Aberdeen

Researchers are evaluating two different pacing methods for patients with slow heart rates in this multi-center trial. The study compares the standard right ventricular pacing with a newer physiological pacing approach, which includes His bundle pacing or left bundle pacing. This trial aims to better understand the effects of these pacing methods on heart function and patient outcomes over time, including a sub-study focused on heart muscle changes related to pacing. Participants will receive a pacemaker implanted at a participating center and be randomly assigned to either right ventricular pacing or physiological pacing. For physiological pacing, if His or left bundle pacing is not successful, biventricular pacing will be used instead. The trial includes an optional echocardiographic sub-study for some patients to assess heart changes over 24 months. Participants will be followed for up to 78 months, with assessments at baseline and every six months. Researchers will measure outcomes such as survival, heart failure events, quality of life questionnaires, symptoms, device-related safety events, and heart rhythm data collected from the pacemakers. The sub-study will use echocardiograms to evaluate changes in heart volume and pumping efficiency. This comprehensive follow-up aims to capture both clinical effects and mechanistic insights of the pacing methods.

Researchers are evaluating MK-2214, a study treatment designed to slow certain brain changes in people with early Alzheimers disease AD, a condition that causes memory loss, speech difficulties, and problems with decision-making. The study aims to find out if MK-2214 can slow the spread of tau protein in the brain compared to a placebo and to assess the treatments safety and tolerability. Tau is a protein that builds up in AD and damages brain cells, impacting daily functioning. Participants will be randomly assigned to receive either MK-2214 or a placebo through intravenous IV infusions every 4 weeks during the study period. The study uses a quadruple-blind design, meaning that participants, care providers, researchers, and those assessing outcomes will not know which treatment is given. This phase 2 trial is planned to last up to approximately 23 months for treatment and assessment. During the study, participants will undergo brain scans including tau PET imaging and assessments of cognitive and daily living abilities at regular intervals. Researchers will monitor changes in tau protein levels, cognitive scores such as the Clinical Dementia Rating-Sum of Boxes CDR-SB, and safety outcomes including adverse events and treatment discontinuations. The total study duration includes up to about 26 months of follow-up to evaluate safety and effectiveness.

Researchers are evaluating the safety, tolerability, and effectiveness of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC that tests positive for human papillomavirus 16 HPV16 and expresses the protein PD-L1. This Phase IIIII trial includes patients whose tumors have a combined positive score of 1 or higher for PD-L1. The study is designed to generate important safety and efficacy data for these treatments in this patient group. The trial consists of two parts Part A is a non-randomized safety run-in phase to confirm the safety and tolerability of BNT113 with pembrolizumab. Part B is a randomized phase comparing BNT113 combined with pembrolizumab versus pembrolizumab alone. Treatments are given by intravenous injection or infusion. Patients may receive treatment for up to 24 months. An optional pre-screening phase allows tumor samples to be tested centrally for HPV16 DNA and PD-L1 expression before entering the main trial. Participants will undergo regular assessments including monitoring for treatment-emergent adverse events, overall survival, and progression-free survival for up to 48 months. Researchers will also measure response rates and duration, disease control, and any dose adjustments due to side effects. Patients provide tumor tissue samples before treatment and are monitored closely throughout the study period. The trial aims to collect comprehensive data on safety, treatment effects, and patient outcomes over this extended follow-up.

Researchers are evaluating the safety and effects of a drug called VHB937 in people with early Alzheimers disease. This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study that lasts 72 weeks, followed by an extension phase. The study aims to see if VHB937 can safely improve memory, thinking abilities, daily activities, and brain changes in individuals diagnosed with mild cognitive impairment or mild Alzheimers disease confirmed by specific biomarkers. Participants will receive intravenous infusions of either a low dose or high dose of VHB937, or a placebo. The study groups are assigned randomly and neither the participant nor the researchers know who receives which treatment during the 72-week double-blind period. After this, there is an extension phase to continue monitoring participants. During the study, participants will have regular assessments including memory and cognitive tests, evaluations of daily living activities, brain imaging, and blood tests to track how the body processes the drug and its immune response. Safety will be monitored by recording any adverse events throughout the study, which can last up to about 63 months. The main outcome measured is the change in the Clinical Dementia Rating scale over 72 weeks.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously completed treatment with the drug nerandomilast. The study aims to understand how well participants tolerate long-term treatment with nerandomilast and whether it helps improve lung function or delays worsening symptoms, hospitalizations, or death. This is a phase 3 open-label extension trial sponsored by Boehringer Ingelheim. Participants will take nerandomilast tablets daily for up to 1 year and 10 months. They may continue their usual treatments for pulmonary fibrosis alongside the study treatment. There is no placebo group, and all participants receive nerandomilast during this extension period. Throughout the study, participants will visit their doctors regularly for health check-ups and lung function tests. Researchers will closely monitor any side effects and changes in lung function, particularly forced vital capacity FVC, over nearly two years. The study will track time until symptom worsening, hospital visits, or death to assess the treatments long-term safety and effects.

Researchers are evaluating the effectiveness and safety of two treatments, rilvegostomig and pembrolizumab, each combined with platinum-based doublet chemotherapy, as first-line therapy for patients with metastatic non-squamous non-small cell lung cancer mNSCLC whose tumors express PD-L1. The study is a Phase III, randomized, double-blind trial conducted globally at multiple centers. It focuses on patients with tumors expressing PD-L1 at 1 or higher and aims to compare these treatment combinations in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group receives rilvegostomig intravenously on Day 1 of each 21-day cycle, combined with platinum-based chemotherapy carboplatin or cisplatin and pemetrexed, followed by maintenance rilvegostomig plus pemetrexed monotherapy. The other group receives pembrolizumab intravenously on the same schedule with the same chemotherapy drugs, followed by pembrolizumab plus pemetrexed maintenance. Chemotherapy is given for up to four cycles. During the study, participants will be monitored for overall survival and progression-free survival for up to approximately five years. Researchers will also assess response rates, duration of response, pharmacokinetics, immunogenicity, and patient-reported physical function and quality of life. Safety will be carefully tracked throughout the study. The trial began in late 2024 and is expected to conclude around March 2030.

Researchers are evaluating the efficacy and safety of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with the same chemotherapy for first-line treatment of patients with metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1 at 1 or higher. This Phase III, randomized, double-blind, global study focuses on patients with squamous mNSCLC without actionable genomic mutations and assesses these treatments over approximately five years. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle, combined with carboplatin and paclitaxel or nab-paclitaxel chemotherapy. Chemotherapy is given up to 4 cycles, with nab-paclitaxel administered on Days 1, 8, and 15 of each cycle. After chemotherapy, patients continue with the assigned immunotherapy drug. The study compares these two treatment regimens as first-line therapy. During the study, participants undergo regular assessments including imaging to measure tumor response, survival, and disease progression up to about five years. Researchers also monitor physical functioning, quality of life, lung cancer symptoms, and drug pharmacokinetics and immunogenicity. Safety is closely followed, and overall survival and progression-free survival are the primary outcomes measured to evaluate the treatments impact.

Researchers are evaluating the effectiveness and safety of volrustomig compared to observation in adults with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not shown disease progression after receiving definitive concurrent chemoradiotherapy cCRT. This phase III global study focuses on patients with specific stages of LA-HNSCC and aims to better understand treatment options after initial therapy. Participants are randomly assigned to one of two groups one group receives volrustomig, a drug being studied, while the other group is placed under observation without additional treatment. The study is open-label and conducted at multiple centers worldwide. The treatment or observation period follows the completion of definitive cCRT with curative intent. During the study, participants undergo regular assessments to monitor progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also track the presence of anti-drug antibodies and measure drug concentrations in blood samples. Safety is monitored by recording adverse events over a period of up to approximately 8 years, allowing long-term evaluation of outcomes and participant well-being.

Researchers are evaluating whether two drugs, retatrutide and tirzepatide, can prevent serious liver problems in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized clinical trial plans to enroll about 4,500 adults and will last approximately 224 weeks, including up to 25 to 30 clinic visits to monitor health and liver disease progression. The study is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. After completing the main study, eligible participants may join a 2-year extension where everyone receives either retatrutide or tirzepatide, regardless of their original group. This Master Protocol evaluates multiple pharmacologic agents under controlled conditions. Throughout the study, participants will undergo various assessments including liver function tests, imaging to measure liver stiffness and fat content, and body weight measurements. Researchers will track the time to major adverse liver outcomes and cardiovascular events. Safety and disease progression will be closely monitored, and the study includes evaluations at baseline, week 104, and up to study completion.

Relapsed neuroblastoma is a common and serious childhood cancer that is difficult to treat, especially in high-risk cases where the disease returns after initial treatment or does not respond to standard therapies. This trial aims to improve survival for children aged 1 year and older with relapsed neuroblastoma by testing new combinations of treatments. It is an international, open-label, randomized phase III study designed to develop and evaluate these new therapies while also studying the biology of the disease using biomarker samples. Participants will be randomly assigned to one of two main treatment groups or enrolled in smaller dose confirmation groups testing new drug combinations. The current main treatments include combinations of dinutuximab beta, irinotecan, temozolomide, and bevacizumab given in 12 cycles every three weeks. Additional experimental groups may receive different combinations of these drugs. The trial includes a translational sub-study collecting tumor, blood, and bone marrow samples to better understand neuroblastoma and improve targeted therapies. During the study, patients will receive their assigned treatments over multiple cycles and be closely monitored for safety, treatment response, and quality of life. Researchers will perform various assessments including imaging scans, laboratory tests, and questionnaires to measure progression-free survival, side effects, and overall clinical benefit. Follow-up will continue up to five years after treatment to assess long-term outcomes and collect further data on patient health and disease progression.