
Non-invasive Neustimulation and Respiratory Rehabilitation
Lung DiseasesIntroduction: Respiratory diseases are associated with high rate of morbidity and mortality in Brazil. Cardiopulmonary rehabilitation through respiratory muscle training, aerobic training and strengthening of upper and lower limbs emerges as one of the resources available for the treatment and monitoring of patients with respiratory diseases. To add in this perspective, the application of HD-tDCS induces significant neurophysiological and clinical effects in several body systems. Objective: To identify the chronic effects of non-invasive neurostimulation associated with the rehabilitation of patients with respiratory disorders. Material and methods: This is a pilot study, quantitative, clinical trial type, randomized and controlled, double blind. The sample will be composed by patients with respiratory diseases, aged above 18 years old. The study will consist of two groups: (1) HD-tDCS will be applied - anodic current + respiratory rehabilitation with respiratory muscle training (RMT) and (2) Sham - Only respiratory rehabilitation with RMT without any type of cortical stimulation. The chronic effects of neurostimulation by HD-tDCS associated with cardiopulmonary rehabilitation, with TMR, during 12 sessions will be evaluated. Patients will be evaluated, before and after the protocol, in relation to cortical activation function, pulmonary function, subjective perception of effort, respiratory muscle function, functional capacity, sensation of dyspnea and quality of life. For statistical analysis, intention-to-treat analysis will be used and groups will be compared using Student's t-test, for continuous variables, or chi-square, for categorical variables. ANOVA split-plot, repeated measures for primary outcomes. Analyzes of covariance to identify differences between groups using baseline scores as covariates. Effect sizes and confidence intervals will be calculated using eta squared (η²). Expected results: Neurostimulation would enhance the effects of respiratory rehabilitation and reduce the symptoms of patients with these diseases.

Post COVID-19 REspiratory Mechanisms and the Efficacy of a Breathing Exercise Intervention for DYsregulated...
COVID-19Respiratory DiseaseA pilot Study To investigate the efficacy of a breathing intervention for improving persistent breathlessness due to dysregulated breathing following COVID-19 when compared to usual care.

Self-help Booklets for Depression in Adults With Pulmonary Hypertension.
Pulmonary HypertensionDepressionThe investigators have developed self-help booklets specifically for adults with PH who are experiencing difficulties with depression. The self-help booklets are based on a type of psychological treatment called Cognitive Behavioural Therapy or CBT for short. CBT looks at the way people think and what they do, and how this affects their mood. It involves making changes to thoughts and behaviours. CBT can help people develop more helpful ways of coping with depression. CBT is one of the most effective therapies for depression, this means it works well. There are four booklets that participants will work though weekly in their own time and at home. The aim of this study is to test whether the self-help booklets are helpful in reducing depression in people with pulmonary hypertension. Those taking part will be asked to complete a series of questions asking about themselves including whether they are experiencing any difficulties such as depression and anxiety. They will then be allocated at random to one of two groups. Group one will receive the self-help booklets, called the intervention group. Group two, or the wait list group, will receive the intervention at a later date if it is found to be helpful. Having two groups is very important as it will allow us to see whether benefits associated with taking part in the project was because of the self-help booklets or something else. Participants in group one will also be contacted partway through the intervention to ask about their experiences of taking part. Both groups will be asked to complete a series of questionnaires four weeks later and then again in one month. Participants in group one will be contacted again to find out more about their experiences of the project.

Clinical Validation of Programmable Drain Fluid Regulator to Reduce Morbidity, Care Requirements,...
Pleural EffusionAscitesThe goal of this Effidrain first-in-human medical device trial is to improve the outcomes of patients with pleural effusions and ascites. The main aims are: The primary aim of this first-in-man device pivotal study (n=120) is to demonstrate that the body fluid drain regulator can perform the function of pleural or ascites drainage, accurately and precisely. The secondary aims are related to explore the effects of Effidrain on health-related outcomes: The investigators hypothesize that Effidrain can reduce the time that the subject requires a pleural or abdominal drain in-situ, compared to conventional care. The investigators hypothesize that the time required for healthcare workers to perform post-procedure monitoring for subjects that require pleural or abdominal drainage using Effidrain, would be reduced compared to conventional care. The effect of technology on physician and nursing hours required for drain care, and cost-effectiveness of the intervention will be studied Participants will be randomized to control and intervention group. Control group will be receiving treatment using manual drainage system while intervention group will be using Effidrain machine. Participants and Nurses from both control and intervention group will be asked to fill participant/nurses questionnaire form respectively.

HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer
Recurrent Extensive Stage Small Cell Lung CarcinomaThe Phase 1b part of this clinical trial is to investigate the safety and pharmacokinetic (PK) characteristics of HTMC0435 tablets combined with temozolomide in patients with various advanced solid tumors (recurrent small cell lung cancer is preferred). The Phase 2 part of the study is a multi-center, open-label, single-arm trial to investigate the preliminary efficacy of HTMC0435 and temozolomide in patients with recurrent small cell lung cancer (SCLC) at the recommended phase 2 dose.

Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation
Advanced NSCLCMetastatic Lung CancerStudy 849-017 is an open-label, Phase 2 clinical trial evaluating the clinical efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS <50% and KRAS G12C mutation

AMAZE-lung: Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small...
Non Small Cell Lung CancerAMAZE-lung is a multicenter single-arm phase II trial. The protocol treatment consists of amivantamab, lazertinib and bevacizumab (Zirabev®), given in a three-weekly regimen. The primary objective of the trial is to assess the efficacy of amivantamab and bevacizumab added to continued treatment with the third-generation EGFR-TKI lazertinib, in patients with EGFR-mutant advanced NSCLC, who have been previously treated with a third-generation EGFR-TKI in order to provide data on treatment effect and sample size required for a future phase III trial. In addition, the safety of the treatment combination will be evaluated.

To Evaluate the Efficacy and Safety of TQC3564 Tablets in the Treatment of Persistent Allergic Rhinitis...
Allergic RhinitisA clinical study to evaluate the efficacy and safety of tqc3564 tablets in the treatment of persistent allergic rhinitis. A total of 24 patients will be enrolled.

Inspiratory Pulmonary Rehabilitation for Children With Obesity and Asthma
Pediatric ObesityPediatric AsthmaThis is a single-center, randomized, SHAM-controlled, parallel assignment, double-masked,8-week interventional study among children aged 8-17 years (not yet 18 years old) of age with obesity and asthma. (n=60), recruited from Duke Health Center Creekstone, to test the effectiveness of inspiratory muscle rehabilitation (IMR) as an acceptable add-on intervention to reduce dyspnea (feeling short-of-breath or breathless) and to promote greater activity in children with obesity and asthma. Clinic to test the effectiveness of inspiratory muscle rehabilitation (IMR) as an acceptable add-on intervention to reduce dyspnea (feeling short-of-breath or breathless) and to promote greater activity in children with obesity

Tezepelumab on Airway Structure and Function in Patients With Uncontrolled Moderate-to-severe Asthma...
AsthmaIn adult patients with uncontrolled moderate-to-severe asthma, blocking TSLP with tezepelumab will improve ventilation heterogeneity (evaluated by hyperpolarized 129Xe MRI), and this will be associated with reduced airway inflammation (evaluated by sputum composition), luminal narrowing and plugging (evaluated by CT).