Kornimate/medical-research-clean huggingface dataset:
risk factors for colonization or infection with carbapenem-resistant enterobacteriaceae in children

Conditions: Carbapenem-Resistant Enterobacteriaceae Infection

Summary: carbapenem-resistant enterobacteriaceae (cre) are increasingly identified in children in china. pediatric intensive care unit (picu) is the high-risk area. however, data on the epidemiology of cre in hospitalized children in picu are limited. the objectives of this study are to characterize the risk factors for colonization or infection with cre and describe the microbiologic characteristics of pediatric cre isolates. the investigators will perform a single retrospective study from january 2018 to december 2019 at picu of children's hospital of fudan university .

the investigators intend to enroll all children who were hospitalized in pediatric intensive care unit picu of children's hospital of fudan university from january 2018 to december 2019. children who had positive cultures for any enterobacteriaceae species before their admission will be excluded. children with a picu length of day less than 48h will also be excluded. according to their clinical cultures results, they will be divided into non-cre、cre colonization and cre infection. cre was defined according to the 2015 centers for disease control and prevention (cdc) definition as an isolate resistant to imipenem, meropenem, or ertapenem. clinical and demographic data will be collected from the electronic health record.

Eligibility criteria:
inclusion criteria: * all children hospitalized in picu of children's hospital of fudan university from january 2018 to december 2019. exclusion criteria: * discharge within 48 hours * patients had a positive culture for cre before admission * incomplete clinical and demographic data
does quality of life improve in multiple sclerosis patients treated with interferon beta-1a?

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: this study was to find out if patients with relapsing remitting multiple sclerosis treated with interferon beta-1a had an improved quality of life after treatment with interferon beta-1a

the study was an open-label, multi-center, international post-marketing study (phase 4). eligible patients were interferon naïve patients suffering from relapsing ms. the duration of a subject's participation in the study was up to a maximum 26 months.

Eligibility criteria:
inclusion criteria: * relapsing remitting multiple sclerosis * interferon naïve * eligible for interferon beta-1a (avonex®) therapy as per summary of product characteristics: * subject has had relapsing ms for \> 1 year * subject has had experienced 2 exacerbations in the last 2 years * subject had an edss \[5\] score of \< 5.5 * subject was ambulant exclusion criteria: * diagnosis of ms defined as progressive * history of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta * history of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin * history of seizures within the 3 months prior to starting this study * history of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen or other nsaids, that would preclude use of at least one of these during the study * history of intolerance to interferons * previous use of interferon beta * female subjects who were pregnant or breast-feeding * for female subjects, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception

Keywords: multiple sclerosis avonex interferon beta-1a
biological diagnosis and monitoring of chronic nitrous oxide abuse

Conditions: Nitrous Oxide Abuse

Summary: there is a toxicity linked to the chronic use of nitrous oxide, leading to neurological disorders such as combined sclerosis of the spinal cord. one thus frequently observes patients presenting disorders of walking or paresthesias, of more or less resolving evolution being able to go until the need for using a wheelchair and more recently cases of thrombosis were reported serum or urine n2o assays are rarely performed routinely, because they do not allow to ensure a real exposure due to the very short half-life of this gas in the body. thus, other biological monitoring markers are mentioned in the literature, such as vitamin b12 or homocysteine. unfortunately, there are still no recommendations for biological monitoring of nitrous oxide consumption. moreover, underlying mechanisms leading to clinical outcomes remains misunderstood.


Eligibility criteria:
inclusion criteria: * a current or former recreational nitrous oxide user defined * with associated clinical signs (group 1) * without associated clinical signs (group 2) * with or without clinico-biological sequelae associated with use * consenting to the conduct of the study * socially insured exclusion criteria: * pregnant or breastfeeding women * never used nitrous oxide or stopped using it more than 6 months ago * lack of social security coverage * not willing to participate in the entire study

Keywords: nitrous oxide neurology thrombosis biomarkers metabolis
efficacy and safety of evoglitin in patients with type 2 diabetes and non-alcoholic fatty liver diseases

Conditions: Type2 Diabetes; Non-Alcoholic Fatty Liver Disease

Summary: a multicenter, double-blind, active-controlled, randomized, parallel, phase iv clinical trial to evaluate the efficacy and safety of evogliptin in patients with type 2 diabetes and non-alcoholic fatty liver diseases

1. evogliptin 5mg group: administration with evogliptin 5mg and placebo for 24weeks 2. pioglitazone 15mg group: administration with pioglitazone 15mg and placebo for 24weeks

Eligibility criteria:
inclusion criteria: * type ii diabetes mellitus * subjects who have not been taking any oral hypoglycemic agent within 8 weeks from screening or who have been taking metformin monotherapy at the same dose for more than 8 weeks before screening * subjects with 6.5%≤hba1c≤9.0% at screening * subjects with 20kg/m2≤bmi≤40kg/m2 at screening exclusion criteria: * type i diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus * ast \> upper normal range\*3 * galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption * subjects who experienced hypersensitivity reaction against dpp-4 inhibitors, thiazolidinediones * pregnant women
targeted literature review and subject interviews in wiskott-aldrich syndrome (was)

Conditions: Wiskott-Aldrich Syndrome

Summary: was is a rare primary immune deficiency disease caused by genetic mutation and is more common in males than females. the purpose of this study is to understand experiences of was subjects and caregivers to identify important concepts of interest that could be measured in future phase iiib trials. this is a qualitative cross-sectional study that will include a sample of approximately, 8 subjects with was and 13 caregivers of subjects with a diagnosis of was in the united states, united kingdom and france. a 60 to 90 minute open-ended interview will be conducted over the telephone or video conference that will be audio-recorded for subsequent transcription. the aim of these interviews is to obtain subject and caregiver perspectives on the impact of was and its associated treatments on quality of life and experiences of living with was.


Eligibility criteria:
inclusion criteria: subjects: * male adolescents or young adults ranging in age from 12 through 30 years old. * diagnosis of was defined by was genetic mutation with a clinical score \>=1 or self-reported disease severity. * subjects who are "conservatively managed" or have not received treatment for was; a maximum of 5 subjects who have received a hematopoietic stem cell transplant within the preceding two years. * able to read, speak, and understand english or french sufficiently to complete all assessments. * willing and able to participate in an audio-recorded, telephone or video conference session, including adherence to the interview instructions and completion of all questionnaires. * parent/guardian/patient signed informed consent. caregivers: * caregivers of children \>=2 years of age diagnosed with was; at least 5 caregivers of subjects under the age of 8. * caregivers of subjects with a diagnosis of was defined by was genetic mutation with a clinical score \>=1 or self-reported disease severity. * caregivers of subjects who are "conservatively managed" or have not received treatment for was; at least 2 caregivers of subjects who have received a hematopoietic stem cell transplant within the preceding two years. * caregivers are defined as primary caregiver. * able to read, speak, and understand english or french sufficiently to complete all assessments. * willing and able to participate in an audio-recorded, telephone or video conferencing interview session, including adherence to the interview instructions and completion of all questionnaires. * caregivers of wiskott-aldrich patients can be of any age or gender and do not have to follow the patient inclusion criteria, as long as their child/patient meets the inclusion criteria, as outlined. exclusion criteria: subjects * subjects who have previously received gene therapy treatment caregivers * caregivers of subjects who have previously received gene therapy treatment * professional caregivers (that is, at home nurse or equivalent).

Keywords: united states united kingdom wiskott-aldrich syndrome caregiver interview immune deficiency france
periodontal health and its impact on oral health-related quality of life among diabetes mellitus patients

Conditions: Diabetes Mellitus; Periodontal Diseases

Summary: periodontal diseases, encompassing a range of inflammatory conditions affecting the supporting structures of the teeth, have long been recognized as a prevalent comorbidity in individuals with diabetes. the severity of periodontal disease is usually documented by research clinicians using clinical parameters such as bleeding on probing (bop), probing pocket depth (ppd), and clinical.

oral health plays a pivotal role in the overall well-being and quality of life of individuals. any condition affecting oral health can have far-reaching consequences for an individual's daily life.both periodontitis and diabetes have been reported to have negative impacts on aspects of daily living and health-related quality of life. evidence suggests that oral health problems can adversely affect an individual's physical functioning, social standing and wellbeing, and that it can be difficult to dissociate oral health from general health with regards to impacts on quality of life. oral health-related quality of life (ohrqol) can be assessed using the oral health impact profile-14 (ohip-14) questionnaire

Eligibility criteria:
inclusion criteria: * individuals diagnosed with diabetes mellitus for case group, non diabetic patients for control group, age range between 18 to 60 years, informed consent, participants with varying degrees of periodontal health exclusion criteria: * participants with severe systemic illnesses and habits that may significantly affect oral health or quality of life, individuals with severe cognitive impairment or psychiatric conditions that hinder their ability to participate and provide informed consent.
prematurity related ventilatory control (pre-vent) - specific aim 2

Conditions: Infant,Premature

Summary: to determine if late (at or beyond postnatal day 14) mild permissive hypercapnia is associated with reduction in apnea, bradycardia, and hypoxemic episodes and with improved stability of oxygenation.

preterm infants who remain intubated or on nasal mechanical ventilation (imv) at 14 days postnatal age, meet blood gas criteria, have transcutaneous carbondioxide (tcco2) monitoring with tcco2 values that trend and correlate appropriately with paco2, and are not judged too unstable by attending neonatologist will qualify. the investigators will use the data from the 96 hours of intensive multiparametric physiologic monitoring at 2 weeks postnatal age. the first 24 hours of data collection will be the baseline data. over the next 72 hours, the investigators will evaluate 3 interventions in a cross-over manner with the initial intervention randomly assigned: intervention 1 (24-48h of data), intervention 2 (48-72h of data) and intervention 3 (72-96h of data).

Eligibility criteria:
inclusion criteria: 1. inborn infants weighing 401-1,000 grams on admission and/or 22w 0/7d to 28w 6/7d (\<29 weeks) inclusive completed weeks of gestation 2. infants eligible for full care and resuscitation as necessary, and surviving beyond 24 h of age 3. enrollment in main study protocol (aim 1 of prevent apnea) at \<1 week post-natal age 4. informed consent from parent/guardian 5. this study will enroll the subset of infants from aim 1 who are still intubated or on nasal imv at 2 weeks postnatal age, meet blood gas criteria (arterial or capillary arterialized blood gas values done q12-24h, as most infants do not have an arterial line at 2 weeks: ph \>7.25, paco2 \>40 mm hg), have tcco2 monitoring with tcco2 values that trend and correlate appropriately with paco2, and are not judged too unstable by the attending neonatologist. exclusion criteria: 1. refusal or withdrawal of consent 2. major congenital malformations (e.g., not including patent ductus arteriosus, small hernia)

Keywords: apnea of prematurity bradycardia hypoxemic episode permissive hypercapnia
t lymphocytes for the treatment of adv, cmv, ebv, bkv and aspergillus fumigatus infections after allogeneic stem cell transplantation

Conditions: Opportunistic Fungal Infection; Opportunistic Viral Infection; Bone Marrow Transplant Infection

Summary: the purpose of the study is to determine the feasibility, safety and efficacy of administering rapidly-generated donor-derived pentavalent-specific t cells (penta-sts) to mediate antiviral and antifungal activity in hematopoietic stem cell transplant (hsct) recipients with adv, ebv, cmv, bkv or aspergillus fumigatus (af) infection/ reactivation or with active disease.

reconstitution of anti-viral and antifungal immunity by donor-derived antigen-specific t cells has shown promise in preventing and treating infections with cmv, or/and ebv, or/and adv or/and bkv, hhv6 or/and af post-transplant. however, the broader implementation of t cell immunotherapy using conventional protocols is limited and until today it was practically impossible for greece by the cost, the complexity and the time required for virus-specific t cells (vsts) production and by the antigenic competition between different antigens, which limits the spectrum of viruses that can be targeted in a single t cell product. in this trial, the investigators will evaluate the feasibility, safety and efficacy of donor-derived penta-sts infusion to allogeneic hsct recipients with confirmed adv, ebv, cmv, bkv and af infection.

Eligibility criteria:
inclusion criteria: 1. received prior myeoloablative or nonmyeloablative allogeneic hematopoietic stem cell transplant. 2. cells administered as treatment for single or multiple infections/reactivations of one or more of the following pathogens: adv, cmv, ebv, βκv and af. 3. karnofsky/lansky score of ≥ 50. 4. anc \> 500/μl. 5. bilirubin ≤ 2x\*, ast \ 8.0 g/dl. 6. pulse oximetry of \> 90% on room air. 7. available pentavalent-specific t cells. 8. negative pregnancy test (if female of childbearing potential) 9. patient capable of providing informed consent. exclusion criteria: 1. received atg, or campath or other t cell immunosuppressive monoclonal antibodies in the last 28 days. 2. steroids \> 0.5 mg/kg/day prednisone. 3. received donor lymphocyte infusion in last 28 days. 4. gvhd ≥ grade 2. 5. active and uncontrolled relapse of malignancy. 6. patients with other uncontrolled infections

Keywords: cmv ebv bk virus adenovirus aspergillus fumigatus
intrahepatic blood flow occlusion and cardiac injury risk in partial hepatectomy

Conditions: Perioperative Myocardial Injury; Myocardial Injury After Non-Cardiac Surgery; Hypotension; Ischemia Reperfusion Injury

Summary: the goal of this observational study is to examine whether intrahepatic blood flow occlusion strategies during partial hepatectomy are associated with postoperative cardiac injury in patients undergoing hepatectomy. the primary questions it seeks to address are: 1. are the intrahepatic blood flow occlusion method, the number of occlusions, and the cumulative occlusion time associated with postoperative cardiac injury? 2. how do intrahepatic blood flow occlusion, intraoperative hypotension, and postoperative cardiac injury interact? participants will contribute their inpatient medical records, including information on medical history, surgical procedures, and anesthesia details.

liver resection is currently the primary surgical treatment for liver tumors, injuries, and other diseases. with the continuous development of surgical techniques, its application has been expanding. however, intraoperative bleeding and poor surgical field exposure remain major challenges in liver resection, seriously affecting the safety and efficacy of the operation. hepatic inflow occlusion is a commonly used technique to address these challenges. it can effectively reduce intraoperative bleeding and improve surgical field exposure. however, it can also lead to hepatic ischemia-reperfusion injury, which may aggravate the damage to the remnant liver and even affect liver regeneration. recent studies suggest that hepatic ischemia-reperfusion injury may affect distant organs such as the kidneys, brain, lungs, and heart. however, there is still insufficient clinical evidence, especially regarding myocardial injury. in addition, intraoperative hypotension is a common complication of liver resection and may exacerbate the impact of ischemia-reperfusion injury on the myocardium. this study intends to construct a model incorporating variables related to intraoperative hepatic ischemia and reperfusion, and analyze the relationship between hepatic inflow occlusion and postoperative myocardial injury in liver resection using logistic regression, while considering the mediating effect of hypotension. the results of this study will provide important clinical evidence for optimizing liver resection strategies, reducing myocardial injury, and improving patient prognosis. this research holds significant scientific and clinical value, and is expected to improve the quality of liver surgery and patient survival rates.

Eligibility criteria:
inclusion criteria: hospitalized patients aged ≥18 years who underwent partial hepatectomy between november 28, 2004, and may 20, 2024. exclusion criteria: 1. end-stage renal disease patients (requiring renal replacement therapy) 2. asa score ≥ 4 3. lack of intraoperative hepatic portal occlusion data 4. insufficient perioperative myocardial injury biomarker measurement data
multicenter assessment of a bedside-testing system (nephrocheck™) for acute kidney injury after thoracoabdominal aortic surgery

Conditions: Early Assessment of AKI After TAAA Repair

Summary: assessment of postoperative acute kidney insufficiency according to the kdigo classification using the nephrocheck system. multicentric, prospective study open taaa repair in 3-4 centers in germany and europe


Eligibility criteria:
inclusion criteria: elective open taaa repai 18-80 years no pregnancy exclusion criteria: emergency treatment participation in another trial renal replacement therapy
aspirin non-responsiveness and clopidogrel endpoint trial.

Conditions: Coronary Heart Disease; Angina Pectoris; Atherosclerosis

Summary: in the ascet study, 1000 patients with documented coronary heart disease will be randomized to either continued treatment with aspirin 160 mg/d or change to clopidogrel 75mg/d. clinical endpoints will be recorded for at least 2 years and related to the initial aspirin response, assessed by the pfa-100® method, to investigate whether aspirin non-responders have higher composite event rate than responders or whether clopidogrel treatment in patients non-responsive to aspirin will reduce their risk of future clinical events. the clinical events are the composite of unstable angina, myocardial infarction, stroke or death.

background: aspirin is widely used as an antiplatelet drug in patients with coronary heart disease. despite documented clinical benefit, many patients on aspirin still experience severe cardiovascular events. several laboratory reports have shown lack of platelet inhibition in 5-40% of aspirin-treated patients, and the term aspirin resistance has been introduced. the clinical relevance of these laboratory findings is, however, still unknown. new antiplatelet drugs have been developed, and the adenosin diphosphate (adp) receptor inhibitor clopidogrel has at least the same efficacy as aspirin with an acceptable safety profile. laboratory methods for determination of platelet reactivity and treatment efficacy have been complicated and time consuming. new methodologies, like the pfa-100® system, have made such analyses more suitable for clinical use. design: in the ascet study, 1000 patients with documented coronary heart disease will be randomized to either continued treatment with aspirin 160 mg/d or change to clopidogrel 75mg/d after initial determination of their platelet reactivity while on aspirin treatment. clinical endpoints will be recorded for at least 2 years and related to the initial aspirin response. scand cardiovasc j. 2004 dec;38(6):353-6.

Eligibility criteria:
inclusion criteria: * stable, symptomatic coronary heart disease, verified by coronary angiography, being treated with angioplasty/stent implantation (pci) or not. exclusion criteria: * indication for warfarin treatment. * indication for or contraindication to the study drugs. * pregnancy or breast-feeding. * malignancy that may interfere with life expectancy. * psychiatric disease, mental retardation, dementia, drug abuse, alcoholism or conditions that can severely reduce compliance.

Keywords: antiplatelet therapy aspirin non-responders aspirin resistance clopidogrel coronary heart disease stable angina pectoris