Kornimate/medical-research-clean huggingface dataset:
comparison of a morphomic-based to the standard-of-care-based cefazolin dose for antimicrobial prophylaxis

Conditions: Surgical Prophylaxis

Summary: the goal of this clinical study is to compare the dosing of an antibiotic in overweight patients having surgery. the main question\[s\] it aims to answer are: * are the antibiotic concentrations in blood and fat tissue in patients that are overweight sufficient to prevent the chance of infection? * can dosing using body composition rather than body weight improve the chance of achieving good antibiotic concentrations in overweight patients? participants will allow us to collect small amounts of blood and fat tissue during their regularly scheduled surgery. researchers will compare differences in antibiotic concentrations based on dosing by standard of care (body weight based) versus body composition.

the risk of surgical site infections are higher in patients with obesity compared to non-obese adults. our group has previously demonstrated that radiologic measures of abdominal subcutaneous fat are associated with surgical site infection risk in patients undergoing colorectal surgeries, which could reflect suboptimal antibiotic exposure in these patients. therefore, we hypothesized that measures of abdominal size and composition in patients undergoing colorectal surgery would be more predictive of antimicrobial pharmacokinetics in this tissue compartment than the current standards of body weight and bmi. we confirmed this hypothesis and identified kidney function and body depth (by morphomics) to be predictive of cefazolin exposure in target tissue. morphomics is a technology that transforms existing computed tomography data into body measures and composition. this study is a head-to-head comparison of this new proposed morphomic test regimen to the standard of care.

Eligibility criteria:
inclusion criteria: 1. accessible abdominal computed tomography scan prior to surgery 2. adult patients \> 18 years of age 3. body mass index ≥ 25 kg/m\^2 4. expected to receive cefazolin prior to surgical incision 5. estimated creatinine clearance ≥90 ml/min exclusion criteria: 1. history of a hypersensitivity reaction to penicillin or cephalosporin 2. pregnancy

Keywords: surgical prophylaxis pharmacokinetics cefazolin obesity morphomics colorectal
comparison of aorto-iliac endovascular interventions with and without the endonaut workstation

Conditions: Aortic Aneurysm; Iliac Aneurysm; Stenoses, Aortic; Iliac Artery Stenosis

Summary: the aim of this retrospective, multicenter study is to demonstrate that the use of endonaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures performed without endonaut.

minimally invasive endovascular interventions are increasingly replacing conventional surgeries, and have become the therapeutic benchmark for a large number of pathologies thanks in particular to advances in image-guided therapy. therenva offers a comprehensive and consistent lightweight navigation solution (endonaut®) for endovascular procedures. this navigation station makes it possible to secure and guide the interventional gesture by providing relevant information extracted during the preoperative phase. this information is rendered in augmented reality using artificial intelligence algorithms and digital simulation. this alternative solution to a hybrid room, but which offers equivalent functionality, is compatible with all operating rooms, regardless of the interventional environment. benefits of imaging fusion remain to be assessed on a larger scale. the aim of this multicenter study is to demonstrate that the use of endonaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures performed without endonaut.

Eligibility criteria:
inclusion criteria: * unilateral or bilateral aorto-iliac or iliac aneurysm/stenosis * suitable for endovascular repair * major patients * patients not opposed to their participation in the study exclusion criteria: * patients requiring conventional surgical revascularization.
effect of milnacipran in chronic neuropathic low back pain

Conditions: Low Back Pain

Summary: low back pain is a public health problem affecting between 70-85% of adults at some time in their life. this study is being done to study the safety and effectiveness of the drug milnacipran in treating chronic low back pain.

this exploratory study aims to evaluate milnacipran in individuals with chronic neuropathic low back pain. a sample of 40 individuals with chronic low back pain will be enrolled in a double-blind, randomized, parallel group study comparing twice daily administration of milnacipran with placebo (total 100 mg bid-or equivalent placebo dosing). the study will last 6 weeks with subjects being evaluated at the start of the study, at the end of a one-week drug-free period, and at 1, 2 and 6 weeks of treatment. additionally, subjects will evaluated after treatment has ended. both standard endpoint outcome measures as well as validated daily self-report measures of pain and activity/disability will be utilized.

Eligibility criteria:
inclusion criteria: 1. history of low back pain for a minimum of 6 months with radiation to leg or buttocks 2. over 18 years of age and under 70 3. must have a visual analogue scale (vas) pain score \>50mm 4. must be in generally stable health 5. must be willing to abstain from alcohol during the course of the study 6. if female, must be post-menopausal, or practicing a highly effective method of contraception or abstinence during the course of the study 7. must be able to read and understand instructions and the questionnaires 8. must be willing to participate in daily data collection requirements via telephone (ivrs) 9. must understand all aspects of the study, and willing to sign an informed consent form in that regard. exclusion criteria: 1. low back pain associated with systemic signs or symptoms (e.g. fever or chills) 2. evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of surgery or tumor in the back 3. involvement in litigation regarding back pain or other disability claim, or receiving workmen's compensation, or seeking either as a result of low back pain. 4. neurological disorder including history of seizures 5. major psychiatric disorder during the past six months 6. active suicidal ideation or recent suicidal behavior 7. significant other medical disease such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease or malignancy 8. significant renal disease or severe renal insufficiency 9. history of, or current, substance abuse/dependence 10. significantly abnormal laboratory values 11. pregnant or lactating any time during the course of the study 12. known sensitivity to savella or other snri 13. glaucoma 14. taking any maoi, sibutramine, digoxin, tricyclic antidepressants, other snri, opioids. 15. beck depression inventory score \>30 16. current sleep disorder
pulsed short wave therapy in cesarean section

Conditions: Postoperative Pain

Summary: this clinical study is designed to assesses the benefit of adding pulsed shortwave therapy to the postoperative pain and recovery protocol following cesarean section. pulsed shortwave therapy is a safe adjunct pain therapy for acute and chronic pain.

pain is ranked highest among undesirable clinical outcomes associated with caesarean section therefore postoperative pain relief following a cesarean section is extremely important to optimize maternal and neonate well being. multimodial analgesics are effective in reducing postoperative pain but analgesia is still not optimized. opiate based analgesics are effective but having troubling side effects. addition of non-drug pain therapies hold promise in improving postoperative recovery while potentially allowing for reduced use of drug based analgesics.

Eligibility criteria:
inclusion criteria: * voluntarily * performed using spinal anesthesia * asa i (normal healthy patients) and ii (patients with mild systemic disease) (as defined by the american society of anesthesiologists physical status classification system) * para 0000, 1, 2, 3 \[i.e. first, second, or third c-section) * at term pregnancy (\>38 weeks) * bmi \<35 * age between 18 - 50 years exclusion criteria: * longitudinal surgical incision * placental abnormalities noted * time of extraction of the fetus \>10 min from cutaneous incision * blood loss during surgery of \>800 ml * any of the conditions not considered in inclusion criteria

Keywords: caesarean section
descriptive and retrospective analysis of acute myocarditis associated with pandemic covid-19 in children

Conditions: COVID-19

Summary: the study objectives are to descript clinical, biological and echocardiographic features of an acute myocarditis in children in the context of covid-19 and to identify the underlying mechanism : direct viral damage and/or inadequate host response risk.

an unexpected increase of shock with fever in children suspected to be infect by the covid-19 is observed. these children present with similar symptoms and seem to have similar clinical time course. this unexpected phenomenon needs to be extensively described in order to further the knowledge of unusual covid-19 presentation in children. the study consists an extensive retrospective data collection from april 2020 till the end of the main sars-cov-2 outbreak, from medical file of children have exhibited acute myocarditis and cared in 4 pediatric intensive care units of assistance publique-hôpitaux de paris of ile-de-france region. the study objectives are to descript clinical, biological and echocardiographic features of an acute myocarditis in children in the context of covid-19 and to identify the underlying mechanism : direct viral damage and/or inadequate host response risk.

Eligibility criteria:
inclusion criteria: * age \< 18 years * admitted to picu from april 2020 * presented with an acute myocarditis, fever and shock with a possible covid-19 infection exclusion criteria: * age ≥ 18 years * other etiologies of acute myocarditis than the covid-19 * opposition expressed by the holders of parental authority

Keywords: covid-19 acute myocarditis children
efficacy and safety of ondansetron versus metaclopromide treatment in infants with gastro oesophageal reflux

Conditions: Gastroesophageal Reflux Disorder

Summary: this study aimed to fill the gaps by comparing the efficacy and safety of ondansetron versus metoclopramide for the control of gastroesophageal reflux disorder in children 1-12 months of age, presenting at the outdoor department of allama iqbal teaching hospital, dera ghazi khan.

since the fda issued a warning against domperidone as a potential proarrhythmic drug in children, its use has been widely discouraged and no longer recommended in safe practices. this warning at one end persuaded the pediatricians to search for the new options; on the other end, the use of metoclopramide, h2 receptor antagonists, and alginate-based medications became superfluous, opening a wide area of research in search of the next potential best option. the findings of this study would add to the existing statistics and help clinicians to have better outcomes among infants with gastroesophageal reflux disorder.

Eligibility criteria:
inclusion criteria: * infants of any gender * aged 1-12 months * presenting with symptoms of gastroesophageal reflux disease not responding to dietary modifications and positioning * afebrile at the time of presentation * vitally stable exclusion criteria: * no evidence of hypertrophic pyloric stenosis on ultrasonography * children with congenital heart disease * any history of prior illness associated with symptoms * with abdominal distension * neurological impairment, like developmentally delayed, grossly microcephalic
immunogenicity and safety of vi-dt (diphtheria toxoid) typhoid conjugate vaccine (phase iii)

Conditions: Safety Issues; Immunogenicity

Summary: phase iii study, randomized, observer blind, lot to lot consistency, non inferiority to pqed typhoid conjugate vaccine and typhoid vi polysaccharide vaccine.

phase iii study, randomized, observer blind, lot to lot consistency, non inferiority to pqed typhoid conjugate vaccine and to typhoid vi polysaccharide vaccine. involved participants aged 6 months old to 60 years old.

Eligibility criteria:
inclusion criteria: * healthy. * subject/parents/legal guardian(s) have been informed properly regarding the study and signed the informed consent form/and informed assent form. * subject/parents/legal guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial. exclusion criteria: * subject concomitantly enrolled or scheduled to be enrolled in another trial. * evolving mild, moderate or severe illness, especially infectious diseases or fever (axilary temperature ³ 37.5°c). * known history of allergy to any component of the vaccines. * history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. * subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, corticosteroid therapy and other immunosuppressants) * any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. * pregnancy \& lactation (adults). * individuals who have previously received any vaccines against typhoid fever. * subjects already vaccinated with any vaccine within one month prior and expect to receive other vaccines within one month following vaccination except mr (measles rubella) vaccine. * individuals who have a previously ascertained typhoid fever by laboratory confirmation (blood culture/new rapid test) at any time. * subject planning to move from the study area before the end of study period.

Keywords: vaccine typhoid conjugate vaccine
clinical trial to evaluate the efficacy and safety of dp-r212

Conditions: Hypertension; Hypercholesterolemia

Summary: the purpose of this study is to determine superiority of dp-r212 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * both man and woman who is over 19 years old * hypertension patient with hypercholesterolemia exclusion criteria: * ssbp difference is ≥20mmhg or sdbp difference is ≥10mmhg * a history of cardiovascular disease * rhabdomyolysis, myopathy * hypertension or hypercholesterolemia due to secondary causes * uncontrolled diabetes * evidence of hepatic or renal disease

Keywords: dp-r212
influence of pain on exercise-induced hypoalgesia

Conditions: Pain; Healthy

Summary: the purpose of this study is to investigate how acute pain induced by hypertonic saline prior to exercise influence the magnitude of exercise-induced hypoalgesia after 1x3 min seated isometric knee extension exercise in healthy women. the study is a blinded randomized cross-over trial the results from the study may be of great importance to the understanding of exercise-induced hypoalgesia, and whether the presence of pain affects the effects of exercise.

exercise is recommended to promote and maintain health and as treatment for more than 25 chronic diseases and pain conditions. the mechanisms underlying pain relief of exercise are largely unknown but may be related to the modulation of central descending pain inhibitory pathways after acute exercise bouts. exercise-induced hypoalgesia (eih) is typically assessed as the temporary change in pressure pain thresholds (ppt) after a short acute exercise bout and eih is seen as a proxy of descending pain inhibitory control. in general, eih seems hypoalgesic (functional) in asymptomatic subjects. a hyperalgesic (impaired) eih response has been reported in different chronic pain populations, although a functional eih response also has been reported in subgroups of knee osteoarthritis patients. this implies differences in the acute response to exercise between healthy (pain-free) subjects and chronic pain patients, but it is still unknown whether the presence of pain itself affects the pain alleviating response (i.e. the eih response) to acute exercise. it is hypothesized that acute pain will decrease the eih response magnitude following hypertonic saline injection compared with the control injection. this study will increase the insight into the eih mechanisms in healthy subjects in general, and how the presence of pain affects the body's own ability to modulate pain during exercise.

Eligibility criteria:
inclusion criteria: * pain-free * understands and writes danish exclusion criteria: * pregnancy * previous addictive behaviour defined as abuse of hash, opioids or other euphoric substances. * previous painful or mental illnesses, neurological or circulatory diseases in the form of heart or lung disease. * surgery in the lower extremities within the last 12 months * chronic or actual pain on the days of testing * under the influence on the days of testing * inability to cooperate
effect of acetazolamide & position in csf leakage and collection and wound dehiscence

Conditions: Fibrolipoma of Filum Terminale; Lipomyelomeningocele; Split Cord Malformation; Dermal Sinus; Tethered Cord Syndrome; Tumor

Summary: * purpose of study : to determine the preventive effect of acetazolamide administration, prone positioning, and the combination of both following the neurosurgical interventions in lumbosacral region for cerebrospinal fluid (csf) leak, csf collection and wound dehiscence. * sample size: 144 * intervention groups: * group a: acetazolamide administration for 10 days * group b: prone positioning for 10 days * group c: acetazolamide administration and prone positioning for 10 days * group d: no intervention * period of study: autumn 2012 to the end of winter of 2015

the purpose of this study is to evaluate the effect of acetazolamide administration and prone positioning following lumbosacral spinal surgery in preventing cerebro-spinal fluid leakage and collection and wound dehissence in children admitted to children medical center of tehran since autumn 2012 to the end of winter of 2015.the study is run under 4 categories of intervention: * group a: acetazolamide administration for 10 days * group b: prone positioning for 10 days * group c: acetazolamide administration and prone positioning for 10 days * group d: no intervention all patients are randomly assigned to these groups and when the patients faced with any of these complications, the protocol changes to acetazolamide administration and prone positioning and the patient is considered as the failure of the protocol.

Eligibility criteria:
inclusion criteria: * untethering surgery for primary tethered cord caused by thick filum * lipomyelomeningocele * split cord malformation management * untethering surgery in uncomplicated dermal sinus * tumors needing intradural management in lumbosacral region * having any other disease with similar management technique exclusion criteria: * infected dermoid tumors * intramedullary abscess * myelomeningocele surgery and related reoperation * meningocele * presence of hydrocephalus

Keywords: acetazolamide administration prone positioning cerebrospinal fluid leakage cerebrospinal fluid collection wound dehiscence
effect of dural release on women with back and neck pain after obstetrics and gynecological surgery

Conditions: Back Pain

Summary: something must be done in order to release the tension within the dura mater before any lasting correction of the spine can be effected. each of the cranial nerves is wrapped in a sheath of dura mater. as they exit the cranial vault they are described by gray's anatomy as having a "dural cuff".


Eligibility criteria:
inclusion criteria: * the age of the participants will be ranged from 20 to 40 years. their body mass index will be ranged from 20 to 25 kg/m2. they will have regular menstrual cycle. they will not receive any hormonal therapy or taking any regular drugs. exclusion criteria: * bone disease. discogenic state with radiculopathy or not. systemic disease of musculoskeletal system. any sensory problems. previous vertebral fractures. major spinal structural abnormality.
preoperative estimation of microvascular invasion in hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: presence of microvascular invasion can be estimated preoperatively, by some clinical imaging features such as patient characteristics, serum biomarkers and radiological features. contrast-enhanced ultrasonography (ceus) and contrast-enhanced computed tomography (cect) are routine preoperative conventional examinations for hepatocellular carcinoma (hcc) patients in china. combining features of ceus, cect and clinical factors may improve preoperative mvi assessment. the purpose of this study is to construct a nomogram for preoperative mvi risk estimation with these possible factors.


Eligibility criteria:
inclusion criteria: * asian patients aged 18～80 years old; * with no preoperative anti-cancer treatment; * scheduled for radical liver resection; * with both ceus and cect performed in 4 weeks before surgery; * postoperative histologically confirmed hcc; * with sufficient surgical specimen for mvi detection (surgical margin ≥1cm); exclusion criteria: * recurrent hcc or combined hepatocellular-cholangiocarcinoma; * with extra-hepatic metastasis or macrovascular invasion; * with incomplete clinical and imaging data; * non-radical resection;

Keywords: microvascular invasion serum biomarker radiological feature pathological differentiation