Kornimate/medical-research-clean huggingface dataset:
a support program for carers of persons with dementia

Conditions: Dementia; Depression

Summary: dementia is one of the most common and devastating diseases in the elderly, it leads to helplessness, no cure exists and therefore care is necessary to provide. the care is associated with a great burden for the family carers and expensive for the society when residential care is required. the purpose of this study is to improve knowledge on how to provide better care for both the patients and their family carers, the investigators want to carry out a controlled trial using a rather cheap form of intervention, a multidimensional support program - an 18 months randomized controlled intervention study.

the 230 dyads of families, patients and carers, will be recruited from 18 municipalities, 18 from each municipality with at least 15 000 inhabitants. only home dwelling patients and carers with at least weekly face-to face contact with the patient will be included. the patients will be recruited both from memory clinics, outpatients clinics in geriatric medicine and old age psychiatry and from home nurse districts. the patients should have a diagnosis of dementia according to icd-10 criteria, have a score on mini mental state examination of at least 15 points and have capacity to give informant consent to participation in the study. the carers should score at least five on the relatives' stress scale. 115 family, control group, will receive care 'as usual' in the municipalities. the 115 family intervention group will have a duration of 18 months consisting individual counselling, education about dementia, problem-solving groups and ad-hoc counselling when needed. effects will be measured at three levels, at patient level, at carer level and at societal level. measurements will take place at baseline, after three, six, 12 and 18 months. at patient level, the cornell scale will be used as the primary outcome. at carer's level, the primary outcome is the relatives' stress scale. for the outcome on the social level resource utilisation in dementia will be used. the carers will be contacted every year up till five years after the intervention ended to give information about their own physical and psychological health and the patient's use of formal help such as day care centre, respite care and permanent nursing home placement.

Eligibility criteria:
inclusion criteria: * home dwelling patients and carers with at least weekly face-to face contact with the patients * the patients should have a diagnosis of dementia according to isd-10 criteria * a mini mental state examination (mmse)og at least 15 point. * have capacity to give informant consent to participation in the study * the carers should score at least five on the relatives'stress scale(rss) exclusion criteria: * result from the inclusion criteria

Keywords: dementia depression burden of care psychosocial intervention family home care
embolization of pelvic varicosities in patients with pelvic congestion syndrome

Conditions: Pelvic Pain; Varicose Veins

Summary: results of recent systematic reviews suggest favorable results of embolization for the treatment of pelvic congestion syndrome (pcs) compared with pre-procedure symptoms for several outcomes, including pain reduction, overall patient satisfaction, and technical feasibility. reported complication rates appears relatively low. pelvic vein embolization is a relatively new technology and the results may provide background for an evidence based decision to offer embolization of pelvic varicosities for women with pcs in norway.


Eligibility criteria:
inclusion criteria: * pelvic pain (lasting for more than 6 months) * symptoms of pcs - deterioration of pain when standing and improvement in supine position (with or without dyspareunia or dysmenorrhea). * confirmed pelvic varicosities by magnetic resonance examination. * signed, written and informed consent exclusion criteria: * inability to communicate in norwegian * known endometriosis * uterine myoma, uterine anomalies, or cancer * postmenopausal * not having been pregnant

Keywords: embolization, therapeutic pelvis
sleep disordered breathing in transient ischemic attack (tia)/ischemic stroke and continuous positive airway pressure (cpap) treatment efficacy

Conditions: TIA; Ischemic Stroke

Summary: the study aims to observe the short term effect (3-month) of sleep disordered breathing (sdb) on cardiovascular parameters, heart rate variability, endothelial function and surrogate markers of atherosclerosis after acute cerebrovascular events (ace). the long-term effect (6-24-month) of continuous positive airway pressure (cpap) on clinical vascular outcome, cardiovascular parameters, evolution of surrogate of atherosclerosis heart rate variability and endothelial function after ace is observed over 24 months. a preventive effect of cpap therapy on cerebro-vascular events in patients with moderate-severe obstructive sdb without sleepiness after ictus or transient ischaemic attack will be evaluated.

sleep disordered breathing is an independent risk factor for cardiovascular morbidity and mortality and is frequent in patients with acute cerebrovascular events. in this study the investigators observe the association between sleep disordered breathing, hypertension, stroke and the evolution of blood markers for atherosclerosis as well as the efficacy of continuous positive airway pressure treatment in patients with acute or subacute cerebrovascular events. sleep disordered breathing is an independent risk factor for cardiovascular morbidity and mortality and is frequent in patients with acute cerebrovascular events. in this study the investigators observe the association between sleep disordered breathing, hypertension, stroke and the evolution of blood markers for atherosclerosis as well as the efficacy of continuous positive airway pressure treatment in patients with acute or subacute cerebrovascular events. the sas care 1 study is planned to verify whether or not sleep disordered breathing has a detrimental 3 months effect on cardiovascular functions and markers after acute cerebrovascular events. the sas care 2 study is designed to address whether or not the treatment of sleep disordered breathing with cpap reduces the combined rate of mortality, stroke, cardiovascular events (myocardial infarction/revascularisation/instable angina/ hospitalisation for heart insufficiency) over a 24 months period in patients after acute cerebrovascular events.

Eligibility criteria:
inclusion criteria: * ≥ 35 years old and \< 75 years old * with clinical diagnosis of tia or ischemic stroke * admitted in a stroke unit within 2 days from onset of symptoms * or with tia or ischemic stroke within the last 60-90 days * signed informed consent exclusion criteria: * with unstable clinical situation (cardio-respiratory or life-threatening medical conditions) * currently on cpap or on cpap during the last 3 months before stroke * with non-ischemic events (intracerebral/subarachnoid haemorrhage) * patients with coma/stupor * with borderline obstructive sdb (ahi 10-19) * with any condition that interferes with the acceptance of cpap treatment

Keywords: sleep disordered breathing continuous positive airway pressure sleep apnoea markers of atherosclerosis
evaluation of the safety and effectiveness of the duraheart™ lvas

Conditions: Heart Failure

Summary: specific aims the aims of this trial are to evaluate the safety and effectiveness of the duraheart™ lvas in patients with advanced heart failure who require lvas support as a bridge to cardiac transplantation. study population the patient population for this trial consists of patients with end stage heart failure awaiting cardiac transplantation. patients must be listed for transplant with unos with status 1a or 1b. all patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity. study design this is a multi-center, prospective, single arm study in which the lower one-sided confidence interval exceeds the performance goal. enrollment is expected to occur within an 18-month time period at up to 40 centers. all patients will be followed for all endpoints for 6 months while on duraheart™ lvas support, or until cardiac transplantation or death, whichever occurs first. for those patients who remain on support after 180 days, survival and device reliability data will continue to be collected on a regular basis. if patients are transplanted, survival at day 30 post cardiac transplantation will also be assessed.


Eligibility criteria:
inclusion criteria: the following are general criteria; more specific conditions are included in the study protocol: 1. approved for cardiac transplantation 2. listed with unos on the status 1 list 3. patient for whom lvas implantation is planned as a clinically indicated bridge to cardiac transplantation exclusion criteria: the following are general criteria; more specific conditions are included in the study protocol: 1. contraindication to the administration of warfarin or anti-platelet agents 2. primary coagulopathy or platelet disorder 3. acute myocardial infarction within 48 hours prior to enrollment 4. anticipated need for rvad support or ecmo at the time of lvas implantation 5. prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty, passive restraint device (i.e., corcaptm cardiac support device) or surgically implanted left ventricular assist device

Keywords: heart failure lvas lvad rotary pump
comparison between the histological and clinical diagnosis of non healing wounds

Conditions: Wounds and Injuries

Summary: 50 patients with non healing wounds will undergo biopsy to conclude wether there is an occult etiology for the wound.

25 patients suffering from non healing wounds which have non typical features for the clinical diagnosis (such as pale granulation, raised lesions and more) will undergo biopsy of the wound. another 25 patients suffering from non healing wounds with typical features for the clinical diagnosis will undergo biopsy of the wound. the hypothesis is that non healing wounds harbor undiagnosed etiologic factors such as bcc, scc, vasculitis etc. and that some clinical features should raise our suspicion for these occult etiologies.

Eligibility criteria:
inclusion criteria: * patients with non-healing wounds (for \> 6 weeks) * consent to be included in the study * age 18-85 exclusion criteria: * patients taking anti coagulant therapy * patients taking steroids or immunosuppressive therapy * pregnancy * pace maker

Keywords: problem wounds non healing wounds bcc scc vasculitis
endomicroscopy in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study in subjects with long standing ulcerative colitis in clinical remission with indication for surveillance colonoscopy. the patients are examined with the pentax ec-3870cifk and ec-3870cilk confocal colonoscopes either by chromoscopy-guided endomicroscopy with targeted biopsies or by standard endoscopy with random and targeted biopsies. the aim is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of intraepithelial neoplasia (in) and to compare the proportion of patients with at least 1 in detected by chromoscopy-guided endomicroscopy versus standard endoscopy.


Eligibility criteria:
inclusion criteria: * written informed consent must be available before any trial-related procedures * male and female patients aged 18 years and older * clinically and histologically verified uc * duration or colitis ulcerosa \>8 years (date of first diagnosis) * colitis activity index ≤ 8 * activity index of truelove and witts: mild * ability of subject to understand character and individual consequences of clinical trial * for women with childbearing potential, adequate contraception. exclusion criteria: * known intraepithelial neoplasia or colorectal cancer * coagulopathy (prothrombin time \ 50 s) * impaired renal function (creatinine \>1.2 mg/dl) * pregnancy or breast feeding * inability to obtain informed consent * active gi bleeding * known allergy to methylene blue or fluorescein * participation in other clinical trials within the last 4 weeks

Keywords: ulcerative colitis endomicroscopy chromoendoscopy confocal colonoscope surveillance colonoscopy
polish microbiome map

Conditions: Melanoma; Healthy Volunteers; Microbiome; Metagenome; Immunotherapy

Summary: knowledge about the correlations between the composition of the gut microbiome and a wide range of diseases has substantially increased in recent years. nonetheless, there is no reference set of information about the microbiome in poland. the development of such a reference will allow polish scientists conducting research in the field of interaction between gut flora components and such characteristics as lifestyle, certain diseases or patient's responses for treatment. following the example of such countries as the united states, investigators propose to build a unique set of scientific processed information describing the variability of the polish population microbiome (polish microbiome map). the investigators will provide a reliable dataset that will characterize the gut microbiomes and their diversity in the polish population. additionally, thanks to the creation of the standard protocol for microbiome data collection the research conducted by the mmp users will be comparable with the information deposited in mmp.


Eligibility criteria:
inclusion criteria for healthy volunteers group: * men or women ≥18 years of age * patients with informed consent to participate in the study. inclusion criteria for melanoma group: * men or women ≥18 years of age * patients with melanoma * patients with informed consent to participate in the study. * patients receiving routine treatment (immunotherapy using anti-pd1 / anti-pdl1 and / or anti ctla4 antibodies), financed by the polish national health fund (nfz). * the applied immunotherapy should be the first or second line of treatment. exclusion criteria: * patients or healthy volunteers who are unable to understand, read and / or sign the informed consent * patients or healthy volunteers who can not collect stools * patients with a fecal transplant * the applied immunotherapy is not the first or second line of treatment.

Keywords: microbiome melanoma healthy volunteers immunotherapy stool samples cancer metagenome neoplasms intestinal microbiota nivolumab ipilimumab atezolizumab
gastrointestinal tolerance and general health status of healthy term infants fed a new infant formula

Conditions: Healthy

Summary: the purpose of this study is to assess stool consistency, in combination with additional health-related parameters including gastrointestinal tolerance and health-related quality of life, in a large sample of chinese infants. we will also assess the timing of, frequency, and reasons for changes in the choice of formula or method of feeding among infants in this sample, as well as incidence of common infant illness and associated healthcare usage. anthropometric measures and the frequency and duration of physician- and parent-reported gastrointestinal and other adverse events will be evaluated.

parents / legally acceptable representatives of eligible infants will be invited to volunteer.

Eligibility criteria:
inclusion criteria: * healthy, term (37-42 weeks gestation), singleton infant at birth. * post-natal age between 35 and 49 days (date of birth = day 0) at time of study entry. * at enrollment, weight-for-age ≥ 5th and ≤ 95th percentile according to world health organization growth tables / charts. exclusion criteria: * infants who are consuming any types/brands of formula other than the new study formula (either exclusively or in a mixed feeding regimen) at time of study enrollment. * suspected or documented severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the infant inappropriate for entry into the study.

Keywords: infant term birth human milk infant formula breast feeding bottle feeding gastrointestinal tract quality of life infant development
the utility of pulse pressure variation to predict the fluid responsiveness during pneumoperitoneum and reverse-trendelenburg position

Conditions: General Anesthesia

Summary: the purpose of this study is to investigate the validity of pulse pressure variation to predict fluid responsiveness in patients undergoing robotic or laparoscopic gastrectomy.


Eligibility criteria:
inclusion criteria: * adult patients aged over 19 years who are scheduled for robotic or laparoscopic gastrectomy exclusion criteria: * cardiac arrhythmia * valvular heart disease * ischemic heart disease * left ventricular ejection fraction less than 40% * pulmonary disease * esophageal disease * upper gastrointestinal bleeding * body mass index more than 40 kg/m2.
low-voltage areas defragmentation in sinus rhythm for radiofrequency ablation of persistent atrial fibrillation

Conditions: Cardiovascular Diseases; Atrial Fibrillation, Persistent

Summary: this is a study evaluating the value of defragmentation of sinus rhythmic low voltage areas in addition to isolation of pulmonary veins in the removal of recurrent atrial fibrillation. the invasive procedure will be performed according to the procedures chosen by the rhythmologist and will in no way be modified by the patient's enrollment in the study. similarly, the frequency of consultations, date and nature of the additional examinations will be defined by the physician, with the purpose of monitoring the patient.

radiofrequency ablation has become standard practice in the approach strategy for the symptomatic treatment of atrial fibrillation. the interest of substrate ablation, completing the isolation of the pulmonary veins is controversial. the usual technique for the ablation of recurrent atrial fibrillation is primarily a disconnection of the pulmonary veins, which can be accomplished by isolating the veins one by one or two by two. the isolation of the pulmonary veins is followed most often by a defragmentation of the atrium (ablation of the substrate). the defragmentation is guided by a map of fragmented potentials, made through a topography catheter, to locate the most abnormal areas that are the target of ablation. this strategy requires extensive ablation of the left atrium, with a long procedure time and repeated many radiofrequency shots. on the one hand there is a risk of complication related to the duration of intervention, but also in the longer term of occurrence of flutter scar. in addition to pulmonary vein isolation, the goal is to identify patients with sinus rhythm atrial arrhythmogenic substrate. once the sinus rhythm has been restored by electrical cardioversion or spontaneously, a voltage map is carried out to identify the most abnormal (low voltage) areas, and intra-atrial fragmented potentials are identified, either spontaneously or spontaneously by the extra-stimulus method. ablation of these abnormal areas may lead to better long-term results, limiting prolonged radiofrequency shots and complications associated with longer procedure times.

Eligibility criteria:
inclusion criteria: * patients with persistent atrial fibrillation ablation, no specific indication restrictions or equipment used and regardless of the outcome of the procedure * patients participating in a biomedical research can participate in this study. exclusion criteria: * pregnant or lactating women can not participate in this study

Keywords: ablation low voltage areas
first-in-human intracoronary oct-flim in patients undergoing pci

Conditions: Atherosclerosis Coronary Artery With Angina Pectoris; Atheroscleroses, Coronary; Atherosclerotic Plaque; Thin-cap fIbroatheroma; Atherosclerosis

Summary: patients will undergo intracoronary imaging using combined optical coherence tomography-fluorescence lifetime imaging (oct-flim) during percutaneous coronary intervention, and the obtained imaging data will be used to assess the efficacy of this dual-modal catheter imaging strategy in characterizing high-risk plaque.

fluorescence lifetime imaging (flim) is a novel imaging approach allowing label-free biochemical characterization of atherosclerotic plaque. a combined optical coherence tomography (oct) and flim that can provide a simultaneous structural and biochemical assessment of atheroma has been constructed successfully. this study sought to investigate whether the dual-modal intravascular oct-flim is able to characterize high-risk plaques in patients undergoing percutaneous coronary intervention. forty patients with multivessel coronary artery disease, who had at least one obstructive lesion (\>70% diameter stenosis) that is considered suitable for pci, will be included in the study. culprit and mildly stenotic non-culprit plaques will be imaged using oct-flim catheter. six-month follow-up assessment is systematically scheduled in all patients to assess temporal changes in flim signatures according to treatment strategies (medical therapy, interventional therapy etc).

Eligibility criteria:
inclusion criteria: * age: greater than 20, less than 80 * patients with significant coronary artery disease (diameter stenosis \>70%) requiring coronary revascularization * reference vessel diameter: between 2.5 and 4.0 mm * obtained informed consent from voluntary participants before study enrollment exclusion criteria: * complex coronary lesion (ostial lesion, unprotected left main lesion, chronic total occlusion, grafted vessels, etc) * reference vessel diameter: less than 2.5 mm, greater than 4.0 mm * coronary lesion with heavy calcification * hemodynamic instability during coronary intervention * contraindication to antithrombotic therapy * chronic renal insufficiency (serum creatinine \>2.0mg/dl) * severe liver dysfunction (ast/alt \> 5 times of upper normal limit) * pregnancy or potential pregnancy * life expectancy less than 1 year * patient refused to sign the informed consent at enrollment

Keywords: fluorescence lifetime imaging high-risk coronary plaque optical coherence tomography intravascular imaging biochemical imaging
anesthesia with epinephrine in diabetes patients is safe and effective

Conditions: Type 2 Diabetes Mellitus; Coronary Disease

Summary: the purpose of this study is to investigate the variation in blood glucose levels, hemodynamic effects and patient anxiety score during tooth extraction in type 2 diabetes mellitus with coronary disease patient under local anesthesia with lidocaine 2% with and without epinephrine.

this is a prospective randomized study including 70 diabetes with coronary disease patients that needed to be submitted to oral surgery. the study was double blind in relation to glycaemia measurements. continuous monitoring of blood glucose levels for 24 hours was performed using the minimed continuous monitoring system (cgms, medtronic). patientes were randomized into two groups: 35 received 5.4 ml of 2% lidocaine and 35 received 5.4 ml of 2% lidocaine with 1:100,000 epinephrine. in addittion, hemodynamic effects (blood pressure and heart rate) and degree of anxiety were also evaluated.

Eligibility criteria:
inclusion criteria: type 2 diabetes mellitus pharmacologically controlled (in use of insulin and/or hypoglycemic agents) coronary disease - exclusion criteria: * pregnant sepsis acute renal failure

Keywords: diabetes mellitus epinephrine anesthesia, dental lidocaine ambulatory surgical procedures