Kornimate/medical-research-clean huggingface dataset:
the effect of high-flux hemodialysis and on-line hemodiafiltration on endothelial function.

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

Summary: the main aim of this project is to evaluate, in patients with chronic kidney disease (ckd5d), the role of adhesion molecules in leukocyte adhesion and transendothelial migration involved in atherogenesis. this trial is a prospective randomized crossover study in ckd5d hemodialysis patients followed in the nephrology unit of the reina sofia university hospital (cordoba, spain). the estimated inclusion period is two years, with a follow-up of 24 months. patients will be randomized to high-flux hemodialysis versus online hemodiafiltration with high convective transport (above 21 liters); after 6 months in each dialysis modality they will be switched the other technique for another 6 months. then, patients will be maintained during 4 weeks in conventional hemodialysis "wash out period", before being started in the other dialysis modality.

the main aim of this project is to evaluate, in patients with chronic kidney disease (ckd5d), the role of adhesion molecules in leukocyte adhesion and transendothelial migration involved in atherogenesis. this trial is a prospective randomized crossover study in ckd5d hemodialysis patients followed in the nephrology unit of the reina sofia university hospital (cordoba, spain). the estimated inclusion period is two years, with a follow-up of 24 months. patients will be randomized to high-flux hemodialysis versus online hemodiafiltration with high convective transport (above 21 liters); after 6 months in each dialysis modality they will be switched the other technique for another 6 months. then, patients will be maintained during 4 weeks in conventional hemodialysis "wash out period", before being started in the other dialysis modality. patients will be stratified by age, gender and the presence of diabetes. routine analytical determinations (urea, creatinine, sodium, potassium, chlorine, total co2, calcium, phosphorus, fa, pth, levels 25oh, β2m, alt, hemoglobin, leukocytes, platelets, glucose, uric acid, total proteins, albumin , pcr, il-6, ferritin, tsat and homocysteine), characteristics of hemodialysis and dialysis dose (kt / v and kt) will be recorded. residual renal function will be analysed every three months. in plasma, micrornas profile and fgf23 levels will be determined. markers of endothelial dysfunction (cd31 +, cd41-, cd144, cd62e) and subclinical atherosclerosis markers (cd11b, cd41 +) will be measured. the hospitalization and mortality rate due to cardiovascular causes and concurrent cardiovascular events throughout the study (acute myocardial infarction, stroke, transient ischemic attack and peripheral vascular disease) will be assessed along the study period.

Eligibility criteria:
inclusion criteria: * vascular access with a blood flow \> 300ml/min * age \>18 \<80 years written informed consent exclusion criteria: * neoplasia * b hepatitis * acute or chronic inflammation life expectance less than one year included in living donor transplant list immunosupressive drugs

Keywords: hemodialysis endothelial dysfunction atherogenesis
disposable versus reusable drapes and gowns for green operating theatres

Conditions: Surgical Site Infection

Summary: multicentre non-inferiority cluster randomised trial testing disposable versus reusable drapes and gowns for green operating theatres. a pragmatic 1:1 international multi-centre non-inferiority cluster randomised controlled trial, with an internal pilot. clusters are individual hospitals.

background: the world health organisation makes no recommendation for the use of disposable or reusable surgical drapes and gowns due to a lack of effectiveness evidence. since disposable versions are likely to have higher financial and carbon costs, they are only justifiable if they can be proven to significantly reduce surgical site infections (ssis). aim: this randomised controlled trial will assess whether reusable surgical drapes and gowns are non-inferior in reducing ssi compared to disposable drapes and gowns in patients undergoing surgery. design: pragmatic 1:1 international multi-centre non-inferiority cluster randomised controlled trial, with an internal pilot. clusters are individual hospitals. intervention: reusable surgical drapes and gowns. comparator: disposable (single-use) surgical drapes and gowns. sample size: the control group ssi event rate is estimated to be 12.5% based on previous literature. to determine whether reusable drapes and gowns are non-inferior to disposable drapes and gowns with a non-inferiority margin of 2.5% would require a total of 26,800 participants from 134 clusters, with an average of 200 participants per cluster, assuming 90% power, 2.5% one-sided alpha, intraclass correlation of 0.01 and 5% participant loss to follow up.

Eligibility criteria:
inclusion criteria: * patients with at least one incision that is ≥5cm in adults and ≥3cm in children aged under 16 years. this can include both open and minimally-invasive surgery providing at least one incision meets this criteria. * patients with a clean-contaminated, contaminated, or dirty surgical wound. definitions of contamination are given in table 2. * patients undergoing emergency (surgery on an unplanned admission) or elective (surgery on a planned admission) surgery. * any operative indication (including caesarean section). * patients aged 10 or over. exclusion criteria * adults with an incision \<5 cm and incision \<3cm in children aged under 16 years. * patients undergoing procedures with a clean surgical wound only.

Keywords: surgery global surgery ssi surgical site infection
riluzole effects on hippocampus biomarkers

Conditions: Posttraumatic Stress Disorder

Summary: to examine the clinical efficacy of the anti-glutamatergic medication riluzole in posttraumatic stress disorder (ptsd), and its effect on hippocampus biomarkers that our laboratory previously has identified using mrs.


Eligibility criteria:
inclusion criteria: 1. male or female age 18-65. 2. right handed 3. able to provide written informed consent. 4. meets dsm-5 criteria for ptsd (current month and past 3 months). 5. if already receiving psychiatric intervention(s), must be on a stable regimen. 6. has normal physical examination, laboratory test results, and electrocardiogram results at pre-treatment visit. exclusion criteria: 1. unwillingness or inability to provide written informed consent. 2. unable to swallow pills. 3. unable to tolerate blood draws. 4. currently enrolled in another intervention study. 5. imminent risk for self-harm (assessed by a licensed clinician) 6. active psychotic symptoms. 7. current panic disorder. 8. lifetime history of schizophrenia spectrum disorder, bipolar disorder, obsessive compulsive disorder, anorexia nervosa, seizure disorder, or neurologic disorder. 9. urine toxicology positive for drug(s) of abuse. 10. evidence of any clinically significant medical disease. 11. women who test positive for ß-hcg, self-report as pregnant, or are nursing. 12. substance or alcohol abuse within 3 months of visit 1. substance or alcohol dependence within 6 months of visit 1. 13. excessive caffeine use, defined as regular consumption of \>700mg caffeine per day. 14. treatment with an antipsychotic, valproate, other anticonvulsant, reversible maoi within 4 weeks of visit 1. other excluded medications will be those with (1) known glutamatergic effects, (2) previous mrs evidence of effects on brain glutamate, (3) potential effects on riluzole levels or (4) risk of neutropenia - used within 4 weeks of the first study visit. 15. previous exposure to riluzole or ketamine. 16. treatment with any investigational medicine within 30 days of visit 1. 17. treatment with electroconvulsive therapy (ect) within 3 months of visit 1. 18. uncorrected thyroid disease. 19. any screening laboratory assay that is deemed to be a clinically significant abnormality by the investigator, with the exception of liver function tests (ast, alt, alkaline phosphatase), which must be within 1.5 times the upper limit of normal. 20. any contraindications to having an mri scan.
a study to evaluate the safety and efficacy of an oxalate strip on adjacent teeth with dentinal hypersensitivity

Conditions: Dentin Sensitivity

Summary: this study will compare the safety and effectiveness of a potassium oxalate desensitizer on adjacent teeth with dentinal hypersensitivity.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age * sign an informed consent form and be given a copy * be in good general health as determined by the investigator/designee * have at least one pair of adjacent teeth, each of which has a screening score of - -greater than or equal to 1 on the schiff sensitivity scale in response to the cold water challenge. exclusion criteria: * severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession * active treatment for periodontitis * any diseases or conditions that might interfere with the subject safely completing the study * inability to undergo study procedures * fixed facial orthodontic appliances * self-reported pregnancy or nursing * a history of kidney stones * known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate.

Keywords: sensitivity
the notice study: neurosurgery and orthopedics communication evaluation study following lumbar fusions

Conditions: Lumbar Spine Degeneration; Lumbar Spine Instability; Lumbar Spondylosis

Summary: the purpose of this single-blind, randomized, controlled study is to assess the efficacy of "informative text messages" vs "traditional handouts" provided to lumbar spine surgery patients post-operatively.

a total of 224 adult patients (18 years or older) undergoing spinal fusion surgery at duke university hospital, will be recruited from the duke department of neurosurgery and the duke department of orthopedics. participants will be consented and will complete standard of care outcomes questionnaires (visual analogue scale, oswestry disability index and euro-quol 5d) at the pre-operative clinic visit for baseline comparison. participants will be randomized, through redcap, with equal probability to either: a) the control group, with standard post-surgery handouts, or b) the experimental group, which will receive text messages for a period of 2 weeks after surgery (daily for the first week, and every other day for the second week). text messages were designed to be standardized and automated, with an embedded link to a video regarding at-home, post-surgery-care instructions. patients will be directed not to respond to the text messages, but to call for any questions or concerns. the primary outcome will be a reduction in 30-days post-surgery readmission rates. the secondary outcomes will be a reduction in 30-days post-surgery ed visits rates, back and leg pain scores, and anxiety levels. these outcomes will be assessed via a phone interview at 30-days (up to max of 37 days) post-discharge for both groups.

Eligibility criteria:
inclusion criteria: 1. primary lumbar fusion 1-4 levels 2. 18 years or older 3. degenerative spine diagnosis 4. answers yes to all the following screening questions: * do you own a mobile phone that is capable of sending and receiving text messages? * do you know how to text and feel comfortable texting? * are you a regular (at least once a day) text-message user? * are you agreeable to regular contact? exclusion criteria: 1. prior lumbar fusions 2. tumors/infection/trauma 3. prisoners or institutionalized patients 4. non-english speaking patients 5. patients who smokes or with uncontrolled diabetes 6. participants will be removed from study if discharged to a rehabilitation center or discharged beyond 7 days post-operatively (we are expecting \~15% of patients to be discharged to a rehabilitation center or discharged beyond 7 days post-operatively)

Keywords: lumbar fusion text message
remission rates of new type 2 diabetes with weight loss and exercise

Conditions: Type 2 Diabetes Mellitus

Summary: this is a study of the effects of weight loss and exercise training on glucose control as measured by the hemoglobin a 1 c in individuals with recently diagnosed type 2 diabetes. study outcomes are measured at 6 months. the primary outcome is the hba1c at 6-months. secondary outcomes include body weight, fitness, lipid profiles and hs-crp, a measure of inflammation. the study hypothesis is that the program of weight loss and exercise will put \>50% of individuals into "remission" of their type 2 diabetes as measured by a hba1c of \< 6.5%.

this is a study of the effects of weight loss and exercise training on glucose control as measured by the hemoglobin a 1 c in individuals with recently diagnosed type 2 diabetes. study outcomes are measured at 6 months. the primary outcome is the hba1c at 6-months. secondary outcomes include body weight, fitness, lipid profiles and hs-crp, a measure of inflammation. the study hypothesis is that the program of weight loss and exercise will put \>50% of individuals into "remission" of their type 2 diabetes as measured by a hba1c of \< 6.5%. the study replicates the clinical situation where selected patients with new type 2 diabetes, who are motivated to try an intensive lifestyle intervention, might replicate our study intervention if we are able to show a high remission rate (e.g. \> 50%) for individuals in the study.

Eligibility criteria:
inclusion criteria: * new diagnosis of type 2 diabetes since 12 months * bmi\>27 * hba1c \> 6.5, , 8.0 exclusion criteria: * hba1c \>8.0 * bmi\< 27

Keywords: type 2 diabetes mellitus behavioral weight loss exercise training hemoglobin a1c
effect of oral melatonin on postoperative analgesia after thoracotomy in infants

Conditions: Postoperative Pain

Summary: thoracotomy pain is one of the severest pain that should be taken seriously, especially in children. (1) inadequate postoperative pain management can compromise respiratory function, delay postoperative extubation, increase the cost and delay hospital discharge. opioids are the most commonly used analgesics to manage postoperative pain; however, they have many possible unfavorable side effects, such as nausea, vomiting, pruritus, and respiratory depression. (3) melatonin is an endogenous indoleamine secreted by the pineal gland. it has several important physiological functions, including regulation of the circadian rhythms, modulation of season changes, antioxidant, anti-inflammatory, and anticonvulsant effects. (4)

the analgesic effect of melatonin may be referred to as gi-coupled melatonin receptors, to gi-coupled opioid-l-receptors or gamma-aminobutyric acid (gaba) receptors with a consequential reduction in anxiety and pain. (5) gitto and co-workers(6) hypothesized that melatonin may have beneficial effects as an analgesic effect in preterm newborns that are subject to painful procedures, such as endotracheal intubation and mechanical ventilation without detected side effects. pro-inflammatory and anti-inflammatory cytokines related to pain were more in the common sedation and analgesia group than in melatonin-treated infants suggesting the use of melatonin as an adjunct analgesic therapy during procedural pain. (6) therefore melatonin may be a useful perioperative drug as it does not have any known undesirable serious adverse effects. (7) to the best of investigators' knowledge, this is the first study investigating the effect of melatonin on postoperative pain scores after thoracotomy in infants.

Eligibility criteria:
inclusion criteria: * american society of anesthesiology( asa) i, ii * less than 18months. * males and females. * scheduled for thoracotomy for closed cardiac surgery. exclusion criteria: * airway abnormalities. * heart failure. * endocrine disorders. * patients with hypersensitivity to any drug. * beta blockers, any analgesics recieved within 24 h before surgery, or any psychotropic drugs. * hepatic, renal diseases neuromuscular disease, * coagulopathy. * a history of hyperthermia. * infection at the site of the block.
approaches to foot complication prevention: a survey of diabetes educators

Conditions: Foot Ulcer, Diabetic

Summary: the purpose of the survey is to assess the knowledge base, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.

podimetrics is a care management company with a temperature-based foot monitoring solution to help prevent diabetic foot ulcers, one of the most debilitating and costly complications of diabetes. diabetes educators within the aade/adces encompass a wide array of medical disciplines including nurses, physicians, dieticians, and pharmacists. diabetes researchers want to better understand the degree to which diabetic foot care and prevention is incorporated into the diabetes education curriculum. to what extent are these topics discussed between diabetes educators and the patients they interact with? and how comfortable are educators in discussing these topics? to gain insight into these questions podimetrics researchers have designed an online questionnaire survey for completion by aade members. the general purpose of the survey is to assess the knowledge base, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings. the specific aim is to collect generalizable data to characterize the current state of diabetic foot education and identify any gaps in knowledge that may be present. furthermore, if it is found that educators are lacking important knowledge which supports ample diabetic foot health education, approaches to bridge these gaps may be suggested through published recommendations.

Eligibility criteria:
inclusion criteria: * american association of diabetes educators (aade) member with accurate email address on file with the aade. exclusion criteria: * aade member with an inability to read english.

Keywords: diabetic foot ulcer care recommendation foot diseases diabetic neuropathies diabetes education diabetes diabetes educator diabetes mellitus diabetes complication care and treatment
parent partnership project

Conditions: Childhood Obesity

Summary: to evaluate the acceptability and feasibility of peers as interventionists in delivering family-based behavioral pediatric weight control intervention.

a new model of delivering family-based pediatric overweight treatment that decreases costs but sustains short- and long-term efficacy is needed. one possible opportunity for this is a peer intervention model in which families receiving professionally-led intervention then subsequently providing intervention to other families. in addition, peer interventionists' continued engagement in the behavior change process through providing intervention to others could improve their own long-term efficacy. the project begins with the standard approach of having professional interventionists provide family-based behavioral pediatric overweight treatment to overweight children and their parent (1st generation families; n=30). subsequently, half of 1st generation families will be randomly assigned to serve as peer interventionists to other overweight parents and children (2nd generation families; n=30). the remaining 1st generation families will neither receive nor provide any additional treatment. this project aims to develop the peer intervention training and delivery and then to examine the feasibility and acceptability of the peer intervention. this project also aims to derive an estimate of the efficacy of peer intervention (receiving and providing) both at the end of receiving treatment and 6 months later, as well as the impact of providing intervention on peer interventionists' weight outcomes.

Eligibility criteria:
inclusion criteria: * child age: 7-11 years at time of enrollment * overweight child: at or above 85th percentile for age- and gender-specific bmi. * at least one overweight parent (bmi≥ 25.0). * parent is willing and able to actively participate in treatment including willingness to serve as a peer interventionist following treatment. * must live within 50 miles of the treatment center. exclusion criteria: * current enrollment in another weight control program for the participating child or parent. * the participating parent is pregnant. * thought disorder, suicidality, or substance abuse disorder in either the participating parent or the participating child. * inability of the child to comprehend english at a 1st-grade level or participating parent to comprehend english at an 8th-grade level. * physical disability or illness in either the participating parent or the child that precludes moderate intensity physical activity. * medication regimen for the child that affects his or her weight. * conditions known to promote obesity in the participating child (e.g. prader-willi). * diagnosed eating disorder (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder) in either parent (participating and nonparticipating) and/or the participating child.

Keywords: childhood obesity
utilizing a multi-gene testing approach to identify hereditary pancreatic cancer

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: the primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic ductal adenocarcinoma.

the proposed research is a multi-site prospective and observational plan to investigate the prevalence of germline mutations in patients diagnosed with pancreatic cancer. thirty two genes will be analyzed, all of which have been associated with an increased risk for cancer. the genes are included on cancernexttm a multi-gene next generation sequencing and array cgh test. the 32 genes include: apc, atm, bard1, brca1, brca2, brip1, bmpr1a, cdh1, cdk4, cdkn2a, chek2, epcam, grem1, mlh1, mre11a, msh2, msh6, mutyh, nbn, nf1, palb2, pms2, pold1, pole, pten, rad50, rad51c, rad51d, smad4, smarca4, stk11, and tp53 .

Eligibility criteria:
inclusion criteria: * male and female patients between the ages of 18 and 89 years of age. * diagnosed within the previous 12 weeks with histologically or cytologically confirmed pdac stage i to iv. * ability of participant to understand and the willingness to sign a written informed consent document. * participant must agree to sample collection and genetic testing using the 32 gene test, cancernexttm and allow the test result to be part of their medical record. exclusion criteria: * diagnosed with intraductal papillary mucinous neoplasms, mucinous cystic neoplasms, pancreatic neuroendocrine tumors or dysplasia without pdac. * diagnosed with pdac more than 12 weeks before presenting to the clinical site. * patients meeting the above enrollment criteria who have had cancernext performed previously.

Keywords: germline pancreatic genetic testing