Kornimate/medical-research-clean huggingface dataset:
nurse-led telehealth for gout

Conditions: Health Literacy; Gout Arthritis; Gout Initiating Urate-loweringUrate-lowering Therapy; Telehealth; Digital Health; Adherence

Summary: the aim of this clinical trial is to evaluate whether nurse-led telehealth support helps individuals with gout better manage their condition and adhere to urate-lowering medication after discharge from a rheumatology clinic. eligible patients will be recruited from five rheumatology departments in the central denmark region after achieving two consecutive target serum urate levels-below 0.36 mmol/l, or below 0.30 mmol/l for patients with tophi. participants will be adults with gout who meet specific medical criteria, are taking medications such as allopurinol or adenuric, and are able to read and write danish. participants will be randomly assigned to one of two groups: * intervention group: nurse-led telehealth support. * control group: usual care with follow-up by their general practitioner. the primary goal is to support patients in maintaining healthy uric acid levels after 52 weeks. participants in the nurse-led group have the option to choose from four support options: i1: app-based support - an app provides information and reminders. i2: letter reminders - messages are sent via digital or postal mail. i3: text reminders - sms messages are sent every three months. i4: phone support - nurses call three times a year to check in.


Eligibility criteria:
inclusion criteria: * ≥18 years old * fulfills acr/eular 2015 gout classification criteria * estimated glomerular filtration rate (e-gfr) \>30 ml/min * prescribed allopurinol or adenuric, and achieved two consecutive serum urate levels of two consecutive serum urate levels of ≤0.30 mmol/l for patients with tophi and ≤0.36 mmol/l for patients without tophi * have sufficient danish reading and writing skills to understand information and complete questionnaires. exclusion criteria: • cognitively impaired, unable to understand or provide informed consent.

Keywords: self-managment
food additives effects on eeg profiles in college students with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of this study is to examine the effects of food additives on college students with adhd. this study could potentially answer an important question which still remains unanswered as to whether certain food additives may be able to cause cognitive and electrical activity changes in college students with and without adhd. in this context, food additives will be artificial food coloring.

consent will be obtained at the first visit. baseline data will be collected on the participants, including height, weight, computerized cognitive functioning, and an eeg recording. participants will also be taught how to keep a detailed food and symptom diary over the following week. one week later, the participant will return to the lab and turn in the food/symptom diary. all adhd participants and a subgroup of controls (called extended controls or ec) will be trained on how to follow the dietary intervention. detailed information on the diet will be given, including food additives to avoid, healthy foods which should be eaten, and shopping tips. for the next two weeks, the participant will follow the dietary intervention at home with access to dr. holton to answer any questions. the participant will return to the lab after following the diet for two weeks and assessments (cognitive testing, and eeg) will be completed again along information on dietary compliance will be collected. the third meeting will also mark the beginning of the first challenge period. for the challenges, the participant will consume chocolate cookies every monday, tuesday, and wednesday for two weeks. the cookies may or may not contain artificial food coloring depending on the week. every wednesday repeat testing will be completed after the cookies are consumed. the participant will be asked not to take adhd medication on testing days. after two weeks of challenges the study will be completed. the participant will receive information on their performance and on the study results overall.

Eligibility criteria:
inclusion criteria: * generally good health * 18-24 years old * currently attending college * physician's diagnosis of adhd (unless control participant) * stable medication dose and frequency for 3 months before the study * willing to suspend adhd medication administration on testing day and the day after testing exclusion criteria: * presence of comorbid psychiatric condition other than comorbid depression or anxiety * autism * severe asthma requiring past hospitalization * seizure disorder

Keywords: adhd food additives artificial food coloring diet
the transition from blastomere to trophectoderm biopsy: comparing two pgs strategies

Conditions: Infertility; Preimplantation Genetic Screening

Summary: shortly after the implementation of comprehensive chromosome screening (ccs) techniques for preimplantation genetic screening (pgs) came the transition in biopsy timing. trophectoderm biopsy is meant to overcome the limitations of cleavage stage biopsy and single cell analysis.

the investigators have recently introduced this new approach and a frozen-thawed policy of euploid blastocysts is routinely performed. this is a single centre retrospective study in patients undergoing a pgs cycle. the aim of the study is to assess the results obtained in a pgs programme after the implementation of a new biopsy timing and transfer policy. results obtained in pgs cycles with blastocyst biopsy and frozen-thawed embryo transfer were analysed in comparison to cycles with cleavage stage biopsy and fresh blastocyst transfer.

Eligibility criteria:
inclusion criteria: * own gametes * pgs for: advanced maternal age, repeated implantation failure, recurrent miscarriages, severe male factor, and previous affected pregnancies exclusion criteria: * pgs cycles with gamete donation * altered karyotypes * combined preimplantation genetic diagnosis (pgd)+pgs cycles
study of a healthy lifestyle intervention for deaf adults who are overweight or obese

Conditions: Overweight; Obesity

Summary: the purpose of the deaf weight wise study is to test a 16 week, evidence-based, comprehensive program to change obesity-related health behaviors in deaf people who use american sign language (asl) as their primary language. participants will be randomized to one of two study arms - immediate intervention or delayed intervention. in addition to the intervention activities, participants will also take part in five study visits over the course of two years. at these study visits, the investigators will administer several surveys as well as conduct biometric assessments. the investigators primary hypothesis is that the immediate intervention group will increase their levels of physical activity and reduce their caloric intake and body weight immediately following the intervention, compared to the delayed intervention group.


Eligibility criteria:
inclusion criteria: * deaf men and women ages 40-70 years who use sign language and live in the rochester metropolitan statistical area (msa), have a body mass index (bmi) of 25-45 * permission to participate from a primary healthcare provider if: 1) self-reported diagnosis of a recent cardiovascular disease event (heart attack or stroke in past 6 months), and 2) self-reported heart condition, chest pain, dizziness, or other reason not to participate in physical activity 3) self-reported weight loss surgery in the past two years * must be willing to follow a healthy dietary pattern and to abstain from using weight loss medications during the study * must be willing and able to attend group sessions and to participate in data collection requirements exclusion criteria: * participants who had a cardiovascular disease event in the past 6 months who did not obtain medical clearance from their provider * participants who had self-reported heart condition, chest pain, dizziness, or other reason not to participate in physical activity who did not obtain medical clearance from their provider * participants who had weight loss surgery in the past two years and who did not obtain medical clearance from their provider * pregnancy, breastfeeding, or planning a pregnancy during the study period (each of which will be determined by subject self-report through an in-person interview with a research team member) * those people who are unable or unwilling to provide written, informed consent * those people who are unable to see and interact with computer-based questionnaires and educational interventions
vitamin c and septic shock

Conditions: Septic Shock; Sepsis

Summary: this is a randomized, double-blind, placebo-controlled clinical trial to compare vitamin c versus placebo for patients presenting to the icu with a diagnosis of septic shock.

this is a multi-site, randomized, double-blind, placebo-controlled trial comparing a regimen of moderate-dose (6000 mg per day) vitamin c supplementation versus placebo for the treatment of patients presenting to the icu with septic shock. both groups will continue to receive all other standard of care measures for septic shock as clinically indicated. groups will be enrolled and receive study drug/placebo for 4 days (96 hours) or until 24 hours post-last pressor dose, whichever is sooner.

Eligibility criteria:
inclusion criteria: * • capability to provide written consent from participant or legally authorized representative (lar) if the participant is unable or incapacitated due to severity of illness. * age ≥ 18 years * septic shock as pragmatically defined as: o order for intravenous antimicrobials with either procalcitonin \> 2 mg/dl within 24 hours of enrollment or other clinical suspicion of infection or confirmed infection and * hypotension requiring vasopressor therapy, despite fluid resuscitation of at least 30 cc/kg and * lactate \> 2 mmol/l 24 hr prior to enrollment and * presence of sepsis defined as equal to or greater than 2 sirs criteria and/or acute increase in qsofa score of 2 points or more. * sirs criteria: 1) temperature greater than 38° or less than 36° celsius. 2) heart rate greater than 90 beats per minute. 3) respiratory rate greater than 20 breaths per minute or arterial carbon dioxide tension less than 32 mmhg. 4) white blood cell count greater than 12,000 cell/µl, less than 4,000 cells/µl, or band cells greater than 10% of the total white blood cell population. * qsofa: 1 point each is assigned for: 1) systolic blood pressure below 100, 2) respiratory rate greater than 22, and 3) mental status not at baseline. exclusion criteria: * • unable to start infusion within 24 hours of septic shock identification * currently pregnant or breastfeeding * patient to receive comfort measures only * cardiac arrest * cardiovascular surgery patients receiving prophylactic peri-operative antibiotics \< 48 hours post-operation * participation in another study involving an investigational product within 30 days of the baseline visit * allergy to vitamin c * history of nephrolithiasis * history of g6pd deficiency * esrd patients, transplant eligible on dialysis currently taking vitamin c supplementation * clinical course that treating clinician decides would preclude safe participation
demographic and clinical predictors of persistence in patients treated with aripiprazole once-monthly in italy

Conditions: Schizophrenia

Summary: this is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated with aripiprazole once-monthly as per normal clinical practice at least 6 months before the data collection starts (inclusion visit), and is designed to evaluate demographic and clinical predictors of persistence with this treatment. data from each patient will be collected after informed consent is signed (inclusion visit), and will include retrospective information from the start of aripiprazole once-monthly treatment initiation (index date) until the follow-up/inclusion visit (minimum of 6 months after the index date). data will be retrospectively collected from all visits occurring as per clinical practice (usually once monthly).


Eligibility criteria:
inclusion criteria: 1. adult patients (age ≥ 18 years at the time of aripiprazole once-monthly initiation) 2. male or female 3. diagnosis of schizophrenia according to diagnostic and statistical manual of mental disorders, fifth edition (dsm-5), available at start of aripiprazole once-monthly treatment, and confirmed by the current investigator 4. aripiprazole once-monthly initiation (at least 1 injection) according to the clinical practice, at least 6 months before the inclusion and on june 1st 2015 or at a later date (index date) 5. aripiprazole once-monthly was the main antipsychotic at the time of treatment initiation 6. willingness to participate in the study; subjects must give their written consent to participate exclusion criteria: 1. the patient has a psychiatric disorder other than schizophrenia as primary diagnosis 2. participation in a clinical trial during the retrospective follow-up period.

Keywords: persistence long-acting injectable antipsychotic adherence
vermont diabetes information system

Conditions: Diabetes Mellitus

Summary: the vermont diabetes information system (vdis) is a registry-based decision support and reminder system based on the chronic care model and targeted to primary care physicians and their patients with diabetes. it will be evaluated by a randomized, controlled study in 60 primary care practices in vermont and nearby new york.

the long-term goal of the vermont diabetes information system is to reduce morbidity and mortality from diabetes mellitus. the project will implement and evaluate a state-wide system to support evidence-based disease management by primary care providers, their practices, and their patients in the community. the primary study question is: "what is the effect of a diabetes information system (including education, feedback and decision support) upon disease control measured by glycated hemoglobin?" secondary questions address the effect of the system upon adherence to guideline recommendations, blood pressure control, patient satisfaction, medication use, and functional status. we hypothesize that the information system will result in improvements in the process and outcomes of clinical care. there are two specific aims: aim 1: implement the diabetes information system. objective 1.1: develop a registry of patients with diabetes in primary care practices in vermont; objective 1.2: provide education and feedback to providers regarding their patients with diabetes; objective 1.3: deliver decision support (flow sheets, alerts and reminders) based on the registry and targeted at primary care providers and patients, to prompt ideal management of diabetes. aim 2: assess the diabetes information system. objective 2.1: assess disease control and guideline adherence by examining registry data in all subjects in a prospective, two-year, randomized, controlled trial in 60 primary care practices; objective 2.2: assess outcomes (blood pressure control, obesity, functional status, symptoms, medication use, and satisfaction) by interview and examination in a sub-sample of patients from the controlled trial.

Eligibility criteria:
inclusion criteria: * adult * diabetes confirmed by primary care provider exclusion criteria: * severe dementia * nursing home resident

Keywords: chronic disease multi-hospital information systems clinical decision support systems reminder systems registries quality of healthcare guideline adherence outcome and process assessment (health care) technology assessment, biomedical primary health care hypercholesterolemia hypertension hyperglycemia
a trial in stable intermediate coronary lesions and grey-zone ffr values

Conditions: Grey-zone Fractional Flow Reserve; Intermediate Coronary Lesions; Stable Angina; Coronary Physiology

Summary: in this randomised controlled trial of patients with stable angina and documented intermediate coronary disease with indeterminate or "grey-zone" fractional flow reserve (ffr) we will randomise patients to either optimal medical therapy alone versus optimal medical therapy with pci and they will be followed up for the primary endpoint of anginal control as measured by the seattle angina questionnaire at 3 months.

pressure derived fractional flow reserve (ffr) is recognised as being the gold standard method of assessing the physiological significance of angiographically intermediate lesions. a grey-zone exists between the originally validated cut-off for ischemia of \<0.75 and the conventionally adopted cut- off of ≤0.80. pilot data from our centre has suggested that only 1 in 3 coronary arteries with grey-zone ffr values demonstrate myocardial perfusion defects on stress cardiac mri and others have suggested that the clinical outcomes in patients with grey-zone ffr are favorable with medical therapy alone. as such, stenting all lesions with grey-zone ffr (as currently recommended) may represent over-treatment and could attenuate the overall benefit of an ffr strategy. in addition to this there are flow derived resistance indices of stenosis severity that have superior diagnostic accuracy and may be helpful in correctly classifying patients with grey-zone ffr. in this study we will a comprehensive analysis of lesions with grey-zone ffr values (0.75-0.82 inclusive) using invasive hyperemic pressure, flow and resistance derived indices of severity with quantitative and qualitative 3t perfusion mri to enable identification of the best invasive predictors of true perfusion defects on 3t cardiac mri. patients will be randomised to optimal medical therapy alone versus optimal medical therapy with pci and followed up for the primary endpoint of anginal control as measured by the seattle angina questionnaire at 3 months.

Eligibility criteria:
inclusion criteria: 1. patients \>18 years 2. 30-80% diameter stenosis on qca 3. stable angina 4. non st-elevation myocardial infarction (nstemi) with stable symptoms 5. able to provide informed consent exclusion criteria: 1. stemi within 5 days 2. tortuous vessels which would render pressure wire studies difficult or impossible 3. heavily calcified vessels which would render pressure wire studies difficult or impossible 4. unstable symptoms requiring definitive interventional management 5. severe claustrophobia 6. age \>90 years 7. life expectancy \<1 year 8. estimated glomerular filtration rate \<30 mls/min/1.73m2 9. inability to undergo mri scanning due to metallic implant or incompatible permanent pacemaker 10. severe asthma or inability to safely receive an adenosine infusion 11. left mainstem disease ≤50% or if considered clinically significant by the operating cardiologist either on angiography or intravascular ultrasound.
impact of the virtual human project on team-based learning: a randomized-controlled trial

Conditions: Leprosy

Summary: team-based learning (tbl) is a learner-centered, instructor-directed strategy for small group active learning in large group educational settings. when tbl is conducted correctly, the students' performances are equivalent or improved in comparison to either lecture-based formats or more traditional small group learning models.1 nevertheless, few studies have been published regarding the insertion of innovative audiovisual tools in the tbl context. the virtual human project is described as powerful sequences of three dimension (3d) computer graphics video of the human body that aids learning by facilitating an understanding in relation to a specific subject. the virtual human is composed by video sequences combining anatomy, physiology, and morphology in the context of various diseases. there are video sequences available for many disciplines, including dermatology and with capacity to produce anatomical structures by 3d printer. despite the incredible potential applications of the virtual human, few studies have assessed its impact on medical education. the investigators did not find any study evaluating tbl with the insertion of iconographic educational material that assessed whether this intervention could change the learning progress of students. this is the aim of the present study, by comparing students tests scores after a tbl session with the virtual human videos about leprosy or a standard tbl session, and to evaluate the student's satisfaction with the virtual human videos.


Eligibility criteria:
inclusion criteria: * undergraduate medical students in the third year of medical school at the federal university of mato grosso do sul. exclusion criteria: * students previously exposed to dermatologic research, extracurricular activities involving dermatology or dermatology rotation in that year
safety, tolerability and immunogenicity of an trivalent inactivated cell-culture influenza vaccine in healthy adults

Conditions: Prevention of Influenza

Summary: a randomized, double-blinded, controlled, phase i clinical trial to assess the safety, tolerability and immunogenicity of 'nbp607(trivalent inactivated cell-culture influenza vaccine)' compared to egg-based influenza vaccine in healthy adult volunteers

1. assessment of safety 2. assessment of immunogenicity 3. estimated enrollment: 100

Eligibility criteria:
inclusion criteria: 1. 20 to \<60 years of age 2. able and willing to give written informed consent prior to study entry 3. if female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (hcg) test at screening exclusion criteria: 1. hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products 2. immunodeficiency disease 3. history of hypersensitivity when vaccination, such as guillain-barre syndrome 4. thrombocytopenia or coagulation disorders 5. experienced fever (\>37.5°c) within the past 24 hours or any acute respiratory infection 6. receipt of immunosuppressants or immunomodulators within the past 3 months 7. receipt of blood products or immunoglobulin within the past 3 months 8. received influenza vaccine within the past 6 months 9. received another vaccine within the past 1 month or plans vaccination within 1 months following the study vaccination 10. participation on another clinical trial within 1 month prior to the study vaccination 11. history of blood donation within 1 week prior to the study vaccination for plan of blood donation within 7 days following the study vaccination 12. any chronic diseases that interfere with the clinical trial or malignant tumors 13. pregnant or breastfeeding 14. any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject.
a multilevel approach to increasing hpv vaccine initiation among adolescents - part 3

Conditions: Human Papilloma Virus

Summary: our project will assess the feasibility and estimate preliminary efficacy of a multilevel intervention to improve hpv vaccine series initiation among adolescents in medicaid and chip. the investigators will use two intervention components: postcards and an ipad survey system. to estimate efficacy the investigators will select potential participants from florida medicaid and chip. the investigators will assess their claims for the hpv vaccine before and after the intervention.


Eligibility criteria:
inclusion criteria: * enrolled in florida medicaid * not initiated the hpv vaccine series at the start of the study period. exclusion criteria: * anyone who has a severe (life threatening) allergy to any component of hpv vaccine, esp yeast * pregnant * not enrolled in florida medicaid

Keywords: preventative postcard vaccinate