| 1. |
- Cesano, A, et al.
(författare)
-
Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume II-practical challenges
- 2020
-
Ingår i: Journal for immunotherapy of cancer. - : BMJ. - 2051-1426. ; 8:2
-
Tidskriftsartikel (refereegranskat)abstract
- The development of strongly predictive validated biomarkers is essential for the field of immuno-oncology (IO) to advance. The highly complex, multifactorial data sets required to develop these biomarkers necessitate effective, responsible data-sharing efforts in order to maximize the scientific knowledge and utility gained from their collection. While the sharing of clinical- and safety-related trial data has already been streamlined to a large extent, the sharing of biomarker-aimed clinical trial derived data and data sets has been met with a number of hurdles that have impaired the progression of biomarkers from hypothesis to clinical use. These hurdles include technical challenges associated with the infrastructure, technology, workforce, and sustainability required for clinical biomarker data sharing. To provide guidance and assist in the navigation of these challenges, the Society for Immunotherapy of Cancer (SITC) Biomarkers Committee convened to outline the challenges that researchers currently face, both at the conceptual level (Volume I) and at the technical level (Volume II). The committee also suggests possible solutions to these problems in the form of professional standards and harmonized requirements for data sharing, assisting in continued progress toward effective, clinically relevant biomarkers in the IO setting.
|
|
| 2. |
- Rutella, S, et al.
(författare)
-
Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I-conceptual challenges
- 2020
-
Ingår i: Journal for immunotherapy of cancer. - : BMJ. - 2051-1426. ; 8:2
-
Tidskriftsartikel (refereegranskat)abstract
- The sharing of clinical trial data and biomarker data sets among the scientific community, whether the data originates from pharmaceutical companies or academic institutions, is of critical importance to enable the development of new and improved cancer immunotherapy modalities. Through data sharing, a better understanding of current therapies in terms of their efficacy, safety and biomarker data profiles can be achieved. However, the sharing of these data sets involves a number of stakeholder groups including patients, researchers, private industry, scientific journals and professional societies. Each of these stakeholder groups has differing interests in the use and sharing of clinical trial and biomarker data, and the conflicts caused by these differing interests represent significant obstacles to effective, widespread sharing of data. Thus, the Society for Immunotherapy of Cancer (SITC) Biomarkers Committee convened to identify the current barriers to biomarker data sharing in immuno-oncology (IO) and to help in establishing professional standards for the responsible sharing of clinical trial data. The conclusions of the committee are described in two position papers: Volume I—conceptual challenges and Volume II—practical challenges, the first of which is presented in this manuscript. Additionally, the committee suggests actions by key stakeholders in the field (including organizations and professional societies) as the best path forward, encouraging the cultural shift needed to ensure responsible data sharing in the IO research setting.
|
|
| 3. |
- Skalkidou, Alkistis, et al.
(författare)
-
Risk of upper limb injury in left handed children : a study in Greece
- 1999
-
Ingår i: Injury Prevention. - 1353-8047 .- 1475-5785. ; 5:1, s. 68-71
-
Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES:To investigate whether left handed children are at increased risk for injuries, particularly upper limb injuries.SETTING:Athens, Greece, during a six month period in 1995-96.METHODS:Cases were 129 children 4-14 years old with unintentional upper limb injuries from a population based injury database. Two control children matched for gender and age were selected from among those seen at the same medical institution for minor, non-injury ailments. On the basis of information provided by the children and their guardians, sociodemographic variables were recorded, hand preference was assessed, and each child's activity score was calculated through an abbreviated version of Achenbach's scale.RESULTS:Left handed children have a moderately increased upper limb injury risk with a tendency of recurrence of this injury. The risk of upper limb injury is also raised among children of young fathers, whereas it appears to be inversely related to crowding index and activity score--three variables that were controlled for as potential confounders.CONCLUSIONS:This study provides limited support for the hypothesis that left handed children are at increased risk for injury. The excess risk, if genuine, is likely to be limited to cultural settings in which right handedness is perceived as the norm.
|
|
| 4. |
- Al-Mashhadi, Ammar Nadhom Farman, et al.
(författare)
-
Changes in arterial pressure and markers of nitric oxide homeostasis and oxidative stress following surgical correction of hydronephrosis in children
- 2018
-
Ingår i: Pediatric nephrology (Berlin, West). - : Springer. - 0931-041X .- 1432-198X. ; 33:4, s. 639-649
-
Tidskriftsartikel (refereegranskat)abstract
- Objective Recent clinical studies have suggested an increased risk of elevated arterial pressure in patients with hydronephrosis. Animals with experimentally induced hydronephrosis develop hypertension, which is correlated to the degree of obstruction and increased oxidative stress. In this prospective study we investigated changes in arterial pressure, oxidative stress, and nitric oxide (NO) homeostasis following correction of hydronephrosis.Methods Ambulatory arterial pressure (24 h) was monitored in pediatric patients with hydronephrosis (n = 15) before and after surgical correction, and the measurements were compared with arterial pressure measurements in two control groups, i.e. healthy controls (n = 8) and operated controls (n = 8). Markers of oxidative stress and NO homeostasis were analyzed in matched urine and plasma samples.Results The preoperative mean arterial pressure was significantly higher in hydronephrotic patients [83 mmHg; 95% confidence interval (CI) 80–88 mmHg] than in healthy controls (74 mmHg; 95% CI 68–80 mmHg; p < 0.05), and surgical correction of ureteral obstruction reduced arterial pressure (76 mmHg; 95% CI 74–79 mmHg; p < 0.05). Markers of oxidative stress (i.e., 11- dehydroTXB2, PGF2α, 8-iso-PGF2α, 8,12-iso-iPF2α-VI) were significantly increased (p < 0.05) in patients with hydronephrosis compared with both control groups, and these were reduced following surgery (p < 0.05). Interestingly, there was a trend for increased NO synthase activity and signaling in hydronephrosis, which may indicate compensatory mechanism(s).Conclusion This study demonstrates increased arterial pressure and oxidative stress in children with hydronephrosis compared with healthy controls, which can be restored to normal levels by surgical correction of the obstruction. Once reference data on ambulatory blood pressure in this young age group become available, we hope cut-off values can be defined for deciding whether or not to correct hydronephrosis surgically.Keywords Blood pressure . Hydronephrosis . Hypertension . Nitric oxide . Oxidative stress . Ureteral obstruction
|
|
