bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of taVNS on Inhibitory Control
Condition: Healthy
Study type: Interventional

Summary: 
      The main aim of the study is to investigate whether the transcutaneous vagus nerve
      stimulation(tVNS) improves the ability of inhibitory control in an emotional Go-Nogo task.
    

Detailed description: 
      A randomized, sham-controlled, between-subject design will be employed in this study. A total
      of 87 healthy subjects will receive either transcutaneous vagus nerve stimulation via tragus
      or sham stimulation via the earlobe in the left ear. Brain activity and behavioral data for
      an emotional Go-Nogo task will be recorded and saliva samples will be collected before,
      during, and after stimulation.

      Some personal traits will be assessed using different kinds of questionnaires, such as the
      State-Trait Anxiety Inventory (STAI), Beck's Depression Inventory(BDI), Autism Spectrum
      Quotient (ASQ) et al.
    

Intervention name(s): Vagus nerve stimulation via tragus; Sham stimulation via earlobe
Intervention type(s): Device; Device
Intervention description(s): The device will send stimulus intensity of around 0.5mA via tragus in the left ear (based on participants' subjective report), delivered with a pulse width of 0.5 ms at 25 Hz. Stimulation will be active for 30 seconds, followed by a break of 30 seconds.; The device will send stimulus intensity of around 0.5mA via the earlobe in the left ear (based on participants' subjective reports), delivered with a pulse width of 0.5 ms at 25 Hz. Stimulation will be active for 30 seconds, followed by a break of 30 seconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
WalkLink: Internet-based Walking Program
Condition: Physical Activity
Study type: Interventional

Summary: 
      The investigators propose a randomized controlled trial based on the Social Networks for
      Activity (SNAP) Model to evaluate: (1) the effectiveness of an internet-based fitness walking
      program delivered to patients with risk factors for cardiovascular disease and stroke; and
      (2) the contribution of social support networks to enhancing the effectiveness of the
      internet-based fitness walking program. The investigators will recruit 308 patients who are
      sedentary and have risk factors for cardiovascular disease and randomly assign them to one of
      the following groups: 1. Internet-based fitness walking program (WalkLink); 2. Internet-based
      fitness walking program plus additional social network intervention (WalkLink+); and 3.
      Minimal treatment control.

      The primary specific aims of this study are to:

        1. Evaluate the effects of WalkLink and WalkLink+ relative to a minimal treatment control
           group on change in: physical activity, aerobic fitness, blood pressure, body
           composition, and body mass index (BMI), from baseline to posttest, and at 6-month
           follow-up.

        2. Compare the differential effectiveness of WalkLink+ to WalkLink on change in: physical
           activity, aerobic fitness, blood pressure, body composition and BMI from baseline to
           posttest, and at 6-month follow-up.

        3. Evaluate the mediator and moderator effects of selected individual-level self-management
           skills (goal setting, planning, self-monitoring), social support variables (number of
           activity partners, social cues for walking, social praise/reinforcement), and
           physical-ecological variables (neighborhood walkability, physical cues for walking) on
           WalkLink and WalkLink+ treatment outcomes.
    


Intervention name(s): Group
Intervention type(s): Behavioral
Intervention description(s): Walking programs with various levels of support will be administered to determine which one is most effective.
Other intervention name(s): Enhanced Usual Care; WalkLink; WalkLink+
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Walking programs; Physical Activity; Behavior Modification; Social Support
Feasibility of Randomizing Danish Citizens Aged 65-79 Years to High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in a Pragmatic Registry-Based Setting
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess the feasibility of identifying, recruiting and
      randomizing a large sample of Danish citizens aged 65-79 years to high-dose quadrivalent
      influenza vaccine or standard-dose quadrivalent influenza vaccine in the 2021/2022 influenza
      season in a registry-based setting using Danish nationwide registries for all data collection
      including baseline information and outcome assessment.
    

Detailed description: 
      To evaluate the feasibility of recruiting and randomizing Danish citizens aged 65-79 years,
      we aim to randomize 40,000 citizens 1:1 to high-dose quadrivalent influenza vaccine or
      standard-dose quadrivalent influenza vaccine in a pragmatic, open-label, registry-based
      design using the infrastructure of Danske Lægers Vaccinations Service (DLVS), an organization
      responsible for numerous vaccination clinics in Denmark, for recruitment and randomization
      and Danish nationwide registries for data collection. Citizens will be recruited by DLVS and
      randomized and vaccinated at the DLVS clinics. All collection of data related to baseline
      information, outcomes, and safety monitoring will be performed by a central trial site
      utilizing information from Danish nationwide health registries.

      The findings of this pilot trial will indicate whether the conduction of a full-scale,
      adequately powered pragmatic RCT is feasible within the Danish registry-based framework.
    

Intervention name(s): Standard-Dose Quadrivalent Influenza Vaccine; High-Dose Quadrivalent Influenza Vaccine
Intervention type(s): Drug; Drug
Intervention description(s): For the control arm, the standard-dose quadrivalent influenza vaccines Influvactetra® and Vaxigriptetra will be used.; For the control arm, the high-dose quadrivalent influenza vaccine Efluelda®/Fluzone® High-Dose Quadrivalent will be used.
Other intervention name(s): QIV-SD; QIV-HD
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Influenza; Vaccination; Pragmatic; Registry
Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause
Condition: Vaginal Dryness
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once
      daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause
      in women with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA.
    


Intervention name(s): Ospemifene; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 60 mg tablet; Tablet identical to the ospemifene tablet without drug
Other intervention name(s): Osphena®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vulvo-vaginal Atrophy; menopause
Comparison of Two Types of Splints to Treat Dental Luxation Injuries
Condition: Dental Trauma; Splints
MeSH terms: Joint Dislocations
Study type: Interventional

Summary: 
      The objectives of this randomized clinical trial (RCT) were:

        1. To compare the efficiency of splinting by two composite materials in terms of retention
           of material

        2. To compare adhesive point dimension between the two groups

        3. To compare time taken to place and remove the splint

        4. To assess the efficacy of bulkfill flowable in reducing mobility of luxated teeth.
    

Detailed description: 
      A Randomized control trial of 6 month period was done. Patients with luxation injuries aged
      between 16- 50 years were asked to participate in the study after taking informed consent.
      They were then assigned to either group (Group 1: Packable Composite (PC), Group 2: Bulkfill
      Flowable) by lottery method. Periotest was used to check the mobility of teeth before the
      placement of splint. Splinting was performed with composite material according to group
      allocation. Time taken to place the splint was recorded. Frontal view images of splinted
      teeth were taken with DSLR and transferred to Adobe Photoshop Version 22.4.1 for windows to
      measure surface area of the restorative material in percentage to total tooth surface area.
      Post-operative instructions were given. After 2 weeks, Periotest readings were recorded,
      immediately after removal of splint. On both visits 3 readings per tooth were recorded. Time
      taken to remove the splint was also recorded. Additionally, the retention of splint was also
      observed.

      STATISTICAL ANALYSIS:

      SPSS version 26 for windows was used, the mean time taken to apply and remove the material
      and mobility before and after removal of splint was compared using the independent samples T
      test. Mann-Whitney test compared the percentage area of the material occupied. Fisher's Eaxct
      test evaluated the retention of splint material. Level of significance was kept at p ≤0.05.
    

Intervention name(s): Splint retained by Bulk-fill flowable; Splint retained by Packable Composite
Intervention type(s): Device; Device
Intervention description(s): Luxated teeth were splinted with bulk-fill flowable composite; Luxated teeth were splinted with packable composite
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study model was a randomised control trial. The included patients were randomly allocated to either group by a lottery method.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental trauma; Splints; bulkfill composite; packable composite
Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)
Condition: Overt Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets
      Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE).
    

Detailed description: 
      The primary objective of this study is to assess the efficacy of rifaximin SSD plus lactulose
      versus placebo plus lactulose for the treatment of overt hepatic encephalopathy (OHE). The
      secondary objectives of this study are to assess the safety of rifaximin SSD in subjects with
      OHE and to assess the effects of treatment with rifaximin SSD on key secondary endpoints.
    

Intervention name(s): 40 mg Rifaximin SSD once daily; 40 mg Rifaximin SSD twice daily; 80 mg Rifaximin SSD once daily; 80 mg Rifaximin SSD twice daily; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): SSD once daily (QD); SSD twice daily (BID); SSD once daily (QD); SSD twice daily (BID); Administered twice daily (BID)
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Music During ESWL for Entire Treatment
Condition: Urolithiasis
MeSH terms: Urolithiasis; Urinary Calculi
Study type: Interventional

Summary: 
      The aim of this study is to evaluate if music listening relieves pain and discomfort during
      Extracorporeal Shock-Waves Lithotripsy (ESWL).
    

Detailed description: 
      Patients undergoing ESWL and interested in music listening are randomly divided in two
      groups: patients in group A listen to music during the ESWL treatment, patients in group B do
      not.

      At the end of the treatment patients are asked to fill in a questionnaire. They are asked if
      they were pleased to have had the opportunity to listen to music during ESWL, if they would
      like to listen to music again in case of further treatments, if they consider music helpful
      in relieving pain and discomfort during ESWL. Patients are also asked to mark their level of
      pain during each part of the treatment on a visual analogue scale (VAS) for pain.
    

Intervention name(s): Music
Intervention type(s): Other
Intervention description(s): Music listening during ESWL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Urolithiasis; Kidney Calculi; Lithotripsy; Pain Management; Music
Effectiveness of Bisacodyl Suppository Agent for Dose Reduction of Low Dose PEG
Condition: Bowel Preparation
Study type: Interventional

Summary: 
      Proper bowel cleansing before colonoscopy is an important factor to increase the detection
      rate of lesions. Low volume polyethylene glycol (PEG) plus ascorbic (PEG-Asc) has reduced the
      dosage of previous bowel preparation agent, but it still presents discomfort to patients. The
      aim of this study was to confirm the efficacy and convenience of volume reduction of PEG-Asc
      by adding bisacodyl suppository at the same day by compared with conventional 2L PEG-Asc.
    

Detailed description: 
      Eligibility criteria: outpatients between the ages of 20 and 70 years, who were scheduled for
      colonoscopy between August 2017 and January 2018

      Exclusion criteria: patients with a history of gastrointestinal tract surgery, inflammatory
      bowel disease, severe active colitis, underlying chronic kidney disease, or pregnancy.

      Outcome measures: the Boston Bowel Preparation Scale (BBPS)
    

Intervention name(s): 2L PEG-Asc; Bisacodyl 10Mg Suppository; 1L PEG-Asc
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PEG-Asc powder; bisacodyl 10 mg suppository; PEG-Asc powder
Other intervention name(s): clicool; coolprep; clicool; coolprep
Intervention MeSH terms: Bisacodyl
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective, randomized, and observer-blind study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparing Effects of 3 Sources of Garlic on Cholesterol Levels
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether fresh garlic can positively affect
      cholesterol in adults with moderately high cholesterol levels. This study will also determine
      whether the same effects can be found for two main types of garlic supplements: a dried
      powdered garlic (designed to yield the same effect as fresh garlic) and an aged garlic
      extract preparation.
    

Detailed description: 
      Garlic supplements are the most consumed herbal products in the United States. The most
      common health claim made for garlic supplements is cholesterol lowering activity. This claim
      has not been supported by recent clinical trials and meta-analyses. However, data suggest
      that it is not necessarily the garlic that has been ineffective, but rather the particular
      garlic preparations being used. To date, the predominant type of garlic preparation used in
      these clinical trials has been dried garlic powders. A few clinical trials have reported
      beneficial lipid effects using an aged garlic extract, and only a small number of
      inconclusive uncontrolled trials have used fresh garlic. A rigorous trial directly comparing
      different types of garlic preparations for their effects on serum lipids is needed.

      Adults with moderately elevated low density lipoprotein cholesterol (LDL-C) will be
      randomized to one of four groups for 6 months: fresh garlic, dried powdered garlic tablets,
      aged garlic extract tablets, or placebo control. The fresh garlic will be provided to
      patients with "study sandwiches"; all other groups will receive the same study sandwiches
      without the garlic. All patients will take daily study tablets, but the tablet assignment
      will be double-blind. Patients will pick up study sandwiches twice a week and study tablets
      once every 2 weeks for 28 weeks. Blood samples will be taken once a month, with additional
      blood draws at the start and end of the study.
    

Intervention name(s): Fresh garlic or garlic supplements
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Garlic; Supplements; Adults; Hypercholesterolemics; Randomized Clinical Trial
Fast Track CSII Using a Novel Device in Young Children With Newly Diagnosed T1DM
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study evaluates early initiation of continuous subcutaneous insulin infusion (CSII)
      therapy in young children using a novel delivery method in the form of a self-contained,
      lightweight, and disposable insulin pump unit controlled with a wireless handheld device. The
      outcomes of interest are the feasibility and potential metabolic benefits of this approach.
      We anticipate that the initiation of this CSII device in the immediate post-diagnosis period
      in this population will result in good glycemic control and greater parental satisfaction
      when compared to intensive insulin injection therapy.
    

Detailed description: 
      The incidence of type 1 diabetes (T1DM) is on the rise worldwide, especially in children
      younger than six years of age. Glycemic control using multiple daily injection (MDI) therapy
      can be difficult to achieve and maintain in the very young, especially in the immediate
      post-diagnosis period. This study evaluates early initiation of continuous subcutaneous
      insulin infusion (CSII) therapy in young children using a novel delivery method in the form
      of a self-contained, lightweight, and disposable insulin pump unit controlled with a wireless
      handheld device. The outcomes of interest are the feasibility, safety, and potential
      metabolic benefits of this approach. We will recruit 14 pediatric patients, aged one to ten
      years, from a pool of all children newly diagnosed with T1DM admitted to the Children's
      Hospital of Alabama to use the pump.General diabetes education and CSII-specific training
      will take place in a series of outpatient sessions with the PI and study nurse. Pump therapy
      will be initiated within two months of diagnosis providing that all requisite education and
      training has been successfully completed. Data will be collected for both study group and
      control group patients for six months via phone calls and monthly clinic visits. Areas which
      will be evaluated include glycemic control, residual endogenous insulin secretion, frequency
      of severe adverse events, parental distress, insulin needs, and physical growth. While
      initiating CSII in the immediate post-diagnosis period in this population may be initially
      time-intensive, it is anticipated that it will ultimately become time-saving because of the
      greater ease in blood sugar management.
    

Intervention name(s): Omnipod Insulin Management System
Intervention type(s): Device
Intervention description(s): Initiation of insulin pump therapy within three months of the diagnosis of type 1 diabetes mellitus
Other intervention name(s): Tubeless insulin pump
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatrics; CSII; diabetes; C-peptide; adverse events
Relative Bioavailability Study of Zoloft Oral Solution to Zoloft Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      In Brazil, sertraline is currently available as film coated tablets for oral administration
      containing sertraline hydrochloride equivalent to 50 mg or 100 mg sertraline.

      The sponsor has developed an oral solution formulation containing 20 mg/mL of sertraline,
      which must be diluted with 120 mL of water, ginger ale, lime/lemon soda or orange juice to be
      palatable before use. The purpose of this study is to evaluate the relative bioavailability
      of Zoloft oral solution compared to Zoloft tablets in healthy participants under fasted
      conditions.
    


Intervention name(s): Zoloft Oral Solution; Zoloft tablets
Intervention type(s): Drug; Drug
Intervention description(s): Test Product: 50 mg sertraline administered as 2.5 mL of Zoloft Oral Solution (20 mg/mL) after dilution with 120 mL of water; Reference Product: 50 mg sertraline administered as 1x Zoloft 50 mg tablet
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
MRI for Non-Invasive Imaging in Neonates and Children
Condition: Healthy; Cystic Fibrosis (CF); Asthma; Bronchopulmonary Dysplasia (BPD)
MeSH terms: Cystic Fibrosis; Bronchopulmonary Dysplasia
Study type: Interventional

Summary: 
      The purpose of this study is to develop rapid MRI techniques for imaging the lung with
      hyperpolarized helium-3 gas as an inhaled contrast agent. These techniques will be piloted in
      adults and older children before testing them in younger children and infants. The purpose is
      to enable imaging of non-sedated infants by imaging so fast as to freeze motion.
    

Detailed description: 
      he purpose of this study is to further develop the techniques to permit the imaging of infant
      lungs with hyperpolarized helium-3 MRI including techniques for acquisition in free breathing
      infants and infants on a ventilator. We have developed fast imaging techniques and obtained
      proof-of-concept data in infants as young as 2 months old. Many pediatric lung diseases
      including CF, bronchopulmonary dysplasia (BPD) and asthma have their origins in infancy so it
      would be desirable to be able to image infants with hyperpolarized gas MRI. We focused on
      developing fast imaging techniques to, in essence, freeze lung motion in non-sedated infants.
      We feel the technique will be more widely adopted if clinically useful images can be obtained
      without sedating the infant. Some very rapid imaging techniques have been developed for
      conventional proton MRI for applications such as cardiac MRI that require very short
      acquisition time. We modified these techniques for use in hyperpolarized gas MRI and
      developed a technique that permits the acquisition of the entire lung volume of an infant in
      less than 1 second. These techniques would also be useful for imaging infants who are still
      on a ventilator with the hope of increasing our understanding of lung development and
      neonatal lung disease.
    

Intervention name(s): Hyperpolarized Helium-3 MRI of the chest
Intervention type(s): Drug
Intervention description(s): hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science