Kornimate/medical-research-clean huggingface dataset:
immune dysfunction in newborn sepsis

Conditions: Sepsis Newborn; Malaria; Immune Responses

Summary: the aim of the project is to study neonatal immune dysfunction associated to the risk of newborn sepsis in a malaria endemic area in benin.

the fetal immunological responses maturate gradually during the last 3 months of pregnancy. to respond to pathogens, newborns depend essentially on their innate immune system. premature babies have a significant impairment of innate and immune regulatory functions, thus promoting neonatal sepsis. in addition, chronic infections during pregnancy, including those of parasitic origin, fetal immunity. in utero exposure to p. falciparum antigens impacts particularly the newborn immune development and is a risk factor predisposing to malaria and also to other infections during the first year of life. the major objectives are to assess: * the relevance of a host biomarker driven diagnostic of sepsis in newborns, * the relevance of immune markers as indicators of sepsis incidence, secondary infections occurrence, and mortality * the role of novel diagnostic techniques (filmarray panels) as part of the microbiological diagnostic, * the immunological profile of the infants in the 3 first months of life. the targeted population is newborns with a high risk to develop sepsis recruited at delivery compared to a control infant population with a low infection risk.

Eligibility criteria:
inclusion criteria for the sepsis risk group (400 infants): * child born from mothers having one of the following criteria before delivery will be included in this study: * spontaneous preterm delivery (\<37 weeks of gestation time) * foul smelling / with meconium / colored / bloody amniotic liquid * rupture of membranes \> 18 hours * maternal fever at delivery * vaginal infection * child born at the maternity of cnhu (centre national hospitalier et universitaire, cotonou, benin) or chumel (centre hospitalier et universitaire de la mère et de l'enfant lagune, cotonou, benin) or hzac (hopital de zone d' abomey-calavi, benin). * mother located near abomey-calavi. this criterion has been included to limit the follow-up expenses and spare the travel to the project staff in charge of the 3 month follow-up. inclusion criteria for the control group (170 infants): - child born from mothers enrolled in the recipal study (pregnancy-associated malaria and intrauterine growth restriction in benin) exclusion criteria for both groups: * hiv + status or unknown hiv status of the mother (as the mother and child will be part of the national program to take care of mother and child hiv+ at delivery) * parents do not consent to be included in the study.
effect of amnioinfusion on external cephalic version successful rate

Conditions: Breech Presentation

Summary: the aim of the study is to evaluate the effect of transabdominal amnioinfusion before second external cephalic version after initial failure.patient with a single foetus, at term, in breech presentation and after a first cephalic version are included. the randomisation determines whether the patient is included in the group with amnioinfusion before second cephalic version or with usual second cephalic version only; the efficacy's evaluation is based on rate of cephalic presentation at birth.success rate of cephalic version with or without transabdominal amnioinfusion, rates of cesarian section in the two groups,maternal and fetal morbidity, time between second cephalic version and birth will be studied. prospective interventional randomized sequential comparative multicentric study. a maximum of 240 patients will be included (120 in each group). as the study is sequential it will be over as soon as a significative difference is shown.

the purpose of the study is to evaluate the effect of transabdominal amnioinfusion before a second external cephalic version after initial failure. in case of success it could be an alternative to cesarian section. without any other technique the foetus is in cephalic presentation after a first external cephalic version in 50%. patients with a single fetus, at term, in breech presentation are proposed to participate. the randomization is done at the inclusion and determines whether the patient is included in the group with amnioinfusion before second cephalic version or usual second cephalic version only. the only difference between the two groups is the realisation of an amnioinfusion, the cephalic version's technique is the same. efficacy's evaluation is based on rate of cephalic presentation at birth. success rate of cephalic version, rates of cesarian section, maternal and fetal morbidity in the two groups, time between second cephalic version and birth will be studied.

Eligibility criteria:
inclusion criteria: * single fetal pregnancy * breech presentation * at term * initial failure of external cephalic version * structurally normal foetus exclusion criteria: * polyhydramnios * anhydramnios * abnormality of the fetal heart rhythm * uterine congenital malformation * cesarian section for a previous birth * unability to understand study

Keywords: transabdominal amnioinfusion external cephalic version breech presentation
stratifying risk for intracerebral haemorrhage

Conditions: Preterm Birth; Coagulation Protein Disorders; Coagulation Disorder Neonatal

Summary: this study aims to investigates the role of gestational age on the prevalence of coagulation factors and components of the complement system in preterm- (≤32+0 weeks) and term neonates (≥37+0 weeks) and their role for the development of brain hemorrhage.

the occurrence of brain hemorrhage (germinal matrix hemorrhage and intraventricular hemorrhage, gm-ivh) in newborns, especially in preterm infants, is one of the most important prognostic factors for mortality and morbidity (especially for later neurological development) in this collective. the risk of high-grade bleeding in extremely premature infants (22 weeks) is approx. 38% and decreases to approx. 7% by the 28th week. the total frequency of gm-ivh is around 8% in gestational weeks 23 to 31, with each additional gestational week reducing the risk by 3.5%. the etiopathology of brain hemorrhage is complex and involves both environmental and genetic factors. recent studies particularly suggest an involvement of the immature coagulation system in preterm neonates. global coagulation parameters, such as the international normalized ratio (inr), have already been associated with an increased risk of bleeding, but rarely show fluctuations outside the norm. furthermore, polymorphisms in the area of individual coagulation factors as well as other inflammatory and vascular individual components of coagulation, are associated with an increased risk of bleeding. mass spectrometry has long been used for the analysis of biological samples and has developed into an indispensable tool for proteomics research. the study aims to establish the mass spectrometric detection of a total of 125 blood plasma factors containing the individual components of the coagulation system and the complement system. the method enables quantitative detection of the coagulation system with even the smallest sample quantities, so that sampling can be combined with routine measures, particularly in the field of neonatology. this pilot study to compare the compositional differences regarding coagulation factors and the complement system in relation to the gestational age (i.e. preterm ≤32+0 weeks vs. term neonates ≥37+0 weeks).

Eligibility criteria:
inclusion criteria: * medical indication (newborn screening) and informed consent for blood drawing exclusion criteria: * clinical evidence of infection * clinical evidence of hyperbilirubinemia * preeclampsia (pe), hellp-syndrome, intrauterine growth restriction (iugr) and pe+iugr

Keywords: preterm coagulation lc-ms/ms ich ivh neonatal
endorphin massage application to women who gave birth vaginally

Conditions: Pain; Birth, First

Summary: in this study, it is aimed to determine the effect of endorphin massage applied to puerperant women who had vaginal delivery on pain, comfort, mood and serum beta endorphin levels in the postpartum period.

massage application provides an increase in the level of endorphins by making a relaxing effect on the muscles. endorphin massage increases the release of endorphins, allowing the individual to relax, relax the muscles and reduce pain. endorphin massage is a light massage technique that can increase the release of oxytocin and endorphin hormones, providing a feeling of calmness and comfort. in addition to reducing pain, the endorphin hormone provides relaxation, supports the immune system, and accelerates metabolic activities. it is also known as the happiness hormone. it is stated that back massage will increase the release of endorphin hormones by relaxing the mother. in other studies conducted in the postpartum period, it has been determined that massage applied reduces the severity of pain and stress, and increases the level of comfort. studies have shown that endorphin massage applied to pregnant women reduces back pain. in another study, it was determined that deep tissue massage applied to the back area after cesarean section reduced the level of pain. in the other study, it was determined that the endorphin massage applied to the 3rd trimester pregnant women reduced the level of anxiety. when the literature is examined, no study has been found that examines the effect of endorphin massage applied to puerperant women on pain, comfort, mood and beta endorphin levels in the postpartum period. the fact that endorphin massage is applied to similar areas with both back massage and oxytocin massage suggests that endorphin massage may affect the pain process experienced in the postpartum period. it is aimed to determine the effect on endorphin level.

Eligibility criteria:
inclusion criteria: * 37-40. those who gave birth vaginally in their gestational week, * in the first 24 hours postpartum, * primiparous, * episiotomy applied, * having a vas value of at least 5 points, * having given birth to a single baby, * your baby's apgar score is between 7-10, * skin-tissue integrity, * no communication problem, * the spoken language is turkish, * voluntary to participate in the study exclusion criteria: * the baby was admitted to the neonatal intensive care unit, * having a cesarean section, * experiencing risky labor, * postpartum bleeding, * epidural analgesia applied * having a psychiatric disease (bipolar disorder, depression, obsessive compulsive disorder), * having chronic disease (heart disease, thyroid problems, diabetes mellitus, hypertension, asthma, copd), * postpartum women diagnosed with risky pregnancy (pre-eclampsia, eclampsi, pregnancy-related hypertension, gestational diabetes, bleeding conditions during pregnancy)

Keywords: birth vaginal birth massage pain endorphin
casein glycomacropeptide in active distal ulcerative colitis (pilot study)

Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases

Summary: casein glycomacropeptide (cgmp) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. its use as a food ingredient has proven safe and with no influence on dietary intake. we hypothesize that orally administered cgmp has a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.

gcmp has mainly been used as food additive in patients with specific dietary needs, i.e. in infant formulas, adipositas, or in patient with phenylketonuria. due to its antiinflammatory properties we hypothesize that it may be used alone or along with conventional therapy in inflammatory diseases such as ulcerative colitis.

Eligibility criteria:
inclusion criteria: * age 18 years or more * diagnosed ulcerative colitis * signs of clinical activity with sccai of 3 or more * extension more than 10 cm and no more than 40 cm from anus exclusion criteria: * rectal temperature more than 38 degrees celcius * diagnosed celiac disease or lactose intolerance * unable to speak or understand danish * prior biologics or systemic steroids 4 weeks up to inclusion

Keywords: glycopeptides dietary proteins
cutaneous jak in vitiligo and acne vulgaris.

Conditions: Vitiligo and Acne Vulgaris

Summary: the janus kinase/signal transducer and activator of transcription (jak-stat) cytokine signaling pathway is an emerging area of interest in dermatology, and emerging evidence suggests that this pathway may play a crucial role in pathogenesis of inflammatory skin disorders. recent advances on the role of cytokines in the pathophysiology of immune mediated inflammatory diseases lead to the understanding that many pro inflammatory interleukins use jak/stat components for signal transduction .

the jak/stat signaling pathway transmits information from extracellular chemical signals to the nucleus resulting in dna transcription. binding of ligands, such as interferon and interleukins, to their specific transmembrane receptors activate associated jaks. phosphorylation of stat follows, and the phosphorylated stat translocates to the cell nucleus and activates transcription or suppression of target genes . the jak family of non-receptor intracellular tyrosine kinases is comprised of four members, jak1, jak2, jak3 and tyrosine kinase (tyk)2. the jaks are selectively activated by different receptors and have, therefore, distinct in vivo roles. jak1 is mainly activated by type ii cytokine receptors. jak2 is crucial in transducing signals for cytokine receptors involved in hematopoiesis (erythropoietin, thrombopoietin and haematopoietic cell development cytokines). jak3 is mainly expressed in b and t lymphocytes, and tyk2 associates commonly with other jaks. cutaneous jak overexpression has already been demonstrated in a number of inflammatory skin diseases (isds) including psoriasis, lichen planus (lp), atopic dermatitis (ad), pyoderma gangrenosum (pg) and alopecia areata (aa); indicating its crucial role in inflammatory keratinocytes. furthermore, the recent discovery of the jak/stat signaling pathway opened a new window of opportunity for the treatment of isds and promoted the development of drugs that block jak activation. jak inhibitors in oral and topical formulations have shown beneficial results in psoriasis and alopecia areata. patients suffering from vitiligo might also benefit from jak inhibition. recently, significant repigmentation was reported in a patient with vitiligo after treatment with tofacitinib, an oral jak 1/3 inhibitor . however, the knowledge of the cutaneous jak involvement in vitiligo is scarce. similarly, little is known about cutaneous jak expression in acne vulgaris. considering the previous findings, there is a need for further elucidation of the jak signaling in other skin diseases as vitiligo and acne vulgaris.

Eligibility criteria:
inclusion criteria: * patients with vitiligo and acne vulgaris. exclusion criteria: * patients below 12 years of age, or receiving systemic treatments in the last month
performance evaluation of the micromedic cd24 in vitro diagnostic assay

Conditions: Colorectal Cancer

Summary: this study is aimed to evaluate the performance of the micromedic cd24 assay in identifying colorectal adenoma using western blot and elisa assays. these assays are designed to detect cd24 protein in peripheral blood leukocytes (pbl). elevated levels of cd24 may be indicative of colorectal adenoma (inclusive of optically detectable early adenoma to late adenoma, and cancer).


Eligibility criteria:
inclusion criteria: * subject is 50 years old and above * subject is asymptomatic and referred for regular recommended screening colonoscopy or subject is referred due to suspicion of colon cancer, prior to beginning of any treatment (enriched population) * subject signed the informed consent exclusion criteria: * subject has been previously diagnosed with any type of cancer * subject has been previously diagnosed with a colorectal abnormality such as colorectal adenoma, hyperplastic polyp or carcinoma * blood sample was not collected on the day of colonoscopy and prior to colonoscopy * subject has first degree family history of colorectal cancer * subject has active infection or inflammation as determined clinically at screening * subject is currently taking medications related to the previous exclusion criteria * subject has participated in, or is participating in, any investigational drug or device study within 30 days prior the date of colonoscopy and any additional study required test * pregnant or lactating woman
molecular analysis of endoscopic cytology samples supernatant in pulmonary nodules

Conditions: Lung Cancer; Lung; Node

Summary: lung cancer screening is based on low dose ct scan (ldct), a highly sensitive but poorly specific tool. complementary specific approaches are thus strongly needed, among which cell-free dna (cfdna) genotyping has been proven highly specific but of low sensitivity (25 to 50% for stage i diseases) due to inconstant tumor shed. tumor biopsy is thus often required and radial endobronchial ultrasound (rebus) bronchoscopy is a minimally invasive approach (\<3% complications) but of limited sensitivity in cases of nodules \< 20 mm. the investigators hypothesized that methylation analysis on cfdna floating in supernatant derived from rebus specimens could improve rebus sensitivity

tumor biopsy is often required to characterize indeterminate nodules. radial endobronchial ultrasound (rebus) bronchoscopy is often used due to a low rate of complications but its sensitivity is limited for small nodules. the investigators hypothesized that methylation analysis on cfdna floating in supernatant derived from rebus specimens could improve rebus sensitivity. the primary outcome of this pilot, diagnostic validation, monocentric study is the sensitivity of targeted (9 genes panel) methylation analysis on supernatant cfdna to detect a malignant nodule. secondary outcomes include the comparison of supernatant to pathology and plasma cfdna methylation analysis. specificity, negative predictive value (npv), positive predictive value (ppv) of targeted (9 genes panel) methylation analysis on supernatant cfdna to detect a malignant nodule will be analyzed. 60 patients planned for a rebus bronchoscopy for one, two or three \< 20 mm nodule, without mediastinal or extra thoracic lesions (ct1n0m0) will be included. the day of the rebus bronchoscopy, 2 7.5 ml blood samples are collected. rebus samples' supernatant, usually discarded, is saved. cell free dna is extracted from these biological specimens at the laboratory of oncological medical biology (lbmo) in toulouse university cancer institute and tested for methylation (targeted analysis on 9 genes). the patients will be followed for one year to obtain a final diagnosis and correlate it with tissue, nodule supernatant and plasma methylation analyses.

Eligibility criteria:
inclusion criteria: * rebus bronchoscopy planned for one, two or three ≤ 20 mm nodule * world health organization (who) performance status 0-3 * informed signed consent * patient affiliated or beneficiary of a social security scheme (social security or universal medical coverage). exclusion criteria: * lung cancer diagnosed before the date of the procedure * lung cancer strongly suspected due to mediastinal or extra thoracic lesions * patient under state medical assistance * patient deprived of liberty on administrative or judicial decision, or patient under guardianship, curators or safeguard of justice

Keywords: circulating free dna methylation lung cancer screening lung nodule radial ebus endobronchial ultrasound
the effect of obesity and weight loss in heart failure with preserved ejection fraction

Conditions: Heart Failure With Preserved Ejection Fraction; Obesity

Summary: this study looks at the effects of weight loss in people who have heart failure with preserved ejection fraction (hfpef) and are overweight or obese. the main questions it aims to answer are whether weight loss in this group of people improves: 1. the heart's shape, how well it pumps blood and how well it uses fuels 2. the person's quality of life and how much they can exercise participants will attend 2 study visits, separated by 3-6 months. the intervention period takes place in between the 2 study visits. each study visit will involve measurements including: * symptom and quality of life questionnaires * body measurements such as height and weight * blood tests * ultrasound scans of the heart (echocardiogram) * magnetic resonance imaging (mri) scans of the heart * exercise components during the scans * 6 minute walk test participants are randomly allocated (in other words, by lottery) to either 'diet' or 'control' groups. the control group will continue standard care. the diet group will be enrolled in a weight loss program supervised by the study team. participants in the diet group will replace their usual meals with meal replacement products specifically designed to deliver a low calorie diet for weight loss. the products will consist of formula soups, shakes and porridges. this diet would last 8 weeks, followed by a guided period of food reintroduction and maintenance.

an interim analysis is planned at 60 recruits to review the recruitment target.

Eligibility criteria:
inclusion criteria: * heart failure with preserved ejection fraction (hfpef) * left ventricular ejection fraction (lvef) =/\> 50% * body mass index (bmi) approximately =/\> 27.5 kg/m\^2 exclusion criteria: * contraindications to magnetic resonance imaging * nyha class iv * significant valvular, ischemic, infiltrative or other potentially confounding cardiac disease * pregnancy, planned pregnancy or lactating * any other conditions which may potentially compromise the safety or scientific validity of the study

Keywords: weight loss heart failure preserved ejection fraction obesity overweight magnetic resonance imaging
vitamin d reabsorption in adolescents and young adults with hiv infection

Conditions: HIV Infections

Summary: the purpose of this study is to test the effects of vitamin d on renal phosphate and bone loss, which are common in hiv infected adolescents and young adults being treated with tenofovir.

atn 063 tests the hypothesis that in a population of adolescents and young adults with hiv infection who are being treated with tenofovir as part of an antiretroviral (arv) combination regimen, vitamin d supplementation will decrease renal phosphate loss, increase plasma phosphate, decrease plasma pth, and improve markers of bone turnover, including a decrease in plasma n-telopeptide and bap.

Eligibility criteria:
inclusion criteria: * age 18 years and 0 days through 24 years and 364 days * hiv-1 infection as documented by any licensed elisa test kit and confirmed by western blot, hiv-1 culture, hiv-1 antigen, plasma hiv-1 rna, or a second antibody test by a method other than elisa at any time prior to study entry * currently being treated with a stable fda-approved arv combination therapy, containing \> 3 antiretrovirals, for \> 28 days, according to hrsa guidelines. treatment regimen will not be started or changed for the purposes of participation in this study. subjects will be receiving therapy at the direction of their treating physician * willingness to remain on the same arv combination therapy for the 12-week duration of the study * ability and willingness to participate in the study by providing written informed consent * willingness to be randomized to receive either vitamin d or placebo exclusion criteria: * prior hypersensitivity to vitamin d * history of arteriosclerosis, renal stones, glomerulonephritis, nephrotic syndrome, or hypercalcemia * lactation or current pregnancy * active therapy for malignancy * known presence of gastrointestinal disease that would interfere with drug administration or absorption * serological evidence of hepatitis b surface antigen (hbsag) * confirmed creatinine clearance \< 90 ml/min (calculated gfr from serum creatinine using the mdrd formula) * grade 3 or higher clinical toxicity

Keywords: vitamin d treatment experienced