Chordomas are rare tumors which originate from the remnants of the notochord. These tumors are locally aggressive and have a predilection for the ends of the axial skeleton. An important prerequisite for optimal manag...Chordomas are rare tumors which originate from the remnants of the notochord. These tumors are locally aggressive and have a predilection for the ends of the axial skeleton. An important prerequisite for optimal management of these tumors is a correct preoperative diagnosis. The present case is the first report of the use of endoscopic ultrasound to obtain transrectal fine needle aspiration biopsy of a presacral chordoma. A review of the prior computer tomography (CT) scans allowed us to calculate the tumor volume doubling time (18.3 mo). Transrectal biopsy of chordomas is controversial, however we believe that such concerns are not justified.展开更多
Gastroenterol Rep(Oxf).2017 doi:10.1093/gastro/gow048.The authors wish to inform the reader that any references to‘confidential interval’throughout the paper have been corrected to‘confidence interval’.The paper h...Gastroenterol Rep(Oxf).2017 doi:10.1093/gastro/gow048.The authors wish to inform the reader that any references to‘confidential interval’throughout the paper have been corrected to‘confidence interval’.The paper has now been corrected online.展开更多
Celiac disease is a lifelong disorder for which there is currently only one known,effective treatment:a gluten-free diet.New treatment approaches have recently emerged;several drugs are in Phase 2 trials and results a...Celiac disease is a lifelong disorder for which there is currently only one known,effective treatment:a gluten-free diet.New treatment approaches have recently emerged;several drugs are in Phase 2 trials and results appear promising;however,discussion around regulatory endpoints is in its infancy.We will briefly discuss the drugs that are under development and then shift our attention to potential trial endpoints,such as patient-reported outcomes,histology,serology,gene expression analysis and other tests.We will outline the differing requirements for proof-of-concept Phase 2 trials and Phase 3 registration trials,with a particular emphasis on current thinking in regulatory agencies.We conclude our paper with recommendations and a glossary of regulatory terms,to enable readers who are less familiar with regulatory language to take maximum advantage of this review.展开更多
文摘Chordomas are rare tumors which originate from the remnants of the notochord. These tumors are locally aggressive and have a predilection for the ends of the axial skeleton. An important prerequisite for optimal management of these tumors is a correct preoperative diagnosis. The present case is the first report of the use of endoscopic ultrasound to obtain transrectal fine needle aspiration biopsy of a presacral chordoma. A review of the prior computer tomography (CT) scans allowed us to calculate the tumor volume doubling time (18.3 mo). Transrectal biopsy of chordomas is controversial, however we believe that such concerns are not justified.
文摘Gastroenterol Rep(Oxf).2017 doi:10.1093/gastro/gow048.The authors wish to inform the reader that any references to‘confidential interval’throughout the paper have been corrected to‘confidence interval’.The paper has now been corrected online.
文摘Celiac disease is a lifelong disorder for which there is currently only one known,effective treatment:a gluten-free diet.New treatment approaches have recently emerged;several drugs are in Phase 2 trials and results appear promising;however,discussion around regulatory endpoints is in its infancy.We will briefly discuss the drugs that are under development and then shift our attention to potential trial endpoints,such as patient-reported outcomes,histology,serology,gene expression analysis and other tests.We will outline the differing requirements for proof-of-concept Phase 2 trials and Phase 3 registration trials,with a particular emphasis on current thinking in regulatory agencies.We conclude our paper with recommendations and a glossary of regulatory terms,to enable readers who are less familiar with regulatory language to take maximum advantage of this review.
