Search results for "Interim"
showing 10 items of 95 documents
Performance of adaptive sample size adjustment with respect to stopping criteria and time of interim analysis
2006
The benefit of adjusting the sample size in clinical trials on the basis of treatment effects observed in interim analysis has been the subject of several recent papers. Different conclusions were drawn about the usefulness of this approach for gaining power or saving sample size, because of differences in trial design and setting. We examined the benefit of sample size adjustment in relation to trial design parameters such as 'time of interim analysis' and 'choice of stopping criteria'. We compared the adaptive weighted inverse normal method with classical group sequential methods for the most common and for optimal stopping criteria in early, half-time and late interim analyses. We found …
Adaptive Modifications of Hypotheses After an Interim Analysis
2001
It is investigated how one can modify hypotheses in a trial after an interim analysis such that the type I error rate is controlled. If only a global statement is desired, a solution was given by Bauer (1989). For a general multiple testing problem, Kieser, Bauer and Lehmacher (1999) and Bauer and Kieser (1999) gave solutions, by means of which the initial set of hypotheses can be reduced after the interim analysis. The same techniques can be applied to obtain more flexible strategies, as changing weights of hypotheses, changing an a priori order, or even including new hypotheses. It is emphasized that the application of these methods requires very careful planning of a trial as well as a c…
PENIS MORPHOLOGY IN ONCOPODIDAE (OPILIONES, LANIATORES): EVOLUTIONARY TRENDS AND RELATIONSHIPS
2002
Abstract An interim report on our ongoing revisional study is given together with a short summary of the current knowledge on the systematics and distribution of the family Oncopodidae (Opiliones, Laniatores). An exceptionally high diversity in male genitalia is shown and its possible evolution is discussed. Four major penis types are distinguished in the Oncopodidae and compared with similar forms in other laniatorean families.
The Artificial Kidney Initiation in Kidney Injury 2 (AKIKI2): study protocol for a randomized controlled trial
2019
Abstract Background The Artificial Kidney Initiation in Kidney Injury (AKIKI) trial showed that a delayed renal replacement therapy (RRT) strategy for severe acute kidney injury (AKI) in critically ill patients was safe and associated with major reduction in RRT initiation compared with an early strategy. The five criteria which mandated RRT initiation in the delayed arm were: severe hyperkalemia, severe acidosis, acute pulmonary edema due to fluid overload resulting in severe hypoxemia, serum urea concentration > 40 mmol/l and oliguria/anuria > 72 h. However, duration of anuria/oliguria and level of blood urea are still criteria open to debate. The objective of the study is to compar…
Results of the TOP Study: Prospectively Randomized Multicenter Trial of an Ex Vivo Tacrolimus Rinse Before Transplantation in EDC Livers
2016
Background. Organ shortage results in the transplantation of extended donor criteria (EDC) livers which is associated with increased ischemia-reperfusion injury (IRI). Experimental studies indicate that an organ rinse with the calcineurin inhibitor tacrolimus before implantation protects against IRI. The tacrolimus organ perfusion study was initiated to examine the effects of ex vivo tacrolimus perfusion on IRI in transplantation of EDC livers. Methods. A prospective randomized multicenter trial comparing ex vivo perfusion of marginal liver grafts (>= 2 EDC according to Eurotransplant manual) with tacrolimus (20 ng/mL) or histidine-tryptophane-ketoglutarate solution (control) was carried ou…
Toward a conceptual understanding of acute cultural adaptation: A preliminary examination of ACA in female swimming
2012
This paper considers a novel approach to researching adaptation in transnational athletes. The first part introduces a conceptualisation of acute cultural adaptation (ACA), which extends the current literature in sport psychology by offering original insights into mechanisms underpinning adaptive processes to a new cultural site during an interim relocation. Rereading a self-determination theory through the lens of cultural epistemology, the proposed theorisation suggests that ACA is realised in everyday practices drawing on a range of material and symbolic cultural resources to satisfy basic psychological needs. The second part of the paper engages the conceptualisation of ACA to make sens…
TCT-663 Comparison of Conformability and Wall Shear Stress Between Resolute Integrity Zotarolimus-Eluting Stent and the XIENCE Xpedition Everolimus-E…
2018
Given its continuous wire molding and sinusoidal design, we hypothesized that Resolute Integrity stent (R-ZES) is more conformable than the XIENCE Xpedition stent (X-EES) and therefore may induce more physiologic wall shear stress (WSS) in angulated coronary arteries. Interim analysis of
Network interimpresa ed opportunità imprenditoriali: il ruolo dei legami deboli e forti nella formazione e nello sfruttamento delle opportunità impre…
2018
L'obiettivo del lavoro è indagare il ruolo dei legami deboli tra imprese nel processo di identificazione del set di potenziali partner di valore tra i quali scegliere con chi attivare legami forti, formalizzati in alleanze, che consentano di sfruttare opportunità imprenditoriali scoperte o create. Numerosi studi manageriali si sono soffermati ad analizzare l'emersione e le dinamiche evolutive della struttura dei network di alleanze ed hanno, complessivamente, individuato le differenti finalità e le logiche di formazione che contraddistinguono due categorie di legami forti: i legami locali che si formano all'interno di cluster appartenenti al network; i bridging ties, che creano ponti tra pa…
Le misure cautelari nei giudizi interstatali sui diritti umani: la prassi recente della Corte internazionale di giustizia e della Corte europea dei d…
2021
In the last few years there has been a significant quantitative increase in requesting interim measures of protection in inter-State cases concerning human rights, namely in inter-State proceedings before the European Court of Human Rights (ECtHR) and in proceedings before the International Court of Justice (ICJ) grounded on the compromissory clauses included in human rights treaties. In these cases, the ultimate beneficiaries of the interim protection are individuals although, formally, proceedings focus on States’ rights and duties (concerning the protection of human rights). The present paper analyses the recent case-law of the said courts from a double perspective: on the one hand, with…
Respingimenti a catena e tutela cautelare del diritto d’asilo. Le ordinanze del Tribunale di Roma sulle ‘riammissioni informali’ in Slovenia
2021
On the 3rd of May, the Rome Tribunal accepted the complaint lodged by the Ministry of Interior against the interim measure with which, last January, the same Court declared the illegitimacy of the procedure of migrants and asylum seekers informal readmission in Slovenia, because of the violation inter alia of the principle of non-refoulement. Despite the negative outcome for the asylum seekers, the order of the complaint did not refute the reasoning of the judge of the first instance who, for the first time, recognized the entry protection by issuing an urgent precautionary measure. This contribution focuses on the recent tendency of States’ national Courts to provide protection, including …