bioihbjkbjnl/mcl2 huggingface dataset:
Defocus Induced Changes on Choroidal Thickness
Condition: Induced Defocus to the Retina
Study type: Interventional

Summary: 
      The goals of this study are to assess the short-term (10-60 minutes) effects of different
      magnitudes of myopic and hyperopic optical defocus on the transient thickness of the choroid
      in children and adults, as well as to assess the recovery period. Choroidal thickness will be
      measured non-invasively following 10-60 minutes of monocular exposure to -5 diopters to +5
      diopters of optical defocus induced by spectacle lenses. The hypothesis is that choroidal
      thickness will increase with increasing myopic defocus and decrease with increasing hyperopic
      defocus. The relationship between the magnitude of defocus and the magnitude and direction of
      choroidal thickness change will be assessed.
    

Detailed description: 
      The purpose of this study is to determine modifying factors inducing or protecting against
      the development or progression of myopia, or nearsightedness. Myopia has reached epidemic
      levels in urbanized countries, reaching up to 90% of the teenage and young adult population
      in urban Asia. Myopia represents a significant socioeconomic burden and poses a risk for
      associated ocular diseases such as retinal detachment, choroidal neovascularization, and
      glaucoma. The economic and public health burden of myopia are growing disproportionately to
      the population, spurring interest in the development of therapies to prevent occurrence or
      progression. Myopia generally occurs because the eye grows too long, with onset and
      progression occurring from about ages 6 to 20. Though much is known about factors that
      influence eye growth, the exact mechanisms by which they do so have not been elucidated.

      The goals of this study are to assess the short-term (10-50 minutes) effects of different
      magnitudes of myopic and hyperopic optical defocus on the transient thickness of the choroid
      in children and adults, as well as to assess the recovery period. Choroidal thickness will be
      measured non-invasively following 10-50 minutes of monocular exposure to -5D to +5D of
      optical defocus induced by spectacle lenses. The hypothesis is that choroidal thickness will
      increase with increasing myopic defocus and decrease with increasing hyperopic defocus. The
      relationship between the magnitude of defocus and the magnitude and direction of choroidal
      thickness change will be assessed.
    

Intervention name(s): Plus powered optical lens
Intervention type(s): Device
Intervention description(s): A plus powered optical lens will be placed in front of one eye.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Myopia; Choroid; Retina; Blur; Defocus; Eye growth
Non-isotope Based Imaging Modalities vs Technetium-99m Single-Photon Emission Computed Tomography(99mTcSPECT)
Condition: Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Observational

Summary: 
      SPECT is currently the dominant clinical test for diagnostic and prognostic purposes as well
      as therapeutic decision-making. Given the shortage of nuclear reactor-produced Tc, advancing
      the use of non-isotope based imaging modalities has the potential to change the standard of
      care for patients with CAD as each one of these technics (CMR, CT, Stress echocardiography)
      has its own distinct potential advantages over SPECT.
    

Detailed description: 
      Obtain a better understanding of the clinical utility of advanced non-isotope-based imaging
      modalities to detect relevant CAD as potential alternatives to SPECT. Approximately 450
      subjects will be enrolled in total. Three groups of about 150 patients per group. Each group
      will undergo imaging with 2 modalities; Group 1: 99mTcSPECT plus CMR, Group 2: 99mTcSPECT
      plus CT, Group 3:99mTcSPECT plus stress echocardiography. All 450 patients will undergo
      standard invasive coronary angiography following completion of non-invasive imaging, except
      for patients in whom both nuclear and non-nuclear imaging modalities reveal a normal result
      confirming the absence of significant coronary artery disease (i.e invasive angiography would
      not be clinically indicated and FFR would be considered to be above 0.8). Thrombolysis in
      Myocardial Infraction (TIMI) flow will be measured in all patients undergoing angiography,
      and fractional flow reserve (FFR) will be measured in all patients except those with TIMI
      flow =0, 1 and 2. All imaging procedures must be completed within 6 weeks. All patients will
      have a follow-up visit at 6 months after enrollment. During the 6 month follow-up visit major
      adverse cardiovascular events will be collected and adjudicated by a clinical endpoint
      committee (CEC).
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 450 patients across Canada. Patients will be identified after a clinically
        indicated SPECT for evaluation of myocardial ischemia.The investigator will assign the
        patient in one of the three groups based on his medical assessment and availability of
        equipment at the centre.
      
Keywords: SPECT; CMR; High risk for ischemic cardiovascular events
Symptoms Experienced and Quality of Life in Breast Cancer Receiving Radiotherapy
Condition: Quality of Life
Study type: Observational [Patient Registry]

Summary: 
      EORTC-QLQ-30 questionnaire filled in by participants 6 times
    

Detailed description: 
      EORTC-QLQ-30 questionnaire filled in by participants 6 times

        -  1st before receive radiotherapy

        -  2nd after receive radiotherapy

        -  3th 1 month after receive radiotherapy

        -  4th 3 month after receive radiotherapy

        -  5th 6 month after receive radiotherapy

        -  6th 1 year after receive radiotherapy
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. It is a copyrighted instrument, which has been translated and validated in over 100 languages and is used in more than 3,000 studies worldwide.
Other intervention name(s): EORTC-QLQ-30 Questionnaire
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with breast cancer
A Pilot Study to Evaluate Ultrasonic Surgical Aspiration as a Treatment Modality for Cervical Dysplasia
Condition: Cervical Dysplasia
MeSH terms: Uterine Cervical Dysplasia; Hyperplasia
Study type: Interventional

Summary: 
      Ultrasonic surgical aspiration of the cervix may be an effective method of treating cervical
      dysplasia without compromising the integrity of the cervix in reproductive age women.
    

Detailed description: 
      Women age 18 to 55 years of age with Cervical Intraepithelial Neoplasia 2 or 3 on colposcopy
      with a negative EndoCervical Curettage are enrolled in a pilot study comparing ultrasonic
      surgical aspiration and traditional cervical excision procedure for the treatment of cervical
      dysplasia. In this pilot study, the patients serve as their own control group. Prior to
      receiving the traditional treatment for cervical dysplasia consisting of Cold Knife
      Conization with EndoCervical Curettage, each patient's cervix is treated with ultrasonic
      surgical aspiration. The aspirate is sent to pathology and the results compared with the
      findings from the cervical cone biopsy. The patients then are followed with Liquid-based
      Cytology pap smears every 4 to 6 months until completion of the study enrollment/treatment
      period.
    

Intervention name(s): cervical conization; ultrasonic surgical aspiration of the cervix
Intervention type(s): Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cervical; dysplasia
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and
      subtropical regions of the world. The purpose of this study is to test the safety of and
      immune response to a new dengue virus vaccine in healthy adults.
    

Detailed description: 
      More than 2 billion people living in tropical and subtropical regions of the world are at
      risk of dengue virus infection. Dengue viruses cause dengue fever, as well as the more severe
      dengue hemorrhagic fever/shock syndrome, and dengue virus infection is the leading cause of
      hospitalization and death in children in several tropical Asian countries. This study will
      evaluate the safety and immunogenicity of a live, attenuated dengue virus called
      rDEN1delta30, which is derived from the Western Pacific DEN1 serotype.

      This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive
      rDEN1delta30 or placebo at study entry. Cohort 2 will begin only after safety review of all
      participants in Cohort 1. Participants in Cohort 2 will receive a higher dose of rDEN1delta30
      or placebo.

      After vaccination, participants will be asked to monitor their temperature every day for 16
      days. Study visits will occur every other day after vaccination until Day 16, followed by 4
      additional visits at selected days through Day 180. Blood collection and a targeted physical
      exam will occur at each study visit. Some participants will be asked to undergo a skin biopsy
      or additional blood collection at selected visits.
    

Intervention name(s): rDEN1delta30; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Live attenuated rDEN1delta30 vaccine; Placebo for rDEN1delta30
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Dengue Vaccine; Dengue Virus; Dengue Hemorrhagic Fever; Dengue Shock Syndrome
Pharmacokinetics of 3 Formulations of Ibuprofen Suppositories
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetic and bioavailability
      characteristics of two test formulations of ibuprofen for rectal administration with the
      profile of a marketed reference formulation of ibuprofen 200 mg (for oral administration).
    

Detailed description: 
      Ibuprofen is a widely used analgesic and antipyretic in adults and children. Two ibuprofen
      suppository formulations have been developed for pediatric use to facilitate dosing in
      younger age groups. This is a single-dose, balanced, randomised, three-period crossover study
      in healthy male and female adult volunteers. Each volunteer will receive a single dose of 50
      mg ibuprofen as a suppository, a single dose of 200 mg ibuprofen as a suppository and a
      single oral dose of 200 mg ibuprofen (tablet). There will be 14 blood samples taken over 12
      hours in each study period. Concentrations in plasma of ibuprofen and its S and R enantiomers
      will be measured using a validated chromatographic method. Standard pharmacokinetic
      parameters will be obtained and bioavailability on the basis of rate and extent of drug
      absorption will be assessed.
    

Intervention name(s): ibuprofen
Intervention type(s): Drug
Intervention description(s): Each subject will receive single doses of (i) ibuprofen 50 mg suppository (ii) ibuprofen 200 mg suppository and (iii) ibuprofen 200 mg tablet in 3 separate dosing periods. Doses will be administered after an overnight fast.
Other intervention name(s): MOTRIN®
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ibuprofen; healthy volunteers; bioavailability; pharmacokinetics; suppository
Re-mineralization Effects of Sugar Free Chewing Gum Sweetened With Different Sugar-substitutes
Condition: Re-mineralization
MeSH terms: Calcinosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the clinical effect of chewing gum containing
      maltitol, on re-mineralization of early caries following daily chewing for 6 months by school
      children, compared to a xylitol gum, gum base and a no gum group.
    


Intervention name(s): maltitol; xylitol; gum base
Intervention type(s): Other; Other; Other
Intervention description(s): maltitol chewing gum: 66% SweetPearlTM Maltitol +30.91% gum base+1.93% Lycasin R 85/55+0.39% glycerin; two pellets for 10 min five times each day; xylitol chewing gum: 67.73% xylitol +30.02% gum base+1.13% Lycasin R 85/55+0.38% glycerin; two pellets for 10 min five times each day; gum base: 99% gum base; two pellets for 10 min five times each day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: maltitol; xylitol; quantitative light-induced fluorescence; saliva pH; re-mineralization; dental caries
A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic Profile and CNS Effects of BIA 2-093
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of multiple dose
      regimens of BIA 2-093 in healthy young male volunteers
    

Detailed description: 
      Single centre, Phase I, double-blind, randomised, placebo-controlled study investigating 4
      multiple rising oral doses of BIA 2-093 in 4 groups of 8 young healthy male subjects. Within
      each group, 2 subjects were randomised to receive placebo and the remaining 6 subjects to
      receive BIA 2-093. No subject was a member of more than one group. The dose regimens
      investigated were: 200 mg b.i.d.(twice daily), 400 mg o.d.(once daily; this was changed from
      400 mg b.i.d. in protocol amendment 1, on the basis of interim pharmacokinetic analysis of
      Group 1 data), 800 mg o.d, and 1200 mg o.d. BIA 2-093/placebo was administered orally once
      daily on Days 1-8, or twice a day (at 12-hour intervals) on Days 1-7 with a final dose in the
      morning of Day 8. The multiple dose regimens were to be investigated in ascending order.
      Progression to each higher dose level was only to occur if the previous dose level was deemed
      by the investigator and the sponsor to be safe and well tolerated.
    

Intervention name(s): Placebo; BIA 2-093
Intervention type(s): Drug; Drug
Other intervention name(s): PLC, Placebo; ESL, Eslicarbazepine acetate
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epilepsy; BIA 2-093; Eslicarbazepine acetate
Colchicine Counteracting Inflammation in COVID-19 Pneumonia
Condition: Coronavirus Infections; Pneumonia, Viral
MeSH terms: COVID-19; Pneumonia; Coronavirus Infections; Pneumonia, Viral
Study type: Interventional
Phase: Phase 2

Summary: 
      Cytokines and chemokines are thought to play an important role in immunity and
      immunopathology during virus infections [3]. Patients with severe COVID-19 have higher serum
      levels of pro-inflammatory cytokines (TNF-α, IL-1 and IL-6) and chemokines (IL-8) compared to
      individuals with mild disease or healthy controls, similar to patients with SARS or MERS .
      The change of laboratory parameters, including elevated serum cytokine, chemokine levels, and
      increased NLR in infected patients are correlated with the severity of the disease and
      adverse outcome, suggesting a possible role for hyper-inflammatory responses in COVID-19
      pathogenesis. Importantly, previous studies showed that viroporin E, a component of
      SARS-associated coronavirus (SARS-CoV), forms Ca2C-permeable ion channels and activates the
      NLRP3 inflammasome. In addition, another viroporin 3a was found to induce NLRP3 inflammasome
      activation . The mechanisms are unclear.

      Colchicine, an old drug used in auto-inflammatory disorders (i.e., Familiar Mediterranean
      Fever and Bechet disease) and in gout, counteracts the assembly of the NLRP3 inflammasome,
      thereby reducing the release of IL-1b and an array of other interleukins, including IL-6,
      that are formed in response to danger signals. Recently, colchicine has been successfully
      used in two cases of life-threatening post-transplant capillary leak syndrome. These patients
      had required mechanically ventilation for weeks and hemodialysis, before receiving
      colchicine, which abruptly restored normal respiratory function and diuresis over 48 hrs [4].
    


Intervention name(s): Colchicine
Intervention type(s): Drug
Intervention description(s): Cochicine 1mg/day
Intervention MeSH terms: Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colchicine; Corona Virus Infection; COVID-19
Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity
Condition: Mitochondrial Diseases
MeSH terms: Mitochondrial Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to test how different doses of a statin, Lipitor, affect muscle
      health and function, and cardiovascular fitness.
    


Intervention name(s): Lipitor 20Mg Tablet; Lipitor 80Mg Tablet; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg/day pills.; 80 mg/day pills.; Matching placebo pill.
Other intervention name(s): atorvastatin; atorvastatin; Placebo
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: insulin sensitivity; cardiorespiratory fitness; skeletal muscle mitochondrial function
Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb)
      VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection in high-risk, HIV-uninfected women.
    

Detailed description: 
      This study will evaluate the safety, tolerability, and efficacy of the VRC01 antibody in
      preventing HIV-1 infection in healthy women at high risk of HIV infection.

      Participants will be enrolled from a cohort of heterosexual women in sub-Saharan Africa. An
      equal number of study participants will be randomized to receive VRC01 mAb by IV infusion at
      a dose of 10 mg/kg or 30 mg/kg every 8 weeks, or to receive control infusions every 8 weeks.
      All participants will receive the VRC01 antibody or placebo by intravenous infusion at Weeks
      0 (study entry), 8, 16, 24, 32, 40, 48, 56, 64, and 72. For 3 days following each infusion,
      participants will be asked to record and report any symptoms to study researchers.

      In addition to the infusion visits, participants will attend study visits at Weeks 4, 8 + 5
      days, 12, 20, 28, 36, 44, 52, 60, 68, 76, 80, 84, 88, and 92. All study visits will include
      blood collection and HIV testing and counseling. Select study visits will include a medical
      history review, physical exam, urine collection, pregnancy testing for participants capable
      of becoming pregnant, risk reduction counseling, and an interview/questionnaire.
    

Intervention name(s): VRC01; Placebo for VRC01
Intervention type(s): Biological; Biological
Intervention description(s): Administered by IV infusion; total dose will vary based on participant's weight; Sodium Chloride for Injection USP, 0.9%; administered by IV infusion
Other intervention name(s): Human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV-1 Infections
Sleep and Exercise in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis; Inflammatory Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      Regular physical activity is important for people with rheumatoid arthritis (RA). Sleep
      requirements for adults should be on a 'sleep needs spectrum' of between 7 to 9 hours per
      day. Poor sleep is a common complaint among people with RA, which may have an effect on their
      activity levels and well-being. There is evidence that physical activity and exercise can
      improve sleep quality and disturbances in other chronic disease populations therefore,
      examining how same affects sleep in RA is important.
    

Detailed description: 
      Sleep is an important aspect in maintaining the body's circadian rhythm. In general getting
      fewer than 5 hours sleep per day has been associated with cardiovascular problems, diabetes
      and obesity and can also be linked to depression and anxiety. Poor sleep is a common
      complaint among people with rheumatoid arthritis (RA) with disturbed sleep and fatigue known
      to affect up to 70% in this population. Poor sleep quality may contribute to the feelings of
      pain, fatigue and poor psychological well-being which in turn may further deteriorate
      functional ability and reduced activity.

      It is known that exercise improves a person's psychological state which can also be an
      additional factor in improving or indeed disrupting quality of sleep. Exercise has been
      identified as an important part of the nonpharmacological management of poor sleep and in
      improving sleep quality however, people with RA were previously cautioned about undertaking
      exercise. Therefore, changes in sleep quality during exercise intervention should be
      evaluated so that society can understand more the potential for long-term changes in overall
      health status, in people who have RA. Indeed the intensity level of the activity in people
      with RA may be of additional importance.
    

Intervention name(s): Walking Programme
Intervention type(s): Behavioral
Intervention description(s): The programme will be devised using incremental targets for daily walks based on the 6-20 Borg of rating of perceived exertion scale (Borg RPE). They will be instructed that they should be moderately short of breath on exertion i.e. unable to comfortably hold a conversation while walking
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single centre, single blinded pilot randomised controlled trial, comparing an aerobic intermittent exercise training intervention (walking programme) against verbal and written instructions regarding the benefits of exercise in RA.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Sleep