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Showing 20 of 28810 trials
Optimization of ITBS for Depression
NCT06464445
Recruiting
Conditions Neuromodulation
Phase NA
Enrollment 30
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Monophasic iTBS
  • Biphasic iTBS
  • Monophasic-Long iTBS

Primary Outcomes

  • TMS derived measure of cortical plasticity
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-08-01
Completion: 2026-07-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Université de Sherbrooke
Contact Information
Study Contact:
Samantha Cote, Ph.D.
819-346-1110
Samantha.cote@usherbrooke.ca
Jean-Francois Lepage, Ph.D.
819-346-1110
jean-francois.lepage@usherbrooke.ca
Interventions
  • Monophasic iTBS
  • Biphasic iTBS
  • Monophasic-Long iTBS
Study Locations (1 sites)
Centre de recherche du Centre hospitalier universitaire de Sherbrook, Sherbrooke, Quebec J1H 5H3 Canada
Eligibility Criteria
Inclusion Criteria: * Be between 18 and 35 years old * Be of right manual dominance * In good health Exclusion Criteria: * Have an implant or pacemaker, * Having tinnitus, * Have a history of fainting, * Have already had an epileptic seizure or have a family history of epilepsy, * Have a known neurological disease, * Be under psychotropic medication, * Have suffered from substance abuse or dependence in the last 6 months, * Have a neurostimulator, * Have a splinter or metallic implant in the head or the rest of the body, * Have a cochlear implant, * Have an automated injection system implanted (insulin pump), * Have a transdermal patch, * Have tattoos in the area to be studied, * Be pregnant or breastfeeding,
Intra-SURGerY High-resolution Specimen PET/CT Imager for Margin Assessment in Early-stage Breast Cancer
NCT06474975
Not yet recruiting
Conditions Breast Cancer, Breast-conserving Surgery
Phase NA
Enrollment 150
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • AURA 10 PET/CT

Primary Outcomes

  • Evaluation of the accuracy to detect positive invasive margins in IDC patients
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: 2024-07
Completion: 2026-07
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: European Institute of Oncology
Principal Investigators:
  • Francesco Ceci (PRINCIPAL_INVESTIGATOR) - European Institute of Oncology
Contact Information
Study Contact:
Francesco Ceci, MD
+390257489315
francesco.ceci@ieo.it
Francesco Mattana
+390257489315
francesco.mattana@ieo.it
Interventions
  • AURA 10 PET/CT
Study Locations (1 sites)
European Institute of Oncology, Milan, Italy
Eligibility Criteria
Inclusion Criteria: * females with an age over 18 years; * confirmed breast cancer with indication to undergo BCS (stage I-II with tumor ≤2.5 in greatest dimension); * vacuum-assisted core breast biopsy is allowed for non-invasive tumors only; * able to understand treatment protocol and informed consent form; * estimated by the investigator to be compliant for study participation. Exclusion Criteria: * general or local contra-indication for BCS; * previous breast surgery; * inflammatory breast cancer; * radiotherapy of the ipsilateral breast; * vacuum-assisted core breast biopsy for all patients with invasive tumors (vacuum-assisted core breast biopsy is allowed for patients with non-invasive tumors as long as the residual tumor size on mammogram is at least 1.0 cm); * pregnancy or lactation; * participation in other clinical studies with a radiation exposure of more than 1 mSv in the past year; * active bacterial, viral or fungal infection.
Taiwan Severe Asthma Biologic Registry
NCT06456450
Recruiting
Conditions Pulmonary Disease, Asthma
Phase Not Applicable
Enrollment 500
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Biological Treatment for severe asthma patients

Primary Outcomes

  • Status of Asthma Control
  • Status of Asthma exacerbations
  • Reduction of daily oral corticosteriod dose
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2023-11-11
Completion: 2043-02-28
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Taichung Veterans General Hospital
Collaborators: E-DA Hospital, National Cheng-Kung University Hospital, National Yang Ming Chiao Tung University Hospital, Chang Gung Memorial Hospital
Contact Information
Study Contact:
Pin-Kuei Fu, MD.,PhD.
886-4-23592525
yetquen@gmail.com
Interventions
  • Biological Treatment for severe asthma patients
Study Locations (1 sites)
Taichung Veterans General Hospital, Taichung, 40705 Taiwan
Eligibility Criteria
Inclusion Criteria: * Provision of informed consent prior to any study specific procedures. * Patient should be reviewed as well as confirmed by the National Health Insurance Administration (NHIA) or by the study board member as a Severe Asthma case. * Female and male aged over 18 years old. * Patients who are treated either with omalizumab, mepolizumab, or benralizumab after January 1, 2020. Exclusion Criteria: * Lack of informed consent for participation. * History of Biologic usage before January 1, 2020, should be ruled out. * The washout period should be at least 12 months. In other words, the enrolled patients should have no experience in receiving a biological treatment or in participating relative clinical trial before his/her biologic initiation. * Comorbid pulmonary diseases (e.g.: Chronic Obstructive Pulmonary Disease, Bronchiectasis, Pulmonary Fibrosis, etc.) or risk factors (e.g.: smoking or environmental exposure, etc..) that could be associated with pulmonary or systemic diseases, other than Asthma.
Cultural Adaptation of EMDR for Major Depressive Disorder and Compaire Its Online and Face-to-Face Testing
NCT06439043
Recruiting
Conditions Major Depressive Disorder 1
Phase NA
Enrollment 90
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • EMDR Psychotherapy
  • Online EMDR Psychotherapy

Primary Outcomes

  • Major Depressive Disorder
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-01-01
Completion: 2025-09-30
Eligibility
Age: 20 Years
Sex: ALL
Volunteers: true
Enrollment: 90 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Khushal Khan Khattak Univeristy, Karak, Pakistan
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • EMDR Psychotherapy
  • Online EMDR Psychotherapy
Study Locations (1 sites)
KKKUk, Kohat, 27200 Pakistan
Eligibility Criteria
Inclusion Criteria: 1. The patient should exhibit symptoms of Major Depressive Disorder. 2. Male and female patients will be chosen equally. 3. Patients between the ages of 20 and 50 will be selected. 4. Patients should preferable be "treatment-naïve," meaning they have no recent history of any psychotherapy or medication. Exclusion Criteria: a. There must be no significant neuropsychological or cognitive disorders among the patients
Psilocybin Therapy for Depression in Parkinson's Disease
NCT06455293
Recruiting
Conditions Parkinson Disease, Depression
Phase PHASE2
Enrollment 60
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Psilocybin
  • Pimavanserin

Primary Outcomes

  • Evaluate the efficacy of psilocybin for improving depression in people living with Parkinson's disease
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-08-19
Completion: 2028-06
Eligibility
Age: 40 Years
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Joshua Woolley, MD, PhD
Principal Investigators:
  • Joshua Woolley, MD,PhD (PRINCIPAL_INVESTIGATOR) - University of California, San Francisco
  • Ellen Bradley, MD (PRINCIPAL_INVESTIGATOR) - University of California, San Francisco
Contact Information
Study Contact:
Brigette Sosa
(415) 935-3489
pdp2@ucsf.edu
Ellen Bradley, MD
Interventions
  • Psilocybin
  • Pimavanserin
Study Locations (1 sites)
University of California, San Francisco, San Francisco, California 94143 United States
Eligibility Criteria
Inclusion Criteria: * Age 40 to 80 * Comfortable speaking and writing in English * Have neurologist-diagnosed idiopathic Parkinson's disease (PD), Hoehn and Yahr stages 1 to 3 during an "on" phase (time when medication/DBS for parkinsonian motor feature, including bradykinesia and rigidity is in effect) * Currently experiencing depressive symptoms * Able to attend all in-person visits at UCSF as well as virtual visits * Have a primary care provider, neurologist, or psychiatrist who is actively managing or coordinating Exclusion Criteria: * Psychotic symptoms involving loss of insight * Significant cognitive impairment * Regular use of medications that may have problematic interactions with psilocybin * A health condition that makes this study unsafe or unfeasible, determined by study physicians
Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders
NCT06450704
Recruiting
Conditions Major Depressive Disorder, Inflammatory ...
Phase NA
Enrollment 124
Locations 5 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Physical Exercise
  • Antidepressant medication (ADM)

Primary Outcomes

  • Inflammatory and oxidative stress biomarkers
  • Brain imaging
  • Clinical evaluation
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-04-21
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 124 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Collaborators: Hospital Universitario La Paz, Hospital Universitario Ramon y Cajal, Hospital Universitario Principe de Asturias, Quirón Madrid University Hospital, Universidad Autonoma de Madrid, Centro de Investigación Biomédica en Red de Salud Mental, Puerta de Hierro University Hospital
Principal Investigators:
  • Pilar López García, PhD (PRINCIPAL_INVESTIGATOR) - Universidad Autonoma de Madrid
Contact Information
Study Contact:
Javier Gómez Cumplido, PT, MSc
(+34) 633467602
javier.gomezc@uam.es
Pilar López García, PhD
(+34) 91 497 54 48
p.lopez@uam.es
Interventions
  • Physical Exercise
  • Antidepressant medication (ADM)
Study Locations (5 sites)
Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Madrid 28805 Spain
Hospital Universitario de La Princesa, Madrid, Madrid 28006 Spain
Hospital Universitario Ramón y Cajal, Madrid, Madrid 28034 Spain
Hospital Universitario La Paz, Madrid, Madrid 28046 Spain
Hospital Universitario Puerta de Hierro-Majadahonda, Majadahonda, Madrid 28222 Spain
Eligibility Criteria
Inclusion Criteria: * A diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria (through the Mini International Neuropsychiatric Interview (MINI) * Severity of depression according to the Hamilton Depression Rating Scale 17 items (HAM-D17): minimum of 14 cut-off score of moderate depression. * Outpatient clinical care. * Current antidepressant treatment that will be maintained during the 12 weeks of the physical exercise intervention. Exclusion Criteria: * Diagnosis of any axis I diagnosis except for MDD; * Contraindications for Magnetic Resonance Imaging. * Antiinflammatory treatments or antibiotics within the week before randomisation. * Vaccines within the month before randomisation. * Fever (\>38ºC) at the moment of study entry. * Pregnant women. * Alcohol or drug abuse.
Adapting and Piloting Acceptance and Commitment Therapy (ACT) for Severe Premenstrual Mood Symptoms
NCT06462391
Active, positions filled
Conditions Premenstrual Dysphoric Disorder, Premens...
Phase NA
Enrollment 50
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Acceptance and Commitment Therapy (ACT) Group

Primary Outcomes

  • Feasibility of recruitment and enrollment: number of participants referred
  • Feasibility of recruitment and enrollment: number of participants eligible
  • Feasibility of recruitment and enrollment to study: number of participants enrolled
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: 2024-12-01
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Women's College Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Acceptance and Commitment Therapy (ACT) Group
Study Locations (2 sites)
Women's College Hospital, Toronto, Ontario L5M6N8 Canada
Women's College Hospital, Toronto, Ontario M5S 1B2 Canada
Eligibility Criteria
Inclusion Criteria: * (1) diagnosed by the psychiatrist who conducted the initial assessment with either Premenstrual Dysphoric Disorder (PMDD), or a bipolar or depressive disorder where there is Premenstrual Exacerbation (PME), after 2-3 months of mood tracking using a validated evidenced based scale for premenstrual mood symptoms (McMaster Premenstrual And Mood Symptom Scale (MAC-PMSS) or similar; * (2) have internet access and a video-enabled device; * (3) residing in Ontario for the duration of the study, necessary because MDs and therapists who could deliver the intervention are all licensed provincially; * (4) regular menstrual cycles (\~21-35 days); and * (5) have a regularly treating physician (e.g. psychiatrist or primary care provider). Exclusion Criteria: * (1) active alcohol or substance use disorder in the previous 12 months; * (2) active suicidal ideation, mania, psychosis, or violence; * (3) current pregnancy or planning a pregnancy during the duration of the study * (4) inability to complete group and/or study measures in English, necessary as the pilot group is only available in English at this time.
Identification of Depressive and Anxiety Symptoms Among a Sample of Emergency Department Patients Using Artificial Intelligence (AI) Technology
NCT06473558
Not yet recruiting
Conditions Artificial Intelligence (AI)
Phase NA
Enrollment 30
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Biometrics (or AI Biomaker)

Primary Outcomes

  • Percentage of participants who score 5-9 on the PHQ-9
  • Percentage of participants who score 10-14 on the PHQ-9
  • Percentage of participants who score 15-19 on the PHQ-9
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: 2026-07-01
Completion: 2027-02-28
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospitals Cleveland Medical Center
Principal Investigators:
  • Kiran Faryar, MD, MPH (PRINCIPAL_INVESTIGATOR) - University Hospitals
Contact Information
Study Contact:
Andie M Moore, MS
(216) 286 - 7239
andie.moore@uhhospitals.org
Interventions
  • Biometrics (or AI Biomaker)
Study Locations (1 sites)
University Hospitals ED, Cleveland, Ohio 44106 United States
Eligibility Criteria
Inclusion Criteria: * Adult patients (age 18 and over) who presents to the UHCMC ED voluntarily with no obvious psychological disturbance by self-report or nurse/provider initial assessment * English-speaking * Patients with non-emergent concerns of Emergency Severity Index (ESI) level 3, 4, or 5 Exclusion Criteria: * Prisoners * Patients who are deemed to be critically ill (including life or limb threatening illness) or unable to consent * Non-English Speaking
A Study to Evaluate the Long-term Safety, Pharmacodynamics and Efficacy of SHR-1703 in Eosinophilic Asthma Patients
NCT06441812
Recruiting
Conditions Eosinophilic Asthma Patients
Phase PHASE2
Enrollment 200
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • SHR-1703 Injection

Primary Outcomes

  • Adverse Events in main peroid,about 1 year
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-07-19
Completion: 2028-09
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Contact Information
Study Contact:
Tianqi Zheng
+0518-81220121
tianqi.zheng.tz6@hengrui.com
Interventions
  • SHR-1703 Injection
Study Locations (1 sites)
West China Hospital of Sichuan University, Chengdu, Sichuan 610041 China
Eligibility Criteria
Inclusion Criteria: 1. At least 18 years of age, Male or Femal. 2. A minimum weight of 40kg. 3. Subjects with the clinical features of asthma that meets the diagnostic criteria of the "Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 Edition)" and has a medical history of at least 1 year. 4. Documentation of current asthma controller medication \[medium or high dose ICS and at least one of additional controller such as long-acting muscarinic antagonist (LAMA), long-acting beta2-agonist (LABA) and leukotriene receptor antagonist (LTRA)\] for at least 1 stable month before first administration of SHR-1703. 5. At least one confirmed history of exacerbation within one year of initial administration of SHR-1703, occurring during the use of medium and high daily dose ICS. 6. Absolute count of eosinophils must be ≥0.15×109/L at visit 0 and visit 1. 7. A pre-bronchodilator FEV1 \<85% and ≥30% predicted at visit 0 and visit 1. 8. Female subjects with fertility agree to have no plan pregnancy and voluntarily adopt high-efficiency contraception measures from signing the informed consent form to 14 months after the last dose of SHR-1703, and male subjects with fertility as partners agree to have no plan pregnancy and voluntarily adopt high-efficiency contraception measures between the first dose of SHR-1703 and the last visit in the study. 9. Subjects must be able to give written informed consent prior to participation in the study. Exclusion Criteria: 1. Presence of a clinically important lung condition. This includes but is not limited to current infection, bronchiectasis, pulmonary fibrosis or a history of lung cancer. 2. A known immunodeficiency. 3. Presence of a clinically significant and uncontrolled serious cardiovascular and cerebrovascular disease, including but not limited to myocardial infarction, unstable angina, heart failure, stroke, and subarachnoid haemorrhage. 4. Within the first 4 weeks before visit 0, presence of exacerbation of allergic rhinitis or sinusitis, or a history of infections with clinical significance and/or requiring clinical intervention, including but not limited to respiratory infections. 5. A known parasitic infection within the first 6 months before visit 0. 6. A malignancy history within the first 5 years before visit 0 (Subjects that had localized basal carcinoma of the skin or cervical carcinoma in situ which was resected for cure will not be excluded). 7. Blood donation or significant blood loss (≥ 400ml) within the first 4 weeks before visit 0, or infusion of blood products or immunoglobulins. 8. Use systemic immunosuppressants (excluding systemic glucocorticoids used for asthma treatment and for non asthma treatment for less than 3 days) or immunomodulators, or biologics or Th2 cytokine inhibitors, including but not limited to methotrexate, cyclosporine, interferon-α, anti IL-5 monoclonal antibodies (including SHR-1703), anti IL-4R monoclonal antibodies, anti TSLP monoclonal antibodies, anti IgE monoclonal antibodies, metformin, etc., and within 5 half-lives of the drug before the first administration (refer to the longer drug instructions; for those with unknown half-lives, 12 weeks before the first administration shall prevail); 9. Subjects who have previously participated in any study and received Investigational Product within the first 30 days before visit 0. 10. There was a surgical plan or other treatment measures that the researcher believed may affect the subject's evaluation during the study period. 11. Laboratory examination shows obvious abnormalities at visit 0 and visit 1: 1. White blood cell count (WBC) \<3.0×109/L; 2. Hemoglobin≤90g/L; 3. Platelet\<100×109/L; 4. Alanine aminotransferase (ALT)\>2×ULN (upper limit of normal); 5. Aspartate aminotransferase (AST) \>2×ULN; 6. Total bilirubin (TBIL)\>1.5×ULN; 7. Prothrombin time (PT) \>ULN+3s; 8. Creatinin\>1.5×ULN; 9. Active hepatitis B (positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) in peripheral blood), or positive for hepatitis C virus antibody, or positive for human immunodeficiency virus (HIV) antibody, or positive for treponema pallidum antibody; 12. ECG QTc\>450ms or other clinically significant abnormal results that may pose significant safety risks to the subjects at visit 0 or visit 1; 13. A history of drug addicts or substance abuse within 1 years prior to Visit 0; 14. Subjects who are pregnant (positive HCG test at visit 0 or visit 1) or breastfeeding should not be enrolled if they plan to become pregnant during the time of study participation; 15. Subjects with a known allergy or intolerance to anti IL-5 monoclonal antibody or other biologic; 16. Other reasons determined by the researcher as unsuitable for participation in the study.
Efficacy and Safety of Low-dose Laser Acupuncture on Treating Insomnia Associated With Major Depressive Disorder
NCT06443242
Not yet recruiting
Conditions Major Depressive Disorder, Insomnia
Phase NA
Enrollment 120
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Low-Dose Laser Acupuncture (LLA)
  • Sham Laser Acupuncture (SLA)

Primary Outcomes

  • Change in sleep quality from pre-treatment assessed by the Pittsburgh Sleep Quality Index (PSQI) score at immediately post-treatment and 12 weeks post-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: 2025-12-01
Completion: 2027-08-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Mohammad Farris Iman Leong Bin Abdullah
Collaborators: Henan Medical University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Low-Dose Laser Acupuncture (LLA)
  • Sham Laser Acupuncture (SLA)
Eligibility Criteria
Inclusion Criteria: 1. Inpatients with a diagnosis of major depressive disorder (diagnosed according to the relevant diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders-V). 2. Male or female, 18 to 60 years of age. 3. Participants complaining of insomnia at initial screening. 4. PSQI score over 7. 5. HAMD score between 20 and 35. 6. No use of hypnotic medication or acupuncture treatment within the last month. 7. No cognitive or communication disorders. 8. Willingness to accept random group assignment and sign an informed consent form. 9. Those who have been on stable dose of antidepressant for at least the most recent two weeks and willing to maintain on the same dosage throughout the study. Exclusion Criteria: 1. Individuals with a marked tendency towards suicide, as assessed by a specialist; 2. Individuals previously diagnosed with schizophrenia, bipolar disorder, or other psychiatric disorders; 3. Individuals with severe alcohol or drug abuse issues; 4. Individuals with liver or kidney dysfunction, or with uncontrollable tumors or significant cerebrovascular diseases; 5. Women who are pregnant or breastfeeding; 6. Individuals likely to have poor compliance or who are fearful of acupuncture treatment.
STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma
NCT06465485
Active, positions filled
Conditions Severe Eosinophilic Asthma
Phase PHASE3
Enrollment 504
Locations 74 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Benralizumab

Primary Outcomes

  • To assess the potential for benralizumab treated patients to reduce their standard of care asthma controller regimen in the overall patient population and by subgroups of baseline background therapy Subgroups of background therapy
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Active, positions filled
Start Date: 2024-02-28
Completion: 2026-05-29
Eligibility
Age: 12 Years
Sex: ALL
Volunteers: false
Enrollment: 504 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: AstraZeneca
Principal Investigators:
  • Min Zhang, Professor (PRINCIPAL_INVESTIGATOR) - ShangHai First General Hospital
  • HuaHao Shen, Professor (PRINCIPAL_INVESTIGATOR) - Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Benralizumab
Study Locations (74 sites)
Research Site, Beijing, 100020 China
Research Site, Beijing, 100029 China
Research Site, Beijing, 100191 China
Research Site, Beijing, 100730 China
Research Site, Changsha, 410005 China
Research Site, Changsha, 410008 China
Research Site, Changsha, 410011 China
Research Site, Chengdu, 610014 China
Research Site, Chengdu, 610021 China
Research Site, Chengdu, 610041 China
Eligibility Criteria
Informed Consent 1.Provision of informed consent prior to any study-specific procedures. Written informed consent, and assent when applicable for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent\[s\]/guardian\[s\]) and according to international guidelines and/or applicable local guidelines. Age 2. Patient must be aged 12-75 years old, inclusively, at the time of Visit 1(Week -1 to Week 0) For those patients, who are 17 on the day of Visit 1(Week -1 to Week 0) but will turn 18 after this day, will be considered an adolescent for the purposes of this study. Type of Patient and Disease Characteristics 3. Documented history of physician-diagnosed asthma prior to Visit 1 * Documented post-bronchodilator (post-BD) reversibility in FEV1 of ≥12% and ≥200 mL in FEV1 or positive result of branchial provocation test within 12 months prior to Visit 1. If historical documentation is not available, reversibility must be demonstrated and documented at Visit 1. * Prior to screening (Visit 1, Week -1 to Week 0), patients must have either a documented asthma diagnosis for \>6 months or a history of ICS/LABA use for \>6 months. 4\. Documented diagnosis of severe eosinophilic asthma (EOS≥150 cells/μL at enrollment, and if EOS 150-\<300 cells/μL at enrollment, must have EOS≥300 cells/μL at sometime within 1 year before enrollment) 5. Documented current maintenance treatment with MD/HD ICS + LABA with up to one additional controller * Other acceptable asthma controller includes LTRA and LAMA 6. On stable MD/HD ICS(\>250μg fluticasone propionate dry powder formulation equivalents total daily dose) + LABA for ≥2 months prior to enrollment (see Appendix F for medium and high daily ICS doses by formulation) 7. For patients on MD ICS/LABA, stable LTRA or LAMA (≥2 weeks) is allowed 8. Documented at least one exacerbation in the year prior to enrolment * A qualifying historical asthma exacerbation is a symptomatic worsening requiring systemic corticosteroid (i.e., oral, intravenous (IV) or intramuscular; any healthcare setting or temporary increase from a stable maintenance dose of oral corticosteroid) or that resulted in hospitalization or emergency room/urgent care visit. * Source documentation is required for physician-diagnosed asthma, ICS-LABA use and asthma exacerbations over the prior year. A patient verbal history suggestive of asthma symptoms and/or prior asthma exacerbations, but without supporting documentation, is not sufficient to satisfy these inclusion criteria. * Examples of acceptable documentation of the asthma disease state and prior asthma exacerbations include clinic visit (primary or specialist Health care provider (HCP)), emergency room/urgent care, or hospital records listing asthma as a current problem, plus documentation of at least 1 asthma exacerbations during the 12 months prior to ICF. Weight 9. Weight of ≥40 kg. Sex and Contraceptive/Barrier Requirements 10. Male and/or female Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Female patients: * Females not of childbearing potential are defined as females who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Females will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to Visit 1(Week -1 to Week 0) without an alternative medical cause. The following age-specific requirements apply: * Females \< 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and FSH levels in the postmenopausal range. * Females ≥ 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment. * Female patients of childbearing potential must use one highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. Females of childbearing potential who are sexually active with a non-sterilised male partner must agree to use one highly effective method of birth control, as defined below, from enrolment throughout the study and until at least 12 weeks after last dose of study intervention. Cessation of contraception after this point should be discussed with a responsible physician. * The following are not acceptable methods of contraception: periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea. Female condom and male condom should not be used together. * All WOCBP must have a negative serum pregnancy test result at Visit 1(Week -1 to Week 0). * Highly effective birth control methods include: Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the patient (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments) \[(periodic abstinence eg, calendar, ovulation,symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to study intervention, and withdrawal are not acceptable methods of contraception\], a vasectomised partner, Implanon®, bilateral tubal occlusion, intrauterine device/levonorgestrel intrauterine system, Depo-Provera™ injections, oral contraceptive, and Evra Patch™, Xulane™, or NuvaRing®.
Effect of Henagliflozein on Hepatic Fat Content in Patients With T2DM and NAFLD
NCT06449833
Recruiting
Conditions Type2 Diabetes Mellitus, Nonalcoholic Fa...
Phase PHASE4
Enrollment 100
Locations 1 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Henagliflozein and Metformin
  • Linagliptin and Metformin

Primary Outcomes

  • The difference of liver fat content (magnetic resonance imaging proton density fat fraction,MRI-PDFF)) between the subjects and the control group.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2024-06
Completion: 2026-11
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Zhujiang Hospital
Principal Investigators:
  • Hong Chen, MD (PRINCIPAL_INVESTIGATOR) - Zhujiang Hospital
Contact Information
Study Contact:
Hong Chen, MD
13602759769
rubychq@163.com
Interventions
  • Henagliflozein and Metformin
  • Linagliptin and Metformin
Study Locations (1 sites)
Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong 510000 China
Eligibility Criteria
Inclusion Criteria: 1. Patients diagnosed with type 2 diabetes within 5 years (According to the diagnostic criteria of WHO Diabetes Classification 2019) 2. Patients who are aware of the purpose of the trail, willing to participate in the trial and sign informed consent forms, and comply with all requirements (including those during follow-up and evaluation investigations) 3. Well-controlled blood glucose through diet and exercise intervention, or stable treatment with 1 or 2 types of hypoglycemic drugs (metformin, sulfonylurea, glinide, α-glycosidase inhibitor ) for at least 8 weeks with a half or full recommended maximum tolerated dose in instructions. 4. HbA1c: 7.0%-8.5% 5. Patients diagnosed with non-alcoholic fatty liver disease (According to the diagnostic criteria of Guidelines for Diagnosis and Treatment of Non-alcoholic Fatty Liver Disease 2010) Exclusion Criteria: 1. Patients with type 1 diabetes, gestational diabetes or other special types of diabetes; 2. Patients with any acute, chronic complication or risk that may cause greater adverse effects than benefits through the trial; or receiving other treatment currently that may affect subjects' compliance or the objectivity of the end point of this trial; (1)Patients with serious acute complications of diabetes in the past 6 months (Eg. diabetic ketoacidosis, hyperosmotic hyperglycemia coma); (2)Patients with unstable proliferative retinopathy or maculopathy,severe diabetic neuropathy, intermittent claudication or diabetic foot in the past 6 months; (3)Patients with serious liver dysfunction and chronic kidney disease or disease of other systems (Eg. Acute and chronic pancreatitis, liver cirrhosis, nephrotic syndrome ect. ); and those who do not meet the requirements after being evaluated by professionals; (4)Have a history of myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, or underwent coronary angioplasty, percutaneous coronary stenting or coronary artery bypass grafting 6 months before the screening; or screening for congestive heart failure (New York Heart Association NYHA grade III and IV), unstable or acute congestive heart failure, or persistent arrhythmias believed to be life-threatening within the first 6 months of the trail; (5)Have a history of hemorrhagic stroke or ischemic stroke in the past 6 months, and was evaluated by the researchers as not suitable to participate in this clinical trial; (6)Have a history of hypertension and was not effectively controlled before screening: systolic blood pressure (SBP) ≥ 160mmHg and / or diastolic blood pressure (DBP) ≥ 100mmHg; 3. Have a history of other endocrine system diseases which affect glucose and lipid metabolism or have an effect on the body weight, such as: multiple endocrine adenomatosis, acromegaly, Cushing syndrome, hyperthyroidism; 4. Have a history of malignant tumour within 5 years before screening, except for local basal cell carcinoma of the skin after treatment; 5. Have a history of severe infection, trauma or major surgery within 3 months; 6. Have a history of drug abuse with 5 years, including repeated use of dependence-producing drug unrelated to medical purposes, including addictive and habitual drugs leading to physical and psychic dependence; 7. Have a history of participating any intervention drug or instrumental clinical trial 3 months before screening; 8. Have a history of severe anemia or need regular blood transfusion treatment; 9. Have a history of any medication or treatment below: (1)Using drugs that may cause weight change 90 days before screening, including diuretics, weight-loss drug etc.; (2)Using drugs that may affect blood glucose for \>1 week within 12 weeks, such as oral/intravenous glucocorticoid, growth hormone, estrogen/progesterone, high-dose diuretics, antipsychotic drugs, etc., but low-dose diuretics for antihypertensive purposes (hydrochlorothiazide \< 25mg/d, indapamide \< 1.5 mg/d) are not included in this restriction; (3)Had bariatric sugery or planning to have bariatric surgery; 10.The laboratory results of patients meet the following standards: 1. AlanineAminotransferase(ALT)and/oraspartateaminotransferase(AST) higher than 5 times of the upper limit of the normal value. 2. Glomerular Filtration Rate (eGFR) estimated by CKD-EPI formula \< 40mL/ (min·1.73m2); 11.Patients are currently pregnant, breastfeeding or planning a pregnancy; 12.Have a history of infectious diseases such as hepatitis B (HBs-Ag), hepatitis C (HCV-Ab), pulmonary tuberculosis or sexually transmitted active diseases such as HIV and syphilis; 13.Have a history of using anti-NASH drugs (vitamin E, ursodeoxycholic acid, s-Adenosylmethionine, betaine, silymarin, gemdibrozil, anti-TNF therapy, probiotics, ect.) within 3 months before random grouping; 14.Having structural and functional genitourinary abnormalities prone to cause genitourinary infection; 15.Patients with abnormal hematologic system or any diseases that may cause hemolysis or unstable erythrocyte; 16.Have a history of using immunomodulators, such as biological agents, cyclophosphamide, cyclosporine, etc.; 17.Patients with MRI incompatible metal or magnetic implant, device or materials.
3D Structural Imaging of Human Breast Tissues
NCT06454214
Not yet recruiting
Conditions Human Breast Tissues
Phase Not Applicable
Enrollment 100
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Multi-photon microscopy

Primary Outcomes

  • Accuracy dependency on staining dye selection
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: 2024-07-01
Completion: 2027-06-04
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: National Taiwan University Hospital
Contact Information
Study Contact:
Ming-Yang Wang, PhD
+886-23123456
A00581@ntucc.gov.tw
Yao-Chen Tseng, Master
+886-33661552
opiuy1234567@yahoo.com.tw
Interventions
  • Multi-photon microscopy
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 and above. * Patients clinically diagnosed with breast cancer. Exclusion Criteria: * Patients unable to provide consent (e.g., inability to speak, inability to communicate in Chinese, etc.). * Patients for whom a definitive pathological diagnosis cannot be established. * Patients suitable only for biopsy and not for surgical excision. * Excised tissue showing severe radiation-induced changes under pathological examination. * Tumor specimens smaller than 1 cm. * Patients with ductal carcinoma in situ (DCIS).
The Ameliorative Effects of GLP-1RA on Diabetic Cardiac Autonomatic Neuropathy
NCT06461377
Recruiting
Conditions Type 2 Diabetes, Diabetes With Diabetic ...
Phase PHASE4
Enrollment 50
Locations 1 sites
Compensation paid available
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Glucagon-like peptide-1 receptor agonist:Semaglutide

Primary Outcomes

  • heart rate variability(HRV)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2024-06-13
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
Principal Investigators:
  • jianbo Li, MD/PhD (PRINCIPAL_INVESTIGATOR) - First Affiliated Hospital,Nanjing Medical University,China
Contact Information
Study Contact:
jianbo Li, MD/PhD
13951750648
ljbzjlx18@aliyun.com
Interventions
  • Glucagon-like peptide-1 receptor agonist:Semaglutide
Study Locations (1 sites)
the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029 China
Eligibility Criteria
Inclusion Criteria: 1. Patients aged 18-70 years 2. Patients with T2DM who meet the diagnostic guidelines 3. The patient signed the relevant informed consent form 4. Being overweight or obese Exclusion Criteria: 1. \<18 years old 2. Pregnant or lactating women 3. Acute and chronic pancreatitis 4. Recent acute complications of diabetes 5. Arrhythmia or taking drugs that affect heart rate 6. Thyroid disease 7. Severe organ dysfunction 8. Denial of informed consen
Interoceptive Intervention for Pulmonary Hypertension
NCT06443580
Recruiting
Conditions Interoception, Pulmonary Hypertension
Phase NA
Enrollment 32
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • interoceptive group based intervention

Primary Outcomes

  • Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-06-17
Completion: 2025-10-18
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 32 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Golden Jubilee National Hospital
Contact Information
Study Contact:
Derick Moore
+44 07805511803
2021489m@student.gla.ac.uk
Lynne Johnston, Doctorate Clinical Psychology
lynne.johnston4@gjnh.scot.nhs.uk
Interventions
  • interoceptive group based intervention
Study Locations (1 sites)
Golden Jubilee National Hospital, Glasgow, Clydebank g81 4dy United Kingdom
Eligibility Criteria
Inclusion Criteria: * Participants will be patients under the care of the Scottish Pulmonary Vascular Unit (SPVU) at the Golden Jubilee University National Hospital (GJUNH). * Diagnosed with any type of PH. * Adults over 18 years. * Fluent in English. * Able to commit to the duration of the research (expected to be three months from initial recruitment to the end of treatment). Exclusion Criteria: * Individuals with current thoughts of self-harm or suicide. * Presenting with comorbid alcohol or substance misuse. * Currently engaging in any additional psychological interventions at the time of the study.
A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma
NCT06471257
Recruiting
Conditions Asthma
Phase PHASE3
Enrollment 790
Locations 102 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Budesonide/Albuterol metered dose inhaler, MDI
  • Albuterol sulfate metered dose inhaler, MDI

Primary Outcomes

  • Time to first severe asthma exacerbation
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2024-06-17
Completion: 2026-10-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 790 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: AstraZeneca
Contact Information
Study Contact:
AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com
Interventions
  • Budesonide/Albuterol metered dose inhaler, MDI
  • Albuterol sulfate metered dose inhaler, MDI
Study Locations (102 sites)
Research Site, Baotou, 014010 China
Research Site, Baotou, 14010 China
Research Site, Beijing, 100020 China
Research Site, Beijing, 100029 China
Research Site, Beijing, 100039 China
Research Site, Beijing, 100191 China
Research Site, Changchun, 130021 China
Research Site, Changchun, 130041 China
Research Site, Changsha, 410005 China
Research Site, Changsha, 410015 China
Eligibility Criteria
Inclusion Criteria: 1. Documented physician-diagnosed asthma for at least 12 months prior to Visit 1 2. Receiving 1 of the scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1 3. Pre-bronchodilator FEV1 of ≥ 40% to \< 90% predicted normal value for adults. 4. Documented reversibility to albuterol 5. A documented history of at least one severe asthma exacerbation within 12 months before Visit 1 6. ACQ-7 score ≥ 1.5 assessed at Visit 1 7. ACQ-5 score ≥ 1.5 assessed at Visit 2 8. Receiving inhaled SABA as needed prior to Visit 1 for at least 3 months 9. Use of Sponsor-provided salbutamol sulfate inhalation aerosol as needed medication due to asthma symptoms on at least 3 days during the last week of the run-in period before Visit 2 10. Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited 11. Able to perform acceptable and reproducible PEF measurements as assessed by the investigator 12. BMI \< 40 kg/m2 13. Negative pregnancy test (urine at Visit 1) for female participants of childbearing potential 14. Women of childbearing potential must agree to prevent pregnancy 15. Compliance: must be willing to remain at the study site as required per protocol and complete all visit assessments Exclusion Criteria: 1. Chronic obstructive pulmonary disease or other significant lung disease 2. Oral/SCS use (any dose) within 6 weeks before Visit 1 3. Chronic use of OCS ≥ 3 weeks use in 3 months prior to Visit 1 4. Having received any marketed or investigational biologic within 3 months or 5 half-lives before Visit 1, whichever is longer, or any other prohibited medication 5. Current smokers, former smokers with \> 10 pack-years history, or former smokers who stopped smoking \< 6 months before Visit 1 6. Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within last 5 years of Visit 1 7. Completed treatment for lower respiratory infection or asthma exacerbation within 6 weeks of Visit 1 8. Upper respiratory infection involving antibiotic treatment not resolved within 7 days before Visit 1 9. Clinically significant laboratory abnormalities 10. Historical or current evidence of a clinically significant disease 11. Cancer not in complete remission for at least 5 years before Visit 1 12. History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity 13. Have a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients 14. Inability to abstain from protocol-defined prohibited medications during the study 15. Having received a live attenuated vaccination within 7 days of Visit 1 16. Currently pregnant or breastfeeding 17. Participants who experience \> 1 asthma exacerbation during the screening period
Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy
NCT06449222
Active, positions filled
Conditions Locally Advanced Breast Cancer, Triple N...
Phase PHASE2
Enrollment 83
Locations 31 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • BNT327 Dose Level 1 (DL1)
  • BNT327 Dose Level 1 (DL2)
  • Nab-placlitaxel
  • Carboplatin
  • Gemcitabine

Primary Outcomes

  • Occurrence of treatment emergent adverse events (TEAEs), adverse events of special interest (AESIs), treatment emergent serious adverse events (SAEs)
  • Occurrence of dose interruption, dose reduction, and discontinuation of study treatment due to adverse events (AEs)
  • Objective Response Rate (ORR)
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: 2024-08-26
Completion: 2029-06
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 83 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: BioNTech SE
Collaborators: Bristol-Myers Squibb
Principal Investigators:
  • BioNTech Responsible Person (STUDY_DIRECTOR) - BioNTech SE
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • BNT327 Dose Level 1 (DL1)
  • BNT327 Dose Level 1 (DL2)
  • Nab-placlitaxel
  • Carboplatin
  • Gemcitabine
Study Locations (31 sites)
Beverly Hills Cancer Center, Beverly Hills, California 90211 United States
Valkyrie Clinical Trials, Los Angeles, California 90067 United States
Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center, Palo Alto, California 94304-2201 United States
Saint John's Health Center - John Wayne Cancer Institute (JWCI), Santa Monica, California 90404-2312 United States
Rocky Mountain Cancer Centers (RMCC), Denver, Colorado 80220 United States
Yale University - Yale Cancer Center, New Haven, Connecticut 06520 United States
Carle Foundation Hospital d/b/a Carle Cancer Center, Urbana, Illinois 61801 United States
HealthPartners Regions Specialty Clinics, Saint Louis Park, Minnesota 55426 United States
Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey), New Brunswick, New Jersey 08901 United States
Stony Brook University Hospital, Stony Brook, New York 11794 United States
Eligibility Criteria
Inclusion Criteria: * Have given informed consent by signing and dating an informed consent form before initiation of any study-specific procedures. * Male or female, aged ≥18 years at the time of giving informed consent. * Are willing and able to comply with scheduled visits, the treatment schedule, the planned study assessments (including participant completed diaries) and other requirements of the study. This includes that they are able to understand and follow study-related instructions. * Have confirmed locally recurrent inoperable or mTNBC as defined by the most recent American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) guidelines. Note, participants initially diagnosed with hormone receptor-positive and/or HER2-positive breast cancer must have histological confirmation of TNBC in a tumor biopsy obtained from a local recurrence or distant metastasis site. * Systemic treatment naïve locally advanced/metastatic participants are eligible if: * They have received no prior systemic therapy in the locally advanced unresectable/metastatic setting including chemotherapy, immunotherapy, or investigational agents. * They have completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months has elapsed between the completion of treatment with curative intent (e.g., date of primary breast tumor surgery or date of last adjuvant chemotherapy administration, or date of last radiation therapy, whichever occurred last) and first documented local or distant disease recurrence. This also includes participants initially diagnosed with hormone receptor-positive and/or HER2-positive breast cancer prior to TNBC diagnosis. * Participants who received one prior systemic therapy in the locally advanced/metastatic setting are eligible if: * They have received one systemic chemotherapy in the metastatic setting and have progressed on first line therapy. Radiographic progression must have been documented. Radiographic progression is defined as unequivocal progression of existing tumor lesions or developing new tumor lesions as assessed by the investigator. * They have had a recurrence-free interval of ≥6 months if they have received treatment with curative intent in the past. A recurrence-free interval of ≥6 months is required for all participants (both first- and second-line treatment settings) who have received prior treatment for breast cancer with curative intent. * Have provided a tissue sample, archival or fresh, during the screening period (bone biopsies, fine needle aspiration biopsies, and samples from pleural or peritoneal fluid are not acceptable; participants with only one target lesion are not eligible to provide a biopsy). If an archival tumor sample is not available, the participant must undergo a fresh biopsy, if medically feasible to be eligible for the study. * Have at least one measurable lesion as the targeted lesion based on RECIST version 1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion). * Eastern Cooperative Oncology Group performance status of 0 or 1. * Have a minimum life expectancy of \>3 months. * Have adequate organ function, as defined below: * Hematology: * Absolute neutrophil count ≥1.5 × 10\^9/L (without G-CSF support within two weeks prior to Cycle 1, Day 1). * Platelet count ≥100 × 10\^9/L (without transfusion within 2 weeks prior to Cycle 1, Day 1). * Hemoglobin ≥90 g/L or 5.6 mmol/L. Note: Criterion must be met without packed red blood cell transfusion or without erythropoietin dependency within the prior 2 weeks before receiving the first dose of study treatment. * Liver function: * Total bilirubin ≤1.5 × upper limit of normal (ULN). * With Gilbert's syndrome total bilirubin \<3 mg/dL and direct bilirubin ≤ULN. Note, Gilbert's syndrome must be documented appropriately as past medical history. * Participants without liver metastasis alanine aminotransferase and aspartate aminotransferase ≤2 × ULN. * Participants with liver metastasis alanine aminotransferase and aspartate aminotransferase ≤5 × ULN. * Albumin ≥3.0 g/dL. * Renal function: Creatinine clearance ≥50 mL/min. Cockcroft-Gault formula. Note, in participants who will be treated with gemcitabine plus carboplatin, creatinine clearance should be ≥60 mL/min. * Qualitative urine protein ≤1+. If qualitative urine protein ≥2+, a 24-hour urine protein quantitative test is required. If the 24-hour urine protein result is \<1 g, the participant can be enrolled. * Coagulation function: International normalized ratio or prothrombin time and activated partial thromboplastin time ≤1.5 × ULN unless the participant is receiving anticoagulation therapy as long as prothrombin or activated partial thromboplastin is within therapeutic range of intended use of anticoagulant. * Are women of childbearing potential (WOCBP) who have a negative serum beta human chorionic gonadotropin pregnancy test. Women who are postmenopausal (defined as 12 months with no menses without an alternative medical cause) or permanently sterilized (verified by medical records) will not be considered WOCBP and therefore will not be required to undergo pregnancy testing. * Are WOCBP who agree to practice a highly effective form of contraception and to require the use of barrier contraception methods, starting at at the time of giving informed consent and continuously until 6 months after receiving the last study treatment. * Are men who are sterile or if they are potentially fertile (i.e., are not surgically \[e.g., have had a vasectomy\] or congenitally sterile) and sexually active with a partner of childbearing potential, who agree to use condoms and to ask their sexual partners to practice a highly effective form of contraception during the study, starting at the time of giving informed consent and continuously until 6 months after receiving the last dose of IMP. * Agree not to donate germ (ova, oocytes, sperm) for the purposes of assisted reproduction during study, starting at the time of giving informed consent and continuously until 6 months after receiving the last dose of IMP. Exclusion Criteria: * Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the study or within 6 months after the last dose of IMP. * Have a medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the study, or that could prevent, limit, or confound the protocol-specified assessments or procedures, or that could impact adherence to protocol described requirements. * Have received any of the following therapies or drugs prior to the initiation of study: * Participants who received prior treatment with a PD(L)-1/Vascular Endothelial Growth Factor bispecific antibody. * Have received a systemic anticancer regimen within 4 weeks prior to the initiation of study treatment or have received palliative radiotherapy within 7 days prior to the initiation of study treatment, or have received any other chemotherapy, curative/palliative radiotherapy, biologic therapy (including tumor vaccines, cytokines, or growth factors for tumor control) or any experimental antitumor drugs within 4 weeks prior to the initiation of study treatment. * Have received other systemic immunostimulatory agents or immunosuppressive therapies (such as interferon-alpha \[IFN-α\], interleukin-2 \[IL-2\], or methotrexate) within 4 weeks prior to the initiation of study treatment or are within five half-lives of the treatment drug (whichever is longer). Exception: Excludin
A Study to Evaluate the Efficacy and Safety of Co-administration of AD-227A and AD-227B
NCT06441630
Recruiting
Conditions Essential Hypertension
Phase PHASE3
Enrollment 251
Locations 1 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • AD-227A
  • AD-227B
  • AD-227C
  • Placebo of AD-227B
  • Placebo of AD-227C

Primary Outcomes

  • Change in MSSBP
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2024-07-31
Completion: 2025-09
Eligibility
Age: 19 Years
Sex: ALL
Volunteers: false
Enrollment: 251 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Addpharma Inc.
Principal Investigators:
  • Chong-Jin Kim (PRINCIPAL_INVESTIGATOR) - Gangnam CHA Medical Center
Contact Information
Study Contact:
JeongEun Park
+82-31-891-6989
parkje@addpharma.co.kr
Interventions
  • AD-227A
  • AD-227B
  • AD-227C
  • Placebo of AD-227B
  • Placebo of AD-227C
Study Locations (1 sites)
Gangnam CHA Medical Center, Seoul, South Korea
Eligibility Criteria
Inclusion Criteria: * Signed informed consent * Patients with Essential Hypertension * Other inclusions applied Exclusion Criteria: * Patient with Secondary Hypertension * Other exclusions applied
ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
NCT06460298
Recruiting
Conditions Triple Negative Breast Cancer
Phase PHASE1, PHASE2
Enrollment 51
Locations 2 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • ProAgio Dose Levels (DL) 1,2,3,4
  • ProAgio Dose Expansion

Primary Outcomes

  • Part 1 (Dose Escalation)
  • Part 2 (Dose Expansion)
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: 2024-08-20
Completion: 2026-10-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 51 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: ProDa BioTech, LLC
Collaborators: Emory University, Georgia State University
Principal Investigators:
  • Kevin Kalinsky, M.D, M.S (PRINCIPAL_INVESTIGATOR) - Emory University Winship Cancer Institute
Contact Information
Study Contact:
Damon Michaels
615-614-1185
damon.michaels@medelis.com
Zhi-Ren Liu
zliu8@gsu.edu
Interventions
  • ProAgio Dose Levels (DL) 1,2,3,4
  • ProAgio Dose Expansion
Study Locations (2 sites)
Emory University Winship Cancer Institute, Atlanta, Georgia 30322 United States
Winship Cancer Institute of Emory University, Atlanta, Georgia 30322 United States
Eligibility Criteria
Inclusion Criteria: * Adult participants, ≥ 18 years of age, with histologically or cytologically confirmed metastatic breast cancer that is estrogen receptor (ER) negative (less than 10%), progesterone receptor (PR) negative (less than 10%), and HER2 negative/unamplified as per ASCO/CAP guidelines (Wolff et al., 2018). If ER/PR less than 10%, prior endocrine therapy is permitted, and the participant is not considered appropriate for hormone based therapy. Participants must agree to provide archival tumor material from metastatic site (most recent archival tumor tissue immediately prior to enrollment is strongly preferred) and must agree to undergo research tumor biopsy before treatment and during cycle 2 at the same site of metastatic disease, if presence of easily accessible lesion, at the discretion of the treating physician. * Participants must have received at least two lines of prior systemic treatment for advanced disease. If participants received systemic therapy in the operable setting and the tumor progressed within 12 months of the receipt of the last dose of systemic therapy, this will be considered one line of prior systemic therapy for advance disease. Participants must be more than 14 days removed from most recent standard of care or experimental drug treatment for their tumor. * ECOG performance status ≤2 * Participants must have adequate organ and marrow function as defined below: * Absolute neutrophil count ≥1,500/mcL * Hemoglobin ≥9 g/ dL (recent transfusion allowed) * Platelets ≥100,000/mcL * AST(SGOT)/ALT(SGPT) ≤3 x ULN. AST and ALT (up to 5x ULN is permitted for participants with liver metastases) * Total bilirubin ≤1.5 x institutional ULN * Creatinine clearance ≥60 mL/min (measured using Cockcroft- Gault equation or the estimated glomerular filtration rate) * Participants with CNS metastases must be treated and/or stable (no progression for at least 4 weeks after local prior therapy as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period). Those with symptoms suggestive of possible CNS metastases (such as new headaches) must undergo brain MRI as part of screening. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * The effects of ProAgio on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for the 6 months following the last dosing of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * During dose escalation, participants with bone only and/or non-measurable disease are eligible. During dose expansion, only participants with measurable disease are eligible. * Ability of subject to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Participants who have had prior treatment with gemcitabine in the metastatic setting. * Platelet transfusion within 7 days prior to treatment start. * Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Patients with history of known congestive heart failure (left ventricular ejection fraction (LVEF) \<50%) must have documented LVEF \>50% within 12 months of study enrollment. * Prolonged QTc interval \>480 msec on screening EKG * Participants with known diagnosis of a chronic neurologic disorders (such as multiple sclerosis, Huntington's disease, Parkinson's disease, or uncontrolled epilepsy) which causes motor disturbance, visual disturbance, or seizure and could confound assessment of neurologic toxicity caused by the study drug. * Pregnant or nursing women are excluded from this study because ProAgio is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ProAgio, breastfeeding should be discontinued if the mother is treated with ProAgio. * Participants who have undergone a major surgical procedure (within \< 28 days) are excluded. * Participants with uncontrolled bleeding episodes \<28 days prior to enrollment are excluded.
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer
NCT06471205
Recruiting
Conditions Triple-negative Breast Cancer
Phase PHASE2
Enrollment 52
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • BL-B01D1
  • PD-1 Monoclonal Antibody

Primary Outcomes

  • Objective Response Rate (ORR)
  • Recommended Phase II Dose (RP2D)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-08-02
Completion: 2028-06
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 52 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Principal Investigators:
  • Jiong Wu (PRINCIPAL_INVESTIGATOR) - Fudan University
  • Jian Zhang (PRINCIPAL_INVESTIGATOR) - Fudan University
Contact Information
Study Contact:
Sa Xiao, PHD
15013238943
xiaosa@baili-pharm.com
Interventions
  • BL-B01D1
  • PD-1 Monoclonal Antibody
Study Locations (1 sites)
Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality China
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily sign the informed consent and follow the requirements of the protocol; 2. Age: ≥18 years old and ≤75 years old; 3. Expected survival time ≥3 months; 4. ECOG 0 or 1; 5. Subjects with histologically and/or cytologically confirmed, inoperable locally advanced or recurrent or metastatic triple-negative breast cancer; 6. Patients should not have received previous systemic therapy for unresectable, locally advanced, recurrent, or metastatic triple-negative breast cancer; 7. A archived tumor tissue specimen or fresh tissue specimen of the primary or metastatic lesion within 2 years must be provided; 8. Must have at least one place in accordance with RECIST v1.1 define measurable lesions; 9. No blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before screening, and the organ function level must meet the requirements; 10. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0; 11. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, the serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment. Exclusion Criteria: 1. ADC drugs that have received topoisomerase I inhibitors as small molecule toxins; 2. Palliative radiotherapy within 2 weeks before the first dose; 3. Patients with checkpoint inhibitors prior to neoadjuvant/adjuvant chemotherapy; 4. Use of an immunomodulatory drug within 14 days before the first dose of study drug; 5. The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened; 6. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia; 7. Active autoimmune and inflammatory diseases; 8. Receiving long-term systemic corticosteroid therapy, etc., before the first dose; 9. Other malignant tumors that progressed or required treatment within 5 years before the first dose; 10. Presence of: a) poorly controlled diabetes mellitus before starting study treatment; b) severe complications associated with diabetes mellitus; c) a glycated hemoglobin level of 8% or more; d) hypertension poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy; 11. Present grade ≥2 radiation pneumonitis according to the RTOG/EORTC definition; Patients with current ILD; 12. Complicated with pulmonary diseases leading to clinically severe respiratory impairment; 13. 6 months prior to screening needs treatment intervention unstable thrombotic events; 14. Patients with active central nervous system metastases; 15. Patients with massive or symptomatic effusions or poorly controlled effusions; 16. Allergic history to recombinant humanized antibody or human-mouse chimeric antibody or allergic to any excipients of the test drug; 17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 18. HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 19. Serious infection within 4 weeks before the first dose of study drug; Signs of pulmonary infection or active pulmonary inflammation within 4 weeks; 20. Participated in another clinical trial within 4 weeks before the first dose; 21. Patients with superior vena cava syndrome should not be rehydrated; 22. Have a history of psychotropic substance abuse with an inability to quit or a history of severe neurological or psychiatric illness; 23. Imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels; 24. Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent; 25. Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 26. Subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose; 27. Other circumstances considered by the investigator to be inappropriate for participation in the trial.