Kornimate/medical-research-clean huggingface dataset:
telehealth enhanced asthma management

Conditions: Asthma

Summary: this study will conduct a 12-month randomized trial with 48 pediatric patients (aged 6-18 years) with persistent asthma to compare outcomes among patients with follow-up visits managed via telemedicine (tm) vs. in-person (ip) visits.

the overarching hypothesis is that utilization of tm for asthma follow-up will result in improved clinical outcomes such as asthma control test (act) scores, lung function and medication adherence compared to participants receiving ip follow-up care. the investigator also hypothesize that tm follow-up will result in higher caregiver satisfaction because families will be able to receive quality subspecialty care in their community (tm) compared to those who travel a distance to receive care (ip).

Eligibility criteria:
inclusion criteria: 1. age ≥6- and ≤18 years 2. persistent asthma as defined by national guidelines standards 3. receives care at an ach asthma subspecialty clinic 4. reside ≤1.5 hour drive from jonesboro, springdale, texarkana, or fort smith, ar exclusion criteria: 1. significant underlying respiratory disease other than asthma, such as cystic fibrosis 2. significant co-morbid conditions, such as individuals with developmental or physical impairments that could interfere with the ability to communicate via interactive video 3. current smoker 4. severe asthma exacerbation requiring intubation in the past 12 months 5. no access to a smartphone or internet

Keywords: telemedicine clinical follow up visits
a study of crisaborole ointment 2% in children aged 3-24 months with mild to moderate atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this 4-week study will evaluate the safety, pharmacokinetics (pk), and efficacy of crisaborole ointment 2%, applied twice daily (bid) in subjects who are 3 months to less than 24 months of age with mild-to-moderate ad.

approximately 125 subjects will be enrolled. subjects must have mild-to-moderate ad involving at least 5% treatable %bsa assessed on baseline/day 1. treatable %bsa will be defined as the percent of a subject's total body surface area that is ad-involved, excluding the scalp. in addition, a cohort of at least 16 of the 125 subjects will be included in a subgroup for pk assessment. these subjects must have moderate ad and a minimum of 35% treatable %bsa, excluding the scalp, and must complete all pk assessments to be included in the pk analysis. of these subjects, at least 3 subjects who are less than 9 months of age will be enrolled. subjects discontinuing for reasons other than treatment emergent adverse event ( teae) may be replaced at the discretion of the sponsor to ensure 16 subjects complete the pk assessments. only selected study sites will participate in the pk assessment. scheduled study visits/telephone contacts for all subjects will occur at screening (up to 28 days prior to baseline/day 1), baseline/day 1, day 8, day 15, day 22, day 29 (end of treatment/early termination), day 36, and day 57 (end of study).

Eligibility criteria:
inclusion criteria: aged ≥ 3 months at the screening visit to \< 24 months on baseline/day 1, diagnosed with ad exclusion criteria: subjects with any clinically significant dermatological condition or disease (including active or potentially recurrent non-ad dermatological conditions that overlap with ad such as netherton syndrome)
treatment of early phase achilles tendinopathy - the effect of nsaids

Conditions: Tendon Injuries; Achilles Tendinopathy; Inflammation

Summary: this study evaluates the addition of initial short term nsaid treatment to physiotherapy prescribed exercise treatment in patient with early phase tendinopathy. half of the participants will initially receive nsaid (naproxen) for 7 days, while the other half will receive a placebo, where after both groups will be subjected to 3 months heavy slow resistance training.

nsaid is effective in short term pain relief in musculoskeletal disorders, but little is known about the long-term effect in early phase tendinopathy, when used as a supplement to treatment as usual, namely heavy slow resistance training and training load reduction. in this study, nsaids will be used, which works through cox inhibition, which again inhibits prostaglandins, in this way investigators attempt to dampen the initial inflammation and pronounced cell activity that is thought to be present in early phase tendinopathy. with this project, it will be attempted to investigate whether initial dampening adds to the effect achieved through heavy load resistance training, which is thought to stimulate structural repair and regeneration in the tendon, by applying appropriate load to the tendon tissue, thereby stimulating the tendon cells to repair and regeneration.

Eligibility criteria:
inclusion criteria: * activity related pain in the achilles tendon * palpation pain in the achilles tendon * onset of symptoms within the last 3 months exclusion criteria: * previous injury in the achilles tendon on the ipsilateral side. * recent infection around the achilles tendon * previous surgery in the achilles tendon. * contraindications for nsaid treatment. * nsaid treatment for the current injury * medication with nsaid interaction
epinephrine inhalation aerosol usp, a hfa-mdi study for assessment of pharmacokinetics

Conditions: Asthma; Bronchospasm; Wheezing; Shortness of Breath

Summary: this study examines the pharmacokinetic profile of armstrong's proposed epinephrine inhalation aerosol usp, an hfa-mdi (e004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers. the current study is designed for a more thorough evaluation of the e004 pharmacokinetics. safety of e004 will also be evaluated, under augmented dose conditions.

e004 is formulated with epinephrine free base as the active ingredient, and hydrofluoroalkane (hfa-134a) as the propellant. in order to differentiate the inhaled epinephrine from the fluctuating background of endogenous epinephrine 1, a stable-isotope deuterium (2h) labeled epinephrine (epinephrine-d3) preparation will be used to formulate e004 inhalers, denoted as e004-d3. pk of e004 at 125 mcg of epinephrine-d3 per inhalation, will be compared to that of the currently marketed, non-labeled, epinephrine-cfc mdi as the reference control (220 mcg per inhalation). this study is a randomized, evaluator-blind, single dose, two-arm, crossover, pk study, to be conducted in \~18 healthy, male and female, adult volunteers. pk will be studied using e004-d3 at 125 mcg per inhalation (arm t). a currently marketed, non-labeled, epinephrine cfc-mdi will be used as a reference control (arm c).

Eligibility criteria:
inclusion criteria: * generally healthy at screening; * no clinically significant respiratory, cardiovascular and other systemic or organic illnesses; * body weight ≥ 50 kg for men and ≥ 45 kg for women, * sitting blood pressure ≤ 135/90 mm hg; * demonstrating negative hiv, hbsag and hcv-ab screen tests; * women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control; * properly consented * other criteria apply exclusion criteria: * a smoking history of ≥10 pack-years, or having smoked within 6 months; * upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk, prior to screening; * any current or recent respiratory conditions that might significantly affect pharmacodynamic response to the study drugs; * known intolerance or hypersensitivity to the study mdi ingredients; * having been on other investigational studies, or donated blood, in the last 30 days; * other criteria apply

Keywords: asthma bronchospasm wheezing shortness of breath
improving high school breakfast environments

Conditions: Obesity

Summary: the goals of this intervention study are to implement best practice strategies to expand and promote the school breakfast program and test the impact upon student participation rates among a) all 10th and 11th grade students and among a randomly selected cohort of 800 students b) total diet and body mass index and percent body fat inin 16 rural minnesota school districts. school-wide primary aim: improve participation in the school breakfast program among high school students. hypothesis: school-wide school breakfast program participation will be higher in the intervention versus comparison group.

we will accomplish the following secondary aims using a random subsample of 800 incoming 10th and11th grade students. student-level secondary aims secondary aim 1: high school students in the intervention condition will decrease their rate of weight gain relative to height gain as measured by change in body mass index and percent body fat compared to students in the control condition. hypothesis: body mass index and percent body fat will be maintained or reduced in the treatment versus control group. secondary aim 2: high school students in the intervention condition will maintain or decrease their energy intake while improving dietary intakes of low fat dairy, whole grains and fresh fruits compared to the control students. hypothesis: energy intake (measured by 3, 24-hour recalls) will be maintained or reduced and intakes of low fat dairy, whole grains and fresh fruits will increase more in the intervention groups. secondary aim 3: compared to students in the control condition, high school students in the intervention condition will report receiving more support to eat school breakfast. support will be social (increased peer and school support) or related to the school environment (satisfaction with serving locations and times, eating locations, foods and increased availability of low fat dairy, fruits and whole grains for breakfast). hypothesis: the treatment group will report receiving more social and school environment support for eating school breakfast than the comparison group (measured by a student survey).

Eligibility criteria:
inclusion criteria: must be in 10th or 11th grade in school year 2013-14 must have access to the internet must have access to a phone exclusion criteria for the cohort: unable to read english unable to speak english pregnant plan to move out of the school district within school year not in school most mornings eat breakfast 4 or more days a week
mucin glycosylating enzymes in head and neck cancers

Conditions: Glycosyltion Enzymes and Function Abnormalities

Summary: head and neck squamous cell carcinoma(hnscc) is the fourth common malignancy in taiwan. it accounts for 5.8% of all cancers and causes 2,463 deaths per year. aberrant glycosylation is the hallmark of most human cancers, including hnscc, and affects many cellular properties. this study is aimed at exploring the role of mucin glycosylating enzymes in hnscc.

glycosylation is the most common post-translational modification of proteins. aberrant glycosylation is the hallmark of most human cancers and affect many cellular properties, including cell proliferation, apoptosis, differentiation, transformation, migration and immune response. though widely explored in various human cancers, the role of mucin glycosylating enzymes in hnscc has not been elucidated. our aims is to analyze the expression patterns of mucin glycosylating enzymes in hnscc tissues. furthermore, we will correlate the expression levels of mucin glycosylating enzymes with clinical characteristics of hnscc patients.

Eligibility criteria:
inclusion criteria: * head and neck cancer patients receiving operation in national taiwan university hospital exclusion criteria: * recurrence or non-operable patients
brief smartphone treatment study

Conditions: Generalized Anxiety Disorder

Summary: little is known about whether and how brief mindfulness therapies yield clinically beneficial effects. this gap exists despite the rapid growth of smartphone mindfulness applications and presence of mental health treatment gap. specifically, no prior brief, smartphone mindfulness ecological momentary intervention (memi) has targeted generalized anxiety disorder (gad). moreover, although theories propose that mindfulness intervention can boost attentional control (ac), executive functioning (ef), perspective-taking, and social cognition skills they have largely gone untested. thus, this randomized controlled trial (rct) aims to address these gaps by assessing the efficacy of a 14-day smartphone mindfulness emi (vs. placebo). participants with gad will be randomly assigned to either memi or self-monitoring placebo (smp). those in treatment will exercise multiple core mindfulness strategies (open monitoring, acceptance, attending to small moments, slowed rhythmic diaphragmatic breathing). also, those in memi will be reminded before bedtime that mindfulness is a lifelong practice. comparatively, participants assigned to smp will only be prompted to practice self-monitoring. they will notice their thoughts, rate any distress associated with them, and will not be taught any mindfulness strategies. all prompts will occur 5 times a day, for 14 consecutive days. they will complete self-reports and neuropsychological assessments at pre-, post-, and 1-month follow-up. multilevel modeling analyses will determine if treatment (vs. self-monitoring placebo (smp)) produces substantially larger reductions in trait worry and negative perseverative cognitions as well as steeper increases in ac and ef (inhibition, set-shifting, working memory updating). in addition, the investigators hypothesized that memi (vs. smp) would lead to greater increases in performance-based and self-reported trait mindfulness, empathy, and perspective taking. findings will advance understanding of the efficacy of unguided, technology-assisted, brief mindfulness in a clinical sample.


Eligibility criteria:
inclusion criteria: * presence of generalized anxiety disorder based on the generalized anxiety disorder questionnaire-iv self-report and mini international neuropsychiatric interview * current student at the pennsylvania state university or a community-dwelling adult who expressed interest to participate through the psu studyfinder portal * expressed interest to seek treatment * currently not receiving treatment from a mental health professional * able to provide consent * proficient in english exclusion criteria: * below age 18 * failure to meet any of above inclusion criteria * participant currently undergoing * presence of suicidality, mania, psychosis, or substance use disorders

Keywords: ecological momentary intervention mindfulness self-help digital health mobile app
a digital patient decision aid to increase sexually transmitted infection testing in the emergency department: the sticker study

Conditions: STI; Sexually Transmitted Infection (STI); Sexually Transmitted Disease (STD)

Summary: this study is a pilot randomized trial of sticker in which 40 providers (20 trained in using the sticker decision aid and 20 providing standard care) will enroll a total of 140 sexually active young emergency department (ed) patients over six months in a pediatric and adult ed setting. the primary goal is to determine if sexually active young individuals who use sticker are more likely to undergo sti testing. by developing an effective automated digital tool to increase sti testing, the investigators aim to improve evidence-based sexual health education, reduce sti rates, and enhance the health outcomes of young individuals nationwide.

improving sexually transmitted infection (sti) screening is vital to combat the sti epidemic, especially among adolescents and young adults (aya) aged 15-24 years in the united states. inadequate testing for stis in different body areas contributes to disease transmission. emergency departments (eds) treat a significant number of young individuals, many of whom come from economically disadvantaged backgrounds and minority communities. previous research has shown inconsistent use of contraception in this population, and despite the willingness of ed providers to support sexual health interventions, time and resource limitations present implementation challenges. to address this issue, the investigators propose developing sticker (sti check in the er), a digital patient decision aid for sti testing in the ed that promotes shared decision-making. sticker involves three steps: (1) patients complete a nonjudgmental sexual health screening assessment by scanning a quick-response (qr) code, (2) educational modules facilitate shared decision-making (sdm) by connecting personalized sti risk with evidence-based testing recommendations, and (3) a confidential, color-coded digital infographic aids the patient-provider discussion on sti testing.

Eligibility criteria:
inclusion criteria: * aya aged 14-24 years * sexually active within the past 6 months (per self-report) * ability to speak english exclusion criteria: * severe illness * cognitive impairment * inability to speak english

Keywords: gonorrhea chlamydia
opioid induced swallowing difficulties and risk for pulmonary aspiration

Conditions: Opioid Induced Swallowing Disorders

Summary: the purpose of this study is to determine weather remifentanil induced swallowing difficulties increase risk for pulmonary aspiration.

remifentanil and other opioids are widely used as anesthetic sedation during minor surgical procedures and as pain relief in icu-patients when the patient is spontaneously breathing and the airway is not secured by endotracheal intubation. in these circumstances inability to clear the pharynx by swallowing may increase risk for aspiration.in a previous study ( not yet published) we showed that remifentanil induce subjective swallowing difficulties in healthy volunteers and the aim of this study is to determine weather remifentanil infusion in healthy non-intubated volunteers increase risk for pulmonary aspiration. to assess this question we are going to study 14 volunteers who are randomised to receive remifentanil infusion with target concentration 3 ng/ml during 60 minutes at one occasion and an equal amount of saline at the other. radioactive technetium colloid solution is parallelly infused through a pliable catheter transnasally. after remifentanil infusion is stopped the transnasal catheter is removed and the volunteer is asked to swallow water to clear the remaining radioactivity from upper gastrointestinal tract. thereafter lung scanning with a gamma camera is performed. through which mechanism remifentanil cause swallowing difficulties is not known.to determine weather remifentanil induce general muscle weakness in volunteers measurements of grip strength using jamar dynamometer are performed before, during and 15 minutes after remifentanil infusion.

Eligibility criteria:
inclusion criteria: * 18 - 40 year old healthy volunteers from both sexes. * have signed and dated informed consent. * willing and able to comply with the protocol for the duration of the trial. exclusion criteria: * pharyngoesophageal dysfunction * anamnesis of pharyngoesophageal dysfunction * known history of cardiac, pulmonary or neurological disease * ongoing medication * allergies to or history of reaction to naloxone, remifentanil, fentanyl analogues or other ingredients * history of reaction to products containing human albumine * pregnancy or breast feeding * bmi \> 30 * previous participation in a medical clinical trial where opioid has been used or have during last 30 days participated in any other medicinal clinical trial or in a trial where follow-up in not completed

Keywords: swallowing difficulties remifentanil pulmonary aspiration scintigraphy
strong men, strong communities diabetes risk reduction in american indian men

Conditions: Diabetes

Summary: smsc will inform the design and implementation of culturally informed, community-based lifestyle interventions for diabetes prevention in ai men in our partner communities and elsewhere, as well as in men of other minority groups who experience a heavy burden of diabetes.

american indian (ai) males experience profound health disparities compared to their counterparts in all other u.s. racial and ethnic groups. ai men have the highest age-adjusted prevalence of type 2 diabetes (\~18%) among u.s. men, while non-hispanic white men have the lowest (\~7%). in recent decades, ais have seen a disproportionate increase in diabetes-related complications and mortality compared to all other groups, such that age-adjusted diabetes death rates in ai men are now almost twice those in white men. several large randomized, con trolled trials in non-ais confirm that type 2 diabetes can be prevented or delayed by interventions that promote healthy lifestyles, but little empirical data exist on interventions to prevent diabetes in ai men. in the clinic-based u.s. diabetes prevention program (dpp), only 55 out of 3,234 participants were ai men. similarly, in the diabetes prevention programs in native communities, participation by ai males is low, ranging from 33% to 74%. many explanations have been posited for the low participation rates among men of all races in lifestyle interventions. recruiting ai men in clinic-based programs is difficult because they tend to seek clinical care less often than women. ai men's perceptions of normative health behaviors and gender roles may also discourage participation, particularly in mixed-gender groups. therefore, an urgent need exists for diabetes risk reduction programs tailored to the unique values and habits of ai men, with a particular focus on recruitment and retention

Eligibility criteria:
inclusion criteria: * must be male and self-reported american indian; ages 18-75, a bmi ≥25 kg/m2 and/or a waist circumference \>90 cm for men; no prior diabetes diagnosis; no history of heart disease, serious illness, cancer diagnosis in the last five years, or other conditions that may impede or prohibit participation; reliable internet access; access to a computer, tablet, or smartphone; have an active email address; and, willingness to consent to randomization exclusion criteria: * females, under 18 years old or older than 75 years