St. Helena

Researchers are evaluating the effects of cannabis and cannabinoid use on cancer-related symptoms in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. This study focuses on patients who are planning to receive or have recently started systemic cancer treatments such as chemotherapy and immune checkpoint inhibitors (ICIs) targeting PD-1, PD-L1, or CTLA-4. The goal is to understand how cannabis use may be associated with symptom changes over time. Participants are enrolled in a non-interventional study where no experimental treatment is given. They complete surveys about their symptoms and cannabis use, and their medical records are reviewed regularly. The study tracks cancer-related symptoms monthly for up to 12 months after enrollment, allowing researchers to observe symptom patterns during ongoing cancer treatment. An optional substudy is available at select sites for patients with non-small cell lung cancer receiving paclitaxel and ICIs. During the study, participants complete online surveys in English or Spanish at their convenience, either at home or in clinic. Medical records are examined to gather information on treatments and health status. The main outcome measured is cancer-related symptoms, assessed monthly for one year. Safety monitoring includes ensuring participants have an expected life expectancy of at least six months and are not enrolled in hospice. The study aims to enroll 2000 patients across multiple sites in the United States.

Researchers are evaluating the safety and effectiveness of the Pulse Biosciences CellFX nsPFA Cardiac Surgery System in treating atrial fibrillation (AF) during other cardiac surgeries. This prospective, multicenter, non-randomized study involves adult patients with paroxysmal or persistent/longstanding persistent AF who are undergoing planned cardiac surgery such as mitral or aortic valve repair or replacement, coronary artery bypass grafting, or repair of certain heart defects. The study aims to see if this device can help prevent AF episodes and reduce the need for antiarrhythmic drugs after surgery. Participants will receive cardiac ablation using the CellFX nsPFA Cardiac Clamp during their scheduled cardiac surgery. The procedure includes isolating specific areas of the left atrium, including the pulmonary veins and posterior wall, either entirely from the outside of the heart or combined with an inside approach when the heart is open. The left atrial appendage is either excluded or removed as part of the treatment to help manage AF. During the study, participants will be monitored for freedom from atrial fibrillation, flutter, or tachycardia lasting more than 30 seconds from 3 to 6 months after the procedure. Safety is also closely tracked by checking for major adverse events such as death, stroke, heart attack, or significant bleeding within 30 days after surgery. Follow-up visits, evaluations, and reviews by a clinical events committee will help ensure thorough assessment of both safety and effectiveness over time.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

This research collects data and biological samples from patients who have experienced side effects from immunotherapy treatments for cancer. The goal is to create a national collection of these samples and clinical information to help future studies understand, predict, prevent, and treat serious immune-related side effects, rare infections, or rapid tumor growth after immunotherapy. Participants provide tissue and blood samples when they join the study and again one month later. Some patients may also provide stool samples if they have certain side effects like colitis. Researchers also review participants' medical records for up to one year to gather detailed health information related to their treatment and side effects. During the study, patients undergo sample collections and have their health records examined. The main outcome measured is the establishment of a national biorepository containing these samples and data, which will be used in future research over the course of one year. This study aims to support better understanding and management of immunotherapy side effects in cancer treatment.

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

Researchers are collecting real-world data on the use of commercially available Boston Scientific drug-eluting devices for treating lesions in the peripheral blood vessels. This study aims to include patient populations not previously well represented in peripheral vascular disease trials and to gather health economic information to support the safe use of these devices. Participants will be treated with any eligible Boston Scientific drug-eluting device, such as the Ranger Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter or the ELUVIA Drug-Eluting Vascular Stent System. These devices are used to treat lesions located in the peripheral vasculature. The study is global, prospective, open-label, non-randomized, and involves multiple centers. During the study, researchers will monitor major adverse events and lesion patency over 12 months. Participants will be followed to assess the safety and effectiveness of the devices in real-world settings. Health economic data will also be collected to better understand the broader impact of these treatments.

Researchers are evaluating a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.

This research evaluates the safety and effectiveness of the Cardioblate iRF and CryoFlex handheld devices for treating non-paroxysmal atrial fibrillation, including persistent and longstanding persistent types. It is a multi-center, single-arm, prospective, non-randomized interventional study involving up to 160 participants undergoing concurrent cardiac surgery at up to 25 centers in the United States. Participants will receive surgical ablation using the Cardioblate and CryoFlex devices alongside their planned open-heart surgery. The procedure requires the Cox Maze IV lesion set and amputation or closure of the left atrial appendage. The study aims to support expanding the product labeling to include treatment for persistent forms of atrial fibrillation. During the study, participants will be followed and assessed after the procedure and monitored for 12 months. Key outcomes include the rate of major adverse events within 30 days post-procedure or hospital discharge and freedom from atrial fibrillation, flutter, or tachycardia from 6 to 12 months after the procedure. Safety and effectiveness will be closely tracked throughout this period.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for treating infrapopliteal lesions in patients with critical limb ischemia (CLI). The study compares the MOTIV device to plain balloon angioplasty to assess safety and effectiveness. This randomized controlled trial aims to address symptomatic CLI classified as Rutherford category 4 or 5. Participants will receive either the MOTIV Sirolimus-Eluting Bioresorbable Scaffold or undergo percutaneous transluminal angioplasty (PTA) as treatment. The devices target native infrapopliteal artery lesions with specific size and length criteria. Treatment involves placing up to a maximum number of scaffolds per lesion and ensuring proper vessel flow without blocking major branches. Successful treatment of inflow artery lesions may be performed before or during the main procedure. During the study, participants will be monitored for limb salvage and vessel patency over six months. Safety is assessed by tracking major adverse limb events and death within 30 days after the procedure. Patients will undergo angiographic evaluations and follow-up assessments to measure outcomes, treatment success, and adverse events. The study requires adherence to protocol procedures and informed consent before participation.