Joao Pessoa

Researchers are evaluating the safety and effectiveness of a new oral medicine called vepugratinib compared with a placebo in adults with advanced or metastatic urothelial carcinoma, a type of bladder cancer that has a specific FGFR3 genetic alteration. This Phase 3 study aims to see if vepugratinib combined with two other drugs, enfortumab vedotin (EV) and pembrolizumab, can improve treatment outcomes for people who have not received prior systemic therapy for their cancer. Participants will receive either vepugratinib or placebo taken orally alongside enfortumab vedotin and pembrolizumab, both administered by intravenous infusion. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison between the vepugratinib and placebo groups. Treatment and monitoring will continue for up to approximately 6 years, allowing long-term assessment of safety and treatment effects. During the study, participants will be regularly evaluated for treatment-related side effects, response rates, and how long the cancer remains controlled without progression. Researchers will use established criteria to measure tumor response and will conduct thorough safety monitoring over the entire study period. Participation may last up to six years, during which participants will undergo laboratory tests, imaging, and clinical assessments to track their health and treatment response.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

This research aims to evaluate the feasibility of conducting a main randomized controlled trial comparing Cognitive Functional Therapy (CFT) with therapeutic exercises in adults with chronic shoulder pain. The study focuses on understanding the barriers, acceptability, adherence, recruitment, retention, and suitability of assessment procedures and outcome measures for these interventions. It recognizes that chronic shoulder pain has physical, functional, and psychological impacts and should be addressed within a biopsychosocial framework. Participants will be randomly assigned to receive either Cognitive Functional Therapy or therapeutic exercises. The CFT intervention targets maladaptive cognitive, physical, and lifestyle behaviors contributing to pain, including education about pain, controlled exposure to movements, functional integration into daily activities, and lifestyle counseling such as physical activity promotion, sleep hygiene, stress management, and social engagement. The exercise group will perform specific stretching and strengthening routines targeting shoulder muscles, using elastic bands and timed repetitions. Throughout the 8-week study, participants will undergo assessments to monitor recruitment and retention rates, intervention acceptability, and adherence. Researchers will evaluate data completeness, variability, and treatment outcomes consistent with expectations. The study includes regular monitoring to understand the feasibility of the main trial and plans to measure key factors influencing participation and clinical delivery of the treatments.

Chronic shoulder pain is a challenging condition that affects physical function, emotional well-being, and daily activities. Researchers are investigating how Cognitive Functional Therapy (CFT), a physiotherapy approach that addresses both the physical and psychological aspects of pain, compares to traditional therapeutic exercises in improving pain and disability. This randomized controlled trial aims to evaluate the effects of these two treatments on biological and psychosocial factors related to shoulder pain, including pain intensity, disability, function, sleep quality, self-efficacy, and other pain-related factors. Participants will be randomly assigned to one of two groups for an eight-week period. The CFT group will receive weekly sessions that focus on understanding pain, improving movement control, and encouraging healthy lifestyle changes such as increased physical activity, better sleep habits, stress management, and social engagement. The therapeutic exercise group will attend sessions twice weekly, performing specific stretching and strengthening exercises targeting shoulder muscles like the trapezius, pectoralis minor, and rotators of the shoulder. Throughout the study, participants will have their pain intensity and disability measured at the start, after four weeks, at the end of treatment (eight weeks), and again at a 12-week follow-up using standardized scales. Additional assessments will evaluate function, self-efficacy, sleep quality, biopsychosocial factors, perception of improvement or worsening, and central pain processing. This comprehensive monitoring will help researchers understand the impact of each treatment on multiple aspects of chronic shoulder pain.

Researchers are evaluating the effectiveness and safety of cerebello-spinal direct current stimulation (csDCS) to treat gait disorders in people who have had a chronic stroke. This Phase 2 trial compares csDCS combined with treadmill training to a sham procedure that mimics the stimulation without any real effect. The study focuses on whether csDCS can improve walking ability and functional mobility in these patients. Participants will receive either csDCS or the sham procedure alongside daily treadmill training for two weeks. The csDCS device works by influencing spinal pathways and reflex excitability to encourage lasting functional changes in the nervous system. The sham procedure provides a brief electrical sensation but stops after 30 seconds, so it does not produce neuromodulation. During the study, participants' functional mobility will be measured at the start, after the two-week treatment, and again 30 days later. Researchers will monitor safety and any side effects throughout. The total involvement includes treatment and follow-up assessments to understand the impact of csDCS on gait and mobility after chronic stroke.

This research aims to find out whether trans-spinal magnetic stimulation can help improve walking and overall movement ability in adults who have chronic stroke and related gait problems. It also seeks to understand whether this technique is safe and if it causes any side effects. The study compares the effects of real trans-spinal magnetic stimulation to a sham stimulation that mimics the process but does not deliver actual magnetic pulses. Participants will receive either trans-spinal magnetic stimulation or the sham version alongside treadmill training. These treatments will be given daily for two weeks. Trans-spinal magnetic stimulation works by activating spinal nerve roots and increasing brain activity related to movement. The sham treatment produces the sound of stimulation but no real magnetic effect. During the study, participants’ functional mobility will be measured at the start, after the two-week treatment period, and again 30 days later. Researchers will evaluate changes in walking ability and monitor for any side effects to assess the safety and effectiveness of the treatment.

Researchers are evaluating the effects of an educational program on people with asthma to better understand how education can improve asthma management. This study focuses on how such an intervention might influence patients' knowledge, clinical control, and lung function. Participants will be drawn from the Pulmonary Function Clinic at the Federal University of Paraíba and will have their asthma control, lung function, and medication use assessed. Participants will be divided into two groups: a control group receiving standard clinic follow-up and an experimental group receiving an educational intervention bundle based on the 2024 Global Initiative for Asthma (GINA) guidelines. The educational session lasts about 60 minutes, includes a group lecture with audiovisual materials, and covers asthma causes, inhaler use, triggers, self-management, environmental control, and the importance of a written treatment plan and regular medical visits. Participants will also receive a booklet summarizing the session and a diary to track medication use and asthma-related health events. Assessments including spirometry, asthma knowledge, inhalation therapy control, clinical control tests (ACT and C-ACT), number of asthma attacks, medication use, hospitalizations, and emergency visits will be conducted at baseline and again 12 weeks later. The main outcomes measured are clinical asthma control and retention of asthma knowledge and inhalation therapy skills at baseline and four weeks. This approach aims to monitor both the immediate and lasting impact of the educational intervention.

Researchers are evaluating the long-term safety of two drugs, Deucravacitinib and Ustekinumab, in adults with moderate-to-severe plaque psoriasis. This Phase 3b/4 study focuses on participants who are candidates for phototherapy or systemic treatment and have specific cardiovascular risk factors such as smoking, hypertension, diabetes, obesity, or a family history of heart disease. Participants will receive either Deucravacitinib or Ustekinumab at specified doses on set days. This open-label, randomized study compares these treatments over an extended period to monitor their safety profiles, including cardiovascular health. Throughout the study, researchers will track major adverse cardiovascular events, including heart attacks, strokes, and related procedures, for up to five years. Participants will undergo regular assessments to monitor their psoriasis and cardiovascular status, ensuring comprehensive safety evaluation during the long-term treatment.

Researchers are evaluating the safety and effectiveness of Volrustomig (MEDI5752) combined with Carboplatin and Pemetrexed compared to either platinum plus Pemetrexed or Nivolumab plus Ipilimumab in adults with unresectable pleural mesothelioma. This is a phase III, randomized, open-label, global study involving participants with histologically confirmed advanced pleural mesothelioma that cannot be removed by surgery. Participants will be randomly assigned to one of two groups: one group receives Volrustomig (MEDI5752), Carboplatin, and Pemetrexed administered by intravenous infusion, while the other group receives the investigator's choice of platinum plus Pemetrexed or Nivolumab plus Ipilimumab, also given intravenously. Treatment is based on the patient's tumor histology and continues according to the study protocol. During the study, participants will be monitored regularly for overall survival up to approximately 61 months. Researchers will assess disease status using measurable disease criteria and evaluate safety through clinical and laboratory tests. The study includes ongoing follow-up to observe treatment effects and monitor participant health over time.

This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months. Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.