Kornimate/medical-research-clean huggingface dataset:
perioperative iron with erythropoietin in bilateral total knee replacement arthroplasty (tkra)

Conditions: Anemia; Transfusion

Summary: the object of this study is to evaluate whether low dose intravenous iron and erythropoietin (epo) can decrease transfusion requirement after the bilateral tkra.

total knee replacement arthroplasty (tkra) in severe osteoarthritis usually requires extensive soft tissue and bone dissection associated with substantial bleeding. because tkra is performed with a pneumatic tourniquet, intraoperative bleeding is not substantial, however, over 80% of the total blood loss occurs within the first 24 hour after the operation and the hidden blood loss is 50% of the total loss, making the true blood loss twice. consequently, many patients can become anemic at early postoperative period and this anemic condition may lead to overall physical deterioration which include fatigue, dizziness, reduced exercise tolerance and delayed recovery. therefore, many patients frequently received the autologous or allogenic blood transfusion. in order to reduce the allogenic blood transfusion (abt), various methods have been used, such as preoperative autologous blood donation (pabd), use of pharmacologic agents, iron or erythropoietin (epo) and postoperative blood salvage. all of the above methods have been proved to reduce the abt effectively6, without increase in cost. iron and epo have been used widely in a variety of clinical situations instead of allogenic rbc transfusion. they also have been used for augmenting pabd or improving preoperative hemoglobin (hb) level. however, there still remains a controversy about the efficacy of the method on the postoperative anemia. we think that these various results may be related with individual iron state of the patients and dose of drug or timing of drug application. in this trial, iron and epo are planned to be administered to the iron deficient non anemic patients during the operation and once again after surgery.

Eligibility criteria:
inclusion criteria: * female patients undergoing bilateral total knee replacement arthroplasty * american society of anesthesiologist class 1-3 * hb\>100 g/l * either serum ferritin\<100 ng/ml or 100\<ferritin\<300 ng/ml with a transferrin saturation (tsat) \<20% exclusion criteria: * hematologic disease * thromboembolic disease * hepatic or renal disease * coagulation disorder * infection * malignancy * under anticoagulant therapy * hypersensitivity to iron sucrose or epo * preoperative autologous blood donation * use of iron or epo and blood transfusion within the previous 1 month

Keywords: iron erythropoietin hemoglobin total knee replacement arthroplasty
study evaluating abt-414 in japanese subjects with malignant glioma

Conditions: Malignant Glioma; Glioblastoma Multiforme

Summary: this study seeks to evaluate the tolerability, pharmacokinetics (pk), efficacy, and safety of abt-414 in japanese participants with newly diagnosed and recurrent, world health organization (who) grade iii or iv malignant glioma.


Eligibility criteria:
inclusion criteria: * japanese participants with who grade iii or iv malignant glioma * 70 or above on karnofsky performance status in arm a of phase 1 portion and phase 2 portion * 80 or above on karnofsky performance status in arm b and arm c of phase 1 portion * adequate bone marrow function * recurrent malignant glioma per rano criteria in arm a of phase 1 portion and phase 2 portion * histologically proven newly diagnosed malignant glioma in arm b and arm c of phase 1 portion * participants must have confirmed egfr amplification by central lab in phase 2 portion exclusion criteria: * anti-cancer treatment 28 days prior to study day 1 for arm a of phase 1 portion and phase 2 portion (except temozolomide therapy for newly diagnosed treatment for phase 2 portion) * anti-cancer treatment prior to study day 1 for arm b and arm c of phase 1 portion * participant has received prior treatment with bevacizumabor, egfr therapy in arm a of phase 1 portion and phase 2 portion, or for recurrent glioblastoma in phase 2 portion * participant has a history of major immunologic reaction to any immunoglobulin g containing agents or component of abt-414.

Keywords: who grade iii who grade iv glioblastoma
a safety and efficacy study of bli-1300 ointment in symptomatic perianal crohn's disease

Conditions: Perianal Crohn's Disease

Summary: this randomized, placebo-controlled, parallel, multi-center, double-blind pilot study is designed to determine the effects of bli-1300 ointment on perianal pain associated with active perianal crohn's disease (pcd).


Eligibility criteria:
inclusion criteria: * all subjects must give written informed consent. * male or female subjects, 18 years of age. * confirmed diagnosis of crohn's disease. * subject must have a 3 month documented history of perianal crohn's disease (pcd) and with clinical evidence of active pcd. * subject must have a crohn's disease activity index (cdai) total score of ≤ 350 at visit 2. * subjects must have a qualifying perianal pain score at visits 1 and 2. exclusion criteria: * women of childbearing potential who are not using adequate contraception. * women who are pregnant or breastfeeding. * subjects on unstable regimens of crohn's therapy (e.g. tumor necrosis factor (tnf) inhibitors, immunosuppressants, steroids). * subjects taking strong analgesics that could interfere with pain measurements. subjects with a perianal abscess requiring incision and drainage. * subjects with anal stenosis. * subjects with fistulae outside the immediate perianal area. * subjects who have had abdominal surgery for crohn's disease within the past 12 weeks. * subjects who have had significant anorectal surgery for crohns disease within the past 8 weeks.

Keywords: crohn's disease perianal inflammatory bowel disease fistula
ezetimibe plus simvastatin versus simvastatin alone in african-american subjects with primary hypercholesterolemia (p03377)

Conditions: Hypercholesterolemia; Atherosclerosis

Summary: the purpose of this study is to evaluate whether coadministration of ezetimibe 10 mg/day with simvastatin 20 mg/day for 12 weeks will result in greater reduction of ldl-c, total cholesterol (tc), triglycerides (tg), non hdl-c, and apolipoprotein b (apob), and greater increase in hdl-c, compared with simvastatin 20 mg/day as monotherapy for 12 weeks in african-american subjects with primary hypercholesterolemia. this study is being performed to better define the efficacy of ezetimibe coadministered with simvastatin in this population.


Eligibility criteria:
inclusion criteria: * adult african-american or black subjects with diagnosis of primary hypercholesterolemia with plasma ldl-c \>=145 mg/dl and \<=250 mg/dl, and plasma tg \<=350 mg/dl * postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifene must be maintained on a stable hrt or raloxifene regimen for at least 6 weeks and throughout the study * female subjects of non-childbearing potential * willingness to give written consent, participate and complete all study-related procedures, and ability to follow a stable ncep step i (or stricter) diet regimen and keep a diet diary when required. * clinical laboratory tests (cbc, blood chemistries, and urinalysis) within normal limits (except as noted below) or clinically acceptable. * alt (sgpt) and ast (sgot) concentrations \<=2 times the upper limit of normal (uln) and creatine phosphokinase \<=2 times the uln. exclusion criteria: * pregnancy or any other situation, condition, or illness that, in the opinion of the investigator, may interfere with optimal participation in the study * secondary forms of hyperlipidemia or underlying disease likely to limit life span to less than one year * known hypersensitivity or any contraindication to simvastatin or ezetimibe * use of investigational drugs within 30 days of study entry * concomitant illnesses: congestive heart failure nyha class iii or iv; obstructive cardiomyopathy; uncontrolled cardiac arrhythmias; severe aortic stenosis; mi, cabg or angioplasty within 3 months of study; unstable or severe peripheral artery disease; unstable angina pectoris; study-limiting disorders of the hematologic, digestive or central nervous systems including cerebrovascular disease and degenerative disease; uncontrolled or newly diagnosed diabetes mellitus; uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (clinically euthyroid subjects on stable replacement doses of thyroid hormone are eligible for enrollment); uncontrolled hypertension; known impairment of renal function (plasma creatinine \>2.0 mg/dl), dysproteinemia, nephrotic syndrome or other renal disease (24-hour urinary protein 3+ or 1 gram); hepatobiliary or hepatic disease (ast or alt \>2 times the upper limit of the reference range); hiv positive; known coagulopathy.
effects of dietary protein intake from beef/pork and soy/legumes on appetite, mood, and weight loss

Conditions: Appetite; Mood; Weight Loss

Summary: the primary aims of this study are to assess the effects of habitual dietary protein intakes across the acceptable macronutrient distribution range with lean beef/pork or soy/legumes as the predominate sources of protein on indices of daily appetite and mood, and on postprandial appetite, mood, energy expenditure, and glycemic responses during energy-restricted weight loss in overweight adults.


Eligibility criteria:
inclusion criteria: * age range: 21 years and older * body mass index between 27.0-36.9 kg/m2 * non-smoking (within the last 6 months) * weight stable (\< 3 kg (\~7 lbs) weight gain or loss within last 3 months) * energy need for weight maintenance 1950-2750 kcal/day * not dietary restrained * menstruating women not pregnant or lactating * constant habitual activity patterns (within last 3 months) * no acute illness (or have chronic diseases known to influence protein or energy metabolism) * non-diabetic * clinically normal blood profiles (within 10% of clinical normalcy) * non-hypertensive * not taking medications known to influence appetite or metabolism * willingness to eat study foods * able to travel to testing facility exclusion criteria: * age: \<21 years * body mass index: outside of the 27.0-36.9 kg/m2 range * smoker (currently or within the last 6 months) * gained or lost \> 3.0 kg (7 lbs) within the last 3 months * energy need for weight maintenance \ 2750 kcal/day * dietary restrained (≥ 14 on three factor eating questionnaire) * pregnant, lactating, or non-menstruating women * clinically diagnosed as a diabetic, or with liver or kidney disease/dysfunction, or osteoporosis * clinically abnormal blood profiles as identified by our study physician, arthur rosen, md * hypertensive * taking medications (currently or within the last 3 months) known to influence appetite or metabolism * allergies to eggs * lactose intolerance * unwillingness to eat study foods * inability to travel to testing facility
neonatal gastro-esophageal reflux disease (gerd) management trial

Conditions: Gastroesophageal Reflux Disease

Summary: the overall purpose of the investigator's study is to evaluate the causes of and treatment for feeding difficulty in infants with gastro-esophageal reflux disease (gerd). new treatments can be possible only if the cause is known. many infants have gerd and feeding difficulties, such as sucking and swallowing problems, vomiting, or delayed emptying of the stomach. some of these infants have difficulty in protecting their airway during feeding or during reflux, and as a result can breathe fluid into their lungs or hold their breath. most gerd treatments are done based on experience, but there is no scientific proof that these methods work for infants. gerd and feeding difficulties can lead to longer hospitalization and more stress for the family. in this clinical trial, the investigators are developing new methods to help with diagnosis as well as defining better treatment strategies in relieving gerd and gerd complications.

gastroesophageal reflux disease (gerd) and its troublesome complications constitute serious diagnostic and management challenges to the development of safe feeding and airway protection strategies among infants convalescing in the neonatal intensive care units; thus contributing to prolonged lengths of stay, recurrent hospitalizations, and death. gerd is frequently diagnosed by inadequate criteria, and the relative risks, benefits and indications of gerd therapies are unclear. significant gaps in knowledge exist in understanding the complex causal or adaptive aerodigestive protective reflex mechanisms implicated in gerd in infants. the long-term goal is to improve digestive health, nutrition, and infant development through the design of simplified personalized treatment paradigms by better understanding the pathophysiology of aerodigestive reflexes. the current objective is to conduct a prospective single center randomized blinded controlled trial comparing the short term effects of the investigators innovative feeding strategy bundle (study approach) versus standard feeding approach (conventional approach).

Eligibility criteria:
inclusion criteria: * hospitalized infants with aerodigestive or gerd symptoms * gestational age ≤42 weeks * premature infants are eligible at 34 weeks postmenstrual age (pma) * enteral or oral fed * average daily total feeding volume ≥ 150ml/kg/day * room air or supplemental oxygen of ≤1 liter/minute (lpm) and/or ≤ 35% by nasal cannula exclusion criteria: * known genetic, metabolic or syndromic disease * neurological diseases such as grade 3 or 4 intraventricular hemorrhage (ivh) or intracranial hemorrhage (ich) and perinatal asphyxia * gastrointestinal malformations and surgical gastrointestinal conditions

Keywords: infant esophagitis neonate gerd
a study of intravenous oseltamivir [tamiflu] in infants with influenza

Conditions: Influenza

Summary: this open-label study will assess the pharmacokinetics and safety of oseltamivir \[tamiflu\] in 3 cohorts of infants, aged 0-30 days, 31-90 days and 91-\<365 days with influenza infection. patients will receive 10 doses of intravenous oseltamivir \[tamiflu\] therapy over 5 or 6 days. optional oral therapy with oseltamivir \[tamiflu\] may be considered following the intravenous dose associated with pharmacokinetic blood sampling. evidence of continued virus shedding at day 6 can allow for up to 5 additional days (10 doses) of oral or intravenous administration. anticipated time on study drug is 5-11 days. target sample size is \<50 patients.


Eligibility criteria:
inclusion criteria: * infant patients * date of birth to date of enrollment is \<1 year * diagnosis of influenza * duration of influenza symptoms \</=96 hours prior to first dose * - parent/guardian willing to have patient receive intravenous therapy for 3 or 4 days (5 or 6 doses of study drug) exclusion criteria: * date of conception to date of birth + date of birth to enrollment is \<36 weeks * creatinine clearance \<30 ml/min/1.73m2 * patients receiving any form of renal replacement therapy at baseline * clinical evidence of severe hepatic decompensation at the time of enrollment * patients taking probenecid medication within 1 week prior to study day 1 or during the study
male mamm organoids

Conditions: Breast Neoplasms, Male

Summary: it is believed that the use of organoids derived from male breast tumors can be of fundamental support for the definition of the molecular mechanisms underlying the onset of the tumor. furthermore, the development of such preclinical models could be of significant support for the identification of specific personalized and ad hoc therapeutic treatments for male pathology.

the main objective of the project is to set up at least 5 organoid cultures of male breast cancer derived from patients who have undergone surgery. this study will allow to define the success rate in the generation of organoids. a secondary objective is to verify the correspondence between the organoids generated and the tumor tissue of origin. in this regard, broad-spectrum molecular investigations will be carried out, such as mutational analysis of dna through whole exome sequencing (wes), gene expression profiles through rna sequencing (rnaseq) and small rna sequencing, proteomic and metabolomic analysis of both the tumors of origin and the cultures of derived organoids (pdo). furthermore, to verify the functional correspondence of the organoids with the tumor of origin, in vitro viability tests will be carried out by treating the pdos with the same drugs administered to the patients.

Eligibility criteria:
inclusion criteria: * men aged \>18 years * patients with histologically confirmed breast cancer with or without synchronous metastases, who will undergo the relevant surgical intervention * adequate biological material to be able to carry out the analyses described above * signing of the relevant informed consent form exclusion criteria: not present

Keywords: organoids
freeo2 prehospital - automated oxygen titration vs manual titration according to the bls-pcs

Conditions: COPD Exacerbation; Trauma

Summary: evaluation of automated oxygen titration in comparison with manual adjustment oxygen in the out-of-hospital setting by paramedics.

it is a single center study in ottawa, ontario canada. this will be a single centered prehospital multi-period cluster crossover feasibility trial, enrolling patients in ottawa, ontario, who are treated by paramedics from the ottawa paramedic service, who have been trained in the use of the automated oxygen delivery device. we will be using the freeo2 device. patients requiring oxygen therapy during prehospital transportation will be enrolled. no randomization will occur within this single centered feasibility study patients requiring oxygen therapy during the prehospital transportation will be enrolled and will be included as soon as they are placed into the ambulance, until handover and transfer of care at receiving hospital. in both groups, spo2 will be collected continuously every second with freeo2 monitoring, in addition to the collection of vital signs carried out by the staff according to the standards.

Eligibility criteria:
inclusion criteria: copd patient: 1. known or suspected acute exacerbation of copd. acute exacerbation is defined by worsening of the respiratory condition for less than 2 weeks. suspected copd is defined by patients of at least 30 years old with respiratory symptoms with a past or current smoking history of at least 10 pack years, or 2. able to measure spo2 via pulse oximetry trauma patient: i) trauma: patients who sustain any trauma (minor or major), ii) able to measure spo2 via pulse oximetry exclusion criteria: * inclusion in another study not allowing the co-enrollment * pregnancy * age \<18 years * prehospital invasive or non-invasive mechanical ventilation * meeting high concentration oxygen administration injury or condition (as per bls-pcs oxygen therapy standard (version 3.0), s(2)a-f).

Keywords: prehospital oxygen therapy automation trauma copd
oral melatonin as premedication during mac for patients undergoing loco-regional chronic subdural hematoma evacuation

Conditions: Monitored Anaesthesia Care; Loco-regional Chronic Subdural Hematoma Evacuation

Summary: investigators assume that administration of preoperative melatonin will reduce the required dose of propofol in participants undergoing loco-regional chronic subdural hematoma evacuation, it may as well provide better postoperative analgesia and decrease the incidence of delirium.

a number of studies showed that premedication with melatonin was associated with sedation without impairment of cognitive and psychomotor skills or prolonging recovery. some studies demonstrated that melatonin decreases the amount of propofol required to produce an adequate depth of hypnosis at induction time the effects of the oral administration of melatonin on the dose of propofol sedation in participants undergoing loco-regional chronic subdural hematoma evacuation have not been documented before. the present study will be conducted to detect the efficacy of oral administration of melatonin on the reduction of the sedative dose of propofol in participants undergoing loco-regional chronic subdural hematoma evacuation.

Eligibility criteria:
inclusion criteria: * 50 -65 years * asa grade i to ii * both sexes * patients with unilateral chronic subdural hematoma * patients who are vitally stable * glascow coma scale 14-15 exclusion criteria: * age below 50 and above 65 years. * gastro intestinal tract impractabililty. * patients with any substance abuse. * patients with hepatic or renal insufficiency. * patients on antipsychotic, anticonvulsant or anti-parkinsonian medication. * vitally unstable patients who cannot tolerate propofol sedation. * patients with known allergies to any of the drugs used.

Keywords: oral melatonin premedication
randomized clinical trial to evaluate the effect of dapagliflozin in patients with diabetic macular edema

Conditions: Diabetic Macular Edema; Center-involved Diabetic Macular Edema

Summary: the purpose of this clinical study is to explore the efficacy of dapagliflozin as an adjunct to intravitreal anti-vascular endothelial growth factor (anti-vegf) for enhanced reduction of retinal thickness and vision improvement in patients with diabetic macular edema. the main question the study aims to answer is: does dapagliflozin reduce the thickness of the macula when combined with the standard of care intravitreal anti-vegf therapy more than the intravitreal anti-vegf therapy alone?

some evidence in the literature suggests that sodium glucose co-transporter 2 (sglt2) inhibitors may be beneficial in reducing diabetic macular edema. the objective of this clinical trial is to investigate the efficacy and safety of dapagliflozin when combined with intravitreal aflibercept injections in the management of patients with type ii diabetes mellitus and center-involved diabetic macular edema (ci-dme). this randomized, double-blind, parallel group, active control design, clinical trial, is investigating the effect of oral dapagliflozin 10 mg given once daily in addition to intravitreal aflibercept versus intravitreal aflibercept alone on reducing macular central subfield thickness (cst) and improving visual acuity in diabetic patients with ci-dme.

Eligibility criteria:
inclusion criteria: * type ii diabetes mellitus (dm) adult patients, on premixed insulin and metformin, who are diagnosed with center-involved diabetic macular edema (ci-dme) exclusion criteria: * patients below 18 years old * patients with type i diabetes mellitus (insulin dependent diabetes mellitus iddm) * pregnant and lactating women * patients with other causes of macular edema such as retinal vein occlusion * patients who had previous macular laser treatment in the affected eye * patients who had previous peripheral panretinal photocoagulation laser (prp) treatment in the affected eye during the past 6 months * patients who had been treated with intravitreal anti-vegf injections in the affected eye during the past 6 months * patients who had myocardial infarction within 3 months of recruitment * patients who had stroke within 3 months of recruitment * patients with severe hepatic impairment of child-turcotte-pugh class c * patients treated with antidiabetic drugs thiazolidinediones (tzd) (rosiglitazone and pioglitazone) * patients already on sglt2 inhibitor drugs (dapagliflozin, canagliflozin, or empagliflozin) before recruitment * patients on topical prostaglandin analogs (e.g., latanoprost, travoprost, ioprost, and tafluprost) * patients diagnosed with ocular surface infections until treated

Keywords: diabetic macular edema center-involved diabetic macular edema anti-vegf aflibercept eylea dapagliflozin forxiga sglt2 inhibitor