bioihbjkbjnl/mcl2 huggingface dataset:
EFFECTIVENESS OF VIRTUAL REALITY GLASSES VERSUS WHITE NOISE ON DENTAL ANXIETY IN CHILDREN WITH ATTENTION DEFICIT/ HYPERACTIVITY DISORDER
Condition: Dental Anxiety
MeSH terms: Anxiety Disorders; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The present study aims to assess and compare the effectiveness of distraction technique using
      virtual reality glasses and white noise with basic behavior guidance techniques on dental
      anxiety in children with Attention Deficit/ Hyperactivity Disorder.
    


Intervention name(s): Virtual Reality Glasses (VR); White noise; Basic behavior management techniques
Intervention type(s): Device; Other; Behavioral
Intervention description(s): Children allocated to this group will be distracted using VR glasses during dental treatment which is an individual headset that has earphones incorporated. Age-appropriate cartoons and movies will be shown to the children. The VR glasses will be then introduced to the children. The children will be given time to accommodate with the device before starting the procedure. The VR glasses will be applied during the dental examination and treatment.; Wireless kids' headphones will be introduced to the children allocated to this group. They will be given some time to accommodate with the headphones. Then, the white noise will be played and children will be asked to concentrate on the music during the procedure.
White noise stimulus will be set at 70 decibels, within the "normal conversation" volume range and below what is considered harmful to hearing. The white noise of rain sound, managed with an iPhone application called Muse. The decibel level of white noise will be calibrated using a portable digital sound level meter; Children allocated to this group will be managed by the basic behavior guidance techniques: (Tell-Show-Do). No adjunctive distraction tool will be used.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
DRIIVE (Data and Research on Interventions to Improve the Vehicular Environment)
Condition: Vehicular Environment
Study type: Interventional

Summary: 
      The purpose of this study is to look at air quality in cabs and see if the air quality inside
      taxi cabs is connected to increased risks for lung and heart health problems. Another purpose
      of the study is to see if putting an air filter inside the car may help improve the air
      quality and lower health risks.

      This is important because air pollution can be harmful to health. Air pollution is made up of
      very tiny particles (things) floating in the air around us, called particulate matter.
      Particulate matter is made up of dust, smoke, dirt, and gas fumes and can get into our bodies
      as we breathe. It has been linked to risk for lung cancer and heart disease. It is important
      because taxi drivers spend many hours of their day inside their cars.

      The investigators hope that this study will help them find out if using air filters inside
      cabs will help lower the levels of pollution in cabs and reduce its effects on the health of
      taxi drivers. They will use these results to educate the taxi driver community.
    

Detailed description: 
      DRIIVE (Data and Research on Interventions to Improve the Vehicular Environment) is a
      community-engaged translational pilot project that will utilize a three parallel arm design
      to obtain preliminary data on associations between Particulate Matter (PM)/air pollution and
      physiologic measurements and biomarkers in taxi drivers, and to determine the impact of a
      HEPA filter (to remove PM and volatile organic compounds) intervention on such physiologic
      measurements and biomarkers. DRIIVE is funded by the New York State Department of Health
      Empire Clinical Research Investigator Program (ECRIP), which trains physicians in clinical
      research in New York. Drivers will be randomized to one of two groups: Intervention or
      Wait-list Control. In total, two groups of 14 participants in each group will be recruited:
      1) Wait List Control group, who will receive a HEPA filter at the end of the 1 month
      participation period, and 2) Intervention group, who will receive a HEPA filter two weeks
      into their participation period. The project will be completed within a 2 year timeframe.
    

Intervention name(s): HEPA air purifier; questionnaires; Log-book; Urine sample
Intervention type(s): Device; Behavioral; Other; Other
Intervention description(s): air purifiers to remove PM and volatile organic compounds will be placed in drivers cars; PM and biological measurements; PAH (Polycyclic Aromatic Hydrocarbon) will be assessed via urine sample collection of Urinary 1 hydroxy pyrene and particulate matter collected via Polyurethane Foam Filter (PUF) sampler
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HEPA filter; 14-247
Clinical Performance of a Phakic Intraocular Lens (IOL)
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      This study will evaluate the clinical performance of a phakic intraocular lens (IOL) for the
      improvement of Uncorrected Near Visual Acuity (UCNVA) in subjects who require between +1.00
      and +2.50 Reading Add.
    

Detailed description: 
      This is a prospective, open-labeled, multi-site evaluation of clinical performance of the
      STAAR EVO+ Visian™ Implantable Collamer® Lens (VICL) with Aspheric (EDOF) Optic [EDOF ICL]
      for the improvement of UCNVA in subjects who require between +1.00 and +2.50 Reading Add.

      Approximately 48 subjects who meet all eligibility criteria will undergo EDOF ICL
      implantation in both eyes. All eyes will be followed for 6 months after surgery.

      The first eye implanted with the study lens and the appropriate time for fellow eye
      implantation will be determined by the medical judgement of the Investigator. All eyes will
      be analyzed for safety and performance.

      The primary performance endpoint is defined as achievement of monocular UCNVA of Snellen
      equivalent 20/40 or better at 40 cm at 6 months after implantation in equal to or greater
      than 75% of implanted eyes.
    

Intervention name(s): EDOF ICL
Intervention type(s): Device
Intervention description(s): The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.
Other intervention name(s): EVO+ Visian ICL with Aspheric (EDOF) Optic
Intervention model: Single Group Assignment
Intervention model description: Device: Open label, all subjects receive same treatment
Masking: None (Open Label)
Primary purpose: Treatment
3D Evaluation of Powerscope Appliance in Treatment of Skeletal Class 2 Malocclusion
Condition: Class II Malocclusion, Division 1
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Interventional

Summary: 
      The study is aiming to evaluate the efficacy of Powerscope appliance in treatment of skeletal
      Class 2 malocclusion by three-dimensional image. Powerscope appliance is a hybrid fixed
      functional appliance used for treatment of Class II malocclusion with a retruded mandible.
    


Intervention name(s): Powerscope group
Intervention type(s): Device
Intervention description(s): Treatment of Class II malocclusions using Powerscope appliance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Single Center Study to Evaluate the Penetration of RO7033877 Into the Lung in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, open-label study will investigate RO7033877 concentrations in plasma and
      in various lung compartments, including epithelial lining fluid (ELF), and alveolar
      macrophages (AM) in healthy volunteers after multiple intravenous (IV) administration.
      Bronchoscopy will be performed after the start of the last infusion on Day 3 at different
      timepoints. Blood, urine and brochoalveolar lavage samples will be collected to determine
      RO7033877 concentrations. The anticipated time on study treatment is 3 days.
    


Intervention name(s): RO7033877 + Bronchoscopy
Intervention type(s): Drug
Intervention description(s): Days 1, 2, and 3: 2.5 mg/kg RO7033877 infused IV over 2 hours, every 8 hours for a total of 7 doses; BAL procedure on Day 3.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Characterization of Hyperparathyroidism and Vitamin D Deficiency in Obesity
Condition: Vitamin D Deficiency; Secondary Hyperparathyroidism; Obesity
MeSH terms: Obesity; Vitamin D Deficiency; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 4

Summary: 
      Obese persons are known to have elevated levels of parathyroid hormone (PTH) and low levels
      of vitamin D. These hormones are important in regulation of the body's calcium stores and
      bone health. We would like to investigate these abnormalities and the accuracy of our current
      diagnostic tests by comparing results of standard assays for vitamin D and PTH to more
      specific tests, in obese subjects at baseline and as vitamin D is replaced. We will also
      compare two standard vitamin D replacement regimens to determine if one is more effective.

      This is a pilot study with two parts: Part 1 will compare levels of PTH and vitamin D using
      two different assays in obese subjects who have normal vitamin D and those who do not. We
      plan to enroll 20 subjects who have normal vitamin D levels and 40 subjects who have vitamin
      D insufficiency. All subjects will fill out questionnaires about the amount of calcium and
      vitamin D in their diet, and their recent sunlight exposure. We will ask for blood samples so
      that we can measure levels of calcium, vitamin D, albumin, creatinine, glucose, insulin and
      the different forms of PTH.

      Subjects who have vitamin D insufficiency will then be randomized to receive Vitamin D2 or
      Vitamin D3 in standard doses for eight weeks, in an open label trial. At four and eight
      weeks, these subjects will fill out the above questionnaires and have the blood tests
      repeated. For safety purposes, urine calcium will also be monitored.
    


Intervention name(s): Ergocalciferol; Cholecalciferol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cholecalciferol; Vitamin D; Ergocalciferols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vitamin D deficiency; Secondary hyperparathyroidism; Obesity
Perceptions of Cigarette Smoking in Young Adults
Condition: Smoking, Cigarette
Study type: Interventional

Summary: 
      This study focuses on menthol (n = 125) and non-menthol (n = 125) smoking young adults (YAs;
      defined here as ages 18 to 24) who started smoking in the past 6-months.
    

Detailed description: 
      The study will occur in three phases.

      In session 1 of Phase 1, participants will engage in ad libitum smoking session of one's
      preferred cigarette brand (menthol or non-menthol). In session 2, participants will take
      several puffs each of a commercially available menthol and non-menthol cigarette (i.e., Camel
      Crush) and complete a complete a series of pre-post smoking questionnaires, and in Session 3
      participants will complete a computerized task to measure perceptions of cigarette smoking.
      For the computerized task, participants will be able to "win" points toward earning puffs of
      a cigarette and will be able to smoke puffs earned. Participants will be asked to abstain
      from smoking for at least 12 hours before each in-person visit.

      Phase 2 participants will engage in 14 days of surveys they will complete on their cell to
      measure different aspects of smoking behavior. These surveys will happen twice a day at
      random times.

      For phase 3, participants will complete an assessment of smoking behavior and related factors
      6-months after the baseline assessment either in-person, in the laboratory, or via telephone
      or online (if in-person follow-up is not viable).

      The order in which phases occur may differ was a result of COVID-19 restrictions on data
      collection.
    

Intervention name(s): Cigarette flavor type
Intervention type(s): Other
Intervention description(s): Participants will smoke several puffs (each) of a menthol Camel Crush and several puffs of a non-menthol Camel Crush cigarette.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pediatric Exploratory Research Study of EGCG Use and Safety (PERSEUS)
Condition: Down Syndrome; Fragile X Syndrome
MeSH terms: Down Syndrome; Fragile X Syndrome; Syndrome
Study type: Interventional

Summary: 
      To evaluate safety and tolerability of epigallocatechin gallate (EGCG) in children from 6 to
      12 years old with Intellectual Developmental Disorders (IDD) (Down syndrome or Fragile X
      syndrome).
    

Detailed description: 
      This project first objective is to evaluate the safety and tolerability of the EGCG molecule
      (extracted form green tea) on children from 6 to 12 years old with Intellectual Development
      Disorder (Down syndrome and Fragile X syndrome).

      The secondary objective is to evaluate the benefits of the EGCG on attention, memory,
      executive functions, language and adaptive behaviour of these children. Dyrk1A and
      homocysteine in plasma will also be quantified, using them as biomarkers of efficacy.
    

Intervention name(s): EGCG FontUp; Placebo FontUp
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Intake of 10mg/kg/day of EGCG, in the form of a dietary supplement (FontUp), two times a day.; Intake of placebo, in the form of a dietary supplement (FontUp) (without EGCG), two times a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cohort I (Down Syndrome children): Phase II Randomized, double-blind, placebo-controlled, parallel groups to evaluate safety and tolerability of EGCG in children. The experimental group will take 10mg/kg/day of FontUp (EGCG on a dietary supplement with chocolate like shake flavor, two times a day) while the placebo group will take the same product but without the EGCG in it, taken with the same posology.
Cohort II (Fragile X syndrome children): exploratory open label study (pilot study) to assess safety and tolerability of EGCG. These patients will receive 10mg/kg/day of FontUp.
This cohort will only be recruited in Spanish sites.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Down Syndrome (DS); Fragile X Syndrome (FXS); Intellectual Development Disorder (IDD); FontUp; EGCG; Epigallocatechin gallate; Dual specificity tyrosine-phosphorylation-regulated kinase 1A (Dyrk1A); Homocysteine; Dietary supplement; Green tea; IMIM; PERSEUS
Effect of Inorganic Nitrate Supplement on Blood Pressure
Condition: Blood Pressure; Endothelial Dysfunction
Study type: Interventional

Summary: 
      The primary purpose of this project is to assess the efficacy (effectiveness) of plant-based
      nitrate tablets to elevate nitric oxide in your system as measured by saliva and effect on
      lowering blood pressure (BP), supporting blood vessel function in men and women with
      hypertension.
    

Detailed description: 
      This clinical trial is to assess the efficacy of plant-based bioequivalent Nitric Oxide
      supplement for improving blood pressure and endothelial reactivity over a 12 weeks
      intervention period in individuals with metabolic syndrome. The study also examines the
      effect of plant-based bioequivalent Nitric Oxide supplement on other markers of
      cardiovascular function and cardiovascular disease risk including Total, LDL and
      HDL-Cholesterol, Triglycerides, and a multitude of inflammatory markers.
    

Intervention name(s): Plant based bioequivalent Nitrate supplementation; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The nitrate supplement consists of nitrate-rich beetroot extract 20mg, thiamine mononitrate 90mg, potassium nitrate 480mg, ascorbic acid 150mg, folic acid 200mcg, methylcobalamin 200mcg, calcium 115mg, pomegranate fruit extract 5mg and green coffee bean extract 115mg.; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double Blind Placebo Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Endothelium
Blood Pressure Reactivity After Resistance Exercise in Older Women
Condition: Resistance Exercise Pressor and Neural Responses in Older Women
Study type: Interventional

Summary: 
      The purpose of this study is to determine and compare the effects of two sessions of
      resistance exercise in blood pressure reactivity to a mental stress test in older
      hypertensive women.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Resistance Training; Psychological Stress; Aging; Hypertension; Autonomic Nervous System
Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aimed to explore the pharmacokinetics and pharmacodynamics of low dose sertraline
      with [11C] sertraline positron emission tomography (PET) study.
    

Detailed description: 
      Open, one arm, single sequence, 3-period, dose escalating study for healthy volunteers are
      investigated. Ten subjects may be enrolled.

      Subjects receive baseline [11C] sertraline PET.

      Period 1 Subjects receive 5 mg of sertraline every day. After 6 day of medication,
      pharmacokinetic and PET studies are performed.

      Period 2 Subjects receive 25 mg of sertraline every day. After 6 day of medication,
      pharmacokinetic and PET studies are performed.

      Period 3 Subjects receive 50 mg of sertraline every day. After 6 day of medication,
      pharmacokinetic and PET studies are performed.
    

Intervention name(s): Sertraline
Intervention type(s): Drug
Intervention description(s): Multiple doses of 5, 25, and 50 mg Sertraline for 6 days each period.
Other intervention name(s): Zoloft(Pfizer)
Intervention MeSH terms: Sertraline
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sertraline; PET; Serotonin receptor occupancy; PK-PD Model
Safety Study of Replication-competent Adenovirus (Delta-24-rgd) in Patients With Recurrent Glioblastoma
Condition: Brain Tumor; Recurring Glioblastoma
MeSH terms: Adenoviridae Infections; Glioblastoma; Brain Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In the Netherlands a 2 center investigator-driven phase I/II clinical trial is initiated in
      June 2010 testing the oncolytic adenovirus Delta24-RGD to treat glioblastoma patients. The
      virus is administrated using convection-enhanced delivery by 4 catheters as delivery
      technique, targeting solid tumor as well as infiltrated tumor cells within the peri-tumoral
      brain. Patients will be enrolled in cohorts of 3 per dose-level. The dose levels to be
      explored are: 10^7, 10^8, 10^9, 10^10, 3*10^10 and 10^11 viral particles (vp). Once the MTD
      has been determined, or the study has reached the highest dose cohort, a further 6 or 9
      patients will be enrolled at the MTD and evaluated for safety and preliminary signs of
      efficacy, such that in total at least 12 patients have received the MTD.

      The primary objective is to determine the safety and tolerability of Delta-24-RGD
      administered by CED to the tumor and the surrounding infiltrated brain in patients with
      recurrent GBM. Secondary objectives are to determine the Progression Free Survival (PFS),
      Overall Survival (OS), and tumor response rate in patients with recurring tumors amenable for
      surgical resection and treated at the MTD.

      Cerebrospinal fluid as well as brain interstitial fluid by microdialysis next to the
      routinely collected samples of blood at various timepoints before, during and after virus
      infusion. Various neurodegenerative biomarkers as well as markers of immune response will be
      assessed in these samples.

      Furthermore extensive sampling and PCR analyses will be performed to evaluate distribution
      and shedding of the virus.
    


Intervention name(s): delta-24-RGD adenovirus
Intervention type(s): Biological
Intervention description(s): slow continuous microinfusion in and around the brain tumor during 44 hrs.by 4 temporary placed catheters
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: brain tumor; virotherapy; glioblastoma; replication competent adenovirus
Tracking Attempts of CSE, Epidural and Spinal Insertions (TRACES)
Condition: Neuraxial Anesthesia Charting
Study type: Observational

Summary: 
      The goal of this study is to compare observed neuraxial (Epidural, spinal, combined
      spinal-epidural) insertion attempts with actual documented attempts in anesthesia providers
      (staff, residents and fellows) at one maternal hospital. Trained research staff will document
      the number of neuraxial attempts before the operation, and compare this with the attempts
      recorded in the patient's chart. The definition of a neuraxial attempt will be determined
      before the study begins through a thorough literature review.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients must meet the inclusion criteria, and give verbal consent to being watched.
        Providers must give verbal consent to being watched
      
Keywords: neuraxial attempts; anesthetic charting; anesthetic documentation