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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the efficacy, safety, and pharmacokinetics of sefaxersen RO7434656, a new Antisense Oligonucleotide ASO therapy, in adults with primary IgA nephropathy IgAN who are at high risk of worsening kidney disease despite receiving optimized supportive care. This phase III study focuses on participants who continue to face disease progression despite standard treatments. Participants will receive subcutaneous injections of either sefaxersen or a matching placebo. The dosing schedule includes injections on Days 1, 15, and 29, followed by doses once every four weeks until Week 105. After Week 105 or the primary data cut-off, eligible participants may switch to open-label sefaxersen treatment at the investigators discretion. Throughout the study, participants will undergo assessments to measure changes in urine protein-to-creatinine ratio at Week 37, kidney function eGFR slope at Week 105, and monitor for hematuria resolution, kidney failure events, fatigue, and treatment-emergent adverse events. Blood samples will be collected to measure plasma sefaxersen levels. The total study duration extends up to approximately 36 months, with ongoing safety and efficacy monitoring.

Age: 18Years +All GendersPhase 3
204 locations
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Actively Recruiting

Researchers are evaluating the impact of a brief motivational intervention BMI delivered by pharmacists to help reduce the use of benzodiazepines and related drugs BZDZ in adults who have been taking these medications long-term at least 6 months. The study aims to see if this intervention can lower the daily dose of these drugs after 6 months without causing worsening of anxiety or sleep disorders, compared to usual pharmacy dispensing practices. This research takes place in the context of increasing prescriptions and concerns about prolonged use of BZDZ, which carry risks and potential adverse effects. Participants will either receive the BMI, which involves identification and a motivational approach that uses patients psychosocial skills and supporting tools to reduce BZDZ use, or continue with the standard practice of dispensing these medications in pharmacies. The intervention targets adults with chronic use of BZDZ, aiming for a practical and scalable method that pharmacists can apply during routine care. The study is randomized and does not use blinding. During the study, participants will be monitored over 6 and 12 months to assess changes in daily BZDZ doses, complete cessation rates, anxiety, depressive symptoms, insomnia severity, misuse, and any adverse events. Questionnaires and clinical evaluations will be used to measure outcomes at several points, including 3, 6, 9, and 12 months. The goal is to understand both the reduction in drug use and the clinical effects on patients symptoms and safety throughout the follow-up period.

Age: 18Years +All GendersPhase Not Applicable
20 locations
F

Actively Recruiting

Many patients who spend time in intensive care units ICU experience significant emotional challenges, including anxiety, depression, and post-traumatic stress disorder. Improving the patient experience in the ICU is a priority, with efforts focused on recreating a familiar environment to support emotional well-being. Animal-assisted interventions, especially involving dogs, have been used in other patient groups to help reduce anxiety and stress, but the use of patients own pets in ICU settings is less common and faces challenges such as animal behavior and infection risks. This study is evaluating the feasibility of allowing conscious adult ICU patients to be visited by their own pets, such as dogs or cats, for 20 minutes. It targets patients who have recovered from acute phases of illness or are undergoing rehabilitation or end-of-life care and are stable without hemodynamic or respiratory failure. The intervention involves a single 20-minute visit by the patients pet, with careful attention to safety and infection control. Participants will be assessed at various times, including day 1 and day 15, with measurements such as the Positive and Negative Affect Schedule PANAS and patient satisfaction at 3 months. Researchers will monitor the microbiological impact on both patients and the ICU environment to ensure safety. The primary outcome is the feasibility of pet visits by day 15, and the study will also evaluate paramedical care and patient satisfaction to understand the interventions effects during and after the visit period.

Age: 18Years +All GendersPhase Not Applicable
2 locations