Kornimate/medical-research-clean huggingface dataset:
conventional versus mini-sternotomy for aortic valve surgery

Conditions: Heart Valve Diseases

Summary: minimally-invasive operative techniques have been introduced in cardiac surgery. these techniques may have several advantages such as a decrease in post operative pain, lower morbidity and mortality, faster recovery, and a shorter hospital stay. however, these advantages have rarely been documented in the setting of a formal randomized controlled trial.

background: minimally invasive techniques for cardiac surgery should be formally evaluated. design: randomized, single-blind, monocentric trial. interventions compared: median sternotomy versus minimally invasive technique. eligibility criteria: indication of isolated aortic valvular replacement, preoperative american society of anesthesiologists (asa) class \ = 40%. primary outcome: forced expiratory volume and peak expiratory volume/second at 48 hours.

Eligibility criteria:
inclusion criteria: * indication of isolated aortic valvular replacement * preoperative asa class \< = 3 * left ventricular ejection fraction \> = 40% * signed informed consent exclusion criteria: * aortic or mitral insufficiency \> 3 * history of cardiac surgery * acute pulmonary edema * endocarditis * chronic renal insufficiency decompensation * operative coagulation disorders regardless of etiology

Keywords: cardiac surgery aortic valve replacement minimally invasive surgery perioperative course
you.mind! | boosting first-line mental health care for youngsters suffering from chronic conditions with mindfulness

Conditions: Chronic Illness

Summary: adolescents with chronic conditions often experience high levels of stress, anxiety and depression and reduced quality of life. mindfulness-based interventions (mbi) have been found to improve emotional distress in clinical and non-clinical populations. recent reviews suggest that mbis are a promising technique to support adolescents with a chronic condition in managing their symptoms and ultimately enhance their quality of life. to test the effects of an mbi on emotional distress and quality of life and delineate the underlying mechanisms, the you.mind! study uses a randomised staggered within-subjects design. 30 adolescents with a chronic condition (taking drop-out into account) will be randomised to a baseline phase of 14 to 28 days followed by an mbi, consisting of 4 online group sessions and online support spread over 8 weeks. outcomes will be assessed by short, repeated measurements throughout the baseline, training, and follow-up phases and by standardized questionnaires and experience sampling measures before randomisation, at post-intervention and 3-months follow-up. analysis will be based on general linear modelling and multilevel mixed-effects modelling. the investigators hypothesize that a mbi can help adolescents with a chronic condition to reduce their symptoms of stress, anxiety and depression, and increase their quality of life.

once a pool of 15 participants has been enrolled, they will be randomised to one of three mbi groups, which start their training with half a week time lag. within each group, participants will be randomised to a baseline phase of 2, 2.5, 3, 3.5 or 4 weeks, with 3-4 days between starting points of individual participants. thus, the baseline phase will start at different time points for participants within the same group to enable them to start the intervention simultaneously while having baseline phases of varying length. participants from different groups may begin their baseline phase at the same time while their intervention starts at a different time point. the same procedure will be repeated for the second pool of 15 participants.

Eligibility criteria:
inclusion criteria: * the adolescents suffer from a chronic condition lasting one year or more that impairs functional mobility and/or requires ongoing medical care. * they should understand and speak dutch. * written informed consent (including informed consent from a parent for those \<18yrs) after having been informed on all aspects of the study. exclusion criteria: * evidence of a current or lifetime severe mental illness. * current treatment for a psychiatric disorder.

Keywords: emotional distress quality of life
health promotion and management for hepatitis b carriers

Conditions: Chronic Hepatitis B

Summary: the investigators propose a project of preventive medicine with concern of local context in taiwan. the target population includes all staff and faculty members, students, and alumni of a university in northern taiwan, with chronic hepatitis b infection. the intervention of this project includes standardized lectures, sports courses, nutrition courses, and an information platform. the investigators will evaluate the efficacy after the intervention, like the reduction of hepatitis b viral load and the associated anthropometric parameters. the results of this project will be initially served as a pilot study for this cohort, and applicated as a promising basis for health promotion.


Eligibility criteria:
inclusion criteria: * participants were recruited from students, alumni, faculty and staff members with chronic hbv infection (positive hbsag serostatus ≥6 months) in a university of northern taiwan from august 1, 2009 to july 01, 2010. only participants aged 18 and older were included. exclusion criteria: * excluded were: * (a) those who had been diagnosed as chronic liver diseases like chronic hepatitis c infection (anti-hcv (+)), autoimmune hepatitis, wilson disease, alcoholic liver diseases, drug-related hepatitis, decompensated liver diseases, cirrhosis, or malignant hepatic tumors; * (b) those who had undergone liver transplantation or major operations for liver except cholecystectomy; * (c) men who consumed more than 30 gram of alcohol per week or women who consumed more than 20 gram of alcohol per week; * (d) women who were pregnant; * (e) those who had current medications for any types of chronic diseases except for hyperglycemia, elevated blood pressure, or dyslipidemia within six months.

Keywords: hepatitis b virus dna metabolic factor body mass index obesity insulin resistance lifestyle factor preventive medicine health promotion
efficacy and safety trial to evaluate the sufentanil nanotab® pca system/15 mcg (zalviso™) for post-operative pain in patients after knee or hip replacement surgery

Conditions: Post Operative Pain

Summary: the purpose of this study is to compare the efficacy and safety of the sufentanil nanotab pca system/15 mcg to the placebo sufentanil nanotab pca system for the management of acute moderate to severe post-operative pain after total unilateral knee or total unilateral hip replacement surgery.


Eligibility criteria:
inclusion criteria: * male or female patients who are 18 years of age or older * patients who are scheduled for an elective cemented or uncemented total unilateral knee replacement or total unilateral hip replacement, under general or spinal anesthesia that does not include use of an intrathecal opioid * post-surgical patients who have been admitted to the pacu and are expected to remain hospitalized and to have acute post-operative pain requiring parenteral opioids for at least 48 hours after surgery exclusion criteria: * patients who have undergone a replacement of the same knee or hip * patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of vicodin®, norco®, lortab® with 5 mg hydrocodone per tablet) * patients with an allergy or hypersensitivity to opioids
manganese-enhanced magnetic resonance imaging (memri) in heart failure with preserved ejection fraction

Conditions: Heart Failure With Preserved Ejection Fraction; Type 2 Diabetes

Summary: heart failure with preserved ejection fraction (hfpef) is a condition in which the heart cannot fill with blood effectively. as a result, people with hfpef suffer fatigue, breathlessness, and develop swollen limbs. the condition often requires multiple admissions to hospital and is associated with a marked loss of lifespan. despite being so common, very little is known about why people develop hfpef and there are hardly any known treatments. type 2 diabetes (t2d) is a major risk factor for hfpef, and people with both hfpef and diabetes are at a heightened risk of hospitalisation and premature death. it is unclear why the combination of diabetes and hfpef is particularly harmful. this may be related to the hearts of people with type 2 diabetes being unable to take up the mineral calcium properly, as well as due to their hearts being less energy efficient. both of these are vital to heart muscle pumping and filling, but until recently it has not been possible to assess these in humans. new advances in heart mri scans, with dedicated scanner techniques and dyes (manganese contrast), now allow extremely detailed pictures of heart structure, function, calcium uptake and energy efficiency, all during the same scan. the investigators will enlist 40 volunteers with hfpef (20 with t2d and 20 without t2d), and up to 20 healthy volunteers, to undergo a heart mri scan with manganese contrast to assess calcium uptake and energy efficiency. this will allow the comparison of people with hfpef with and without t2d, to see how their hearts are different to healthy volunteers.


Eligibility criteria:
inclusion criteria: * capacity to provide informed consent * symptoms (e.g. breathlessness, orthopnoea, ankle swelling, fatigue), signs (e.g. elevated jugular venous pressure, peripheral oedema, third heart sound) or established diagnosis of hf with lv ejection fraction ≥ 50%, or * meets hfpef diagnostic criteria in accordance with the hfa-peff diagnostic algorithm form the heart failure association of the european society of cardiology, in which a score ≥5 points confirms diagnosis of hfpef exclusion criteria: * known diagnosis of type 1 diabetes * pregnancy or breast-feeding or females of child bearing age without a negative pregnancy test * receiving an investigational drug or device within 30 days prior to participating in the study * decompensated heart failure or pulmonary oedema * history of prolonged corrected qt interval or torsades de pointes * second- or third-degree atrioventricular block * abnormal liver function tests (\> 3x upper limit of normal) or history of liver disease * baseline egfr \< 30ml/min/1.73m2 * any contraindications to mri including implanted devices/pacemakers * severe native valve disease, restrictive cardiomyopathy, constrictive pericarditis or hypertrophic cardiomyopathy, myocarditis or takotsubo cardiomyopathy. * recent myocardial infarction within the previous 3 months * known diagnosis of pheochromocytoma
rest after spontaneous breathing trial for prevention of post-extubation failure

Conditions: Weaning Failure

Summary: to evaluate if a rest period before extubation after a successful sbt trial could reduce the extubation failure rate.

intubation and mechanical ventilation are related with several complications. this increased the risk of mortality of intensive care patients. so, we always look for an early extubation when patients are recovered for the trigger disease. in spite of standardized manoeuvres to decided readiness for extubation these are not quite good because it has been described a failure extubation rate of 5% and a reintubation rate of 15%. furthermore several risk factors has been associated with a major failure rate:\>65 years old, congestive cardiac insufficiency, chronic obstructive pulmonary disease, apache ii \>12 the extubation day, bmi \>30, ineffective cough, a lot of bronchial secretions (as the need for \>2 endotracheal suctioning in the last 8h before extubation), failure of a previous sbt,alterations of high respiratory tract or intubation for more than 7 days.patients without any of these factors risk has an extubation failure rate of 10% while if any of these are present extubation failure increase to 30%. the most used technique as a weaning trial is named spontaneous breathing trial (sbt). some physiological aspects suggest that breathing through an endotracheal tube could be a really effort trial. so our hypothesis is that a period of rest after sbt and before extubation could reduce the extubation failure rate.

Eligibility criteria:
inclusion criteria: * patients ventilated for more than 12h and ready to perform a sbt exclusion criteria: * patients under 18 years old, * tracheostomy, * excessive bronchial secretions, * agitation, * hypercapnia during sbt and not resuscitation orders.

Keywords: mechanical ventilation weaning extubation failure
a validation study of the german autobiographical memory interview

Conditions: Retrograde Amnesia

Summary: electroconvulsive therapy (ect) is recommended for the treatment of severe depression. but, despite the high remission rates the use of ect is strongly limited by the social stigma and treatment-emergent cognitive side effects in patients. the most relevant is retrograde amnesia (ra), because it can persists for months and years. to measure ra after ect the short-form of the autobiographical memory interview (sf-ami) is commonly used. however, the validation of the german sf-ami has not yet been carried out. thus, the aim of this study is to validate the german sf-ami in depressed patient and healthy controls. the investigators hypothesize that the german sf-ami is reliable and valid to quantify ra.

to measure retrograde amnesia of autobiographical memory after ect, various tests were used so far. currently, the short form of the autobiographical memory interview (ami-sf) was used most frequently internationally. in germany there is no validated translation of the ami-sf. however, in order to be able to systematically record the cognitive side effects of ect in clinical practice as well as in research in the german-speaking area, it is important to have validated test procedures that can be successfully used in repeated measurements. in this study, the german version of the ami (d-ami), i.e. the specificity of the german short version of the autobiographical memory in patients with depression will be investigated. it is also known in healthy people that autobiographical memory contents can no longer be called up over time. therefore, the aim of this study is to investigate whether a change in autobiographical memory over the course of time in depressed patients differs from healthy control subjects. it should also be shown whether this german short version for examining autobiographical memory (d-ami) can be carried out.

Eligibility criteria:
inclusion criteria: * mdd * hdrs \> 17 * age 18-80 * ability to give informed consent exclusion criteria: * drugs or drug abuse or addictions * use of benzodiazepine equivalent to lorazepam\> 1.5 mg per day * cognitive impairments * history of traumatic brain injury * relevant organic disease, e.g. multiple sclerosis, parkinson's disease * bipolar illness, dementia or schizophrenic disorder * german is not the mother tongue * inability to give informed consent

Keywords: electroconvulsive therapy depression cognitive side effects
early versus differed arterial catheterization in critically ill patients with acute circulatory failure:

Conditions: Acute Circulatory Failure

Summary: the objective of the present research is a combination of a one-sided test of non-inferiority and a one-sided test of superiority. a stepped approach will be used to evaluate these hypotheses: 1. a less invasive intervention (i.e., no indwelling arterial catheter insertion until felt absolutely needed, according to consensual and predefined safety criteria) is non inferior to usual care (i.e., systematic indwelling arterial catheter insertion in the early hours of shock) in terms of mortality at day 28 (non-inferiority margin of 5%). 2. a less invasive intervention is not only non-inferior but also superior to usual care in terms of mortality. multi-centre, pragmatic, randomised, controlled, open, two-parallel group, non-inferiority clinical trial.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years the day of inclusion * existence of an acute circulatory failure defined by the presence of the following items 1 and 2: 1. persisting hypotension (systolic blood pressure less than 90 mmhg or mean arterial blood pressure less than 65 mmhg) for more than 15 min at intensive care unit admission or within the following 24 hours, or requirement of continuous intravenous vasopressor treatment (i.e. any dose of norepinephrine / epinephrine) 2. presence at least one of the following signs of hypoperfusion: alteration of mental status; skin mottling; oliguria defined as a urine output \ 2 mmol/l; peripheral venous lactate \> 3.2 mmol/l; scvo2 \<70% * free express oral and informed consent of the patient or a proxy in case of impossibility for the patient to consent; emergency inclusion possible when legal representatives and patient's family are not available * french health insurance holder exclusion criteria: * acute circulatory failure, as defined by items 1 and 2 in inclusion criteria list (cf. supra) present for more than 24 hours * non invasive blood pressure (nibp) device fails to display a blood pressure value, or cuff placement impossible * patient for whom an extra-corporeal membrane oxygenation (ecmo) therapy (either veno-arterial or venous-venous) is already in place or is to be initiated within the next 6 hours * patient treated with vasopressor doses of more than 2.5 μg/kg/min of norepinephrine tartrate plus epinephrine for at least 2 hours (i.e., for instance, more than 8 mg of norepinephrine tartrate in 50 ml at the rate of 66 ml/hour for a patient weighing 70 kg) (please note that in fact this dosage corresponds to 1.25 μg/kg/min of norepinephrine base) * severe traumatic brain injury (i.e., traumatic brain injury with a glasgow coma scale score of less than 9 before sedation) * patient previously included in the trial * body mass index (bmi) above 40 kg/m2 * pregnancy * brain death * moribund patient * patient known, at time of inclusion, as being under guardianship, authorship or curators
study to evaluate the efficacy and safety of jp-1366 in the prevention of nsaids-induced peptic ulcers

Conditions: Peptic Ulcer

Summary: the sutdy aims to to demonstrate the non-inferiority of jp-1366 10 mg compared to lanston capsule 15 mg in preventing nsaids-induced peptic ulcers and to compare/evaluate the efficacy and safety of jp-1366 10 mg.


Eligibility criteria:
inclusion criteria: 1. adult male/female aged 19 years or older as of the date of obtaining consent 2. those who are diagnosed with musculoskeletal diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, or other diseases at the time of screening and require continuous administration of nsaids for 24 weeks or more 3. those with one or more of the following risk factors for ulcer development at the time of screening 4. subjects who fully understand this study and voluntarily signed the informed consent form. exclusion criteria: 1. those who cannot undergo upper gastrointestinal endoscopy 2. at the time of screening, those who were confirmed to have active stage ulcers (a1, a2) or healing stage ulcers (h1, h2) in the stomach or duodenum according to the sakita-miwa classification\* 3. those with a confirmed history of malignant tumor within 5 years 4. those with a confirmed history of signal symptoms suggestive of malignant disease of the gastrointestinal tract 5. those who need to continuously take corticosteroids, antiplatelet agents, and anticoagulants during this study (however, the following cases are permitted): 6. pregnant and lactating women or those with a positive pregnancy test result at screening 7. those who participated in another study and were administered investigational products or had medical devices applied at least once within 4 weeks from the screening visit(visit 0)
diabetes acute complications and health literacy in children

Conditions: Childhood; Diabetes; Health Literacy

Summary: in this study, in which education on acute complications of type 1 diabetes is planned with board games based on bandura's social learning theory, children can indirectly learn common points that they may hear about acute complications of diabetes by watching board games of other group members. in line with this theory, children's knowledge needs regarding acute complications of diabetes can be determined, and interventions can be planned to meet the determined needs of children. thus, the level of knowledge of diabetes health literacy for acute complications of diabetes can be increased. this study will be carried out in a randomized controlled manner to evaluate the effect of educational play in children on acute complications of diabetes and health literacy.

this study was conducted to determine the turkish validity and reliability of the "health literacy scale for acute complications of type 1 diabetes for children (8-12 years)" and to provide a diabetes health literacy box game to 8-12 school age children diagnosed with type 1 diabetes. it will be carried out in two stages in order to evaluate the effect of educational games on acute complications of diabetes and health literacy in children. in the first stage of the research, a general screening methodological method will be carried out to determine the current situation by quantitative analysis of the data obtained with the "health literacy scale for acute complications of type 1 diabetes for children (8-12 years)". in the second stage; randomly determined intervention and control groups will be applied to the intervention and control groups in a quasi-experimental type at the pre-test and the 1st and 3rd months after the training.

Eligibility criteria:
inclusion criteria: 1. diabetes age is at least one year 2. regular attendance to the three-month routine outpatient clinics 3. not having any other disease accompanying diabetes 4. the child is between 8-12 years old exclusion criteria: 1. children not coming to the given appointment 2. children who do not play the diabetes health literacy (disoy) board game at home

Keywords: childhood diabetes health literacy social learning theory board game
mindfulness and neural cardiovascular control in humans

Conditions: Elevated Blood Pressure

Summary: this study evaluates the impact of mindfulness-based stress reduction (mbsr) on sympathetic nerve activity and arterial stiffness. the investigator's central hypothesis is that mbsr will reduce sympathetic activity and arterial stiffness.

this study will recruit male and female subjects with elevated blood pressure who will participate in a randomized, active control study to examine the impact of mindfulness-based stress reduction (mbsr) on blood pressure, muscle sympathetic nerve activity and arterial stiffness. the study will utilize established techniques for assessing blood pressure patterns (24-hour ambulatory monitoring), peripheral sympathetic activity (microneurography) and vascular stiffness (applanation tonometry) in humans. this study includes a stress management education class for the active control.

Eligibility criteria:
inclusion criteria: * seated systolic blood pressure \>119 mmhg and/or diastolic blood pressure \>79 mmhg * body mass index \<30 kg/m2 exclusion criteria: * smokers * diabetes * pregnant women * history of autonomic dysfunction * cardiovascular medication