Navi Mumbai

Researchers are evaluating the effects of Native CT-II4 (undenatured type II collagen) on knee joint health in adults aged 40 to 65 years with knee osteoarthritis (OA). This randomized, double-blind, placebo-controlled study compares Native CT-II4 to glucosamine HCL plus chondroitin sulfate and a placebo to assess improvements over 90 days. Knee OA is a common, painful joint condition that limits movement and quality of life, especially in older adults, and current treatments may have side effects. This study aims to find better options for managing knee OA symptoms and function. Participants are assigned to one of three groups: one receives Native CT-II4 at 40 mg daily in divided doses, another receives glucosamine HCL plus chondroitin sulfate (2700 mg daily), and the third group receives a placebo made of microcrystalline cellulose. Each participant takes three capsules after breakfast and three after dinner for 90 days. The study plans to enroll about 114 participants, aiming for 90 to complete the trial, with knee OA grades II or III. The interventions are given orally, and the study compares the effects of these supplements on joint health. During the study, participants undergo assessments at days 0, 7, 30, 60, and 90, including evaluation of knee pain and function using the modified Western Ontario and McMaster Universities Osteoarthritis Index (mWOMAC). Researchers monitor changes in symptoms, joint health, and quality of life. Participants are also required to avoid certain foods and medications that could affect collagen levels or knee pain relief during the study. Safety and adherence are tracked throughout the 90-day period to evaluate the supplements' impact on knee osteoarthritis.

Researchers are conducting a Phase 1, open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose of AUR107 in adult patients with relapsed advanced solid tumors. These tumors include non-small cell lung cancer, gastric cancer, urothelial cancer, kidney cancer, colon cancer, and esophageal cancer. Participants must have no available curative or life-prolonging treatments and have exhausted all effective local therapies. Participants will receive oral AUR107 once daily. The study uses a traditional 3+3 dose escalation design to assess safety and determine the optimal biological dose based on safety, pharmacokinetics, and pharmacodynamics data. The treatment period focuses on finding the best dose and assessing how the drug behaves in the body. During the study, participants will be monitored for dose limiting toxicities and treatment-related adverse events over 28 days. Researchers will evaluate pharmacokinetics parameters such as maximum concentration, time to maximum concentration, area under the curve, mean residence time, and half-life at specified days. Safety assessments, disease measurements, and tolerability will be closely followed to understand the effects of AUR107.

Researchers are evaluating the safety and effectiveness of brenipatide combined with standard care compared to a placebo with standard care in adults with schizophrenia. This phase 2 study aims to understand how well brenipatide works as an additional treatment for schizophrenia and monitor any side effects. Participants eligible for the study must have schizophrenia and be on stable standard care medication. The trial consists of three main periods: a screening period lasting about one month, a treatment period that can last up to 12 months, and a follow-up period of approximately two months. During the treatment phase, participants receive either brenipatide or placebo administered by subcutaneous injection alongside their standard care. The study includes careful monitoring and adherence to study procedures such as self-injection, keeping diaries, and completing questionnaires. Participants will be involved in regular visits and assessments throughout the entire study duration, which may last up to 15 months. Researchers will measure changes in body weight from baseline to week 52 as a primary outcome. Participants will also be monitored for safety and efficacy through ongoing evaluations, including the use of electronic or paper diaries and required questionnaires to track their progress and response to treatment.

The main aim of this study is to check how safe brentuximab vedotin is in adults with untreated Hodgkin Lymphoma (HL) when given together with doxorubicin (Adriamycin), vinblastine and dacarbazine therapy ('AVD'). Another aim is to learn how well treatment of brentuximab vedotin plus AVD works. All participants will receive brentuximab vedotin plus AVD for approximately 6 months. Participants will undergo tests like Echocardiography (ECHO) and pulmonary function testing (PFT) during the study. ECHO is a test that uses ultrasound to show how the heart muscle and valves are working; PFT is a test to check how well a participant's lungs work. Each participant will undergo a final health status check 2 months after the last treatment with brentuximab vedotin plus AVD.

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are evaluating the effectiveness of iberdomide maintenance therapy compared to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in adults with newly diagnosed multiple myeloma. This phase 3 study aims to determine which maintenance treatment better supports patients following their initial transplant and induction therapies. Participants must have responded to prior treatments and undergone ASCT within specified time frames. Participants will receive either iberdomide or lenalidomide at specified doses on scheduled days as maintenance therapy after their ASCT. The study is randomized, multi-center, and open-label, meaning both participants and researchers know which treatment is given. The treatments will be administered following a standard induction therapy including proteasome inhibitors, immunomodulatory drugs, and possibly monoclonal antibodies, with or without consolidation after transplant. Throughout the study, participants will be monitored for progression-free survival for up to 6 years to assess how well the maintenance therapies prevent disease progression. Researchers will also evaluate safety and treatment response according to established myeloma criteria. Regular assessments will include clinical evaluations and monitoring for any signs of disease relapse or adverse effects over the long term.

Researchers are evaluating the effectiveness and safety of the drug BMS-986365 compared to the investigator's choice of therapy in men with metastatic castration-resistant prostate cancer. This Phase 3 study aims to measure the length of time participants live without radiographic disease progression, using established criteria for bone and soft tissue cancer progression. The study focuses on patients who have already been treated with androgen receptor pathway inhibitors and have metastatic prostate cancer confirmed by imaging. Participants will be randomly assigned to receive either one of two dose levels of BMS-986365 or the investigator's choice of treatment, which may include Docetaxel plus Prednisone/Prednisolone, Abiraterone plus Prednisone/Prednisolone, or Enzalutamide. The study has two parts: initially, participants are assigned to one of three groups including two BMS-986365 doses or comparator therapy, followed by a second part where they are randomized to either the selected BMS-986365 dose or the comparator treatment. During the study, participants will be monitored for disease progression through scans and evaluations using Response Evaluation Criteria in Solid Tumors and Prostate Cancer Clinical Trials Working Group criteria, with follow-up lasting up to four years. Safety and treatment effects will be assessed regularly, and participants' symptoms and quality of life will be closely observed. This long-term follow-up helps researchers understand the treatment's impact on cancer progression and patient well-being.

Researchers are evaluating the safety and effectiveness of once-weekly Somatrogon compared to daily Growth Hormone (Genotropin) in pre-pubertal children with short stature who were either born small for gestational age (SGA) or have idiopathic short stature (ISS). This is a Phase 3 randomized, open-label study that plans to enroll two groups of children: 140 with SGA and 114 with ISS, all of whom have not received prior growth hormone treatment. The study duration is 12 months, with an initial screening period of up to 30 days. Participants will be randomly assigned to receive either Somatrogon once weekly or Genotropin daily for 12 months. The study involves two parallel groups: one group for children with SGA and another for children with ISS, each split evenly between the two treatment options. The treatments are administered as growth hormone injections either weekly or daily, and the study monitors their effects over a full year. Throughout the study, children will have regular visits to monitor growth, including measuring annualized height velocity after 12 months of treatment. Assessments will include growth measurements and evaluations of safety and treatment adherence. Researchers will collect data to compare the outcomes and safety profiles of the two growth hormone regimens over the study period, supporting ongoing treatment decisions for children with short stature related to SGA or ISS.

Researchers are working to develop advanced, personalized treatment methods for cervix cancer by combining radiation technology, detailed imaging, molecular biology, and machine learning. This research uses patient data from completed and ongoing clinical trials to create knowledge-based systems that improve treatment delivery and identify patients who might benefit from more intensive therapies. The study focuses on automating tumor and tissue target identification, predicting treatment side effects, and pinpointing high-risk patient groups. The study involves several goals: first, using MRI and CT scans to automatically outline tumor areas and surrounding tissues important for treatment. Second, employing machine learning to develop better models that predict normal tissue damage from radiation, including creating a library of proton therapy plans to find patients who may benefit from this advanced treatment. Third, integrating imaging features and molecular markers to identify patients who respond well or poorly to chemoradiation, aiming to create risk prediction models. Participants are patients who have completed or are undergoing treatment for cervix cancer with available MRI or CT imaging and clinical data from clinical trials. Researchers analyze imaging and molecular data to validate their models and tracking systems. Over three years, the study will generate software for automated tumor delineation, validate tissue complication prediction plots, and identify high-risk patients for targeted treatment intensification, all aimed at improving individualized treatment strategies for cervix cancer.

Researchers are evaluating the effect of adding oral rifaximin tablets during allogeneic stem cell transplant in adults with acute leukemia. This randomized phase II trial aims to see if rifaximin can improve the gut microbiome quality and reduce the risk of death, infections, and graft versus host disease (GVHD) after transplant. The study also explores how rifaximin affects immune recovery and the local gut immune environment using advanced cell analysis techniques. Participants are randomly assigned to receive oral rifaximin 200 mg twice daily from 8 days before transplant up to 60 days after, along with standard post-transplant care. The control group receives standard treatment alone, including usual anti-GVHD measures and antibiotics as needed. The study collects stool and blood samples for microbiome and immune cell analysis, and in some cases, gut biopsy samples are taken to study immune cell profiles in the gut. During the study, researchers monitor participants for gut microbial diversity 14 days after transplant, immune cell recovery, infection rates, severe GVHD, and overall survival up to one year. Samples for advanced genetic and immune testing are collected at various times. The total follow-up includes assessments for at least one year post-transplant to evaluate the impact of rifaximin on transplant outcomes and immune health.