Independence

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are investigating autonomic dysfunction AD and orthostatic intolerance OI in patients who have undergone bariatric surgery BS. This observational study aims to assess how common AD is after BS and to better understand the underlying causes and outcomes. Previous research has shown limited and low-quality evidence on this topic, prompting this study to improve knowledge about ADOI following bariatric procedures. The study includes both retrospective and prospective phases. Patients who have had BS within the last 3 years or will undergo BS soon are observed to characterize the development of ADOI after surgery. Bariatric surgeries studied include gastric bypass, sleeve gastrectomy, and biliopancreatic diversion with duodenal switch. The study does not involve any experimental treatments but focuses on monitoring and collecting data about ADOI symptoms and progression. Participants will provide consent and maintain follow-up with their bariatric surgery team. Researchers will evaluate the prevalence and outcomes of autonomic dysfunction at around 3 months after surgery. Data collection includes medical history, symptom tracking, and follow-up evaluations to better define ADOI characteristics. The study will end in December 2025, allowing for thorough observation and outcome assessment over time.

Researchers are evaluating a medicine called elranatamab in people with multiple myeloma MM, a type of cancer. This study compares elranatamab to other commonly used combination therapies for MM that has returned or not responded to previous treatments. Participants must be 18 years or older and have received prior treatments, including an anti-CD38 antibody and lenalidomide. The study is a phase 3, randomized trial sponsored by Pfizer. Participants will be randomly assigned to receive either elranatamab alone or one of several combination therapies chosen by the study doctor. Elranatamab is given as a shot under the skin at the study clinic about once a week, with possible adjustments later. The combination therapies include two to three medicines taken by mouth or given by injection or infusion at the clinic. Treatment continues until the multiple myeloma stops responding. During the study, participants attend regular visits to monitor their response and side effects. Follow-up continues after treatment ends through telephone contacts or visits. Researchers will measure outcomes such as progression-free survival, overall survival, response rates, duration of response, and quality of life over approximately five years. Safety monitoring includes tracking adverse events and laboratory results throughout and after treatment.

Researchers are evaluating whether simply observing patients after surgery is as effective as continuing pembrolizumab treatment in preventing cancer recurrence in people with early-stage triple-negative breast cancer TNBC who had a complete response after receiving chemotherapy plus pembrolizumab before surgery. This Phase III trial aims to determine if stopping pembrolizumab post-surgery can maintain recurrence-free survival while potentially improving quality of life and reducing treatment burden. Participants are randomly assigned to one of two groups after finishing chemotherapy with pembrolizumab and surgery. One group continues pembrolizumab intravenously every 3 or 6 weeks for 27 weeks. The other group undergoes observation without further pembrolizumab for the same period. Throughout the study, patients have tumor biopsies and blood collected, along with imaging such as mammography, breast ultrasound, or MRI during follow-up. Participants will be monitored for recurrence-free survival and overall survival for up to 10 years. The study also assesses adverse events, quality of life, financial impact, and work productivity at about 27 weeks after starting the assigned treatment or observation. Safety and treatment effects are tracked through biopsies, imaging, blood tests, and patient questionnaires during the study and follow-up.

This observational study focuses on patients with Premature Ventricular Contractions PVCs, either with symptoms or without, to better understand the occurrence of all types of cardiac arrhythmias detected through long-term monitoring. Researchers aim to assess the role of implantable loop recorders ILRs in managing PVCs and to investigate clinical, biomarker, and radiological signs of myocarditis in this group. The study is conducted at a single center and will follow about 50 patients over 12 months. Participants will be monitored using implantable loop recorders from the time they first present with PVCs or ventricular arrhythmias. These devices will continuously record heart rhythms to detect arrhythmias. Alongside this, patients will be evaluated for evidence of myocarditis through clinical assessments and biomarker and imaging tests. The study does not involve experimental treatments but focuses on monitoring and data collection. During the 12-month follow-up, patients will undergo evaluations to identify unrecognized myocarditis, monitor PVC burden, assess improvements in heart function such as left ventricular ejection fraction, and detect associated atrial and ventricular arrhythmias. The study includes regular assessments and data collection to understand the link between myocarditis and arrhythmias. Participants will be closely observed to gather information that may inform future management of PVCs using ILRs.

Researchers are evaluating patients with metastatic HER-2-positive breast cancer who are receiving trastuzumab-based therapy and are at risk of heart problems. The study includes two groups one large observational group taking beta blockers, ACE inhibitors, or ARBs alongside trastuzumab, and a smaller randomized group comparing the effects of carvedilol versus no treatment. The aim is to understand the occurrence of heart issues and whether carvedilol might help prevent cardiac side effects from chemotherapy. Participants are assigned to one of three arms based on their current medications. Patients not on beta blockers, ARBs, or ACE inhibitors are randomized to either receive carvedilol orally twice daily or no study intervention. Those already taking these heart medications enter an observational arm without additional treatment. Treatment and observation continue for up to 108 weeks unless disease progression or unacceptable side effects occur. Throughout the study, participants undergo heart function monitoring with echocardiograms every 12 weeks and provide blood samples for biomarker analysis. Researchers track the time to the first sign of heart dysfunction and any cardiac events, as well as adherence to medication and side effects. The study also collects data to develop models predicting heart risk and banks samples for future research. Participant involvement may last over two years with regular assessments to monitor safety and heart health.

Researchers are evaluating how well serum tumor marker directed disease monitoring STMDDM works compared to usual care in patients with hormone receptor positive, HER2-negative metastatic breast cancer. This trial aims to see if monitoring with serum tumor markers can provide similar overall survival outcomes to the standard approach, which involves regular imaging scans. The study also looks at healthcare costs, patient anxiety, and quality of life related to these monitoring methods. Participants are randomly assigned to one of two groups. In the usual care group, patients receive imaging studies at least every 12 weeks and may have serum tumor marker tests as determined by their doctor. In the STMDDM group, patients have blood tests for specific tumor markers every 4 to 8 weeks, and imaging scans are only done if these markers indicate a possible progression of disease. Both groups continue their monitoring for up to 312 weeks unless the disease progresses. During the study, participants undergo regular assessments including blood tests for tumor markers, imaging scans as needed, and questionnaires about anxiety and quality of life. Researchers track overall survival for up to 312 weeks and compare healthcare costs and patient-reported outcomes for up to 48 to 102 weeks. The study also collects data on how often and by what methods disease monitoring is performed, along with patient and physician preferences related to monitoring.

Researchers are evaluating the investigational drug omecamtiv mecarbil to see if it can lower the risk of serious effects related to heart failure, such as hospitalization, heart transplantation, or death, in patients with symptomatic heart failure and severely reduced ejection fraction. This phase 3 trial aims to assess both the effectiveness and safety of the drug compared to placebo in reducing cardiovascular events including death, heart failure events, left ventricular assist device implantation, cardiac transplantation, and stroke. Participants will be randomly assigned to receive either omecamtiv mecarbil or a placebo. Those in the omecamtiv mecarbil group will take an oral tablet twice daily at a dose based on their blood drug levels 25, 37.5, or 50 mg. The placebo group will receive matching tablets twice daily. The study will continue until at least 850 participants experience a heart failure event or cardiovascular death. An interim analysis will be performed when about 67% of these events have occurred. The total estimated participation duration is up to 3 years. During the trial, participants will be regularly monitored for cardiovascular events, hospitalizations, and other health outcomes. Researchers will measure the time to first cardiovascular death or heart failure event among other secondary outcomes such as stroke and overall survival. Safety will be carefully tracked throughout the study. Participants adherence to the study medication and health status will be assessed at scheduled visits over the course of the study.

This research aims to evaluate the effectiveness of the LockeT device for achieving hemostasis after venous procedures compared to the current standard method of Manual Compression MC. The study focuses on patients undergoing catheter ablation for atrial fibrillation and other arrhythmias, where vascular closure following large-bore sheath femoral access remains challenging. The trial is prospective, randomized, and conducted at a single center, enrolling around 110 patients. Participants are randomly assigned to one of two groups the LockeT device group or the Manual Compression group. In the LockeT group, a healthcare professional places the LockeT device with suture above the wound to apply compression, aiming to mimic manual pressure but without continuous bedside presence. After hemostasis is achieved and before walking, the device and sutures are removed. The Manual Compression group receives the standard care of manual pressure to close the access site wound. During the study, researchers will assess the effectiveness of the LockeT device within 2 days following the procedure. They will also evaluate benefits to patients, physicians, and nursing staff, measure patient discomfort, track hematoma or bruising incidence, monitor safety, and compare labor and device costs. Participants will be closely monitored during this short follow-up period to understand outcomes related to vascular closure methods.

Researchers are evaluating the effects of several targeted drugsvismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclibon patients with progressive meningiomas. These tumors are growing, spreading, or worsening, and the study focuses on different genetic mutations in the tumors to match patients with the appropriate drug. The trial is a phase II study aiming to measure progression-free survival and response rates over six months, along with overall survival and adverse events. Participants are assigned to one of four groups based on their tumor mutation status. Those with SMOPTCH1 mutations receive vismodegib daily those with NF2 mutations receive FAK inhibitor GSK2256098 twice daily patients with AKT1, PIK3CA, or PTEN mutations take capivasertib twice daily on days 1-4 weekly and those with CDK pathway alterations receive abemaciclib twice daily. Treatment cycles repeat every 28 days as long as the disease does not progress or unacceptable side effects occur. After treatment, participants are followed every six months for up to five years. During the study, patients undergo regular monitoring including imaging to assess tumor size and progression, lab tests to monitor blood counts and organ function, and evaluations of side effects. Researchers track progression-free survival at six months and tumor response rates, as well as overall survival. Safety is closely observed up to four weeks after treatment ends. The total study duration includes active treatment cycles and long-term follow-up extending up to five years from registration.