Kornimate/medical-research-clean huggingface dataset:
native t1 cmr imaging for diagnosis of cardiac amyloidosis

Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure NYHA Class IV; Heart Failure With Preserved Ejection Fraction; Heart Failure With Mid Range Ejection Fraction; Hypertrophy, Left Ventricular; Cardiac Amyloidosis

Summary: the study aims to test the diagnostic accuracy of native t1 mapping for the diagnosis of cardiac amyloidosis prospectively. the hypothesis is that native t1 mapping with a cut-off value of 1341ms (3 tesla cmr) in older patients with symptomatic heart failure, increased lv wall thickness and elevated cardiac biomarkers is non-inferior to the reference method to diagnose cardiac amyloidosis (ca). as secondary measure, a web-based attr probability estimator for the diagnosis of ca will be evaluated.

cardiac amyloidosis (ca) is an important differential diagnosis in older patients with symptomatic heart failure with preserved or mid-range ejection fraction and increased left ventricular wall thickness. the prevalence of ca among patients with heart failure and left ventricular (lv) hypertrophy is approximately 13%. however, diagnosis of ca is challenging because specific clinical signs are often lacking. amyloid fibrils deposit in the extracellular space of the myocardium increases myocardial t1 values on cardiac magnetic resonance (cmr). therefore, native t1 imaging provides a promising non-invasive method to identify ca. a preliminary retrospective analysis of 128 patients with increased lv wall thickness identified an area under the curve of 0.9954 (p\<0.0001) for native t1 to detect ca. the optimal cut-off value was 1341ms, with a sensitivity of 100% and a specificity of 97%. the investigators aim to test the diagnostic accuracy of native t1 mapping with the threshold of 1341ms for the diagnosis of ca compared to the reference method prospectively. moreover, the web-based attr probability estimator for the diagnosis of ca will be evaluated.

Eligibility criteria:
inclusion criteria: * age ≥ 60 years * symptomatic heart failure (nyha ii-iv) with lvef ≥40% * increased lv wall thickness (≥12mm end-diastolic) * nt-probnp ≥1000pg/ml * elevated hs-troponin t ≥14ng/l exclusion criteria: * contraindications for cmr * acute myocarditis * acute myocardial infarction \<1 month * severe aortic stenosis and raise score \< 2 points
perceived impact of the covid-19 pandemic on medical management and symptoms in a high risk group

Conditions: COVID-19 Pandemic; Vulnerable Subjects; Long-term Non-invasive Ventilation

Summary: the swiss population underwent a period of confinement related to the covid-19 pandemic (march 16 to may 11, 2020) decided by the swiss federal government. among the swiss population, certain groups were identified as vulnerable subjects by the federal office of public health. this study focuses on the perceived impact of this period on health care and health status in a specific vulnerable group: patients under long term noninvasive ventilation (respiratory support) at home for chronic respiratory failure.

the swiss population underwent a period of confinement related to the covid-19 pandemic (march 16 to may 11, 2020) decided by the swiss federal government. among the swiss population, certain groups were identified as vulnerable subjects by the federal office of public health. this study focuses on the perceived impact of this period on health care and health status in a specific vulnerable group: patients under long term noninvasive ventilation (respiratory support) at home for chronic respiratory failure. the objective is to determine, in a specific vulnerable group, how the confinement related to the covid-19 pandemic affected health care and health status, as perceived by the patients. the primary outcome is a questionnaire focusing on practical health care issues regarding respiratory support, health status and perception of the covid-19 issue: * symptom score (related to noninvasive ventilation: niv) * thymic disturbances (score of anxiety and depression) * compliance to treatment (assessed via tele-monitoring: routine procedure) it is a non-interventional questionnaire-based observational study of patients followed by the division of pulmonology of geneva university hospitals with home niv, aged above 18 years of age and in a stable clinical condition.

Eligibility criteria:
inclusion criteria: * patients followed by the division of pulmonology of geneva university hospitals with home niv * aged above 18 years of age * stable clinical condition exclusion criteria: * age below 18 years of age * unwillingness to participate * unstable clinical condition
the pharmacokinetic study of wh-1 ointment in subjects with chronic diabetic foot ulcers

Conditions: Diabetic Foot

Summary: the objective of this study is to evaluate the systemic exposures of wh-1 ointment which includes salvigenin and asiaticoside a in subjects with chronic diabetic foot ulcers following topical application of wh-1.

this trial is designed as an open label, non-comparative study to evaluate the pharmacokinetic profiles of salvigenin and asiaticoside a in subjects who received the treatment of wh-1 ointment for diabetic foot ulcers. a total of 12 subjects will be completed in study. each subject will be applied the one dose of wh-1 ointment on day 1 following with the blood sampling collection, then twice a day of wh-1 application from day 2 to day 13, and another blood sampling collection scheduled on day 14 after one dose application.

Eligibility criteria:
inclusion criteria: 1. male or female is at least 20 years of age; 2. diabetes mellitus (type i or ii) was diagnosed with an hba1c ≤ 12.0% measured during screening or within three months prior to randomization; 3. the target diabetic foot ulcer must have the following characteristics: 1. ≤ grade 2 per wagner ulcer classification system; 2. lower limbs; 3. no-infected; 4. a cross-sectional area of between 1 and 25 cm2 post-debridement; 4. if female and of childbearing potential has a negative pregnancy test and is neither breastfeeding or intending to become pregnant during the study; 5. able and willing to follow with study scheduled visits, comply with study procedures, and sign the informed consent. exclusion criteria: 1. acute charcot' s neuroarthropathy as determined by clinical and/or radiographic examination; 2. poor nutritional status defined as an albumin \< 2.5 g/dl; 3. ast and/or alt \> 3x of the normal upper limit; 4. clearance of creatinine (ccr) \< 30 ml/min; 5. treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids within 4 weeks prior to enroll; 6. a psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject' s medical history, which, in the opinion of the investigator, may pose a threat to subject compliance 7. subjects who have received an experimental agent within 30 days, prior to enroll. 8. subjects who have received wh-1 ointment within 30 days, prior to enroll. 9. subjects who have history of smoking (define as more than 20 cigarettes per day) within 3 months prior to admission to the hospital site. 10. judged by the investigator not to be suitable for the study for any other reason.

Keywords: wh-1,diabetic foot,ulcer
lignocaine nebulization for attenuation of intubation stress response

Conditions: Pressor Response

Summary: to study the effect of lignocaine nebulization on attenuation of the pressor response during induction and emergence of anesthesia in patients with severe pre-eclampsia

the pressor response to laryngoscopy and tracheal intubation is a very important issue in hypertensive pregnant patients that can lead to increased maternal intracranial pressure, cerebral haemorrhage, and cardiac failure with pulmonary oedema and may result in maternal mortality. the catecholamine release associated with laryngoscopy and intubation also causes uteroplacental vasoconstriction and adversely affect the neonate well-being. therefore, the precise control of stress is necessary during general anesthesia in pre-eclamptic patients.various drugs are used to suppress the pressor response including opioids, lidocaine, along with α and β adrenergic blockers. in this study the investigators will evaluate the effect of lignocaine nebulization on attenuation of the pressor response.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologist (asa) ii , iii with severe pre-eclampsia * scheduled for caesarean deliveries under general anesthesia exclusion criteria: * severe obesity (bmi ≥ 40 ) * cardiac patients * history of diabetes * renal dysfunction (elevated creatinine ≥ 2 mg\\dl) * hepatic dysfunction (elevated hepatic enzymes three times above normal value) * known fetal anomalies

Keywords: pressor response pre-eclampsia lignocaine
emotional fluctuations in the flow of daily life. ecological analysis of depressive symptoms in the general population.

Conditions: Depression; Happiness; Personal Satisfaction

Summary: the aim of this study is to analyze both depressive symptomatology and psychological well-being fluctuation in a day-to-day basis in the general population, in order to identify contextual determinants of the mood and well-being changes

introduction: the experience sampling method is a research tool to study what people do and feel in their day to day. it allows to analyse temporal relationships between variables and has a high ecological validity. aim: to evaluate fluctuations of depressive symptoms and subjective well-being and to analyse the factors related to these fluctuations. methodology: longitudinal study that will follow up for two weeks a representative sample of the population aged 18 to 65 years living in madrid using the experience sampling method. an interviewer will visit the participants at their home to carry out a structured interview on mental health and well-being and to install a mobile app on the smart phone of participants in order for them to fill out information about their emotional state during the following two weeks. participants will use the smart phone screen to fill out a brief questionnaire about their feelings, the activities they are doing and the people with whom they are interacting. multilevel analysis based on lineal hierarchical models will be employed for data analysis as well as methods based on machine learning.

Eligibility criteria:
inclusion criteria: * 18-65 years old * non-institutionalized resident in madrid * to own a smart phone exclusion criteria: * to present noticeable cognitive or other limitations that impede following the interview
study evaluating tigecycline versus clindamycin or vancomycin on complicated skin and skin structure infections including those due to methicillin-resistant staphylococcus aureus (mrsa) in pediatric subjects

Conditions: Skin Diseases; Infection

Summary: the main purpose of this study is to compare the safety and efficacy of tigecycline versus clindamycin (including subjects treated with vancomycin) in pediatric subjects (aged 8 to 17 years) with complicated skin and skin structure infections (csssi), including those caused by methicillin-resistant staphylococcus aureus (mrsa).


Eligibility criteria:
inclusion criteria: * male or female subjects 8 to 17 years old. children with bone maturation less than 8 years old should be enrolled with caution due to potential risk of tooth discoloration. * have a diagnosis of a serious infection requiring hospitalization and administration of iv antibiotic therapy. * complicated skin and skin structure infections (csssi) requiring significant surgical intervention or involving deeper soft tissue with the presence of at least one sign of systemic infection exclusion criteria: * subject with any concomitant illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and/or completion of the study, or could preclude the evaluation of the subject's response (e.g., life expectancy \< 30 days).

Keywords: pediatry children skin bacteria mrsa
hfr cartridge and inflammation

Conditions: Inflammatory Status; P-cresol

Summary: a major limitation of standard hemodialysis is that it does not clear the plasma from interleukin-6 (il-6) and p-cresol, two uremic toxins responsible for the high cardiovascular risk in end stage renal disease (esrd). in the present study, we evaluated whether these compounds are removed by hfr-supra, a double-chamber hemodiafiltration system in which the ultrafiltrate (uf) returns to the patient after its regeneration through a resin cartridge. we selected 8 inflamed chronic hemodialysis (hd) patients, which underwent a single 240 minutes hfr session. we studied the change in both il-6 and p-cresol circulating levels, by comparing pre- and post-hfr serum concentrations. in addition, we compared il-6 and p-cresol levels in the uf entering (ufin) and exiting (ufout) from the cartridge, either at the start or at the end of the hfr session. the proinflammatory activity of ufin and ufout was determined by evaluating the changes that they induced in il-6 messenger ribonucleic acid (mrna) expression and release in peripheral blood mononuclear cells (pbmc) collected from 8 healthy volunteers and cultured in vitro for 24 hr.


Eligibility criteria:
inclusion criteria: * hd patients undergoing three weekly haemodialysis \> 1 year exclusion criteria: * none
self-awareness of symptoms, signs and medical compliance using a patient diary in heart failure management

Conditions: Heart Failure

Summary: before a hf patient gets maximally decompensated and visit emergency department, most patients experience symptoms and signs of "on-going decompensation (or pre-decompensation)", which may not be noticed by the patients. if hf patients were aware of symptoms and signs of adhf and received early intervention to stop the process of "on-going decompensation (or pre-decompensation)", it would be possible to reduce the rate of hospitalization for adhf or death. thus, self-awareness and self-examination of heart failure symptoms, signs and medical compliance using a patient diary in hf management may improve the outcomes in chronic stable hf patients. a patient diary with 6 parameters can serve this purpose: body weight, blood pressure, heart rate, drug compliance expressed as number of remaining pills of previous day, edema grade, and dyspnea grade.


Eligibility criteria:
inclusion criteria: * patients who are 18 years or older * patients admitted for acute heart failure and scheduled for discharge after medical stabilization * chronic stable heart failure patients with a history of hospitalization for ahf exclusion criteria: * patients with limited cognitive function who cannot not perform self-recording (in case that the patient has a family member who can perform the recording, the patient can be rerolled)

Keywords: heart failure patient's diary self awareness
one vs. two hand use after stroke: role of task requirements

Conditions: Stroke

Summary: to further develop interventions, the investigators need a better understanding of which task requirements (i.e. size or weight of object, location in workspace, etc.) drive a person after stroke to use 2 hands (as opposed to 1), and how the severity of their injury impacts this relationship and compare this to reaching in age-matched healthy controls subjects. a better understanding of this relationship will promote more informed development of rehabilitative interventions. this study proposes to explore in people after stroke and healthy controls: i.) how specific functional tasks requirements relate to 1 vs. 2 handed use, and ii.) how stroke severity impacts this arm use. we are proposing to study 15 individuals more than 6 months after stroke in the csu motor behavior lab for a two x 3 hour session of task-related reaching in sitting and 33 age matched (double sample size) healthy controls. the investigators will systematically vary task requirements (i.e. object size or weight, location in workspace, etc.), and record use of 1 versus 2 hands using videotaping as well as recording of quality of arm movement (kinematics) and muscle activity (emg) in both arms.


Eligibility criteria:
inclusion criteria: subjects post-stroke * passive flexibility (i.e. passive range of motion) in both arms such that the elbows can be straightened within 15 degrees of normal and shoulders be flexed (lifted up) at least 90 degrees and the hand needs to be able to open at least 75% of the way * actively (of each subject's own accord/ability) they must be able to, without assist in sitting and standing: straighten each elbow within 15 degrees of full range of motion, lift each arm up at at least 60 degrees from at the side, open each hand from a gross grasp volitionally. * able to lift a glass jar using 1 or 2 hands in sitting and standing 10" above the table top. * able to come to csu for two x 3 hour visits with or without assistance of their caregiver/significant other * no arm/hand injury within the last 3 months. \* individuals with common visual deficits post-stroke (1 side partial visual field cut aka homonymous hemianopsia) will be included. healthy controls: -age matched (double sample size); no known injury to arms within last 3 months, able to carry out experimental task, no neurologic diagnoses/perceptual or sensory deficits affecting arm movement exclusion criteria: * individuals who have any additional/other neurologic condition (i.e. parkinsons disease, multiple sclerosis, spinal cord injury) * severe perceptual neglect (tested using clock drawing test ). * any individual who cannot answer phone screen questions competently and/or follow simple 2 step commands during the in-person screen
x-mas biliary study with covered biliary stent

Conditions: Biliary Tract Cancer

Summary: the purpose of this study is to provide safety and efficacy data for the x-suit nir® covered biliary metallic stent for subjects with malignant stricture(s) in the biliary tree. the study is designed to support the regulatory requirement of a 510(k) marketing application in the united states.

this is a non-randomized, multi-center, prospective, single arm clinical study of the x-suit nir® covered biliary metallic stent for the palliation of malignant strictures in the biliary tree via endoscopic approach. adult males and females (≥ 18 years old), with clinical symptoms of biliary obstruction and inoperable extrahepatic biliary obstruction by any malignant process. the expected duration of this study is approximately 18 months from the time of first subject enrollment to the time of the last subject's 6-month post stent implantation follow-up visit.

Eligibility criteria:
inclusion criteria: 1. age 18 or older. 2. clinical symptoms of biliary obstruction. 3. presence of inoperable extrahepatic distal biliary obstruction by any malignant process (the subject not being a surgical candidate based on the finding of a pancreatic mass \>2.0cm or a severe medical illness). 4. subject is willing and able to comply with the study procedures and provide written informed consent to participate in the study. 5. insured by social security (applicable to subjects screened in france). exclusion criteria: * 1. participation in an investigational study within 90 days prior to date of subject consent. 2. perforation of any duct within the biliary tree. 3. presence of more than one previously implanted plastic stent. 4. previous plastic stent implantation less than 2 weeks prior to current procedure. 5. presence of a metal biliary stent. 6. presence of any esophageal or duodenal stent. 7. previous bilroth ii or roux-en-y gastric resection, a significant duodenal obstruction or any other altered anatomy which could prevent access to ampulla. 8. subjects for whom endoscopic procedures are contraindicated. 9. subjects with known sensitivity to any components of the stent or delivery system. 10. subjects with active hepatitis or other hepatic diseases that may cause jaundice. 11. subjects with a who performance score of 4 - bedbound (completely disabled, cannot carry on any self-care, totally confined to bed or chair). 12. subjects known to be pregnant. cholangiographic exclusion criterion: 13. strictures that cannot be passed by the guide wire or the delivery system.

Keywords: covered biliary stent x-suit nir covered biliary stent malignant strictures in biliary tree
effects of hyperuricemia reversal on features of the metabolic syndrome

Conditions: Gout

Summary: this study is being done to evaluate whether the medication, febuxostat, can improve the degree of insulin resistance and other features of the metabolic syndrome (high blood pressure, elevated insulin levels, excess body fat around the waist, and/or high cholesterol) by lowering uric acid levels in the blood.

the metabolic syndrome (ms) is characterized by a constellation of metabolic features including dyslipidemia, hyperglycemia, hypertension, obesity, and insulin resistance. this cluster of features is strongly associated with type 2 diabetes, atherosclerotic cardiovascular disease, and increased cardiovascular and all-cause mortality. hyperuricemia (elevated serum uric acid) is associated with insulin resistance and features of the ms in cross-sectional epidemiological studies. however, it remains unclear whether this association is causal or simply coincidental. if hyperuricemia causes insulin resistance, then lowering serum uric acid by pharmacological means may result in improved insulin sensitivity and reversal of features of the metabolic syndrome. in some recent small studies, lowering serum uric acid with allopurinol was associated with improvement in some of the features and/or complications of the ms: allopurinol use resulted in reduction in blood pressure in adolescents and improvement in exercise capacity in patients with chronic stable angina. a low urine ph is strongly associated with insulin resistance, and individual features of the metabolic syndrome. similarly, a low fractional excretion of uric acid is also associated with metabolic syndrome feature. we therefore would like to examine the effect on febuxostat on these two parameters which have been linked with the metabolic syndrome. the goal of this study is to evaluate whether pharmacological lowering of serum uric acid with the medication febuxostat is associated with improvement in the degree of insulin resistance and various features of the metabolic syndrome.

Eligibility criteria:
inclusion criteria: * age \> 21 years * gout * hyperuricemia (serum uric acid \> 7.0 mg/dl in men and \>6.0 mg/dl in women). exclusion criteria: * current treatment with insulin, azathioprine, mercaptopurine, or theophylline. * treatment with febuxostat, allopurinol or other uricosuric agents (including losartan, probenecid) within the past year * uncontrolled hypertension (clinic systolic blood pressure \> 160 mmhg or diastolic blood pressure \> 90 mmhg within the past 6 months) * uncontrolled diabetes mellitus (hba1c \> 7%) * estimated gfr \< 60 ml/min by mdrd * elevated liver function tests (ast or alt greater than 3 times the upper limit of normal) * pregnancy