bioihbjkbjnl/mcl2 huggingface dataset:
Role of Provider-at-Triage on ED Efficiency and Quality of Care
Condition: Patient Satisfaction With Emergency Department Efficiency
MeSH terms: Emergencies
Study type: Observational

Summary: 
      The United States spends over $8,000 per capita annually on health care and its health care
      system is more expensive than other developed countries. Even with high per capita costs and
      a high proportion of physician specialists, the US lags in health care performance from
      patients' perspectives.

      The hospital emergency department (ED) is often the portal of entry for patients seeking
      health care services and is therefore an ideal setting for initiatives to improve efficiency
      of care delivery and patient satisfaction. Reduction in wait times, enhanced information
      delivery and ED staff service quality all have a positive influence on patient perception of
      health care quality and satisfaction.

      Prior studies have attempted to increase patient satisfaction by improving staff
      communication and courtesy, implementing a patient satisfaction team in triage, and
      delivering information to patients in a timely manner. Another strategy to increase the
      efficiency of ED operations is adding a physician to triage to perform brief medical
      screenings and initiate necessary patient testing and treatment. This contrasts to usual
      practice in which physicians evaluate patients only following registration and nurse
      assessment of illness or injury severity.
    

Detailed description: 
      This study will assess the impact of early patient assessment by a physician at Emergency
      Department (ED) triage on patient perception of information delivery, overall patient
      satisfaction and ED efficiency. ED efficiency will be assessed by ED length of patient stay,
      ED left-without-being-seen and ED left during treatment rates.

      Participants who decide to take part in this study, will be asked questions by research
      staff, who will document responses on a secure iPAD device. The survey will ask participants
      how they feel about their health condition, the emergency department wait, the care they
      received in the emergency department and how satisfied the participant was with the care
      received.
    

Intervention name(s): Physician at triage; Usual Care
Intervention type(s): Behavioral; Other
Intervention description(s): A physician embedded at triage; No physician at triage
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals receiving care from the Emergency Department between 10am-3pm on days a
        physician is (Monday-Wednesday) and is not (Thursday-Sunday) assigned to triage.
      
Keywords: Patient Satisfaction; Emergency Department efficiency
Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional

Summary: 
      Objective: Prospective evaluation of GoCheckKids™, a smartphone application ('App') as a
      photo screening device in a pediatric population to detect amblyopia risk factors (ARFs)

      Method: Photorefraction images are captured using up to 4 different devices with GoCheckKids™
      App and patients are evaluated with cycloplegic refraction.
    


Intervention name(s): GoCheck Kids (iOS); GoCheck Kids (Windows)
Intervention type(s): Device; Device
Intervention description(s): Photorefraction method is used to screen amblyopia risk factors.; Photorefraction method is used to screen amblyopia risk factors.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Myopia; Hyperopia; Anisometropia; Amblyopia Risk Factors; Risk Factors; Smartphone Application (App); Photoscreening; Vision Screening; Mobile Vision Screening
Video Training to Reduce Insulin Administration Errors
Condition: Diabetes Mellitus, Type 2; Insulin Injection Pad; Injection Site; Insulin Implementation Errors; Educational Problems
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Efficiency of training with video to reduce injection errors in patients using insulin
    

Detailed description: 
      The aim of this study is to examine the effects of using insulin administration video and
      insulin administration brochure as teaching materials in insulin administration training
      given to type 2 diabetes patients on correcting insulin administration errors. This
      randomized controlled experimental study was carried out with 94 people who applied to the
      diabetes outpatient clinic of Istanbul Medeniyet University Goztepe Training and Research
      Hospital between December 2019 and January 2021. Using a computer-based randomization method,
      52 and 42 people were assigned to the groups that received training with video and brochures,
      respectively. In the first interview, patients' insulin administration characteristics were
      evaluated, and the training was repeated using the video or brochure, after which the
      training material corresponding to the group according to the randomization list was given.
      Insulin administration characteristics of the patients were re-evaluated one week and three
      months later. Patient information form developed by the researcher based on the literature
      was used to collect the data. Data were analysed using descriptive statistics, independent
      sample t-test and Mann Whitney U test. The error rates in the interviews were analysed with
      the Cochrane Q test, and the relationship between independent categorical variables was
      examined with the Chi-square test.
    

Intervention name(s): Video group
Intervention type(s): Behavioral
Intervention description(s): Insulin administration video was sent to the mobile phones of the patients assigned to the video group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Effects of Rec 0/0438 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury
Condition: Neurogenic Detrusor Overactivity
MeSH terms: Spinal Cord Injuries; Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Rec
      0/0438 in subjects with neurogenic detrusor overactivity due to spinal cord injury
    

Detailed description: 
      Multicentre, double-blind, randomised, parallel groups, placebo-controlled study to be
      conducted in specialized centres in Europe to investigate the safety, tolerability,
      pharmacokinetics and pharmacodynamics of two different doses of Rec 0/0438 in comparison with
      placebo, in subjects with neurogenic detrusor overactivity due to spinal cord injury.
    

Intervention name(s): Rec 0/0438 1 mg or Rec 0/0438 2 mg; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each vial content will be administered via the catheter used for the self-catheterization; Each vial content will be administered via the catheter used for the self-catheterization
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: two sequential cohorts, each corresponding to a dose level.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Immune Benefits of Coffee
Condition: Immune Senescence; Low-grade Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      This study will assess whether coffee consumption:

        -  increases immune responses

        -  decreases inflammatory status
    

Detailed description: 
      Epidemiological studies suggest that coffee consumption is associated with protective effects
      against several types of chronic diseases. Recent data have shown that certain coffee
      components may possess anti-inflammatory and immune-enhancing properties. Low-grade
      inflammation and poor capacity of immune response is highly prevalent in elderly subjects.

      The purpose of this study is to evaluate whether coffee consumption improves immune and
      inflammatory status in healthy elderly subjects. To sort out the role of antioxidants, we
      will test 2 different soluble coffee, i.e. fully torrefied coffee and partially torrefied
      coffee.
    

Intervention name(s): Fully torrefied coffee; Partially torrefied coffee
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fully torrefied coffee; Partially torrefied coffee
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coffee; Elderly; Immune response; Inflammatory status
Understanding Variability in Behavioral Weight Loss Treatment Response in Young Women (Ready SET Health)
Condition: Weight Loss; Weight Change, Body; Overweight or Obesity
MeSH terms: Obesity; Overweight; Body Weight; Weight Loss; Body Weight Changes
Study type: Interventional

Summary: 
      This study is a single-arm behavioral weight loss intervention for emerging adult women with
      in-person assessments at 0 (baseline) and 4 months (post-treatment) in addition to EMA data
      collection regarding risk factors known to interfere with program engagement and weight loss
      in this high-risk population (e.g., sleep, psychological distress, life events).
    

Detailed description: 
      This study will implement a 4-month Internet-based behavioral weight loss intervention in
      order to collect ecological momentary assessment (EMA) data that will shed light on real-time
      barriers to weight management. The intervention is evidence-based and adapted with respect to
      content and delivery mode in order to meet the needs of emerging adult women. Consenting and
      eligible participants will receive 1 virtual group session led by a trained interventionist
      followed by weekly emails directing them to an intervention website housing video and .pdf
      content, weekly text messages, emailed tailored feedback regarding their weight loss
      behaviors and progress, and a closed Facebook group to facilitate social support. All
      participants will be followed for 4 months with hybrid in-person/virtual assessments at 0 and
      4 months; in addition, all participants will be asked to respond to EMA prompts throughout
      the 4-month intervention period (Week 2, Week 4, Week 7, and Week 13).
    

Intervention name(s): Ready SET Health
Intervention type(s): Behavioral
Intervention description(s): This behavioral weight loss intervention will span 16 weeks. The first session (Week 1) will be a virtual "Weight Loss 101" group kick-off followed by 15 weeks of a technology-mediated program consisting of the following: weekly emailed content (videos and readings explaining key skills and strategies to produce weight loss) and weekly emailed tailored feedback (based on self-monitoring data from participants). A trained interventionist ("coach") will lead the group session, provide weekly tailored feedback, and monitor participant progress.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: emerging adults; women; weight loss barriers
Maine Lung Cancer Coalition: Using CHWs for the Annual Lung Cancer Screening Reminder
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      This research study will test whether support from a Community Health Worker (CHW) to address
      barriers to annual LDCT screening will result in an increased number of patients who receive
      the annual screening as per the recommended standard of care compared to passive outreach
      using a reminder letter.
    

Detailed description: 
      This research study is a randomized controlled trial comparing phone outreach by a trained
      Community Health Worker (CHW) following a reminder letter to the reminder letter alone for
      patients who are at least a month overdue to have a routine annual low dose CT scan (LDCT)
      screening for lung cancer. CHWs will be able to identify and address barriers to accessing
      screening for those patients randomized to that arm of the study. Outcomes that will be
      measured include scheduling and completing the LDCT as well as agreeing to a referral for
      tobacco treatment.
    

Intervention name(s): Letter; Community Health Worker Phone Call
Intervention type(s): Behavioral; Behavioral
Intervention description(s): MaineGeneral Radiology will generate a reminder letter about their need for an annual low dose CT scan to the subjects in this arm.; Patients will receive a phone call from community health worker, offering to help them overcome barriers to repeat annual screening and offering to help them schedule their screening.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible patients will be randomly assigned to one of the following two groups:
1. Control Group:
o Annual reminder letter only
Intervention Group:
Annual reminder letter and Community Health Worker proactive outreach
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: Screening
Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the repeat-dose safety and effectiveness of a
      bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11
      years with asthma. The dosing period lasts three weeks and starts following a three-week
      run-in period.
    


Intervention name(s): Albuterol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Albuterol 90mcg; Placebo
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Pediatric asthma
Relationship Between HbA1c Level, Sleep Quality and Sleep Duration
Condition: Diabetes Mellitus, Type 2; Pre Diabetes; Sleep Disorder
MeSH terms: Sleep Wake Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
Study type: Observational

Summary: 
      The study will be conducted during the period of, January 2019 - August 2019 with
      pre-diabetic participants on a NHS England funded National Diabetes Prevention Program (NDPP)
      with a clinically diagnosed Haemoglobin A1c (HbA1c) referral reading of between 42mmol/mol -
      47mmol/mol within the last 12 months. The term pre-diabetic can all be used to explain blood
      glucose levels that are higher than normal, but not high enough for participants to be
      diagnosed with Type 2 diabetes. Having high blood glucose levels can increase a participant's
      risk of developing Type 2 diabetes and other health complications, although this is not
      inevitable.

      100 participants will take part in the study. Participants will be eligible if they are aged
      between 18 and 65 years and have an HbA1c referral reading of between 42-47mmol/mol within
      the last 12 months.

      The participants will be given a written consent form to sign to take part in the study,
      after receiving both written and verbal information beforehand on the study protocol from the
      researcher. Health screening to determine eligibility for the NHS funded program will be
      undertaken directly by the intervention provider.

      Study design and procedures:

      The study will be delivered in a controlled format and will be designed to assess the
      relationship between the elevation of HbA1c level, sleep quality and sleep duration in
      clinically diagnosed pre-diabetic participants referred and registered to join the NHS NDPP.
      Participants will receive a pre-program information pack in conjunction with a sleep quality
      and sleep duration questionnaire at the end of their 1:1 initial appointments for the NHS
      NDPP.

      Participants will be given prepaid envelopes to send their anonymised questionnaires back to
      the researcher once completed after their appointments. The researcher will ensure
      confidentiality by keeping all questionnaires in a securely combination coded locked cupboard
      that only the researcher has access to. Participants will be instructed to not write their
      names on the questionnaires but to only state their gender, age, and referral HbA1c reading
      received from the relevant health care professional.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Aged 18 years - 65 years with pre-diabetes (diagnosed as HbA1c referral reading of between
        42-47mmol/mol within the last 12 months)
      
Keywords: HbA1c; Sleep Quality; Sleep Duration; PSQI
Tx for Child Sexual Behavior Problems
Condition: Sexual Behavior
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      A significant minority of children (ages 5-12) display problematic sexual behavior and the
      persistence of this behavior is oftentimes as stable as other child behavior problems, such
      as aggression and defiance. Unfortunately, the only tested intervention protocols for these
      concerns utilize a group treatment modality that is not feasible in most community treatment
      settings. This project will define and pilot test an intervention for child sexual behavior
      problems that is applicable in most settings and can be easily disseminated as a first step
      toward validation in larger clinical trials.
    


Intervention name(s): Phase-based treatment of sexual behavior problems of children
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of VEC-162 compared to
      placebo to improve sleep parameters in a model of insomnia.
    


Intervention name(s): 20 mg VEC-162; 50 mg VEC-162; 100 mg VEC-162; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 20 mg VEC-162; 50 mg VEC-162; 100 mg VEC-162; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects
Condition: Healthy Male Chinese Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of a 200 mg single dose Lacosamide
      (LCM) intravenous (iv) solution with a 200 mg single dose LCM oral tablet in healthy Chinese
      male subjects.
    


Intervention name(s): Lacosamide (LCM) tablet; Lacosamide (LCM) solution for infusion
Intervention type(s): Drug; Drug
Intervention description(s): Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg; Treatment B: Single dose of Lacosamide (LCM) 200 mg administered as intravenous infusion
Other intervention name(s): Vimpat; Vimpat
Intervention MeSH terms: Lacosamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Lacosamide; Bioequivalence; Intravenous solution; Tablet
A Study to Determine the Safety and Efficacy of a New Non-invasive Heating Garment to Reduce Urinary Hesitancy
Condition: Benign Prostatic Hyperplasia (BPH); Urinary Retention; Urinary Hesitancy Intermittent
MeSH terms: Prostatic Hyperplasia; Urinary Retention; Hyperplasia
Study type: Interventional

Summary: 
      To determine the safety and efficacy of the ThermaRx heating device for the application of
      controlled low level heat to improve symptoms of LUT dysfunction (hesitancy, urgency).
    

Detailed description: 
      This study will assess the safety and efficacy of ThermaRx heat treatment in subjects who
      have urinary hesitancy.

      The rationale for this approach is based on anecdotal evidence and case reports suggesting
      that urinary hesitancy can be effectively reduced by external skin heating (hot tub "Jacuzzi"
      effect, perineal hot water spray). However, to date, there have been no formal studies of
      this non-invasive form of treatment, and the mechanism of action is still unclear.

      This is a two-day study in which each subject will receive an oral fluid load and then one
      (1) heating treatment with the device. Ultrasound-based measurements of bladder volume will
      be performed both before and after voiding. On Day 1, voiding will be performed in a standing
      position; on Day 2, voiding will be done in a sitting position.
    

Intervention name(s): FlowPants(R) Garment
Intervention type(s): Device
Intervention description(s): The garment is shaped like a pair of boxer briefs. Garment heating is battery-powered.
The garment is activated and begins to heat up 5-15 minutes prior to voiding.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Benign Prostatic Hyperplasia; BPH; Benign Prostatic Hypertrophy; Urinary Retention; Shy Bladder; Urinary Hesitancy; Bashful Bladder; Paruresis