Kornimate/medical-research-clean huggingface dataset:
evita study - epstein-barr virus infection monitoring in renal transplant recipients

Conditions: EBV Infection; EBV Viremia; Epstein-Barr Virus Associated Lymphoproliferative Disorder; Post-transplant Lymphoproliferative Disorder

Summary: transplant recipients are treated with immunosuppressive drugs to avoid rejection of the transplanted organ. as the medication impairs the immune response, it also increases the risk of serious infections and cancer in transplant recipients compared with the general population. previous studies have shown a close association between epstein-barr virus (ebv) and post transplant lymphoproliferative disorder (ptld), with frequent demonstration of the virus in lesional tissues. transplant recipients without evidence of ebv infection prior to transplantation (ebv seronegative) are at particularly high risk of developing ptld. other risk factors include a high viral load. as part of a preventive approach against ptld, several transplantation units now monitor the occurrence of ebv dnaemia after transplantation. however, there is little evidence to guide this strategy; nor is there consensus concerning either the best specimen to use for ebv analysis (whole blood or plasma) or the appropriate clinical action to take if ebv dnaemia is detected. our aim is to estimate the incidence and clinical consequences of epstein-barr virus (ebv) dnaemia in whole blood and plasma in renal transplant recipients, and to determine if persistence of ebv dnaemia can predict excessive immunosuppression as indicated by the incidence of infections requiring hospitalisation, ebv driven ptld and mortality.


Eligibility criteria:
inclusion criteria: * children from 2 years of age receiving a kidney transplant from a living or deceased donor. * adults 18 years or older who receive a kidney transplant from a living or deceased donor. * capable of giving written informed consent to participation in the study (legal guardians capable of giving written informed consent to participation in the study in case of children younger than 18 years old). exclusion criteria: * patients unable to comply with the study requirements. * withdrawal of consent.
vr for burn dressing changes at home

Conditions: Burns; Acute Pain; Procedural Pain

Summary: this study will evaluate the impact of our smartphone-based virtual reality pain alleviation tool (vr-pat) during the repeated at-home burn dressing changes of children (5-17 years) with a burn injury in comparison with a control group of children with a burn injury who will not use vr-pat during at-home burn dressing changes. we hypothesize that children using vr-pat will report less pain during their dressing changes.

subjects will be randomly assigned to either the vr-pat intervention group or control group. subjects and caregivers in both groups will perform daily dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. subjects and caregivers in the intervention group will answer additional questions about their experience using the vr-pat, ease of use, and helpfulness. surveys will be repeated with each dressing changes for one week.

Eligibility criteria:
inclusion criteria: * pediatric patients age 5-17 years (inclusive) * receiving first outpatient dressing change or being discharged from the inpatient burn unit at our institution * have a dressing that requires daily changes at home for at least one week * can communicate orally exclusion criteria: * any wounds that may interfere with study procedures (i.e. face) * vision, hearing, or cognitive/motor impairments preventing valid administration of study measures * history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras * minors in foster care * suspected child abuse * unable to communicate in english * families who do not have access to a smartphone (due to the vr-pat game requirements)

Keywords: virtual reality vr burns pain dressing changes
efficacy and safety study of multiple doses of vit-2763 in adults with transfusion-dependent beta-thalassemia

Conditions: Beta-Thalassemia

Summary: the main purpose of this study is to evaluate the efficacy of 3 multiple doses of vit-2763 as measured by the reduction in red blood cell (rbc) transfusion burden from week 13 to week 24, to identify the most efficacious and safe dose.

all patients giving written informed consent will undergo a 12-week screening period to determine eligibility for study entry. at day 1, patients who meet the eligibility requirements will be randomized in a double-blind manner to 1 of 4 treatment groups: vit-2763 60 mg (once daily), 60 mg (twice daily), or 120 mg (twice daily) or placebo. the randomisation will be stratified (balanced allocation across treatment groups) according to β0/β0 genotype (yes/no). the duration of the treatment with vit-2763 or placebo is 24 weeks, after which patients will undergo a 12-week post-treatment follow-up period.

Eligibility criteria:
inclusion criteria: * body weight ≥40.0 kg and ≤100 kg at screening * documented diagnosis of beta-thalassemia or hb e/beta-thalassemia * red blood cell (rbc) transfusion dependence, defined as at least 6 rbc units in the 24 weeks prior to randomization and no transfusion-free period for ≥35 days during that period * ability to understand the requirements of the study and provide written informed consent exclusion criteria: * documented diagnosis of hb s/beta-thalassemia, alpha-thalassemia, or delta beta (δβ)-thalassemia, or hereditary persistence of foetal hb. * history of partial or total splenectomy within 4 months prior to screening. * history of myocardial iron overload * chronic liver disease or history of liver cirrhosis * clinically relevant renal disease * history or clinically important finding of cardiac disorders * history of clinically significant lung disease * uncontrolled hypertension (\> grade 1 according to nci ctcae current version) * unable to take and absorb oral medications. * pregnancy or breastfeeding * history of drug or alcohol abuse within 2 years prior to screening * history or concomitant solid tumors and/or hematological malignancies unless resolved in the ≥5 past years.

Keywords: beta-thalassemia transfusion-dependent thalassemia
prevalence of hypoglycaemia in congenital adrenal insufficiency

Conditions: Adrenal Insufficiency, Congenital

Summary: children with congenital primary and secondary adrenal insufficiency, who are deficient in cortisol, are at risk for hypoglycaemia, irrespective of appropriate hydrocortisone treatment, which can lead to potentially serious neurological complications. few series are described in pediatrics. the prevalence of hypoglycaemia is probably underestimated because it is often asymptomatic and capillary blood glucose monitoring is not always performed routinely. the objective of the study is to evaluate the prevalence of hypoglycaemia in children with adrenal insufficiency.

children with congenital primary and secondary adrenal insufficiency, who are deficient in cortisol, are at risk for hypoglycaemia, irrespective of appropriate hydrocortisone treatment, which can lead to potentially serious neurological complications. few series are described in pediatrics. the prevalence of hypoglycaemia is underestimated because it is often asymptomatic and capillary blood glucose monitoring is not always performed routinely. the objective of the study is to evaluate the prevalence of hypoglycaemia in children with congenital adrenal insufficiency. the study will follow for one year children from 6 months to 6 years, with central and peripheral adrenal insufficiency. 4 study times are planned with two measurement methods: * continuous blood glucose measurement with abbott freestyle pro for 14 days, repeated twice at 6 months intervals. * measurement of capillary blood glucose, in the morning on an empty stomach, every first week of each month for 12 months, with abbott's freestyle optium neo reader, used with the accu-chek fastclix lancing device and the test strips accu-chek performed. * measurement of capillary glycaemia in case of suspicion of hypoglycaemia. measure left free according to the judgment of the parents of the necessary character or not. with abbott's freestyle optium neo reader, used with the accu-chek fastclix lancing device and the accu-chek performa strips.

Eligibility criteria:
inclusion criteria: * all male and female patients, followed in the paediatric endocrinology department at necker hospital, with congenital primary and secondary adrenal insufficiency. * age between 6 months and 6 years. * included in the social security system. * parental consent and willingness to participate in this study: involves training and skills in the use of blood glucometers. exclusion criteria: * patients with acquired adrenal insufficiency. * patients with type 1 or type 2 diabetes. * patients with somatotropic deficiency associated with adrenal insufficiency. * refusal or impossibility to perform the glycaemic measurements according to the procedure of the study. * not covered by the social security system.

Keywords: congenital primary and secondary adrenal insufficiency cortisol deficiency hypoglycaemia children
comparison of efficacy and safety of tachosil® versus surgicel® original for the secondary hemostatic treatment of needle hole bleeding in vascular surgery

Conditions: Bleeding

Summary: present trial is the third study that in combination with two completed studies (one being a trial in hepatic resection surgery also comparing tachosil® and surgicel® original) targeted toward providing clinical safety and efficacy data to support extending the current label of tachosil® to a general hemostasis indication across several surgical procedures and organ systems in the usa.

the drug being tested in this study is called tachosil®. tachosil® was used to treat people undergoing scheduled subacute vascular surgery. this study looked at how well tachosil® patches stopped bleeding at the surgical site compared to surgicel® original patches. the study enrolled 150 patients. participants were randomly assigned (by chance, like flipping a coin) to one of the two open label treatment groups in a 2:1 ratio: * tachosil® * surgicel® original this multi-center trial was conducted in the united states. the overall time to participate in this study was approximately 6 months. participants made multiple visits to the clinic, including safety follow-up visits at 1, 3 and 6 months after surgery.

Eligibility criteria:
main inclusion criteria: * planned elective and subacute procedures with a polytetrafluoroethylene (ptfe) graft including at least one expected end-to-side anastomosis of a ptfe graft to the femoral artery (e.g. femoral-femoral cross-over, aorto-(bi)femoral, axillo-(bi)femoral, femoro-popliteal, femoro-crural bypass grafting), a ptfe patch angioplasty of the femoral artery, or an end-to-side anastomosis of a ptfe graft to an upper extremity artery in connection with arteriovenous bypass grafting for dialysis access. * the evaluation site for the planned femoral anastomosis must be a de novo site. * the participant must be heparinized during surgery. intra-operatively (before randomization) * the participant has a need for secondary hemostatic treatment * verification of the evaluation site being a de novo site * verification of the surgical procedure performed as being either an end-to-side or ptfe patch angioplasty. main exclusion criteria: * thrombolytic therapy administered within 12 hours before surgery (e.g. the recombinant tissue plasminogen activator (rt-pa) alteplase). * liver cirrhosis. intra-operatively (before randomization) * severe bleeding at the anastomosis of the arterial bypass using ptfe graft prosthesis or the ptfe patch angioplasty * no bleeding (dry surgical field) at the targeted application area * disseminated intravascular coagulopathy (dic) * application of topical hemostatic material including fibrin sealant/glue on the evaluation site.

Keywords: vascular surgery secondary treatment of needle hole bleeding subjects undergoing vascular surgery and who need supportive treatment in order to control bleeding
expanded access program (eap) for ciltacabtagene autoleucel (cilta-cel) out-of-specification (oos) in participants with multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this expanded access program (eap) is to provide ciltacabtagene autoleucel (cilta-cel) that does not meet the commercial release specifications of carvykti and is not available via the local health care system in the country where the treatment is requested.


Eligibility criteria:
inclusion criteria: * eligible for treatment with cilta-cel per united states prescribing information (uspi) * has serious or life-threatening multiple myeloma per uspi, and where re-apheresis, re-manufacturing, or other anti-myeloma directed therapy is not considered feasible or adequate per treating physician discretion * favorable participant benefit/risk assessment determined by janssen medical review * treating physician confirms the favorable risk benefit profile, and that proceeding with this treatment is in the best interest of the participant * able to provide informed consent indicating they understand the purpose of this expanded access program (eap) * a woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hcg\]) pregnancy test during screening and prior to the first dose of cyclophosphamide and fludarabine
risk and incidence of aortic graft and endograft infection with bsi

Conditions: Aortic Infections and Inflammations

Summary: what is the risk of aortic vascular graft and endograft infection in patients with aortic vascular graft/endograft and bloodstream infection?

all patients with previous aortic vascular graft and endograft surgery between years 2010 and 2021 in four regions of south sweden (skåne, halland, kronoberg and blekinge) will be included in the study. these patients will be evaluated for bloodstream infection (bsi) or not. for all patients with bsi, the risk of aortic vascular graft and endograft infection will be investigated. aortic vascular graft and endograft infection will be determined by usage of the magic-criteria. risk factors for developing aortic vascular graft and endograft infection will be investigated, and if possible used to construct a risk score. this risk score could be used by clinicians to determine if bacteremic patients with aortic vascular grafts or endografts should be evaluated for aortic vascular graft and endograft infection.

Eligibility criteria:
inclusion criteria: previous aortic vascular graft or endograft infection with bloodstream infection. exclusion criteria: -
ultrasound-guided axillary vein catheterization in trauma

Conditions: Multiple Trauma/Injuries

Summary: it is very important to choose the best central venous catheterization route for trauma patients, the determinants that need to be considered comprehensively include coagulation dysfunction, fracture of the clavicle on the side of the puncture, and tracheotomy care. more importantly, whether it can used simultaneously for accurate volume and invasive hemodynamic monitoring. for the purpose of support of cardiopulmonary function, the ideal position of the catheter tip is vital with regard to an accurate cvp and hemodynamic monitoring. cannulation of the axillary vein is ideal for patients with severe poly-trauma because it avoids the thoracic cavity, intercostal arteries, tracheostomy, and clavicle, and is prone to compression even if the artery is injured. at present, there is no systematic introduction of ultrasound-guided axillary vein catheterization in the trauma icu in the literature. since oct 2021, the investigators have attempted to practice axillary vein catheterization for this crucial trauma population; unfortunately, the investigators have not know till now whether this procedure is associated with accurate tip placement and its safety should also be weighted. so it is necessary to summarize the relevant clinical data.


Eligibility criteria:
inclusion criteria: * trauma patients admitted to ticu * receiving axillary vein catheterization during ticu stay exclusion criteria: * without record of axillary vein catheterization * without imaging confirming （x-ray or chest ct） the location of catheter tip

Keywords: multiple trauma axillary vein catheterization intensive care unit complications
daily study of caregiving relationships and health

Conditions: Caregiver Burnout; Dementia; Dementia of Alzheimer Type; Relations, Family; Social Stress; Relation, Interpersonal; Loneliness

Summary: the purpose of the daily study of caregiving relationships and health is to learn how caregiving relationships and social connectedness are associated with dementia caregivers' health, health behaviors, and diurnal patterns of salivary cortisol. this is a pilot study wherein the purpose is to test the feasibility and acceptability of study protocols.

the purpose of the daily study of caregiving relationships and health is to learn how caregiving relationships and social connectedness are associated with dementia caregivers' health, health behaviors, and diurnal patterns of salivary cortisol. investigators are asking caregivers to complete 14-days of surveys which ask about their relationships and health behaviors, in addition to 2 longer surveys (baseline and 3-month follow up). investigators hypothesize that on days when caregivers receive more emotional support, they will report better health behaviors (e.g., improved sleep quality). on days when caregivers experience greater 1) strain and 2) loneliness, they will report poorer health behaviors. information about which aspects of social relationships and social connectedness most affect health will be used to inform interventions programs.

Eligibility criteria:
inclusion criteria: * spouse or partner to an individual living with adrd who has received a diagnosis from a physician * aged 18 years or older provides assistance with at least one instrumental activities of daily living or activities of daily living * not paid to provide care * cares for someone with a global deterioration score of 1 to 5 (early to mid-stage dementia) * has reliable access to email and text messaging, and smart phone device * live within 40 miles of ut health san antonio (if completing saliva collection protocol) exclusion criteria: * inability to read and speak english or spanish * vision or hearing impairment affecting ability to complete study protocols (e.g., blindness) additional exclusion criteria if completing saliva collection protocol: * experiencing a major health event within the previous 6 months (e.g., stroke, myocardial infarction, in-patient surgery, cancer besides skin cancer) * symptoms of infectious disease within the previous 14-days (e.g., covid-19, oral infection) * diagnosis of major depressive disorder * hpa axis endocrine disorder (e.g., cushings or addison's disease) * use of corticosteroid medication * pregnancy * participation in overnight shift work
connected health care in exercise program for obesity

Conditions: Obesity; Physical Activity; Exercise

Summary: many kinds of wearable technology have become available, but the superiority of those devices in weight loss compared to the standard care without them is uncertain. the possible problems are long-term self-motivation, utility and validity of the device, and outcome measures in clinical trials. the connected health care with motivational interviewing as an intervention, and body composition parameters in addition to body weight as outcome measures are employed in the project. the expected outcome is that connected health care, which is more individualized approach by heath care professionals, is more effective compared to self-monitoring using wearable devices. two types of wearable device are going to be used to monitor 1) body activity and 2) heart rate variables during exercise which reflect fitness level in this study in order to investigate appropriate monitoring parameters to predict outcome measures. the hypothesis is that addition of connected health system will result in improvement of body composition and fitness level compared to self-monitoring.

patients with age 18 to 59 years old and body mass index between 30 to 39.9 are to be enrolled at mayo clinic in arizona. all enrolled subjects receive wearable monitoring devices with remote tracking capability and brochure regarding nutrition and physical exercise with basic instruction. subjects are randomly assigned to connected health care group versus self-monitoring group. connected health care group will have 2 interviews about physical exercise and 6 communications with individualized instruction and counseling of their exercise including the usage of the monitoring devices. self-monitoring group will do physical exercise following the initial basic instruction and self-monitor them. all subjects visit mayo clinic to get outcome measures at 0, 12, and 24weeks. outcome measures will be compared before, at 12 weeks, and after the 24 weeks of the fitness program.

Eligibility criteria:
inclusion criteria: * body mass index of 30 to \<40 kg/m\^2 exclusion criteria: * end of organ damage from hypertension * diabetes * liver disease * chronic lung disease * neuromuscular disease * any conditions that limit exercise * currently involved in other weight program

Keywords: obesity physical activity exercise wearable device
representation and medication use in juvenile idiopathic arthritis

Conditions: Juvenile Idiopathic Arthritis

Summary: according to the international league of associations for rheumatology classification, juvenile idiopathic arthritis (jia) comprises a heterogeneous group of arthritis of unknown cause and with onset before 16 years of age, characterized by joint inflammation lasting for 6 or more weeks. few studies exist regarding the care experience of children affected by this rheumatic condition. on the other hand, methotrexate and biologics constitute the primary treatment for children with jia. as with adults undergoing the same treatment, adherence is critical. difficulties for children to take the drugs have been reported. notwithstanding, if adherence promotion in pediatric chronic conditions has been the subject of recommendations with regard to care management, the investigators lack information to understand the grounds for adherence specifically in jia. in order to understand and decipher the parent-child adherence mechanisms and practices, the rumaji study will be conducted. indeed, improving the relational approach between children and their caregivers as well as unrestricted drug adherence involves researching and understanding how appropriation of the disease and treatment could be achieved.


Eligibility criteria:
inclusion criteria: * all jia forms * all treatment type (nsaids, mtx, bdmards) exclusion criteria: - none

Keywords: role of parents, children and physician qualitative interview juvenile idiopathic arthritis adherence mechanisms of adherence in juvenile idiopathic arthritis