Kornimate/medical-research-clean huggingface dataset:
association between muscular tissue oxygen saturation and aki in older patients undergoing major abdominal surgery

Conditions: Acute Kidney Injury

Summary: the aim of this study is to investigate association between muscular oxygen saturation and postoperative acute kidney injury(aki) in older patients undergoing abdominal surgeries.the investigator also intend to explore the thresholds of muscular oxygen saturation that correlate with a reduced risk of aki and therefore have the potential to be used as therapeutic targets in future.

acute kidney injury is one of the common and serious complications after major abdominal surgeries,which a reported incidence is as high as 7.5-13.4%.the evidence shows that nearly 20% of elder patients with comorbidity are severely related to postoperative aki,which lead to increased complications, prolonged stays in hospital and higher mortality.what'more,even smaller increases in the levels of serum creatinine (scr) may predict worse kidney function after 1or 2 years.but there is no effective treatment or strategy for acute kidney injury at the moment.therefore,early identification and prevention for aki in perioperative period are key points. the mechanism of aki is complex and multifaceted,which includes that surgeries or anesthesia lead to renal hypoperfusion,ischemia and hypoxia. if the anesthesiologists can monitor the oxygenation status of renal tissues and improve it during surgery, it may reduce the incidence of aki. near-infrared spectroscopy (nirs) is a new noninvasive technique that continuously monitors tissue oxygen saturation by measuring the relative concentrations of oxygenated and deoxygenated hemoglobin within a local tissue area.it has been improved that perioperative muscular oxygen saturation is related to patients outcome.a observational study showed an association between lower intraoperative tissue oxygen saturation monitored on both sides of paraspinal muscle and higher risk of postoperative aki in patients having cardiac surgery, suggesting a potential similarity of tissue perfusion and oxygenation between renal and muscular tissue beds. therefore,in this study, the investigator hypothesizes that monitoring muscular oxygen saturation during period may reflect some part of renal tissue oxygen saturation and associate with postoperative aki.

Eligibility criteria:
inclusion criteria: * age ≥65 years old, * asa scoreⅰ-ⅲ, * scheduled to undergo a 2-hour-or-longer elective major abdominal surgeries exclusion criteria: * urological surgery or procedure related to renal tissue may be performed during surgeries. * nephrectomy or partial nephrectomy was performed before surgeries. * preoperative glomerular filtration rate\<30ml/1.73m2, or end-stage renal disease or renal transplant. * poor hearing or vision and language barrier impeding postoperative assessment. * skin condition incompatible with the adhesive oximetry probe. * refuse to participate in the trial.

Keywords: postoperative acute kidney injury muscular tissue oxygen saturation near-infrared spectroscopy
economic medical evaluation of treatment of the neuropathic pain rebel by cortical stimulation

Conditions: Neuropathic Pain Rebel

Summary: all neuropathic chronicle pains are difficult to treat. currently many patients are not relieved by electric stimulations of central nervous system, existing. recently cortical stimulation had a development important and benefit effects are proven. in this study we evaluate medico-economic impact of this treatment.


Eligibility criteria:
inclusion criteria: * presence of pain caused by lesion of central or peripheral nervous system * pain persistent since one year at least * pain untreated with 3 different antalgic treatments exclusion criteria * pain linked t a malignant affection * patient \< 18 years-old

Keywords: neuropathic pain electric cortical stimulation economic medical evaluation
a study of mehd7945a and cobimetinib in patients with locally advanced or metastatic cancers with mutant kras

Conditions: Neoplasms

Summary: this open-label, multicenter, global phase ib study will evaluate the safety, tolerability and pharmacokinetics of intravenous (iv) dosing of mehd7945a in combination with oral dosing of cobimetinib in patients with locally advanced or metastatic solid tumors that carry a kirsten rat sarcoma viral oncogene homolog (kras) mutation and for which standard therapies do not exist, have proven ineffective or intolerable or are considered inappropriate. the study comprises a dose-escalation (stage 1) and an indication-specific cohort expansion stage (stage 2).


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic solid kras-mutant tumors, for which standard therapies do not exist, have proven ineffective or intolerable or are considered inappropriate * eastern cooperative oncology group (ecog) performance status of 0 or 1 * evaluable disease or disease measurable per modified response evaluation criteria in solid tumors version 1.1 (recist v1.1) * consent to provide archival tumor tissue for biomarker testing * additionally, for patients who are considered for enrollment into the indication specific expansion cohorts in stage 2, the current cancer must be either kras-mutant colorectal cancer (crc) or kras-mutant non-small cell lung cancer (nsclc) exclusion criteria: * history of prior significant toxicity from another mek pathway inhibitor or combination of another mek and epidermal growth factor receptor (egfr) inhibitor requiring discontinuation of treatment * previous treatment with a combination of a mek inhibitor with an egfr inhibitor (applies only to the indication specific expansion cohorts in stage 2) * allergy or hypersensitivity to components of the cobimetinib formulations * history of severe (grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies that required discontinuation of therapy * history of interstitial lung disease (ild) * known severe ulcer disease * history of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, central serous chorioetinopathy (cscr), retinal vein occlusion (rvo), or neovascular macular degeneration patients will be excluded if they currently have either of the following conditions which have been identified as risk factors for cscr: * uncontrolled glaucoma with intraocular pressure greater than (\>) 21 millimeters of mercury (mm hg) * grade greater than equal to (\>=) 3 hypertriglyceridemia
compressive device to prevent keloïd scars recurrence [scarwars]

Conditions: Keloid

Summary: scarwars study deals with the first on-human evaluation of a compressive device dedicated to the prevention of keloïd scars recurrence after surgery. the tested device is made with clinical grade silicon. scarwars is a monocentric study. 27 patients will be include and follow during one year. the primary outcome of this study is the number of keloid recurrence after treatment.


Eligibility criteria:
inclusion criteria: * patient over 18 yo; * patient with aer lobe keloid; * patient with an indication of reconstructive surgery; * signature of informed consent from the patient; * indication that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study; * patient with french social insurance. exclusion criteria: * patient with cutaneous dermatosis or other skin pathology able to interfere with evaluated parameter (recurrence and healing quality); * patient with know nickel allergy; * patient with know silicon allergy; * pregnant women; * legal incapacity or limited legal capacity; * patient unlikely to cooperate in the study and / or low cooperation anticipated by the investigator; * patient without health insurance; * the patient is in the period of exclusion of another study.

Keywords: ear lobe compression medical device recurrence
predicting the conversion from mild cognitive impairment to dementia

Conditions: Mild Cognitive Impairment; Alzheimer Disease; Dementia, Vascular

Summary: mild cognitive impairment (mci) is believed to be the early stage of dementia. the investigators assume that some psychological and imaging risks may predict the conversion. in the current longitudinal study, psychological and imaging data of people with mci will be obtained at baseline, and will be followed at 26 weeks and 52 weeks. the predictors will be found in comparison with controls.

mci increases the risk of later developing dementia. about 10-15% of the amnestic form of mild cognitive impairment will progress to alzheimer's disease in one year. but some people with mci never get worse. others with mci later have test results that return to normal for their age and education. to develop a new drug for the prevention of dementia(dementia due to alzheimer's disease or vascular dementia), investigators need a sensitive and specific tool for recognizing patients who will converse to dementia. the investigators want to establish an operational diagnostic criteria instead of a descriptive criteria for mild cognitive impairment.

Eligibility criteria:
inclusion criteria: * complaint about cognitive decline compared to previous performance * objective cognitive impairment in one or more cognitive domains for age * preservation of independence in functional abilities * mini-mental state examination(mmse) scores between 24 and 30 * a clinical dementia rating(cdr) score of 0.5 exclusion criteria: * dementia * patient with any following disease: parkinson's disease, multiple system atrophy, normal pressure hydrocephalus, progressive supranuclear palsy, subarachnoid hemorrhage, brain neoplasms, huntington disease, epilepsy * depression(hamd \>7) or psychosis * uncontrolled severe medical conditions(i.e., acute heart failure, renal insufficiency) * current treatment with benzodiazepines, antidepressants, antipsychotics, or other medications with significant psychotropic or central cholinergic effects * abnormal thyroid, low vitamin b12 level or low folic acid level * patient with visual and auditory disorders can't cooperate with neuropsychological assessment * patient can't cooperate with following up * informed consent is not obtained

Keywords: dementia alzheimer's disease mild cognitive impairment
sildenofil in persistent pulmonary hypertension in newborns

Conditions: Persistent Fetal Circulation Syndrome

Summary: this study hopes to evaluate the effectiveness of early combined use of sildenafil and nitric oxide (ino) in newborns with persistent pulmonary hypertension (pphn) and or hypoxemic respiratory failure and assess whether this would improve oxygenation, improve time on mechanical ventilation for these babies and also prevent rebound hypoxic episodes.

pphn is characterized by hyper reactivity of the muscle layer in pulmonary arterioles and right to left shunt across the ductus arteriosus and the foramen ovale in the absence of structural heart defects. it could also include right ventricle dysfunction in many cases. the reported incidence of this disease is 0.43 to 6.8/1000 live new born infants with a mortality of 10-20%. the main objective of therapy in pphn is to reduce pulmonary vascular resistance. to this purpose, inhaled nitric oxide has been used in developed and several under developed countries. however 30-40% of these patients do not respond to this therapy. extra corporeal membrane oxygenation is also useful but is an invasive therapy in pphn with serious adverse effects reported. recently sildenafil has been evaluated as an alternative or adjunctive pulmonary vasodilator. it inhibits phosphodiesterase type 5 and elevates the concentration of cyclic guanosine monophosphate in the muscle cells of pulmonary vessels, which in turn decreases pulmonary vascular resistance. the fda in the usa has recently approved the use of sildenafil for use in adults with pphn. recently 3 clinical trials have evaluated sildenafil versus placebo or control in newborns with pphn,all of them showing a significant improvement in oxygenation index, decreased mortality and reduced risk of rebounds after discontinuing ino. the use of sildenafil in treating pphn secondary to chronic lung disease in older infants had been receiving significant attention over the last few years. at hmc, women's hospital, the number of deliveries average 15,000 to 16,000 per year with an admission rate to the nicu of about 10%. the number of pphn cases admitted to our nicu ranges between 14-20 cases per year. in this study the investigators plan to compare the effectiveness of the use of early combined sildenafil and ino in newborns with pphn and or hypoxemic respiratory failure and whether it would improve oxygenation, decrease the time spent in mechanical ventilation and prevent rebound hypoxic episodes.

Eligibility criteria:
inclusion criteria: 1. newborn infants of post natal age less than 48 hours 2. gestational age equal to or more than 34 weeks 3. oxygen index of more than or equal to 20 (moderately ill infants) 4. radiological, clinical and biochemical evidence of acute hypoxic respiratory failure 5. surfactant therapy has been established when indicated 6. presence of arterial line exclusion criteria: 1. congenital diaphragmatic hernia 2. major congenital abnormalities 3. significant congenital heart disease 4. cyanotic congenital heart disease

Keywords: newborn ino sildenafil pphn
human genes and microbiota in early life

Conditions: Host and Microbiome; Pregnancy Outcomes; Pregnancy Complications; Neurodevelopmental Disorders; Immune Development; Childhood Obesity; Type 2 Diabetes

Summary: the long-term goal of the human genes and microbiota in early life (hugme) is to explore the short- and long-term effects of maternal microbiota during pregnancy and the microbiota colonization of their offspring early in life and their interaction with the host on maternal-offspring health consequences in later life in the born in guangzhou cohort study in china. identification of the effect of microbiota in early life, as well as environmental factors and microbe-host interaction, will lead to a better understanding of disease pathogenesis and provide a foundation for targeted mechanistic investigation into the consequences of microbial-host crosstalk for long-term health. it also can result in new strategies to predict and prevent diseases in later life.

prenatal and early postnatal life represent critical windows for growth and cognitive and immune system development. in addition to genetics and host biology, the environment plays a critical role in the health of a child. one key player in this process is the maternal and infant gut microbiomes. the establishment and progression of the intestinal microbiota from birth to childhood are dependent on a range of factors, including maternal microbiota, diet, environment, and medical exposures. the host-microbial crosstalk during this time is thought to be involved in the pathobiology of later-life diseases, such as allergic disease, obesity, and neurodevelopmental delay. although the microbiome and its importance for health have been extensively studied, it remains unclear how maternal microbiota-fetal interaction, the establishment, and progression of microbiota in infant adaptation to postnatal environmental exposures, and microbial-host crosstalk affect the health of the children in later life. hypotheses: 1. maternal microbiota-fetal interaction has an essential effect on fetal immune system development and adverse pregnancy outcomes. 2. host genes can shape infant gut microbial assembly and metabolism. 3. early-life interactions between host genes and microbiota have an impact on immune system development and atopic disease in later life. 4. co-metabolism of the gut microbiome and metabolites in the host affects childhood obesity 5. early-life interactions between the host and microbiota have an impact on the neurodevelopment of the children. 6. maternal microbiota influence the metabolism of the mother during pregnancy and postpartum.

Eligibility criteria:
inclusion criteria: pregnant women with \< 20 weeks of gestation pregnant women intended to eventually deliver in guangzhou women and children's medical center permanent residengts of families intended to remain in guangzhou with their child for ≥3 years exclusion criteria: refuses to have blood and stool samples stored at born in guangzhou cohort study biobank.
ureagenesis analysis in healthy subjects and in urea cycle disorder patients

Conditions: Urea Cycle Disorders

Summary: urea cycle disorders (ucds) are dramatic congenital inherited metabolic disorders. there is no cure. many novel therapeutic approaches are currently being developed, which hopefully will change the current situation. testing the efficacy of such new therapies in patients is a challenge, because many clinical parameters are influenced by several disturbances and biochemical parameters are often not very specific. the measurement of ureagenesis is a tool to analyze the entire function of the urea cycle in a single test. this is more meaningful for the characterization of ucd patients than the analysis of single metabolites or enzymes. therefore, the test will be important to evaluate current and future novel therapies. the term "ureagenesis" means "production of urea", which is the main task of the urea cycle. this total urea production can be measured with a "tracer" (in this case a stable ammonium chloride isotope). this tracer is non-radioactive and non-toxic. it is for example used as an unmarked substance in cough syrup, diuretic drugs and as food additive. thus, the tracer does not pose a risk to the participant, especially since only a very low dose is applied. the investigators will analyze specific substances from the urea cycle (namely \[15n, 14n\] urea and several \[15n\] amino acids) that are produced during the test and compare them with results from healthy people. the maximum test duration is 5 hours. this project is being carried out at one site, namely the university children's hospital in zurich. this project is being carried out under swiss law. the responsible ethics committee has reviewed and approved the study.


Eligibility criteria:
inclusion criteria: * healthy subjects at any age and given written informed consent * subjects with a ucd confirmed by genetic or enzymatic diagnostics at any age and given written informed consent exclusion criteria: * healthy subjects with acute and chronic disease requiring treatment of any kind * pregnant or lactating women. * ucd patients with acute and chronic (other than her/his ucd) disease requiring treatment * ucd patients in which intake of carglumic acid cannot be stopped for 24 hours prior to the test
effect of a mixture of probiotics on the antigen specific antibody response in a influenza vaccination model of healthy adults

Conditions: Enhancement of Protective Antibody Response After Probiotic Consumption

Summary: the aim of the study is to get evidence for an enhancement of immune status in subjects after probiotics mixture consumption ( lactobacillus gasseri pa 16/8, bifidobacterrium longum sp 07/3, bifidobacterium bifidum mf 20/5) based on influenza vaccination model - compared to placebo.

probiotics are "live microorganisms which when administered in adequate amounts confer a health benefit on the host" . many health effects are associated with probiotics , but various degrees of evidence support the benefits associated to probiotics consumption . impact on defences and the immune system has been shown with several strains and this may result in improved protection against some infections or improvment of vaccine efficacy . in its scientific requirments for health claims related to immune function, efsa indicates that it is generally accepted that higher vaccination responses are beneficial.

Eligibility criteria:
inclusion criteria: * healthy male and female adult * between 18 and 60 years old non menopausal female( with effective contraception) * female non pregnant- not wishing to be pregnat during the study capable to respect the protocol * affialted to the social security system aggreeing to be registered in the national fileof volunteers exclusion criteria: * food allergy( component of the experimental product- vaccines) * manifestation of allergy * vaccinated against flu during the 2 previous winters * food allergy, allergy to one of the component of the experimental products or allergy to one of the component of the flu vaccine; * subject displaying manifestation of allergy or being treated for these; * subject vaccinated against flu during the 2 previous winter (winter 2009-2010 and winter 2010-2011); * subject who had symptoms evocating flu during the previous winter (winter 2010-2011); * subject immunodepressed; * subject with immunomodulatory treatment; * subject who received a treatment resulting in systemic immunossuppression or local immunosuppression at pulmonary level, for at least 1 week during the last 3 months before inclusion (v1); * subject with auto-immune disease; * subject with inflammatory and chronic diseases; * subject with on-going antibiotics treatment at the time of the inclusion; * subject not agree to stop his/her usual probiotics supplementation during the study; * use of medication which could interfere with the study in the investigator's opinion (antibiotics, etc...); * any health condition for which the influenza vaccine is not recommended; * subject having received any other vaccine within one month prior to enrolment or intent to receive any other vaccination during the study period.
intensive combo chemo with autologous bm rescue for metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: to determine the therapeutic efficacy of high-dose cyclophosphamide and bcnu with autologous bone marrow transplantation after initial tumor cytoreduction for patients with receptor-negative metastatic breast carcinoma and to determine the optimal timing of cybcnu-abmt after initial development of metastatic breast carcinoma


Eligibility criteria:
inclusion criteria: * breast carcinoma at first clinical evidence of metastatic disease * must have measurable disease by physical exam, x-ray, or scan * age \< or equal to 55 * performance status 0-2 exclusion criteria: * can't have had more than one prior chemotherapy regimen * can't have had concurrent hormonal therapy * no brain metastases * no previous pelvic radiation * no history of another malignancy