Overcoming recruitment hurdles in clinical trials: An investigation of remote consenting modalities and their impact on workload, workflow, and usability.

Travel constraints can hinder the recruitment of eligible research participants in clinical trials, causing research timeline extensions, added costs, underpowered results, and early termination. Remote consenting can help solve these issues by allowing researchers and potential participants to connect remotely. This controlled experimental study investigates the effect of remote consenting on workload, workflow, usability, and barriers and facilitators to its implementation. Using a mixed experimental design, simulated consenting sessions were conducted with three different modalities (remote paper consent, eConsent, and teleconsent) with 23 researchers and 93 research participants. Each session involved a single researcher who experienced all three modalities, while three different research participants were assigned to each modality individually. Research participants and researchers completed surveys measuring workload and usability. Remote consenting allows researchers and participants to connect at their preferred location and time, and teleconsenting was found to be the preferred modality by the researchers, primarily due to its ability to exchange visual cues. However, challenges such as training requirements and technology dependence need to be addressed for widespread implementation. Future research should aim to eliminate these barriers and improve remote consenting modalities to facilitate clinical research participation.

Validated Postbiotic Screening Confirms Presence of Physiologically-Active Metabolites, Such as Short-Chain Fatty Acids, Amino Acids and Vitamins in Hylak® Forte.

Hylak® forte is a postbiotic that inhibits the growth of pathogenic bacteria by reducing intestinal pH. It is assumed the potential presence of short-chain fatty acids (SCFAs) in Hylak® forte may contribute to this effect. In this current study, we analysed the composition of Hylak® forte, using a validated gas chromatography assay test method, to ascertain whether SCFAs are present in this postbiotic treatment. Hylak® forte was screened for C1 to C10 SCFAs by a gas chromatographic assay. In this assay, SCFAs were analysed as for their volatile ethyl ester derivatives in a 3.0 mL Hylak® forte sample. An additional screening procedure was conducted for the presence of vitamins and simple sugars. The gas chromatographic method for determining SCFAs was validated according to the requirements of ICH guideline Q2 (R1). Formic and acetic acids were identified in Hylak® forte at 27.92 ppm (90% confidence interval (CI), 26.90-28.94) and 306.17 ppm (90% CI, 277.11-335.22), respectively. Additional compounds were quantified in the solution, including vitamin B1 (0.029 mg/100 g), monosaccharides and disaccharides (2.767 g/100 g), as well as glutamic acid and glutamine (0.047 g/100 g). This study has identified formic acid in a range of 39.33 (90% CI, 36.50-42.17)-48.33 (90% CI, 45.91-50.76) ppm and acetic acid dropping down to 312.33 (90% CI, 295.32-329.35) from initial 415.67 ppm (90% CI, 385.93-445.41) in commercial Hylak® forte samples under forced degradation conditions. In addition, a range of other compounds in Hylak® forte was identified, including riboflavin and glutamine. Further studies are necessary to establish whether these compounds translate into tangible therapeutic effects.

Excision Arthroplasty for First CMC Joint Tuberculous Osteomyelitis.

INTRODUCTION: Tuberculous involvement of metacarpals and phalanges is a rare presentation of extrapulmonary tuberculosis in adult. Tuberculous infection of the metacarpals, metatarsal and phalanges of hands and feet is known as tubercular dactylitis. CASE REPORT: A 65 years old female with history of pain and swelling at 1st metacarpal of left hand, since 3 months which gradual in onset and progressive in nature associated with multiple cervical swellings. While radiographs showed a pathological fracture of the 1st carpo-metacarpal joint (CMCJ) with soft tissue swelling, MRI revealed a large heterogenous lesion at the carpo-metacarpal joint of the thumb with bony erosions of the trapezium and 1st metacarpal base on T2W-STIR images. The lesion was extending upto the palmar aspect of the hand and displacing flexor pollicis longus tendon medially. During surgery, there was caseous material seen which was debrided and the fractured fragment was excised and sent for biopsy. The CMCJ was found to be unstable and a kirschner wire was used to stabilize the 1st CMCJ and immobilized in a POP splint. The biopsy of the fragment revealed tuberculous osteomyeltis. On follow-up the K-wire had backed out partially at the end of 5 weeks which was then removed and range of motion was started. At end of 1 year follow up the patient had little restriction of movement as compared to the opposite hand with no pain and hindrance in daily activity. CONCLUSION: The swelling subsided once Anti-Tubercular Treatment was started. The cervical lymphadenopathy also resolved over a period of 1 month.

Water as an oxygen source in the generation of mononuclear nonheme iron(IV) oxo complexes.

Give me an "O"! Mononuclear nonheme iron(IV) oxo complexes have been generated using water as an oxygen source and cerium(IV) as an oxidant. The high-yield oxygenation of organic substrates in this system (see picture, Fe green, O red, N blue, C gray) is catalyzed by iron(II) complexes. The source of oxygen in the iron(IV) oxo complexes and the oxygenated products has been assigned unambiguously by isotopic labeling experiments.