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1.
BMC Womens Health ; 23(1): 277, 2023 05 19.
Article in English | MEDLINE | ID: covidwho-2323655

ABSTRACT

Single-parent adolescents are vulnerable individuals and it is necessary to improve their health, particularly during epidemics. This study aimed to investigate the effects of virtual logotherapy (VL) on health-promoting lifestyle (HPL) among single-parent adolescent girls during the COVID-19 pandemic. This single-blind randomized clinical trial was conducted on 88 single-parent adolescent girls recruited from the support organization for vulnerable individuals in Tehran, Iran. They were randomly allocated to a control and an intervention group through block randomization. Participants in the intervention group received VL in three-five person groups in 90 min biweekly sessions. The Adolescent Health Promotion Short-Form was used to assess HPL. Data were analyzed using the SPSS software (v. 26.0) and through the independent-sample t, Chi-square, Fisher's exact, and Mann-Whitney U tests. There was no significant difference between the intervention and the control groups respecting the pretest mean score of HPL (73.58±16.74 vs. 72.80±9.30; P=0.085). However, the posttest mean score of HPL in the intervention group (82 with an interquartile range of 78-90) was significantly more than the control group (71.50 with an interquartile range of 63.25-84.50) (P=0.001). Moreover, after adjusting the effects of the significant between-group differences respecting pretest mean scores, the pretest-posttest differences of the mean scores of HPL and all its dimensions in the intervention group were significantly more than the control group (P<0.05). VL is effective in significantly improving HPL among single-parent adolescent girls. Healthcare authorities are recommended to use VL for health promotion among single-parent adolescents.Trial registrationThis research was registered (17/05/2020) in the www.thaiclinicaltrials.org with registration number: TCTR20200517001.


Subject(s)
COVID-19 , Female , Humans , Adolescent , Pandemics , Logotherapy , Single-Blind Method , Iran , Healthy Lifestyle , Parents
2.
Trials ; 22(1): 962, 2021 Dec 27.
Article in English | MEDLINE | ID: covidwho-2314904

ABSTRACT

BACKGROUND: Multiple observational studies have associated metformin prescription with reduced progression of abdominal aortic aneurysm (AAA). The Metformin Aneurysm Trial (MAT) will test whether metformin reduces the risk of AAA rupture-related mortality or requirement for AAA surgery (AAA events) in people with asymptomatic aneurysms. METHODS: MAT is an international, multi-centre, prospective, parallel-group, randomised, placebo-controlled trial. Participants must have an asymptomatic AAA measuring at least 35 mm in maximum diameter, no diabetes, no contraindication to metformin and no current plans for surgical repair. The double-blind period is preceded by a 6-week, single-blind, active run-in phase in which all potential participants receive metformin. Only patients tolerating metformin by taking at least 80% of allocated medication will enter the trial and be randomised to 1500 mg of metformin XR or an identical placebo. The primary outcome is the proportion of AAA events defined as rupture-related mortality or need for surgical repair. Secondary outcomes include AAA growth, major adverse cardiovascular events and health-related quality of life. In order to test if metformin reduced the risk of AAA events by at least 25%, 616 primary outcome events will be required (power 90%, alpha 0.05). DISCUSSION: Currently, there is no drug therapy for AAA. Past trials have found no convincing evidence of the benefit of multiple blood pressure lowering, antibiotics, a mast cell inhibitor, an anti-platelet drug and a lipid-lowering medication on AAA growth. MAT is one of a number of trials now ongoing testing metformin for AAA. MAT, unlike these other trials, is designed to test the effect of metformin on AAA events. The international collaboration needed for MAT will be challenging to achieve given the current COVID-19 pandemic. If this challenge can be overcome, MAT will represent a trial unique within the AAA field in its large size and design. TRIAL REGISTRATION: Australian Clinical Trials ACTRN12618001707257 . Registered on 16 October 2018.


Subject(s)
Aortic Aneurysm, Abdominal , COVID-19 , Metformin , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Australia , Humans , Metformin/adverse effects , Pandemics , Prospective Studies , Quality of Life , Randomized Controlled Trials as Topic , SARS-CoV-2 , Single-Blind Method
3.
Trials ; 23(1): 596, 2022 Jul 26.
Article in English | MEDLINE | ID: covidwho-2318264

ABSTRACT

BACKGROUND: Large-scale trials of multidomain interventions show that modifying lifestyle and psychological risk factors can slow cognitive decline. We aim to determine if a lower intensity, personally tailored secondary dementia prevention programme for older people with subjective or mild objective memory decline, informed by behaviour change theory, reduces cognitive decline over 2 years. METHODS: A multi-site, single-blind randomised controlled trial recruiting 704 older adults at high dementia risk due to mild cognitive impairment (MCI) or subjective cognitive decline (SCD). Participants are randomised using 1:1 allocation ratio to the APPLE Tree intervention versus control arm (dementia prevention information), stratified by site. The intervention explores and implements strategies to promote healthy lifestyle, increase pleasurable activities and social connections and improve long-term condition self-management. Two facilitators trained and supervised by a clinical psychologist deliver ten, 1-h group video call sessions over 6 months (approximately every fortnight), video-call 'tea breaks' (less structured, facilitated social sessions) in intervening weeks and individual goal-setting phone calls every 2 weeks. From 6 to 12 months, participants meet monthly for 'tea breaks', with those not attending receiving monthly goal-setting phone calls. Participants receive a food delivery, pedometer and website access to cognitive training and information about lifestyle modification. Follow-ups for all outcome measures are at 12 and 24 months. The primary outcome is cognition (Neuropsychological Test Battery (NTB) score) at 24 months. Secondary outcomes are quality of life, cost per quality-adjusted life year (QALY) and wellbeing and lifestyle factors the intervention targets (diet, vascular risk, body weight, activity, sleep, anxiety, depression, social networks and loneliness, alcohol intake and smoking). Participants from purposively selected sites participate in qualitative process evaluation interviews, which will be analysed using thematic analytic methods. DISCUSSION: If effective, the intervention design, involving remote delivery and non-clinical facilitators, would facilitate intervention roll-out to older people with memory concerns. TRIAL REGISTRATION: ISRCTN17325135 . Registration date 27 November 2019.


Subject(s)
Dementia , Malus , Aged , Cost-Benefit Analysis , Humans , Life Style , Quality of Life , Single-Blind Method , Tea , Technology
4.
Emerg Microbes Infect ; 12(1): 2212806, 2023 Dec.
Article in English | MEDLINE | ID: covidwho-2319462

ABSTRACT

Monoclonal antibodies (mAbs) and the post-exposure prophylaxis (PEP) with mAbs represent a very important public health strategy against coronavirus disease 2019 (COVID-19). This study has assessed a new Anti-SARS-COV-2 mAb (SA58) Nasal Spray for PEP against COVID-19 in healthy adults aged 18 years and older within three days of exposure to a SARS-CoV-2 infected individual. Recruited participants were randomized in a ratio of 3:1 to receive SA58 or placebo. Primary endpoints were laboratory-confirmed symptomatic COVID-19 within the study period. A total of 1222 participants were randomized and dosed (SA58, n = 901; placebo, n = 321). Median of follow-up was 2.25 and 2.79 days for SA58 and placebo, respectively. Adverse events occurred in 221 of 901 (25%) and 72 of 321 (22%) participants with SA58 and placebo, respectively. All adverse events were mild in severity. Laboratory-confirmed symptomatic COVID-19 developed in 7 of 824 participants (0.22 per 100 person-days) in the SA58 group vs. 14 of 299 (1.17 per 100 person-days) in the placebo group, resulting in an estimated efficacy of 80.82% (95%CI 52.41%-92.27%). There were 32 SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) positives (1.04 per 100 person-days) in the SA58 group vs. 32 (2.80 per 100 person-days) in the placebo group, resulting in an estimated efficacy of 61.83% (95%CI 37.50%-76.69%). A total of 21 RT-PCR positive samples were sequenced and all were the Omicron variant BF.7. In conclusion, SA58 Nasal Spray showed favourable efficacy and safety in preventing symptomatic COVID-19 or SARS-CoV-2 infection in adults who had exposure to SARS-CoV-2 within 72 h.


Subject(s)
COVID-19 , Adult , Humans , COVID-19/prevention & control , SARS-CoV-2 , Nasal Sprays , Post-Exposure Prophylaxis , Single-Blind Method , Double-Blind Method , Antibodies, Viral
5.
Clin Ther ; 45(3): e103-e114, 2023 03.
Article in English | MEDLINE | ID: covidwho-2317433

ABSTRACT

PURPOSE: Metabolic syndrome (MetS) is a major public health concern that increases the risk of cardiovascular disease and mortality. In previous studies of MetS management, low-carbohydrate diets have been strongly emphasized, despite the fact that many apparently healthy individuals have difficulties adhering to these diets on a long-term basis. The purpose of the present study was to elucidate the effects of a moderately restricted carbohydrate diet (MRCD) on cardiometabolic risk factors in women with MetS. METHODS: This parallel 3-month, single-blind randomized controlled trial was conducted in Tehran, Iran, among 70 women with overweight or obesity aged 20 to 50 years with MetS. Patients were randomly allocated to receive either MRCD (42%-45% carbohydrates and 35%-40% fats) (n = 35) or a normal weight loss diet (NWLD) (52%-55% carbohydrates and 25%-30% fats) (n = 35). Both diets contained the same quantity of protein, which accounted for 15% to 17% of total energy. Anthropometric measurements, blood pressure, lipid profile, and glycemic indices were all assessed before and after the intervention. FINDINGS: Compared with the NWLD group, following an MRCD significantly decreased weight (-4.82 vs -2.40 kg; P = 0.01), body mass index (-1.88 vs -0.94 kg/m2; P = 0.01), waist circumference (-5.34 vs -2.75 cm; P = 0.01), hip circumference (-2.58 vs -1.11 cm; P = 0.01), serum triglyceride (-26.8 vs -7.19 mg/dL; P = 0.01), and increased serum HDL-C levels (1.89 vs. 0.24 mg/dL; P = 0.01). There was no significant difference between the 2 diets in waist-to-hip ratio, serum total cholesterol, serum LDL-C, systolic and diastolic blood pressure, fasting blood glucose, insulin levels, or the homeostasis model assessment for insulin resistance. IMPLICATIONS: Moderate carbohydrate replacement with dietary fats significantly improved weight, body mass index, waist circumference, hip circumference, serum triglyceride, and HDL-C levels among women with MetS. Iranian Registry of Clinical Trials identifier: IRCT20210307050621N1.


Subject(s)
Metabolic Syndrome , Female , Humans , Overweight/complications , Cardiometabolic Risk Factors , Single-Blind Method , Iran , Dietary Carbohydrates/adverse effects , Obesity , Body Mass Index , Blood Glucose/metabolism , Triglycerides , Risk Factors
6.
Trials ; 24(1): 323, 2023 May 11.
Article in English | MEDLINE | ID: covidwho-2314176

ABSTRACT

BACKGROUND: This protocol is for a multi-centre randomised controlled trial to determine whether the computer-aided system ENDOANGEL-GC improves the detection rates of gastric neoplasms and early gastric cancer (EGC) in routine oesophagogastroduodenoscopy (EGD). METHODS: Study design: Prospective, single-blind, parallel-group, multi-centre randomised controlled trial. SETTINGS: The computer-aided system ENDOANGEL-GC was used to monitor blind spots, detect gastric abnormalities, and identify gastric neoplasms during EGD. PARTICIPANTS: Adults who underwent screening, diagnosis, or surveillance EGD. Randomisation groups: 1. Experiment group, EGD examinations with the assistance of the ENDOANGEL-GC; 2. Control group, EGD examinations without the assistance of the ENDOANGEL-GC. RANDOMISATION: Block randomisation, stratified by centre. PRIMARY OUTCOMES: Detection rates of gastric neoplasms and EGC. SECONDARY OUTCOMES: Detection rate of premalignant gastric lesions, biopsy rate, observation time, and number of blind spots on EGD. BLINDING: Outcomes are undertaken by blinded assessors. SAMPLE SIZE: Based on the previously published findings and our pilot study, the detection rate of gastric neoplasms in the control group is estimated to be 2.5%, and that of the experimental group is expected to be 4.0%. With a two-sided α level of 0.05 and power of 80%, allowing for a 10% drop-out rate, the sample size is calculated as 4858. The detection rate of EGC in the control group is estimated to be 20%, and that of the experiment group is expected to be 35%. With a two-sided α level of 0.05 and power of 80%, a total of 270 cases of gastric cancer are needed. Assuming the proportion of gastric cancer to be 1% in patients undergoing EGD and allowing for a 10% dropout rate, the sample size is calculated as 30,000. Considering the larger sample size calculated from the two primary endpoints, the required sample size is determined to be 30,000. DISCUSSION: The results of this trial will help determine the effectiveness of the ENDOANGEL-GC in clinical settings. TRIAL REGISTRATION: ChiCTR (Chinese Clinical Trial Registry), ChiCTR2100054449, registered 17 December 2021.


Subject(s)
COVID-19 , Stomach Neoplasms , Adult , Humans , Computers , Multicenter Studies as Topic , Pilot Projects , Prospective Studies , SARS-CoV-2 , Single-Blind Method , Stomach Neoplasms/diagnosis , Treatment Outcome
7.
Clin Interv Aging ; 18: 143-155, 2023.
Article in English | MEDLINE | ID: covidwho-2292546

ABSTRACT

Purpose: We compared two different strategies providing professional coaching to administer an exercise program for women with postmenopausal osteoporosis (POP): individual training (IT) at home with trainer's supervision provided by telephone contacts at regular time-intervals or group training (GT) with trainer's live supervision. Our working hypothesis was that IT is a valid alternative to GT when GT is not feasible. Patients and Methods: This was a single-blind, randomized study. We recruited 52 women with POP, without significant comorbidity, and no participation in any structured exercise program within the previous 6 months. They were assigned randomly to IT or GT groups (n = 26 each). Distribution of age (IT: 68±4, GT: 67±8 years) and body mass index (IT: 23.0±2.5, GT: 21.4±5.1) was similar between groups. Each group performed the exercise program in two 1-hour sessions per week for 18 months. Primary outcome measure was Health-Related Quality of Life (HRQoL), as measured by the Short Osteoporosis Quality of Life Questionnaire. Secondary outcome measures focused on domains acknowledged to influence HRQoL (disability, fear of falling, weekly physical activity, physical function) or the effectiveness of the exercise program (retention, adherence, and safety). Significance level was set at p < 0.05. Results: No significant differences were observed between IT and GT groups for any domain. Retention, adherence, and safety were also similar. HRQoL, disability and fear of falling did not change between baseline and follow-up for either group. However, for both groups, physical function (knee flexion, shoulder mobility) and functional capacity (6-minute walking test) improved. Weekly physical activity levels increased from moderate range at baseline to intense at final assessment for both groups. Conclusion: IT and GT supervised exercise programs for women with POP provide similar effectiveness, participation and safety. Hence, both modalities should be considered for future translation in clinical practice of exercise recommendations for POP.


Subject(s)
Mentoring , Osteoporosis, Postmenopausal , Osteoporosis , Humans , Female , Aged , Exercise Therapy , Quality of Life , Single-Blind Method , Postmenopause , Fear , Exercise , Osteoporosis, Postmenopausal/therapy
8.
Hum Vaccin Immunother ; 19(1): 2203632, 2023 12 31.
Article in English | MEDLINE | ID: covidwho-2304772

ABSTRACT

Optimum formulation of Biological-E's protein subunit CORBEVAX™ vaccine was selected in phase-1 and -2 studies and found to be safe and immunogenic in healthy adult population. This is a phase-3 prospective, single-blinded, randomized, active controlled study conducted at 18 sites across India in 18-80 year-old subjects. This study has two groups; (i) immunogenicity-group, participants randomized either to CORBEVAX™ (n = 319) or COVISHIELD™ arms (n = 320). (ii) Safety-group containing single CORBEVAX™ arm (n = 1500) and randomization is not applicable. Healthy adults without a history of COVID-19 vaccination or SARS-CoV-2 infection were enrolled into immunogenicity arm and subjects seronegative to SARS-CoV-2 infection were enrolled into the safety arm. The safety profile of CORBEVAX™ vaccine was comparable to the comparator vaccine COVISHIELD™. Majority of reported AEs were mild in nature in both arms. The CORBEVAX™ to COVISHIELD™ GMT-ratios at day-42 time-point were 1·15 and 1·56 and the lower limit of the 95% confidence interval for the GMT-ratios was determined as 1·02 and 1·27 against Ancestral and Delta strains of SARS-COV-2 respectively. Both COVISHIELD™ and CORBEVAX™ vaccines showed comparable seroconversion post-vaccination against anti-RBD-IgG response. The subjects in CORBEVAX™ cohort also exhibited higher interferon-gamma secreting PBMC's post-stimulation with SARS-COV-2 RBD-peptides than subjects in COVISHIELD™ cohort.


Subject(s)
COVID-19 , Vaccines , Adult , Humans , Adolescent , Young Adult , Middle Aged , Aged , Aged, 80 and over , ChAdOx1 nCoV-19 , COVID-19 Vaccines/adverse effects , Leukocytes, Mononuclear , Prospective Studies , Single-Blind Method , COVID-19/prevention & control , SARS-CoV-2 , Immunogenicity, Vaccine , Antibodies, Viral , Antibodies, Neutralizing , Double-Blind Method
9.
J Infect ; 86(6): 574-583, 2023 06.
Article in English | MEDLINE | ID: covidwho-2303587

ABSTRACT

BACKGROUND: Heterologous COVID vaccine priming schedules are immunogenic and effective. This report aims to understand the persistence of immune response to the viral vectored, mRNA and protein-based COVID-19 vaccine platforms used in homologous and heterologous priming combinations, which will inform the choice of vaccine platform in future vaccine development. METHODS: Com-COV2 was a single-blinded trial in which adults ≥ 50 years, previously immunised with single dose 'ChAd' (ChAdOx1 nCoV-19, AZD1222, Vaxzevria, Astrazeneca) or 'BNT' (BNT162b2, tozinameran, Comirnaty, Pfizer/BioNTech), were randomised 1:1:1 to receive a second dose 8-12 weeks later with either the homologous vaccine, or 'Mod' (mRNA-1273, Spikevax, Moderna) or 'NVX' (NVX-CoV2373, Nuvaxovid, Novavax). Immunological follow-up and the secondary objective of safety monitoring were performed over nine months. Analyses of antibody and cellular assays were performed on an intention-to-treat population without evidence of COVID-19 infection at baseline or for the trial duration. FINDINGS: In April/May 2021, 1072 participants were enrolled at a median of 9.4 weeks after receipt of a single dose of ChAd (N = 540, 45% female) or BNT (N = 532, 39% female) as part of the national vaccination programme. In ChAd-primed participants, ChAd/Mod had the highest anti-spike IgG from day 28 through to 6 months, although the heterologous vs homologous geometric mean ratio (GMR) dropped from 9.7 (95% CI (confidence interval): 8.2, 11.5) at D28 to 6.2 (95% CI: 5.0, 7.7) at D196. The heterologous/homologous GMR for ChAd/NVX similarly dropped from 3.0 (95% CI:2.5,3.5) to 2.4 (95% CI:1.9, 3.0). In BNT-primed participants, decay was similar between heterologous and homologous schedules with BNT/Mod inducing the highest anti-spike IgG for the duration of follow-up. The adjusted GMR (aGMR) for BNT/Mod compared with BNT/BNT increased from 1.36 (95% CI: 1.17, 1.58) at D28 to 1.52 (95% CI: 1.21, 1.90) at D196, whilst for BNT/NVX this aGMR was 0.55 (95% CI: 0.47, 0.64) at day 28 and 0.62 (95% CI: 0.49, 0.78) at day 196. Heterologous ChAd-primed schedules produced and maintained the largest T-cell responses until D196. Immunisation with BNT/NVX generated a qualitatively different antibody response to BNT/BNT, with the total IgG significantly lower than BNT/BNT during all follow-up time points, but similar levels of neutralising antibodies. INTERPRETATION: Heterologous ChAd-primed schedules remain more immunogenic over time in comparison to ChAd/ChAd. BNT-primed schedules with a second dose of either mRNA vaccine also remain more immunogenic over time in comparison to BNT/NVX. The emerging data on mixed schedules using the novel vaccine platforms deployed in the COVID-19 pandemic, suggest that heterologous priming schedules might be considered as a viable option sooner in future pandemics. ISRCTN: 27841311 EudraCT:2021-001275-16.


Subject(s)
COVID-19 , Vaccines , Adult , Female , Humans , Male , COVID-19 Vaccines , ChAdOx1 nCoV-19 , BNT162 Vaccine , Pandemics , Single-Blind Method , COVID-19/prevention & control , Vaccination , Immunity , Immunoglobulin G , Antibodies, Viral
10.
J Surg Res ; 287: 134-141, 2023 07.
Article in English | MEDLINE | ID: covidwho-2273936

ABSTRACT

INTRODUCTION: We conducted a single-blind, prospective, randomized, 3-arm controlled trial to compare the efficacy of interactive and noninteractive video-based with instructor-led teaching in acquiring and retaining basic surgical skills. METHODS: Participants were pretested after providing written instruction using a simulator. After the pretest, students were randomized to three groups: noninteractive video-based instruction (NIVBI), instructor-led teaching with concurrent feedback, and interactive video-based instruction (IVBI). An immediate post-test and a retention test were performed 1 mo after the practice session's end to assess the efficacy of practice conditions. Two experts blinded to the experimental condition evaluated performance using expert-based assessment. Data were analyzed using SPSS. RESULTS: There were no differences in expert-based assessments between groups at the pretest. All three groups showed significant improvements in expert-based scores between the pretests and post-tests as well as between pretests and retention tests (P < 0.0001). Instructor-led teaching and IVBI were equally effective initially for teaching this skill to naive medical students and showed better performance than NIVBI (P < 0.0001 each). At retention, IVBI displayed superior performance compared to NIVBI and the instructor-led group (P < 0.0001 each). CONCLUSIONS: Our result showed that video-based instruction could be as effective as instructor-led teaching in acquiring basic surgical skills. These findings support the idea that with thoughtful incorporation into technical skill curricula, video-based instruction may efficiently use faculty time and serve as a helpful adjunct for basic surgical skills training.


Subject(s)
Students, Medical , Humans , Prospective Studies , Single-Blind Method , Clinical Competence , Curriculum , Teaching
11.
Int J Environ Res Public Health ; 20(5)2023 02 24.
Article in English | MEDLINE | ID: covidwho-2283998

ABSTRACT

This study examined whether the moisture control innovation (tongue and cheek retractors and saliva contamination (SS-suction)) used without dental assistance could improve the quality of dental sealant in rural Thai school children compared to a standard treatment, i.e., high power suction with dental assistance. A single blind, cluster randomized controlled trial was conducted. Participants were 15 dental nurses working in sub-district health promoting hospitals and 482 children. All dental nurses attended workshops of SS-suction and revised dental sealant procedures. Children with sound lower first permanent molar teeth were simple-randomly assigned to either an intervention or control group. The children in the intervention group were sealed with SS-suction, and the children in the control group were sealed with high power suction and dental assistance. There were 244 children in the intervention group and 238 children in the control group. Dental nurses' satisfaction on SS-suction was record by visual analogue scale (VAS) for each tooth during treatment. After 15-18 months, caries on sealed surfaces were examined. The results showed that the median satisfaction score of SS-suction was 9 out of 10, and 17-18% children experienced uncomfortable sensation during insertion or removal. The uncomfortable feeling disappeared once the suction was in place. Caries on sealed surfaces did not differ significantly between the intervention and control groups. Caries on the occlusal surface was present in 26.7% and 27.5%, and caries on the buccal surface was present in 35.2% and 36.4% of cases in the intervention and control groups, respectively. In conclusion, dental nurses were satisfied with SS-suction in terms of both function and safety. The effectiveness of SS-suction was compatible with the standard procedure after 15-18 months.


Subject(s)
Dental Caries , Pit and Fissure Sealants , Child , Humans , Single-Blind Method , Suction , Molar , Thailand
12.
Jpn J Nurs Sci ; 20(3): e12533, 2023 Jul.
Article in English | MEDLINE | ID: covidwho-2287856

ABSTRACT

AIMS: This study was conducted with the aim of examining the effect on pain intensity of the vibration technique applied at the injection site and squeezing a stress ball during the administration of Pfizer-BioNTech COVID-19 vaccination. METHODS: This was a randomized controlled single-blind experimental study. The study included 120 adults who were randomly selected between July and November 2022. One experimental group (n = 40) received local vibration by means of a Buzzy® device, and the other (n = 40) were given a stress ball to squeeze. Routine vaccination procedure was performed with the control group (n = 40). The level of pain felt during the vaccination procedure was assessed on a visual analog scale. RESULTS: The pain score of individuals during the vaccination procedure was found to be significantly lower in the vibration group than in the control group (P = .005) and the stress ball group (P = .036), but there was no significant difference between the control and stress ball groups (P = .851). Also, it was found that the variables of gender, age and body mass index did not affect the average pain intensity of individuals during the vaccination procedure. CONCLUSIONS: It was found that local vibration applied by means of the Buzzy® device was effective in reducing the levels of pain relating to administration of the Pfizer-BioNTech COVID-19 vaccination. Nurses should think of the application of vibration as a choice in the management of pain relating to Pfizer-BioNTech COVID-19 vaccination.


Subject(s)
BNT162 Vaccine , COVID-19 , Adult , Humans , Pain Management , COVID-19 Vaccines , Single-Blind Method , COVID-19/prevention & control , Pain
13.
J Diabetes Complications ; 37(4): 108436, 2023 04.
Article in English | MEDLINE | ID: covidwho-2251594

ABSTRACT

BACKGROUND: Pulse wave velocity (PWV) and augmentation index (AIx) are indices used to assess arterial stiffness. We aim to compare the effect of empagliflozin, liraglutide and their sequential combination on arterial stiffness indices in patients with type 2 diabetes (T2D). METHODS: This was a randomized single blind study evaluating the effect of empagliflozin vs liraglutide in adult patients with T2D. Patients were randomized to liraglutide titrated gradually to 1.8 mg or empagliflozin 25 mg in 1:1 ratio. Three months later empagliflozin was added to the liraglutide group, and liraglutide was added to the empagliflozin group. Patients were assessed with non-invasive tests for arterial stiffness (i.e., carotid-femoral PWV and AIx of aortic pressure) at baseline, 3-month and 9-month visits (final visit was extended for 3 months from the initial design due to Covid 19 pandemic). The primary outcome was the between-group difference of PWV change (ΔPWV) and ΔAIx at 3 months. Secondary outcomes included the between-group difference of ΔPWV and ΔAIx at 9 months, as well as the ΔPWV and ΔAIx between baseline and 9-month visit when total study population was assessed. RESULTS: A total of 62 patients with T2D (30 started liraglutide; 32 empagliflozin, mean age 63 years, 25 % with established cardiovascular disease) participated in the study. We failed to show any significant between-group differences of ΔPWV and ΔΑΙx at 3 and 9 months, as well as between-group difference of ΔPWV and ΔAIx for the total study population between baseline and 9-month visit. In contrast, systemic vascular resistance and lipoprotein(a) levels improved, showing better results with liraglutide than empagliflozin. Favorable effects were also observed on body weight, body mass index, body and visceral fat, blood pressure, HbA1c, and uric acid levels. CONCLUSION: No evidence of a favorable change in arterial stiffness indices was seen with empagliflozin or liraglutide or their combination in this study. Well-designed powerful studies are needed to address any potential effects on arterial stiffness in selected populations.


Subject(s)
COVID-19 , Cardiovascular Diseases , Diabetes Mellitus, Type 2 , Sodium-Glucose Transporter 2 Inhibitors , Vascular Stiffness , Humans , Middle Aged , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/prevention & control , Cardiovascular Diseases/complications , COVID-19/complications , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/drug therapy , Liraglutide/adverse effects , Prospective Studies , Pulse Wave Analysis , Single-Blind Method , Sodium-Glucose Transporter 2 Inhibitors/therapeutic use , Sodium-Glucose Transporter 2 Inhibitors/pharmacology
14.
Respir Res ; 24(1): 58, 2023 Feb 18.
Article in English | MEDLINE | ID: covidwho-2261821

ABSTRACT

BACKGROUND: Acute respiratory distress syndrome (ARDS) results in significant hypoxia, and ARDS is the central pathology of COVID-19. Inhaled prostacyclin has been proposed as a therapy for ARDS, but data regarding its role in this syndrome are unavailable. Therefore, we investigated whether inhaled prostacyclin would affect the oxygenation and survival of patients suffering from ARDS. METHODS: We performed a prospective randomized controlled single-blind multicenter trial across Germany. The trial was conducted from March 2019 with final follow-up on 12th of August 2021. Patients with moderate to severe ARDS were included and randomized to receive either inhaled prostacyclin (3 times/day for 5 days) or sodium chloride (Placebo). The primary outcome was the oxygenation index in the intervention and control groups on Day 5 of therapy. Secondary outcomes were mortality, secondary organ failure, disease severity and adverse events. RESULTS: Of 707 patients approached 150 patients were randomized to receive inhaled prostacyclin (n = 73) or sodium chloride (n = 77). Data from 144 patients were analyzed. The baseline PaO2/FiO2 ratio did not differ between groups. The primary analysis of the study was negative, and prostacyclin improved oxygenation by 20 mmHg more than Placebo (p = 0.17). Secondary analysis showed that the oxygenation was significantly improved in patients with ARDS who were COVID-19-positive (34 mmHg, p = 0.04). Mortality did not differ between groups. Secondary organ failure and adverse events were similar in the intervention and control groups. CONCLUSIONS: The primary result of our study was negative. Our data suggest that inhaled prostacyclin might be beneficial treatment in patients with COVID-19 induced ARDS. TRIAL REGISTRATION: The study was approved by the Institutional Review Board of the Research Ethics Committee of the University of Tübingen (899/2018AMG1) and the corresponding ethical review boards of all participating centers. The trial was also approved by the Federal Institute for Drugs and Medical Devices (BfArM, EudraCT No. 2016003168-37) and registered at clinicaltrials.gov (NCT03111212) on April 6th 2017.


Subject(s)
COVID-19 , Respiratory Distress Syndrome , Humans , Epoprostenol/adverse effects , Prospective Studies , Single-Blind Method , Sodium Chloride , Prostaglandins I , Respiratory Distress Syndrome/diagnosis , Respiratory Distress Syndrome/drug therapy
15.
BMC Health Serv Res ; 23(1): 199, 2023 Feb 24.
Article in English | MEDLINE | ID: covidwho-2267885

ABSTRACT

BACKGROUND: In high-resource settings, structured diabetes self-management education is associated with improved outcomes but the evidence from low-resource settings is limited and inconclusive. AIM: To compare, structured diabetes self-management education to usual care, in adults with type 2 diabetes, in low-resource settings. DESIGN: Single-blind randomised parallel comparator controlled multi-centre trial. Adults (> 18 years) with type 2 diabetes from two hospitals in urban Ghana were randomised 1:1 to usual care only, or usual care plus a structured diabetes self-management education program. Randomisation codes were computer-generated, and allotment concealed in opaque numbered envelopes. The intervention effect was assessed with linear mixed models. MAIN OUTCOME: Change in HbA1c after 3-month follow-up. Primary analysis involved all participants. CLINICALTRIAL: gov identifier:NCT04780425, retrospectively registered on 03/03/2021. RESULTS: Recruitment: 22nd until 29th January 2021. We randomised 206 participants (69% female, median age 58 years [IQR: 49-64], baseline HbA1c median 64 mmol/mol [IQR: 45-88 mmol/mol],7.9%[IQR: 6.4-10.2]). Primary outcome data was available for 79 and 80 participants in the intervention and control groups, respectively. Reasons for loss to follow-up were death (n = 1), stroke(n = 1) and unreachable or unavailable (n = 47). A reduction in HbA1c was found in both groups; -9 mmol/mol [95% CI: -13 to -5 mmol/mol], -0·9% [95% CI: -1·2% to -0·51%] in the intervention group and -3 mmol/mol [95% CI -6 to 1 mmol/mol], -0·3% [95% CI: -0·6% to 0.0%] in the control group. The intervention effect was 1 mmol/mol [95%CI:-5 TO 8 p = 0.726]; 0.1% [95% CI: -0.5, 0.7], p = 0·724], adjusted for site, age, and duration of diabetes. No significant harms were observed. CONCLUSION: In low-resource settings, diabetes self-management education might not be associated with glycaemic control. Clinician's expectations from diabetes self-management education must therefore be guarded.


Subject(s)
Diabetes Mellitus, Type 2 , Self-Management , Adult , Humans , Female , Middle Aged , Male , Glycated Hemoglobin , Glycemic Control , Single-Blind Method
16.
J Craniomaxillofac Surg ; 50(12): 923-928, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-2257888

ABSTRACT

This study focused on the effects of teriparatide (CinnoPar) on healing and postoperative complications in mandibular bone fractures. In this single-blind randomized controlled trial, 30 patients with a mandibular fracture hospitalized for open reduction internal fixation were randomly assigned to the intervention (I) (n = 15) and control (C) (n = 15) groups. Both groups received daily acetaminophen and cephalexin for 1 week. For 1 month, Group I received daily subcutaneous teriparatide injections. The Radiographic Union Scale of the Mandible (RUSM) was used to assess mandibular bone fusion subjectively, and the Hounsfield unit (HU) was used to objectively assess radiodensity in a computed tomography (CT) scan. In both groups, the visual analog scale (VAS) score was used to assess postoperative complications such as pain, swelling, wound opening, pus secretion, and bitter taste. There was no significant difference in bone repair between the two groups in this study (P > 0.05). Teriparatide also had no effect on the postoperative complication rate in the control group (P > 0.05). Within the limitations of the study it seems that in mandibular fractures, teriparatide did not affect bone fusion or postoperative complications, so its use is not recommended for better bone fusion and fewer postoperative complications of mandibular fracture during the first month.


Subject(s)
Bone Density Conservation Agents , Mandibular Fractures , Humans , Teriparatide/therapeutic use , Mandibular Fractures/diagnostic imaging , Mandibular Fractures/drug therapy , Mandibular Fractures/surgery , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/pharmacology , Single-Blind Method , Postoperative Complications/prevention & control
17.
PLoS One ; 18(1): e0268428, 2023.
Article in English | MEDLINE | ID: covidwho-2224420

ABSTRACT

BACKGROUND: Pulmonary physiotherapy (PPT) is an important treatment in the management of patients with different types of pulmonary disorders. We aimed to evaluate safety and efficacy of PPT in hospitalized patients with severe COVID-19 pneumonia. METHODS: In this randomised, single-blind, controlled trial, we enrolled hospitalized, non-intubated patients (18 to 75 years with oxygen saturation (Spo2) in free-air breathing ≤90%) with COVID-19 pneumonia at a referral hospital. Participants were randomly assigned (1:1) to receive PPT (six sessions PPT with breathing exercises and airway clearance techniques) or basic care. The primary outcomes were venous blood O2 (pO2) and CO2 (pCO2) pressures, Spo2, and three-minute walking test (3MWT) that were assessed before and end of sixth session. Secondary outcomes included level of dyspnea, venous blood PH, one-month mortality, three-month mortality and short form-36 (SF-36) after one and three months. The assessor was blinded to the assignment. This trial is registered with ClinicalTrials.gov (NCT04357340). FINDINGS: In April-May 2020, 40 participants were randomly assigned to PPT or basic care groups. While at the end of intervention, pO2 (adjusted mean difference to baseline measure (AMD) 6.43 mmHg [95%CI 2.8, 10.07], P<0.01), Spo2 (AMD 4.43% [95%CI 2.04, 6.83], P = 0.0011), and 3MTW (AMD 91.44 m [95%CI 68.88, 113.99], P<0.01) were higher in PPT group and basic care group, pCO2 was not improved (AMD -2.1 mmHg [95%CI-6.36, 2.21], P = 0.33). Based on the logistic model adjusted to baseline Spo2, the risks of mortality were reduced 81% ([95%CI: 97% reduction to 30% increase], P = .09) and 84% ([95%CI 74% reduction to 5% increase], P = .06) at one-month and three-month, respectively. There were no significant differences in most SF-36 domains scores after one and three months. No serious adverse event was observed during PPT sessions. CONCLUSION: Early PPT can be considered a safe and relatively effective therapeutic choice for patients with severe COVID-19.


Subject(s)
COVID-19 , Humans , COVID-19/therapy , SARS-CoV-2 , Prospective Studies , Single-Blind Method , Physical Therapy Modalities , Treatment Outcome
18.
Trials ; 24(1): 61, 2023 Jan 26.
Article in English | MEDLINE | ID: covidwho-2214624

ABSTRACT

INTRODUCTION: Many adults hospitalised with COVID-19 have persistent symptoms such as fatigue, breathlessness and brain fog that limit day-to-day activities. These symptoms can last over 2 years. Whilst there is limited controlled studies on interventions that can support those with ongoing symptoms, there has been some promise in rehabilitation interventions in improving function and symptoms either using face-to-face or digital methods, but evidence remains limited and these studies often lack a control group. METHODS AND ANALYSIS: This is a nested single-blind, parallel group, randomised control trial with embedded qualitative evaluation comparing rehabilitation (face-to-face or digital) to usual care and conducted within the PHOSP-COVID study. The aim of this study is to determine the effectiveness of rehabilitation interventions on exercise capacity, quality of life and symptoms such as breathlessness and fatigue. The primary outcome is the Incremental Shuttle Walking Test following the eight week intervention phase. Secondary outcomes include measures of function, strength and subjective assessment of symptoms. Blood inflammatory markers and muscle biopsies are an exploratory outcome. The interventions last eight weeks and combine symptom-titrated exercise therapy, symptom management and education delivered either in a face-to-face setting or through a digital platform ( www.yourcovidrecovery.nhs.uk ). The proposed sample size is 159 participants, and data will be intention-to-treat analyses comparing rehabilitation (face-to-face or digital) to usual care. ETHICS AND DISSEMINATION: Ethical approval was gained as part of the PHOSP-COVID study by Yorkshire and the Humber Leeds West Research NHS Ethics Committee, and the study was prospectively registered on the ISRCTN trial registry (ISRCTN13293865). Results will be disseminated to stakeholders, including patients and members of the public, and published in appropriate journals. Strengths and limitations of this study • This protocol utilises two interventions to support those with ongoing symptoms of COVID-19 • This is a two-centre parallel-group randomised controlled trial • The protocol has been supported by patient and public involvement groups who identified treatments of symptoms and activity limitation as a top priority.


Subject(s)
COVID-19 , Adult , Humans , Quality of Life , Single-Blind Method , Dyspnea , Fatigue/diagnosis , Fatigue/etiology , Randomized Controlled Trials as Topic
19.
Trials ; 24(1): 48, 2023 Jan 20.
Article in English | MEDLINE | ID: covidwho-2214623

ABSTRACT

BACKGROUND: Cognitive difficulties experienced by people with multiple sclerosis (MS) impact on quality of life and daily functioning, from childcare and work to social and self-care activities. The Cognitive Occupation-Based programme for people with MS (COB-MS) was developed as a holistic, individualised cognitive rehabilitation intervention to address the wide-ranging symptoms and functional difficulties that present in MS, including the ability to maintain employment, social activities, home management and self-care. The aim of the research is to evaluate the feasibility and preliminary efficacy of COB-MS for people with MS. METHODS: Due to the impacts of COVID-19, trial activities that were planned for in-person delivery were completed remotely. One hundred and twenty people with MS will be assigned to participate in either the COB-MS programme or a treatment-as-usual, wait-list control group as part of this single-blind, cluster-randomised controlled feasibility and preliminary efficacy trial of the COB-MS programme. The COB-MS group will participate in an eight-session occupational-based cognitive rehabilitation programme over 9 weeks. The COB-MS intervention was planned for in-person delivery but was delivered online by occupational therapists to small groups of people with MS. The primary outcome measure is the Goal Attainment Scaling at 12 weeks. Participants will be assessed pre-intervention, post-intervention, 12 weeks post-intervention and 6 months post-intervention. Qualitative evaluations of participants' perspectives will also be examined as part of the feasibility study. Data, due to be collected in-person, was collected online or by post. The original study design, including the statistical analysis plan, remains unchanged despite the shift to a remote trial conduct. DISCUSSION: Results will provide recommendations for a future definitive trial of COB-MS, with respect to both feasibility and preliminary, clinical efficacy. TRIAL REGISTRATION: ISRCTN ISRCTN11462710 . Registered on 9 September 2019 and updated on 23 September 2020 to account for changes outlined here.


Subject(s)
COVID-19 , Multiple Sclerosis , Humans , Multiple Sclerosis/diagnosis , Multiple Sclerosis/therapy , Feasibility Studies , Quality of Life , Single-Blind Method , Cognition , Occupations , Randomized Controlled Trials as Topic
20.
Lancet ; 401(10376): 557-567, 2023 02 18.
Article in English | MEDLINE | ID: covidwho-2211739

ABSTRACT

BACKGROUND: Metabolic acidosis is common in kidney transplant recipients and is associated with declining graft function. Sodium bicarbonate treatment effectively corrects metabolic acidosis, but no prospective studies have examined its effect on graft function. Therefore, we aimed to test whether sodium bicarbonate treatment would preserve graft function and slow the progression of estimated glomerular filtration rate (GFR) decline in kidney transplant recipients. METHODS: The Preserve-Transplant Study was a multicentre, randomised, single-blind, placebo-controlled, phase 3 trial at three University Hospitals in Switzerland (Zurich, Bern, and Geneva), which recruited adult (aged ≥18 years) male and female long-term kidney transplant recipients if they had undergone transplantation more than 1 year ago. Key inclusion criteria were an estimated GFR between 15 mL/min per 1·73 m2 and 89 mL/min per 1·73 m2, stable allograft function in the last 6 months before study inclusion (<15% change in serum creatinine), and a serum bicarbonate of 22 mmol/L or less. We randomly assigned patients (1:1) to either oral sodium bicarbonate 1·5-4·5 g per day or matching placebo using web-based data management software. Randomisation was stratified by study centre and gender using a permuted block design to guarantee balanced allocation. We did multi-block randomisation with variable block sizes of two and four. Treatment duration was 2 years. Acid-resistant soft gelatine capsules of 500 mg sodium bicarbonate or matching 500 mg placebo capsules were given at an initial dose of 500 mg (if bodyweight was <70 kg) or 1000 mg (if bodyweight was ≥70 kg) three times daily. The primary endpoint was the estimated GFR slope over the 24-month treatment phase. The primary efficacy analyses were applied to a modified intention-to-treat population that comprised all randomly assigned participants who had a baseline visit. The safety population comprised all participants who received at least one dose of study drug. The trial is registered with ClinicalTrials.gov, NCT03102996. FINDINGS: Between June 12, 2017, and July 10, 2019, 1114 kidney transplant recipients with metabolic acidosis were assessed for trial eligibility. 872 patients were excluded and 242 were randomly assigned to the study groups (122 [50%] to the placebo group and 120 [50%] to the sodium bicarbonate group). After secondary exclusion of two patients, 240 patients were included in the intention-to-treat analysis. The calculated yearly estimated GFR slopes over the 2-year treatment period were a median -0·722 mL/min per 1·73 m2 (IQR -4·081 to 1·440) and mean -1·862 mL/min per 1·73 m2 (SD 6·344) per year in the placebo group versus median -1·413 mL/min per 1·73 m2 (IQR -4·503 to 1·139) and mean -1·830 mL/min per 1·73 m2 (SD 6·233) per year in the sodium bicarbonate group (Wilcoxon rank sum test p=0·51; Welch t-test p=0·97). The mean difference was 0·032 mL/min per 1·73 m2 per year (95% CI -1·644 to 1·707). There were no significant differences in estimated GFR slopes in a subgroup analysis and a sensitivity analysis confirmed the primary analysis. Although the estimated GFR slope did not show a significant difference between the treatment groups, treatment with sodium bicarbonate effectively corrected metabolic acidosis by increasing serum bicarbonate from 21·3 mmol/L (SD 2·6) to 23·0 mmol/L (2·7) and blood pH from 7·37 (SD 0·06) to 7·39 (0·04) over the 2-year treatment period. Adverse events and serious adverse events were similar in both groups. Three study participants died. In the placebo group, one (1%) patient died from acute respiratory distress syndrome due to SARS-CoV-2 and one (1%) from cardiac arrest after severe dehydration following diarrhoea with hypotension, acute kidney injury, and metabolic acidosis. In the sodium bicarbonate group, one (1%) patient had sudden cardiac death. INTERPRETATION: In adult kidney transplant recipients, correction of metabolic acidosis by treatment with sodium bicarbonate over 2 years did not affect the decline in estimated GFR. Thus, treatment with sodium bicarbonate should not be generally recommended to preserve estimated GFR (a surrogate marker for graft function) in kidney transplant recipients with chronic kidney disease who have metabolic acidosis. FUNDING: Swiss National Science Foundation.


Subject(s)
Acidosis , COVID-19 , Kidney Transplantation , Adult , Humans , Male , Female , Adolescent , Sodium Bicarbonate/therapeutic use , Bicarbonates/therapeutic use , Switzerland , Kidney Transplantation/adverse effects , Single-Blind Method , Double-Blind Method , SARS-CoV-2 , Acidosis/drug therapy , Acidosis/etiology , Treatment Outcome
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