bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of a Novel Workplace-based Exercise Intervention: a Pilot Study
Condition: Health Behavior
Study type: Interventional

Summary: 
      Sufficient physical activity and a good cardiorespiratory fitness level (CRF) are central in
      cardiovascular disease (CVD) risk reduction. However, many people remain inactive, partly
      because current exercise recommendations fail to address important barriers to exercise. A
      novel exercise protocol has previously been developed called 'reduced-exertion high-intensity
      interval training' (REHIT), which can remove several common perceived barriers to exercise.
      REHIT 1) improves CRF and other key CVD risk factors, 2) is genuinely time-efficient (total
      time-commitment of just 2x10 min per week), 3) is well-tolerated, manageable, and not
      associated with negative affective responses, and 4) can be done in the workplace, in
      work-clothes and without a need to shower afterwards. To date, this intervention has only
      been investigated in a lab-setting. Therefore, in the present randomised controlled trial,
      the 'real-world' effectiveness of REHIT in improving maximal aerobic capacity (V̇O2max; a key
      risk factors of CVD) will be investigated in a workplace setting. Participants' attitudes and
      psychological responses to REHIT will be assessed to evaluate the likelihood of successful
      implementation. In 2 study centres, a total of up to n=50 physically inactive male and female
      office workers will be recruited to perform 6 weeks of unsupervised, computer-guided,
      office-based REHIT (n=25) or act as a control (n=25).
    


Intervention name(s): Reduced-Exertion High-Intensity Interval Training (REHIT)
Intervention type(s): Behavioral
Intervention description(s): REHIT is a type of Sprint Interval Training (SIT) that has been shown to be efficacious at improving maximal aerobic capacity using a minimal volume of exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise
Treating Depressed Mood With a Smartphone-delivered Positive Word Stimulation for Subthreshold Depression
Condition: Subthreshold Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Major depressive disorder (MDD) is an important public health problem. Thus, preventive
      interventions against subthreshold depression (StD), which is one of the key risk factors for
      the development of MDD, are important. The study developed a smartphone application (SPSRS)
      that improves depressive symptoms in people with StD by automatically presenting positive
      word stimuli during videos. The SPSRS application has the potential to improve depressive
      symptoms in people with StDs. However, whether it can immediately improve depressed moods in
      people with StD is unclear. The study aims to investigate the immediate effects of SPSRS
      applications on depressed mood in people with StD.
    


Intervention name(s): Smartphone Application (SPSRS); Smartphone Application (YouTube)
Intervention type(s): Device; Device
Intervention description(s): The experimental group receives video-viewing intervention using the SPSRS application, which is a smartphone application. SPSRS is programmed to present 150 ms of positive words after presenting 17 ms of self-confidence-boosting words in videos.
These words are repeated every 5 s. The words to increase self-confidence are "can," "let us try," "good luck," "able," and "do not worry". These self-confidence-boosting words randomly appear in the four corners of the screen. The positive words are "nice," "great," "fantastic," "satisfactory," and "enjoyable". These words are displayed at the center of the screen. Interveners use the SPSRS application according to the operating manual. The participants will use an iPhone managed by interveners to watch a pre-determined 10-minute video.; The control group uses the same iPhone as the experimental group. The control group uses the YouTube application to receive video-viewing intervention. The control group videos do not show confidence-boosting and positive words. The control group watches the same video as the experimental group for 10 min.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 1 Double-Blinded Study for Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ATI-2173 in Healthy Subjects and Subjects With Chronic Hepatitis B Virus Infection
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Virus Diseases; Herpesviridae Infections; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blinded, randomized, placebo-controlled study of safety, tolerability,
      pharmacokinetics, and antiviral activity in both healthy volunteers and volunteers with
      chronic hepatitis B virus infection. Healthy volunteers will be administered either a single
      oral dose or multiple oral doses of ATI-2173 and assessed for safety and tolerability
      including blood tests to show how the body metabolizes and eliminates the investigational
      drug. Volunteers with a diagnosis of chronic hepatitis B virus infection will be administered
      multiple oral doses of ATI-2173 and assessed for safety and tolerability including blood
      tests to show how the body metabolizes and eliminates the investigational drug as well as how
      the drug effects the virus infection.
    


Intervention name(s): ATI-2173; ATI-2173 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ATI-2173 is a liver-targeted phosphoramidate prodrug of clevudine designed to enhance anti-HBV activity while decreasing systemic exposure to clevudine. It will be dosed as a capsule by mouth.; ATI-2173 Placebo is used as an inactive comparator to ATI-2173. It will be dosed as a capsule by mouth.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial With Diclofenac Sodium Medicated Plaster in Patients With Impact Injuries of the Limbs
Condition: Trauma Injury; Inflammation
MeSH terms: Inflammation; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase III, multinational, multicentre, randomized, prospective, double blind, parallel
      groups, placebo-controlled study to evaluate the analgesic effects of Test Diclofenac Sodium
      140mg medicated plaster, Reference DIEP 180 mg medicated plaster, Flector® and Placebo
      plaster in patients with painful and phlogistic disease due to acute traumatic events of the
      limbs.
    

Detailed description: 
      This will be a Phase III, multinational, multicentre, randomized, prospective, double blind,
      parallel groups, placebo-controlled study to evaluate the analgesic effects of Test
      Diclofenac Sodium 140mg medicated plaster (once a day), Reference DIEP 180 mg medicated
      plaster, Flector® (once a day) and Placebo plaster once a day (i.e. the placebo arm) in
      patients with painful and phlogistic (inflammatory response) disease due to acute traumatic
      events (injury/contusion) of the limbs.
    

Intervention name(s): Diclofenac Sodium 140 mg medicated plaster; Diclofenac epolamine (DIEP) 180mg medicated plaster, Flector; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Test product: Diclofenac Sodium 140 mg medicated plaster, topical application once a day; Reference product: Active-comparator, Diclofenac epolamine (DIEP) 180 mg medicated plaster, Flector®, topical application once a day; Placebo: Placebo plaster, topical application once a day.
Other intervention name(s): EQI7; Flector; Placebo plaster
Intervention MeSH terms: Diclofenac; Diclofenac hydroxyethylpyrrolidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: traumatic
Computer Decision Support to Achieve Glycemic Control in the ICU
Condition: Burns; Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to fill the knowledge gap regarding the burn population with research
      that achieves scientific merit. we will determine the effectiveness of the computer decision
      support system (CDSS) to facilitate glucose management in the critically ill burn patient.

      The EndoTool™ computer decision support system will achieve glycemic control (defined as
      80-110 mg/dL) in a shorter time, reduce glycemic excursion outside of target range, and
      reduce incidence of hypoglycemia (blood glucose less than 50 mg/dL) in the critically ill
      burn patient compared to the standard of care USAISR insulin titration protocol (Appendix A).
    

Detailed description: 
      This is a prospective, paired, randomized, cross-over design, with two groups: current
      standard of care using the USAISR Burn Center insulin titration nomogram (Appendix A) and
      insulin management using EndoTool™ (MD Scientific, LLC) decision support software. Patients
      will thus serve as their own controls.

      Upon admission to the burn ICU, patients expected to require continuous insulin infusion for
      a minimum of 7 days will be placed on EndoTool™ CDSS for the first 24 hours of glycemic
      management. At the 24 hour mark the patients will be randomly assigned to either the CDSS or
      standard of care group in pairs. Thus, the first subject will be randomized to a group and
      the second subject will be placed in the alternate group. This method will ensure equal
      numbers of patients are enrolled in each group to eliminate bias of timing of intervention
      due to the effect of increasing insulin resistance over time demonstrated in the burn
      population (Pidcoke, unpublished, USAISR).
    

Intervention name(s): Endo Tool
Intervention type(s): Device
Intervention description(s): Computer tool to help achieve glucose control
Other intervention name(s): Computer Software for glucose control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: burns; hypoglycemia; hyperglycemia; glucose monitoring
Parental Involvement Improves the Effect of Motivational Interviewing on Weight Loss in Obese Adolescents: A Randomized Controlled Trial Study
Condition: Obesity, Adolescent
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Motivational interviewing (MI) has been shown to be an effective strategy in targeting
      obesity in adolescents and parental involvement has been associated with increased
      effectiveness. The aim of the study is to evaluate and compare the role of parental
      involvement in MI interventions for obese adolescents
    


Intervention name(s): motivational interviewing; motivational interviewing with parental involvement; Control group
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: obese adolescents; BMI ≥ 95th percentile for age and gender
Buprenorphine as a Treatment for Individuals Dependent on Analgesic Opioids
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Opioids used to treat chronic pain have a high abuse potential. The purpose of this study is
      to determine the effectiveness of buprenorphine in treating opioid dependent individuals who
      abuse opioids that are prescribed for chronic pain.
    

Detailed description: 
      Many individuals who take opioids for chronic pain abuse the opioid medication. Buprenorphine
      is an opioid partial agonist that may be effective in treating individuals who abuse opiate
      pain medication. The purpose of this study is to compare two buprenorphine dosing regimens in
      order to determine which regimen is more effective in reducing opiate pain medication use and
      facilitating successful opioid detoxification.

      This study will last 27 weeks. Participants will receive a maintenance dose of 8 mg of
      buprenorphine for 6 weeks, followed by a dose reduction in 2 mg increments over the course of
      the following 20 weeks. All participants will attend weekly clinical management sessions for
      the duration of the study.
    

Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: opioid dependence
Omega 3 Supplementation in Children With Non Alcoholic Fatty Liver
Condition: Fatty Liver
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      this is a prospective, interventional, open-label, randomized study on the efficacy of omega
      3 fatty acids supplementation in Egyptian children with non-alcoholic fatty liver disease who
      had been selected from nutrition and outpatient clinic at Pediatric hospital, Ain Shams
      University
    


Intervention name(s): omega 3 fatty acids
Intervention type(s): Dietary Supplement
Intervention description(s): : Life style modification, diet regimen and Omega-3 fatty acids supplementation: The dose of omega-3 fatty acids depended on the weight of patients according to World Health Organization recommendations 400 milligrams per 10 kilograms of body weight and had been given into two doses per day, before morning and evening meals
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Impact of Cranberries On the Microbiome and the Brain in Healthy Ageing sTudy (COMBAT)
Condition: Aging; Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Tremendous progress has been made in characterizing the interactions between the central
      nervous system and the gastrointestinal tract. This concept of a gut-brain axis suggests that
      influencing bacteria in the gut is a promising approach for developing new ways of benefiting
      brain function. This is particularly relevant for an ageing population for which cognitive
      decline is a common symptom and can be an indicator for the development of neurodegenerative
      conditions such as dementia. There is good evidence already that nutrition can delay the
      development of cognitive decline in ageing, in particular for ageing-sensitive brain regions
      such as the medial temporal lobe, however this has been little explored for cranberry intake.
      Cranberries are high in plant-derived nutrients called polyphenols, which have been suggested
      to promote brain function and protect against disease-causing mechanisms. In the proposed
      project we will pioneer work to investigate the impact of cranberry intake on gut bacteria
      and how it relates to cognitive performance in ageing and associated regions in the brain.

      This study is being conducted by Chief Investigators Dr David Vauzour and Prof Michael
      Hornberger at the University of East Anglia. Sixty participants (i.e. n=30 control and
      treatment groups) aged 50-80 years old, with no memory complaints will be recruited for this
      12-week double-blind placebo-controlled parallel intervention of cranberry flavonoids.
      Freeze-dried cranberry or a matched placebo will be taken twice daily for the duration of the
      trial. Blood, urine and faecal samples will be collected for microbiome, DNA, biochemical and
      nutritional analysis. Participants will also undergo cognitive testing, as well as MRI
      scanning to detect changes in brain physiology.
    


Intervention name(s): Freeze-Dried Cranberry Powder; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Freeze-dried cranberry powder (or matched placebo), approximating 500mg active flavonoids per day, taken twice daily for 12 weeks.; Placebo food powder matched for taste, colour, energy and macronutrient content to the active cranberry powder.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind placebo-controlled parallel intervention
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cognition; Ageing; Nutrition; Microbiome; Flavonoids
VR/AR Educational Module on Oral Care Practices for Home Care Worker
Condition: Virtual Reality; Augmented Reality; Oral Care Performance
Study type: Interventional

Summary: 
      This study is to evaluate the effect of the elderly oral care knowledge, attitude
      ,self-efficacy ,oral care behavior between the home care workers(HCW) in VR(Virtual
      reality)/AR(Augmented reality)group and control group after intervention. Home care workers
      will be randomly assigned to the VR/AR group and the control group. Home care workers in the
      VR/AR group will use VR to learned about the oral care methods and processes in the different
      case. AR allows HCWs to actually operate cleaning teeth. The home care workers in the control
      group used traditional teaching methods for oral care. Baseline and follow-up survey were
      used to collect the data in oral care knowledge, attitude ,self-efficacy ,oral care behavior.
    

Detailed description: 
      A randomized experimental design was used. Home care workers (HCWs) in the VR/AR group
      received 2.5 hours of VR(Virtual reality) and AR(Augmented reality) training. VR offered
      learners the standard oral care procedures under different physical and oral health
      conditions in elderly people and AR simulation training for the manual Bass brushing
      technique. The home care workers in the control group used traditional teaching methods for
      oral care. A self-administered questionnaire was used to collect data regarding oral
      care-related knowledge, attitude, self-efficacy, intention to assist in oral care behavior
      and behavior before and after the intervention, 3-month follow-up and 6-month follow-up. All
      participants finished the self-administered questionnaire within 10-15 minutes and handed it
      to researchers at VR/AR oral care training center in Kaohsiung Medical University.Generalized
      estimating equations (GEEs) was used to analyze the differences between pre-test, post-test
      and follow-ups.
    

Intervention name(s): VR and AR oral healthcare curriculum training; traditional teaching methods oral healthcare curriculum
Intervention type(s): Behavioral; Behavioral
Intervention description(s): HCWs in the VR/AR group received 2.5 hours VR and AR oral healthcare curriculum training. VR oral care training system was training the standard oral healthcare procedure for different physical and oral conditions in elderly people.AR oral care training system was training for the manual Bass brushing technique.; HCWs in the control group received 2.5 hours traditional teaching methods of oral healthcare curriculum training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Virtual reality; Augmented reality; Oral Care Performance; home care worker; elderly
BRAN Pilot Study: Metabolic Signature of Wheat Bran Related to Gut Fermentation in Humans
Condition: Healthy
Study type: Interventional

Summary: 
      It is a pilot study, conducting on 6 healthy women and aiming at defining new biomarkers
      related to wheat bran fermentation. For this, a breakfast, containing 5 biscuits enriched in
      13-C wheat bran (which grown under 13-CO2 enriched atmosphere) is given to the subjects, then
      a following will be realized on 24h with breath, urine, fecal and blood samples. Analysis
      will be performed on these samples in order to determine potential biomarkers of fibers
      consumption to evaluate the metabolic effects of this consumption and to refine the relevance
      of nutritional recommendation regarding fibers for healthy subjects.
    


Intervention name(s): Nutritional Intervention
Intervention type(s): Other
Intervention description(s): The intervention will be done on 1 day, time during which, each subject will stay at the CRNH. A breakfast containing the fibers will be given to them, then during 24h a following will be done to get fecal, urinary, plasmatic and expiratory samples. Standardized lunch, dinner and collation will be served during the day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: biomarkers; fermentation; labeled wheat bran
Phase 2 Study for the Treatment of Superficial Lipomas
Condition: Lipoma
MeSH terms: Lipoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research is to compare the safety and effectiveness of 3 different
      concentrations of deoxycholic acid for injection against a placebo in the treatment of
      superficial lipomas.
    

Detailed description: 
      A lipoma is a fatty lump typically located on the trunk, shoulder, arms, or legs. For the
      purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas
      on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not
      treated.)
    

Intervention name(s): Deoxycholic Acid Injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered via intralipomal injection.; Matching vehicle placebo administered via intralipomal injection.
Other intervention name(s): sodium deoxycholate; ATX-101
Intervention MeSH terms: Deoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment