Kornimate/medical-research-clean huggingface dataset:
fine75+: 5 year follow up

Conditions: Non ST Elevation Myocardial Infarction (NSTEMI); Frailty

Summary: in the fine 75+ study, 307 non st elevation myocardial infarction (nstemi) patients, 75 years old or older, were included between september 2009 and june 2010. the purpose of this observational study (fine75+5) is to describe these patients, especially regarding the following variables: cardiovascular risk, co-morbidity and frailty, and to assess the prognostic value of frailty on 5-year outcomes. we hypothesize that frailty is independently associated with 5-year mortality.

the term frailty denotes a multi-dimensional syndrome characterized by increased vulnerability and decreased physiologic reserves. frailty stratification predicts a patient's risk of death and need for institutional care. the construct is well validated, but there is not one single accepted operational definition. the csha clinical frailty scale (cfs) is a 7-point scale relying on clinical judgement. it is a global clinical measure of biological age, and it mixes co-morbidity, disability and cognitive impairment.though frailty instruments so far mainly have been used in a geriatric context, it has been pointed out as relevant for cardiologic patients as well, e.g. regarding risk stratification for elderly patients with nstemi. in the fine 75+ study, 307 non st elevation myocardial infarction (nstemi) patients, 75 years old or older, were included between september 2009 and june 2010. we reported importance of frailty for short-term (1 month) and medium-term outcome (1 year) in a nstemi population (ekerstad et al. 2011, ekerstad et al. 2013). however, there are no published data on the importance of frailty on longer-term outcome. information on long-term prognosis may substantially improve informed decision making in elderly patients with nstemi, with acute potentially harmful treatments aiming at improved long-term prognosis. the purpose of this study is to describe patients, 75 years old or older, with nstemi especially regarding the following variables: cardiovascular risk, co-morbidity and frailty, and to assess the prognostic value of frailty on 5-year outcomes.for the purpose of the current analysis all patients included in the final fine 75+ study will be followed over 5 years from hospital admission. we hypothesize that frailty is independently associated with 5-year mortality.

Eligibility criteria:
inclusion criteria: * all patients included in the fine 75+ study population between october 2009 and june 2010. patients, 75 years old or older, with diagnosed nstemi, and cared for at one of the following hospital care units: cardiology, acute medicine, geriatrics, other internal medicine unit. exclusion criteria: * not willing to participate. non-evaluable patient due to communication problems and insufficient clinical information for the judgement of frailty.

Keywords: non st elevation myocardial infarction (nstemi) elderly frailty prognostic value
impact on invasive fungal infections by immune checkpoint inhibition

Conditions: Invasive Fungal Infections

Summary: this observational study aims to compare immune checkpoint expression in blood samples from patients with invasive fungal infections (ifi) against healthy controls.

participating sites will screen patients with invasive aspergillosis for eligibility. the investigators will enroll patients with aspergillosis and healthy controls. patients will be informed by study personnel. samples for imune phenotyping will be obtained within 7 days after diagnosis of ifi. a bronchoalveolar lavage (bal) biopsy is taken at initial diagnostic bronchoscopy or other biopsy during surgical debridement whenever applicable and feasible. the following data items will be collected: patient characteristics, details on invasive fungal infection (ifi), underlying disease, outcome after 90 days (response, remission, progress, death). all collected data will be interpreted at the end of the study. all patients must agree to participate and sign the informed consent form. the primary objective is to compare immune checkpoint expression in blood samples from patients with ifi against healthy controls. exploratively, lymphocytic immune phenotypes in bal or other biopsy samples from patients with ifi will be assessed. further, cytotoxic t cell responses in blood samples from patients with ifi shall be investigated and the level of immune checkpoint expression correlated with mortality.

Eligibility criteria:
inclusion criteria: * age ≥18 years * proven or probable, incl. pcr, positive ifi along 2019 eortc/msg criteria * signed icf exclusion criteria: * none.

Keywords: immune checkpoint invasive fungal infection
mre predictors of disease relapse after stopping biologics

Conditions: Crohn's Disease

Summary: this study aims to investigate if mr enterography (mre) improves the ability to predict which crohn's disease patients will relapse quickly (disease comes back) after stopping biologic medication. mre is a safe mri scan of the bowel, widely used in crohn's disease patients.

this study aims to investigate if mr enterography (mre) improves the ability to predict which crohn's disease patients will relapse (disease comes back) after stopping biologic medication when clinically well. mre is a safe mri scan of the bowel, widely used in crohn's disease patients. using a network of british society of gastrointestinal and abdominal radiology (bsgar) affiliated nhs hospitals, up to 200 patients who have stopped biologic treatment and recently underwent mre as part of usual care will be identified. detailed analysis will be performed on these mri scans using scores measuring residual bowel inflammation, and retrospectively collect standard clinical data such as blood, stool and colonoscopy results. using hospital records (accessed by each local care team before being pseudoanonymised) the study will see what happened to patients after one year, specifically if they relapsed or remained well off the biologics. based on a literature review, the most promising predictors of early relapse will be identified, such as blood/stool tests, to build a statistical model that provides the risk of a patient relapsing within one year. mre scores will be added to this model to see if it improves the ability to predict relapse. the results of the study could form part of a clinical decision support tool to help risk stratify patients and improved joint management decision making.

Eligibility criteria:
inclusion criteria: * luminal small bowel or colonic crohn's disease in clinical remission * 16 years or older * mre as part of routine care performed within three months prior, or one month after the decision to stop biologic therapy anti-tnf (adalimumab, infliximab, certolizumab) il-23 or il-12 antagonists (ustekinumab) anti-integrin biologics (natalizumab, vedolizumab) * biologic therapy stopped due to clinical remission only definition of clinical remission: there is no agreed consensus on how clinical remission is defined and practice differs between hospitals and patients. to mirror current clinical practice, no strict definition of clinical remission will therefore be used. detailed clinical parameters the time of stopping biologic agents will be collected. exclusion criteria: \<16 years of age non-biological therapy, unless part of combination therapy with biologic agents biological therapy stopped for other reasons e.g. loss of effect, side effects resection of diseased segment(s) after mre but before stopping biologic agent. no mre with the time window defined by eligibility criteria

Keywords: crohn's
influence of hepatic impairment on pharmacokinetic (pk) and pharmacodynamic (pd) of gemigliptin pk and pd after multiple oral doses in healthy white volunteers

Conditions: Hepatic Impairment

Summary: the trial will investigate the influence of hepatic function on the pk of gemigliptin. in an additional treatment period, the pk and safety of multiple dosing of gemigliptin in healthy white subjects will be investigated.


Eligibility criteria:
inclusion criteria: * male and female subjects who are able to understand and follow instructions during the study and available for study participation. * signed informed consent. * white exclusion criteria: * unwilling or unable to give informed consent. * as a result of the medical screening process, a study physician considers the subject unfit for the study. * the subject has a history of drug or other allergy which contraindicated study participation. * female subjects who are pregnant or lactating. * any other condition (surgical or medical) or history of severe disease with sequelae which increases the risk to the subject or affected absorption, distribution, metabolism or excretion of the study drug or otherwise

Keywords: hepatic impairment pharmacokinetics pharmacodynamics gemigliptin
a multi-dimensional program for parents of adolescents with high-functioning autism

Conditions: Autism Spectrum Disorder

Summary: the purpose of this pilot study is to examine the initial efficacy of a multi-dimensional coaching intervention ("parentship") for parents of adolescents with high functioning autism (hfasd). the "parentship" protocol is a short-term intervention program in occupational therapy that aims to promote parental resilience and enhance adolescents' participation in daily life.

"parentship" is a structured occupational therapy intervention for promoting parental resilience and enhance adolescents' participation in daily life the parentship protocol uses opc (graham \& rodger, 2010) as the primary treatment approach. its primary goal is to lead parents into recognition and understanding of their adolescent's multi-dimensional personal profile that includes sensorimotor, cognitive-behavioral, and social-communicative and personal factors, as required by the international classification of functioning (icf) model (who, 2007). the intervention will be administered by occupational therapists on an individual (or both parents) basis, once a week, over 3-4 months. 10-15 families will be recruited through community advertising. data will be collected at the onset and completion of the intervention. data will be analysed using quantitative and qualitative methods. adverse events, if occur, will be reported to supervising neurologist and the helsinki committee.

Eligibility criteria:
inclusion criteria: * asd diagnosed by certified medical practitioner * parent report regarding barriers to occupational performance/participation * sp2 or brief-parent or ssis scores reflecting at least 1 sd from typical exclusion criteria: * diagnoses of severe neurological or psychiatric health condition. * instability in pharmacological treatment

Keywords: adolescents parents coaching
feasibility study using the xoft system for the treatment of endometrial cancer

Conditions: Endometrial Cancer

Summary: multicenter, non-randomized, feasibility study to evaluate the treatment and assess acute safety of the fda cleared axxent electronic brachytherapy system and vaginal applicator for intracavitary vaginal cuff treatment according to the physician's current standard of care.


Eligibility criteria:
inclusion criteria: * most types of endometrial (uterine) cancer stage i and stage ii (see exclusion criteria below) * post hysterectomy exclusion criteria: * endometrial (uterine) cancer stage ia grade 1 * scleroderma * collagen vascular disease * active lupus

Keywords: endometrial cancer uterine cancer electronic brachytherapy xoft
open study of bay77-1931 (lanthanum carbonate) in continuous ambulatory peritoneal dialysis patients

Conditions: Hyperphosphatemia

Summary: the purpose of this study is to assess the effect on reduction of serum phosphate and the safety of bay77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis.


Eligibility criteria:
inclusion criteria: * serum phosphate levels: \>5.0 mg/dl and \<11.0 mg/dl 2 weeks after the initiation of the washout period * out-patient * undergoing capd for at least previous 3 consecutive months exclusion criteria: * who may not enable to continue capd * serum phosphate levels of \>=10.0 mg/dl at the start of the washout period or \>=11.0 mg/dl 2 week after * corrected serum calcium level of \ =11.0 mg/dl 2 week after * serum intact pth (parathyroid) of \>=1000 pg/ml at the start of the washout period * pregnant woman, or lactating mother * significant gastrointestinal disorders including known acute peptic ulcer * liver dysfunction * history of cardiovascular or cerebrovascular diseases

Keywords: hyperphosphatemia in esrd (end stage renal disease) patients on dialysis
intravenous fluid for pediatric migraine in the emergency department

Conditions: Migraine; Headache

Summary: the purpose of this study is to evaluate the effect of intravenous fluid (0.9% sodium chloride and water) alone on headache pain in children with migraine visiting the emergency department.

migraine is a common and disabling disorder for children. the pain may be severe and relatively few effective medications are approved for use in children. the emergency department (ed) remains an important resource for children suffering from migraine whom have not responded to their usual therapy. while a number of effective intravenous therapies have been studied in adults, there has been only one such study in children. as such, emergency physicians have little or no information about the safety and efficacy of these medications in children. however, the conduct of clinical trials where pain is the outcome measure is often limited by a high placebo-response rate. the expectation of treatment can significantly alter the response to medications especially when pain severity is the outcome measure. moreover, the investigators have found that intravenous fluid alone may help to treat migraine headache in children. the investigators propose a study to examine the response to intravenous fluid hydration as initial therapy comparing a group with expectation of medication and another group without the initial expectation of medication. the results of the study will help to estimate the rate of response to intravenous fluid and to evaluate the placebo-effect (i.e. expectation of treatment) in studies of migraine treatment in the ed. exposure to additional and possibly unnecessary medications will thus be minimized and the results of future trials more definitive on the effect of the study medication.

Eligibility criteria:
inclusion criteria: * diagnosis of migraine or probable migraine (with or without aura) per the international classification of headache disorders (2nd edition) * visiting the emergency department for migraine treatment * emergency department physician has chosen to administer intravenous medication * has taken usual therapy at home or at least one does of either ibuprofen or acetaminophen in the emergency department exclusion criteria: * other probable cause for headache (e.g. ventriculoperitoneal shunt, neoplasm, intracranial cyst) * head trauma causing loss of consciousness within 1 week of presentation * fever (temperature \> 38.5 oc) * signs or symptoms of meningitis

Keywords: migraine headache pediatric children emergency department
improving decision-making for low health literate prostate ca patients

Conditions: Prostate Cancer

Summary: this study used a randomized controlled trial to evaluate whether healium (designed to target preference elicitation) is as efficacious as healing choices (a comprehensive education and decision tool) in improving outcomes for decision-making and emotional quality of life.

background: elicitation of patients' preferences is an integral part of shared decision making, the recommended approach for prostate cancer decision making. however, existing decision aids for this population do not specifically focus on patients' preferences. healium is a brief interactive web-based decision aid that aims to elicit patient's treatment preferences and is designed for a low health literate population. this study used a randomized controlled trial to evaluate whether healium (designed to target preference elicitation) is as efficacious as healing choices (a comprehensive education and decision tool) in improving outcomes for decision-making and emotional quality of life. method: patients diagnosed with localized prostate cancer who had not yet made a treatment decision were randomly assigned to the brief healium intervention or healing choices, an extensive decision aid previously developed by our group that serves as a virtual information center on prostate cancer diagnosis and treatment. assessments were completed at baseline, 6-weeks and 3-months post-baseline, and included decisional outcomes (decisional conflict, satisfaction with decision, preparation for decision-making), and emotional quality of life (anxiety/tension and depression), along with demographics, comorbidities, and health literacy.

Eligibility criteria:
inclusion criteria: * a diagnosis of localized prostate cancer and eligible for all treatment options (ie., surgery, radiation, active surveillance); * had not yet made a treatment decision or begun treatment; and * have basic proficiency (grade school level) in reading english. exclusion criteria: • none
evaluation of oral potentially malignant disorders (opmds) with straticyte™

Conditions: Mouth Diseases

Summary: the purpose of this study is to validate the ability of the straticyte™ predictive model to predict the transformation of oral potentially malignant disorders (opmds) to oral squamous cell carcinoma (oscc) in a retrospective cohort of patients who received biopsies.

the study objectives are to: 1. evaluate straticyte™ sensitivity and specificity in a cohort of patients that meet the inclusion/exclusion criteria. 2. identify patient and clinical characteristics influencing the sensitivity and specificity of the straticyte™ model. 3. estimate the correlation between straticyte™ outcome and time to a positive diagnosis of oral cancer.

Eligibility criteria:
inclusion criteria: * from the archive, any patient who presents with clinically evident oral lesions and biopsy-proven dysplasia (punch or scalpel biopsies; any grade or classification system) * patients with initial oral lesions with epithelial atypia suspicious for neoplasia, with: * no histological evidence of cancer with clinical follow-up data for a period of at least five years; or * oscc development (histologic or documented evidence of invasive cancer). * patients who had archived biopsy tissue blocks of a previous oral lesion(s) meeting the above criteria and retained at the same clinical center. exclusion criteria: * patients with oral lesions or dysplasia with no indication of oscc development or follow-up data of less than five years in non-oscc patients. * patients diagnosed with oral epithelial dysplasia concomitant with oscc at the time of the biopsy's original pathology report or a subsequent clinical note of cancer progression within three months post-biopsy.

Keywords: leukoplakia erythroplakia erythroleukoplakia lesion oral epithelial dysplasia s100a7 biomarker s100a7 immunohistochemistry signature-based early diagnosis straticyte oral neoplasia oral epithelial atypia hyperplasia hyperkeratosis potentially premalignant oral epithelial lesion oral potentially malignant disorders mild dysplasia moderate dysplasia severe dysplasia low-grade dyspalsia high-grade dysplasia personalized medicine predictive assay whole slide imaging computational pathology digital pathology oral potentially malignant lesion
emphasis: empowering pharmacists in asthma management through interactive sms

Conditions: Asthma

Summary: between 8% and 12% of canadians suffer from asthma. although there are effective and inexpensive treatments, adherence to asthma treatment is amongst the lowest for all chronic diseases.the purpose of this study is to determine whether enhancing the role of community pharmacists in asthma management using interactive short messaging service (sms) with asthma patients is a cost-effective model that will improve adherence to inhaled corticosteroid medications compared to usual care.


Eligibility criteria:
inclusion criteria: * individuals who fill a (incident or prevalent) prescription for inhaled corticosteroids (either monotherapy or in combination inhaler with long-acting beta-agonists) who have been diagnosed by a doctor as having asthma * possessing a cell-phone with ability to send/receive text messages * residing in british columbia (bc), canada and planning to reside in bc for the next 12 months * registered with the medical services plan (msp, the provincial insure of medically-required services) in the past 12 months, and planning to remain registered for the next 12 months * designated pharmacy being the main drugstore for patient * not participating in another interventional study * consent to participate in the study. exclusion criteria: * unable to communicate in english * under 14 years of age

Keywords: asthma mhealth cluster randomized controlled trial pharmacy practice pharmacist
renal cancer detection with liquid biopsy

Conditions: Renal Cancer; Oncocytoma

Summary: glycosaminoglycans (gags) were significantly altered in localized as well advanced rcc compared to healthy samples. in addition, gag scores correlated with progression-free survival and overall survival (os) in a prospective cohort of patients with metastatic ccrcc and localized rcc. however, it is still unknown whether alterations in plasma and urine gags are exquisitely specific to rcc or are shared by other benign lesions in the kidney, such as angiomyolipomas, oncocytomas, or pecoma.


Eligibility criteria:
inclusion criteria: 1. patients who underwent ct-scan with suspicion of renal tumor and the scans show no sign of renal cancer. 2. for patient with ccrcc or oncocytoma, they should have a histological verified tumor (biopsy or surgical specimen) 3. sign up information consent 4. can perform protocol procedure exclusion criteria: 1. non-clear cell renal cell carcinoma 2. rcc with pure sarcomatoid differentiation, also called sarcoma of the kidney 3. use of heparin for concurrent disease in need of blood dilution (e.g. ongoing deep vein thrombosis or lung emboli). note: use of of heparin for thrombus prophylaxis in conjunction with primary surgery or postoperatively ≤4 weeks will be allowed.