Kornimate/medical-research-clean huggingface dataset:
potential association of a common l-fabp polymorphism with lipid-induced hepatic insulin resistance

Conditions: Wildtype; Polymorphism Liver FABP

Summary: the investigators hypothesise that a common a277g polymorphism of the liver fatty acid binding protein (l-fabp) gene, which leads to an amino acid exchange, may be associated with alterations of lipid-induced hepatic insulin resistance. in the present study the investigators will investigate potential differences in lipid-induced hepatic insulin resistance, and in the relation between glycogenolysis and gluconeogenesis, in healthy subjects with the a277g polymorphism vs. subjects carrying the wildtype.

liver fatty acid binding protein (l-fabp) is an abundant cytosolic lipid-binding protein that regulates lipid transport and metabolism. only one common non-synonymous polymorphism (a227g) leading to an amino-acid exchange in the exonic region of the l-fabp gene has been previously identified. experimental elevations of free fatty acids (ffas) have been shown to impair insulin mediated suppression of endogenous glucose production (egp). deletion of the l-fabp gene shows no obvious phenotype in mice receiving a low fat chow diet, but leads to decreased hepatic triglyceride accumulation in the prolonged fasted state, which exposes mice to an increased fatty acid flux to the liver. the function of the l-fabp gene may be altered by polymorphisms in coding regions of the gene, probably leading to modifications in hepatic triglyceride accumulation and hepatic insulin resistance.we hypothesize that carriers of the a277g snp, when compared to matched wild-type subjects, may show altered responses of hepatic glucose production upon exposure to increased peripheral fatty acid concentrations, as achieved by lipid / heparin infusions. because it is known that free fatty acids potently increase insulin secretion, we use somatostatin clamps in our experiments, followed by replacement of postabsorptive insulin and glucagon concentrations.

Eligibility criteria:
inclusion criteria: * healthy subjects with normal glucose tolerance (ngt) exclusion criteria: * any severe cardiac, liver, or kidney diseases * pregnant or lactating women, menstrual irregularities * cortisone, antidiabetic drugs

Keywords: lipid induced hepatic insulin resistance polymorphisms liver fatty-acid-binding-protein gluconeogenesis glycogenolysis endogenous glucose production
thrombin generation as a new test for anticoagulation management in patients with ecmo

Conditions: Implantation of a Veno-arterial or Veno-venous ECMO

Summary: ecmo (extracorporeal membrane oxygenation) is a circulatory assistance device aiming at maintaining or restoring cardiopulmonary circulation. complications of this device are mainly hemorrhagic, related to coagulopathy induced by the initial pathology or by the device itself, or thrombotic and ischemic. one of the major challenges is therefore the management of a suitable curative anticoagulation, sufficient to limit the activation of hemostasis du to the ecmo, but reasonable to prevent hemorrhagic complications. to date, there is no standardized and validated protocol for the management of anticoagulation of patients under ecmo. the thrombin generation may be a valuable test to manage anticoagulation of patients with ecmo.


Eligibility criteria:
inclusion criteria: * male or female age ≥ 18 years old * implantation of a veno-arterial or veno-venous ecmo during hospitalization in intensive care * informed consent exclusion criteria: * patient on veno-arterial ecmo after cardiac, cardiopulmonary surgery or after insertion of a left or biventricular cardiac assist device * contraindication to curative anticoagulation * congenital hemostasis disorder or anatomical abnormality predisposing to hemorrhage (hemophilia, constitutional thrombocytopathies, willebrand disease, hereditary hemorrhagic telangiectasia, etc.) * history of heparin-induced thrombocytopenia * moribund patient at the day of inclusion * do not resuscitate decision * subject under the protection of justice * subject under guardianship or curatorship * pregnancy * breastfeeding

Keywords: ecmo thrombin generation test hemostasis bleeding events thrombotic events
up-2 study: cognitively engaging walking exercise and neuromodulation to enhance brain function in older adults

Conditions: Cognitive Dysfunction; Mobility Limitation; Frail Elderly

Summary: declines in cognitive function and walking function are highly intertwined in older adults. a therapeutic approach that combines complex (cognitively engaging) aerobic walking exercise with non-invasive electrical brain stimulation may be effective at restoring lost function. this study tests whether electrical stimulation of prefrontal brain regions is more beneficial than sham stimulation.

efficacy of transcranial direct current stimulation (tdcs) combined with complex (cognitively engaging) walking exercise in older adults. the primary outcome measures are executive function (computer-based assessment battery) and complex walking function (speed on an obstacle negotiation task). this will be a two-site trial conducted at the university of florida (lead site) and brooks rehabilitation hospital, which is necessary to achieve enrollment targets and will allow us to develop a multi-site research infrastructure for a future phase 3 multi-site trial. the study will enroll up to 120 older adult women and men, who exhibit mild to moderate decline of executive function. all experimental groups will receive the same complex walking intervention, which will focus on use of cognitively engaging tasks such as obstacle crossing, accurate foot placement, and walking on complaint surfaces. each session will consist of 30 minutes of walking. for tdcs, the active treatment group will receive 20 minutes of 2ma tdcs over prefrontal regions f3/f4 ("treatment group"). the second group is a sham control group. tdcs will be delivered simultaneously with complex walking exercise for 18 sessions over a 6-week period. assessments will be conducted at baseline, post intervention (within one week), and 12 weeks post-intervention.

Eligibility criteria:
inclusion criteria: * age 65+ * objective executive function decline, based on standardized cognitive assessments. * subjective cognitive decline, based on the question: "during the past 12 months, have you experienced confusion or memory loss that is happening more often or getting worse?" * ability to walking independently for 6 minutes (use of cane permitted) exclusion criteria: * major cognitive disorder that interferes with independence * percentile score less than 10th percentile on standardized cognitive assessments * medications that are thought to influence tdcs neuroplasticity. * contraindications to tdcs or mri.
dreamkit diagnostic validation

Conditions: Sleep Apnea, Obstructive; Sleep Apnea, Central

Summary: this study has been developed in order to demonstrate diagnostic efficacy of the dreamkit device against polysomnography.

the primary objective of this study is to assess the diagnostic performance of the dreamkit device against the gold-standard comparator, polysomnography (psg). data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the dreamkit device and in-laboratory psg.

Eligibility criteria:
inclusion criteria: * aged ≥18 years; * fluent in english; * able to provide informed consent. exclusion criteria: * self-reported habitual sleep duration of \<4 hours/night on average ("how many hours sleep do you usually get per night?"); * circadian phase disorder, shift work, or any other issue/condition that would, in the opinion of the site investigator, reduce the likelihood of obtaining at least four hours of sleep during the overnight study; * history of allergic reactions to medical adhesives; * skin rash or other dermatological condition that would impact correct placement of the dreamkit device and/or psg sensors, and/or would be exacerbated by the presence of the device or sensors; * presence of a pacemaker; * severe medical condition (controlled or uncontrolled) that would impede data collection in the opinion of the site investigator, including the requirement for oxygen therapy; * \[for those currently using overnight therapy\]: unwilling to withdraw from overnight therapy for a single night and/or clinically unsuitable to withdraw from overnight therapy in the opinion of the site investigator, with overnight therapy including but not limited to any form of pap or ventilation, oral device including mandibular advancement devices or mouthguard for bruxism, nasal dilator strips, and/or positional device; * \[for those currently using overnight therapy\]: considered by the site investigator to be at risk of an ae resulting from hypersomnolence the day after the overnight visit, such as a high-risk occupation including but not limited to a pilot or commercial driver; * an employee, or family member of an employee, of a company that designs, sells, or manufactures sleep related products (including philips).
mscopilot users' feedback in real life - outcomes regarding integration in patients' pathway and users' experience

Conditions: Multiple Sclerosis

Summary: this us multicenter, prospective cohort study aims to evaluate how mscopilot can be seamlessly integrated into the current care pathway and identify potential optimizations to enhance its impact on both ms patients and clinicians, facilitating broader implementation. specifically, the study will assess: * the overall integration of mscopilot into routine clinical practice, * patients' ability to use mscopilot at home without supervision, * the need for patient support when using mscopilot at home, * user behavior based on usage analytics data from the mscopilot mobile app and dashboard, * patient adherence to mscopilot use in routine clinical practice, * the adequacy of the onboarding/training process for hcps, * the effectiveness of hcps onboarding/training in ensuring successful patient onboarding, * the variances in user behavior and adherence to mscopilot use according to socio-demographic factors and edss scores


Eligibility criteria:
inclusion criteria: for patients * 18 years and older * with a confirmed and documented ms diagnosis, per the 2010 revised * mcdonald criteria * with an edss score ranging from 0 to 6.5 * able to monitor their disease from home (i.e. not hospitalized or under medical assistance). * having a personal smartphone with a mobile operating system above 16 for ios (iphone) and 8 for android and having access to a good internet connection. * able to read language in which the mobile application is available and able to understand pictograms having read the information sheet and signed the informed consent form for hcps: * licensed neurologists trained in the management of multiple sclerosis patients and allowed to conduct clinical studies within their departments * if applicable: nurses or medical assistants specifically trained in the management of multiple sclerosis and allowed to participate in clinical studies within their departments * ability to use a computer exclusion criteria (for patients): * pregnant and nursing women * person under guardianship or curatorship * inability to use a smartphone application * patient who previously participated in a study using mscopilot early termination criteria (for patients): * exclusion criteria, * death, * abandon, * loss of follow-up, * investigator's decision
feasibility study of uterine transplantation from living donors in terms of efficacy and safety in patients with mayer-rokitansky-küster-hauser syndrome (mrkh)

Conditions: Mayer Rokitansky Kuster Hauser Syndrome

Summary: in france, one in 4500 women is affected by the mayerrokitantskyküsterhauser (mrkh) syndrome which is characterized by the absence of uterus at birth. currently, the only solutions for these patients are: * gestational surrogacy, prohibited in france * adoption * resignation uterine transplantation could become a good alternative. this study is conducted in 10 patients with mrkh type i syndrome, who will be transplanted from a living donor uterus

the aim of the study is to obtain a pregnancy after uterine transplantation from a living donor. also, this study will assess (anatomically and functionally) the issue of the transplants of a uterus taken from a living donor and the safety of the living donor (functionally and psychologically)

Eligibility criteria:
inclusion criteria: graft recipient is a patient with mayer-rokitansky-küster-hauser type i uterine vaginal agenesis (without renal, cardiac and bone malformations): * being aged between 18 and 38 years old * in stable couple, with a pregnancy project, favorable psychological evaluation * no history of cancer and transfusion the living donor is a woman related to the graft recipient with * absence of comorbidity (neurological, nephro-urological pathology, infectious, psychiatric or psychological pathology) * absence of uterine surgery, abdomino-pelvic major pathology history exclusion criteria: graft recipient: * extreme oligo-astheno-spermia and azoospermia in the husband * history of abdominopelvic surgery excluding uncomplicated appendectomy; vaginal residue not allowing anastomosis living donor : * known thromboembolic risk factor * no compatibility with the recipient (group, rhesus, hla)
yoga and psychological and physiological health

Conditions: Stress; Anxiety; Depression; Sleep; Physiological Stress

Summary: this study aims to evaluate the benefits of yoga as a 'mind-body' practice, by measuring it's effects on health-related psychological and physiological variables. the study also aims to investigate whether an association exists between subjective (psychological) and objective (physiological) measures, with a particular focus on stress as the primary outcome.

stress and worry in everyday life are common features of western society. stress is a biological mechanism tapping the fight-or-flight-response via activation of the sympathetic nervous system. when exposed to stress during prolonged periods of time, the immune system is affected, leading to physiological as well as psychosocial problems. the consequences of untreated high stress can not only turn into reduced job capacity, and work roles conflicts, but also into cardiovascular disease, and mental illness such as an anxiety disorder or/and depression. one common and recommended strategy to manage stress is to exercise regularly. yoga is an umbrella term for a wide variety of physical, mental, and spiritual practices with its roots in ancient india. most previous research on the health effects of yoga has demonstrated benefits on psychological health factors including mental stress, anxiety, depression and sleep problems. the aim of the study is thus to investigate the effects of two types of yoga intervention on psychological and physiological health.

Eligibility criteria:
inclusion criteria: * a score on four items of the perceived stress scale between 8-16, thereby indicating a current stress experience of at least moderate level. * ability to participate in the intervention during the time-period. * comprehensive in swedish. exclusion criteria: * ongoing yoga practice or any regular practice of yoga or meditation within the last 6 months. * any known physical limitations that may prevent light physical activity (yoga postures). * current psychological or psychopharmacological treatment. * inability to attend more than 5 of the scheduled 10 yoga sessions.

Keywords: yoga stress anxiety depression sleep quality physiological stress biomarkers
nutritional status among older adults. risk factors and consequences of malnutrition

Conditions: Malnutrition

Summary: the aim of the study is to estimate the prevalence of malnutrition among older adults admitted to hospital and to analyse predictive factors for malnutrition. further, the aim was to analyse the association between nutritional status and all-cause and cause-specific mortality. the hypothesis is that malnourished patients have a higher mortality then well-nourished patients after three years.

the baseline survey was a cross-sectional study of 1771 patients aged ≥65 years who were admitted to hospital. nutritional status was assessed using the mna instrument, and possible risk factors associated with malnutrition were recorded during the hospital stay. all-cause mortality was followed up after median 3.5 years s in a cohort study of 1767 participants. cause-specific mortality was followed up after median 4.7 years in a cohort of 1767 participants. previous dietary intake in middle-aged and older adults was recorded at basline in 725 participants, who had their nutritional status assessed with the mna when admitted to hospital 10 years later.

Eligibility criteria:
inclusion criteria: * patients 65 years or older exclusion criteria: * unable to communicate and no relative could anwer the questions (n = 356) * receiving palliative care (n = 44) * impossible to measure height or weight (n = 22) * miscellanious (n = 71)

Keywords: malnutrition aged aged 80 and over prevalence mortality
effect of amoxicillin/clavulanic acid combination on postoperative endodontic pain

Conditions: Symptomatic Periapical Periodontitis

Summary: the aim of this prospective, randomized, placebo controlled study is to evaluate the effect of amoxicillin/clavulanic acid combination on post-operative pain and swelling in adult patient with symptomatic apical periodontitis.

medical and dental history will be obtained from all patients participating in this trial. clinical and radiographic evaluation for each tooth included in this study will be recorded. clinical diagnosis of symptomatic apical periodontitis is to be confirmed. after single-visit root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (taking oral tablet 1000 mg of amoxicillin/ clavulanic acid combination) or control group (taking placebo tablet). each patient will receive a 7-day diary to record postoperative pain and swelling.in case of pain, the participant will be instructed to take an analgesic. post-operative pain will be measured as a primary outcome on 11-point scale (nrs) at the following time points: 6, 12, 24, 48, 72 hours and 7 days. the occurrence of swelling will be reported by participant as a secondary outcome.

Eligibility criteria:
inclusion criteria: 1. patients with symptomatic apical periodontitis who do not have evidence of spreading infection or systemic involvement. 2. mandibular posterior teeth with positive response to percussion. 3. patients with non-contributory systemic condition. 4. patients who can understand pain scales and able to sign informed consent. exclusion criteria: 1. patients allergic to penicillin. 2. patients who have a draining sinus tract. 3. retreatment cases.

Keywords: amoxicillin clavulanic acid periapical periodontitis post-operative pain
changes in blood gases, disturbance of breath during sleep and cardiovascular co-morbidity in copd patients

Conditions: Pulmonary Disease; Chronic Obstructive; Hypercapnia; Hypoxemia; Arrhythmias, Cardiac

Summary: respiration failure type 2 is loss of the lungs ability to take up oxygen (o2) and get rid of carbon dioxide (co2). the diagnosis is based on blood gas measurement of pressures of o2 and co2. patients with copd is often seen to have co-morbidity with cardiac diseases. chronic systemic inflammation is seen in both copd and cardiac diseases. the investigators will investigate the sleep quality, co2-retention, o2-saturation, cardiac arrythmias and markers of inflammation in 120 patients with copd in different stages of the disease. our hypotheses are: * that the first signs of respiration failure type 2 is seen during sleep with alteration of sleep patterns and greater and more long-lasting retention of co2 in the blood compared to those with a normal lung function * that the use of alcohol, zopiclone or supplementary oxygen will make these differences even greater * that cardiac arrythmias correlates with hypoxemia * that cardiac arrythmias and respiration failure correlates with degree of inflammation


Eligibility criteria:
inclusion criteria: * copd (fev1 \< 80 % of pred. and fev1/fvc \< 0,7) exclusion criteria: * other serious disease (like lung cancer, sarcoidosis, restrictive lung disease) * exacerbation of copd within 3 weeks before inclusion * coronary heart disease with unstable angina pectoris or myocardial infarction within 3 months of incl. * uncontrolled hypertension * cerebral infarction * neurological, muscular or skeletal disease/disorder that affect abdominal- and/or thoracal movements (kyphoscoliosis, paresis, etc) * unstable diabetes mellitus or signs of organ failure (anaemia, kidney failure, liver failure, etc) * misuse/dependency of alcohol, sedatives, neurostimulating or narcotic drugs) * obstructive sleep apnoea/hypopnoea syndrome * using cpap/bipap or home respirator * pregnancy * if psg shows ahi \> 30, or if patient becomes acutely ill between the nights with psg, he/she will be withdrawn from the study

Keywords: pulmonary disease chronic obstructive hypercapnia hypoxemia arrhythmias, cardiac polysomnography capnography electrocardiography, holter
post-market surveillance registry to monitor performance and safety of v8 device

Conditions: Aortic Valve Stenosis

Summary: this registry is designed to monitor the real world clinical performance and safety of the v8 device used to perform balloon aortic valvuloplasty (bav). additional analyses or calculations may be obtained from the imaging or evaluations already performed per the sites' standard of care

the study is an open-label observational study involving a minimum of 10 centers. a minimum of 100 patients, including a minimum of 30 stand-alone balloon aortic valvuloplasty (bav) treatment patients, will be enrolled. enrollment will continue until all 3 of these conditions are met. bav-only patients will be followed through a 6-month post-treatment telephone follow up. patients treated with the v8 device for bav as a bridge to transcatheter aortic valve replacement (tavr) or surgical aortic valve replacement (savr) or as an intraprocedural predilatation prior to tavr, will exit the study at the time of the tavr or savr implant or at 6 months post-bav treatment, whichever comes first.

Eligibility criteria:
inclusion criteria: * symptomatic severe aortic stenosis (as) patients who are not suitable candidates for aortic valve replacement surgery at the time of bav procedure. * subject meets the indication for use. * probable survival to hospital discharge. * subject is competent, willing to comply with evaluations, understands risks, benefits and alternatives and has signed the informed consent form. alternatively, the legal guardian of the patient is able to give consent to participate. exclusion criteria: * patient has undergone previous avr * greater or equal to 3+ aortic insufficiency by echocardiogram obtained prior to planned bav or intra-procedural predilation tavr procedure * non-valvular as * known congenital av abnormality (e.g., bicuspid av) * cardiogenic shock, as defined by a consistent systolic blood pressure \<80 mmhg off vasopressors or \<90 mmhg on vasopressors. * bacterial endocarditis ≤ 12 months prior to planned bav procedure * unable to take aspirin (acetyl salicylic acid, asa) or thienopyridine * any illness or condition which, in the investigator's judgment, will compromise patient safety, or interfere with the interpretation of the treatment results * echocardiographic evidence of intracardiac mass, thrombus or vegetation.

Keywords: balloon aortic valvuloplasty valvuloplasty transcatheter aortic valve replacement surgical aortic valve replacement