Kornimate/medical-research-clean huggingface dataset:
isglt2 in patients without dm with acute mi

Conditions: Acute Coronary Syndromes; Heart Failure

Summary: this study will evaluate the effect of isglt2 (dapagliflozin or empalgliflozin), administered once daily in addition to standard of care treatments for non-diabetic patients with myocardial infarction (mi) treated with pci, on hospitalization for heart failure, readmissions for acute coronary syndrome and all-cause mortality.

this is a single-center, prospective study in non-diabetic patients with acute coronary syndrome (acs) (st elevation (stemi) or non-st elevation (nstemi) with left ventricular systolic dysfunction (defined as ejection fraction\<50% assessed by 2d simson bi-plane echocardiography) or evidence of acute de novo heart failure. the study will assess the effect of dapagliflozin or empagliflozin versus placebo, administered once daily in addition to standard therapy, on hf hospitalizations, all-cause deaths and acs readmissions.

Eligibility criteria:
inclusion criteria : * participant must approved the informed consent. * confirmed mi, either stemi or nstemi, according to the fourth universal definition of mi (thygesen et al 2019). * evidence of impaired regional or global lv systolic function at any timepoint during current mi-related hospitalisation with ejection fraction\<50%(established with echocardiogram, radionuclide ventriculogram, contrast angiography or cardiac mri) or symptoms of acute heart failure without cardiogenic shock. * hemodynamically stable (no episodes of symptomatic hypotension, or arrhythmia with haemodynamic compromise in the last 24 hours). exclusion criteria: * known type 1 diabetes mellitus (t1dm) or t2dm at the time for admission. * chronic symptomatic hf with a prior hhf within the last year and known reduced ejection fraction (lvef≤40 %), documented before the current mi hospitalization. * patients with cardiogenic shock who received vasoactive drugs during index. * hospitalization severe (egfr \<20 ml/min/1.73 m2 by local laboratory), unstable or rapidly progressing renal disease at the time of randomization * severe hepatic impairment (child-pugh class c) at the time of inclusion into the trial. * active malignancy requiring treatment at the time of screening. * any non-cv condition, eg malignancy, with a life expectancy of less than one years based on the investigator´s clinical judgement. * currently on treatment, or with an indication for treatment, with a sodium glucose co-transporter 2 inhibitor (sglt2-inhibitor)

Keywords: acute coronary syndronme isglt2 heart failure
drug interaction study of azithromycin and theophylline

Conditions: Chronic Obstructive Pulmonary Disease; Asthma

Summary: macrolides are potent inhibitors of cytochrome p450 isoenzyme 3a4（cyp3a4）and thus interfere with the pharmacokinetics of many other drugs that are metabolised by this enzyme like theophylline.the aim of this study is to determine whether azithromycin can effect theophylline metabolism in patients.

in this non-blinded,auto-control study,patients with chronic obstructive pulmonary disease（copd）or asthma will serve as their own controls during the 2-week treatment phase.the subjects will be co-administered oral doses of sustained release theophylline (100mg tablets,twice daily) and azithromycin (2x250mg capsules,once daily )in the first week.then patients will received theophylline therapy alone with the same dose in the second week.blood samples for the measurement of theophylline plasma concentrations will be collected on days 8 and 15 prior to dosing.all adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Eligibility criteria:
inclusion criteria: * patients with copd or asthma，aged 18-75 years; * regularly visiting our hospital; * meeting the indications for azithromycin and theophylline simultaneously; exclusion criteria: * patients with renal or hepatic dysfunction; * patients with congestive heart failure; * patients with hypothyroidism or hyperthyroidism; * patients taking drugs likely to affect the theophylline metabolism in the preceding week; * patients with severe chronic obstructive pulmonary disease,asthma or respiratory infection;

Keywords: azithromycin theophylline cyp3a4
antibiotic prophylaxis in primary joint arthroplasty of the hip and knee.

Conditions: Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Antibiotic Prophylaxis

Summary: a retrospective study will be performed to compare the incidence of revision procedures performed for the treatment of postoperative periprosthetic joint infection (pji) between patients treated with a single preoperative antibiotic prophylaxis and patients treated with multiple shot antibiotic prophylaxis following primary arthroplasty of hip or knee. this study will be conducted in two phases. in phase 1 the investigators will evaluate which antibiotic prophylaxes (type of antibiotic and duration of prophylaxis) are regularly used in the netherlands, by contacting all orthopaedic centres implanting total hip and total knee prostheses. in phase 2 the investigators will compare infection rate (defined as revision for infection as registered in the lroi database) between a single-shot and multiple shot antibiotic prophylaxis. knee and hip primary arthroplasties will be considered separately.

in phase 1 of this study all dutch hospitals and clinics performing hip and/or knee arthroplasty will be contacted to supply data concerning type and duration of antibiotic prophylaxis. the investigators will also ask whether debridement with implant retention for early infection is registered in the lroi. the investigators will ask permission to have access to unblended data on institutional level to be able to connect the type of antibiotic prophylaxis to outcome. in phase 2 the investigators will include all adult patients whom have a primary hip or knee arthroplasty and are registered in the national joint implant registry (lroi) between 2011 and 2016.those patients will be followed until they are revised (irrespectively of the indication), they died or the end-point of the study, i.e. end of 2016 (to allow at least one year follow-up for those operated late 2015). exclusion criteria are patients aged under 18. patients with no primary procedure recorded in the lroi for the period of interest but records of revision surgeries will be excluded. the investigators will compare the results found in the lroi database in two groups for both hip and knee arthroplasties. group one will consist of patients receiving a single shot antibiotic prophylaxis, while group two will consist of patients receiving multiple shot antibiotic prophylaxis. analyses will be adjusted for known and available confounders such as age, gender, bmi, and asa score. in the lroi debridement without exchange of mobile parts for early infection, is only scarcely reported. the authors realise not all early infection treatments, such as debridement with or without exchange of mobile parts, are registered in the lroi database.

Eligibility criteria:
inclusion criteria: - all adult patients whom have a primary hip or knee arthroplasty and are registered in the national joint implant registry (lroi) between 2011 and 2014 exclusion criteria: * patients aged under 18. * patients with no primary procedure recorded in the lroi for the period of interest but records of revision surgeries will be excluded.
study of degenerescence csf hallmarks in older bipolar patients

Conditions: Bipolar Disorder; Alzheimer's Disease

Summary: analysis of 4 csf alzheimer's disease biomarkers (total and phosphorylated tau protein, aß40 and aß1-42) and morphological brain mri in older patients (\>60 year's old) with bipolar disorder, after an evaluation of their cognitive functions. comparison between two groups of patients : patients with cognitive disorders and patients without cognitive disorders. the objective is to describe and compare the profile of those biomarkers in those two populations.

describe the profile of the 4 neurodegeneration's biomarkers of alzheimer's disease dosed in the cerebrospinal fluid (total tau proteins, phosphorylated, aß40 and aß1-42) for old subjects suffering from bipolar disorder with or without cognitive impairment.

Eligibility criteria:
inclusion criteria: * male or female between 60 and 80 * french-speaking, reading and writing patient * affiliation to the french social security * written informed consent obtained from the patient * agree to undergo a lumbar puncture * easy accessibility for the lumbar puncture * mini mental state examination (mmse) \> 20 * bipolar patients : * type i or ii * state of euthymia for at least 4 weeks * stable psychotropic drug treatment for at least 8 weeks * no electroconvulsive therapy during the 6 months before inclusion * distribution in the "with cognitive disorder" or "without cognitive disorder" group is function of the result of the neuropsychological evaluation non-inclusion criteria : * severe visual or auditory disorder * advanced lumbar osteoarthritis * history of severe head injury, neurological disorders, diagnosed dementia * addiction weaned for less than 12 months * forced hospitalization in psychiatry * mri contraindications * lp contraindications exclusion criteria: - at least one of the outcome measures can't be performed : * mri * lp : anticoagulation, bad accessibility

Keywords: biomarkers csf mri alzheimer's disease bipolar disorder cognitive functions
a pilot study assessing the treatment responsiveness of a novel osteoarthritis stiffness scale

Conditions: Osteoarthritis, Knee

Summary: osteoarthritis is a common, chronic, progressive, skeletal, degenerative disorder that frequently affects several joints such as knee, hip, spine and hands.this placebo-controlled clinical trial assessed the effects of naproxen sodium, acetaminophen and celecoxib on stiffness in subjects with osteoarthritis.

the primary objective of the study was to assess the responsiveness of the brief arthritis stiffness scale (bass) for detecting treatment effects of common over-the-counter (otc) analgesics and a common prescription analgesic in subjects with knee osteoarthritis.

Eligibility criteria:
inclusion criteria: * age between 40 and 80 years * body mass index (bmi) between 18 and \<40 kg/m\^2 * unilateral or bilateral osteoarthritis of the knee * diagnostic quality radiography of the target knee performed no more than 1 year prior to baseline showing evidence of osteoarthritis (oa) with kellgren and lawrence grade of ii or iii * joint stiffness severity score ≥3.0 on a 0-10 numerical rating scale (nrs) at screening exclusion criteria: * history of underlying inflammatory arthropathy, rheumatoid arthritis or fibromyalgia * history of or scheduled for target knee replacement surgery * recent injury in target knee (past 4 months)
international severe crswnp registry 2024-2028

Conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Summary: the objective of the study is to collect real-life data worldwide, which already have been collected in national databases, to merge the data and the knowledge with the focus of better care for the individual patients, more efficient use of the hospital cost of biologics and working for "personalized medicine".

regional or national registries have evaluated the efficacy of different biologics in severe uncontrolled crswnp coordinated by several academic centres in europe. at present, these registries have not been merged nor allowed the comparison in real-life efficacy between the 3 different monoclonal antibodies (mepolizumab, dupilumab, omalizumab) with different mechanism which has been approved for the indication of crswnp and the effect of the nasal polyp score. some countries have allowance for some of the different biologic drugs, other countries have other combination of the drugs. despite the heterogeneity in availability of biologics for the indication of crswnp, the merge of data might lead to very interesting outcomes. the objective of the study is to collect real-life data worldwide, which already have been collected in national databases, to merge the data and the knowledge with the focus of better care for the individual patients, more efficient use of the hospital cost of biologics and working for "personalized medicine". compare the outcomes of different biologics in different national registries, at screening and 6-month follow-up: primary aims: 1. delphi process to point at the viable of importance. 2. the speed and size of snot-22 reduction 3. the speed and size of nps reduction 4. the speed and size of nasal congestion score (ncs) reduction 5. the speed and size of smell score increase. 6. the ctscan/lund-mackay score response 7. the evolution of the response on vas scale (patients) 8. the type 2 biomarkers at entrance and during the study 9. the (non)responder percentages defined based on euforea criteria 10. the use of ocs (amount and frequency) 11. the frequency and time (days) since last sinus surgery 12. the effect of biologics on comorbidities (atopic dermatitis, allergic rhinitis, asthma and nsaid intolerance) in patients with crswnp 13. the reduced in need of otrivin or similar drugs 14. differences between inclusion criteria for biologic drugs, and differences between countries.

Eligibility criteria:
inclusion criteria: * symptoms of crswnp * indication for biologic treatment as suggested by epos/euforea * have been followed for 6 months exclusion criteria: * unilateral polyps * non-type-2 inflammation * treatment less than 6 months

Keywords: crswnp asthma biologic treatment effect of treatment different geographic collection
endoscopic ultrasound radiofrequency ablation, database repository

Conditions: Pancreatic Neoplasm

Summary: the purpose of having this database is to collect data related to endoscopic ultrasound rfa procedures performed by indiana university eus physicians for the treatment of tumors or adenopathy. this database is a repository database only, all information will be obtained in the electronic medical record. no additional clinical procedures will be performed outside current standard of care for endoscopic ultrasound. the patient will have already signed an informed consent for the endoscopic ultrasound. subjects will be entered into the database for up to 10 years after the most recent procedure.

radiofrequency ablation (rfa) is a well-established therapeutic option for ablation of dysplastic and neoplastic tissue by the use of local thermal coagulative necrosis. options for administration include percutaneous or a surgical approach. percutaneous rfa is effective and safe, but it is unfeasible in cases of lesions with interposition of organs and/or vessels. for lesions such as the pancreas, surgery-assisted rfa has been described but requires general anesthesia and is associated with a substantial risk of thermal injuries to major vessels or adjacent structures. eus-guided rfa is a minimally invasive approach that offers high-quality real-time imaging guidance during selective ablation of benign (1-5) or malignant (6-7) pancreatic lesions. treatment in small case series has shown to produce local necrosis with minimal adverse events. other sites treated include the liver and metastatic adenopathy. this database will collect data related to endoscopic ultrasound rfa procedures performed by indiana university eus physicians for the treatment of tumors or adenopathy. no additional clinical procedures will be performed outside current standard of care for endoscopic ultrasound. the patient's information collected will be pre-procedure identification of the adenopathy, labs, the endoscopic ultrasound(s) and post procedure follow up and care related to the adenopathy. patients will be contacted by phone at post-procedure 1 \& 2 weeks and asked to report symptoms related to the procedure.

Eligibility criteria:
inclusion criteria: subjects 14 years of age and older referral for the treatment of a benign or malignant tumor or adenopathy exclusion criteria: * subjects less than 14 years of age unable to comprehend the study consent due to language or disability
pregnancy in women with hiv infection

Conditions: HIV Infections; Pregnancy Related

Summary: women living with hiv face multiple challenges regarding pregnancy, encompassing not only their intention to procreate, but also difficulties during the course of pregnancy. compared to hiv-negative controls, hiv-infected women have a higher risk of pregnancy complications such as preeclampsia, gestational diabetes, or preterm labor. in addition, the treatment of hiv among pregnant women entails specific difficulties, such as changes in bioavailability of antiretroviral drugs, or the concern about the association of certain antiretrovirals with adverse pregnancy outcomes. there is very little evidence about pregnancy among women living with hiv in spain. very few studies have been published, performed in single centers or in small cohorts with a limited number of patients. the cohort of the spanish aids research network (coris) offers a unique setting to answer questions that are unlikely to be answered by a single study. the aims of this study are (i) to describe the incidence of pregnancies and their temporal trends from 2004 to 2019, (ii) o describe the clinical and epidemiological characteristics of women who become pregnant, (iii) to assess the diagnostic delay among women diagnosed with hiv infection after becoming pregnant, (iv) to investigate the clinical course during pregnancy and its predictive factors, (v) to describe the antiretroviral treatment administered to pregnant women, (vi) to describe clinical outcomes after pregnancy, (vii) to describe the outcome of the conception in terms of interrupted pregnancies, spontaneous abortions, term pregnancies, type of delivery (vaginal or caesarean section) and hiv infection of the newborn, and (vii) to evaluate attitudes towards pregnancy (ie. planned pregnancy) and social support among women who become pregnant during the year 2020. study population will be women from the cohort of the spanish aids research network (coris) who have become pregnant in the period 2004-2010.


Eligibility criteria:
inclusion criteria: * hiv-positive women recruited in coris * became pregnant from january 2004 to november 2019 * or become pregnant during the year 2020 and agree to participate in a telephone survey

Keywords: hiv pregnancy adverse pregnancy outcomes
dispensing evaluation of subjective comfort, vision, and handling of a new lens compared to a marketed lens

Conditions: Refractive Ametropia

Summary: to evaluate and compare the performance of a new contact lens to a marketed contact lens.


Eligibility criteria:
inclusion criteria: * the subject must be a healthy adult at least 18 years of age and no more than 34 years of age. * the subjects must be female, dark eye caucasian, non-hispanic habitual soft contact lens wearer (both eyes). * the subject rated the concept statement positively (i.e., a rating of 4 or 5). if not the subject is not eligible to participate. * the subject must have no known ocular or systemic allergies that might interfere with contact lens wear. * the subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear. * the subject's optimal vertexed spherical equivalent distance correction must be between-1.00 and -4.00d. * any cylinder power must be:\<=0.75d. * the subject must have visual acuity best correctable to 20/25 or better for each eye. * the subject must have normal eyes (no ocular medications or ocular infection of any type). * the subject must read and sign the statement of informed consent. * the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. exclusion criteria: * ocular or systemic allergies or disease which might interfere with contact lens wear. * systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear. * clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. * clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. * any ocular infection. * any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * any color deficiencies (color blindness) - to the best of the subject's knowledge. * pregnancy or lactation. * diabetes. * infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. hiv). * habitual contact lens type is toric, multifocal, or is worn as extended wear. * subject presents with one dark iris color and one light iris color * subject has heterochromia iridis (a difference in color between parts of one iris) * the subject is an employee or family member of the clinical study site.
study on cerebral protection of dexmedetomidine for patients with traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the aim of the study is to investigate whether dexmedetomidine could suppress catecholamine release into peripheral blood to prevent psh attacks and to achieve neuroprotection.

paroxysmal sympathetic hyperactivity (psh) is a syndrome typically recognized in patients suffering from traumatic brain injury, characterized by paroxysmal increases in sympathetic activity such as elevated heart rate, increased blood pressure and respiratory rate, high temperature, excessive sweating and abnormal motor (posturing) activity. this prospective study will include patients with traumatic brain injury,who will be divided into two groups, evaluated by the paroxysmal sympathetic hyperactivity-assessment measure (psh-am). patients will also be evaluated with head ct. the aim of the study is to investigate whether dexmedetomidine could suppress catecholamine release into peripheral blood to prevent psh attacks and to achieve neuroprotection.

Eligibility criteria:
inclusion criteria: 1. age: 18-70 years 2. moderate or severe traumatic brain injury 3. gcs≤12 4. diagnosed by ct 5. no catecholamines (such as dopamine, adrenaline, norepinephrine) have been used before admission 6. have a clear history of head trauma 7. non-open traumatic brain injury exclusion criteria: 1. severe liver dysfunction (child-pugh b or c) 2. severe renal dysfunction (serum creatinine \> 445 mmol / l or blood urea nitrogen \> 20 mmol / l) 3. hemodynamic instability when entering the icu (heart rate \<50 beats / min or hypotension, sbp \<90mmhg or map \<65mmhg) 4. deaths within 72 hours after entering the icu 5. severe multiple injuries (iss≥25 points) 6. have central nervous system diseases (such as hypoxic ischemic encephalopathy, stroke, brain tumors, etc.) 7. allergic to dexmedetomidine or midazolam 8. observed with the results of disease interference test (such as pheochromocytoma, etc.) 9. in pregnancy or lactation 10. receiving hypothermia treatment 11. are participating in other drug research or clinical trials