Ivrindi

This research aims to evaluate the impact of artificial intelligence AI-assisted mobilization education on patients undergoing total knee arthroplasty, focusing on reducing fear of movement kinesiophobia and improving readiness for hospital discharge. The study involves adult patients having their first total knee replacement and compares AI-assisted education with standard care. Early mobilization after surgery is important for recovery, and this study explores whether AI-based education can better prepare patients for this process. Participants are divided into two groups a control group receiving standard verbal mobilization education and an intervention group receiving an AI-assisted video-based mobilization education delivered by a nurse before the first postoperative mobilization. Both groups complete assessments of kinesiophobia using the Tampa Scale before and after education on the first day after surgery. Readiness for hospital discharge is measured by both patient and nurse assessments about four hours before discharge. During the study, participants complete personal information forms and undergo evaluations on postoperative day 1 and shortly before discharge. Researchers collect and analyze data on kinesiophobia changes and readiness for discharge using validated scales. The study includes 72 patients and is designed to provide evidence on whether AI-assisted education can support recovery and discharge preparation. Participation lasts from hospital admission through to discharge, with assessments focused around early postoperative mobilization.

Researchers are investigating new treatments for radiographic axial spondyloarthritis r-axSpA, a form of arthritis causing pain, stiffness, and swelling in the spine and pelvis joints. This condition shows visible damage on X-rays. The study aims to evaluate if different doses of the medicine tulisokibart can improve r-axSpA symptoms compared to a placebo, which helps measure the medicines effects accurately. Participants will be assigned to one of several groups receiving high, medium, or low doses of tulisokibart, or a placebo. The study includes a 16-week placebo-controlled phase. After that, participants receiving the low dose or placebo will be re-assigned to medium or high doses. Following this, there is a long-term extension lasting 124 weeks, which has a 40-week main extension and an 84-week optional extension, allowing continued treatment and observation. Throughout the study, participants will have regular assessments to monitor symptoms and disease activity using various indexes and imaging scores. Researchers will track the percentage of participants who achieve improvement at week 16 and monitor safety by recording adverse events up to approximately 154 weeks. The study uses injections of tulisokibart or placebo under the skin and includes ongoing evaluations of physical function, pain, inflammation, and quality of life.

Researchers are evaluating the long-term safety of subcutaneous guselkumab injections in children with moderately to severely active ulcerative colitis, Crohns disease, or juvenile psoriatic arthritis. This Phase 3 study focuses on pediatric participants who have previously been treated with guselkumab and will continue therapy in this extension study to monitor safety over an extended period. Participants who completed dosing in one of three primary pediatric guselkumab studies and are deemed by their investigator to benefit from continued treatment will join this long-term extension. Guselkumab is administered as a subcutaneous injection either every 8 weeks or every 4 weeks, depending on prior study assignment and clinical status. Some participants may switch dosing frequency once during the extension before unblinding, after which dosing aligns with their original regimen. Dose adjustments are restricted based on the primary study they came from. During the study, participants will receive guselkumab injections regularly and be monitored for treatment-emergent adverse events for up to nearly seven years. Researchers will assess safety outcomes through ongoing clinical evaluations over this time. Parents or legal representatives provide consent for children to participate, and children capable of understanding the study will give assent. The total participation duration may extend up to six years and nine months, allowing long-term safety data collection.

Researchers are evaluating the treatment of anemia in patients with chronic kidney disease CKD who are on hemodialysis. This Phase III, investigator-blinded, randomized, multicenter study compares two drugs, efepoetin alfa and darbepoetin alfa, to see how well they maintain hemoglobin levels in these patients. The study aims to maintain hemoglobin between 10.0 gdL and 12.0 gdL, which is important for managing anemia in CKD. Participants will be randomly assigned in a 21 ratio to receive either efepoetin alfa or darbepoetin alfa. Both drugs are given by intravenous injection, typically after dialysis sessions. Efepoetin alfa is administered weekly from Day 1 to Week 28, with possible interval changes to one or two weeks from Week 29 to Week 52 based on investigator judgment. The study consists of three periods screening up to 28 days, treatment about 52 weeks, and a 4-week follow-up with phone contacts up to Week 56 or the last visit. During the study, participants will undergo regular assessments including hemoglobin level monitoring to evaluate the mean change between Week 20 and Week 28. Safety and efficacy are closely observed, with dosages adjusted to maintain target hemoglobin levels. Follow-up will include phone contacts to monitor participants up to Week 56. The total participation duration is approximately one year, starting from screening through treatment and follow-up.

Researchers are evaluating the effects of combining baxdrostat with dapagliflozin versus baxdrostat with a placebo on albuminuria in adults with chronic kidney disease CKD and high blood pressure. This Phase IIb, randomized, multicenter, double-blind study includes participants aged 18 and older, with or without type 2 diabetes and with or without prior SGLT2 inhibitor treatment. The goal is to understand how these treatments affect kidney function and safety in this population. Participants will be randomly assigned to receive either a daily dose of baxdrostat combined with dapagliflozin or baxdrostat with a placebo matching dapagliflozin. Before randomization, some participants may go through an optional pre-screening and a washout period if they are currently taking an SGLT2 inhibitor. The study includes stratification based on diabetes status to balance groups. Throughout the study, participants will undergo assessments including measurements of urine albumin-to-creatinine ratio UACR to evaluate changes in albuminuria from baseline over up to 12 weeks. Safety and other health parameters such as blood pressure, potassium, and sodium levels will also be monitored. Study completion is defined by finishing all scheduled procedures, and the study continues until the last participant completes their last visit globally.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are evaluating oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.

Researchers are evaluating the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate, delivered via a multidose dry powder inhaler with an electronic module, in participants aged 12 years and older with asthma. This Phase 3 trial aims to compare this combination treatment to fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. The study also assesses different dosing schedules, safety, tolerability, and pharmacokinetics of these inhalers. Participants will be randomly assigned to one of four groups receiving either the combination inhaler, fluticasone propionate inhaler, albuterol sulfate inhaler, or placebo, all with integrated electronic modules. Treatments are administered over a 4-week period with dosing four times daily. Pharmacokinetic assessments will be conducted after a single dose administration. The study is double-blind and placebo-controlled, with a parallel group design. Throughout the approximately 10-week study period, including screening and treatment, participants will undergo evaluations including lung function tests measuring forced expiratory volume in one second FEV1, asthma control questionnaires, and safety assessments. Researchers will monitor treatment-emergent adverse events and measure blood concentrations of the inhaled drugs. The study includes electronic monitoring of inhaler use and collects data at baseline, during treatment, and at week 4, with follow-up to assess efficacy and safety.

Researchers are evaluating the safety and effects of different doses of a new medicine called NNC0519-0130 in people living with chronic kidney disease, some of whom have type 2 diabetes and are overweight or obese. This Phase 2 study also compares NNC0519-0130 to semaglutide, an already prescribed medicine, and a placebo to see how they may improve kidney function. Participants will be randomly assigned to receive once-weekly subcutaneous injections of NNC0519-0130 with a fixed dose escalation until reaching a maintenance dose, semaglutide with a similar dosing schedule, or a placebo matching NNC0519-0130. The treatment period lasts up to 43 weeks with several dosing schemes and groups. During the study, participants will have their kidney function monitored through urine albumin-to-creatinine ratio changes at weeks 12, 24, and 36. Other assessments include estimated glomerular filtration rate, body weight changes, waist circumference, blood pressure, and glycated hemoglobin levels. Safety will be evaluated by tracking adverse events throughout the trial duration. Participants will be regularly assessed to understand the medicines effects and safety.