Faro

Researchers are evaluating Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma HNSCC. This phase 3 trial aims to assess the safety and effectiveness of Dostarlimab as a sequential therapy following chemoradiation treatment in participants with this type of cancer. Participants are randomly assigned to receive either Dostarlimab or a placebo, both given as intravenous infusions. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The treatments follow completion of chemoradiation with cisplatin and radiotherapy intended to cure the cancer. During the study, participants will be monitored for up to approximately 5 years. Researchers will evaluate event-free survival and overall survival, with safety assessments including treatment-emergent adverse events and laboratory tests. Blood samples will be taken to measure drug levels and immune responses. This long-term follow-up will help understand the effects and safety of Dostarlimab after chemoradiation therapy.

This trial investigates the effectiveness of elacestrant compared to standard endocrine therapy for adults with node-positive, estrogen receptor-positive ER, HER2-negative early breast cancer who are at high risk of recurrence. The study aims to understand if elacestrant can improve outcomes in this group over standard treatments. Participants will be randomly assigned to receive either 345 mg of elacestrant once daily for five years or continue with their previous standard endocrine therapy, which may include anastrozole, letrozole, exemestane, or tamoxifen. Both treatments are taken orally, and the study is open-label, meaning participants and researchers know which treatment is given. During the study, participants will be monitored for up to five years for outcomes such as invasive breast cancer-free survival, distant relapse-free survival, overall survival, and quality of life changes. Assessments include questionnaires on health status and physical functioning, symptom evaluation, and blood tests to measure elacestrant levels. Safety and adverse events will be tracked throughout and for 28 days after treatment ends.

Researchers are studying the effects of sotagliflozin on symptoms and functional limitations in adults with symptomatic hypertrophic cardiomyopathy HCM, including both obstructive and non-obstructive types. This phase 3 trial aims to compare sotagliflozin to a placebo to understand changes in symptom scores and heart function. Participants have HCM diagnosed according to established guidelines and experience moderate symptoms as classified by the New York Heart Association NYHA. Participants will enter a screening period lasting up to 3 weeks. Those eligible will be randomly assigned to receive either sotagliflozin 400 mg daily two 200 mg tablets or a matching placebo once daily before their first meal. This double-blind treatment will continue for up to 26 weeks. The study includes careful monitoring to evaluate both groups over this period. During the study, participants will undergo regular assessments including symptom questionnaires like the Kansas City Cardiomyopathy Questionnaire KCCQ and NYHA functional class evaluations. Researchers will track changes in clinical summary scores and symptom severity from baseline to week 26. Safety and tolerability will be monitored throughout the trial. The total participant involvement may last around 29 weeks including screening and treatment.

Researchers are evaluating the safety and effectiveness of ABBV-CLS-628, an investigational drug, for adults with Autosomal Dominant Polycystic Kidney Disease ADPKD, a common genetic kidney disorder that causes cysts to grow in the kidneys. This Phase 2 study involves about 240 adult participants worldwide and aims to understand how the treatment affects kidney size and kidney function over time. Participants are randomly assigned to one of four groups, receiving either one of three different doses of ABBV-CLS-628 or a placebo. The drug or placebo is given through an intravenous infusion every 4 weeks for a total of 92 weeks. After this treatment period, participants will be followed for up to 15 additional weeks to monitor ongoing effects and safety. During the study, participants will regularly visit a hospital or clinic for medical assessments, blood tests, side effect checks, and questionnaires. Researchers will track changes in total kidney volume and kidney function, along with any adverse events. The study will last approximately 107 weeks, including treatment and follow-up, to carefully monitor participants health and treatment impact.

Researchers are evaluating ivonescimab as a first-line treatment for patients with metastatic non-small cell lung cancer NSCLC whose tumors have high PD-L1 expression. This study compares ivonescimab against pembrolizumab, another intravenous treatment, to assess overall survival and progression-free survival in these patients. The trial is a randomized, double-blinded, phase 3 study sponsored by Summit Therapeutics. Participants receive either ivonescimab or pembrolizumab as intravenous injections. The study includes two groups one receiving ivonescimab and the other pembrolizumab. Treatment is administered during the study period, and patients are monitored for up to approximately 36 months for survival outcomes and cancer progression. Safety is closely observed through adverse event reporting during and after treatment. Throughout the study, participants undergo evaluations including tumor assessments using RECIST 1.1 criteria and laboratory tests to monitor health and treatment effects. Researchers track objective response rates, disease control, duration of response, and adverse events up to 24 months after treatment. The total study duration allows for comprehensive follow-up to understand treatment impact and safety in this patient population.

Researchers are conducting a combined phase 2b and phase 3 study to evaluate the drug CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing dialysis. The study focuses on participants with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. The trial aims to find the best dose of CSL300 and then assess its effects on cardiovascular outcomes and safety compared to a placebo. The study is divided into two parts Part 1 phase 2b is a dose-finding phase where different doses of CSL300 are given intravenously to participants to determine the optimal dose versus placebo. Part 2 phase 3 evaluates the efficacy and safety of the selected CSL300 dose compared to placebo over approximately five years. All treatments are administered by intravenous infusion. Participants will be involved in regular assessments including blood tests to measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events tracking, and monitoring for adverse events. The phase 2b portion includes up to 24 weeks of follow-up for dose evaluation, while the phase 3 portion monitors cardiovascular outcomes like heart attacks or cardiovascular death over about five years. Safety and drug levels in the blood will also be closely observed throughout the study.

Researchers are evaluating the effects of the medicine BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. This study includes people with or without type 2 diabetes and those who may or may not be taking certain blood pressure medicines such as ACE inhibitors or ARBs. The goal is to understand if adding BI 690517 to empagliflozin helps reduce the risk of kidney failure, heart disease, or hospitalization due to heart failure. The study has two parts. In the first part, all participants receive empagliflozin or a placebo similar to BI 690517 for at least six weeks while continuing any indicated ACEi or ARB treatments. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the remainder of the study. The study lasts about three to four years until enough events related to kidney or heart health occur. During the study, participants visit the study site about four times in the first six months and then every six months afterward. At these visits, doctors check health status, collect blood and urine samples, measure blood pressure and weight, assess kidney function, and monitor any side effects. Researchers track the time until worsening kidney disease, heart failure hospitalizations, or cardiovascular death to compare outcomes between treatment groups.

Researchers are evaluating a new ultrasound-guided radiofrequency ablation RFA method for treating long-term knee pain caused by joint damage, specifically moderate to severe osteoarthritis. This study focuses on a novel targeting protocol for the genicular nerves around the knee, based on recent anatomical research to improve accuracy and consistency in nerve localization. The aim is to see if this new approach can safely reduce pain and improve movement for people who have not found relief from medicines, physical therapy, or joint injections. Participants will receive a single-session ultrasound-guided thermal RFA treatment targeting three specific genicular nerve branches around the knee. The procedure uses local anesthesia and involves inserting radiofrequency needles under ultrasound guidance. Sensory and motor stimulations confirm correct needle placement before applying heat at 85C for 90 seconds at each site. This approach avoids fluoroscopy and follows updated anatomical landmarks to enhance precision. The treatment session is one-time, with follow-up scheduled for two years. During the study, participants will complete questionnaires about their knee pain and function before treatment and multiple times afterward. Researchers will monitor changes in pain intensity, physical function, and any side effects, including a phone call one week after the procedure to check for any adverse events. The primary outcome is pain change at three months, with additional assessments extending up to two years. The study is free to join, voluntary, and all personal information is kept confidential.