Kornimate/medical-research-clean huggingface dataset:
postoperative neurocognitive disorders

Conditions: Obstructive Sleep Apnea; Neurocognitive Disorders

Summary: the purpose of this study is to examine the mechanisms of brain injury contributing to postoperative neurocognitive disorders (pncd) in an at-risk population (obstructive sleep apnea (osa)) undergoing surgery. the investigators will enroll 50 osa patients scheduled for surgery. all patients will have a brain scan (fmri) within five days before surgery and two days and six months after surgery. during this visit cognitive function will be assessed using the wide range assessment of memory and learning (wraml2) and montreal cognitive assessment (moca) tests. patients will also be asked to participate in a blood draw during the first 2 visits for fmri (within five days of surgery and two days after surgery). the confusion assessment method (cam-s) test, will be used to examine postoperative delirium.

the investigators will examine the potential mechanisms of brain injury contributing to postoperative neurocognitive disorders (pncd) in an at-risk population (obstructive sleep apnea (osa)). this study proposes that neuro-inflammation is associated with measurable tissue changes that can be examined with md measures and blood biomarkers. on the day of surgery, standard of care procedures will take place. hemodynamic vitals will be continuously monitored. as per the latest guidelines and recommendations from the american society of anesthesiologists (asa), mean arterial pressure (map) will be targeted to \> 60 mmhg or within 20% of baseline values, and processed eeg-guided anesthesia will be monitored to maintain a patient state index between 20-50. electronic medical records and intraoperative integrated physiologic waveform will be collected. in summary, the investigators will examine the potential mechanisms of brain injury contributing to postoperative delirium (pod) and acute and long-lasting neurocognitive deficits in an at-risk population (osa).

Eligibility criteria:
inclusion criteria: subjects with a diagnosis of moderate-to-severe osa (apnea hypopnea index \[ahi\]\>15 events/hour confirmed by overnight polysomnography), scheduled for open or robotic surgery (abdominal, gynecologic, or urologic), and upper or lower extremity orthopedic procedures

Keywords: brain imaging neurocognitive testing
metformin versus vildagliptin for diabetic hypertensive patients

Conditions: Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients

Summary: this is a controlled study to measure the efficacy of using metformin or vildagliptin for type 2 diabetic patients who suffers from hypertension to reduce cardiovascular risk resulting from both diabetes and hypertension using different parameters measuring

several studies indicated that type 2 diabetes mellitus and hypertension are associated with increased cardiovascular complications. recently, studies suggest that metformin and vildagliptin can reduce cardiovascular complications in diabetic patients with unclear mechanisms. this work aimed to determine the effect of metformin and vildagliptin on diabetic-hypertensive patients. patients were allocated into four groups: groupi: healthy volunteers, groupii: patients recently diagnosed with their hypertension and diabetes, groupiii: patients treated with captopril (25mg once daily) for their hypertension in addition to metformin (1000mg bid) groupiv: patients treated with captopril (25mg bid) for hypertension in addition to vildagliptin (50mg bid). at the end of the therapeutic period, then total cholesterol, ldl,serum creatinine level, blood pressure and vascular endothelial growth factor (vegf) levels in serum will be measured for different groups to estimate the benefits of one drug over the other one in protecting against cardiovascular risks for diabetic hypertensive patients..

Eligibility criteria:
inclusion criteria: * patients suffering from moderate htn and dm, their hba1c ≥ 7 and age range between 40-60 years, treatment with diet alone, any combination of oral antidiabetic agents and/or insulin before admission exclusion criteria: * clinical evidence of ischemic heart disease, chronic obstructive pulmonary disease, presence of diabetic ketoacidosis (dka), patients admitted to intensive care unit (icu), subjects expected to undergo surgery during the study period, patients with clinically relevant hepatic disease, impaired renal function (serum creatinine ≥3.0 mg/dl), systemic infections or pregnancy. also, patients on medications known to interfere with the blood glucose level (either increasing or decreasing) were excluded from the study.

Keywords: diabetes metformin vildagliptin hypertension cardiovascular risk
efficacy of respiratory rehabilitation after covid-19 severe infection

Conditions: COVID-19 Respiratory Infection; Rehabilitation; Physical Therapists

Summary: the purpose of this study is to investigate the effects of a training program in patients that have suffered a covid infection

once patients have been selected and meet inclusion criteria, they will sign informed consent. they will make a first visit to obtain the basal parameters. once done, they will start the individualized training program for 12 weeks 3 times a week.

Eligibility criteria:
inclusion criteria: * men and women ≥18 years * patients discharged from the pulmonology service with a diagnosis of covid-19 by positive pcr and with severe pneumonia. * at least three months after the presence of at least one of the following criteria: 1. mrc dyspnea greater than or equal to 2. 2. decrease in the meters walked with respect to the reference values in the 6-minute walking test. c) decreased respiratory muscle strength measured at maximum inspiratory pressure (pim) and / or maximum expiratory pressure (pem) with respect to reference values. * sign informed consent from the study exclusion criteria: * patients who do not want to be included in the study. * pregnant women. * impossibility to perform ergometry or ultrasound.

Keywords: covid-19 training program respiratory physiotherapy
ketamine and kidney injury in cardiac surgery

Conditions: Cardiac Surgery

Summary: the purpose of this study is to investigate the affects of ketamine use for anesthesia at the beginning of heart surgery on kidneys compared to the use of propofol.


Eligibility criteria:
inclusion criteria: * presenting for cardiac surgery at the mayo clinic in rochester, minnesota. * scheduled to undergo complex cardiac surgery with the use of cardiopulmonary bypass. complex cardiac surgery will be defined as surgery involving more than one heart valve, redo-sternotomy procedures, or combined valvular and coronary artery bypass graft procedures (aortic repair not excluded if meets other criteria). exclusion criteria: * left or right ventricular assist device implantation or explantation. * procedures not requiring cardiopulmonary bypass. * active infection or sepsis requiring antimicrobial therapy and/or vasopressor therapy (treated endocarditis is not excluded). * severe hepatic disease resulting in ascites. * pre-operative significant renal dysfunction including a baseline creatinine equal to or greater than 2 mg/dl or requiring dialysis. * immunosuppressive medication use (including current iv or oral steroids use, use of anti-rejection medications for transplant within 1 month, or chemotherapy within 6 months). * immunodeficiency syndrome including hiv/aids, leukemia, and multiple myeloma

Keywords: cardiopulmonary bypass
same day discharge (sdd) after implantable cardioverter defibrillator (icd) implant

Conditions: Heart Failure; Coronary Artery Disease

Summary: the purpose of this study is to determine whether it is safe to send patients home from the hospital on the same day following an implantable cardioverter defibrillator (icd) implant.

sdd for icd is a prospective, randomized, multi-center study designed to show that sdd is safe in a defined patient population receiving an icd implant and that this approach can be more cost effective for the hospital than the current ndd approach. safety is to be demonstrated by showing that postoperative complications do not occur at a higher rate in the sdd group of patients when compared to the ndd group. cost effectiveness is to be demonstrated by comparing health care utilization between the sdd and ndd groups for the first week post implantation. patients who were implanted with a st. jude medical single or dual chamber icd for primary prevention and who met all inclusion and exclusion criteria may be enrolled in the study. patients areconsidered enrolled at the point of randomization. randomization is assigned in a 1:1 ratio between the ndd group and the sdd group. patients will undergo study evaluations after implant, pre-discharge, 1-week and 6 months post implant.

Eligibility criteria:
inclusion criteria: * patient has a st jude medical device that is compatible with merlin.net (remote monitoring) * patient is receiving an implantable cardioverter defibrillator for primary prevention * patient lives within 50 miles of an emergency room or 24 hour urgent care * patient is able to sign informed consent exclusion criteria: * patient experiences a complication during or 4 hours after implantable cardioverter defibrillator procedure * physician elects to keep the patient in over night due to a change in medical condition or a pre-existing condition that requires administration of continuous blood thinners * physician is unable to program the implantable cardioverter defibrillator to collect all required information remotely from device * patient is pregnant
oxytocin regimen to prevent atony and postpartum hemorrhage during vaginal delivery: 3-arm rct

Conditions: Uterine Atony; Postpartum Hemorrhage

Summary: this is a double-blind 3-arm randomized clinical trial to determine whether higher dose oxytocin regimens (compared to the standard regimen) reduce the frequency of uterine atony and postpartum hemorrhage after vaginal delivery. uterine atony is a loss of tone in the uterine musculature which can cause acute postpartum hemorrhage, which is the major cause of maternal mortality worldwide. oxytocin is routinely administered postpartum in the us and effectively reduces uterine atony. the optimal dose of oxytocin for vaginal delivery is not known.

same as brief summary. prospective interim monitoring (stopping) rules will be assessed upon recruitment of 2/3rds of the sample size of 1800. interim review was conducted by a 3-member dsmb in january of 2010 and their recommendations were implemented.

Eligibility criteria:
inclusion criteria: * \> 24 weeks, viable pregnancy, singleton or twins exclusion criteria: * no consent * contraindication to oxytocin * antepartum fetal demise * intrapartum use of concentrated oxytocin * planned cesarean * dic or coagulopathy

Keywords: uterine atony postpartum hemorrhage clinical trial prophylactic oxytocin
intra-articular injection in the knee of adipose derived stromal cells and platelet rich plasma for osteoarthritis

Conditions: Osteoarthritis

Summary: stromal vascular fraction (svf) can easily be obtained from a mini-lipoaspirate procedure of fat tissue and platelet rich plasma (prp) can be obtained from peripheral blood. evaluated the safety and preliminary efficacy of administering svf and prp intra-articularly into patients with osteoarthritis grade 1 and 2.


Eligibility criteria:
inclusion criteria: * patients age 50 or older who present with symptomatic primary osteoarthritis of the knee * daily pain for the previous 3 months * analgesics usage at least once a week * less than 30 minutes of morning stiffness * womac score of ≤ 75 in the target knee * brandt radiographic grading scale of osteoarthritis grade 1 and 2 exclusion criteria: * evidence of secondary knee osteoarthritis * severe osteoarthritis (joint space width - jsw \< 2 mm) * prior intra articular injections within the previous one year prior to inclusion * patients with clinically significant systemic disease
comparison of erector spinae plane block with pecs ii block in patients undergoing breast cancer surgery

Conditions: Breast Cancer; Anesthesia, Local

Summary: backgroung:regional anesthesia in breast surgery is of paramount importance to reduce pain in perioperative period. pecs ii block is an interfascial block that has been used widely as regional anesthesia technique in breast surgery. esp block is a novel interfascial block proposed in 2016 by forero. several reports used this technique in breast surgery to provide analgesia but to date no studies comparing these technique exists. our hypotesis is that this two technique are equally able to provide analgesia in breast surgery. study type: rct, single blind.


Eligibility criteria:
inclusion criteria: * mastectomy program with axillary clearence exclusion criteria: * bilateral surgery

Keywords: pecs esp rct
pancrelipase in people with pancreatic ductal adenocarcinoma (pdac)

Conditions: Metastatic Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Cancer; Metastatic Pancreatic Adenocarcinoma; Metastatic Pancreatic Carcinoma; Pancreatic Carcinoma; Pancreatic Carcinoma Metastatic; Pancreatic Carcinoma Non-resectable; Pancreatic Cancer; Pancreatic Cancer Non-resectable; Pancreatic Cancer Stage IV; Pancreatic Cancer Metastatic; PDAC; PDAC - Pancreatic Ductal Adenocarcinoma

Summary: the main purpose of this study is to see how pancrelipase affects the body mass index (bmi) in people with metastatic pdac. bmi is a measure based on a person's height and weight. other study goals are to explore two different dosing schedules of pancrelipase and to evaluate pancrelipase in people who do not have symptoms of epi.


Eligibility criteria:
inclusion criteria: * histopathologic or cytologic diagnosis of pancreatic adenocarcinoma, or adenosquamous cancer, or any non-neuroendocrine primary pancreas variant, including acinar cancer. * de novo or recurrent diagnosis of previously untreated stage iv pdac with intent to receive folfirinox/mfolfirinox. * ecog 0-2. * no use of pancreatic enzyme replacement therapy within prior 2 weeks. * patients with biliary obstruction are eligible provided biliary stenting has or will occur before treatment with folfirinox. * ability to understand and the willingness to sign an informed consent document. * ability to swallow capsules. * age ≥18 years. * anticipated life expectancy of at least 6 months. exclusion criteria: * chronic illness associated with malabsorption (celiac disease, cystic fibrosis, chronic pancreatitis, crohn's disease). * fibrosing colonopathy. * prior history of surgical resection of the pancreas or gastric bypass. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to pancrelipase. * patients cannot receive radiation, ire, or other localized therapy directed to the pancreas while on study.

Keywords: metastatic pancreatic ductal adenocarcinoma metastatic pancreatic cancer pancrelipase memorial sloan kettering cancer center 21-419
the comparison of uniportal and tubeless video assisted thoracic surgery and transbronchial lung cryobiopsy in the diagnosis of interstitial lung disease

Conditions: Surgical Lung Biopsy; Transbronchial Lung Cryobiopsy; Interstitial Lung Disease

Summary: to compariing the uniportal and tubeless video assisted thoracic surgery and trnsbronchial lung cryobiopsy within the multidisciplinary discussion context in the diagnosis of interstitial lung disease，and assess the safety and cost-effectiveness. this is a prospective control trial.


Eligibility criteria:
inclusion criteria: 1. 18 yrs ≤ age\<75yrs 2. patients diagnosed as interstitial lung disease with comprehensive clinical data (including history, serological test, spirometry test and high resolution computed tomography) 3. further pathological data was still required after multidisciplinary discussion. exclusion criteria: 1. severe pulmonary dysfunction: forced vital capacity (fvc) ≤65% or carbon-monoxide diffusion coefficient (dlco) ≤45% of predicted value 2. pulmonary hypertension: an estimated systolic pulmonary artery pressure\>50mmhg on echocardiography 3. abnormal coagulation parameters or thrombocytopenia (\<50\*109/l) 4. severe comorbidities leading to inoperable condition 5. patients cannot give consent or refuse biopsy

Keywords: surgical lung biopsy transbronchial lung cryobiopsy interstitial lung disease
a clinical trial of the efficacy and safety of levilimab (bcd-089) in patients with severe covid-19

Conditions: COVID-19

Summary: the objective: to study the efficacy and safety of levilimab in subjects with severe covid-19.

this study is multicenter, comparative, randomized, double-blind, placebo controlled clinical trial with adaptive design. females and males, aged 18 years and older, admitted to hospital with severe covid-19 pneumonia on soc therapy will receive either levilimab 324 mg s/c or placebo s/c. in case of no clinical improvement is observed, investigator can administer a rescue therapy - open label lvl 324 mg s/c. the outcomes will be assessed up to day 60. results of interim analysis of safety and efficacy data of first 60 enrolled subjects will be submitted for independent dmc review and decision about changes to the protocol.

Eligibility criteria:
inclusion criteria: 1. signed informed consent (subject; legally authorized representative) or signed conclusion of panel of independent medical doctors 2. males and non-pregnant females aged 18 years or older at the ic date 3. positive test for sars-cov2 nucleic acid (rna) at the ic date 4. admitted as inpatient to a hospital with radiologically confirmed pneumonia 5. severe form of covid-19. 6. subjects meeting any of the following criteria: * total respiratory rate \> 30 breaths per minute * spo2 ≤ 93% * pao2 /fio2 ≤ 300 mmhg * chest imaging (x-ray, ct, us) showed lesion progression within 24-48 hours \>50% * decrease of consciousness level, psychomotor agitation/irritability * hemodynamically unstable (systolic blood pressure \<90 mmhg or diastolic blood pressure \< 60 mmhg or urine output \< 20 ml/h) * arterial lactate \> 2 mmol/l * qsofa (quick sequential organ failure assessment score) \> 2. subjects meeting three following criteria: low blood pressure (sbp ≤ 100 mmhg); high respiratory rate (≥ 22 breaths/min); altered mentation (glasgow coma scale ≤ 14) exclusion criteria: 1. critical covid-19. subjects meeting any of the following: * respiratory failure and requiring invasive mechanical ventilation (tracheal intubation) * septic shock * multiple organ failure 2. life expectancy \< 24h, in the opinion of the investigator, 3. unlikely to remain at the investigational site beyond 48 hours 4. use of other monoclonal antibodies for covid-19 treatment 5. current treatment with immunosuppressive agents (including corticosteroids) 6. participating in other drug clinical trials at the ic date or within 60 days after randomization (participation in covid-19 anti-viral trials may be permitted if approved by sponsor) 7. laboratory values: * alt / ast \> 10 uln at screening * platelets \< 50х109/l at screening * absolute neutrophil count \< 1х109/l at screening 8. suspected active bacterial, fungal, viral, or other infection (besides covid-19) 9. confirmed active tuberculosis 10. history of allergic reaction to monoclonal antibodies 11. pregnancy or breastfeeding 12. any illness or laboratory findings that, in the opinion of the study investigator, might pose an additional risk to the patient by their participation in the study,
multi-center clinical evaluation of two daily disposable contact lenses (study 2)

Conditions: Refractive Error

Summary: the purpose of this study is to compare the subjective performance of two daily disposable contact lenses with respect to comfort and handling.


Eligibility criteria:
inclusion criteria: * adapted soft contact lens wearer; * spherical distance contact lens prescription between -1.00 and -6.00 diopter (inclusive); * spectacle cylinder ≤0.75 diopter in the least astigmatic eye, ≤1.00 diopter in the other; * correctable to 6/9 (20/30) in both eyes; * read, understand, and sign the informed consent; * willing to comply with the wear schedule; * willing to comply with the study visit schedule; * other protocol-defined inclusion criteria may apply. exclusion criteria: * any active corneal infection, injury or inflammation; * systemic or ocular allergies which might interfere with contact lens wear; * systemic or ocular disease which might interfere with contact lens wear; * strabismus or amblyopia; * corneal refractive surgery and any anterior segment surgery; * use of systemic/topical medication contraindicating contact lens wear; * use of gas permeable contact lenses within 1 month preceding the study; * participation in any concurrent clinical trial or in the last 30 days; * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses daily disposable contact lenses silicone hydrogel contact lens comfort near-sighted
impact of inspiratory muscle training on daily physical activity (inaf)

Conditions: Inspiratory Muscle Training

Summary: the impact of the reduction of daily physical activity (dpa) in patients with copd (chronic obstructive pulmonary disease) is a highly studied area, due to its impact on the quality of life and the clinical evolution of the disease . this fact has multifactorial components: its function is naturally diminished with time, and its effects on the loss of physical condition (decondition). however, dynamic hyperinflation and respiratory muscular dysfunction, especially in patients with more symptomatology, have been identified as those that have the most relevant factors that impact on daily physical activity due to the detrimental effects of the pulmonary hyperinflation, the diaphragm is flatter and shorter, being in a position of mechanical disadvantage. this contributes to a reduced effort capacity and increase in the dyspnea of patients during daily activities. resistance training improves their exercise capacity and reduces dyspnea, however it does not improve inspiratory muscle strength. it is for this reason, that specific training of the inspiratory muscles, offers special interest in patients with decreased inspiratory muscle strength and pulmonary hyperinflation.


Eligibility criteria:
inclusion criteria: * to be eligible for the respiratory rehabilitation programme participants must have stable copd (at least 4 weeks), inspiratory muscle weakness (pimax \ 120%). patient that have signed inform consent. exclusion criteria: * hospitalization within the previous 14 days * current participation in rehabilitation program, * locomotor or neurological condition or disability limiting the ability to perform exercise, * lung transplantation or lung volume reduction surgery foreseen within 1 month after discharge.