New Britain

Researchers are studying the effects of combining baxdrostat with dapagliflozin in adults who have chronic kidney disease CKD and high blood pressure hypertension. This Phase III, international, multicenter, double-blind, placebo-controlled trial aims to evaluate whether this combination can reduce the risk of significant kidney function decline, kidney failure, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes a 4-week period where participants not already on SGLT2 inhibitors take dapagliflozin alone. Afterward, participants are randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those in the baxdrostat group may start on a lower dose and increase if needed. Treatment continues with regular visits scheduled at 2, 4, 8, 16, 34, and 52 weeks after randomization, followed by visits approximately every 4 months. If study medication is stopped early, participants continue dapagliflozin if possible and remain in the study for ongoing monitoring. During the trial, participants will have various assessments including kidney function tests, blood pressure measurements, and monitoring for heart and kidney events. The main outcome is to see if the combination reduces the risk of major kidney and heart problems over up to 37 months. Safety and tolerability will also be closely followed. The study will end once a set number of key health events have occurred, with a final visit planned for all participants to collect last data and ensure ongoing care.

Researchers are evaluating two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 gene mutations. This trial compares bilateral salpingectomy, which removes the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The study aims to see if the less extensive surgery is nearly as effective at lowering cancer risk and assesses effects on quality of life, menopausal symptoms, sexual function, and medical decision making. Participants choose between two groups one undergoing bilateral salpingectomy with possible delayed removal of ovaries, and the other undergoing immediate removal of both fallopian tubes and ovaries. Before surgery, patients have pelvic or transvaginal ultrasounds or pelvic MRIs and blood samples collected. Follow-up visits occur at 10 to 60 days, 6, 12, and 24 months after surgery, then annually for up to 20 years. During the study, researchers will monitor the development of ovarian, primary peritoneal, or fallopian tube cancers over 20 years. They will also assess quality of life, cancer-related distress, menopausal and estrogen deprivation symptoms, sexual dysfunction, medical decision making, and adverse events up to 24 months after surgery. Blood samples and tissue are collected for future research. The long-term follow-up helps understand both cancer risk and patient well-being after surgery.

Researchers are evaluating 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 a COPD diagnosis of at least one year, be receiving inhaled maintenance therapy, and have experienced at least two moderate or one severe COPD exacerbations in the past year. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to better understand tezepelumabs impact on COPD symptoms and exacerbations. Participants will be randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment phase will last for a minimum of 52 weeks and up to 76 weeks. After completing the treatment period, there will be a 12-week off-treatment safety follow-up to monitor participants health. Throughout the study, participants will undergo regular assessments including lung function tests, questionnaires such as the St. Georges Respiratory Questionnaire SGRQ and COPD Assessment Test CAT, and blood tests to measure eosinophil counts and drug levels. Researchers will track the annualized rate of moderate or severe COPD exacerbations as the primary outcome. Other evaluations include monitoring exacerbations requiring emergency visits or hospitalization, lung function changes, symptom scores, and immune responses. Participant safety and adherence to the study protocol will be closely monitored during and after treatment.

Researchers are evaluating survival outcomes for patients with early stage cervical cancer undergoing either robotic-assisted laparoscopy or open hysterectomy with lymph node assessment. This multi-center, randomized trial tests the hypothesis that robotic hysterectomy with tumor containment before colpotomy is not inferior to abdominal hysterectomy regarding disease-free survival. The study focuses on patients with specific cervical cancer stages and tumor sizes, aiming to compare surgical approaches. Participants are randomly assigned to one of two groups the standard open surgery group performing radical or simple hysterectomy using established techniques with vaginal closure over the tumor before colpotomy, and the robotic surgery group using minimally invasive robotic-assisted hysterectomy with vaginal closure prior to intracorporeal colpotomy. Surgeons perform thorough intraoperative assessments for metastatic disease, and certain patients with confirmed metastases are excluded from final analysis. Detailed surgical data and complications are recorded for all cases. During the study, participants will undergo preoperative assessments, surgery, and follow-up evaluations. Researchers will monitor survival over 36 months as the primary outcome, documenting operative time, findings, blood loss, and complications. Patients will be followed to assess disease-free survival, with attention to surgical outcomes and safety. The total duration of participation includes the surgery and long-term survival monitoring to compare the effectiveness of the two surgical methods.

Researchers are collecting a wide range of samples, clinical information, and measurements from people with symptomatic Amyotrophic Lateral Sclerosis ALS, ALS gene carriers, and control groups without ALS. This observational study, funded by the NIHNINDS and managed by centers at Barrow Neurological Institute and Massachusetts General Hospital, aims to build a large database to support future ALS and related neurological disease research. Participants include symptomatic ALS patients and controls without ALS or related conditions. The study includes three groups ALS participants attending on-site visits at 35 clinical sites, ALS participants participating remotely through video calls with home blood collection, and control participants attending on-site visits. Participants are followed for two years, with medical histories, clinical outcomes, and blood samples collected every four months. They also complete speech recordings and patient-reported outcomes monthly. Optional cerebrospinal fluid samples may be collected from those attending clinics. Participants will undergo regular assessments including ALS Functional Rating Scales, cognitive tests, lung function tests, hand muscle strength measurements, and social and environmental health surveys. These are scheduled at various intervals over the 24-month period. Data collected will help researchers understand ALS progression and support future studies. Participants are monitored closely throughout the study, which involves both on-site and remote visits over two years.

Researchers are evaluating whether adding adjuvant chemotherapy ACT to ovarian function suppression OFS plus endocrine therapy ET improves invasive breast cancer-free survival in premenopausal women with early-stage, estrogen receptor-positive, HER2-negative breast cancer. This Phase III trial focuses on patients with specific 21-gene recurrence scores and aims to clarify the best treatment approach for younger women, who face higher risks despite current therapies. The study addresses the uncertainty about the role of ovarian suppression combined with chemotherapy versus ovarian suppression alone in this patient group. Participants are randomly assigned to one of two treatment groups one receiving ovarian function suppression with an aromatase inhibitor for 5 years, and the other receiving adjuvant chemotherapy followed by the same ovarian suppression and aromatase inhibitor regimen. The choice of drugs and dosing schedules for the aromatase inhibitor and GnRH agonist are determined by the investigators, with common options including monthly or every-three-months administration of agents like goserelin, leuprolide, or triptorelin. Endocrine therapy may continue beyond five years at the investigators discretion, and bilateral oophorectomy can substitute for ovarian suppression if preferred. Throughout the trial, participants will be closely monitored over 11 years for outcomes including invasive breast cancer-free survival, overall survival, distant recurrence-free interval, and breast cancer-free interval. Evaluations of menopausal symptoms and pain during aromatase inhibitor therapy will be conducted one year after randomization. The study involves regular assessments and follow-up to track the effectiveness and impact of the treatments on patients health and quality of life.

The HEALEY ALS Platform Trial is an ongoing multi-center study designed to evaluate the safety and effectiveness of multiple investigational treatments for Amyotrophic Lateral Sclerosis ALS. This trial uses a single Master Protocol to test several investigational drugs either simultaneously or one after another. Each treatment regimen includes a placebo-controlled comparison, with new regimens added over time as new investigational products become available. Participants are randomly assigned to one of the active treatment regimens available at screening. Within each regimen, they receive either the study drug or a matching placebo in a 31 ratio. The study includes various drugs such as Zilucoplan, Verdiperstat, CNM-Au8, Pridopidine, SLS-005 Trehalose, ABBV-CLS-7262, DNL343, and NUZ-001, administered through oral doses, subcutaneous injections, or infusions at specified doses and schedules. During the trial, participants will undergo assessments including measurements of disease progression over 36 weeks as the primary outcome. Secondary outcomes include respiratory function and survival. The trial employs quadruple masking and randomized allocation to ensure unbiased results. Participants are monitored throughout the study for safety and compliance, with ongoing enrollment as new treatment regimens are introduced. The total study duration varies per participant depending on the regimen and ongoing trial additions.

Researchers are studying how certain factors like age, gender, other medical conditions, and the type of immunotherapy affect whether patients with malignant solid tumors develop mild or serious side effects from immune checkpoint inhibitor treatments. This observational study aims to develop and validate a model that predicts severe immune-related side effects during the first year of immunotherapy, while also assessing quality of life and adverse events over 12 months. The study is sponsored by the SWOG Cancer Research Network and includes translational medicine goals such as evaluating cytokine levels as predictors and establishing a tissue and blood sample repository. Participants will provide a tissue sample at the start of their routine cancer treatment and complete questionnaires at multiple time points at treatment start, and weeks 4, 12, 24, and 52. They may also provide optional blood samples during the study. This design allows researchers to monitor immune-related side effects and patient-reported outcomes over time. During the study, participants will complete various questionnaires to report their quality of life, cognitive function, and side effects. Blood and tissue samples will be analyzed to explore predictive markers of toxicity. Researchers will track the occurrence of severe immune-related side effects over 52 weeks and assess changes in patient-reported outcomes. The study includes ongoing monitoring and data collection, with participation lasting approximately one year from treatment start.

Researchers are evaluating durvalumab, an immunotherapy drug, compared to standard patient observation after surgery in patients with early-stage non-small cell lung cancer who have no remaining cancer cells. The trial aims to determine if durvalumab can improve disease-free survival and overall outcomes compared to the usual approach of monitoring without additional treatment. This is a phase III randomized trial focusing on patients with stage II-IIIB non-small cell lung cancer who achieved a complete response after neoadjuvant chemo-immunotherapy. Participants are randomly assigned to one of two groups. One group receives durvalumab intravenously every 28 days for up to 12 cycles, pending no disease progression or unacceptable side effects. The other group undergoes active surveillance through regular follow-up without additional treatment for 12 months. Both groups have scheduled computed tomography scans and blood sample collections throughout the trial. Patients are followed annually for up to 10 years after treatment completion. During the study, participants undergo various assessments including CT scans, blood tests, and patient-reported quality of life questionnaires. Researchers monitor disease recurrence, new lung cancers, survival, and treatment side effects over a 10-year period. Quality of life and symptom evaluations related to skin and nerve sensations are also compared between the groups. This extensive follow-up helps evaluate the long-term effects and safety of durvalumab versus observation.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.