Kornimate/medical-research-clean huggingface dataset:
high risk myelodysplasia treated by azacytidine : genetic and epigenetic (myrage)

Conditions: High-risk Myelodysplastic Syndromes With Excess Blasts

Summary: myelodysplastic syndromes (mds) are the most frequent myeloid neoplasms in western countries.they mainly affect patients aged 65 years or older. this is a very heterogenous group of diseases, which prognosis is evaluated with international prognosis scoring system. high risk mds present with high frequency of transformation into acute myeloid leukemia. treatment of high risk mds often is based on hypomethylating agents, such as 5'-azacytidine (azacytidine), with a complete response in approximativel 20% of cases.. this treatment is based on 4-week cycles, with daily injection during the first week and rest during the 3 next weeks of the cycle. azacytidine efficacy is commonly evaluated with clinical and biological parameters determined by the international working group 2006. these parameters are usually evaluated after at least 6 cycles of treatments. there is a response with azacytidine treatment in 60% of cases, including 40% of partial responses and 20% of complete responses. in 40% of patients, there is no response, which means that the disases is stable or in progression under therapy. in this regard, early evaluation of treatment response is an issue. we want to improve our knowledge about early response criteria in azacytidine-treated high-risk mds, focusing on smd with excess blasts, which represent 30 to 40% of total mds. then, the investigator team want to compare dna methylation profile at diagnosis and after 3 cycles of azacytidine treatment. main objective : identify dna methylation profiles related to response to azacytidine therapy, after only 3 cycles of treatment, in high risk mds with excess blasts. secondary objective : identify at diagnosis dna methylation profiles that are predicitive of response to azacytidin, in high risk mds with excess blasts.


Eligibility criteria:
pre-inclusion criteria: * patient benefiting from social welfcare * patient followed at the university hospital of nancy * patient aged 18 years or older * patient informed on research organization and having signed an informed pre-inclusion consent * no personal history of myelodysplastic syndrome * clinical exam adapted to research * one or more blood cytopenia inclusion criteria: * patient benefiting from social welfcare * patient followed at the university hospital of nancy * patient aged 18 years or older * patient informed on research organization and having signed an informed inclusion consent * definitive diagnosis of high risk myelodysplastic syndrome with excess blasts * eligibility to an azacytidine therapy as first-line treatment exclusion criteria: * personal history or current other cancer * immediate acute myeloid leukemia * personal history of demethylation treatment * pregnant or breast feeding women * life-theatening condition * guardianship * imprisoned patients

Keywords: myelodysplastic syndromes
institut paoli calmettes colorectal cancer database

Conditions: Colorectal Neoplasms

Summary: database of institut paoli-calmettes patients diagnosed with colorectal cancer


Eligibility criteria:
inclusion criteria: * patients with a colorectal cancer diagnosis exclusion criteria: * non applicable
time-dependent functional results following hto. closing wedge vs opening wedge technique.

Conditions: Osteoarthritis

Summary: prospective randomized study. compare two techniques for high tibial osteotomy (hto) for treatment of medial knee osteoarthritis. opening wedge osteotomy using puddu plate vs closing wedge osteotomy using cramp fixation. we will compare functional results and patient satisfaction with repetitive evaluations from preoperatively to 2 years postoperatively.

determination of the time course of patient-relevant functional outcome and the time course of range of motion (rom) following hto. comparison of the opening wedge and closing wedge methods. time-dependent improvement in functional outcome following high tibial osteotomy. medial opening wedge vs lateral closing wedge. a two-year prospective randomized study involving 70 patients. in a prospective randomized study, we plan to include 70 patients aged 30-60 years operated with valgus high tibial osteotomy. 2 groups: 35 opening wedge, and 35 closing wedge osteotomies. data are collected by independent investigators (physiotherapists) preoperatively and at 3 months, 6 months, 1 year, and 2 years postoperatively. knee injury and osteoarthritis outcome score (koos) and rom are determined at all follow-ups.

Eligibility criteria:
inclusion criteria: * medial osteoarthritis in the knee (x-ray and arthroscopy) * pain in medial compartment of the knee * correction angle of 5 degrees or more exclusion criteria: * former or active infection in the knee * rheumatoid arthritis or other similar disease * cancer * neurological disease * kidney disease or metabolic disease

Keywords: osteoarthritis osteotomy closing opening wedge kne tibia
european, open-label, prospective, multinational, multicenter study in adult subjects with type 1 or type 2 diabetes previously on mdi or csii therapy. subjects home setting is considered routine practice.

Conditions: Type 2 Diabetes, Type 1 Diabetes

Summary: accu-chek® insight insulin pump eu study is a multicenter study to evaluate the accu-chek® insight insulin pump in routine practice. this is an open-label, prospective, multinational, multicenter study evaluating the csii therapy with the accu-chek insight insulin pump in routine practice in adult subjects with type 1 or type 2 diabetes. subjects must have been on intensive insulin therapy for at least six months i.e. either on csii or mdi. all subjects will receive training in the preparation, programming and daily use of the accu-chek insight insulin pump. in addition, subjects previously on mdi may receive more training in order to be comfortable with the use of an insulin pump. the study will be conducted in 10-12 sites in austria, france and the united kingdom. a total of 80-95 subjects will be enrolled in this study.


Eligibility criteria:
inclusion criteria: * male or female at least 18 years old * diagnosed at least for 12 months with type 1 or 2 diabetes requiring insulin therapy * intensive insulin therapy by mdi or csii at least 6 months * willing to self monitor blood glucose 4 times daily exclusion criteria: * significantly impaired awareness of hypoglycemia * unstable chronic disease other than diabetes * acute illness or inability to recognize pump signals or alarms as determined by the investigator * pregnancy
artemis peanut allergy in children

Conditions: Peanut Allergy

Summary: the purpose of this study is to demonstrate the efficacy and safety of ar101 through oral immunotherapy (oit) in peanut-allergic children.

this is a european, multicenter, double-blind, randomized, placebo-controlled 2-arm study of the efficacy and safety of ar101 in peanut-allergic children.

Eligibility criteria:
key inclusion criteria: * age 4 to 17 years, inclusive * clinical history of allergy to peanuts * serum spt ≥ 3 mm greater than control and/or psige ≥ 0.35 kua/l * dose limiting symptoms after consuming a single dose of peanut protein ≤ 300 mg * written informed consent from the subject's parent/guardian * written assent from the subject as appropriate (per local regulatory requirements) * use of effective birth control by sexually active female subjects of childbearing potential key exclusion criteria: * history of cardiovascular disease, including uncontrolled or inadequately controlled hypertension * history of severe asthma (nhlbi criteria steps 5 or 6), or mild to moderate asthma (2007 nhlbi criteria steps 1-4) that is uncontrolled or difficult to control * history of severe or life threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening * history of eosinophilic esophagitis (eoe), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (gerd), symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology * history of a mast cell disorder, including mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema * any other condition that, in the opinion of the investigator, precludes participation for reasons of safety

Keywords: ar101 characterized peanut allergen cpna (characterized peanut allergen) oit (oral immunotherapy) peanut allergy peanut-allergic children desensitization artemis allergy
bioavailability of insulin administered in duodenum

Conditions: Diabetes Mellitus

Summary: a study of the bioavailability of insulin after infusion in the duodenum in healthy volunteers.

methodology all subjects will be admitted fasting to the clinical trial unit at århus community hospital at 8 a.m. a gastrointestinal tube will be placed in duodenum distal to papilla vaterii with a ph of approximately 7.0 as measured by the ph meter distal in the tube. an indwelling catheter for glucose infusion (20 %) in cases of hypoglycaemia will be placed in an antecubital vein. in the contralateral anticubital vein a catheter will be placed for blood sampling. all subjects will have 4 tests with duodenal infusion of the insulin aspart solution. the first 4 volunteers will receive 4 doses of insulin aspart solution in 1 ml (150, 300, 600 and 1000 iu) with 3-6 hours apart. blood sampling for insulin aspart, total insulin, and glucose (beckmann apparatus) will be done every 10 minutes the first two hours, and then every 20 minutes. when final the subjects will receive a meal before leaving the hospital. based on data from the pilot a dose will be determined for the remaining 8 subjects. these will then based again on results from the pilot on two separate study days receive 4 infusions with 3-6 hours split. two infusions will be at ph 7 and two infusions will be more proximal at a ph of 5.5 (two different insulin concentrations but the same dose given at the two places in duodenum). frequency and interval of blood sampling in the second part will be determined by results from the pilot study. for comparison with the clinical situation and estimation of bioavailability all subjects will receive a subcutaneous and an intravenous (iv) bolus injection of 6 iu of insulin aspart. the iv injection will be followed by blood sampling for three hours as above, but every 5 minutes the first two hours, and the sc injection will be followed by blood sampling for three hours as above, but again with 10 minutes interval the first two hours.

Eligibility criteria:
inclusion criteria: * signed informed consent * healthy volunteers * age \>18 - \< 50 years * bmi 18-30 kg/m2 exclusion criteria: * any history of gastrointestinal or endocrine disorders (e.g. diabetes mellitus) * pregnancy or nursing * suspected or known allergy towards the drug * participation in other research trials within 3 months before the study

Keywords: insulin bioavailability duodenum infusion healthy diabetes absorption
pre-operative surgical difficulty stratification using predicted tumor perfusion and consistency

Conditions: Pituitary Adenoma

Summary: pituitary adenomas (pas) are among the most prevalent lesions of the sella turcica, accounting for 10%-25% of all intracranial neoplasms. pituitary macroadenomas (pmas) are defined with a maximum diameter of over 1 cm. tumor characteristics are key factors influencing surgical effectiveness and complications of pmas, with tumor perfusion and consistency identified as major predictive factors in literature. conventional sequences provide limited information for predicting the perfusion and consistency of pituitary adenomas. advanced sequences offer additional insights. however, the efficacy of combining radiomic features from multiparametric sequences, incorporating both conventional and advanced sequences, has not yet been proved. we aim to develop machine learning models that combines radiomic features developed from both conventional and advanced sequences to predict the perfusion and consistency of pmas. furthermore, we aim to demonstrate the clinically applicability of these models by constructing a mr-pit stratification (multiparametric radiomic derived and tumor perfusion and consistency based surgical difficulty stratification), which correlated with the surgical strategy and outcomes.


Eligibility criteria:
inclusion criteria: * patients with tumor more than 2.5 cm of maximal diameter in the coronal plane * functional and non-functional pituitary tumors exclusion criteria: * incomplete image data
the vida after covid study

Conditions: Covid19

Summary: the purpose of this study is to objectively identify and address social determinants of health (sdoh) priorities and barriers in latino patients who survived or are vulnerable to covid-19, and to understand the consequences of covid-19 survivorship in local latino communities.


Eligibility criteria:
inclusion criteria: * study population will be identified via community partnerships and peer referrals. * participants include latino families in southern minnesota (dover, olmsted and mower county, minnesota) who survived covid-19 after requiring icu or hospital admission, and their families and/or their care partners, or latino patients who are vulnerable to covid-19, that have provided research authorization o identified via electronic health registries (following institutional review board approved guidelines). exclusion criteria: * families that do not identify as latino. * those living outside dover, olmsted and mower county, minnesota. * those that do not provide written consent.
an assistive powered wheelchair: stage 2 trial

Conditions: Multiple Sclerosis; Stroke; Cystic Fibrosis; Motor Neurone Disease; Craniocerebral Trauma; Guillain-Barre Syndrome

Summary: preliminary evaluation of an obstacle alerting system to enhance the user's independent mobility by improving their confidence to drive and their safety in driving a powered wheelchair.

many powered wheelchair users find that collision free driving presents a significant challenge to confident and safe driving. in some cases so much so that the user will not drive their chair in some environments. interviews with users in the educat project confirmed that users had problems driving safely and confidently in a confined space, passing through doorways or down narrow corridors and when reversing. therefore the goal of this stage of the project is to improve the quality of life of the powered chair user by developing an obstacle alerting system which will help improve their confidence and safety in driving. this was to be achieved by asking expert users to provide feedback on the impact and usefulness of providing information about the presence and location of obstacles in the vicinity of their powered wheelchair. there are two aspects to this. 1. user assessment of the usefulness of the obstacle alerting feedback. this will include user evaluation of the value of the different modes of feedback - audio, visual and haptic - and how best to adapt these to the range of driving environments and driving speeds. and what level of control the user requires to select and deselect these options. 2. monitoring the user's driving patterns with and without obstacle alerting -using the stage 1 recording device. the analysis of this data, and feedback from the users and carers will inform the development and design of the obstacle alerting system. because of the covid-19 pandemic the trial could not be carried out with powered wheel-chair users participating as they represented a clinically vulnerable part of the population. the trial was, therefore, adapted and carried out with adult non-wheelchair users.

Eligibility criteria:
inclusion criteria: 1. adults who are not wheelchair users. 2. willing and able to provide a valid consent. 3. able to participate in interviews aided or unaided using preferred method of communication. 4. willing to drive a powered chair. exclusion criteria: 1. lacks capacity to consent
evaluation of the risk of infection during fever in labor

Conditions: Fever; Labor

Summary: * fever during labor affects more than 8% of parturients. it is a heterogeneous entity and can be due to an infectious process, a side effect of a drug, or to labor itself (physiological hyperthermia). * it has been the subject of several retrospective studies and a few prospective studies with varying methodologies, definitions, and inclusion criteria. none have proposed a combined obstetric, neonatal, infectious disease, and microbiological analysis. * it raises concerns about the possibility of an emerging maternal (obstetric or otherwise) and/or fetal infection. * analysis of the available literature does not clarify the exact frequency of these infections or the predictive factors for their occurrence. * it often justifies systemic antibiotic therapy, the modalities and benefits of which have never been evaluated. the investigators aim to conduct a prospective multicenter study to analyze fever during labor with a combined obstetric, infectious disease, pediatric, and microbiological perspective.

the primary objective of this study is to analyze the causes of fever during labor by categorizing them into 3 etiological categories: 1. fever indicative of maternofetal infection: potentially early intrauterine infection leading to proven or probable early-onset neonatal bacterial infection, endometritis, or maternal sepsis. 2. fever indicative of maternal infectious pathology outside the obstetrical field (e.g., pyelonephritis, influenza, covid, etc.). 3. fever of non-infectious origin. secondary objectives include: * describing the epidemiology and local ecology of bacterial infections. * identifying predictive factors for each category (obstetrical infection, non-obstetrical infection, and non-infectious fever) when fever occurs during labor. * evaluating the maternal and neonatal prognosis of mother-child pairs who do not receive antibiotic treatment according to local protocols (e.g., in cases of fever below a threshold value). depending on the results and sample size, the study will also attempt to evaluate the maternal and neonatal prognosis of mother-child pairs in cases where fever is attributed to maternofetal infectious causes (category 1) according to the antibiotic management strategy for fever during labor at each center.

Eligibility criteria:
inclusion criteria: * pregnant women at least more than 37 weeks * who have not opposed the collection of their health data for the purposes of studies and analyzes * in work between 07/01/2023 and 06/01/2024 * admitted to the work room at port royal, necker sick children or trousseau * with fever defined as a tympanic temperature \> 38°c at least 2 times at 10 min intervals during labor. exclusion criteria: * pregnant women : * \< 37nt * express their opposition to the collection of their data for research purposes * minors or under legal protection * context of medical termination of pregnancy or fetal death

Keywords: fever labor puerpueral infection anti-bacterial agents
a research study of nnc0165-1875 alone or together with semaglutide in people who are overweight or obese

Conditions: Obesity and Overweight

Summary: the study is looking at possible new medicines for weight control in people with high body weight. the study looks at how the new medicines work in the body. the study consists of two parts. if participants take part in part 1, they will either get a single dose of nnc0165-1875 or a "dummy" medicine (placebo). if participants take part in part 2, they will either get a single dose of nnc0165-1875 or "dummy" medicine and also a single dose of semaglutide. which treatment participants get is decided by chance. for part 1 participants will get 1 injection. for part 2 participants will get 2 injections. a study nurse at the clinic will inject the medicine with a thin needle in a skin fold in the stomach. the study will last for about 9 weeks. participants will have 7 visits to the clinic with the study doctor.


Eligibility criteria:
inclusion criteria: * males, aged 18-55 years (both inclusive) at the time of signing informed consent * body mass index (bmi) between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening. overweight should be due to excess adipose tissue, as judged by the investigator * body weight greater than or equal to 70 kg exclusion criteria: - male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
nippv versus bi-level nasal continuous positive airway pressure following extubation

Conditions: Intubation Complication; PreTerm Birth

Summary: mechanical ventilation is important in the care of preterm infants with respiratory failure, but may be associated with lung injury. efforts are needed to avoid or minimize the use of mechanical ventilation. however, there is no consensus on the best non-invasive ventilation mode after extubation in preterm infants. objective: to compare the effectiveness of nasal intermittent positive pressure ventilation (nippv) versus bi-level nasal continuous positive airway pressure (bipap) following extubation in preterm infants ≤ 1250 g birthweight.

in this study , mechanically ventilated preterm infants with birthweight ≤1250 g will screen for eligibility. infants with major congenital malformations, neuromuscular disease and lack of parental consent were excluded. enrolled infants will randomize into two study groups (nippv group and bipap group) following the decision to extubate by using sealed opaque envelopes. extubation criteria are; loaded with caffeine according to standard clinical protocol, satisfactory blood gases (ph of more than 7.25), mean airway pressure of 7 cm water or less, fractional inspired oxygen concentration of 35 % or less and good respiratory effort. non-invasive respiratory support will deliver using the device of sle 5000 (specialised laboratory equipment, south croydon, united kingdom) in nippv group and infant flow- deriver device (viasys corp, care fusion, ca) in bipap group. the short binasal prongs will use as interface. the initial ventilator parameters for nippv were: pip levels set 2 cm h2o above the pre-extubation pip, peep: 5 cm h2o, rate the same as was being given before extubation and for bipap were: lower cpap levels 4 to 6 cmh2o (maximum 7 cmh2o) and higher cpap levels 8 to 9 cmh2o (maximum 10 cmh2o), thigh 0.5-0.6 second, and a pressure exchange rate of 20-30/ minute, with the lowest adjusted fio2 to maintain an oxygen saturation of 90% to 95%. extubation failure was defined as: development of respiratory acidosis (blood gases with ph \ 60 mmhg), or hypoxemia (blood gases with pao2 \< 50 mmhg despite oxygen supplementation of 60 percent), or severe apnea requiring mask ventilation. surfactant requirement is goingto evaluate in all infants after nicu admission. poractant alfa was administered if necessary. the primary end-point, rate of extubation failure within 96 hours following first extubation, will compared between the groups. short and long-term neonatal outcomes will also evaluate.

Eligibility criteria:
inclusion criteria: * mechanically ventilated preterm infants with birthweight ≤1250 g exclusion criteria:. * infants with major congenital malformations, neuromuscular disease and lack of parental consent

Keywords: neonatal nippv bipap extubation failure