New Lambton Heights

Researchers are studying pulmonary arterial hypertension PAH, a condition where lung blood vessels become thick and narrow, causing high blood pressure in the lungs and making it hard for the heart to work. PAH can cause difficulty breathing and limit activity. While standard treatments help symptoms, they do not stop the disease from worsening. This research focuses on sotatercept, a targeted therapy aimed at specific proteins involved in PAH, to learn about its long-term safety and tolerability when added to usual PAH treatments. Participants in this long-term follow-up study, who previously took part in certain sotatercept trials, may continue receiving sotatercept by subcutaneous injection every three weeks. Those coming from blinded studies start at 0.3 mgkg with possible increases up to 0.7 mgkg, while those from unblinded studies continue their current dose with possible titration to 0.7 mgkg. The study monitors participants over an extended period to assess continued effects alongside their usual PAH therapy. During the study, participants will have regular assessments including monitoring for adverse events, blood tests for blood components and chemistry, body weight, blood pressure, and ECG readings. Researchers will also evaluate exercise capacity, heart function markers, and risk scores related to PAH. The study aims to follow participants for up to approximately 7 to 8 years to understand long-term safety, treatment tolerability, and health changes while using sotatercept with standard PAH care.

Researchers are studying DB-1311BNT324 in adults with advanced solid tumors that have progressed after standard treatments or have no standard options available. This Phase 12a trial aims to evaluate the safety, tolerability, and early effectiveness of DB-1311BNT324, including its use alone or combined with new hormone therapies in prostate cancer. The study also investigates drug interactions with lopinavirritonavir and itraconazole. Participants receive intravenous doses of DB-1311BNT324 every three weeks at different dose levels to identify the best tolerated dose and recommended dose for further study. The trial includes various groups with specific tumor types, such as small cell lung cancer, non-small cell lung cancer, esophageal cancer, prostate cancer, melanoma, liver cancer, cervical cancer, ovarian cancer, head and neck cancer, and rare tumors. Some groups receive DB-1311BNT324 alone, while others receive it combined with oral hormone therapies or other drugs. During the study, participants undergo regular safety checks including vital signs, blood tests, heart function tests, and cancer status assessments. Researchers monitor side effects, serious adverse events, and tumor responses up to about one year after treatment. The main goal is to find the maximum tolerated dose and assess the drugs safety and preliminary antitumor activity. Participants health and cancer are closely followed throughout and after treatment.

Researchers are evaluating oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.

Researchers are evaluating the safety and effectiveness of UBT251, a medicine not yet available for prescription, in adults with type 2 diabetes. This study compares UBT251 with semaglutide, an already approved treatment, and their respective placebos. The goal is to see how well different doses of UBT251 lower blood sugar over time. Participants will be randomly assigned to receive either UBT251, UBT251 placebo, semaglutide, or semaglutide placebo. All treatments are given once weekly by injection under the skin. The study follows participants over several weeks, measuring effects at weeks 16, 28, and 40, focusing on blood sugar control and body weight changes. Throughout the study, participants will have regular assessments including blood tests to measure glycated hemoglobin HbA1c, insulin resistance, beta-cell function, fasting glucose, body measurements, blood pressure, cholesterol levels, and other health markers. Safety is monitored by tracking any adverse events, with total participation lasting up to 40 weeks of treatment plus additional safety follow-up.

Researchers are evaluating how well combination chemotherapy works in treating patients with newly diagnosed stages 2 to 4 diffuse anaplastic Wilms tumor DAWT and patients with relapsed favorable histology Wilms tumor FHWT. This phase II trial compares the effects of two chemotherapy regimens, UH-3 and ICECycloTopo, on event-free survival and overall survival, aiming to improve outcomes based on different relapse risk groups and prior treatments. The study also explores kidney toxicity, genetic markers, surgery impacts, and radiation therapy techniques to reduce side effects and better understand tumor behavior. Participants are assigned to one of two treatment groups. In Arm I Regimen UH-3, patients receive cycles of vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan intravenously over various days in a 21-day cycle, with radiation therapy at week 7 of cycle 3 if needed. In Arm II Regimen ICECycloTopo, patients receive cycles of carboplatin, etoposide, ifosfamide, cyclophosphamide, and topotecan intravenously over 10 cycles every 21 days, with surgery andor radiation therapy during certain cycles as clinically indicated. Throughout the trial, patients undergo multiple imaging tests including CT scans, PET scans, chest x-rays, MRIs, abdominal ultrasounds, and bone scans, along with blood sample collections and biopsies. After completing treatment, follow-up visits occur every 3 months for the first 2 years, then every 6 months for years 3 and 4, and once at year 5. The main outcomes measured are event-free survival and overall survival up to 5 years from study entry, with ongoing monitoring for treatment effects and safety.

Researchers are evaluating icotrokinra for its effectiveness and safety in people with moderately to severely active Crohns disease, a condition causing severe inflammation in the intestines. This clinical trial is a Phase 2b3 study aiming to understand how well icotrokinra works compared to placebo to improve symptoms and intestinal healing. Participants will be randomly assigned to receive one of several treatments two different doses of icotrokinra or a matching placebo, taken orally every day during an induction period of up to 12 weeks. Based on their response at Week 12, participants may continue with maintenance dosing or placebo up to Week 40. Those completing the maintenance phase may join a long-term extension study for further evaluation. During the trial, participants will be monitored with clinical assessments, endoscopy, and patient-reported outcomes to measure response, remission, and safety. The main outcomes include clinical response and remission at Weeks 12 and 40, along with endoscopic healing. Safety will be tracked through adverse event reporting up to four weeks after the last dose. The study is expected to continue until 2032, with multiple visits for treatment and evaluations throughout.

Heart attacks occur when a blood clot blocks the hearts blood vessels, stopping blood flow to the heart muscle. This trial focuses on patients with ST-elevation myocardial infarction STEMI and looks at how microcirculatory damage can be measured using the Index of Microcirculatory Resistance IMR. The study aims to find out if treating patients with impaired microcirculatory perfusion using low-dose intracoronary thrombolytic therapy can reduce heart muscle damage and improve clinical outcomes. Participants who have had a heart attack and undergone angioplasty will have their IMR measured. Those with an IMR above 32 will be randomly assigned to receive either low-dose tenecteplase a clot-dissolving drug or a placebo sterile water administered directly into the coronary artery. Patients with lower IMR will be followed in a registry. The treatment is given as an intracoronary infusion over 3 minutes. Cardiac enzymes, MRI scans, and other heart function tests will be done at various time points. During the study, participants will have heart enzyme tests at hospital admission and discharge. Those in the randomised group will receive cardiac MRI scans at discharge and six months later. Follow-up visits will occur at 30 days, then 6, 12, and 24 months after discharge to monitor heart function, rehospitalisation, and mortality. The main outcomes measured include cardiovascular death, heart failure rehospitalisation, heart attack size, and bleeding events, with safety and efficacy monitored closely throughout the study period.

Researchers are evaluating a phase II trial studying how well lower dose radiotherapy after chemotherapy works in treating children and young adults with central nervous system CNS germinomas. This trial aims to compare reduced radiation doses to standard treatment while maintaining effectiveness, potentially reducing long-term side effects. The study also investigates survival rates, tumor response, neuroendocrine function, and cognitive processing speed in participants with localized, metastatic, and basal ganglia or thalamic germinomas. Participants receive chemotherapy with carboplatin and etoposide intravenously over several days, repeated every 21 days for up to four cycles. After chemotherapy, patients are assigned to different treatment groups strata based on tumor response and location. Radiation therapy is delivered using advanced techniques such as 3D conformal radiation, proton therapy, or intensity-modulated radiation daily on weekdays for 16 to 24 days depending on the stratum. Some patients may undergo second-look surgery. The study includes collection of blood, cerebrospinal fluid, and tumor tissue samples for research. Throughout the study, participants undergo MRI scans and may have lumbar punctures for cerebrospinal fluid collection. Follow-up occurs every three months for the first year, then every four months for two years, and annually up to ten years. Researchers measure event-free survival, overall survival, tumor response, neuroendocrine function, and cognitive processing speed at multiple time points. The study also monitors for cerebral vascular events and evaluates long-term cognitive, social, and behavioral outcomes.

This research aims to evaluate the rate and severity of eye-related side effects caused by mirvetuximab soravtansine MIRV in women with recurrent ovarian cancer that expresses high levels of folate receptor alpha. The study compares two strategies to prevent these eye side effects by randomly assigning participants to receive either steroid eye drops or vasoconstricting eye drops as primary prophylaxis. Participants include those with platinum-sensitive or platinum-resistant ovarian cancer who have undergone prior therapies and meet specific safety and recovery criteria. Participants will be randomly placed into one of two groups. One group will use prednisolone acetate steroid eye drops six times daily initially, then four times daily, along with lubricating eye drops throughout each 21-day treatment cycle. The other group will use brimonidine tartrate vasoconstricting eye drops three times daily plus lubricating drops on the same schedule. All participants receive MIRV intravenously at a dose of 6 mg per kilogram of adjusted ideal body weight on the first day of each 21-day cycle. The study treatment continues for up to 18 weeks or through five cycles, followed by a 30-day follow-up. Throughout the study, participants undergo regular eye examinations to monitor for treatment-emergent adverse events and complete questionnaires measuring visual function. Blood samples are collected to analyze MIRV drug levels. The main outcome is the number of participants experiencing moderate or worse corneal side effects during treatment. Secondary outcomes include other eye-related symptoms and drug concentration measures. Safety and adherence to the eye drop schedules are carefully tracked during the trial period.

This trial is studying how safe and effective the VARIPULSE catheter system is for treating persistent atrial fibrillation PsAF, a heart rhythm disorder. It focuses on participants undergoing catheter ablation procedures that isolate veins in the heart, specifically pulmonary vein isolation PVI and superior vena cava isolation SVCI, with or without posterior wall isolation PWI. The study also looks at safety for participants receiving a left atrial appendage occlusion LAAO procedure during the catheter ablation to reduce stroke risk. Participants will be treated with the VARIPULSE catheter system, which delivers pulsed field ablation, using the VARIPULSE bi-directional catheter and TRUPULSE generator. The study has two groups one undergoing PVI and SVCI, and another undergoing PVI, SVCI, plus PWI. Some participants may also receive the LAAO procedure using commercially available devices as per device instructions. All participants will be followed for up to 36 months after their procedure. During the study, participants will undergo catheter ablation treatment and may receive the LAAO procedure if applicable. Researchers will monitor safety by tracking early adverse events up to 7 days post-procedure and will assess how well the treatment prevents atrial tachyarrhythmia episodes from day 61 to 180 and up to one year. Quality of life will be measured at baseline and 12 months after treatment. Participants need to comply with pre-, post-, and follow-up testing throughout the study and will be observed for up to three years in total.