Find Clinical Trials

Search thousands of clinical trials by condition, location, and eligibility criteria

0
Total Trials
0
Trials Recruiting
0
Conditions Covered
0
Locations Worldwide
0
Sponsors
Showing 20 of 26908 trials
ClimAIr: AI to Assess the Impact of Pollution and Climate on Respiratory Health in Europe
NCT07107009
Not yet recruiting
Conditions Allergic Rhinitis, Asthma
Phase Not Applicable
Enrollment 1906
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

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.

Design

Study type: Observational Observational model: Other Time perspective: Other

Primary Outcomes

  • Mean Symptom Score of Allergic Rhinitis Patients by Environmental Exposure (Retrospective data collected over a 3-year period prior to study enrollment.)
  • Proteomic Biomarker Levels (NPX) by Environmental Exposure (Samples collected prospectively between months 10 and 15 (October-March, out-of-pollen season).)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2026-01
Completion: 2027-12
Eligibility
Age: 12 Years
Sex: ALL
Volunteers: false
Enrollment: 1906 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Collaborators: Theramed Healthcare SRL (Romania), Centre Hospitalier Universitaire de Toulouse, FRANCE, Charite-Universitaetsmedizin Berlin (Germany), Aristotelio Panepistimio Thessalonikis (Greece), Uniwersytet Medyczny w Lodzi (Poland), Universita degli Studi di Milano (Italy), Bukovinian State Medical University (Ukraine), Luxembourg Institute of Health, Andaluz Health Service
Contact Information
Study Contact:
Ibon Eguiluz Gracia, MD, PhD
+34 951 291 073
iboneguiluz@gmail.com
Interventions
N/A
Eligibility Criteria
Inclusion Criteria: 1. Patients with health insurance based in Malaga, Milan, Luxembourg, Thessalonikki, Lodz, Berlin, Toulousse, Chervnivtsi and Brasov (the places where environmental/climate information will be obtained from, only one recruitment place for partner). 2. 3-year history of chronic rhinitis symptoms during the corresponding pollen season, while residing in the same household AND attending the same school/college or holding the same job position. 3. Positive SPT and serum allergen-specific IgE \>0.35 kUA/L. The pollen species driving the nasal symptoms will be Olea europaea, Phleum pratense or Betula pendula. 4. Patients can be sensitized to other aeroallergens if the nasal symptoms occur exclusively or aggravate unequivocally during the pollen season of the three allergens of interest. Exclusion Criteria: Lack of reliable information in e-health records, allergen immunotherapy (any allergen) during the previous 5 years, systemic immunosuppressants or biologicals in the previous six months, chronic rhinosinusitis, and severe systemic conditions.
Project Viva: a Longitudinal Study of Health for the Next Generation
NCT02820402
Active, positions filled
Conditions Pediatric Obesity
Phase Not Applicable
Enrollment 2128
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

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.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Primary Outcomes

  • Cross-sectional and longitudinal measurements of child BMI z-score in kg/m^2, standardized into a sex- and age-specific z-score using national reference data (CDC growth charts) (Research measurements at birth, 6mo, early childhood (~3y), mid-childhood (~8y), early teen (~14y), and mid-late teen (~17y).)
  • Maternal post-partum weight retention, calculated as the difference between weight in kg at 1 year postpartum and pre-pregnancy weight (Before the Project Viva pregnancy and 1-year postpartum)
  • Child metabolic risk score, calculated as a standard deviation (SD) score (HDL-cholesterol, triglycerides, insulin, glucose and waist circumference measured at ~8y, ~14y, and ~17y of age. Blood pressure measured at birth, ~6mo, ~3y, ~8y, ~14y, and ~17y. Metabolic risk score calculated at ~8y, ~14y, and ~17y.)
  • Child neurodevelopment, assessed by continuous scores on the Wide Range Assessment of Memory and Learning, Second Edition (WRAML2), Design and Picture Memory subtests and The Kaufman Brief Intelligence Test, Second Edition (KBIT-2) (Children completed both the WRAML2 and the KBIT-2 at the mid-childhood visit (~8y))
  • Mother's report of a clinical diagnosis of asthma, wheeze or reactive airway disease (Interviews administered at 6mo, early childhood (~3y), mid-childhood (~8y), early teen (~14y), and mid-late teen (~17y).)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 1999-01
Completion: 2027-08
Eligibility
Age: 0 Years
Sex: ALL
Volunteers: false
Enrollment: 2128 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Harvard Pilgrim Health Care
Collaborators: Brigham and Women's Hospital, Harvard School of Public Health (HSPH)
Principal Investigators:
  • Emily Oken, MD, MPH (PRINCIPAL_INVESTIGATOR) - Harvard Medical School / Harvard Pilgrim Health Care Institute
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Eligibility Criteria
Inclusion Criteria: * Less than 22 weeks pregnant at the time of enrollment * Receive prenatal care at one of the selected practices * Plan on delivering at one of two study hospitals * Be able to answer questionnaires in English. Exclusion Criteria: * Multiple gestation * Plans to move away before delivery * Plans to terminate the pregnancy
Downstream Effects of Airway Mucus Plugs on 129Xenon MRI in Severe Asthma
NCT07139899
Recruiting
Conditions Severe Asthma
Phase Not Applicable
Enrollment 5
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

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.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Combination Product: Hyperpolarized Xenon 129 — Pulmonary magnetic resonance imaging using hyperpolarized xenon-129 gas as an inhaled contrast agent

Primary Outcomes

  • Ventilation Defect in Mucus-blocked regions (12 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-11-17
Completion: 2027-09
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 5 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Bastiaan Driehuys
Collaborators: University of Kansas Medical Center, Polarean, Inc.
Principal Investigators:
  • David Mummy, PhD (PRINCIPAL_INVESTIGATOR) - Duke University
Contact Information
Study Contact:
David Mummy, PhD
9846847783
david.mummy@duke.edu
Bastiaan Driehuys, PhD
919-684-7786
bastiaan.driehuys@duke.edu
Interventions
  • Combination Product: Hyperpolarized Xenon 129 — Pulmonary magnetic resonance imaging using hyperpolarized xenon-129 gas as an inhaled contrast agent
Study Locations (1 sites)
Duke University Medical Center, Durham, North Carolina 27713 United States
Eligibility Criteria
Inclusion Criteria: * Adequate completion of informed consent process with written documentation * Patients 18 - 65 years old * Physician diagnosis of asthma for \> 1 year * Able to perform reproducible spirometry according to ATS criteria based on clinical PFTs within previous 30 days of enrollment * All racial/ethnic backgrounds may participate * Blood eosinophil count \> 300 cells/μL * Smoking history \<10 pack years * No smoking history (including vapes, cigar, or marijuana use) in the last 3 months * About to initiate asthma therapy with either dupilumab, tezepelumab, or benralizumab as part of their standard of care Exclusion Criteria: * Respiratory tract infection within the 4 weeks prior to Visit 1 * Body mass index (BMI) \> 30 at Visit 1 * One-time doses such as intra-articular injections require a 4-week washout prior to Visit 1 * Asthma-related ER visit within the previous 4 weeks of Visit 1 or at any time while on the study * Significant concomitant medical illness, including (but not limited to) heart disease, cancer, uncontrolled diabetes, other chronic lung diseases (determined by the Investigator.) * Resting O2 saturation \<90% with maximum supplemental O2 delivered by nasal cannula * Positive urine pregnancy test at Visit 1 or at any time while on the study * Participation in an intervention study (including bronchoscopy) or use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study * Unable or unlikely to complete study assessments in the opinion of the Investigator * Study intervention poses undue risk to patient in the opinion of the Investigator * Conditions that will prohibit MRI scanning determined by the MRI safety screening.
The Role of Biomarkers in the Occurrence and Development of Asthma
NCT05768399
Recruiting
Conditions Asthma in Children
Phase Not Applicable
Enrollment 2
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

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.

Design

Study type: Observational Observational model: Case Control Time perspective: Prospective

Interventions / Regimen

  • Diagnostic Test: The level of biomarkers in Peripheral blood — All participants will be extracted 5ml peripheral blood into the anticoagulant tube by nurses and the peripheral blood will be detected for biomarkers of asthma. Children with asthma will take pulmonary function, blood test and specific IgE test etc. The lung function test will be performed by professional technicians and the results will be interpreted by specialists. The blood test and specific IgE test will be collected by specialist nurses and the results will be issued by professional inspectors. Children with asthma and their guardians will be asked for filling the questionnaire of Childhood Asthma Control Test (C-ACT). And then the doctor will check and calculate the scores after completion.

Primary Outcomes

  • The level of biomarkers (2years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2023-07-04
Completion: 2029-12-31
Eligibility
Age: 4 Years
Sex: ALL
Volunteers: true
Enrollment: 2 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Children's Hospital of Chongqing Medical University
Contact Information
Study Contact:
Ding Fengxia, PhD
86-15178712548
dingfengxia305@163.com
Li Yuehan, PhD student
86-15397618298
1214987864@qq.com
Interventions
  • Diagnostic Test: The level of biomarkers in Peripheral blood — All participants will be extracted 5ml peripheral blood into the anticoagulant tube by nurses and the peripheral blood will be detected for biomarkers of asthma. Children with asthma will take pulmonary function, blood test and specific IgE test etc. The lung function test will be performed by professional technicians and the results will be interpreted by specialists. The blood test and specific IgE test will be collected by specialist nurses and the results will be issued by professional inspectors. Children with asthma and their guardians will be asked for filling the questionnaire of Childhood Asthma Control Test (C-ACT). And then the doctor will check and calculate the scores after completion.
Study Locations (1 sites)
Shaoqing Zhang, Chongqing, Chongqing Municipality 400000 China
Eligibility Criteria
Inclusion Criteria: * In line with the diagnostic criteria in the Guidelines for the Diagnosis and Prevention of Bronchial Asthma in Children (2016 Edition) * Age: 4-12 years old for new diagnosis or recurrent episodes * Typical clinical manifestations and complete clinical data * Family members or guardians of children with informed research and signed consent * All healthy control subjects had no history of lung disease, allergic rhinitis or any other atopic disease Exclusion Criteria: * Suffering from other respiratory diseases (such as bronchiectasis, allergic rhinitis, respiratory failure, tuberculosis, obstructive airway disease) or other inflammatory diseases. * Abnormal development of congenital airway and lung tissue * History of immunosuppressant or glucocorticoid use in the first 4 weeks * Suffering from other endocrine system and immune system diseases * Incomplete clinical data or examinations.
A Multi-centered,Randomized,Double-blind,Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma
NCT06653322
Active, positions filled
Conditions Asthma With Eosinophilic Phenotype
Phase PHASE3
Enrollment 401
Locations 1 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Drug: HR-1703 — HR-1703 will be administered by SC injection.
  • Drug: Placebo — Matching Placebo will be administered by the SC injection.

Primary Outcomes

  • Annualised asthma exacerbation rate,about 48weeks (about 48weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Active, positions filled
Start Date: 2024-11-21
Completion: 2027-12
Eligibility
Age: 12 Years
Sex: ALL
Volunteers: false
Enrollment: 401 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: HR-1703 — HR-1703 will be administered by SC injection.
  • Drug: Placebo — Matching Placebo will be administered by the SC injection.
Study Locations (1 sites)
West China School of Medicine West China Hospital of Sichuan University, Chengdu, Sichuan 610041 China
Eligibility Criteria
Inclusion Criteria: 1. At least 12 years of age 2. A minimum weight of 40kg 3. A medical history of at least 1 year that meets the diagnosis of asthma; 4. Current treatment with medium- or high- doses of ICS for at least 6 months and using steadily at least 3 months 5. Current treatment with an additional controller medication, besides ICS, for at least 3 months and using steadily at least 1 month 6. Absolute count of blood eosinophils suggests eosinophilic asthma 7. During the screening period and baseline, pre- BD FEV1% \< 80% 8. During the screening period and baseline, ACQ-6 score indicates asthma poor control 9. History of severe asthma exacerbation within the past 12 months prior to screening 10. Good compliance with eDiary completion 11. Take efficient contraceptive measures 12. Voluntarily sign the informed consent form to participate in this study Exclusion Criteria: 1. With other condition that could lead to elevated eosinophils 2. With Clinically significant pulmonary diseases 3. With existing immunodeficiency disease 4. With other clinically significant diseases that may affect lung function 5. With uncontrolled severe cardiovascular and cerebrovascular diseases 6. With uncontrolled hypertension and/or diabetes 7. With exacerbation, allergic rhinitis or sinusitis attacks, or clinical significant infection requiring intervention during 4 weeks prior to randomization 8. Recent major surgeries or surgical plans during the study period, or treatment measures that investigators believe may affect subject evaluation 9. Existing parasitic infections 10. Diagnosed as malignant tumor within the first 5 years of randomization 11. Significant abnormalities in screening period or baseline laboratory tests 12. Screening period or baseline ECG QTc prolongation 13. Prohibited drugs using during the pre randomization period 14. Participated in other clinical trials within 30 days prior to screening and used research drugs containing active ingredients, or was still within 5 half lives of the research drug at the time of screening 15. Smoking or quitting smoking for less than 6 months during screening, or previous smoking history ≥ 10 pack years 16. History of drug use, alcoholism, or substance abuse within the past year prior to screening 17. Allergic or intolerant to IL-5 monoclonal antibodies or other biological agents 18. Pregnant or lactating subjects 19. Other reasons why the researcher deemed it unsuitable for conducting this experiment
Identification of Multiple Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath
NCT06528418
Recruiting
Conditions Lung Cancer, Lung Infection, COPD, Bronc...
Phase Not Applicable
Enrollment 10000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

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.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Other: Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system — Exhaled breath samples from these participants will be collected and analyzed to detect volatile organic compound molecules in human exhaled breath by GC-MS and μGC-PID

Primary Outcomes

  • The diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in the diagnosis of several common pulmonary diseases. (2 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-06-30
Completion: 2027-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 10000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: ChromX Health
Collaborators: The First Affiliated Hospital of Guangzhou Medical University, First People's Hospital of Foshan, Sichuan Cancer Hospital and Research Institute, Liwan District Central Hospital, Shanghai Chest Hospital, Peking Union Medical College Hospital, Guangzhou Development Zone Hospital, Huangpu District Hongshan Street Community Health Service Center, Huangpu District Chinese Medicine Hospital, Fifth Affiliated Hospital of Guangzhou Medical University, Huangpu District Jiufo Street Community Health Service Center, Huangpu District Xinlong Town Central Hospital, Huangpu District Yonghe Street Community Health Service Center, Huangpu District Lianhe Street Second Community Health Service Center
Principal Investigators:
  • Jianxing He, MD (STUDY_CHAIR) - The First Affiliated Hospital of Guangzhou Medical University
Contact Information
Study Contact:
Hengrui Liang, MD
+86 15625064712
hengrui_liang@163.com
Interventions
  • Other: Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system — Exhaled breath samples from these participants will be collected and analyzed to detect volatile organic compound molecules in human exhaled breath by GC-MS and μGC-PID
Study Locations (1 sites)
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510140 China
Eligibility Criteria
Inclusion Criteria: * Males or females, age must be 18 years old or above. * Patients must meet the CT imaging diagnostic criteria for different lung diseases, and patients must be able to provide electronic versions of CT image data. * Patients must have a clear clinical diagnosis. * All participants must sign a written informed consent form. Exclusion Criteria: * Pregnant women. * Individuals with a history of cancer other than lung disease. * Individuals who have undergone organ transplants or non-autologous (allogeneic) bone marrow or stem cell transplants. * Individuals with other severe organic diseases or mental illnesses. * Individuals with metabolic diseases such as diabetes, hyperlipidemia, etc. * Any other condition that researchers deem unsuitable for participation in this clinical trial.
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
NCT02327897
Recruiting
Conditions Asthma
Phase Not Applicable
Enrollment 400
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

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.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Primary Outcomes

  • The overall goal is to study the natural history of atopic asthma, focusing on moderate to severe asthma. The primary objective is to collect prospective data and samples for future use to better understand the interaction between environmental ... (End of Study)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2015-09-10
Completion: 2030-04-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 400 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: National Institute of Environmental Health Sciences (NIEHS)
Principal Investigators:
  • Stavros Garantziotis, M.D. (PRINCIPAL_INVESTIGATOR) - National Institute of Environmental Health Sciences (NIEHS)
Contact Information
Study Contact:
NIEHS Join A Study Recruitment Group
(855) 696-4347
myniehs@nih.gov
Stavros Garantziotis, M.D.
(984) 287-4412
garantziotis@mail.nih.gov
Interventions
N/A
Study Locations (1 sites)
NIEHS Clinical Research Unit (CRU), Research Triangle Park, North Carolina 27709 United States
Eligibility Criteria
* Inclusion Criteria Participants must meet all of the following criteria for enrollment: * Male or female, 18 to 60 years of age * Must have clinical evidence of moderate-severe atopic asthma: * self-reported symptoms suggestive of asthma (such as wheezing, chest tightness, shortness of breath, cough nocturnal symptoms) within the past year, and --\*a positive methacholine test confirming diagnosis \[provocative concentration causing a 20% fall in forced expiratory volume in 1 second (PC20 FEV1) \<16 mg/mL for participants on inhaled corticosteroids and \<8 mg/mL for participants not on inhaled corticosteroids\] or postbronchodilator FEV1 with at least 12% or 200 mL increase in FEV1 or forced volume vital capacity (FVC) on bronchodilator challenge, and --no other diagnosis that could explain symptoms. If there is documentation of a recent methacholine challenge, those results may be used in lieu of conducting a secondary methacholine challenge. * Permanently resides within 50 miles of the CRU. * Able to present a valid government issued form of identification for entry to the NIEHS campus * Able to receive asthma treatment medication(s) via mail * Willingness to comply with instructions regarding medication regimen, diet, and life style as directed by the investigator that are required per protocol * Access to a vacuum cleaner with a detachable hose component * If a woman is found to be pregnant or breastfeeding at the screening or baseline visit, they may continue their participation in the study but will be excluded from participation in the methacholine challenge and bronchoscopy procedures in this study while pregnant. Bronchoscopy Visit Inclusion Criterion In addition to the above inclusion criteria, participants must be able to fast for 6 hours (no food or drink, except a small amount of water if needed to take approved medications) prior to the bronchoscopy visit in order to be eligible for enrollment in the bronchoscopy visit. Exclusion Criteria Participants meeting any of the following criteria at screening will not be eligible for enrollment or to continue with study visits: * Current smoker, significant second-hand smoke exposure (defined by urine cotinine \>200 ng/mL at screening), or a history of smoking greater than 5 pack years. Smoking encompasses all inhaled products, including e-cigarettes. * piCO Smokealyzer value of \>11ppm * History of the following comorbidities: chronic obstructive pulmonary disease, cystic fibrosis (CF), emphysema, non-CF bronchiectasis, pulmonary fibrosis, sarcoidosis, unstable angina, pulmonary hypertension * Allergy or history of adverse reactions to methacholine * Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures * Comorbid diseases that affect global health or survival- such as DVT, pulmonary embolism, class III - IV congestive heart failure, or a malignancy under treatment Bronchoscopy Visit Exclusion Criteria In addition to the above exclusion criteria, participants meeting any of the following criteria will not be eligible for enrollment into the bronchoscopy visit: * Pregnancy, as indicated by urine pregnancy test, if of childbearing age and/or ability contraindication * Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with bronchoscopy * Bleeding disorders * Facial deformity, major facial surgery * Asthma exacerbation or respiratory infection less than or equal to 4 weeks prior to study visit * Severe persistent asthma, defined as by ATS-ERS criteria. * Allergy or history of adverse reactions to lidocaine * Temperature \>37.6 (Infinite)C; blood pressure \<90/50 mm Hg or \>160/100 mm Hg; pulse rate \<50 or \>100 beats/minute * Body weight \<50 kg (\<110 lbs) * The following abnormal lab values (values obtained during clinical assessment): * Platelet count \<100,000 per microliters * White blood cells count \<3000 per microliters * Absolute neutrophil count \<1000 per microliters * Hematocrit \<35% for both female and male * Prothrombin time (PT) / abnormal international normalized ratio (INR) and partial prothromboplastin time (PTT) based on reference laboratory established reference ranges * Serum creatinine \>1.4 mg/dL If a participant is recruited for the Bronchoscopy Visit but does not have current lab values (within 4 weeks), the participant may be asked to return to the CRU for an additional blood draw in order to run the requisite clinical assessments for safety purposes. The participant will be compensated for the additional visit. This is anticipated to be a rare occurrence, as the study team will make all efforts to schedule and complete the bronchoscopy procedure while the lab results are current. Participants with active bronchospasm on the day of the bronchoscopy will not undergo bronchoscopy.
The French E3N Prospective Cohort Study
NCT03285230
Active, positions filled
Conditions Breast Cancer, Colo-rectal Cancer, Parki...
Phase Not Applicable
Enrollment 100000
Locations 1 sites
Compensation reimbursement available
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

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.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Primary Outcomes

  • Anthropometric measurements (From 1990 until now)
  • Educational level (1990)
  • Professional activity (1992 and 2005)
  • Age at cessation of activity (From 2005 until now)
  • Menstrual factors (From 1990 to 2002)
  • Reproductive history (From 1990 to 1992)
  • Menopause (1990, 1995, 1997, 2000, 2002, 2005)
  • Hormonal Treatments (From 1992 to 2008)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 1990-06-15
Completion: 2046-12-31
Eligibility
Age: 40 Years
Sex: FEMALE
Volunteers: true
Enrollment: 100000 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Collaborators: Université Paris-Sud, Gustave Roussy, Cancer Campus, Grand Paris, Ligue contre le cancer, France
Principal Investigators:
  • Gianluca Severi, PhD (STUDY_DIRECTOR) - INSERM (Institut National de la Sante et de la Recherche Medicale)
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (1 sites)
, Villejuif, 94800 France
Eligibility Criteria
Inclusion Criteria: * only women * born between 1925 and 1950 * insured by the Mutuelle Générale de l'Education Nationale (MGEN) Exclusion Criteria: \- men
The Airports, Air Quality, and Asthma (AAA) Study
NCT07047430
Recruiting
Conditions Pediatric Asthma
Phase NA
Enrollment 60
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

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.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Supportive Care Masking/blinding: Double

Interventions / Regimen

  • Device: Portable air cleaner with HEPA filter — The Winix 9800 is a true HEPA air cleaner that has been AHAM (Association of Home Appliance Manufacturers) Verifide® for rooms that are 500 square feet in size. The air cleaner has a washable fine mesh pre-filter that captures large airborne particles, an activated carbon filter that reduces volatile organic compounds and odors, and a true HEPA filter that captures 99.99% of airborne allergens as small as 0.003 microns in size.
  • Device: Less effective portable air cleaner (no HEPA) — Winix 9800 air cleaner, with data logging energy use monitor is installed in the child's bedroom. In the sham group, the Winix 9800 true HEPA filter and activated carbon filter were removed. This was an internal modification and not visible to the user. The air cleaner still included a washable fine mesh pre-filter that captures large airborne particles.

Primary Outcomes

  • Symptom days over 7 days (Repeated measure, assessed on a weekly basis throughout the 3 month observation period.)
  • Change in Asthma Control Score (From the baseline visit until the end of study follow-up, 3 months later.)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-06-01
Completion: 2027-06-01
Eligibility
Age: 6 Years
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Washington
Principal Investigators:
  • Elena Austin, Sc.D. (PRINCIPAL_INVESTIGATOR) - University of Washington
Contact Information
Study Contact:
Christine Loftus, PhD, MPH
206-753-9079
cloftus@uw.edu
Interventions
  • Device: Portable air cleaner with HEPA filter — The Winix 9800 is a true HEPA air cleaner that has been AHAM (Association of Home Appliance Manufacturers) Verifide® for rooms that are 500 square feet in size. The air cleaner has a washable fine mesh pre-filter that captures large airborne particles, an activated carbon filter that reduces volatile organic compounds and odors, and a true HEPA filter that captures 99.99% of airborne allergens as small as 0.003 microns in size.
  • Device: Less effective portable air cleaner (no HEPA) — Winix 9800 air cleaner, with data logging energy use monitor is installed in the child's bedroom. In the sham group, the Winix 9800 true HEPA filter and activated carbon filter were removed. This was an internal modification and not visible to the user. The air cleaner still included a washable fine mesh pre-filter that captures large airborne particles.
Study Locations (1 sites)
University of Washington, Seattle, Washington 98195 United States
Eligibility Criteria
Inclusion Criteria: * Child is 6-12 years old with a health care provider-diagnosed asthma. * Caregiver is comfortable in participating in all study activities in English (communicating with study staff by phone and completing online surveys). * Caregiver is familiar with the child's daily asthma health. * Residence within 10 miles of Seattle-Tacoma International Airport as determined by zip code * Child resides in caregiver's home at least five nights a week on a regular basis and has no plans to move in the next three months. Exclusion Criteria: * Child has severe asthma at baseline. Severe asthma was defined in consultation with pediatric pulmonologists to be caregiver-reported asthma symptoms every day over the past 14 days and/or two or more inpatient hospitalizations for asthma in the past 12 months. * Households were excluded if there were multiple individuals within the same household with asthma eligible for the King County CHW Asthma Program or had severe asthma.
A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Asthma
NCT07436221
Not yet recruiting
Conditions Asthma
Phase PHASE2
Enrollment 160
Locations 2 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of participants with moderate to severe asthma.

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Double

Interventions / Regimen

  • Drug: AK139 — AK139 regimen 1- subcutaneous injection.
  • Drug: AK139 — AK139 regimen 2- subcutaneous injection.
  • Drug: AK139 — AK139 regimen 3- subcutaneous injection.
  • Drug: Placebo — subcutaneous injection.

Primary Outcomes

  • Absolute change from baseline in pre-bronchodilator FEV1 (Up to week 12)
  • Absolute change and percent change from baseline in FENO (Up to week 12)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Not yet recruiting
Start Date: 2026-02-28
Completion: 2027-02-26
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 160 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Akeso
Contact Information
Study Contact:
Guoqin Wang
+86 (0760) 8987 399
global.trials@akesobio.com
Interventions
  • Drug: AK139 — AK139 regimen 1- subcutaneous injection.
  • Drug: AK139 — AK139 regimen 2- subcutaneous injection.
  • Drug: AK139 — AK139 regimen 3- subcutaneous injection.
  • Drug: Placebo — subcutaneous injection.
Study Locations (2 sites)
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
Shanghai General Hospital, Shanghai, China
Eligibility Criteria
Inclusion Criteria: 1. Diagnosed with asthma at least one year; 2. Evidence of the reversibility of airflow limitation meets the requirements of the protocol; 3. Pre-bronchodilator forced expiratory volume (FEV1) meets the requirements of the protocol at screening and baseline; 4. Asthma Control Questionnaire 5-question version (ACQ-5) score≥1.5 at screening and baseline; 5. The participants agree to use highly effective contraception methods from the moment of signing of the ICF to 3 months after the last dose of the investigational product. Exclusion Criteria: 1. Concomitant respiratory diseases that, as determined by investigators, may affect the evaluation of therapeutic effects or safety of the investigational product; 2. A participant who experiences a severe asthma exacerbation at any time from 4 weeks prior to the screening up to and including the baseline; 3. Allergic to any component of the investigational product or intolerant to basis treatment; 4. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to; 5. Other reasons the investigators believe that the participants are not suitable to enrolled in this study.
Compare the Efficacy and Safety of QL2302 Versus Tezspire® in Severe Asthma
NCT07302516
Not yet recruiting
Conditions Asthma
Phase PHASE3
Enrollment 636
Locations 0 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to compare the efficacy and safety of QL2302 and Tezspire® in patients with uncontrolled severe asthma. The main questions it aims to answer are: * if the efficacy of QL2302 and Tezspire® are similar * if the safety of QL2302 and Tezspire® are similar Participants will be randomised to QL2302 or Tezspire® group and asked to receive one injection of QL2302 or Tezspire® subcutaneously every four weeks till Week 48, which means participants will receive a total of 13 injections. And be observed for another 12 weeks after the end of treatment.

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Biological: tezepelumab (Arm1&Arm2) — 210mg Q4W (Arm1\&Arm2)

Primary Outcomes

  • Primary endpoint : (52 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Not yet recruiting
Start Date: 2025-12-25
Completion: 2029-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 636 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Qilu Pharmaceutical Co., Ltd.
Contact Information
Study Contact:
Min Zhang, PhD
13482345145
13482345145@163.com
Interventions
  • Biological: tezepelumab (Arm1&Arm2) — 210mg Q4W (Arm1\&Arm2)
Eligibility Criteria
Inclusion Criteria: 1. 18-80 year of age 2. Body weight ≥40 kg 3. Diagnosed with asthma ≥12 months 4. Received a total daily dose of medium/high dose of ICS for more than 3 months steadily 5. At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months. 6. Morning pre-BD FEV1 \<80% but ≥35% predicted normal 7. Evidence of asthma as documented by reversibility test or change of PEF. 8. Documented history of at least 1 asthma exacerbation events within 12 months. 9. ACQ-5 score ≥1.5 at screening and on day of randomization Exclusion Criteria: 1. Pulmonary disease other than asthma. 2. History of cancer within 5 years except those cured. 3. History of a clinically significant infection within 4 weeks. 4. Current smokers or participants with smoking history ≥10 pack-yrs. 5. History of chronic alcohol or drug abuse within 12 months. 6. Positive Hepatitis B, C or HIV infection. 7. Pregnant or breastfeeding. 8. History of anaphylaxis following any biologic therapy. 9. Participant received tezepelumab or other TSLP antibody priorly. 10. Participant received bronchial thermoplasty within 12 months.
A Study Comparing a Pre-filled Safety Syringe and an Autoinjector for SHR-1703 Injection in Healthy Participants
NCT07701239
Not yet recruiting
Conditions Asthma With Eosinophilic Phenotype
Phase PHASE1
Enrollment 84
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This is a single-center, randomized, parallel-group, open-label clinical study designed to compare the bioavailability and safety of SHR-1703 Injection administered subcutaneously using a pre-filled safety syringe (PFS) or a pre-filled autoinjector (AI) in healthy participants. A total of 84 healthy participants are planned to be enrolled and randomized in a 1:1 ratio to either the PFS group or the AI group. Participants in the PFS group will receive a single subcutaneous injection of SHR-1703 Injection using a pre-filled safety syringe, while participants in the AI group will receive a single subcutaneous injection of SHR-1703 Injection using a pre-filled autoinjector.

Design

Study type: Interventional Phases: Phase1 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: SHR-1703 Injection — A single subcutaneous dose of SHR-1703 Injection administered via pre-filled safety syringe.
  • Drug: SHR-1703 Injection — A single subcutaneous dose of SHR-1703 Injection administered via autoinjector.

Primary Outcomes

  • peak concentration (Cmax) (Days 1-267)
  • area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t), (Days 1-267)
  • area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-∞) (Days 1-267)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Not yet recruiting
Start Date: 2026-07
Completion: 2027-04
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 84 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Contact Information
Study Contact:
Wenzheng Xiong
+86 13616029339
wenzheng.xiong.wx10@hengrui.com
Interventions
  • Drug: SHR-1703 Injection — A single subcutaneous dose of SHR-1703 Injection administered via pre-filled safety syringe.
  • Drug: SHR-1703 Injection — A single subcutaneous dose of SHR-1703 Injection administered via autoinjector.
Study Locations (1 sites)
The First Affiliated Hospital , Zhejiang University School of Medicine, Hangzhou, Zhejiang 310000 China
Eligibility Criteria
Inclusion Criteria: 1. Aged 18-55 years at ICF signing. 2. Screening BMI 19-26 kg/m², weight 50-80 kg. 3. Normal or NCS findings at screening/baseline: physical exam, lab tests (CBC, blood chemistry, UA, coagulation), ECG, abdominal ultrasound, chest X-ray. 4. Investigator-assessed absence of diseases that could significantly impact the study or pose additional health risks; stable health expected, no medical intervention needed. Clinically significant lab abnormalities may be retested within 1 week if justified; retest results determine eligibility. 5. Females of childbearing potential and males with female partners of childbearing potential must avoid sperm/egg donation, have no pregnancy plan, and use appropriate contraception from ICF signing through 14 months post-last dose (see Section 13.1.2). 6. No heavy smoking (\<5 cigarettes/day) or alcohol abuse (≤15 g/day \[e.g., 450 mL beer, 150 mL wine, or 50 mL low-alcohol liquor\], ≤2×/week) within 6 months pre-screening; no drug abuse history. Negative drug screen and alcohol breath test at baseline. Exclusion Criteria: 1. AST, ALT, or bilirubin \> ULN at screening/baseline. 2. eGFR \< 90 mL/min/1.73m² at screening/baseline. 3. Clinically significant abnormal blood pressure (SBP \>140 or \<90 mmHg; DBP \>90 or \<60 mmHg) at screening/baseline. 4. Positive for HBsAg, HBcAb with HBV-DNA \> ULN, HIV-Ab, syphilis serology, or HCV-Ab at screening. 5. Suspected or confirmed active tuberculosis (clinical symptoms or imaging evidence within 3 months). 6. QTcF \> 450 ms on repeated 12-lead ECG at screening/baseline. 7. Participation in another drug/device clinical trial within 3 months prior to screening (defined as signed ICF and received study drug/device, or still in follow-up or within 5 half-lives of prior investigational drug, whichever is longer). 8. Use of any prescription drugs, OTC drugs, or herbal medicines within 1 month prior to dosing (except routine vitamins ≤100% RDA or occasional paracetamol ≤2 g/day for ≤5 days/month), or less than 5 half-lives washout. 9. Major trauma or surgery within 6 months prior to screening, or planned surgery during the study. 10. Blood donation or significant blood loss (≥400 mL) within 1 month, or blood transfusion within 2 months prior to screening. 11. Receipt or planned receipt of live (attenuated) vaccine within 1 month prior to dosing or during the study. 12. Suspected or confirmed parasitic infection within 6 months prior to screening. 13. Pregnant or breastfeeding women, or positive pregnancy test (HCG). 14. Investigator or site personnel directly involved in the study. 15. Any other condition deemed by the investigator to preclude study participation or increase risk to the participant.
Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations
NCT07112456
Not yet recruiting
Conditions Asthma Acute, Asthma Attack, Asthma Exac...
Phase PHASE2
Enrollment 100
Locations 0 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to learn if nebulized ketamine helps treat moderate to severe asthma attacks in adults in the emergency department. It will also learn about the safety of ketamine when inhaled through a nebulizer. The main questions it aims to answer are: * Does nebulized ketamine improve breathing more than standard treatment alone? * What side effects, if any, do participants experience after receiving nebulized ketamine? Researchers will compare nebulized ketamine to a placebo (a saltwater mist with no medication) to see how well it works and how safe it is. Participants will: * Receive either nebulized ketamine or a placebo mist, along with standard asthma treatment * Have their breathing checked before and after treatment using a peak flow meter * Be monitored for 60 minutes and have their symptoms, vital signs, and any side effects recorded

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Drug: Nebulized ketamine (0.5 mg/kg in normal saline to a total volume of 5ml) plus standard asthma excaerbationcare — \*\*Intervention Description:\*\* Nebulized ketamine is administered as a single dose of 0.5 mg/kg of ketamine hydrochloride diluted in 0.9% normal saline to a total volume of 5ml. The solution is delivered via a standard jet nebulizer over approximately 15-20minutes. This intervention is given once at the time of enrollment in the emergency department, in addition to standard asthma care. The ketamine used is in injectable solution form (typically 50 mg/mL concentration), drawn and diluted immediately prior to nebulization. Participants are monitored continuously for 60 minutes after administration to assess changes in peak expiratory flow rate (PEFR), symptom relief, and adverse events. The goal is to evaluate the bronchodilatory effect and safety of nebulized ketamine in adults with moderate to severe asthma exacerbation who present to the emergency department.
  • Drug: Placebo nebulization (5 mL normal saline) plus standard asthma care — \*\*Intervention Description (Control Group):\*\* Participants in the control group will receive a single nebulized dose of 5 mL of 0.9% normal saline, delivered using a standard jet nebulizer over approximately 10-15 minutes. This placebo intervention is administered once at the time of enrollment in the emergency department, after standard asthma care. Standard care includes repeated doses of nebulized salbutamol and ipratropium, systemic corticosteroids (oral or intravenous), and supplemental oxygen as needed. The placebo solution is identical in appearance and volume to the active ketamine solution used in the intervention group to maintain blinding. All participants will be monitored for 60 minutes after nebulization to assess changes in peak expiratory flow rate (PEFR), symptom relief using a visual analog scale (VAS), and the occurrence of any adverse events.

Primary Outcomes

  • Change in Peak Expiratory Flow Rate (PEFR) from baseline to 60 minutes post-intervention (Baseline (0 minutes) and 60 minutes post-intervention)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Not yet recruiting
Start Date: 2026-09-01
Completion: 2029-08-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Oman Medical Speciality Board
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Nebulized ketamine (0.5 mg/kg in normal saline to a total volume of 5ml) plus standard asthma excaerbationcare — \*\*Intervention Description:\*\* Nebulized ketamine is administered as a single dose of 0.5 mg/kg of ketamine hydrochloride diluted in 0.9% normal saline to a total volume of 5ml. The solution is delivered via a standard jet nebulizer over approximately 15-20minutes. This intervention is given once at the time of enrollment in the emergency department, in addition to standard asthma care. The ketamine used is in injectable solution form (typically 50 mg/mL concentration), drawn and diluted immediately prior to nebulization. Participants are monitored continuously for 60 minutes after administration to assess changes in peak expiratory flow rate (PEFR), symptom relief, and adverse events. The goal is to evaluate the bronchodilatory effect and safety of nebulized ketamine in adults with moderate to severe asthma exacerbation who present to the emergency department.
  • Drug: Placebo nebulization (5 mL normal saline) plus standard asthma care — \*\*Intervention Description (Control Group):\*\* Participants in the control group will receive a single nebulized dose of 5 mL of 0.9% normal saline, delivered using a standard jet nebulizer over approximately 10-15 minutes. This placebo intervention is administered once at the time of enrollment in the emergency department, after standard asthma care. Standard care includes repeated doses of nebulized salbutamol and ipratropium, systemic corticosteroids (oral or intravenous), and supplemental oxygen as needed. The placebo solution is identical in appearance and volume to the active ketamine solution used in the intervention group to maintain blinding. All participants will be monitored for 60 minutes after nebulization to assess changes in peak expiratory flow rate (PEFR), symptom relief using a visual analog scale (VAS), and the occurrence of any adverse events.
Eligibility Criteria
Inclusion Criteria: 1. Adults aged 18 years or older presenting to the Emergency Department with a clinical diagnosis of moderate to severe asthma exacerbation based on SIGN (Scottish Intercollegiate Guidelines Network) criteria. 2. PEFR between 33% and 75% of predicted value or personal best, as measured using a peak flow meter. 3. Stable vital signs as deemed by the treating physician 4. Alert and oriented, able to understand the study purpose and provide informed consent. 5. Not requiring immediate advanced airway intervention, including intubation or emergency non-invasive ventilation. Exclusion Criteria: 1. Known hypersensitivity or allergy to ketamine or any component of the nebulized solution. 2. History of psychosis, schizophrenia, or other severe uncontrolled psychiatric disorders. 3. Uncontrolled hypertension, defined as systolic BP \> 180 mmHg or diastolic BP \> 110 mmHg on two consecutive readings at least 5 minutes apart, despite initial ED management. 4. Hemodynamic instability, including persistent hypotension (SBP \< 90 mmHg) or tachyarrhythmias requiring urgent treatment. 5. Significant chronic lung disease, including: * COPD with frequent exacerbations or baseline FEV₁ \< 50% predicted * Interstitial lung disease (ILD) * Clinically significant bronchiectasis with baseline productive cough or infection 6. Pregnancy or currently breastfeeding. 7. Home BiPAP use or requirement for non-invasive ventilation (e.g., BiPAP/CPAP) during the ED visit (Note: isolated home CPAP for sleep apnea without daytime symptoms is acceptable). 8. Current intubation or imminent need for mechanical ventilation based on clinical judgment. 9. Severe cardiac disease, including decompensated heart failure, recent myocardial infarction (\<6 weeks), or known severe valvular disease. 10. Any other medical, surgical, or psychiatric condition that in the opinion of the investigator would place the patient at undue risk from study participation or interfere with the interpretation of study results.
Transplacental Transmission of RSV (TTRSV)
NCT05443607
Active, positions filled
Conditions SARS CoV 2 Infection, Respiratory Syncyt...
Phase Not Applicable
Enrollment 300
Locations 2 sites
Compensation Compensation varies
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Aim 1: To study transplacental transmission of Respiratory Syncytial Virus (RSV) and how this is moderated by other maternal infections during pregnancy Aim 2: To test maternal blood for presence of RSV-specific immunoglobulins and how this is moderated by other maternal infections during pregnancy Aim 3: To test cord blood (fetal blood) for presence of RSV-specific immunoglobulins and other common viral pathogens Aim 4: To perform further tests (Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), Droplet Digital Polymerase Chain Reaction (ddPCR) and immunoprobing) to confirm the presence of RSV and other common viral pathogens Aim 5: To follow these newborn infants up to 4 years of age to look for redisposition to respiratory diseases and growth parameters

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Primary Outcomes

  • Postnatal respiratory morbidity (5 Years)
  • Passage of antiviral antibodies from mother to newborn (5 Years)
  • Vertical transmission of RSV and/or SARS-COV2 from infected mother to the offspring (5 Years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2020-05-25
Completion: 2028-08
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 300 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Tulane University
Collaborators: National Institutes of Health (NIH)
Principal Investigators:
  • Giovanni Piedimonte, MD, FAAP, FCCP (PRINCIPAL_INVESTIGATOR) - Tulane University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (2 sites)
Tulane University Lakeside Hospital, Metairie, Louisiana 70001 United States
Ochsner Baptist Hospital, New Orleans, Louisiana 70115 United States
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 years or older; 2. Reported 2 or more signs and symptoms of respiratory infection during pregnancy, including but not limited to: fever, nasal congestion/discharge, cough, and sore throat and/or a positive SARS-CoV-2 test 3. Deliveries at full term or near term (minimum 34 weeks gestation) in Labor and Delivery (L\&D) facilities at Tulane Lakeside Hospital and Clinic or Ochsner Baptist Medical Center who were pregnant during RSV season. 4. History negative for Human Immunodeficiency Virus (HIV) 5. No use of immunosuppressive medications/therapies. 6. Singleton gestation; 7. Willing to allow for follow up of the child via their medical record from the time of delivery to 4 years of age. 8. Clearly understands the study procedures and visit schedule, alternative treatments, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent. 9. English or Spanish proficiency Exclusion Criteria: 1. Under 18 years of age at the time of consent. 2. Gestational age less than 12.0 weeks at the time of consent. 3. Does not report at least 2 of the following signs and symptoms of respiratory infection during pregnancy, including but not limited to: fever, nasal congestion/discharge, cough, and sore throat. 4. Positive medical history for HIV. 5. Current use of immunosuppressive therapies/drugs. 6. Newborn has been diagnosed with congenital abnormality or chronic disease at birth. 7. Unwilling or unable to provide written informed consent. 8. Mother was not pregnant during the RSV season or no positive SARS-CoV-2 test during pregnancy. 9. Subject is unwilling to allow for follow up of the child via medical records from the time of delivery to 4 years of age; 10. Multiple birth; 11. Lacks English or Spanish proficiency Infants will be excluded from the study in the event of a Serious Adverse Event such as fetal or acute neonatal death (in the delivery room) if the mother does not provide clinical consent for an autopsy.
Eosinophil Subpopulations in Eosinophilic-associated Diseases
NCT06911775
Not yet recruiting
Conditions Eosinophilic Asthma, Eosinophilic Granul...
Phase Not Applicable
Enrollment 160
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This single-center, non-commercial study will involve 160 participants (80 with eosinophilic asthma (EA), 30 with eosinophilic granulomatosis with polyangiitis (EGPA), 25 with hypereosinophilic syndrome (HES), and 25 healthy donors) to investigate eosinophil subpopulations in these diseases. The study will run from Q4 2024 to Q4 2026. Objectives: Primary: To verify two eosinophil subpopulations (iEos and rEos) in EGPA and HES and analyze the role of type 2 cytokines on their plasticity. Secondary: Compare iEos proportion between different eosinophilic diseases and correlate with disease severity. Exploratory: Assess the effect of mepolizumab on eosinophil subpopulations in vitro. Population: Adults aged 18-75 with EA, EGPA, or HES, and healthy controls. EA patients must have \>300 eosinophils/mcL, EGPA requires asthma + eosinophilia + other specific features, and HES requires high eosinophil counts (\>1500 cells/mL). Methods: Data will be analyzed using Mann-Whitney U, ANOVA, and Spearman correlation tests, with results presented as mean ± SEM. This study will help explore eosinophil behavior in eosinophilic diseases and evaluate mepolizumab's effects on these cells.

Design

Study type: Observational Observational model: Case Control Time perspective: Prospective

Primary Outcomes

  • Primary objective: first outcome measure (From the enrollment of the first patient at 20 months)
  • Primary objective: second outcome measure (From the enrollment of the first patient at 20 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2025-04
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 160 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Florence
Collaborators: GlaxoSmithKline
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Eligibility Criteria
Inclusion Criteria: \- For inclusion in the study subjects should fulfill the following criteria based on local regulations: Patients with Asthma, or EGPA or HES: 1. Age between 18 and 75 years at the time of signing the informed consent 2. Patients with EA, EGPA or HES 3. Provision of signed and dated written informed consent form prior to any mandatory study procedures, sampling and analysis. Healthy donors: 1\. Age between18 and 75 years healthy donors Exclusion Criteria: * Subjects should not enter the study if any of the following exclusion criteria are fulfilled: 1. Presence of other chronic pulmonary diseases including COPD 2. Presence of other chronic immuno-mediated inflammatory diseases 3. Treatment with oral prednisone or equivalent \&gt; 7.5 mg/day 4. Treatment with long-acting depot corticosteroids in the last three months 5. Use of immunosuppressive medications (cyclosporine A; azathioprine; methotrexate; mycophenolate mofetil) 6. Receipt of live attenuated vaccines 30 days prior to the enrollment 7. Acute upper or lower respiratory infections within 30 days prior to the date informed consent is obtained or during the screening/run-in period. 8. A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy 9. Subjects who are pregnant or breastfeeding 10. Current smoking 11. Any clinically significant abnormal findings in physical examination, vital signs, hematology, or clinical chemistry during screening period, which in the opinion of the investigator may put the patient at risk of his/her participation in the study, or may influence the results of the study, or the patient\&#39;s ability to complete entire duration of the study. 12. Concurrent enrolment in another interventional or post-authorization safety study.
Mind-Body Interventions in Coronary Artery Disease
NCT07633132
Recruiting
Conditions Coronary Artery Disease (CAD)
Phase NA
Enrollment 40
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This randomized controlled study aims to evaluate the effects of a combined mind-body intervention consisting of progressive muscle relaxation and guided imagery on psychological outcomes in patients with stable coronary artery disease. A total of 40 participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive eight individualized sessions over four weeks in addition to standard medical care, while the control group will continue with standard care only. Primary and secondary outcomes will be assessed using validated self-report instruments, including the Perceived Stress Scale (PSS), Hospital Anxiety and Depression Scale (HADS), and COPE Inventory, administered at baseline and after the intervention period. The main objective of the study is to determine whether structured mind-body techniques can reduce perceived stress, anxiety, and depressive symptoms and improve coping strategies in patients with coronary artery disease.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Behavioral: Progressive Muscle Relaxation and Guided Imagery — A structured mind-body intervention consisting of progressive muscle relaxation and guided imagery techniques delivered in eight individualized sessions over four weeks.

Primary Outcomes

  • Change in Perceived Stress Scale (PSS) Score (Baseline and 4 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-06-09
Completion: 2026-09
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: şeyda candeniz
Principal Investigators:
  • Şeyda Candeniz, PhD (STUDY_DIRECTOR) - Ankara University
Contact Information
Study Contact:
Seyda Candeniz, PhD
+905367923404
seydacuma15@gmail.com
Gamze Ekici, PhD
+905323246924
fztgamze@yahoo.com
Interventions
  • Behavioral: Progressive Muscle Relaxation and Guided Imagery — A structured mind-body intervention consisting of progressive muscle relaxation and guided imagery techniques delivered in eight individualized sessions over four weeks.
Study Locations (1 sites)
Ufuk University Faculty of Medicine, Department of Cardiology, Ankara, 06000 Turkey (Türkiye)
Eligibility Criteria
Inclusion Criteria: * Diagnosed with stable coronary artery disease * Aged between 18 and 65 years * Able to read and understand Turkish * Able to complete study questionnaires and assessments * Willing to provide written informed consent Exclusion Criteria: * History of acute coronary syndrome within the last 3 months * Presence of a diagnosed severe psychiatric disorder * Cognitive impairment or communication difficulties that may interfere with study participation * Previous regular participation in mind-body interventions such as progressive muscle relaxation, guided imagery, meditation, or similar programs
Fluoxetine and Understanding Social Experiences
NCT07456501
Not yet recruiting
Conditions Depression in Adolescence, Antidepressan...
Phase NA
Enrollment 80
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Adolescence is a critical developmental period marked by significant social, cognitive, and emotional changes. Unfortunately, it is also a time when the risk of depression and anxiety rises dramatically. Early, effective treatment is essential to mitigate long-term impacts on relationships, education, and life satisfaction. While psychological therapies are recommended as first-line treatment for mild to moderate depression in young people, antidepressant use (particularly SSRIs such as Prozac) has risen sharply, especially among girls aged 15-17. Despite their widespread use, there is limited research on how SSRIs address adolescent depression, leaving clinicians with little evidence to guide treatment decisions. The Fluoxetine and Understanding Social Experiences (FUSE) study aims to shed light on how Prozac (medically known as fluoxetine) influences decision-making in healthy young people in four key areas that are known to be affected by depression: emotional processing (e.g., facial expression recognition), social function (e.g., sensitivity to peer rejection), reward processing (e.g., how people learn from rewards and punishments), and motivation (e.g., how people make decisions about whether a certain outcome or reward is worth the effort to obtain). Some of the tests employed in the study use facial expression and heart-rate recording as aditional measures. We are aiming to recruit and test 80 young people between the ages of 18 and 24. When included in the study, participants are randomly assigned to receive either a weeklong treatment with fluoxetine, or a placebo (a pill with no active ingredients). The study follows a double-blind design, which means that neither the researchers nor the participants are aware of the treatment received so as to not influence the results. We belive that fluoxetine will have beneficial effects on social decision-making in young people, which might manifest as increased accuracy labelling positive facial expressions, less sensitivity to negative feedback, lower self-reported negative mood in response to social exclusion and reduced heart rate/negative facial expressivity in response to unpleasant social experiences. The FUSE study aims to deepen our understanding of how antidepressants affect decision-making in young people, at a time when antidepressant prescriptions have risen but research is scarce. By identifying the exact domains of functioning which are affected by antidepressant use in this age group, this research will help inform which young people are likely to benefit most from drug treatment. The project results will be published in peer-reviewed journals and presented at academic conferences. We are also working with a group of young advisors who will help us decide how to best share our results with others in their age group. A brief summary of the study findings will also be provided to participants who would like to receive it. All research data, excluding information that could…

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Basic Science Masking/blinding: Triple

Interventions / Regimen

  • Drug: Fluoxetine — Participants will be taking a 20mg fluoxetine capsule daily for 7 days.
  • Drug: Placebo — Participants will be taking a placebo capsule daily for 7 days.

Primary Outcomes

  • Behavioural measure: Facial Expression Recognition Task (FERT) (On the last day of the 7-day treatment)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-03
Completion: 2027-07-22
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 80 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Oxford
Collaborators: Wellcome Trust, National Institute for Health Research, United Kingdom
Contact Information
Study Contact:
Catherine Harmer
+44 1865 618326
catherine.harmer@psych.ox.ac.uk
Andreea Raslescu
+44 1865 618245
andreea.raslescu@psych.ox.ac.uk
Interventions
  • Drug: Fluoxetine — Participants will be taking a 20mg fluoxetine capsule daily for 7 days.
  • Drug: Placebo — Participants will be taking a placebo capsule daily for 7 days.
Study Locations (1 sites)
University of Oxford Department of Psychiatry, Oxford, OX3 7JX United Kingdom
Eligibility Criteria
Inclusion Criteria: * Be aged 18-24 years (inclusive) * Be resident in the UK for the duration of the study * Have normal or corrected to normal vision * Participant is willing and able to give informed consent for participation in the research * Sufficiently fluent English to understand and complete the study Exclusion Criteria: Psychiatric History: * Current or past diagnosis of any psychiatric disorder, as determined by the SCID-5 and self-report. This includes, but is not limited to, depression, anxiety disorders, alcohol or drug dependency, personality disorders, suicidal ideation, and other psychiatric conditions; * First degree relative with a diagnosis of mania. Lifestyle: * Heavy smoker or vaper (\> 10 cigarettes per day, or \>2 mL e-liquid, or \>15mg/day from a nicotine patch); * Heavy use of caffeine (drink \> 4 of 250ml cups/cans of coffee or energy drinks per day); * Heavy alcohol drinker (drink \>14 standard alcoholic drinks per week); * Current or recent use (in the last 3 months) of any psychoactive substance according to self-report and a urine drug test screening for recent use of 10 common recreational substances. * Unable or unwilling to consume gelatine (study capsules will be gelatine-based). Physical Health: * Severely underweight or overweight in a manner that renders them unsuitable for the study in the opinion of the study medical advisor; * Known contraindication to fluoxetine, such as hypersensitivity to fluoxetine or any component in its formulation; * Pregnancy, as determined by a urine pregnancy test or plans to become pregnant within the next 3 months; * Breastfeeding. Medical History: * Past or ongoing health issue which, in the opinion of the study medical advisor, may interfere with the safety of the participant or the scientific integrity of the study. This can include but is not limited to: seizures or epilepsy, abnormal heart rhythm, renal disease, hepatic disease, glaucoma, diabetes, bleeding disorders or clotting conditions (e.g., haemophilia, thrombocytopenia); * Diagnosis of a significant neurological condition (e.g., epilepsy, multiple sclerosis, traumatic brain injury); * Current or recent use of medication that might interfere or interact with the effects of fluoxetine, in the opinion of the study medical advisor. This can include but is not limited to: monoamine oxidase inhibitors (MAOIs), medications affecting serotonin levels (e.g., tramadol, triptans, St. John's Wort), anticoagulants or blood thinners (e.g., warfarin), anti-inflammatory medications (e.g., aspirin, ibuprofen), or medications known to affect heart rhythm. Prior Study Participation: * Participation in any other psychological or medical experiment involving taking any kind of drug/medication/vaccine, within the last 3 months; * Participation in any other study involving the current or similar tasks, within the last 6 months. Other considerations: •Any other significant finding which may arise during the screening process and which, in the opinion of the Principal Investigator/medical advisor, may influence the scientific integrity of the study, or the participant's safety or ability to participate in the study.
Maternal Stress on Human Milk and Infant Outcomes
NCT04821544
Recruiting
Conditions Postpartum Depression, Preterm Labor
Phase NA
Enrollment 500
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The overarching purpose of this study is to determine if a modified 8-week mindfulness-based intervention (with a focus on self-compassion; MBSC) or 8 weeks of 2000 IU vitamin D supplementation will reduce stress and increase self-compassion in mothers of preterm infants and beneficially modify the human milk produced, and subsequently improve infant health.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Prevention Masking/blinding: Quadruple

Interventions / Regimen

  • Behavioral: Mindfulness-based intervention (with a focus on self-compassion; MBSC) — 8-week MBSC intervention with a focus on increasing self-compassion
  • Dietary Supplement: Vitamin D — Vitamin D at 2,000 IU/day for 8 weeks.

Primary Outcomes

  • Maternal Stress - Biomarker Change (Baseline to 4 and 8 weeks)
  • Maternal Stress - Psychometric Measure Change (Baseline to 4 and 8 weeks)
  • Maternal Self-compassion - Biomarker Change (Baseline to 4 and 8 weeks)
  • Maternal Self-compassion - Psychometric Measure Change (Baseline to 4 and 8 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2021-05-01
Completion: 2027-06-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Idaho
Collaborators: Oregon State University, National Institute of General Medical Sciences (NIGMS), Kootenai Health
Principal Investigators:
  • Yimin Chen, PhD (PRINCIPAL_INVESTIGATOR) - University of Idaho
Contact Information
Study Contact:
Yimin Chen, PhD
2088857264
yiminc@uidaho.edu
Interventions
  • Behavioral: Mindfulness-based intervention (with a focus on self-compassion; MBSC) — 8-week MBSC intervention with a focus on increasing self-compassion
  • Dietary Supplement: Vitamin D — Vitamin D at 2,000 IU/day for 8 weeks.
Study Locations (1 sites)
Kootenai Health, Coeur d'Alene, Idaho 83814 United States
Eligibility Criteria
Inclusion Criteria: * Mothers of newborn infants at Kootenai Health NICU and the Palouse region Exclusion Criteria: \-
Evaluation of the Naturalistic User Experience of the Website "ich Bin Alles"
NCT06668701
Recruiting
Conditions Depressive Disorder, Depression, Depress...
Phase Not Applicable
Enrollment 300
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Using a multi-method approach, the aim of this study is to investigate the naturalistic user experience and acceptance of the German website "ich bin alles". This website offers evidence-based information about the symptoms, causes, course, treatment, and prevention of youth depression. Another aim of this study is to determine whether the desired target groups of the website can be reached.

Design

Study type: Observational Observational model: Other Time perspective: Cross Sectional

Interventions / Regimen

  • Device: "ich bin alles" — The web-based information platform "ich bin alles" (www-ich-bin-alles.de) on depression and mental health in childhood and adolescence was developed by the Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy of the LMU Munich Hospital together with the Prof. Otto Beisheim Foundation. It is aimed at children and adolescents with depression, healthy children and adolescents and parents. The project focuses on education, prevention, support and destigmatisation through the transfer of evidence-based knowledge.

Primary Outcomes

  • The characteristics of the people who are interested in "ich bin alles" (i.e. the users) - Assessed via self-designed questionnaire (post (40 seconds after Website-use))
  • Perception of the users of website content - Assessed via WEB-CLIC-S (post (40 seconds after Website-use))
  • Perceived Website Usability - Assessed via Perceived Website Usability - German (post (40 seconds after Website-use))
  • Visual Aesthetics of Website - Assessed via Visual Aesthetics of Website Inventory - Short (post (40 seconds after Website-use))
  • Overall impression - assessed via a single item (school grade) (post (40 seconds after Website-use))
  • Intentions to act - Assessed via Scale assessing the intention to revisit the website (post (40 seconds after Website-use))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-06-20
Completion: 2025-06
Eligibility
Age: No restriction
Sex: ALL
Volunteers: true
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Ludwig-Maximilians - University of Munich
Collaborators: Prof. Otto Beisheim Foundation
Principal Investigators:
  • Gerd Schulte-Körne, Prof. Dr. (STUDY_DIRECTOR) - Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, LMU University Hospital
Contact Information
Study Contact:
Ellen Greimel, Prof. Dr.
+4989 4400 56952
Ellen.Greimel@med.uni-muenchen.de
Sara Kaubisch
+49 89 4400 56919
sara.kaubisch@med.uni-muenchen.de
Interventions
  • Device: "ich bin alles" — The web-based information platform "ich bin alles" (www-ich-bin-alles.de) on depression and mental health in childhood and adolescence was developed by the Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy of the LMU Munich Hospital together with the Prof. Otto Beisheim Foundation. It is aimed at children and adolescents with depression, healthy children and adolescents and parents. The project focuses on education, prevention, support and destigmatisation through the transfer of evidence-based knowledge.
Study Locations (1 sites)
LMU University Hospital, Munich, Bavaria 80336 Germany
Eligibility Criteria
Inclusion Criteria: * 40 seconds website-use Exclusion Criteria: * no exclusion criteria
tDCS in People With Subthreshold Depression
NCT06517121
Recruiting
Conditions Subthreshold Depression
Phase NA
Enrollment 204
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-10
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study evaluates the effects of multi-session transcranial direct current stimulation on loneliness, mood and depressiveness in people with subthreshold depression.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Double

Interventions / Regimen

  • Device: Personalized Experimental Transcranial Direct Current Stimulation (tDCS) — This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants will receive 20 minutes of active stimulation with a 2mA intensity over personalized brain regions based on the particular neural correlates of socio-affective processing.
  • Device: Sham Transcranial Direct Current Stimulation (tDCS) — This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants assigned to the sham control group will only receive 30 seconds of active stimulation.
  • Device: Conventional Experimental Transcranial Direct Current Stimulation (tDCS) — This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants will receive 20 minutes of active stimulation with a 2mA intensity with anode placed over F3.

Primary Outcomes

  • Changes in self-reported loneliness (From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-01-16
Completion: 2027-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 204 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Education University of Hong Kong
Collaborators: The University of Hong Kong, Chinese University of Hong Kong, Hong Kong Baptist University
Principal Investigators:
  • Nichol ML Wong, PhD (PRINCIPAL_INVESTIGATOR) - Education University of Hong Kong
Contact Information
Study Contact:
Nichol ML Wong, PhD
852-29487431
nmlwong@eduhk.hk
Interventions
  • Device: Personalized Experimental Transcranial Direct Current Stimulation (tDCS) — This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants will receive 20 minutes of active stimulation with a 2mA intensity over personalized brain regions based on the particular neural correlates of socio-affective processing.
  • Device: Sham Transcranial Direct Current Stimulation (tDCS) — This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants assigned to the sham control group will only receive 30 seconds of active stimulation.
  • Device: Conventional Experimental Transcranial Direct Current Stimulation (tDCS) — This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants will receive 20 minutes of active stimulation with a 2mA intensity with anode placed over F3.
Study Locations (1 sites)
The Education University of Hong Kong, Hong Kong, Hong Kong
Eligibility Criteria
Inclusion Criteria: * No histories of learning impairment, major psychiatric disorders including Major Depressive Disorder or neurological disorders * At least primary school education * Subthreshold depression Exclusion Criteria: * On medication or treatments within 2 weeks prior to the beginning of the study that would affect the individual's brain, cognitive and affective functions