Volta Redonda

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating the safety and effectiveness of induction therapy using Afimkibart also called RO7790121 in people with moderately to severely active ulcerative colitis UC. This Phase III study is designed as a multicenter, double-blind, placebo-controlled trial to compare Afimkibart with a placebo. The study aims to understand how well Afimkibart works to induce remission in UC and its safety profile. Participants will be randomly assigned to one of two groups. One group will receive Afimkibart through an intravenous IV infusion followed by a subcutaneous SC injection, while the other group will receive matching placebo infusions and injections. The treatment period lasts 12 weeks, during which researchers will assess the effects of the therapies. Throughout the study, participants will undergo various assessments including evaluations of clinical remission, endoscopic improvement, histologic changes, and symptom severity at specified time points such as baseline, Week 2, and Week 12. Safety will be monitored by tracking adverse events for up to 30 weeks after starting treatment. The total participation duration spans the treatment and follow-up periods to gather comprehensive data on outcomes and safety.

Researchers are evaluating the efficacy and safety of Afimkibart also known as RO7790121 as an induction therapy in people aged 16 to 80 with moderately to severely active Crohns disease. This Phase III, multicenter, double-blind, placebo-controlled study aims to compare Afimkibart with placebo to understand its potential benefits and risks for this condition. Participants will be randomly assigned to receive either Afimkibart through an intravenous infusion followed by a subcutaneous injection, or a placebo infusion followed by Afimkibart subcutaneous injection. The study treatment is given to assess the impact on Crohns disease activity over a 12-week period. During the study, participants will have their symptoms and disease activity monitored using assessments like the Crohns Disease Activity Index CDAI, endoscopic evaluations, stool and abdominal pain tracking, and quality of life questionnaires. Safety will be closely observed up to 30 weeks after starting treatment. This study helps to measure remission rates and responses to treatment over time.

Researchers are evaluating the best sequence of chemotherapy drugs for treating locally advanced HER2-negative breast cancer. This phase III, open-label, randomized trial includes 494 female patients with invasive breast carcinoma stages IIB to III. The study compares starting treatment with either anthracyclines plus cyclophosphamide or taxanes, with or without carboplatin for triple-negative subtypes, to determine which sequence is more effective. Participants are randomly assigned to one of two treatment groups. One group receives doxorubicin and cyclophosphamide intravenously every 21 days for three cycles, followed by docetaxel every 21 days for four cycles or weekly paclitaxel for 12 weeks. The other group starts with docetaxel or paclitaxel followed by doxorubicin and cyclophosphamide on the same schedule. Other treatments like surgery, radiotherapy, and hormone therapy are given according to usual care and are not part of the study. Throughout the study, participants undergo regular assessments including cardiac function tests such as echocardiogram or MUGA before treatment starts. The main outcome measured is invasive disease-free survival over an average of eight years. The trial monitors patient health and treatment response but does not alter standard post-chemotherapy care. Participation involves signing informed consent and agreeing to use contraception during and after treatment as required.

Researchers are evaluating the safety and initial effectiveness of the drug Codivir in adults hospitalized with moderate COVID-19 symptoms. The study involves 130 patients whose symptoms have started within 7 days before enrolling. This phase IIa, double-blind, randomized placebo-controlled trial is conducted across multiple centers and countries to better understand how Codivir may impact COVID-19 recovery. Participants receive either Codivir or a placebo, administered as a 20 mg subcutaneous injection twice daily for 7 days. Treatment begins in the hospital, and if medically appropriate, patients continue treatment at home with nurse visits twice daily until Day 7. After treatment, participants are followed up by telephone up to Day 28 to monitor health, collect information on symptoms and any side effects, and provide guidance. During the study, participants undergo various assessments including physical exams, electrocardiograms, blood tests, and symptom scoring. Researchers track changes in the World Health Organization Ordinal Scale for clinical improvement up to 28 days, as well as COVID-19 symptom scores, viral load, antibody levels, and any adverse events. Safety and health status are monitored throughout the study, with medical decisions guiding continued treatment or hospitalization as needed.