Salem

This research aims to evaluate the effectiveness, safety, and tolerability of DermaBind TL, a full-thickness dehydrated placental allograft, in patients with chronic non-healing ulcers, including diabetic foot ulcers DFUs and venous leg ulcers VLUs. The trial focuses on patients whose wounds have not responded to standard treatments. The study is a prospective, multi-center, open-label, single-arm clinical trial led by HealthTech Wound Care, designed to collect outcome data over a 12-week treatment period. Participants will receive DermaBind TL applied to their wounds while following standard care, including offloading with devices like CAM boots or total contact casting, wound debridement, infection management, and layered dressings for protection. The treatment phase lasts 12 weeks with assessments for wound area protection, infection rates, and adverse events. The study includes a screening phase to determine eligibility before treatment begins. During the study, clinicians will assess wounds regularly to monitor wound size, infection, and healing progress. Data will be collected on the number of grafts used and any treatment-related adverse effects. Outcome measures include wound area preservation and protective effects of the dressing over 13 weeks. Participants must comply with offloading and dressing protocols and will be followed for safety and treatment tolerability throughout the study duration.

Researchers are evaluating the effectiveness of a long-acting injectable form of buprenorphine compared to the daily sublingual under the tongue buprenorphine in treating Veterans with moderate to severe opioid use disorder OUD. This open-label, randomized controlled trial aims to see which treatment better retains Veterans in opioid therapy and helps sustain opioid abstinence. The study also examines secondary outcomes such as substance use, overdose incidents, infectious disease testing, psychiatric symptoms, housing status, dental health, and cost-effectiveness. Participants are Veterans aged 18 and older diagnosed with moderate to severe OUD and beginning a new treatment episode. After an induction period on daily sublingual buprenorphine, participants are randomly assigned to receive either a 28-day supply of daily sublingual buprenorphine or a monthly injectable buprenorphine shot administered in the clinic. Doses for the injectable form target 300mg, with a 100mg option for those who cannot tolerate the higher dose. Study visits occur weekly during the first month, then every two weeks until week 52, including medication management. Throughout the 52-week active phase, participants report opioid use and provide urine samples every two weeks to evaluate abstinence and treatment retention. Additional assessments include HIV, Hepatitis B and C testing, psychiatric questionnaires, risk behavior evaluations, and dental health surveys. After the active phase, participants are followed passively using medical records for up to 10 years to monitor long-term outcomes. The study expects to recruit 952 Veterans over 7 years across multiple VA Medical Centers.

Researchers are evaluating the real-world use and safety of BRIUMVI4 ublituximab-xiiy in adults with relapsing multiple sclerosis RMS. The study aims to understand the safety, effectiveness, and treatment experience of participants prescribed this medication outside of controlled clinical trials. This observational study is sponsored by TG Therapeutics, Inc. and focuses on patients receiving routine care with BRIUMVI4. Participants in this study will receive BRIUMVI4 through intravenous infusion as prescribed for RMS treatment. The study includes participants who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. No placebo or other interventions are involved, and the study observes the treatment as it is given in real-world medical settings. During the study, participants will be monitored for up to 96 weeks to assess their annualized relapse rate ARR. Researchers will also track adverse events, serious adverse events, and infusion-related reactions at each infusion. Participant safety and treatment experience will be observed through regular clinical assessments and data collection, with the study lasting until April 2032.

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

Researchers are evaluating the combination of fruquintinib and FOLFIRI as a second-line treatment for adults with metastatic colorectal cancer mCRC. This open-label Phase II trial focuses on assessing the effectiveness and safety of this combination in participants previously treated with first-line therapies including oxaliplatin, fluoropyrimidine, and bevacizumab. The study excludes those with certain genetic mutations and aims to enroll up to 60 participants. Participants will receive fruquintinib orally for 21 days followed by a 7-day break in each 28-day cycle. Concurrently, they will receive FOLFIRI intravenously every 2 weeks within each cycle. Treatment continues until disease progression or unacceptable side effects. The FOLFIRI regimen includes irinotecan, leucovorin, and 5-fluorouracil, with possible adjustment to the 5-fluorouracil bolus based on prior treatment tolerance. During the study, participants will be closely monitored with assessments every two cycles 56 days including progression-free survival evaluation, response rates, duration of response, disease control, and overall survival. Safety is tracked through adverse event monitoring from consent to 30 days after treatment ends, up to one year. The total study duration for each participant may last up to two years to fully capture treatment outcomes and safety data.

Researchers are evaluating whether combining tucatinib with trastuzumab and mFOLFOX6 works better than standard treatments for people with HER2 positive colorectal cancer that has spread or cannot be removed by surgery. This Phase 3 study also aims to learn about the side effects that may occur when taking this combination of drugs. Participants have metastatic or unresectable colorectal cancer and are randomly assigned to different treatment groups. Participants are randomly placed in one of two study groups. One group receives tucatinib taken orally twice daily along with trastuzumab given intravenously every 3 weeks and mFOLFOX6 chemotherapy every 2 weeks. The other group receives standard care, which may be mFOLFOX6 alone or combined with bevacizumab or cetuximab, both given intravenously on different schedules. Tissue samples and biopsies are collected before treatment to confirm HER2 positivity and other markers. During the study, participants will have regular evaluations including imaging scans to measure cancer progression, blood tests, and assessments of side effects and quality of life. Progression-free survival is the primary outcome measured for up to about 3 years, with other outcomes like overall survival and response rate also tracked. Safety monitoring continues for about one year after the last treatment. The study lasts several years, with ongoing follow-up to understand long-term effects and benefits.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 in adults with primary hypothyroidism who have been stable on synthetic T4 treatment. The study will also assess how well patients tolerate switching from synthetic T4 to Armour Thyroid. This trial is a Phase 23, randomized, double-blind study sponsored by AbbVie to compare these two thyroid hormone replacement therapies. Participants will be randomly assigned to receive either Armour Thyroid or to alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. The treatments are oral capsules or tablets taken daily, with doses carefully converted from their stable synthetic T4 dose. The study includes a dose-conversion period where dosage adjustments may be made to maintain appropriate thyroid hormone levels. During the study, participants will have regular blood tests to measure thyroid-stimulating hormone TSH levels, including at week 55 to see who achieves a target TSH response. Researchers will also monitor for any adverse events throughout the study, which lasts up to about 90 weeks. Dose adjustments and safety data will be tracked closely to understand treatment effects and tolerability over time.

Researchers are studying finerenone to evaluate its safety and effectiveness in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international trial is randomized, double-blind, and placebo-controlled, focusing on how finerenone compares to placebo in reducing heart failure events and cardiovascular death. Participants receive either oral finerenone or a matching placebo while hospitalized or recently discharged for heart failure. The study monitors patients over approximately 30 months to assess the total heart failure events, cardiovascular death, and adverse events related to the treatment. Throughout the study, participants undergo regular assessments including symptom scoring using the Kansas City Cardiomyopathy Questionnaire, monitoring for serious adverse events, and evaluation of heart failure outcomes. The study tracks safety and efficacy data over the long term, with follow-up visits scheduled to measure the impact of treatment on morbidity and mortality in heart failure patients.

Researchers are evaluating the effectiveness and safety of standard chemotherapy with or without the drug INCB161734 in participants who have metastatic pancreatic ductal adenocarcinoma PDAC with a KRAS G12D mutation and have not received prior treatment for metastatic disease. This phase 3 study compares two groups to understand whether adding INCB161734 to chemotherapy improves outcomes in this condition. Participants will receive either oral INCB161734 tablets combined with chemotherapy chosen by their doctor either mFOLFIRINOX or GemNabP or a placebo tablet combined with the same chemotherapy options. The treatments are given according to the study protocol, and the study is conducted in a randomized, double-blind design to fairly compare the effects of INCB161734 plus chemotherapy versus placebo plus chemotherapy. During the study, participants will be monitored for overall survival, progression-free survival, and tumor response up to about two to three years. Researchers will also assess treatment side effects, quality of life using questionnaires, and other health outcomes. Participants will have regular visits for assessments, and safety will be closely tracked throughout the study period, which lasts until the study completion date in 2029.

Researchers are evaluating the effectiveness and safety of ENERGI-F703 GEL in treating diabetic foot ulcers classified as Wagner Grade 1 to Grade 2. This Phase 3, randomized, double-blind, vehicle-controlled study includes participants with ulcers of different sizes and aims to compare the gel against a vehicle control across multiple centers. The total study duration is up to 31 weeks, encompassing screening, treatment, and safety follow-up phases. Participants will be randomly assigned to receive either ENERGI-F703 GEL or a matching vehicle gel, both applied topically twice daily for 16 weeks. The study uses a web-based system to assign participants to one of the two groups. After the treatment phase, a 12-week safety follow-up is conducted to monitor participants. Initial screening lasts approximately 2 to 3 weeks before treatment begins. Throughout the study, participants undergo regular assessments including evaluation of ulcer closure rates at week 16, and monitoring of ulcer healing progress at multiple time points. Safety is tracked by recording adverse events from week 1 through week 28. Participants will have visits to assess wound status, adverse events, and overall health, with the primary outcome being the complete closure of the ulcer by week 16.