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 ...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 determined.Herein,we sought to evaluate the impact of time-to-enrollment in chronic SCI clinical trials.A data set comprising 957 clinical studies from clinical Trials.gov was downloaded and analyzed focusing on the eligibility criteria for post-injury time-to-enrollment.We also aggregated individual patient data from nine clinical trials of regenerative interventions for chronic SCI selected by a systematic literature search from 1990 to 2018.Characteristics 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 Trials.gov registry,445 trials were identified for chronic SCI where 87%(385)were unrestricted in the maximum post-injury time for trial eligibility.From systematic literature search,nine studies and 156 patients(group 1=30,group 2=55 and group 3=71)were included.The range of time-to-enrollment was 0.5 to 321 months in those studies.We also observed various degrees of motor and sensory improvement in between three time-to-enrollment groups.Our results indicate that enrolling wide ranges of time-to-enrollment in a group may present imprecise outcomes.Clinical trial designs should consider appropriate postinjury time frames to evaluate therapeutic benefit.展开更多
Androgen deprivation therapy(ADT)is the mainstay for the treatment of advanced prostate cancer.Since the clinical evolution from surgical orchiectomy,we have typically used ADT and orchiectomy to be synonymous terms f...Androgen deprivation therapy(ADT)is the mainstay for the treatment of advanced prostate cancer.Since the clinical evolution from surgical orchiectomy,we have typically used ADT and orchiectomy to be synonymous terms for castration.The goal of this study is to determine if,in contemporary medical practice,surgical and chemical castration provide for similar levels of diminishment of total and free testosterone.Further,what approaches should be used to most accurately measure testosterone levels in men with advanced prostate cancer and what cutoff values,for example for total testosterone 50 ng dl-1 or 20 ng dl-1,should be utilized.Studies available in the literature have been analyzed and compiled to address these questions.Finally,evidence is provided that free testosterone,the biologically active component,should be utilized to provide clinically relevant state of castration.展开更多
文摘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 determined.Herein,we sought to evaluate the impact of time-to-enrollment in chronic SCI clinical trials.A data set comprising 957 clinical studies from clinical Trials.gov was downloaded and analyzed focusing on the eligibility criteria for post-injury time-to-enrollment.We also aggregated individual patient data from nine clinical trials of regenerative interventions for chronic SCI selected by a systematic literature search from 1990 to 2018.Characteristics 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 Trials.gov registry,445 trials were identified for chronic SCI where 87%(385)were unrestricted in the maximum post-injury time for trial eligibility.From systematic literature search,nine studies and 156 patients(group 1=30,group 2=55 and group 3=71)were included.The range of time-to-enrollment was 0.5 to 321 months in those studies.We also observed various degrees of motor and sensory improvement in between three time-to-enrollment groups.Our results indicate that enrolling wide ranges of time-to-enrollment in a group may present imprecise outcomes.Clinical trial designs should consider appropriate postinjury time frames to evaluate therapeutic benefit.
文摘Androgen deprivation therapy(ADT)is the mainstay for the treatment of advanced prostate cancer.Since the clinical evolution from surgical orchiectomy,we have typically used ADT and orchiectomy to be synonymous terms for castration.The goal of this study is to determine if,in contemporary medical practice,surgical and chemical castration provide for similar levels of diminishment of total and free testosterone.Further,what approaches should be used to most accurately measure testosterone levels in men with advanced prostate cancer and what cutoff values,for example for total testosterone 50 ng dl-1 or 20 ng dl-1,should be utilized.Studies available in the literature have been analyzed and compiled to address these questions.Finally,evidence is provided that free testosterone,the biologically active component,should be utilized to provide clinically relevant state of castration.
