Kornimate/medical-research-clean huggingface dataset:
serum levels of bupivacaine in autotransfusion drains following total joint arthroplasty

Conditions: Knee Pain Arthritis

Summary: the purpose of this study is to quantify the total blood serum levels of bupivacaine in orthopat® collected blood 2 hours and 5 hours postoperatively. hypothesis: filtered blood from the orthopat® autotransfusion system contains low or undetectable levels of bupivacaine hydrochloride (hcl). reinfusion of collected blood from the orthopat® device when used in conjunction with periarticular bupivicaine injections will not pose a bupivocaine toxicity risk to patients undergoing a total joint arthroplasty.

total joint arthroplasty (tja) is a commonly performed surgical procedure that can result in considerable postoperative pain which can limit social and functional recovery and a return to quality of life. traditionally, pain control following tja has been conducted with parenteral and oral narcotics. recently, a number of studies have demonstrated the efficacy of multimodal analgesia following a variety of surgical procedures.1-2 these multimodal regimens vary and consist of any number of medications including narcotics, non-steroidal anti-inflammatories, anti-epileptics, and peripheral nerve blocks among others. these multimodal regimens have been associated with a reduction in the use of opioid analgesics, leading to fewer opioid-associated adverse events.3-5 one of the newest modalities introduced on the market is liposomal bupivacaine, trade name exparel. the advertised advantage of liposomal bupivacaine compared with bupivacaine hcl is a longer duration of analgesia owing to gradual release from the liposomes. liposomal bupivacaine is employed in a periarticular injection at the conclusion of tjas to aid in post-operative pain control. patients receive a periarticular injection of liposomal bupivacaine intra-operatively during tja. at the conclusion of the procedure, a specialized intra-articular drain (orthopat®) is placed. the orthopat® perioperative autotransfusion system collects the patient's blood in the immediate postoperative period and then allows for it to be transfused to the patient while on the floor. a potential risk, although low, is the concern for bupivicaine toxicity. toxicity from bupivicaine is associated with central nervous system issues (seizures) and cardiac toxicity. toxicity is dose dependent and recommended levels should not exceed 400mg/24 hr period. with autotransfusion, there is a theoretical concern that blood, potentially with increased levels of bupivicaine, could be reinfused into the vascular system and create toxicity.

Eligibility criteria:
inclusion criteria: * patients undergoing primary total joint arthroplasty with use of periarticular bupivicaine and liposomal bupivicaine and orthopat® auto reinfusion system. * at least 18 years of age. exclusion criteria: * allergy to bupivacaine. * allergy to epinephrine. * patients that are not presenting for a primary tja * patients who are having a tja without orthopat® auto reinfusion system. * patients under age 18.

Keywords: arthroplasty knee replacement analgesia pain
trial of vaccine therapy with mrna- transfected dendritic cells in patients with advanced malignant melanoma

Conditions: Malignant Melanoma

Summary: primary objectives: determination of safety and toxicity of vaccination with patients' tumour mrna transfected dcs . secondary objectives:determine immunological response to the vaccine (induction of specific t-cell response) and assessment of tumour response


Eligibility criteria:
inclusion criteria: * accessible tumour tissue for vaccine production (extraction of tumour mrna) i.e.subcutaneous or lymph node metastases. * must be at least 18 years of age. * must have histologically confirmed advanced, metastatic cutaneous melanoma no longer amenable for surgery. * must have evidence of disease progression and measurable or evaluable metastases * must be ambulatory with a ecog performance score of \<2 * must have lab.values as following : anc \> 1.5 x 109/l; platelets \> 100 x 109/l, hb \> 9g/dl (\> 5.6 mmol/l). creatinine \ 40 ml/min, bilirubin \ 2.5 g/l. * prior radiotherapy: a minimum of 4 weeks (8 weeks in case of extensive radiotherapy) must have elapsed between the end of the prior radiotherapy and entry into the protocol. * prior chemotherapy: a minimum 4 weeks must have elapsed between the end of the prior chemotherapy and entry into the protocol. * signed informed consent of the patients for the treatment and follow up must be obtained and documented according to the ich-gcp guidelines. exclusion criteria: * history of prior malignancy other than melanoma, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin and ca. cervix stage 1b. * active infection requiring antibiotic therapy. * significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia. * autoimmune disease currently treated with steroids. * adverse reactions to vaccines such as anaphylaxis or other serious reactions. * history of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome. * chemotherapy or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination. * pregnancy or lactation. * any reason why, in the opinion of the investigator, the patient should not participate.
effect of anti-inflammatory topical prednisolone, nepafenac and ketorolac in intra-operative mydriasis in facetectomies

Conditions: Cataract

Summary: the main objective of this study is to compare the effect of preoperative use of anti-inflammatory topical prednisolone acetate 1%, nepafenac 0.1% and ketorolac tromethamine 0.4% of, plus a placebo, in maintaining the intra-operative mydriasis in extraction.

will be conducted with a randomized clinical trial volunteers with indication of extraction in recife, brazil. the surgical technique is employed phacoemulsification with implantation of intraocular lens. digital photos are taken of the eye at the beginning and end of surgery and with them will be digitally determined the relationship between the corneal area and pupillary area. each volunteer will be drawn to one of four groups of study (group 1, prednisolone acetate 1%, group 2, of ketorolac tromethamine 0.4%, 0.1% nepafenac group 3 and group 4, placebo). for the volunteers randomly selected for each group will be prescribed medication in its presentation as eye drops (prednisolone acetate 1%, pred fort ®, allergan ®; of ketorolac tromethamine 0.4%, incite l ®, allergan ®; nepafenac 0.1%, nevanac ® alcon ® and 0.5% methylcellulose, fresh tears ®, allergan ®), 01 drop every 8 hours for 48 hours before surgery. for all volunteers will also be prescribed gatifloxacin (zymar ®), 01 drop every 8 hours starting 48 hours before surgery. was scheduled a minimum sample of 60 volunteers (15 per group).

Eligibility criteria:
inclusion criteria: * carriers of senile cataract (\> 50 years of age) with indication for cataract extraction with implantation of intraocular lens, with local anesthesia exclusion criteria: * diabetic * using systemic anti-hormonal and non-hormonal * using topical ocular medication (including anti-glaucomatous) * individuals with congenital ocular abnormalities and cases in which there is intra-operative complications (hernia or trauma in the iris, posterior capsule rupture or zônula and prolonged phacoemulsification time of ≥ 1 minute). * volunteers with incipient nuclear cataract (density 1) or advanced (density 4) by the locs ii classification (density of nuclear cataract ranked 1 to 4 (chalk et al, 1989)

Keywords: cataract pupillary dilation anti-inflammatory therapeutic use
facilitated tucking position and reiki efficacy in orogastric tube insertion

Conditions: Premature; Feeding Behavior; Infant, Premature, Diseases

Summary: the aim of this study is to determine the effects of faciliated tucking and reiki given manually during orogastric tube insertion in preterm infants treated in the nicu on stress, pain and physiological parameter (heartbeat, blood pressure, spo2 and respiratory rate) levels.

regardless of the severity and duration, preterm infants give physiological and behavioral responses to a painful application. while infants show behavioral responses such as crying, changes in facial expressions, acceleration or deceleration in motor movements during painful interventions, they may subjectively show changes in physiological parameters such as heart rate, respiratory rate, blood pressure, and decrease in saturation value. because preterm infants are sensitive to many stress factors and due to reasons such as separation from the mother during the treatment process, environments with excessive light, sound and temperature changes, and the absence of a single caregiver. they do not yet have the physiological maturity to cope with painful interventions. this randomized controlled trial was planned to determine the changes in stress, pain, and physiological parameters of faciliated tucking and reiki administered during orogastric tube insertion in preterm infants 32-37 weeks of gestation.

Eligibility criteria:
inclusion criteria: * 32-37 gestational weeks, * from the postnatal 3rd day, * feeding with orogastric tube * apgar \>5 exclusion criteria: * premature infants with congenital anomaly, malformation * premature infants on mechanical ventilator * premature infants receiving sedation

Keywords: premature reiki pain facilitated tucking
comparison between losartan and benazepril in diabetic hypertensive patients not controlled by amlodipine

Conditions: Hypertension; Diabetes Mellitus

Summary: the purpose of this study is to compare losartan and benazepril in diabetic patients whose high blood pressure is not controlled by amlodipine and its relationship to statin current use.

hypertension and diabetes mellitus are important risk factors for cardiovascular morbidity and mortality. endothelial dysfunction and vascular rigidity are two pathophysiological mechanisms that may explain this relationship. recent publications showed that both acei (angiotensin-converting enzyme inhibitor-induced) and arb (angiotensin receptor blocker) were capable of improving vascular stiffness and endothelial function, and that these effects occurred despite blood pressure reduction. this study main objective is to assess if arb (losartan) effects are different from acei (benazepril) in endothelial function in patients with diabetes mellitus type 2 and blood pressure not controlled by amlodipine and its relationship to statin current use. secondary analysis of vascular stiffness will be measured by pulse wave velocity and augmentation index. echocardiographic parameters, such as indexes of diastolic function, will also be measured.

Eligibility criteria:
inclusion criteria: * ambulatorial patients with age between 40 and 70 years-old. * systemic arterial hypertension previously diagnosed and in use of two or less anti-hypertensive drugs in the preceding 4 weeks. * type 2 diabetes mellitus in use of oral medication that were not changed in the preceding 4 weeks. glycated hemoglobin a1c less than 9.0%. * accepted the consent form. exclusion criteria: * office systolic blood pressure equal or more than 180 mmhg, with or without treatment * office diastolic blood pressure equal or more than 110 mmhg, with or without treatment * evidences of a secondary cause for hypertension * glycated hemoglobin a1c \> 9.0% * insulin therapy * chronic kidney disease stage 4 or 5 or in dialysis * advanced target organ lesion, obtained by history or additional exams, and defined by: previous myocardial infarction, heart failure with ejection fraction less than 40%, cerebral vascular accident (ischemic or hemorrhagic), peripheral vascular disease (claudication or doppler with obstruction \> 50% of vascular lumen), retinopathy with visual loss, symptomatic neuropathy. * cardiac arrhythmias, except for ectopic beats * any clinical or disabling condition that, in the opinion of the investigators, may confound or prejudice study results. * severe mitral regurgitation. * women in fertile age without contraceptive methods in use. * breastfeeding women.

Keywords: hypertension diabetes mellitus vascular stiffness endothelial function
study in healthy volunteers to prove that two rotigotine patches from different manufacturing sites deliver equivalent drug amount to the body

Conditions: Healthy Volunteers

Summary: the major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing sites.


Eligibility criteria:
inclusion criteria: * healthy, white, male volunteers between 18 and 55 years of age (inclusive) * bmi between 19 and 28 kg/m² (inclusive) exclusion criteria: * previous participation in a clinical study with rotigotine * history or current condition of epilepsy and/or seizures * known clinically relevant allergy or known/suspected clinically relevant drug hypersensitivity * history of significant skin hypersensitivity to adhesives or other transdermal products or recently unresolved contact dermatitis * history or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease * clinically relevant abnormality in physical examination, ecg, vital signs or safety laboratory examinations * positive hiv, hepatitis b or c test or positive alcohol or drug test * relevant hepatic or renal dysfunction * intake of medication that might interfere with the test drug within 2 weeks prior to dosing * thickly hair-covered abdomen resulting in difficulties in finding appropriate patch application sites

Keywords: rotigotine neupro®
robotic transanal specimen extraction surgery versus robotic transabdominal incision specimen extraction surgery for patients with rectal cancer: a multicenter randomized controlled trial

Conditions: Rectal Neoplasms; Robotic Surgery; Natural Orifice Specimen Extraction Surgery

Summary: this prospective, multicenter, randomized, open-label study aims to evaluate the perioperative safety and feasibility of specimen extraction through anus regarding robotic radical excision of rectal cancer.

in this study, investigators will evaluate the perioperative safety and feasibility of robotic transanal specimen extraction surgery with robotic transabdominal incision specimen extraction surgery as a control.the study is prospective, randomized, open-label, and multicenter conducted at 12 centers. considering the significance level and abscission rate, it is expected that a total of 556 subjects will be included in the two groups from january 2023 to june 2024, with the incidence of postoperative complications as the main study endpoint.

Eligibility criteria:
inclusion criteria: 1. age between 18 to 75 years; 2. historically confirmed rectal adenocarcinoma; 3. diagnosed with rectal cancer by pelvic/rectal magnetic resonance imaging; 4. ct1-4anxm0 high rectal adenocarcinoma; ct1-3nxm0 mid/low rectal adenocarcinoma; 5. no evidence of distant metastases; 6. a maximum of 5cm in diameter; 7. body mass index (bmi) ≤ 30 kg / m2; 8. no local complications (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, preoperatively abscess formation, no local invasion); 9. willing to undergo surgery; 10. sign the informed consent; exclusion criteria: 1. presence of lateral/inguinal lymph node metastases; 2. previous history of malignant colorectal tumor; 3. multiple primary colorectal tumors; 4. neoadjuvant therapy; 5. salvage surgery for endoscopic surgery; 6. history of previous abdominopelvic surgeries or extensive intra-abdominal adhesion; 7. familial adenomatous polyposis, lynch syndrome, and inflammatory bowel disease; 8. comorbid with other malignancies within 5 years; 9. asa ≥ iv and/or ecog performance status score ≥ 2; 10. severe liver, kidney, cardiopulmonary insufficiency, coagulopathy or serious underlying diseases; 11. serious mental illness; 12. pregnant or lactating women; 13. uncontrolled infection; 14. abnormal anal function or anal stenosis;
effect of transversus abdominis plane (tap) block after laparoscopic colon surgery

Conditions: Laparoscopic Colon Surgery

Summary: the purpose of this study is to investigate the effectiveness of transversus abdominis plane (tap) block as a part of a multimodal postoperative pain management after laparoscopic surgery on colon.


Eligibility criteria:
inclusion criteria: * age 18 - 80 * bmi 18 - 40 * asa 1 - 3 * written consent * can cooperate exclusion criteria: * mb chron and collitis ulcerosa * drug and alcohol abuse * pregnancy * consumption of opioids * drug allergy
acute kidney injury after cardiac surgery

Conditions: Cardiac Surgical Procedures; Extracorporeal Circulation; Complications; Acute Kidney Injury

Summary: primecc is a colloid priming solution for cardiopulmonary bypass/ extracorporeal circulation (ecc) based on ringers lactate, supplmeneted with dextran 40 and dextran 1. in a previous rct comparing primecc with crystalloid priming fluid, patients in the primecc group experienced less hemolysis, less tubular cell injury and beneficial effect on the fluid balance. this study will investigate if, in a population at high risk of acute kidney injury (aki), priming the ecc circuit with primecc instead of crystalloid solution will lead to a reduction of postoperative aki. the hypothesis is that primecc, compared to crystalloid prime, will reduce postoperative aki. the study is a swedish multicenter, double-blinded, randomized, controlled clinical trial. the trial will include 366 patients aged ≥18 years, scheduled for cardiac surgery with cardiopulmonary bypass, with an "acute kidney injury risk score" ≥30% according to birnie et al. (2014). the primary outcome of the study is the incidence of postoperative aki of any stage according to the kdigo creatinine criteria (serum-creatinine increase ≥ 27 μmol/l within 48 h or ≥ 50 % increase from baseline) within 96 hours after arrival to the icu. secondary outcomes are between-group differences in hemolysis, tubular cell injury (nag-excretion), estimated gfr, and incidence of aki of different stages according to the kdigo creatinine criteria. in addition, differences in cns (tau, nfl, nse, and s100b) and cardiac (tnt/tni) injury markers will be investigated.


Eligibility criteria:
inclusion criteria: * has signed and dated the ec approved informed consent * subject is ≥ 18 years of age * requires elective or urgent (non-emergency) cardiac procedure requiring the use of ecc. * preoperative "acute kidney injury risk score" ≥30%, found at http://cardiacsurgeryleicester.com/our-research/acute-kidney-injury-risk-score-calculator/ exclusion criteria: * unable to give informed consent * known bleeding disorder * known intolerance or contraindication to dextran * acute surgery (requires emergency cardiac procedure/surgery) * currently using an antithrombotic medication which has not been discontinued per institution protocol * malignancy; surgery within 5 years or ongoing antitumoral treatment * has ongoing sepsis or endocarditis * requires pre-operative dialysis

Keywords: colloid priming solution cardiopulmonary bypass extracorporeal circulation ecc acute kidney injury aki
interleukin (il)-1 blockade in acute heart failure (anakinra adhf)

Conditions: Heart Failure

Summary: anakinra adhf is a double-blind randomized clinical trial of anakinra, recombinant human interleukin-1 receptor blocker, or placebo in patients with acute decompensated heart failure with the aim to quench the acute inflammatory response, as measured by the area-under-the-curve for c reactive protein over 14 days.


Eligibility criteria:
inclusion criteria: all 5 criteria need to be met for enrollment of the patient in the study 1. primary diagnosis of acute decompensated heart failure within the last 24 hours as evidenced by both of the following: 1. dyspnea or respiratory distress or tachypnea at rest or with minimal exertion 2. evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met); i. pulmonary congestion/edema at physical exam or chest x-ray; ii. plasma brain natriuretic peptide (bnp) levels ≥200 pg/ml; iii.invasive measurement of left ventricular end-diastolic pressure \>18 mmhg or of pulmonary artery occluding pressure (wedge) \>16 mmhg. 2. left ventricular systolic dysfunction (lvef\<40%) during index hospitalization or prior 12 months. 3. age ≥18 years old 4. willing and able to provide written informed consent. 5. screening plasma c-reactive protein levels \>5 mg/l. exclusion criteria subjects will not be eligible if they meet any of the following 15 exclusion criteria. 1. the primary diagnosis for admission is not decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias. 2. concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study including but not limited to acute coronary syndromes, uncontrolled hypertension or orthostatic hypotension, tachy- or brady-arrhythmias, acute or chronic pulmonary disease or neuromuscular disorders affecting respiration. 3. recent (previous 3 months) or planned cardiac resynchronization therapy (crt), coronary artery revascularization procedures, or heart valve surgeries. 4. previous or planned implantation of left ventricular assist devices or heart-transplant. 5. chronic use of intravenous inotropes. 6. recent (\<14 days) use of immunosuppressive or anti-inflammatory drugs (not including non-steroidal anti-inflammatory drugs \[nsaids\]). 7. chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus). 8. active infection (of any type); 9. chronic/recurrent infectious disease (including hepatitis b virus \[hbv\], hepatitis c virus \[hcv\], and hiv/aids). 10. prior (within the past 10 years) or current malignancy. 11. any comorbidity limiting survival or ability to complete the study. 12. end stage kidney disease requiring renal replacement therapy. 13. neutropenia (\<2,000/mm3) or thrombocytopenia (\<50,000/mm3). 14. pregnancy. 15. angina, arrhythmias, or electrocardiograph (ecg) changes that limit maximum exertion during cardiopulmonary exercise testing obtained during the baseline testing.
skin irritation of leo 90100 foam (calcipotriol hydrate plus betamethasone dipropionate) in healthy japanese subjects

Conditions: Psoriasis Vulgaris

Summary: this trial is looking at whether the leo 90100 foam causes irritation of the skin in healthy japanese male adults without psoriasis. a single application of leo 90100 foam and its vehicle will each be made to 2 body sites in 20 subjects.


Eligibility criteria:
key inclusion criteria: * signed informed consent has been obtained. * healthy japanese male subjects. * aged 20 to 40 years inclusive. key exclusion criteria: * body mass index outside the range 18-25 kg/m² * use of any medication (systemic or topical) within 2 weeks of day 1.