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Purpose Patient registries are used to monitor safety, examine real-world effectiveness, and may potentially contribute to comparative effectiveness research. To our knowledge, life sciences industry (LSI)-sponsored registries have not been systematically categorized. This study represents a first step toward understanding such registries over time. Methods Studies described as registries were identified in the ClinicalTrials.gov database. Characteristics from these registry records were abstracted and analyzed. Results Of 1202 registries identified, approximately 47% reported LSI sponsorship. These 562 LSI registries varied in focus: medical devices ( n = 193, 34%), specific drugs ( n = 173, 31%), procedures ( n = 29, 5%), or particular diseases ( n = 139, 25%). Thirty-three registries (<6%) evaluated pregnancy outcomes. The most common therapeutic area was cardiovascular ( n = 234, 42%); others included endocrinology, immunology, oncology, musculoskeletal disorders, and neurology. The two most often measured outcomes were clinical effectiveness and safety, each of which appeared in 363/562 (65%) of LSI registries. Other outcomes included real-world clinical practice patterns ( n = 122, 22%), patient-reported outcomes ( n = 106, 19%), disease epidemiology/natural history ( n = 69, 12%), and economic outcomes ( n = 30, 5%). The number of LSI registries and their geographic diversity has increased over time. Conclusions The LSI registries represent a substantial proportion of all patient registries documented in ClinicalTrials.gov. These prospective studies are growing in number and encompass diverse therapeutic areas and geographic regions. Most registries measure multiple outcomes and capture real-world data that may be unavailable through other study designs. This classification of LSI registries documents their use for studying heterogeneity of diseases, examining treatment patterns, measuring patient-reported outcomes, examining economic outcomes, and performing comparative effectiveness research. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Insertion site injuries of the flexor digitorum profundus (FDP) tendon often present for delayed treatment. Apart from gross observations made at the time of surgery, the changes that occur in the flexor tendon stump during the interval from injury to repair are unknown. These changes may include tendon softening and loss of viability, which may contribute to the poor outcomes observed clinically and experimentally. Thirty-eight FDP tendons from 23 adult dogs were transected sharply from their insertions on the distal phalanges and were not repaired. Dogs were allowed full weight bearing and were euthanized 7 or 21 days after injury. Biomechanical testing indicated that the resistance of injured tendons to pullout of a Kessler-type suture was not different from control tendons at 7 days and was increased at 21 days by 25% (p<0.05). Morphologically, at 7 and 21 days the cut surface had a smooth appearance and the end of the injured tendon was increased in thickness by 30% and 50%, respectively (p<0.05). Histologically, we observed increased cellularity and dramatic fibroblast proliferation within the injured tendon stump; there was no evidence of decreased cell viability. We conclude that during the interval from 0 to 21 days after FDP insertion-site injury, tendons cells are viable, proliferative and synthesizing new matrix. This leads to increased tendon size and enhanced resistance to suture pullout. These findings offer a scientific rationale supporting the clinical practice of surgical re-attachment within the first 3 weeks after injury. [Copyright &y& Elsevier]

Treatment of injuries of the flexor digitorum profundus (FDP) tendon insertion site has changed little during the past 50 years, in part because there are no reports describing flexor tendon insertion site healing. Our objective was to assess the effects of repair technique and post-operative time on tendon–bone healing using a canine model of injury and repair. We transected 48 FDP tendons from 24 dogs at their insertions and repaired them using either a four- or eight-strand suture technique. We assessed the mechanical properties of the repaired tendon–bone construct, tendon collagen biochemistry, and distal phalanx bone mineral density (BMD) at 0, 10, 21 and 42 days. Suture method had no significant effect on any outcome (p>0.05). In particular, use of an eight-strand double modified Kessler technique did not result in increased stiffness or strength compared to a four-strand technique. With time, the repair site became stiffer, as demonstrated by a 230% increase in rigidity and a 50% decrease in strain from 0 to 42 days. However, from 0 to 42 days the ultimate force of the insertion site did not increase. This lack of increase in ultimate force was consistent with decreases in collagen content, non-reducible crosslinks and distal phalanx BMD. Taken together, our results indicate that the canine FDP tendon heals slowly after it is injured at its insertion site and sutured onto the distal phalanx. While these findings may be limited to the particular repair method we used, they demonstrate a need for devising new treatment strategies to improve healing of flexor tendon insertion site injuries. [Copyright &y& Elsevier]

In a recent study by Hsu and Hilpert (2011), the Green-Ampt (GA) model for water infiltration was modified to account for a dynamic capillary pressure that depends on the wetting front velocity. In that study, the only transient flow, to which the modified GA approach was compared, was capillary rise. In this paper, transient downward infiltration experiments were performed using three different ponding depths. We demonstrated that infiltration can be effectively modeled using the modified GA approach. The parameters of the dynamic capillary pressure relationship were fitted and independent of the ponding depth. Furthermore, the experimental data could not be described accurately at early times with the classical GA approach. This was particularly evident when plotting the product between the Darcy velocity and the wetting front position against the wetting front position. In these plots, the initial unphysical infinite rate of infiltration, that occurs in the classical GA model, appears to be a primary element of inaccuracy. It was furthermore verified that the limited ability of the classical GA approach to describe the experimental data is not related to inertial forces arising during the initial phase of infiltration. [ABSTRACT FROM AUTHOR]