Kornimate/medical-research-clean huggingface dataset:
endothelial function and arterio-venous fistula maturation

Conditions: Chronic Kidney Disease

Summary: an arterio-venous fistula is a surgical procedure that supports access for people undergoing hemodialysis (hd) for end stage renal disease (esrd). this observational pilot study seeks to better understand the factors that contribute to the successful maturation of an arterio-venous fistula. a primary aim of this study is to see if endothelial function (the biochemical events initiated by cells lining the arteries) is associated with successful maturation. other aims include determining if pro-inflammatory markers in the blood or evidence of gene expression are associated with successful maturation.

current practice guidelines stipulate that 65% of all prevalent esrd patients should receive hd through some sort of arterio-venous fistula (avf). an avf is a subcutaneous, permanent vascular access created surgically by connecting a vein with an artery and is the preferred mode of access due to lower rates of infection or thrombosis compared to prosthetic grafts or tunneled lines. an avf is mature if it can sustain high quality hd. however, rates of primary failure (the inability of an avf to sustain hd) are high, ranging from 40-70%. traditional coronary risk factors such as hypertension, hypercholesterolemia, and diabetes mellitus, have limited ability to allow surgeons to predict which avfs will mature. one possible explanation involves vascular remodeling, the structural changes which occur in a blood vessel in response to hemodynamic stimuli. the endothelial, lying at the interface of the vessel wall and flowing blood, is a "biosensor", responding to changes in blood flow and pressure. it initiates a complex biological response including cellular proliferation and migration, matrix degradation, and cellular apoptosis. this longitudinal, observational study hypothesizes that endothelial function is a critical modulator of avf maturation. specifically, that patients with inflammation will have impaired endothelial function and demonstrate less significant remodeling than others.

Eligibility criteria:
inclusion criteria: * chronic kidney disease classification stage iv or v * adequate quality cephalic or basilic vein based on pre-operative assessment * able to provide written informed consent * able to travel to the sfva medical center or ucsf medical center for follow-up examination exclusion criteria: * age \>90 or \< 18 years * diagnosed hypercoaguble state * recent surgery or other major illness or infection within 6 weeks * use of immunosuppresive medication * history or organ transplantation * pregnancy or plans to become pregnant * estimated life expectancy is less than 1 year

Keywords: chronic kidney disease ckd esrd av fistula arterio-venous fistula hemodialysis
effects of mannitol on delayed graft function after cadaveric renal transplantation

Conditions: Kidney Transplantation, Mannitol

Summary: in this study we want to evaluate the effect of mannitol on postoperative renal biomarkers in patient receiving cadaveric renal transplantation. furthermore we want to evaluate the effect of mannitol on perioperative redox status in patients receiving renal transplantation using the oxidation-reduction potentials assessed with the redoxsys®system. we are planning to perform a double-blind randomized controlled trial. in the study, mannitol 20% with a dose of 1g / kg / bw (5 ml / kg / bw) will be compared to placebo with nacl 0.9% in the dose of 5 ml / kg / bw. patients will be randomized to receive either the mannitol or nacl. the follow-up of the study is 24 hours. the following biomarkers will be determined befor induction of anesthesia and 24 hours after administration of study medication: ccl2, chi3li, gh, hgf, mmp1, mmp8, tie2, tnf-r1, vcam-1, kim-1, cystatin c, fgf23, igfb7, ngal and il 18. furthermore we want to perform sorp and corp before induction of anesthesia, just before bolus of mannitol, 5 min after bolus of mannitol and after operation in anesthetic recovery room. data will be collected, compared and published at the end of the study. it is planned to include a total of 34 patients in the study.


Eligibility criteria:
inclusion criteria: all patients with end stage renal diseases - exclusion criteria: patients younger than 18 years of age or older than 80, alergy to mannitol, pregnancy, breast-feed -
improving disease knowledge in adolescents with sickle cell disease

Conditions: Sickle Cell Disease; Quality of Life

Summary: increased knowledge about an illness can increase self-management among those afflicted. in order to facilitate people with sickle cell disease living a longer and healthier life, they should be taught to manage their illness.an adolescent with a chronic illness has many unique challenges, in addition to maneuvering the turbulent adolescence period itself. it has been that better knowledge and more positive perceptions of their illness equate not only to better control of their illness but also better quality of life.studies have also shown the benefits of self-management: when patients are responsible for managing their own illness, their clinical outcomes and quality of life improve and they become less dependent on health care services. in this study we aim to examine if knowledge, and any changes in knowledge, will each have any association with quality of life (qol) and their perceptions of their illness (ip). we also seek to investigate the effects of an educational booklet, as well as an intervention including the educational booklet with formal counselling on their knowledge, qol and ips.

in this inquiry, we wish to apply an educational intervention to determine if there are any improvements in disease knowledge as a result among adolescents attending the sickle cell unit (scu) in jamaica. we also wish to examine if knowledge, and any changes in knowledge, will each have any association with quality of life (qol) and their perceptions of their illness (ip). our specific hypotheses are: 1. important predictors of knowledge among adolescents with sickle cell disease (scd) are gender, age, education of the adolescent as well as of the parents, socioeconomic status, frequency of attendance at scu, rural/urban residence, and disease severity. 2. the intervention involving training using an educational booklet specific to 'teens living with scd' will improve knowledge among the adolescents 3. adding 'individual counselling' to the intervention will increase the benefits 4. improvements in knowledge will translate to improvements in qol and positive ips.

Eligibility criteria:
inclusion criteria: * all adolescent patients, ages 13-19 years inclusive, with sickle cell disease that attend the sickle cell unit at university of the west indies, mona campus will be eligible for the study and hence will be asked to participate. exclusion criteria: * adolescent with neurological disorders e.g. cerebrovascular accidents or with physical or intellectual disabilities will be excluded.

Keywords: educational intervention formal counselling knowledge illness perception
post approval study to evaluate the effectiveness and safety of cartiva implant in the treatment of oa of the great toe

Conditions: Osteoarthritis of First Metatarsalphalangeal Joint

Summary: evaluate and confirm the long-term safety and effectiveness of the cartiva sci implant established by the pivotal trial.

as part of the conditions of approval of cartiva sci for the treatment of first mtp osteoarthritis, the food and drug administration (fda) requires additional long term data to evaluate the long term safety and effectiveness of cartiva including the durability and survivorship of the implant. this post-approval study (pas) addendum is intended to supplement the initial 24 months follow up period and provide additional long term safety and effectiveness data on cartiva

Eligibility criteria:
inclusion criteria: * subject must have been treated with cartiva under motion study protocol ptc-0031; and, * have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the irb/ethics committee for long-term follow-up. exclusion criteria: * subjects who underwent a secondary surgical intervention to have the cartiva implant removed during the 24-month time period of participation in the motion study.

Keywords: first mtp joint hallux rigidus hallux limitus cartilage replacement osteoarthritis first mtp joint osteoarthritis big toe pain
developing a new questionnaire about patient expectations of breast conserving therapy

Conditions: Breast Cancer

Summary: the purpose of this study is to develop a questionnaire to measure patient expectations of breast-conserving therapy (breast-conserving surgery and radiation). this questionnaire will assist both surgeons and patients by helping provide valuable information to patients about what to expect during and after surgery.


Eligibility criteria:
inclusion criteria: * female * age 18-75 * patients who are scheduled to undergo lumpectomy at mskcc as part of breast conserving therapy for invasive breast cancer or who have completed bct (lumpectomy and radiation) at least 6 months prior to recruitment exclusion criteria: * inability to speak or understand english * inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability * patients undergoing lumpectomy without radiation

Keywords: breast conserving therapy reported outcomes instrument 16-325
improving the outcomes of community-based management of acute malnutrition

Conditions: Severe Acute Malnutrition

Summary: severe acute malnutrition (sam) affects 16 million children at any one time and is responsible for the deaths of over 500,000 children under 5 years of age each year. treatment for severe acute malnutrition is based on the community-based management of acute malnutrition (cmam) model. the current methods used for detecting high risk children have not prevented 5% mortality observed in regions using this program. the purpose of the study is to provide evidence that objective methods for detecting high risk children can be used to optimize efficiency of community-based management of acute malnutrition (cmam) treatment programs and thus improve child health outcomes.

a prospective observational study in inpatient care within community-based management of acute malnutrition(cmam) program run by the nongovernmental organization called alliance for international medical action (alima) within the university of maiduguri teaching hospital, maiduguri, nigeria the objectives of the study are to validate the bedsidepews scores as a measure of severity of illness in children who are treated as inpatients for severe acute malnutrition and to compare the bedsidepews scores with other risk factors associated for mortality and relapse of children with severe acute malnutrition. the design is a prospective observational study of 1000 children admitted as inpatients in a cmam program in maidaguri teaching hospital in maidaguri, nigeria. data collection (estimated duration 4-5 months) involves vital signs, and risk factor assessment every 12 hours for duration of hospitalization. blood test for hemoglobin and malaria will be done once upon admission. outcomes will be measured every 12 hours and include mortality and/or escalation and de-escalation of care. logistic regression with significance testing will be used to compare bedsidepews scores and risk factors between patients and among individual patients within the outcome categories. exploratory sensitivity analyses will repeat the main logistic regression analyses to evaluate the performance of partial bedsidepews score in patients with missing data of 1-3 of the 7 components, by randomly removing 1-3 data elements from the score calculation from patients, and by removing systolic blood pressure from scoring.

Eligibility criteria:
inclusion criteria: * aged 1 to 59 months * diagnosed with severe acute malnutrition (criteria for severe acute malnutrition is \<3z weight for height z score, and/or muac \<115mm, and/or bilateral pitting oedema) * meet the criteria for admission into inpatient care (failed appetite test, and/or medical conditions). study amendment for inclusion: children with and without severe acute malnutrition admitted to emergency pediatric unit (epu) exclusion criteria: - children with congenital anomalies that interfere with feeding (ie. cleft lip and/or palate); previous enrolment in this study.
kaposi sarcoma chemotherapy and research (ks-care)

Conditions: Kaposi Sarcoma; HIV

Summary: this prospective, nonrandomized, open-label, single-arm, cohort study examines the effects of chemotherapy provided under local standard of care in patients with pathologically confirmed hiv-associated kaposi sarcoma (hiv-ks). previous hiv-ks studies demonstrated significant variability in clinical outcomes based on differences in gender or baseline kshv dna levels in patients with hiv-ks. patients will receive chemotherapy according to local site treatment guidelines and standard of care. chemotherapy regimen for two treatments that are used locally based on physician's choice namely intravenous (iv) paclitaxel (ptx) or the combination of bleomycin and vincristine (bv). in addition, all histologically proven hiv-ks could be enrolled, irrespective of their prior length of combination anti-retroviral treatment (cart). this enrolment strategy will reflect a more realistic picture of hiv-ks management. this study result could trigger treatment alteration of hiv-ks. the treatment approaches to hiv-ks can be individualized if clinically relevant subsets and novel prognostic markers are defined. in that case, newer and potentially more expensive agents can be selectively applied to those patients most likely to benefit, especially if prolonged treatment is needed.


Eligibility criteria:
inclusion criteria: participants meeting all the inclusion criteria listed below will be eligible for screening. * histologically confirmed t1 ks presenting to tbh combined kaposi sarcoma clinic with or without visceral disease. no evidence of improvement in human immunodeficiency virus (hiv)-associated kaposi sarcoma (hiv-ks) in the 4 weeks immediately prior; and a clinical indication for systemic chemotherapy treatment * known hiv-1 infection status, as documented by any nationally approved, licensed hiv rapid test and confirmed at any time point prior by the local standard of care assay. * on art or not on art. * age ≥18 years. * participants able to understand and provide written informed consent in english, afrikaans, or isixhosa. exclusion criteria: failure to meet the inclusion criteria listed above. * specifically, pregnancy and breastfeeding are not exclusion criteria given the observational nature of the study with diagnostic and treatment interventions administered according to local standards of care. * specifically, the absence of skin lesions is not an exclusion criterion if recorded evidence of * visceral or nodal disease is present in the form of a radiology or endoscopy report. * participants who have had prior chemotherapy or radiotherapy for human immunodeficiency virus (hiv)-associated kaposi sarcoma. * specifically, patients who have had prior cart will not be excluded. * participants who are receiving any other investigational agents.

Keywords: paclitaxel bleomycin vincristine anti- retroviral
analysis of suprapectoral and subpectoral biceps tenodesis

Conditions: Biceps Tendonitis

Summary: biceps pathology typically includes pain in the anterior shoulder that is reproduced with provocative maneuvers. however, optimal treatment of patient with this diagnosis is not clear and can include tenotomy (cutting the biceps) or various forms of tenodesis (cutting then reattaching). as tenotomy can lead to cosmetic deformity and anterior humeral discomfort from spasms, many surgeons perform tenodesis. there are various techniques for tenodesis. this study will compare 2 methods: suprapectoral (doing the surgery using an incision higher in the shoulder) versus subpectoral fixation (surgery which involves making an incision lower in the shoulder). purpose of the study is to prospectively determine whether arthroscopic suprapectoral or open subpectoral biceps tenodesis results in better function.


Eligibility criteria:
inclusion criteria: * scheduled to undergo biceps tenodesis * pain at intertubercular groove * anterior humeral pain * patient agrees to follow up and consent exclusion criteria: * biceps tenotomy * revision biceps procedure * prior slap or labral repair * concomitant subscapularis repair * more than 1 rotator cuff repair at time of surgery * concomitant arthroplasty * prior infection
assessment of methadone dose taken

Conditions: Methadone Toxicity; Methadone Overdose; Pain, Chronic; Drug Metabolism, Poor, CYP2D6-Related; Metabolism Medication Toxicity

Summary: proof of concept: pilot study a pilot, proof of concept, observational study with a long-term goal to develop a minimally invasive wearable remote medication monitor (rmm) that provides continuous, real-time data on methadone levels in interstitial fluid (isf). an rmm could be used as a medication adherence monitor and would allow for the physician, counselor, patient, or family member to remotely verify that a physician-prescribed dose has been taken.

the investigator will conduct a non-randomized, non-blinded, feasibility study at a single center in the united states. the study will include up to 20 subjects of an equal number of male and female adults (ages 18-70) who have a prescription for methadone for chronic pain. in aim 1, the investigator will determine if an rmm can assess the status of taking a prescribed dose of methadone, using biosamples (i.e., isf, blood) collected from subjects and tested in a laboratory setup. biosample collections and pharmacokinetic monitoring will take up to 6 consecutive hours. by completing this aim, the investigator will determine if a physician is able to recognize the peak and trough of a methadone dose using ex vivo continuous monitor. in aim 2, the investigator will determine if an rmm can continuously assess the status of taking a prescribed dose of methadone over time, by inserting the intradermal microneedle sensing elements into the subjects' skin. biosample collections (i.e., isf, blood) and pharmacokinetic monitoring will occur over a 6-hour period. by completing this aim, the investigator will determine if a physician is able to recognize the pharmacokinetic profile of a taken dose of methadone. the physician will see a dosing curve display generated from intradermal microneedle sensing elements that are worn continuously on the skin. completion of aims 1-2 will require two separate visits.

Eligibility criteria:
inclusion criteria: * age 18-70 * a prescription for methadone for chronic pain at a dose of 10mg or more for at least one week. * taking methadone as prescribed during the last 4 days before consent to participate in the study. exclusion criteria: * age \ 70 * a condition preventing or complicating isf collection * dermatological (skin) condition * immunodeficiency * recent blood donation * anemia * end stage renal disease * liver cirrhosis * cancer * congestive heart failure * bleeding diathesis * tuberculosis (tb) * any active severe depression * suicidal ideation * mania symptoms * pregnancy * intending to become pregnant during the course of the study * enrolled in a substance use disorder treatment program * under a conservatorship.

Keywords: pharmacokinetics
phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the effects of ep262 in subjects with chronic spontaneous urticaria

Conditions: Chronic Spontaneous Urticaria

Summary: phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the effects of ep262 in subjects with chronic spontaneous urticaria


Eligibility criteria:
inclusion criteria: * documented history of chronic spontaneous urticaria (csu) with a uas7 greater than or equal to 16 despite stable treatment with h1 antihistamine consistent with standard of care * must be on a stable dose of h1 antihistamine up to 4 times the approved dose per local treatment guidelines exclusion criteria: * urticaria with a clear underlying etiology other than csu * urticaria with a clearly defined or sole trigger (chronic inducible urticaria) * other active skin diseases associated with chronic pruritus (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis)

Keywords: chronic spontaneous urticaria chronic urticaria urticaria ep262 calm-csu calm
surgical site infections after liver transplantation based on perioperative antibiotics

Conditions: Liver Transplantation; Surgical Site Infection

Summary: this study will be to prospectively determine differences in surgical site infection (ssi) if a prolonged course of post-operative antibiotics are used following liver transplantation.

this study will be to prospectively determine differences in ssi if a prolonged course of post-operative antibiotics are used following liver transplantation. all adult patients, admitted to the university of virginia (uva) medical center for first-time liver transplantation will be randomized to the standard of care of peri-operative antibiotics or extended course of three total days. patients will be evaluated primarily for the presence of post-operative surgical site infections but also for fever, elevated white blood counts, secondary infections (urinary tract, pneumonia, and blood stream), length of hospital stay, graft loss, and mortality for 30 days after liver transplant.

Eligibility criteria:
inclusion criteria: * all patients ≥ 18 years of age. * eligible for liver transplantation by uva standard protocol. * first-time transplantation. * no active infections - requiring antibiotics - excluding antifungals. exclusion criteria: * all patients \< 18 years of age. * previous liver transplantation. * active infections - requiring antibiotics. * allergy to all standard peri-operative antibiotics (piperacillin/tazobactam or uva standard alternatives for penicillin allergic patients: ciprofloxacin and vancomycin).
role of cysteinyl leukotrienes in the pathogenesis of asthma in obesity

Conditions: Asthma; Obesity

Summary: the purpose of this study is to examine whether there are higher levels of cysteinyl leukotrienes in obese subjects than in non-obese subjects. cysteinyl leukotrienes are pro-inflammatory substances that cause asthma by narrowing the airways of the lung. the investigators want to see if subjects with increased fat stores and therefore increased leptin, which is a fat-related protein that regulates leukotrienes, have increased levels of leukotrienes in the blood, lung and urine. the investigators would also like to determine the relationship between cysteinyl leukotrienes and exhaled nitric oxide levels in asthmatics with and without obesity. nitric oxide is anti-inflammatory and suppresses leukotriene synthesis.

this is a cross-sectional observational study to characterize the association between obese asthmatics and the inflammatory mediators cysteinyl leukotrienes. our hypothesis is that altered adipokine levels in obesity result in augmented cysteinyl leukotriene synthesis that play a significant role in the pathogenesis of asthma in these subjects.

Eligibility criteria:
inclusion criteria: * 18-65 yr old adults with asthma, non-smoking for at least one year * healthy non-smoking adults, aged 18-65 without asthma * heavy subjects with bmi \> 30 kg/m2 * subjects with normal weight (bmi between 20-25 kg/m2) * subject not taking anti-leukotriene therapy (singulair, accolate, zyflo) exclusion criteria: * no chronic oral steroid use * no recent history of infection * no recent history of flare of lung disease

Keywords: asthma obesity