Kornimate/medical-research-clean huggingface dataset:
resynchronization surgery combined unified efficacy

Conditions: Ischemic Heart Failure

Summary: the purpose of the study is to compare survivability and efficacy of the patients with severe ischemic heart failure after coronary artery bypass grafting alone and coronary artery bypass grafting with single-step implantation of crt system (cabg alone vs cabg + crt )


Eligibility criteria:
inclusion criteria: * men and women * age 18-80 * history of ischemic heart failure and indications for cabg * lvef less than 35% estimated by echocardiography measured within 3 months of study entry * nyha and ccs (angina) ii-iv functional class * signs of dyssynchrony (at least one of the following three): qrs \> 120 ms or dyssynchrony based on doppler-methods (tissue tracking and tsi methods) or care hf criteria: aortic pre-ejection delay \>140ms, interventricular mechanical delay \>40 ms, delayed activation of postero-lateral lv wall exclusion criteria: * failure to provide informed consent. * previous cardiac surgery * non-cardiac illness with a life expectancy of less than 3 year * non-cardiac illness imposing substantial operative mortality * previous heart, kidney, liver, or lung transplantation * current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device * successful coronary revascularization (сabg or pci) within 12 months of study enrollment * chronic atrial fibrillation

Keywords: resynchronization therapy
diabetes research on patient stratification (direct): glp-1r agonists

Conditions: Diabetes

Summary: the purpose of this study is to collect a cohort of patients treated with glp-1r agonists and to assess phenotypic, genetic and genomic biomarkers of glycaemic response to these agents.

to develop a cohort of patients treated with glp-1 r agonists who are phenotyped at baseline and at 6 month follow up to determine clinical, imaging and other biomarker predictors of glycaemic response to glp-1r agonists. the hypothesis is that one, or a combination, of these biomarkers is associated with glycaemic response to glp-1r agonists. the primary outcome is therefore hba1c reduction after 6 months of glp-1r a treatment. this is a cohort study of 800 patients being treated with either exenatide or liraglutide for 6 months, and carried out in 4 uk centres.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes where a clinical decision has been made to commence a glp-1r agonist * either: 1. on any combination of oral hypoglycaemic agents 2. on insulin (+/- oral hypoglycaemic agents) * hba1c ≥7.5% (58mmol/mol) and hba1c \< 12% (108mmol/mol) * white european * age ≥ 18 and \< 80 exclusion criteria: * type 1 diabetes * hba1c \<7.5% (58 mmol/mol) * hba1c ≥ 12% (108 mmol/mol) * pregnancy or lactation * any other significant medical reason for exclusion as determined by the investigator * inability to consent * participating in a ctimp during the study period and within 30 days prior to study start.

Keywords: glp-1r agonist biomarker
impact of oxidized silver wound dressings on wound bacteria

Conditions: Wounds

Summary: chronic non-healing wounds considerably impact quality of life in affected patients and are a substantial burden on the canadian health care system. microbes colonizing a chronic wound play an important role in impeding effective healing. chronic wounds are colonized by polymicrobial communities and no single organism can be seen as causal. only a small fraction of wound bacteria are cultured by diagnostic tests and studies have shown little agreement between culture and molecular based approaches, therefore an effective diagnostic for wound microbes is required. it is know that the composition of the microbial community associated with a wound changes as it heals although the causal relationship is somewhat unclear. although not very effective in treating chronic non-healing wounds, antibiotics are often administered, contributing to concerns of antibiotic resistance. the wound dressings produced by exciton technologies inc. (eti) effectively aid in the healing process in chronic wounds through unknown mechanisms. eti's wound dressings contain a combination of silver salts with three different valence, +1, +2 and +3 that have antimicrobial activity and are effective in reducing biofilm formation in vitro. however, it is not known how these silver salts impact microbial ecology of the wound and the role this plays in wound healing. the objectives of this research are to develop a new diagnostic tool based on molecular characterization of wound sites so as to predict how to best treat wounds and to identify new microbes to be targeted by eti's technology. this project will utilize molecular microbial ecology for the assessment and evaluation of topical silver interventions, gaining insight into the management of chronic infection. substantiating the microbiota-modifying effectiveness of silver wound dressings towards increasing clinician and patient understanding to improving clinical outcomes.


Eligibility criteria:
inclusion criteria: 1. signed or verbal informed consent 2. \>17 yrs and \<70 yrs of age 3. have a chronic wound (defined as \>6 weeks, non-healing), with or without clinical signs of infection. 4. requires visitation or admittance to the clinic and subsequent visits for dressing changes exclusion criteria: 1. systemic antibiotics within the last 2 weeks. 2. known skin sensitivity to any of the dressing components 3. poor prognosis and who are unlikely to survive the trial period. 4. participating in another concurrent trial. 5. exhibiting any other medical condition, which, according to the investigator, justifies the subject's exclusion from the trial.
dysphagia in mechanically ventilated icu patients

Conditions: Deglutition Disorders

Summary: dysphagia significantly contributes to morbidity and mortality in non-critically ill patients (as e.g. in stroke). long term consequences of dysphagia include, among others, malnutrition, prolonged enteral tube feeding and increased risk of aspiration. in the present observational analysis, the investigators aim to elucidate the incidence and the impact of dysphagia on the clinical course of a mixed population of icu patients post invasive mechanical ventilation.

dysphagia significantly contributes to morbidity and mortality in non-critically ill patients (as e.g. in stroke). long term consequences of dysphagia include, among others, malnutrition, prolonged enteral tube feeding and increased risk of aspiration. in the present observational analysis, we aim to elucidate the incidence and the impact of dysphagia on the clinical course of a mixed population of icu patients post invasive mechanical ventilation. icu patients are at increased risk for oropharyngeal dysphagia following endotracheal intubation. however, the incidence, respective underlying causes and clinical consequences of dysphagia in icu patients are currently understudied. the impact on clinical outcomes of respective icu patients thus remains currently unclear. a systematic review \[1\] reported highly variable dysphagia frequency rates depending on the time of mechanical ventilation/ intubation. however, previous clinical trials were heterogeneous in design, methods of screening, and study outcome. the overall quality of evidence is considered low. the systematic review highlights the limited available evidence for dysphagia following intubation and hence the need for high-quality prospective trials. a recent retrospective single-centre trial \[2\] in a tertiary care icu demonstrated a high presence of dysphagia in mechanical ventilated (mv) patients following extubation. screening was performed using bedside swallowing evaluation (bse). in a prospective observational analysis, we aim to further elucidate the impact of dysphagia on respective clinical outcomes in icu patients after mechanical ventilation.

Eligibility criteria:
inclusion criteria: all adult icu patients post mechanical ventilation (observational analysis) exclusion criteria: * patients prone to die / moribund patients/ or dying patients * patients post oesophageal resection / with oesophageal rupture

Keywords: deglutition disorders dysphagia mechanical ventilation sepsis
pharmacological modulation of cocaine effects - 1

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to conduct human laboratory studies of possible cocaine interactions with various potential treatment medications.


Eligibility criteria:
please contact site for information.

Keywords: cocaine dependence
functional disorders of the musculoskeletal system in people with multiple sclerosis

Conditions: Multiple Sclerosis; Rehabilitation; Musculoskeletal Complication

Summary: the randomized controlled trial is aimed to study the efficacy of treatment approaches based on developmental kinesiology models and its impact on balance, gait and mobility in people with mild to severe multiple sclerosis (pwms). the main goal is to compare two out-patient physiotherapeutic methods, that will be attended 1-hour twice a week for one month and once a week for next two months (16 therapies in total). the efficacy will be assessed by a blinded independent clinical examiner using clinical examination and questionnaire survey one month before the therapy programme, immediately before and after the therapy and two months after termination of the therapy.

the participants were randomly divided into two groups for three-month outpatient physiotherapeutic programme. one group obtained treatment by mfk method (manual physiotherapeutic correction) and the second by dns (dynamic neuromuscular stabilization ). both treatment methods were developed in the czech republic. all participants attended 1-hour mfk method or dns twice a week for one month and once a week for next two months (16 therapies in total). the participants were examined three times - before the start of the physiotherapy program, immediately after its completion and six months apart.

Eligibility criteria:
inclusion criteria: * exact diagnosis of ms stated by neurologist * expanded disability status scale (edss) ≥ 2 and ≤ 6,5 * no previous physiotherapy in six months * no clinical relapses and changes in pharmacotherapy in the previous month or during the rehabilitation trial * ability to undergo ambulatory physiotherapy exclusion criteria: * other neurological disease or conditions disabling movement (e.g. stroke, pregnancy, fracture)

Keywords: developmental kinesiology physiotherapy muscle imbalance musculoskeletal disorders
personalization of long-term antiplatelet therapy - rapid extend

Conditions: Coronary Artery Disease; Myocardial Infarction

Summary: in patients after myocardial infarction (mi) (heart attacks) and treated with percutaneous coronary intervention (pci), the current standard is dual antiplatelet therapy (dapt), with aspirin and a p2y12 receptor inhibitor, for 1 year of treatment. at 1 year, there are several options including: i) ongoing dapt (with aspirin and ticagrelor), ii) selective treatment use of a p2y12 inhibitor based on risk profiles. this study is a pilot vanguard study to evaluate several strategies for choosing anti-platelet regimen among patients post mi and pci at 1 year.

the present study is a pilot/vanguard 3-arm study that seeks to compare 3 possible strategies for patients that are 1 year post mi and pci. the 3 randomized groups include: i) aspirin and ticagrelor 60 mg twice daily, ii) monotherapy with ticagrelor 60 mg twice daily and iii) a personalized arm (pa), where patients will get selective therapy based on demographic and genetic risks. the pa group will use a modified dapt score based on patient demographics to decide whether p2y12 treatment is warranted. for those patients where treatment is warranted, a bedside genetic test will be used to determine whether they are carriers of at-risk genotypes, which put them at risk for under-responsiveness to clopidogrel (one of the specific p2y12 inhibitors). those identified as carriers will be treated with ticagrelor while non-carriers will be treated with clopidogrel. the study will act as a vanguard study to prove feasibility of enrollment and document overall bleeding rates. the long-term goal of the study is determine whether a personalized approach will decrease bleeding versus an approach of dapt with ticagrelor and versus an approach with ticagrelor monotherapy.

Eligibility criteria:
inclusion criteria: * \>50 years old at 1-year after myocardial infarction (non-st-elevation myocardial infarction (nstemi) or st-elevation myocardial infarction (stemi)) during which they had percutaneous coronary intervention (pci) * compliant with dual antiplatelet therapy (dapt) for ≥ 1 year without an ischemic or bleeding complication after pci * still on dapt regimen at enrollment * patients must have 1 of the following atherothrombotic risk enrichment criteria: i) age≥ 65 years ii) diabetes iii) 2nd prior mi (\>1 year ago) iv) multi-vessel coronary disease v) creatinine clearance (crcl) \<60 ml/min. exclusion criteria: * intolerance to ticagrelor or clopidogrel * \>18 months post percutaneous coronary intervention (pci) and myocardial infarction (mi) * requirement of a p2y12 inhibitor * requirement of oral anticoagulation * take concurrent cyp3a inducing drugs which may interact with ticagrelor (e.g. anti-epileptic drugs) * history of stroke, tia or intracranial bleed * recent gi bleed or major surgery * life expectancy of \< 1 year * platelet count \< 100,000/μl * bleeding diathesis * on dialysis * severe liver disease * at risk for bradycardia.

Keywords: 1-year post myocardial infarction p2y12 inhibitor antiplatelet regimen
slp model development in the diagnosis of copd patients

Conditions: COPD; Healthy Smoker

Summary: this is an observational, comparative, multicentre study to develop a model for the thora3di™ against standard practice in patients who are undergoing investigation for copd. the core methodology involves capturing of data during a short period of measurement of breathing using slp against spirometric outcomes.

this study will generate data to characterise the tidal breathing patterns and parameters with thora-3di™ against spirometry fev1/fvc and %predicted. subjects will have a part a visit (development phase) to develop algorithms for copd diagnosis. at part a visit, subjects will have two 5-minute slp measurements (pre and post bronchodilator). the slp measurement should be performed prior to standard lung function tests with minimal impact on clinical time and no change to hospital attendance. also, subjects will be asked to report concomitant medications and adverse events and fill in copd assessment test (cat™).

Eligibility criteria:
inclusion criteria: * any adult (≥18 years old) who has been diagnosed with copd guide gold criteria (fev1/fvc ratio post bronchodilator \<0.70) * healthy smokers (≥35 years old, current or ex-smoker with a history of ≥10 pack years (20 cigarettes smoked per day for 10 year)) exclusion criteria: * be unable to sit in an upright position for required period * have had deteriorated copd symptoms since the last spirometry unless willing to undergo spirometry testing * have significant co-morbidities (i.e. chest work or spinal deformity, osa, ahi \>30 secs * any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participants' ability to participate in the study * height \> 194 cm * bmi \>40 * female participant who is pregnant, lactating or planning pregnancy during the course of the study * be unable to consent or comply with the study protocol
first in human study of cdr404 in hla-a*02:01 participants with mage-a4 expressing solid tumors

Conditions: Select Advanced Solid Tumors

Summary: cdr404 is a highly potent and specific t-cell engaging bispecific and bivalent antibody designed for the treatment of cancers positive for the tumor-associated antigen melanoma-associated antigen 4 (mage-a4). this is a first-in-human study designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of cdr404 in adult patients who have the appropriate germline human leukocyte antigen hla-a\*02:01 tissue marker and whose cancer is positive for mage-a4.

the cdr404-001 phase 1 study will enrol patients with locally advanced, unresectable or metastatic tumors expressing mage-a4, which include advanced solid tumors, and will be conducted in multiple phases: 1. to identify the maximum tolerated dose (mtd) and pharmacologically effective dose range (pedr) for cdr404 2. to assess preliminary evidence of anti-tumor activity of cdr404 3. to characterise the pharmacokinetics of cdr404 4. to characterise the immunogenicity of cdr404 5. to assess translational biomarkers

Eligibility criteria:
inclusion criteria: 1. provision of written informed consent 2. hla-a\*02:01 positive 3. mage-a4 positive tumor 4. eastern cooperative oncology group (ecog) performance status (ps) \[ecog ps\] 0 or 1 5. selected advanced solid tumors 6. relapsed from, refractory to, or intolerant of standard therapy 7. measurable disease per recist v1.1 8. adequate organ function 9. if applicable, must agree to use highly effective contraception exclusion criteria: 1. symptomatic or untreated central nervous system metastasis 2. inadequate washout from prior anticancer therapy 3. significant ongoing toxicity from prior anticancer treatment 4. recent surgery 5. clinically significant cardiac disease 6. active infection requiring systemic antibiotic treatment 7. human immunodeficiency virus (hiv) at risk of acquired immunodeficiency syndrome (aids)-related outcomes 8. active hepatitis b virus (hbv) or hepatitis c virus (hbc) 9. ongoing treatment with systemic steroids or other immunosuppressive therapies 10. significant secondary malignancy 11. history of chronic or recurrent active autoimmune disease requiring treatment 12. uncontrolled intercurrent illness 13. pregnancy or lactation.
effect of flex-a-new on osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: comparative trial of placebo versus flex-a-new (a food supplement) containing glucosamine an chondroitin sulfate for the symptom modification is knee osteoarthritis

comparative trial of placebo versus flex-a-new (a food supplement) containing glucosamine an chondroitin sulfate for the symptom modification is knee osteoarthritis

Eligibility criteria:
inclusion criteria: knee osteoarthritis grade 1 to 3 - exclusion criteria: ischemic heart disease with chf -

Keywords: knee osteoarthritis
decolonization of carbapenem-resistant enterobacterales (cre) in patients with faecal carriage of cre with neomycin

Conditions: Colonization, Asymptomatic

Summary: rates of antimicrobial resistance are increasing worldwide. there is increasing evidence that physiological gut microbiota is a large reservoir of antibiotic-resistance genes. healthy gut microbiota is known to prevent the colonization of the gastrointestinal tract by pathogens, the so-called mechanism of colonization resistance, but this protective mechanism can be altered by therapies that impair gut microbiota, including antibiotics with consequent colonization of gut pathogens, including carbapenem-resistant enterobacterales (cre). cre carriers represent an epidemiological threat to other hospitalized patients and to the whole community, but are also at risk of developing clinical consequences of this colonization, including bloodstream infections from these pathogens. neomycin has shown high efficacy in the eradication of cre invitro. neomycin has also been approved to treat hepatic coma by eradicating bacterial in gastrointestinal tract. therefore, this evidence suggests that this procedure could be useful in eradicating cre. however, current evidence is mostly limited. the aim of this study is to investigate the efficacy of neomycin, compared with no intervention in eradicating gut colonization from cre.

the investigators will randomize patients colonized by cre (diagnosed by rectal swab) to neomycin by stratified randomization according to type of cre species (e.coli or non-e.coli). then, patients will be followed up, rectal swabs will be repeated, and stool samples for culture and will be collected, up to 14 days after neomycin.

Eligibility criteria:
inclusion criteria: * patient aged \>18 years * hospitalized in medical wards * presence of cre in stool/rectal swab without symptom from active surveillance of cre * sign informed consent to participate the study exclusion criteria: * cre infected patients * receiving anti-cre antibiotics * known allergy to neomycin or other aminoglycosides * receiving cidofovir, colistin methate sodium, foscarnet , furosemide, digoxin * egfr (estimated glomerular filtration rate) \< 30 ml/min/1.73 m2 * had gastro-intestinal tract diseases * pregnancy or breast-feeding

Keywords: neomycin cre carbapenem-resistant enterobacterales
non-invasive vagus nerve stimulation in acute ischemic stroke

Conditions: Ischemic Stroke

Summary: the main objective of the study will be to investigate whether treatment with non-invasive vagus nerve stimulation (nvns) on top of best medical practice in acute ischemic stroke patients results in less infarct growth in the penumbra and smaller infarct volumes compared with those of patients not treated with nvns. the study will be a prospective randomized clinical trial with blinded outcome assessment (probe design). 150 patients will be randomized to nvns with the gammacore sapphire™ device on top of best medical practice versus best medical practice alone (including intravenous thrombolysis and/or thrombectomy if indicated). if patients are randomized to nvns, two stimulations of two minutes each will be applied in the neck every 15 minutes in the first 3 hours. thereafter two stimulations will be applied every 8 hours over the next 5 days or until discharge, whichever occurs first. the stimulation side in the neck will be the radiological side of the stroke. the primary endpoint will be the final infarct volume on mri scan on day 5 of patients treated with nvns compared with those of patients not treated with vns.


Eligibility criteria:
inclusion criteria: * ischemic stroke * nihss ≥1 * perfusion deficit on the admission ctp scan; the penumbra must comprise at least 1/3 of the total ischemic area (ischemic core and penumbra) * the infarct has to comprise the anterior circulation * treatment has to start \<12 hours after stroke onset * patients or their representatives need to give their informed consent exclusion criteria: * a life expectancy of less than three months * mrs \>2 prior to admission * contra-indication for contrast ct * contra-indications for vns: * an active implantable medical device such as a pacemaker, deep brain stimulator, or any implanted electronic device * symptomatic stenosis or dissection of the carotid artery (in these patients the other side will be stimulated unless a significant stenosis on the other side is present as well) * structural abnormality e.g. lymphadenopathy, previous surgery or abnormal anatomy (in these patients the other side will be stimulated) * metal cervical spine hardware or metallic implant near the stimulation site * cervical vagotomy (in these patients the other side will be stimulated) * pregnancy

Keywords: brain infarction brain ischemia vagus nerve stimulation penumbra