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Showing 20 of 25890 trials
Multimodal Tongue-Pulse Information Fusion for Syndrome Diagnosis and Cohort Study in Children With Asthma
NCT07383883
Recruiting
Conditions Asthma
Phase Not Applicable
Enrollment 1000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
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Study Details Design, interventions, and primary outcomes

About This Study

Asthma is one of the most prevalent chronic respiratory diseases in children, and accurate phenotyping and disease monitoring remain challenging in routine clinical practice. This observational cohort study aims to investigate the clinical value of multimodal tongue and pulse information in the syndrome diagnosis and phenotypic characterization of pediatric asthma. Children aged 5-18 years with a confirmed diagnosis of asthma will be enrolled at Shanghai Children's Medical Center and followed in routine outpatient care. Standardized tongue images and pulse wave data will be collected using validated acquisition devices during visits when lung function testing is performed. Quantitative features extracted from tongue and pulse data will be integrated with clinical information, including asthma stage, lung function parameters, eosinophil counts, allergic sensitization status, and Asthma Control Questionnaire-5 (ACQ-5) scores. The primary objective is to evaluate the associations between tongue-pulse multimodal features and asthma clinical stages and pulmonary function. Secondary objectives include exploring their relationships with airway inflammation and asthma control status. This study seeks to establish a non-invasive, objective, and quantifiable approach to asthma phenotyping, providing evidence for integrating traditional diagnostic features with modern clinical data to support precision management of pediatric asthma.

Design

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

Interventions / Regimen

  • Other: No intervention (observational study) — No intervention (observational study)

Primary Outcomes

  • Association Between Tongue-Pulse Multimodal Features and Pulmonary Function in Pediatric Asthma (During routine outpatient visits at baseline and follow-up when pulmonary function testing is performed (up to 12 months))
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: 2026-02-01
Completion: 2028-01-31
Eligibility
Age: 5 Years
Sex: ALL
Volunteers: false
Enrollment: 1000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Shanghai Children's Medical Center
Principal Investigators:
  • Yong Yin (PRINCIPAL_INVESTIGATOR) - Shanghai Children's Medical Center
Contact Information
Study Contact:
Yong Yin
86-021-38626161
yinyong9999@163.com
Interventions
  • Other: No intervention (observational study) — No intervention (observational study)
Study Locations (1 sites)
Shanghai Children's Medical Center, Shanghai, 200127 China
Eligibility Criteria
Inclusion Criteria: * Children aged 5 to 18 years. * Clinically diagnosed asthma according to established pediatric asthma guidelines. * Receiving routine outpatient follow-up at Shanghai Children's Medical Center. * Able to cooperate with tongue image acquisition and pulse wave data collection. * Able to perform pulmonary function testing when clinically indicated. * Written informed consent obtained from parents or legal guardians, with assent from the child when appropriate. Exclusion Criteria: * Presence of other chronic respiratory diseases (e.g., cystic fibrosis, bronchiectasis, primary ciliary dyskinesia). * Congenital cardiopulmonary malformations or significant cardiovascular disease. * Acute respiratory infection or fever at the time of data collection. * Severe systemic diseases or immunodeficiency that may affect study participation. * Inability to comply with study procedures or incomplete clinical data.
A Study of CDX-622 in Participants With Mild to Moderate Asthma
NCT07330778
Recruiting
Conditions Mild to Moderate Asthma
Phase PHASE1
Enrollment 12
Locations 4 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-14
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Study Details Design, interventions, and primary outcomes

About This Study

This is a study to determine the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of CDX-622 in adults with mild to moderate asthma.

Design

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

Interventions / Regimen

  • Drug: CDX-622 — Administered Intravenously

Primary Outcomes

  • To evaluate the safety and tolerability profile of CDX-622 in adults with mild to moderate asthma. (Day 1 up to Day 85 (12 weeks))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2026-06-01
Completion: 2027-03
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 12 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Celldex Therapeutics
Contact Information
Study Contact:
Celldex Therapeutics
844-723-9363
clinicaltrials@celldex.com
Interventions
  • Drug: CDX-622 — Administered Intravenously
Study Locations (4 sites)
University of California, San Francisco, San Francisco, California 94143 United States
The University of Kansas Medical Center, Kansas City, Kansas 66160 United States
Brigham and Women's Hospital, Boston, Massachusetts 02115 United States
University of Pittsburgh Asthma and Environmental Lung Health Institute at UPMC, Pittsburgh, Pennsylvania 15213 United States
Eligibility Criteria
Key Inclusion Criteria: 1. Males and females, ≥ 18 years of age 2. Diagnosis of mild to moderate asthma for at least 12 months 3. Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted normal 4. Airway reversibility ≥ 12% and 200 mL improvement in FEV1 5. Both males and females of child-bearing potential must agree to use contraception during the study and for 150 days after treatment 6. Willing and able to comply with all study requirements and procedures Key Exclusion Criteria: 1. Females who are pregnant or nursing 2. Pulmonary disease other than asthma 3. Systemic diseases with elevated eosinophils other than asthma 4. Hospitalization for treatment of asthma in the past 12 months or required oral corticosteroids due to asthma within the past 6 months 5. History of needing ventilator support due to asthma 6. Current nasal polyps 7. Severe or uncontrolled asthma 8. History of smoking or vaping within the past 6 months 9. Tuberculosis, hepatitis B or C virus, or HIV 10. Immunomodulating biologic therapies within the past 3 months for non-extended half-life biologics. 11. Prior receipt of TSLP or KIT inhibitors such as tezepelumab or briquilimab Additional protocol defined inclusion and exclusion criteria could apply.
Association Analysis of Depression and Asthma
NCT07377552
Not yet recruiting
Conditions Depression,Asthma
Phase Not Applicable
Enrollment 500
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-09-14
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Study Details Design, interventions, and primary outcomes

About This Study

Main Studies Integrate retrospective studies, observational studies, and Mendelian randomization (MR) study methods to systematically analyze the strength and direction of the association between depression and asthma. Explore whether a causal relationship exists between depression and asthma, and identify potential confounding factors and effect modifiers. Secondary Studies Screen for key confounding variables that affect the association between depression and asthma (e.g., age, gender, lifestyle, comorbidities, etc.). Analyze the correlation between depression and the severity of asthma. Verify the stability of instrumental variables (IVs) and the reliability of causal effects in the MR study. Key Term Supplementary Explanations Effect modifiers: Factors that alter the strength or direction of the association between an exposure (e.g., depression) and an outcome (e.g., asthma) (e.g., certain genes or medications may modify how depression influences asthma risk). Instrumental variables (IVs): Genetic variants used in MR studies that are associated with the exposure (e.g., depression-related SNPs) but not directly associated with the outcome (e.g., asthma) except through the exposure, helping to reduce confounding and infer causality.

Design

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

Primary Outcomes

  • Integrate retrospective studies, observational studies, and Mendelian randomization (MR) methods to systematically analyze the strength of the association between depression and asthma. (November 1, 2025 - October 31, 2026)
  • Explore whether a causal relationship exists between depression and asthma, and identify potential confounding factors. (November 1, 2025 - October 31, 2026)
  • Screen for key confounding variables that influence the association between depression and asthma. (November 1, 2025 - October 31, 2026)
  • Analyze the correlation between depression and the severity of asthma. (November 1, 2025 - October 31, 2026)
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: 2026-01-31
Completion: 2026-10-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Contact Information
Study Contact:
Zhenghua Wu
+86-15901617923
wuzhenghua@sjtu.edu.cn
Interventions
N/A
Eligibility Criteria
Inclusion Criteria For Retrospective Study * Age ≥ 18 years old * Complete medical records, including demographic characteristics (age, gender, ethnicity, etc.), clinical diagnosis information (diagnosis time of depression/asthma, diagnostic basis), treatment plans (medication type, dosage), and follow-up records * Depression diagnosis conforms to relevant clinical criteria; asthma diagnosis conforms to Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 Edition) For MR Study (GWAS Data) * Data have undergone strict quality control * Study participants are of European ancestry (to reduce population stratification bias) * Clear division of case group and control group, as well as available sample size information Exclusion Criteria For Retrospective Study * Comorbidity with other severe mental illnesses (e.g., schizophrenia, bipolar affective disorder) * Comorbidity with severe respiratory diseases (e.g., chronic obstructive pulmonary disease \[COPD\], pulmonary fibrosis, lung cancer) * Comorbidity with severe organ failure (e.g., heart, liver, or kidney failure) * Lack of key information in medical records (e.g., diagnosis time, core symptoms, treatment plan) For MR Study (IVs Screening) * Single nucleotide polymorphisms (SNPs) with an association significance P-value ≥ 5×10-⁸ with the exposure (depression/asthma) * SNPs with high linkage disequilibrium (LD, r² ≥ 0.001, distance ≤ 10000 kb) * SNPs located in coding regions or those that may affect gene expression regulation (at risk of horizontal pleiotropy) * SNPs with an F-statistic \< 10 (at risk of weak instrumental variable bias)
A Population-based Investigation of Asthma in the Telemark Region of Norway
NCT02073708
Active, positions filled
Conditions Obstructive Lung Diseases, Respiratory S...
Phase Not Applicable
Enrollment 2000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Respiratory conditions impose an enormous burden on the individual and the society. According to the WHO World Health Report 2000, the top five respiratory diseases - including asthma and COPD - account for 17% of all deaths and 13% of all Disability-Adjusted Life Years (DALYs). Obstructive lung diseases are among the most common chronic diseases in working-aged populations affecting \~40 million individuals in Europe. The greatest economic burden of respiratory diseases on health services and lost production in the EU is due to COPD and asthma, at about €20 billion each for healthcare and €25 billion and €15 billion, respectively, for lost production. For Norway, there are no estimates of asthma prevalence for the country as a whole, but 80/1000 women and 55/1000 men used asthma medication in 2013 according to the national prescription register. Estimated annual deaths in Norway due to COPD were 4070 in 2015, which is 30% higher than for lung cancer. Unfortunately, a substantial proportion of patients are still difficult to treat. This underlines the need for better primary prevention and more knowledge regarding causes and exacerbating factors. Several risk factors for chronic respiratory diseases are identified, most important tobacco smoke, closely followed by air pollution and occupational exposure. However, according to recent reviews there is a lack of understanding regarding environmental risk factors and mechanisms of how these affect respiratory health, the importance of biological markers and comorbidity, and of socioeconomic risk factors. Moreover, there is a need for assessment of interactions between risk factors and between the individual and the environment. Telemark has a high proportion of craft- and industrial workers providing exposure contrasts. Furthermore, the use of medication against respiratory diseases and the rate of sick leave are higher in Telemark than elsewhere in Norway. Moreover, the county has a high rate of disability. There are previous studies from other parts of Norway, which have estimated the occurrence of respiratory diseases and provided valuable knowledge regarding some risk factors. However, these studies use crude measures of self-reported exposure and do not provide sufficient information on how to target intervention and implement effective prevention. In contrast to the Telemark study, these studies have not included register data or advanced modelling of environmental exposure.

Design

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

Primary Outcomes

  • The occurence of asthma and the association to specific occupational and environmental exposures and comorbidity (Five 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: 2018-02-01
Completion: 2035-12-31
Eligibility
Age: 16 Years
Sex: ALL
Volunteers: false
Enrollment: 2000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sykehuset Telemark
Collaborators: Oslo University Hospital, National Institute for Occupational Safety and Health (NIOSH/CDC), Göteborg University
Principal Investigators:
  • Johny Kongerud, Professor (STUDY_DIRECTOR) - Oslo University, Oslo University Hospital
  • Anne Kristin Møller Fell, PhD (PRINCIPAL_INVESTIGATOR) - Sykehuset Telemark
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (1 sites)
Telemark Hospital, dep. of Occupational and Environmental Medicine, Skien, Telemark 3710 Norway
Eligibility Criteria
Inclusion Criteria: * Physician diagnosed asthma * Controls without physician-diagnosed asthma Exclusion Criteria: * inability to fill-inn the questionnaire
Clinical and demOgRaphic Features of Patients With Uncontrolled Severe Asthma in Russia (CORSAR)
NCT06472310
Recruiting
Conditions Severe Asthma
Phase Not Applicable
Enrollment 5000
Locations 40 sites
Compensation Compensation varies
Data Updated 2026-09-14
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Study Details Design, interventions, and primary outcomes

About This Study

This study is an observational multicenter cross-sectional study. Planned study population consists of 5 000 adult patients with uncontrolled SA receiving treatment according to standard of care (except biologics). Planned number of study site is 50 outpatient centers with experience of uncontrolled SA treatment in about 50 regions of Russia (in order to describe characteristics of patients with uncontrolled SA in different regions in the most comprehensive way). This non-interventional study does not imply any intervention into a routine clinical practice, and does not provide for any diagnostic and therapeutic procedures other than those used in routine practice.

Design

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

Primary Outcomes

  • To characterise the profile of routine therapy used for patients with uncontrolled SA not receiving biological therapy in proportion of patients receiving different classes of drugs will be calculated (June 2024 - June 2027)
  • To determine the pattern and trends of OCS prescription (June 2024 - June 2027)
  • To describe clinical and demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the inclusion into the study will be collected (June 2024 - June 2027)
  • To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the primary asthma diagnosis will be collected (June 2024 - June 2027)
  • To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation mean age at the diagnosis of SA will be collected (June 2024 - June 2027)
  • To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of men and women will be calculated (June 2024 - June 2027)
  • To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation data on mean body mass index (BMI) will be collected (June 2024 - June 2027)
  • To describe demographic characteristics of patients with uncontrolled SA not receiving biological therapy in Russian Federation proportion of patients with overweight will be calculated (June 2024 - June 2027)
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: 2024-06-06
Completion: 2027-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 5000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: AstraZeneca
Contact Information
Study Contact:
AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com
Interventions
N/A
Study Locations (40 sites)
Research Site, Astrakhan, Russia
Research Site, Barnaul, Russia
Research Site, Blagoveshchensk, Russia
Research Site, Bryansk, Russia
Research Site, Chelyabinsk, Russia
Research Site, Gatchina, Russia
Research Site, Irkutsk, Russia
Research Site, Izhevsk, Russia
Research Site, Kazan', Russia
Research Site, Kemerovo, Russia
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years at the time of inclusion; 2. Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study; 3. Patients with diagnosis of uncontrolled SA (Asthma Control Questionnaire-5 (ACQ-5) score \> 1,5) established no less than 52 weeks prior to inclusion; Severe asthma is defined as asthma, that is controlled due to treatment with ICS in medium or high doses plus LABA and/or ALP, and/or LAMA, and/or systemic corticosteroids (sCS), and/or immunobiological therapy, while attempts to reduce the volume of therapy lead to a loss of symptom control, or asthma remains uncontrolled despite this treatment. Such therapy should be carried out at least 3 months before inclusion. Uncontrolled asthma is defined as ACQ-5\>1.5. 4. Patients with the availability of at least 52 weeks of follow-up data (prior to inclusion) in the medical records. Exclusion Criteria: 1. Patients receiving any biological therapy currently or within 52 weeks prior to inclusion; 2. Presence of chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (ILF) currently or in the anamnesis; 3. The participation in any clinical study currently or within 52 weeks prior to inclusion; 4. An acute or chronic disease that, as deemed by Investigator, limits the ability of patients to participate in this study or could influence the interpretation of the results.
Chronic Effects of Photobiomodulation With an LED Vest on Functional Capacity, Inflammatory Markers, and Muscle Perfusion in Children With Asthma
NCT07613671
Not yet recruiting
Conditions Asthma (Diagnosis)
Phase NA
Enrollment 60
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Asthma is a chronic inflammatory disease of the airways that results in tissue remodeling, airflow limitation, and bronchial hyperresponsiveness. This study aims to evaluate the long-term effects of photobiomodulation using an LED vest in the management of pediatric asthma. It is a randomized clinical trial involving children aged 6 to 17 years diagnosed with mild to moderate asthma, divided into two groups: an intervention group (using a vest with active LEDs) and a control group (using the vest turned off, simulating the intervention without light emission). The methodology includes clinical and functional assessments such as spirometry, the Asthma Control Test (ACT), the GINA questionnaire, and the Incremental Step Test (IST), which measures exercise tolerance. Photobiomodulation through LEDs promotes cellular biostimulation without thermal effects, modulating inflammatory processes and optimizing tissue regeneration. It is expected that the LED vest will contribute to improving pulmonary function, enhancing quality of life, and complementing conventional treatments. This project aims to advance the clinical application of photobiomodulation as an accessible and effective therapeutic alternative for pediatric asthma.

Design

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

Interventions / Regimen

  • Other: Photobiomodulation — 1\. Duration: 20 minutes per session. Intervention group: vest with active LEDs (according to the table below). Control group (placebo): identical vest without light emission. Application site: anterior and posterior thoracic regions, covering the pulmonary fields and dorsal musculature. Frequency: twice weekly, with a minimum interval of 48 hours between sessions. Conditions:\*application performed at rest, with the child comfortably seated or lying down, under the supervision of the principal investigator.
  • Other: Exercise — Supervised Physical Training: The physical exercise protocol will be initiated immediately after vest application, aiming to improve functional capacity and respiratory symptom control, with safety and continuous monitoring.

Primary Outcomes

  • Functional exercise capacity (From enrollment to the end of treatment at 8 week)
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: 2026-07-30
Completion: 2028-01-30
Eligibility
Age: 6 Years
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Nove de Julho
Principal Investigators:
  • Luciana M Sampaio, Dra (PRINCIPAL_INVESTIGATOR) - University of Nove de Julho
Contact Information
Study Contact:
Luciana M Sampaio, Dra
+55011996002075
lucianamalosa@gmail.com
Emilia R Nascimento
+55019997924782
ernemilia@gmail.com
Interventions
  • Other: Photobiomodulation — 1\. Duration: 20 minutes per session. Intervention group: vest with active LEDs (according to the table below). Control group (placebo): identical vest without light emission. Application site: anterior and posterior thoracic regions, covering the pulmonary fields and dorsal musculature. Frequency: twice weekly, with a minimum interval of 48 hours between sessions. Conditions:\*application performed at rest, with the child comfortably seated or lying down, under the supervision of the principal investigator.
  • Other: Exercise — Supervised Physical Training: The physical exercise protocol will be initiated immediately after vest application, aiming to improve functional capacity and respiratory symptom control, with safety and continuous monitoring.
Study Locations (1 sites)
Uninove, São Paulo, São Paulo 01525000 Brazil
Eligibility Criteria
Critérios de Inclusão: Crianças em idade escolar de 6 a 17 anos Diagnosticado com asma leve a moderada (tratamento farmacológico regular) clinicamente estável Critérios de exclusão:Histórico de exacerbação da asma dentro de 30 dias antes do início do estudo, FAlha no preenchimento dos questionários
Investigation of the Effects of Oxidized Antigens on the T-Cell Response and the Epigenetic Reprogramming of Neutrophils in Lung Diseases - OXIGENE -
NCT07386912
Not yet recruiting
Conditions Asthma, COPD, Bacterial Pneumonia, Viral...
Phase Not Applicable
Enrollment 100
Locations 2 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The OXIGENE study is a research project that aims to better understand how the immune system behaves in people with lung diseases such as asthma, COPD, pneumonia, tuberculosis, and viral lung infections. By analyzing a single blood sample, the study examines how certain immune cells react during inflammation and infection, and whether lasting changes in these cells influence how strongly the body responds to disease. Although participants do not receive direct medical benefit, the results may help improve future diagnosis and treatment of lung diseases by providing deeper insight into immune responses.

Design

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

Interventions / Regimen

  • Other: Characterization of the neutrophil granulocyte epigenome — Characterization of epigenomic differences in neutrophils from patients with different lung diseases (asthma, COPD, pneumonia, tuberculosis, and viral pulmonary infections such as COVID-19 and influenza) by identifying disease-specific epigenetic and functional signatures
  • Other: Characterization of the T-cell immune response to to various oxidatively modified mycobacterial antigens — Investigation of the response (activation/stimulation) of antigen-specific T cells from patients with tuberculosis to various oxidatively modified mycobacterial antigens, with the aim of determining whether changes in the redox status of these antigens measurably influence the adaptive immune response.

Primary Outcomes

  • Characterization of the neutrophil granulocyte epigenome (2030)
  • Characterization of functional signatures (2030)
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: 2026-02-01
Completion: 2030-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Research Center Borstel
Principal Investigators:
  • Jan Heyckendorf, Prof. Dr. med. (PRINCIPAL_INVESTIGATOR) - University Hospital Schleswig-Holstein
Contact Information
Study Contact:
Tobias Dallenga, Dr. rer. nat.
+49 4537 188 5561
tdallenga@fz-borstel.de
Niklas Koehler, Dr. med.
+49 4537 188 8080
studienzentrum@fz-borstel.de
Interventions
  • Other: Characterization of the neutrophil granulocyte epigenome — Characterization of epigenomic differences in neutrophils from patients with different lung diseases (asthma, COPD, pneumonia, tuberculosis, and viral pulmonary infections such as COVID-19 and influenza) by identifying disease-specific epigenetic and functional signatures
  • Other: Characterization of the T-cell immune response to to various oxidatively modified mycobacterial antigens — Investigation of the response (activation/stimulation) of antigen-specific T cells from patients with tuberculosis to various oxidatively modified mycobacterial antigens, with the aim of determining whether changes in the redox status of these antigens measurably influence the adaptive immune response.
Study Locations (2 sites)
Medical Service Center MVZ, Research Center Borstel, Leibniz Lung Center, Borstel, Schleswig-Holstein 23845 Germany
Department of Pulmonology, University Hospital Schleswig-Holstein, Kiel, Schleswig-Holstein 24105 Germany
Eligibility Criteria
Inclusion Criteria: * Diagnosis of an acute or chronic inflammatory lung disease, infectious or non-infectious, including asthma, COPD, pneumonia, tuberculosis, or viral pulmonary infection (e.g., COVID-19, influenza). * Age ≥ 18 years at the time of informed consent. * Ability to provide informed consent and consent to the collection and processing of clinical and laboratory data, as well as to the analysis of blood samples as part of study participation. * Sufficient physical condition to undergo a single venous blood draw (approximately 50 mL), as assessed by the treating physician. Exclusion Criteria: * Active malignant disease or ongoing cancer therapy (e.g., chemotherapy or immunotherapy), due to potential immunological confounding. * Immunosuppressive therapy or known severe immunodeficiency that could interfere with the interpretation of cellular immune responses. * Pregnancy or breastfeeding, for general research-ethical reasons and to protect vulnerable populations. * Acute unstable clinical condition that, in the opinion of the treating physician, makes study participation unreasonable. * Known intolerance to blood sampling or relevant hematological disorders that could compromise the safety or feasibility of venipuncture. * Lack of capacity to provide informed consent or insufficient understanding of the study content despite supportive explanation.
Effect of CPAP Treatment in Patients With Severe Uncontrolled Asthma: The ASTHMA-SLEEP Trial
NCT06314477
Recruiting
Conditions Obstructive Sleep Apnea, Asthma
Phase NA
Enrollment 138
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The aim of the study is to evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and obstructive sleep apnea (OSA)

Design

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

Interventions / Regimen

  • Device: CPAP treatment — Subjects allocated to this arm will receive continuous positive airway pressure (CPAP)
  • Other: Hygienic and dietary advice — Subjects allocated to this arm will receive hygienic and dietary counselling

Primary Outcomes

  • Asthma control questionnaire (12 months)
  • Asthma control test (12 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-12-27
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 138 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Hospital Clinic of Barcelona
Principal Investigators:
  • Mireia Dalmases, MD (PRINCIPAL_INVESTIGATOR) - Hospital Clinic
Contact Information
Study Contact:
Mireia Dalmases, MD
+34932275746
mdalmase@clinic.cat
Interventions
  • Device: CPAP treatment — Subjects allocated to this arm will receive continuous positive airway pressure (CPAP)
  • Other: Hygienic and dietary advice — Subjects allocated to this arm will receive hygienic and dietary counselling
Study Locations (1 sites)
Hospital Clinic Barcelona, Barcelona, Spain 08036 Spain
Eligibility Criteria
Inclusion Criteria: * Age \>18 years * Diagnosis of severe uncontrolled asthma according to the criteria of the Spanish Asthma Management Guide (GEMA) or the Global Initiative for Asthma (GINA) and no hospitalizations the month prior to inclusion in the study. * Apnea hypopnea rate greater than or equal to 15/hour * Punctuation in the Epworth Sleepiness Scale ≤10 * Obtaining informed consent. Exclusion Criteria: * Previous treatment with CPAP * Patient with central sleep apnea or Cheyne-Stokes respiration * Other sleep disorders: narcolepsy, restless leg syndrome, chronic insomnia, * Resistant hypertension * Active Smoking * Unstable comorbidities or medications may interfere with asthma control * Pregnancy * Any process that reduces life expectancy to \<1 year, * Any medical or social factor that may limit CPAP compliance
A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-2)
NCT07782996
Not yet recruiting
Conditions Asthma
Phase PHASE3
Enrollment 370
Locations 0 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The study aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma exacerbations.

Design

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

Interventions / Regimen

  • Drug: GSK5784283 — GSK5784283 will be administered.
  • Drug: Placebo — Placebo will be administered.
  • Drug: Standard of care — Standard of care will be administered.

Primary Outcomes

  • Annualized rate of clinically significant asthma exacerbations (Up to Week 52)
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: 2026-08-31
Completion: 2029-12-28
Eligibility
Age: 12 Years
Sex: ALL
Volunteers: false
Enrollment: 370 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: GlaxoSmithKline
Principal Investigators:
  • GSK Clinical Trials (STUDY_DIRECTOR) - GlaxoSmithKline
Contact Information
Study Contact:
US GSK Clinical Trials Call Center
877-379-3718
GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center
+44 (0) 20 89904466
GSKClinicalSupportHD@gsk.com
Interventions
  • Drug: GSK5784283 — GSK5784283 will be administered.
  • Drug: Placebo — Placebo will be administered.
  • Drug: Standard of care — Standard of care will be administered.
Eligibility Criteria
Inclusion Criteria: * Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in Informed consent form (ICF), For participants aged 12 to 17 years, signed assent must be obtained from the participant in addition to signed consent from their Legally acceptable representative (LAR). * Participants aged 12 to 80 years at the time of signing the informed consent. * Male or eligible female participants: * Female participants: * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: i. Is a Participant of non-childbearing potential (PONCBP) or ii. Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\<) 1 percent (%), 28 days prior to the first dose of the study drug, and during the study intervention period and follow-up period for at least 60 weeks after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention. * A POCBP must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before each dose of study intervention. * If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. * Contraceptive use by women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical trials. * A documented physician diagnosis of asthma for at least 12 months prior to Visit 1, according to the Global Initiative for Asthma (GINA) 2026 guidelines. * Evidence of variable airflow obstruction consistent with asthma. * Documented history of asthma exacerbation within 12 months prior to Visit 1. * A well-documented requirement for regular treatment with medium or high dose Inhaled corticosteroid (ICS) for at least 3 months prior to screening with or without maintenance oral corticosteroids (OCS). * At least 1 additional maintenance asthma controller medication is required according to standard practice of care (e.g., Long-acting beta-2 agonist \[LABA\], Leukotriene receptor antagonists \[LTRA\], theophylline, Long-acting muscarinic agonists \[LAMA\], chromones, etc.). Use of additional asthma controller medications must be documented for at least 3 months prior to screening. * Uncontrolled asthma based on ACQ-5 score. Exclusion Criteria: * Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of participant safety or study results. * History of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix). * Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia. * New York Heart Association (NYHA) class III or IV heart failure. * Other significant medical conditions that could impact participants' safety or study outcomes. * History of an unresolved clinically significant infection within 30 days prior to Visit 1. * A known immunodeficiency other than that explained by the use of corticosteroids taken as therapy for asthma. * Receipt of any marketed or investigational biologic agent or investigational non-biologic agent, prior to Visit 1. * Use of systemic immunosuppressive medication within 3 months prior to Visit 1 (other than systemic corticosteroid burst or stable maintenance OCS for treatment of asthma). * Current smokers (tobacco and/or marijuana), current users of vaping products/electronic-cigarettes or participants with a smoking history \>=10 pack-years.
NIOSH R21 WTC Asthma
NCT07222501
Active, positions filled
Conditions Asthma
Phase Not Applicable
Enrollment 56
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Aim 2: Conduct a pilot RCT of SaMBA-WTC to determine feasibility and preliminary impact in preparation for a fully powered trial. (7M-24M) The investigators will conduct a pilot RCT (n=58) of the SaMBA-WTC model vs. an attention control. Data will be collected on the primary outcomes (asthma control \[asthma control test, ACT\], medication use, inhaler technique) as well as on other secondary outcomes including measures of physical function, self-management behaviors, feasibility and fidelity at baseline, at intervention completion at 3 months, and for sustainability at 6 months. This project will prepare the team for all aspects of a subsequent larger efficacy trial of SaMBA-WTC.

Design

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

Interventions / Regimen

  • Behavioral: SaMBA — The health coach will ask many questions to determine how best to help asthma management and to improve asthma control. The intervention lasts 3 months. During those 3 months, the health coach will speak with participant by phone or video chat several times. Meetings will occur once a week for the first 2-3 weeks, then every 2-4 weeks until the intervention ends. The days and times of the meetings will be up to the participant.
  • Behavioral: Asthma Education - WTC Related — 1-3 visits with an asthma educator to receive basic asthma education

Primary Outcomes

  • Asthma Control Test (ACT) (12 months and 3 months post intervention)
  • Number of times controller inhaler used (12 months and 3 months post intervention)
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: 2025-03-03
Completion: 2026-07-01
Eligibility
Age: 21 Years
Sex: ALL
Volunteers: false
Enrollment: 56 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Icahn School of Medicine at Mount Sinai
Principal Investigators:
  • Juan Wisnivesky, MD, DrPH (PRINCIPAL_INVESTIGATOR) - Icahn School of Medicine at Mount Sinai
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Behavioral: SaMBA — The health coach will ask many questions to determine how best to help asthma management and to improve asthma control. The intervention lasts 3 months. During those 3 months, the health coach will speak with participant by phone or video chat several times. Meetings will occur once a week for the first 2-3 weeks, then every 2-4 weeks until the intervention ends. The days and times of the meetings will be up to the participant.
  • Behavioral: Asthma Education - WTC Related — 1-3 visits with an asthma educator to receive basic asthma education
Study Locations (1 sites)
Mount Sinai Hospital, New York, New York 10021 United States
Eligibility Criteria
Inclusion Criteria: * Age \>=21 years; * English or Spanish speaking; * World Trade Center-certified asthma; * on asthma controller medications (as needed or standing); * uncontrolled asthma. Exclusion Criteria: * Physician's diagnosis of dementia, * COPD or other chronic pulmonary disease, * \>15 pack-years history of smoking to avoid enrolling WTC responders with undiagnosed COPD.
Allergy and Immunology Natural History Study
NCT05584488
Recruiting
Conditions Immune Deficiency, Immune Dysregulation ...
Phase Not Applicable
Enrollment 10000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This protocol is a natural history study designed to evaluate subjects (and some family members) with suspected or identified genetic diseases of allergic inflammation or Immune Dysregulation. Patients determined by clinical history and outside evaluations to be of interest will be consented and enrolled into this study. Blood specimens, stored blood products and derivatives, saliva, hair, fingernail clippings, cord blood, umbilical cord, bone marrow, tissue biopsies and/or buccal swabs from such patients and/or their family members will be obtained for research studies related to understanding genetic and immunopathogenic bases of these diseases. Outside medical records may be obtained, and patient evaluations may be performed to correlate to research laboratory testing results.

Design

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

Primary Outcomes

  • Total number of underlying susceptibility trait(s) identified (Up to 1 year)
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: 2010-07-16
Completion: 2027-01
Eligibility
Age: No restriction
Sex: ALL
Volunteers: true
Enrollment: 10000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Columbia University
Principal Investigators:
  • Joshua D. Milner, MD (PRINCIPAL_INVESTIGATOR) - Columbia University
Contact Information
Study Contact:
Joshua D. Milner, MD
212-305-2100
jdm2249@cumc.columbia
Yannett Franklin
212-305-0473
ym206@cumc.columbia.edu
Interventions
N/A
Study Locations (1 sites)
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital, New York, New York 10032 United States
Eligibility Criteria
Inclusion Criteria: * Subjects, ages birth to 99 years old, known to have or suspected of having an inherited disorder of allergic inflammation, or mast cell homeostasis, or activation or immune dysregulation. * Blood relatives of enrolled subjects will be eligible for enrollment. * There will be no discrimination as to age, gender, race, or disability. * Subjects/guardians must be willing and able to give informed consent. * Subjects must agree to have their blood stored for future studies of the immune system and/or other medical conditions. Exclusion Criteria: • The presence of an acquired abnormality of the immune system, such as cytotoxic chemotherapy or malignancy may be grounds for possible exclusion if, in the opinion of the investigator, the presence of such a disease process would interfere with evaluation.
Preventing Asthma in High Risk Kids
NCT02570984
Active, positions filled
Conditions Asthma
Phase PHASE2
Enrollment 200
Locations 13 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This trial is a randomized, double-blind, placebo controlled trial designed to test whether two years treatment of preschool children aged 2-3 years of age at high risk for asthma with omalizumab (anti-IgE) for two years will prevent the progression to childhood asthma, as reflected by a reduction in the prevalence of active asthma in the Final 12 months during 2 year observation period off study drug.

Design

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

Interventions / Regimen

  • Drug: Omalizumab — anti-ige injection
  • Drug: Placebo — placebo comparator arm, injection similar to active

Primary Outcomes

  • active asthma diagnosis (Final 12 months during 2 year observation period off study drug)
  • asthma severity (Final 12 months during 2 year observation period off study drug)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2018-11-27
Completion: 2028-03-31
Eligibility
Age: 24 Months
Sex: ALL
Volunteers: false
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Boston Children's Hospital
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigators:
  • Wanda Phipatanakul, MD, MS (PRINCIPAL_INVESTIGATOR) - Boston Children's Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Omalizumab — anti-ige injection
  • Drug: Placebo — placebo comparator arm, injection similar to active
Study Locations (13 sites)
Phoenix Children's Hospital, Phoenix, Arizona 85016 United States
Rady Children's Hospital - San Diego, San Diego, California 92123 United States
Childrens Hospital Colorado, Aurora, Colorado 80045 United States
Connecticut Children's Hospital, Hartford, Connecticut 06106 United States
Children's National Medical Center, Washington D.C., District of Columbia 20010 United States
Emory University, Atlanta, Georgia 30322 United States
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois 60611 United States
Indiana University/Riley Children's Hospital, Indianapolis, Indiana 46202 United States
Boston Children's Hospital, Boston, Massachusetts 02115 United States
Washington University, St Louis, Missouri 63110 United States
Eligibility Criteria
Inclusion Criteria: 1. Parent/guardian must be able to understand and provide signed and dated written informed consent; he/she must also be able to communicate with study staff. 2. 24-47 months of age at randomization 3. 2-4 wheezing episodes in the past year 4. positive allergy to aeroallergen 5. first degree relative with history or current diagnosis of asthma or allergy 6. If is participating in a food immunotherapy treatment that is not part of a clinical trial, has been on an established maintenance regimen implemented continuously for a minimum of 2 months. Exclusion Criteria: 1. \>4 episodes of wheezing in the past year 2. Use of Step 5 or Step 6 therapy (ICS plus LABA ) at the time of enrollment (Visit 0). 3. Need for systemic corticosteroids or a hospitalization for respiratory symptoms within four weeks prior to screening. 4. Three or more courses of systemic corticosteroids for wheezing illnesses in the last year 5. More than four days of symptoms of wheezing, or tightness in the chest or cough in the past two weeks causing at least minimal limitation of activity 6. More than four days of albuterol treatment (for symptoms) in the past two weeks 7. More than one night of symptoms of wheezing, or tightness in the chest or cough causing sleep disruption in the past two weeks 8. More than one night of albuterol treatment (for symptoms) in the past two weeks 9. Prematurity (\<34 weeks gestation) 10. Need for oxygen for more than 5 days in the neonatal period 11. History of intubation or mechanical ventilation for respiratory illness 12. Other significant medical conditions, including: major congenital anomalies, cystic fibrosis, chronic pulmonary diseases, bronchopulmonary dysplasia, thoracic surgery, history of tuberculosis, immunodeficiency (primary or secondary), seizure disorders 13. Expecting to relocate within 4 years of study initiation to a place which would make in-person clinical visits impossible 14. Deemed unable to adhere to study activities 15. Prior aeroallergen immunotherapy or use of biologics including anti-IgE 16. Prior IVIG or systemic immunosuppressant other than corticosteroids 17. History of hypoxic seizures during a wheezing episode 18. Total IgE outside of the omalizumab dosing range. 19. Enrolled in any clinical medication trial within the past 30 days. 20. With platelet counts \< 150 x 109/L at the Screening Visit (V0) 21. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study. 22. History of severe anaphylactic/anaphylactoid reactions from any cause
VR vs Treadmill Exercise in Children With Asthma
NCT07610447
Recruiting
Conditions Asthma (Diagnosis)
Phase NA
Enrollment 30
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study aims to compare the effects of virtual reality-based aerobic exercise and treadmill-based aerobic exercise on functional capacity, pulmonary function, and clinical outcomes in children with asthma. Participants aged 10-17 years with physician-diagnosed asthma will be randomly assigned to either a virtual reality-based exercise group or a treadmill exercise group. Both groups will undergo supervised exercise training sessions twice a week for 8 weeks. Primary outcome will be the 6-Minute Walk Test. Secondary outcomes include pulmonary function, respiratory muscle strength, asthma control, quality of life, and exercise adherence.

Design

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

Interventions / Regimen

  • Device: Virtual Reality-Based Aerobic Exercise — Participants will perform supervised moderate-intensity aerobic exercise using a Meta Quest 3S virtual reality headset and game-based activities. Each session will include a 5-minute warm-up period, 30 minutes of aerobic exercise, and a 5-minute cool-down period. Sessions will be conducted twice weekly for 8 week
  • Behavioral: Treadmill-Based Aerobic Exercise — Participants will perform supervised moderate-intensity treadmill-based aerobic exercise. Each session will include a 5-minute warm-up period, 30 minutes of aerobic exercise, and a 5-minute cool-down period. Sessions will be conducted twice weekly for 8 weeks.

Primary Outcomes

  • Functional Capacity: 6-Minute Walk Test Distance (Baseline and Week 8)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-05-25
Completion: 2027-05-10
Eligibility
Age: 10 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Bezmialem Vakif University
Contact Information
Study Contact:
Ayşe Sena Manzak Dursun, PT, PhD
+905356735150
amanzak@bezmialem.edu.tr
Interventions
  • Device: Virtual Reality-Based Aerobic Exercise — Participants will perform supervised moderate-intensity aerobic exercise using a Meta Quest 3S virtual reality headset and game-based activities. Each session will include a 5-minute warm-up period, 30 minutes of aerobic exercise, and a 5-minute cool-down period. Sessions will be conducted twice weekly for 8 week
  • Behavioral: Treadmill-Based Aerobic Exercise — Participants will perform supervised moderate-intensity treadmill-based aerobic exercise. Each session will include a 5-minute warm-up period, 30 minutes of aerobic exercise, and a 5-minute cool-down period. Sessions will be conducted twice weekly for 8 weeks.
Study Locations (1 sites)
Bezmialem Vakif University, Istanbul, Eyupsultan Turkey (Türkiye)
Eligibility Criteria
Inclusion Criteria: * Children and adolescents aged between 10 and 17 years * Physician-diagnosed asthma according to Global Initiative for Asthma (GINA) criteria * Stable medical treatment for asthma * Ability to participate in an aerobic exercise program * Willingness of the participant and parent/legal guardian to provide informed consent Exclusion Criteria: * Presence of orthopedic, neurological, cardiovascular, or systemic conditions limiting participation in exercise * Contraindications to virtual reality use (e.g., epilepsy, photosensitivity) * Participation in a structured exercise program within the previous month * Asthma exacerbation within the previous month * Obesity diagnosis
Mobile Cognitive Behavioral Therapy in Early Stroke Recovery
NCT07639606
Not yet recruiting
Conditions Anxiety, Stroke, Depression - Major Depr...
Phase NA
Enrollment 10
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study aims to pilot "Maya," a mobile cognitive behavioral therapy app, for use in adults with stroke experiencing depression and/or anxiety. This study will assess the acceptability, feasibility, and preliminary efficacy of Maya within the acute rehabilitation period.

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Device: Mobile Cognitive Behavioral Therapy App — A mobile cognitive behavioral therapy (CBT) app called "Maya" that includes modules with educational content and teaching and practice of strategies that address depression and anxiety after stroke.

Primary Outcomes

  • Feasibility and Acceptability of Maya as measured by the Mobile Application Rating Scale-User Version (uMARS) (Week 5 of treatment)
  • Percent of Sessions completed over study time period (From Week 1 to Week 5 of treatment)
  • Percent of homework exercises completed (From Week 1 to Week 5 of 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: 2026-07
Completion: 2029-03
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 10 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Weill Medical College of Cornell University
Principal Investigators:
  • Abhishek Jaywant, PhD (PRINCIPAL_INVESTIGATOR) - Weill Medical College of Cornell University
Contact Information
Study Contact:
Abhishek Jaywant, PhD
212-746-4666
abj2006@med.cornell.edu
Interventions
  • Device: Mobile Cognitive Behavioral Therapy App — A mobile cognitive behavioral therapy (CBT) app called "Maya" that includes modules with educational content and teaching and practice of strategies that address depression and anxiety after stroke.
Study Locations (1 sites)
Weill Cornell Medicine, New York, New York 10065 United States
Eligibility Criteria
Inclusion Criteria: * Age 18-79 * Positive screen on the Hospital Anxiety and Depression Scale (HADS), either the HADSD (depression, score \>= 8) and/or HADS-A (anxiety, score \>= 8). * Stroke that occurred within 1 month prior to study initiation. * Capacity to provide consent as determined by the UCSD Brief Assessment for Capacity to Consent (UBACC) * Montreal Cognitive Assessment (MoCA) score greater than or equal to 18, indicating no more than mild cognitive difficulties * Ability to use iPhone or iPad independently or through the assistance of a caregiver (participants will use their own iPhone if they have one, otherwise they will be loaned an iPad by the study team) * Able to adhere to all study requirements and willingness to participate in the full study duration Exclusion Criteria: * Aphasia or neglect that would interfere with use of the app, as determined through evaluation by speech-language pathology and occupational therapy conducted as part of standard clinical care * Non-fluency in English * History of a major neurologic disorder or of serious mental illness (bipolar or psychotic disorder, alcohol or substance use disorder as assessed through chart review) * Active suicidal ideation requiring a higher level of care * Severe depression and/or anxiety based on the initial evaluation and clinical judgment of the PI, which warrants a higher level of care and/or immediate referral to psychiatric services * Any other clinical or medical reason in the initial evaluation that suggests the study is not appropriate for the participant
Mindfulness and Meditation Based Lactation Education on Maternal Breastmilk in the Neonatal ICU
NCT07351799
Recruiting
Conditions Lactation, Mindfulness, NICU, Breastmilk...
Phase NA
Enrollment 40
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this research is to investigate associations between mindfulness and meditation techniques and changes in maternal breastmilk in the mother pumping for her NICU infant.

Design

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

Interventions / Regimen

  • Behavioral: Standard of Care — No additional session with the lactation consultant will be provided beyond the standard of care lactation admission visit with a lactation consultant within 72 hours of their infant's admission to the NICU. On days 0, 10 and 20, participants will be asked to record pumping session times and breastmilk volumes expressed for 24 hours, collect salivary oxytocin sample and salivary cortisol sample at minute 4 of one pumping session, and fill out the GAD7, PSS, and PHQ-8 surveys.
  • Behavioral: Mindfulness-based Intervention — In addition to the standard of care lactation admission visit, participants will receive an additional session with the lactation consultant for mindfulness-based lactation education. Participants will also be provided with a pumping meditation audio recording that they will be asked to listen to at least once daily for the next 20 days. On days 0, 10 and 20, participants will be asked to record pumping session times and breastmilk volumes expressed for 24 hours, collect salivary oxytocin sample and salivary cortisol sample at minute 4 of one pumping session, and fill out the GAD7, PSS, and PHQ-8 surveys. In addition, the intervention group participants will also be asked to record the number of times they listened to the recording daily, minutes listened to recording daily, and time of day listened to recording.

Primary Outcomes

  • Change in breastmilk volume (Baseline, 10 days, 20 days)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-09-22
Completion: 2026-11-02
Eligibility
Age: 20 Years
Sex: FEMALE
Volunteers: true
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Mayo Clinic
Principal Investigators:
  • Ashley Thompson (PRINCIPAL_INVESTIGATOR) - Mayo Clinic
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Behavioral: Standard of Care — No additional session with the lactation consultant will be provided beyond the standard of care lactation admission visit with a lactation consultant within 72 hours of their infant's admission to the NICU. On days 0, 10 and 20, participants will be asked to record pumping session times and breastmilk volumes expressed for 24 hours, collect salivary oxytocin sample and salivary cortisol sample at minute 4 of one pumping session, and fill out the GAD7, PSS, and PHQ-8 surveys.
  • Behavioral: Mindfulness-based Intervention — In addition to the standard of care lactation admission visit, participants will receive an additional session with the lactation consultant for mindfulness-based lactation education. Participants will also be provided with a pumping meditation audio recording that they will be asked to listen to at least once daily for the next 20 days. On days 0, 10 and 20, participants will be asked to record pumping session times and breastmilk volumes expressed for 24 hours, collect salivary oxytocin sample and salivary cortisol sample at minute 4 of one pumping session, and fill out the GAD7, PSS, and PHQ-8 surveys. In addition, the intervention group participants will also be asked to record the number of times they listened to the recording daily, minutes listened to recording daily, and time of day listened to recording.
Study Locations (1 sites)
Mayo Clinic in Rochester, Rochester, Minnesota 55905 United States
Eligibility Criteria
Inclusion Criteria: * Maternal age \> 20 years of age * Read, write and understand English * Infant NICU admit * Infant birthplace of Rochester, MN (Mayo Clinic) * Maternal adherence to pumping ≥ 8 times in 24 hours * Mother enrolled within 72 hours of birth * Gestational age of neonate at birth of \< 34 0/7 weeks Exclusion Criteria: * Maternal extensive existing mindfulness practice * Maternal breast/chest surgery * Maternal polycystic ovarian syndrome (PCOS) * Maternal current illicit substance abuse * Diagnosis of maternal current severe mental health concerns * Maternal multiple gestation (twins or higher order) pregnancy and delivery
The Purpose of the Study is to Investigate if a Smartphone App Combined With Internet Based Cognitive Behavioural Therapy (ICBT) Leads to Improved Symtoms in Depressive Adults on Antidepressive Medicine, Compared to a Wait-list Control Condition
NCT06907134
Active, positions filled
Conditions Depressive Symptoms
Phase NA
Enrollment 150
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of the study is to investigate if a smartphone app combined with internet delivered cognitive behavioural therapy (ICBT) leads to improved symptoms in depressive adults on antidepressive mediation. The participants in the treatment group will get access to a smartphone app based on CBT-principles for 9 weeks. They will also get access to an internet platform with extra treatment material based on CBT and receive therapist support on demand. Participants will be recruited in Sweden with nationwide recruitment.

Design

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

Interventions / Regimen

  • Behavioral: Smartphone delivered internet-based Cognitive Behavioural Therapy — The intervention is 9 week long were partipants use an smartphone app based on CBT-principles with while having access to an internet platform where extra working material and therapist support is available on demand.

Primary Outcomes

  • Montgomery Asberg Depression Ranging Scale (MADRS) (From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2024-11-02
Completion: 2028-09-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Linkoeping University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Behavioral: Smartphone delivered internet-based Cognitive Behavioural Therapy — The intervention is 9 week long were partipants use an smartphone app based on CBT-principles with while having access to an internet platform where extra working material and therapist support is available on demand.
Study Locations (1 sites)
Linköping University, Linköping, Östergötland County 58183 Sweden
Eligibility Criteria
Inclusion Criteria: * Ongoing drug treatment with an antidepressant mediated by an established care contact in (primary) care. * 18 years or older. * Be able to speak, read and write Swedish. * Have access to a computer, tablet or other device with internet connection and smartphone to download the app. Exclusion Criteria: * Severe psychiatric or somatic problems that make participation difficult or impossible * Ongoing abuse (via Audit and during interview) * Acute suicidality * Other ongoing psychological treatment or planned investigation. * Planned dose change of medicine or change of medicine during pre-measurement.
Mental Health CPR for Cancer Survivors
NCT07219264
Recruiting
Conditions Mental Health Care, Mental Health, Depre...
Phase NA
Enrollment 1260
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This is a parallel, two-arm interventional study comparing the Mental Health CPR behavioral intervention to standard community health education. The goal of this clinical trial is to learn if Mental Health CPR program, a culturally and linguistically adapted behavioral intervention, helps improve emotional well-being and access to mental health services among Hispanic/Latino cancer survivors in Puerto Rico. The main questions it aims to answer are: * Does Mental Health CPR help more people complete psychological distress screening? * Does it help more participants connect with psycho-oncology services? Researchers will compare the Mental Health CPR program to standard community health education to determine whether it improves emotional well-being, enhances communication between patients and caregivers, reduces negative attitudes toward mental health care, and lowers emotional distress levels. Participants will: * Attend community sessions led by trained Community Mental Health Workers (CMHWs) * Receive printed materials and educational resources * Take part in brief follow-ups over about 36 weeks

Design

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

Interventions / Regimen

  • Behavioral: Mental Health CPR — The Mental Health CPR is a culturally adapted behavioral intervention implemented by trained Community Mental Health Workers (CMHWs). It includes interactive sessions designed to improve emotional well-being, communication between cancer survivors and caregivers, and access to mental health services. The content integrates educational videos, group discussions, and digital resources from the Community Mental Health Toolbox. The intervention also reinforces sustainability by promoting local resource use and peer support networks. Additionally, the intervention will periodically conduct mental health and distress screenings, integrate mental health promotion educational activities and skill-building activities, case management component will integrate the cancer-mental health toolbox and linkage to Psycho-Oncology Mental Health Services (MHCS) component through the PAPSI psycho-oncology mental health service program at PHSU if needed.
  • Behavioral: Standard Community Health Education — The control group receives standard behavioral health education materials commonly distributed in community health settings. These materials include information on stress reduction, healthy lifestyle habits, and general mental health awareness but do not include interactive or CMHW-facilitated sessions.

Primary Outcomes

  • Development of the Community Toolbox for the Mental Health CPR Intervention (18 months)
  • Distress Thermometer (DT) (9 months)
  • Psych-oncology mental health service referral uptake (9 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-09-26
Completion: 2028-08-31
Eligibility
Age: 21 Years
Sex: ALL
Volunteers: true
Enrollment: 1260 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Ponce Medical School Foundation, Inc.
Collaborators: University of Rochester, University of Puerto Rico Medical Sciences Campus
Principal Investigators:
  • Eida M Castro-Figuera, PsyD, MSc (PRINCIPAL_INVESTIGATOR) - Ponce Medical School Foundation, Inc.
Contact Information
Study Contact:
Eida M Castro-Figueroa, PsyD, MSc
787-840-2575
ecastro@psm.edu
Guillermo N Armaiz-Pena, PhD
787-840-2575
garmaiz@psm.edu
Interventions
  • Behavioral: Mental Health CPR — The Mental Health CPR is a culturally adapted behavioral intervention implemented by trained Community Mental Health Workers (CMHWs). It includes interactive sessions designed to improve emotional well-being, communication between cancer survivors and caregivers, and access to mental health services. The content integrates educational videos, group discussions, and digital resources from the Community Mental Health Toolbox. The intervention also reinforces sustainability by promoting local resource use and peer support networks. Additionally, the intervention will periodically conduct mental health and distress screenings, integrate mental health promotion educational activities and skill-building activities, case management component will integrate the cancer-mental health toolbox and linkage to Psycho-Oncology Mental Health Services (MHCS) component through the PAPSI psycho-oncology mental health service program at PHSU if needed.
  • Behavioral: Standard Community Health Education — The control group receives standard behavioral health education materials commonly distributed in community health settings. These materials include information on stress reduction, healthy lifestyle habits, and general mental health awareness but do not include interactive or CMHW-facilitated sessions.
Study Locations (1 sites)
Ponce Medical School Foundation, Inc., Ponce, Puerto Rico 00732 Puerto Rico
Eligibility Criteria
The study will include adults of all ages representing individuals across all the adulthood stage. The minimum age requirement is 21, which is the legal age of majority in Puerto Rico. Inclusion Criteria: * Eligibility Criteria for Sub-Aim 1a. The eligibility criteria for the qualitative interviews will be 1: Participants over 21 years old, 2: through their role or status, represent any of the following community sectors: cancer care community organization representatives, clinical care providers of cancer patients and survivors, and cancer health educators; 3: self-identified as a Latino/Hispanic; 4: be able to complete an interview. * Eligibility Criteria for Aim 2. Community Forums stakeholders eligibility criteria. The community stakeholders inclusion criteria for the community forum are 1: Participants over 21 years old, 2: through their role or status, represent any of the following community sectors: cancer patients/survivors, cancer patients/survivors identified family caregiver, healthcare providers, cancer supportive care organizations, and advocacy groups, 3: self-identified as a Latino/Hispanic, 4: be able to attend the community forums. * Community Leaders Eligibility Criteria for CMHW training. The inclusion criteria for the community leaders to be trained as CMHW are 1: Participants over 21 years of age, 2: living in a limited resource community in southern Puerto Rico, 3: self-identified as a Latino/Hispanic, and 4: be able to provide support to H-CAPS through their role as CMHW. * Communities Eligibility Criteria. Community municipalities included from the southern health region of Puerto Rico are: Ponce, Arroyo, Coamo, Yauco, Salinas, Guanica, Guayanilla, Juana Diaz, Adjuntas, Guayama, Patillas, Santa Isabel, Penuelas and Villalba. These municipalities were chosen because they represent the catchment area of Ponce Health Sciences University. Also, they are comprised of mostly rural areas (south-central region of Puerto Rico) and present a higher incidence of cancer (south region) and cancer mortality (south-central region) compared to other Puerto Rican Health regions. * Intervention eligibility criteria. The eligibility criteria for the community intervention are 1: Participants over 21 years old, 2: living in any of the municipalities of the southern health region of Puerto Rico and within a limited resource community according to the CDC SVI, 3: self-identified as a Latino/Hispanic, and 4: have had a cancer diagnosis during their adulthood. Exclusion Criteria: * Participants residing outside the catchment area.
Prevalence of Psychiatric Problems Among Patients and Healthcare Providers in a Cardiology Department: A Cross-Sectional Study
NCT07274865
Not yet recruiting
Conditions Anxiety Depression, Burnout, Sleep
Phase Not Applicable
Enrollment 380
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this observational cross-sectional study is to determine the prevalence of psychiatric problems (depression, anxiety, stress, and burnout) among patients with cardiovascular diseases and healthcare providers working in the Department of Cardiovascular Medicine at Assiut University Heart Hospital. The main questions it aims to answer are: * What is the prevalence of depression, anxiety, and stress among cardiovascular patients? * What is the prevalence of burnout, depression, and anxiety among healthcare providers in the same department? The study will also explore potential sociodemographic, occupational, and clinical factors associated with these psychological outcomes.

Design

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

Interventions / Regimen

  • Other: Psychological Assessment using Validated Questionnaires — Participants will complete validated mental health questionnaires, including SCL-90R, COPE Inventory, Eysenck Personality Questionnaire, Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI). Healthcare providers will additionally complete the Maslach Burnout Inventory (MBI). No experimental treatment or behavioral intervention will be applied.

Primary Outcomes

  • Measuring the prevalence of depressive symptoms among cardiovascular patients assessed by SCL-90R (Within 12 months)
  • Measuring the prevalence of anxiety symptoms among cardiovascular patients assessed by SCL-90R (Within 12 months)
  • Prevalence of burnout among healthcare providers assessed by Maslach Burnout Inventory (MBI) (Within 12 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: 2026-01
Completion: 2028-03
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 380 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Assiut University
Principal Investigators:
  • Ali Mohammed Tohamy, Ass. Professor (STUDY_DIRECTOR) - Assiut University
  • Ayman Khairy Hassan, Professor (STUDY_DIRECTOR) - Assiut University
  • Hossam Loly Abdullah, bachelor's (PRINCIPAL_INVESTIGATOR) - Assiut University
Contact Information
Study Contact:
Hossam Loly Abdullah, bachelor's
00201279533575
hossam.17289754@med.aun.edu.eg
Interventions
  • Other: Psychological Assessment using Validated Questionnaires — Participants will complete validated mental health questionnaires, including SCL-90R, COPE Inventory, Eysenck Personality Questionnaire, Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI). Healthcare providers will additionally complete the Maslach Burnout Inventory (MBI). No experimental treatment or behavioral intervention will be applied.
Study Locations (1 sites)
Assiut university hospital, Asyut, Asyut Governorate 71515 Egypt
Eligibility Criteria
Inclusion Criteria: Patients Age ≥ 18 years. Diagnosed with a cardiovascular disease (e.g., ischemic heart disease, heart failure, valvular disease). Able to understand and complete self-administered questionnaires or participate in structured interviews. Provided informed written consent. Healthcare Providers Physicians, residents, nurses, or allied staff working in the Department of Cardiovascular Medicine for ≥6 months. Provided informed written consent. Exclusion Criteria: Severe cognitive impairment or communication difficulties that prevent questionnaire completion. Refusal to participate.
Accelerated rTMS vs. Sham for Stroke Apathy
NCT07113067
Recruiting
Conditions Apathy, Stroke, Stroke Sequelae, Stroke/...
Phase PHASE1, PHASE2
Enrollment 40
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Apathy is a common set of symptoms seen in many people following a stroke. Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them. Apathy has a large negative impact on a person's quality of life, and can also have a large impact the people who take care of them. There are currently no FDA-approved treatments to help with apathy, and other services like therapy may be difficult to access for people who have had a stroke. To address this problem, investigators are conducting a study to find out if a form of treatment called repetitive transcranial magnetic stimulation (rTMS) can be safe and helpful for people struggling with apathy after a stroke. This study will apply a new form of rTMS which can be delivered quickly to a part of the brain called the medial prefrontal cortex (mPFC). This study will help establish whether this treatment is safe, comfortable, and effective for people with apathy after a stroke, and will help researchers develop new forms of treatment.

Design

Study type: Interventional Phases: Phase1, Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Triple

Interventions / Regimen

  • Device: MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System (Active) — Active treatment will consist of high-dose iTBS-rTMS to left dmPFC delivered in runs of 600 pulses at an intensity of 120% resting motor threshold (rMT). iTBS triplets at 50 Hz will be delivered for 2 seconds, repeated every 10 seconds for a total of 190 seconds. Each session will be separated by at least 10-15 minutes and a total of 12 sessions will be given on each treatment day (3-4 hours per study day). A total of 43,200 pulses will be delivered over the entire six days of treatment.
  • Device: MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System (Sham) — For the sham stimulation group, a focal electric sham will be used which is indistinguishable from active TMS including a pretreatment individualized sham titration, sham outputs noises synchronized to pulse delivery, and an individualized level of sham stimulation throughout the treatment. Technicians administering active vs sham TMS will be masked by using a random code generated by the statistician that will indicate whether to use the active or sham side of the coil. Treatments will appear identical to the technician regardless of whether active or sham TMS is administered.
  • Other: Brainsight Neuronavigation System — A brainsight neuronavigation system will be used during TMS treatments to target treatment location using individual MRI data

Primary Outcomes

  • Change in apathy symptoms, as measured by the Lille Apathy Rating Scale (LARS) compared to baseline (Pre-treatment, immediately post-treatment, and at one month post-treatment follow-up)
  • Change in apathy symptoms as measured by the Apathy Evaluation Scale (AES) - Self and Informant Versions (Pre-treatment, immediately post-treatment, and weekly for four weeks post-treatment.)
  • Incidence of Treatment-Emergent Adverse Events and Side Effects as assessed by change in the Review of Systems Criteria compared to baseline (After each session of rTMS during each of six treatment days within two weeks)
  • Change From Baseline Cognition, as Measured by the Fluid Cognition Composite Score From the NIH Toolbox Cognition Battery compared to baseline (Pre-treatment, immediately post-treatmen)
  • Participant retention rate (calculated at the end of the study follow-up assessment period (one month post-treatment))
  • Patient perception of treatment acceptability as assessed by study-specific questionnaire (After each session of rTMS during each of three treatment days within one week, and at one month post-treatment follow-up)
  • Frontal Systems Behavior Scale (FrSBE)-Apathy scale (Pre-treatment, post-treatment and at 4 weeks post treatment)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Recruiting
Start Date: 2025-08-08
Completion: 2027-06-30
Eligibility
Age: 40 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Medical University of South Carolina
Principal Investigators:
  • Parneet Grewal, PhD (PRINCIPAL_INVESTIGATOR) - Medical University of South Carolina
  • Lisa McTeague, PhD (PRINCIPAL_INVESTIGATOR) - Medical University of South Carolina
  • Kevin Caulfield, PhD (PRINCIPAL_INVESTIGATOR) - Medical University of South Carolina
Contact Information
Study Contact:
Parneet Grewal, MD
843-792-3020
grewalp@musc.edu
Lisa McTeague, PhD
843-792-8274
mcteague@musc.edu
Interventions
  • Device: MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System (Active) — Active treatment will consist of high-dose iTBS-rTMS to left dmPFC delivered in runs of 600 pulses at an intensity of 120% resting motor threshold (rMT). iTBS triplets at 50 Hz will be delivered for 2 seconds, repeated every 10 seconds for a total of 190 seconds. Each session will be separated by at least 10-15 minutes and a total of 12 sessions will be given on each treatment day (3-4 hours per study day). A total of 43,200 pulses will be delivered over the entire six days of treatment.
  • Device: MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System (Sham) — For the sham stimulation group, a focal electric sham will be used which is indistinguishable from active TMS including a pretreatment individualized sham titration, sham outputs noises synchronized to pulse delivery, and an individualized level of sham stimulation throughout the treatment. Technicians administering active vs sham TMS will be masked by using a random code generated by the statistician that will indicate whether to use the active or sham side of the coil. Treatments will appear identical to the technician regardless of whether active or sham TMS is administered.
  • Other: Brainsight Neuronavigation System — A brainsight neuronavigation system will be used during TMS treatments to target treatment location using individual MRI data
Study Locations (1 sites)
Medical University of South Carolina Brain Stimulation Lab, Charleston, South Carolina 29403 United States
Eligibility Criteria
Inclusion Criteria: * 40 years old or greater * Right- or left-hemisphere ischemic or hemorrhagic stroke with at least 6 months chronicity * Symptomatic apathy as confirmed by (A) total score on the Apathy Evaluation Scale by the participant or the caregiver/co-participant (AES) of ≥39 * Ability to participate in psychometric testing and cognitive tasks * Intact cortex at the TMS target site as confirmed by pre-treatment MRI * Ability to have a co-participant/caregiver who meets the criteria as detailed below. Exclusion Criteria: * Primary extra-axial hemorrhage (subdural or subarachnoid) without ischemic stroke or intraparenchymal hemorrhage * Concomitant neurological disorders affecting motor or cognitive function (e.g. dementia) * Moderate or severe global aphasia * Visual impairment precluding completion of cognitive tasks * Presence of contraindications to MRI or TMS including electrically, magnetically or mechanically activated metal or nonmetal implants such as cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system; * Pregnancy (to be later confirmed by UPT in any premenopausal female participants) * History of a seizure disorder * Preexisting scalp lesion, wound, bone defect, or hemicraniectomy * Claustrophobia precluding ability to undergo an MRI * Active substance use disorder * Psychotic disorders * Bipolar 1 Disorder * Acute suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)30 or suicide attempt in the previous year For CO-PARTICIPANT/CAREGIVER: Inclusion Criteria: * Age 18 years or older * Is a reliable informant who has at least weekly contact with the participant and can speak to the participant's cognitive and everyday functioning. Exclusion Criteria: \- Unable to engage with study procedures in which Co-Participant input is needed.
Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression
NCT06263660
Recruiting
Conditions Depression
Phase PHASE2
Enrollment 75
Locations 1 sites
Compensation incentive available
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study aims to determine whether a keto-like supplement relative to placebo results in functional brain changes during fMRI tasks evaluating positive and negative valence in individuals with moderate to severe depression. In this double-blind randomized placebo-controlled trial, 75 individuals with a Patient Health Questionnaire (PHQ-9) scale score ≥ 10 (MDD) will be enrolled to participate in an 8-week treatment study to obtain 60 completers. Participants will be randomized with a 1-1 ratio to receive the keto-like supplement (n= 30 completers) or placebo (n=30 completers) taken orally three times per day for 8 weeks. Participants will undergo a 10.5-hour screening/baseline evaluation visit split over 2 days at week 0 including questionnaires, neuroimaging before and after supplement or placebo administration and blood draws, office visits at week 2 (1.5 hours), week 4 (3 hours), week 6 (0.5 hours), week 8 (6 hours), a follow-up visit at week 10 (1.5 hours) and two phone calls between visits (weeks 1 and 3) during which a brief clinical assessment will be obtained (10 minutes each). The total time involved in the study is approximately 23.5 hours.

Design

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

Interventions / Regimen

  • Dietary Supplement: Keto-like supplement — Participants will consume 9.25g stick packs of the keto-like supplement dissolved in water 3 times per day for 8 weeks.
  • Dietary Supplement: Placebo — Participants will consume 9.25g stick packs of placebo dissolved in water 3 times per day for 8 weeks.

Primary Outcomes

  • BOLD response during Monetary Incentive Delay Task (week 0 pre, week 0 post, week 8)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-01-09
Completion: 2027-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 75 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Laureate Institute for Brain Research, Inc.
Principal Investigators:
  • Martin Paulus, MD (PRINCIPAL_INVESTIGATOR) - Laureate Institute for Brain Research
Contact Information
Study Contact:
Teresa Victor, PhD
918-502-5108
tvictor@laureateinstitute.org
Colleen McCallum
918-502-5180
cmccallum@laureateinstitute.org
Interventions
  • Dietary Supplement: Keto-like supplement — Participants will consume 9.25g stick packs of the keto-like supplement dissolved in water 3 times per day for 8 weeks.
  • Dietary Supplement: Placebo — Participants will consume 9.25g stick packs of placebo dissolved in water 3 times per day for 8 weeks.
Study Locations (1 sites)
Laureate Institute for Brain Research, Tulsa, Oklahoma 74136 United States
Eligibility Criteria
Inclusion Criteria: * Meets the Diagnostic and statistical manual - 5 (DSM-5) diagnostic criteria for MDD without psychotic features (past or present), as confirmed by the M.I.N.I v7.0 * PHQ-9 score of ≥10 * C-Reactive Protein (CRP) value \> 1 * Age 18-65 * Consent ability and written consent * Body Mass Index (BMI) between 19 and 38 kg/m2 * Medically stable based on clinical laboratory tests, medical history and vital signs * No intention to become pregnant during the study * A woman of childbearing potential must have a negative serum pregnancy test at screening * Consent that possible random finding is reported (e.g. brain abnormality during imaging) Exclusion Criteria: * Has a current or recent history of clinically significant suicidality * Has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 12 months before screening * Has positive test result(s) for alcohol or drugs of abuse (including methadone, opiates, cocaine, cannabinoids, amphetamine/methamphetamine and ecstasy) * Has a current diagnosis of a psychotic disorder (e.g. schizophrenia, bipolar disorder), an eating disorder (e.g. anorexia, bulimia), or learning disability or a personality disorder that is considered by the investigator to interfere with the ability of the subject to adhere to the protocol (e.g. narcissistic personality, borderline personality disorder) * Change in medication dose and/or frequency within the last 6 weeks. Participants must be on stable medications for 6 weeks prior to enrollment. * Plans to change medication dose/frequency during the course of the study. Must plan to remain on stable dose for the duration of the study, unless otherwise indicated by their provider during the course of the study. * Plans to take vitamins and/or mineral supplements during the study. Must refrain for the duration of the study * Unable to complete MRI scans * Is a woman who is pregnant or breast feeding * Plans to conceive a child while enrolled in this study or within 3 months after the last dose of the keto-like supplement * Has received an investigational drug/vaccines, used an invasive investigational medical device within 60 days before the planned first dose of the keto-like supplement or has participated in 2 or more interventional clinical studies in the previous 1 year, or is currently enrolled in any drug or non-drug interventional study. * Has had major surgery, (i.e. requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time they are expected to participate in the study. * Intake of Omega 3 fatty acids (DHA, EPA, fish oil supplements) * Significant cognitive impairment, clinically relevant or progressive disease (e.g., liver, kidney, cardiovascular system, respiratory tract, vascular system, brain, metabolism, thyroid) that could affect the course of the study * Known metabolic disorders (e.g., fatty acid oxidation disorders, ketolysis/ketogenesis or glucogenesis disorder, hyperinsulinism (e.g., pancreatic neuroendocrine tumor), pyruvate carboxylase deficiency, Type 1 and Type 2 diabetes * Allergy to Stevia sweetener, malic acid or orange flavoring * Concern for inability to maintain adherence to the keto-like supplement administration protocol * Currently practicing a ketogenic or paleo diet or planning to do so during the study period. * Change in body weight of more than 5 kg within one month before the start of the intervention * Medical, psychiatric or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study * Contraindications to MRI examinations \[persons with metallic implants (e.g., intracranial metal clips) and carriers of electronic devices (e.g., pacemaker) or persons with claustrophobia\]