Kornimate/medical-research-clean huggingface dataset:
safety study of me-609 for treatment of herpes simplex labialis in adolescents

Conditions: Herpes Labialis

Summary: the purpose of this study is to evaluate the safety of me-609 for the treatment of recurrent herpes labialis in adolescents.

the objective of the study was to evaluate the safety of me-609 for the treatment of herpes labialis recurrences in immunocompetent adolescents, 12 - 17 years of age, following a 5-day treatment with 5-time daily topical administration.

Eligibility criteria:
inclusion criteria: * general good health * history of recurrent herpes labialis with at two recurrences during the last twelve months exclusion criteria: * treatment with systemic or topical antiviral agents or steroids within two weeks prior to inclusion * significant skin condition that occur in the area of herpes recurrences * nursing or/and pregnancy * immunosupressed state due to underlying disease (e.g. hiv infection or concomitant treatment (e.g. cancer chemotherapy)
research study to look at how well semaglutide works in people living with heart failure, obesity and type 2 diabetes

Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2

Summary: this study will look at how participants' daily life is affected by their heart failure. the study will also look at the change in participants' body weight. this study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms. participants will either get semaglutide or "dummy" medicine, which treatment participants get is decided by chance. participants will need to take 1 injection once a week. the study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm. during the study participants will have talks with the study staff about healthy lifestyle and physical activity. the study will last for about 59 weeks, that is a little more than 1 year. participants will have 12 clinic visits with the study doctor. * at 6 of the visits participants will have blood samples taken. * at 5 of the visits participants will be asked to fill in a questionnaire * at 4 of the visits participants will have to do a 6-minute walking test * at 3 of the visits participants will have a test to check the heart. * participants will have their eyes checked before or at the start of the study and at the end of the study women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility criteria:
inclusion criteria: * male or female, age above or equal to 18 years at the time of signing informed consent. * body mass index (bmi) greater than or equal to 30.0 kg/m\^2 * new york heart association (nyha) class ii-iv * left ventricular ejection fraction (lvef) greater than or equal to 45% at screening * diagnosed with t2d greater than or equal to 90 days prior to the day of screening * hba1c of below or equal to 10.0% as measured at the screening visit exclusion criteria: * a self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records * uncontrolled and potentially unstable diabetic retinopathy or maculopathy. verified by a fundus examination performed within 90 days prior to screening or in the period between screening and randomisation. pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
role of cherry consumption in reducing risk factors for chronic inflammatory diseases

Conditions: Inflammation; Cardiovascular Diseases

Summary: the goal of this study is to examine if chronic cherry consumption will decrease lipid peroxidation and serum concentration of inflammatory markers in human subjects with elevated serum c reactive protein (crp), and to examine the relationship between serum concentrations of crp and polyphenols. the investigators hypothesize that cherry consumption will reduce serum concentration of inflammatory markers, including crp, inflammatory cytokines and adhesion molecules.

the study will last a total of 64 days with three different metabolic periods. first 8 days will be period 1, when base line fasting blood samples will be collected on day 1 and 8. for the next 28 days (period 2 or intervention period) subjects will supplement their diets with 280 g/d of pitted bing cherries by replacing an equivalent amount of carbohydrate calories. we will prefer that the subjects split the cherries into three equal portions and consume one with each meal; however, this will not be mandatory. subjects will be asked to record all foods and drinks consumed for three 24-hr periods during the study. fasting blood samples will be drawn on study days 22 and 36 (14 and 28 day after the start of cherry consumption). the third period of 28 days will be post-intervention, when the subjects will return to their normal diets without cherries. post-intervention blood samples will be drawn on study day 64. all blood draws will follow a 12-hour fast. blood samples will be processed within one hour of draw and the plasma stored frozen in different aliquots, until analysis.

Eligibility criteria:
inclusion criteria: * healthy men and women * 45-65 years of age * serum crp concentrations between 3-25 mg/l * bmi \< 35 kg/m2 exclusion criteria: * bmi \> 35 kg/m2 * current infection * taking anti-inflammatory medications

Keywords: anthocyanins catechins chlorogenic acid flavanol glycosides
a study of the grip influenza and sars-cov-2 poc assays

Conditions: COVID-19; Influenza

Summary: the purpose of this research is to determine if the use of a new device can accurately detect a virus infection.

grip has developed a novel, graphene-based detection system for potential use in point-of-care settings. this study will compare the performance of the grip device to routine pcr testing for detection of covid-19 and influenza viruses. when patients present for routine testing for covid-19 and influenza, they will also have a separate nasal swab collected that will be tested by the grip point-of-care device.

Eligibility criteria:
inclusion criteria: * patients being tested for covid 19 or influenza exclusion criteria: * patients \< 18 years of age
efficacy, safety and tolerability of spd485 in children aged 6-12 diagnosed with adhd

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: this study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of spd485 in 6-12 year old subjects diagnosed with adhd.

attention-deficit/hyperactivity disorder (adhd) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. this study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of spd485 in 6-12 year old subjects diagnosed with adhd.

Eligibility criteria:
inclusion criteria: * subjects have primary diagnosis of adhd * females of childbearing potential must have a negative serum beta human chorionic gonadotropin (hcg) pregnancy test * subject has an iq score of \>_ 80 * subject is able to complete as least the basic test of the permp assessment exclusion criteria: * subject has a comorbid psychiatric diagnosis such as axis ii disorders or severe axis i disorders * subject is taking strattera(r) * subject has a recent history of suspected substance abuse or dependence disorder
cardioprotective activities of whole eggs on vascular endothelial function in prediabetic adults

Conditions: Prediabetes; Cardiovascular Disease

Summary: cardiovascular disease (cvd) is largely a lifestyle-related condition that is the #1 killer of adults in the united states. our work is aimed at understanding how short-term increases in blood sugar, like those that accompany eating a meal, affect blood vessel function and the risk of cvd. this research is aimed at understanding how meals composed of eggs affect short-term increases in blood sugar from eating, which are connected with increased risk of cvd. in particular, the investigators are trying to identify a specific meal composed of either whole eggs, egg yolks, or egg whites, that best reduces acute increases in blood sugar brought on by meals that consist of majority carbohydrate. at the same time, the investigators are trying to explore the protective affects that eggs may have on blood vessel function and the reduction of cvd risk.

cardiovascular disease (cvd) is the leading cause of death in the united states \[1\]. the inability of your blood vessels to properly enlarge and shrink, known as vascular endothelial dysfunction (ved), is an early event leading to cvd and can be caused by postprandial hyperglycemia (pph) \[1\] or short-term increases in blood sugar that occur after you have eaten. although we do not know how this occurs, research shows that temporary increases in blood sugar impair the blood vessel's ability to properly enlarge and shrink. we also know that impaired vessel function is an early event leading to cvd and that research shows that short-term increases in blood sugar impair blood vessel function, even in healthy people \[2\]. because high blood levels of cholesterol increase cvd risk, this has triggered flawed guidelines to restrict cholesterol in our diet \[3\], including limiting egg consumption. the misguided fear towards eating eggs has been routinely challenged by large-scale studies failing to associate eggs with heart disease risk \[4-8\]. research shows that eggs improve the functioning of insulin to reduce blood sugar \[9\]. they also contain bioactive peptides that may attenuate oxidative stress \[10-11\]. this provides rationale for their study as a dietary strategy to reduce pph and ved. thus, the objective of this study is to define the potential benefits of eggs and its components (egg yolk and egg whites) on blood vessel health in adults with prediabetes.

Eligibility criteria:
inclusion criteria: 1. fasting glucose 100-125 mg/dl, 2. non-dietary supplement user, 3. no medications affecting vasodilation, inflammation, or energy metabolism, 4. no cvd, 5. nonsmokers, 6. individuals having blood pressure \<130/85 mmhg and total cholesterol \<240 mg/dl. exclusion criteria: 1. unstable weight (±2 kg), 2. vegetarian or egg allergy, 3. alcohol intake \>3 drinks/d or \>10 drinks/wk), or 4. ≥7 h/wk of aerobic activity.

Keywords: cvd hyperglycemia postprandial vascular function
implementation of evidence-based breathing retraining for patients with asthma in region zealand

Conditions: Asthma

Summary: this study aims to implement the evidence-based intervention breathing retraining into clinical care of patients with symptomatic asthma irrespective of asthma severity or comorbidities, and in a diverse multicentre setting to evaluate implementation outcomes. this will meet patients' needs and improve health and life situation in patients with uncontrolled asthma. further, the study will evaluate implementation outcomes.

this study is a hybrid-designed prospective multicenter implementation evaluation study, in which the investigators secondarily will maintain measuring effectiveness of breathing retraining in a real-world setting including primary and secondary health care and add cross-sectorial co-operation. thus, investigators include more primary outcomes. the study is part of exercise first-project, a collaboration of the national health service, region zealand and the research unit progrez, department of physiotherapy and occupational therapy at næstved, slagelse, ringsted hospitals.

Eligibility criteria:
inclusion criteria: * doctor diagnosed asthma; * incompletely controlled asthma or worse: asthma control questionnaire (acq5) score ≥0.8; * residence (or asthma treatment program) in region zealand, denmark; * able to read and understand danish or available assistance to help understand information material, intervention content and respond to questionnaires. exclusion criteria: * unwilling to participate; * unable to participate in the intervention due to physical or mental condition.

Keywords: implementation asthma breathing retraining
decongestant effect, timing of effect and impact on sleep and general well-being of xylometazoline in subjects with a common cold

Conditions: Common Cold

Summary: the aim of this study is to characterize the time profile of the decongestant properties of xylometazoline and to investigate its effect on sleep, general well-being and smell/taste.


Eligibility criteria:
inclusion criteria: * over 18 years * have had moderate common cold symptoms for less than 36 hours. exclusion criteria: * congested/runny nose for more than two continuous weeks in the previous 12 months * deviated septum or nasal polyps * recent use of antibiotics * recent sinusitis other protocol-defined inclusion/exclusion criteria may apply.

Keywords: common cold, xylometazoline
optimizing infection prophylaxis prior to shoulder surgery

Conditions: Arthroplasty Shoulder; Periprosthetic Joint Infection

Summary: the goal of this interventional study is to determine the amount of skin c. acnes reduction with increased pressure during the chlorhexidine gluconate, brand name chloraprep, application. the main question it aims to answer is: does changing the pressure applied during the chloraprep application impact the amount of c. acnes bacteria on the skin after one hour? researchers will compare chloraprep applied at a pressure similar to a gentle wipe to chloraprep applied at a pressure similar to a massage to see if wash the amount of c. acnes on the skin after one hour is different. participants will have one shoulder washed with chloraprep using pressure meant to impact the dermal layer, similar to a gentle wipe, and the other shoulder washed with chloraprep using pressure meant to impact the subdermal layer, similar to a massage. participants will have swabs taken of their skin before the chloraprep application and again one hour after application to look for the amount of c. acnes on the skin.


Eligibility criteria:
inclusion criteria: * english speaking exclusion criteria: * self report very sensitive skin * allergic to chlorhexidine * used antibiotics in the last three months * used acne treatment in the last three months * wounds on your shoulders

Keywords: periprosthetic joint infection cutibacterium shoulder arthroplasty chlorhexidine
title: "intervention based on didactic model for suicidal behavior in the framework of impulsivity and ideations."

Conditions: Suicidal Ideation and Behavior; Impulsivity

Summary: suicide has become a major public health problem among young people around the world. this study will examine the effects of higher secondary school-based suicide prevention (hsssp) program on youth suicidal thoughts and impulsive behavior (stib). therefore, the purpose of this study is to examine the effects of didactic approach for youth stib on the hsssp program. this study is designed to address this issue at the secondary school level. therefore, this research is divided into two studies. in the first study, our goal was to arrange a baseline assessment for the screening process of adolescents at risk of suicide. while in second study we aim to implement a didactic approach based on religious teachings and culture milieu and examine its effects as an evidence based suicide prevention program.

suicide has become a major public health problem around the world. according to a recent report by the world health organization (who) suicide is the fourth leading cause of death among youth. suicidal thoughts and suicide attempts are on the rise among youth. therefore, evidence-based prevention programs need to fill this gap with interventions at the higher secondary schools. for decades, research and prevention efforts have been failed in developing meaningful predictions and reductions in suicide. however, significant efforts are needed to stop the rising tide of suicide. for the purpose, it is important to understand the suicidal thought at first as not everyone who commits suicide attempts suicide first. therefore, in this study an attempt has been made to investigate profoundly the understanding of suicide which has been emerged a serious problem around the globe and in particular in pakistani society. the researcher has planned to conduct psychological measures with established psychometric properties to look at the relationship between suicidal ideation and impulsivity anticipating suicidal behavior. during study the role of moderators i.e. social effectiveness and level of religiosity shall also be investigated. findings of this study shall comprehensively provide data in order to design an inclusive prophylactic strategy known as didactic intervention to prevent the suicidal act before it occurs. it is expected that this approach grounded on religious teaching and cultural milieu in line with the best practices, will be adapted. subsequently, this study also aims to evaluate the effectiveness of the didactic approach as an evidence based suicide prevention program in higher secondary schools with selective prevention programs.

Eligibility criteria:
inclusion criteria: * higher secondary school students * young people at risk of suicide: those who are impulsive and have suicidal thoughts. exclusion criteria: * who has a history of suicide attempts
medication intervention in transitional care to optimize outcomes & costs for ckd & esrd

Conditions: Chronic Kidney Disease; End-Stage Renal Disease

Summary: transitional care strategies focused on enhancing the accuracy and comprehensiveness of medication information transfer will lead to improved health outcomes among hospitalized patients with chronic kidney disease.

patients with ckd and esrd have more co-morbidities, are hospitalized more often and for longer lengths of stay, and incur greater healthcare costs than patients with other chronic conditions. enhanced hospital to home transitional care interventions have been shown to improve medication information transfer, reduce hospital readmissions, and slow the progression of declining health in the general population of hospitalized patients. what is not known is the impact enhanced transitional care can have for a very high-risk population, such as those with ckd and esrd. interventions that prevent or slow ckd progression, i.e. blood pressure control and intensive glycemic control in patients with diabetes, are all highly dependent on meticulous medication management. for hospitalized patients with ckd or esrd who are transitioning to home, accurate and comprehensive information transfer is essential to optimal medication management. ckd and esrd patients are in critical need of improved transitional care that includes accurate and comprehensive medication information transfer. the main objective of this application is to pilot-test the effectiveness of a medication information transfer intervention to improve clinically-relevant outcomes. to this end, the following specific aims will be achieved: 1. evaluate the impact of transitional care interventions on acute care utilization following hospital discharge among patients with ckd or esrd. 2. evaluate the impact of transitional care strategies on management of ckd or esrd management and complications.

Eligibility criteria:
inclusion criteria for ckd arm: 1. hospitalized patients 2. \> 21 years of age 3. diagnosis of ckd stages 3-5, not treated by dialysis inclusion criteria for esrd arm: 1. hospitalized patients 2. \> 21 years of age 3. patients treated with hemodialysis or peritoneal dialysis exclusion criteria: 1. kidney transplant

Keywords: glomerular filtration rate albuminuria medical therapy hospital discharge hospital readmission ckd complications ckd risk factors
evaluating adapted structured clinical management for people with a diagnosis of personality disorder

Conditions: Personality Disorders

Summary: camden and islington nhs foundation trust in london has a personality disorder service (pds) which offers a number of evidence-based interventions to people with a diagnosis of personality disorder. one team in the pds, the community team, offers an adapted form of structured clinical management (scm; bateman and kravitz, 2013). as these adaptations are novel, this study aims to formally explore the effectiveness of this intervention, through a sample of clients under the team, with outcomes (proxy measures of distress such as inpatient admissions) pre- and post- intervention.


Eligibility criteria:
inclusion criteria: * allocated to a care coordinator at the pds for greater than one year (a reasonable time period for therapeutic rapport to form and the effect of the intervention to manifest). exclusion criteria: * no existing notes for one year prior to allocation. * no primary diagnosis of personality disorder.
benefits of nicotinamide riboside upon cognition and sleep

Conditions: Cognitive Impairment; Sleep Quality

Summary: poor sleep quality and short sleep duration may be a mechanistic component of cognitive impairment in older adults, associated with a decline in brain-derived neurotrophic factor. increasing the availability of nicotinamide adenine dinucleotide (nad+) with supplementation of its precursor, nicotinamide riboside (nr), a form of vitamin b3 may increase the expression of brain-derived neurotrophic factor. this study proposes to examine the benefits of nr supplementation on sleep and cognitive function in older adults with comprehensive subjective and objective measures and to explore its impacts on serum brain-derived neurotrophic factor.

ten percent of adults aged ≥ 65 years and fifty percent of adults ≥ 85 years exhibit cognitive impairment. dementia treatment cost $277 billion in 2018 and is predicted to surpass $500 billion with the aged population reaching 70 million by 2030 in america. in addition, 50% of older adults experience poor sleep quality, including fragmented nighttime sleep, reduced sleep efficiency, and earlier bedtime and wake-up times. consequently, millions of americans are at risk for both cognitive impairment, including alzheimer's disease and other dementias, and disrupted sleep. sleep disruptions alter underlying circadian rhythms and synaptic plasticity in the hippocampus, as well as reduce expression of brain-derived neurotrophic factor (bdnf) - elements associated with impaired memory, dementia, and alzheimer's disease. importantly, sleep disturbances and mild cognitive impairment may appear several years before the development of clinical dementia. therefore, interventions that improve sleep may prevent cognitive impairment and would have substantial clinical importance. pre-clinical animal models suggest that enhancing the availability of nicotinamide adenine dinucleotide (nad+) may reduce cognitive decline and support sleep quality by boosting mitochondrial function and bdnf expression. additionally, supplementation with nad+ precursor nicotinamide riboside (nr), a form of vitamin b3, improves cognition in aged mice. the hypothesis for this study is that nr supplementation will enhance cognition by improving objective sleep duration and sleep quality in older persons. to test the hypothesis, this study will measure the benefits of nr supplementation on sleep and cognition in older veterans and determine the role of bndf as a potential biomarker of sleep quality.

Eligibility criteria:
inclusion criteria: * sleep quality. pittsburgh sleep quality index (psqi) global score \>5 exclusion criteria: * dementia. veteran affairs - st. louis university mental status questionnaire (va-slums) score \<20