Kornimate/medical-research-clean huggingface dataset:
local, non-interventional study of roactemra (tocilizumab) in poland (act-pol): first-line treatment in routine clinical practice of participants with rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: the aim of this non-interventional, prospective, observational study is to assess the effectiveness and tolerability of roactemra (tocilizumab) used as a first-line biologic treatment in participants with moderate to severe active ra who are inadequate responders to disease-modifying antirheumatic drugs (dmards), or participants who are intolerant to dmards, in a routine clinical practice setting in poland. the length of the entire study will be 24 months.


Eligibility criteria:
inclusion criteria: * participants at least 18 years of age * a diagnosis of moderate to severe ra * treating physician has made the decision to commence tocilizumab in first line biologic treatment (population of dmards inadequate responders or participants who are intolerant to dmards) in a routine clinical practice in poland * informed consent exclusion criteria: n/a
maastricht ibs cohort

Conditions: Irritable Bowel Syndrome

Summary: to set up a cohort of at least 400 ibs patients in order to identify different patient subgroups according to phenotypical and genotypical patterns and to set up a biobank for future translational studies on the pathophysiology of ibs, in order to identify genetic factors to unravel the pathogenesis of ibs and to provide novel therapeutic targets.

aim of the present study is to set up a large cohort of ibs patients in order to identify different disease characteristics as well as aetiological and pathophysiological factors in (sub)groups of patients with this heterogeneous disorder. various phenotypical and genotypical markers will be evaluated. for this purpose, blood and faecal samples as well as symptom questionnaires will be collected and visceral perception and intestinal permeability will be measured. in order to increase the sensitivity of the barostat procedure, a pilot study will be performed by measuring patients and healthy controls under meal stimulated and fasting conditions. we aim to set up a biobank for studies on the pathophysiology of ibs, in order to identify genetic factors that may help unravel the pathogenesis of ibs and provide novel therapeutic targets. consent will be asked to collect data from questionnaires, to store serum samples, dna, stool and, when endoscopy is performed for clinical reasons, also biopsy specimens.

Eligibility criteria:
inclusion criteria: * ibs-patients exclusion criteria: * severe co-morbidity hindering a rectal barostat procedure, according to the gastroenterologist's perception. * abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy or hysterectomy. * inability to stop medication that can influence gastrointestinal motility or perception (like loperamide, butylscopolamine, psylliumsead (metamucil), duspatal, metoclopramide, domperidon, erytromycin and serotonin reuptake inhibitors), for at least 3 days before tests.
multicenter study for the validation of an ai-based ecg platform for early cardiac amyloidosis diagnosis

Conditions: Transthyretin Cardiac Amyloidosis

Summary: concerto is a retrospective, observational, multicentric and single-arm study to perform an external validation of the cloud-based and ai-powered electrocardiogram (ecg) analysis platform, named willem™, to detect transthyretin cardiac amyloidosis (attr-ca). thus, this study will assess willem™ ability to distinguish between truly diagnosed attr-ca patients and confirmed non-attr-ca patients from ecg data.

transthyretin cardiac amyloidosis (attr-ca) is an infiltrative cardiomyopathy affecting cardiac health. results from clinical trials have shown the importance of early diagnosis to improve outcomes and maximize treatment efficacy. an electrocardiogram (ecg) is the most commonly performed cardiac diagnostic procedure, providing a large amount of information that can reflect cardiac structure and physiology. in this regard, ecg could be an ideal screening tool for attr-ca given its wide use, non-invasive nature, low cost and high sensitivity to reflect attr-ca abnormalities. the ce-marked willem™ ecg analysis platform has already shown its capability to process ecg data to detect cardiac patterns and arrythmias. this retrospective, observational, multicentric and single-arm study aims to expand the capabilities of the willem™ ecg analysis platform, in this case to detect attr-ca from ecg analysis.

Eligibility criteria:
inclusion criteria: * subjects ≥ 18 years old * subjects with 12-leads ecg records with a 10 seconds minimum length on digital format exclusion criteria: * patients with paced rhythm on the ecg.

Keywords: transthyretin cardiac amyloidosis attr ai-based ecg analysis
drug use study of febuxostat after recent changes in the prescribing information

Conditions: Gout; Cardiovascular Diseases

Summary: the prescribing information provides information on medicines. this study will check the number of patients starting febuxostat and the number of febuxostat users with cardiovascular disease after changes to the prescribing information.

this is a descriptive, cross-sectional, non-interventional study of participants with gout. the study will evaluate the impact of the 2019 labeling changes (boxed warning and modified indication), based upon results of the cardiovascular safety of febuxostat and allopurinol in participants with gout and cardiovascular morbidities (cares) trial, on febuxostat utilization. the study will evaluate data from approximately 24046 participants. the data will be collected from optum clinformatics datamart (cdm) including the medicare advantage administrative us claims database and the iqvia pharmetrics plus claims database. all participants will be enrolled in a single observational cohort. this trial will be conducted in the united states. the overall duration of this study is approximately 14 months.

Eligibility criteria:
inclusion criteria: 1. index fill date on or after 01 june 2016. 2. having at least one diagnosis for gout (identified with diagnosis codes, international classification of diseases, clinical modification, ninth revision \[icd-9-cm\]: 274.x or international classification of diseases, tenth revision \[icd-10\]: m10.x) at any time in the participant's record. 3. continuously enrolled for at least 12 months prior to index fill date.
phenol neurolysis of genicular nerves for osteoarthritic knee pain

Conditions: Osteoarthritis, Knee; Knee Pain Chronic

Summary: as the aging and obese populations continue to increase, there is a rapidly growing number of people at risk for knee osteoarthritis. treatment typically starts conservatively with analgesics, physical therapy, and bracing. intra-articular injections with corticosteroids and/or viscosupplementation may also be utilized in those with persistent knee pain. genicular nerve radiofrequency ablation (gnrfa) is an increasingly employed procedure for refractory osteoarthritic knee pain with promising efficacy for pain relief. however, due to its reliance on expensive equipment, additional staff, and need for specialized rooms (eg. fluoroscopy suite), gnrfa is a costly procedure with limited availability. chemical neurolysis is an alternative method of nerve ablation using alcohol or phenol utilized in the management of pain. recent literature has demonstrated good efficacy for pain relief and function with chemical ablation of the genicular nerves using both alcohol and phenol. this study is a double-blind, randomized, placebo-controlled pilot study to assess the efficacy of phenol neurolysis of the genicular nerves for pain and function due to refractory osteoarthritic knee pain. we hypothesize that a significant improvement in both pain and function will be observed with chemical neurolysis of the genicular nerves using 6% phenol compared to placebo.


Eligibility criteria:
inclusion criteria: * radiographic knee osteoarthritis (kellgren-lawrence grade 2-4) * knee pain of moderate intensity or greater (nrs of 4 or greater) * knee pain for 3 months or longer * persistent knee pain despite conservative treatment including oral/topical analgesics, physiotherapy, intra-articular injection with corticosteroid and/or hyaluronic acid exclusion criteria: * prior total or partial knee arthroplasty in the knee(s) to be treated * prior radiofrequency ablation treatment in the affected knee * other rheumatological or connective tissue disease(s) affecting the knee to be treated * history of bleeding disorder * any psychiatric or neurologic disease (eg. dementia, brain injury, etc.) that may preclude reliable reporting of symptoms and response to treatment * pregnancy * recent treatment with intraarticular hyaluronic acid, platelet-rich plasma, or corticosteroid injections to the affected knee in the past 3 months * skin or joint infection in the knee(s) to be treated * concomitant radicular pain
monoclonal antibody therapy plus sargramostin in treating patients with advanced neuroblastoma

Conditions: Neuroblastoma

Summary: rationale: monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. combining colony-stimulating factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for advanced neuroblastoma. purpose: phase ii trial to study the effectiveness of monoclonal antibody 3f8 plus sargramostim in treating patients who have advanced neuroblastoma.

objectives: * define the antitumor effects of monoclonal antibody 3f8/sargramostim (3f8/gm-csf) in patients with advanced neuroblastoma. * assess the biological effects of 3f8/gm-csf in these patients. outline: patients receive monoclonal antibody 3f8 iv over 1.5 hours on days 0-4 and 7-11 and sargramostim (gm-csf) iv over 2 hours on days -5 to 11. treatment is repeated every 4 weeks for up to 4 courses in the absence of progressive disease, hama response, or unacceptable toxicity. projected accrual: a total of 11-40 patients will be accrued for this study over 4 years.

Eligibility criteria:
disease characteristics: * neuroblastoma diagnosed by inss criteria, i.e., either: * histologic proof of disease or * tumor clumps in bone marrow plus elevated catecholamine levels * relapsed disease with poor long-term prognosis as indicated by at least one of the following: * n-myc amplification in tumor cells * diploid chromosomal content in tumor cells * distant skeletal metastases * unresectable primary tumor crossing the midline * bone marrow with greater than 10% tumor cells * documentation of measurable progressive disease or biopsy- proven stable disease at least 4 weeks after prior systemic therapy required * no rapidly progressive disease * poor risk neuroblastoma (but without measurable disease) not eligible for other neuroblastoma protocols patient characteristics: age: * 2 to 21 performance status: * not specified life expectancy: * greater than 8 weeks hematologic: * not specified hepatic: * no grade 3/4 toxicity * ldh no greater than 1.5 times upper limit of normal renal: * creatinine clearance at least 60 ml/min * no grade 3/4 toxicity cardiovascular: * no grade 3/4 toxicity pulmonary: * no grade 3/4 toxicity other: * no grade 3/4 neurologic, gastrointestinal, or other organ toxicity except grade 3 hearing deficit * no active life threatening infections * no human antimouse antibody (hama) greater than 1,000 elisa units/ml * no allergy to mouse proteins * no pain requiring opiates prior concurrent therapy: biologic therapy * not specified chemotherapy * standard chemotherapy to which disease is resistant or myeloablative therapy followed by disease recurrence required endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: recurrent neuroblastoma
continuous regional anesthesia for septic limb orthopedic surgery

Conditions: Osteo Arthritis; Cellulitis

Summary: this study aims to assess the safety of using continuous regional anesthesia for post-operative analgesia during septic limb orthopedic surgery. the study hypothesis is that continuous regional anesthesia would not induce septic complication in the operated limb and could improve post-operative recovery.


Eligibility criteria:
inclusion criteria: * osteo arthritis or cellulitis requiring surgical intervention * anatomical possibility of regional anesthesia * age \>18 ans * written informed consent exclusion criteria: * loco-regional anesthesia impossibility (puncture zone infection, local anesthesics allergie, amiodarone or mexilétine treatment, neurologic deficit for exemple) * patient under tutelle or curatelle * pregnant or beast feeding woman
simulation trial of telemedical support for paramedics

Conditions: Emergencies; Cardiopulmonary Arrest; Acute Respiratory Failure; Status Epilepticus

Summary: in the united states, the current standard of prehospital (i.e. outside of hospitals) emergency care for children with life-threatening illnesses in the community includes remote physician support for paramedics providing life-saving therapy while transporting the child to the hospital. most prehospital emergency medical services (ems) agencies use radio-based (audio only) communication between paramedics and physicians to augment this care. however, this communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment. the purpose of this pilot randomized controlled trial (rct) is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine expert (intervention = "telemedical support") will improve the quality of care provided by paramedics to infant simulator mannequins with life threatening illness (respiratory failure). paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction. because real pediatric life-threatening illnesses are rare, high stakes events and involve a vulnerable population (children), this rct will test the effect of the intervention on paramedic performance in simulated cases of pediatric medical emergencies. the two specific aims for this research are: * aim 1: to test the intervention efficacy by determining if there is a measurable difference in the frequency of serious safety events between study groups * aim 2: to compare two safety event detection methods, medical record review, and video review


Eligibility criteria:
inclusion criteria: * certified emergency medical technicians (emts), advanced emts (aemts), and paramedics (emt-ps) who provide direct scene response. * board-certified pediatric emergency medicine (pem) and emergency medicine (em) physicians whose practice includes online medical support for ems are eligible. * the control arm will include physicians who provide radio/telephone support in usual care at each site. in the intervention arm, experts will be pem with/without ems board-certification as they have relevant pediatric training and experience. exclusion criteria: * ems personnel providing interfacility transport and/or pediatric specialty transport * resident physicians-in-training * non-physician providers

Keywords: prehospital emergency care emergency medical services (ems) paramedics infant simulator mannequins telemedical support critically ill infants and children pediatric emergencies
personalizing intervention to reduce clinical inertia in the treatment of hypertension

Conditions: Hypertension

Summary: this is a three-arm pragmatic randomized controlled trial to test two interventions targeting clinical inertia in hypertension compared to control, followed by predictive modeling to identify factors that are associated with intervention responsiveness. study investigators will use ehr data to identify providers of patients whose hypertension treatment was not intensified. primary care physicians will then be randomized to one of three arms: pharmacist e-detailing, provider dashboards, or no intervention (control). after the intervention, the investigators will conduct virtual interviews with select providers from each arm. a predictive modeling approach will then be used to identify patient and provider characteristics that are associated with inertia and with responsiveness to each intervention.

we propose a pragmatic randomized controlled trial to test two interventions targeting clinical inertia in hypertension compared to control, followed by predictive modeling to identify factors that are associated with intervention responsiveness. for aim 1, we will use electronic health record (ehr) data to identify physicians of patients whose hypertension treatment was not intensified despite their having persistently elevated blood pressure. we will then randomize primary care physicians to on of three arms: academic e-detailing, social norming, or no intervention (control). for aim 2, we will conduct interviews with select physicians from each arm. we will then identify patient and physician characteristics that are associated with inertia and with responsiveness to each intervention.

Eligibility criteria:
provider inclusion criteria: * primary care physician * practicing in primary care at massachusetts general hospital * caring for at least 2 patients: (1) aged 18-79, (2) for whom the recent bp history in the last 18 months is above goal, (3) whose most recent bp at an outpatient visit was above goal, and (4) who did not have their hypertension treatment regimens intensified (dose increase, new medication, or medication exchange) at or since that time. the bp goal will be \<140/90 for all patients. to accommodate changes in care delivery that occurred during the covid surge, outpatient visits will include in-office and virtual visits that had vitals recorded in the ehr the same day. provider exclusion criteria: * fewer than 100 patients on their primary care panel * practice less than one session per week patient inclusion criteria: * had a blood pressure greater than 140/90 mmhg at 2+ pcp visits in the past 12 months * treatment was not intensified at any of these visits patient exclusion criteria: * excluded from the hypertension registry * currently pregnant or post-partum 6 months * receiving hospice care
thromboelastography (teg®) and platelet function in patients on anti-platelet agents

Conditions: Blood Clotting

Summary: can a post-operative analysis using a simple blood test (thromboelastography(teg®)) and platelet mapping assay (pma™) be able to detect the occurence of clotting or bleeding complications in patients on blood thinning (anti-platelet) agents?

two hundred patients coming for surgery who are taking anti-platelet medications will be enrolled in this study as a pilot, to determine the feasibility for a larger study. a simple blood test for clotting function will be done after surgery. patients will be assessed daily during their hospital stay to determine if they have any clotting or bleeding complications. for analysis, groups will be divided into normal and increased or decreased ability to make a blood clot based on the teg® and pma™ test done. complications will be recorded for each group and analyzed to determine if there is any difference between groups.

Eligibility criteria:
inclusion criteria: * patients on aspirin and/or clopidogrel for at least 10 days, having non-ambulatory, non-cardiac, elective surgery exclusion criteria: * anemia (hb \< 100) or thrombocytopenia (platelet count \< 80), having any known clotting abnormalities * family history of clotting abnormalities * concurrently on nsaids, warfarin therapy or other treatments affecting platelet function * renal impairment (cr \> 110 mg for females or cr \> 125 mg) or inr \> 1.2

Keywords: thromboelastography post-operative complications anti-platelet agents prospective pilot patients taking anti-platelet agents
effect of repeat administration of eslicarbazepine acetate on the pharmacokinetics of a combined oral contraceptive

Conditions: Partial Epilepsy

Summary: the purpose of this study is to investigate whether multiple-dose administration of eslicarbazepine acetate (esl, bia 2-093) 800 mg once-daily (qd) affects the pharmacokinetics and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).


Eligibility criteria:
inclusion criteria: * pre-menopausal female subjects * age 18-40 years, inclusive * body mass index (bmi) 19-30 kg/m2, inclusive * healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ecg * negative tests for hbsag, anti-hcvab and hiv-1 and hiv-2 ab at screening * negative urine pregnancy test at screening and admission to each treatment period. * using one of the following methods of contraception: double barrier or intrauterine device exclusion criteria: * subjects who have any contra-indication to the use of oral contraceptives * history or presence of clinically relevant diseases, disorders or surgical history * history of alcoholism or drug abuse * have used medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion

Keywords: partial epilepsy eslicarbazepine acetate combined oral contraceptive pharmacokinetics tolerability
impact on uvb narrow band and uva1 therapy on serum 25-hydroxyvitamin d levels

Conditions: Skin Disease

Summary: we plan to investigate the serum elevation of 25(oh)d under uvb nb and uva1 therapy, in order to determine the effect of these nowadays frequently used wavelengths for phototherapy on vitamin d plasma levels. we hope for a better understanding of steady-state and treatment-induced levels of vitamin d changes to better recognize the impact of phototherapy on vitamin d synthesis in the skin, the dimension of vitamin d production to be expected in the course of standard phototherapy and a potential gap in vitamin d production compared to physiological needs which then should be supplemented orally.

this is an open observational study in dermatological patients undergoing phototherapy. in patients with a skin disease and the routinely given indication for a phototherapy with uvb narrow-band (uvb nb, 311nm) or uva1 (340-400 nm), the serum 25-hydroxyvitamin d, calcium, parathormone, phosphate and albumin levels will be measured before, during and after completion of the 12-week therapy (30 patients per group). patients will be recruited in the department of dermatology of the university hospital zürich in the outpatient clinic. following oral and written consent, serum 25-hydroxyvitamin d, calcium, parathormone, phosphate and albumin levels will be measured before the therapy, one week after start as well as after completion of the uvb nb/uva1 therapy. in parallel to the study the patients will be asked to fill in a questionnaire evaluating the daily vitamin d consume (milk and milk products, fish, food enhanced in vitamin d, multivitamin supplements), sun exposure per week during previous weeks, degree of tanning, the use of sunscreen, the dlqi and skindex-29. a physical examination including clinical score where available will be performed at every "checkpoint". during the first physical examination the fitzpatrick-skin type of patient will be recorded. the following participant characteristics will be recorded: age, weight, body mass index (bmi), phototype, skin disease, comorbidities, usual medication, and period of the year where uvb nb/uva1 therapy is performed (summer vs. winter), cumulative uvb nb/uva1 doses.

Eligibility criteria:
inclusion criteria: 1. dermatological indication for a phototherapy with uvb nb or uva1 2. oral and written informed patient consent exclusion criteria: 1. interruption of the light therapy for more than 14 days 2. withdrawal of consent to participate

Keywords: vitamin d level under phototherapy