Kornimate/medical-research-clean huggingface dataset:
effect of occupational therapy in promoting medication adherence

Conditions: Hypertension; Diabete Type 2

Summary: the purpose of this research study is to see if an occupational therapist can help people with high blood pressure and/or diabetes find ways to better take their medicine. participants will be recruited from the jordan valley community health center in springfield, missouri.

the purpose of this study is to determine whether the addition of an occupational therapy intervention to counseling by a clinical pharmacist (current usual care) compared to counseling by a clinical pharmacist only, will affect three-month medication adherence rates among community-dwelling adults with uncontrolled hypertension and/or diabetes. to meet this purpose, the following objectives will be addressed: 1. to determine if the addition of the delivery of an occupational therapy intervention (specifically the integrative self-management intervention) to usual care improves three-month medication adherence rates, as measured by the adherence to refills and medication scale (arms-7), pill count, blood pressure and/or hemoglobin a1c. 2. to determine whether the administration of the occupational therapy intervention in addition to usual care influences an individual's readiness for change as measured by the stages of change measure; and 3. to explore whether participant demographics (e.g., gender, age, race/ethnicity, assist at home, co-morbidities, and number of medications) impact three-month medication adherence rates.

Eligibility criteria:
inclusion criteria: * jordan valley community health center clients will be considered eligible for inclusion in the study if they are 18 years or older, have a confirmed diagnosis of hypertension, receive a score of less than or equal to 21 on the adherence to refills and medication scale (arms-7) and they provide written informed consent. exclusion criteria: * participants will be excluded if they indicate via self-report that they are unable to read or understand spoken english without an interpreter or translator or if they have a medical power of attorney and are unable to provide their own informed consent.
tirbanibulin for pediatric warts

Conditions: Warts Hand

Summary: warts are common, benign skin lesions caused by the human papillomavirus (hpv). treatment is challenging, particularly in the pediatric population, where standard modalities such as cryotherapy and intralesional immunotherapy are poorly tolerated. existing topical treatments, such as imiquimod and 5-fluorouracil, have low efficacy and require prolonged use. case reports suggest tirbanibulin ointment may provide an effective and well-tolerated alternative for pediatric warts. this study will evaluate the efficacy and safety of tirbanibulin ointment in treating pediatric hand warts.


Eligibility criteria:
inclusion criteria: 1. age 8-18 2. subject and their legally authorized representative must be able to understand and be willing to adhere to all protocol requirements and voluntarily sign and date informed consent and assent for minors. 3. subject is judged to be in good health as determined by the principal investigator, based upon the results of the screening assessments and medical history. 4. diagnosis of warts on the hands 5. wart count on the hands and 3-10 exclusion criteria: 1. wart duration \>2 years. 2. more than 10 warts in non-hand areas. 3. total wart surface area on the hands bigger than 100 cm2 4. prior treatment failure with the following modalities: 1. intralesional immunotherapy 2. intralesional bleomycin, 5-fluorouracil, methotrexate 3. intralesional cidofovir 5. any over the counter, prescription topical, or in-office procedural wart treatment within 6 weeks of baseline (day 1) 6. known immuno-suppressed state due to disease or medication, medical treatment o 7. known allergy to any component of the ip 8. any conditions that, in the principal investigator's opinion, may interfere with the course of the study
yoga effect on quality of life study among patients with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this study will evaluate whether regular yoga exercises designed specifically for patients with idiopathic pulmonary fibrosis is associated with any change in quality of life. half of the participants will be randomized to yoga, half to usual care. yoga was conducted live, virtually, in the setting of the covid pandemic.

idiopathic pulmonary fibrosis (ipf) is a chronic progressive fibrotic (scarring) disease of the lung of unknown cause. approximately 100,000 americans will die from ipf this year. there is no cure for ipf other than lung transplantation, which only 1% of patients will receive. recently, 2 drugs were approved by the fda to slow the rate of decline in lung function among patients with ipf. these drugs do not decrease symptoms or improve quality of life. symptoms of ipf include shortness of breath, cough, and fatigue, all of which may also adversely affect quality of life. yoga is a practice of exercises, including breathing exercises, that has been shown to be relatively safe and to improve quality of life in some patients with other advanced lung diseases. we hypothesize that regular yoga and breathing exercises, specifically designed for patients with idiopathic pulmonary fibrosis, over a period of 12 weeks will lead to improved quality of life as measured by several different quality of life questionnaires.

Eligibility criteria:
inclusion criteria: adults 18 years of age or older. we will include all consecutive consenting patients with ipf who are able to provide informed consent and are seen and followed at the center for interstitial lung disease at the university of washington medical center. exclusion criteria: subjects with comorbid diseases that would prohibit them from taking part in yoga will be excluded at the discretion of the clinical-investigators. such comorbid diseases would include paralysis, musculoskeletal discomfort that would interfere with participation or broken limbs. since we are interested in the effect of yoga among subjects with ipf, we will exclude subjects who have previously received lung transplantation. to assess the effect "new" or "initial" participation in a yoga program with breathing exercises on quality of life, subjects who are regularly participating in yoga (outside of the study) will be excluded.

Keywords: idiopathic pulmonary fibrosis yoga quality of life
stool collection sub-study of exact sciences protocol 2018-01

Conditions: Colorectal Cancer; Colo-rectal Cancer; Cancer

Summary: the primary objective of this sub-study is to obtain de-identified, clinically characterized, stool specimens from subjects with untreated solid tumors for research use in the development and validation of a stool-based test for colorectal cancer.


Eligibility criteria:
inclusion criteria: * subject is currently enrolled in exact sciences protocol 2018-01. * subject is willing and able to provide a stool sample. * subject understands the study procedures and is able to provide written informed consent to participate in the study. exclusion criteria: * subject has a condition the investigator believes would interfere with his or her ability to provide informed consent, comply with the sub-study protocol, or put the person at undue risk.

Keywords: colorectal cancer cologuard sample collection
hepatitis b vaccine in chronic hepatitis b patients with low serum hbsag

Conditions: Chronic Hepatitis B

Summary: background: the hbsag clearance rate in interferon-treated responders is significantly higher than that in lamivudine-treated responders, implying immune control is the key to hbsag clearance. there is a good chance to further increase the cure rate if the investigators can enhance the hbv-specific immune response when the hbsag level already comes to a low level. hypothesis: hbsag-based vaccine can enhance hbsag clearance in chronic hepatitis b patients whose hbsag already \<=2000 iu/ml. patients and methods: this pilot study will enroll 20 chronic hepatitis b patients with hbsag ≦2000 iu/ml, no hepatic decompensation, no hiv coinfection, nor clinical immunodeficiency. engerix-b vaccine (20μg for \<20 years old and 40 μg for ≥ 20 years old) will be given every 2 months for one year. hbsag quantification, anti-hbs, and hbv dna will be surveyed regularly before each dose during the treatment period and every 3 months for another year following the last dose. viral and cellular factors will be studied to discover determinants affecting hbsag clearance. aims 1. to elucidate whether hbsag-based vaccine can reactivate host immunity to eliminate chronic hbv infection in patients with low titer hbsag. 2. to delineate the doses to response (hbsag clearance or decline rate) correlation so as to design a feasible schedule for future clinical trials in a larger group of patients. 3. to discover viral and host factors which can be used as biomarkers for personalized vaccine therapy.

vaccination schedule: engerix-b (20μg/ml, glaxosmithkline biologicals) will be administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months or until hbsag clearance. the dosage will be 20μg in those \ 20 years old. hbsag and anti-hbs: qhbsag will be checked by commercial kits (elecsys, roche diagnostics, indianapolis, in) at baseline, right before every dose, and every 3 months following the last dose for one year. alt, ast, alpha-fetoprotein, bilirubin and anti-hbs will be checked simultaneously.

Eligibility criteria:
inclusion criteria: 1. naïve or treated chronic hepatitis b patients with positive hbsag and negative hbeag; 2. quantitative serum hbsag (qhbsag) \<2000 iu/ml; 3. no hiv co-infection; 4. no obvious immunodeficiency (such as renal failure, chemotherapy, radiotherapy, immunosuppressant); 5. aged 3 to 80 years; exclusion criteria: 1. pregnancy 2. allergic to hbv vaccine or yeast. 3. hepatic decompensation

Keywords: therapeutic vaccine hbsag clearance immune clearance hbsag clearance induced by vaccination s seroconversion in carriers after vaccination
virtual reality in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis; Pain; Quality of Life

Summary: one of the main challenges facing the therapist in the treatment of adhesive capsulitis is to motivate the patient throughout conventional therapy. as noted in a recent review, individuals are more interested in leisure activities rather than performing repetitive tasks during therapy. virtual reality (vr) is a three-dimensional computer-aided programme built with a system that creates virtual reality movements and generates a high amount of visual and sensory feedback during exercise. as a result, virtual reality (vr) has been used in many medical indications and has been shown to promote adherence to treatment by increasing patient motivation.

different vr systems have been shown to be effective in individuals with kinesiophobia as well as stroke patients. virtual reality guided exercise is a proven method already used in stroke, parkinson's, cerebral palsy rehabilitation, vestibular rehabilitation and orthopaedic rehabilitation. however, there is limited data on its effectiveness in patients with adhesive capsulitis. this randomized controlled study will contribute to the literature by investigating the effects of vr based exercises in individuals with ac

Eligibility criteria:
inclusion criteria: * diagnosis of chronic (\>3 months) knee osteoarthritis between the ages of 40-85 * kellgren and lawrence score ≥ 2 on knee radiograph * visual analogue scale result vas 4-8 exclusion criteria: * orthopedic surgery performed on the lower extremity * cognitive dysfunction (mini mental test score \<23) * having received any treatment for knee osteoarthritis in the last 6 months * following any ongoing exercise program (tai chi, pilates, yoga, fitness) * history of ligament and ligament injury around the knee

Keywords: knee osteoarthritis virtual reaility pain quality of life
immune response to covid-19 vaccine in immunotherapy (io) and non-io treated cancer patients

Conditions: COVID-19; Cancer

Summary: evaluation of antibody response against sars-cov-2 vaccination in patients treated with io-treatment, in comparison with antibody titers in patients treated with non-io treatment.

blood samples will be analyzed to determine the magnitude of sars-cov-2 immunity in cancer patients treated with immunotherapy by quantifying antibodies and other tumor or blood-based biomarkers against sars-cov-2 epitopes following vaccination. we will also explore for potential development of autoantibodies and other blood-based biomarkers, following sars-cov-2 vaccination, and their correlation with clinical manifestation of io related immune-related adverse events.

Eligibility criteria:
inclusion criteria: 1. patients with solid malignancies treated with either io or non-io treatment. 2. all categories of io treatment allowed (immune-checkpoint inhibitors, bi-specific t cell engagers, cytokine agonists and others), as well as all categories of non-io treatment (such as chemotherapy and targeted therapies). these can be given as part of standard of care or within participation in a clinical trial. 3. patients are allowed to have any of the approved vaccines in canada, such as pfizer, moderna, astrazeneca or their approved combinations. 4. patients must receive all appropriate doses of sars-cov-2 vaccination, as dictated by the respective vaccine schedules. exclusion criteria: * none

Keywords: covid-19 vaccine
'spring'-study: "subfertility guidelines: patient related implementation in the netherlands among gynaecologists"

Conditions: Male Infertility; Female Infertility; Ovarian Hyperstimulation Syndrome; Premature Ovarian Failure; Endometriosis

Summary: the purpose of this study is to compare two different strategies to implement the existing guideline programme on subfertility, as issued by the dutch society of obstetrics and gynaecology (nvog). therefore, an innovative patient-directed strategy will be compared to a control strategy and effectiveness, costs and feasibility of both strategies will be assessed.

the dutch society of obstetrics and gynaecology (nvog) has developed a guideline programme on subfertility, including 9 guidelines concerning diagnosis and treatment of subfertility and a national ivf protocol. however, guidelines in general do not implement themselves; large gaps consists between best evidence (as described in the guidelines) and practice, resulting in a large variation between professionals. our study will compare an innovative patient-directed strategy with a (minimal intervention) control strategy, and effectiveness, costs and feasibility of both will be assessed. we eventually aim at the most cost-effective strategy to implement the existing subfertility guideline programme. please note: in our protocol, we consider only 'couples' undergoing fertility treatment; therefore, we aim at gathering information from approximately 5200 records, of both male and female participants. when reporting eventually on their treatment, we will consider them only as couples, resulting in reported numbers of approximately 2600 participating couples.

Eligibility criteria:
inclusion criteria: * each patient, male or female, visiting the opd for a subfertility related problem or treatment * each patient admitted to the hospital with complications of an infertility treatment exclusion criteria: * patients receiving insemination with donor sperm * patients receiving icsi treatment * patients who are non-dutch speaking or understand too little dutch to fill out the questionnaires

Keywords: infertility guideline health care implementation intervention gynecology
thoracic paraspinal soft tissue mobilizations in treatment of patients with upper limb complex regional pain syndrome

Conditions: Complex Regional Pain Syndromes

Summary: this study examines the prevalence of trigger points in muscles in the thorax in upper limb complex regional pain syndrome (crps) patients, compared to healthy subjects. in addition, we will examine if adding treatment to muscles in the thoracic area (to the regular physical therapy treatment) will alleviate some of the sensitivity in the upper limb in crps patients.

this study examines the prevalence of trigger points in muscles in the thorax in upper limb complex regional pain syndrome (crps) patients, compared to healthy subjects. the muscles that will be examined are: subclavius, pectoralis minor, rhomboids, infraspinatus and serratus superior posterior. in addition, we will examine if adding treatment to muscles in the thoracic area (to the regular physical therapy treatment) will alleviate some of the sensitivity in the upper limb in crps patients.this will be examined in an a-b-a design: at first the patients will be examined. then they will recieve conventional physiotherapy treatment for a month. after a month, they will be examined again, and then they will recieve soft tissue massage to the thoracic area for 15 minutes in addition to the conventional physiotherapy treatment. after a month of the combined treatment, the patients will be examined a third and final time.

Eligibility criteria:
inclusions criteria for "cases" in stage 1 and all subjects of stage 2: * age between 18-70 * crps diagnosed by board certified specialist in rehabilitation or pain medicine * constant chronic pain for ≥six months preceding the trial; * spontaneous pain in a day of first evaluation (numeric pain rating scale (nprs) ≥4/10) * stimulated pain is not attributable to other causes, such as peripheral inflammation. inclusions criteria for "controls" in stage 1: * age between 18-70 * do not suffer from any medical issues or chronic pain exclusion criteria for all subjects in stages 1 and 2: * tumors * participation in another interventional clinical trial. * history of major psychiatric or neurological illness (like stroke). * rheumatoid arthritis or other major rheumatologic disorders. * fibromyalgia or any other systemic illness. * pregnancy.
cgm use in preterm infants

Conditions: Very Low Birth Weight Infant; Very Preterm Maturity of Infant; Hyperglycemia

Summary: preterm infants (gestational age (ga) at birth \< 31 weeks) admitted to the university of minnesota masonic children's hospital nicu will have a dexcom g6 sensor continuous glucose monitor (cgm) placed shortly after consent and wear the device for up to 10 days. the low alarm threshold will be set at 60 mg/dl or 80mg/dl (depending on whether they are receiving continuous insulin) to detect the potential for hypoglycemia. a suggestion will be made to the clinical team to draw a blood glucose to correlate with cgm values ≤60 mg/dl and the infant will be treated according to neonatal intensive care unit (nicu) protocol for corroborating blood glucose levels. infants will also be monitored per current nicu protocol (blood glucose checks every 1-2 hours while on insulin) and treated accordingly. clinical data and long-term growth, body composition and neurodevelopmental outcomes will be recorded.


Eligibility criteria:
inclusion criteria: * preterm infants (gestational age (ga) at birth \< 31 weeks) * admitted to the university of minnesota masonic children's hospital neonatal intensive care unit * written informed consent can be secured from a parent within 96 hours of birth. exclusion criteria: * infants born at ≥31 weeks ga * infants with a prenatally diagnosed clinical or genetic condition (other than prematurity) that is known to affect growth rate, adiposity, or neurocognitive development * children experiencing severe birth asphyxia, * children enrolled in another nutritional study, * children likely to be transferred out of the nicu

Keywords: continuous glucose monitor neonates hyperglycemia hypoglycemia very low birth weight
quality of incoming call handling in an emergency dispatch center

Conditions: Medical Emergencies

Summary: the aim of emergency medical dispatch (emd) is to ensure prompt access to medical care for all at all times, initiate appropriate responses quickly, arrange suitable hospital facilities, and coordinate patient transport and hospitalization. in france, care begins with an incoming call managed by the em dispatchers, who collect the patient's details and assess the seriousness of the situation. this severity assessment is essential for triggering the appropriate resources: direct dispatch of first-aiders in extreme emergencies, or transfer of the call to an emergency or general practitioner. under- or over-assessment will necessitate redirection, resulting in a loss of time and opportunity for the patient, or emergency channel congestion. errors at this stage can impact the entire care pathway. to assist em dispatchers, aids have been developed. firstly, in france, a diploma course was created in 2019. various training methods exist. their contribution to the quality of incoming calls handling remains unevaluated. secondly, em centers use regulation protocols designed to guide dispatchers in call handling and identifying the seriousness of the situation. the regulation protocol used at besançon university hospital is proqa (priority dispatch corporation, salt lake city, ut, us). it uses standardized questions and records em dispatchers' decisions and the responses they obtain from callers. these responses are considered by proqa, which then assigns a "severity" code to the call. the assistance provided by regulation protocols, however useful, remains insufficient. contextual factors can complicate compliance with regulation protocols, making matching resources to needs challenging. aqua is a software package dedicated to quality control, enabling em dispatcher's supervisors to rate the quality of all stages of the call-taking process. this ensures that all key questions have been asked and that they have been asked correctly. in addition, the 'severity' code obtained by the em dispatcher can be compared with the 'severity' code obtained by the supervisor, using a qualifying analysis method and data entry software. the calls are replayed under optimal conditions, in a calm environment and allowing supervisors to listen multiple times to ensure no information is missed. the supervisors' code is therefore the reference code. crraqpa study's aim is to assess the quality of incoming call handling and to identify the factors that influence this quality.


Eligibility criteria:
inclusion criteria: * calls handled by a professional em dispatcher during the study period. exclusion criteria: * calls handled by a medical student functioning as an em dispatcher. * calls for which the "severity" code is unfounded.
evaluating the durability of closure for venous leg ulcers

Conditions: Venous Leg; Venous Leg Ulcer (VLU); Venous Leg Ulcer; Venous Ulcer; VLU

Summary: the goal of this observational study is to determine the durability of closure for venous leg ulcer subjects that achieved closure in the thor trial.

to determine durability of closure (rate of target wound recurrence) of subjects with a closed venous leg ulcer during the thor clinical trial comparing subjects treated with intact fish skin graft (ifsg) plus standard of care (soc) to subjects treated with soc alone.

Eligibility criteria:
inclusion criteria: * 1. subjects must have participated in the thor trial and achieved complete closure by the 12-week endpoint. exclusion criteria: * 1. subjects who did not participate in the thor trial. 2. subjects who participated in the thor trial and did not achieve complete closure.