Kornimate/medical-research-clean huggingface dataset:
study of xmab®819 in subjects with advanced clear cell renal cell carcinoma

Conditions: Clear Cell Renal Cell Carcinoma

Summary: the purpose of this study is to assess the safety and tolerability of xmab®819 administered intravenous (iv) or subcutaneous (sc) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (rd).

this is a phase 1, multicenter, open-label, multiple-dose study designed in 2 parts: part a, dose escalation, and part b, dose expansion. the study is designed to establish the dosing schedule of xmab819 administered iv and the dosing schedule of xmab819 administered sc. the study is designed to evaluate safety and tolerability; to assess pk/pd and immunogenicity; and to preliminarily assess antitumor activity of xmab819 in subjects with ccrcc. all eligible subjects will have relapsed or refractory disease after standard therapy.

Eligibility criteria:
inclusion criteria: * subjects must have measurable disease by response evaluation criteria in solid tumors (recist 1.1) as assessed by the local site investigator. lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. * subjects who have relapsed and refractory ccrcc with evidence of disease progression on standard-of-care therapies * ecog performance status of 0 or 1. * all subjects must have adequate tumor sample available (slides or archival ffpe blocks) exclusion criteria: * prior treatment with an investigational anti-enpp3/cd203c therapy * history of serious allergic or anaphylactic/hypersensitivity reaction to monoclonal antibody therapy * systemic antineoplastic therapy within 5 half-lives on the first dose of study treatment. * failure to recover from any clinically significant toxicity related to previous anticancer treatment * have known active central nervous system metastases and/or carcinomatous meningitis. subjects with previously treated brain metastases may participate provided they are radiologically stable, * active known autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus; residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and nonsteroidal anti-inflammatory drugs) * evidence of any serious infection requiring iv anti-infective treatment within 14 days prior to the first dose of study drug * have a known additional malignancy that is progressing or has required active treatment within the past 2 years

Keywords: ccrcc rcc renal cell cancer kidney cancer
resistance training as treatment of achilles tendinopathy

Conditions: Achilles Tendinopathy

Summary: the use of eccentric resistance training as management of achilles tendinopathy is widespread. the investigators have recently demonstrated that heavy slow resistance training was superior in the management of patellar tendinopathy. hypothesis: heavy slow resistance training is more effective than eccentric resistance training in the clinical management of achilles tendinopathy.


Eligibility criteria:
inclusion criteria: * unilateral achilles tendon pain, * symptoms for at least three months, * ultrasonographical tendon abnormalities, and * able to comply with both intervention arms. exclusion criteria: * bilateral symptoms, * previous surgery below knee, * corticosteroid injections below the knee during past year, * hypercholesterol, * diabetes, or * arthritis.

Keywords: tendinopathy, achilles, eccentric training, heavy slow resistance training
expanded access study of exebacase in covid-19 patients with persistent mrsa bacteremia

Conditions: MRSA Bloodstream Infection; MRSA Bacteremia; MRSA Right-sided Endocarditis; Covid19

Summary: this is an open-label, expanded access study of exebacase used in addition to antistaphylococcal antibiotics in adult patients with persistent methicillin-resistant staphylococcus aureus (mrsa) bloodstream infections (bsi), including right-sided endocarditis (r-ie), who are hospitalized with coronavirus disease 2019 (covid-19). patients with left-sided endocarditis (l-ie) are excluded. patients will receive a single dose of exebacase. patients will continue to receive antistaphylococcal antibiotics as prescribed by the treating physician. exebacase phase 3 study sites (study cf-301-105) may participate in this expanded access study (study cf-301-107). exebacase, a direct lytic agent, is an entirely new treatment modality against s. aureus. exebacase is a recombinantly-produced, purified cell wall hydrolase enzyme that results in rapid bacteriolysis, potent biofilm eradication, synergy with antibiotics, low propensity for resistance, and the potential to suppress antibiotic resistance when used together with antibiotics. exebacase represents a first-in-field, first-in-class treatment with the potential to improve clinical outcome when used in addition to standard-of-care antibiotics to treat s. aureus bsi including ie.


Eligibility criteria:
inclusion criteria: * male or female, 18 years of age or older. * hospitalized with known covid-19 infection confirmed by positive diagnostic test. * not eligible for the exebacase phase 3 study (cf-301-105). * blood cultures positive for mrsa for ≥3 days. * patient is not pregnant or breastfeeding and is not of reproductive potential or agrees to remain abstinent or use contraception if of reproductive potential. exclusion criteria: * known or suspected left-sided ie. * intubated for covid-19. * presence of prosthetic valve or cardiac valve support ring, or presence of known infected orthopedic hardware, prosthetic joint, or cardiac device. * known or suspected brain abscess or meningitis. * participation in an investigational study or expanded access protocol for another antistaphylococcal antibacterial agent.
major hepatectomy and vascular clamping

Conditions: Liver Diseases

Summary: a major hepatectomy consists of the resection of 3 or more liver segments. its indications are mainly secondary malignant lesions, then primary malignant lesions, benign lesions and septic resections. around a hundred major hepatectomies are carried out every year in strasbourg. this surgery is burdened by 4.5% mortality at day 90 and 20 to 50% morbidity. the main intraoperative risks are hemorrhage and hemodynamic instability. surgical vascular clamping helps reduce the risk of bleeding but is responsible for sometimes major hemodynamic variations, ischemia-reperfusion syndromes and can lead to acute post-operative liver failure. recent literature attests to the safety of liver resection without vascular clamping, which is why it is less and less practiced. different elements are identified as independent risk factors for morbidity and mortality: the presence of cirrhosis, portal embolization, history of renal or cardiac failure, duration of vascular clamping, resected liver volume, transfusion of products labile blood and associated surgical procedures. given the significant risk of intra- and post-operative complications, it seems relevant to analyze pre- and intra-operative data in order to highlight risk factors for vascular clamping. this would allow better anticipation of complications, patient information, adaptation of intraoperative monitoring and postoperative surveillance and perhaps a reduction in complications. this study also makes it possible to take stock of the epidemiology around hepatectomies performed at the strasbourg university hospital.


Eligibility criteria:
inclusion criteria: * major subject (≥ 18 years old) * subject operated on for a major hepatectomy at strasbourg university hospital during the period from january 1, 2023 to december 31/2023 * subject who has not expressed opposition to the reuse of their data for scientific research purposes. exclusion criteria: * subject having expressed opposition to participating in the study * history of liver resection

Keywords: liver diseases hepatectomy liver cancer
immunologic action of a single dose cholecalciferol

Conditions: Vitamin D Deficiency

Summary: vitamin d receptors are expressed in activated different immune cells. it is not known, which immune cell type is targeted by exogenous vitamin d. here, vitamin d-deficient individuals will receive once 100.000 i.u. vitamin d3 either intramuscular or subcutaneous in a double-blind placebo controlled setting. immune cells will be monitored from the blood over time.

vitamin d-deficient individuals will receive once * double-blind, placebo controlled 100.000 i.u.vitamin d3 * intramuscular or subcutaneous blood will be taken over time and * immune cells (t cells, b cells, myeloid antigen presenting cells) are characterized by flow-cytometry * vitamin d-metabolites will be monitored

Eligibility criteria:
inclusion criteria: * informed consent * 18-60 yrs * 25-hydroxyvitamin d serum below 50 nmol/l * women only: effective contraception exclusion criteria: * 25-hydroxyvitamin d serum above 50 nmol/l * body-mass index \ 30 kg per m2 * planned uv-exposure (uv-index \> 5) * hypersensitivity to vitamin d * history of hypercalcemia, kidney stones, kidney insufficiency, sarcoidosis, pseudohyperparathyroidism concomitant vitamin a- and/or vitamin d treatment * treatment with immunosuppressants, immunomodulators, phenytoin, barbiturate, thiazide-diuretics, glycosides * immobile patients * out of normal range on screening visit (calcium,phosphate,creatinin,hematology) * psychiatric hospitalization * pregnancy / breast-feeding * dependency / relationship on sponsor * concomitant participation in other clinical trials (30 days before) * drug or alcohol abuse * lack of compliance

Keywords: vitamin d vitamin d deficiency immune cells pharmacokinetic < 50 nmol/l 25(oh)d serum concentration
metabolic, endocrine and appetite-related responses in healthy, adolescent males after acute and daily milk consumption

Conditions: Appetite Regulation

Summary: comprising two experiments, the investigators assessed the metabolic, endocrine and appetite-related responses to acute (1-d, part 1) and daily mid-morning milk consumption (28-d, part 2) in adolescent males (15-18 y).

the aims of the present study were twofold. firstly, this study sought to examine the acute (1-d) effects of mid-morning milk consumption on subsequent metabolic, endocrine and appetite-related responses relative to an isoenergetic and isovolumetric serving of fruit-juice (part 1). considering the putative mechanisms of milk consumption on appetite, feeding behavior and metabolism no studies are available that have explored the impact of daily milk or dairy food consumption on the above mentioned constructs in children and adolescents. this study therefore also aimed to compare the effect of daily (28-d) mid-morning milk or fruit-juice consumption on the above mentioned constructs (part 2). eleven adolescents participated in part 1 of this study and completed two trials (milk or fruit-juice mid-morning snack) in a randomized crossover design. for part 2, a parallel design with two intervention groups was employed. participants were randomly allocated to groups, and received either a milk (n = 10) or an isocaloric and isovolumetric fruit-juice (n = 9) mid-morning snack for 28-d. on laboratory visits (for both part 1 and 2) participants remained at rest for 180 min. during this time, circulating concentrations of glp-17-36, glucagon, insulin, leptin and blood glucose were determined. measures of energy expenditure, substrate metabolism and subjective appetite were also collected. at 180 min, a homogenous ad libitum pasta meal was provided. for the remainder of the study day, subsequent energy intake was recorded utilizing a combined weighed self-reported food record and 24-h dietary recall technique.

Eligibility criteria:
inclusion criteria: 1. male 2. non diabetic 3. 15-18 yrs exclusion criteria: 1. are outside of the stipulated age range (15-18 years old) 2. a diabetic 3. hold an aversion/dislike to milk, milk based products and the test meals provided. 4. are known to be lactose intolerant 5. currently taking any form of medication known to affect taste, smell and appetite 6. female

Keywords: dairy appetite feeding behaviour
virtual reality technology versus standard technology during pediatric oral food challenge

Conditions: Food Allergy in Children; Food Allergy

Summary: the purpose of this study is to determine if non-invasive distracting devices (virtual reality headset) are more effective than the standard of care of utilizing existing technologies that are currently more common in food allergy research treatment and clinics (i.e. television and patients' personal electronic devices) for decreasing levels anxiety and fear in pediatric patients undergoing oral food challenge (ofc) and their caregivers.


Eligibility criteria:
inclusion criteria: * between the ages of 5 and 17 * willing to participate in both the vr and standard of care technology conditions * able to consent or have parental consent * undergoing at least two oral food challenges within the window of recruitment at the sean n. parker center exclusion criteria: * people who do not consent * significant cognitive impairment * history of severe motion sickness * current nausea * seizures * visual problems * non-english speaking * patients who clinically unstable or requires urgent/emergent intervention * asa class 4 or higher

Keywords: food allergy oral food challenge virtual reality
antimicrobial resistance of bacteria in burn patients

Conditions: Burns

Summary: the purpose of this study is to test the resistance of pathogenic bacteria in infected tissues of burn patients to various antimicrobials and enzyme debriders.

bacteria that is present in infected burn wounds will be isolated and identified. the isolates will be tested for resistance to commercially available antimicrobials.

Eligibility criteria:
inclusion criteria: * males and females of any age * have open, unhealed wounds(s) that will be cultured per standard of care * subject or authorized representative provide informed consent exclusion criteria: * informed consent not provided or able to be obtained

Keywords: burn antimicrobial bacteria resistance biofilm pathogen
neuraxial preservative free morphine for normal spontaneous vaginal delivery

Conditions: Postpartum Pain; Postpartum Depression; Opioid Consumption

Summary: patients presenting for normal spontaneous vaginal delivery who have a neuraxial anesthestic will be randomized to receive preservative free morphine or saline placebo after delivery.

after obtaining consent, women presenting to the labor floor at mount sinai hospital will be randomized into two groups, intervention and placebo. baseline demographic data and surveys in regards to postpartum depression, anxiety, breastfeed willingness and pain scores will be obtained. after delivery of the baby patients will either receive 2mg preservative free morphine or saline via the epidural catheter prior to its removal. the study team will then record pain and recovery scores, as well as follow up screens to the aforementioned endpoints. the study will end at the 6 week postpartum visit with the patient's obstetrician.

Eligibility criteria:
inclusion criteria: * pregnant women in labor exclusion criteria: * not a candidate for neuraxial anesthesia * patient refusal * allergy to morphine * patients with chronic pain syndromes

Keywords: postpartum depression postpartum anxiety postpartum opioids
contingency management for smoking in substance abusers

Conditions: Substance Abuse

Summary: the aim of this study is to determine whether contingent reinforcement for smoking abstinence, compared to noncontingent reinforcement, increases the effectiveness of brief counseling and nicotine replacement on smoking abstinence of substance abusers in residential treatment.

substance abusers have a high prevalence and rate of smoking with little success in quitting, so stronger approaches are needed to encourage attempts to quit smoking. the aim of this study is to determine whether contingent reinforcement for smoking abstinence (cm), compared to noncontingent reinforcement (nr), increases the effectiveness of brief counseling and nicotine replacement on smoking abstinence of substance abusers in residential treatment. the proposed study will be a 2-group design in which up to 274 substance abusers who smoke 10 or more cigarettes per day receive brief advice (4 sessions) and nicotine replacement (nrt) (8 weeks), and are randomized to 19 days of cm for smoking vs. a matched nr condition. the brief advice is adapted slightly for sobriety settings. point-prevalence abstinence will be assessed at 1, 3, 6 and 12 months after starting treatment. secondary aims evaluate effects of cm on substance use outcomes and potential mediators of effects on outcome, including within-treatment abstinence, motivation level and tolerance for smoking discomfort. the significance is to add knowledge about the most effective ways to maximize smoking cessation among substance abusers, important given that no methods are known to work with this population.

Eligibility criteria:
inclusion criteria: * diagnosis of substance abuse or dependence by dsm-iv criteria * in residential treatment at one particular agency * currently smoking at least 10 cigarettes per day for the past 6 months exclusion criteria: * hallucinating or delusional or marked organic impairment (to the point of impairing ability to understand informed consent) according to medical records * current use of nicotine replacement therapy, zyban, or any other smoking cessation treatment * medical exclusions for nrt: pregnant or nursing; treatment in the last 3 months for unstable angina, severe congestive heart failure, uncontrolled hypertension; lung cancer; supplemental oxygen; history of adverse reactions to nrt; allergies to adhesive; or any severe skin disease that requires treatment (e.g., psoriasis or eczema).

Keywords: contingency management for smoking for substance abusers contingency reinforcement for smoking abstinence contingency management noncontingent reinforcement
d-dimer testing tailored to clinical pretest probability in suspected pulmonary embolism

Conditions: Pulmonary Embolism

Summary: prospective, multicentre, cohort study assessing a diagnostic management strategy for suspected pulmonary embolism with independent central adjudication of outcomes

this is a prospective, multi-centre, cohort study that will assess a new diagnostic management strategy for suspected pulmonary embolism (inpatients and outpatients). the new diagnostic strategy is designed to reduce the use of imaging tests for pulmonary embolism, particularly computed tomography pulmonary angiogram, by excluding pulmonary embolism with combinations of clinical pretest probability and d-dimer results in a higher proportion of patients. the safety of this management strategy will be established by demonstrating a very low rate of proximal deep vein thrombosis or pulmonary embolism during 90 days of follow-up in patients who had anticoagulant therapy withheld in response to negative diagnostic testing. diagnostic test utilization will be assessed. all clinical outcomes will be adjudicated by a central independent adjudication committee that will be blind to initial d-dimer measurements and patient management.

Eligibility criteria:
inclusion criteria: * patients (either outpatients or inpatients) with clinically suspected pulmonary embolism. exclusion criteria: 1. age less than 18 years. 2. treated with full-dose anticoagulation for ≥ 24 hours before d-dimer was measured. 3. major surgery (general or spinal anesthesia) in the past 21 days. 4. result of the d-dimer assay that will be used to manage the patient in the study is known before clinical pretest probability was done. 5. computed tomography pulmonary angiogram or ventilation perfusion scan was performed: 1. before clinical pretest probability was documented, or 2. in a patient with low clinical pretest probability and a d-dimer level \<1,000 ug/l (or equivalent), or 3. in a patient with moderate clinical pretest probability and a d-dimer level \<500 ug/l (or equivalent). 6. computed tomography of the chest with contrast will be performed for another reason (e.g. to assess for malignant disease or aortic dissection), and would be performed even if pulmonary embolism is excluded by clinical pretest probability and d-dimer testing. 7. ongoing need for anticoagulant therapy. 8. life expectancy less than 3 months. 9. geographic inaccessibility which precludes follow-up. 10. known pregnancy. 11. inability to provide informed consent.
bariatric surgery on the west coast of norway (vestlandet)

Conditions: Weight Loss; Diabetes Mellitus; Urinary Incontinence

Summary: bariatric surgery of morbid obesity was first located at førde central hospital, but it is now an established treatment at several other hospitals in the health region (voss hospital (helse bergen), haugesund hospital (helse fonna) stavanger university hospital ((sus) helse stavanger). surgical methods vary between hospitals: voss: sleeve gastrectomy, haugesund: gastric bypass (roux-en y),sus: gastric bypass (roux-en y); førde: biliopancreatic diversion with duodenal switch (bpd / ds) and sleeve gastrectomy . the investigators have then in helse-vest a unique opportunity to examine the various clinical and metabolic effects from different surgical methods. this project is part of the regional strategic research initiative in the helse vest

primary endpoints for the study are weight loss and self-reported quality of life (qol) evaluated by short form (sf)-36 and impact of weight wed quality of life-lite (iwqol-lite)) our hypothesis is that patients operated with rygbp (roux a-y gastric bypass) and bpd / ds (biliopancreatic diversion with duodenal switch) have the same weight and same qol after 5 years of follow-up as patients treated with gastric sleeve (laparoscopic gastric sleeve (lsg)) we will also compare the groups with respect to a number of secondary endpoints 400 patients (approximately 100 patients / institution) will be included in the main study. some of the programs that run on secondary endpoints will be conducted separately under study at each hospital. these studies will be reported in separate articles.

Eligibility criteria:
inclusion criteria: * both sexes 18-60 years old * patients with morbid obesity that is applied to the bariatric surgery. * signed informed consent exclusion criteria: * patients who become pregnant in the follow-up period will not continue in the study but the data will be treated as lost too follow up.

Keywords: lipids
clinical trial to assess the immunogenicity and safety of the vero cell-derived je vaccine in korea

Conditions: Japanese Encephalitis

Summary: to assess the immunogenicity and safety of the vero cell-derived inactivated je vaccine in korean healthy children aged 12\~23 months

to compare the vero cell-derived inactivated japanese encephalitis(je) vaccine 'kd-287(jeimmugen inj.)' with the mouse brain-derived inactivated je vaccine in terms of the immunogenicity and safety, in korean healthy children aged 12\~23 months

Eligibility criteria:
inclusion criteria: * healthy children aged 12-23 months * written informed consent exclusion criteria: * history of documented hiv * known or suspected impairment of immunologic function * history of serious chronic disease * received any je vaccine prior to enrollment

Keywords: jev vero cell