ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)
Covid19The purpose of this study is to evaluate the effectiveness of repurposed medications (study drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19. Participants will receive either study drug or placebo. Participants will self-report any new or worsening symptoms or medical events experienced while taking study drug or placebo. This study is intended to be all remote with no in person visits, unless the study team feels it is in the best interest of a participant to be seen in person. Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the activation of any new drug arms. Each study arm will also have its own clinicaltrials.gov entry and will include "Pro00107921" in the Unique Protocol ID.
Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults...
Rifampicin Susceptible Pulmonary TuberculosisA Phase 2, Single-Centre, Open-Label, Parallel Control Arm, Randomised Clinical Study to Evaluate the Early Bactericidal Activity (EBA), Safety and Tolerability of Nebulised RESP301 in Adults with Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis
Stroke and CPAP Outcome Study 3
Ischemic StrokeIntra Cerebral Hemorrhage4 moreA problem with breathing during sleep, called obstructive sleep apnea (OSA), likely increases the risk of stroke and is common in people who have had a stroke, present in about 2/3 of stroke survivors. There is also evidence that OSA predicts worse outcome after stroke. The question being addressed in the Stroke and CPAP Outcome Study 3 (SCOUTS3) is how to improve use of continuous positive airway pressure (CPAP) therapy to treat OSA when started during intensive stroke rehabilitation.
Selective Lymph Node Dissection for cT1N0M0 Invasive NSCLC With CTR>0.5 Located in the Apical Segment...
Lung AdenocarcinomaLymph Node MetastasisThis is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1018. The goal of this clinical trial is to confirm the theraputic effect of selective lymph node dissection for cT1N0M0 invasive non-small cell lung cancer with CTR>0.5 located in the apical segment. The main questions it aims to answer are: The 5-year overall survival of patients having cT1N0M0 invasive non-small cell lung cancer with CTR>0.5 located in the apical segment; The post-operative lymph node metastasis and recurrence-free survival. Participants will receive selective lymph node dissection as the surgical procedure.
Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Control the Immune Hyperactivation...
Systemic Inflammatory Response SyndromeThe investigators developed a GMP protocol to isolate Treg cells from thymic tissue (thyTreg). The thyTreg cells are being evaluated in a Phase I/II clinical tria l to evaluate the safety and efficacy of the adoptive transfer of autologous thyTreg to prevent rejection in heart transplant children. The preliminary results of the ongoing clinical trial indicate that this therapy is not immunogenic, indicating that allogeneic use of these thyTreg cells would be feasible and safe . The goal of this open-label Phase I/IIa study is to evaluate the safety, tolerability and efficacy of allogeneic thymus derived Tregs (thyTreg) in controlling the Immune Hyperactivation in SARS-CoV-2 infected-patients. These thyTreg cells could inhibit an excessive inflammation, improving life-threatening manifestations, restoring immune balance, and protecting infected tissues.
Efficacy of EFA in Acquired Brain Injury
Acquired Brain InjuryComparative Effectiveness Research2 moreAcquired brain injury (ABI) is one of the biggest cause of death and disability in the world. Patients with ABI often have difficulties with swallow and breath. The study purpose is to evaluate if the Expiratory Flow Accelerator (EFA) technology has positive effects on the respiratory and swallowing function in patients with acquired brain injury (ABI). Researchers recruit patients at Centro Ettore Spalenza-Fondazione Don Carlo Gnocchi in Rovato, Italy. To partecipate, patients should satisfy certain eligibility criteria; they will not be enrolled if they satisfy exclusion criteria. If a patient can be recruited, researchers do a swallow, consciousness and respiratory assessment with him. After that, the patient will be randomized to the study or control group. If the patient is in the control group, he will receive a traditional rehabilitation treatment. Otherwise, the patient will receive an additional treatment with the EFA device. Researchers will assess again the patient (with the same tools of the previous assessment) after 12 weeks of treatment. They want to see if the EFA device could help patients with ABI to improve their health conditions. The study will last extensively from January 2023 to December 2024.
Pilates Exercises in Patients With Inhalation Injury
Inhalation InjuryInhalation injury is a composite of multiple insults including: supraglottic thermal injury, subglottic airway and alveolar poisoning, and systemic poisoning from absorbed small molecule toxins. These contaminant insults independently affect each of the pulmonary functions as well as having a direct effect on systemic physiology. Further, anatomic characteristics can predispose patients to inhalation injury. For example, an infant will develop airway obstructions much faster than an adult due to reduced airway diameter. Understanding the contributions of each of these pathologies to the patient's disease is critical to managing inhalation injury.
Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cance...
Advanced Non-small Cell Lung CancerTo evaluate the efficacy and safety of almonertinib plus anlotinib as first-line treatment for advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation. This study is an exploratory single-arm study. The specific treatment regimen is as follows: Non-squamous NSCLC: almonertinib (110 mg/d) plus anlotinib (12mg/d) is started on the first day of each treatment cycle and administered every three weeks until disease progression or intolerable toxicity. Anlotinib was given for two weeks, followed by one week off. Patients are assessed for measurable disease at baseline, 6 weeks, 12 weeks after starting treatment, and every 9 weeks thereafter according to RECIST 1.1 criteria during the treatment period until disease progression or intolerable toxicity withdrawal. Following discontinuation of treatment, subjects are followed for survival status every 3 months until death. Subject safety was assessed during treatment according to NCI CTCAE Version 4.0 criteria. Subjects who experience an AE should be followed until the AE returns to baseline. The primary endpoints is Progression-free survival (PFS) . Secondary endpoints include objective response rate (ORR), overall survival (OS) and safety (NCI CTCAE v 4.0). Statistical methods: The PFS curve was estimated using the Kaplan-Meier method for the largest population to be analyzed. The confidence interval method was used as the criterion for the main analysis. OS was calculated in the same way as the secondary endpoint. Descriptive statistics will be used to analyze ORR, DCR, etc. It is expected that almonertinib plus anlotinib as first-line treatment will prolong median PFS and OS of advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation patients.
Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without Glottal Enlargement
Bilateral Vocal Cord ParalysisThe goal of this clinical investigation is to learn about the use of a novel medical device, the SPIRION Laryngeal Pacemaker, in patients suffering from bilateral vocal fold paralysis (BVFP). The main questions it aims to answer are: Is the use of the device safe? Does the device improve the participants ability to take a breath? Participants will be implanted with the SPIRION Laryngeal Pacemaker and the development of their symptoms will be observed for the following 2 years.
Cadonilimab (AK104) Plus Chemotherapy as First-line Treatment in Non-squamous Non-Small Cell Lung...
CarcinomaNon-Small-Cell LungThis is a single arm, multi-center clinical trial. Target population is advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients with Programmed Cell Death Ligand 1 (PD-L1) negative, aiming to evaluate the efficacy and safety of the combination therapy of Cadonilimab and chemotherapy. Cadonilimab is a PD-1/CTLA-4 bi-specific antibody.