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Treatment Trial - Europe PMC

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Last Updated: 06 July 2022

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157 Evaluating Interest in Clinical Trial Participation for the Treatment of Pediatric Food Allergy

OBJECTIVES/GOALS: About 8% of children in the United States have a diagnosed food allergy. This report will investigate the impact of biopsychosocial conditions on CT participation for pediatric FA. Patients and families who satisfy the following criteria are eligible participants in a follow-up clinic visit; 2 children are between the ages of 6-months to 12 years, and 4 have no history of developmental disorders; 3 are English speaking; and 4 have no history of developmental disorders. 4 families with higher educational attainment will show increased interest in CT participation; 4 parents with greater FA knowledge, greater health monitoring skills, and less FA-related anxiety will be less interested; and 5 families with lower educational attainment will have lower interest in CT participation; and 6 families with higher educational attainment will report lower rates of interest in participating; and 6 families with higher educational achievement will report lower rates of interest in CT participation; 5 parents with greater experience and children with a higher confidence level will express greater interest in CT participation; This innovative approach will help us determine families who may benefit from experimental treatment options for pediatric FA, as well as helping healthcare professionals determine families who may be at the highest risk of anaphylaxis and help healthcare professionals identify families that could benefit from medical research choices for pediatric FA.

Source link: https://europepmc.org/article/MED/PMC9209089


Efficacy and safety of chitosan-based bio-compatible dressing versus Nano-silver (Acticoat) dressing in treatment of recalcitrant diabetic wounds: A randomized clinical trial.

Nano-chitosan films' effectiveness in wound healing has been reported before. Aims (Total) Data is used to assess the clinical effectiveness and safety of two dressings in the treatment of refractory diabetic wounds. Methods (Total) 31 eligible patients with a persistent diabetic wound were included in the study and randomly selected to receive chitosan or nanosilver dressing. Using the diabetic-foot-infection score at the 2nd, 4th, and 6th weeks during therapy, clinical evaluations and healing rates were recorded. The results The changes in total 10-item-DFI wound scores didn't change significantly over time between the two groups didn't change dramatically over time. In the chitosan and nanosilver dressing groups, respectively, the mean percentage change of this score from baseline was 71% to 79%. Conclusions Our results showed that chitosan can be safely and effectively used for diabetic wound treatment, just like nanosilver dressing.

Source link: https://europepmc.org/article/MED/35778935


Cognitive behavioral therapy delivered via digital mobile application for the treatment of type 2 diabetes: Rationale, design, and baseline characteristics of a randomized, controlled trial.

Background Type 2 diabetes is a form of diabetes that is increasing in the United States and around the world. Cognitive behavioral therapy has been shown to enhance T2D-patient glycemic stability in patients with T2D, but widespread use has been limited by inherent availability and funding constraints. Hypothesis - Hypothesis Description Hypothesis The objective and design of a trial establishing the validity and safety of a digital therapy with CBT in adults with T2D adults is discussed. Change in HbA1c change from baseline to 90 days for BT-001-allocated subjects compared to those assigned to the control app is the main endpoint. Conclusions This randomized, controlled trial investigates a cognitive behavioral intervention that can be delivered via smartphone app and has the potential to be a scalable treatment option for patients with T2D.

Source link: https://europepmc.org/article/MED/35778834


Insomnia as an Unmet Need in Patients With Chronic Hematological Cancer: Protocol for a Randomized Controlled Trial Evaluating a Consumer-Based Meditation App for Treatment of Sleep Disturbance.

Background In this population, we recommend the first randomized controlled trial to determine the effects of a consumer-based mobile meditation app, Calm, on sleep disturbances. The goal of this report is to determine the safety of daily meditation delivered via Calm, as well as secondary sleep improvements such as sleep impairment and sleep quality; and assess free-living use in patients with persistent hematological cancer. Methods We will recruit 276 patients with persistent hematological cancer to an 8-week app-based wellness intervention, as the primary, daily, app-based meditation group or the health education podcast app control group, followed by a 12-week follow-up period. Conclusions This study will support broader public health campaigns by providing researchers and clinicians with an evidence-based commercial product to improve sleep in the long run in underserved and understudied cancer population with a high incidence of sleep disturbances.

Source link: https://europepmc.org/article/MED/35776489


Botulinum toxin injection as a single or combined treatment with non-cross-linked high molecular weight and low molecular weight HA gel for neck rejuvenation: A Randomized Clinical Trial.

The current research was designed to determine the safety of botulinum toxin injection as a single or combined treatment with Profhilo gel for neck rejuvenation. Patients with a request for neck reconstruction were randomly divided into two groups according to the inclusion criteria. Both groups were injected with Dysport Botox for all of the participants, moreover, Profhilo gel was injected for all of the participants in one of the groups after two weeks, and a follow-up visit was organized for both groups three months later. The intervention group's hydration and Thickness of the skin in the intervention group were clearly higher than those in the control group three months after the program. Conclusion Profhilo gel based on Dysport Botox injection alone in patients who are not eligible for surgery due to any reason.

Source link: https://europepmc.org/article/MED/35775872


HIV drug resistance in a community-randomized trial of universal testing and treatment: HPTN 071 (PopART).

Introduction Universal HIV testing and treatment has individual and public health benefits. UTT's 071, a community-randomized trial in Zambia and South Africa, showed that it reduced HIV incidence in Zambia and South Africa. We investigated the effect of UTT on HIV drug resistance in this cohort and compared other resistance-related outcomes in participants with recent versus non-recent HIV infection. For viremic participants in three groups, seroconverters, non-seroconverters, and patients with uncertain duration of infection were tested by HIV genotyping and antiretroviral drug testing. For all viremic people and 11% for all HIV-positive people, the estimated prevalence of resistance in the study populations was 37 percent for all viremic people and 11% for all HIV-positive people. There was no correlation between UTT and drug resistance. Mutations used for monitoring transmitted drug resistance were found in 10. 5% of seroconverters and 15. 1% of non-seroconverters who were ARV naive. In non-seroconverters, higher rates of drug resistance and multi-class resistance were observed than seroconverters, as well as seroconverters.

Source link: https://europepmc.org/article/MED/35775502


Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial.

BACKGROUNDANCE The monoclonal antibody eptinezumab, which targets calcitonin gene-related peptide, has shown migraine prevention starting the day after infusion and acceptable safety and tolerability in phase 3 trials, but studies of patients with recent preventive therapy failures were not investigated. We wanted to investigate the safety and effectiveness of eptinezumab for migraine relief in adults with migraine, as well as two-to-four previous preventive treatment failures. From 96 research centers around Europe and the United States, we recruited adults with episodic or chronic migraine with at least four monthly migraine days and documented evidence of two-to-four previous preventive treatment failures in the last ten years. With eptinezumab 100 mg, -5u00b73, and -2u00b71 with placebo, the change from baseline to week 1-12 in mean monthly migraine days was -478, -5, and -21% for placebo. With eptinezumab 100 mg and eptinezumab 300 mg, the difference from placebo in change in mean monthly migraine days from baseline was significant. In 120 of 294 of 299 patients in the eptinezumab 300 mg group, 127 of 299 patients in the eptinezumab 300 mg group died, and in 119 of 298 in the placebo group. Embetiment Explicitation This is a post-graduate course in medicine With exceptional safety and tolerability, eptinezumab has shown significant migraine relief in adults with migraine and two-to-four previous preventive treatment failures, suggesting that eptinezumab may be an appropriate treatment option for this patient population.

Source link: https://europepmc.org/article/MED/35716692


Rapid Transition to Virtual Assessment and Treatment in an Interdisciplinary Randomized Clinical Trial for Youth With Chronic Pain: Adaptations and Implications for Future Trials.

The first remotely administered pediatric chronic pain diagnosis and remotely administered biomechanical evaluation for pediatric chronic pain provided the opportunity to develop this unexpected transition of a two arm randomized controlled trial investigating interdisciplinary graded exposure therapy compared with multidisciplinary pain management for youth with chronic pain. Here we introduce these new trends and share lessons learned to inspire future efforts in digital health care. Methods The RCT enrolled a total of 68 youngsters in the program. The virtual format change was also analyzed using exit interviews to assess perspectives on the exit interview process. Effects When virtual care was an option rather than in-person, the enrollment rate increased dramatically. Novel methods used in this RCT will aid in the trial design and analysis of clinical endpoints for future digital health services.

Source link: https://europepmc.org/article/MED/35686576


Long-term Safety of Treatment with Autologous Mesenchymal Stem Cells in Patients with Radiation-Induced Xerostomia: Primary Results of the MESRIX Phase I/II Randomized Trial.

Objective : Mesenchymal stem/stromal cell therapy may reduce radiation-induced xerostomia. Patients with oropharyngeal squamous cell carcinoma with radiation-induced xerostomia were randomly selected to receive a 2. 8 million ASCs/cm3 injection or placebo in both submandibular glands and followed for at least two years. 6 of 15 of the ASC-treated patients versus 5 of 15 of the placebo patients experienced an SAE, while 5 of 15 of the placebo patients did not experience an SAE, and no SAEs seemed to be medical-related; no SAEs appeared to be treatment-related. The ASC and placebo groups' entire saliva flow rate increased to 0. 20 and 0. 16 mL/minute, respectively, yielding a 0. 05 mL/minute difference between groups. P = 0. 013; P = 0. 013). According to a decreased xerostomia questionnaire summary score of 35. 0 and 45. 1, respectively, patient-reported xerostomia symptoms lessened despite a decreased xerostomia questionnaire summary score of 35. 0 and 45. 1, respectively [-10. 1 ; P = 0. 013]. Following the use of ASC, three of the visual analog scale xerostomia tests demonstrated clinical benefit. Conclusions Our results show that ASC therapy is safe with a medically relevant effect on xerostomia-related disorders.

Source link: https://europepmc.org/article/MED/35486613


Difluprednate 0.05% twice a day vs prednisolone acetate 1% 4 times a day for cataract postsurgical inflammation treatment: noninferiority trial.

A day for postsurgical inflammation treatment with difluprednate 0. 05% nanoemulsion twice a day is as safe as prednisolone acetate 0. 1 percent suspension versus 0. 12 suspension four times a day. Methods used A total of 259 patients with phacoemulsification randomly received DIFL or PRED, beginning the day before surgery and lasting for 28 days. If the difference in corneal thickness between baseline and day 4 did not differ beyond 17 bcm between treatments, noninferior anti-inflammatory therapy was considered. In addition, no statistically significant differences were reported between treatments in CDVA, endothelial cell count, OCT central macular thickness, and intraocular pressure results. Conclusions Difluprednate administered twice a day was at least as safe as prednisolone acetate administered 4 times a day for inflammatory therapy following cataract surgery.

Source link: https://europepmc.org/article/MED/34759176

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions