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Knowledge Area 2: Teaching and Research
Published in Rekha Wuntakal, Ziena Abdullah, Tony Hollingworth, Get Through MRCOG Part 1, 2020
Rekha Wuntakal, Ziena Abdullah, Tony Hollingworth
Randomized controlled studies are a type of parallel study.Further readingRCOG online learning resource: StratOG: Assessing Evidence.CEBM. Centre for Evidence Based Medicine.
Regulatory Standards for Approval of Topical Dermatological Drug Products
Published in Tapash K. Ghosh, Dermal Drug Delivery, 2020
April C. Braddy, Dale P. Conner
BE studies with clinical endpoints are commonly required for the approval of generic topical drug products. A BE study with clinical endpoints is often designed as a randomized, blinded, parallel study using a placebo arm. The placebo arm is to confirm that there is a therapeutic response and detectable differences between the generic and RLD products. The U.S. FDA will recommend the endpoint to be used in the clinical endpoint BE study. If the RLD product is labeled for multiple indications, then the indication that is most sensitive to differences in local delivery of the drug is usually preferred. This may be due to some of the clinical endpoints not being sensitive or more sensitive to formulation differences.
Clinical Drug Trials In Alzheimer’s Disease
Published in Zaven S. Khachaturian, Teresa S. Radebaugh, Alzheimer’s Disease, 2019
The most widely utilized and robust clinical trial design is that of a parallel study. In this type of trial, subjects are randomized to receive either drug or placebo, then followed over time. If the randomization is carried out appropriately, there should be no bias in the allocation of subjects to treatment group. Subject characteristics should be equally represented in the two groups and any differences that emerge should be due to the application of the treatment rather than to other random factors. Parallel design studies suffer from none of the disadvantages of carryover that might occur in crossover or enrichment designs. In addition, side effects of the drug can be accurately gauged by comparing them to the frequency of the same adverse events in the matched placebo group. The only disadvantage of a parallel trial design is that it generally requires a somewhat larger sample size. If properly performed, however, results from this design are the easiest to interpret.
The Effect of Nitrate-Rich Beetroot Juice on Markers of Exercise-Induced Muscle Damage: A Systematic Review and Meta-Analysis of Human Intervention Trials
Published in Journal of Dietary Supplements, 2022
Louise Jones, Stephen J. Bailey, Samantha N. Rowland, Nehal Alsharif, Oliver M. Shannon, Tom Clifford
Inclusion criteria were based on our PICOS framework (see Supplementary materialTable S1) and included: (1) adult participants (≥18 years); (2) inorganic nitrate/nitrite or nitrate-rich vegetable supplementation with a supervised EIMD protocol; (3) a comparator group that received a control supplement (placebo) or no supplement but completed the same EIMD protocol; (4) reporting of changes in at least one of the following markers of EIMD pre and up to 168 h post-exercise: muscle function, muscle soreness, creatine kinase, myoglobin, inflammation, oxidative stress, and range of motion; (5) randomized controlled trials performed in humans. These outcomes were based on previous studies that outline the most frequent and valid markers of EIMD and its underlying causes (Hyldahl and Hubal 2014; Paulsen et al. 2012; Warren et al. 1999). The 168 h cut off for follow up data was adapted from a similarly designed review (Ranchordas et al. 2017). Crossover and parallel study designs were eligible. Studies were excluded if other nutrients were taken alongside the nitrate supplement or if insufficient information was provided on the type, dose, formulation, frequency, or route of administration. Studies were excluded if the intervention was not combined with a supervised exercise protocol and if the full text was not available in English.
Functional high-intensity interval training is not equivalent when compared to combined training for blood pressure improvements in postmenopausal women: a randomized controlled trial
Published in Clinical and Experimental Hypertension, 2022
Paulo R. P. Nunes, Thalles R. G. B. Silva, Marcelo A. S. Carneiro, Fernanda M. Martins, Aletéia P. Souza, Fábio L. Orsatti
This study is a part of a Research Project (trial registration: NCT03200639, with previous publication (24,26,27)), in which BP and resting heart rate were an additional analysis. A randomized (stratified randomization), controlled and parallel study was performed over 12 weeks. The groups were randomized (CT or F-HIIT) after all the women fulfilled the inclusion criteria (Figure 1). The BP and resting heart rate were assessed at the rest and at the end of the exercise sessions in the first week (pre-values) and last week (post-values). The CT group performed a total training protocol composed of 30 min moderate-intensity walking combined with five total body resistance exercises. The F-HIIT group performed a total training protocol composed of ten sets of 60 seconds of high-intensity exercise (30 seconds of steps climbing plus 30 seconds of free body weight squats) interspersed with a recovery period of 60 seconds of light walk. Both groups trained for 12 weeks and performed a three-day-a-week (no consecutive days) routine (Table 2). The study was approved by the local Research Ethics Committee (CAAE: 45108115.8.0000.5154) and was conducted in accordance with the Declaration of Helsinki. All women gave written informed consent.
Hepatoprotective Effect of Antrodia cinnamomea Mycelium in Patients with Nonalcoholic Steatohepatitis: A Randomized, Double-Blind, Placebo-Controlled Trial
Published in Journal of the American College of Nutrition, 2021
Ya-Ling Chiou, Charng-Cherng Chyau, Tsung-Ju Li, Chia-Feng Kuo, Yu-Yling Kang, Chin-Chu Chen, Wang-Sheng Ko
This six-month double-blind randomized placebo-controlled parallel study was performed in adult human subjects with NASH. Participants were treated with three capsules per day containing either 420 mg of ACM or 420 mg of starch (placebo) with similar appearance and taste. The basis of the ACM dose was based on the same material applied on other in vivo study (18) which indicated that the dose of 131 mg/Kg in rat is equivalent to 1456 mg/day for human presents significantly protective effects against the thioacetamide-induced liver fibrosis. Both groups received standardized lifestyle modification. The participants were required to follow a predetermined regular visit to Kuang Tein General Hospital every three months during the intervention period (6 months). During each study visit, subjects underwent anthropometric measurements and blood testing for biochemical analysis, immune function assay, inflammatory cytokines assay, and FibroMax test.