Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2026-01-20
Completion: 2027-08
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This is a phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and tolerability of GL0034 among type II diabetes mellitus subjects who are obese or overweight with weight-related comorbidities. Subjects will be put on either one of the four treatment arms (GL0034, once a week, subcutaneous injection) or placebo arm (once a week, subcutaneous injection) following initial dose-up titration that takes up to approximately 20 weeks. The primary end point is change in HbA1c levels from baseline (Week 0) to Week 36 following treatments in all participants.
Purpose: To evaluate the efficacy of artificial intelligence (AI)-based decision-making technology in managing glycated hemoglobin (HbA1c) and blood glucose levels compared to the control group. Methods: For the AI Intervention group, the patients will be trained to independently use the diabetes telemedicine platform application. Each patient will be equipped with a glucometer and exercise bracelet, and the data will be automatically transmitted to the medical server via Bluetooth. The healthcare platform will analyze the uploaded data and provide feedback suggestions on medication, diet, and exercise automatically. The platform will also monitor the medical and lifestyle data of the patients every two weeks, offer feedback based on the analyses, and remind the patient to adhere to the self-management protocol based on the platform. The platform is a digitally integrated healthcare platform that patients can use independently without the need for monitoring and assistance by healthcare professionals. The glucometer and pedometer bracelet will automatically connect to the platform through Bluetooth. The patient lab sheet identification and structured conversion system, AI for food picture identification and calorie calculation systems, and the AI decision-making system are on the cloud server. Patients upload image information, such as lab sheets and meal pictures, through the patient's diabetes mobile health system, and the cloud platform intelligently analyzes the patient's disease, medication, and daily life status to develop personalized solutions according to individual control goals. Free outpatient visits will be provided to both the intervention and control groups every twelve weeks. For the conventional treatment group, patients will receive a free blood glucometer and will have regular outpatient appointments. There is no limit to the number of outpatient visits; however, they are required to regularly monitor and record their blood glucose, diet, and exercise data to ensure that the medical team objectively conduct their diagnosis and treatment activities. The medical team will provide free outpatient visits every 12 weeks, along with advice on medication, diet, and exercise based on the individual's blood glucose level. Expected results: A significant difference in HbA1c change from baseline to 48 weeks and improved FPG and 2-hour postprandial blood glucose levels in the AI intervention group were observed.
This observational study aims to establish a digital registry, screening platform for patients with monogenic diabetes using internet-based and mobile application technologies. The primary objectives are to: Characterize the genetic landscape of monogenic diabetes in the Chinese population, including pathogenic variants and their distribution Participants will: * Enroll in the monogenic diabetes registry via mobile application or web-based platform * Undergo molecular genetic testing to establish a definitive diagnosis
The objective of this study is to assess the effect Spinal Cord Stimulators have toward improving vascular changes of diabetes mellitus in patients eligible for SCS placement based on their condition of painful diabetic neuropathy; we will evaluate improving their disability and quality of life, improving micro-circulatory changes induced by Diabetes Mellitus (DM), improving macro-circulatory changes induced by DM and improving arterial stiffness of the vessels of the lower extremity.
Glycemic Variability of Combination Therapies in T2DM
The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.
This study is a randomized, double-Blind, placebo-controlled, Single and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in Healthy Volunteers and Participants with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) with or without Asthma.
The goal of this registry is collecting data of severe asthma patients, recruited by specialized centers, in a real life setting, homogeneously placed on a database management system to follow them over the time. The information recorded will provide: 1. The collection of homogeneous clinical, functional and biologic data of patients with severe asthma in a real life setting. 2. The evaluation of adherence to treatment in real life. 3. The clinical eligibility of patients treated with biologics. 4. The evaluation of patients' clinical response to each treatment. 5. The monitoring of tolerability and safety. 6. The long-term follow up of patients with severe asthma.
The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) \[PC20\]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. Part 2: to compare the comparative dose response on efficacy (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.
The purpose of this research study is to evaluate the impact of pharmacist led educational interventions on Asthmatic patients, and also determine their medication adherence. Pharmacist's intervention aims to answer: 1. How a pharmacist intervention program impact medication adherence in persistent asthma? 2. To assess how pharmacist led educational intervention like patients' counseling and medication reminders through Telemedicine have an impact on patient's asthma control? 3. Which mode of communication (Verbal instructions, videos and pamphlets) for the patient counselling is most beneficial for the patients in asthma control.
Often when people with asthma get a virus caused by the common cold (rhinovirus), they also experience an increase or worsening of their asthma symptoms. The purpose of this study is to see if the study medication dupilumab helps prevent those with mild to moderate asthma from having increased asthma symptoms, after being exposed to an experimental rhinovirus inoculation. This is a study about dupilumab which is a drug approved by the U.S. Food and Drug Administration (FDA) for treatment of moderate to severe asthma. Dupilumab is a medication that blocks pathways that cause asthmatic inflammation in the lungs, leading to symptoms and worsening lung function. During this study, subjects will be given either dupilumab or placebo and will subsequently be exposed to the the "common" cold virus (rhinovirus). The virus that the investigators are using has been safely used before in many studies like this involving thousands of volunteers, and the safe use of the virus in this research study has been reviewed by the FDA. The investigators will track asthma symptoms during the study with lung function tests, questionnaires, specimen collection, biomarkers, and physical exams. For data analysis the investigators will assess the samples collected to determine changes in the treatment groups. The investigators will also asses the symptom scores and deviations from baseline measures for lung function.
The ClimAIr project will expand the evidence-based understanding of climate change, air pollution, and non-communicable respiratory diseases by using Artificial Intelligence (AI) tools. It will gather data on greenhouse gases levels and disaster risks, information on serious air pollutants and respiratory diseases' prevalence. The AI powered tools will be employed to generate better intervention methods and improve public health outcomes. Federated Learning (FL) will be used to develop AI models to protect patients' privacy. By raising public awareness and delivering the ClimAIr tool - specifically designed to health workers, urban planners and policy makers - the project aims to influence policy decisions, promote healthier environments, and reduce respiratory diseases in Europe, which will be tested and validated the ClimAIr tool in specific municipalities that are part of the project. ClimAIr draws on a consortium of 21 partners from 15 European countries, including carefully selected health centres across Europe - in Spain, Luxembourg, Ukraine, Italy, France, Germany, Greece, Romania and Poland - focused on respiratory diseases, which will provide disease data and explore metabolic routes of the studied contaminants/diseases. ClimAIr is composed of an interdisciplinary team formed by research centres, ethical AI and modelling experts, SSH specialists, municipal governance, and a Communication \& Dissemination (C\&D) expert team dedicated to achieving and spread the results of the project.
Project Viva is a prospective cohort study of maternal and child health, following over 2,000 mother-child pairs from the mother's pregnancy into the child's adolescence.
In this study, xenon MRI will be used to evaluate regional functional consequences of mucus plugs in the lungs of patients with severe asthma. Mucus plugs will be identified using CT imaging, and xenon MRI will be used to evaluate ventilation and gas exchange impairments in regions of the lungs corresponding to the airways downstream of mucus plugs.
To study the expression level of biomarkers such as GITRL in peripheral blood of children with asthma and analyze their correlation with the severity of asthma. To study the predictive value of biomarkers level for the occurrence and development of asthma. And to provide supplementary detection means and predictive indicators for the diagnosis of asthma and the severity of asthma.
The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype
The goal of this observational study is to develop an advanced expiratory algorithm model utilizing exhaled breath volatile organic compound (VOC) marker molecules. This model aims to accurately diagnose mutiple pulmonary diseases. The primary objectives it strives to accomplish are: 1. To assess the diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in diagnose several common pulmonary diseases. 2. To assess the diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in diagnose more pulmonary diseases.
Background: \- Asthma is a serious clinical and public health problem. Researchers want to collect data to better understand how bacteria and other things in the environment can affect people's asthma. Eligibility: \- Nonsmoking adults age 18 - 60 who have moderate to severe asthma. Design: * Participants will complete a medical history form before the first visit. * Study visits will include collecting medical history, and conducting physical exam, lung and smoking tests. Participants will give blood, urine, stool, dust, saliva, and sputum samples. * Participants will take tests that measure their breathing abilities. They will give saliva samples for DNA study. They will get kits to collect stool and dust samples at home. They will fill out surveys. * Participants will have visits every 6 months for 5 years. They can schedule sick visits, if needed, at no cost to the participant. For all visits, they will have asthma check-ups and get treatment, at no cost to the participant. * Some participants may take part in a sub-study that includes one 4-hour visit. They will have medical history, physical exam, and lung tests. They will have urine tests to check for pregnancy and tobacco exposure. Then they will have bronchoscopy. For this, an intravenous line will be placed in an arm vein. The nose and throat will be numbed. A flexible fiber-optic tube will be inserted into their airways through the nose. Their airways will be examined and areas of their lung will be washed. A small sample of cells will be taken.
The French E3N cohort was initiated in 1990 to investigate the risk factors associated with cancer and other major non-communicable diseases in women. The participants were insured through a national health system that primarily covered teachers, and were enrolled from 1990 after returning baseline self-administered questionnaires and providing informed consent. The cohort comprised nearly 100 000 women with baseline ages ranging from 40 to 65 years. Follow-up questionnaires were sent approximately every 2-3 years after the baseline and addressed general and lifestyle characteristics together with medical events (cancer, cardiovascular diseases, diabetes, depression, fractures and asthma, among others). The follow-up questionnaire response rate remained stable at approximately 80%. A biological material bank was generated and included blood samples collected from 25 000 women and saliva samples from an additional 47 000 women. Ageing among the E3N cohort provided the opportunity to investigate factors related to agerelated diseases and conditions as well as disease survival.
For children with asthma, exposure to indoor air pollution increases the risk of a serious asthma exacerbation, which can be life-threatening. Interventions aimed at improving indoor air quality, including use of a portable air cleaner with a high-efficiency particulate air (HEPA) filter, can reduce this risk, but the effectiveness, feasibility and acceptability of HEPA air cleaners varies by setting. In collaboration with a community health worker (CHW) delivered asthma education program, the investigators are conducting a randomized clinical trial to evaluate the effectiveness of HEPA air cleaners to improve indoor air quality and child asthma health in South King County of Washington state, a vulnerable community impacted by air pollution from airports and highway traffic. Key features of the Airports, Air Quality and Asthma (AAA) design include integration of CHWs into study procedures, including CHWs recruited from community-based organizations, into multiple aspects of the trial protocol. The investigators aim to recruit up to N=60 children with asthma randomized into intervention and control groups in a 1:1 ratio, conduct baseline assessments of indoor air quality and airway health, and collect repeated assessments of air quality and airway health during the three-month intervention period and after the trial concludes. Study findings will inform future approaches to integrate HEPA air cleaners into existing CHW asthma education programs in this and similar communities.