Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of exo-cd24 in preventing clinical deterioration in patients with mild-moderate ards

Conditions: ARDS

Summary: this is phase iib, randomized, double-blinded, placebo-controlled study to evaluate the safety and efficacy of exosomes overexpressing cd24 of one dose 10\^10 exosome particles, to prevent clinical deterioration in patients with mild-moderate ards

the study population will include patients with mild-moderate ards and laboratory markers predictive of the cytokine storm, who have provided an informed consent. 90 patients will be initially screened, randomized and stratified by center in a 2:1 ratio to receive either 1010 exosome particles (60 patients) or placebo (30 patients). study drug will be delivered using standard jet nebulizer that produce aerosol particles size of 0.4-4.4 µm. the exosomes will be diluted in 1.5 ml normal saline for inhalation, administered twice a day (bid) for 5 days study treatments will be given as an add-on to the standard of care. following the 5 days of treatment, patients will remain in follow-up for 23 additional days. in case of hospital discharge before the full follow-up planned, the patient will be required to return to the site for completion of all study assessments.

Eligibility criteria:
inclusion criteria: 1. direct and indirect lung injury etiology 2. age ≥18 years 3. patients with early acute lung injury (eali) \> 2 ,or patient on hfnc/nippv \[(1 point for an oxygen requirement \> 2 to 6 liters/min or 2 points for \> 6 liters/min; 1 point each for a respiratory rate ≥ 30 breaths/min and baseline immune suppression) (immune system compromised by exogenous drug etc.)\] (for saturation goal \>90%) \[1\], or ards diagnosis (mild/moderate) 4. willing and able to sign an informed consent, or has a legal guardian who is able to sign exclusion criteria: 1. any concomitant illness that, based on the judgment of the investigator might affect the interpretation or the results of the study (immunodeficiency, primary immune deficiency due to virus, hematological malignancy etc.) 2. patients with sao2/fio2\<150 3. patients with mechanical ventilation (ecmo). 4. pregnancy \[positive urine pregnancy test (women of childbearing potential only)\] or breastfeeding 5. participation in any other interventional study in the last 30 days or within 5 half-lives of receiving an investigational agent.
adrenomedullin upregulation in apical periodontitis

Conditions: Periapical Periodontitis

Summary: the aim of the present study was to investigate the relationship between apical periodontitis (ap) severity and inflammatory markers (il-12, tnf-alpha), and mid-regional pro adrenomedullin (mr-proadm) in patients with ap. a total of 174 subjects were divided into three categories: ap group (n=82), chronic periodontitis (cp) group (n=42), healthy control group (n=50). blood samples were collected from all of the patients. enzyme-linked immunosorbent assay was used to evaluate the samples.

bone destruction in apical periodontitis (ap) depends on the microorganisms' efficiency to breach the host-epithelial barrier and various antimicrobial peptides. mid-regional pro adrenomedullin (mr-proadm) is one such potent antimicrobial peptide, which plays a regulatory and stabilizing role among proinflammatory and anti-inflammatory cytokines. a broad range of cells and tissues produce mr-proadm such as adrenal medulla, kidney, lungs, and endothelial cells. mr-proadm was found to be present in circulation and in various biological fluids. it is reported to function both as a generalized hormone and locally affecting autocrine or paracrine mediator. its plasma level is usually elevated in certain conditions such as heart failure, hypertensive situations, cerebro-vascular events, chronic kidney failure, diabetes mellitus, sepsis and periodontitis. besides these, mr-proadm has drawn attention as it stimulates the proinflammatory cytokine il-6 and suppresses cytokines, like tnf- α, for regulating inflammation, being a potent of inhibitor of apoptosis and stimulating angiogenesis in tumor cells. however, there is still a large information gap on mr-proadm. despite all these effects, there is not enough information in the literature about the effect of mr-proadm on oral and dental health and its effectiveness in apical periodontitis. whether ap can cause any alterations in the mr-proadm value is also unknown. therefore, the aim of this study is to investigate the relationship between ap severity and inflammatory markers (il-12, tnf-alpha), and mr-proadm in patients with ap. in addition, the results will be compared with the results of healthy controls and patients with chronic periodontitis.

Eligibility criteria:
inclusion criteria: must be systemically healthy patients with only apical periodontitis (for ap group) patients with only chronic periodontitis (for cp group) orally healthy patients exclusion criteria: any local or systemic inflammatory disease connective tissue diseases like systemic lupus erythematosus (sle) cardiovascular disease inflammatory and rheumatic disease diabetes rheumatoid arthritis, or behcet's disease granulomatous diseases like sarcoidosis inflammatory intestinal diseases like ulcerative colitis and crohn's autoimmune intestinal diseases like celiac thyroid diseases like hashimoto and graves patients who had taken antibiotics and/or anti-inflammatory drugs within the last 6 months those with pregnancy or lactation

Keywords: apical periodontitis, chronic periodontitis, mid regional proadrenomedullin, il-12, tnf-α
cutaneous diphtheria in france : observational, retrospective study of patient characteristics

Conditions: Corynebacterium Diphtheriae Infection

Summary: toxigenic cutaneous diphtheria is a notifiable disease that is re-emerging in the world and particularly in france. a better description of the epidemiological characteristics, as well as a refinement of the clinical characteristics of patients with cutaneous diphtheria, are essential to better understand this pathology, which has important public health issues and whose diagnosis absence can have catastrophic consequences for the patient and their contacts. microbiological data (species identification, toxigenicity or not, resistance profile...) will be transmitted by the national reference center for corynebacteria of the diphtheriae complex and then caregivers who have managed the corresponding patients with cutaneous diphtheria will be contacted.


Eligibility criteria:
inclusion criteria: * culture or pcr positive skin samples for corynebacteria diphtheria, ulcerans, pseudotuberculosis, belfantii or rouxii * patient living in metropolitan france exclusion criteria: - patient opposition

Keywords: cutaneous diphteria
skin glue cesarean study

Conditions: Cesarean Section; Complication; Wound

Summary: the aim of this study is to compare cesarean incision outcomes between patients with incision closed with the dermabond prineo system compared to standard subcuticular suture.

the purpose of this study is to assess patient satisfaction with their incision after undergoing cesarean delivery. patient satisfaction with their cesarean scar at 4-6 weeks after their surgery will be compared amongst women receiving skin closure with the dermabond prineo skin adhesive system versus standard subcuticular suture. dermabond prineo has been shown to have improved cosmesis outcomes in non-obstetric populations but has not yet been studied for women receiving cesarean section. in addition to scar appearance, outcomes such as wound infection, postoperative pain, and operative time will be assessed.

Eligibility criteria:
inclusion criteria: * women age 18 years or older * all women scheduled for primary or repeat cesarean deliveries * all women undergoing intrapartum or antepartum cesarean delivery * pfannenstiel skin incision * birth of a live infant at time of cesarean delivery exclusion criteria: * vertical skin incision * cesarean hysterectomy * emergency or stat cesarean delivery excluding standard preoperative preparation measures (i.e., use of chlorhexidine skin prep, vaginal prep, etc) * intrapartum stillbirth * planned postpartum follow up at another facility * contraindications to routine postpartum pain medications * adhesive or tape allergy

Keywords: complications wound hematoma surgical incision
supplemental hydrogen plus pqq for mitochondrial biomarkers and brain function in elderly with mild cognitive impairment

Conditions: Age-associated Memory Impairment

Summary: the goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of dietary supplementation with molecular hydrogen and pyrroloquinoline quinone in elderly. the main questions it aims to answer are: (1) whether the supplementation affects biomarkers of mitochondrial function in serum, and (2) whether the supplementation affects cognition and brain metabolism. the participants will be subjected to take the dietary supplement during 6 weeks.


Eligibility criteria:
inclusion criteria: * age \> 65 years * mmse scores ranged from 23-27 * informed consent signed exclusion criteria: * take part in exercise on a regular basis * severe chronic disease and acute injuries * history of dietary supplement use during the past 4weeks * no consent to randomization * participation in other studies

Keywords: mitochondrial biomarkers brain metabolism cognition
recurrent campylobacter bacteraemia in immunocompromised patients

Conditions: Campylobacter Infections

Summary: some rare cases of recurrent campylobacter bacteraemia (rcb) exist with relapses months to years after an effective treatment and a negativation of all bacterial samples. as of today, only around 20 cases have been described in the international literature for the last 30 years. the cases are likely highly underreported. no study describes those recurrent campylobacter bacteraemias at the scale of a country. the aim of this multicentre, nationwide, retrospective study is to describe their precise epidemiology in france for the last 25 years, the immune profile of the patients, the specificities of the bacteria involved, the treatments received and the evolution of these infections. the perspective is to propose a standardization of the medical care of those patients mainly by describing the effective treatments and the explorations of the immune system which should be considered.


Eligibility criteria:
inclusion criteria: * 2 episodes or more of campylobacter bacteraemia separated by at least 60 days * and immunodeficiency condition * followed by a french hospital exclusion criteria: -opposition of the patient

Keywords: primary immunodeficiency campylobacter relapsing bacteraemia
idiopathic hypersomnia

Conditions: Hypersomnia, Idiopathic

Summary: idiopathic hypersomnia (ih) is characterized by non-restoring night-time sleep, excessive daytime sleepiness, sleep inertia, impaired cognitive functioning and autonomic symptoms. ih seems to be long lasting, once established, but little is known about long-time consequences, and research on the relationship between idiopathic hypersomnia and all-cause mortality is however sparse. ih is thus a poorly characterized disorder of hypersomnolence, and the present study aims to answer the following research questions: 1. are there subgroups within the ih-group, that can be retrospectively characterized out of data from polysomnography, psg and mslt. 2. what are the relationships between ih, and possible ih subgroups, and morbidity, mortality, and sick leave, using retrospective register data? 3. what is the natural course of ih, and possible ih subgroups, assessed with questionnaires that measures daytime sleepiness, depression, and insomnia? 4. how do subjects diagnosed with ih think about their disease, cope with it, and perceive the effects of treatments, using qualitative interviews? 185 individuals assessed and diagnosed at the sleep unit, uppsala university hospital between 2010-01-01 and 2019-12-31 will be contacted. after collecting informed consents, psg and mslt data will be analysed together with register data regarding morbidity, mortality, sick leave, and pharmacotherapy.questionnaires used at the time of the original assessment will be reviewed and, to study the natural course of the syndrome, the same questionnaires will be sent to the participants by mail.


Eligibility criteria:
inclusion criteria: * idiopathic hypersomnia, according to the the international classification of sleep disorders - third edition (icsd-3) exclusion criteria: * other serious somatic or psychiatric disease * drug additction with drug seeking behaviour
rtms-tacs stimulation on improving cognitive function in bipolar disorder

Conditions: Bipolar Disorder in Remission

Summary: based on the individualized positioning technology of diffusion tensor imaging (dti), the purpose of this study is to explore a new stimulation target and protocol for the treatment of bipolar disorder in remission through the repetitive transcranial magnetic stimulation(rtms) and transcranial alternating current stimulation（tacs）under neuronavigation，verify whether there is abnormal functional connectivity and structural connections between the dorsolateral prefrontal cortex (dlpfc) and the dorsal anterior cingulate gyrus (dacc) related to cognitive impairment in bipolar disorder in remission, which will contribute to further understand the relevant neural pathway and mechanism.


Eligibility criteria:
inclusion criteria: * 1. age 14-45 years old, regardless of gender\] 2.meet dsm-v diagnostic criteria for bipolar depressive in remission 3.young mania rating scale (ymrs) ≤ 6 points; 4.hamilton depression scale(hamd-17)≤7 points; 5.cognitive deficit questionnaire pdq≥17 points; 6.han nationality, right-handed; 7.more than 9 years of education. exclusion criteria: 1. history of severe somatic or brain organic diseases and craniocerebral trauma; 2. abnormal brain structure or any mri contraindications were found by magnetic resonance examination; 3. those who do not cooperate or cannot effectively complete the experiment; 4. drug, alcohol or other psychoactive substance abusers; 5. pregnant, lactating or planned pregnancy; 6. ect or rtms or tacs treatment was performed within six months.

Keywords: repetitive transcranial magnetic stimulation，transcranial alternating current stimulation，diffusion tensor imaging，bipolar disorder
cytokines and sevoflurane during surgery

Conditions: Cytokines; Inflammatory; Sevoflurane

Summary: the aim of the present study was to evaluate the effects of anaesthesia with sevoflurane and surgery on cytokines response.


Eligibility criteria:
inclusion criteria: * both gender, asa i physical status, 18-50 years old, tympanoplasty and septoplasty. exclusion criteria: * malignant or genetical diseases; diabetes; smoking; elicit drugs, recent rx radiation.

Keywords: anaesthetic techniques, inhalation sevoflurane cytokines immune response
protocolized sedative weaning vs. usual care in pediatric critically ill, rct

Conditions: Withdrawal Syndrome

Summary: sedative and analgesic agents are widely used in the icu. these agents can provide hypnotic effect, pain alleviation, cooperation, and synchronizing ventilatory support. prolonged use of the agents can lead to withdrawal symptoms when the drugs are weaned. prior study showed the longer duration of sedative drugs, cumulative dose of medications and younger age were the risk factors of withdrawal syndrome. additional, some study showed the sedation protocol can reduce the incidence of withdrawal syndrome. however, no worldwide standardized sedative weaning protocol including our hospital. the objectives in this study are to establish the sedative weaning protocol and to compare the protocol sedative weaning with the usual care weaning.

sedative and analgesic agents, particularly benzodiazepines and opioids, are widely used in picu. these agents can provide calmness, hypnotic effect, pain alleviation, cooperation, immobilization and synchronizing ventilatory support. prolonged use of the agents can lead to withdrawal symptoms when the drugs are weaned. incidence of withdrawal syndrome is about 50%. withdrawal syndrome can lead to unnecessary and costly diagnostic tests, prolongation of mechanical ventilation and hospital stay, and increasing of suffering. prior study showed the longer duration of sedative drugs, cumulative dose of medications and younger age were the risk factors of withdrawal syndrome. additional, some study showed the sedation protocol can reduce the incidence of withdrawal syndrome. however, no worldwide standardized sedative weaning protocol including our hospital.

Eligibility criteria:
inclusion criteria: * patients aged 1 mo to 18 yrs, at least 37 week of postmenstrual age * patient who was admitted in picu or intermediate ward at ramathibodi hospital * use analgesic/sedative drugs (parenteral)≥ 3 days exclusion criteria: * patients in whom level of sedation or withdrawal assessment cannot be scored. * patients transferred from other hospitals in which the patients have already presented of withdrawal symptoms * patient/parent refuse this study
imatinib mesylate and mycophenolate mofetil for steroid-refractory sclerotic/fibrotic cgvhd in children

Conditions: Chronic Graft-versus-host Disease

Summary: in this study we will combine mycophenolate mofetil and imatinib mesylate to treat steroid-refractory sclerotic/fibrotic type chronic graft-versus-host disease (gvhd) to see the response rate and to find the safety of combination.

sclerotic/fibrotic type chronic gvhd is one of the most severe forms of the disease and is frequently refractory to standard treatment approaches. imatinib mesylate, a tyrosine kinase inhibitor, has been shown to be effective in patients with sclerotic/fibrotic type chronic gvhd by strongly inhibiting both pdgf (platelet-derived growth factor) and tgf-β (transforming growth factor-β) intracellular signaling, which is responsible for the expression of extracellular matrix genes. mycophenolate mofetil (mmf) is one of effective agent for the treatment of chronic graft-versus-host disease. mmf is rapidly absorbed after oral administration and hydrolyzed to the active metabolite, mpa (mycophenolic acid). mpa selectively inhibits inosine monophosphate dehydrogenase, blocking the pathway of purine synthesis in t and b lymphocytes. in this study we will combine mmf and imatinib mesylate to treat steroid-refractory sclerotic/fibrotic type chronic gvhd to see the response rate and to find the safety of combination.

Eligibility criteria:
inclusion criteria * patients must have a diagnosis of chronic gvhd with fibrotic/scleroderma-like features. this diagnosis can be made clinically or by histopathology. * patients must have active disease with at least one of the following manifestations: skin sclerosis, symptomatic bronchiolitis obliterans, extensive lung fibrosis, pathologically demonstrated visceral fibrotic involvement of the gut. * patients with corticosteroid refractory or dependant cgvhd are eligible. steroid-refractory chronic gvhd is defined as chronic gvhd of sustained severity during the last full month during which the patients received the equivalent of prednisone 0.5 mg/kg or more per day or 1 mg/kg or more every other day. * age under 21 years old exclusion criteria * patients who have had chemotherapy, radiotherapy within 4 weeks prior to entering the study. * patients who have not recovered from adverse events. * prior treatment with imatinib mesylate or other tyrosine kinase inhibitor after the date of transplant. * patients on pregnancy or lactating

Keywords: children chronic graft-versus-host disease
padn to treat severe obstructive sleep apnea

Conditions: Obstructive Sleep Apnea Syndrome

Summary: this project is focused on the treatment of severe obstructive sleep apnea with pulmonary artery denervation (padn). although it has now been proved that continuous positive airway pressure (cpap) is the primary treatment for obstructive sleep apnea, on the other hand, there is evidence that 25 to 50% of patients can not tolerate cpap. the investigators previously reported the safety and efficacy of pulmonary artery denervation (padn) for treatment of pulmonary hypertension. excessive sympathetic activation play an important role in the occurrence and development of osa and cause cardiovascular events. it is worth evaluating the feasibility and tolerance of introducing padn at the severe stage of obstructive sleep apnea. therefore, the purpose of our study is to evaluate the safety and feasibility of padn in the treatment of severe osa.


Eligibility criteria:
inclusion criteria: * apnea hypopnea index more than 30, not tolerated or refused continuous positive airway pressure; exclusion criteria: * acute coronary syndrome; * pregnant; * expected life less than 12 months;
infloran® for prevention of necrotizing enterocolitis

Conditions: Necrotizing Enterocolitis

Summary: necrotizing enterocolitis (nec) is one of the most devastating gastrointestinal emergencies in preterm neonates and a leading cause of death and morbidity. the pathogenesis of nec remains largely unclear, but it is widely considered as a multifactorial disease. prematurity, enteral feeding, bacterial colonisation of the gut and intestinal ischemia have been proposed as major risk factors. probiotics may prevent nec by improving the maturity and function of the gut mucosal barrier, modulating the immune system, promoting colonization of the gut with beneficial organisms and preventing colonization by pathogens. a variety of clinical trials have evaluated the effect of different probiotic preparations on the occurrence of nec in preterm infants. the results of recent metaanalyses suggest a benefit of probiotic bacteria in reducing the incidence of nec and propose a change of practice. the aim of the study is to evaluate the efficacy of the probiotic preparation infloran® in reducing the incidence of nec after implementation in clinical routine in preterm (\< 34 weeks gestational age) very low birth weight infants compared to a historical cohort.


Eligibility criteria:
inclusion criteria: * neonates admitted to the neonatal intensive care unit on day 1 of life * very low birth weight (\<1500 gram) * prematurity \< 34/0 weeks gestational age * for group receiving probiotics: 230 infants born after the 20/sep/2010 (i.e. date of introduction of infloran in clinical routine) * for control group (historical): 230 infants born before 2010 exclusion criteria: * malformation of the gut (omphalocele, gastroschisis, intestinal atresia) * death before seven days of life, except due to nec * transfer to another hospital before 37 weeks of corrected gestational age, except those who were transferred to a partner clinic using the same protocol for probiotic supplementation * for group receiving probiotics: infants who did not receive infloran® starting in the first week of life or stopped before 34 weeks gestational age, except infants who developed nec (reason for discontinuation of infloran)

Keywords: very low birth weight infants probiotics necrotizing enterocolitis
evaluation of vepoloxamer in chronic heart failure

Conditions: Chronic Heart Failure

Summary: the purpose of this study is to evaluate whether vepoloxamer can provide a blood chemical marker and functional benefit to damaged heart muscle cells. this will be evaluated by measurement of blood-based laboratory markers, exercise tolerance, and echocardiograms. in addition, the safety and blood levels of vepoloxamer in subjects with chronic heart failure will be evaluated.


Eligibility criteria:
inclusion criteria: * age 18 through 74 * duration of documented heart failure \>3 months * on stable concomitant medication regimen ≥4 weeks * left ventricular ejection fraction ≤35% * systolic blood pressure ≥90 mmhg exclusion criteria: * severe valvular stenosis or primary valvular regurgitation as the cause of heart failure * history of myocardial infarction, coronary artery bypass graft surgery, or percutaneous intervention within the prior 3 months * estimated glomerular filtration rate ≤45 ml/min/1.73 m2 * acutely decompensated heart failure within 1 month prior to the screening visit

Keywords: heart failure