devices such as the GlucoWatch G2 Biographer (GW2B), which constantly measure blood sugar
      levels, may improve the treatment of Type 1 diabetes mellitus in children. This study
      evaluated the GW2B when used by children in their homes.
    

Detailed description: 
      The proper role of the GW2B in the management of Type 1 diabetes in children has not been
      determined. As a prelude to a large-scale randomized clinical trial (RCT) to compare the
      effect on glycemic control, hypoglycemia, and quality of life of using a GW2B versus standard
      care, the DirecNet Study Group conducted a pilot study to assess the feasibility of the
      protocol planned for the RCT and to collect data on changes in HbA1c, frequency of
      hypoglycemia, frequency of skin reactions, and quality of life after using the GW2B for three
      months.

      Fifteen children and adolescents with Type 1 diabetes participated in this study. Each
      patient was provided with a personal computer for weekly downloading of the GW2B and for
      completion of questionnaires regarding hypoglycemia and GW2B use. Participants received study
      telephone calls after 1, 2, and 4 weeks and every 4 weeks thereafter to review their diabetes
      management. Participants had a follow-up visit at Week 29. The Continuous Glucose Monitoring
      System was inserted at this visit to assess hypoglycemia over three days. A follow-up visit
      was performed at Week 30 to measure HbA1c and administer psychosocial questionnaires.
    

Intervention name(s): GlucoWatch® G2™ Biographer (GW2B); Continuous Glucose Monitoring System™ (CGMS)
Intervention type(s): Device; Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Diabetes Mellitus, Insulin-Dependent; Type 1 Diabetes; Continuous Glucose Monitoring Devices; Electronic Data Collection
Investigating Handwriting Characteristics and Underlying Factor in Children With Autism Spectrum Disorder
Condition: Children With Autism Spectrum Disorder; Typical Developed Children
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Observational

Summary: 
      The mechanism of the motor problem in children with autism spectrum disorder (ASD) in
      handwriting has been investigated in the following three aspects, including collecting
      dynamic handwriting performance, exploring the related underlying factors, and investigating
      corresponding brain activities. This study aimed to investigate the underlying factor of
      handwriting issue in children with ASD. There are four study aims. The first is to examine
      the differences of handwriting performance between children with ASD and TD using kinetic and
      kinematic measurements and handwriting difficulties questionnaires. The second is to
      investigate the group difference of the underlying motor factors, including fine motor
      ability and sensorimotor ability. The third is to explore the relationship between underlying
      motor factors and handwriting performance. The fourth is to explore the corresponding
      cortical activity during writing in children.
    


Intervention name(s): handwriting experiment and motor ability test
Intervention type(s): Behavioral
Intervention description(s): Participants will be instructed to participate in a handwriting experiment, which involves utilizing a Force Acquisition Pen (FAP) system and Near Infrared Spectroscopy (NIRS) to collect force data and cortical activation, respectively, during handwriting tasks. Children will be tasked with completing various assignments, such as tracing lines, writing numbers, and characters, among others. Additionally, assessments of motor ability and handwriting proficiency will be conducted using the Movement Assessment Battery for Children (MABC) and the Chinese Handwriting Evaluation Form (CHEF). The Pinch Holding Up Activity (PHUA) Test will also be administered to assess their sensorimotor ability.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children with ASD group:

          -  Meeting the criteria for ASD according to DSM-5 from psychiatrist

          -  ASD core symptoms: CARS higher than 30

        TD group:

        - The percentage score of MABC-2 is larger than 25% (not determined as "impaired motor
        coordination")
      
Keywords: Autism; Handwriting; Kinetic and kinematic; Cortical activation; Sensorimotor
RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders
Condition: Child Development Disorders, Pervasive
MeSH terms: Autistic Disorder; Developmental Disabilities; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      This 24-week study will compare the safety and effectiveness of medication treatment alone
      (risperidone or aripiprazole) to medication treatment in combination with a parent management
      training program.
    

Detailed description: 
      PDD can be a profoundly disabling condition across social, emotional, and academic domains.
      Safe and effective treatments for PDD are needed.

      Participants are randomly assigned to receive either risperidone plus parent management
      training or risperidone alone for 24 weeks. Participants who show deterioration at Week 4
      will be offered an alternative mediation treatment, aripiprazole. These participants will
      remain in their original treatment group (either med alone or med plus parent management
      training). After 6 months of treatment (Week 24), participants who respond to their treatment
      will be gradually discontinued from their medication treatment to learn if the response can
      be sustained without continued medication treatment (This phase of the study was ended in
      Nov. 2006) Adaptive and behavioral outcomes are assessed during the study.
    

Intervention name(s): Risperidone; Behavior Therapy
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autistic Disorder; Asperger Syndrome