Burlingame

Researchers are evaluating the safety and effectiveness of the Vagus Nerve Stimulation VNS Therapy System as an additional treatment for people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, and blinded trial compares active VNS therapy to a no stimulation control group in reducing depressive symptoms over 12 months. The study follows guidelines aligned with Medicare and Medicaid coverage decisions for VNS in this condition. Participants receive an implant of the VNS device and are randomized at least two weeks after implantation to either have the device activated or remain without stimulation for the first 12 months. After this initial period, those in the control group can begin stimulation. Following the 12-month randomized phase, all participants enter an open-label, longitudinal study lasting about five years, including new enrollees after the initial trial phase. During the study, participants are monitored through various depression rating scales, including the Montgomery sberg Depression Rating Scale MADRS, to assess response and remission rates up to 12 months. Safety is tracked by recording adverse events from implantation through the first year. Additional assessments include disability and health outcome scales, as well as suicidality tracking. The study aims to gather long-term data on treatment effects and participant well-being.

Researchers are evaluating the safety and effectiveness of the BWI OMNYPULSE pulsed field ablation PFA system for treating people with symptomatic paroxysmal atrial fibrillation PAF, a condition causing irregular heart rates and abnormal blood flow. This study aims to assess the safety and 12-month effectiveness of this treatment approach in managing PAF symptoms. Participants will receive a pulsed field ablation procedure using the OMNYPULSE catheter combined with the TRUPULSE generator to isolate pulmonary veins and deliver pulsed field energy to treat atrial fibrillation. After the procedure, participants will be followed for 12 months to monitor outcomes related to the treatment. During the study, participants will undergo assessments to measure adverse events within 7 days after the procedure and track freedom from atrial tachyarrhythmia episodes between day 91 and day 365. Researchers will also evaluate changes in quality of life related to atrial fibrillation from the start of the study through 12 months. Participants will be monitored throughout the follow-up period to gather safety and effectiveness data.

Researchers are evaluating the safety and effectiveness of the Trilogy Transcatheter Heart Valve THV System compared with traditional surgical aortic valve replacement SAVR in patients with significant native aortic regurgitation AR. The trial aims to show that the Trilogy THV system is not inferior to SAVR for treating this heart valve condition, which causes the aortic valve to leak, leading to symptoms and heart complications. Participants are randomly assigned to receive either the Trilogy THV device via transcatheter aortic valve replacement TAVR or a commercially available surgical prosthetic valve through SAVR. These two treatment groups allow comparison between the less invasive TAVR procedure and traditional open-heart surgery. The study involves monitoring participants for outcomes related to mortality, stroke, rehospitalization, and valve function at several time points. Throughout the trial, participants will return for follow-up visits where heart function is assessed using echocardiography and questionnaires about symptoms and quality of life are completed. Researchers will track important health events such as strokes, atrial fibrillation, and rehospitalizations for up to 12 months or longer. The total study duration extends through 2036, with primary outcomes assessed at 12 months and additional long-term monitoring for adverse cardiovascular events.

Researchers are evaluating the LivIQ leadless pacemaker system in patients who need ventricular pacing according to Class I or II guidelines. This study aims to confirm the devices safety and performance, including a sub-study focused on its ability to maintain atrioventricular synchrony. The trial is open-label, prospective, single-arm, and conducted internationally across multiple centers. Participants will receive the LivIQ leadless pacemaker, implanted directly into the right ventricle. The study includes a main phase and an integrated atrioventricular synchrony sub-study, where specific heart rhythm data is collected at 1 and 6 months. Follow-ups occur at implant, pre-hospital discharge, 1, 3, 6, and 12 months, then every 6 months until market approval, with a remote 24-month visit after U.S. approval. Participants undergo regular on-site examinations and monitoring including device performance checks and health questionnaires. The study measures freedom from serious device-related effects, pacing adequacy, sensing performance, quality of life, battery longevity, and survival at 24 months. Participants are expected to complete all scheduled visits over the study duration, which may extend beyond two years.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are evaluating an investigational in-ear positional therapy device called WhisperPT for adults with positional obstructive sleep apnea OSA. The study aims to assess whether the device can reduce breathing disturbances by encouraging participants to avoid sleeping on their backs, a position that tends to worsen OSA symptoms. The trial will measure changes in the apnea-hypopnea index AHI and examine participant comfort and ease of use of the device. Participants will first complete a home sleep study using WatchPAT to establish baseline sleep patterns. They will then use the WhisperPT device for a 3-day acclimation period, followed by another WatchPAT home sleep study while using the device to evaluate its effect on sleep position and breathing events. The device works by monitoring head position and delivering gentle audio cues to prompt participants to shift away from back-sleeping. During the study, participants will be assessed for reductions in AHI, percentage of time spent sleeping on the back, and self-reported comfort and ease of use. The primary outcome is the proportion of participants achieving at least a 50% reduction in AHI within about 7 days. Secondary outcomes include the percentage of time spent supine under 15% and participant feedback on the device. Participants must avoid other sleep-disordered breathing treatments and alcohol during study nights. The overall study duration is approximately one week.

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

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.

Researchers are comparing two chemotherapy combinations for treating advanced, unresectable, or metastatic HER2 negative adenocarcinomas of the esophagus, gastroesophageal junction, and stomach. This phase III trial evaluates modified FOLFIRINOX fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan with or without nivolumab versus modified FOLFOX fluorouracil, leucovorin calcium, and oxaliplatin with or without nivolumab. Chemotherapy drugs act to stop tumor growth by killing cells or stopping division, and immunotherapy with nivolumab may affect the immune system to hinder tumor growth and spread. Participants are randomized into two groups one receives mFOLFIRINOX plus nivolumab as clinically indicated, and the other receives mFOLFOX plus nivolumab as clinically indicated. Treatments are administered intravenously. Throughout the study, participants undergo magnetic resonance imaging MRI, computed tomography CT scans, and may provide blood samples. Nivolumab is given as needed based on clinical assessment during the trial. Participants will be monitored up to 2 years from randomization for overall survival, with secondary measures including progression-free survival, response rates, duration of response, adverse events, and patient-reported outcomes collected at baseline and during treatment cycles. Safety and tolerability are evaluated, and exploratory analyses include biomarker assessments such as PD-L1 combined positive score and cell-free DNA. The trial includes regular imaging and clinical assessments to track disease status and treatment effects.

Researchers are evaluating recombinant Factor VIIa rFVIIa as a potential treatment for acute spontaneous intracerebral hemorrhage ICH, a type of stroke caused by bleeding in the brain. This global Phase III trial, called FASTEST Part 2, aims to identify the subgroup of patients most likely to benefit when treated early, within 120 minutes of stroke onset. The study compares rFVIIa plus best standard care against placebo plus best standard care, focusing on improving outcomes measured by the Modified Rankin Scale at 90 days and reducing ongoing bleeding. Participants will be randomly assigned to receive either rFVIIa at a dose of 80 micrograms per kilogram up to 10 mg or a matching placebo. Both treatments are given as an intravenous injection over 2 minutes within 120 minutes of stroke onset. All participants will also receive the best standard therapy according to guidelines, including blood pressure management targeting a systolic pressure of 140 mm Hg. The trial includes patients with specific brain hemorrhage volumes and timing criteria, with some treated within 90 minutes regardless of certain imaging findings. Emergency consent procedures and mobile stroke units are used to enable rapid treatment. During the study, participants will have brain scans at baseline and 24 hours to measure bleeding volume and swelling. Assessments of disability and quality of life will be conducted remotely at 30, 90, and 180 days after treatment. The main outcome is the disability level at 90 days, and safety and other effects will be monitored throughout. Participation may last up to six months, with follow-up assessments to evaluate recovery and treatment impact over time.