Articles tagged with Randomization
A digital therapeutic intervention CT-155 has shown promising results in improving motivation and pleasure negative symptoms of schizophrenia with a small-to-moderate effect size comparable to psychosocial interventions and pharmacologic treatment. CT-155 is a scalable and accessible option for improving schizophrenia negative symptoms.
A new tool, INSPECT-SR, has been developed to assess the trustworthiness of randomized controlled trials (RCTs) and identify problematic studies. This tool, which has been endorsed by the Cochrane community, provides a rigorous and transparent method for reviewers to evaluate the integrity of trial data.
A randomized clinical trial found that 200-mg/d DNL343 did not slow disease progression in ALS patients, suggesting the need for alternative therapeutic approaches. The study highlights the importance of exploring new treatment options for ALS, a devastating neurological disease.
A multicenter randomized clinical trial of 370 nulliparous individuals found that intrauterine mepivacaine instillation significantly reduced pain and improved tolerability during IUD placement compared to placebo saline. The study supports mepivacaine instillation as a simple approach to improve the IUD placement experience.
The study confirms the durability of benefit for pembrolizumab plus chemotherapy as a first-line standard-of-care option for recurrent and metastatic cervical cancer. This treatment regimen has been shown to provide a significant advantage over traditional chemotherapy in patients with this type of cancer.
A crossover randomized clinical trial found that cannabis edibles impaired simulated driving performance at blood THC concentrations below per se thresholds. The study's findings suggest that even low doses of THC can have significant effects on driving ability.
A new Cochrane map has identified significant gaps in dengue prevention research, with most studies lacking synthesis into reliable reviews that policymakers can use. The map highlights areas such as vaccine implementation, adult mosquito control, and environmental interventions, which require more evidence to inform effective dengue c...
This randomized clinical trial found spectacle lenses with highly aspherical lenslets reduced myopia progression and axial elongation in children over 24 months. The study supports the use of these lenses as a safe and effective myopia control intervention.
A meta-analysis of randomized clinical trials found that mindfulness-based cognitive therapy is associated with worsening symptoms of depression. The study examined individual participant data from over 13,000 participants, providing evidence for the potential negative effects of this therapy on depression.
A randomized clinical trial found that daily zinc supplementation at 20 mg reduced all-cause infections in children with sickle cell anemia over 6 months compared to placebo. No adverse events were observed in the study, suggesting zinc supplementation may be a useful preventive measure for these children.
A randomized clinical trial found that preoperative high-dose corticosteroids did not improve major postoperative outcomes in elective digestive cancer surgery. The study suggests that routine use of high-dose corticosteroids in this setting is not justified
A post hoc analysis of a cluster randomized clinical trial found that the Real-time Prescription Benefit Tool (RTPB) increased fill rates for high-cost medications, especially among patients from low-income communities. However, the tool's recommendations were only made for a small proportion of orders, limiting the study's applicability.
A hybrid lifestyle program showed potential benefits for cardiometabolic health among adherent participants with obesity, but failed to achieve significant weight loss. The study suggests further investigation into the program's effects on metabolic health.
Researchers develop two virtual culturally grounded interventions to address substance use among urban American Indian and Alaska Native emerging adults. The studies show reduced substance use, including cannabis and alcohol consumption, as well as social connections with tribal communities.
A randomized phase 3 study found that first-line osimertinib plus chemotherapy significantly improved median progression-free survival compared to osimertinib alone in patients with advanced non–small cell lung cancer (NSCLC) and concurrent EGFR and TP53 mutations. This study provides evidence for incorporating TP53-based molecular ris...
This study investigates the link between vegan diets and dietary energy density, finding that adopting a vegan diet may lead to lower energy intake. The randomized clinical trial analyzed data from over 10,000 participants, suggesting that a well-planned vegan diet can be an effective way to reduce energy consumption.
A randomized clinical trial found that digital patient-reported outcome (PRO) monitoring with alert-based interventions led to clinically meaningful reductions in fatigue and improved physical functioning in metastatic breast cancer patients. This study supports further evaluation of PRO monitoring in routine oncology care.
This randomized clinical trial evaluates safety and efficacy of intra-arterial thrombectomy vs. medical management in patients with large-core infarcts after an acute ischemic stroke. The study found that endovascular treatment showed significant benefits in improving outcomes.
A randomized clinical trial found that dexamethasone eye drops reduced the progression of retinopathy of prematurity to severe disease requiring invasive treatment in preterm infants. However, no differences in adverse events were observed.
Autonomous oxygen titration increased the proportion of time spent in normoxemia and decreased time spent in hypoxemia compared to usual care. The intervention safely increased targeted normoxemia range time in acutely ill adults.
A randomized clinical trial found video laryngoscopy with a Macintosh blade (VLM) and hyperangulated blade (VLH) to have significantly higher first-pass success rates compared to direct laryngoscopy (DL). The study supports the use of video laryngoscopy as a new standard for routine airway management in adult patients.
A noninferiority randomized clinical trial found that an alternative first-line regimen containing doravirine, lamivudine, and tenofovir disoproxil fumarate produced less weight gain than a combination of dolutegravir, emtricitabine, and tenofovir alafenamide. The regimen was noninferior for viral suppression at 48 weeks.
Combining cemiplimab, fianlimab, and paclitaxel-based neoadjuvant chemotherapy improved pathologic complete response rates in high-risk -negative breast cancer. Patients with the ImPrint immune signature showed enhanced sensitivity to the combination.
A cross-sectional study identified critical methodological limitations in RCTs of CHM, including unclear hypotheses and inadequate allocation concealment. The study highlights the need for improved planning and conduct of CHM RCTs, with superior designs published in English-language journals.
Clesrovimab, a long-acting monoclonal antibody, demonstrates safety and efficacy in reducing severe respiratory syncytial virus (RSV) disease in high-risk infants over two RSV seasons. The study supports the use of clesrovimab in children at increased risk for severe RSV disease during their second season.
A mindfulness-based group medical visit program for persons with chronic low back pain showed significant improvements in pain intensity and interference compared to usual care. However, the changes did not meet the minimal clinically important difference threshold.
A phase III trial is investigating whether an immune-boosting drug can help keep early-stage lung cancer from coming back after surgery. Researchers aim to enroll 336 participants with stage I non-small cell lung cancer and determine if the treatment reduces recurrence.
A study found that implementing earlier egg introduction guidelines resulted in measurable decreases in egg allergy cases. The updated guidelines, based on randomized trial evidence, may contribute to a reduction in food allergy prevalence when effectively implemented.
Adding fovinaciclib to first-line aromatase inhibitor therapy confers significant progression-free survival benefits and consistent improvements in efficacy outcomes. The treatment also has manageable safety profiles with no negative impact on quality of life.
A randomized clinical trial found that an app-facilitated palliative care intervention maintained health-related quality of life and reduced acute care use. This digital self-management approach also boosted patient self-efficacy.
Interleukin 6 is investigated as a treatment target for depression in this randomized clinical trial. The study highlights the therapeutic potential of IL-6 or IL-6 receptor inhibition and proposes suitable patient selection methods.
A post hoc analysis of a randomized clinical trial found high-dose vitamin D3 supplementation in pregnancy to be positively associated with visual memory, verbal memory, and flexibility among offspring at age 10. This strengthens evidence on the association between prenatal vitamin D exposure and childhood cognition.
A single dose of psilocybin was associated with rapid antidepressant effects, persisting for more than 3 months. The study suggests that psilocybin may provide a rapid and relatively long-lasting antidepressant effect on major depressive disorder.
A cohort study found a potential association between GLP-1 RA use and improved survival rates among obese breast cancer patients with related metabolic conditions. Further evaluation of GLP-1 RA therapy in randomized clinical trials is warranted based on these findings.
A cluster randomized trial found comparable improvements in 6-month outcomes between intervention and control groups, indicating no independent effect of the clinical decision support system. The study suggests that other factors may be responsible for the observed benefits.
A randomized clinical trial suggests psilocybin is safe and efficacious for treating cocaine use disorder. The study found psilocybin to be effective in reducing substance use and improving mental health outcomes.
A randomized clinical trial found that genotype-guided prescribing of SSRIs did not improve depression symptoms at 3 months but showed higher remission rates at 6 months. Future studies should focus on the long-term impact of this approach.
The ASPIRE trial aims to enroll 1,200 participants with advanced prostate cancer and assess the impact of chemotherapy on overall survival and disease progression. Genetic profiling is included to identify patients who benefit most from intensified treatment.
A randomized clinical trial found that proactive outreach for care coordination did not lead to better outcomes compared to usual care post-hospitalization coordination. Many participants declined the offer. The study suggests that current strategies may need to be reassessed.
A randomized clinical trial found symptom-based dosing decreases discharge time compared to scheduled opioid taper approaches among infants with opioid withdrawal. This approach, using Eat, Sleep, Console, led to faster recovery and improved outcomes.
A cluster-randomized trial found that an adaptive mobile health intervention effectively reduced the rate of gestational weight gain and total gestational weight gain among pregnant patients with overweight or obesity. The study suggests that technology-based interventions can be a valuable tool in managing excess weight during pregnancy.
In this randomized clinical trial, mirtazapine effectively reduced methamphetamine use in adults with methamphetamine use disorder. The study's findings have important implications for the treatment of this condition, which currently lacks approved pharmacotherapies.
Early and continuous acoramidis treatment resulted in sustained incremental reductions in all-cause mortality, cardiovascular-related mortality, and first cardiovascular hospitalization. The findings support the importance of early and continuous long-term treatment with acoramidis in transthyretin amyloid cardiomyopathy.
Extended low-dose apixaban effectively reduced symptomatic superficial vein thrombosis (SuVT) risk. Patients with enduring risk factors for SuVT benefited from this anticoagulation strategy.
A post hoc analysis of the Finerenone Trial reveals that sudden death in heart failure was often preceded by modest worsening of symptoms and declining quality of life. The study suggests limited specificity for sudden death among other modes of death, implying a complex trajectory before modes of death.
A multicenter randomized clinical trial found no significant differences in cognitive improvement between exercise, intensive pharmacological reduction of cardiovascular risk factors, or both in older adults. The study results challenge current recommendations on lifestyle modifications for dementia prevention.
A randomized clinical trial investigated the effectiveness of low-use vs high-use physical restraint strategies in critically ill patients receiving mechanical ventilation in the ICU. The study found no significant reduction in days free of delirium or coma at 14 days, regardless of the restraint strategy used.
Continuing GLP-1/GIP agonists before upper endoscopy increased clinically significant residual gastric volume, but did not elevate adverse event risk. Clear liquids the day prior to the procedure may mitigate this risk.
A low-cost digital intervention increased expectation to adopt health behaviors among adults using GLP-1RAs, with effects persisting for 2 weeks. The written microsteps intervention plus short video boosters may play a role in promoting sustained behavior change.
A study found that only 9% of older adults with advanced cancer prioritize extending survival over maintaining quality of life. The lack of responsiveness of the current oncology care delivery system to patient preference may be a significant issue. This highlights the need for care system changes to prioritize patient needs.
Researchers investigated low-dose lithium as a potential treatment for mild cognitive impairment in a pilot clinical trial. The study found that none of the primary outcomes met the significance threshold, but effect size estimates suggest potential benefits for future trials.
Daily aspirin use offers no quick or reliable way to prevent bowel cancer in the general population, increasing risk of serious bleeding. However, it may have potential long-term benefits for people at high genetic risk of colorectal cancer.
A ketogenic diet was found to have a modest effect in reducing depressive symptoms in patients with treatment-resistant depression. The study's results suggest that this dietary approach may be worth exploring as an adjunct therapy option.
A national clinical trial found that oxybutynin significantly reduced hot flash frequency and quality of life for men undergoing hormone therapy for prostate cancer. The study showed substantial improvements in hot flash symptoms, often within the first week of treatment.
A recent study found that low-dose aspirin use was not associated with incident cancer incidence in older adults, contrary to previous findings. However, the study revealed a significant elevation in cancer mortality risk during the randomized clinical trial period, which did not persist after the trial ended.
This randomized clinical trial found yoga to significantly accelerate opioid withdrawal recovery and improve autonomic regulation, anxiety, sleep, and pain. The study supports the integration of yoga into withdrawal protocols as a neurobiologically informed intervention addressing core regulatory processes.
In a prespecified exploratory analysis of the SELECT randomized clinical trial, semaglutide demonstrated significant reductions in hospital admissions and overall time spent in hospital. This finding suggests that semaglutide has broader health benefits for patients with obesity and established cardiovascular disease.
A randomized clinical trial found digital cognitive behavioral therapy to be significantly beneficial for adults with generalized anxiety disorder. The treatment provided sustained benefits and has the potential for public health impact due to its accessibility.
The WISDOM randomized clinical trial found risk-based breast cancer screening to be equally effective as annual screening in detecting advanced cancers. However, it did not reduce breast biopsy rates. The study suggests a safer and more efficient approach to breast cancer screening.
A randomized clinical trial shows that semaglutide improves glycemic control and weight outcomes in individuals with schizophrenia. The study suggests using glucagon-like peptide-1 receptor agonists as an early intervention strategy to reduce cardiometabolic risk in this population.