scholarly journals Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials

2019 ◽  
Vol 85 (6) ◽  
pp. 1270-1282
Author(s):  
Kimie Sai ◽  
Akiomi Yoshida ◽  
Tadaaki Hanatani ◽  
Takuya Imatoh ◽  
Masahiro Takeuchi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Retrospective Study ◽  
Regional Differences ◽  
East Asians ◽  
Psychotropic Agents

scholarly journals Rivaroxaban versus warfarin for the management of left ventricle thrombus

2021 ◽  
Vol 73 (1) ◽  
Author(s):  
Monirah A. Albabtain ◽  
Yahya Alhebaishi ◽  
Ola Al-Yafi ◽  
Hatim Kheirallah ◽  
Adel Othman ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Retrospective Study ◽  
Left Ventricle ◽  
Surface Area ◽  
Median Time ◽  
Randomized Clinical Trials ◽  
Off Label Use ◽  
Duration Of Treatment ◽  
Off Label ◽  
Warfarin Group

Abstract Background Rivaroxaban has been recently introduced for the management of non-valvular intra-cardiac thrombosis with variable results. We aimed to compare the results of the off-label use of rivaroxaban versus warfarin in the management of patients with left ventricle (LV) thrombus. This research is a retrospective study conducted on 63 patients who had LV thrombus from January to December 2016. We compared patients treated with warfarin (n=35) to patients who had rivaroxaban (n=28), and study outcomes were time to thrombus resolution, bleeding, stroke, and mortality. Results The median duration of treatment was 9.5 (25th-75th percentiles: 6-32.5) months for rivaroxaban and 14 (3-41) months for warfarin. Thrombus resolution occurred in 24 patients in the warfarin group (68.6%) and 20 patients in the rivaroxaban group (71.4%). The median time to resolution in the warfarin group was 9 (4-20) months and 3 (2-11.5) months in the rivaroxaban group. Thrombus resolution was significantly faster in patients on rivaroxaban (p= 0.019). Predictors of thrombus resolution were thrombus surface area (HR: 1.21; CI 95% (1.0-1.46); p= .048) and the use of rivaroxaban (HR: 1.92; CI 95% (1.01-3.65); p= 0.048). There was no difference in stroke, bleeding, and mortality between both groups. Conclusion Rivaroxaban was as effective and safe as warfarin in managing patients with left ventricle thrombus. Larger randomized clinical trials are recommended to confirm our findings.

scholarly journals Regional differences in Alzheimer’s disease pathology confound behavioural rescue after amyloid-β attenuation

Brain ◽  
2019 ◽  
Vol 143 (1) ◽  
pp. 359-373 ◽  
Author(s):  
Christopher D Morrone ◽  
Paolo Bazzigaluppi ◽  
Tina L Beckett ◽  
Mary E Hill ◽  
Margaret M Koletar ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Cognitive Function ◽  
Spatial Memory ◽  
Regional Differences ◽  
Amyloid Β ◽  
Amyloid Β Peptide ◽  
Barnes Maze ◽  
Tau Pathology

Abstract Failure of Alzheimer’s disease clinical trials to improve or stabilize cognition has led to the need for a better understanding of the driving forces behind cognitive decline in the presence of active disease processes. To dissect contributions of individual pathologies to cognitive function, we used the TgF344-AD rat model, which recapitulates the salient hallmarks of Alzheimer’s disease pathology observed in patient populations (amyloid, tau inclusions, frank neuronal loss, and cognitive deficits). scyllo-Inositol treatment attenuated amyloid-β peptide in disease-bearing TgF344-AD rats, which rescued pattern separation in the novel object recognition task and executive function in the reversal learning phase of the Barnes maze. Interestingly, neither activities of daily living in the burrowing task nor spatial memory in the Barnes maze were rescued by attenuating amyloid-β peptide. To understand the pathological correlates leading to behavioural rescue, we examined the neuropathology and in vivo electrophysiological signature of the hippocampus. Amyloid-β peptide attenuation reduced hippocampal tau pathology and rescued adult hippocampal neurogenesis and neuronal function, via improvements in cross-frequency coupling between theta and gamma bands. To investigate mechanisms underlying the persistence of spatial memory deficits, we next examined neuropathology in the entorhinal cortex, a region whose input to the hippocampus is required for spatial memory. Reduction of amyloid-β peptide in the entorhinal cortex had no effect on entorhinal tau pathology or entorhinal-hippocampal neuronal network dysfunction, as measured by an impairment in hippocampal response to entorhinal stimulation. Thus, rescue or not of cognitive function is dependent on regional differences of amyloid-β, tau and neuronal network dysfunction, demonstrating the importance of staging disease in patients prior to enrolment in clinical trials. These results further emphasize the need for combination therapeutic approaches across disease progression.

Sunitinib dosing, toxicity, and outcomes in first-line advanced renal cell carcinoma (aRCC): A U.S. Oncology Network (USON) retrospective study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15089-e15089
Author(s):  
Ian D. Schnadig ◽  
Thomas E. Hutson ◽  
Hsingwen Chung ◽  
Rahul Dhanda ◽  
Melissa Halm ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Retrospective Study ◽  
Kinase Inhibitor ◽  
Objective Response ◽  
Median Number ◽  
First Line ◽  
Primary Tumors ◽  
Full Dose ◽  
First Line Therapy ◽  
Dose Reductions

e15089 Background: Sunitinib is a first-line therapy for patients (pts) with aRCC. As a multitargeted tyrosine kinase inhibitor (TKI), it is associated with toxicities that may impact dosing; dose reductions may result in inferior clinical outcomes (Motzer, 2011 ASCO GU, abstract LBA308). This retrospective study was initiated by USON to evaluate dosing patterns of first-line sunitinib, and its association with toxicities and outcomes in community practices. Methods: Pts with aRCC who started first-line sunitinib between June 1, 2007 and May 31, 2011 at 17 USON practices were identified; clinical data were extracted by chart review from iKnowMed electronic medical records that were linked to USON retail pharmacy database. Pts who were enrolled in clinical trials or receiving care for other primary tumors were excluded. Results: Pt characteristics: N=134; median age = 64 years (range 41–87); ECOG PS 0/1 = 85%; clear cell RCC = 81%; and nephrectomy = 61%. Objective response rate was 16%. Overall survival (OS) was 15.4 months (95% confidence interval 11.9–20.8). Median treatment duration was 4 cycles (range 1–19): 27 pts (20.1%) received only 1 cycle of sunitinib (23 at full dose [50 mg] and 4 at <full dose); 107 pts (79.9%) received >1 cycle of sunitinib (53 received full dose; 35 started at full dose but were dose-reduced; 14 always received <full dose; 5 started at <full dose but were dose-increased to 50 mg). Overall, 45 pts were dose-reduced, principally (93%) due to toxicities; 67% of all dose reductions occurred in the first 3 cycles. 121 pts discontinued sunitinib after completing at least 1 cycle, mostly due to disease progression (PD; 44%) or toxicities (17%); 74% of all discontinuations occurred within the first 5 cycles. Conclusions: RCC pts in community practices commonly undergo sunitinib dose reductions in the first 3 cycles due to toxicities, and discontinue therapy within the first 5 cycles due to PD. The median number of cycles and OS were lower than those reported in clinical trials (Motzer JCO 2009;27:3584–3590). More selective TKIs are needed to reduce toxicities, optimize dosing, and potentially improve outcomes. Funded by a grant from AVEO Pharmaceuticals, Inc.

scholarly journals A Retrospective Observational Study of Chlorine Dioxide Effectiveness to Covid19-like Symptoms Prophylaxis in Relatives Living with COVID19 Patients

2021 ◽  
Vol 04 (08) ◽  
Author(s):  
Manuel Aparicio Alonso ◽  
Keyword(s):  
Aqueous Solution ◽  
Clinical Trials ◽  
Retrospective Study ◽  
Chlorine Dioxide ◽  
Prophylactic Treatment ◽  
Family Members ◽  
Blood Parameters ◽  
Qtc Interval ◽  
Prophylactic Agent ◽  
Sick Patient

To date, there is no effective prophylactic agent to prevent COVID-19. However, the development of symptoms similar to covid19 could be prevented with an aqueous solution of chlorine dioxide (ClO2). This retrospective study evaluated the effectiveness of an aqueous solution of ClO2 (CDS) as a prophylactic agent in 1,163 family members living with positive/suspected COVID19 patients. Prophylactic treatment consisted of 0.0003% chlorine dioxide solution (CDS) orally for at least fourteen days. Family members in whom no reports of the development of covid19-like symptoms were found in the medical history were considered successful cases. The efficacy of CDS in preventing covid19-like symptoms was 90.4% (1,051 of 1,163 relatives did not report any symptoms). The comorbidities, sex and severity of the illness of the sick patient did not contribute to the development of symptoms similar to covid19 (P = 0.092, P = 0.351 and P = 0.574, respectively). However, older relatives were more likely to develop covid19-like symptoms (ORa = 4.22, P = 0.002). There was no evidence of alterations in blood parameters or in the QTc interval in relatives who consumed CDS. The recent findings regarding Chlorine Dioxide justify designing clinical trials to assess its efficacy for preventing SARS-CoV-2 infection.

Blinding in randomised clinical trials of psychological interventions: a retrospective study of published trial reports

2020 ◽  
pp. bmjebm-2020-111407
Author(s):  
Sophie Juul ◽  
Christian Gluud ◽  
Sebastian Simonsen ◽  
Frederik Weischer Frandsen ◽  
Irving Kirsch ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Retrospective Study ◽  
Null Hypothesis ◽  
Primary Outcome ◽  
Randomised Clinical Trials ◽  
Psychological Interventions ◽  
Potential Bias ◽  
Treatment Providers ◽  
Monitoring Committee ◽  
Bias Risk

ObjectivesTo study the extent of blinding in randomised clinical trials of psychological interventions and the interpretative considerations if randomised clinical trials are not blinded.DesignRetrospective study of trial reports published in six high impact factor journals within the field of psychiatry in 2017 and 2018.SettingTrial reports published in World Psychiatry, JAMA Psychiatry, Lancet Psychiatry, American Journal of Psychiatry, British Journal of Psychiatry, or Psychotherapy and Psychosomatics.Main outcome measuresBlinding status of participants, treatment providers, outcome assessors, data managers, the data safety and monitoring committee, statisticians and conclusion makers, if trialists rejected the null hypothesis on the primary outcome measure, and if trialists discussed the potential bias risk from lack of blinding in the published trial report.Results63 randomised clinical trials of psychological interventions were identified. None (0%; 95% CI 0% to 5.75%) of the trials reported blinding of all possible key persons. 37 (58.7%; 95% CI 46.42% to 70.04%) trials reported blinding of outcome assessors. Two (3.2%; 95% CI 0.87% to 10.86%) trials reported blinding of participants. Two (3.2%; 95% CI 0.87% to 10.86%) trials reported blinding of data managers. Three (4.8%; 95% CI 1.63% to 13.09%) trials reported blinding of statisticians. None of the trials reported blinding of treatment providers, the data safety and monitoring committee, and conclusion makers. 45 (71.4%; 95% CI 59.30% to 81.10%) trials rejected the null hypothesis on the primary outcome(s). 13 (20.7%; 95% CI 12.48% to 32.17%) trials discussed the potential bias risk from lack of blinding in the published trial report.ConclusionsBlinding of key persons involved in randomised clinical trials of psychological interventions is rarely sufficiently documented. The possible interpretative limitations are only rarely considered. There is a need of randomised clinical trials of psychological interventions with documented blinding attempts of all possible key persons.

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