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Trending Papers in clinical trials

Intermittent fasting (with feeding in the morning) improves insulin sensitivity in pre-diabetic men
From Paper: Early Time-Restricted Feeding Improves InsulinSensitivity, Blood Pressure, and Oxidative StressEven without Weight Loss in Men with Prediabetes
Intermittent fasting (IF) improves cardiometabolic health; however, it is unknown whether these effects are due solely to weight loss. We conducted the first supervised controlled feeding trial to test whether IF has benefits independent of weight loss by feeding participants enough food to maintain their weight.Our proof-of-concept study also constitutes the first trial of early time-restricted feeding (eTRF), a form of IF that involves eating early in the day to be in alignment with circadian rhythms in metabolism. Men with prediabetes were randomized to eTRF (6-hr feeding period, with dinner before 3 p.m.) or a control schedule (12-hr feeding period) for 5 weeks and later crossed over to the other schedule. eTRF improved insulin sensitivity, bcell responsiveness, blood pres-sure, oxidative stress, and appetite. We demonstrate for the first time in humans that eTRF improves some aspects of cardiometabolic health and that IF’s effects are not solely due to weight loss.
Submitted by Kayla Burris
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Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19
From Paper: Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19
  • This trial may not inform whether an effect would be observed in populations at higher risk for severe COVID-19. Further randomized controlled clinical trials are needed in early COVID-19
  • A 5-day course of hydroxychloroquine failed to show a substantial clinical benefit in improving the rate of resolution of COVID-19 symptoms
Submitted by Patrick Joyce
L-dopa, a precursor of dopamine used to treat Parkinsons patients, does not improve cognitive performance in older adults
From Paper: Effects of daily L-dopa administration on learning and brain structure in older adults undergoing cognitive training: a randomised clinical trial
Basic research has implicated dopaminergic signaling in neural plasticity. This study investigated if enhancement of dopamine signaling via administration of L-dopa improves the effects of cognitive training on performance
Submitted by Karl Erikson
Crohn's disease patients effectively mobilize peripheral blood stem cells to perform autologous haematopoietic stem cell transplantation
Ruiz, Lilian, et al
Published: Jun 2018
Background: Treatment with high doses chemotherapy followed by autologous haematopoietic stem cell transplantation is promising for refractory Crohn's disease patients with no therapeutic option and at imminent risk of further surgeries. Objectives: To evaluate the feasibility and efficacy of haematopoietic progenitor cell mobilization in a group of Crohn's disease patients preparing for autologous unselected haematopoietic stem cell transplantation in a single institution. This is the first study to evaluate mobilization for Crohn's disease. Methods: Patients were selected according to criteria of the European Bone Marrow Transplant Society. Results: All patients mobilized with the mean number of haematopoietic progenitor cells obtained and infused being 16.17 x 106/CD34+/kg. Most patients required only one leukapheresis session to reach the ideal number of cells. Grafting occurred around ten days after cells infusion. Complications and adverse events during the mobilization period were rare with only one patient presenting sepsis as a relevant event in the period. Most patients 20 (70%) had anaemia from the beginning of the mobilization but only 11 (37.9%) received packed red blood cell transfusions. Conclusion: Mobilization in patients with Crohn's disease is effective and it seems they are good mobilizers. Clinical Trial Registration ID #NCT03000296.
Retrieved from biorxiv
Optimizing Communication of Emergency Response Adaptive Randomization Clinical Trials to Potential Participants
Bredan McEvoy, David Haidar, Jason Tehranisa, William Meurer
Published: Dec 2016
Introduction: Acute clinical stroke trials are challenging to communicate to patients and families considering participation. Response adaptive randomization (RAR) is a technique that alters the proportion of trial subjects receiving active treatment, based on the outcomes of previous subjects. We aimed to determine how well interactive videos would improve understanding of a simulated acute stroke trial scenario that incorporated a design with RAR. Methods: We performed a cross-sectional study of emergency department patients who were without stroke, altered mental status, or critical illness. Subjects viewed a hypothetical stroke and clinical trial scenario. They were randomized into one of four groups with either an RAR or fixed randomization clinical trial design and with either a standard consent video, or an interactive video. Results: We enrolled 720 participants. In the RAR group with interactive video, 128 out of 149 (85.9%) of the subjects were able to correctly identify the allocation method, compared to the 172 out of 285 (61.6%) in the RAR group with the uninterrupted video for an absolute increase of 25.6% (95% CI 17,33%). The RAR group with interactive video had a higher odds of correct identification of allocation method (O.R. 2.767, 95% CI [1.011,7.570] while controlling for age, sex, ethnicity, education, self-reported understanding of protocol, stroke awareness and agreement to participate in trial. Conclusions: The interactive video increased participant understanding of an RAR design in a simulated stroke scenario. Future research should focus on whether acute trial recruitment can be enhanced using similar techniques.
Retrieved from biorxiv
Derivation of a simple postoperative delirium incidence and severity prediction model
H., Lindroth, et al
Published: Sep 2018
Background: Delirium is an important postoperative complication, yet a simple and effective delirium prediction model remains elusive. We hypothesized that the combination of the National Surgical Quality Improvement Program (NSQIP) risk calculator for serious complications (NSQIP-SC) or risk of death (NSQIP-D), and cognitive tests of executive function (Trail Making Test A and B [TMTA, TMTB]), could provide a parsimonious model to predict postoperative delirium incidence or severity. Methods: Data were collected from 100 adults (>65yo) undergoing major non-cardiac surgery. In addition to NSQIP-SC, NSQIP-D, TMTA and TMTB, we collected participant age, sex, ASA score, tobacco use, type of surgery, depression, Framingham risk score, and preoperative blood pressure. Delirium was diagnosed with the Confusion Assessment Method (CAM), and the Delirium Rating Scale-R-98 (DRS) was used to assess symptom severity. LASSO and Best Subsets logistic and linear regression were employed in line with TRIPOD guidelines. Results: Three participants were excluded due to intraoperative deaths (2) and alcohol withdrawal (1). Ninety-seven participants with a mean age of 71.68+4.55, 55% male (31/97 CAM+, 32%) and a mean Peak DRS of 21.5+6.40 were analyzed. Of the variables included, only NSQIP-SC and TMTB were identified to be predictors of postoperative delirium incidence (p<0.001, AUROC 0.81, 95% CI: 0.72, 0.90) and severity (p<0.001, Adj. R2: 0.30). Conclusions: In this cohort, preoperative NSQIP-SC and TMTB were identified as predictors of postoperative delirium incidence and severity. Future studies should verify whether this two- factor model could be used for accurate delirium prediction. Keywords: aging, delirium, perioperative, prediction, surgical risk. Clinical Trial Registration ID #NCT03124303 and #NCT01980511
Retrieved from biorxiv
The effect of dietary intervention on inflammatory markers in patients with type 2 diabetes. An analysis of the Lifestyle Over and Above Drugs in Diabetes (LOADD) study
Booker, Chris, et al
Published: Dec 2018
Ninety-three participants with poorly controlled type 2 diabetes despite optimized drug therapy were randomised to receive intensive dietary advice or usual care for six months. Following dietary intervention a significant reduction in interleukin-18 levels was observed, with a ratio of change (95% CI) of 0.90 (0.82-0.99); p = 0.033. Changes in IL-18 correlated with changes in neopterin, r = 0.299 (p = 0.009). Clinical Trial registration ID #NCT00124553.
Retrieved from biorxiv
Similar clinical improvement and maintenance after rTMS at 5 Hz using a simple vs. complex protocol in Alzheimer's disease
Alcalá-Lozano, R., et al
Published: Dec 2017
Brackground: Current treatments for Alzheimer's disease (AD) have a limited clinical response and methods, such as repetitive transcranial magnetic stimulation (rTMS), are being studied as possible treatments for the clinical symptoms with positive results. However, there is still seldom information on the type of rTMS protocols that deliver the best clinical improvement in AD. Objetive: To compare the clinical response between a simple stimulation protocol on the left dorsolateral prefrontal cortex (lDLPFC) against a complex protocol using six regions of interest. Methods: 19 participants were randomized to receive any of the protocols. The analysis of repeated measures evaluated the change. Results: Both protocols were equally proficient at improving cognitive function, behavior and functionality after 3 weeks of treatment, and the effects were maintained for 4 weeks more without treatment. Conclusion: We suggest rTMS on the lDLPFC could be enough to provide a clinical response, and the underlying mechanisms should be studied. Clinical trial registration ID #NCT03270137.
Retrieved from biorxiv
Dose Escalation for Locally Advanced Pancreatic Cancer: How High Can We Go?
Colbert, Lauren, et al
Published: May 2018
Stereotactic body radiotherapy SBRT is a common practice for consolidation in pancreatic cancer, but the currently used dose of 33Gy/5fx is considered inadequate for long term control. Given these data, we initiated a phase I/II adaptive dose escalation trial using stereotactic body radiation therapy (SBRT) for LAPC ( Identifier: NCT03340974). In preparation, we undertook this dosimetric feasibility study to determine the maximum deliverable biological effective dose (BED) using dose escalated SBRT (DE-SBRT) while maintaining standard organ at risk (OAR) constraints to gastrointestinal (GI) mucosa. Our goal was to evaluate the feasibility of DE-SBRT in 2 separate cohorts of patients, one treated with DE-IMRT and the other treated with SD-SBRT. This article is a step-by-step guide to simulation, contouring, treatment planning, and treatment delivery for simultaneous integrated boost technique to pancreatic tumors based on our approach. We performed dosimetric planning studies to determine the highest reasonably achievable dose in five fractions, while respecting standard OAR constraints. Indeed, we show that it is possible and feasible to deliver up to 12Gyx5fx (60Gy total) to the GTV of pancreatic tumors while not significantly exceeding the dosimetric paramters used to treat tumors with much more typical and modest dose (33Gy/5fx). We believe our study will provide a helpful guide to radiation oncologists wishing to implement this dose-escalated technique in their practice. These higher doses could lead to improved oncologic control without compromising patient safety, and could be particularly useful for those centers using MR-LINAC. Clinical trial registration ID #NCT03340974
Retrieved from biorxiv
Influence of APOA5 locus on the treatment efficacy of three statins: evidence from a randomized pilot study in Chinese subjects
Hua, Sha, et al
Published: Nov 2017
Pharmacogenetics or pharmacogenomics approaches are important for addressing the individual variabilities of drug efficacy especially in the era of precision medicine. One particular interesting gene to investigate is APOA5 which has been repeatedly linked with the inter-individual variations of serum triglycerides. Here, we explored APOA5-statin interactions in 195 Chinese subjects randomized to rosuvastatin (5-10 mg/day), atorvastatin (10-20 mg/day), or simvastatin (40 mg/day) for 12 weeks by performing a targeted genotyping analysis of the APOA5 promoter SNP rs662799 (-1131T>C). There were no significant differences between the treatment arms for any of the statin-induced changes in clinical biomarkers. Reductions in LDL cholesterol were influenced by the APOA5 genotype in all three treatment groups. By contrast, changes in HDL cholesterol and triglycerides were only affected by the APOA5 genotype in the atorvastatin and simvastatin groups and not in the rosuvastatin group. Our results support earlier findings indicating that rosuvastatin is a better treatment option and that future studies should consider stratifying subjects not only by genetic background but also by statin type. Clinical trial registration ID# ChiCTR-RRC-16010131.
Retrieved from biorxiv
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