Kornimate/medical-research-clean huggingface dataset:
stroke and carotid-cerebral vascular disease after cabg

Conditions: Coronary Artery Bypass

Summary: review the data of patients who underwent coronary artery bypass grafting (cabg) at the department of cardiovascular surgery in ruijin hospital from march 2020 to may 2022, including medical history, head and neck cta, head ct scan, and early postoperative (within 7 days after surgery) neurological complications (defined as a composite of stroke, delayed awakening and severe delirium) . case-control and retrospective cohorts were built to explore risk factors of early postoperative neurological complications, and its association with baseline carotid-cerebral vascular disease. describe the epidemiological data of early postoperative neurological complications (stroke, delayed awakening, and severe delirium) after cabg surgery (within 7 days after surgery); explore independent risk factors of compound neurological complications, build predictive models; compare the effects of carotid-cerebral artery disease on early postoperative compound neurological complications.


Eligibility criteria:
inclusion criteria: 1. patients who received cabg at the department of cardiac surgery in our hospital. 2. surgery that patients received includes both isolated and combined cabg surgery. 3. includes both cardiopulmonary and non-cardiopulmonary bypass. exclusion criteria: 1. without complete preoperative examination data, such as carotid-cerebral artery cta, head ct imaging results and so on. 2. without complete baseline medical history and 7 day post-surgery record.

Keywords: neurological complications carotid-cerebral artery disease cabg cad
long-term immune persistence of gsk biologicals' combined hepatitis a & b vaccine injected according to a 0,6 month schedule

Conditions: Hepatitis B; Hepatitis A

Summary: the aim of this study is to evaluate the long-term persistence of hepatitis a and b antibodies at years 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis a/hepatitis b vaccine. this protocol posting deals with objectives \& outcome measures of the extension phase at year 6 through to 10. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

to evaluate the long-term antibody persistence, volunteers will be bled at years 6, 7, 8, 9 and 10 after the first vaccine dose of the primary vaccination course to determine their anti-hav and anti-hbs antibody concentrations. if a subject has become seronegative for anti-hav antibodies or lost anti-hbs seroprotection concentrations at the long-term blood sampling time point (i.e. years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.

Eligibility criteria:
inclusion criteria: * subjects participating in this study should have participated in the primary study with combined hepatitis a/ hepatitis b vaccine. * written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood sampling visit of each year.

Keywords: hepatitis a hepatitis b twinrix™ adult
efficacy and safety of switching from retrovir to tenofovir or abacavir in hiv-infected patients

Conditions: HIV Infections

Summary: to evaluate the efficacy and safety of switching from retrovir to tenofovir or abacavir in hiv-infected patients


Eligibility criteria:
inclusion criteria: * hiv-infection with undetectable viral load * antiretroviral treatment including retrovir for more than three months * if fertile female: negative pregnancy test and use of safe contraception * negative hbs-antigen titer exclusion criteria: * prior treatment with abacavir or tenofovir * resistance towards abacavir or tenofovir * tissue type hla-b5701 * renal disease * diabetes mellitus * osteoporosis * pregnant or lactating subjects * intravenous drug abuse * hypersensitivity towards drugs or active ingredient used * alat \> 5 times upper normal level * current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance

Keywords: tenofovir abacavir antiretroviral therapy hiv nucleoside analogue reverse transcriptase inhibitor
procalcitonin as a marker of severity of non-cystic fibrosis bronchiectasis in children

Conditions: Non-cystic Fibrosis Bronchiectasis

Summary: the aim of this study is to evaluate the role of procalcitonin in bronchoalveolar lavage as a biomarker for assessment of severity of non-cf bronchiectasis in children in correlation with other markers (functional and radiological severity )

• the severity of bronchiectasis will be assessed using forced expiratory volume in 1s (fev1), and bronchiectasis severity scores which included bronchiectasis severity index (bsi) , fev1, chronic colonization, extension of lobes and dyspnea which were performed to assess non-cf bronchiectasis patients. bsi score * this score incorporates 9 variables. the total score is calculated by summing the scores for each variable and can range from 0 to 26 points. according to the overall score, patients are classified into three classes: patients with low bsi score (0---4 points), intermediate bsi score (5---8 points), high bsi score (≥9 points) * chest x ray and hrct of the chest: to assess the radiological severity of bronchiectasis using the radiological findings will be measured by assessing the most recent chest x ray and hrct of the chest performed in the last six months using bhalla score(10) * culture and sensitivity from bronchoalveolar lavage for isolation of pseudomonas aeruginosa and any other organism. * sputum procalcitonin level was measured in bal samples using bronchoscopy. * bronchoscopy: would be undertaken when the children were in a stable clinical condition as part of their annual review

Eligibility criteria:
inclusion criteria: 1. children of both sex 2. children aged from 6-17 years old. 3. documented diagnosis of non-cf bronchiectasis by confirmed bronchiectasis findings using high-resolution computed tomographic (hrct) lung scanning, and clinical symptoms consistent with bronchiectasis with a negative sweat test exclusion criteria: 1. age less than 6 years or more than 17 years. 2. children diagnosed with cystic fibrosis bronchiectasis with confirmed positive sweat chloride test(6). 3. if there was a history of a recent exacerbation during the previous month preceding the study.
clinical study of methylene blue - mediated photodynamic therapy for diabetic lower limb ulcer

Conditions: Diabetic Extremity Lower Ulcers

Summary: the investigators designed this prospective, randomized control study to confirm the efficacy and safety of methylene blue - mediated photodynamic therapy for diabetic lower limb ulcer and to explore its mechanism.

objective- infection is associated with poor healing of diabetic lower limb ulcer. diabetic lower limb ulcer are often lower extremity vascular stenosis or occlusion, poor blood supply, making local ulcer local antibacterial drugs difficult to effectively reach and distribution, resulting in systemic antibacterial efficacy is limited, and easy to induce bacterial resistance at the same time . in recent years, the incidence of clinical multidrug-resistant bacteria increased, increasing the difficulty and cost of treatment. the current study attempts to identify whether the photodynamic therapy (pdt) would kill the surface of ulcer bacteria and promote ulcer healing, and explore the mechanism of methylene blue-mediated photodynamic therapy for diabetic lower limb ulcer research design and methods-this study evaluated six clinical indicators： diabetic foot ulcer area reduction rate, inflammation control rate, local bacterial load, the dose and use time of antibiotics, adverse reaction rate, bacterial biofilm,local neutrophil extracellular traps. the efficacy and safety of pdt could be confirmed if the clinical indicators of pdt group is better than the control group. in this study, three methods were used to investigate the mechanism of -methylene blue mediated photodynamic therapy for diabetic lower limb ulcer: a comparison of the bacterial load, bacterial biofilm,local neutrophil extracellular traps of the ulcer immediately pre-treatment and immediately,1-week ,2 week,1 momth post-treatment ; expected results-the investigators will expect that methylene blue-mediated photodynamic therapy could kill bacteria on the surface of diabetic lower limb ulcer and accelerate wound healing.

Eligibility criteria:
inclusion criteria: * 1. understand the whole test process, voluntary and signed informed consent form. * 2. men and women aged 18 to 80 years old. * 3. diagnosed with diabetic lower limb ulcer. * 4. ulcer duration\> 1 month of wagner grade ⅱ, ⅲ subjects. * 5. an ulcer area ≤100 cm² or of linear dimension ≤ 10 cm. exclusion criteria: * 1. diagnosis of systemic infection or any concomitant infection that would require treatment with an additional antimicrobial agent. * 2. pregnant or lactating women. * 3. wagner grade ⅰ, ⅳ, ⅴ subjects. * 4. patients with a peripheral vascular disease require immediate revascularization, and/or an ankle brachial systolic blood pressure (sbp) index\<0.5 in the infected limb. * 5. patients with inappropriate health to participate as determined by the principal investigators. * 6. patients in the hepatitis a, hepatitis b, aids, tuberculosis and other infectious diseases of the active period.

Keywords: methylene blue photodynamics therapy
investigation on safety, tolerability and pharmacokinetics of single doses of nnc0174-0833 in normal weight, overweight to obese but otherwise healthy male subjects

Conditions: Metabolism and Nutrition Disorder; Obesity

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to investigate the safety, tolerability and pharmacokinetics of single doses of nnc0174-0833 in normal weight, overweight to obese but otherwise healthy male subjects.


Eligibility criteria:
inclusion criteria: * normal weight, overweight or obese (body mass index \[bmi\]) between or equal to 20.0 and 35.0 kg/m\^2 but otherwise healthy men * age between or equal to 22 and 64 years at the time of signing informed consent exclusion criteria: * history of, or presence of, cancer, diabetes or any clinically significant cardiovascular,respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders including sleep apnoea, as judged by the investigator * subjects with history of, or presence of, a disease being associated with impaired calcium homeostasis and/or increased bone turnover (e.g. paget´s disease, osteoporosis) * male subjects of reproductive age who are not using a highly effective physical barrier method of contraception (sexual abstinence, or condom with spermicidal foam/gel/film/cream) combined with a method with pearl index less than 1% for their nonpregnant partner(s) (such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices or diaphragm+spermicide, or surgical sterilisation or post-menopausal) and/or who intend to donate sperm in the period from start of visit 2 up to 3 months following the administration of the investigational medicinal product
integrating the genetic and metabolic faces of obesity

Conditions: Insulin Resistance; Obesity; Metabolic Syndrome

Summary: the goal of this study is to determine why some obese individuals develop insulin resistance and others do not. we hypothesize that an impairment in differentiation of fat cells (adipocytes) is responsible for the development of insulin resistance in select obese individuals. this study will evaluate obese individuals at baseline with respect to characteristics of adipocytes, including gene expression, and will then entail randomizing subjects to either weight loss or treatment with an insulin sensitizing drug (pioglitazone). changes in insulin resistance will be associated with changes in adipocyte morphology and gene expression.

healthy overweight/obese individuals will be screened for insulin resistance. both insulin resistant individuals and insulin sensitive individuals (to serve as controls) will be eligible to enroll. fat cel biopsy and ct scan of the abdomen is required at baseline and after an intervention with either weight loss or pioglitazone (drug to improve insulin resistance). subjects will repeat insulin resistance test after the intervention as well. subjects will learn much about their metabolism in this study, and will have an opportunity to improve their insulin resistance.

Eligibility criteria:
inclusion criteria: * nondiabetic defined as fasting plasma glucose \< 126 mg/dl * body mass index 27 to 35 kg/m2 * no major organ diseases * able to come to stanford for regular clinical research center visits * english speaking or has own translator exclusion criteria: * pregnancy/lactation * history of eating disorder or major psychiatric illness * allergy to thiazolidinedione * elevation of liver enzymes (\> 2.5 times upper normal limit)

Keywords: obesity insulin resistance thiazolidinedione weight loss adipose tissue metabolic syndrome diabetes prevention cardiovascular disease prevention
foresight intracardiac echocardiography system (ice)

Conditions: Atrial Fibrillation

Summary: this study will evaluate the efficacy of the foresight intracardiac echocardiography system ,with improved image quality, in guiding trans-septal punctures during atrial fibrillation ablation procedures.

the study will recruit 10 patients at a single center.

Eligibility criteria:
inclusion criteria: * patient is at least 18 years old. * patient is undergoing an atrial fibrillation ablation procedure. * patient has a transesophageal echocardiogram (tee) within the 48 hours prior to ablation procedure to rule out left atrial thrombus. * patient provides informed, written consent for participation in the study. exclusion criteria: * patients in whom placement of an ice catheter in the right atrium for adequate atrial visualization is not technically feasible (as evaluated and determined by the physician/study investigator performing the procedure). * patients in whom transseptal puncture is relatively contraindicated. * patients in whom left atrial clot or dense spontaneous contrast is identified on tee, which would increase thromboembolic risk. * women of child bearing potential, in whom pregnancy cannot be excluded. * patients unable to grant informed, written consent for participation in the study.

Keywords: ice ablation trans-septal septum echocardiography
assessment of ovarian reserve tests in unexplained infertile women

Conditions: Infertility; Infertility, Female

Summary: in unexplained infertility in women ,ovary reserve is borderline if assessed using high-sensitive tests.

in unexplained infertility ovarian reserve tests were assessed. in this study, a comparison is done between 35 women with unexplained fertility(the patient) and 35 women who don't have any fertility problems and have at least a child (the control group). the study participants should have the following criteria inclusion criteria: less than 35 years old, married women should have regular menses should have at least a year of unprotected sex. the husband's spermogram should have no abnormalities the subject should have a normal hysterosalphingography exclusion criteria: having any systemic disease. long history of any drug usage. for the control group inclusion criteria: less than 35 years old, married women should have regular menses at least have a child the husband's spermogram should have no abnormalities the subject should have a normal hysterosalphingography exclusion criteria: having any systemic disease. long history of any drug usage. the study includes the following tests being done on the patients: the following hormones' levels were studied:amh (anti-mullerian hormone),fsh (follicular stimulating hormone) , e2 (estradiol) and inhibin b.the former three hormone levels should be assessed on the third day of menses in the study,transvaginal ultrasonographic ovarian volume ,ovarian antral follicule number,ovarian stromal bloodflow and ovarian arterial resistance was measured using doppler ultrasonogram.

Eligibility criteria:
inclusion criteria: * less than 35 years old, * married women * should have regular menses * should have at least a year of unprotected sex. exclusion criteria: * having any systemic disease. * long history of any drug usage.
outcomes of surgery in covid-19 infection: international cohort study (covidsurg)

Conditions: COVID-19; Coronavirus; Surgery

Summary: covidsurg will capture real-world international data, to determine 30-day mortality in patients with covid-19 infection who undergo surgery. this shared international experience will inform the management of this complex group of patients who undergo surgery throughout the covid-19 pandemic, ultimately improving their clinical care.

there is an urgent need to understand the outcomes of covid-19 infected patients who undergo surgery. capturing real-world data and sharing international experience will inform the management of this complex group of patients who undergo surgery throughout the covid-19 pandemic, improving their clinical care. the primary aim of the study is to determine 30-day mortality in patients with covid-19 infection who undergo surgery. in doing so, this will inform future risk stratification, decision making, and patient consent. covidsurg is an investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk. this study does not collect any patient identifiable information (including no dates) and data will not be analysed at hospital-level.

Eligibility criteria:
inclusion criteria: * patients undergoing any type of surgery in an operating theatre, this includes obstetrics and - the patient had covid-19 infection either at the time of surgery or within 30 days of surgery, based on (i) positive covid-19 lab test or computed tomography (ct) chest scan or (ii) clinical diagnosis (no covid-19 lab test or ct chest performed) exclusion criteria: * if covid-19 infection is diagnosed \>30 days after discharge, the patient should not be included.

Keywords: covid-19 coronavirus surgery
study of chimerivax™-japanese encephalitis vaccine in toddlers in thailand and the philippines

Conditions: Japanese Encephalitis; Hepatitis A

Summary: this study is to assess the safety and immunogenicity of three consecutive lots of je-cv in toddlers aged 12-18 months. primary objective: to demonstrate the bio-equivalence of three lots of je-cv vaccine manufactured by sanofi pasteur. secondary objective: to describe the safety of vaccination in all subjects

this is a phase iii trial in toddlers in thailand and the philippines.

Eligibility criteria:
inclusion criteria : * aged 12 to 18 months on the day of inclusion. * in good general health, without significant medical history. * provision of informed consent form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations. * subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures. * completion of vaccinations according to the national immunization schedule. exclusion criteria : * participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination. * planned participation in another clinical trial during the present trial period. * known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy. * known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances. * chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator. * receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response. * administration of any anti-viral within 2 months preceding v01. * history of central nervous system disorder or disease, including seizures. * personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. * receipt of any vaccine in the 4 weeks preceding the first trial vaccination. * planned receipt of any vaccine in the 4 weeks following any trial vaccination. * personal human immunodeficiency virus seropositivity in the blood sample taken at screening. * receipt of any je vaccine or hepatitis a vaccine. * previous vaccination against flavivirus disease. * history of flavivirus infection (confirmed either clinically, serologically or microbiologically) * thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination. * febrile illness (temperature ≥38°c) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.

Keywords: japanese encephalitis, hepatitis a, inactivated mouse-brain
aligning with schools to help manage asthma (project asthma)

Conditions: Asthma

Summary: project asthma is a school-based health center intervention program that institutes guideline-based chronic asthma care and provides supervised administration with daily preventive asthma medications to improve asthma symptoms and lung function, reduce emergency visits, and decrease missed days of school among children from communities with health disparities.

project asthma in schools is a 7 month randomized control intervention pilot trial. forty students, ages 4 to 14 years, with persistent asthma, or who utilize acute care facilities frequently for their asthma, will be recruited from 3 urban sbhcs in the fall of 2018. all students will receive nhlbi guideline-based asthma assessments to determine eligibility and proper dosing of preventive medication. the asthma assessment will include spirometry testing. all enrolled students and parents will receive asthma education at the time of enrollment. eligible students will be randomized to an intervention or usual care group using permuted block randomization stratified by sbhcs. in collaboration with the student's pcp, the sbhcs' mid-level providers will prescribe the preventive medication to the students in the intervention group. these students will receive the morning dose of their preventive medication from the school nurse each school day for the remainder of the school year. students and their parents will be responsible to administer the evening and non-school day doses. students randomized to the usual care group will be referred back to their pcp for further asthma management. all participants will be re-evaluated at 1, 3 and 7 months after enrollment, and medication dose adjustments will be made in the intervention group as needed.

Eligibility criteria:
inclusion criteria: * active asthma * diagnosed with asthma for at least 12 months * enrolled in the school-based health center * persistent asthma as defined by naepp-epr3 guidelines or at least 1 hospitalizations or at least 2 ed/urgent care visits or at least 2 courses of oral steroids for asthma in the previous 12 months for asthma exclusion criteria: * underlying heart or lung disease other than asthma * student has well controlled asthma

Keywords: pediatric school based health center