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Investigator-driven randomized trials
Published in Yoshinobu Onuma, Patrick W.J.C. Serruys, Bioresorbable Scaffolds, 2017
Daniele Giacoppo, Roisin Colleran, Adnan Kastrati
The BVS in STEMI (Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct; NCT02067091) trial is a multi-center, open-label, randomized clinical trial sponsored by the Haukeland University Hospital. The trial was initiated in August 2014 and is currently ongoing with primary outcome assessment expected in August 2016. In brief, a total of 120 patients with acute STEMI requiring primary PCI will be randomized after thrombus aspiration with restoration of TIMI 2-3 flow to treatment with either the everolimus-eluting bioresorbable scaffold (ABSORB, Abbott Vascular, Abbott Park, IL) or everolimus-eluting metallic stent (XIENCE, Abbott Vascular, Abbott Park, IL). Exclusion criteria include severe impairment of blood flow or persistent occlusion following thrombectomy (TIMI flow 0) or anatomic limitations preventing advancement of the thrombectomy catheter. Angiographic exclusion criteria are heavy calcification, tortuosity, and bifurcation lesion with side branch >2.5 mm. Key clinical exclusion criteria include cardiac arrest or refractory cardiogenic shock; eGFR <45 mL/min; and contraindication to long-term dual antiplatelet therapy.
Asbestos exposure and mesothelioma
Published in Dorsett D. Smith, The Health Effects of Asbestos, 2015
Patients with advanced disease who are not surgical candidates can be treated with a talc pleurodesis. A British group undertook an open-label, parallel-group, randomized controlled trial with any subtype of confirmed or suspected mesothelioma with pleural effusion recruited from 12 hospitals in the United Kingdon. Eligible patients were randomly assigned (1:1) to either video-assisted thoracoscopic partial pleurectomy (VAT-PP) or talc pleurodesis. Overall survival at 1 year was 52% (95% CI: 41–62) in the VAT-PP group and 57% (95% CI: 46–66) in the talc pleurodesis group. The authors concluded that VAT-PP is not recommended for improving overall survival in patients with pleural effusion due to malignant pleural mesothelioma, and talc pleurodesis might be preferable considering the fewer complications and shorter hospital stay associated with this treatment. (Rintoul RC, Ritchie AJ, Edwards JG et al. Efficacy and cost of videoassisted thoracoscopic partial pleurectomy versus talc pleurodesis in patients with malignant pleural mesothelioma (MesoVATS): An open-label, randomised, controlled trial. Lancet 2014;384:1118–27.)
Prophylaxis and Chemotherapy
Published in Ronald Fayer, Lihua Xiao, Cryptosporidium and Cryptosporidiosis, 2007
Heather D. Stockdale, Jennifer A. Spencer, Byron L. Blagburn
There have been two placebo–controlled trials of spiramycin for cryptosporidiosis in immunocompetent children, and one in adults with AIDS. In 39 immunocompetent infants and children in Durban, South Africa, randomized to 5 days of treatment with either spiramycin (75 mg/kg) or placebo (Wittenberg et al., 1989), no difference was found between active drug and placebo, possibly because the dose was too low or the duration of therapy was too short. In a study of 44 immunocompetent infants in Costa Rica randomized to spiramycin (100 mg/kg/day) or matching placebo (which contained lactose) for 10 days, a statistically significant decrease in diarrhea and oocyst excretion was found in the spiramycin-treated group (Saez-Llorens et al., 1989). In a randomized, double-blind, placebo-controlled trial, 3.0 MIU (approximately 3 g) spiramycin thrice daily for 3 weeks was no better than the placebo in the treatment of cryptosporidial diarrhea in 73 patients with AIDS (Blagburn and Soave, 1997). A food interaction study in normal hosts indicated that spiramycin absorption was significantly decreased in the presence of food, perhaps explaining the poor results obtained in the controlled trial with AIDS patients. Interestingly, less rigorously obtained data from the open-label compassionate use program that ran concomitantly with the placebo-controlled study revealed that 28 of 37 AIDS patients had a favorable clinical response and 12 had parasitologic eradication, thus underscoring the importance of placebo-controlled clinical treatment trials (Moskovitz et al., 1988).
Coldzyme® Mouth Spray reduces duration of upper respiratory tract infection symptoms in endurance athletes under free living conditions
Published in European Journal of Sport Science, 2021
Glen Davison, Eleanor Perkins, Arwel W. Jones, Gabriella M. Swart, Alex R. Jenkins, Hayley Robinson, Kimberly Dargan
It is possible that some findings of this study may be influenced by the open label nature of the trial. For the primary outcomes (URTI reporting) previous research (Barrett et al., 2011) has shown that the magnitude of the placebo effect has a small influence on URTI reporting (see further discussion in limitations below). For the other (secondary) parameters, such as missed or reduced training, we are not aware of any research on how the placebo effect may influence these. Ultimately, the decision to deviate from planned training is a choice made by the athlete so it is possible that the placebo effect influences this to a greater extent. However, a possible explanation for our findings for missed training days could also be that both poor IFU compliance and good IFU compliance groups reported significantly lower average daily severity ratings than the control group. Indeed, it would seem logical that symptom severity would be the most important factor influencing athletes’ decisions about whether to train as normal, reduce training or miss training altogether. We also cannot exclude the possibility that those in the treatment group felt more willing to continue with training as they knew they were receiving an intervention that may help.