New Britain

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating two surgical procedures, bilateral salpingectomy and bilateral salpingo-oophorectomy, to see how well they reduce the risk of ovarian cancer in women who have BRCA1 gene mutations. The study aims to determine if removing just the fallopian tubes (bilateral salpingectomy) is almost as effective as removing both the fallopian tubes and ovaries (bilateral salpingo-oophorectomy) in lowering ovarian cancer risk. This trial also assesses symptoms related to estrogen loss, quality of life, sexual function, cancer-related distress, decision-making about surgery, and treatment side effects in these patients. Participants choose between two groups: one group undergoes bilateral salpingectomy and may have their ovaries removed later, while the other group undergoes bilateral salpingo-oophorectomy. Both groups receive pelvic or transvaginal ultrasounds or pelvic MRI scans during screening, and blood samples are collected throughout the trial. Ancillary studies include quality-of-life assessments and questionnaires. The study also collects tissue and blood samples for future research. After surgery, participants have follow-up visits at 10 to 60 days, then at 6, 12, and 24 months, and annually for up to 20 years. Researchers monitor the time until any high-grade serous carcinomas develop, specifically ovarian, primary peritoneal, or fallopian tube cancers. They also track menopausal symptoms, sexual function, quality of life, cancer distress, medical decisions about surgery, and any adverse events during this long-term follow-up.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). Participants must have experienced at least two moderate or one severe COPD exacerbations in the year before joining and be receiving inhaled maintenance therapy. The study focuses on adults who continue to experience symptoms despite current treatments and aims to assess the impact of tezepelumab on COPD exacerbations. Participants will be randomly assigned to receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and may extend up to 76 weeks. After the treatment period, there will be a 12-week safety follow-up phase to monitor participants after stopping the study drug. The study compares tezepelumab to placebo to determine its efficacy and safety over this extended period. During the study, participants will undergo regular assessments to monitor their COPD status and any exacerbations. The main outcome measured is the annual rate of moderate or severe COPD exacerbations from the start of treatment through up to 76 weeks. Safety and tolerability will also be closely monitored throughout the treatment and follow-up periods. This long-term involvement ensures comprehensive data on how tezepelumab affects COPD progression and exacerbation frequency.

Researchers are conducting a multi-center, open-label, randomized clinical trial to compare survival outcomes between robotic-assisted laparoscopy and open surgery for patients with early stage cervical cancer. The study tests whether robotically assisted hysterectomy with tumor containment before colpotomy is not worse than abdominal hysterectomy regarding disease-free survival. Patients must have specific cancer types and stages without evidence of metastases to participate. Participants will be randomly assigned to either the robotic surgery group or the open surgery group. In the robotic arm, hysterectomy is performed using a minimally invasive robotic device with specific surgical protocols to close the vagina prior to colpotomy. In the standard arm, an open radical or simple hysterectomy is performed with vaginal closure over the tumor before colpotomy. Both groups may have ovary removal or preservation, and detailed surgical records are maintained. During the study, patients undergo preoperative assessments including imaging and lab tests, and pregnancy tests for pre-menopausal women. Surgeons document operative details and complications. The primary outcome is survival measured over 36 months. Follow-up includes monitoring for disease-free survival and safety. Participants must be able to attend follow-up visits and provide consent to share health information.

Researchers are conducting the ASSESS ALL ALS Clinical Research Consortium study to collect a variety of samples, clinical details, and measurements from people with symptomatic Amyotrophic Lateral Sclerosis (ALS), individuals carrying ALS genes, and control groups without ALS. This study is funded by the National Institutes of Health and managed by two clinical coordinating centers at Barrow Neurological Institute and Massachusetts General Hospital. The goal is to harmonize and share this data with the research community to support future ALS and related neurological disease research. Participants include symptomatic ALS patients and control individuals who may participate either on-site or remotely. The study follows participants for 24 months, collecting medical history, clinical outcomes, and blood samples every four months. Monthly patient-reported outcomes and speech recordings are also gathered. For those visiting clinics, optional cerebrospinal fluid samples may be collected via lumbar puncture. During the study, participants complete various assessments including the ALS Functional Rating Scale-Revised (ALSFRS-R) and its self-entry version at multiple time points over 24 months. Researchers monitor clinical status, collect biological samples, and record speech. Safety and adherence are observed throughout the two-year follow-up, enabling comprehensive tracking of ALS progression and control participant health.

This research aims to develop and improve ways to increase access to, participation in, and engagement with Medication Assisted Treatment (MAT) among Black and Latinx communities living in areas with high rates of overdose. The study focuses on people with Alcohol Use Disorder or Opioid Use Disorder and evaluates whether adding a church-based telehealth MAT option to the existing Imani program improves treatment outcomes compared to the Imani program combined with traditional MAT referral and linkage. The Imani program is a faith-based, culturally informed harm reduction recovery program conducted in community churches that addresses social determinants of health and offers education and referrals for FDA-approved treatments for substance use disorders. Participants who want MAT will be randomly assigned to receive either the Imani program plus telehealth MAT through their church or the Imani program plus traditional MAT referral and linkage, while those who choose not to use MAT will continue with the Imani program alone. The study uses a community-based participatory research approach, collaborating with churches, providers, policymakers, and the community to improve understanding and reduce barriers to treatment. The study also explores how social factors and personal choices affect treatment initiation, engagement, and substance use over time. During the study, researchers will measure attendance and treatment adherence up to 24 weeks, and follow participants for up to 12 months to assess changes in substance use and wellness. They will use surveys and other tools to evaluate participants' engagement with the program, medication use, and overall wellbeing across multiple social and citizenship domains. The study will also monitor safety and seek to inform future healthcare policies to better support people with substance use disorders in these communities.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

The HEALEY ALS Platform Trial is an ongoing, multi-center study designed to evaluate the safety and effectiveness of various investigational treatments for Amyotrophic Lateral Sclerosis (ALS). This perpetual platform trial uses a single Master Protocol to test multiple treatments either simultaneously or one after another, allowing efficient study of different therapies under one trial structure. Participants diagnosed with ALS are randomly assigned to receive one of the active investigational drugs or a matching placebo in a controlled setting. The study includes several treatment regimens, each testing a different investigational product. These treatments include subcutaneous injections and oral medications given daily or twice daily, such as Zilucoplan, Verdiperstat, CNM-Au8, Pridopidine, and others. Each regimen is placebo-controlled and has its own specific study details summarized in separate appendices. New investigational products and regimens are continuously added to the trial, allowing enrollment of additional participants over time. Participants will be involved in regular assessments over a minimum 36-week period to monitor disease progression and treatment effects. Evaluations include clinical exams, consent and compliance checks, and respiratory function measurements. Safety is closely monitored throughout the trial. The study aims to gather detailed information on how these investigational products impact ALS progression, with participants having equal chances of being assigned to any active regimen at screening.

Researchers are evaluating how factors like age, gender, other medical conditions, and the type of immunotherapy affect the development of side effects in patients with malignant solid tumors receiving immune checkpoint inhibitor (ICI) therapy. The study aims to develop and validate a risk prediction model for serious immune-related side effects during the first year of ICI treatment. Additional goals include tracking the occurrence of various side effects, quality of life, patient-reported symptoms, and treatment patterns over 12 months, along with studying biological markers that may predict side effect risk. Participants will have tissue samples collected at the start of their cancer treatment and will complete questionnaires at baseline and at weeks 4, 12, 24, and 52. Blood samples may also be collected at multiple times during the study. The study focuses on patients receiving standard-of-care ICI therapy for solid tumors, without combination chemotherapy or other non-ICI treatments. During the study, participants will complete patient-reported outcome forms and health questionnaires to assess side effects and quality of life. Researchers will monitor the occurrence of severe immune-related side effects over 52 weeks and evaluate biological markers from blood and tissue samples. The study also assesses the use of electronic methods for collecting patient data. Total participation includes assessments over approximately one year following treatment start.

Researchers are evaluating durvalumab, an immunotherapy drug, compared to the usual approach of patient observation after surgery in people with early-stage non-small cell lung cancer (NSCLC) who have no remaining cancer cells following standard treatment. This phase III trial aims to determine if durvalumab can improve disease-free survival and overall survival, as well as assess its safety and impact on quality of life. The study focuses on participants with stage II to IIIB NSCLC who achieved a complete response after neoadjuvant chemo-immunotherapy and surgery. Participants are randomly assigned to one of two groups: one group receives durvalumab intravenously every 28 days for up to 12 cycles if there is no disease progression or unacceptable side effects, while the other group undergoes active surveillance without additional treatment for 12 months. Both groups have regular computed tomography (CT) scans and blood sample collections during the study. After treatment or surveillance, participants are followed annually for up to 10 years. Throughout the study, participants complete questionnaires about their quality of life and report symptoms such as rash or numbness. Researchers monitor disease recurrence, new lung cancers, or death, as well as treatment side effects. Specimens and images are collected for future research. The total participation time includes treatment or observation plus long-term follow-up visits to assess the effects and safety of durvalumab compared to observation alone.