Kornimate/medical-research-clean huggingface dataset:
phmb-based antiseptic use in full-thickness surgical wounds

Conditions: Surgical Site Infections

Summary: to study the effect of applying a phmb-based antiseptic solution to tie-over dressings in full-thickness surgical wounds in dermatologic surgery in order to minimise the development of surgical site infections. the bacterial dynamics in wounds pre-,intra-, and postoperatively will be examined in order to understand the pathogenesis of surgical site infections better.

40 patients with suspected skin cancer in the face planned for full-thickness surgery will be randomised into two groups: one will receive a traditional tie-over dressing saturated with nacl and the other group will receive a tie-over dressing saturated with a phmb-based antiseptic. a quantitative and qualitative bacterial analysis of wounds by using a modified levine's swabbing technique will be carried out pre-,intra-,and postoperatively. the effect of nasal colonisation with s.aureus on the development of surgical site infections will be investigated. all wounds will be followed a week after surgery to assess development of infections.

Eligibility criteria:
inclusion criteria: * patients planned for full-thickness skin grafting in the face exclusion criteria: * patients with no diabetes * patients with no current/previous/recent antibiotic therapy
effects of prebiotic supplementation and exercise on inflammatory markers, vascular function and cognition in ckd

Conditions: Chronic Kidney Diseases

Summary: the study is primarily designed to examine the effect of 16 weeks of prebiotic supplementation (resistant starch)and moderate intensity aerobic training on markers of inflammation in stage 3-4 patients with chronic kidney disease.

the primary aim of the proposed study is to determine whether the consumption of a prebiotic supplement (resistant starch) coupled with moderate intensity endurance training over 16 weeks leads to reductions in key inflammatory markers in stage 3-4 predialysis ckd patients and whether this reduction is associated with favorable changes in vascular function and indicators of stress and emotional reactivity. the investigators hypothesize that supplementation with the prebiotic (resistant starch) will lead to normalization of the microbiome of our sample of patients with chronic kidney disease (ckd) and reduce key markers of inflammation. reductions in these biomarkers will be associated with favorable changes in cardiovascular variables along with indices of stress and emotional reactivity. moderate intensity aerobic training will have an additive anti-inflammatory effect along with the consumption of the resistant starch.

Eligibility criteria:
inclusion criteria: * stage 3-4 of ckd (gfr 15-59 ml/min/1.73m2), * ages of 30-75 years old, * must be capable of complying with and following the study protocol(diet and exercise) * must be capable of independently giving informed consent exclusion criteria: * kidney transplant * currently in a structured exercise program * on antibiotic therapy within the last month * on a probiotic or prebiotic supplement within the last month * a gi disorder that prohibits the use of resistant starch (ie. high-amylose corn starch, which resists digestion * hiv positive * gastric by-pass surgery * clostridium difficile * marijuana user * lupus * rheumatoid arthritis * hepatitis c * post-traumatic stress disorder * deep vein thrombosis * pancreatitis

Keywords: microbiome inflammation resistant starch exercise training
evolution® revision stemmed cs post market clinical follow-up study protocol

Conditions: Joint Diseases

Summary: microport (mpo) is conducting this pmcf study to evaluate the safety and effectiveness of its evolution® revision tibial system and evolution® revision stemmed cs femur with the evolution® mp cs tibial insert. this type of study is required by regulatory authorities for all devices that have been approved in europe to evaluate the medium and long-term clinical evidence.

the primary objective of this study is to estimate individual component survivorship for tibial base, femoral component, and tibial insert at specified intervals out to 10 years follow-up. the secondary objectives include: * determine the cumulative incidence of individual component revision at specified intervals out to 10 years follow-up; * characterize functional scores for subjects, as assessed by koos scores and eq-5d-5l scores, out to 10 years follow-up; * to assess subject satisfaction with their tka procedure using the forgotten joint score and a satisfaction survey; * to assess the presence, zone, and the size of radiolucencies surrounding implanted components out to 10 years follow-up; * to assess safety and characterize protocol defined adverse events and adverse device effects.

Eligibility criteria:
inclusion criteria: 1. has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires implantation of the components under study (evolution® revision tibial system and evolution® stemmed cs femur with the evolution® mp cs tibial insert) 2. decision to perform the study index surgery with the required study components is pre-determined regardless of the research; 3. previously implanted subjects must be enrolled within 3 years (+ 6 months) of their study index surgery 4. willing to voluntarily sign the informed consent form 5. willing and able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol through the 10-year postoperative follow-up visit. exclusion criteria: 1. skeletally immature (less than 21 years of age) at time of implantation 2. has or had an overt infection at the time of implantation 3. has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable 4. currently enrolled in another clinical investigation which could affect the endpoints of this protocol 5. has or had documented substance abuse issues 6. has or had an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study 7. currently incarcerated or has impending incarceration 8. has a medical condition, as judged by the investigator, that would interfere with the subject's ability to comply with the requirements of the protocol

Keywords: knee osteoarthritis revision procedure knee arthroplasty
a study of non-invasive measurement of blood glucose and blood pressure

Conditions: Diabetes

Summary: the purpose of this research is to compare blood glucose, blood pressure and electrocardiogram (ecg) readings on the lifeleaf smartwatch compared to standard methods of measurement.


Eligibility criteria:
inclusion criteria: * diabetic patients on insulin undergoing four times daily blood sugar checks as part of standard of care. * patients undergoing continuous monitoring for heart rate and blood pressure as part of their routine care. * patients undergoing catheter ablation for atrial fibrillation. exclusion criteria: * patients unable to provide informed consent. * patients without arms as these are needed to wear the wrist-based sensor.
effects of glimepiride on recovery from hypoglycemia in participants with type 2 diabetes mellitus (mk-0000-253)

Conditions: Type 2 Diabetes Mellitus

Summary: this study aims to assess how glimepiride affects the recovery from hypoglycemia in participants with type 2 diabetes mellitus. the primary objective is to estimate the time taken by participants to recover from hypoglycemia to euglycemia after treatment with either 2 mg or 4 mg of glimepiride when compared to placebo.


Eligibility criteria:
inclusion criteria: * has clinically confirmed diagnosis of type 2 diabetes mellitus (t2dm) controlled by diet and exercise alone, or treated by metformin only with same dose for \>= 12 weeks prior to screening visit. * females of reproductive potential who demonstrate nongravid state, agree to use (and/or have partner use) two acceptable methods of birth control starting at least two weeks prior to study, throughout study, and at least two weeks after last dose of study drug. * females of non-reproductive potential, post menopausal, status post hysterectomy, oophorectomy or tubal ligation. * is in good health, other than t2dm. * has been a nonsmoker and/or non user of nicotine-containing products for the previous 6 months. if discontinued use for previous 3 months, may be enrolled at investigator's discretion. * will follow american heart association weight maintaining diet and exercise program or equivalent beginning 2 weeks prior to study until poststudy visit. * at screening visit has a body mass index (bmi) =\< 40 kg/m\^2. * at screening visit has a hemoglobin a1c (hba1c) of \>= 7% and \< 10% (+/- 0.1%). * on the morning of randomization at predose has fasting plasma glucose (fpg) \>= 126 mg/dl, and =\< 250 mg/dl. exclusion criteria: * has a history of stroke, chronic seizures, or major neurological disorder. * has a history of any illness that might confound the results of the study or pose additional risk to the participant. * has a history of type 1 diabetes mellitus, ketoacidosis, c-peptide =\< 0.8 ng/ml, secondary forms of diabetes or diabetic complications. * has a history of neoplastic disease. * is a nursing mother. * has been treated =\< one year of screening visit with sulfonylurea agents, meglitinides, dipeptidyl peptidase-4 (dpp-4) inhibitors, glucagon-like peptide-1 (glp-1) analogs, or insulin. * has received treatment within =\< 12 weeks of screening visit with a peroxisome proliferator-activated receptor γ (pparγ) agonist. * is taking medications for a co-morbid condition or anticipates taking new medications beginning 2 weeks prior to study. * consumes excessive amounts of alcohol or caffeinated beverages. * is a regular user of illicit drugs, or has a history of drug abuse within the previous 6 months. * has had major surgery, lost 500 ml of blood, or participated in another investigational study within 4 weeks prior to screening visit. * is on a weight loss program, but not in the maintenance phase, or treated with a weight loss medication within 8 weeks of prestudy visit. * has a history of severe allergies, anaphylactic reaction or intolerability to drugs, food, insulin, glimepiride or sulfonamide derivatives.
therapeutic drug monitoring of anti-infectious drugs in intensive care unit

Conditions: Infection, Bacterial

Summary: this research targets four anti-infectives commonly prescribed in intensive care: ceftazidime, cefepime, cefotaxime and meropenem, used for severe infections for patient hospitalized in intensive care unit , there is little or no pharmacokinetic data for these four molecules.

antibiotics, and especially beta-lactams, are among the most used drugs in the world. the good use of antibiotics and the prevention of selection of resistant strains has been a public health priority for many years. in this context, it is essential to obtain effective antibiotic concentrations at the site of infection. in order to obtain effective concentrations, ceftazidime, cefepime, cefotaxime, piperacillin and meropenem are administered in this population by continuous infusion at high dose. although beta-lactams are mostly well tolerated, they can cause adverse effects such as severe neurological toxicities. the critically ill patient has physiological alterations that can significantly alter the pharmacokinetics of drugs. several studies have clearly shown that the pharmacokinetics of beta-lactams in the critically ill patient is different from those of other patients. depending on the clinical context and the co-morbidities of the patient, sub-therapeutic or potentially toxic concentrations can be observed for the same dosage. the risk of ineffective treatment and the development of resistance remains, despite the high doses administered. in addition, this pharmacokinetic variability may be responsible for the observation of toxic concentrations and the occurrence of adverse effects in this population. following these arguments, therapeutic drug monitoring (tdm) of beta-lactams accompanied by personalized dosage adjustment appears to be an essential tool to optimize the management of critically ill patients. although strongly recommended, the tdm of beta-lactams in the critically ill patient accompanied by a dosage adjustment is not currently performed systematically in all patients. the objective of this study is to evaluate the impact of the use of a systematic therapeutic drug monitoring of beta-lactams in the critically ill treated with cefotaxime, ceftazidime, cefepime, meropenem or piperacillin, in terms of efficacy and prevention of neurotoxicity.

Eligibility criteria:
inclusion criteria: * adult patient (age\> 18 years) * patient hospitalized in intensive care for a duration greater than 7 days, treated with cefotaxime, ceftazidime, cefepime, piperacillin or meropenem according to a standardized dosing regimen. exclusion criteria: * age \<18 * pregnant woman * patient allergic to beta-lactams * no written informed consent by the patient or his/her (legal) representative
a study to assess adjuvant immunotherapy with nivolumab plus relatlimab versus nivolumab alone after complete resection of stage iii-iv melanoma

Conditions: Melanoma

Summary: the purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (fdc) versus nivolumab alone in participants with completely resected stage iii-iv melanoma.


Eligibility criteria:
inclusion criteria: * must have been diagnosed with either stage iiia (\> 1 mm tumor in lymph node)/b/c/d or stage iv melanoma by american joint committee on cancer (ajcc) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible * participants ≥ 18 years of age must have an eastern cooperative oncology group (ecog) performance status of ≤ 1. adolescent participants between 12 and \< 18 years of age must have a lansky/karnofsky performance score ≥ 80% * complete resection must be performed within 90 days prior to randomization * all participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization * tumor tissue must be provided for biomarker analyses exclusion criteria: * history of ocular melanoma * untreated/unresected cns metastases or leptomeningeal metastases * active, known, or suspected autoimmune disease * participants with serious or uncontrolled medical disorder * prior immunotherapy treatment for any prior malignancy: no prior immunotherapies are permitted * severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection within 4 weeks prior to screening * history of myocarditis, regardless of etiology. other protocol-defined inclusion/exclusion criteria apply

Keywords: melanoma relatlimab nivolumab opdivo
regadenoson r-t perfusion imaging trial

Conditions: Coronary Artery Disease; Myocardial Perfusion Abnormalities

Summary: to exam the feasibility and accuracy of regadenoson real time perfusion (rtpe) imaging during vasodilator stress with regadenoson for detection of significant coronary artery disease (cad) in patients scheduled to undergo coronary angiography.

to exam the feasibility and accuracy of rtpe during vasodilator stress with 400micrograms of the adenosine receptor (a2a) agonist regadenoson for detection of significant coronary artery disease (cad) in patients scheduled to undergo coronary angiography. sensitivity, specificity , and accuracy of perfusion and wall motion analysis to identify a coronary stenosis\> 50% in diameter by quantitive angiography will be analyzed

Eligibility criteria:
inclusion criteria: * male or female. age ≥30 years. * resting left ventricular ejection fraction \> 40% using simpson's biplane measurement. * scheduled for coronary angiography within 30 days of the regadenoson stress test. * negative urine pregnancy test within 2 hours of ultrasound contrast administration required of females of childbearing age unless post-menopausal or with evidence of surgical sterilization. * be conscious and coherent, and able to communicate effectively with trial personnel. * agreeable to undergo the additional stress test and coronary angiography * have at least an intermediate likelihood of coronary disease based on the following clinical profile * good apical echo images with at least 50% of each coronary artery territory well visualized. exclusion criteria: * known or suspected hypersensitivity to ultrasound contrast agent used for the study. * pregnancy or lactation. * complicated hemodynamic instability (i.e., new york heart association (nyha) class iv heart failure, unstable angina at rest despite medical therapy). * life expectancy of less than two months or terminally ill. * congestive (idiopathic) or hypertrophic cardiomyopathy. * known left main disease. * heart transplant recipient, hypertrophic cardiomyopathy, acute myo- or pericarditis. * resting left ventricular ejection fraction \< 40% * large inducible perfusion defects or wall motion abnormalities during prior stress imaging study associated with left ventricular cavity dilatation. * early positive treadmill ekg within the first stage of the test. * history of \>1st degree heart block, sick sinus syndrome or high grade atrioventricular (av) block without a pacemaker. * dipyridamole use within 30 hours of stress test, or consumption of methylxanthines within 12 hours, or use of sublingual nitroglycerin within two hours. * participation in another investigational study within one month of this study.

Keywords: stress echocardiography spect myocardial perfusion imaging
effect of allopregnanolone on stress-induced craving

Conditions: Alcohol Use Disorder

Summary: the goal of this study is to determine whether intravenous infusion of allopregnanolone (allo) attenuates stress-induced craving and stress-induced anxiety in a clinical laboratory setting. the secondary objective of this project is to characterize the behavioral effects of allo in heavy drinkers.

this is a double-blind, placebo-controlled study that will randomize 60 heavy "at risk" drinkers to 2 groups: targeted dose of targeted dose of 100 nm of allo (n=30) or placebo (n=30). participants will receive a continuous infusion of allo (or placebo) for 175 min. sixty min. after the start of the infusion, when allo levels are relatively stable, the stress induction paradigm will be introduced. participants will be presented with a stress cue and a neutral cue in random order. stress and neutral cues will consist of personalized 5 min. scripts created prior to testing. measures of stress-induced craving and stress-induced anxiety will be presented before the cue (pre), immediately following the cue (post) and 10 min after (recovery).the study outcomes will include measures of stress-induced craving and stress-induced anxiety as well as measures of subjective mood effects, cognitive performance, and motor coordination.

Eligibility criteria:
inclusion criteria: * non-treatment seeking individuals with current dsm-5 aud * no current substance use disorder (except tobacco, alcohol, and marijuana) * no current medical problems and normal ecg * for women, not pregnant as determined by pregnancy screening, not breast feeding. exclusion criteria: * current major psychiatric illnesses including mood, psychotic, or anxiety disorders * history of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study * liver function tests (alt or ast) greater than 3 times normal * weight \>120kg * renal impairment * patients on the following medications: a) medications for alcoholism (e.g. naltrexone, disulfiram, topiramate, acamprosate); b) psychotropic medications that promote sedation (please note patients on psychotropic medications for current psychiatric conditions will also be excluded); and c) patients currently taking antibiotics or antifungals
physical activity scale in individuals with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: the aim of this study was to improve the cultural adaptation and turkish version of the the physical activity scale for individuals with physical disabilities (pasipd) and to investigate the validity and reliability of the turkish version of pasipd in individuals with spinal cord injury. pasipd, which consists of 13 questions, will be adapted to turkish by translation and back translation method. the study included 47 wheelchair-dependent patients over the age of 18 who were able to read and write turkish (26 females, 21 males). in order to determine the reliability and internal consistency of pasipd, item-total correlation, if item deleted cronbach alpha coefficient and cronbach alpha coefficient of the whole scale will be calculated. test-retest method will be used for the stability of the scale. in the test-retest method, the scale will be re-applied to the same people with 7-day intervals. pearson correlation analysis will be performed between the first test and the second test total and sub-parameters after 1 week. test-retest reliability will be determined using the intraclass correlation coefficient (icc). in the validity test of pasipd; construct validity and criterion validity will be used. test of construct validity; factor analysis and convergent and discriminant validity methods. the barthel index of activities of daily living and functional independence measure (fim); world health organization quality of life scale abbreviated version (whoqol-bref), nottingham health profile (nhp) and craig handicap assessment and reporting technique (chart-sf) will be used to convergent and discriminant validity. manual wheelchair propulsion tests will be used to demonstrate criterion validity.


Eligibility criteria:
inclusion criteria: * classified as group a, b, c or d according to american spinal injury association (diagnosed with spinal cord injury), * fully or partially wheelchair dependent * over 18 years old * willing to research, * can read and write and read and write in turkish * patients without cognitive impairment. * having the upper extremity muscle strength required for wheelchair use exclusion criteria: * reluctant and unwilling to research, * having any progressive discomfort * bed dependent, * patients with severe cognitive impairment.