Kornimate/medical-research-clean huggingface dataset:
integration of navoy® sepsis in an electronic health record system

Conditions: Sepsis

Summary: the study aims to evaluate the performance of navoy® sepsis in predicting the sepsis risk in adult icu patients. data collection is performed via automatic retrieval from the electronic health record system to algodx proprietary cloud service where it is analysed in a simulated environment.


Eligibility criteria:
inclusion criteria: * the subject is admitted to the icu during the enrolment period. * the subject is 18 years of age or older at the time of admission to the icu. exclusion criteria: * none.

Keywords: sepsis icu prediction decision support machine learning intensive care
a study to evaluate tar-210 versus single agent intravesical cancer treatment in participants with bladder cancer

Conditions: Non-Muscle Invasive Bladder Cancer

Summary: the main purpose of this study is to compare the disease-free survival between participants receiving treatment with tar-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk nmibc.


Eligibility criteria:
inclusion criteria: * have a histologically confirmed diagnosis (within 90 days of randomization) of ir-nmibc with at least one of the following criteria fulfilled: a. ta low grade (lg)/ grade 1 (g1): primary or recurrent, b. ta lg/g2: primary or recurrent and c. greater than or equal to (\>=) 1 of the following risk factors: i. multiple ta lg tumors, ii. solitary lg tumor \>= 3 cm, iii. early recurrence (less than \[\ \] 1 per year), v. recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor) * have a susceptible fibroblast growth factor receptor (fgfr) mutation or fusion either by urine testing or tumor tissue testing (from turbt tissue), as determined by central or local testing * participants must be willing to undergo all study procedures (e.g., multiple cystoscopies from screening through the end of study and turbt for assessment of recurrence/progression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm. * visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at screening cystoscopy * can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment * have an eastern cooperative oncology group performance status of 0 to 2 exclusion criteria: * known allergies, hypersensitivity, or intolerance to any study component or its excipients, including: a. erdafitinib excipients; b.tar-210 drug delivery system constituent materials ; c. urinary placement catheter materials; d. mmc or chemically related drugs; e. gemcitabine or chemically related drugs * presence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of tar-210 or passage of a urethral catheter for intravesical chemotherapy * polyuria with recorded 24-hour urine volumes \> 4000 milliliters (ml) * current indwelling urinary catheters, however, intermittent catheterization is acceptable * had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (turbt is not considered major surgery)
replication of the einstein-dvt anticoagulant trial in healthcare claims data

Conditions: Venous Thromboembolism

Summary: investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. the investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

this is a non-randomized, non-interventional study that is part of the rct duplicate initiative (www.rctduplicate.org) of the brigham and women's hospital, harvard medical school. it is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. investigators assume that the rct provides the reference standard treatment effect estimate and that failure to replicate rct findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original rct finding.

Eligibility criteria:
criteria: please see https://drive.google.com/drive/folders/1wd618wrywyjeaxzfltcuk-vccnb6b-gv for full code and algorithm definitions. inclusion criteria: - confirmed acute symptomatic proximal dvt without symptomatic pe exclusion criteria: * age ≤ 18 * thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of dvt or pe two weeks prior to and including day of enrollment * other indications for vka than dvt and/or pe six months prior to and including day of enrollment * any of the following six months prior to and including day of enrollment: * creatine clearance \< 30 ml/min * significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or alat\>3 uln * bacterial endocarditis * active bleeding or high risk for bleeding contraindicating treatment with enoxaparin or vka * systolic blood pressure \> 180 mghg or diastolic blood pressure \> 110 mghg * childbearing potential without proper contraceptive measures, pregnancy, or breastfeeding * life expectancy \< 3 months in the last year prior to and including day of enrollment * concomitant use of strong cyp3a4 inhibitors (e.g. hiv protease inhibitors, systemic ketoconazole) or strong cyp3a4 inducers two weeks prior to and including day of enrollment * symptomatic pulmonary embolism two weeks prior to and including day of enrollment
effect of topical tetracycline and dexamethasone on periodontal and pulpal regeneration of replanted avulsed teeth

Conditions: Dental Trauma; Avulsion; Periodontal Regeneration; Pulpal Regeneration; Topical Dexamethasone; Topical Tetracycline

Summary: to evaluate the effect of topical tetracycline and dexamethasone on periodontal and pulpal regeneration of avulsed permanent teeth after an observation period between 9-16 years.

two different medications were applied prior to replantation. a) topical tetracycline, b) topical dexamethasone. teeth were splinted using a non-rigid titanium trauma splint for 7-14 days. endodontic treatment was performed within 1-7 days, except for teeth with an open apex and a short extraoral dry time. all patients received systemic tetracycline for 10 days after accident and were subsequently re-examined. follow-up examinations included periodontal examination, percussion, periotest measurements, pulp sensitivity using co2 snow, periapical radiograph and intraoral photographs. additionally a ohip-14 questionnaire was carried out to determine the oral health-related quality of life.

Eligibility criteria:
inclusion criteria: * avulsion of a permanent tooth * written informed consent exclusion criteria: * extended dry period of more than 60 minutes
a study of met233 in combination with met097 in individuals with obesity or overweight with or without diabetes

Conditions: Obesity and Obesity-related Medical Conditions

Summary: this study is designed to test how well the combination of met233 with met097 works to treat individuals with obesity or overweight with or without diabetes.

this is a randomized, placebo-controlled, double-blind, double-dummy study to investigate the safety, tolerability, pk, and pd of subcutaneous (sc) doses of met233 co-administered with met097 in adult participants with a bmi of 27 to 38 kg/m2, including some participants with t2dm. for part a, after the up to 4-week screening period, the study includes 1 dose and a 12-week safety follow-up after administration. for part b and part c, after the up to 4-week screening period, the study includes 5 once-weekly doses and an approximately 11-week safety follow-up after the last administration. parts a and b will include only participants with overweight or obesity without type 2 diabetes. part c will include participants with overweight or obesity who also have type 2 diabetes.

Eligibility criteria:
inclusion criteria: * bmi ≥27 kg/m2 and ≤38.0 kg/m2 (inclusive) at screening * for participants in part a and b, no history of clinically significant diseases or clinically significant findings from the physical examination. for participants in part c, no clinically significant diseases except t2dm, well controlled hypertension, and/or dyslipidemia. * for participants in part c, diagnosed with t2dm for at least 3 months before screening. * for participants in part c, t2dm includes glycated hemoglobin (hba1c) value ≤10.5% at screening and treated with stable therapy for at least 30 days prior to screening/visit 1. exclusion criteria: * female who is lactating or who is pregnant according to the pregnancy test at screening or on day 1. * seated blood pressure higher than 160/100 mmhg at the screening visit or prior to the first study drug administration. * elevated resting pulse greater than 100 beats per minute at screening visit or prior to the first study drug administration. * estimated glomerular filtration rate (egfr) \<80 ml/min at the screening visit. * diagnosis of type 1 diabetes. * for part a and part b: diagnosis of t2dm or glycated hemoglobin (hba1c) \> 6.4% or fasting plasma glucose \>126 mg/dl at the screening visit or history of taking any medications to lower glucose. * for part a and part b: participant reported weight-related comorbidity, including sleep apnea and cardiovascular disease. * history of bariatric or weight loss surgeries. * personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome. * lifetime history of acute or chronic pancreatitis or pancreatic cancer. * participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration or plans to do so.

Keywords: glp-1 metsera
medium and long term follow-up of covid-19 infected patients: research and characterization of pulmonary sequelae

Conditions: Sars-CoV2

Summary: severe acute respiratory syndrome coronavirus 2 (sars-cov-2) is the cause of atypical emerging pneumonia. the clinical spectrum varies from an asymptomatic or mild illness to a serious illness with a high risk of mortality. the most severely affected patients (5%) present an acute respiratory distress syndrome (ards), requiring assistance with mechanical ventilation in intensive care. in 2003, persistent lung damage was observed in a third of patients in a singaporean cohort one year after sars-cov infection. a chinese study showed that 27.3% of their sars-cov patients presented a decreased carbon monoxide diffusion (dlco) and 21.5% of pulmonary fibrosis lesions. due to the very recent emergence of sars-cov-2, no data is currently available of long-term outcome of these patients. however, recent publications including short-term ct monitoring suggest the genesis of fibrotic pulmonary parenchymal sequelae. in view of these data, the investigators can fear the occurrence of pulmonary sequelae in patients infected with sars-cov-2. it is therefore essential to evaluate the evolution of the respiratory status of the most severe patients who have had a stay in intensive care with respiratory assistance.


Eligibility criteria:
inclusion criteria: * patient infected by sars-cov-2 (diagnosed by rt-pcr and / or typical ct imaging) * patient hospitalized in the intensive care units of besançon or dijon hospitals for severe sars-cov-2 pneumonia * postmenopausal woman for at least 24 months or surgically sterilized, or, for woman of childbearing age, use of an effective method of contraception * signature of informed consent to participate indicating that the subject has understood the purpose and the procedures required by the study and that he agrees to participate in the study. * affiliation to a french social security system . exclusion criteria: * chronic respiratory failure under long-term oxygen therapy * known diffuse invasive pneumonia * life expectancy estimated at less than one year by the doctor * legal incapacity or limited legal capacity * history of psychiatric illness, intellectual disability, lack of motivation or other conditions that may limit the understanding of informed consent * subject unlikely to cooperate in the study and / or weak cooperation anticipated by the investigator * subject without health insurance * pregnant and / or lactating woman * subject being in the exclusion period of another study or foreseen by the "national file of the volunteers".
development, feasibility testing and validation of a survey set to measure patient-reported outcomes among hemodialysis patients in turkey

Conditions: Renal Failure; End Stage Renal Disease

Summary: development, feasibility testing and validation of a survey set to measure patient-reported outcomes among hemodialysis patients in turkey: creating and testing an electronic patient questionnaire that is suitable to measure health-related quality of life in turkish dialysis patients in clinical as well as in home care settings.

individuals with chronic kidney disease represent a growing population in adult and pediatric practices. this has resulted in a drive to optimize patient care and outcomes. historically, healthcare outcomes focused on morbidity, mortality or complication rates, but failed to provide meaningful data on the value of medicine to patients and the quality of life gained or lost. several studies have revealed that treatments aimed at minimizing morbidity and mortality in end-stage renal disease (esrd) have very often been ineffective. therefore, attention to hrqol among esrd patients is crucial. the aim of this pilot study is creating and testing an electronic patient questionnaire that is suitable to measure health-related quality of life in turkish dialysis patients. this questionnaire consists of the promis cognitive function and abilities subset, the promis-29, a new post-dialysis recovery time module, the mos-social support scale (mos-sss), subscales of the kdqol sf 1.3 (sexual function \& cognitive function), the general self-efficacy scale and the health services utilization and productivity loss survey which are to be delivered together on a tablet computer.

Eligibility criteria:
inclusion criteria: * informed consent signed and dated by study patient and investigator/authorized physician * age of 18 -80 years * ability to understand the nature and requirements of the study * literacy in turkish including the ability to read with regards to visual acuity and the ability to understand what is read * general ability to use a tablet (the study nurse will instruct the patient how to use the study-tablet during the conduct of the study) * to be on stable maintenance hemodialysis (hd) for over 3 months (prevalent patients) exclusion criteria: * any conditions which could interfere with the patient's ability to comply with the study * previous participation in the same study * participation in an interventional clinical study during the preceding 30 days * serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease, which causes life-expectancy less than a year, * acute cardiovascular events including myocardial infarction, stroke and unstable angina pectoris requiring hospitalization within the last 6 months, * to have cognitive or mental co-morbidities which prevent reliable answering of questions

Keywords: hemodialysis psychometric tests patient questionnaire
s-asenosyl-l-methionine vs placebo for osteoarthritis of the hands

Conditions: Osteoarthritis Hand

Summary: the primary objective of this study is to demonstrate the feasibility of evaluating same tolerability, analgesic benefits, and daily functional improvement in patients with osteoarthritis of the hands compared to placebo. the secondary objective of this study is to generate preliminary data on discomfort, function, quality of life in patients with osteoarthritis of the hands when taking same compared to placebo.

at week 0, all patients giving written informed consent and meeting eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to same (400mg orally, twice daily) or placebo (400mg, twice daily) for 8 weeks. followed by a one week wash out period followed by another 8 weeks of same (400mg, twice daily) or placebo (400mg, twice daily) for 8 weeks (whichever was not given during the first 8 week period). participants will complete weekly surveys during the entire study regarding hand discomfort, functional limitations and side effects

Eligibility criteria:
inclusion criteria: * current primary care provider within the dartmouth health system * office visit at dartmouth health in the past 3 years * participants must be 40 or older at the time of signing the informed consent * participants have discomfort or functional limitations of one or both hands and either: 1. objective findings of at least one hand meeting diagnostic criteria based on the american college of rheumatology (acr)\* or 2. existing radiographic evidence of osteoarthritis as judged by a radiologist * patients taking otc or prescription analgesics who are willing to stop their current analgesics for two weeks prior to study entry and remain off those medications over the course of the study * \*objective inclusion criteria (see poster schematic) swelling or deformity of 2 of the following ten joints: the 2nd and 3rd distal interphalangeal (dip) of each hand, the 2nd and 3rd proximal interphalangeal (pip) of each hand, and the 1st carpometacarpal joints of both hands. exclusion criteria: * patients taking prescription medications other than nsaids for their oa who are unable to stop their medication * patients with diagnoses of arthritis from conditions other than oa * patients whose symptomatic joint is an artificial joint * patients with bipolar disorder * patients taking any of the following medications at study entry or starting any of these medications during the study period: 1. daily opioids (including tramadol or buprenorphine) 2. gabapentin or pregabalin 3. prednisone 4. prescription nsaids that they are unable to stop or topical diclofenac 5. snri drugs (effexor, cymbalta, fetzima, pristiq) * the participant has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study

Keywords: same s-adenosyl-l-methionine
study of possible brain hormone problems after open heart surgery in infants

Conditions: Congenital Heart Disease

Summary: the goal of this study is to evaluate specific hormone levels in children undergoing heart surgery in order to identify patterns associated with any unstable vital signs. the data collected will provide preliminary answers to the question "are hormone values a determining factor for drug administration and dosing levels?" and help establish the benefits of routine steroid and hormone administration. sixty subjects will be enrolled. blood samples will be drawn before the surgery,and again nine hours after surgery for analysis. other patient data such as medications, vital signs, routine lab values and treatments will also be analyzed. as our current standard of care includes routine doses of steroids, we believe this study will increase our general knowledge and improve the care of these critically ill children. the study will also provide the foundation needed for grant support from the american heart association, allowing for future larger scale studies.


Eligibility criteria:
inclusion criteria: * children with congenital heart disease requiring cardiopulmonary bypass(cpb) surgery less than 1 year of age admitted to the cardiac intensive care unit (cicu) preoperatively, who required blood sampling as part of their care. * subject must have arterial or central venous lines to be enrolled. * subject must have a documented weight of 2.5 kilograms or greater. * subjects' legal guardian shall possess the ability to understand the purposes and risks of the study and provide an informed consent signature. exclusion criteria: * medical urgency preventing timely administration of the consenting process. * any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating. specific conditions might include, but are not limited to, anemia or coagulopathy. * have given steroids intravenously (iv) or oral steroids within the last month. * have a preexisting neuroendocrine disorder. * have been treated with antipsychotic medication. * have human immunodeficiency virus (hiv). * have received etomidate for intubation. * other technical considerations that would prevent acquisition of sufficient samples or inability / unwillingness of the legal guardian to provide consent.

Keywords: biological response modifiers bypass surgery cardiology congenital heart disease endocrinology hormone dysfunction hormones neuroendocrinology pediatric surgery
clopidogrel only before percutaneous coronary intervention or before every coronarography?

Conditions: Ischemic Heart Disease

Summary: clopidogrel pre-treatment before planned percutaneous coronary intervention was proved to reduce periprocedural complications. however, the vast majority of patients in the current interventional cardiology practice do not undergo planned pci, but rather "ad-hoc" pci performed immediately after coronary angiography . whether clopidogrel should be administered as pre-treatment to all patients undergoing elective cag with the aim to ensure therapeutic levels at the time of possible ad-hoc pci is not known.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. elective cag for suspected or proven coronary artery disease (stable forms or fully stabilized acute coronary syndrome) 3. signed written informed consent exclusion criteria: 1. thienopyridine treatment in previous two weeks 2. contraindication for clopidogrel 3. cag scheduled less than 6 hours after potential randomization 4. clinically significant bleeding (i.e. with hemoglobin fall by \> 50 g/l and/or requiring transfusions or surgery) in previous 3 months.