Columbia

Researchers are evaluating whether a 7 Tesla (7T) MRI can detect brain metastases earlier than the standard 1.5T or 3T MRI scans in patients with small-cell lung cancer (SCLC) who have declined prophylactic cranial irradiation (PCI). Participants must have had a recent 1.5T or 3T MRI that showed no brain metastases before joining the study. The study aims to determine if the 7T MRI can identify micro brain metastases sooner than standard scans. Participants will undergo a 7T brain MRI and then continue with their usual care involving 1.5T or 3T MRI scans for up to 12 months. If brain metastases are confirmed during follow-up, the standard scans will be compared to the 7T MRI to analyze the timing of detection. This device-based study focuses on the imaging technology rather than therapeutic treatments. Throughout the study, patients will be monitored with brain MRIs at 3, 6, 9, and 12 months after the initial 7T MRI. Researchers will review these scans to measure the detection of brain metastases over time. Safety and tolerance to the 7T MRI will also be assessed. The total participation period lasts up to 12 months unless metastases are found earlier, which will end the follow-up.

Researchers are evaluating new treatments for people with high-risk non-muscle invasive bladder cancer (HR NMIBC), a type of bladder cancer that has not spread to the muscle but has a high chance of worsening or returning. This cancer type may include carcinoma in situ (CIS), which is a flat, surface-level bladder cancer. The study aims to learn whether adding intismeran autogene (V940), a treatment designed to boost the immune system's attack on cancer, to the standard Bacillus Calmette-Guerin (BCG) immunotherapy can help people live longer without the cancer growing, spreading, or coming back. Participants will receive either the combination of V940 with BCG or BCG alone. BCG is given as a bladder instillation, while V940 is given as an intramuscular injection. The study is phase 2, open-label, and randomized. As of a 2026 amendment, outcome measures for a monotherapy arm of V940 are no longer primary or secondary. Treatment is focused on Cohort A, which includes people with high-risk non-muscle invasive bladder cancer who are BCG-naïve or meet specific recurrence criteria. During the study, participants will be monitored for event-free survival for up to approximately 5 years. Researchers will assess how long participants live without the cancer worsening or returning. The study includes regular evaluations, imaging, and safety monitoring. The total duration of participation depends on individual outcomes and follow-up but includes long-term observation to assess treatment effects and safety.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are studying children with Hypochondroplasia, a genetic condition affecting growth, to observe how their growth changes over time and to understand the clinical course of this condition. The study gathers detailed growth measurements and other important health variables to track development. This is an observational study conducted across multiple centers and countries, focusing on children up to 15 years old with confirmed genetic diagnosis of Hypochondroplasia. The study does not involve active treatments but monitors participants regularly over a long period, up to 15 years. Every six months, various growth measurements are taken, including annualized growth velocity, height, body mass index (BMI), and ratios of different body segments such as upper to lower body, leg length ratios, and arm span to height. These detailed assessments help track changes in physical growth and body proportions over time. Participants will attend scheduled visits every six months for up to 15 years, during which researchers will measure and record growth parameters and body ratios. The study aims to capture changes in growth patterns and body measurements continuously throughout the study period. No specific interventions are given, but the study carefully monitors participant growth and development to better understand Hypochondroplasia and its effects on children.

This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC/TAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG/3TC). The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing formulation for further evaluations.

Researchers are investigating the effects of two different doses of Glycopyrronium (GP) metered dose inhaler (MDI) compared to a placebo MDI when added to background treatment with Budesonide and Formoterol Fumarate (BFF) MDI. This study focuses on children aged 4 to less than 12 years who have asthma. The goal is to assess how these treatments affect lung function in this pediatric population during a Phase II clinical trial. The study is designed as a multi-center, randomized, double-blind, 3-period, 6-sequence crossover trial. It begins with a 3-week run-in period, followed by three separate 3-week treatment periods during which participants receive one of the three treatments: BFF MDI plus GP MDI Dose A, BFF MDI plus GP MDI Dose B, or BFF MDI plus placebo MDI. All inhalers are taken twice daily via oral inhalation. After completing the treatment periods, participants attend a safety follow-up visit 12 to 16 days after their last dose. Participants will undergo regular assessments including lung function tests to measure Forced Expiratory Volume in one second (FEV1) one hour after dosing at the end of treatment. Researchers will monitor safety through clinical exams and follow-up visits. The total participation duration includes the run-in, treatment periods, and safety follow-up, providing a comprehensive evaluation of the treatments' effects on asthma control in children.

Researchers are evaluating the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy as an additional treatment compared to no stimulation in people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, blinded trial focuses on reducing depressive symptoms over 12 months using multiple depression rating scales. The study follows guidelines from the Centers for Medicare and Medicaid Services regarding evidence development for this treatment. Participants receive implantation of the VNS device, which delivers stimulation to the vagal nerve. After a minimum two-week period post-implantation, participants are randomly assigned to either active VNS treatment or no stimulation control, with outcomes observed for 12 months. Following this randomized phase, all participants enter an open-label extension where those in the control group receive active stimulation. Additional subjects may join this open-label study for up to five years to further assess long-term effects. Throughout the study, participants undergo regular assessments including the Montgomery Åsberg Depression Rating Scale (MADRS), WHO Disability Assessment Schedule, Health Outcome Scale, Clinical Global Impressions Scale, and Suicidality Tracking Scale. Researchers monitor response rates, remission times, duration of effects, and adverse events from implantation through 12 months. This comprehensive evaluation includes safety monitoring and functional outcome measures to understand the impact of VNS therapy on depression and related disabilities.

Researchers are evaluating the safety, tolerability, and effect size of STIMULAN VG combined with debridement and systemic antibiotics compared to standard care involving debridement and systemic antibiotics alone for treating osteomyelitis associated with stage IV pressure ulcers. This is a phase II, open-label, multi-center, randomized controlled trial involving patients diagnosed with stage IV pressure ulcers. Participants are randomly assigned in a 1:1 ratio to either receive STIMULAN VG inserted into the ulcer cavity before flap or primary closure surgery along with systemic antibiotics or to receive the standard care which includes ulcer bursectomy, debridement, flap or primary closure, and peri-operative antibiotics. The trial focuses on comparing these two treatment methods for their safety and effectiveness in managing the condition. During the study, patients will be closely monitored and evaluated, with the main outcome being individual patient success assessed at an 8-week follow-up visit. The study includes assessments such as imaging to confirm osteomyelitis, treatment adherence, and safety monitoring. Participants must be adults and able to comply with all study procedures, including scheduled visits and treatment plans.