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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

This trial focuses on elderly patients aged 80 years or older, or those 75 years and older who are considered frail, with untreated diffuse large B-cell lymphoma DLBCL and related lymphoma subtypes. The study is a phase III, randomized, open-label, multicenter trial conducted in several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. It aims to compare the standard chemotherapy regimen R-miniCHOP with an experimental treatment R-pola-miniCHP, where vincristine is replaced by polatuzumab vedotin, to assess differences in outcomes for this patient population. Participants will be randomly assigned to one of two treatment groups. One group will receive R-mini-CHOP consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone over six 21-day cycles. The other group will receive R-pola-mini-CHP, which includes rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin instead of vincristine, also given over six 21-day cycles. Both treatments last approximately 18 weeks. The study includes a screening period lasting up to 4 weeks before treatment begins. During the study, participants will be followed for up to 36 months after completing treatment to monitor progression-free survival over two years. Researchers will evaluate disease progression and safety outcomes through regular assessments during and after the treatment period. Participants will provide informed consent and undergo evaluations including health status and disease measurements to ensure eligibility and monitor treatment effects throughout the trial.

Age: 75Years +All GendersPhase 3
69 locations
E

Actively Recruiting

Researchers are evaluating the impact of two different guidelines for monitoring labor progress on neonatal and maternal outcomes. The study compares the World Health Organizations Labour Care Guide LCG with standard delivery care in Sweden. The goal is to see if using the LCG can reduce adverse neonatal outcomes and lower the rate of intrapartum Cesarean sections. This study uses a multicenter, stepped-wedge cluster randomized design to explore these effects along with economic considerations and experiences related to childbirth. Participants will receive labor monitoring either according to the WHOs LCG guidelines or standard care. The study will involve multiple delivery units in Sweden, and women in active labor will be randomly assigned to either group as the new guidelines are gradually introduced. Alongside the main study periods, researchers will examine perinatal interventions, labor complications, and collect qualitative data through questionnaires, focus groups, and interviews with women, their partners, and healthcare providers. During participation, women and their partners will be asked about their childbirth experiences, while providers compliance and views on using the LCG will also be assessed. The study will track outcomes such as perinatal mortality, neonatal morbidity, cesarean section rates, and obstetric events like postpartum hemorrhage and labor duration. Data collection and follow-up will occur from 12 weeks up to 18 months after delivery, including economic evaluations and provider experiences to fully understand the effects of the labor monitoring methods.

FEMALEPhase Not Applicable
24 locations
D

Actively Recruiting

Researchers are evaluating a new e-health program designed to improve the neurodevelopment of very preterm infants, born before 32 weeks or with low birth weight, by supporting parents in responsive caregiving. The study aims to see if this program, called INSPIRE, can enhance cognitive, motor, feeding, language, and socio-emotional development up to 2 years of age. Additional goals include assessing parental stress, emotional availability, health inequalities, and gender differences. This trial is conducted by Ume University with a multi-professional team and builds on a pilot study involving nine families. The intervention group will receive the INSPIRE program, which consists of 18 sessions delivered digitally over two years, starting at hospital discharge. This program focuses on strengthening parent-child interactions and empowering parents with responsive parenting skills. Families in the control group will receive standard care without the INSPIRE intervention. The study randomly assigns families to either group and follows up with assessments over time. Participants will be involved from discharge through at least 2 years corrected age, with evaluations including neurodevelopmental tests such as the Bayley Scales of Infant Development at 24 months. Additional assessments cover motor skills, language, feeding, emotional availability, parental stress, and mental health using various standardized tools at multiple time points up to 5.5 years of age. Researchers will monitor child development, parent well-being, and other outcomes to understand the interventions impact and safety over the study period.

Age: 0Months - 4MonthsAll GendersPhase Not Applicable
7 locations