Kornimate/medical-research-clean huggingface dataset:
the impact of bright classroom on myopia

Conditions: Myopia

Summary: this trial aims to test the effectiveness and practicality of study in the bright classrooms with skylight and artificial light renovation in reducing incident myopia in chinese primary school children over three years, as compared to children studying in conventional classrooms.

the investigators now propose a cluster-randomized controlled trial of bright classrooms to provide a definitive answer as to their effect on the reduction of myopia incidence with the interventions of students studying in bright classroom from skylight and artificial light renovation. the bright classroom trial will be conducted in jiangxi province, south-east china via nanchang university affiliated eye hospital and the artificial light renovation study will be in zhejiang province via eye hospital, wenzhou medical university. classroom design and build will be supported by leading firm in this space, velux. if the principal can be proven that such innovative architectural modifications and classroom light renovation successfully prevent myopia, it will provide an evidence-based justification for a broad variety of low-cost retrofits, new build designs and light renovation appropriate for various chinese settings. these might include larger windows, skylights, artificial lighting and appropriate seating arrangements. once in place, such architectural and light interventions could benefit children over many years, without extensive and difficult-to-sustain programs of behaviour change. this proof-of-principle project could address a significant global eye health challenge and have significant and sustainable socio-economic impact for china and built environments elsewhere throughout the world. schools selected for the trial are: yifen county: 2 schools, lichuan county: 2 schools, yiyang county: 2 schools, fuliang county: 1 school and shanggao county: 1 school.

Eligibility criteria:
inclusion criteria: * willingness of parents to give consent * membership in randomly-selected classes at the selected schools. exclusion criteria: * children without consent from their parents will be excluded. * children having myopia (myopic spherical equivalent refractive error of \<= -0.5d in one or both eyes) at baseline are excluded from the primary analysis, although they will be included in the secondary analyses, so there will be no need to exclude them from continuing to study with their classmates and use the assigned classroom.

Keywords: bright classroom, myopia, rct, china
serology and other immunologic response tests in the diagnosis of covid-19 in pediatrics

Conditions: COVID-19

Summary: despite the sars-cov-2 virus being present worldwide, and although it is now clear that children are affected by the disease with milder symptoms than adults, many immunological questions, which are very relevant for public health reasons and for the organization of services, remain unsolved. the role of serology for the diagnosis of covid-19, particularly in the pediatric age, is still very uncertain. preliminary evidence suggests that not all children with sars-cov-2 infection develop antibody levels that can be detected by currently employed methods. this makes it crucial to identify other methodologies that are able to evaluate the true prevalence of prior sars-cov-2 infection in the pediatric population. many other aspects of the immunological mechanisms of response to sars-cov-2 are also uncertain, such as the role of cellular immunity, and generally the role of immunity (cellular and antibody) in protecting against the disease in the medium and long term. finally, questions remain open regarding cross-immunity with other previously circulating coronaviruses and their impact on the pediatric population in terms of protection against covid-19 infection, disease development, or reinfection. this study aims to help clarify the role of serology and other immune response tests in the diagnosis of covid-19 in the pediatric population. specifically, it aims to assess: the prevalence of sars-cov-2 seroconversion cases among the pediatric population accessing the national health system (nhs), at different moments in time and in different regions of italy; whether cellular immunity tests can help to identify children who have had sars-cov-2 infection, particularly children with low antibody levels, and thus to better estimate the prevalence of prior sars-cov-2 infection; the prevalence of cross-reactivity with other coronaviruses; whether immunity (antibody and cellular) is protective in the medium/long term; and if there are healthy carriers, i.e. individuals who have had prior sars-cov-2 infection, who are asymptomatic but may harbor sars-cov-2 in the pharynx, with the risk of transmitting it.


Eligibility criteria:
inclusion criteria: * children aged 0-17 years * access to national health system facilities for blood collection. exclusion criteria: * immunodepression (primary or secondary) * refusal to participate in the study

Keywords: covid-19 pediatrics immunology
the effects of spinal mobilizations on symptoms, neck 3d movement, neck muscle electromyography and sympathetic nervous system activity in people with neck pain

Conditions: Neck Pain

Summary: this study investigates the effects of spinal mobilizations on symptoms, 3d movement of the neck, neck muscle electromyography and sympathetic nervous system activity in people with neck pain.


Eligibility criteria:
inclusion criteria: * intermittent neck pain * that worsens or improves with certain neck movements or positions * has not been caused by a blow, fall or accident exclusion criteria: * cervicobrachialgia * has been treated with or is awaiting neck surgery * diagnosed with a particular inflammatory disease or spinal condition * where treatment with cervical mobilizations is contraindicated
short-term fat overfeeding on the effects of liver metabolism

Conditions: Liver Fat; Cardiac Function; Lipid Disorder; Adiposity

Summary: despite work showing the overconsumption of saturated fatty acids (sfa) to be metabolically deleterious, debate continues about whether there is a link between sfa and cardiovascular disease risk. to explore this, we are undertaking a human in vivo parallel-design study, comparing two isocaloric high-fat diets; one enriched with sfa and the other enriched with unsaturated fatty acids (ufas), to determine the impact of dietary fat composition on postprandial metabolism, liver fat, cardiac fat and cardiac function.

the investigators will recruit men and women with no medical condition or relevant drug therapy that affects lipid, glucose or liver metabolism. purpose and design: the investigators are asking the research question: "how does the amount and type of fat consumed, influence liver fat content, cardiac function and postprandial fatty acid and liver fat metabolism when someone is not gaining or losing body weight?" to address this research question investigators want to undertake detail physiological studies, in a parallel dietary intervention, where individuals will have an mri/s scans to assess liver fat, cardiac fat and cardiac function, along with a postprandial study day to assess how their metabolic response to a experimental test meal, before and then 28 days after consumption of a eucaloric, high fat intervention diet that will be either enriched in saturated or unsaturated fat.

Eligibility criteria:
inclusion criteria: * the participant is willing and able to give informed consent for participation in the study. * male or female, aged ≥18 or ≤65 years. * body mass index ≥19 ≤35 kg/m2 * no medical condition or relevant drug therapy that is known to affect liver or adipose tissue metabolism. * weight stable for the previous 3 months exclusion criteria: * the participant is unwilling or unable to give informed consent for participation in the study. - aged ≤18 or ≥65 years * body mass index ≤19 or ≥35kg/m2 * blood haemoglobin \<135mg/dl for men and \<120mg/dl for women * donated (or lost) ≥250 ml of blood in the previous two months. * on a weight loss diet or have decreased their body weight by \>5% in the previous 3 months. * have increased their body weight by \>5% in the previous 3 months. * any metabolic condition or relevant drug therapy * current smoker * history of alcoholism or a greater than recommended alcohol intake (\>30 g of alcohol daily for men and \>20 g of alcohol daily for women) * haemorrhagic disorders * anticoagulant treatment * history of albumin allergy * pregnant or nursing mothers * women prescribed any contraceptive agent or device including oral contraceptives, hormone replacement therapy (hrt) or who have used these within the last 12 months history of severe claustrophobia * presence of metallic implants, pacemakers, or are unwilling to remove any piercings * history of an eating disorder or any other psychological condition that may affect the participant's ability to adhere to study intervention/experimental diets.
lidocaine for pain after urodynamic testing

Conditions: Voiding Disorders; Overactive Bladder; Urinary Incontinence

Summary: urodynamic testing can be associated with mild discomfort, particularly at the time of insertion, repositioning, and removal of the bladder catheter (a tube inserted into the bladder via the urethra). few studies have investigated ways to improve patient comfort during this procedure. in this study, the investigators want to see if applying external lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.

urodynamic testing can be associated with mild discomfort, particularly at the time of insertion, repositioning, and removal of the bladder catheter (a tube inserted into the bladder via the urethra). few studies have investigated ways to improve patient comfort during this procedure. in this study, the investigators want to see if applying lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort. participation in this study will involve only 1 clinic visit (for urodynamic testing), plus 2 phone calls to ask participants about pain (1 at 4-6 hours after testing; and 1 at 24 hours after testing). additionally, the investigators will record any adverse effects (such as an allergic reaction to the gel or new irritation/pain) that happen within 2 weeks after testing. participants will be randomly assigned to receive either lidocaine gel or placebo gel for their urodynamic testing. the placebo gel will be a standard lubricant gel, meaning that it contains no active drug. the assigned study regimen will be chosen by chance, like flipping a coin. participants will have an equal (50/50) chance of being given either study regimen. neither the participant nor the study doctor or nurse practitioner will know which study regimen the participant is getting. additionally, a member of the study team will ask participants about their pain level before and after the testing. the rest of the urodynamic testing procedure will take place exactly as it would if the participant was not in this research study.

Eligibility criteria:
inclusion criteria: • all female patients between the ages of 40-80 undergoing urodynamic testing. exclusion criteria: * urinary tract infection or symptoms of infection at time of procedure or within past 2 weeks * history of urinary retention * known or suggested history of urethral syndrome or painful bladder syndrome * prior anti-incontinence surgery * prior pelvic surgery with placement of transvaginal mesh * known urethral or bladder anomaly including urethral diverticulum or congenital anomalies of the bladder or urethra * history of genital herpes outbreak within the past 3 months * defects in mucosal surfaces including periurethral or vaginal abrasions, ulcerations, or lacerations * neurologic disease affecting urethral sensation * chronic pelvic pain * contraindication or allergy to topical anesthetic * pregnancy * syncopal episode during preparation for or execution of uroflowometry
covid-19 neurological disease: a prospective study

Conditions: Diseases of the Nervous System; Other Specified Viral Diseases

Summary: background: recent reports increasingly recognize neurological manifestations in covid-19 patients. however, the full spectrum of the disease and risk factors are not well understood. aim: to describe the full spectrum of neurological manifestations in covid-19 and assess the clinical characteristics, risks and prognostic factors. outcomes: identification of covid-19 associated neurological disease is the primary outcome while requirement for admission to critical care unit, mortality, length of hospital stay, quality of life, and neurological disability are the secondary outcomes. participants: patients above age more than 18 years enrolled based on new-onset acute neurological disease and covid19 positive will serve as cases while patient with confirmed covid-19 without neurological manifestation will serve as controls. design and procedures: the study is prospective case control in design and is divided into three phases in india, brazil and malawi ; the first phase will address role of hypoxia in causation of neurological diseases, the second phase will compare characteristics of patients hospitalized with covid-19 with and without neurological disease and the third phase will assess the long-term follow up (at 3 months and 9 months) of cases.


Eligibility criteria:
cases inclusion criteria: 1. confirmed or probable new-onset acute neurological disease (according to study definitions) and 2. confirmed or probable covid-19 (according to study definitions), diagnosed using tests performed no later than 5 days after presentation with neurological disease exclusion criteria (any of): * age \<18 years * neurological features are explained fully by a previous neurological disease * pcr test performed \>5 days after admission to hospital, in the absence of clinical illness meeting criteria for suspected covid-19 (to exclude those with hospital-acquired infection). * enrolled on the basis of new-onset acute neurological disease, but subsequently does not meet definition for probable or confirmed covid-19. controls two controls with non-neurological covid-19 will be recruited per case. they will meet all of the following criteria: * adults, no more than 5 years younger or older than the case. * enrolled at a similar time since admission to hospital as the case, defined as: \<7 days; 7-13 days inclusive; or ≥14 days. * hospitalised patients with confirmed or probable covid-19 (according to study definitions) * not meeting criteria for confirmed or probable new-onset acute neurological disease (according to study definitions). some potential controls may be reclassified as cases if they develop neurological manifestations at up to 30 days after admission to hospital.
naviicusp: bicuspid aortic valve stenosis with navitor platform international experience

Conditions: Bicuspid Aortic Valve

Summary: the aim of this prospective registry is to evaluate the clinical impact of the new navitor prosthesis (abbott, minneapolis, mn, usa) in bav and evaluate both the main sizing methods (the classical annular or the supra-annular with icd measurement at 4 mm above the virtual basal ring).


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. nyha ≥ 2 and/or syncope and/or angina. 3. symptomatic severe calcified aortic stenosis with ava \ 4 m/s or mean gradient \> 40 mmhg or dvi \< 0.25'. 4. patient judged by the heart team as indicated for tavi. 5. anatomical suitability for transfemoral-tavi with navitor, based on msct assessment. 6. estimated life-expectancy \> 1 year. exclusion criteria: 1. age \< 18 years 2. asymptomatic patients 3. estimated life expectancy \< 1 year 4. pure aortic regurgitation. 5. lvef \< 20% 6. no baseline msct evaluation. 7. unsuitable aortic root anatomy for navitor. 8. unsuitable peripheral vasculature for transfemoral navitor. 9. type 2 bicuspid aortic valve 10. excessive leaflet calcifications 11. moderate or severe raphe calcifications 12. severe lvot calcifications 13. perimeter-derived annular dimension exceeding ifu recommendation 14. dilated ascending aorta \>45 mm

Keywords: bicuspid aortic valve tavi navitor
a study to evaluate 0.003% ar-15512 safety and drop attributes

Conditions: Dry Eye Disease

Summary: the purpose of this study is to evaluate the proportion of ocular adverse events reported in subjects with dry eye disease (ded) between the intervention arm (0.003% ar-15512) and refresh® classic.

this is a 1-visit study (screening, enrollment, assessments).

Eligibility criteria:
key inclusion criteria: * corrected visual acuity (snellen) 20/200 or better in both eyes; * good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history; * capable of giving signed informed consent. key exclusion criteria: * current evidence of other clinically significant ophthalmic disease other than dry eye; * history of ocular surgery within 1 year of the study visit; * use of any topical ocular anti-inflammatory medications (for example, restasis®, cequa™, vevye™, xiidra®), other prescription ophthalmic product for dry eyes, topical ocular corticosteroid, or non-steroidal-anti-inflammatory agents within 30 days of the study visit; * positive pregnancy test or currently breastfeeding.

Keywords: dry eyes
the incidence of postoperative pain after using different types of sealers

Conditions: Post Operative Pain; Root Canal Sealers; Sillicon Based Sealers; Resin Based Sealers

Summary: the aim of this randomized clinical trial is to evaluate and compare the incidence and intensity of post-operative pain after obturation using resin and silicon-based sealers.

the main objectives of root canal therapy are to achieve long-term comfort, function, and aesthetics for the patients and prevention of reinfection of tooth. these objectives are provided through complete cleaning, shaping, and obturation of canals of affected teeth . some patients may report moderate-to-severe pain and/or swelling following root canal treatment . this is detrimental for both patient and dentist and may entail an unscheduled emergency visit by patients to relieve their symptoms. postoperative pain is considered a clinical outcome that exhibits the multifactorial nature of patients' responses to variables among treatment procedures such as maintaining the working length to the apical constriction, finishing the endodontic treatment in single visit or multiple visit, instrumentation technique and the type of endodontic sealer used for obturation . such pain occurrence is mainly due to mechanical, chemical or microbial injury to the periapical tissues . trauma of periapical tissue or bacterial extrusion and root canal sealer specifically, extrusion of root canal sealer can disrupt periodontal tissues and cause inflammatory reactions. the intensity of this reaction depends on the composition of the sealer . root canal sealers can play a crucial role in this regard by coming in contact with the periapical tissues through apical foramen and lateral canals causing a localized inflammation with a direct influence on the degree of inflammation based on the composition of the sealer in turn influencing postoperative pain levels . silicone is inert and biocompatible and has been widely used in medicine as an implant material silicone-based root-canal sealers are also available. however, there are no data on the clinical performance of this type of material in endodontic treatment .

Eligibility criteria:
inclusion criteria: * • patient's age ranges from 18-50 years old. * patients with teeth diagnosed with symptomatic irreversible pulpitis. * normal periapical condition confirmed by normal periapical radiograph * the teeth are restorable * teeth are periodontally free, with no mobility and negative to percussion and palpation test. exclusion criteria: * • teeth with immature roots * non restorable teeth * medically compromised patients with systemic complication that would alter the treatment. * necrotic teeth * teeth with apical periodontitis or periapical lesions * necrotic teeth.
open label study of mrna-3704 in patients with isolated methylmalonic acidemia

Conditions: Methylmalonic Acidemia (MMA); Metabolism, Inborn Errors

Summary: this first-in-human (fih) phase 1/2 study will evaluate mrna-3704 in patients with methylmalonic acidemia/aciduria (mma) due to methylmalonyl-coenzyme a mutase (mut) deficiency between 1 to 18 years of age with elevated plasma methylmalonic acid. the study is designed to characterize baseline biomarker levels followed by assessment of safety, pharmacokinetics, and pharmacodynamics of different doses of mrna-3704 in patients affected by mma as part of the dose escalation phase. during the dose escalation phase, three dose levels of mrna-3704 are planned to be investigated in this study among patients with mma due to mut deficiency: low dose, mid dose, and high dose. an additional cohort to evaluate a fourth dose level may be considered jointly by the independent smc and the sponsor. upon establishment of a dose with acceptable safety and pharmacodynamic activity, additional patients will be enrolled in a dose expansion phase to allow for further characterization of the safety and pharmacodynamics of mrna-3704. patients in both phases of study will participate in a pre-dosing observational period, followed by a treatment period, and then a follow-up period after withdrawal of treatment.


Eligibility criteria:
inclusion criteria: patients are eligible to be included in the study only if all of the following criteria apply: * confirmed diagnosis of isolated mma due to mut deficiency based on the following criteria: * elevated plasma methylmalonic acid concentrations (≥ 100 µmol/l) * presence of normal serum/plasma vitamin b12 and plasma homocysteine levels * confirmed diagnosis by molecular genetic testing * patient must be ≥ 1 year of age at the time of consent/assent (inclusion of the first three patients will be restricted to individuals age ≥ 8 years) exclusion criteria: patients are excluded from the study if any of the following criteria apply: * diagnosis of isolated mma cbla, cblb, or cbld enzymatic subtypes or methylmalonyl-coa epimerase deficiency or combined mma with homocystinuria * history of organ transplantation * previously received gene therapy for the treatment of mma. * estimated glomerular filtration rate (gfr) \< 30 ml/min/1.73 m2; or patients who receive chronic dialysis