Clinical Trials
Category Added in a WPeMatico Campaign
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First-line talazoparib plus enzalutamide versus placebo plus enzalutamide in men with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: patient-reported outcomes from the randomised, double-blind, placebo-controlled, phase 3 TALAPRO-2 trial
BACKGROUND: In the phase 3 TALAPRO-2 trial, talazoparib plus enzalutamide significantly improved radiographic progression-free survival compared with placebo plus enzalutamide in men with metastatic castration-resistant prostate cancer harbouring alterations in genes involved in homologous recombination repair (HRR). We aimed to assess patient-reported outcomes in patients with HRR-deficient metastatic castration-resistant prostate cancer in TALAPRO-2.
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Patient-reported outcomes from the MIRASOL trial evaluating mirvetuximab soravtansine versus chemotherapy in patients with folate receptor alpha-positive, platinum-resistant ovarian cancer: a randomised, open-label, phase 3 trial
BACKGROUND: Mirvetuximab soravtansine-gynx (MIRV) is a first-in-class antibody-drug conjugate targeting folate receptor α (FRα), approved by the US Food and Drug Administration for the treatment of platinum-resistant ovarian cancer in the USA. Here, we report patient-reported outcomes for participants treated with MIRV compared with investigator’s choice of chemotherapy from the phase 3 MIRASOL trial, which…
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First-line talazoparib plus enzalutamide versus placebo plus enzalutamide for metastatic castration-resistant prostate cancer: patient-reported outcomes from the randomised, double-blind, placebo-controlled, phase 3 TALAPRO-2 trial
BACKGROUND: Patients with metastatic castration-resistant prostate cancer have poor prognoses, underscoring the need for novel therapeutic strategies. First-line talazoparib plus enzalutamide significantly improved radiographic progression-free survival compared with placebo plus enzalutamide in men with metastatic castration-resistant prostate cancer in the phase 3 TALAPRO-2 study. We aimed to evaluate patient-reported outcomes in the all-comers cohort of…
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Intravenous Immunoglobulin Alone for Coronary Artery Lesion Treatment of Kawasaki Disease: A Randomized Clinical Trial
CONCLUSIONS AND RELEVANCE: This randomized clinical trial demonstrated the noninferiority of IVIG alone compared with IVIG plus aspirin, with a noninferiority margin set at 10%. The findings suggest that addition of high-dose aspirin during initial IVIG treatment is not clinically meaningful for CAL reduction in children with KD. Future studies on IVIG treatment alone for…
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The effect of patient-centered empowerment program through telenursing on self-management in people with multiple sclerosis: a double-blinded randomized clinical trial
CONCLUSION: Empowering PwMS, focusing on their unique needs and delivering it through telenursing, can be an effective method in enhancing their self-management capabilities. Therefore, it is recommended that healthcare providers in chronic diseases prioritize patient empowerment based on individual needs.
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Phase IIa randomized placebocontrolled clinical trial to evaluate the efficacy of bromhexine in combination with standard therapy in the early treatment of COVID-19 in primary care patients
CONCLUSIONS: Since coughing is one of the primary forms of transmission for SARS-CoV-2, the observed reduction of coughing might be highly beneficial, particularly for patients living in crowded, poorly ventilated, or confined environments.
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Evaluation of an Online-Based Self-Help Program for Patients With Panic Disorder: Randomized Controlled Trial
CONCLUSIONS: The presented online intervention can help reduce the core symptomatology of panic disorder and agoraphobia, as well as anxiety symptoms and associated depression. No effects were found for well-being and secondary outcomes. This may be due to higher illness burden in the intervention group and possibly the COVID pandemic, which caused unique challenges to…
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A 3-week pause versus continued Bruton tyrosine kinase inhibitor use during COVID-19 vaccination in individuals with chronic lymphocytic leukaemia (IMPROVE trial): a randomised, open-label, superiority trial
BACKGROUND: Chronic lymphocytic leukaemia is the commonest leukaemia and is associated with profound immunosuppression. Bruton tyrosine kinase inhibitors (BTKi) have revolutionised chronic lymphocytic leukaemia management; however, therapy impairs vaccine-induced immunity. We evaluated whether a 3-week pause of BTKi treatment improved spike protein receptor binding domain (RBD) immunity to SARS-CoV-2 booster vaccination while maintaining disease control.
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Impact of a Symptom Checker App on Patient-Physician Interaction Among Self-Referred Walk-In Patients in the Emergency Department: Multicenter, Parallel-Group, Randomized, Controlled Trial
CONCLUSIONS: We found no evidence that the SCA improved satisfaction with the patient-physician interaction or care in an acute care setting. By contrast, both patients and their treating physicians predominantly described the SCA’s impact as beneficial. Our study did not identify negative effects of SCA use commonly reported in the literature, such as increased anxiety…
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Evaluation of volumetric wear loss and pain scores of the digitally and conventionally manufactured occlusal splints for individuals with sleep bruxism
CONCLUSION: Occlusal splint wear can gradually alter the balance of occlusal contact and potentially reduce its therapeutic effectiveness, highlighting the importance of using wear-resistant materials. Our findings indicate that digital manufacturing processes provide advantages due to their long-term clinical outcomes.