Kornimate/medical-research-clean huggingface dataset:
a safety and efficacy trial of multiple dosing regimens of abt-719 for the prevention of acute kidney injury in subjects undergoing high risk cardiac surgery

Conditions: Acute Kidney Injury

Summary: this study will evaluate the safety and efficacy of abt-719 in preventing acute kidney injury in patients undergoing high risk cardiac surgery.


Eligibility criteria:
inclusion criteria: * subject must be male or female, age greater than or equal to 18 years old. * subjects must have stable renal function, per investigator discretion and no known increase in serum creatinine of greater than or equal to 0.3 mg during the preceding 4 weeks. * subjects with estimated glomerular filtration rate less than or equal to 60 ml/min/1.73 m2 who require intravascular iodinated contrast within 48 hours of the day of surgery, will only be included if there is no known serum creatinine increase greater than or equal to 0.3 mg. * subjects must be undergoing a pre-defined on-pump cardiac surgery meeting one of the following acute kidney injury risk factors: * subject is undergoing combined coronary artery bypass grafting (cabg) surgery and surgery of one or more cardiac valve (valve(s) surgery), or * subject is undergoing surgery of more than one cardiac valve (valves surgery), or * subject is undergoing surgery of the aortic root or ascending part of the aorta, or * subject is undergoing surgery of the aortic root or ascending part of the aorta, combined with coronary artery bypass graft and/or valve(s) surgery, or * subject has an estimated glomerular filtration rate greater than or equal to 16 ml/min/1.73 m2 and less than or equal to 59 ml/min/1.73 m2 as determined by chronic kidney disease epidemiology collaboration (ckd epi) formula at screening, and is undergoing coronary artery bypass graft or single valve surgery. exclusion criteria: * has an egfr less than or equal to 15 ml/min/1.73 m2. * cardiac surgery to be performed without cardiopulmonary bypass. * has ongoing sepsis or history of sepsis within the last 2 weeks or untreated diagnosed infection prior to screening visit. sepsis is defined as presence of a confirmed pathogen, along with fever or hypothermia, and hypoperfusion or hypotension. * has known or documented rifle "r" or akin "stage i" within the previous 4 weeks. * recently received (within the last 10 weeks) or is anticipated to receive chemotherapy which can interfere with kidney function

Keywords: gfr acute kidney injury high risk cardiac surgery
feasibility and therapeutic potential of free fat grafts in the treatment of urethral strictures

Conditions: Urethral Stricture; Fat Graft

Summary: in this study the investigators investigate the feasibility and therapeutic potential of free autologous fat grafting combined to direct visual urethrotomy (dviu) in the treatment of urethral strictures.

in this study the investigators wish to proof the concept of free fat grafting into urethral stricture via urethroscope. the investigators will recruit twenty male patients suffering from (endoscopy proven) benign stricture of spongy urethra. all recruited patients have undergone at least one direct visual internal urethrotomy (dviu) before recruitment. ipss-score and uroflowmetry are recorded upon recruitment. the ipss-score is repeated one day preoperatively. urine sample is gathered for bacterial and cytological analysis. prophylactic single dose levofloxacin antibiotic is orally administered before operation. the operation is performed in the operation room by one urologist and one surgeon under general anesthesia. first abdominal liposuction (roughly 20 ml) and fat graft preparation is performed. the fat graft is processed into nano-fat using tulip gems single-use nanotransfer set. then urethroscopy is performed, urethral stricture is visually graded (location, length, lumen), photographed, dviu performed and nano fat graft (0,1-0,5ml) injected to stricture site beneath the mucosal layer at three locations. urinary foley ch 18 catheter is inserted. patients are discharged the next day. urinary catheter is removed after 20 hours. patients are contacted by phone 1 week after the operation. post-operative symptoms are recorded and the patients are requested to contact the researcher if needed. patient records are screened for pre- and postoperative symptoms, medication, long term illnesses and possible postoperative contacts to the hospital. three months later uroflowmetry, urethroscopy and ipss-questionnaire are repeated. stricture site is photographed and visually graded. in case of symptomatic re-stricture, the dviu and fat grafting is repeated once. after 12 months uroflowmetry and ipss-questionnaire are repeated. in case of suspected re-stricture the urethroscopy is repeated. follow-up time is 12 months from the last fat graft injection. trial starts in fall 2019. the clinical studies have been completed and the data analysis and writing of the manuscript will be finalized in 2022.

Eligibility criteria:
inclusion criteria: * urethral stricture that has re-occurred at least once. exclusion criteria: * malignant etiology of urethral stricture

Keywords: urethral stricture fat graft direct visual urethrotomy
food genetics behavior study

Conditions: Obesity, Childhood

Summary: a genetic risk for obesity does not always translate to the development of obesity among children, which points to the presence of risk-modifying factors that likely relate to energy balance behaviors as key behavioral drivers. using an integrated approach to comprehensively examine the interplay between genotype and phenotype, this study will systematically assess the extent to which energy balance behaviors, alone or in combination, in conjunction with family-level influences can modify behavioral and genetic predispositions to childhood obesity in a high-risk sample of predominantly minority children from low-resource backgrounds. identifying protective factors that may mitigate the impact of obesity risk on weight and adiposity outcomes is critical for moving the prevention of childhood obesity into a new direction.

this study examines the interplay between genotype and phenotype and assesses if energy balance behaviors in the context of the family environment, alone or in combination, can modify behavioral and genetic predispositions to childhood obesity. the research aims to prospectively evaluate the extent to which associations of a heightened drive to eat (hde) on 1-year changes in weight and adiposity outcomes are independent or additive to those of a genetic risk for obesity among children. in addition, the study aims to prospectively examine risk-modifying energy balance behaviors in areas of diet, physical activity, and sleep that may mitigate the detrimental impact of a hde or high genetic risk on weight and adiposity outcomes and test whether these factors differ for hde versus a high genetic risk of obesity on those outcomes. lastly, the research aims to examine the impact of family-level influences in areas of family functioning and parent feeding on risk-modifying energy balance behaviors in children.

Eligibility criteria:
inclusion criteria: * healthy children * children ages 5-7 years * children with bmi equal to or greater 5th percentile * mother must be children's biological mother and primary caregiver * mother must be able to read and understand english exclusion criteria: * children with serious medical conditions or medication use known to affect food intake, body weight, physical activity, or sleep * children with developmental and/or psychiatric conditions that may impact study compliance * children with food allergies related to study foods or lactose intolerance * children with low preference for study foods
low and high dose zonisamide in children as monotherapy

Conditions: Epilepsy

Summary: the purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy.


Eligibility criteria:
inclusion criteria: 1. pediatric patients with epilepsy whose age is 2\~15 years old. 2. patients had at least two seizures for the last 6 months before entry. 3. patients who had never taken antiepileptic drugs. 4. patients with no chance of progressive disease based on the result of magnetic resonance imaging (mri) or electroencephalogram (eeg). 5. agreement of the guardian is needed. exclusion criteria: 1. patients who have progressive central nervous system (cns) disease. 2. patients with serious disorder. 3. patients who have abnormal liver function (serum glutamic oxaloacetic transaminase \[sgot\]) or (serum glutamic pyruvic transaminase \[sgpt\]) values more than twice the normal values. 4. patients who have abnormal renal function (blood urea nitrogen (bun) or creatinine) values more than three times the normal values. 5. hemolytic anemia.
effects of vitamin d supplementation on immune function in infants

Conditions: Vitamin D Deficiency

Summary: current study shows that vitamin d deficiency might affect human's immune function. although breast milk is the best food of infants, however the vitamin d content in breast milk is low. thus, breastfeeding infants are at high risk of vitamin d deficiency.children's development and health are always the most important issues for parents. however, high prevalence of allergy in infants in taiwan were not only with environmental factor which may also relate to their nutritional status. the aim of this study was to enroll breastfeeding infant at age of 4 month, and provide vitamin d supplement 10 μg daily until 6 month, to discuss the effects of vitamin d supplementation on immune function in infants.

study plan to enroll breastfeeding infant at age of 4 month, and provide vitamin d (vitd) supplement 10 μg daily until 6 month. we also enroll 6 month-old infant as control group. all infants collected 5 ml artery blood and measured vitd nutritional status and immune function. blood analysis contain complete blood count (cbc), differential count (dc), serum calcium, serum parathyroid hormone (pth), serum 25(oh)d3, serum total immunoglobuline (ige) and cell phagocytosis. peripheral blood mononuclear cell (pbmc) in blood was separated and cultured with complete medium contain 10% fetal bovine serum (cm10), or with different mitogens, include lipopolysaccharide (lps), phorbol 12-myristate 13-acetate and ionomycin (pi) and house dust mite extract (hdm). pbmc are incubated at 37 ℃, 5% co2 for 48 hours, and determined the expression of b cell with ige receptor cd21 and cd23 and t regulatory cell with transcription factor foxp3 by flow cytometry. all data were analyzed with spss 20.0. infant sex and feeding type were analyzed by chi-square analysis. difference between vitd supplement group and control group were analyzed by student's t test. relationship between 25(oh)d3 and calcium or pth were analyzed by pearson correlation analysis. there was a significant difference when p-value was less than 0.05.

Eligibility criteria:
inclusion criteria: * breastfeeding healthy infants exclusion criteria: * heart disease * liver disease * lung disease * intestinal disease

Keywords: vitamin d, immune, infants, breastfeeding
strength training and resveratrol

Conditions: Sarcopenia; Anabolic Resistance

Summary: the main goal of this study is to find out if supplementing with resveratrol improves skeletal muscle adaptations to strengthening exercise (resistance training or strength training) in adults age 60+, and to determine whether circulating vehicles of inter-organ communication (extracellular vesicles) and their cargo might help explain those responses. the investigators will also examine whether resveratrol supplementation improves blood vessel function and cognitive function (brain health) in response to strength training.

after screening and providing informed consent, participants (healthy older adults, age 60+, minimally active) will be familiarized with the procedures and undergo pre-testing. after pre-testing, participants will be assigned to supplement with resveratrol or placebo (double-blinded) daily while undergoing a strength training intervention. strength training will be performed 3x/week for two 6-week blocks, and each visit will be supervised by a member of the study team. an additional week of testing will follow each of the two 6-week blocks.

Eligibility criteria:
inclusion criteria: * age 60+ * minimally active (less than 1 hour of structured exercise/week other than walking) * no resistance training for the previous 6 months * not currently taking resveratrol supplements * stable medication, supplement, dietary, and physical activity regimens for the previous 3 months and no plans to change throughout the study period exclusion criteria: * medical complications that could increase risk during exercise (e.g., cardiovascular disease, uncontrolled hypertension, type 1 or 2 diabetes, orthopedic contraindication to exercise, kidney disease, etc.) * cannabis or nicotine use * consume more than 7 alcohol-containing beverages per week

Keywords: resistance training aging resveratrol sarcopenia extracellular vesicles micrornas
frequency analysis of raw eeg during sevoflurane anesthesia in children younger than 2 years old

Conditions: Anesthesia, General; Sevoflurane; Infant

Summary: the purpose of this study is to analyze raw electroencephalogram in infants younger than 2 years old undergoing general anesthesia using sevoflurane.

after obtaining an informed consent from one of the parents, patients undergo routine anesthetic induction using sodium thiopental. bispectral index and patient state index are both monitored simultaneously. raw electroencephalogram data are transmitted and recorded via a dedicated equipment. anesthesia is maintained using sevoflurane with end-tidal level of less than 2 minimum alveolar concentration (mac) adjusted to age. fentanyl of up to 1 mcg/kg can be administered in case of increased heart rate and mean blood pressure with a degree of 30% of baseline. during anesthesia, patients' status of sedation is defined as 'maintenance of surgical state of anesthesia (mossa)' when the end-tidal concentration of sevoflurane is maintained between 0.7 and 1.3 mac and mean blood pressure and heart rate is between 80-120% of baseline. 'emergence' is defined as a 3-minute period in the middle of continuous decrease in end-tidal concentration of sevoflurane in the range of less than 0.7 mac and finally reaching 0.2 mac. raw electroencephalogram waves are analyzed by distribution of power along frequency bands and compared according to the state of anesthesia or bispectral index / patient state index value.

Eligibility criteria:
inclusion criteria: * pediatric patients aged between 4 months and 2 years planned to undergo surgery under general anesthesia * american society of anesthesiologists physical status 1 or 2 exclusion criteria: * history of preterm birth (postconceptual age \< 32 wks) or history of mechanical ventilation immediately after birth * presence of genetic disease or chromosomal abnormality that can affect brain development * presence of disease in central nervous system * history of head trauma or surgery involving head * history of hypersensitivity to anesthetic drugs * intubated or sedated state before induction of anesthesia * difficulty in attaching both the bispectral index and patient state index probes to patient's forehead * expected operation time of less than 5 minutes

Keywords: electroenphalography frequency analysis
single dose escalation study in patients with chronic heart failure

Conditions: Heart Failure

Summary: this study is to demonstrate the safety and tolerability of a single oral dose of bay60-4552 in a single dose escalation design. furthermore, this study examines the changes in hemodynamics after application of the test substance.42 hospitalized stable patients with chronic heart failure will be included. several measurements will be performed to test how good the drug works and wether there are any unwanted reactions to the drug (e.g. blood tests, ecg, heart rate, blood pressure, adverse events). after a observation period the patient will be discharged from the hospital.


Eligibility criteria:
inclusion criteria: * patients with chronic heart failure, undergoing routine invasive measurement of hemodynamic parameters exclusion criteria: * acute heart failure or acute decompensated heart failure, need for acute cardiologic intervention or surgery, severe renal or hepatic insufficiency, severe valvular disease

Keywords: biventriular chronic heart failure, pulmonary hypertension
mechanisms of smell improvement with dupilumab.

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Summary: this study seeks to explore the mechanism through which dupilumab improves olfactory cleft inflammation in patients with chronic sinusitis with nasal polyps (crswnp). the investigators expect this study to provide convincing evidence that dupilumab improves clinical olfaction via direct reduction in olfactory cleft inflammation.

post-marketed administration of dupilumab (fda approved medication for crswnp) in patients with chronic rhinosinusitis with nasal polyps (crswnp) will result in significant improvement in objective measures of olfactory cleft inflammation and psychophysical olfaction. the investigators seek to explore the mechanism through which dupilumab improves olfactory cleft inflammation in patients with crswnp. the investigators also want to determine whether change in olfactory cleft inflammation correlates with improvement in olfaction (one of the cardinal symptoms of crswnp) at 3 months. the investigators hypothesize that after 3 months of treatment with dupilumab, non-inflammatory factors will explain a significant degree of variation in residual clinical olfaction. additionally, the investigators want to explore the determinants of ongoing olfactory loss after 3 months of treatment with attention to non-inflammatory factors. the investigators expect this study to provide convincing evidence that dupilumab improves clinical olfaction via direct reduction in olfactory cleft inflammation. specifically, the investigators expect to show that reduction in olfactory cleft inflammation is the result of reduction in il13 levels in olfactory cleft mucus. finally, the investigators expect to show that most of the variation in post-treatment olfaction can be explained by non-inflammatory measures that are independent of crswnp.

Eligibility criteria:
inclusion criteria: * adults ≥18 years of age * meet criteria for crswnp as defined by icar-21 * 2 out of 4 cardinal symptoms for ≥12 weeks * visible evidence of inflammation on endoscopy or imaging * bilateral visible nasal polyps ≥1 in each nasal cavity (0-4 scale each side) * olfaction score ≥1 (0-3 scale) * candidate for treatment with dupilumab for crswnp * elected to proceed with dupilumab for treatment of crswnp exclusion criteria: * prior use of dupilumab * previous treatment with another biologic medication for crswnp or asthma within 6 months * any nasal or sinus surgery within the last 3 months * oral corticosteroid use within the last 1 month * current pregnancy, breast-feeding, or plan to become pregnant during next 3 months * presence of antrochoanal nasal polyps; acute rhinosinusitis; upper respiratory infection; * allergic granulomatous angiitis/eosinophilic granulomatosis with polyangiitis; * granulomatosis with polyangiitis; cystic fibrosis; young syndrome; * kartagener syndrome; or dyskinetic cilia syndrome * poorly controlled asthma

Keywords: chronic rhinosinusitis nasal polyps dupilumab
real-world outcome research study on quality of life, work productivity and health care resource utilization in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: this real-life health economics and outcome research (heor) study will enable to assess the impact of current therapies on quality of life (qol), productivity loss and health care resource utilization in metastatic breast cancer (mbc). this prospective study will estimate patient-reported outcomes (pros) and resource utilization data for mbc patients stratified according to treatment type, treatment line and disease status (progression vs. progression free) in a real-life setting. to estimate qol, work productivity and health care resource utilization of post-menopausal patients with er+/her2- locally advanced or metastatic breast cancer in a real-life setting. the secondary objective is to estimate qol and work productivity of mbc patients' caregivers. during the course of the study, data will be collected on quality of life and work productivity. patients and caregivers will be asked to fill a set of questionnaires at their recruitment in the study, at 3 months and at 6 months after recruitment.


Eligibility criteria:
inclusion criteria: * diagnosis of locally advanced or metastatic breast cancer * post-menopausal women * er+/her2- mbc * signature of informed consent form * ability to read and understand english or french exclusion criteria: * participation to a clinical trial
pilot study of novel postpartum educational video intervention

Conditions: Behavior; Communication; Language

Summary: a child's early language environment is pivotal for language development. disparities in early language environments contribute to the gap in school readiness between poor and more advantaged children. ultimately this leads to disparities in students' school achievement and economic outcomes. while recent research has highlighted the value of early intervention for children in disadvantaged families, most existing interventions begin too late, reach only a small proportion of children at risk, and do not capitalize on the critical role that parent language plays in a child's educational trajectory. to address this challenge, the investigators propose to develop and evaluate a novel language-based, perinatal public health intervention, thirty million words newborn initiative (tmw-ni). it is proposed that new mothers will receive this educational intervention while their babies are undergoing the universal newborn hearing screen. the intervention will use video, animation, and interactive questions to convey the importance of the early language environment and to illustrate strategies parents can use to promote language learning. the investigators will conduct formative research with mothers of low socioeconomic status (low-ses) and with healthcare providers to inform the content and format of the intervention prototype. also critical for acceptability, the investigators will use an iterative approach to develop the intervention, with review of the work-in-progress by the intended audience. to assess feasibility and initial efficacy, the investigators will conduct a randomized-controlled trial with low-ses mothers during the newborn period. the investigators hypothesize that tmw-ni will positively impact parents' knowledge and beliefs about the role of language input for a child's language development.


Eligibility criteria:
inclusion criteria: -postpartum mothers admitted to the mother-baby unit. exclusion criteria: * mothers of infants who were admitted to the neonatal intensive care unit (nicu). * mothers who experienced any serious medical complications during birth. * mothers who do not expect to reside in illinois for the duration of the study (approximately two months).

Keywords: educational intervention language development universal newborn hearing screening postpartum parental attachment loss to follow-up hearing loss achievement gap language gap school readiness