Pittsburgh

This research aims to evaluate a web-based decision support tool designed to help men make informed choices about vasectomy and other birth control options. The study focuses on understanding whether the decision aid improves users knowledge about vasectomy, reduces decisional conflict, and influences interest in vasectomy compared to men who do not use the tool. The trial is randomized and compares two groups to assess these outcomes. Participants are randomly assigned to either use the Vasectomy Right for Me web-based decision aid or to complete a survey without using the decision aid. Those in the decision aid arm engage with the tool to learn about vasectomy and alternative contraception methods before answering survey questions. The control group completes the survey directly after randomization without access to the decision aid. During the study, participants will complete surveys assessing their knowledge about vasectomy, their decisional conflict regarding contraceptive choices, and their interest in vasectomy. These assessments occur up to 45 minutes after the assigned intervention or survey completion. The study is sponsored by the University of Pittsburgh and aims to better understand factors that influence mens reproductive decisions related to vasectomy.

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

Researchers are evaluating the effects of two types of maxillary expanders used to widen the upper jaw in children aged 8 to 13 years with maxillary transverse deficiency. This trial compares a traditional expander made by hand in a laboratory to a newer expander designed on a computer and produced with 3D printing technology. The goal is to determine if the 3D-printed expander is as effective as the conventional one while potentially offering greater comfort to the patient. Participants will be randomly assigned to two groups one group receives the conventional laboratory-made Hyrax expander, and the other group receives the 3D-printed Hyrax expander. Both devices are used in the orthodontic clinic to treat upper jaw expansion. The treatment period includes follow-up visits over six months where dental photos, X-rays, and scans are taken to monitor progress. Patients and their parents or guardians will also complete online questionnaires about quality of life and pain experienced at various times during the study. During the study, participants will attend regular clinical visits for standard orthodontic follow-up, including photos, X-rays, and dental scans to assess the expanders effects. Researchers will measure changes in the midpalatal suture opening, interincisal diastema width, molar inclination, and maxillary arch widths after two weeks. Pain perception and oral health-related quality of life will also be evaluated using specific pain scales and questionnaires. This study lasts six months, with ongoing monitoring of treatment progress and patient comfort.

Researchers are studying a combination treatment involving 9-ING-41 elraglusib, retifanlimab, and modified FOLFIRINOX chemotherapy in patients with advanced pancreatic adenocarcinoma who have not received prior systemic therapy for their advanced disease. This Phase 1b study aims to evaluate the safety, tolerability, and potential anti-tumor activity of these combined therapies, as 9-ING-41 inhibits GSK-3 which may enhance immune response when combined with a PD-1 inhibitor like retifanlimab. The study builds on previous positive safety and efficacy data for each agent separately but seeks to understand their combined effects. The treatment involves chemotherapy with oxaliplatin, leucovorin, irinotecan, and 5-FU administered every 14 days, retifanlimab given by IV infusion at 500 mg on day 1 of every other cycle, and 9-ING-41 given intravenously twice weekly for the first four cycles then weekly thereafter. The study starts with a safety lead-in cohort of 6 patients to assess dose-limiting toxicities and may adjust doses accordingly before expanding to a larger group up to 12 patients total. This combination has not been previously tested together in humans. Participants will undergo scheduled visits with laboratory tests and imaging to monitor treatment safety and tumor response. Researchers will track dose-limiting toxicities within 28 days of treatment start and measure disease control rates, response rates, progression-free survival, overall survival, and treatment-related adverse events over months to years. The study includes detailed monitoring of lab function, performance status, and tumor measurements to assess outcomes and safety during follow-up periods up to 42 months.

This research aims to study cocaine use disorder CUD, a chronic condition with frequent relapses and abstinence periods. Researchers are evaluating brain dopamine release triggered by amphetamine using special PET scans in people with CUD. The study also looks at brain receptor changes related to stress and relapse, focusing on nociceptin opioid peptide receptors NOP and their role in counteracting stress effects in the brain. Understanding these mechanisms may help develop medications to prevent relapse in CUD. Participants will undergo a baseline PET scan using the radiotracer C-11NPA, followed by an oral dose of d-amphetamine at 0.5 mgkg. After amphetamine administration, a second PET scan will measure dopamine release in the brains striatum region. This study builds on previous imaging of NOP receptors before and after a hydrocortisone challenge and will explore how dopamine release relates to NOP receptor expression. The trial uses a single group design without masking. During the study, participants will have PET scans before and 2.5 to 3 hours after amphetamine intake to measure changes in dopamine binding. Researchers will assess dopamine release as their main outcome, focusing on changes in binding potential in the brain. Participants must meet strict health and substance use criteria, and safety monitoring includes screening for medical conditions and medication use. The study duration extends until September 2028, with comprehensive evaluations to understand the brain chemistry behind addiction and relapse.

Researchers are evaluating the progress of chronic venous leg ulcers in adults using a non-bordered foam dressing. This prospective, open, multi-center, interventional study aims to track wound healing over a 6-week period or until the wound heals. The study focuses on venous leg ulcers that produce moderate to large amounts of fluid and includes 20 participants across centers in the US and Canada. All participants will use the ALLEVYN Non-Adhesive foam dressing as the primary absorbent dressing. This device combines a breathable top film, a highly absorbent foam core, and a non-adhesive wound contact layer designed for comfort and optimal moist wound healing. The dressing will be worn continuously and changed every week during the treatment period. Participants will attend seven visits a baseline visit followed by weekly visits up to six weeks. At each visit, wound progress will be assessed by measuring wound size and evaluating wound condition. Researchers will also monitor pain, comfort, quality of life, dressing performance, and safety throughout the study. The main outcome measured is wound progress from baseline to last follow-up, with additional assessments including wound area reduction, tissue changes, exudate characteristics, skin condition, and adverse events.

Researchers are evaluating the progress of chronic wounds, specifically venous leg ulcers VLU and diabetic foot ulcers DFU, using an absorbent dressing called Mepilex Up. This study is a prospective, open, multi-center, interventional trial designed to observe wound healing over a period of up to six weeks. The goal is to track changes in wound area and condition while participants receive treatment according to local standards of care. Participants will use the Mepilex Up dressing, which is a soft, silicone-based absorbent foam dressing designed to manage wound exudate and protect the skin. The dressing will be applied as the primary dressing and changed weekly for up to six weeks or until the wound heals. The study includes seven visits a baseline visit followed by weekly visits to monitor wound healing and dressing performance. During each visit, researchers will assess wound progress through measurements and evaluations of wound area, volume, tissue quality, exudate, and skin condition. Participants will report on pain, comfort, and quality of life related to wound care. Safety will be monitored at all visits. The total treatment period is a maximum of 44 days or until healing occurs, with detailed tracking of dressing wear time, wound changes, and any adverse events.

This research investigates treatments for metastatic castration-resistant prostate cancer mCRPC focusing on a drug called ifinatamab deruxtecan I-DXd. The study aims to assess the safety, how well participants tolerate the treatments, and appropriate dosing levels of I-DXd alone or combined with other therapies. Researchers will also monitor participants prostate specific antigen PSA levels during treatment to understand its effects. Participants are assigned to one of several treatment groups. One group receives docetaxel every three weeks for up to 10 cycles. Other groups receive I-DXd alone or combined with either opevesostat or androgen receptor pathway inhibitors such as abiraterone acetate or enzalutamide. I-DXd is given every three weeks until unacceptable side effects, disease progression, death, or withdrawal, while the other drugs continue until specific discontinuation criteria are met. Premedication is required before each I-DXd dose to prevent nausea and vomiting. Throughout the study, participants undergo various assessments including monitoring of dose-limiting toxicities, adverse events, and PSA response rates. Researchers also track objective response rates, progression-free survival, overall survival, and other clinical outcomes over up to approximately 54 months. The study involves regular evaluations to assess safety and treatment effects until study completion.

Researchers are studying the safety and initial effects of T3011, given directly into tumors, alone and combined with the intravenous drug pembrolizumab. This Phase 12a open-label study focuses on adults with advanced or metastatic solid tumors, including melanoma, head and neck squamous cell carcinoma HNSCC, sarcoma, cutaneous squamous cell carcinoma cSCC, and non-small cell lung cancer NSCLC. The study aims to find safe dose levels and assess how well these treatments are tolerated and work in these cancer types. The study involves several groups Phase 1 tests increasing doses of T3011 alone to determine a recommended dose. Phase 2a Part 1 evaluates T3011 alone in participants with melanoma, HNSCC, sarcoma, and cSCC. Phase 2a Part 2 studies T3011 with pembrolizumab in NSCLC patients. A rollover arm allows participants whose cancer progresses on T3011 alone to receive the combination treatment. T3011 is given as an intratumoral injection every two weeks, and pembrolizumab is given intravenously every three weeks when combined. Participants will have tumor biopsies, imaging, and laboratory tests to monitor safety, drug levels, and cancer response. Researchers will track side effects and measure outcomes like tumor response and survival for up to two years after the first dose. Safety and tolerability are closely followed throughout, with additional monitoring for immune responses and drug presence in bodily fluids. Participants may be followed for up to one year after their last treatment dose to assess overall survival and long-term effects.

Researchers are evaluating new medicines to prevent HIV-1 Human Immunodeficiency Virus Type 1 infection. This Phase 3 clinical study aims to determine if taking the drug MK-8527 once a month can prevent HIV-1 infection as well as or better than the standard daily pre-exposure prophylaxis PrEP. The study also assesses the safety and tolerance of MK-8527 in participants. Participants are randomly assigned to one of two groups. One group receives 11 mg of MK-8527 once monthly along with a daily placebo pill matching FTCTDF. The other group receives a daily dose of FTC245 mg TDF and a monthly placebo matching MK-8527. This treatment period lasts for approximately two years, followed by an additional 28-day period where all participants receive open-label FTCTDF daily. During the study, participants will undergo regular monitoring to check for HIV-1 infection and any adverse events. Researchers will track the number of participants who acquire HIV-1, experience side effects, or stop treatment due to side effects over the two-year period. Safety and adherence assessments will be conducted to evaluate the study treatments. The total participation time includes the two-year treatment phase plus the 28-day follow-up with open-label FTCTDF.