Kornimate/medical-research-clean huggingface dataset:
perioperative continuation of metformin therapy in patients with typ 2 diabetes mellitus undergoing non-cardiac surgery

Conditions: Hyperglycemia; Metformin; Type 2 Diabetes; Hyperlactatemia

Summary: evaluation of the effect of peri-operative continuation of oral metformin therapy on the incidence of perioperative hyperglycemia compared to standard preoperative cessation of oral metformin therapy 24h before surgery.

surgical procedures cause metabolic stress and can impair glucose control especially in patients with diabetes mellitus, which often results in peri-operative hyperglycemia. peri-operative hyperglycemia is associated with impaired wound healing, secondary wound infections, endothelial dysfunction, sepsis, prolonged hospital stay and higher mortality. metformin is still the first line treatment in patients with type 2 diabetes mellitus. historically it has been stopped before surgery due to fear of hypoglycemia and metformin induced lactic acidosis. however recent studies have suggested that perioperative continuation of metformin might be safe and patients could benefit from more stable preoperative blood sugar levels. prospective studies evaluating the benefit of continuing oral metformin therapy in the perioperative period are rare. the investigators plan to conduct a prospective, randomized-controlled, unblinded clinical trial where patients with type ii diabetes mellitus and oral metformin therapy undergoing non-cardiac surgery will be randomized in either an interventional group or a control group. in the interventional group patients will be instructed to continue their regular metformin dose even on the day of surgery, in contrast to the control group, where the patients will be instructed to stop taking metformin 24h prior to surgery. all other oral anti-diabetic drugs will be paused according to the local anesthesia guidelines. the investigators plan to evaluate whether or not continuation of metformin can reduce the incidence of perioperative hyperglycemia and whether or not it is associated with elevation of blood lactate levels.

Eligibility criteria:
inclusion criteria: * age 18-99 years * diabetes mellitus typ 2 * oral metformin therapy * non cardiac-surgery * informed consent exclusion criteria: * insulin therapy * ambulatory surgery * preoperative therapy with glucocorticoids (prednisolon or equivalent ≥ 5mg/day for more than 7 days) * planned postoperative icu-stay * advanced renal insufficiency (egfr \< 45ml/kg/min) * advanced liver cirrhosis or failure (child-pugh b or c) * alcohol abuse * pregnancy, * perioperative administration of contrast dye
compare the efficacy of levocetirizine and montelukast to placebo in reducing seasonal allergic rhinitis (sar) symptoms in ragweed sensitive subjects

Conditions: Rhinitis, Allergic, Seasonal

Summary: to compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.


Eligibility criteria:
inclusion criteria: * have had seasonal allergic rhinitis due to ragweed for the last 2 consecutive years * subjects who obtain a minimum sum score, considering seasonal allergic rhinitis (sar) related symptoms (mean value), as defined by the protocol exclusion criteria: * any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety * have used forbidden concomitant medications as defined by the protocol

Keywords: levocetirizine xyzal rhinitis allergic seasonal ragweed
remimazolam vs propofol on intraoperative hypotension in major noncardiac surgery

Conditions: Intraoperative Hypotension

Summary: intraoperative hypotension is common during major noncardiac surgery and is associated with adverse postoperative outcomes. propofol, the most commonly used intravenous anesthetic agent worldwide, is associated with hypotension on induction and maintenance of general anesthesia. remimazolam is a newly developed short-acting benzodiazepine drug and has been approved for use in procedural sedation and general anesthesia. it was associated with a lower incidence of hypotension during procedural sedation in previous studies. the aim of this study is to tested the primary hypothesis that total intravenous anesthesia with remimazolam reduces the duration and severity of hypotension during major noncardiac surgery compared with total intravenous anesthesia with propofol.


Eligibility criteria:
inclusion criteria: * age ≥45 years; * undergoing elective major surgery under general anesthesia (expected surgery time \>2 h, expected length of postoperative stay \>2 d); * need for intraoperative invasive blood pressure monitoring via arterial line; * fulfilling ≥1 of the following criteria (a-k): 1. history of coronary artery disease; 2. history of stroke; 3. history of congestive heart failure; 4. preoperative nt-probnp \>200 pg/ml; 5. preoperative high sensitivity troponin t \> 14 ng/l; 6. age ≥70 years; 7. diabetes requiring medical treatment; 8. asa status 3 or 4; 9. history of chronic kidney disease (preoperative scr \>133μmol/l or 1.5 mg/dl); 10. preoperative serum albumin \<30 g/l; 11. preoperative hemoglobin \<100 g/l. exclusion criteria: * undergoing organ transplantation, cardiac, neurological, or adrenal gland surgery; * planned intraoperative map higher or lower than 65 mmhg; * severe untreated or uncontrolled hypertension (preoperative sbp \>180 mmhg and/or dbp \>110 mmhg); * end-stage renal disease requiring renal-replacement therapy; * asa score ≥5; * preoperative requirement of vasopressor infusion; * unable to receive bispectral index monitoring; * known allergy to benzodiazepines, propofol, opioids or cisatracurium; * current participation in another interventional study; * previous participation in this study; * pregnant or breastfeeding women.
a trial of lu af82422 in participants with multiple system atrophy (msa)

Conditions: Multiple System Atrophy

Summary: the main goal of this trial is to evaluate the efficacy and safety of lu af82422 for the treatment of participants with multiple system atrophy (msa).

this study will consist of a 3-6-week screening period, a 72-week placebo-controlled period (pcp), and will include a 72-week optional dose-blinded open-label treatment extension (ole) period. participants in the pcp will be randomized to lu af82422 high dose, lu af82422 low dose or placebo (1:1:1). all participants entering the ole will receive lu af82422 during the ole. participants will receive intravenous infusions approximately every 4 weeks during both the pcp and ole.

Eligibility criteria:
key inclusion criteria: * the participant has a diagnosis of clinically established multiple system atrophy parkinsonian type (msa-p) or multiple system atrophy cerebellar type (msa-c), or clinically probable msa-p or msa-c, according to the 2022 movement disorders society (mds) criteria for the diagnosis of msa at the screening visit. * the participant had onset of motor msa symptoms (i.e., parkinsonian and/or cerebellar) within 5 years prior to the screening visit in the judgement of the investigator. * the participant has an anticipated survival of \>3 years, in the opinion of the investigator, at the screening visit. * the participant has suitable peripheral venous access for investigational medicinal product (imp) administration and blood sampling. * the participant has an umsars part i score ≤16 (omitting item 11 on sexual function) at the screening visit. exclusion criteria: * the participant has previously been dosed with lu af82422. * the participant has taken any imp \<3 months or \<5 half lives of that product, whichever is longer, prior to the first dose of imp. * the participant has 2 or more first degree relatives with a history of msa. * the participant, if of msa-p subtype, has unexplained anosmia (not explained by other common causes such as allergic rhinitis or smoking, nasal structural lesions, or nasal surgery) on olfactory testing at the screening visit. * the participant has evidence (clinically or on magnetic resonance imaging (mri)) and/or history of any clinically significant disease or condition other than msa, that is, in the investigator's opinion, likely to affect cns functioning, e.g., serious neurological disorder, other intracranial or systemic disease. * the participant has a current diagnosis of movement disorders that could mimic msa, e.g., parkinson' disease, dementia with lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, pharmacological, or post-encephalitic parkinsonism, per investigator discretion. participants who have previously been incorrectly diagnosed with parkinson's disease will not be excluded. other protocol-defined inclusion and exclusion criteria apply.

Keywords: lu af82422 msa neurodegenerative disorder
a study to evaluate efficacy and safety of glinib in newly diagnosed cml patients

Conditions: Chronic Myeloid Leukemia

Summary: this study is to evaluate efficacy and safety of imatinib in two groups of patients; all patients should be diagnosed less than 3 months as chronic myeloid leukemia in a chronic phase. the group a, the reference group, will have 10% or less than 10% of the bcr-abl level after three month dosing and be maintained their dose of 400mg/day. on the other hand, the group b, will have more than 10% and the dose will be increased from 400mg/day to 600mg/day. the superiority of the group b will be proved by evaluating the mmr rate of these two groups after 12 months of administeration of imatinib.


Eligibility criteria:
inclusion criteria: * at the age of 18 or more * newly diagnosed within three months as a chronic myeloid leukemia * with positive philadelphia chromosome and appearance of bcr-abl transcript * with 0 - 2 of ecog performance status * with normal renal function * with normal hepatic function * able to understand and decide to involve the study exclusion criteria: * history of radiation therapy for more than 25% of bone marrow due to other malignant diseases * history of other clinically relevant malignant tumors * with bleeding disorders which are not related to leukemia * evidence of clinically relevant cardiac dysfunction * with severe disease which cannot be regulated by other organs * a previous administration of imatinib more than a week prior to the first dose. * participation in other drug study(eg. intervention trial) within 30 days prior to the screening visit * hiv-infected * females with pregnancy, childbearing or lactating potential * other reasons determined by investigators
feasibility clinical evaluation of the calibreye system

Conditions: Glaucoma, Open-Angle

Summary: to evaluate the safety and feasibility of the calibreye system in patients with open angle glaucoma.

this is a prospective, nonrandomized, open-label feasibility clinical trial, to evaluate the surgical procedure, safety and effectiveness of the calibreye system in reducing intraocular pressure in subjects with open angle glaucoma.

Eligibility criteria:
inclusion criteria: * open angle, pseudoexfoliative or pigmentary glaucoma * iop at preoperative visit of ≥ 18mmhg and ≤ 45mmhg * visual field mean deviation score of -3db or worse * area of healthy, free and mobile conjunctiva in the target quadrant * shaffer angle grade ≥ 3 in the target quadrant exclusion criteria: * angle closure glaucoma * congenital, neovascular or other secondary glaucomas * previous intraocular surgery (with the exception of laser trabeculoplasty or uncomplicated phacoemulsification with iol occurring \> 3 months prior to the preoperative visit) * previous glaucoma shunt/valve in the target quadrant * clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit * history of corneal surgery, corneal opacities or corneal disease * active diabetic retinopathy
gemcitabine with antiangiogenic peptide vaccine therapy in patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to evaluate the safety, tolerability and immune response of different doses of vegfr2-169 emulsified with montanide isa 51 in combination with gemcitabine and to determine the recommended phase ii dose.

vascular endothelial growth factor receptor 2(vegfr2) is essential target for tumor angiogenesis, and vegfr2-169 induces specific cytotoxic t lymphocytes (ctl) against vegfr2 expressed targets. vegfr2-169 shows strong anti-tumor effects restricted to hla-a\*2402 in vitro, and this peptide induces ctl from cancer patients. 60% in japanese population have hla-a\*2402. vegfr2-169 is suitable for clinical trial, and gemcitabine has been approved against pancreatic cancer. gemcitabine is reported to improve immune-response, therefore synergistic effect between vaccine therapy and chemotherapy will be expected. in this clinical trial, we evaluate the safety, tolerability and immune response of different doses of vegfr2-169 emulsified with montanide isa 51 in combination with gemcitabine and to determine the recommended phase ii dose of peptide.

Eligibility criteria:
inclusion criteria: disease characteristics 1. locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer 2. measurable disease by ct scan patient characteristics 1. ecog performance status 0-2 2. life expectancy \> 3 months 3. laboratory values as follows * 2000/mm3 \< wbc \< 15000/mm3 * platelet count \> 75000/mm3 * bilirubin \< 3.0 mg/dl * aspartate transaminase \< 150 iu/l * alanine transaminase \< 150 iu/l * creatinine \< 3.0 mg/dl 4. hla-a\*2402 5. able and willing to give valid written informed consent exclusion criteria: 1. pregnancy(woman of childbearing potential:refusal or inability to use effective means of contraception) 2. breastfeeding 3. active or uncontrolled infection 4. concurrent treatment with steroids or immunosuppressing agent 5. prior chemotherapy of gemcitabine 6. prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks 7. serious or nonhealing wound, ulcer, or bone fracture 8. active or uncontrolled other malignancy 9. ileus 10. interstitial pneumonia 11. decision of unsuitableness by principal investigator or physician-in-charge
vitamin d supplementation after parathyroid surgery

Conditions: Primary Hyperparathyroidism

Summary: a randomised double blind clinical trial, accepted by the medical products agency and registered in the european clinical trials database. aims to evaluate the prevalence of vitamin d deficiency in a phpt population in relation to gender and age, the correlation between vitamin d status, pre- and postoperative parathyroid hormone level and bone density and the correlation between vitamin d status, metabolic, cardiovascular risk factors and qol aspects before and after parathyroid adenomectomy.

150 phpt patients were randomized six weeks after surgery, 75 into each group, to 1 year of oral treatment with either calcium carbonate 1 g (500 mg twice daily) alone or calcium carbonate 1 g combined with cholecalciferol 1600 iu (800 iu twice daily). exclusion criteria were age under 18, manifest osteoporosis at phptdiagnosis, persistent hypercalcemia after surgery, postoperative hypocalcemia requiring vitamin d treatment, glomerular filtration rate (gfr) below 40 ml/min, pregnancy, breast feeding, or logistical difficulties, for example living far from the hospital. included patients had to withdraw any current supplementation with calcium and vitamin d during the study period. all tablets were identical in appearance, the tins were numbered and randomization followed a list compiled by an independent clinical research support organization. the time for randomization was chosen to make sure that the phpt patients were cured before starting the study medication. nearly three-quarters of the patients were randomized within 6 weeks after ptx.the primary end point was the change in pth after ptx and treatment with the study medication. secondary end points were vitamin d levels, insulin resistance, blood pressure and other cardiovascular risk factors, biochemical markers of bone turnover, bone mineral density and self estimated health related quality of life (sf- 36).

Eligibility criteria:
inclusion criteria: * primary hyperparathyroidism subjected to parathyroid surgery exclusion criteria: * renal insufficiency * severe osteoporosis * pregnancy

Keywords: primary hyperparathyroidism postoperative vitamin d supplementation
microvascular reactivity in cardiac surgery

Conditions: Cardiac Disease

Summary: microcirculatory disturbance occurs most seriously during cardiopulmonary bypass (cpb) in cardiac surgery. if microvascular reactivity compensates for microcirculatory disturbance during cpb, tissue hypoxemia may be minimized. on the other hand, tissue hypoxemia may develop and lead to poor clinical outcomes. the primary aim of this study was to assess whether microvascular reactivity during cpb can predict major adverse events (mae) within 30 days after cardiac surgery. this prospective, observational, single-center study was conducted on 115 patients who underwent elective on-pump cardiac surgery. the vascular occlusion test (vot) with near-infrared spectroscopy was performed five times for each patient, before the induction of general anesthesia (baseline, t0), 30 min after the induction of general anesthesia (t1), 30 min after applying cpb (t2), 10 min after injection of protamine (t3), and after sternal closure (t4). sequential organ failure assessment (sofa) and acute physiologic and chronic health evaluation (apache) ii scores and the length of ventilator care, intensive care unit stay, and hospital stay were recorded. postoperative mae within 30 days after surgery was also recorded.

the vot was performed five times in each patient, before the induction of general anesthesia (baseline, t0), 30 min after the induction of general anesthesia (t1), 30 min after applying cpb (t2), 10 min after injection of protamine (t3), and after sternal closure (t4). before induction of anesthesia, an nirs sensor (invos® 5100c cerebral/somatic oximeter; medtronic, minneapolis, mn, usa) was placed on the thenar eminence and an automated tourniquet (a.t.s® 3000 automatic tourniquet system; zimmer inc., warsaw, il, usa) was placed around the upper arm. the arterial catheter was placed in the contralateral radial artery and the baseline blood pressure was measured. when the baseline tissue oxygen saturation (sto2) was stabilized, the automatic tourniquet was inflated to 50 mmhg over the patient's baseline systolic blood pressure and maintained for 5 min. after the 5-min ischemic period, the tourniquet rapidly deflated to 0 mmhg. sto2 data were continuously recorded during the vot procedure. baseline sto2, minimum sto2 during the 5-min inflation of the tourniquet, and maximum sto2 during deflation of the tourniquet were obtained. the occlusion slope and recovery slope were calculated based on the measured sto2 data. the occlusion slope, which is related to oxygen extraction, was defined as the slope of the sto2 descent to the lowest value. the recovery slope, which is related to microvascular reactivity, was calculated from the deflation of the tourniquet until the recovery of sto2 to the highest value.

Eligibility criteria:
inclusion criteria: * adult patients aged \>18 years * elective on-pump cardiac surgery exclusion criteria: * pregnancy * inability to tolerate vot (e.g., patients with arm deformities, arteriovenous shunts, burns)adult patients aged \>18 years scheduled for elective on-pump cardiac surgery * refusal to participate in the study
shared decision making to improve goals of care in the ed

Conditions: Goals

Summary: this project will develop and refine a shared decision making (sdm) intervention (decision aid tool) to improve and normalize high quality end of life discussions in the emergency department (ed) setting.

develop a shared decision making (sdm) intervention informed by insights elicited from patients and clinicians to improve goals of care discussions. the process of decision aid design involves: (1) review and synthesis of the evidence; (2) an analysis of usual practice through observation of clinical encounters; (3) development of an initial decision aid prototype; (4) field testing in the context of clinical care to gain insights on both intended and unintended effects of its use in practice to facilitate patient centered goals of care discussions; and (5) successive iterations of the decision aid until thematic saturation is reached and it is ready for testing in a clinical trial.

Eligibility criteria:
inclusion: 1. patients presenting to mayo clinic rochester, saint marys' emergency department, 2. patients at high risk for critical illness as determined by an elderly risk assessment (era) score ≥ 16 or as determined by provider discretion, 3. ≥ 60 years of age, 4. ability to provide informed consent, 5. medically stable at the time of enrollment, 6. able to participate without causing a delay in care. exclusion: 1. gcs scores \< 15, 2. signs of altered mental status, 3. known to be pregnant, 4. incarcerated or in police custody, 5. communication barriers such as visual or hearing impairment that may preclude use of the decision aid.
prognosis in uc after first biological

Conditions: Ulcerative Colitis

Summary: to study the long-term clinical outcome of patients with ulcerative colitis treated with first trial of biological therapy.

uc patients treated with at least one biological in tampere university hospital between january 2009 and january 2020 were identified and reviewed from patient records.

Eligibility criteria:
inclusion criteria: * patients treated for ulcerative colitis for the first trial of biological exclusion criteria: * age under 16 years

Keywords: infliximab adalimumab golimumab ustekinumab vedolizumab tofacitinib