Taco, Spain

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis and in Participants With Systemic Sclerosis-Associated Interstitial Lung Disease

TYRO Champion Dads Project Study

Anthem Strong Families (ASF) is reviewing the Ray of Hope curriculum as a possible addition to standard TCD services to better meet the needs of populations that may have unmet needs to address domestic violence in their families. The Ray of Hope curriculum is designed to help participants develop communication and conflict management skills like Core Communication but is a more robust approach since it adds a sharp focus on the dynamics of domestic violence and related risk factors. The impact of the addition of the Ray of Hope curriculum will be assessed by comparing outcomes for participants who receive standard TYRO Champion Dads (TCD) services, which includes the TYRO curriculum plus support services, and participants who receive both standard services plus 10 Ray of Hope curriculum hours. Goal 1: determine if treatment group participants who receive enhanced TCD services report healthier parenting attitudes compared to control group participants who receive only standard TCD services 6 months after TCD enrollment. Goal 2: determine if treatment group participants who receive enhanced TCD services report healthier partner relationship behavior compared to control group participants who receive only standard TCD services 6 months after TCD enrollment. Goal 3: determine if treatment group participants who receive enhanced TCD services report healthier parenting behavior compared to control group participants who receive only standard TCD services 6 months after TCD enrollment. Goal 4: determine if treatment group participants who receive enhanced TCD services report healthier co-parenting behavior compared to control group participants who receive only standard TCD services 6 months after TCD enrollment.

Family Champions Project

Efforts to conduct CQI are in the early stages of development in the field of Healthy Marriage and Relationship Education (HMRE). The Office of Family Assistance (OFA) has required HMRE grantees to conduct CQI as part of project activities since funding began for them in 2006. However, HMRE grantees have likely not bought into the CQI Process given the absence of user-friendly conceptual frameworks to guide CQI efforts and empirical evidence to demonstrate they improve implementation of project activities and, in turn, enhance participant outcomes that might be attributed to them. The CQI Process used in this study was developed by Dr. Theodore C. Jurkiewicz and then enhanced after starting work at MER, and it begins by forming a CQI-Team. The CQI-Team is a collaboration between practitioners with the authority to make implementation decisions about the FCP and evaluators at MER who handle data analyses and reporting. The CQI Team carries out a multistep plan that is repeated each program year to fully implement FCP educational services over time by using a series of indicators to track performance trends for various outputs from a different perspective in each step. Percentage of target enrollment, percentage of target population that reflect eligibility characteristics, hours of dosage received by participants, response rates to participant surveys that measure outcomes among other indicators and outputs are tracked for monthly and quarterly enrollment cohorts in each program year and presented in CQI Reports that take the perspective associated with each of the steps. The CQI Team discusses findings presented by evaluators for overall performance trends in bi-weekly reports for the 1st step and performance trends by site in quarterly reports presented twice per year for steps 2 and 3. Then, members of the CQI-Team collaborate with front line service staff to develop interventions for any performance trend with an output that seems likely to fall short of standards by the end of the program year. Effects of interventions on outputs are reported by site in step 4. Ultimately, successful performance interventions designed and implemented by the CQI Team in collaboration with front-line service staff should improve the outputs associated with FCP services over time, and the most immediate impact should be evident in participant retention rates. Interventions that lead to higher enrollment and then improved attendance should lead to a higher incidence of complete program status (active, complete, not in program), which means FCP services are being delivered to more participants in larger doses. Larger doses of services delivered to participants after performance interventions which means the CQI Team is facilitating progress to meet performance standards because participants receive the amounts of FCP services intended for them. What is more, higher retention rates over time should lead to improved short-term outcomes for participants. Participants who receive larger doses of FCP services after performance interventions should acquire more knowledge in educational sessions than those who receive smaller doses. However, rigorous measures of participant knowledge are not available because it was not possible to get full access to proprietary curricula to develop them. Consequently, participant attitudinal changes will be the only focus for measuring short-term outcomes in this study. Attitudes change more quickly in healthy and productive ways after merely exposing participants to new ways of thinking about parenting, handling finances, or accessing employment with curriculum content in the FCP. Finally, FCP services cannot determine participant outcomes but only contribute to them amongst a host of other factors, which makes it difficult for a descriptive study to link behavioral change to CQI efforts. Healthier and more productive behaviors take time to emerge, develop, and hopefully replace old behaviors because they are subject to a host of other influences on FCP participants. What is more, low-income individuals in the FCP target population, especially those who are parents, experience changing life circumstances more often than those from wealthier households that make them more vulnerable to a host of risk-related factors, such as unstable employment, tenuous housing situations, or limited sources of support that are available from family and friends. Changing life circumstances for low-income individuals make it more difficult for FCP services to have a positive, lasting impact on their behavior. In sum, immediate effects of successful performance interventions that result from the CQI Process should be evident in retention rates for FCP services over time because they are being delivered to more participants in larger doses, as indicated by more hours of attendance in TYRO Leadership and Core Communication workshops and higher workshop completion rates. Higher retention rates mean more participants acquire more knowledge from curriculum content to influence their attitudes about partner relationships.

Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD

Using three treatment arms, the study will examine Posttraumatic Stress Disorder (PTSD) symptom reduction when (1) 1 Hz (hertz) repetitive transcranial magnetic stimulation (rTMS) to the right dorsolateral prefrontal cortex (rDLPFC) is administered prior to each of 12 Cognitive Processing Therapy (CPT) sessions compared to when (2) sham rTMS is administered to the rDLPFC is administered prior to each of 12 CPT sessions and to when (3) 1 Hz rTMS is delivered to rDLPFC alone over 12 sessions. Veterans with combat-related PTSD will be randomly assigned to one of the three treatment arms. Primary outcome PTSD symptom severity measures, secondary neuropsychological, electroencephalography (EEG), and magnetic resonance imaging (MRI) outcome measures, and prescreening assessments for study contraindicators will be collected prior to being assigned to a treatment arm (i.e., baseline). Primary outcome PTSD symptom severity measures and secondary neuropsychological outcome measures will be collected twice within the span of the treatment sessions (i.e., sessions 5 and 9) and at three times following treatment competition (i.e., 1-month, 6-months, and 12-months). EEG also will be collected at the 1-month, 6-month, and 12-month assessments, and MRI will be collected at the 6-month and 12-month assessments.

Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

This is a global Phase 2, multicenter, single-arm, open label study of taletrectinib in patients of NSCLC harboring with ROS1 fusion gene. About 224 patients will be enrolled and divided into 6 cohorts, depending on past history of ROS1 TKI treatment. In the cohorts open to enrollment, taletrectinib will be administered either 400mg or 600mg once daily in 21-day cycles. In one cohort, this will be in combination with carboplatin and pemetrexed both administered by IV infusion in 21-day cycles for 4 cycles. Patients will continue with the treatment on taletrectinib until progression of disease as determined by the investigator. The tumor response evaluation will be conducted on a regular basis until progression of disease. Long-term survival follow up will be conducted as well.

MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study

In this study the treatment group will include all patients receiving MILD, and the control group will include all patients receiving IPD for the treatment of LSS during the enrollment period. Reoperation and harms data will be studied for the MILD and IPD procedures for a 24-month follow-up period after the index procedure using Medicare claims data. This study is exempt from IRB oversight (Department of Health and Human Services regulations 45 CFR 46) and does not require prior enrollment nor patient consent. The inclusion of the study's NCT number on MILD Medicare claims is required and results in enrollment.

Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma