49 research outputs found
Critical Research Ethics as Decolonial Praxis
Get PDFIn the comment “Critical Research Ethics as Decolonial Praxis” Rosa Cordillera A. Castillo emphasises the importance of critical research ethics in decolonial praxis within academia, highlighting the harmful effects of irresponsible and extractive scholarship that perpetuates epistemic violence and injustice by disregarding non-Western epistemologies, knowledge-makers, agency, and history. The author argues that confronting the embeddedness of knowledge production in imperial, colonial, and patriarchal ideologies, practices, and histories is crucial for engaging in a rehumanising and redistributive academic praxis. June Rubis continues the discussion, pointing out the limitations of superficial attempts to decolonise academic institutions, which often exclude Indigenous voices and fail to confront ongoing colonial violence. She suggests that a more meaningful decolonial project requires remaking relationships towards liberatory justice, including ethical collaboration and accountability with the communities researchers work with. Antony George Pattathu concludes that decolonial praxis and ethics must address colonial continuities and complicities and work towards preventing their perpetuation in research. He focusses on the roles of rehumanising and of Whiteness in decolonial praxis, critical research ethics, and the importance of the emotional dimension involved in decolonial debates
Critical Research Ethics as Decolonial Praxis: A comment and responses
No full textIn the comment “Critical Research Ethics as Decolonial Praxis” Rosa Cordillera A. Castillo emphasises the importance of critical research ethics in decolonial praxis within academia, highlighting the harmful effects of irresponsible and extractive scholarship that perpetuates epistemic violence and injustice by disregarding non-Western epistemologies, knowledge-makers, agency, and history. The author argues that confronting the embeddedness of knowledge production in imperial, colonial, and patriarchal ideologies, practices, and histories is crucial for engaging in a rehumanising and redistributive academic praxis. June Rubis continues the discussion, pointing out the limitations of superficial attempts to decolonise academic institutions, which often exclude Indigenous voices and fail to confront ongoing colonial violence. She suggests that a more meaningful decolonial project requires remaking relationships towards liberatory justice, including ethical collaboration and accountability with the communities researchers work with. Antony George Pattathu concludes that decolonial praxis and ethics must address colonial continuities and complicities and work towards preventing their perpetuation in research. He focusses on the roles of rehumanising and of Whiteness in decolonial praxis, critical research ethics, and the importance of the emotional dimension involved in decolonial debates
Cactus Hill, Rubis-Pearsall and Blueberry Hill: one is an accident; two is a coincidence; three is a pattern – predicting "old dirt" in the Nottoway river valley of Southeastern Virginia, U. S. A.
No full textThis thesis covers more than thirty years of the author's research into the Paleoamerican period of the Middle Atlantic Region of North America, including the last 19+ years of focused work on the Cactus Hill site (44SX202) and replication of the Paleoamerican occupation discovered there. Using a landform and geology based predictive model derived from the Paleoamerican occupation at Cactus Hill, the author directed preliminary archaeological testing in three other areas of the same Nottoway River Valley, where Cactus Hill is located. These areas were the Barr site, located 11 miles (18 km.) downriver from Cactus Hill; the Chub Sandhill Natural Resource Conservation Area, located 19 miles (30 km.) downriver from Cactus Hill; and the Blueberry Hill site (44SX327), located approximately 1,000 feet (300 meters) east of Cactus Hill. The latter two produced OSL dated, pre-Younger-Dryas landforms, as predicted. The Rubis-Pearsall site (44SX360), located in the Chub Sandhill preserve also produced a buried Paleoamerican, Clovis age cultural level confirming the model. In addition to the OSL dates, Blueberry Hill also produced a distinct and apparently discrete activity surface with a possible pre-Clovis age Cactus Hill point at the same depth as the Paleoamerican levels at Cactus Hill and Rubis-Pearsall
Cactus Hill, Rubis-Pearsall and Blueberry Hill: one is an accident; two is a coincidence; three is a pattern – predicting "old dirt" in the Nottoway river valley of Southeastern Virginia, U. S. A.
No full textThis thesis covers more than thirty years of the author's research into the Paleoamerican period of the Middle Atlantic Region of North America, including the last 19+ years of focused work on the Cactus Hill site (44SX202) and replication of the Paleoamerican occupation discovered there. Using a landform and geology based predictive model derived from the Paleoamerican occupation at Cactus Hill, the author directed preliminary archaeological testing in three other areas of the same Nottoway River Valley, where Cactus Hill is located. These areas were the Barr site, located 11 miles (18 km.) downriver from Cactus Hill; the Chub Sandhill Natural Resource Conservation Area, located 19 miles (30 km.) downriver from Cactus Hill; and the Blueberry Hill site (44SX327), located approximately 1,000 feet (300 meters) east of Cactus Hill. The latter two produced OSL dated, pre-Younger-Dryas landforms, as predicted. The Rubis-Pearsall site (44SX360), located in the Chub Sandhill preserve also produced a buried Paleoamerican, Clovis age cultural level confirming the model. In addition to the OSL dates, Blueberry Hill also produced a distinct and apparently discrete activity surface with a possible pre-Clovis age Cactus Hill point at the same depth as the Paleoamerican levels at Cactus Hill and Rubis-Pearsall
Developing regulatory-compliant eletronic case report forms for clinical trials:the DEMAND trial
No full textDeveloping Regulatory-compliant Electronic Case Report Forms for Clinical Trials: Experience with The Demand Trial
No full textThe use of electronic case report forms (CRF) to gather data in randomized clinical trials has grown to progressively replace paper-based forms. Computerized form designs must ensure the same data quality expected of paper CRF, by following Good Clinical Practice rules. Electronic data capture (EDC) tools must also comply with applicable statutory and regulatory requirements. Here the authors focus on the development of computerized systems for clinical trials implementing FDA and EU recommendations and regulations, and describe a laptop-based electronic CRF used in a randomized, multicenter clinical trial
System Load Characterization Using Low-Level Performance Measurements
No full textThe performance of a software system directly influences customer satisfaction. Self-adaptiveness can contribute to this customer satisfaction by (1) taking appropriate measures when the performance becomes critical, e.g., the system load is too high, or (2) scheduling intensive tasks when the load is low. We investigate how self-adaptive systems can use low-level system measurements to characterize the load on a system. Our approach uses a combination of statistics and association rule learning to perform the characterization. We evaluate our approach using two case studies: a large-scale industrial system and a widely used synthetic benchmark (RUBiS). From our case studies follows that our approach is capable of closely characterizing the load on a system and that it is successful in detecting performance anomalies as well.Software Computer TechnologyElectrical Engineering, Mathematics and Computer Scienc
The Remission Clinic approach to halt the progression of kidney disease
No full textRandomized multicenter studies in diabetic and nondiabetic patients with chronic proteinuric nephropathies have clearly demonstrated that renin-angiotensin system (RAS) inhibitors, such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) used alone or in combination, effectively retard renal disease progression. Proteinuria reduction, in addition to arterial blood pressure control, largely mediates the nephroprotective effect of RAS inhibitor therapy. Despite RAS inhibition, however, most patients with chronic kidney disease (CKD) progress to end-stage renal disease (ESRD). This highlights the importance of innovative therapies to halt or revert CKD progression in those at risk. Along this line, a multimodal strategy (Remission Clinic) targeting urinary proteins by dual RAS inhibition with ACE inhibitors and ARBs up-titrated to maximum tolerated doses, by intensified blood pressure control, amelioration of dyslipidemia by statins, smoking cessation and healthy lifestyle implementation was safely and effectively applied at our outpatient clinic to normalize urinary proteins and prevent renal function loss in patients otherwise predicted to rapidly progress to ESRD because of nephrotic-range proteinuria refractory to standard antihypertensive dosages of an ACE inhibitor. This approach achieved remission or regression of proteinuria and stabilized kidney function in most cases, and almost fully prevented progression to ESRD. Provided patients are closely monitored and treatment is cautiously up-titrated according to tolerability, this approach might be safely applied in day-by-day hospital practice. Effective prevention of ESRD would reduce costs of renal replacement therapy by dialysis or transplantation and would be life-saving where these are not available for all patients in need
Rituximab in steroid-dependent or frequently relapsing idiopathic nephrotic syndrome
Get PDFThe outcome of steroid-dependent or frequently relapsing nephrotic syndrome of minimal change disease (MCD), mesangial proliferative GN (MesGN), or FSGS may be poor and with major treatment toxicity. This academic,multicenter, off-on trial (ClinicalTrials.gov #NCT00981838) primarily evaluated the effects of rituximab therapy followed by immunosuppression withdrawal on disease recurrence in 10 children and 20 adults with MCD/MesGN (n=22) or FSGS who had suffered ≥2 recurrences over the previous year and were in steroidinduced remission for ≥1 month. Participants received one dose (n=28) or two doses of rituximab (375 mg/m2 intravenously).At 1 year, allpatientswere in remission: 18were treatment-free and 15 never relapsed.Compared with the year before rituximab treatment, total relapses decreased from 88 to 22 and the per-patient median number of relapses decreased from 2.5 (interquartile range [IQR], 2-4) to 0.5 (IQR, 0-1; P<0.001) during 1 year of follow-up. Reduction was significant across subgroups (children, adults,MCD/MesGN, and FSGS; P<0.01). After rituximab, the per-patient steroid maintenance median dose decreased from 0.27 mg/kg (IQR, 0.19-0.60) to 0mg/kg (IQR, 0-0.23) (P,0.001), and the median cumulative dose to achieve relapse remission decreased from 19.5 mg/kg (IQR, 13.0-29.2) to 0.5 mg/kg (IQR, 0-9.4) (P<0.001). Furthermore, the mean estimated GFR increased from 111.3±25.7 to 121.8±29.2ml/min per 1.73m2 (P=0.01),with the largest increases in children and in FSGS subgroups. The mean height z score slope stabilized in children (P<0.01). Treatment was well tolerated. Rituximab effectively and safely prevented recurrences and reduced the need for immunosuppression in steroiddependent or frequently relapsing nephrotic syndrome, and halted disease-associated growth deficit in children
Effects of Octreotide–Long-Acting Release Added-on Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease: Pilot, Randomized, Placebo-Controlled, Cross-Over Trial
Get PDFBackground
Tolvaptan and octreotide–long-acting release (LAR) have renoprotective effects in autosomal dominant polycystic kidney disease (ADPKD) that are partially mediated by amelioration of compensatory glomerular hyperfiltration. We compared the effects of tolvaptan and octreotide-LAR combination therapy versus those of tolvaptan monotherapy in patients with ADPKD.
Methods
This pilot, randomized, placebo-controlled, cross-over trial primarily compared the effects of 1- and 4-week treatments with octreotide-LAR (two 20-mg i.m. injections) or placebo (two i.m. 0.9% saline solution injections) added-on tolvaptan (up to 90 and 30 mg/d) on GFR (iohexol plasma clearance) in 19 consenting patients with ADPKD referred to a clinical research center in Italy. Analyses were intention-to-treat. The local ethical committee approved the study.
Results
At 4 weeks, GFR significantly decreased by a median (interquartile range) of 3 (−1 to 5) ml/min per 1.73 m2 with tolvaptan and placebo (P=0.01) and by 7 (3–14) ml/min per 1.73 m2 with tolvaptan and octreotide-LAR (P=0.03). GFR changes during the two treatment periods differed by 2 (−5 to 14) ml/min per 1.73 m2 (P=0.28). At 1 week, GFR significantly decreased by 3 (0–7) ml/min per 1.73 m2 with tolvaptan and placebo (P=0.006) and by 10 (−6 to 16) ml/min per 1.73 m2 with tolvaptan and octreotide-LAR add-on therapy (P<0.001). GFR changes during the two treatment periods significantly differed by 3 (0–12) ml/min per 1.73 m2 (P=0.012). Total kidney volume nonsignificantly changed by 4 (−48 to 23) ml with tolvaptan and placebo (P=0.74), whereas it decreased significantly by 41 (25–77) ml with tolvaptan and octreotide-LAR (P=0.001). Changes during the two treatment periods differed by 36 (0–65) ml (P=0.01). Octreotide-LAR also attenuated (P=0.02) the aquaretic effect of tolvaptan. Treatments were well tolerated.
Conclusions
In patients with ADPKD, octreotide-LAR added-on tolvaptan reduced GFR more effectively than octreotide-LAR and placebo. Octreotide-LAR also reduced total and cystic kidney volumes and attenuated the acquaretic effect of tolvaptan
