Kornimate/medical-research-clean huggingface dataset:
pre-operative exposure to sglt2 inhibitors and post-operative acute renal failure in cardiac surgery

Conditions: Acute Kidney Injury; Cardiac Surgery; Sodium/Glucose Cotransporter Inhibitor 2

Summary: cardiac surgery with cardiopulmonary bypass exposes patients to the risk of post-operative acute kidney injury. in the specific setting of cardiac surgery, acute kidney injury is often of multifactorial origindue to particular haemodynamic mechanisms, renal hypoxia, or damage linked in the inflammatory reaction or haemolysis. in recent years, inhibitors of the sodium/glucose co-transporter type 2 have demonstrated their relevance in reducing the morbidity and mortality associated with chronic or acute heart failure and chronic kidney disease. these drugs were initially developed to optimise glycaemic control in diabetic patients. they are currently recommended as part of the management of diabetic patients at high cardiovascular risk, patients with systolic and/or diastolic heart failure, and patients with chronic kidney disease. some pharmacodynamic properties of sglt2i suggest that they could have a beneficial effect in preventing the onset of acute kidney injury, but also that they could lead to potentially deleterious effects in renal haemodynamic in specific situations. the aim of the study was to estimate the impact of pre-operative exposure to sglt2i on the occurrence of post-operative acute kidney injury in high-risk renal patients undergoing cardiac surgery.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * cardiac surgery with cardiopulmonary bypass * presenting a simplified renal risk score ≥ 2 points defined as follows: * pre-operative glomerular filtration rate (≤ 60; ≤ 30 ml/min/1.73m2): 1-2 points * diabetes requiring treatment: 1 point * lvef ≤ 40%: 1 point * previous cardiac surgery: 1 point * pre-operative intra-aortic counter pulsation: 1 point * non elective surgery: 1 point * surgery other than closure of an atrial septal defect or coronary bypass surgery: 1 point exclusion criteria: * haemodialysis prior to surgery * acute kidney injury prior to surgery as defined in the primary endpoint. if this criterion is not available, patients will only be included if glomerular filtration rate estimated by the ckd-epi formula is ≥75 ml/min/1.73m2. * death in the operating theatre * opposition of the patient to the use of his/her health data

Keywords: acute kidney injury
phase 2 open label study of tafenoquine for treatment of chronic babesiosis patients with severe fatigue

Conditions: Chronic Babesiosis

Summary: phase 2 open label study of tafenoquine for treatment of chronic babesiosis patients with severe fatigue


Eligibility criteria:
inclusion criteria: * male or female, aged ≥ 18 years * has received a diagnosis of chronic babesiosis * severe disabling fatigue * able and willing to give written informed consent * able and willing to perform all study assessments * if female negative urine pregnancy test and * if female agree to use an acceptable method of birth control exclusion criteria: * glucose-6-phosphate-dehydrogenase (g6pd) deficiency * breastfeeding * unmanaged psychotic disorder * known hypersensitivity reaction to tafenoquine or other 8-aminoquinolines * current or planned treatment with quinine * any concomitant significant illness unrelated to babesiosis * any excluded concomitant medication * taking or intending to take quinine * the patient is unable to tolerate medication by the oral route * the patient has previously taken tafenoquine

Keywords: chronic babesiosis
effects of ketone monoesters on brain function

Conditions: Brain Insulin Sensitivity; Brain Vascular Function; Cerebral Blood Flow; Cognitive Performance; Appetite Control

Summary: disturbances in brain insulin-sensitivity are not only observed in obesity and type 2 diabetes (t2d), but also during brain aging and in dementia. ketone monoester supplements may improve brain insulin-sensitivity, which can be quantified by measuring the gray-matter cerebral blood flow (cbf) response to intranasally administered insulin. we hypothesize that acute ketone monoester supplementation increases (regional) brain vascular function and insulin-sensitivity thereby improving cognitive performance and appetite control. the primary objective is to evaluate in older men the acute effect of ketone monoester supplementation on (regional) brain vascular function and insulin-sensitivity, as quantified by the non-invasive gold standard magnetic resonance imaging (mri)-perfusion method arterial spin labelling (asl). the cbf response to intranasal insulin is a robust and sensitive physiological marker of brain insulin-sensitivity. secondary objectives are to investigate effects on cognitive performance as assessed with a neuropsychological test battery, and appetite control as quantified by functional mri (fmri) with visual food cues.


Eligibility criteria:
inclusion criteria: * men, aged between 60-75 years * bmi between 25-30 kg/m2 * fasting plasma glucose \< 7.0 mmol/l * fasting serum tc \< 8.0 mmol/l * fasting serum tag \< 4.5 mmol/l * systolic blood pressure \< 160 mmhg and diastolic blood pressure \< 100 mmhg * stable body weight (weight gain or loss \< 3 kg in the past three months) * willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study * no difficult venipuncture as evidenced during the screening visit exclusion criteria: * women * left-handedness * following a low-carbohydrate diet or consuming nutritional ketone supplements * current smoker, or smoking cessation \< 12 months * diabetic patients * familial hypercholesterolemia * abuse of drugs * more than 3 alcoholic consumptions per day * use of products or dietary supplements known to interfere with the main outcomes as judged by the principal investigators * use medication to treat blood pressure, lipid or glucose metabolism, or neurological or mental disorders. * use of an investigational product within another biomedical intervention trial within the previous 1-month * severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis * active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident * contra-indications for mri imaging (e.g. pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia).
open dialogue about complementary alternative medicine

Conditions: Cancer

Summary: the purpose of this phase iii parallel-group randomized controlled trial is to assess the efficacy of open dialogue about complementary alternative medicine integrated in conventional oncology care (odc-coc). the investigators hypothesize that patients in the intervention group participating in an odc-coc with a nurse specialist report better quality of life compared to patients in the control group receiving standard care alone.

patients randomized to the intervention group will participate in a scheduled odc-coc with a specialist nurse, who has completed the fellowship in integrative medicine at the university of arizona. this is a training program for health professionals in empowering individuals and communities to optimize health and well-being through evidence-based, sustainable and integrative approaches. the odc-coc will be based on the fundamentals of person-centered care according to this program and include patient preferences and wishes, reliable information and counselling and advice about the potential risks and benefits of using complementary alternative medicine as an adjunct to conventional oncology care. the dialogue lasts approximately 60 minutes and will take place as soon as possible and no later than two weeks after enrolment. the same nurse will conduct all dialogues. according to patient needs and wishes there may be a follow-up dialogue over the telephone or in the oncology outpatient clinic. the potential second dialogue is estimated to last approximately 30 minutes. participants in the control group will receive standard information including reference to www.kabcancer.dk, which is a website presenting research on cam, including information about its potential effects and outcomes.

Eligibility criteria:
inclusion criteria: * speaks and reads danish * diagnosed with a new primary cancer or a relapse of cancer within the last 3 months * planned or initiated medical oncology treatment at the department of oncology, vejle hospital * at least two months of oncology treatment is realistic based on clinical assessment * life expectancy of at least six months * informed consent exclusion criteria: -participation in other trials

Keywords: alternative medicine cancer communication complementary medicine dialogue integrative medicine oncology
interest of day hospital care for patients with chronic regional pain syndrome referred to the chronic pain unit for the first time

Conditions: Chronic Regional Pain Syndrome

Summary: chronic regional pain syndrome (crps) is a chronic disabling disease. patients present a variable picture associating pain localized to an articular or peri-articular region, motor and vasomotor disorders and trophic disorders. its pathophysiology, still poorly understood to this day, results from local inflammatory phenomena complicated by peripheral sensitization and central spinal and cerebral sensitization. the diagnosis is made difficult by the fluctuating nature of the symptoms and the absence of specific complementary examination. the treatment of crps is symptomatic and requires multidisciplinary care. crps is responsible for an alteration in the patient's quality of life. this pathology has a global impact because it affects not only the biomedical sphere but also the socio-family, professional and psychological spheres. the investigators hypothesize that multidisciplinary intervention in the day hospital would improve the quality of life of patients with crps. the investigators also think that the passage in day hospital would make it possible to improve the pains, the functionality of the affected limb as well as the satisfaction of the patients.


Eligibility criteria:
inclusion criteria: * patient volunteers over 18 years of age * diagnosis of crps according to the budapest criteria * referred to pain assessment and treatment center exclusion criteria: * patients unable to express their wishes or understand the protocol * diagnosis of crps not meeting budapest criteria * patients previously seen at pain assessment and treatment center for the care of crps

Keywords: chronic regional pain syndrome day hospital chronic pain unit
zostavax™ safety and immunogenicity in korean adults (v211-034)

Conditions: Herpes Zoster; Shingles

Summary: this study will evaluate the safety, tolerability, and immunogenicity of zostavax™ in korean adults. approximately 180 herpes zoster history negative subjects ≥ 50 years of age will be enrolled in the study. each subject will receive a single dose of zostavax™. no statistical hypothesis testing will be conducted in the study.


Eligibility criteria:
inclusion criteria: * no fever on day of vaccination * females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal * underlying chronic illness must be stable exclusion criteria: * history of hypersensitivity reaction to any vaccine component * prior history of herpes zoster * prior receipt of varicella or zoster vaccine * pregnant or breastfeeding * have recently received immunoglobulins or blood products other than autologous blood transfusion * received any inactivated other live virus vaccine within 4 weeks prior to vaccination, or is expected to received any other live virus vaccine during the duration of the study * received any inactivated vaccine within 7 days prior to vaccination, or is expected to receive any inactivated vaccine during the duration of the study * use of immunosuppressive therapy * known or suspected immune dysfunction * use of nontopical antiviral therapy with activity against herpes virus * known or suspected active untreated tuberculosis
multidimensional school-based and family interventions to promote healthy and sustainable lifestyle for the childhood

Conditions: Childhood Obesity

Summary: childhood obesity condition has increased 10 times in the last 40 years, representing one of the most important public health challenges of our century. the overweight and obesity in children are conditions associated with several determinants, mostly related to dietary habits, physical activity, and environmental behavior. to counteract childhood obesity, several prevention programs have been promoted, however evidence concerning their efficacy was contrasting, especially among the younger population and in the long term. moreover, due to the wide variety of interventions administered it is not clear which specific strategy (or combinations of strategies) was the most effective. the lively study aims 1) to assess the prevalence and the factors associated to childhood overweight and obesity; 2) to develop multidimensional strategies for prevention of childhood obesity by involving families and recognizing the role of schools as an environment for raising awareness on healthy and sustainable dietary patterns and lifestyle.

lively is a study with a one group pre-test - post-test design (without control). the study will be conducted in the primary schools of the istituto luigi cadorna in milano (lombardy region, northern italy). the study population will involve children (6-11 years) belonging to different socioeconomic status and ethnic groups, attending classes of the school whose teachers will accept to participate. the educational interventions will consist in:

Eligibility criteria:
inclusion criteria: * children 6-11 years * children whose parents will provide written consent to participate. exclusion criteria: * children who do not have inclusion criteria.

Keywords: childhood obesity prevention childhood obesity determinants educational interventions primary schools
human beta-defensin 1 in vitiligo

Conditions: Vitiligo

Summary: there is a need to know the role of human beta defensin-1 in vitiligo pathogenesis and the probability of finding newer and effective therapy for vitiligo in the future.


Eligibility criteria:
inclusion criteria: * patients with non-segmental vitiligo. * both genders. * age more than 18 years old. * new cases or cases not receiving any treatment for at least 3 months prior to the study. exclusion criteria: * universal or segmental vitiligo. * any contraindication to phototherapy treatment. * history of autoimmune diseases or other systemic diseases. * any other skin disease.
hypovitaminosis d prediction score

Conditions: Vitamin D Status

Summary: vitamin d has effects on many tissues, and hypovitaminosis d is frequent. in a french survey conducted among 1587 adults, vitamin d insufficiency (\<30ng/ml) has been reported in 80% of subjects, including 43% with moderate deficiency (\<20ng/ml) and 5% with severe deficiency (\<10ng/ml). because of the possible consequences of hypovitaminosis d (osteomalacia in adults...), the number of vitamin d determination has increased ten-fold since 2005 in france, reaching 4.5 million € in 2011, and with it the costs for health insurance. however, there is currently no consensus on the strategy for detection, diagnosis and treatment of hypovitaminosis d. we propose to develop a predictive clinical score of hypovitaminosis d based on the accurate assessment of solar exposure, vitamin d intakes and hypovitaminosis d risk factors collected through a self-administered questionnaire.


Eligibility criteria:
inclusion criteria: - men and women aged 18 to 70 years old exclusion criteria: * participation in a study related to vitamin d * taking at least 80 000 iu vitamin d in the last 3 months as a single dose * pregnancy or breast-feeding * renal failure : severe renal impairment, dialysis, having kidney transplant * known hepatic impairment * gastrointestinal disorders: celiac disease, crohn's disease, ulcerative colitis, bariatric surgery, gastrointestinal surgery with stoma * known primary hypo/hyperparathyroidism * bone cancer/metastases current or in the last 2 years * treatment with antiepileptics * long-term treatment with glucocorticoids (\> 3 months) * treatment with antiretroviral * legal incapacity or limited legal capacity * non-recipient of french social security
acupuncture in neonatal abstinence syndrome (nas) babies

Conditions: Neonatal Abstinence Syndrome

Summary: this pilot study is intended to assess feasibility of auricular acupuncture in nas infants who require pharmacologic therapy. we intend to evaluate acceptability of auricular acupuncture, infant tolerance, recruitment strategies, and methodological issues. we plan to also test and generate hypotheses in preparation to apply for funding a larger randomized controlled trial.

objectives: primary: to establish feasibility of a protocol for auricular acupuncture in infants suffering from nas admitted to the nicu receiving pharmacologic therapy. secondary: in infants suffering from nas admitted to the neonatal intensive care unit (nicu) receiving pharmacologic therapy: 1. determine parent and staff acceptability of auricular acupuncture 2. determine infant tolerance to auricular acupuncture 3. evaluate the effect of auricular acupuncture on individual items of the modified finnegan neonatal abstinence severity score associated with sympathetic nervous system responses 4. evaluate the effect of auricular acupuncture on time to return to birth weight

Eligibility criteria:
inclusion criteria: 1. gestational age ≥37.0 wks assessed by the obstetrical team from dating of last menstrual period, ultrasound, or best obstetric estimate 2. admitted to nicu with diagnosis of nas requiring pharmacologic therapy 3. parents give written consent within 72 hours of infant receiving first dose of methadone exclusion criteria: 1. helix or antihelix of ear is deformed and needle is unable to be placed 2. a suspected or confirmed genetic or metabolic syndrome 3. custody retained by the department of children and families 4. any skin condition involving the ear(s) 5. suspected or documented infection at the time of enrollment

Keywords: acupuncture
clinical study on the effect of ivf-et on mother-to-child transmission of hepatitis b virus

Conditions: Pregnancy

Summary: this study is intended to retrospectively collect hbv-infected pregnant women and non-hbv-infected pregnant women who have been born in ivf in the investigators' hospital, collect pregnant women's data during pregnancy, newborn birth data, and hepatitis b virus in july after birth of newborns born to hbv-infected pregnant women. infection, explore the impact of hbv infection on ivf outcomes and whether ivf operations increase the risk of mother-to-child transmission of hbv.

this study is a retrospective study that only retrospectively collects a variety of patient data and does not perform any treatment or examination on the patient. the research design is as follows: 1. all patients with hbv-infected pregnant women and non-hbv-infected pregnant women who had undergone ivf operation were retrospectively collected from the investigators' hospital his system. 2.collecting pregnant women's data from the his system (including age, maternal history, liver function during pregnancy, hbv dna in early pregnancy and before delivery, complication and complications during pregnancy, antiviral use before and during pregnancy, father hbv infection status), neonatal birth data (including body length, weight, apgar score, feeding status, hepatitis b vaccination, hepatitis b immunoglobulin use, hbsag at birth and 7 months after birth, hbv dna). 3. statistical analysis: (1) compare the body length, body weight, apgar score of newborns born to pregnant women with hbv infection and non-hbv infection, and understand the effect of hbv infection on ivf outcomes. (2) newborns born to hbv-infected pregnant women were divided into hbv dna-negative group, low-viral group, and high-viral group according to hbv dna status. the hbv infection status of these newborns was counted in july, and the different viral loads were tested. the impact on mother-to-child transmission of hbv. (3) when discussing whether ivf operation increases the rate of mother-to-child transmission of hbv, it is more scientific and persuasive to use hbv-infected pregnant women who have not been operated with ivf, but the incidence of twins in ivf is significantly higher than that of natural pregnancy. further lead to premature birth, postpartum hemorrhage, cesarean section rate, etc., the weight and length of newborns are also affected, so it is difficult to match the appropriate population, so this study decided to hbv infection rate of different hbv dna load ivf compared with the literature, the corresponding viral load of hbv infection was compared with the rate of mother-to-child transmission of ivf pregnant women.

Eligibility criteria:
inclusion criteria: * pregnant women who have been ivf-operated * hbv-infected pregnant women need to be positive for hbsag for more than half a year. exclusion criteria: * combined with pregnancy-induced hypertension, premature rupture of membranes, prenatal bleeding and other diseases; * history of amniocentesis during pregnancy; * combined with other viral infections: such as hcv, hiv, cmv.
study to evaluate the safety of subcutaneous alemtuzumab in patients with b-cell chronic lymphocytic leukemia

Conditions: B-CLL

Summary: this is a phase ii trial to study the safety and tolerability of subcutaneous alemtuzumab administered without dose escalation to patients with advanced b-cell chronic lymphocytic leukemia (b-cll).


Eligibility criteria:
inclusion criteria: * b-cll that has failed fludarabine exclusion criteria: * performance status grade 3