Kornimate/medical-research-clean huggingface dataset:
observational study to evaluate the epidemiology of surgical-induced acute kidney injury

Conditions: Acute Kidney Injury (AKI)

Summary: the evaluation of an accurate occurrence rate for aki is of great importance for health policy, quality initiatives as well as for designing clinical trials. the primary objective is to prospectively evaluate the incidence of aki within 72 h after extended surgical procedures that require admission to an observation unit.

acute kidney injury (aki) is a severe clinical complication with increasing incidence and is associated with adverse short- and long-term outcomes resulting in a major health care burden worldwide. the introduction of consensus classification systems has enhanced the awareness for aki. the evaluation of an accurate occurrence rate for aki is of great importance for health policy, quality initiatives as well as for designing clinical trials. however, analyzing aki from existing databases is often limited by missing data elements, especially the inclusion of the urine output criteria. missing data and the use of different definitions before the consensus classification are the reasons for large variations in reported occurrences of surgical induced aki. the primary objective is to prospectively evaluate the incidence of aki within 72 h after extended surgical procedures that require admission to an observation unit (e.g., intensive care unit, intermediate care, post anesthesia care unit) using the latest consensus definition for aki (kidney disease: improving global outcomes criteria) and a standardized data collection instrument and to assess the dependence of aki on preoperative and intraoperative factors. method: international prospective, observational, multi-center, cross-sectional cohort study eligible patients will be identified during preoperative assessment. all eligible patients will be approached to obtain written consent.

Eligibility criteria:
inclusion criteria: * major elective or emergency surgery procedures with a duration of at least 2 h * admission to the intensive care unit, intermediate care unit after surgery informed consent exclusion criteria: * preexisting acute kidney injury * acute kidney injury within the last 3 months * end stage renal disease with dialysis dependency * kidney transplant

Keywords: acute kidney injury injury surgery
multidisciplinary intervention for adults with chronic graft-versus-host disease

Conditions: Bone Marrow Transplant Complications; Graft-versus-Host Disease

Summary: the goal of this study is to demonstrate the efficacy of a multidisciplinary group-based telehealth intervention (horizons) compared to minimally enhanced usual care for improving self-management and quality of life for hematopoietic stem cell transplant (hsct) survivors living with chronic graft-versus host disease, and to identify critical facilitators and barriers for horizons implementation and adoption.

this is a randomized clinical trial to determine whether a multidisciplinary group-based telehealth intervention is effective at improving the quality of life and reducing psychosocial distress in patients living with chronic graft-versus-host disease. the horizons intervention was developed with the goal of improving the experience and needs of patients living with chronic graft-versus-host disease. participants will be randomized into one of the two study groups: horizons plus usual care or minimally enhanced usual care. participation in this study is expected to last up to 18 weeks after enrollment. the investigators expect that about 350 adult allogeneic hematopoietic cell transplant recipients with moderate to severe chronic graft versus host disease will take part in this research study.

Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years) who have undergone allogeneic hct * have moderate to severe cgvhd based on patient-report * have ability to participate in english or spanish language group telehealth intervention. exclusion criteria: * patients with mild cgvhd based on their self-report. * patients with a major untreated psychiatric or cognitive condition which the treating oncology clinicians believes interferes with the capacity to provide informed consent.

Keywords: neoplasms hematologic diseases neoplasms by site hematologic neoplasms graft-versus-host disease
anti tumor necrosis factor alpha agents and surgical stress response

Conditions: Inflammatory Bowel Diseases

Summary: background: the immunologic response to stress is regulated by the cytokines. anti-tumor necrosis factor-α agents are antibodies directed against a key cytokine in the process angiogenesis and collagen synthesis. it is not known whether they intervene with surgical stress response increasing the rate of postoperative complications. method: un-blinded prospective, non-interventional cohort single centre study including all the patients with crohn's disease and ulcerative colitis undergoing abdominal surgery. immunological and endocrinological parameters will measured in blood samples taken from these patients before and after surgery. power calculations showed that 17 patients in each arm are needed.

the baseline patient characteristics will be evaluated based on pilot tested data extraction sheets. the assessment will include demographics, clinical data as well as laboratory work up. the charlson morbidity index, will be used to assess co-morbidity, the nutritional risk score (nrs) to assess nutrition status and the harvey-bradshaw index (hbi) to evaluate the activity of crohn's disease. the duration of surgical procedure, along with the amount of blood transfused, will be recorded in all patients. laboratory variables the following variables will be assessed based on previous evidence about their role in surgical stress response: 1. immunological parameters: tumor necrosis factor-alpha, interleukin-1, interleukin-6, interleukin-10, c reactive protein, and white blood cell counts. 2. endocrinological parameters: plasma cortisol, growth hormone , adrenocorticotropic hormone, epinephrin and norepinephrine

Eligibility criteria:
inclusion criteria: patients with crohn disease, ulcerative colitis and indeterminate colitis undergoing elective abdominal surgery (laparoscopic or open) exclusion criteria: no patients will be excluded

Keywords: surgery,crohn's disease,ulcerative colitis
tolerability of using a post-treatment topical adjuvant combination following fractional radiofrequency ablation

Conditions: Skin Disorders

Summary: the purpose of this study is to compare the tolerability of the application of a combination of a serum containing human bone marrow stem cell derived growth factor (scr complex) and cytokines and a botanical lipid-based occlusive (bio cel) immediately following fractional radiofrequency treatment using the venus viva versus standard of care.

randomized, open-label, multi-centre study to evaluate the tolerability of the application of a combination of a serum containing human bone marrow stem cell derived growth factor and cytokines (scr complex™) and a botanical lipid based occlusive (bio cel™) following facial fractional rf treatments using the venus viva™ sr system. each subject will receive 2 treatments separated by a 3-week interval. subjects will complete a vas and tolerability scale immediately following each treatment. telephone follow-up calls by the site will ask the subject to respond to the self-report adverse event questionnaire 24 and 72 hours after the first treatment and 24 hours after the second treatment. subjects will complete a home tolerability scale 24 and 72 hours after the first treatment and 24 hours after the second treatment. subjects will return for the final fu visit and be asked to respond to the self-report adverse event questionnaire and complete the home tolerability scale for 72 hours. the investigator will also evaluate the subject's improvement using the gais at this visit.

Eligibility criteria:
inclusion criteria: * undergoing a dermatological procedure requiring ablation and resurfacing of the facial skin utilizing the venus viva™ sr system. * women of child-bearing age are required to be using a reliable method of birth control prior to enrollment and throughout their participation in the study. * able to tolerate the treatment as determined by a test spot application(s). exclusion criteria: * superficial metal or other implants in the treatment area * tattoos, permanent makeup, scars or piercings in the treatment area. * any active condition in the treatment area, such as sores, psoriasis, eczema and rash. * any surgical procedure in the treatment area within the last three months or before complete healing. * receiving therapies or medication that may interfere with the study treatment.

Keywords: resurfacing ablation
added value of svc isolation in patients with pulmonary vein reconnection undergoing repeat ablation for recurrent paroxysmal af

Conditions: Paroxysmal Atrial Fibrillation

Summary: redo procedures after close-guided pulmonary vein isolation (pvi) for atrial fibrillation (af) occur in 10% of patients. in case of pulmonary vein (pv) reconnection, electrophysiologists may re-isolate the pulmonary veins with or without the ablation of other commonly known pv-triggers. the superior vena cava (svc) is one of the most common non pv-triggers for atrial tachyarrhythmias. svc electrical isolation can be reached by circular radiofrequency-ablation under close monitoring of the phrenic nerve. however, it's added value remains unclear. with this prospective, randomized, controlled, unblinded, mono-center study, the investigators aim to evaluate the 1-year recurrence rate in paroxysmal af patients with reconnected pulmonary veins during a redo ablation with pv re-isolation or pv re-isolation with svc isolation.


Eligibility criteria:
inclusion criteria: * patients older than 18 years * patients scheduled for a repeat ablation of paf after a previous pvi * pv reconnection (in ≥1 pv's) found during procedure at the time of randomization exclusion criteria: * patients with persistent af * patients with durable pvi (no pvr) * previous ablation with isolation of the svc, roofline, mitral line or previous vein of marshal ethanol infusion * left atrial thrombus. laa thrombus can be determined by preprocedural imaging: ct, tee or mri. * left ventricular ejection fraction \<35%. * cardiac surgery within the previous 90 days. * expecting cardiac transplantation or other cardiac surgery within 180 days. * coronary ptca/stenting within the previous 90 days or myocardial infarction within the previous 60 days. * documented history of a thromboembolic event within the previous 90 days. * diagnosed atrial myxoma. * significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms. * significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment * women who are pregnant or who plan to become pregnant between signing the informed consent form and the index ablation. * acute illness or active infection at time of index procedure * advanced renal insufficiency * unstable angina. * history of blood clotting or bleeding abnormalities. * contraindication to anticoagulation. * life expectancy less than 1 year. * presence of a condition that precludes vascular access. * inr greater than 3.5 within 24 hours of procedure - for patients taking warfarin. * patient cannot be removed from antiarrhythmic drugs for reasons other than af. * unwilling or unable to provide informed consent.
benzocaine versus placebo spray for pain relief at hysterosalpingogram

Conditions: Pain Relief; Analgesia

Summary: the objective of this study is to assess the utility of benzocaine spray versus a placebo spray in alleviating pain during and after hysterosalpingogram (hsg).

hysterosalpingography (hsg) is a radiographic evaluation during which a radio-opaque medium is inserted through the cervical canal in order to define the size and shape of the uterine cavity and patency of the fallopian tubes. the utility of hsg is an integral part of the evaluation of infertile women for intrauterine pathology. in some cases, hsg can be a painful procedure. poor pain control can limit the quality of the study due to inability to complete the procedure in cases of extreme discomfort. there is little consensus regarding pain control during hsg, although a number of approaches have been studied. patients undergoing hsg are typically advised to premedicate with ibuprofen, which is consistent with the current standard of care. this study will assess pain control using a benzocaine spray (in addition to ibuprofen) in patients undergoing routine hsg at the hospital of the university of pennsylvania. all patients who present to the hospital of the university of pennsylvania for hsg will be eligible for the study. benzocaine spray versus a placebo spray will be applied to a tenaculum (a surgical hooklike instrument used to grasp and hold the cervix). the tenaculum will then be applied to the cervix prior to hsg and pain relief will be assessed at 3 time intervals: 0, 5, and 30 minutes. the primary outcome is the mean difference in patients pain score and will be measured using the visual analogue scale (vas) which has been shown to be a valid and reliable scale. the secondary outcome will assess patient satisfaction in each group using a validated patient satisfaction survey. the study design will be prospective, randomized, placebo controlled, and double blinded.

Eligibility criteria:
inclusion criteria: * all women who present to penn fertility care over the age of 18 years old exclusion criteria: * patients under the age of 18 * pregnant patients * patients with a history of hypersensitivity to benzocaine * patients with a history of asthma or bronchitis

Keywords: hysterosalpingogram hsg pain relief analgesia benzocaine
markers of atrial cardiopathay

Conditions: Atrial Cardiopathy

Summary: marker of atrial cardiopathay as apredictor value of ischemic stroke

detection of the presence of atrial dysfunction or atrial cardiopathy and its degree among patients complaining of palpitation, with a one-year follow-up for any cardioembolic events (stroke /tia).

Eligibility criteria:
inclusion criteria: * patients complaining of palpitation referred for holter monitoring exclusion criteria: * • valvular af, moderate to severe mitral/ tricuspid/ aortic stenosis or regurgitation. * recent myocardial infarction within 3 months. * acute pulmonary embolism. * newly onset af during or shortly after cardiac surgery. * specific type of cardiomyopathy such as cardiac amyloidosis, obstructive hypertrophic cardiomyopathy. decompensation stage of organ failure
negative postprandial effect on endothelium after a not-healthy meal in type 2 diabetes as affected by training

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to examine whether exercise reduces the postprandial effects of an unhealthy meal on heart function and endothelial function. both healthy people and type 2 diabetes subjects will during three days either carry out two different sessions of exercise training or not before ingesting an unhealthy meal high in saturated fat and fast carbohydrates. the two different exercise training modes used are high intensity interval training (hiit) and moderate intensity training (mit) hypothesis: exercise training in advance of an unhealthy meal will improve endothelial- and cardiac function in healthy and type 2 diabetes individuals. hiit will reduce the negative postprandial effects on the endothelium more than mit.


Eligibility criteria:
inclusion criteria: * healthy or type 2 diabetes exclusion criteria: * type 2 diabetes more than 10 years * unstable angina * myocardial infarction * overt cardiovascular disease. * severe valvular disease. * overt lung disease. * orthopedical- /neurological restrictions * severe disease related to diabetes type 2 (neuropathy, micro-or macroalbuminuria, retinopathy) * body mass index \>35 * severe eating disorders. * personality disturbances. * planned surgery during the project period. * patients who achieve greater than the current exercise guidelines for type 2 diabetes (210 min/week) before the start of the study. * uncontrolled hypertension * kidney failure * cardiomyopathy * smoking * patients who probably not will be able to complete the study * alcohol or drug abuse

Keywords: exercise endothelium postprandial period
coronary artery disease mechanisms in high risk families--racial difference

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases

Summary: to examine whether differences existed between asymptomatic white and african americans known to be at high risk for premature coronary artery disease (cad) in risk factor distributions, prevalence of occult coronary disease, and mechanisms of coronary disease expression.

background: the investigators hypothesized that increased platelet activation and coronary artery vasoconstriction exist in african americans, due to greater vascular endothelial dysfunction, heightened adrenergic drive, and greater vascular reactivity, resulting in excess sudden death and the occurrence of myocardial infarction in people with less severe angiographic coronary disease. the study was one of eight grants awarded as part of the request for applications "mechanisms underlying coronary heart disease in blacks". the initiative was released in october 1991 and awarded in september 1992. design narrative: previous studies had demonstrated high prevalences of coronary disease risk factors and occult coronary disease in this sibling population. subjects were recruited to come for a one day screening, with measurement of coronary disease risk factors (blood pressure, smoking, lipid profile, apolipoproteins b and a1, lipoprotein(a), blood glucose, insulin, and fibrinogen), and a maximal treadmill test with tomographic thallium imaging to identify occult coronary disease. platelet function was assessed by spontaneous in-vitro aggregation, activated iia/iiib receptor density, and serum thromboxane b2 concentration. factors contributing to sudden cardiac death were assessed by an echocardiogram for left ventricular mass, electrocardiogram (ecg) for qrs late potentials, and 24 hour ecg monitoring for ventricular arrhythmias, episodes of silent ischemia, and heart rate variability (to assess adrenergic drive). vascular reactivity was characterized by heart rate and blood pressure changes during stroop color card and cold pressor testing. siblings with an abnormal exercise ecg and/or thallium scan were offered coronary arteriography to assess the severity of angiographic coronary disease and the vasomotor responses to isometric handgrip and intracoronary acetylcholine, an endothelium-dependent vasodilator. in coronary arteries with minimal angiographic disease, changes in coronary vascular resistance during handgrip and acetylcholine were also measured with a doppler flow velocity catheter and the proximal arteries were imaged with intravascular ultrasound. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
pharmacogenomic testing of the elderly to reduce morbidity

Conditions: Genetics of Drug Metabolism

Summary: the goal of the poetry registry is to determine whether data from pharmacogenomic (pgx) testing for elderly and disabled patients can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug events, hospitalizations, and emergency department visits. the way an individual processes or metabolizes a drug is in part determined by their genes, and there is known to be genetic variation from one human to another. the study of the way in which genes affect an individual's response to drugs is known as "pharmacogenomics."


Eligibility criteria:
inclusion criteria: * subject underwent pgx testing for the alleles appropriate to the target drugs within the prior 90 days ('index pgx test') * males and females aged ≥65 years or male and females aged ≥18 years who have a disability * subject is able and willing to provide written informed consent * subject was receiving at least one medication known to be associated with allelic variation at the time of the index pgx test, including over-the-counter medications * subject has a history of at least one target drug-related adverse event (tdae) over the 12-month period preceding receipt of pgx test results, or has experienced inadequate efficacy from a target drug exclusion criteria: * subject is currently hospitalized * subject's medical and medication history is unavailable over the 90-day period preceding the receipt of pgx test results * subject is unable to provide an accurate history due to mental incapacity * subject is known to have undergone prior pgx testing for genes specific to the target drug(s), exclusive of the pgx test relating to this registry

Keywords: pharmacogenomics adverse drug reactions
the effect of a ketone drink on blood glucose levels in people with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: ketones are naturally produced by our body and can affect our blood sugar levels. ketones could be important in the treatment of type 2 diabetes (t2d). the purpose of this research is to determine if a ketone drink can lower blood sugar in people with t2d following a meal. this research will provide new knowledge about the regulation of blood sugar. this may also inform if ketone drinks could be used as a treatment for t2d.


Eligibility criteria:
inclusion criteria: 1. aged 41-70 years old 2. body mass index 27-40 mg/m² 3. type 2 diagnosis for more than 1 year 4. hba1c \>6% exclusion criteria: 1. currently following ketogenic diet 2. use of insulin 3. hba1c \>10% 4. recent weight loss (\>5kg in 6 months) 5. recent egfr \<30ml/min 6. heart failure 7. substance abuse 8. cancer 9. myocardial infarction within 6 months 10. pregnancy or consideration of 11. use of antipsychotic drugs
the use of fentanyl in general anesthesia for craniotomy with or without 0.5% levobupivacaine scalp block

Conditions: Brain Tumor

Summary: this study evaluates the use of fentanyl during craniotomy in two groups of brain tumor patients. the control group will receive standard general anesthesia with the use of fentanyl for intraoperative pain control and the study group will receive scalp nerve block with 0.5% levobupivacaine (local anesthetic) and also fentanyl for intraoperative pain control. the scalp nerve block might reduce the dose of fentanyl and promote faster emergence from general anesthesia.

fentanyl has widely been used for intraoperative analgesia for craniotomy. in craniotomy, the long and complex operation, the continuous infusion or repeated use of fentanyl can significantly delay emergence from general anesthesia. the scalp block with local anesthesia is widely used for awake craniotomy with great success but it is not routinely used in general craniotomy. in this study, the control group will receive standard general anesthesia with the use of fentanyl for intraoperative pain control and the study group will receive the addition of scalp nerve block with 0.5% levobupivacaine (local anesthetic). the scalp nerve block might reduce the total dose of fentanyl and promote faster emergence from general anesthesia.

Eligibility criteria:
inclusion criteria: * supratentorial brain tumor exclusion criteria: * tumor size\>4 cm * glasgow coma score (gcs) \<15 * already intubated * uncontrolled hypertension * can not communicate

Keywords: fentanyl, scalp block