Kornimate/medical-research-clean huggingface dataset:
study of absorb stent in acute myocardial infarction

Conditions: Acute Myocardial Infarction; Artery; Deformity, Coronary (Acquired)

Summary: the aim of our study is to evaluate the clinical outcomes at 30 days and 1 year (cardiac death, myocardial infarction, target lesion revascularization (tlr), target vessel revascularization (tvr), thrombosis of the device in patients who are undergoing angioplasty in myocardial infarction and in which bioabsorbable stent was implanted (bvs). additionally, we will evaluate the acute recoil after implantation of bioabsorbable stents. a 24 months follow-up , by means of coronary angiography accompanied by qca and assessment with intracoronary ultrasound (ivus) and vh (virtual histology) is scheduled.

the drug -eluting stents (drug eluting stents , des) are currently used routinely in the course of coronary angioplasty ( percutaneous coronary intervention , pci ) and have significantly reduced the incidence of adverse events during follow-up in the medium and long term . however, the persistence of the metal structure of these devices within the coronary artery over time adds no additional benefit but , on the contrary , it is potentially harmful because it may predispose to coronary thrombosis even after years of implantation, can alter the structure of the vessel for remodeling phenomena, can decrease a coronary vasomotion and reducing the possibilily of a future surgery. the recent development of new devices such as bioabsorbable vascular scaffold " bvs " release of antiproliferative drug ( everolimus ), could provide new clinical advantages especially in patients who are revascularized during acute myocardial infarction. these patients are at higher risk of mace and stent thrombosis late . the aim of our study is to evaluate the clinical outcomes conventional to 30 days and 1 year, such as cardiac death, myocardial infarction, target lesion revascularization(tlr ), target vessel revascularization (tvr ), thrombosis of the device in patients who undergo angioplasty in the course of acute coronary syndrome and in which it was implanted bioabsorbable stent ( bvs ). the acute recoil after implantation of bioresorbable vascular scaffold will also be assessed finally, a follow-up of 24 months we will conduct, by means of coronary angiography accompanied by qca and ivus with vh .

Eligibility criteria:
inclusion criteria: * patients older than 18 years with acute coronary syndrome (stemi and nstemi) will be enrolled exclusion criteria: * patients with these characteristics will be excluded: cardiogenic shock (defined as systolic blood pressure less than 80 mmhg for more than 30 minutes or the need for compressors or intravenous-intraaortic balloon counterpulsation), history of bleeding diathesis, history of leukopenia , thrombocytopenia, or severe hepatic or renal dysfunction, a non-cardiac disease associated with a life expectancy of less than one year, participating in another study, or not able to give informed consent due to a prolonged resuscitation cardiopulmonary.

Keywords: acute myocardial infarction bioresorbable vascular scaffold percutaneous coronary intervention
plasma chile (plasma chile)

Conditions: Heart Failure

Summary: prospective, multicenter, observational cohort study to collect data on chilean patients diagnosed with heart failure with reduced ejection fraction, their treatments, and their progress in a real-world environment. additional objectives will be analyzed, such as mortality, and the barriers, if any, to receiving the indicated treatment.

identify the main epidemiological and clinical characteristics of patients with heart failure with reduced ejection fraction, as well as the medical treatment models used.

Eligibility criteria:
inclusion criteria: * men and women ≥18 years old. * patients with heart failure with left ventricular ejection fraction (lvef) ≤ 40% will be included. * patients must be willing to comply with the study requirements and complete the informed consent form (defined as the legally valid and documented confirmation of a patient's voluntary agreement to participate in the clinical study). exclusion criteria: * patients without heart failure or with heart failure with left ventricular ejection fraction (lvef)\> 40%. * patients unable to comply with the clinical investigation plan. * patients who are already enrolled or plan to participate in a concurrent clinical study of any medication and/or device at any time during the course of this clinical study without prior documented approval of the medtronic study manager.
the effects of palmar cooling on repeated sprinting ability

Conditions: Exercise Induced Fatigue

Summary: repeated sprinting ability is key for athletic performance in a variety of sport settings. significant degradations in work output (i.e. fatigue) have been shown to develop after just one sprinting bout1. this pilot study aims to investigate the effects that noninvasive transient temperature manipulation has on an individual's ability to perform repeated sprints. the investigators aim to enroll 90 healthy individuals, 18-30 years of age. participants will be randomized into two groups (group a, and b). all groups will perform a ten-minute warm-up followed by two minutes of rest. following the warm-up and rest period, all groups will participate in a series of five sprints, 60 meters in total length with two 180 degree changes in direction. between sprints, participants will have 10 seconds rest. after the first series of five sprints participants will be given a 2-minute rest interval. then participants will perform another series of five sprints followed by another 2-minute rest interval. during each rest interval, group a will utilize a palmar cooling device. group b will utilize a placebo version of the palmar cooling device. all sprints will be timed. heart rate recovery will be measured during all rest breaks, and a rating of perceived exertion will be measured at the beginning and end of each resting interval. delayed onset muscle soreness will be assessed 48 hours post sprinting, utilizing a visual analog scale.


Eligibility criteria:
inclusion criteria: * healthy individuals 18-30 years of age exclusion criteria: * participant self-reporting injury or illness that will prevent them from exercising at maximal capacity * if participant has been told by their healthcare provider that they should avoid exercising at maximal capacity * has previously used the palmar cooling device
transcatheter mitral valve replacement with the medtronic intrepid™ tmvr system in patients with severe symptomatic mitral regurgitation.

Conditions: Mitral Valve Regurgitation

Summary: multi-center, global, prospective, non-randomized, interventional, pre-market trial. all subjects enrolled with receive the study device.


Eligibility criteria:
inclusion criteria: * moderate to severe or severe symptomatic mitral regurgitation * local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention exclusion criteria: * prior transcatheter mitral valve procedure with device currently implanted * anatomic contraindications * prohibitive mitral annular calcification * left ventricular ejection fraction \<25% * need for emergent or urgent surgery * hemodynamic instability

Keywords: heart disease valve disease heart valve disease mitral regurgitation cardiovascular disease mitral insufficiency
digital health intervention to promote quality of life in adults with chronic graft versus host disease

Conditions: Chronic Graft-Versus-Host Disease; Quality of Life

Summary: the goal of this interventional study is to learn if the horizons mobile application is feasible for survivors of allogeneic hematopoietic stem cell transplant who have chronic graft-versus-host disease. participants will be asked to complete surveys and use the horizons mobile application.


Eligibility criteria:
inclusion criteria: * underwent allogeneic hematopoietic stem cell transplant * have moderate to severe chronic graft-versus-host disease * currently receiving care at the sylvester comprehensive cancer center bone marrow transplant program * able to use an ipad to participate in the horizons app intervention * able to participate in study procedures in english exclusion criteria: * comorbid conditions or cognitive impairment that the treating clinician believes prohibits informed consent or participation in the intervention * vulnerable patients, defined here as prisoners and pregnant women
evaluation of main determinants of postprandial glucose response in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the goal of this observational study is to explore inter- and intra-individual determinants of postprandial glucose response in patients with type 1 diabetes using continous glucose monitoring (cgm). blood samples and anthropometrics will be collected during hospital visit. participants will be asked to: * record a seven-day food diary * complete epic food frequency questionnaire * complete questionnaires on sleep hygiene * collect a stool sample

postprandial glucose response (pgr) is a main determinant of blood glucose control in people with type 1 diabetes (t1d) and it's still difficult to manage also in patients treated with advanced technologies. dietary composition of meals represents one of main determinant of pgr. however, growing evidence indicates that pgr to the ingestion of the same meal may significantly differ between individuals. this effect could be explained by non-nutritional determinants, including gut microbiota composition. on this background, the aim of the study is to investigate the relative contribution of intra- and inter-individual variability in determining pgr in individuals with type 1 diabetes. patients with t1d regularly attending the diabetes outpatient clinic of federico ii university teaching hospital, will be recruited. participants' eating habits will be collected through a 7-day food record and the european prospective investigation into cancer and nutrition (epic) questionnaire. fasting blood samples will be collected for the evaluation of serum short-chain fatty acids, zonulin, metabolomic, and epigenetics. moreover, participants will be asked to collect at home a faecal sample to determine gut microbiota composition (16s rna sequencing). patients will be asked to complete web-based questionnaires on sleep hygiene (pittsburgh sleep quality index, epworth). postprandial glucose response will be assessed by data derived from continuous glucose monitoring (cgm) used for clinical care. the association between the pgr, calculated as incremental auc using the trapezoidal method, and gut microbiota composition will be assessed. moreover, the association between pgr, dietary composition, metabolomics and epigenetics will be investigated.

Eligibility criteria:
inclusion criteria: * type 1 diabetes exclusion criteria: * pregnancy and/or breastfeeding * other chronic or acute diseases * use of antibiotics in the past 3 months

Keywords: type 1 diabetes gut microbiota dietary habits postprandial glucose response hybrid artificial pancreas continuous glucose monitoring
ivabradine effects in cardiogenic shock requiring inotropic support

Conditions: Heart Failure; Cardiogenic Shock; Ischemic Heart Disease

Summary: data regarding the safety and efficacy of ivabradine use in severely decompensated hfref requiring inotropic support is limited to case series.1 this study aimed to evaluate ivabradine safety and tolerability in admitted cardiogenic shock patients who started on dobutamine infusion for inotropic support.

background and study rationale: ivabradine is a heart rate (hr) lowering agent which acts by inhibiting the if current in the sinoatrial node. it is currently indicated in patients with chronic heart failure with reduced ejection fraction (hfref). dobutamine is an inotropic drug used in cardiogenic shock patients and it is associated with an increase in hr and incidence of cardiac arrhythmias.2 however, studies have suggested that increased heart rate may be deleterious in decompensated hfref due to an inverted bowditch-treppe response. data regarding the safety and efficacy of ivabradine use in severely decompensated hfref requiring inotropic support is limited to case series.1, 2 aim of the work: * this study aims to evaluate ivabradine safety and tolerability in admitted cardiogenic shock patients who started on dobutamine infusion for inotropic support. * design: randomized open-label interventional clinical trial. methods and patients: * study type: interventional (clinical trial) * estimated enrollment: 200 participants * allocation: randomized * perspective: prospective study * intervention model: two group assignment * masking: none (open label) * primary purpose: treatment * official title: ivabradine effects in cardiogenic shock requiring inotropic support (iva-cs) * start date: 01 august 2022 * estimated primary completion date: 01 january 2023

Eligibility criteria:
inclusion criteria: * decompensated heart failure with reduced ejection fraction (hfref) admitted for cardiogenic shock requiring inotropic support. exclusion criteria: * decompensated heart failure with reduced ejection fraction (hfref) not requiring inotropic support. * patients with no oral intake * patients who refused to sign the consent

Keywords: heart failure cardiogenic shock ivabradine
repare: rating evaluations in psoriatic arthritis (psa) with etanercept (enbrel®)

Conditions: Psoriatic Arthritis

Summary: the overall objective of the study was to describe the long-term effectiveness and safety of etanercept in patients with psoriatic arthritis in a canadian clinical practice setting.


Eligibility criteria:
inclusion criteria: * presence of psoriasis or previous evidence of psoriasis documented by a dermatologist as part of usual care * at least one of the following forms of psoriatic arthritis (psa): * distal interphalangeal (dip) involvement (inflammatory) * polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis * arthritis mutilans * asymmetric peripheral arthritis or * spinal involvement * active psoriatic arthritis at the time of the study enrollment * patients must demonstrate greater than 3 swollen joints and greater than 3 tender/painful joints * greater than 18 years of age at the time of consent * able to start etanercept therapy per the approved product monograph * informed consent must be provided before any study specific procedures are performed exclusion criteria: * active infections at time of initiating enbrel® therapy * evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the study medication * a malignancy, other than basal cell carcinoma of the skin or, in situ carcinoma of the cervix, within the past 5 years * known hypersensitivity to etanercept or any of its components * patients receiving, or who have received: * remicade® (infliximab) in the previous 3 months or -- humira® (adalimumab) in the previous 3 months or * kineret® (anakinra) in the previous 15 days * patients receiving or who have received etanercept * treatment with any investigational therapy in the 30 days prior to enrollment or during the study * active guttate, erythrodermic or pustular psoriasis at the time of screening * presence of any significant and uncontrolled medical condition, which in the investigator's opinion, precludes the use of etanercept as outlined in the product monograph * sepsis or at risk of septic syndrome * patients not available for follow-up assessment * concerns for subject's compliance with the protocol procedures

Keywords: psoriatic arthritis psa commercial product american college of rheumatology acr/pasi
investigating a model for acute ischemic pain in humans

Conditions: Peripheral Arterial Disease

Summary: the pathophysiology of acute ischemic pain is not well established. the aim of the present study was to investigate acute ischemic pain in humans with a view to establish a scientific model to perform future studies. the investigators examined whether peripheral nerve damage and acute inflammation occur during short episodes of acute ischemia.


Eligibility criteria:
inclusion criteria: * patients over 40 years * unilateral femoral-popliteal pad, fontaine grade ii exclusion criteria: * patients with pain at rest or other pain origin * diabetic polyneuropathy * deep vein thrombosis

Keywords: acute ischemic pain model s100 interleukine 6
tolerability and efficacy of modified vcd regimens in previously untreated multiple myeloma.

Conditions: Multiple Myeloma

Summary: this phase 2 study will be conducted at 10 centers and enroll patients from august 2013 to august 2017.firstly, all patients included will provide written informed consent. secondly, they will be randomized equally to receive modified vcd regimen arm 1 or modified vcd regimen arm 2. in total, 47 patients per arm (or 94 in total) are required. the treatment consists of four 4-week cycles of induction therapy followed by intensive therapy with another five modified vcd regimens and maintenance treatment with cp regimen. then, patients will be followed up for 24 months after chemotherapy. the investigators will record all the laboratory and clinical investigations to assess response at different points of the study. we also monitor and assess adverse events (aes), as graded according to nci-ctcae version 3.0.response categories were based on the international myeloma working group uniform response criteria.in addition, 20 patients (10 in vcd regimen arm 1 group, 10 in vcd regimen arm 2 group) from ten centres will be enrolled in the pharmacodynamic substudy.


Eligibility criteria:
inclusion criteria: * patients with previously untreated symptomatic mm * 18 years of age or older, regardless of gender * secretory mm with measurable diseases * karnofsky performance status≥50%（pathological fractures excluded） * patients without heart and pulmonary dysfunction ≤class i exclusion criteria: * peripheral neuropathy of grade 2 or higher according to nci-ctcae version 3.0 * relapse and refractory mm * mm without symptom * non-secretory mm without measurable diseases * karnofsky performance status\<50%（pathological fractures excluded） * patients with heart and pulmonary dysfunction\> class i
drug patch tests in patients with severe cutaneous adverse reaction to drugs (scars)

Conditions: Drug Reaction

Summary: the study is about drug patch tests in patients who have history of severe cutaneous drug reaction including steven johnson syndrome (sjs), toxic epidermal necrolysis (ten), drug-induced eosinophilia and systemic symptoms (dress), agep (acute generalized exanthematous pustulosis) and generalized bullous fixed drug eruptions. this study also investigate in enzyme-linked immunosorbent spot assay (elispot) and lymphocyte transformation test. we also trying to prove the correlation among result of drug patch tests, elispot and ltt.


Eligibility criteria:
inclusion criteria: * patients with history of steven johnson syndrome (sjs), toxic epidermal necrolysis (ten), drug-induced eosinophilia and systemic symptoms (dress), acute generalized exanthematous pustulosis (agep), generalized bullous fixed drug eruption in the past 24 months. * age more than 18 years old exclusion criteria: * receiving immunosuppressive drugs or more than 10 mg/day of prednisolone within 1 month. * pregnancy and lactation

Keywords: drug patch tests
nature-based therapies in stroke rehabilitation

Conditions: Rehabilitation; Stroke

Summary: stroke rehabilitation patients are subjected to additional nature-based therapies during a rehabilitation ward period.

inward stroke rehabilitation patients are selected randomly into two groups: intervention and control groups in proportions 1-2:1. blood samples and microbiome samples of saliva, skin and feces are taken from all patients prior to interventions. these are controlled after 4 weeks from the beginning of the study and 3 months after signing-off the ward. questionnaires eg on moods, life quality and function deficits are conducted in the beginning of the study, after 4 weeks from the start and 3 months after signing-off. physiological measurements will be done to observe autonomic nerve status. the interventions consisting of therapy sessions in the hospital nearby nature will be conducted thrice a week one of them being an individual nature-visit with the research worker, one in group and one with family-member or volunteer. the moods and quality of life of the family-member participating in the study will also be followed up. the control group is advised to do simple, more conventional rehabilitative tasks indoors.

Eligibility criteria:
inclusion criteria: * acute/subacute stroke * rehabilitation ward patient exclusion criteria: * incapable of independent decision making * traumatic bleeding in brain tissue * severe aphasia * severe, malign ongoing disease

Keywords: rehabilitation stroke nature-based therapy microbiome gut-brain axis
coffee trial - does coffee intake reduce postoperative ileus after elective colectomy?

Conditions: Colectomy

Summary: the purpose of the investigators study is to investigate the effects of coffee on the return of bowel function and appetite, length of hospital stay, and complications after elective open colectomy in a prospective randomized trial. the primary efficacy endpoint is time to first bowel movement.

coffee is a popular beverage. its effects on general well being, central nervous system and cardiovascular system are well known, but there is limited information regarding its effects on gastrointestinal function.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective open or laparoscopic colectomy * age equal or greater than 18 years * informed consent exclusion criteria: * participation in concurrent intervention trials * need for a stoma * known hypersensitivity or allergy to coffee * expected lack of compliance * impaired mental state or language problems * change in surgical procedure

Keywords: postoperative ileus after colonic resections
implantable loop recorder in traumatic syncope

Conditions: Syncope

Summary: prospective, observational registry enrolling consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation with the aim to evaluate the incidence of recurrence of traumatic syncope during follow-up.

this observational, prospective registry enrolled consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation according to current clinical practice. the patients were evaluated every 6 months based on current clinical practice and the risk of recurrence of traumatic syncope was assessed during follow-up.

Eligibility criteria:
inclusion criteria: * patients with recurrent, unexplained, traumatic syncope * patients underwent implantable loop recorder implantation exclusion criteria: * patients unable to attend scheduled outpatient visits