scholarly journals The effects of nano-curcumin as a nutritional strategy on clinical and inflammatory factors in children with cystic fibrosis: the study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Saeedeh Talebi ◽  
Mahammad Safarian ◽  
Mahmood Reza Jaafari ◽  
Seyed Javad Sayedi ◽  
Zahra Abbasi ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Controlled Trial ◽  
Genetic Disorder ◽  
The Body ◽  
Inflammatory Factors ◽  
Secondary Outcome ◽  
Nasopharyngeal Swab ◽  
Nutritional Strategy ◽  
Cftr Protein ◽  
The Impact

Abstract Background Cystic fibrosis (CF) is a genetic disorder, which is caused by the CFTR protein defects. Along with CFTR dysfunction, inflammation plays a key role in the disease outcomes. Inflammation may develop due to the internal dysfunction of the CFTR protein or external factors. Curcumin affects the CFTR protein function primarily as a corrector and potentiator and secondary as an anti-inflammatory and antimicrobial agent. The present study aims to assess the impact of nano-curcumin on clinical and inflammatory markers in children with CF. Methods This prospective, double blind control trial will be conducted at the Akbar Children’s Hospital in Mashhad, Iran. Children with CF will be enrolled based on the eligibility criteria. Placebo and curcumin with the maximum dose of 80 mg considering the body surface of the patients will be administrated for 3 months. The primary outcome is to evaluate inflammation based on serum interleukin-6, interleukin-10, and hs-CRP, stool calprotectin, and neutrophil count of nasopharyngeal swab. The secondary outcome involved clinical assessment via spirometry, anthropometrics, and quality of life. They will be assessed before and after 3 months. Discussion Due to the multifarious effects of curcumin on CF disease, it could be proposed as a nutritional strategy in the treatment of cystic fibrosis. Trial registration Iranian Registry of Clinical Trials IRCT20200705048018N1. Registered on July 10, 2020.

scholarly journals The Effects of Nano-Curcumin as A Nutritional Strategy on Clinical and Inflammatory Factors in Children with Cystic Fibrosis: A Protocol Study and Review Article

2020 ◽  
Author(s):  
Hamid Reza Kianifar ◽  
Saeedeh Talebi ◽  
Mahammad Safarian ◽  
Seyed Javad Sayedi ◽  
Mahmod Reza Jaafari ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Genetic Disorder ◽  
The Body ◽  
Inflammatory Factors ◽  
Secondary Outcome ◽  
Nasopharyngeal Swab ◽  
Double Blind ◽  
Nutritional Strategy ◽  
Cftr Protein ◽  
The Impact

Abstract Background: Cystic fibrosis(CF) is a genetic disorder, which is caused by the CFTR protein defects. Along with CFTR dysfunction, inflammation plays a key role in the disease outcomes. Inflammation may develop due to the internal dysfunction of the CFTR protein or external factors. Curcumin affects the CFTR protein function primarily as a corrector and potentiator and secondary as an anti-inflammatory and antimicrobial agent. The present study aims to assess the impact of Nano-curcumin on clinical and inflammatory markers in children with CF.Methods: This prospective, double blind control trial will be conducted at Akbar Children's Hospital in Mashhad, Iran. children with CF will be enrolled based on the eligibility criteria. Placebo and curcumin with the maximum dose of 80 milligrams considering the body surface of the patients will be administrated for three months. The primary outcome is to evaluate inflammation based on serum interleukin-6, interleukin-10, and hs-CRP, stool calprotectin, and neutrophil count of nasopharyngeal swab. The secondary outcome involved clinical assessment via spirometry, anthropometrics, and quality of life. They will be assessed before and after three mounts.Discussion: Due to the multifarious effects of curcumin on CF disease, it can be used as a nutritional strategy in the treatment of cystic fibrosis.Trial registration: Iranian Registry of Clinical Trials, IRCT20200705048018N1, Registered on 2020-07-10, https://en.irct.ir/search/result?query=IRCT20200705048018N1

scholarly journals CFTR Modulators: Impact on Fertility, Pregnancy, and Lactation in Women with Cystic Fibrosis

2020 ◽  
Vol 9 (9) ◽  
pp. 2706 ◽  
Author(s):  
Jennifer L. Taylor-Cousar
Keyword(s):  
Quality Of Life ◽  
Cystic Fibrosis ◽  
Genetic Disorder ◽  
Safety Data ◽  
Single Copy ◽  
The Body ◽  
Pregnancy And Lactation ◽  
The Impact ◽  
Cftr Modulators

Cystic fibrosis (CF) is a life-shortening genetic disorder caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. These mutations lead to abnormal ion transport in mucous membranes throughout the body, including in the respiratory and gastrointestinal and reproductive tracts. Improvements in care and therapy have led to substantial increases in the quantity and quality of life for those with CF. Consequently, women with CF are increasingly interested in having families. Although pregnancy was once discouraged for women with CF, at this point, even women with moderately severe lung disease can successfully navigate pregnancy. With the recent approval of a triple combination CFTR modulator therapy that improves lung function, nutritional status, and quality of life for people with a single copy of the most common CFTR mutation, it is expected that the number of women with CF who choose to become pregnant will continue to increase. Although animal reproduction models show no alarming signals for use during pregnancy at normal human doses, there is a paucity of human safety data in pregnancy and lactation. This review summarizes what is currently known about the impact of use of CFTR modulators on fertility, pregnancy, and lactation in women with CF.

scholarly journals Body Mass Index, Multi-Morbidity, and COVID-19 Risk Factors as Predictors of Severe COVID-19 Outcomes

2021 ◽  
Vol 12 ◽  
pp. 215013272110185
Author(s):  
Sanjeev Nanda ◽  
Audry S. Chacin Suarez ◽  
Loren Toussaint ◽  
Ann Vincent ◽  
Karen M. Fischer ◽  
...  
Keyword(s):  
Risk Factors ◽  
Body Mass Index ◽  
Hospital Admission ◽  
Body Mass ◽  
Risk Score ◽  
The Body ◽  
Risk Scores ◽  
Nasopharyngeal Swab ◽  
Morbidity Score ◽  
The Impact

Purpose The purpose of the present study was to investigate body mass index, multi-morbidity, and COVID-19 Risk Score as predictors of severe COVID-19 outcomes. Patients Patients from this study are from a well-characterized patient cohort collected at Mayo Clinic between January 1, 2020 and May 23, 2020; with confirmed COVID-19 diagnosis defined as a positive result on reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assays from nasopharyngeal swab specimens. Measures Demographic and clinical data were extracted from the electronic medical record. The data included: date of birth, gender, ethnicity, race, marital status, medications (active COVID-19 agents), weight and height (from which the Body Mass Index (BMI) was calculated, history of smoking, and comorbid conditions to calculate the Charlson Comorbidity Index (CCI) and the U.S Department of Health and Human Services (DHHS) multi-morbidity score. An additional COVID-19 Risk Score was also included. Outcomes included hospital admission, ICU admission, and death. Results Cox proportional hazards models were used to determine the impact on mortality or hospital admission. Age, sex, and race (white/Latino, white/non-Latino, other, did not disclose) were adjusted for in the model. Patients with higher COVID-19 Risk Scores had a significantly higher likelihood of being at least admitted to the hospital (HR = 1.80; 95% CI = 1.30, 2.50; P < .001), or experiencing death or inpatient admission (includes ICU admissions) (HR = 1.20; 95% CI = 1.02, 1.42; P = .028). Age was the only statistically significant demographic predictor, but obesity was not a significant predictor of any of the outcomes. Conclusion Age and COVID-19 Risk Scores were significant predictors of severe COVID-19 outcomes. Further work should examine the properties of the COVID-19 Risk Factors Scale.

scholarly journals Impact of screening for risk of suicide: randomised controlled trial

2011 ◽  
Vol 198 (5) ◽  
pp. 379-384 ◽  
Author(s):  
Mike J. Crawford ◽  
Lavanya Thana ◽  
Caroline Methuen ◽  
Pradip Ghosh ◽  
Sian V. Stanley ◽  
...  
Keyword(s):  
Primary Care ◽  
Suicidal Ideation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Worth Living ◽  
Early Screening ◽  
Care Services ◽  
Randomised Controlled ◽  
The Impact

BackgroundConcerns have been expressed about the impact that screening for risk of suicide may have on a person's mental health.AimsTo examine whether screening for suicidal ideation among people who attend primary care services and have signs of depression increases the short-term incidence of feeling that life is not worth living.MethodIn a multicentre, single-blind, randomised controlled trial, 443 patients in four general practices were randomised to screening for suicidal ideation or control questions on health and lifestyle (trial registration: ISRCTN84692657). The primary outcome was thinking that life is not worth living measured 10–14 days after randomisation. Secondary outcome measures comprised other aspects of suicidal ideation and behaviour.ResultsA total of 443 participants were randomised to early (n = 230) or delayed screening (n = 213). Their mean age was 48.5 years (s.d. = 18.4, range 16–92) and 137 (30.9%) were male. The adjusted odds of experiencing thoughts that life was not worth living at follow-up among those randomised to early compared with delayed screening was 0.88 (95% CI 0.66–1.18). Differences in secondary outcomes between the two groups were not seen. Among those randomised to early screening, 37 people (22.3%) reported thinking about taking their life at baseline and 24 (14.6%) that they had this thought 2 weeks later.ConclusionsScreening for suicidal ideation in primary care among people who have signs of depression does not appear to induce feelings that life is not worth living.

scholarly journals Effect of medically lowering intraocular pressure in glaucoma suspects with high myopia (GSHM study): study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Feng Bin Lin ◽  
◽  
Shi Da Chen ◽  
Yun He Song ◽  
Wei Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intraocular Pressure ◽  
High Myopia ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Rank Test ◽  
Inner Plexiform Layer ◽  
Randomized Controlled ◽  
The Impact

Abstract Background Currently, whether and when intraocular pressure (IOP)-lowering medication should be used in glaucoma suspects with high myopia (GSHM) remains unknown. Glaucoma suspects are visual field (VF) defects that cannot be explained by myopic macular changes or other retinal and neurologic conditions. Glaucoma progression is defined by VF deterioration. Here we describe the rationale, design, and methodology of a randomized controlled trial (RCT) designed to evaluate the effects of medically lowering IOP in GSHM (GSHM study). Methods The GSHM study is an open-label, single-center, RCT for GSHM. Overall, 264 newly diagnosed participants, aged 35 to 65 years, will be recruited at the Zhongshan Ophthalmic Center, Sun Yat-sen University, between 2020 and 2021. Participants will be randomly divided into two arms at a 1:1 ratio. Participants in the intervention arm will receive IOP-lowering medication, while participants in the control arm will be followed up without treatment for 36 months or until they reach the end point. Only one eye per participant will be eligible for the study. If both eyes are eligible, the eye with the worse VF will be recruited. The primary outcome is the incidence of glaucoma suspect progression by VF testing over 36 months. The secondary outcomes include the incidence of changes in the optic nerve head morphology including the retinal nerve fiber layer, and retinal ganglion cell-inner plexiform layer loss, progression of myopic maculopathy, visual function loss, and change in the quality of life. Statistical analyses will include baseline characteristics comparison between the intervention and control groups using a two-sample t-test and Wilcoxon rank sum test; generalized linear models with Poisson regression for the primary outcome; Kaplan-Meier curve and log-rank test for the incidence of the secondary outcome; and longitudinal analyses to assess trends in outcomes across time. Discussion To the best of our knowledge, the GSHM study is the first RCT to investigate the impact of medically lowering IOP in GSHM. The results will have implications for the clinical management of GSHM. Trial registration ClinicalTrials.gov NCT04296916. Registered on 4 March 2020

scholarly journals Comparison of the Impact of Wikipedia, UpToDate, and a Digital Textbook on Short-Term Knowledge Acquisition Among Medical Students: Randomized Controlled Trial of Three Web-Based Resources (Preprint)

2017 ◽  
Author(s):  
Michael A Scaffidi ◽  
Rishad Khan ◽  
Christopher Wang ◽  
Daniela Keren ◽  
Cindy Tsui ◽  
...  
Keyword(s):  
Medical Students ◽  
Medical School ◽  
Knowledge Acquisition ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Short Term ◽  
Web Based ◽  
Canadian Medical School ◽  
Digital Textbook ◽  
The Impact

BACKGROUND Web-based resources are commonly used by medical students to supplement curricular material. Three commonly used resources are UpToDate (Wolters Kluwer Inc), digital textbooks, and Wikipedia; there are concerns, however, regarding Wikipedia’s reliability and accuracy. OBJECTIVE The aim of this study was to evaluate the impact of Wikipedia use on medical students’ short-term knowledge acquisition compared with UpToDate and a digital textbook. METHODS This was a prospective, nonblinded, three-arm randomized trial. The study was conducted from April 2014 to December 2016. Preclerkship medical students were recruited from four Canadian medical schools. Convenience sampling was used to recruit participants through word of mouth, social media, and email. Participants must have been enrolled in their first or second year of medical school at a Canadian medical school. After recruitment, participants were randomized to one of the three Web-based resources: Wikipedia, UpToDate, or a digital textbook. During testing, participants first completed a multiple-choice questionnaire (MCQ) of 25 questions emulating a Canadian medical licensing examination. During the MCQ, participants took notes on topics to research. Then, participants researched topics and took written notes using their assigned resource. They completed the same MCQ again while referencing their notes. Participants also rated the importance and availability of five factors pertinent to Web-based resources. The primary outcome measure was knowledge acquisition as measured by posttest scores. The secondary outcome measures were participants’ perceptions of importance and availability of each resource factor. RESULTS A total of 116 medical students were recruited. Analysis of variance of the MCQ scores demonstrated a significant interaction between time and group effects (P<.001, ηg2=0.03), with the Wikipedia group scoring higher on the MCQ posttest compared with the textbook group (P<.001, d=0.86). Access to hyperlinks, search functions, and open-source editing were rated significantly higher by the Wikipedia group compared with the textbook group (P<.001). Additionally, the Wikipedia group rated open access editing significantly higher than the UpToDate group; expert editing and references were rated significantly higher by the UpToDate group compared with the Wikipedia group (P<.001). CONCLUSIONS Medical students who used Wikipedia had superior short-term knowledge acquisition compared with those who used a digital textbook. Additionally, the Wikipedia group trended toward better posttest performance compared with the UpToDate group, though this difference was not significant. There were no significant differences between the UpToDate group and the digital textbook group. This study challenges the view that Wikipedia should be discouraged among medical students, instead suggesting a potential role in medical education.

scholarly journals A randomized controlled trial of online symptom searching to inform patient generated differential diagnoses

2019 ◽  
Vol 2 (1) ◽  
Author(s):  
Seth S. Martin ◽  
Emmanuel Quaye ◽  
Sarah Schultz ◽  
Oluwaseun E. Fashanu ◽  
Jane Wang ◽  
...  
Keyword(s):  
Medical Center ◽  
Controlled Trial ◽  
Academic Medical Center ◽  
Differential Diagnoses ◽  
Secondary Outcome ◽  
Patient Anxiety ◽  
Waiting Room ◽  
Online Searching ◽  
Health Related ◽  
The Impact

Abstract Patient online health searching is now commonplace, however, the accuracy of patient generated differentials for new symptoms and potential for patient anxiety are concerns. We aimed primarily to determine the accuracy of patient generated differentials for new symptoms with and without online searching, and secondarily, to evaluate the impact of searching on anxiety levels. In the waiting room prior to seeing a clinician, 300 patients with new symptoms were randomly assigned 1:1:1 to Google searching with health related features including a symptom search tool vs Google searching with health related features disabled vs no searching. Participants were 18 years or older and presenting to the emergency department of an urban academic medical center with new low-acuity symptoms that were not due to exacerbation of a chronic condition. Search groups received access on a tablet/smartphone to Google searching with or without health related features. Both search groups could access any websites; health related features led the patient to common diagnoses and physician-validated information. The primary outcome was accuracy of the patient generated differential assessed by matching at least two of the top three diagnoses on the clinician’s differential. A secondary outcome was anxiety by a visual analogue scale. Patients were a median of 33.1 (IQI 26.2–45.9) years old, 60% women, 63% black, 82% had a high school education or less, and 45.7% reported having performed an online search prior to presentation. Search group patients spent a median of 3.82 (2.53–5.72) minutes searching online. Similar proportions of patients in each group matched at least two of three clinician diagnoses: 27.0% and 28.3% for Google searching with and without health related features vs 23.8% in the no search group. Patients in the search groups had a similar odds of matching ≥2/3 diagnoses as the no search group [OR (95% CI): 1.23 (0.70–2.13), p = 0.47]. Anxiety was unchanged with online searching. In conclusion, brief online searching in the waiting room did not improve accuracy of patient generated differential diagnoses for new symptoms. The absence of an increase in patient anxiety provides reassurance for subsequent work to refine and investigate online symptom search tools.

scholarly journals Impact of Altered Gut Microbiota and Its Metabolites in Cystic Fibrosis

Metabolites ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 123
Author(s):  
Aravind Thavamani ◽  
Iman Salem ◽  
Thomas J. Sferra ◽  
Senthilkumar Sankararaman
Keyword(s):  
Cystic Fibrosis ◽  
Genetic Disorder ◽  
Vital Role ◽  
Immune Functions ◽  
Gene Encoding ◽  
Gut Dysbiosis ◽  
Multiple Organs ◽  
Fluid Regulation ◽  
Cftr Protein ◽  
Cystic Fibrosis Transmembrane

Cystic fibrosis (CF) is the most common lethal, multisystemic genetic disorder in Caucasians. Mutations in the gene encoding the cystic fibrosis transmembrane regulator (CFTR) protein are responsible for impairment of epithelial anionic transport, leading to impaired fluid regulation and pH imbalance across multiple organs. Gastrointestinal (GI) manifestations in CF may begin in utero and continue throughout the life, resulting in a chronic state of an altered intestinal milieu. Inherent dysfunction of CFTR leads to dysbiosis of the gut. This state of dysbiosis is further perpetuated by acquired factors such as use of antibiotics for recurrent pulmonary exacerbations. Since the gastrointestinal microbiome and their metabolites play a vital role in nutrition, metabolic, inflammatory, and immune functions, the gut dysbiosis will in turn impact various manifestations of CF—both GI and extra-GI. This review focuses on the consequences of gut dysbiosis and its metabolic implications on CF disease and possible ways to restore homeostasis.

A randomized trial of erector spinae plane block for analgesia after video-assisted thoracoscopic surgery

2019 ◽  
Author(s):  
Yang Jin ◽  
Xuemei Jiang ◽  
Meng Sun ◽  
Xin Lv ◽  
Zongmei Wen
Keyword(s):  
Postoperative Pain ◽  
Thoracoscopic Surgery ◽  
Controlled Trial ◽  
Opioid Consumption ◽  
Erector Spinae ◽  
Secondary Outcome ◽  
Video Assisted ◽  
Erector Spinae Plane Block ◽  
The Impact ◽  
Video Assisted Thoracoscopic Surgery

Abstract Background: Erector spinae plane block (ESPB) is a novel local nerve block technique. However, evidence regarding the impact of ESPB on postoperative pain management after video-assisted thoracoscopic surgery (VATS) is lacking. This randomized controlled trial aimed to evaluate the effect of erector spinae plane block on postoperative analgesia and intra-operative opioid consumption for video-assisted thoracoscopic surgery patients. Methods: We randomly allocated 91 participants to block with 30ml ropivacaine 0.375% (n=45), or no block without placebo or sham procedure (n=46). We analyzed results from 41 participants in each group ultimately. The primary outcome was postoperative NRS pain score. The secondary outcome was intra-operative sufentanil consumption. Postoperative QoR-40 scores and postoperative complications were also recorded. Results: Erector spinae plane block reduced the median (IQR) pain scores during postoperative 0-1h, 1-6h, 6-12h and 12-24h: 3 (3-5) vs. 6 (5-7), p<0.0001; 5 (3-5) vs. 6 (5-7), p<0.0001; 4 (3-5) vs. 6 (5-7), p<0.0001 and 4 (3-5) vs. 5 (5-7), p<0.0001, respectively. Block also reduced the mean (SD) intra-operative total sufentanil consumption and per hour, per kilogram sufentanil consumption, as well as increased the median (IQR) global QoR-40 scores on POD1. Conclusions: Erector spinae plane block can be used to reduce postoperative pain and intra-operative opioid consumption for VATS patients.

scholarly journals Advance notice of contraceptive availability at surgical abortion: a pilot randomised controlled trial

2018 ◽  
Vol 44 (3) ◽  
pp. 187-192 ◽  
Author(s):  
Andrea H Roe ◽  
Jennifer Fortin ◽  
Danielle Gelfand ◽  
Elizabeth Janiak ◽  
Rie Maurer ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Contraceptive Method ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Pilot Randomised Controlled Trial ◽  
Contraceptive Knowledge ◽  
Advance Notice ◽  
Randomised Controlled ◽  
Surgical Abortion ◽  
The Impact

BackgroundWith advance notice about the availability and effectiveness of contraceptive methods, abortion patients have more time and information for decision-making. We assessed the impact of an informational telephone call prior to the surgical abortion visit on patient contraceptive knowledge.MethodsThis was a pilot randomised controlled trial. Prior to their abortion visit, participants were randomised to the intervention message, a standardised notification about the availability, effectiveness and safety of long-acting (LARC) and short-acting reversible contraception (SARC) on the day of the abortion, or to the control message, a reiteration of appointment logistics without information about contraception. At the visit, participants completed a pre-procedure survey to assess contraceptive knowledge and usefulness of the intervention. The primary outcome was knowledge of LARC availability immediately after surgical abortion. A secondary outcome was contraceptive method uptake.ResultsWe enrolled 234 subjects. The pre-visit telephone notification improved knowledge that LARC is available immediately after surgical abortion (71.3% vs 50.9%, P<0.01). Participants in both study arms found the telephone notifications useful. Post-abortion contraceptive method choice did not differ between study arms.ConclusionsAdvance notice about contraception was acceptable to surgical abortion patients and improved their contraceptive knowledge.Trial registration numberNCT02836561.

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