Kornimate/medical-research-clean huggingface dataset:
rate control versus rhythm control for postoperative atrial fibrillation

Conditions: Postoperative Atrial Fibrillation

Summary: the purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (af). in patients who develop af during hospitalization after cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in hospital within 60 days of the occurrence of af compared to a strategy of rate control.

the purpose of the research is to compare two strategies for treating atrial fibrillation or atrial flutter, both of which are referred to as af, after cardiac surgery. af is the most common complication after cardiac surgery. af is when the upper chambers of the heart (atria) experience disorganized electrical activity which causes the heart beat to be irregular. the two treatment strategies to be used in this study are called rhythm control and rate control. the rhythm control strategy will attempt to bring the heart beat back to a regular rhythm using treatments known and approved to control heart rhythm. the rate control strategy will attempt to bring the heart rate to less than 100 beats per minute at rest using medications known and recommended to control heart rate. both strategies are commonly used to treat af. all of the medications that will be used in this study are the standard of care for use in patients experiencing af. this research seeks to determine whether rhythm control is better than rate control in patients with af after cardiac surgery.

Eligibility criteria:
enrollment inclusion criteria: * age \> 18 years * undergoing heart surgery for coronary artery bypass (on-pump or off-pump cabg) and/or valve repair or replacement (excluding mechanical valves), including re-operations * hemodynamically stable randomization inclusion criteria * af that persists for \> 60 minutes or recurrent (more than one) episodes of af up to 7 days after surgery during the index hospitalization. exclusion criteria: * lvad insertion or heart transplantation * maze procedure * tavr * history of or planned mechanical valve replacement * correction of complex congenital cardiac defect (excluding bicuspid aortic valve, atrial septal defect or pfo) * history of af or afl * history of af or afl ablation * contraindications to warfarin or amiodarone * need for long-term anticoagulation * concurrent participation in an interventional (drug or device) trial

Keywords: heart surgery cardiac surgery coronary artery bypass mitral valve surgery aortic valve surgery atrial fibrillation atrial flutter cardiac arrhythmia valve surgery
registry autolog lipid removal and blood component characterization

Conditions: Trauma

Summary: the purpose of this study is to show the success of the autolog system in removing lipids to less than 10mg/dl in vivo. the autolog registry has two objectives: 1. to determine the lipid removal capabilities of the medtronic autolog system. 2. to obtain in vivo data on blood component removal and washing capabilities of the medtronic autolog system.

since the in house data strongly suggest that the medtronic autolog is uniquely high performing in lipid removal in-vitro, the registry autolog lipid removal and blood component characterization is initiated to determine if the autolog system is successful in removing lipids in vivo as it is in-vitro. therefore, it is expected that the lipid amounts after washing will be less than 10 mg/dl. the study is designed as a multi-center, non-randomized, non-interventional, post market release study (a registry). the study has a single arm, without controls, as it is descriptive in nature.

Eligibility criteria:
inclusion criteria: * patients with an indication for surgery procedures in which the hospital treatment protocol requires the routine use of an autotransfusion system are eligible for participation. exclusion criteria: * the use of citrate-based anticoagulant in patients with impaired liver function * gross contamination and/or septic procedures * surgery within the malignant area that may allow dissemination of tumor/malignant cells, if aspirated, into the autotransfusion system * caesarean sections in presence of amniotic fluid * presence of high concentrations of prostatic fluid * contamination of salvaged blood with drugs not intended for intravenous administration * use of collagen-based haemostatic agents and gel foam used in combination with any autotransfusion system * coagulopathy * not willing to sign a patient informed consent/data release form

Keywords: autolog post market release non-interventional
tezosentan in patients with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: multicenter, double-blind, randomized, placebo-controlled, cross-over study to demonstrate that a single infusion of tezosentan has minimal effect on blood pressure in patients with pulmonary arterial hypertension, treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or a combination of both.


Eligibility criteria:
inclusion criteria : 1. signed informed consent prior to initiation of any study-mandated procedure 2. male and female patients 18 years of age or older 3. patients with pah according to one of the following subgroups of the dana point classification group 1: * idiopathic, or * heritable, or * associated with connective tissue disease 4. documented hemodynamic diagnosis of pah by right heart catheterization (not part of study mandated procedures): * resting mean pulmonary arterial pressure (mpap) ≥ 25 mmhg and * resting mean pulmonary vascular resistance (pvr) ≥ 240 dyn•s•cm 5 and * pulmonary capillary wedge pressure ≤ 15 mmhg 5. modified nyha functional class ii-iii 6. patients on treatment with eras, pde-5 inhibitors or a combination of both, if used for at least 3 months prior to visit 1 and dosing kept stable for at least 28 days prior to visit 1. exclusion criteria : 1. patients with pah in dana point classification groups 2-5, and pah group 1 subgroups not covered by inclusion criterion no. 3 2. patients with sitting sbp \< 100 mmhg 3. patients with sitting dbp \< 60 mmhg 4. patients with body weight \< 50 kg (110 lbs) 5. patients with clinically significantly elevated liver enzymes (ast, alt and/or alkaline phosphatase \> 3 times upper limit) 6. patients with clinically significant chronic renal insufficiency (serum creatinine \>2.5mg/dl / 221 µmol/l) 7. patients with moderate or severe hepatic impairment (child-pugh b and c) 8. patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (e.g., treprostinil, iloprost and beraprost) within 28 days of visit 1 9. patients who have received any investigational drugs within 28 days of visit 1 10. patients who have received cyclosporine a (csa) or tacrolimus within 28 days of visit 1 11. psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with the study 12. life expectancy less than 12 months 13. females who are lactating or pregnant (positive pre-treatment pregnancy tests) (serum test at screening and urine test on visit 1 and 2) or females who are not using a reliable method of birth control (failure rate less than 1% per year) during the study and for at least one month after last administration of study drug 14. known hypersensitivity to any of the excipients of the drug formulation.
hungarian coronavirus disease-19 epidemiological research

Conditions: Coronavirus Infection

Summary: hungarian coronavirus disease-19 epidemiological research

the planned large-scale, cross-sectional, representative population screening can show the prevalence of covid-19 and the degree of infection and trans-infection in hungary after more than one month of strict restriction. in addition, it can have an impact on further actions, and we can track the impact of the decisions we make by repeating the screenings.

Eligibility criteria:
inclusion criteria: * hungarian male or female patients aged 14 and over who live in private households * inactivated social security number does not infer the exclusion of the study exclusion criteria: * patients under the age of 14 * patients living in institutional households

Keywords: coronavirus
optimal egm configuration for morphology discrimination

Conditions: Premature Ventricular Complexes

Summary: the study will be a prospective cohort study of 20 patients recruited from site's defibrillator clinic patient population who are followed at the site. hypothesis: among the available egm configuration options, one is better than the others for detection enhancements purposes.


Eligibility criteria:
inclusion criteria: 1. patients must already have an implanted st. jude medical dual chamber icd with a dual coil defibrillator lead. 2. patients must be willing to sign an informed consent form. 3. patients must have frequent pvcs (minimum of 30/hour) exclusion criteria: 1. known history of slow vt (under 160 bpm). 2. patients under the age of 18 years. 3. pregnant women. 4. pacemaker dependent rhythm. 5. ongoing angina pectoris. 6. current nyha class 3-4 heart failure.

Keywords: icd patients with pvcs and egm recordings
tdm-optimized teicoplanin dosing versus standard of care

Conditions: Bacterial Infections

Summary: value of tdm for teicoplanin is not well defined. in this single-center low-interventional randomized trial the investigators aim to investigate the superiority of teicoplanin tdm-optimized using model-informed-precision-dosing (mipd) of unbound concentrations versus the standard of care (dosing based on antibiotic guidelines) in target attainment.

teicoplanin is a glycopeptide antibiotic that is frequently used in the treatment of gram-positive bacterial infections. the glycopeptide antibiotic vancomycin is currently the first choice of treatment against methicillin-resistant staphylococcus aureus (mrsa), but teicoplanin is found to have a similar efficacy while showing less nephrotoxicity (4.8% vs 10.7%). vancomycin dosing is based on therapeutic drug monitoring (tdm). in contrast to vancomycin, value of tdm for teicoplanin is not as well defined. in this study the superiority of teicoplanin tdm-optimized dosing using model-informed-precision-dosing (mipd) of unbound concentrations versus the standard of care (dosing based on antibiotic guidelines) in target attainment will be investigated. the overall aim of this research is to improve antibiotic treatment with teicoplanin to allow safe and optimal treatment of glycopeptide susceptible strains and to prevent de novo development of resistance.

Eligibility criteria:
inclusion criteria: 1. the patient is admitted to the icu, haematology, gastroenterology or orthopaedics department. 2. the patient is at least 18 years old on the day of inclusion. 3. the patient is treated with teicoplanin as part of standard care. 4. the patient or a representative is willing to sign the informed consent form exclusion criteria: 1. the patient has previously participated in this study. 2. the patient receives any form of renal replacement criteria (rrt) other than cvvhd / cvvhdf. 3. expected duration of teicoplanin therapy is less than 5 days. 4. the patient is pregnant
sural flap and anterolateral thigh flap in tissue reconstruction around the ankle

Conditions: Ankle Injuries

Summary: the aim of the study is to evaluate the outcomes of coverage of soft tissue defects of leg and foot by modified sural flap versus anterolateral thigh flap

the leg and foot contain a thin subcutaneous layer and few muscles, thus the tibia and tendons can easily become exposed due to trauma. therefore leg and foot injuries are often associated with a loss of soft tissues and exposed fractures. one of the following reconstructive options are chosen: 1. the defect is allowed to heal by secondary intention. 2. the wound is closed primarily. 3. a split or full thickness skin graft and or neodermis is applied. 4. a local random flap or propeller flap is transposed or advanced. 5. a pedicled or island flap is transferred. 6. a microvascular free flap is transferred. the method of soft tissue reconstruction chosen hinges on the patient's medical condition, the surgeon's experience, the size of the wound, the vascular status of the foot and the exposed structures the skin in this region has low flexibility and the subcutaneous circulation does not allow the use of long randomized flaps, the task of finding flaps to cover bones or tendons in wounds with cutaneous loss in the legs and feet is difficult. the sural flap acts as an axial flap and has 3 sources of nutrition,the vascular plexus of the deep fascia, the medial superficial sural artery which follows the medial sural nerve and the arteries that follow the minor saphenous vein. venous return is ensured by the minor saphenous vein which may be used as a distal pedicle to provide reverse flow. sural flap has the advantages of easy and quick harvesting without sacrificing major arteries and can be done in one stage operation. in the other hand,since introduction of the anterolateral thigh flap in 1984 by song et al it has gained widespread popularity, especially in asian countries, where it has replaced the radial forearm flap as being the workhorse in head and neck surgery. anterolateral thigh flaps have been introduced also in lower extremity reconstruction.

Eligibility criteria:
inclusion criteria: * • patients aging 5 to 70 years. * defect at the lower leg ,ankle or foot * palpable distal pulse exclusion criteria: * • peripheral vascular disease * underling bone osteomyelitis * unhealthy skin of posterior or lateral aspect of leg. * vascular injury. * patients with chronic diseases * patients associated with vital organ injuries * patients unfit to surgery
autologous bone marrow mesenchymal stem cell transplantation for chronic stroke

Conditions: Stroke

Summary: stroke is one of the leading causes of disability in the world, and stem cell - transplantation provides a promising approach for rehabilitation. the main objective of this study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.

for many stroke survivors, the best hope is a lengthy program of rehabilitation, followed by a life-long process of clinical support. however, even with rehabilitation therapy, 50% to 95% of stroke survivors remain impaired. there is thus a great need for new therapeutic developments for patients with disability after stroke, which is largely unexplored. regenerative cell-based therapies offer long-term hope for many patients with stroke, as stem cells might be possible for dead or injured neural cells to be replaced after acute stroke. in this study, the investigators will assess the safety and feasibility of intracerebral transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke. the neurological outcome will be determined after transplantation.

Eligibility criteria:
inclusion criteria: * aged 40-70 ischemia stroke or intracerebral hemorrhage patient * with stroke history of more than 3 months, less than 60 months * with stable hemiplegia condition * nihss (nih stroke scale) score of 7 or more points * patient is stable (normal respiration, afebrile, bp less than mean arterial pressure of 125 mm of hg, fasting blood sugar \<7 mg, and normal urea/electrolytes for at least 48 hours.) exclusion criteria: * patients aged less than 40 or more than 70 * lacunar infarction * history of neurological disease, head injury or psychiatric disorder with disablity * pregnant women * impaired liver function, abnormal blood coagulation, aids, hiv, combine other tumor or special condition * inaccessibility for follow up * unwillingness to provide written informed consent

Keywords: chronic ischemic stroke intracerebral hemorrhage bone marrow mesenchymal stem cell
improving primary care to prevent childhood obesity

Conditions: Overweight in Preschool Age Children; Risk of Overweight in Preschool Age Children

Summary: to determine the extent to which a clinical intervention based on the chronic care model (ccm), compared with the usual care control condition, results in a smaller age-associated increase in body mass index (bmi) over a 1 year intervention (primary outcome) and a 1 1/2-year follow-up period.

overweight in the preschool age group is prevalent, increasing, and of consequence. during the last 30 years in the u.s., the prevalence of overweight among youth has dramatically increased. overweight in young children is associated with later overweight, with childhood conditions such as hyperlipidemia, hypertension, and type ii diabetes, and with higher morbidity and mortality in adulthood. along with the long-term risks associated with overweight in the preschool age group, there come unique opportunities to intervene and alter the subsequent course of health and disease for these individuals. these regular visits allow both detection of elevated bmi levels and opportunities for intervention. the overall goal of this research is to assess a comprehensive, innovative, primary care practice change intervention to prevent obesity among children age 2 through 5 years at elevated risk of obesity. to achieve this goal, we will conduct a cluster-randomized controlled trial in 10 pediatric practices of harvard vanguard medical associates, a large multi-site group practice in eastern massachusetts with a track record of research collaboration. we will randomize five health centers to the intervention condition, and five health centers to the control (usual care) condition. the intervention will consist of state-of-the-science approaches to changing dietary, activity, and inactivity behaviors among the children. the intervention period will be 1 year, followed by a 1 1/2 year maintenance follow-up period. frequency of visits will be every 6 weeks for the first 6 months, and every 6 months after that. participating families will complete a telephone-administered interview at baseline and all follow-up timepoints. there will be 3 types of measurements: 1) measurements made by the clinical staff that will also be used for outcomes in the research study (only height and weight); 2) measurements made by clinicians for feedback during counseling sessions, which will not be used for study outcomes; and 3) measurements made by the research staff for study outcomes and processes.

Eligibility criteria:
inclusion criteria: * age 2.0 through 5.9 years receiving primary care in a multi-site group practice * bmi \> 95th percentile for age and sex, or 85th - 95th percentile if at least one parent is overweight exclusion criteria: * child currently enrolled in a formal weight management program * child is in foster care * chronic conditions that may limit our ability to measure height and weight or that may interfere with their growth, physical activity, or dietary recommendations

Keywords: chronic care model obesity overweight children body mass index primary care
effect of preoperative exercise on postoperative outcome in aaa patients: pilot study

Conditions: Aortic Aneurysm, Abdominal; Surgery

Summary: basic animal research has demonstrated that exercise training can protect the myocardium from ischemia-reperfusion injury through several biological mechanisms . this effect of exercise training may be beneficial in the perioperative period when cardiac complications may arise. however, exercise induced cardioprotection is lost completely within 18 days of stopping the training program. this finding from animal research will be used to test the hypothesis that 3 days of consecutive exercise with the last bout conducted within the last 24/48 hours prior to surgery, will have a cardioprotective effect . specifically, exercise has been shown to protect cardiac myocytes against reperfusion induced oxidative stress and mitochondria against reperfusion induced damage. this exercise mediated cardioprotection is observed in short moderate duration ischemia (i.e. 5-20 min) and moderate to severe (i.e.20-60 min) ischemic insults. the effects of exercise induced cardioprotection have only been investigated at cell level and it has not been shown whether this will translate into a reduction in postsurgical reperfusion injury and associated complications. to study this potential cardioprotective effect the investigators will aim to recruit patients who have a high risk of receiving reperfusion injury during surgery. specifically, the investigators will recruit abdominal aortic aneurysm patients where the risk of heart complications is high. there is also currently no evidence in the published literature with regard to the effect of preoperative supervised exercise.


Eligibility criteria:
inclusion criteria: * patients aged \>18 years of age. * patients able to give informed consent. * able to comply with the study protocol * patients undergoing open repair for an asymptomatic perirenal and infrarenal abdominal aortic aneurysm exclusion criteria: * patients with severe disabling disorders limiting mobility, e.g. severe osteoarthritis * patients undergoing thoracoabdominal aneurysm surgery * patients physically unable or unwilling to undertake maximal cardiopulmonary exercise testing and the other fitness tests * patients younger than 18 years of age.
study of the efficience of chewing-gum to reduce the duration of postoperative ileus

Conditions: Postoperative Ileus

Summary: postoperative ileus (poi) is a serious complication after surgery. while it complicates all type of surgery, it is more frequent after abdominal surgery (especially bowel or colorectal surgery). many studies aim to reduce the occurence of poi without efficiency. the aim of this study is to assess the efficiency of the vagal stimulation, by the mean of chewing, to reduce the duration of poi.


Eligibility criteria:
inclusion criteria: * patients undergoing colorectal surgery or small bowel surgery * elective or in emergency * open surgery or laparoscopy * diagnosis of poi * indication of fasting or nasogastric tube placement exclusion criteria: * contra-indication of chewing * pregnancy