Medication Management

This research aims to evaluate whether taking antipsychotic medication every other day is as effective as the usual daily dosing for people with schizophrenia or related disorders. The study also explores if the alternate day dosing reduces side effects compared to daily treatment. It is a randomized, double-blind trial designed to compare these two dosing schedules over one year. Participants will be randomly assigned to either continue their current daily antipsychotic medication (risperidone, olanzapine, or paliperidone) or switch to an alternate day dosing schedule. To maintain blinding, active medication and placebo capsules are provided in matching blister packs so participants and staff cannot tell which regimen is assigned. Doses range from 1 mg to 16 mg for risperidone, 5 mg to 20 mg for olanzapine, and 3 mg to 12 mg for paliperidone. Treatment is individualized, and other psychotropic medications can continue if stable. Participants will attend 22 visits over 52 weeks, with visits every two weeks for the first six months and monthly visits for the final six months. Researchers will assess symptom severity and side effects using several scales, including the Brief Psychiatric Rating Scale and multiple symptom and wellbeing questionnaires. The main outcome focuses on clinical deterioration at the start and end of the study. Safety and medication adherence will be closely monitored throughout the trial.

This research aims to compare the effectiveness of monitoring blood sugar levels at 1 hour versus 2 hours after meals in pregnant women diagnosed with Gestational Diabetes Mellitus who require treatment. The study focuses on understanding which monitoring time better supports managing blood sugar during pregnancy to improve outcomes for both mother and baby. Participants are pregnant women attending an antenatal clinic and are treated with metformin, insulin, or a combination. Participants will be randomly assigned to monitor their blood sugar either 1 hour or 2 hours after meals using self-monitoring of capillary blood glucose. Their blood sugar is tracked at seven staggered points to provide a detailed profile. This monitoring continues until delivery, with participants followed regularly in the research clinic. Throughout the study, women will have regular visits to assess their health and that of their baby. Researchers will collect data on mode of delivery, gestational age at birth, and fetal weight. They will also monitor maternal and perinatal complications from randomization to delivery. The total participation lasts from enrollment until the birth of the baby, allowing detailed observation of pregnancy outcomes related to the glucose monitoring method.

This research aims to evaluate a 5-session cognitive behavioral program called 1MoreStep, designed for Black women living with HIV who have experienced intimate partner violence in the past two years. The study focuses on teaching skills to access personal and external strengths, safety strategies, knowledge about HIV care and stigma, communication skills to handle stigma, and addressing barriers to HIV care. It also examines the program's acceptability and feasibility among participants. Participants are randomly assigned to either the 1MoreStep intervention or an equal attention control group. The intervention includes seven group sessions and one individual session held weekly, led by experienced facilitators from the Black community. Sessions cover topics such as safety planning, HIV care engagement, stigma communication, and goal setting using cognitive behavioral skills. The control group attends weekly support group sessions that cover general health topics important to Black women living with HIV but not directly related to the intervention's goals. Throughout the study, participants complete assessments at baseline, 3 months, and 6 months to measure changes in safety strategies and HIV care engagement. Measures include surveys, medical record reviews, and interviews to evaluate treatment acceptance, session attendance, and participant experiences. The study spans approximately 6 months post-baseline, with follow-up surveys and qualitative interviews to explore program fit and barriers to participation.

Researchers are evaluating the efficacy and safety of HSK21542 injection for managing postoperative pain in patients undergoing orthopedic surgery. This is a Phase III, multi-center, randomized, double-blind, placebo and active-controlled study involving 405 participants. The trial compares HSK21542, morphine, and placebo to understand their effects on pain relief after surgery. Participants will be randomly assigned to receive either HSK21542, morphine, or a placebo. The study treatments are administered following surgery under general anesthesia, specifically for patients undergoing hip replacement. The trial monitors pain intensity and other effects over a 48-hour period post-treatment. During the study, participants will be assessed for pain relief using the Sum of Pain Intensity Differences (SPID) at 48 hours as the primary measure. Secondary measures include nausea and vomiting occurrence, additional pain assessments at shorter intervals, rescue medication use, and total morphine consumption. Safety and effectiveness will be closely monitored throughout the trial lasting until March 2026.

Researchers are evaluating the mobile game Viral Combat to see if it helps improve adherence to PrEP among diverse participants aged 15 to 34 years receiving PrEP care in clinical settings in New England and Mississippi. The study includes formative interviews with healthcare workers, clinic administrators, and patients to adapt the game for different populations and clinics. A randomized controlled trial will then compare Viral Combat to a non-PrEP related game to assess effects on biological and behavioral measures. Participants will be randomly assigned to one of two groups. One group will receive the Multilevel Gaming Adherence Intervention, which includes the Viral Combat mobile game and adherence-based text messages for 24 weeks. The other group will receive treatment as usual plus a non-HIV related mobile game. After the trial, additional interviews will evaluate factors that could affect future use of the game in clinical settings. Participants will complete assessments including biological tests measuring tenofovir blood levels at 24 and 48 weeks, self-reported medication adherence, and medical appointment adherence. The study will also collect data on knowledge, motivation, self-efficacy, and game metrics. The total participation includes a 24-week intervention period with follow-up assessments, along with interviews before and after the trial to inform game adaptation and implementation.

Childhood obesity is a growing global health concern linked to serious health problems such as type 2 diabetes, high blood pressure, certain cancers, and mental health challenges. Researchers are evaluating a digital support system called Evira to help improve treatment outcomes for children with obesity. This randomized controlled study aims to assess the effects of adding Evira to the usual lifestyle treatment for childhood obesity in children aged 4 to 17 years. The study compares two groups: one receiving Evira Care combined with standard lifestyle treatment, and the other receiving standard lifestyle care alone. Evira Care involves daily weight monitoring at home using a special scale connected to a mobile app and website, allowing parents and clinicians to track weight changes and communicate easily. The intervention group will receive guidance on how to use the system and make feasible lifestyle changes, with weight targets set for the first three months. The control group continues with standard care without restrictions on visits or clinical support. Participants will be involved for 12 months, undergoing clinical exams including puberty assessment, cardio-respiratory, thyroid, skin, and abdominal checks, along with measurements of weight, height, and blood pressure. Blood tests may be done as needed. All participants will complete questionnaires about quality of life, eating disorders, and treatment satisfaction. Researchers will monitor weight change as the primary outcome, along with treatment compliance and psychosocial health measures, while collecting information on any side effects.

Researchers are evaluating whether maintenance therapy with Zanubrutinib alone can improve the two-year progression-free survival for patients with mantle cell lymphoma who have achieved remission after first-line immunochemotherapy. This study is a multicenter, prospective, phase II trial focusing on patients in remission, aiming to explore the effectiveness and safety of Zanubrutinib maintenance treatment. Patients who achieved complete or partial remission after initial immunochemotherapy, including regimens like R-CHOP or BR, will receive Zanubrutinib monotherapy for up to two years. Treatment will continue until disease progression, intolerable side effects, death, withdrawal, or study termination. This approach allows researchers to assess Zanubrutinib as a maintenance therapy in this patient population. Participants will be monitored over two years, with assessments including progression-free survival, event-free survival, overall survival, toxicity evaluations, and quality of life questionnaires. The study will collect data on blood counts, liver and kidney function, heart function, and coagulation status to ensure safety. The total participation duration may last up to two years, with regular follow-up and safety monitoring throughout the trial period.

Researchers are exploring how giving pregnant individuals a choice among different nutrition and exercise programs affects their ability to stick to the program and maintain healthy pregnancy outcomes. The study focuses on preventing excessive gestational weight gain by comparing adherence to three lifestyle intervention strategies within the Nutrition and Exercise Lifestyle Intervention Program (NELIP). This research uses a pseudo-randomized design to examine if choice improves participation compared to no choice in pregnant individuals between 12 and 18 weeks of pregnancy with a single fetus. Participants are divided into two groups: one group chooses from three intervention strategies and the other group is matched to a choice participant and receives the same strategy without choice. The three strategies vary in timing of introducing nutrition and exercise components; either both simultaneously starting at 12-18 weeks, or nutrition first followed by exercise at 25 weeks, or exercise first followed by nutrition at 25 weeks. The exercise involves a supervised walking program with gradually increasing duration, and nutrition is based on a modified gestational diabetic meal plan tailored per participant. The full program continues until delivery, with final intervention measures between 34 and 36 weeks gestation. Participants will be monitored weekly for adherence using a point system, with additional assessments of satisfaction and health outcomes like weight gain, birth measurements, and pregnancy complications. Follow-up visits occur at birth and at 2, 6, and 12 months postpartum to track maternal and infant health. The study collects detailed data on nutrition, exercise, and pregnancy progress to understand how choice impacts adherence and outcomes over this extended timeline.

This research aims to evaluate the effectiveness and safety of menin inhibitor maintenance therapy in patients with acute leukemia who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT). Patients with high-risk subtypes, such as those with KMT2A rearrangements, face high relapse rates after transplantation. The study focuses on understanding how menin inhibitors, including drugs like Revumenib, BN104, Ziftomenib, and HMPL-506, may impact relapse-free survival and overall outcomes in a real-world setting. Eligible patients will receive menin inhibitor maintenance therapy as part of their routine clinical care, with the choice of specific drug, timing, dosage, and treatment duration decided by their doctors. The study does not impose extra interventions beyond usual clinical management. After starting maintenance therapy, patients will be monitored during each treatment cycle, and after treatment ends, survival follow-up visits will occur every three cycles to track long-term outcomes. Participants will be regularly assessed for treatment effectiveness and safety throughout the therapy and follow-up periods. Key outcomes include the two-year relapse-free survival rate, overall survival, event-free survival, relapse incidence, and treatment-related safety measures such as graft-versus-host disease. The study will continue until December 2029, providing comprehensive data on menin inhibitor use in post-transplant maintenance therapy for acute leukemia.

The GEROS Project is designed to develop and implement a Service-Learning program that combines Comprehensive Geriatric Assessment (CGA) and health promotion for older adults aged 60 and above. It involves university students from various health-related fields and aims to foster intergenerational learning and community engagement. The study follows a non-experimental mixed-method design and focuses on evaluating frailty, intrinsic capacity, quality of life, and other health indicators in participating older adults. Participants will receive a series of three sessions at the University of Vic - Central University of Catalonia, where students supervised by health professionals conduct CGA evaluations. Following the assessment, users receive a report with their CGA results along with personalized health education and recommendations. The program integrates practical student training with real-world health promotion for older adults. During the study, researchers will assess frailty and quality of life at baseline, and measure satisfaction and self-perceived knowledge and skills of both students and older adult participants after the intervention sessions. Data will be collected through questionnaires and recorded using REDCap. The study supports active aging and aligns with global health and equality goals, with total participation spanning up to 2-4 weeks after intervention.