Kornimate/medical-research-clean huggingface dataset:
warming mattress versus polyethylene wrapping to prevent hypothermia in preterm newborns.

Conditions: Hypothermia

Summary: mean axillary temperatures, taken during nicu resuscitation upon admission to the nicu, will not differ between vlbw babies who are occlusively wrapped and very low birth weight (vlbw) babies who are placed on thermal warming blankets.


Eligibility criteria:
inclusion criteria: * participants in this study will be selected from the inborn population at university hospital. eligible patients will be selected from the group of babies with estimated gestational ages of 24-28 weeks and \<1250g. exclusion criteria: * congenital anomalies with open lesions such as meningomyelocele, or omphaloceles * blistering skin conditions * resuscitation not performed secondary to infant being below limits of viability as assessed by the in-house attending physician (specifically, according to current nrp recommendations): * where gestation, birth weight, and/or congenital anomalies are associated with almost certain early death, and unacceptably high morbidity is likely among the rare survivors, resuscitation is not indicated. exceptions may be made based on parental desires. * newborns with confirmed gestation age of less than 24 weeks or birth weight less than 400 grams * anencephaly * confirmed trisomy 13 or trisomy 18 syndrome * meconium staining of amniotic fluid * birth assessment of gestational age \> 28 weeks or \>1250 grams * maternal temp \>38 degrees c around the time of delivery.

Keywords: hypothermia prevention elgans(extremely low gestational age neonates) polyethylene wrap sodium acetate transport mattress
convergent mechanisms underlying reprometabolic syndrome in women

Conditions: Infertility, Female; Obesity

Summary: dr. nanette santoro proposes to test the specific question that obesity results in abnormal estradiol response at the level of the pituitary and hypothalamus. this will be shown in diminished pituitary sensitivity to gonadorelin releasing hormone with a reduced estradiol induced luteinizing hormone surge in obese women.

this is an open-label, single site study in pre-menopausal women aged 18-40 years old with a history of regular menstrual cycles (25-35 days long) of normal bmi or high bmi. the objective of the study is to determine the effects of an estradiol patch on luteinizing hormone rise in both cohorts. the study consists of 2 periods: a screening period of up to 3 weeks and a treatment period of 7-10 days. during the treatment period participants will wear estradiol patches for up to 7 days and have on blood draw on day 3 of wearing the patches. participants will also collect daily morning urine for all the days they wear the patches. participants will use a reliable barrier method of birth control or abstain from intercourse for the duration of the study.

Eligibility criteria:
inclusion criteria: * age 18-38 * regular menstrual cycles every 25-35 days * no use of reproductive hormones within the past 3 months * no use of medications interacting with reproductive hormones * agreement to use reliable barrier contraception or to abstain from intercourse for the duration of the study * normal thyroid stimulating hormone, prolactin and lipid profiles * no more than 4 hours of moderate to vigorous intensity exercise per week * no history of chronic disease impacting reproductive hormones * no contraindications to administration of estradiol * no history of estrogen dependent cancer * negative pregnancy test exclusion criteria: * has diabetes * is a smoker * history of venous thromboembolism or known thrombophilia

Keywords: obesity infertility hypothalamic-pituitary-ovarian axis pituitary dysfunction
brain blood flow and lactate in non-obese and obese subjects

Conditions: Diabetes; Obesity

Summary: cerebral blood flow (cbf) is essential for maintaining brain health and function, as it ensures delivery oxygen and nutrients necessary to support neuronal activity. reduced cbf can impair the brain's ability to meet its metabolic demands, leading to deficits in cognitive ability. impairments in cbf are associated with cognitive decline and neurodegenerative disease such as alzheimer's and dementia. many factors influence cbf, but recently lactate has emerged as a key player. blood glucose has long been considered the primary fuel for the brain, but emerging evidence indicates that lactate may be the preferred fuel for neurons, and lactate may become even more important under stressful conditions. individuals with obesity often have impaired lactate metabolism resulting in higher resting blood lactate concentrations and reduced ability to clear lactate after a physiological stress. at the same time, it is known that exercise is a powerful intervention for improving lactate metabolism. thus, this project seeks to investigate the role of lactate in brain blood flow in individuals with and without obesity as well as establish if short term exercise training (individuals with obesity only) will alter circulating lactate concentrations at rest and in response to exercise.

blood lactate is often considered a waste product from aerobic metabolism. many people assume it causes fatigue and muscle. lactate is a signaling molecule in the body. in addition lactate is also a fuel. evidence supports that lactate may be more important when the brain is stressed. we also know that individuals with obesity and/or type 2 diabetes may have impaired lactate metabolism. the investigators will compare brain blood flow and lactate response to an exercise stress test and submaximal exercise in obese and non-obese individuals.

Eligibility criteria:
inclusion criteria: healthy adult men and women 18-45 years of age bmi 18-40 kg/m2 not pregnant, premenopausal with regular menstrual cycles not breastfeeding non-nicotine users exclusion criteria: medications known to affect sleep, autonomic control, blood lactate levels or metabolic, or cardiovascular function (pi discretion) self-reported history of hepatic, renal, pulmonary, cardiovascular, or neurological disease, stroke or neurovascular disease, bleeding/clotting disorders, sleep apnea or other sleep disorders, diabetes, history of alcoholism or substance abuse major cardiovascular event or surgical procedure within the past three months hypertension (\>140/90 mmhg or at pis discretion). -

Keywords: lactate obesity exercise
physiologic investigation of the renin angiotensin aldosterone axis in hiv

Conditions: HIV-infection

Summary: the purpose of this study is to see if individuals with hiv-infection, particularly those with increased belly fat, have abnormalities in the renin angiotensin aldosterone axis. renin, angiotensin, and aldosterone are hormones that regulate salt and water balance in the body, and they may also have effects on sugar metabolism and cardiovascular health. there is some evidence that individuals with hiv-associated abdominal fat accumulation may have increased aldosterone, which may contribute to abnormalities in sugar metabolism and increased cardiovascular disease seen in hiv. the purpose of this study is the measure renin, angiotensin, and aldosterone activity, as well as other hormonal axes, in people with and without hiv infection, and with and without increased belly fat. the investigators hypothesize that aldosterone will be increased in hiv-infected individuals compared to those without hiv-infection, and that aldosterone will be further increased in hiv-infected individuals with increased abdominal fat compared to those without abdominal fat accumulation.


Eligibility criteria:
inclusion criteria: 1. stable use of antiretroviral therapy for at least 3 months (hiv group) 2. age ≥ 18 and ≤ 65 years of age exclusion criteria: 1. antihypertensive use, including angiotensin converting enzyme inhibitors or angiotensin ii receptor blocker use, diuretics, beta-blockers, calcium-channel blockers, potassium supplements, and spironolactone; and/or blood pressure (bp) \>140/90 at screen 2. current or recent steroid use within last 2 months. 3. known diabetes and/or use of antidiabetic medications 4. creatinine \> 1.5 mg/dl 5. potassium (k) \> 5.5 meq/l 6. hemoglobin (hgb) \< 11.0 mg/dl 7. alanine aminotransferase (alt) \> 2.5 x upper limit of normal (uln) 8. thyroid disease/abnormal thyroid stimulating hormone (tsh) 9. significant electrocardiographic abnormalities at screen such as heart block or ischemia 10. history of congestive heart failure, stroke, myocardial infarction, or known coronary artery disease (cad) 11. for women: pregnant or actively seeking pregnancy, or breastfeeding 12. estrogen, progestational derivative, growth hormone (gh), growth hormone releasing hormone (ghrh) or ketoconazole use within 3 months. 13. current viral, bacterial or other infections (excluding hiv) 14. current cigarette smoker/use of nicotine (patch/gum) or current active substance abuse

Keywords: hiv-infection renin aldosterone visceral fat
effects of degludec/liraglutide on time in range, inflammation and endothelial function vs insulin basal bolus in diabetic inpatients

Conditions: Diabetes Mellitus, Type 2

Summary: the study aims to evaluate the effects of insulin degludec/liraglutide on glycemic variability assessed by continuous glycemic monitoring with the function time in range, serum markers of inflammation, markers of endothelial dysfunction and a possible correlation with intra and extra-hospital mortality rates in a group of hospitalized diabetic patients compared to a control group of in-patient diabetic in treatment on insulin basal-bolus.

100 patients with type 2 diabetes mellitus were recruited at the internal medicine with stroke care ward of the university hospital of palermo "p. giaccone" from april 2022 to april 2024. 50 patients were treated with insulin degludec/liraglutide, 50 were undertaken treatment regime with insulin basal bolus (control group). the study was carried out in accordance with the principles of the helsinki declaration revised in 2001 and all patients gave their written consent to take part in this research. each patient treated was compared for age, sex and cardiovascular risk with control patients. the diagnosis of type 2 diabetes mellitus was based on the revised criteria of the american diabetes association (ada), and using a clinical algorithm that considered the age of onset of the disease, the symptoms and weight present, the family history and the therapy practiced. arterial hypertension was defined according to the 2017 esc-esh criteria. dyslipidemia was defined based on total cholesterol levels\> 200 mg/dl, triglycerides\> 150 mg/dl and hdl levels \<40 mg/dl regardless of the patient's gender. among the cases enrolled, 135 (100%) had type 2 diabetes mellitus, 110 (80 %) had arterial hypertension and 74 (55%) hypercholesterolemia. clinical and anthropometric data were collected at the time of recruitment. blood samples were taken from each patient (cases and controls) to determine serum glucose, hba1c, crp, ferritin, il-6. these withdrawals were then repeated three months and six months from the time of recruitment. the glycemic variability was assessed by continuous glycemic monitoring with the analysis of time in range the digital endothelial function was evaluated through the rhi-pat analysis using endo-pat2000.

Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 * mild-moderate hyperglycemia (180-400 mg/dl) * acute events (pneumonia, acute cardiac ischemia, ictus, ivu) exclusion criteria: * diabetes mellitus type 1 * diabetic ketoacidosis * hyperosmolar coma * severe hypoglycaemia * acute pancreatitis * cancer * use of corticosteroids * pregnancy * chronic kidney disease (\< 30 ml/min) or hemodialysis

Keywords: insulin degludec/liraglutide
incidence of covid-19 in school children

Conditions: Infection; Viral, Coronavirus

Summary: the coronavirus disease 2019 (covid-19) is causing a global pandemic with high morbidity and mortality among adults and mainly the elderly. children seem to be little or not affected by this infection. it is estimated that children could be asymptomatic or pauci-symptomatic carriers and thus be vectors of the disease. this is why measures to close schools and confine populations have been decreed in a large number of countries, including france. however, there are only a few data on the prevalence of covid19 disease in children. the deconfinement strategy depends on data on the prevalence of the disease, especially in children. investigators propose to evaluate the incidence of covid-19 in preschool and elementary schools children in the city of nice (south of france) during the pandemic period using a local prospective study of 914 children

the coronavirus disease 2019 (covid-19) is causing a global pandemic with high morbidity and mortality among adults and mainly the elderly. children seem to be little or not affected by this infection. it is estimated that children could be asymptomatic or pauci-symptomatic carriers and thus be vectors of the disease. however, the role of the children in the spread of covid-19 injection remains unclear. measures to close schools and to confine populations have been decreed in a large number of countries, including france. this decision has been based on epidemiologic data of other viral infections having droplet transmission and on data of middle east respiratory syndrome-related coronavirus (mers-cov) asymptomatic portage. furthermore, there are only a few data on the prevalence of covid19 disease in children. the deconfinement strategy depends on data on the prevalence of the disease, especially in children. therefore, investigators propose to evaluate the incidence of covid-19 in preschool and elementary schools children in the city of nice (south of france) during the pandemic period using a local prospective study of 914 children. this study will start on 11th may 2020, date of school reopening, in order to collect epidemiologic data about covid-19 carriage among schoolers and to support governmental strategy for the new school year in september 2020.

Eligibility criteria:
inclusion criteria: age ranging from 3 to 10 years old * children attending to school in nice * informed consent * french insurance subscribed exclusion criteria: * refusal to participate from the parents or the child * bleeding disorders

Keywords: covid19 incidence school pandemia children
a study to measure energy expenditure and food intake in participants with obesity using tirzepatide

Conditions: Obesity

Summary: this is a study of tirzepatide in participants with obesity. the main purpose is to learn more about how tirzepatide affects the number of calories participants burn and the amount of food they eat. the study lasted for 28 weeks and will include about 21 visits to the study center.


Eligibility criteria:
inclusion criteria: * have body mass index of 30 to 45 kilograms per square meter (kg/m²), inclusive * have a stable body weight in the past 1 month prior to screening * willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff exclusion criteria: * have undergone gastric bypass or bariatric surgery * have a diagnosis of type 2 diabetes * have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data * have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening * have any lifetime history of a suicide attempt * patient health questionnaire-9 (phq-9) score of 15 or more at screening * positive responses to selected items on the columbia suicide severity rating scale (c-ssrs)
prospective study to assess the safety and efficacy of the prow lif procedure

Conditions: Degenerative Disc Disease

Summary: this is a prospective, single-arm, open-label, non-randomized study. the aim of the study is to assess the safety and efficacy of the prow lif procedure in transforaminal lumbar interbody fusion (tlif) procedures for the treatment of subjects with symptomatic degenerative disc disease (ddd).

primary endpoints: * safety: incidence of device-related anticipated and unanticipated serious adverse events (sae). however, all complications and adverse events (ae) will be monitored and recorded. * primary radiographic effectiveness outcome parameter: evaluations of fusion rate.

Eligibility criteria:
inclusion criteria:main inclusion criteria 1. male and female between 18-65 years of age (skeletally mature). 2. subjects suffering from degenerative disc disease (ddd) accompanied by back pain with leg pain at a single level between l2 and s1 confirmed by history and radiographic studies and that are scheduled for a fusion operation. ddd is determined to be present if one or more of the following are noted: 1. instability (defined as angulation ≥ 5° and/or translation ≥ 4mm on flexion/extension radiographs); 2. osteophyte formation; 3. decreased disc height; 4. ligamentous thickening; 5. disc degeneration/herniation; or 6. facet joint degeneration. 3. a pre-op oswestry low back pain disability questionnaire (odi) score of 35 % or more; 4. be non-responsive to non-operative treatment for at least 6 months; - exclusion criteria: 1. the antero-posterior (ap) diameter (at midline) of the involved level is \<31mm. 2. any previous spinal surgery at the involved level; 3. spondylolisthesis \> grade i; 4. ankylosed segment at the affected level; 5. history or radiographic evidence of osteoporotic fractures in the spine; 6. paraparesis; 7. progressive neurologic conditions; -

Keywords: ddd prow fusion espin cage ibf discectomy lumbar fusion tlif mis
single dose pg102 in patients with active psoriatic arthritis

Conditions: Arthritis, Psoriatic

Summary: the primary objective is to evaluate the safety and tolerability of a single intravenous dose of pg102 in patients with psoriatic arthritis. the secondary objectives are to evaluate how pg102 moves around the body and to explore its effects on the disease.


Eligibility criteria:
inclusion criteria: * arthritis that meets classification of psoriatic arthritis (caspar) criteria * plaque psoriasis for at least 6 months prior to study enrollment exclusion criteria: * clinically significant psoriasis flare * unstable doses of pain relief medication * treatment with systemic corticosteroids other than prednisone ≤ 10 mg/day or equivalent * treatment with any biologic therapy * treatment with immunosuppressive agents or disease modifying anti-rheumatic drugs (dmards) other than methotrexate * treatment with lithium, any anti-malarial, chlorambucil, cyclophosphamide or therapies for psoriasis other than low potency topical corticosteroids on intertriginous and groin areas, tar or salicylate preparations on the scalp, and emollients and moisturisers * family history of multiple thrombotic events or a personal history of any venous or arterial thrombotic event * clinically significant result for anti-cardiolipin, activated protein c resistance test, protein c, free protein s, antithrombin iii, factor v leiden, prothrombin variant, homocysteine, lupus anticoagulant, prothrombin time, activated partial thromboplastin time, fibrinogen, thrombin time, factors ix and xi * currently smoking ≥ 10 cigarettes per day or equivalent * active tuberculosis or other infection * current or previous malignancies * clinically significant abnormality on physical examination, laboratory testing, vital signs or 12-lead electrocardiogram
use of demineralised bone matrix (dbx) in osteochondritis dissecans (ocd)

Conditions: Osteochondritis Dissecans

Summary: this is a 1:1 randomised pilot study in 30 patients in 1 site in helsinki, finland. the investigators hypothesize that function, pain, type and quality of cartilage in adult patients with osteochondritis dissecans of the knee will be better in the dbx group compared to the mosaicplasty group.


Eligibility criteria:
inclusion criteria: * males or females, age between 18 years and 65 years * females of childbearing potential must have a negative serum or urine pregnancy test at the time of inclusion * females of childbearing potential must be willing to use effective means of birth control for at least 1 year post surgery. medically acceptable contraceptives include: 1. surgical sterilisation 2. approved hormonal contraceptives 3. barriers methods combined with a spermicide 4. an intrauterine device 5. abstinence alone is not considered an acceptable method of contraception * late stage osteochondritis dissecans (icd-10 code m93.2) of the knee classified as stage iii or iv (anderson mri classification) * mature skeleton * written informed consent prior to any study specific procedures (except the procedures necessary to determine eligibility) * ability and willingness to comply with all study specific procedures, including attending all follow-up visits up to 12 months postoperative and completing questionnaires in a local language exclusion criteria: * more than 1 knee affected * patients who can be treated with conservative treatment alone, unless there is evidence of at least 6 months failed previous treatment * systemic disease including aids, hiv, hepatitis or any other disease that would prevent normal organ and marrow function. * patients undergoing systemic cortisone treatment or immunosuppressive therapy (e.g. avascular necrosis) * patients undergoing active cancer therapy (chemotherapy, radiation treatment). * history of alcohol abuse or illegal drug use. * participation in any other device or drug trial within 3 months prior to the inclusion in the study * presence of at least one contraindication for dbx® putty

Keywords: osteochondritis dissecans ocd mosaicplasty demineralised bone matrix dbx dbx putty
predicting the risk of post-operative delirium: use of neuropsychology, serum and csf biomarkers and genetics to predict risk of post-operative delirium

Conditions: Delirium

Summary: the purpose of the study is to determine if pre-operative neuropsychological characteristics, apolipoprotein e4 status and/or cerebrospinal fluid (csf) and serum biomarkers can predict those most at risk of post-operative delirium. patients over the age of 65 years undergoing elective primary hip or knee arthroplasty in musgrave park hospital are invited to take part. participants undergo a pre-operative neuropsychological assessment which is repeated 6-12 weeks post-operatively at the time of surgical review appointment. at the time of surgery advantage is taken of the necessary venous cannulation and spinal anaesthetic to gain venous blood and csf samples respectively. venous blood is also sampled post-operatively. patients are assessed daily for delirium, using the confusion assessment method, until discharge. the association between delirium and subsequent cognitive decline is now well established in the literature. it is not yet clear whether this is solely because delirium following elective surgery indicates a previously unrecognised neurodegenerative process or whether the delirium itself exerts an additional pathophysiological insult. in order to investigate this, a follow-up study of these participants, approximately 8 years later is currently being conducted. neuropsychological assessment and venous blood sampling will be repeated with consenting participants. furthermore, the significance of subtle symptoms, not sufficient to fulfil the criteria for delirium and known as subsyndromal delirium, in relation to cognitive function years later will be analysed.


Eligibility criteria:
inclusion criteria: * living at home * undergoing primary, elective hip or knee arthroplasty * spinal anaesthetic with intrathecal diamorphine anticipated exclusion criteria: * neurological, hearing or visual disability affecting ability to participate in study * known neurodegenerative condition eg dementia, parkinson's disease, multiple sclerosis