Maine Paid Clinical Trials

Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years. Read Less

This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading. Read Less

This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type. Read Less

This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation. Read Less

This study is focused on understanding how the investigators can improve upon breast cancer and health outcomes for older participants with breast cancer. Read Less

This is a Phase 1/2a randomized, double-blind, two-part, dose-ascending, multicenter study of AR-501 (gallium citrate) solution, administered via inhalation, in healthy adult and P. aeruginosa infected cystic fibrosis (CF) subjects. Phase 1 of the study in HV subjects will consist of a single-ascending-dose (SAD) cohort, followed by the HV multiple-ascending-dose (MAD) cohort. Phase 2a of the study in CF subjects will consist of a MAD study design. The study will evaluate the safety and pharmacokinetic (PK) profile of single and repeat administrations of inhaled AR-501 solution in healthy adults, and the safety, PK and efficacy of repeat administrations of inhaled AR-501 solution in P. aeruginosa infected CF subjects. Read Less

This project is focused on evaluating outcomes related to this statewide clinical training effort in the RUBI parent training program. Up to 400 providers in Maine are enrolling in a "Level 1" 16-hour RUBI introductory training through one of three modalities (1) self-paced "On Demand" webinars, (2) 16 weekly one-hour meetings ("ECHO group"); or (3) "2-day live virtual trainings." Up to 140 providers who complete Level 1 are then being offered the option to advance to "Level 2" RUBI Certification Training. These varying clinical training options create the opportunity to study three groups of RUBI Training participants who received varying intensities/doses of training: (1) those who completed only the 16-hr psychoeducational training either live or On Demand, (2) those who complete only the 16-hr training via the hybrid consultation/training ECHO model, and (3) those who complete intensive fidelity consultation training in addition to the 16-hr introductory training. In order to examine the impact of training dosage and modality on outcomes of this RUBI clinical training effort, we are conducting two related studies: The purpose of Study 1 is to learn about the crucial elements of RUBI intervention training in relation to promoting community provider implementation success. This will be measured by providers' self-reported data related to: 1) satisfaction with the RUBI training, 2) knowledge gained about behavioral principles through the training, 3) improvements in self-efficacy in supporting autistic youth with challenging behaviors and their caregivers, and 4) satisfaction with the RUBI intervention, including strategies used in practice with caregivers of youth with ASD/IDD. In other words, what is a "good enough" dose of RUBI training to promote provider satisfaction with the training, intervention, and use of RUBI strategies? The purpose of Study 2 is to provide an examination of RUBI intervention implementation by examining outcomes related to: 1) provider self-reported and observed implementation fidelity of RUBI during sessions, 2) caregiver implementation of RUBI strategies with their child, 3) caregiver satisfaction with the RUBI intervention, and 4) the effects of caregiver implementation of RUBI on child challenging behavior. Read Less

This study will evaluate the efficacy and safety of niraparib and novel treatment combinations of niraparib as described within each cohort-specific supplement in participants with ovarian, fallopian tube, or primary peritoneal cancer. Cohort A (single arm) includes participants with recurrent ovarian cancer. Cohort B will not be initiated. Cohort C (randomized-2 arms) includes participants with newly diagnosed ovarian cancer. Read Less

This study examines the role of the epidermal growth factor (EGF) receptor family and the EGF family of ligands in the regulation of non-myocytes isolated from the human heart. Read Less

Surgical treatment for patients with a fracture of the ankle or distal radius is commonly offered on an outpatient basis. Patients are routinely discharged from hospital within 4 hours of their procedure. The surgery is commonly performed under peripheral nerve block with sedation, or under general anesthesia with postoperative peripheral nerve block, (if required for analgesic purposes). It is unclear which of these two strategies offers patients superior pain relief in the first few days following surgery. This trial aims to compare the pain intensity and analgesic medication consumption between patients in these two groups. Read Less

The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL. Read Less

This is a multi-center, double-masked, randomized, vehicle-controlled study testing PL9643, an opthalmic solution to determine if safe and efficacious for dry eye patients. After a 2-week run-in period, patients will be randomized equally to the PL9643 opthalmic solution or vehicle opthalmic solution administered bilaterally three times a day for 12 weeks. A Data Monitoring Committee will be engaged to review interim data. Read Less