Parallel Arms Research Articles

Effect of a patient education program focused on weight stigma on quality of life and self-efficacy in patients living with obesity: study protocol for a randomized controlled trial

BackgroundAfter a literature review and interviews with patients living with obesity, key psychosocial determinants such as coping strategies, weight bias internalization, body dissatisfaction and self-efficacy were identified as critical to address obesity-related stigma. The intervention was tailored using evidence-based techniques and input from health professionals to ensure relevance and avoid redundancy. This randomized controlled trial (RCT) aims to evaluate the effect of an intervention specifically designed to address weight stigma among individuals living with obesity.MethodsThe study compares two parallel arms following different interventions: Patient Education as Usual (PEU) program and the newly developed Patient Education STEREOBES (PES) program, which integrates additional components to counteract weight stigma. The PES program, crafted using the Intervention Mapping process, addresses key psychosocial determinants such as self-efficacy, body image, and coping strategies. It incorporates workshops focused on psychoeducation, physical activity, and emotional regulation through innovative techniques like mindfulness, assertiveness training, and Acceptance and Commitment Therapy (ACT). The program emphasizes group activities and patient interaction to foster resilience against stigmatizing experiences and promote healthier lifestyle choices. This comprehensive intervention is designed to improve psychological, behavioral, and physical outcomes, particularly by reducing the internalization of weight bias and enhancing coping mechanisms.DiscussionPatients in the PES arm should demonstrate significant improvements in quality of life and self-efficacy compared to the PEU arm. Psychosocial factors should mediate the effect of the intervention on the outcomes involving quality of life and behaviors. This study will provide valuable insights into the role of weight stigma in obesity treatment and the effectiveness of targeted interventions.Trial registrationThis research protocol has been approved by the Individual Protection Committee Northwest IV (National n°2023-A00327-38) and registered on Clinicaltrial.gov (NCT05906238) on June 7, 2023.

Empathetic solicitude attenuates the affective and sensory dimensions of CO2-induced dyspnea: A randomized parallel arm experimental trial in healthy humans.

Dyspnea testifies to profound suffering in patients and its relief is a priority for caregivers. This can be achieved by correcting causative disorders ("etiopathogenic" approach) or targeting the dyspnea itself ("symptomatic" approach), as is done for pain. Empathetic solicitude from caregivers has an intrinsic analgesic effect, but its effects on dyspnea have not been formally documented. This study tests the hypothesis that the empathetic solicitude behavior of a caregiver during experimental induction of acute and intense dyspnea would have a mitigating effect. In a double-blind, randomized, controlled experimental trial, 80 healthy participants were assigned to a neutral behavior arm or a solicitude behavior arm. During two successive visits (V1 and V2), dyspnea was induced through CO2-rebreathing and (i) assessed in an immediate manner using 10 cm affective and sensory visual analog scales (A-VAS and S-VAS) and (ii) post hoc using the Multidimensional Dyspnea Profile (MDP). A-VAS ratings at the end of the dyspnea challenge were significantly lower at V2 in the "solicitude behavior" arm than in the "neutral behavior" arm (6.69 [3.825-9.67] vs. 8.05 [6.43-10], p = 0.039). There were no significant differences between arms regarding S-VAS. MDP analysis showed that CO2-rebreathing induced dyspnea of the air hunger type, with statistically significant reductions in its intensity and both the sensory and affective dimensions of dyspnea. This study shows that empathetic solicitude can reduce the affective and sensory dimensions of experimentally induced dyspnea in healthy volunteers. Future studies should evaluate the impact of empathetic solicitude on clinical dyspnea.

An upcycled dietary fiber rich in bioactives from hemp hulls supports digestive comfort in healthy adults: Randomized, placebo-controlled trial

Background: Dietary fiber is a key component of a health-promoting diet, and it is acknowledged as a short-fall nutrient in most Western diets. Some sources of dietary fiber, such as hemp hull fiber, also include inherent small molecule bioactive that further promote health and well-being. While dietary fiber is a key component that supports digestive health, certain types of fiber can cause digestive discomfort. Digestive symptoms such as gas, bloating, belly pain, and the resulting decrease in digestive quality of life are common among adults. Objective: The aim of this study was to evaluate changes in digestive comfort, after consuming a proprietary dietary fiber supplement from hemp hull to a dietary fiber supplement made from inulin in individuals who currently experience digestive discomfort. Methods: This study was a completely virtual, double-blind, placebo-controlled, randomized clinical trial of healthy adults. The parallel arm study tested two fiber supplements at a practical dose yielding a “Good Source of Fiber” based on United States Dietary Reference Intakes (2.8 grams of fiber per day) and a digestible control (Maltodextrin) for six weeks. The study is registered at ClinicalTrials.gov: NCT06009614. Results: Five hundred seventy-nine randomized participants provided follow-up outcomes data. Digestion-associated quality of life questionnaire, belly pain, and gas and bloating scores were assessed and found to be superior after hemp hull fiber intake compared to inulin intake at multiple time points (p<0.05). Conclusion: This study demonstrated that a practical dose of bioactive-rich fiber from hemp hull is well-tolerated, provides superior digestive comfort relative to both placebo and inulin fiber, and can aid in reaching total fiber intake goals. Keywords: dietary fiber; hemp hull fiber; inulin; digestive tolerance; gas, bloating; abdominal pain

Phase II Parallel Arm Study of Sacituzumab Govitecan-Hziy in Patients with Advanced Thymoma or Thymic Carcinoma

BackgroundThymic epithelial tumors (TETs), including thymoma and thymic carcinoma, are rare thoracic tumors of the anterior mediastinum. For those with advanced disease, platinum-based chemotherapy is used as first-line treatment. However, there is no standard regimen established for TET at progression after initial therapy, and treatment options for advanced/recurrent TETs are limited. Trop-2, a transmembrane glycoprotein, is overexpressed in solid tumors including thymomas and thymic carcinomas. Sacituzumab govitecan-hziy, a Trop-2-directed antibody-drug conjugate, has shown efficacy and safety in several tumors including breast cancer. The overexpression of Trop-2 in TETs and the clinical efficacy in other malignancies provide rationale for exploring its use in thymoma and thymic carcinoma. MethodsThis open-label, single-arm, parallel cohort, multi-center study assesses the safety and efficacy of sacituzumab govitecan-hziy in patients with advanced thymoma (cohort A) and thymic carcinoma (cohort B) who have received at least one prior line of systemic therapy (NCT06248515). The study employs a Simon optimal two-stage design, enrolling patients with adequate performance status, measurable disease, and adequate organ function. Sacituzumab govitecan-hziy is administered at a fixed dose of 10 mg/kg weekly on days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity. Follow-up continues every 6 months for 2 years post-discontinuation. Archival tissue is obtained prior to initiation of study treatment with an optional biopsy at the time of progression. In cases where archival tissue is not available, a fresh biopsy is obtained at baseline. The primary endpoint is investigator-assessed response rate using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST) criteria, with tumor imaging assessments every 2 cycles during the first 3 months and every 3 cycles thereafter. Secondary endpoints comprise adverse events by Common Terminology Criteria for Adverse Events v5.0, median and 6-month progression-free survival, duration of response, and overall survival. For each cohort, 9 patients will be enrolled. If 0 of the 9 achieve a response, no further patients will be enrolled in that cohort. If 1 or more of the first 9 patients has a response, accrual will continue until a total of 17 patients have been enrolled in that cohort.

Effectiveness of the community paramedicine at home (CP@home) program for frequent users of emergency medical services in Ontario: a randomized controlled trial

ObjectiveTo evaluate the impact of the Community Paramedicine at Home (CP@home) program, a community paramedicine home-visit intervention, on reducing emergency medical services (EMS) calls among frequent users.DesignA 6-month, open-label, pragmatic, randomized controlled trial with parallel intervention and control arms. An online automated platform (randomizer.org) was used to randomly allocate participants using a 1:1 allocation sequence.SettingIn homes of frequent EMS users in four paramedic services and regions across Ontario, Canada.ParticipantsEligible participants were frequent callers (≥ 3 EMS calls within six months and ≥ 1 EMS call within the previous month), or had ≥ 1 lift assist call within the previous month, or were referred by paramedics.InterventionCommunity paramedics conducted risk assessments, provided health education, referred appropriate resources, and reported to family physicians for up to three home visits. The control arm received usual care.Primary outcome measureEMS calls in 6 months during intervention.ResultsTwo thousand two hundred eighty four eligible participants were randomly allocated to the intervention and control groups, with 265 participants lost to follow-up due to inability to retrieve participant records from EMS databases. There were 1025 intervention participants (52.7% female, mean age 69.65 years [standard deviation (SD) = 19.98]) and 994 control participants (52.0% female, mean age 69.78 years [SD = 19.09]). In the post-intervention intention-to-treat analysis (zero-inflated negative binomial regression), the EMS call rate was not significantly lower in the intervention group compared to the control group (incidence rate ratio [IRR] = 0.88, 95% confidence interval [CI]: 0.76, 1.01). In the subgroup analysis, the intervention had a significant effect in the lift assist caller subgroup (IRR = 0.73, 95% CI: 0.58, 0.92), but no significant effect among the frequent caller subgroup (IRR = 0.97, 95% CI: 0.82, 1.14). The sensitivity analyses found a similar association for the lift assist caller subgroup. There was a significant subgroup effect (p-value for interaction < 0.01).ConclusionsCP@home had a significant impact on reducing EMS calls for those with a lift assist call but not for the overall sample. This program filled a healthcare gap by shifting primary care delivery, which could reduce the disproportionate number of EMS calls, thus reducing healthcare costs.Trial registrationRegistered with ClinicalTrials.gov NCT02835989 on July 14, 2016.

Optimizing Neoadjuvant Treatment Response Prediction for Triple-Negative Breast Cancer Using Clinical Trial Data and Deep Auxiliary Learning.

Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer with limited treatment options and poor prognosis. Developing predictive models for TNBC treatment responses is crucial but challenging due to data scarcity and the reliance on cell line data, which limits clinical translational value. Leveraging omics data from clinical trials, particularly through auxiliary learning, offers a potential solution to enhance predictive accuracy and reduce data requirements. In this study, we propose a new approach utilizing deep auxiliary task reweighting learning methods to automatically reweight auxiliary tasks, thereby optimizing the performance of the primary task of predicting TNBC treatment responses. We benchmark various auxiliary learning methods, including ARML, AdaLoss, GradNorm, and OL AUX, against traditional supervised machine learning algorithms and single-task learning baselines. Our results characterize the performance of auxiliary learning across various contexts, including utilizing parallel treatment arms within a multi-arm clinical trial, leveraging treatment arms from different clinical trials, and integrating multiple arms with the same treatment regimens across separate clinical trials. The last scenario also provides an opportunity for validating prediction models on an independent dataset, demonstrating the superior performance of the auxiliary learning models in predicting pathological complete response (pCR) in TNBC patients treated with standardized combinational chemotherapy with Taxane, Anthracycline, and Cyclophosphamide (TAC). Source code and additional resources can be accessed at https://github.com/moonchangin/DeepAux TxPred TNBC.

Lefamulin for Mycoplasma genitalium treatment failure in Australia and the USA: a case series and pilot open-label parallel arm randomised trial

ObjectivesMycoplasma genitalium (MG) causes urethritis and is associated with cervicitis, pelvic inflammatory disease and preterm delivery. Antimicrobial resistance is widespread and cure rates are declining. Lefamulin, a novel pleuromutilin, may...

Reevaluating antibiotic prophylaxis: insights from a network meta-analysis on dry socket and surgical site infections.

Three databases (MEDLINE, Cochrane Library, and Scopus) were searched in December 2021 for 16 Randomised Clinical Trials (RCTs). Three reviewers reviewed the articles on oral antibiotic prophylaxis (ABP) for the prevention of surgical site infection (SSI) and dry socket (DS) after lower third molar (L3M) extraction using the PICO framework. From 1999 to 2021, RCTs involving healthy patients undergoing L3M extraction with ABP, placebo, or no therapy were included. Adverse effects (AEs) associated with antibiotic usage, along with the main outcomes (DS and SSI), were also documented. Three independent investigators selected articles based on pre-established inclusion criteria, with any disagreements resolved by consensus or additional researchers. PRISMA guidelines were followed, involving initial title and abstract screening, followed by full-text evaluation. Exclusion reasons were documented, and the most recent report was included when multiple reports on the same patients were found, with no language restrictions applied. Two investigators evaluated studies quality and quality of evidence respectively using the Cochrane Collaboration tool and GRADEpro GDT. They independently extracted data, focusing on the type of extraction and the number of extracted L3M. They also detailed the use of antibiotics, including dosage, dosage regimen, timing, and duration. Among 16 articles, 15 used a parallel arm design, while one used a crossover design. The antibiotics studied included Amoxicillin+Clavulanic acid (7 articles), Amoxicillin (6), Metronidazole (2), Azithromycin (1), and Clindamycin (2), all compared with no treatment or placebo. A pairwise meta-analysis was used to combine studies with equivalent treatment (direct estimation), and a network meta-analysis compared outcome variables across different treatments (indirect comparison). Two included articles had a low risk of bias and the level of evidence was low according to GRADE. Pooled results supported the use of antibiotics to reduce DS and SSI following L3M extraction with a number needed to treat 25 and 18, respectively. Despite the fact that ABP reduces the risk of DS and SSI, it is recommended to consider systemic conditions and individual patient risk factors before prescribing antibiotics, due to global health threat.

Phase IV adaptive randomised clinical trials evaluating efficacy and cost-efficacy of pre-emptive pharmacogenetic genotyping strategies in the Spanish National Health System: iPHARMGx Master Protocol and PREVESTATGx nested clinical trial

IntroductionGenetic variations impact drug response, driving the need for personalised medicine through pre-emptive pharmacogenetic testing. However, the adoption of pre-emptive pharmacogenetic testing for commonly prescribed drugs, such as statins, outside...

Effectiveness of micro-electrolysis associated with exercises versus exercises alone on pain intensity and disability in individuals with chronic rotator cuff tendinopathy: A randomized clinical trial

ObjectiveTo compare the effectiveness of intratissue percutaneous micro-electrolysis (IPM) in addition to shoulder exercise program on pain intensity and disability in individuals with rotator cuff tendinopathy. Study designTwo parallel arms, single blind superiority randomized control clinical trial. SiteOutpatient clinic (Alcides Carneiro University Hospital) Participants42 individuals with rotator cuff tendinopathy were randomly allocated (1:1) into 2 groups: IPM associated with exercises (IPM+Ex) and exercises only (Ex). InterventionsBoth groups underwent a therapeutic exercise program (6 in-person sessions) conducted by a physiotherapist, but only the IPM+Ex group received additional treatment with IPM (6 sessions). Linear mixed models were used to compare groups. Main outcome measuresPain intensity was measured with the Numerical Pain Rating Scale (NPRS) and shoulder disability with the Shoulder Pain and Disability Index (SPADI). The outcomes were evaluated (blinded assessor) at baseline and 8 weeks after the intervention protocol. Secondary outcomes: adverse effects, frequency of the weekly home exercises, and overall perceived effect. ResultsForty individuals completed the 8-week follow-up. There were statistically significant within-group changes in both IPM+Ex and Ex for pain (IPM+Ex: mean difference -3.19; 95% CI:-4.45 to -1.94; Ex: mean difference: -3.99; 95% CI:- 5.27 to -2.72) and disability (IPM+Ex: mean difference -35.76; 95% CI:-47.77 to -23.76; Ex: mean difference: -38.26; 95% CI:-50.45 to -26.07). We found no between-group significant differences in either pain (mean difference: -1.23; 95% CI: -2.54, 0.07) or disability (mean difference 7.17; 95% CI:-7.02, 21.35). We found no differences between the groups (p < 0.05) regarding adverse effects, frequency of the weekly home exercises, and overall perceived effect. ConclusionApplying IPM along with therapeutic exercises does not have additional effects on pain intensity and disability in individuals with rotator cuff tendinopathy.

Efficacy of Otago versus Bosu ball exercise protocol on core stabilization, static and dynamic balance in non-specific chronic low back pain: a randomized parallel arm clinical trial

Abstract Chronic non-specific low back pain (NSLBP) is a pain and stiffness in the lower back region for which specific cause of the pain is unknown. Otago exercises and Bosu ball exercises aim to improve balance and reduce pain and disability. There is a lack of literature where these approaches are not compared and hence the need arises to evaluate their efficacy in the management of NSLBP. A randomized parallel arm clinical trial was conducted in physiotherapy outpatient department at tertiary care center located in Belagavi city, India. 36 individuals with NSLBP, where 18 individuals were randomly allocated into two groups, i.e. Group A (Otago exercise) and Group B (both sides utilized (Bosu) ball exercise). Both the groups received conventional therapy (hot moist pack and interferential current therapy) 3 times/ week for 4 weeks. Outcome measures like plank holding test, star excursion balance test (SEBT), single-leg stance test (SLST), visual analogue scale (VAS) and Oswestry disability index (ODI) were assessed at baseline and on day 12 post-treatment. A within-group analysis using the Wilcoxon matched-pairs test and the dependent t-test showed statistically significant improvements in all outcome measures (). Between group analysis has shown both interventions to be equally effective in ODI () in individuals with NSLBP. In conclusion both Otago and Bosu ball exercises were effective, Bosu ball exercise demonstrated greater efficacy in enhancing core stability, static and dynamic balance, as well as reducing disability and pain in individuals with chronic NSLBP. Clinical trial registry of India: registration number CTRI/2023/11/059489

A Randomized, Double-Blind, Controlled Trial to Assess the Effects of Lactoferrin at Two Doses vs. Active Control on Immunological and Safety Parameters in Healthy Adults.

Recombinant human lactoferrin (rhLF) is of commercial interest for immune support as a food ingredient. The objective was to evaluate the immunogenicity/alloimmunization potential of Helaina rhLF (effera™) from K. phaffii over a 28-day period compared to bovine LF (bLF). Study 1 was a randomized, double-blind, parallel arm, controlled trial where 66 healthy adults were randomly allocated to 1 of 3 groups: high-dose rhLF (3.4g/d), low-dose rhLF (0.34g/d), or bLF (3.4g/d). Participants completed a 28-day supplementation period with follow-up visits on Days 28, 56, and 84. Study 2 was a 12-week observational study with no intervention that enrolled 24 healthy adults. In both studies, serum was obtained for analysis of anti-LF antibody levels as the primary endpoint. In Study 1, change from baseline to Day 56 in serum anti-bLF antibodies in the bLF group (least squares geometric mean and 95% confidence interval for the post/pre ratio: 3.01; 2.08, 4.35) was greater than the changes in serum anti-hLF antibodies in the low-dose rhLF (1.07; 0.77, 1.49; P < 0.001) and high-dose rhLF (1.02; 0.62, 1.70; P < 0.001) groups. The rhLF groups had similar changes to the observational study, indicating no change in anti-hLF antibodies and no evidence of alloimmunization following ingestion. Changes in safety outcomes were similar between groups and within normal ranges. These results show that under the conditions of the protocol, no increased anti-hLF antibodies or adverse events were identified following ingestion of effera™ as a food ingredient at an intake level up to 3.4g/d in healthy adults (clinicaltrials.gov: NCT06012669).

Long-term follow-up after catheter ablation of atrial fibrillation and atrial tachycardia in patients with pulmonary hypertension

Abstract Introduction Catheter ablation of atrial fibrillation and atrial tachycardia (AF / AT) is established treatment in selected population. Only limited data, including long-term results, exist in patients with pulmonary hypertension (PH). Recently published prospective multicentric trial showed that more extensive radiofrequency catheter ablation of the bi-atrial arrhythmogenic substrate instead of clinical arrhythmia ablation alone is not beneficial in terms of arrhythmia recurrence in patients with AF / AT and PH. Now, we present the results of an extended, long-term follow-up from one of the study centres. Methods Patients with combined post- and pre-capillary or isolated pre-capillary PH and AF / AT indicated to catheter ablation were enrolled and randomised 1:1 into two parallel treatment arms. Patients underwent either clinical arrhythmia ablation only (Limited ablation group) or clinical arrhythmia plus substrate-based ablation (Extended ablation group). The primary endpoint was arrhythmia recurrence &amp;gt;30 s without antiarrhythmic drugs after the 3-month blanking period. Results A total of 52 patients (median age 71 years (IQR 62-75); 27 males) were enrolled. The presumable clinical arrhythmia was AF in 20 and AT in 32 patients, including typical AFL in 22 patients. Limited and extended ablation group included 28 and 24 patients, respectively. During the extended follow-up period of median 31 (IQR: 18; 46) months, the primary endpoint occurred in 17 patients (71 %) vs. 13 patients (46 %) in the Extended vs. Limited ablation group (p = 0.096). In parallel, overall mortality was comparable between groups (9 [38 %] vs. 11 [39 %]). Only 2 patients had recurrence of AFL during the extended follow-up. However, new different arrhythmia was documented in another 7 patients after the AFL ablation. Conclusion In PH patients, recurrence of AF / AT after a catheter ablation is frequent and the recurrence rate increases with the duration of follow-up. Ablation strategy seems to have no impact on arrhythmia free survival. Patients with typical atrial flutter have significantly higher chance to maintain sinus rhythm after a catheter ablation compared to AF or other AT.

To Determine Efficacy Aspirin 150 mg vs 75 mg in Prevention of Preeclampsia and its Associated Complications

Background: Preeclampsia is a pregnancy-specific multisystem progressive disorder, characterized by a new onset of hypertension and proteinuria or significant end-organ dysfunction without proteinuria typically after 20 weeks. If not controlled, it can lead to adverse fetal outcomes. Aspirin a COX inhibitor can delay or prevent the onset of PE. Its effectiveness and safety in relatively higher doses (150mg) need to be investigated in the local population. To compare the two different low doses of aspirin 75mg vs. high dose of 150mg in moderate and high-risk women for prevention of preeclampsia and its associated complications. Methods: A Parallel arm randomized control open-label study was conducted at the Department of Obstetrics and Gynaecology of Ziauddin University Hospital Kemari, Karachi. A sample of 156 women, age &gt;18 years, with moderate and high risk of Preeclampsia was selected consecutively. Random allocation of 78 women each was done to group A (75mg) versus group B (150 gm) of Aspirin. Patients with multifetal gestation, major fetal anomaly, thrombocytopenia, peptic ulcer, or bleeding disorder were excluded from the study. Ethical approval was sought from the ERC of Ziauddin University. Descriptive and analytical results expressed through SPSS software. Results: Both groups were comparable in terms of their basic demographics. The effectiveness of Aspirin 75mg was 53% compared to 70% of Aspirin 150mg in the prevention of pre-eclampsia among high-risk women. With 75mg Aspirin the incidence of PE decreased slightly with increasing age while with 150mg, it increased (P values = 0.141, 0.111 &amp; 0.290 respectively. Higher rates of placental abruption (54.3%) accompanied by preeclampsia were seen in group A as compared to (21.7%; p value = 0.016) in group B. The incidence of pre-term delivery, miscarriage, NICU admission &amp; superimposed eclampsia were higher with low-dose aspirin (P values = 0.779, NA, 0.210, 0.592, NA &amp; 0.772 respectively). Conclusion: Aspirin 150mg in moderate and high-risk pregnancies starting at 11-14 weeks is more effective and safer than 75mg Aspirin reducing the incidence of Preeclampsia.

Rationale and design of the multicentric randomized EVAOLD trial: Evaluation of a strategy guided by imaging versus routine invasive strategy in elderly patients with ischemia

BackgroundThe management of myocardial infarction without ST segment elevation (NSTEMI) in elderly patients remains challenging, in particular the benefit/risk balance of routine revascularization remains uncertain. Study designEVAOLD is s a multicenter, prospective, open-label trial with 2 parallel arms in NSTEMI patients ≥ 80 years of age. The aim of the trial is to test whether a strategy of selective invasive management guided by ischemia stress imaging (IMG group) will be non-inferior in preventing Major Adverse Cardiac and Cerebrovascular Events (MACCE, ie all-cause death, non-fatal myocardial infarction, non-fatal stroke) rates at 1 year compared with a routine invasive strategy (INV Group). Geriatric assessment and cost- effectiveness analysis will also be performed. A sample size of 1756 patients (assuming a 10% rate of patients lost to follow-up) is needed to show non-inferiority with 80% power. Non-inferiority based on exponential survival curves will be declared if the upper limit of the one-sided 97.5% confidence interval for the hazard ratio is lower than 1.24, corresponding to a non-inferiority margin of 7% in absolute difference and an event rate of 40% in the INV group. ConclusionEVAOLD is a nationwide, prospective, open-label trial testing the non-inferiority of a strategy of selective invasive management guided by ischemia stress imaging versus routine invasive strategy in elderly NSTEMI patients. ClinicalTrials.gov Identifier: NCT03289728

Pharmacological Thromboprophylaxis Effectiveness in Low-Risk Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial

Background: There is a paucity of evidence and controversies regarding prophylaxis strategies in low-risk patients undergoing knee arthroscopy. This study aims to evaluate the effectiveness and safety of aspirin and low-molecular-weight heparin (LMWH) in an arthroscopic anterior cruciate ligament (ACL) reconstruction for low-risk patients. Methods: We performed a preoperational evaluation a week before surgery for any sign of pulmonary embolism (PE) and deep vein thrombosis (DVT). For this purpose, we used single limited compression Doppler ultrasonography (CUS) of the lower extremities. Rehabilitation started before the time of the surgery to improve the range of motion (ROM) and quadriceps muscle function. A team of 3 orthopedists performed the procedures. The same surgical technique and graft were used with spinal anesthesia, and operation time was recorded. Results: The mean age of participants was 31.4 ± 5.6 years, with 93 individuals (67%) being men and 23% women. No cases of DVT or PE were observed. Three cases in the LMWH group and one case in the aspirin group experienced minor surgical site bleeding. One case of hemarthrosis with normal ultrasonography occurred in the LMWH group. Regarding safety and effectiveness, there was no statistically significant difference between the parallel arms. Conclusion: The use of LMWH or aspirin after simple arthroscopic ACL reconstruction in low-risk patients showed no difference in effectiveness. Hence, the routine use of thromboprophylaxis in this setting is questionable although adverse events are rare

Effectiveness of a resilience school-based intervention in adolescents at risk: a cluster-randomized controlled trial.

School offers a key context to promote resilience. The aim of this study was to assess the effectiveness of a school-based resilience intervention in 578 at-risk adolescents aged 12 to 15, emphasizing the significance of resilience improving mental health. A cluster-randomized controlled trial with parallel arms was conducted during the 2021/22 academic course. A specific training of six 55-minute sessions over 6 weeks was carried out for the students. Each session consisted of 5 minutes of mindfulness, followed by 45 minutes of the corresponding activity: introduction to resilience, self-esteem, emotional regulation strategies, social skills, problem solving, community resources, and peer support. Primary outcomes were assessed by the Child Youth Resilience Measure-32 at baseline (T1), post-intervention (T2), and then at the 24-week follow-up (T3). Both groups were compared using the Student's t-test. The effect size was calculated using Cohen's d and linear regression models were used. A total of 578 adolescents were included, 323 in the control group and 255 in the intervention group. Significant differences in both crude and adjusted analyses for Child Youth Resilience Measure were observed at 24 weeks follow-up, showing higher resilience for the intervention group [IG, M = 128.7, SD = 14.2; CG, M = 125.3, SD = 18.4; p = 0.027; d = 0.2; p = 0.043, d = 0.16]. Furthermore, in Depressive symptoms, lower values were found for the intervention group in both crude and adjusted analyses [IG, M = 2.3 (SD = 2.5); CG, M = 2.8 (SD = 2.5); p = 0.04; d = -0.20; p = 0.037, d = -0.18]. This study contributes to fostering resilience and positive adolescent development. It also reinforces the potential of multicomponent interventions. More continuous follow-up assessments are needed to identify possible long-term changes in resilience. Identifier: NCT05133115. https://clinicaltrials.gov/study/NCT05133115.

Impact of early continuous positive airway pressure in the delivery room (DR-CPAP) on neonates < 1500 g in a low-resource setting: a protocol for a pilot feasibility and acceptability randomized controlled trial

BackgroundPreterm birth is the leading cause of childhood mortality, and respiratory distress syndrome is the predominant cause of these deaths. Early continuous positive airway pressure is effective in high-resource settings, reducing the rate of continuous positive airway pressure failure, and the need for mechanical ventilation and surfactant. However, most deaths in preterm infants occur in low-resource settings without access to mechanical ventilation or surfactant. We hypothesize that in such settings, early continuous positive airway pressure will reduce the rate of failure and therefore preterm mortality.MethodsThis is a mixed methods feasibility and acceptability, single-center pilot randomized control trial of early continuous positive airway pressure among infants with birthweight 800–1500 g. There are two parallel arms: (i) application of continuous positive airway pressure; with optional oxygen when indicated; applied in the delivery room within 15 min of birth; transitioning to bubble continuous positive airway pressure after admission to the neonatal unit if Downes Score ≥ 4 (intervention), (ii) supplementary oxygen at delivery when indicated; transitioning to bubble continuous positive airways pressure after admission to the neonatal unit if Downes Score ≥ 4 (control). A two-stage consent process (verbal consent during labor, followed by full written consent within 24 h of birth) and a low-cost third-party allocation process for randomization will be piloted.We will use focus group discussions and key informant interviews to explore the acceptability of the intervention, two-stage consent process, and trial design. We will interview healthcare workers, mothers, and caregivers of preterm infants. Feasibility will be assessed by the proportion of infants randomized within 15 min of delivery; the proportion of infants in the intervention arm receiving CPAP within 15 min of delivery; and the proportion of infants with primary and secondary outcomes measured successfully.DiscussionThis pilot trial will enhance our understanding of methods and techniques that can enable emergency neonatal research to be carried out effectively, affordably, and acceptably in low-resource settings. This mixed-methods approach will allow a comprehensive exploration of parental and healthcare worker perceptions, experiences, and acceptance of the intervention and trial design.Trial registrationThe study is registered on the Pan African Clinical Trials Registry (PACTR) PACTR202208462613789. Registered 08 August 2022. https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=23888.

Effects of polarized and pyramidal training, with or without mindfulness, on race time and performance in amateur runners: Protocol for a randomized controlled trial

Problem: Road races in athletics has increased worldwide in recent years, leading to a growth in amateur runners (AR). Despite this growth, research aimed at this population is scarce and has methodological weaknesses. One topic of recent interest in AR is the effects of training intensity distribution (TID) and mindfulness on race time (RT); however, there is not enough evidence to establish a consensus among scientists, trainers, and athletes. Objective: To compare the effects of four training programs with polarized and pyramidal TID models on 10 km RT, ventilatory thresholds one and two, maximum aerobic speed, maximum oxygen consumption and body composition in AR. Method: A randomized controlled clinical trial with four parallel arms. The study groups include two with a polarized TID model and two with a pyramidal TID model, both combined with and without a mindfulness program over 12 weeks. Mindfulness practice will consist of 65 minutes per week through individual sessions and group workshops. Discussion: The practice of recreational athletics is increasing; however, the effect of TID and mindfulness on RT in this population have not been extensively studied. Keywords: Training intensity distribution, mindfulness, amateur runners, race time, body composition, polarized training, pyramidal training.

263 - Warm Irrigation Improving Perioperative Outcomes of Transurethral Resection of Prostate: A Prospective Parallel Arm Single Blinded Randomized Control Trial

263 - Warm Irrigation Improving Perioperative Outcomes of Transurethral Resection of Prostate: A Prospective Parallel Arm Single Blinded Randomized Control Trial