North Miami

Researchers are evaluating the safety, tolerability, and effectiveness of CYB003, a Deuterated Psilocin Analog, compared to a placebo when added to current antidepressant treatment in adults with moderate to severe Major Depressive Disorder (MDD). This Phase III trial focuses on participants aged 18 to 85 years who have had inadequate response to a stable antidepressant dose, aiming to better understand how CYB003 might improve depressive symptoms. Participants receive oral doses of CYB003 or matching placebo along with manualized psychological support provided by trained facilitators. The treatment period includes multiple dosing sessions with monitoring and assessments throughout. Placebo is used as a comparator to evaluate the combined safety and efficacy of CYB003 in this population. During the study, participants undergo evaluations using the Montgomery-Åsberg Depression Rating Scale (MADRS) at several time points, including screening, baseline, and multiple days up to the end of treatment at Day 42. Researchers monitor symptoms, side effects, and overall safety. Participants provide informed consent and are assessed regularly to track changes in depression severity and any adverse events over the course of the study.

Researchers are evaluating the effects of ASTX727 combined with iadademstat versus ASTX727 alone in patients with accelerated or blast phase Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs), including subtypes like polycythemia vera and myelofibrosis. This phase II trial aims to compare the complete acute leukemia response rate within four 28-day treatment cycles and assess survival outcomes and transplant rates. The study also explores molecular changes and resistance pathways related to these treatments. Participants are randomly assigned to one of two groups: one receives ASTX727 alone, which is a combination of decitabine and cedazuridine taken orally once daily on days 1 through 5 of each cycle; the other group receives the same ASTX727 dosing plus iadademstat taken orally on days 1-5, 8-12, 15-19, and 22-26. Treatment cycles repeat every 28 days until disease progression or unacceptable side effects occur. The study includes a dose escalation phase before randomization. During the study, participants undergo buccal swab, blood sample collections, and bone marrow aspiration and biopsy to monitor disease and treatment effects. After stopping treatment for reasons other than disease progression, patients are followed up every three months; if stopping due to progression, follow-up occurs every six months. Researchers measure treatment response using established leukemia criteria and track safety and overall survival throughout the study.

Researchers are evaluating the safety and effects of a medicine called disitamab vedotin for adults with advanced breast cancer that is hard to treat and has spread in the body. This study focuses on participants whose tumors express HER2 and who have received previous treatments for their advanced breast cancer. The goal is to understand how well this medicine works and its safety in these patients through a Phase 1b/2 open-label study. All participants will receive disitamab vedotin intravenously (IV) once every two weeks at the study clinic. They will continue the treatment until they or their doctor decide to stop, which could be due to cancer progression, side effects, or personal choice. During treatment, study visits occur every two weeks. After stopping treatment, participants will have follow-up visits about every six weeks, and later follow-up phone calls approximately every twelve weeks. Participants will undergo evaluations including assessments of their cancer response by the study doctors, following recognized criteria. The study team will monitor the participants for up to about two years or until their disease progresses or they pass away. This includes safety monitoring and collecting information about the medicine’s effects to determine its safety and effectiveness.

Researchers are evaluating two surgical procedures, bilateral salpingectomy and bilateral salpingo-oophorectomy, to see how well they reduce the risk of ovarian cancer in women who have BRCA1 gene mutations. The study aims to determine if removing just the fallopian tubes (bilateral salpingectomy) is almost as effective as removing both the fallopian tubes and ovaries (bilateral salpingo-oophorectomy) in lowering ovarian cancer risk. This trial also assesses symptoms related to estrogen loss, quality of life, sexual function, cancer-related distress, decision-making about surgery, and treatment side effects in these patients. Participants choose between two groups: one group undergoes bilateral salpingectomy and may have their ovaries removed later, while the other group undergoes bilateral salpingo-oophorectomy. Both groups receive pelvic or transvaginal ultrasounds or pelvic MRI scans during screening, and blood samples are collected throughout the trial. Ancillary studies include quality-of-life assessments and questionnaires. The study also collects tissue and blood samples for future research. After surgery, participants have follow-up visits at 10 to 60 days, then at 6, 12, and 24 months, and annually for up to 20 years. Researchers monitor the time until any high-grade serous carcinomas develop, specifically ovarian, primary peritoneal, or fallopian tube cancers. They also track menopausal symptoms, sexual function, quality of life, cancer distress, medical decisions about surgery, and any adverse events during this long-term follow-up.

Researchers are investigating the potential benefits of GB-0895 as an additional treatment for adolescents and adults with severe asthma that remains uncontrolled despite using inhaled corticosteroids and other usual asthma treatments. This global, multicenter Phase 3 trial compares the effects of GB-0895 to a placebo in patients aged 12 to 80 years with severe uncontrolled asthma. The study also includes an optional open-label extension phase to further assess long-term effects and safety. Participants are randomly assigned to receive either GB-0895 or a placebo through subcutaneous injections every 6 months over a 52-week treatment period. Before treatment, there is a screening and run-in phase lasting about 6 weeks. After the 52 weeks of treatment, participants enter a follow-up period lasting up to 38 weeks or may choose to join the optional open-label extension lasting up to 90 weeks, during which they continue receiving GB-0895 at specified intervals. Throughout the study, participants attend visits every 1 to 2 months after the first month to monitor their health and asthma control. Researchers evaluate the annualized asthma exacerbation rate as the main outcome. Safety assessments include physical exams, vital signs, lab tests, and careful monitoring for adverse effects. The study aims to enroll about 786 participants globally to thoroughly assess the safety and effectiveness of GB-0895 as an add-on therapy for severe uncontrolled asthma.

Researchers are investigating the use of PhotoBioModulation (PBM) to reduce stress in people with epilepsy. Epilepsy affects over 50 million individuals worldwide, and current treatments like medication often have limited success and side effects. This study focuses on PBM, a non-invasive therapy that uses infrared light to stimulate brain cells, potentially improving brain stability and reducing inflammation. The goal is to see if PBM can help lower perceived stress, which may contribute to a healthier lifestyle for those with epilepsy. Participants will receive PBM treatments three times a week for 15 to 20 weeks, totaling 45 sessions of 20 minutes each. The treatment involves using the Vielight Pro 2 device that emits low-level infrared light through the scalp to energize brain cells. The study includes four clinical sites across the U.S. and involves random assignment to either the active PBM treatment or a control group. The treatment period is followed by assessments at intake, baseline, mid-treatment, post-treatment, and a six-month follow-up. During the study, participants will undergo extensive testing including EEG recordings, metabolic panels, and behavioral questionnaires measuring stress, anxiety, depression, and lifestyle. Sleep will be monitored continuously with an ura ring worn throughout the study. Researchers will track changes in subjective stress levels from the start of treatment through six months after. Safety and study consistency are ensured through protocol adherence and regular monitoring at all sites. Overall participation lasts about 3 to 4 months with ongoing follow-up to assess longer-term effects.

Researchers are investigating treatments for patients newly diagnosed with AL amyloidosis, a condition involving abnormal protein deposits in organs. This phase III trial compares the effects of adding a stem cell transplant with melphalan chemotherapy after initial treatment with a combination of daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-VCD) versus continuing Dara-VCD chemotherapy alone. The goal is to evaluate differences in major organ deterioration progression-free survival, overall survival, organ response, toxicity, and quality of life between the two approaches. Participants first receive induction therapy with Dara-VCD drugs over three 28-day cycles. Those who respond to induction are randomized to one of two consolidation treatments: either continued Dara-VCD chemotherapy or high-dose melphalan chemotherapy followed by autologous stem cell transplant. After consolidation, all participants receive maintenance therapy with daratumumab monthly for up to 18 cycles unless disease progresses or toxicity occurs. The study also collects tissue and blood samples for disease and response assessments. Throughout the study, participants undergo regular examinations including echocardiography, bone marrow biopsies, imaging scans (CT, MRI, or PET-CT), and blood and urine tests. Physical function, fatigue, and patient-reported symptoms are assessed with questionnaires. Follow-up visits occur every 3 to 6 months for up to 4 years after registration. The main outcome measured is the time without major organ deterioration or disease progression, assessed for up to four years from randomization.

Researchers are evaluating the effectiveness of two different monoclonal antibody treatments, rituximab and mosunetuzumab, for patients with follicular lymphoma that has a low tumor burden. This is a phase III trial aiming to compare how well these treatments work in preventing disease progression, transformation to a more aggressive lymphoma, or death. The study also looks at overall survival, response rates, event-free survival, and the frequency and severity of side effects. Specimens will be collected and stored for future research. Participants are randomly assigned to one of two treatment groups. In the first group, patients receive rituximab intravenously on the first day and then rituximab combined with hyaluronidase subcutaneously on several days during a 56-day cycle, repeated for up to five cycles if the disease does not worsen or cause unacceptable side effects. In the second group, patients receive mosunetuzumab subcutaneously on several days during a 21-day cycle, repeated for up to eight cycles under the same conditions. Both groups undergo CT or PET/CT scans and blood sample collection during treatment and follow-up. After completing the treatment cycles, patients are followed every six months for five years and then yearly up to a total of 10 years to monitor their health and disease status. Researchers collect imaging results, blood tests, and other assessments to track progression-free survival, overall survival, treatment response, and safety. The study measures how long participants live without disease progression or transformation and records any treatment-related toxicities throughout the study period.

Researchers are investigating whether adding the chemotherapy drug Docetaxel to the usual hormone treatments can better control metastatic castration sensitive prostate cancer (mCSPC) in patients who have a less than optimal PSA response after 6 to 12 months of androgen-targeting therapy. This phase III, open-label, randomized international trial compares the effectiveness of Docetaxel combined with standard Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitors (ARPI) versus ADT and ARPI alone. The study focuses on men with metastatic prostate adenocarcinoma who have a suboptimal PSA decline following initial hormone therapy. Participants receive standard ADT and an ARPI such as abiraterone, enzalutamide, apalutamide, or darolutamide, which are assigned before enrollment. At enrollment, patients are randomized to receive either the addition of Docetaxel chemotherapy or no chemotherapy alongside their hormone therapy. The goal is to assess whether this combination reduces cancer growth or spread compared to hormone therapy alone. Treatment begins within five working days after enrollment, with close monitoring throughout the study. Throughout the trial, participants undergo regular assessments including PSA measurements to monitor cancer activity and overall survival tracked at 39 months. Eligibility requires stable organ function, performance status, and recovery from prior treatment side effects. Patients are monitored for adverse events, safety, and treatment response. The study also ensures participants and their partners use contraception if of childbearing potential, and participants must be accessible for treatment and follow-up visits to document outcomes and safety data.

Researchers are evaluating the safety and tolerability of Alocyte, a cellular product derived from umbilical cord blood, for treating facetogenic back pain. This condition results from inflammation and damage to the facet joints in the spine, often caused by repetitive stress or trauma. Current treatments focus only on relieving symptoms but do not address the underlying joint degeneration. This Phase 1 pilot study aims to see if Alocyte can reduce local inflammation and alleviate facetogenic pain. The study involves three dose levels of Alocyte administered directly into the affected facet joints. The low dose treats a single joint with 2 mL of diluted product, the medium dose treats three joints with 6 mL total, and the high dose treats five joints with 10 mL total. Each dose contains specific amounts of cord blood plasma and mononuclear cells designed to promote tissue repair and reduce inflammation. The treatment is delivered via intra-facet injection. Participants will be monitored for an average of 13 months after treatment to assess safety and any side effects. Researchers will conduct blood tests including complete blood count, metabolic panel, coagulation panel, and biomarker analyses at 1, 3, and 6 months. Participants will also have multiple follow-up visits to evaluate pain relief and treatment tolerability. The study focuses on tracking adverse events and the overall safety of Alocyte for back pain patients.