Current Issue : January-March Volume : 2022 Issue Number : 1 Articles : 5 Articles
Participation of pregnant women in clinical trials entails challenges mainly related to concerns about the risks for fetuses. We undertook a qualitative study from June to October 2020 to assess the acceptability of participating in COVID-19 clinical trials among pregnant women in Spain. Phenomenology and grounded theory were used as methodological approaches. Semi-structured interviews were conducted with 24 pregnant women and six healthcare providers. Women were unsure if pregnancy was a risk factor to acquire the infection or to develop severe disease and expressed the limited information they had received, which led to uncertainties and emotional suffering. They had concerns regarding participation in clinical trials on COVID-19, regardless of the drug under study. Healthcare providers alluded to the importance of involving pregnant women’s relatives at the recruitment visit of the clinical trial. These findings may be useful to facilitate pregnant women’s participation in clinical trials....
In a previous randomized trial, the non-inferiority of two hyaluronic acid injections (Synolis VA versus Synvisc-One) was assessed in patients with knee OA, with a response rate of 79% for Synolis VA. To assess whether a responder profile could be established for this treatment modality, we used the Synolis VA arm of a published 6-month prospective, multicenter, comparative, randomized, double-blinded trial. At baseline and during the study, pain and function were assessed using theWestern Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire. Ninetysix subjects from the intention-to-treat trial were included in the analysis. The 6-month change of WOMAC Pain with Synolis VA was not associated with any baseline clinical data. However, the change in WOMAC Function was significantly associated with its baseline level, even after adjustment for potential confounding variables (p = 0.028), i.e., a poorer physical function at baseline was associated with a better response. In conclusion, in addition to the high absolute response rate to Synolis VA, the probability of success is even increased if administered in patients with more limited physical function at baseline. Further research with other potential confounding clinical variables is warranted in order to better applicate the concept of personalized medicine....
Objectives. Dexamethasone has been shown to have analgesic properties in the general surgical population. However, the analgesic effects for women that undergo cesarean deliveries under spinal anesthesia remain unclear and may be related to the timing of dexamethasone administration. We hypothesized that intravenous dexamethasone administered before skin incision would significantly reduce postoperative opioid consumption at 24 h after cesarean delivery under spinal anesthesia with intrathecal morphine. Methods. Women undergoing elective cesarean deliveries under spinal anesthesia were randomly assigned to receive 8 mg of intravenous dexamethasone or placebo prior to skin incision. Both groups received a standardized spinal anesthetic and multimodal postoperative analgesic regime. The primary outcome was cumulative opioid consumption at 24 h. Secondary outcomes included cumulative opioid consumption at 48 h, time to first analgesic request, and pain scores at rest and on movement at 2, 24, and 48 h. Results. 47 patients were analyzed—23 subjects that received dexamethasone and 24 subjects that received placebo. There was no difference in the median (Q1, Q3) cumulative opioid consumption in the first 24 hours following cesarean delivery between the dexamethasone group {15 (7.5, 20.0) mg} and the placebo group {13.75 (2.5, 31.25) mg} (P 0.740). There were no differences between the groups in cumulative opioid consumption at 48 h, time to first analgesic request, and pain scores. Conclusions. Intravenous dexamethasone 8 mg administered prior to skin incision did not reduce the opioid consumption of women that underwent cesarean deliveries under spinal anesthesia with intrathecal morphine and multimodal postoperative analgesic regimen....
In COVID-19-induced acute respiratory distress syndrome, the lungs are incapable of filling with sufficient air, leading to hypoxemia that results in high mortality among hospitalized patients. In clinical trials, low-molecular-weight heparin was administered via a specially designed soft-mist inhaler device in an investigator initiated, single-center, open-label, phase-IIb clinical trial. Patients with evidently worse clinical presentations were classed as the “Device Group”; 40 patients were given low-molecular-weight heparin via a soft mist inhaler at a dose of 4000 IU per administration, twice a day. The Control Group, also made up of 40 patients, received the standard therapy. The predetermined severity of hypoxemia and the peripheral oxygen saturation of patients were measured on the 1st and 10th days of treatment. The improvement was particularly striking in cases of severe hypoxemia. In the 10-day treatment, low-molecular-weight heparin was shown to significantly improve breathing capability when delivered via a soft-mist inhaler....
No therapies have been proven to increase survival after a hepatic encephalopathy (HE) episode. We hypothesize that two doses of albumin could improve 90-day survival rates after a HE episode. Methods: (1) A randomized double-blind, placebo-controlled trial (BETA) was conducted in 12 hospitals. The effect of albumin (1.5 g/kg at baseline and 1 g/kg on day 3) on 90-day survival rates after a HE episode grade II or higher was evaluated. (2) A meta-analysis of individual patient’s data for survival including two clinical trials (BETA and ALFAE) was performed. Results: In total, 82 patients were included. Albumin failed to increase the 90-day transplant-free survival (91.9% vs. 80.5%, p = 0.3). A competing risk analysis was performed, observing a 90-day cumulative incidence of death of 9% in the albumin group vs. 20% in the placebo (p = 0.1). The meta-analysis showed a benefit in the albumin group, with a lower rate of clinical events (death or liver transplant) than patients in the placebo (HR, 0.44; 95% CI, 0.21–0.82), when analyzed by a competing risk analysis (90-days mortality rate of 11% in the albumin group vs. 30% in the placebo, p = 0.02). Conclusions: Repeated doses of albumin might be beneficial for patient’s survival as an add-on therapy after an HE episode, but an adequately powered trial is needed....
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