Kornimate/medical-research-clean huggingface dataset:
rezafungin prophylaxis in liver transplant

Conditions: Liver Transplant Infection; Fungal Infection

Summary: this is an interventional study to evaluate the efficacy of rezafungin, a new echinocandin, for the prevention of invasive fungal infections (ifis) after liver transplantation. patients who receive rezafungin will be compared to a similar group of patients who underwent liver transplantation in the preceding two years for the incidence of ifis.

this is a single arm interventional study of consecutive liver transplant recipients who have consented to this rezafungin prophylaxis study. the outcome will be compared with that of similar group of patients not enrolled in the study and those who underwent liver transplant in the preceding two years (historical controls). propensity score matching will be used to select retrospective cohort. there will be 3 groups: 1. study group (prospective intervention cohort): rezafungin (180 patients) 2. prospective control group (prospective control cohort): patients who receive fluconazole/voriconazole or no antifungal prophylaxis as part of upmc's tiered antifungal prophylaxis standard of care (20 patients: 10 who receive fluconazole/voriconazole and 10 who do not receive fluconazole/voriconazole) 3. historical control group (retrospective control cohort): patients at risk for ifi who received fluconazole/voriconazole (tier approach) in the two years preceding this study (180 patients)

Eligibility criteria:
inclusion criteria: * liver transplant recipient * 18 years of age or older * ≥1 risk factor(s) for ifi: living donor transplant, retransplantation, complicated operations (based on duration of transplant and number of blood products required in the peri-transplant period), choledochojejunostomy anastomosis, or peri-operative candida colonization, recent candida infection, renal replacement therapy post-transplant, and reoperation within the first 90 days of transplant. exclusion criteria: * participants who are perceived not to survive past 7 days after transplant * participants who elect not to participate in the prospective trial * participants who had active candidiasis at the time of transplant * participants with a history of allergy to an echinocandin * participants who are pregnant.

Keywords: rezafungin liver transplant prophylaxis
vestibular rehabilitation for strokepatients with dizziness

Conditions: Stroke; Dizziness

Summary: recently, the investigators has shown that dizziness is common among patients with first time stroke and that it affects self perceived health. there are indications that vestibular rehabilitation can have effect of neurological causes of dizziness and vertigo and it therefore seems important to find out if vestibular rehabilitation can affect dizziness among patients with stroke. the aim of this study is to find out if vestibular rehabilitation can have any effect on function, balance and self-rated health among patients with first time stroke.


Eligibility criteria:
inclusion criteria • first time stroke with dizziness - exclusion criteria * not first time stroke * no dizziness

Keywords: stroke dizziness vestibular rehabiliation balance
a pharmacokinetic (pk) study of nilotinib in pediatric patients with philadelphia chromosome-positive (ph+) chronic myelogenous leukemia (cml) or acute lymphoblastic leukemia (all)

Conditions: Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia

Summary: this study will assess the pharmacokinetics of nilotinib in ph+ cml pediatric patients that are newly diagnosed or resistant or intolerant to imatinib or dasatinib or refractory or relapsed ph+ all compared to the adult populations. it will also evaluate safety and activity of nilotinib as secondary objectives.


Eligibility criteria:
inclusion criteria: * must have one of the following: newly diagnosed cp ph+cml, cp or ap resistant/ intolerant to imatinib and/or dasatinib, or ph+ all either relapsed after or refractory to standard therapy * adequate renal, hepatic and pancreatic function exclusion criteria: * patients receiving therapy with strong cyp3a4 inhibitors and/or inducers and treatments cannot be stopped or changed to a different medication at least 14 days prior to starting study drug * patients receiving therapy with any medications with a known risk or possible risk to prolong the qt interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. * gastrointestinal impairment or disease that may interfere with drug absorption * liver, pancreatic or severe renal disease unrelated to disease under study * impaired cardiac function * patients who received dasatinib within 3 days of starting study drug * patients who received imatinib within 5 days of starting study drug * patients receiving hydroxyurea or corticosteroids that has not been discontinued at least 1 week after initiation of nilotinib * patients who received hematopoietic growth factors within 7 days of starting study drug or pegfilgrastim (neulasta®) within 14 days of starting study drug * patients with stem cell transplant (sct) or rescue without tbi: evidence of active graft vs. host disease and \< 3 months since sct other protocol-defined inclusion/exclusion criteria may apply

Keywords: chronic myeloid leukemia acute lymphoblastic leukemia ph+ cml ph+ all pediatric nilotinib imatinib chronic phase accelerated phase newly diagnosed ph+ cml dasatinib
vitamin d in dialysis patients - diagnostic and therapeutic management

Conditions: Vitamin D Deficiency Due to Chronic Kidney Disease

Summary: the goal of this observational study is to learn about the effects of cholecalciferol administration, according to guidelines for the general population, on laboratory parameters of chronic kidney disease-mineral and bone disorder in dialysis patients, depending of the attained levels of vitamin d (25oh)d). the main question it aims to answer is: how does cholecalciferol affect calcium and phosphate metabolism parameters depending on the achieved levels of 25(oh)d? participants taking cholecalciferol as part of their regular medical care for ckd-mbd will have the laboratory result parameters observed for up to 4 years.

the analysis will involve data obtained from medical records of dialysis patients who receive standard procedures consistent with national and international guidelines for specialized care. specifically, we will analyze the levels of: * 25(oh)d, * 1,25(oh)2d * calcium * phosphates * pth * fgf23 * gdf15 to assess the efficacy and safety of cholecalciferol in dialysis patients.

Eligibility criteria:
inclusion criteria: * ckd stage 5,dialysed patients with vitamin d deficiency or insufficiency (level of 25(oh)d \< 30 ng/ml) exclusion criteria: * dialysis time of less than 3 months * inadequately controled secondary hyperparathyroidism (ipth\>800pg/ml) * treatment with calcimimetics * treatment with active forms of vitamin d3, * parathyroidectomy * bilateral nephrectomy * treatment with corticosteroids * lack of consent to take part in the study.

Keywords: vitamin d cholecalciferol 25-hydroxycholecalciferol parathyroid hormone fgf23 gdf15 chronic kidney disease-mineral and bone disorder dialysis
a prospective trial comparing the cost of post operative x-rays for fractures treated with stable internal fixation

Conditions: Simplified Postoperative Radiographs

Summary: the standard post-operative radiographic protocol for the monitoring of fractures at hsc includes post-operative in hospital radiographs as well as radiographs at the two week follow up appointment. this is in addition to good quality intra-operative radiographs. with current operative techniques and implants, orthopaedic surgeons can achieve reliably stable internal fixation. in fact, patients are often allowed to take weight through the fractured limb immediately post-operatively. in these cases, redundant post-operative radiographs likely represent an avoidable cost to the system financially, and an avoidable cost to the patient in additional time spent in hospital and unnecessary radiation exposure.


Eligibility criteria:
inclusion criteria: * femur fracture treated with intramedullary nailing * tibia fracture treated with intramedullary nailing * ankle fractures treated with standard compression technique * humeral shaft fractures treated with standard compression technique * forearm fractures treated with standard compression technique * one or both bones fractured * simple fracture or presence of single butterfly fragment treated with lag screw * clavicle fracture treated with standard compression technique * olecranon fracture treated with standard compression technique exclusion criteria: * age \< 17 years, or open growth plates * multiple orthopaedic fractures * history of radiographic appearance of osteoporosis or osteopenia or poor operative bone quality * likely difficult with follow-up in first 6 weeks * same day surgery case * surgeon feels patient should be excluded
accuracy of laa occluder size selection: ct vs. dsa during combined af ablation and laa occlusion

Conditions: Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases

Summary: this study is a prospective, multi-center, randomized controlled trial. the subjects are patients scheduled to undergo a combined procedure of atrial fibrillation (af) ablation and left atrial appendage (laa) occlusion. after signing the informed consent form, the subjects will be randomly assigned to either the cardiac computed tomography (ct) group or the digital subtraction angiography (dsa) group. the operator will select the appropriate laa occluder size for implantation based on different measurement methods. all subjects will undergo clinical follow-up before discharge and at 3 months postoperatively, as well as telephone follow-up 1-5 years after the surgery.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. patients with non-valvular atrial fibrillation scheduled to undergo atrial fibrillation ablation and percutaneous left atrial appendage occlusion; 3. able to understand the purpose of the trial, willing to participate in the study, and the subject or their legal representative has signed the informed consent form, and is willing to complete the follow-up according to the protocol requirements. exclusion criteria: 1. allergy to contrast agents or other conditions that preclude cardiac ct or dsa imaging; 2. absence of clear images for measuring the diameter of the laa in all layers of the ct scan; 3. imaging indicates the presence of thrombus in the left atrium or laa; 4. patients with valvular af (mechanical valve replacement or moderate to severe mitral stenosis combined with af); 5. laa depth \ 33 mm; 6. female patients of childbearing age planning to become pregnant during the follow-up period required by this study; 7. currently participating in another clinical trial of drugs or medical devices and has not yet completed the primary endpoints of that study, which may confound the results of this study or affect the participant's compliance with the follow-up; 8. other conditions that the investigator deems make the participant unsuitable for this study.

Keywords: left atrial appendage closure atrial fibrillation pacifier-like occluder stroke prevention
the influence of sampling site when assessing glucose tolerance or insulin sensitivity with oral glucose ingestion

Conditions: Hyperglycemia; Insulin Sensitivity

Summary: for decades, it has been known that post-meal blood glucose concentrations were associated with the risk of t2d, which was reflected in early diagnostic guidelines. the oral glucose tolerance test (ogtt) has been used since at least 1923 and has remained the most common test for assessing glucose tolerance. arterial blood (or arterialised blood using heated hand technique) is most appropriate for determining glucose tolerance and insulin sensitivity since this best represents the concentrations of metabolites and hormones that peripheral tissues are exposed to. it is essential to investigate whether venous blood (sometimes used during an ogtt) is representative of arterialised blood during an ogtt, and under different metabolic conditions. the investigators want to understand whether ogtt-derived insulin sensitivity indices differ from venous and arterialised blood; and 2) investigate whether metabolic status (i.e. rest vs lower-limb exercise) influences the difference between forearm venous and arterialised concentrations of glucose and insulin during an ogtt.


Eligibility criteria:
inclusion criteria: * aged 18-49 years * able and willing to safely comply with all study procedures * able to provide written informed consent for participation exclusion criteria: * diagnosis of any bleeding disorder or taking medication which impacts blood coagulation * the presence of any contraindications to maximal exercise testing, as determined using a physical activity readiness questionnaire (par-q). * any diagnosis of metabolic disease (i.e. cardiovascular disease or type 2 diabetes).
etiological factors, risk factors and early stages of chronic disease in different degrees of childhood overweight

Conditions: Childhood Obesity

Summary: children and adolescents with overweight and obesity are predisposed to significant health problems. it is known that childhood obesity can adversely affect almost every organ system, and if left untreated, the major impact of childhood overweight is likely to be felt in the next generation of adults. the aim of " kijk op overgewicht bij kinderen" is to collect and follow-up longitudinal data from a population of different degrees of children with overweight regarding etiological factors, risk factors and early stages of chronic disease in different degrees of childhood overweight.

furthermore, from april 2020 onwards, a prospective sub study will be conducted. this sub study aims to investigate the changes in lifestyle behaviour of children with overweight or obesity and their families during the covid-19 pandemic, including the (governmental) measures taken for this, and the effect of obesity and different weight-related risk factors on the host response of these children. the goal of this sub study is to collect data to enable analyses for future research questions regarding the influence of the covid-19 on the lifestyle of a child with overweight and their family. endpoints are for example physical activity, eating behavior, bmi-z score, remote lifestyle coaching, quality of life and parental practices regarding nutrition and physical activity behavior. we will also measure symptoms associated with covid-19 and the host response that target covid-19.

Eligibility criteria:
inclusion criteria: * participation in the coach program * aged till 18 years old (at time of inclusion) * overweight or obesity according to international obesity task force (iotf) criteria exclusion criteria: • none

Keywords: overweight obesity children lifestyle intervention
randomized study of fetal neurotransplantation for the treatment of parkinson's disease

Conditions: Parkinson Disease

Summary: objectives: i. assess the safety and efficacy of embryonic mesencephalic dopamine cell implants into the putamen of patients with parkinson's disease.

protocol outline: this is a randomized, double blind, placebo controlled study. patients are stratified by age (over and under 60). patients are randomized to receive either sham surgery or tissue implantation. embryonic tissue is prepared. while patients are awake, but sedated, bilateral incisions are made in the skin and burr holes drilled in the skull. a cannula is inserted into the brain to the posterior putamen. implant patients receive embryonic neural tissue or sham patients have no needles penetrate the brain. after 1 year, patients who receive the sham operation in the first operation may receive embryonic neural tissue in a second operation. patients are followed every 4 months during the first year and every 6 months thereafter.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * idiopathic parkinson's disease for at least 7 years with rest tremor or bradykinesia and one of the following cardinal signs: rigidity flexed posture loss of postural reflexes freezing (motor blocks) * continuing response to levodopa * presence of at least one of the following intractable symptoms or signs: intractable disabling fluctuations intractable disabling dyskinesias intractable "on" freezing (i.e., motor blocks that interfere with walking despite being "on" * bilateral parkinsonism when "off" (may be asymmetry between right and left sides) * decreased dopa uptake in the striatum --prior/concurrent therapy-- * no prior brain surgery --patient characteristics-- * cardiovascular: no severe cardiopulmonary disease * neurologic: no history of strokes no neuroleptics no encephalitis no oculogyric crisis no remission no cerebellar signs no dementia (mini-mental state score no greater than 22) no supranuclear gaze palsy no babinski sign no orthostatic hypotension no hydrocephalus no brain tumor no occlusive cerebrovascular disease * pulmonary: absolute standing pressure at least 90/60 mmhg * other: no diabetes mellitus no exposure to toxins no other severe medical disease hamilton depression scale score of less than 20 points

Keywords: parkinson disease neurologic and psychiatric disorders rare disease
local heat-stress as a mechanism of hearing preservation

Conditions: Hearing Loss

Summary: this pilot study plans to determine whether or not local heat-stress as a mechanism can help to preserve hearing in adults treated with cisplatin.

evidence from the laboratory over the past 10-15 years has demonstrated that heat stress to the ear is otoprotectant against a variety of insults. the strongest evidence supports heat-shock protein 70 (hsp70) as a key facilitator in this protection. hsp70 is well established as a cell stabilizer, especially for cells undergoing significant stress. hsp70 has been shown to protect against cisplatin-induced ototoxicity. induction of hsp70 may be accomplished pharmacologically, by whole-body heat stress, or by local heat stress. a form of local heat-stress is already employed in the common clinical setting of the warm caloric. this vestibular test has been in place since the early 20th century with a variety of studies evaluating the patient vestibular response to a variety of times and temperatures. current clinical practice recommends either water or air calorics of 45°c or 50°c (respectively) at 45-60 seconds. several studies have described administering prolonged caloric stimulation to individual subjects without ill effect. patients are able to tolerate stimulation up to 60 minutes without intolerable nystagmus or vertiginous symptoms or significant injury. thus, it is feasible to provide warm stimulus to the ear for the recommended time of 30 minutes at the recommended temperature of 50°c (air) without significant risk to the patient. the purpose of this study is to evaluate the impact of heat stress to the inner ear as an otoprotectant intervention against cisplatin-induced hearing loss. patients that meet inclusion criteria will be offered audiometric evaluation before each cisplatin treatment and at 1, 3, 6, and 12 months following their chemotherapy. patients will undergo their heat-stress 5-7 hours prior to their cisplatin treatment. patients will serve as their own controls with one ear randomly receiving treatment and the other not. the primary outcome will be audiometric testing. blood samples will be collected for serum levels of hsp70 as a secondary outcome. a sample size of 12 achieves 80% power to detect a 0.9 standard deviation difference between ears using a two-sided paired t-test at 0.05 significance level.

Eligibility criteria:
inclusion criteria: * any patient undergoing total cisplatin in total doses \> 100mg/m2. * written consent. * age \> 19 years. exclusion criteria: * inability to tolerate the intervention * exposure to cisplatin treatment without intervention. * head and neck carcinoma * baseline asymmetric hearing loss. * pregnant or breastfeeding women.
efficacy of the all you need is love healthcare transition syllabus among pre- and posttransplant adolescents in cali, colombia

Conditions: Renal Transplant

Summary: background: to achieve optimal outcomes, adolescents with chronic or end-stage kidney disease must undergo healthcare transition (hct) preparation from a pediatric- to an adult-focused setting. the pediatric nephrology group at the fundación valle del líli in cali, colombia, collaborated with the university of north carolina chapel hill starx program and hospital infantil de méxico federico gómez to start an hct preparation program using their tools. the objective of this study was to evaluate the efficacy of the "all you need is love" syllabus (spanish version) and its effects on hct readiness in young patients with kidney failure, including renal transplants. methods: a pre-test/post-test quasi-experimental study was conducted without control group in 11- to 21-year-old consecutive patients with kidney failure followed at the fundación valle de lili. using the trxansition index, hct readiness skills were measured before and after implementing the "all you need is love" syllabus, an educational curriculum delivered in three monthly 2-hour sessions. analysis was performed using linear mixed models in r studio software to evaluate intervention effects while accounting for participant characteristics.


Eligibility criteria:
inclusion criteria: * patients aged 11 to 21 years along with their primary caregivers * either renal transplant recipients or in a renal transplant protocol * under follow-up by the nephrology service at fundación valle del lili. exclusion criteria: * patients were excluded if they did not sign the informed consent and/or assent to participate in the study. * if they lost their care agreement with fundación valle del lili due to administrative reasons related to their health insurance provider

Keywords: pediatric nephrology educational healthcare transition kidney failure