Newcastle Upon Tyne

Perimenopause is the phase before menopause where women experience symptoms like hot flushes, night sweats, mood swings, anxiety, sleep problems, fatigue, and trouble with memory or concentration. These symptoms can be frequent and intense, affecting quality of life. Despite growing awareness, there is limited research on how diet and supplements impact menopause symptoms. This study investigates the effects of 12 weeks of magnesium supplementation on symptoms, cognition, sleep, and psychological well-being in perimenopausal women. The study compares two groups one taking a magnesium hydroxide supplement and the other a placebo, both for 12 weeks. Each participant will take two capsules daily of either magnesium hydroxide or placebo. The trial is randomized and triple-blinded to fairly assess the effects of magnesium. The treatment period lasts 84 days with assessments conducted at baseline, 6 weeks, and 12 weeks. Participants will complete memory and cognitive tasks, such as numeric and alphabetic working memory tests, recognition tasks, and the Corsi blocks task, at three time points. They will also fill out questionnaires measuring menopause-specific quality of life, depression, anxiety, stress, mood, and sleep quality. These measures will help researchers understand how magnesium may influence cognition, psychological health, and sleep during perimenopause. The study is led by Northumbria University and plans to end in August 2026.

Perimenopause is a transition phase before menopause, marked by symptoms such as mood changes, anxiety, sleep problems, hot flushes, night sweats, fatigue, and cognitive challenges. These symptoms can significantly impact womens quality of life. Although awareness of menopause has grown, research on nutritional approaches to manage these symptoms remains limited. This study aims to evaluate the impact of a 12-week multi-vitaminmineral and herbal supplement on perimenopause symptoms, memory, concentration, sleep, and psychological well-being compared to a placebo. Participants will be randomly assigned to one of two groups one taking a placebo capsule daily for 84 days, and the other taking a multi-vitaminmineral supplement daily for the same duration. The supplement includes herbal extracts and vitamins recommended by menopause societies. The study will compare the effects of these supplements on symptoms and cognitive function over the 12-week period. Throughout the study, participants will be assessed at the start, at 6 weeks, and at 12 weeks. Assessments include various memory and cognitive tests such as numeric and alphabetic working memory, 3-back task, word and picture recognition, as well as questionnaires on menopause quality of life, depression, anxiety, stress, mood, and sleep quality. The study monitors changes in these areas to understand the supplements effects on perimenopausal women aged 40 to 60 years.

Researchers are evaluating the effects of delgocitinib cream 20 mgg applied twice daily compared to a non-active cream vehicle in adults aged 18 years and older with mild to severe palmoplantar pustulosis PPP. This skin condition involves pustules on the palms and soles and can persist for more than three months. The study aims to determine if delgocitinib improves the severity and symptoms of PPP over 16 weeks. Participants will be randomly assigned to one of two groups one applying delgocitinib cream twice a day and the other applying a matching vehicle cream twice a day, both for 16 weeks. The study is double-blind, meaning neither participants nor researchers know which treatment is given. The total study duration for each participant is about 18 weeks, including approximately 9 visits. During the study, participants will attend regular visits where their skin condition will be evaluated using several measures, including the Palmoplantar Pustulosis Area and Severity Index PPPASI and Physician Global Assessment PGA. Researchers will also assess symptoms like pustule counts, itch, pain, quality of life, and work productivity. Safety and any side effects will be monitored throughout the study period.

Researchers are evaluating the safety and tolerability of multiple doses of an investigational medicine called PGN-EDODM1 in adults with myotonic dystrophy type 1 DM1. This randomized, double-blind study compares PGN-EDODM1 to a placebo to better understand its effects on this condition. The study is a Phase 2 trial sponsored by PepGen Inc and aims to assess how well participants tolerate the treatment and monitor any adverse events. Participants will be randomly assigned to receive either ascending doses of PGN-EDODM1 or a placebo, both given by intravenous infusion once every 4 weeks for a total of 12 weeks. The treatment period spans these 12 weeks during which doses are administered and safety is closely monitored. The placebo group receives saline infusions on the same schedule to provide comparison data. During the study, participants will be regularly assessed for safety by tracking any adverse events from the start through day 112. Researchers will also measure how the drug behaves in the body, including plasma concentration and half-life, as well as changes in muscle function and myotonia using video hand opening time, hand grip strength, and 10 meter walkrun tests. Muscle biopsies will be performed to study tissue changes. The entire participation period includes baseline assessments, treatment, and follow-up evaluations lasting up to about 112 days.

Researchers are investigating new treatments for Pulmonary Arterial Hypertension PAH, a condition where the blood vessels in the lungs thicken and narrow, causing high blood pressure in the lungs and making it difficult for the heart to work properly. PAH can lead to breathing difficulties and reduced activity levels. While current treatments help manage symptoms, they do not stop the disease from progressing. Sotatercept is a study medicine designed to target specific proteins involved in PAH, and this long-term follow-up study aims to assess its safety and tolerability when used alongside standard PAH treatments over an extended period. Participants who have completed previous sotatercept PAH studies may join this open-label follow-up study. Those from blinded studies will start sotatercept at 0.3 mgkg by subcutaneous injection every three weeks and may increase to 0.7 mgkg. Participants from unblinded studies will continue their current dose and may also increase to 0.7 mgkg. The study focuses on monitoring sotatercept use combined with background PAH therapy to observe long-term effects. Throughout the study, participants will undergo regular assessments including tracking adverse events, laboratory tests for blood and chemistry markers, body weight, blood pressure, and electrocardiograms up to approximately 7 years. Additional measurements include walking distance tests, heart function markers, and risk scores related to PAH. Safety monitoring and tolerance to the medication will be closely observed over time to better understand sotatercepts long-term impact in managing PAH.

Researchers are evaluating the safety, effectiveness, best dose, and how the body processes BNT326 when used alone or combined with other immunotherapy drugs in adults with advanced solid tumors. These tumors are either metastatic, recurrent without further treatment options, or have relapsed after previous therapy. The study includes patients with different types of advanced cancers such as melanoma, lung cancer, breast cancer, gastric cancer, colorectal cancer, and cervical cancer. In Part 1, participants receive BNT326 alone across several cancer-specific groups, including cutaneous melanoma, non-small cell lung cancer with or without specific mutations, rare melanomas, advanced tumors, and cervical cancer. Part 2 evaluates BNT326 alone or combined with another immunotherapy drug called pumitamig. Participants are assigned to different dose levels, sometimes randomly, depending on their cancer type and group. The study includes a screening period, treatment for up to 24 months or until progression or other reasons, and follow-up periods. During the study, participants undergo assessments including tumor tissue sampling, monitoring of treatment side effects, blood tests to measure drug levels, and evaluations of tumor response and survival. Safety is closely followed up to 42 or 90 days after treatment ends, with longer-term monitoring for up to 38 months Part 1 or 48 months Part 2. Participants overall response rates, adverse events, and pharmacokinetics are key outcomes. The study is sponsored by BioNTech SE and includes open-label, adaptive design across two phases.

This research aims to evaluate treatments for chronic urinary tract infection UTI in females, a condition where symptoms occur every day without symptom-free breaks. Current treatments often involve low-dose antibiotics or methenamine hippurate but may not fully resolve symptoms. The trial investigates whether longer courses of higher-dose antibiotics combined with methenamine hippurate are more effective than standard care in reducing infection and symptoms. Participants will be randomly assigned to one of two groups. One group receives a higher-dose antibiotic cefalexin, nitrofurantoin, or trimethoprim combined with methenamine hippurate taken twice daily for 12 weeks. The other group receives a low-dose prophylactic antibiotic amoxicillin, cefalexin, nitrofurantoin, or trimethoprim or methenamine hippurate alone, also for 12 weeks. Treatments are selected by clinicians based on individual medical needs. During the 12-week treatment, participants visit the clinic every 4 weeks for assessments. They complete questionnaires and provide blood, urine, and perineal swab samples. Researchers measure changes in urinary white blood cell counts, symptom scores, quality of life, medication satisfaction, treatment adherence, urine cultures, and safety markers like vital signs and blood tests over the course of the study.

This research aims to learn about the safety and effects of marstacimab, a study medicine being evaluated for treating Hemophilia in pediatric patients. It focuses on children aged 1 to 17 years with severe Hemophilia A or moderate to severe Hemophilia B, including those with or without inhibitors. The study compares participant experiences on marstacimab with their past standard treatments to see if it helps prevent bleeding episodes common in Hemophilia. All participants will receive weekly marstacimab injections under the skin. The first dose is administered at the study site, and subsequent doses during the 12-month treatment period can be given at home or the study site. The study enrolls participants in age groups sequentially, starting with adolescents 12-17 years, followed by children 6-11 years, and then 1-5 years. The full participation lasts about 14 months, including screening, treatment, and follow-up periods. Participants will visit the study site at least 10 times and have 6 scheduled phone calls every two months. Researchers will monitor bleeding rates, adverse events, immune reactions, and joint health, along with quality of life changes. Safety assessments cover the entire study period, including follow-up, to evaluate marstacimabs effects and tolerability in children with Hemophilia.

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 evaluating the combination of two investigational drugs, BNT326 and BNT327, in adults with advanced or metastatic non-small cell lung cancer NSCLC that has either relapsed, progressed, or is treatment-naefve. The study aims to find safe dosage levels and assess the safety, preliminary efficacy, and tolerability of this combination therapy. It involves participants with histologically or cytologically confirmed NSCLC without curative treatment options. The trial has several parts Part 1 focuses on dose escalation to establish safe dose levels of BNT326 combined with BNT327. Part 2a expands to evaluate preliminary effectiveness and safety, enrolling participants with different treatment histories. Part 2b involves dose optimization and compares treatments in randomized cohorts. Participants receive intravenous infusions of the study drugs and may also receive pembrolizumab or standard chemotherapy depending on their cohort. Dosing decisions for later cohorts are based on earlier study data. Participants will go through screening, treatment, safety follow-up, efficacy follow-up, and long-term survival follow-up periods. Treatments continue until disease progression, unacceptable side effects, withdrawal, study end, or a maximum of 24 months. Researchers will monitor dose-limiting toxicities, adverse events, treatment responses, progression-free survival, and overall survival over about 36 months. Blood samples will be collected for pharmacokinetic and antibody assessments. Participants health and disease status will be regularly assessed by imaging and clinical evaluations throughout the study.