The Oncology QCARD Initiative: Fostering efficient evaluation of initial real-world data proposals.

Purpose: The oncology quality, characterization, and assessment of real-world data (Oncology QCARD) Initiative was formed to develop a set of minimum study design and data elements needed to evaluate the fitness of the real-world data (RWD) source(s) proposed in an initial study concept as part of early interaction with scientific reviewers.

Methods: A multidisciplinary executive committee (EC) was established to guide the Oncology QCARD Initiative. The EC conducted a landscape review of published literature, guidances, and guidelines to evaluate relevant dimensions of data quality measurement.

COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients.

Background: The COVID-19 pandemic remains a significant global threat. However, despite urgent need, there remains uncertainty surrounding best practices for pharmaceutical interventions to treat COVID-19. In particular, conflicting evidence has emerged surrounding the use of hydroxychloroquine and azithromycin, alone or in combination, for COVID-19.

Helminth-induced regulation of T-cell transfer colitis requires intact and regulated T cell Stat6 signaling in mice.

Infection with parasitic worms (helminths) alters host immune responses and can inhibit pathogenic inflammation. Helminth infection promotes a strong Th2 and T regulatory response while suppressing Th1 and Th17 function. Th2 responses are largely dependent on transcriptional programs directed by Stat6-signaling.

Recirculating Immunocompetent Cells in Colitic Mice Intensify Their Lung Response to Bacterial Endotoxin.

Background: Patients with inflammatory bowel disease have higher incidence of airway hyperresponsiveness compared to the general population. Lung inflammation leading to airway hyperresponsiveness causes illnesses for more than ten percent of the population in USA.

Aims: We investigated the lung response to bacterial endotoxin in colitic mice.

A sensitive monitoring system for mammalian cell cultivation processes: a PAT approach.

Biopharmaceuticals such as antibodies are produced in cultivated mammalian cells, which must be monitored to comply with good manufacturing practice. We, therefore, developed a fully automated system comprising a specific exhaust gas analyzer, inline analytics and a corresponding algorithm to precisely determine the oxygen uptake rate, carbon dioxide evolution rate, carbon dioxide transfer rate, transfer quotient and respiratory quotient without interrupting the ongoing cultivation, in order to assess its reproducibility. The system was verified using chemical simulation experiments and was able to measure the respiratory activity of hybridoma cells and DG44 cells (derived from Chinese hamster ovary cells) with satisfactory results at a minimum viable cell density of ~2.

Multiparameter analysis of serum levels of C-telopeptide crosslaps, bone-specific alkaline phosphatase, cathepsin K, osteoprotegerin and receptor activator of nuclear factor κB ligand in the diagnosis of osteoporosis.

Objectives: C-telopeptide crosslaps (CTX) and bone-specific alkaline phosphatase (BAP) do not provide sufficient sensitivity and specificity for diagnosis of osteoporosis. Cathepsin K (CatK), osteoprotegerin (OPG), and receptor activator of nuclear factor κB ligand (total (t) and soluble (s) RANKL) play an important role in bone metabolism. Thus serum levels of biochemical markers, each or in combination, may be useful in diagnosis of osteoporosis.

[Preventive bone mineral density measurement in postmenopausal women. Differentiation of treatment of recommendations Guidelines of the Umbrella Organization for Osteology ("Dachverband Osteologie")].

Background: Osteopenia (OP) or osteoporosis (OST) was diagnosed by bone densitometry (DXA) in postmenopausal women free of known skeletal disorders and without acute fracture. DVO guidelines were applied to define therapeutic indication.

Methods: The study included 94 women aged 59-81 years.

Serum cathepsin K levels are not suitable to differentiate women with chronic bone disorders such as osteopenia and osteoporosis from healthy pre- and postmenopausal women.

Objectives: Cathepsin K (CatK) is expressed in high levels in osteoplasts and therefore plays an important role in bone resorption. Thus CatK serum levels may be useful in the diagnosis of chronic bone disorders such as osteopenia and osteoporosis. Therefore we aimed at studying CatK levels in women putatively free of known skeletal disorders.

[Results after Judet radial head prosthesis for non-reconstructable radial head fractures].

Background: With regard to the treatment of non-reconstructable radial head fractures, both the resection and the implantation of a prosthesis are considered. Various studies have shown poor results concerning the resection of the radial head with accompanying osteoligamentous injuries. Due to these experiences, different types of prosthesis have been developed.

[Unrepaired fracture of the styloid process of the ulna: not a bad treatment result at distal radius fracture].

Background: There are well-defined criteria for the treatment of distal radius fractures but the impact of an unrepaired fracture of the styloid process of the ulnar on recovery after operative treatment is uncertain. This study evaluated radiological and functional results after different operative treatment procedures of distal radius fractures in patients with an untreated fracture of the styloid process of the ulna and those without such a fracture.

Methods: Out of 480 patients with operatively treated distal radius fractures 238 were examined at least 1 year after injury.

[The scaphocapitate fracture syndrome (Fenton)].

The scaphocapitate fracture syndrome as a greater arc injury is a special form of the perilunate fracture dislocation. It is a combination of fractures of the scaphoid and capitate bones. This severe injury of the carpus is rare and therefore difficult to diagnose.

Retrograde cement removal in periprosthetic fractures following hip arthroplasty.

Introduction: Revision of cemented hip arthroplasty after periprosthetic fractures of the femur is a demanding procedure. Many different technical devices have been developed for this purpose. This paper presents a new surgical technique of cement removal avoiding excessive exposure of the fracture site.

[Value of a combined ossification prophylaxis with indomethacin and radiotherapy for acetabular fractures].

Background: Heterotopic ossification is a complication in patients with surgically treated acetabular fractures. The incidence is related to the surgical approach (extended iliofemoral, posterior or a combined approach). The objective of this study was to evaluate the incidence of heterotopic ossification in patients with acetabular fractures who received a combined prophylaxis with both a single dose of radiation and indomethacin compared to those who received only a prophylaxis with radiation or indomethacin.

Outcome after surgery of distal radius fractures: no differences between external fixation and ORIF.

The purpose of this study was to determine the most appropriate surgical treatment from three procedures used for fractures of the distal radius. In a retrospective comparative study, 166 out of 237 patients who underwent surgery for AO/ASIF A3 or C2 distal radius fractures were evaluated. Surgical procedures were external fixation or open reduction and internal fixation with either palmar or dorsal plates.

Outcome of surgically treated intraarticular calcaneus fractures--SF-36 compared with AOFAS and MFS.

Background: There is no consensus as to which is the best treatment for intraarticular fractures of the calcaneus. Furthermore, few studies have assessed general health after calcaneus fractures. We therefore measured the state of general health after operation of calcaneal fractures and compared these data with usual foot-scores.

Expression of cell surface antigens in diabetic patients and healthy controls after injury.

Aims: Due to the systemic character of Type 2 diabetes, cellular disturbances paralleled by an altered expression of various growth factors constitute the basis for impaired wound healing. Cell-surface antigens are altered in chronic wounds and may also have an effect on the persistance of diabetic foot lesions.

Methods: We investigated blood samples of diabetic patients with diabetic foot ulcers (n=21) in comparison with those from healthy control patients subsequent to an injury (n=9).

Extemporaneous compounding: a return to regulatory limbo?

Extemporaneous compounding of medications has been an integral component of the practice of pharmacy and medicine since the practices began. A staple of early medical and pharmacy practice, even today many patients benefit from compounding at some point in their care. Unfortunately, the regulation of the practice has not been so consistent.

[Quality of life after calcaneal fractures. A matched-pairs trial with a standardised German control group].

The purpose of the study was the assessment of the limitations of health related quality of life after open reduction and internal fixation (ORIF) of calcaneal fractures and the comparison of these results with those of normal foot-scores. The quality of life of 55 patients with calcaneal fractures treated by ORIF was compared 2.9 years after injury with that of 55 people from the standardised German population of the German-Health-Survey 1998 using the Short Form 36 (SF-36) (Wilcoxon test).

[Intramedullary stabilisation of metastatic fractures of long bones].

Unlabelled: Surgical treatment of metastatic fractures of long bones is mostly a palliative one. Intramedullary stabilisation without resection of metastases follows the aim of the palliative therapy concept.

Patients And Methods: From 01.