Kornimate/medical-research-clean huggingface dataset:
cynergy: the cypher-nevo registry

Conditions: Coronary Artery Disease

Summary: the purpose of this registry is to compare the safety and the performance of the nevo™ sirolimus-eluting coronary stent, once commercially available, to the cypher select® plus sirolimus-eluting coronary stent in complex subjects presenting with acute stemi for primary intervention, diabetes mellitus or multi vessel disease. the second purpose of this registry is to evaluate the safety and performance of the nevo™ sirolimus-eluting coronary stent, once commercially available and the cypher select® plus sirolimus-eluting coronary stent in complex subjects diagnosed with acute stemi for primary intervention, diabetes mellitus and/or multi vessel disease. the data will be collected from subjects treated with commercially available product and following routine clinical practice. uniform, complete and accurate data will be collected on the subject's medical history, peri-procedurally, during the index hospitalization, and during follow-up.

the cypher select® plus sirolimus-eluting coronary stent (ses) is a balloon-expandable intracoronary 316l stainless steel stent with a coating that consists of a blend of sirolimus and polymers. sirolimus is a potent immunosuppressive agent which has been proven to prolong graft survival in many animal models of transplantation. sirolimus prevents both proliferation and migration of smooth muscle cells (in vivo and in vitro) in graft and balloon injury models. furthermore, sirolimus has been shown to be effective in reducing restenosis and the need for repeat revascularization while demonstrating superior efficacy measures such as angiographic late loss and binary restenosis. the nevo™ sirolimus-eluting coronary stent is a cobalt-chromium alloy stent platform that incorporates two unique features: reservoir technology, and a bioresorbable polymer which prevents initial contact between the polymer and the vessel wall and chronic polymer exposure. this design minimized initial tissue exposure to polymer, and also enables polymer resorption within approximately three months.

Eligibility criteria:
inclusion criteria: - subjects treated in routine clinical practice with a nevo™ sirolimus-eluting coronary stent once commercially available, or a cypher select® plus sirolimus-eluting coronary stent and diagnosed with acute stemi for primary intervention and/or diabetes mellitus and/or multi vessel disease. exclusion criteria: * in case, during the index procedure, the subject was treated with a stent other than the cypher select® plus sirolimus-eluting coronary stent or the nevo™ sirolimus-eluting coronary stent or a mix of the cypher select® plus ses and nevo™ ses * in case, during the index procedure, the subject was treated with other therapy (e.g. balloon angioplasty, cutting balloons, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.) in segments not ultimately treated with a cypher select® plus ses or nevo™ ses.

Keywords: coronary artery disease drug-eluting stents sirolimus-eluting coronary stents
feasibility study of iv recombinant tissue plasminogen activator (rtpa) vs. primary endovascular therapy for acute ischemic stroke

Conditions: Stroke; Ischemic Stroke

Summary: this pilot trial will be the first step toward direct comparison of delivery of endovascular reperfusion therapy to intravenous recombinant tissue plasminogen activator (rt-pa) in a time-to-treatment framework shown as most effective by the ninds rt-pa stroke trial. a randomized trial is justified for the following reasons: 1) the high rate of death and disability associated with ischemic stroke despite treatment with intravenous rt-pa mandates critical analysis of alternate therapies with therapeutic potential, 2) endovascular treatment for acute ischemic stroke is expanding in north america without compelling evidence of safety and efficacy from well-designed clinical trials, 3) critical cost-effectiveness analysis cannot be done without acquiring pertinent outcomes data from controlled studies.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * definite or probable ischemic stroke * ct angiographic (cta) evidence of intracranial vascular occlusion (internal carotid, middle cerebral - m1 or m2 divisions, anterior cerebral, posterior cerebral, or basilar artery) within 3.5 hours of symptom onset * able to receive assigned treatment within 4.5 hours of symptom onset * written informed consent from patient or surrogate, if unable to provide consent exclusion criteria: * ct evidence of early infarction in \>1/3 of middle cerebral artery distribution * blood pressure \> 185/110 mmhg refractory to anti-hypertensive therapy * history of intracranial hemorrhage * history of ischemic stroke within past 3 months * history of major surgical procedure within past 14 days * gastrointestinal or genitourinary bleeding within past 14 days * glucose \ 400mg/dl * platelet count \<100,000 * international normalized ratio (inr) ≥ 1.7 * known history of bleeding diathesis
randomized study using accelerometry to compare sacubitril/valsartan and enalapril in patients with heart failure

Conditions: Chronic Heart Failure With Reduced Ejection Fraction

Summary: the purpose of this randomized, actively controlled, double-blind study with prospective data collection was to assess differences between sacubitril/valsartan versus enalapril in increasing exercise capacity and non-sedentary physical activity in hfref patients. physical activity was assessed by the 6 minute walk test, and daily physical activity was continuously measured by means of a wrist-worn accelerometry device from 2 weeks before until 12 weeks after start of study therapy (sacubitril/valsartan or enalapril).


Eligibility criteria:
key inclusion criteria: * written informed consent obtained before any study assessment is performed. * ambulatory ≥ 18 years of age with a diagnosis of chronic symptomatic hf (nyha class ≥ ii) with reduced ejection fraction, defined as known lvef ≤ 40% and one of the following two criteria: * plasma nt-probnp level of ≥ 300 pg/ml or bnp ≥ 100 pg/ml (measurement may be recorded no longer than past 12 months) or * confirmation of a heart failure hospitalization last 12 months. * patients must be on stable hf medication for at least 4 weeks prior to week - 2, where the minimal daily dose of current evidence based therapies is equivalent to at least 2.5 mg/d enalapril * willingness to wear the accelerometer wristband continuously for the duration of the trial. * patients must be living in a setting, allowing them to move about freely and where they are primarily self-responsible for scheduling their sleep and daily activities. key exclusion criteria: * history of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes * use of sacubitril/valsartan prior to week - 2. * bedridden patients, or patients with significantly impaired/limited physical activity and/or fatigue due to medical conditions other than hf, such as, but not limited to angina (chest pain at exertion), arthritis, gout, peripheral artery occlusive disease, obstructive or restrictive lung disease, malignant disease, neurological disorders (e.g. parkinson's or alzheimer's disease, central and peripheral neuroinflammatory and -degenerative disorders or functional central nervous lesions due to hemodynamic or traumatic incidents), injuries (incl. diabetic foot ulcers) or missing limbs * patients with palsy, tremor or rigor affecting the non-dominant arm. * patients with any skin or other condition of the non-dominant arm that would limit the ability to wear the actigraphy device continuously (24h/day) over 14 weeks. * patients fully depending on a mobility support system, e.g. wheelchair, scooter or walker. patients are allowed to use a cane as long as this is not used with the non-dominant arm.

Keywords: sacubitril/valsartan enalapril physical activity actigraphy sleep heart failure reduced ejection fraction randomized controlled trial accelerometry
mucosal pressure of the laryngeal mask airway supreme versus the i-gel in paralyzed anesthetized female patients

Conditions: Device Induced Injury; Necrosis, Pressure; Complication of Device Insertion; Airway Morbidity

Summary: in the following randomized non-crossover study, the investigators test the hypothesis that directly measured mucosal pressure differ between the laryngeal mask airway (lma) supreme and the i-gel in paralyzed anesthetized females. thirty females aged 19-65 years were randomly allocated to receive either the size 4 lma supreme or i-gel for airway management. microchip sensors were attached to the lma supreme/i-gel at four locations corresponding to the a, base of tongue; b, distal oropharynx; c, hypopharynx; and d, pyriform fossa. insertion success rate and oropharyngeal leak pressure were also measured.


Eligibility criteria:
inclusion criteria: * asa i/ii * female * age 19-65 years exclusion criteria: * \< 19 years * had a known or predicted difficult airway * a body mass index \> 35 kg m-2, or * were at risk of aspiration
efficiency of continuous glucose monitoring in critically ill patients

Conditions: Critical Illness

Summary: the purpose of this study is to determine whether, real-time continuous glucose monitoring in critically ill patients with intensive insulin therapy would increase the percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl.

hyperglycemia is associated with more complications and higher morbidity and mortality in critically ill patients. therefore, strict glycemic control with a target blood glucose level between 80 and 110 mg/dl is recommended. intensive insulin therapy requires continuous intravenous insulin infusion according to an algorithm and frequent blood glucose measurements. implementation of intensive insulin therapy increases workload for both physicians and especially for nurses. the current gold-standard in intensive care units to achieve normoglycemia in critically ill patients is intensive insulin therapy according to a well established algorithm along with frequent blood glucose measurements. however, applying this gold-standard method, normoglycemia, defined as blood glucose levels below 110 mg/dl, can be achieved in approximately 50 percent of time only. we hypothesized, that real-time continuous glucose monitoring would increase the percentage of time of blood glucose levels below 110 mg/dl in critically ill patients.

Eligibility criteria:
inclusion criteria: * admitted critically ill patients expected to stay \>48h on the icu after initiation of intensive insulin therapy. * age \> 18 years. exclusion criteria: * admitted patients expected to stay \<48h * age ≤ 18 years

Keywords: critical illness hyperglycemia intensive insulin therapy glucose monitoring
dcp (radico cohort) (radico-dcp)

Conditions: Primary Ciliary Dyskinesia

Summary: primary ciliary dyskinesias (pcd) are rare, autosomal recessive respiratory diseases, due to a defect in mucociliary clearance linked to abnormalities in the structure and/or function of the cilia. the variety of ciliary abnormalities identified reflects the genetic heterogeneity of pcds. the thirty or so genes currently implicated explain the pathology in about half of the patients. pcds are characterized by recurrent infections of the upper (rhinosinusitis) and lower (bronchitis) airways, beginning in early childhood and progressing respectively to nasal polyposis and bronchial dilatation. in half of the cases, there is a lateralization defect of the organs (situs inversus) corresponding to kartagener's syndrome. there is more frequent infertility in men (immobility of spermatozoa) than in women (miscarriages and tubal pregnancies). about a third of patients progress to respiratory failure. the identification of predictive factors of severity, specific to pcds, would improve patient care. it is also important to assess the quality of life of patients with pcd, particularly at the ent level. data from prevalent patients are currently integrated into three separate and complementary databases: the "e-respirare" database, the "dcp cils" database and the "dcp genes" database. the first step is therefore to constitute the radico-dcp database which will include data from prevalent and incident patients whose diagnosis of pcd is certain. the cohort aims to improve the routine care of pcd patients, in particular by highlighting predictive factors of severity, allowing early and personalized care, to assess the social impact (quality of life) and medical conditions of ent impairment, as well as adult infertility, to finely characterize the ciliary phenotype. the study also aims to search for new dcp genes and to allow genotype/phenotype correlation studies.


Eligibility criteria:
inclusion criteria: * patient fulfilling at least one of the following criteria for pcd confirmed diagnosis: kartagener's syndrome and/or specific anomaly of the ciliary ultrastructure and/or an unambiguous mutation in a pcd gene * having at least one annual follow-up visit non-inclusion criteria: * patients with an unconfirmed diagnosis of pcd * patients with an evolving concomitant pathology that may interfere with the assessment of pcd-related manifestations
comparative spectroscopic analysis of synovial fluid from the stable and unstable ankle

Conditions: Chronic Ankle Instability

Summary: a population of patients with chronic ankle instability for whom arthroscopic ligament stabilisation was indicated. main objective: to use the raman microspectroscopy technique to characterise the synovial fluid of the unstable ankle in comparison with the synovial fluid of the healthy ankle.

single-centre, prospective, open-label study of patients undergoing ankle stabilisation surgery. patients will participate in the study for six months. three arthrocentheses with synovial fluid sampling will be performed two at d0: on the healthy ankle and the pathological ankle one at m6: on the operated ankle a follow-up visit will take place 10 days after the arthrocentesis performed at d0 and after the one performed at m6. the purpose of these visits, which are carried out systematically by the centre's doctors as part of the surgical procedures, is to check that there are no complications.

Eligibility criteria:
inclusion criteria: * patients aged 18 or over who have signed their consent to participate in the study * patients with chronic unilateral lateral ankle instability * patients who have not responded to medical treatment and for whom arthroscopic stabilisation of the ankle is planned. exclusion criteria: * any history, anomaly or symptom relating to the contralateral ankle * patient under court protection, guardianship or curatorship
secondary cancers in myeloproliferative neoplasms (mpn-k study)

Conditions: Polycythemia Vera; Essential Thrombocythemia; Myelofibrosis

Summary: the incidence of secondary cancer (sc) in patients with myeloproliferative neoplasms (mpn) is high and comparable to that of thrombosis. however, the identification of patient subgroups that might be at increased susceptibility of developing sc has not been systematically addressed. this international case-control study (mpn-k) is aimed to elucidate the prognostic role of jak2v617f mutation in predicting the occurrence of sc in patients with classical mpn, polycythemia vera (pv), essential thrombocythemia (et) and myelofibrosis (mf)

for each recruited case with concomitant diagnosis of myeloproliferative neoplasms (mpn) and secondary cancer each participating center will provide up 3 control patients (1 control for each case could be accepted but the optimal number is 3). controls are patients with myeloproliferative neoplasms and no history of cancer. each control will be matched to the paired case for sex, age (+/- 3 years), date of mpn diagnosis (+/- 5 years), and mpn disease duration (+/- 3 years). each control is censored at the date of the secondary cancer occurrence in his matched case (index date). data will be collected retrospectively from pre-existing medical records and reported by each center on a web-based and validated ecrf developed to record y all study data. in order to maintain patient privacy, all data records will be treated anonymously and no personal data to identify patient will be recorded: patients will be identified in the study by an alphanumeric code.

Eligibility criteria:
inclusion criteria: * diagnosis of philadelphia-negative myeloproliferative neoplasms (mpn) according to pvsg, 2008 and 2016 who criteria, including: * polycythemia vera (pv) * essential thrombocythemia (et) * myelofibrosis (mf), including both primary and secondary mf * diagnosis performed between 1st january 2000 to 31 december 2016 * diagnosis of secondary cancer(s) performed concurrently or subsequently the diagnosis of mpn exclusion criteria: - diagnosis of cancer occurred before the diagnosis of mpn (pv, et, mf)

Keywords: myeloproliferative neoplasms secondary cancer jak2v617f mutation
effects of whole food, plant-based nutrition on chronic kidney disease with proteinuria

Conditions: Chronic Kidney Disease Stage 3B; Chronic Kidney Disease, Stage 4; Proteinuria

Summary: this study will test the hypothesis that lifestyle intervention consisting of a whole food, plant-based (wfpb) diet and group education will favorably impact outcomes germane to individuals with chronic kidney disease (ckd) stage 3b and 4, including blood pressure control, amount of proteinuria (protein in the urine), and preservation of glomerular filtration rate (gfr). in addition, this study will assess weight and body composition, diabetic control in subjects with diabetes as well as ckd, and quality of life. safety of a wfpb diet in subjects with ckd will be tested with respect to the development of elevated serum potassium and phosphorus, hypoalbuminemia (low blood protein), hypotension (low blood pressure), and hypoglycemia (low blood sugar). an exploratory aim is to test the effects of a wfpb diet on the microbiome of subjects by collecting and analyzing stool samples.


Eligibility criteria:
inclusion criteria: * age greater than 18 years * subjects with ckd 3b and 4 (as determined by an estimated glomerular filtration rate of ≥ 15 ml/min but ≤ 45 ml/min for at least three months) * subjects with proteinuria documented at least twice with the most recent test within the last 6 months as determined by: * urine albumin excretion rate of \> 300 mg/day or urine albumin to creatinine ratio of \> 300 mg/g of creatinine * urine protein excretion rate of \> 500 mg/day or urine protein to creatinine ratio of \> 0.5 g/g of creatinine * if using angiotensin converting enzyme inhibitor, angiotensin receptor blockers and/or aldosterone antagonists, on a stable dose of for greater than one month * fluent in english language * able and willing to comply with the testing and group education schedules * able and willing to comply with a whole-food, plant-based diet * able and willing to give informed consent exclusion criteria: * any kidney disease requiring immunosuppressive therapy * pregnancy or intent to become pregnant in the next 12 months * life expectancy \< 12 months * history of solid organ transplant or anticipated solid organ transplant in next 12 months * history of hyperkalemia: two potassium measurements \> 5.1 meq/l within the last three months, or history of any intervention for hyperkalemia in the last 6 months * subjects with malabsorptive syndromes * subjects with history of bariatric surgery or planned bariatric surgery in the next 12 months * subjects on warfarin * subjects with current eating disorders * subjects with tobacco or illicit substance use * subjects with alcohol use of \> 7 drinks per week * allergy or intolerance of a plant-based or plant-derived food (gluten, soy, etc.) * following a vegan diet in the six months prior to consent * major surgery within 60 days prior to consent

Keywords: ckd proteinuria diet plant-based diet vegan randomized controlled trial
investigation of efficacy of incobotulinumtoxina (xeomin) in relieving symptoms of restless leg syndrome.

Conditions: Restless Leg Syndrome

Summary: the purpose of this research study is to compare the safety and effectiveness of local injections of botulinum toxin a (xeomin®) to an inactive test substance (placebo) in a medical condition called restless leg syndrome. this study has a double blind cross over design. cross over means that you will have two sets of injections. the first set of injections can be either xeomin or placebo. the order of injection will be reversed at the three month point following the first injection. double blind means neither the investigators nor you know which one of the two (xeomin or placebo) you received.

please contact the pi for details about the clinical study.

Eligibility criteria:
inclusion criteria: * subjects 18- 80 years of age, both sexes, all races and ethnic groups. * diagnosis of restless legs syndrome * disease duration longer than 3 months * restless leg syndrom rating scale score of 11 or above (moderate and above) * subjects who are eligible to be treated with a botulinum toxin for a therapeutic reason based upon the physicians' clinical experience. * subjects who are able to read, speak, and understand english. exclusion criteria: * existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic, neoplastic, infectious, or autoimmune disorders). * pregnancy or planned pregnancy (determined by urine pregnancy test). women of childbearing age should use a reliable mode of contraception during the study period (abstinence, etc). * active breast feeding. * enrollment in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol. * any subject for whom botulinum toxin treatment would be contraindicated; known allergy or sensitivity to medication. * subjects who are younger than 18 years of age. * neuromuscular-junction disorders. * evidence of acute pathology by neuro-imaging. * axis i diagnosis determined by a neurologist or psychiatrist. * anesthetic medications within two weeks and corticosteroid injections within 4 weeks of enrollment. * subject has received botulinum toxin injections in the past 4 months.

Keywords: restless legs syndrome leg pain sleep dysesthesias incobotulinumtoxin