Contemporary clinical trials最新文献

Background: More than half of pregnant patients with overweight or obesity exceed national gestational weight gain (GWG) guidelines, increasing their risk of adverse outcomes. There is an urgent need to develop effective and scalable interventions to improve GWG.

Objective: To describe the protocol of Lifestyle, Eating, and Activity in Pregnancy (LEAP), a cluster randomized controlled trial evaluating a mobile health (mHealth) intervention promoting appropriate GWG in an integrated healthcare system.

Methods: LEAP is a cluster randomized trial with randomization at the clinician level. Patient eligibility includes a pre-pregnancy BMI of 25.0-40.0 kg/m² and singleton pregnancy. Consented patients receive standard care or standard care plus mHealth intervention per their clinician's randomization. The patient adaptive intervention provides personalized, automated feedback on GWG and physical activity using 1) a smartphone application, 2) a Wi-Fi scale and activity tracker; 3) weekly educational topics; and 4) step-wise support (added when GWG is >75th percentile of the GWG guidelines). Intervention clinicians receive newsletters with motivational interviewing tips to facilitate discussing GWG. Primary outcomes are total GWG (last measured weight - pre-pregnancy weight) and weekly rate of GWG (total GWG/gestational weeks at delivery) as continuous variables and categorized per the IOM GWG guidelines. Secondary outcomes include trimester-specific rate of GWG, GWG trajectory, diet and physical activity, postpartum weight retention, birthweight, infant size for gestational age, and infant growth to 12 months.

Conclusions: LEAP addresses gaps in the implementation of GWG interventions in healthcare settings. The adaptive and mHealth nature of the intervention may enhance scalability.

Trial registration: ClinicalTrials.govNCT03880461.

Adolescent and young adult cancer survivors (AYAs) experience clinically significant distress and have limited access to supportive care services. Interventions to enhance psychological well-being have improved positive affect and reduced depression in clinical and healthy populations and have not been routinely tested in AYA survivors. We are optimizing a web-based positive skills intervention for AYA cancer survivors called Enhancing Management of Psychological Outcomes With Emotion Regulation (EMPOWER) by: (1) determining which intervention components have the strongest effects on well-being and (2) identifying demographic and individual difference variables that mediate and moderate EMPOWER's efficacy. EMPOWER is a five-session online intervention that teaches behavioral and cognitive skills for increasing psychological well-being. Guided by the Multiphase Optimization Strategy (MOST), we assign two levels (yes, no) to each of five intervention components (positive events, capitalizing, & gratitude; mindfulness; positive reappraisal; personal strengths & goal-setting; acts of kindness), allowing us to evaluate the effects of individual and combined intervention components on positive affect in a full factorial design. Post-treatment AYA cancer survivors (N = 352) are recruited from participating NCI-designated comprehensive cancer centers and randomized to one of 32 experimental conditions. Our primary outcome is positive affect; potential mediating and moderating variables include coping self-efficacy and emotional support, respectively. Upon trial completion, we will have an optimized, digital health intervention to enhance psychological well-being among AYA cancer survivors. EMPOWER will be scalable and primed for a large, multi-site trial among AYAs who would otherwise not have access to supportive care interventions to manage distress and enhance well-being.

Adolescents and young adults in the legal system (AYALS) are at high risk for opioid use disorder (OUD). Effective, efficient interventions to prevent OUD that support youth as they transition to the community are needed. The Positive Outcomes through Supported Transition intervention trial is designed to identify the optimal intensity and sequence of behavioral skills and case management components for OUD prevention. This sequential, multiple assignment randomized trial addresses three research questions: 1.whether to begin with a high-intensity, broad-scope intervention (Enhanced Adolescent Community Reinforcement Approach; E-ACRA) or a lower intensity intervention (Assertive Community Support; ACS), 2. whether to continue with E-ACRA or step-down to ACS after release, and 3. whether to step-up to E-ACRA or continue ACS for youth reporting problematic substance use after release. Youth committed to state custody will be recruited prior to their release and randomized to E-ACRA or ACS. At five weeks post-release, E-ACRA participants will be re-randomized to E-ACRA or ACS. ACS participants reporting problematic substance use at five weeks will be re-randomized to E-ACRA or ACS. Primary analyses will test the effects of initial intervention (E-ACRA vs. ACS); secondary analyses will test the effects of second-stage interventions. Cost-effectiveness analysis will determine whether the additional resources deployed to E-ACRA are justified economically by the outcomes achieved. Prevention is critical for this population. High-intensity interventions can be burdensome for participants (and agencies) and costly to deliver. This study examines how best to sequence high and low intensity interventions to maximize beneficial outcomes for the most youth. This study's design was pre-registered with clinicaltrials.gov (NCT04901312).

Background: Aromatase inhibitors (AIs) are a cornerstone of adjuvant systemic therapy for postmenopausal patients with hormone-receptor positive (HR+) breast cancer. Although AIs decrease cancer recurrence rates and improve survival rates, approximately 50 % of patients experience arthralgia-persistent pain related to worse patient outcomes and poor AI adherence. Current medical interventions for AI-associated arthralgia have limited efficacy and side effects that restrict their use among older patients.

Objective: The SKIP-Arthralgia trial will test the efficacy of Pain Coping Skills Training (PCST), a cognitive-behavioral therapy (CBT)-informed intervention, delivered via a web-based program called painTRAINER®. PCST and similar CBT-informed pain interventions are efficacious in non-cancer pain and commonly delivered via the Internet, although they have not been tested as a treatment for AI-associated arthralgia.

Methods: 452 breast cancer survivors with AI-associated arthralgia will complete a baseline assessment before being randomized to either painTRAINER plus enhanced usual care (EUC; educational materials about AI therapy, arthralgia, and pain), or to EUC alone. Follow-up assessments will occur approximately 2 weeks after the 8- to 10-week intervention period (post-intervention) and at 3- and 6-months post-intervention. Primary outcomes are pain severity and interference at post-intervention. Secondary outcomes include emotional distress, AI adherence, and health-related quality of life.

Discussion: This trial aims to fill a gap in evidence-based behavioral pain interventions for breast cancer survivors with AI-associated arthralgia by providing an effective, accessible intervention that could be implemented quickly, including in areas with limited PCST access. If successful, this study could enhance health outcomes for breast cancer survivors on AI therapy and improve adherence to this life-saving medication.

Introduction: Effective spontaneous preterm birth (sPTB) prevention is an urgent unmet clinical need. Vaginal depletion of Lactobacillus crispatus is linked to sPTB. This trial will investigate impact of an oral Lactobacillus spp. probiotic product containing an L. crispatus strain with other Lactobacilli spp., on the maternal vaginal and gut microbiome in pregnancies high-risk for sPTB.

Methods: A double-blind, placebo-controlled, randomised trial will be performed at the National Maternity Hospital Dublin, Ireland. Inclusion criteria are women with history of sPTB or mid-trimester loss, cervical surgery (cone biopsy or two previous large-loop-excision-of-transformation-zone) or uterine anomaly. The intervention is oral supplementation for twelve weeks with probiotic or identical placebo. The probiotic will contains: ◦ 4 billion CFU Lactobacillus crispatus Lbv 88(2x10⁹CFU/Capsule) ◦ 4 billion CFU Lactobacillus rhamnosus Lbv 96(2x10⁹CFU/Capsule) ◦ 0.8 billion CFU Lactobacillus jensenii Lbv 116(0.4x10⁹CFU/Capsule) ◦ 1.2 billion CFU Lactobacillus gasseri Lbv 150(0.6x10⁹CFU/Capsule). Investigators and participants will be blinded to assignment.

Results: The primary outcome is detectable L. crispatus in the vaginal microbiome after twelve weeks of treatment, measured using high-throughput DNA sequencing. A total of 126 women are required to detect a 25 % increase in detectable L. crispatus. Secondary outcomes include impact of intervention on the gut microbiome and metabolome, rate of sPTB and mid-trimester loss, neonatal outcomes and maternal morbidity.

Conclusions: This randomised trial will investigate ability of an oral probiotic containing L. crispatus to increase its abundance in the vaginal microbiome, both directly by horizontal transfer and indirectly via microbiome and metabolome of the gut.

Background: Suicide is a leading cause of death in young persons. While ketamine has demonstrated rapid anti-suicidal effects, its safety and efficacy in youth has not been fully investigated. The Collaborative Assessment and Management of Suicidality (CAMS), a suicide-focused treatment shown to decrease suicidal ideation and symptom distress, has never been studied in combination with ketamine.

Objectives: This study investigates whether ketamine infusion, as compared to placebo, rapidly reduces severe suicidality in youth and young adults and enhances effectiveness of CAMS to decrease suicidality after acute treatment and at 3-month follow-up. We explore whether participants who receive ketamine, as compared to placebo, have decreased suicidality, suicide attempts, emergency department visits for suicidality, and psychiatric readmissions over 3-month follow-up.

Methods: This randomized controlled trial is enrolling 140 participants (ages 14-30) hospitalized with severe suicidal ideation or after attempted suicide. While hospitalized, participants are randomized to receive up to 6 treatments of either ketamine or placebo. Concurrently, participants engage in CAMS sessions, starting while inpatient and continuing post-discharge for up to 12 sessions via telehealth or until resolution of suicidality criteria are met. Monthly follow-up assessments are conducted for 3 months.

Discussion: Historically, hospital admissions have not decreased suicidal behavior following discharge. We hypothesize that ketamine, as compared to placebo, will lead to rapid improvement in suicidality and enhance engagement in CAMS, requiring significantly fewer sessions to resolve high-risk suicidality after discharge. We hypothesize that the ketamine group will have decreased suicidality, suicide attempts, and readmissions compared to the placebo group over 3-month follow-up.

This study presents an in-depth analysis of vaccine clinical trials in Africa, emphasising the significance of local investments to address the continent's healthcare requirements. The research scrutinises vaccine trials across various African nations, focusing on trial distribution, phases, funding sources, recruitment sites, recruitment statuses, and age group participation. The findings suggest substantial trial activity in countries like Kenya, Ghana, and Gambia, whereas nations like the Democratic Republic of the Congo and Tunisia exhibit minimal representation. Notably, COVID-19, HIV, and Yellow Fever vaccines prominently feature in the trials, with Phase 3 trials being the most prevalent. The presence of "Not Applicable" trials indicates adopting adaptive trial designs. Analysis of funding patterns reveals substantial international and local support, reflecting an escalating commitment to vaccine research in Africa. Nevertheless, concerns persist regarding disparities in trial distribution and age group participation, underscoring the necessity for robust regulatory frameworks and augmented local R&D capacity. Addressing these disparities can enhance the efficacy of vaccine research and elevate health outcomes across the African continent.

Background: The social information processing (SIP) model of trauma and intimate partner violence (IPV), which emphasizes the impact of trauma on one's ability to accurately process social information and subsequent failure to generate and enact nonaggressive responses, has gained attention in the United States. Recent clinical trial evidence suggests that the Strength at Home (SAH) intervention, a 12-session program that is based on this model, is efficacious in reducing and ending abusive behavior among U.S. veterans. However, such a clinical trial has yet to be conducted among a civilian population nor in a different cultural context (e.g., Israel). This paper describes the methods of a randomized controlled trial to test the efficacy of SAH compared to a treatment as usual comparison condition in Israel.

Methods: 300 men referred (court-, clinically-, and self-referred) to IPV intervention from adult outpatient clinics at Social Affairs and Social Services offices in Israel will be randomly assigned to the SAH intervention or a treatment-as-usual comparison group. Outcomes are measured at six timepoints (baseline, post-treatment, and four 3-month follow-ups). The primary outcome is use of IPV; however, we will also examine reductions in SIP deficits. Secondary outcomes include symptoms of posttraumatic stress disorder (PTSD), depression, and anxiety, and changes in emotion regulation strategies.

Conclusion: Study findings will determine the efficacy of SAH in a civilian population and in a different cultural context. Additionally, findings will determine whether SIP is a mechanism of change for such intervention.