Ruskin

Researchers are evaluating how a new medicine called PF-08052667 works alone or in combination with Bacillus Calmette Guerin BCG andor sasanlimab in adults with a type of bladder cancer that has not spread into the muscle layer but has a high risk of recurrence or growth. This study includes adults whose cancer has returned or persisted after standard treatments like BCG, or those who cannot receive such treatments due to medical reasons or availability. The study is a phase 1 trial sponsored by Pfizer focusing on treatment.

This research evaluates the combination of pembrolizumab, an immunotherapy drug, with radiation therapy after chemotherapy in patients with muscle invasive bladder cancer. The goal is to prevent the need for surgery to remove the bladder cystectomy following standard chemotherapy that aims to shrink or eliminate the tumor. This phase II trial focuses on bladder preservation and improving survival without bladder removal in this patient group. Participants receive photon beam radiation therapy daily from Monday to Friday for up to 20 treatments. Pembrolizumab is given intravenously on the first day of each 21-day cycle, for up to 18 cycles totaling 12 months, including the prior chemotherapy phase. Before and during treatment, patients undergo tissue collection via transurethral resection of bladder tumor TURBT, imaging scans such as CT, MRI, or PET, as well as cystoscopy and urine and blood tests. Throughout the study, patients are monitored for treatment effects, tumor recurrence, metastasis, and overall survival, with assessments of side effects and patient-reported symptoms related to gastrointestinal, urinary, and sexual function. After treatment, follow-up visits occur every 26 weeks until two years, then annually up to five years. Specimens are also collected for future research. The main outcome measured is bladder intact event-free survival within three years after registration.

Researchers are comparing two monoclonal antibody treatments, rituximab and mosunetuzumab, for adults with previously untreated follicular lymphoma that has a low tumor burden. The study aims to understand which treatment better controls disease progression and improves outcomes over time. Both drugs target cancer cells but work differently, and this phase III trial evaluates their effectiveness and safety. Participants are randomly assigned to one of two groups. One group receives rituximab intravenously and subcutaneously in cycles repeating every 56 days for up to five cycles unless the disease progresses or side effects become unacceptable. The other group receives mosunetuzumab subcutaneously in cycles repeating every 21 days for up to eight cycles under similar conditions. During treatment, patients undergo CT or PETCT scans and blood tests to monitor their disease and health. After completing the treatment phase, participants are followed with visits every six months for five years, then annually up to ten years. Researchers collect imaging and blood samples during and after treatment to assess progression-free survival and other health outcomes, including overall survival and treatment side effects. This long-term follow-up helps understand the treatments lasting effects and safety.

Researchers are evaluating treatments for patients with high-risk, locally advanced cervical cancer that has spread to nearby tissue or lymph nodes. This Phase III trial compares adding induction chemotherapy with carboplatin, paclitaxel, and pembrolizumab before standard chemotherapy, radiation, and pembrolizumab maintenance against the standard treatment of chemotherapy, radiation, and pembrolizumab maintenance alone. The study aims to investigate whether this induction approach improves progression-free survival and overall survival, while assessing treatment toxicity and biomarker effects. Participants are randomly assigned to one of two groups. In the standard care group, patients receive weekly cisplatin and pembrolizumab every three weeks alongside daily radiation therapy for 5 weeks, followed by brachytherapy for 4 to 5 treatments, and then pembrolizumab maintenance every six weeks for up to 15 cycles. In the experimental group, patients first receive induction chemotherapy with carboplatin and paclitaxel weekly for 3 weeks, plus pembrolizumab every three weeks for 2 cycles, then receive the same chemoradiation and pembrolizumab maintenance schedule, with radiation delivered in weeks 7 to 13. Treatment is given unless disease progression or unacceptable side effects occur. Throughout the trial, participants undergo imaging scans including PET, CT, chest x-ray, and MRI, along with blood sample collection to monitor disease and biomarkers. After completing treatment, patients are followed every 3 months for 2 years, then every 6 months for up to 3 more years. Researchers measure progression-free survival as the primary outcome and assess overall survival, adverse events, treatment completion, biomarker levels, and radiation quality. Safety and treatment effects are closely monitored during the study period lasting several years.

Researchers are evaluating the use of lanreotide before surgery compared to surgery alone to prevent pancreatic fistulas in patients with pancreatic cancer or pancreatic lesions that might become cancerous. This phase III trial aims to see if lanreotide, a drug similar to the bodys hormone somatostatin and used in certain tumors, can reduce complications like pancreatic fistulas after distal pancreatectomy surgery. Participants are randomly assigned to receive either lanreotide or a saline placebo by a quick injection under the skin within 36 hours before their planned distal pancreatectomy. Blood samples will be taken before surgery and on the first and third days after surgery, with possible collection of pancreatic fluid on these days as well. After surgery, patients will be followed up at 4, 8, and 12 months. During the study, researchers will assess the occurrence of pancreatic fistulas within 60 days after surgery, hospital stay length, and quality of life changes using specific questionnaires. They will also monitor other postoperative complications and the time to start any additional chemotherapy. Blood, pancreatic fluid, and tissue samples will be collected for future research, with all participants monitored carefully throughout the study period.

Researchers are evaluating a simplified form of Behavioral Activation called Do More, Feel Better DMFB, delivered by trained lay volunteers, to help older adults 60 with depression who attend senior centers. This study compares the volunteer-delivered approach to Behavioral Activation provided by masters level clinicians. The goal is to see if the volunteer model can increase activity levels and reduce depression symptoms similarly to traditional clinician delivery, potentially expanding access to mental health support in senior communities. Participants receive either the DMFB intervention delivered by volunteers or the standard Behavioral Activation by clinicians. Both approaches focus on encouraging engagement in enjoyable and rewarding daily activities to reduce depressive symptoms. The study measures changes in activity and depression over several weeks, with assessments at 3, 6, 9, 24, and 36 weeks after treatment begins. Researchers will also explore treatment satisfaction, overall functioning, costs, and factors that affect how well the interventions are delivered and sustained. During the study, participants complete various assessments including depression rating scales HAM-D, activity level scales BADS, disability assessments WHODAS II, and satisfaction surveys. These happen multiple times over a 36-week period. The study monitors participants depression symptoms and activity levels to understand the impact of each intervention. The total participation time extends up to 36 weeks after starting treatment, allowing researchers to observe both short- and longer-term effects.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating Telitacicept, a recombinant fusion protein, in adults with active primary Sjogrens Disease, an autoimmune condition characterized by B-cell hyperactivity and autoantibody production. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the effectiveness and safety of Telitacicept by modulating B-cell-mediated immune pathways through inhibiting BLyS and APRIL signaling, which are involved in disease activity. Participants will receive either Telitacicept or a placebo through subcutaneous injections as part of a parallel study design. The trial compares these two groups over a treatment period lasting 48 weeks, focusing on changes from baseline in disease activity and related symptoms. Telitacicept binds specific cytokines to reduce B-cell survival and autoantibody production, potentially impacting disease manifestations. During the study, participants will undergo assessments including the EULAR Sjogrens Syndrome Disease Activity Index ESSDAI, glandular function tests, patient- and physician-reported outcomes, and fatigue evaluations. Safety and efficacy will be monitored through these measures at Week 48. The trial spans from screening through treatment and follow-up, with a planned completion by January 2029.

Researchers are studying the effects of the medicine PF-08634404, given alone or with another antibody called ipilimumab, for treating advanced liver cancer known as hepatocellular carcinoma HCC that cannot be removed by surgery or has spread to other parts of the body. This is a clinical trial that includes adults aged 18 years or older who have locally advanced or metastatic HCC and have not received whole-body treatment for this cancer. Participants will be randomly assigned to receive either PF-08634404 alone or PF-08634404 combined with ipilimumab. Both medicines are given through intravenous IV infusions directly into a vein. The study involves sequential dose levels and will be conducted at clinical trial sites where medical staff will monitor participants during and after treatment visits. During the study, participants will be monitored for side effects and overall response to treatment. Researchers will evaluate safety, pharmacokinetics, and preliminary efficacy by measuring adverse events, dose-limiting toxicities, and tumor response using RECIST 1.1 criteria. Laboratory tests and immunological assessments will be performed up to approximately 24 months to understand how the medicines behave in the body and their effects on the cancer.

Researchers are comparing two radiation therapy approaches for men with high-risk prostate cancer to see if a shorter treatment duration can prevent cancer recurrence as effectively as the usual longer radiation schedule. This phase III trial evaluates stereotactic body radiation therapy SBRT, which delivers higher doses in five treatments over two weeks, against standard external beam radiation therapy EBRT, which involves 20 to 45 treatments over 4 to 9 weeks. The study includes men with specific high-risk features and uses advanced imaging to assess outcomes. Participants are randomly assigned to one of two groups. One group receives SBRT, involving five precise radiation treatments over two weeks, while the other group receives EBRT with 20 to 45 treatments over 4 to 9 weeks. Both groups undergo imaging tests such as bone scans, CT, MRI, or PETCT during screening and on study. Optional blood and urine samples may be collected during the trial. During the study, participants are followed every six months for up to five years to monitor metastasis-free survival, treatment effects on urinary, bowel, and sexual functions, fatigue, and overall quality of life. Various patient questionnaires and physician assessments track side effects and treatment burden. The trial also includes long-term evaluations of survival and disease progression, with imaging and laboratory tests supporting these assessments.