Bristol

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation CIC. This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

This research aims to evaluate the safety and effectiveness of increasing doses of NNC0662-0419 for adults living with obesity. The study is a phase 2 randomized trial comparing different dosing approaches of NNC0662-0419 and semaglutide, both administered by subcutaneous injection. Participants include adults with obesity who are committed to losing at least 25% of their body weight. Participants are randomly assigned to one of four groups receiving either NNC0662-0419 or semaglutide, or their matching placebos. All treatments are given by subcutaneous injection in a dose-escalation manner, meaning doses increase over time. This allows researchers to compare the safety and response to these drugs and their placebos. Throughout the study, participants are monitored for gastrointestinal side effects from week 0 to week 39. Body weight and body mass index BMI changes are also measured from week 0 to week 32. Participants will attend regular visits for dosing, safety assessments, and evaluations of weight and related health measures. The trial is expected to last until July 2027.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection. This study focuses on adults with type 1 diabetes to see how well the weekly insulin controls blood sugar when combined with insulin aspart, which is taken 2 to 4 times daily. The trial aims to assess blood sugar control over about 8.5 months. Participants will be randomly assigned to receive either insulin icodec once a week with insulin aspart daily or insulin glargine once a day with insulin aspart daily. Both insulins are given as subcutaneous injections. The study is designed as a parallel comparison to evaluate the effects of these insulin regimens on blood sugar control. During the study, participants will have regular assessments including blood tests to measure HbA1c and glucose levels, monitoring of hypoglycemic episodes, and tracking of insulin doses and body weight. The primary outcome is the change in HbA1c from baseline to week 26. Secondary outcomes include time spent in target glucose ranges and frequency of low blood sugar events. The study will last about 8.5 months with ongoing monitoring to evaluate treatment effects and safety.

Researchers are evaluating the safety of the medicine Cagrilintide compared to a placebo in adults living with overweight or obesity who have stopped using glucagon-like peptide-1 receptor agonist GLP-1-RA therapies due to gastrointestinal side effects. This study is a randomized, double-blinded, placebo-controlled trial that aims to understand how well people tolerate Cagrilintide when other similar therapies are not suitable. The study is sponsored by Novo Nordisk AS and will last about 8 months. Participants will be randomly assigned to receive either Cagrilintide or a matching placebo, both administered as subcutaneous injections. The treatment period is 26 weeks long. The study is conducted in a parallel design, meaning each participant receives only one of the treatments. The main goal is to compare the percentage of participants who can stay on the standard or higher dose of Cagrilintide versus placebo at week 26. During the study, participants will be monitored regularly to assess their ability to tolerate the assigned treatment. The primary outcome measures whether participants remain on the standard or higher dose after 26 weeks. Safety and tolerability will be carefully observed throughout the treatment period. The total participation time is approximately 8 months, including screening and follow-up. Participants will not receive any active treatment if assigned to the placebo group, but all will be monitored closely for any side effects or issues.

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 conducting a study to evaluate the feasibility and acceptability of collecting patient-reported outcomes PROs from adolescents and young adults AYAs aged 18 to 39 who have been diagnosed with cancer. The study compares two approaches allowing participants to choose five health-related quality of life HRQOL domains they find most important Choice PRO versus completing five standard HRQOL domains selected by researchers Fixed PRO. The goal is to understand which method better supports AYA engagement and data completion. Participants are randomized into two groups. One group selects five from 15 PRO domains to complete at baseline and at 1, 3, 6, and 12 months, while the other group completes a fixed set of five domains at the same intervals. Questionnaires are completed online, facilitated by reminders via calls and text messages to improve adherence. The study also explores AYA preferences on how their PRO data should be shared with themselves, their families, and healthcare providers. During the study, participants complete assessments online at multiple timepoints, including baseline, 1, 3, 6, and 12 months, using a mix of computerized adaptive tests and static forms. Researchers measure feasibility based on the percentage of completed PROs and participant acceptability. The study monitors response rates, preferences, and data sharing views, aiming to enhance future patient-centered care and support in clinical trials involving AYAs with cancer.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating a connected customized treatment platform called CONCURxP to improve medication adherence in patients with metastatic hormone receptor-positive, HER2-negative breast cancer who are taking CDK46 inhibitors. The study compares CONCURxP, which includes the WiseBag medication monitoring device with personalized text message reminders and healthcare provider follow-ups, to enhanced usual care where patients only use the WiseBag and receive educational materials. The purpose is to see if these approaches affect how well patients follow their medication schedules, symptom burden, quality of life, and other outcomes over 12 months. Participants are randomly assigned to one of two groups Arm A uses the WiseBag dispenser and receives educational materials every 4 weeks for 12 months, while Arm B uses the WiseBag plus receives personalized text reminders, medication tracking, and provider follow-ups through CONCURxP for 12 months. A third group Arm C involves non-patient participants completing interviews 15 to 39 months after the first patient enrollment. After the 12-month intervention period, patients may be followed for an additional 6 months. During the study, patients complete surveys and electronic monitoring to assess medication adherence, symptom burden, quality of life, patient-provider communication, self-efficacy for symptom management, and financial worry at multiple time points. Some participants may also complete interviews about their experiences. Researchers review healthcare utilization, progression-free survival, and overall survival at 12 months. The study involves continuous monitoring using the WiseBag device and regular follow-ups to measure adherence and related outcomes.

Researchers are evaluating early versus delayed treatment with venetoclax and obinutuzumab in patients newly diagnosed with high-risk chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. This phase III trial aims to determine if starting treatment before symptoms appear improves overall survival and other outcomes compared to starting treatment after symptoms develop. Venetoclax blocks a protein important for cancer cell survival, while obinutuzumab is an immunotherapy antibody that may help the immune system attack cancer cells. Participants are randomly assigned to receive either early or delayed treatment with venetoclax and obinutuzumab. Both groups receive obinutuzumab intravenously on specific days during six cycles and venetoclax orally daily for up to 12 cycles, each cycle lasting 28 days. Treatment continues unless disease progression or unacceptable side effects occur. During and after treatment, patients undergo CT scans, blood sample collection, and bone marrow biopsies. Throughout the study, participants are closely monitored with various assessments including laboratory tests, imaging, and quality of life questionnaires. Researchers measure overall survival, response rates, progression-free survival, and patient-reported outcomes over up to 10 years. Safety, tolerability, and disease markers such as measurable residual disease are also evaluated. Follow-up continues for 10 years after treatment completion to observe long-term outcomes.

Researchers are evaluating the addition of pembrolizumab immunotherapy to standard chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer NSCLC that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival among different treatment approaches, including chemotherapy alone, chemotherapy followed by pembrolizumab, and chemotherapy combined with pembrolizumab. The study also assesses quality of life and adverse event rates in these patient groups. Participants are randomly assigned to one of three groups. One group receives only chemotherapy with observation afterward. The other two groups receive chemotherapy followed by pembrolizumab or chemotherapy combined with pembrolizumab. Chemotherapy involves one of four platinum doublet regimens administered every 21 days for four cycles, depending on the physicians choice. Pembrolizumab is given intravenously over 25-40 minutes, either after chemotherapy or alongside it, repeated every 21 days or every 6 weeks for multiple cycles. Patients also undergo heart ultrasound, MRI, CT scans, and blood sample collections as part of the study. During the trial, participants have regular medical assessments including imaging and blood tests to monitor their health. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years from randomization. Researchers measure disease-free survival as the main outcome, tracking the time until cancer recurrence or death. They also evaluate overall survival, side effects, drug tolerability, and patient-reported quality of life over time.