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Time-to-enrollment in clinical trials investigating neurological recovery in chronic spinal cord injury:observations from a systematic review and clinical *** database

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Neural Regeneration Research 2022年第5期17卷 953-958页

作者： F M Moinuddin Yagiz Ugur Yolcu Waseem Wahood Jad Zreik Sandy Goncalves Anthony John Windebank Wenchun Qu Mohamad Bydon mayo clinic neuro-informatics laboratory Mayo ClinicRochesterMNUSA Department of neurologic Surgery Mayo ClinicRochesterMNUSA Dr.Kiran C.Patel College of Allopathic Medicine Nova Southeastern UniversityDavieFLUSA Department of neurology Mayo ClinicRochesterMNUSA Department of Physical Medicine&Rehabilitation Mayo ClinicRochesterMNUSA

Currently,large numbers of clinical trials are performed to investigate different forms of experimental therapy for patients suffering from chronic spinal cord injury(SCI).However,for the enrollment process,there are different views on how the time period between injury and interventions should be ***,we sought to evaluate the impact of time-to-enrollment in chronic SCI clinical trials.A data set comprising 957 clinical studies from clinical *** was downloaded and analyzed focusing on the eligibility criteria for post-injury *** also aggregated individual patient data from nine clinical trials of regenerative interventions for chronic SCI selected by a systematic literature search from 1990 to *** of the studies were assessed and compared by dividing into three groups based on time-to-enrollment(group 1≤12 months,group 2=12-23 months and group 3≥24 months).In clinical *** registry,445 trials were identified for chronic SCI where 87%(385)were unrestricted in the maximum post-injury time for trial *** systematic literature search,nine studies and 156 patients(group 1=30,group 2=55 and group 3=71)were *** range of time-to-enrollment was 0.5 to 321 months in those *** also observed various degrees of motor and sensory improvement in between three time-to-enrollment *** results indicate that enrolling wide ranges of time-to-enrollment in a group may present imprecise *** trial designs should consider appropriate postinjury time frames to evaluate therapeutic benefit.

关键词： chronic clinical trial spinal cord injury systematic review time-to-enrollment

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Colonoscopy surveillance for high risk polyps does not always prevent colorectal cancer

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World Journal of Gastroenterology 2018年第8期24卷 905-916页

作者： Mohamad A Mouchli Lidia Ouk Marianne R Scheitel Alisha P Chaudhry Donna Felmlee-Devine Diane E Grill Shahrooz Rashtak Panwen Wang Junwen Wang Rajeev Chaudhry Thomas C Smyrk Ann L Oberg Brooke R Druliner Lisa A Boardman Division of Gastroenterology and Hepatology Mayo Clinic Knowledge and Delivery Center Mayo Clinic Biostatistics and Bioinformatics Health Sciences Research Mayo Clinic Division of Biomedical Statistics and informatics Health Sciences Research Mayo Clinic Biostatistics and Bioinformatics Health Science Research Center for Individualized Medicine Mayo Clinic Department of Biomedical informatics Arizona State University Primary Care Internal Medicine Mayo Clinic Center for Innovation Mayo Clinic Department of laboratory Medicine and Pathology Mayo Clinic

AIM To determine the frequency and risk factors for colorectal cancer(CRC) development among individuals with resected advanced adenoma(AA)/traditional serrated adenoma(TSA)/advanced sessile serrated adenoma(ASSA). METHODS Data was collected from medical records of 14663 subjects found to have AA, TSA, or ASSA at screening or surveillance colonoscopy. Patients with inflammatory bowel disease or known genetic predisposition for CRC were excluded from the study. Factors associated with CRC developing after endoscopic management of high risk polyps were calculated in 4610 such patients who had at least one surveillance colonoscopy within 10 years following the original polypectomy of the incident advanced polyp. RESULTS84/4610(1.8%) patients developed CRC at the polypectomy site within a median of 4.2 years(mean 4.89 years), and 1.2%(54/4610) developed CRC in a region distinct from the AA/TSA/ASSA resection site within a median of 5.1 years(mean 6.67 years). Approximately, 30%(25/84) of patients who developed CRC at the AA/TSA/ASSA site and 27.8%(15/54) of patients who developed CRC at another site had colonoscopy at recommended surveillance intervals. Increasing age; polyp size; male sex; right-sided location; high degree of dysplasia; higher number of polyps resected; and piecemeal removal were associated with an increased risk for CRC developmentat the same site as the index polyp. Increasing age; right-sided location; higher number of polyps resected and sessile endoscopic appearance of the index AA/TSA/ASSA were significantly associated with an increased risk for CRC development at a different site. CONCLUSION Recognition that CRC may develop following AA/TSA/ASSA removal is one step toward improving our practice efficiency and preventing a portion of CRC related morbidity and mortality.

关键词： Colon cancer Rectal Cancer Advanced adenoma Sessile serrated adenoma High risk polyps Post-polypectomy colorectal cancer

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Isolated hepatic non-obstructive sinusoidal dilatation, 20-year single center experience

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World Journal of Hepatology 2018年第5期10卷 417-424页

作者： Dharma Budi Sunjaya Guilherme Piovezani Ramos Manuel Bonfim Braga Neto Ryan Lennon Taofic Mounajjed Vijay Shah Patrick Sequeira Kamath Douglas Alano Simonetto School of Graduate Medical Education Mayo Clinic Division of Biomedical Statistics and informatics Mayo Clinic laboratory Medicine and Pathology Mayo Clinic Gastroenterology and Hepatology Mayo Clinic

AIM To characterize isolated non-obstructive sinusoidal dilatation(SD) by identifying associated conditions, laboratory findings, and histological patterns. METHODS Retrospectively reviewed 491 patients with SD between 1995 and 2015. Patients with obstruction at the level of the small/large hepatic veins, portal veins, or right-sided heart failure were excluded along with history of cirrhosis, hepatic malignancy, liver transplant, or absence of electrocardiogram/cardiac echocardiogram. Liver histology was reviewed for extent of SD, fibrosis, red blood cell extravasation, nodular regenerative hyperplasia, hepaticpeliosis, and hepatocellular plate atrophy(HPA). RESULTS We identified 88 patients with non-obstructive SD. Inflammatory conditions(32%) were the most common cause. The most common pattern of liver abnormalities was cholestatic(76%). Majority(78%) had localized SD to Zone Ⅲ. Medication-related SD had higher proportion of portal hypertension(53%), ascites(58%), and median AST(113 U/L) and ALT(90 U/L) levels. Nineteen patients in our study died within one-year after diagnosis of SD, majority from complications related to underlying *** Significant proportion of SD and HPA exist without impaired hepatic venous outflow. Isolated SD on liver biopsy, in the absence of congestive hepatopathy, requires further evaluation and portal hypertension should be rule out.

关键词： Sinusoidal dilatation Sinusoidal obstruction syndrome Hepatic plate atrophy

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Magnetic resonance elastography is accurate in detecting advanced fibrosis in autoimmune hepatitis

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World Journal of Gastroenterology 2017年第5期23卷 859-868页

作者： Jin Wang Neera Malik Meng Yin Thomas C Smyrk Albert J Czaja Richard L Ehman Sudhakar K Venkatesh Department of Radiology Mayo Clinic College of MedicineMayo Clinic Department of Radiology the Third Affiliated HospitalSun Yat-Sen University laboratory Medicine and Pathology Mayo Clinic College of MedicineMayo Clinic Department of Gastroenterology and Hepatology Mayo Clinic College of MedicineMayo Clinic

AIM To assess the value of magnetic resonance elastography (MRE) in detecting advanced fibrosis/cirrhosis in autoimmune hepatitis (AIH). METHODS In this retrospective study, 36 patients (19 treated and 17 untreated) with histologically confirmed AIH and liver biopsy performed within 3 mo of MRE were identified at a tertiary care referral center. Liver stiffness (LS) with MRE was calculated by a radiologist, and inflammation grade and fibrosis stage in liver biopsy was assessed by a pathologist in a blinded fashion. Two radiologists evaluated morphological features of cirrhosis on conventional magnetic resonance imaging (MRI). Accuracy of MRE was compared to laboratory markers and MRI for detection of advanced fibrosis/cirrhosis. RESULTS Liver fibrosis stages of 0, 1, 2, 3 and 4 were present in 4, 6, 7, 6 and 13 patients respectively. There were no significant differences in distribution of fibrosis stage and inflammation grade between treated and untreated patient groups. LS with MRE demonstrated stronger correlation with liver fibrosis stage in comparison to laboratory markers for chronic liver disease (r = 0.88 vs -0.48-0.70). A trend of decreased mean LS in treated patients compared to untreated patients was observed (3.7 kPa vs 3.84 kPa) but was not statistically significant. MRE had an accuracy/sensitivity/specificity/positive predictive value/negative predictive value of 0.97/90%/100%/100%/90% and 0.98/92.3%/96%/92.3%/96% for detection of advanced fibrosis and cirrhosis, respectively. The performance of MRE was significantly better than laboratory tests for detection of advanced fibrosis (0.97 vs 0.53-0.80, p laboratory assessment and MRI.

关键词： autoimmune hepatitis advanced fibrosis magnetic resonance elastography liver stiffness cirrhosis

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A microfluidic platform for cultivating ovarian cancer spheroids and testing their responses to chemotherapies

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Microsystems & Nanoengineering 2020年第1期6卷 315-326页

作者： Neda Dadgar Alan M.Gonzalez-Suarez Pouria Fattahi Xiaonan Hou John S.Weroha Alexandre Gaspar-Maia Gulnaz Stybayeva Alexander Revzin Department of Physiology and Biomedical Engineering Mayo ClinicRochesterMN 55905USA Department of Medical Oncology Mayo ClinicRochesterMN 55905USA Department of laboratory Medicine and Pathology Mayo ClinicRochesterMN 55905USA

There is increasing interest in utilizing in vitro cultures as patient avatars to develop personalized treatment for *** cultures utilize Matrigel-coated plates and media to promote the proliferation of cancer cells as spheroids or tumor ***,standard culture conditions operate in large volumes and require a high concentration of cancer cells to initiate this *** limitations include variability in the ability to successfully establish a stable line and inconsistency in the dimensions of these microcancers for in vivo drug response *** paper explored the utility of microfluidics in the cultivation of cancer cell *** patient-derived xenograft(PDX)tumors of high-grade serous ovarian cancer were used as the source material to demonstrate that viability and epithelial marker expression in the microfluidic cultures was superior to that of Matrigel or large volume 3D *** further demonstrate the potential for miniaturization and multiplexing,we fabricated multichamber microfluidic devices with integrated microvalves to enable serial seeding of several chambers followed by parallel testing of several drug *** valve-enabled microfluidic devices permitted the formation of spheroids and testing of seven drug concentrations with as few as 100,000 cancer cells per ***,we demonstrate the feasibility of maintaining difficul-to-culture primary cancer cells and testing drugs in a microfluidic *** microfluidic platform may be ideal for drug testing and personalized therapy when tumor material is limited,such as following the acquisition of biopsy specimens obtained by fine-needle aspiration.

关键词： testing fluid cancer

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Assessment of the diagnostic performance and interobserver variability of endocytoscopy in Barrett's esophagus:A pilot ex-vivo study

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World Journal of Gastroenterology 2013年第46期19卷 8652-8658页

作者： Yutaka Tomizawa Prasad G Iyer Louis M Wongkeesong Navtej S Buttar Lori S Lutzke Tsung-Teh Wu Kenneth K Wang Barrett’s Esophagus Unit Division of Gastroenterology and Hepatology Mayo Clinic Rochester Department of laboratory Medicine and Pathology Mayo Clinic Rochester

AIM: To investigate a classification of endocytoscopy (ECS) images in Barrett’s esophagus (BE) and evaluate its diagnostic performance and interobserver variability.

关键词： Endocytoscopy, Barrett’ s esophagus, Dysplasia, Esophageal adenocarcinoma, Interobserver agreement

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Gene expression profiles of human adipose-derived mesenchymal stem cells dynamically seeded on clinically available processed nerve allografts and collagen nerve guides

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Neural Regeneration Research 2021年第8期16卷 1613-1621页

作者： Femke Mathot Nadia Rbia Roman Thaler Allan B.Dietz Andre Jvan Wijnen Allen T.Bishop Alexander Y.Shin Department of Orthopedic Surgery Mayo ClinicRochesterMNUSA Department of Plastic Surgery RadboudumcNijmegenThe Netherlands Department of Dermatology Erasmus Medical CenterRotterdamThe Netherlands Department of Biochemistry and Molecular Biology Mayo ClinicRochesterMNUSA Department of laboratory Medicine and Pathology Mayo ClinicRochesterMNUSA

It was hypothesized that mesenchymal stem cells(MSCs) could provide necessary trophic factors when seeded onto the surfaces of commonly used nerve graft substitutes. We aimed to determine the gene expression of MSCs when influenced by Avance■ Nerve Grafts or Neura Gen■ Nerve Guides. Human adipose-derived MSCs were cultured and dynamically seeded onto 30 Avance■ Nerve Grafts and 30 Neura Gen■ Nerve Guides for 12 hours. At six time points after seeding, quantitative polymerase chain reaction analyses were performed for five samples per group. neurotrophic [nerve growth factor(NGF), glial cell line-derived neurotrophic factor(GDNF), pleiotrophin(PTN), growth associated protein 43(GAP43) and brain-derived neurotrophic factor(BDNF)], myelination [peripheral myelin protein 22(PMP22) and myelin protein zero(MPZ)], angiogenic [platelet endothelial cell adhesion molecule 1(PECAM1/CD31) and vascular endothelial cell growth factor alpha(VEGFA)], extracellular matrix(ECM) [collagen type alpha I(COL1A1), collagen type alpha III(COL3A1), Fibulin 1(FBLN1) and laminin subunit beta 2(LAMB2)] and cell surface marker cluster of differentiation 96(CD96) gene expression was quantified. Unseeded Avance■ Nerve Grafts and Neura Gen■ Nerve Guides were used to evaluate the baseline gene expression, and unseeded MSCs provided the baseline gene expression of MSCs. The interaction of MSCs with the Avance■ Nerve Grafts led to a short-term upregulation of neurotrophic(NGF, GDNF and BDNF), myelination(PMP22 and MPZ) and angiogenic genes(CD31 and VEGFA) and a long-term upregulation of BDNF, VEGFA and COL1A1. The interaction between MSCs and the Neura Gen■ Nerve Guide led to short term upregulation of neurotrophic(NGF, GDNF and BDNF) myelination(PMP22 and MPZ), angiogenic(CD31 and VEGFA), ECM(COL1A1) and cell surface(CD96) genes and long-term upregulation of neurotrophic(GDNF and BDNF), angiogenic(CD31 and VEGFA), ECM genes(COL1A1, COL3A1, and FBLN1) and cell surface(CD96) genes. Analysis demonstrat

关键词： Avance■Nerve Grafts dynamic seeding mesenchymal stem cell NeuraGen■Nerve Guides peripheral nerve repair qPCR

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How close is the stem cell cure to the Alzheimer's disease Future and beyond?

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Neural Regeneration Research 2012年第1期7卷 66-71页

作者： Jun Tang Department of laboratory Medicine and Pathology Robert and Arlene Kogod Center on Aging Mayo Clinic Rochester Minnesota 55905USA

Alzheimer＇s disease, a progressive neurodegenerative illness, is the most common torm or dementia. So far, there is neither an effective prevention nor a cure for AIzheimer＇s disease. In recent decades, stem cell therapy has been one of the most promising treatments for Alzheimer＇s disease patients. This article aims to summarize the current progress in the stem cell treatments for Alzheimer＇s disease from an experiment to a clinical research.

关键词： Alzheimer's disease stem cells cell replacement neurogenesis neural regeneration reviews

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Fibrolamellar hepatocellular carcinoma:Exploring molecular mechanisms and differentiation pathways to better understand disease outcomes and prognosis

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Liver Research 2017年第4期1卷 187-192页

作者： Cassandra A.Kersten Elise N.Sloey Eric Zhou Ying Peng Michael S.Torbenson Yi Guo Department of Biochemistry and Molecular Biology Mayo ClinicRochesterMNUSA Division of Gastroenterology and Liver Pathology Department of Laboratory Medicine and PathologyMayo ClinicRochesterMNUSA Division of Gastroenterology and Hepatology Mayo ClinicRochesterMNUSA

Fibrolamellar hepatocellular carcinoma(FLC)is a rare but aggressive liver cancer of children that occurs predominantly in teenagers without a history of liver *** resection remains the only therapeutic option,and the recurrence rate is extremely high(>50%within 3 years).A newly discovered chromosomal deletion that occurs in the majority of FLCs generates a novel kinase fusion between DnaJ heat shock protein family member B1(DNAJB1)and protein kinase cAMP-activated catalytic subunit alpha(PRKACA)(DNAJB1-PRKACA).Despite its high penetrance and apparent specificity for FLC,the oncogenic role of this fusion event remains *** this review article,we discuss the histology,presentation and diagnosis,current treatment,and roles of the DNAJB1-PRKACA as well as research models contributing to our understanding of this disease.

关键词： Fibrolamellar hepatocellular carcinoma(FLC) DnaJ heat shock protein family member B1 (DNAJB1) Protein kinase cAMP-activated catalytic subunit alpha(PRKACA)Pediatric cancer Liver cancer

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Model combining pre-transplant tumor biomarkers and tumor size shows more utility in predicting hepatocellular carcinoma recurrence and survival than the BALAD models

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World Journal of Gastroenterology 2018年第12期24卷 1321-1331页

作者： Nicha Wongjarupong Gabriela M Negron-Ocasio Roongruedee Chaiteerakij Benyam D Addissie Essa A Mohamed Kristin C Mara William S Harmsen J Paul Theobald Brian E Peters Joseph G Balsanek Melissa M Ward Nasra H Giama Sudhakar K Venkatesh Denise M Harnois Michael R Charlton Hiroyuki Yamada Alicia Algeciras-Schimnich Melissa R Snyder Terry M Therneau Lewis R Roberts Division of Gastroenterology and Hepatology Mayo ClinicRochesterMN 55905United States University of Puerto Rico Medical Sciences Campus San Juan 00921Puerto Rico Department of Medicine Faculty of MedicineChulalongkorn University and King Chulalongkorn Memorial HospitalThai Red Cross SocietyBangkok 10400Thailand Division of Biomedical Statistics and informatics Mayo ClinicRochesterMN 55905United States Division of laboratory Medicine Department of Laboratory Medicine and PathologyMayo Clinic College of MedicineRochesterMN 55905United States Department of Radiology Mayo Clinic College of MedicineRochesterMN 55905United States Department of Transplantation Mayo Clinic FloridaJacksonvilleFL 32224United States Wako Life Sciences IncorporatedMountain ViewCA 94043United States

AIM To assess the performance of BALAD, BALAD-2 and their component biomarkers in predicting outcome of hepatocellular carcinoma(HCC) patients after liver *** BALAD score and BALAD-2 class are derived from bilirubin, albumin, alpha-fetoprotein(AFP), Lens culinaris agglutinin-reactive AFP(AFP-L3), and des-gammacarboxyprothrombin(DCP). Pre-transplant AFP, AFP-L3 and DCP were measured in 113 patients transplanted for HCC from 2000 to 2008. Hazard ratios(HR) for recurrence and death were calculated. Univariate and multivariate regression analyses were conducted. C-statistics were used to compare biomarker-based to predictive models. RESULTS During a median follow-up of 12.2 years, 38 patients recurred and 87 died. The HRs for recurrence in patients with elevated AFP, AFP-L3, and DCP defined by BALAD cut-off values were 2.42(1.18-5.00), 1.86(0.98-3.52), and 2.83(1.42-5.61), respectively. For BALAD, the HRs for recurrence and death per unit increased score were 1.48(1.15-1.91) and 1.59(1.28-1.97). For BALAD-2, the HRs for recurrence and death per unit increased class were 1.45(1.06-1.98) and 1.38(1.09-1.76). For recurrence prediction, the combination of three biomarkers had the highest c-statistic of 0.66 vs. 0.64, 0.61, 0.53, and 0.53 for BALAD, BALAD-2, Milan, and UCSF, respectively. Similarly, for death prediction, the combination of three biomarkers had the highest c-statistic of 0.66 vs 0.65,0.61, 0.52, and 0.50 for BALAD, BALAD-2, Milan, and UCSF. A new model combining biomarkers with tumor size at the time of transplant(S-LAD) demonstrated the highest predictive capability with c-statistics of 0.71 and 0.69 for recurrence and death. CONCLUSION BALAD and BALAD-2 are valid in transplant HCC patients, but less predictive than the three biomarkers in combination or the three biomarkers in combination with maximal tumor diameter(S-LAD).

关键词： alpha-fetoprotein AFP-L3 des-gammacarboxyprothrombin BALAD BALAD-2 Hepatocellular carcinoma Liver transplant Recurrence Outcome

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