Kornimate/medical-research-clean huggingface dataset:
effect of adding dapagliflozin to allograft dysfunction of renal transplanted patients.

Conditions: Kidney Transplantation; Diabetes Mellitus, Type 2; Diabetes Complications

Summary: sodium-glucose co-transporter 2 (sglt2) inhibitors reduce plasma glucose and haemoglobin a1c(hba1c) in patients with type 2 diabetes mellitus by increasing urinary glucose excretion in a non-insulin-dependent fashion. however, in some situations lead to a diminished number of functional glomeruli with a consequent hyperfiltration in the remaining ones. this fact may be where the use of sglt2 inhibitor could attenuate the renal damage. the purpose of our study is to evaluate the impact of using dapagliflozin on the renal functional deterioration of renal transplanted patients diabetics or not. this is a prospective, randomized, single-blinded, double-center, controlled trial. patients will be randomized to add either dapagliflozin 10 mg or placebo to their treatment. study drug will be administered by once-daily orallly. the first dose must be started within 1 and 7 days after randomization. the subsequent doses will be administered 24 ± 4 hours after the previous dose.


Eligibility criteria:
inclusion criteria: 1. renal transplanted patients with one to 5 years after transplantation, being followed at the out-patient clinics of the hcfmusp and hrim; 2. ≥18years of age; 3. 45 ≥ egfr ≥ 25 ml/min/1.73m2 or 45\<egfr\<60 ml/min/1.73m2 with a loss of egfr of ≥10% in the last year. exclusion criteria: 1. type 1 diabetes; 2. new york heart association class iv congestive heart failure; 3. myocardial infarction, unstable angina, stroke or transient ischaemic attack within 8 weeks prior to enrolment; 4. coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 8weeks prior to enrolment; 5. any condition outside the renal and cardiovascular study area with a life expectancy of \< 1 year based on investigator's clinical judgement; 6. hepatic impairment \[aspartate transaminase or alanine transaminase \>3 times the upper limit of normal (uln) or total bilirubin \>2 times the uln at the time of enrolment; 7. acute or chronic antibody mediated rejection; 8. albuminuria due to other causes (mtor inhibitors, polyoma nephropathy, lymphoproliferative disorder etc...) 9. patients with a previous medical history of recurrent urinary tract infections or severe genital infection; 10. renal biopsies showing acute or chronic anti-body mediated rejection, transplant glomerulopathy, bkv nephropathy. 11. patients under any other is regimen besides tacrolimus/mpa/steroids 12. pregnant patients as well as those breastfeeding.

Keywords: kidney transplantation diabetes mellitus, type 2
nursing homes study of fall risk assessment oriented to intervention

Conditions: Accidental Falls; Activities of Daily Living; Quality of Life; Self-Efficacy

Summary: the aim of the study is to establish the impact of a falls screening questionnaire in the adoption of preventive interventions and eventually in the reduction of falls and its consequences in elder people living in nursing homes.

falls are the most frequent accidents in nursing homes, affecting more than a third of residents each year. up to 10% of fallers require hospitalization or suffer a fracture. psychological consequences affects between 20 and 80% of fallers, which suffer a lack of self-confidence that leads to reduction of activities and an increase of the dependence in activities of daily living. not all the residents have the same risk, and each person can have more than one risk factor that can be identified (previous falls, self confidence, weakness, gait disorders, dizziness, cognitive impairment, etc). identification of risk factors is the first step to reduce falls, but is not enough by itself. for this reason, interventions directed towards the correction of identified risk factors are required. in this setting, multifactorial interventions are the most successful to reduce falls numbers and its consequences. as individual randomization of residents presents important inconveniences (group contamination, control arm residents could felt discriminated), we will randomized nursing homes to each group.

Eligibility criteria:
inclusion criteria: * people with or without cognitive impairment living indefinitely in a nursing home place * able to walk with or without any kind of help or able to self transfer (as defined in category d420 of the who international classification of functioning, disability and health) without help * give their consent (or the legal guardian in case of cognitive impairment). exclusion criteria: * terminal illness (expected death before 6 months). * occupying temporarily a nursing home place (convalescence period) or another kind of place(day center, long term care, etc).

Keywords: falls nursing homes elderly prevention spain cluster randomized clinical trial
outcome of the semibranch in pararenal and thoracoabdominal aortic pathologies. a prospective, multicentre registry.

Conditions: Aortic Aneurysm; Endovascular Aortic Repair; Stent-Graft Endoleak

Summary: the goal of this registry is to evaluate the semibranch in branched endovascular aortic repair, which is a new tool in endovascular branched aortic repair.

the main question it aims to answer are: * patency of the semibranch * feasibility of the technique regarding cannulation and stentgrafting the participants will treated with the custom made semibranch device and enrolled in the registry if they consent. no change in treatment will be made when enrolled.

Eligibility criteria:
inclusion criteria: * 18 years or older * presence of pararenal or thoracoabdominal aortic pathology * treatment planned a semibranch device branch from artivion * availability of the patients during the follow up period * informing patients about the study and providing written informed consent exclusion criteria: * women of childbearing age * patients under 18 years
development of bone-vestibular evoked myogenic potential

Conditions: Noise; Vestibular Disorder

Summary: this study aims to evaluate the effects of different masking conditions on cervical vestibular evoked myogenic potential (cvemp) responses. vertical-axis vibrations (vavs) of 500-hz short-tone bursts (stb500) and 750-hz short-tone bursts (stb750) were used to elicit cvemp responses. these stimuli were delivered through a mini-shaker placed at the vertex (cz) under three masking conditions: no masking (nom), speech noise masking (snm), and random interstimulus-interval tone bursts (risitb). the study focused on testing protocols that can potentially improve unilateral vemp testing and explore its clinical applicability.

participants and ethics: the study recruited 20 healthy adults (10 males and 10 females, aged 20-37 years), all of whom had normal otoscopic findings and no history of hearing issues. ethical approval was obtained, and all participants provided informed consent. bone conduction vibrations (bcv): bone-conducted vibrations were generated using a smartep system and delivered via a mini-shaker transducer. stimuli included 500 hz and 750 hz short-tone bursts (stb500 and stb750), calibrated to appropriate levels, with specific rise, plateau, and fall times. masking conditions: masking sounds included speech noise (250-1000 hz, calibrated at 100 db spl) and random interstimulus-interval tone bursts (risitb, 500 hz, 100 db spl). testing procedure: vertical-axis bcv was delivered to the vertex (cz) while participants maintained steady neck muscle tension in specified head positions. electrodes were placed using a standard montage for cvemp recording. each side was tested under three masking conditions (nom, snm, risitb) with a 24-hour interval between tests. responses were recorded bilaterally and repeated for reproducibility. study focus: the study investigates the effects of different masking conditions on response characteristics, including latencies, amplitudes, and asymmetry ratios. the aim is to refine vemp testing protocols, explore its potential for unilateral testing, and evaluate its applicability for specific vestibular organ assessments.

Eligibility criteria:
inclusion criteria: * 20y-40y adult exclusion criteria: * having history of hearing loss or dizziness * failed hearing screening test * having history of head or neck surgery

Keywords: bone conduction masking noise random vestibular evoked myogenic potentials
disease characteristics, treatment patterns and clinical outcomes in patients with newly diagnosed unresectable stage iiib/iv non-small cell lung cancer (nsclc) in china

Conditions: Non-Small Cell Lung Cancer, Lung Cancer, Cancer

Summary: the purpose of this observational study is to describe patient and disease characteristics as well as treatment patterns in chinese patients with unresectable stage iiib or iv non-small cell lung cancer (nsclc). in addition, this study characterizes the clinical outcomes for various populations of patients defined by clinical and tumor characteristics, treatment patterns, and hospital category defined by city tier and geographic region.


Eligibility criteria:
inclusion criteria: * histologically/cytologically confirmed, unresectable stage iiib or iv non-small cell lung cancer (nsclc) * received at least one anti-cancer treatment targeting unresectable stage iiib or iv nsclc in the study site after study initiation * radiographic evidence of disease exclusion criteria: * prior systematic treatment for unresectable stage iiib or iv non-small cell lung cancer (nsclc) * participation in any anti-cancer, regimen-specified clinical study of first-line treatment for unresectable stage iiib or iv nsclc.
usability of the preview php for home use in intermediate amd patients

Conditions: Age Related Macular Degeneration

Summary: to demonstrate the ability of intermediate amd subjects to follow the instructions for use and properly operate on their own the preview php in home use environment, after going through training session.

the study purpose is to demonstrate that the target population can use the system after going through a supervised training session. the preview php will be operated in the same manner in the simulated setting as it will be in future home use.

Eligibility criteria:
inclusion criteria: * capable and willing to sign a consent form and participate in the study subjects diagnosed as intermediate amd in at least one eye * age ≥65 years * va with habitual correction better than 20/60 in the study eye * ability to speak, read and understand instructions in english or hebrew * qualified to use the device by health care professional exclusion criteria: * evidence of macular disease other than amd or glaucoma in the study eye * presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, cfp. * any non-macular related ocular surgery or macular surgery performed within 3 months prior to study entry in the target eye * participation in another study with the exclusion of areds study * patients diagnosed with geographic atrophy (ga)

Keywords: amd
the cardiac autonomic system response to activity and cognitive tasksinjury

Conditions: Brain Injuries

Summary: 18 children post acquired brain injury and 18 typically developed controls matched for age and gender. all children aged 10-18 yrs who understand simple commands. tools: 1. heart rate monitor 2. six minute walk test 3. the behavior rating inventory method: 1. at the introductory visit the child will be asked to walk for six minutes, to sit and perform a cognitive test and then to walk on a treadmill for 5 seconds. 2. at the second visit the child will be asked to go on the treadmill for 5 minutes and at the same time to perform the cognitive assignment; after a rest the child will be asked to walk on the treadmill for 5 minutes and at the end to perform the cognitive assignment .


Eligibility criteria:
inclusion criteria: aged 10-18 understand simple commands walk independently exclusion criteria: canot understand simple commands
investigation of biomarker response to sglt2 inhibition in heart failure

Conditions: Heart Failure

Summary: this is a 26-week, open label, single-arm prospective evaluation of the effects of sodium glucose cotransporter 2 (sglt2) inhibition on cardiac biomarkers, myocardial remodeling and patient reported outcomes in heart failure with both impaired and preserved left ventricular fraction.

the primary aims of this study are to evaluate whether sglt2 inhibition in patients with heart failure effects changes in novel cardiac biomarkers. this is an exploratory evaluation of novel cardiac pathways which may serve to establish, as of yet unknown, therapeutic mechanisms of action of sglt2 inhibition in heart failure. secondary aims include evaluation of changes in standard of care biomarkers following sglt2 inhibition and changes in markers of cardiac remodeling as identified on echocardiography. further exploratory analysis will seek to correlate changes in quantitative and qualitative heart failure outcomes with changes in both novel and standard of care cardiac biomarkers.

Eligibility criteria:
inclusion criteria: 1. provision of signed informed consent prior to any study specific procedures. 2. male or female, between 40 and 90 years of age. 3. lvef \ 50%, co-existing structural markers of diastolic dysfunction must be present; * la width (diameter) ≥3.8 cm or la length ≥5.0 cm, or la area ≥20 cm, or la volume ≥55 ml or la volume index ≥29 ml/m. * left ventricular hypertrophy. * markers of diastolic dysfunction as assessed by pulsed wave doppler echocardiography. * n-terminal pro-b-type natriuretic peptide (nt-probnp) of at least 125pg per millilitre (or ≥365pg per millilitre if co-existing atrial fibrillation). 4. new york heart association (nyha) class ii, iii, or iv symptoms. 5. on optimal tolerated evidence-based hf medications. 6. patients may be ambulatory or recently hospitalized; however, must be \>6 weeks post-discharge on stable diuretic therapy. exclusion criteria: 1. receiving therapy with an sglt2 inhibitor \> 6 weeks prior to enrolment or previous intolerance of an sglt2 inhibitor. 2. severe (egfr \<20 ml/min/1.73m2), unstable or rapidly progressing renal disease at the time of recruitment. 3. type 1 diabetes mellitus 4. recent hospitalisation \< 1 month. 5. symptomatic hypotension or systolic bp \<95 mmhg at 2 out of 3 measurements 6. symptomatic bradycardia or second or third-degree heart block without a pacemaker. 7. previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after recruitment. 8. cardiomyopathy secondary to uncorrected primary valvular disease, infiltrative, arrhythmogenic or right ventricular dysplasia. 9. significant comorbidity including; pulmonary lung disease requiring home oxygen or non-invasive ventilation, cteph or primary pulmonary hypertension.

Keywords: heart failure cardiac imaging sglt2 biomarkers
open label trial to study the long-term safety and efficacy of seletracetam for the treatment of epilepsy

Conditions: Epilepsy

Summary: this is a safety and efficacy study of add-on therapy with seletracetam in epilepsy patients who have participated in a previous seletracetam study


Eligibility criteria:
inclusion criteria: * a signed and dated irb/iec approved written informed consent form * male/female age 18 years (16 years where permitted) to 65 years * minimum body weight of 40 kg * patients having participated in a previous seletracetam study * female patients without childbearing potential or using a medically accepted non-hormonal contraceptive method are eligible. exclusion criteria: * ongoing psychiatric disease other than mild controlled disorders * subject with clinically significant abnormalities in laboratory tests or ecg * poor compliance with visit schedule or medication intake in a previous seletracetam study * subject taking part in another clinical/pharmacological study, with the exception of seletracetam studies, in the 30 days preceding enrollment

Keywords: partial onset, primary generalized seizures, seletracetam
evaluate the ability of systane ultra to improve subjective symptoms of ocular irritation post 60 min. athletic performance.

Conditions: Dry Eye Symptoms; Visual Performance

Summary: the primary objective of this study is to compare visual degradation in a stressed (forced stare) environment in patients before and after acute administration of systane ultra.


Eligibility criteria:
inclusion criteria: * player/ coach must answer "yes" to the survey eligibility question. * player/coach must voluntarily agree to participate in survey exclusion criteria: * none.

Keywords: dry eye visual performance
effect of polyphenol-rich dark chocolate on obesity

Conditions: Obesity

Summary: this study aims to investigate the effect of polyphenol-rich dark chocolate (dc) on insulin resistance, adiponectin , blood pressure (bp), lipid profile in obese subjects and determine possible associations between all assessed parameters. it hypothesizes that consumption of polyphenol-rich dc could lower fasting glucose levels, insulin resistance and improve bp, total cholesterol, low-density lipoprotein (ldl) and triglycerides while increasing adiponectin and high-density lipoprotein (hdl) in overweight or obese individuals.

it is well acknowledged that the main mechanism by which cocoa and dc polyphenols improve fasting glucose levels, insulin sensitivity, bp and lipid profile in healthy individuals and those with hypertension and/or impaired glucose-tolerance, involves increased nitric oxide (no) bioavailability. no is essential for the regulation of blood pressure, glucose and lipid balance. this is evident in that e-nosynthase knockout mice exhibit insulin resistance, hypertension and hyperlipidemia, a cluster of diseases that is also observed in the metabolic syndrome. recently, it was shown that adiponectin regulates enosynthase activity through the phosphatidylinositol 3-kinase-dependent pathway wherein enosynthase is phosphorylated by 5'-amp-activated protein kinase at ser1179 and that plasma adiponectin levels are inversely correlated with bmi, waist-to-hip ratio, fasting plasma glucose, insulin, triglyceride, hyperinsulinemia, and glucose intolerance and positively with hdl-cholesterol, but not bp. this suggests a strong link between impaired no bioavailability, adiponectin levels and obesity. indeed, apart from exhibiting impaired no bioavailability, obese individuals also have decreased plasma adiponectin levels. since cocoa and dc are known to modulate no activity, investigating the impact of cocoa or dc polyphenols on adiponectin levels and observing a correlation between its levels and improved fasting glucose levels, insulin resistance, bp and lipid profile is essential in improving our understanding of the relationship between diet and health, particularly that polyphenols in apples, oolong and green tea polyphenols have been previously shown to influence adiponectin levels. this study uses a randomised single-blind, placebo-controlled design. following a 1-week run-in phase, each group will be randomised to one of the two groups: placebo-polyphenol-rich dc, polyphenol-rich dc-placebo. subjects will follow each diet for 4weeks, after which they will cross-over to the next diet separated by a 2-week washout period and until each subject completes both interventions.

Eligibility criteria:
inclusion criteria: * healthy female volunteers * aged 18-50 years * group 1 will consist of volunteers with bmi of 18-25 kg/m2 * group 2 will consist of women with bmi of 25-35 kg/m2 exclusion criteria: * cardiovascular disease * hypertension * diabetes * smokers * people taking dietary supplements * hypertension or cholesterol-lowering drugs * those with high cocoa or dc intake, soy or nut allergies
validity of an app to detect frailty and sarcopenia syndromes in elderly

Conditions: Sarcopenia; Frailty Syndrome; Aging; Aged; Diagnosis

Summary: frailty and sarcopenia are two age-related syndromes which can result in adverse health-related events. the combination of both is more predictive of mortality than either condition alone. these conditions can be reversed through an early detection and appropriate interventions. nevertheless, scientific community highlights the lack of cheap, portable, rapid and easy-to-use tools for detecting frailty and sarcopenia in combination. the aim of this study is to validate an iphone app to detect frailty and sarcopenia syndromes in community dwelling older adults. this is a protocol study of a retrospective diagnostic test accuracy study which will include at least 400 participants older than 60 years recruited from elderly social centers of murcia city. researchers will recollect data of health status, dependency, cognitive status, and functional capacity of the participants. the index test will consist in the measurement of muscle power exerted during a single sit-to-stand through an app (iphone), combined with calf and mid-upper arm circumference. the reference standard will be frailty syndrome and sarcopenia assessed according to fried's phenotype and to the european working group on sarcopenia in older people 2 (ewgsop2) (2019) recommendations, respectively. sensitivity, specificity, positive predictive value, negative predictive values, and area under the curve will be reported.


Eligibility criteria:
inclusion criteria: * community-dwelling older adults living in the region of murcia exclusion criteria: * barthel index \< 90 pts. * mini-cog test \< 3 pts. * severe cardiovascular problems * pacemaker * automatic defibrillator

Keywords: functional capacity sit-to-stand test muscle power chair rise
nitrate use to obtain radial spasm embarrassment (nurse - tts trial)

Conditions: Radial Artery Spasm

Summary: transradial cardiac catheterization and percutaneous coronary intervention are increasingly being performed worldwide in elective and emergency procedures, with many centres adopting the transradial route as their first choice of arterial access. one of the most common complications encountered during transradial procedures is radial artery spasm. the aim of this study is to evaluate the efficacy and safety of the use of transdermal glyceryl trinitrate patches applied to skin before cardiac catheterization to prevent the occurrence of radial artery spasm during transradial access cardiac catheterization.


Eligibility criteria:
inclusion criteria: * male or female 18 -85 years old who has been admitted for scheduled coronary angiography by radial artery exclusion criteria: * prior same radial artery catheterization * positive allen test * severe hypotension (sbp\<100 mmhg) * pregnancy * ongoing acute myocardial infarction * ongoing cardiogenic shock * known history of nitrates intolerance/allergy