Alhambra

Researchers are evaluating a combination therapy of ruxolitinib, steroids, and lenalidomide in adults with relapsed or refractory multiple myeloma MM who have progressive disease despite previous treatments. MM is a cancer of plasma cells in the bone marrow with complex causes and limited curative options. This phase 1, open-label, multicenter study aims to assess the safety and effectiveness of these drugs together in patients who have failed at least two prior therapies including immunomodulatory drugs and proteasome inhibitors. Participants receive varying doses of ruxolitinib orally twice daily, lenalidomide once daily, and methylprednisolone every other day. The study includes dose escalation periods and treatment adjustments based on disease progression. Some groups start with ruxolitinib and steroids, adding lenalidomide only if the disease worsens. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants will have regular evaluations including blood tests and clinical assessments to monitor safety, side effects, and treatment response. Researchers will measure outcomes such as the maximum tolerated dose, adverse events, response rates, progression-free and overall survival over a follow-up period extending up to 54 months. Participants are expected to adhere to visit schedules and study requirements throughout the trial.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating the effect of fisetin, a natural substance found in strawberries and other foods, on physical function in postmenopausal women who have received chemotherapy for stage I-III breast cancer. This phase II trial focuses on whether fisetin can help improve physical function by eliminating senescent cells that accumulate after chemotherapy, which may cause inflammation and damage to healthy cells. Participants are randomly assigned to receive either fisetin or a placebo orally on days 1, 2, and 3, repeated every two weeks for up to eight weeks, unless disease progression or unacceptable side effects occur. Blood samples are collected throughout the trial to study various biological markers. After treatment, participants are followed yearly for up to three years to monitor long-term outcomes. During the study, participants undergo assessments of physical function such as the 6-minute walk distance, grip strength, and frailty measures. Researchers also evaluate fatigue, neuropathy, cognitive function, quality of life, sleep, anxiety, and depression. Safety and adherence to the study treatment are monitored through patient reports and diaries. The study tracks recurrence-free survival and overall survival over three years, aiming to better understand how fisetin affects health after chemotherapy.

Researchers are evaluating whether using GPS tracking can improve medication adherence among patients diagnosed with Hepatitis C virus infection who are also experiencing unsheltered homelessness and receiving care through street medicine. This study compares standard medical care for Hepatitis C alone versus standard care combined with GPS tracking to help locate and follow up with patients. The study addresses challenges in traditional healthcare models for homeless populations and aims to explore patient perspectives on GPS tracking in treatment. Participants are randomly assigned to one of two groups one receives the standard Hepatitis C treatment provided through street medicine, while the other receives the same standard treatment plus a GPS tracker device. The GPS device is intended to assist healthcare providers in locating patients for follow-up care during the 8 to 12 weeks of daily medication treatment. This multi-site randomized controlled study includes individual interviews to understand patient experiences in both groups. During the study, participants will be monitored for medication adherence over 8 to 12 weeks, with treatment length also recorded. Researchers will assess sustained virologic response up to about 24 weeks through the study completion. Participants will receive regular street medicine care, and their medication use will be tracked. The study ensures ethical use of GPS tracking and does not involve initial HCV screening, which occurs before enrollment. The total participation time varies with the treatment course and follow-up.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating how fisetin, a natural substance found in strawberries and available as a supplement, combined with exercise, may help prevent frailty in postmenopausal breast cancer survivors who have completed chemotherapy. Frailty is a concern because aging cells called senescent cells can cause inflammation and harm healthy tissues. This phase II trial aims to see if fisetin and exercise improve physical function and other health measures in this group. Participants are randomly assigned to one of four groups fisetin with exercise, fisetin with a physical activity handout, placebo with exercise, or placebo with a physical activity handout. Fisetin or placebo is taken orally on days 1-3 of every 14-day cycle for 8 cycles, while exercise groups receive supervised aerobic and resistance training three times a week for 16 weeks. Blood samples are collected during the study. Participants are assessed for changes in physical function using tests like the 6-minute walk distance, grip strength, fatigue levels, neuropathy symptoms, cognition, and quality of life from baseline to day 120. Safety and adherence to treatments are monitored, and participants are followed up at days 120 and 180, then annually for up to three years to track survival and recurrence outcomes.

Researchers are investigating whether combining the investigational drug mevrometostat PF-06821497 with enzalutamide works better than enzalutamide alone for men with metastatic castration-sensitive prostate cancer mCSPC who have not previously received androgen receptor pathway inhibitors ARPI or chemotherapy in this setting. This Phase 3, global, multicenter, randomized, double-blind, placebo-controlled study aims to compare these treatments to understand if the combination improves outcomes for participants. Participants will be randomly assigned to one of two groups one group will receive mevrometostat 875 mg twice daily plus enzalutamide 160 mg once daily, while the other group will receive a placebo plus enzalutamide 160 mg once daily. The study includes several phases Screening, Randomization, Treatment, Safety Follow-up, and Long-Term Follow-up. Prior short-term androgen-deprivation therapy ADT of up to 3 months is allowed if there is no disease progression before starting the study. During the study, participants will have regular assessments including radiographic scans to monitor disease progression, laboratory tests, patient-reported questionnaires on pain and quality of life, and blood samples to evaluate tumor DNA and drug levels. The main measure is radiographic progression-free survival tracked for up to about 4 years. Safety outcomes and overall survival will also be monitored for several years. The total participation may last up to nearly 9 years, including long-term follow-up to understand treatment effects and safety over time.