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Showing 20 of 29277 trials
Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation
NCT06039930
Recruiting
Conditions Depression, Elder Abuse
Phase NA
Enrollment 140
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

  • Tele PROTECT
  • Depression Education

Primary Outcomes

  • Montgomery Asberg Depression Rating Scale (MADRS)
  • Montgomery Asberg Depression Rating Scale (MADRS)
  • Montgomery Asberg Depression Rating Scale (MADRS)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-09-22
Completion: 2029-01-01
Eligibility
Age: 60 Years
Sex: ALL
Volunteers: false
Enrollment: 140 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Weill Medical College of Cornell University
Collaborators: New York City Department for the Aging, National Institute of Mental Health (NIMH), Memorial Sloan Kettering Cancer Center
Principal Investigators:
  • Jo Anne Sirey, Ph.D (PRINCIPAL_INVESTIGATOR) - Weill Medical College of Cornell University
Contact Information
Study Contact:
Jo Anne Sirey, Ph.D
914-997-4333
jsirey@med.cornell.edu
Interventions
  • Tele PROTECT
  • Depression Education
Study Locations (1 sites)
Weill Cornell Medicine, New York, New York 10065 United States
Eligibility Criteria
Inclusion Criteria: * ≥60 years of age * Capacity to consent (per elder abuse staff) * Depression, i.e., PHQ-9≥10 (by elder abuse staff), represents mild to moderate severity of depression and has a sensitivity of 88% and a specificity of 88% for major depression * Need for elder abuse services as verified by the elder abuse case worker. Exclusion Criteria: * Active suicidal ideation (MADRS item 10 ≥4) * Inability to speak English or Spanish * Axis 1 DSM-5 diagnoses other than unipolar depression or comorbid generalized anxiety disorder (by SCID) * Mini-MOCA less than 11 * Severe or life-threatening medical illness * Elder abuse emergency and or referral out of elder abuse agency.
Maternal Mental Health Access - MaMa
NCT06049433
Recruiting
Conditions Postpartum Depression, Perinatal Depress...
Phase NA
Enrollment 120
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

  • Maternal Mental Health Access for Postpartum Depression- Prevention and UPLIFT- intervention
  • On-Demand + Discussion board (DB)
  • Arm 2
  • On Demand (OD) + Video Conference (VC)
  • Arm 3

Primary Outcomes

  • Implementation outcome; Feasibility and acceptability
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-04-04
Completion: 2025-12-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Utah
Collaborators: National Institute of Nursing Research (NINR)
Principal Investigators:
  • Gwen Latendresse (PRINCIPAL_INVESTIGATOR) - University of Utah
Contact Information
Study Contact:
Gwen Latendresse, PhD CNM
(801) 587-9636
gwen.latendresse@nurs.utah.edu
Julie Neuberger, BS
801-587-3930
julie.neuberger@nurs.utah.edu
Interventions
  • Maternal Mental Health Access for Postpartum Depression- Prevention and UPLIFT- intervention
  • On-Demand + Discussion board (DB)
  • Arm 2
  • On Demand (OD) + Video Conference (VC)
  • Arm 3
Study Locations (1 sites)
University of Utah, Salt Lake City, Utah 84132 United States
Eligibility Criteria
Inclusion Criteria: * 18+ years of age, who at the time of screening * Have a viable pregnancy or are postpartum (up to 1 year) * Identified as at-risk for PD (any one of the following: * EPDS score equal to or greater than 9 or less than 21 * History of depression/anxiety * 2 or more significant life events) * English- or Spanish-speaking * Currently attending a UHealth clinic or rural public health partner clinic. Exclusion Criteria: * Have a substance use disorder * Current diagnosis of serious mental illness, such as psychosis, schizophrenia, bipolar disorder, severe depression (including EPDS \> 20) * Severe anxiety, suicidality, or currently taking any medications for a mental health condition.
Circulating Tumour Cells Characterization in Breast Cancer Patients
NCT06048835
Recruiting
Conditions Breast Cancer
Phase Not Applicable
Enrollment 80
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Blood sample

Primary Outcomes

  • Detect specific proteins on CTCs in breast cancer patients
Interested in this trial?
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Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2022-12-01
Completion: 2028-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 80 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA
Collaborators: Carlo Morasso
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Blood sample
Study Locations (1 sites)
Istituti Clinici Scientifici Maugeri SpA, Pavia, Lombardy 27100 Italy
Eligibility Criteria
Inclusion Criteria: * female patients with diagnosis of metastatic breast cancer, confirmed by clinical practice staging exams. * female patients with biopsy-confirmed diagnosis of early-breast cancer candidate for primary surgery after multidisciplinary evaluation. * patients not affected by any neoplastic disease. Exclusion Criteria: * Diagnosis of any neoplastic disease
REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEctive Study
NCT06041386
Active, positions filled
Conditions Asthma
Phase PHASE4
Enrollment 336
Locations 65 sites
Compensation reimbursement available
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Mepolizumab
  • Spirometry

Primary Outcomes

  • Percentage (%) of Participants Achieving 4-Component Clinical Remission
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Active, positions filled
Start Date: 2024-03-20
Completion: 2028-06-14
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 336 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: GlaxoSmithKline
Principal Investigators:
  • GSK Clinical Trials (STUDY_DIRECTOR) - GlaxoSmithKline
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Mepolizumab
  • Spirometry
Study Locations (65 sites)
GSK Investigational Site, La Jolla, California 92037 United States
GSK Investigational Site, Newport Beach, California 92663 United States
GSK Investigational Site, Aurora, Colorado 71105 United States
GSK Investigational Site, Colorado Springs, Colorado 80923 United States
GSK Investigational Site, New Haven, Connecticut 06510 United States
GSK Investigational Site, Homestead, Florida 33032 United States
GSK Investigational Site, Jacksonville, Florida 32209 United States
GSK Investigational Site, Miami, Florida 33125 United States
GSK Investigational Site, Plantation, Florida 33317 United States
GSK Investigational Site, Adairsville, Georgia 30103 United States
Eligibility Criteria
Inclusion Criteria: * Participant has a confirmed asthma diagnosis and has been prescribed NUCALA by their physician for the treatment of asthma, as per local label. NUCALA can be initiated up to 7 days prior to study enrollment. * No NUCALA use in the 6 months prior to enrollment. * Participants with greater than or equal to (≥)60 percentage (%) predicted forced expiratory volume in 1 second (FEV1) and less than or equal to (≤)4 exacerbations per year, as confirmed by the physician. * Other local prescription criteria of NUCALA not described above at NUCALA initiation (e.g., local reimbursement criteria). * Written informed consent Exclusion Criteria: * Investigator concerns about participant's willingness to adhere to biologic treatment for any reason (e.g., cost, behavior, difficulty with access to healthcare) * Participants currently on maintenance OCS or intramuscular corticosteroids. * Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment * Participants participating in an interventional study with a treatment intervention
Artificial Intelligence in Mammography Screening in Norway
NCT06032390
Recruiting
Conditions Breast Cancer
Phase NA
Enrollment 150000
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

  • AI assisted mammography screening interpretation
  • Standard mammography screening interpretation

Primary Outcomes

  • Screen-detected breast cancers
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-11-25
Completion: 2033-06
Eligibility
Age: 50 Years
Sex: FEMALE
Volunteers: true
Enrollment: 150000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Norwegian Institute of Public Health
Collaborators: Helse Vest, Helse Midt-Norge, Helse Nord, Norwegian Cancer Society
Principal Investigators:
  • Solveig Hofvind, PhD (PRINCIPAL_INVESTIGATOR) - Norwegian Institute of Public Health
Contact Information
Study Contact:
Solveig Hofvind, PhD
22928828
sshh@kreftregisteret.no
Åsne S Holen, MSc
asho@kreftregisteret.no
Interventions
  • AI assisted mammography screening interpretation
  • Standard mammography screening interpretation
Study Locations (1 sites)
Cancer Registry of Norway, Norwegian Institute of Public Health, Oslo, Norway
Eligibility Criteria
Inclusion Criteria: * Women attending the population-based mammography screening program BreastScreen Norway providing a signed, informed consent Exclusion Criteria: * Women attending the population-based mammography screening program BreastScreen Norway not providing a signed, informed consent
Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells With or Without Naxitamab (Danyelza) for the Treatment of Patients With Metastatic, GD2 Expressing, HER2 Negative Breast Cancer
NCT06026657
Recruiting
Conditions Anatomic Stage IV Breast Cancer AJCC v8,...
Phase PHASE1, PHASE2
Enrollment 42
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Biospecimen Collection
  • Computed Tomography
  • Gemcitabine
  • Magnetic Resonance Imaging
  • Naxitamab

Primary Outcomes

  • Incidence of adverse events
  • Objective response rate
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: 2024-04-02
Completion: 2027-10-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 42 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Margaret Gatti-Mays
Principal Investigators:
  • Margaret E Gatti-Mays, MD MPH (PRINCIPAL_INVESTIGATOR) - Ohio State University Comprehensive Cancer Center
Contact Information
Study Contact:
The Ohio State University Comprehensive Cancer Center
800-293-5066
OSUCCCClinicaltrials@osumc.edu
Amanda Kabetso
614-257-2400
amanda.kabetso@osumc.edu
Interventions
  • Biospecimen Collection
  • Computed Tomography
  • Gemcitabine
  • Magnetic Resonance Imaging
  • Naxitamab
Study Locations (1 sites)
Ohio State University Comprehensive Cancer Center, Columbus, Ohio 43210 United States
Eligibility Criteria
Inclusion Criteria: * Patients must have histologically or cytologically confirmed, HER2 negative metastatic breast cancer that is historically GD2 expressing (e.g., triple negative breast cancer, metaplastic breast cancer, high grade 3 estrogen positive breast cancer at initial diagnosis) with available archival tissue. Well differentiated neuroendocrine tumor (NETs) are not eligible for this trial since GD2 expression is unknown. GD2 expression is not required for eligibility but a primary tumor paraffin block is required at enrollment for assessment of GD2 expression * Patients must have measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for the evaluation of measurable disease * Patients must have received at least one prior treatment for metastatic disease and progressed on treatment or been intolerant to treatment * Female or male \>=18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Absolute neutrophil count \>= 1,500/mcL (\> 1.5 X 10\^6/L) * Platelets \>= 100,000/mcL * Hemoglobin \>= 9 mg/dL (transfusion to obtain hemoglobin \>= 9 mg/dL within 24 hours prior to dosing is allowed) * Serum creatinine =\< 1.5 X upper limit of normal (ULN) or measured or calculated creatinine clearance (CrCl) \>= 60 mL/min for participant with creatinine levels \> 1.5 X institutional upper limit of normal (ULN) (Glomerular filtration rate \[GFR\] can also be used in place of creatinine or CrCl) * Patients must have adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels =\< 3 X ULN and total bilirubin \< 1.5 X ULN, unless known diagnosis of Gilbert's syndrome, where bilirubin =\< 5 mg/dL will be permitted. Gilbert's syndrome will be defined as elevated unconjugated bilirubin, with conjugated (direct) bilirubin within the normal range and less than 20% of the total. Total bilirubin will be permitted up to 5 mg/dL, if patients have historical readings consistent with the definition of Gilbert's syndrome prior to entering study. Adequate hepatic function for patients with known liver metastases is defined as AST and ALT levels ≤ 5 X ULN * The effects of the trial agents on the developing human fetus are unknown. However, gemcitabine is known to have negative fetal effects. For this reason: Women of childbearing potential must agree to use adequate contraception at study entry, for the duration of study participation and for 7 months after the last dose of study medication based upon estimated half-life or receptor occupancy. Adequate contraception is defined as 2 highly effective methods of contraception (including a physical barrier). 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. Men should refrain from fathering a child using adequate contraception or donating sperm during the study and for 6 months after the last dose of study medications. Adequate contraception is defined as 2 highly effective methods of contraception (including a physical barrier) * Patients with well-controlled human immunodeficiency virus (HIV) infection are eligible for trial as long as: * On an effective anti-retroviral therapy (ART) ˃ 4 weeks and with evidence of viral-suppression as defined as HIV viral load ˂ 400 copies/mL within the last 3 months * CD4 \> 200 cells/µL within the last 3 months; and * No reported opportunistic infections within 6 months prior to enrollment, except for the following which will be allowed: * Esophageal candidiasis treated within last 6 months or currently improving with antifungal treatment. * Oral and/or genital herpes simplex virus (HSV) treated within last 6 months or currently improving with antiviral treatment. * Mycobacterium avium infection in last 6 months or that has been treated for at least 1 month * Patients with evidence of chronic hepatitis B virus (HBV) infection are eligible for trial as long as the HBV viral load is undetectable on suppressive therapy, if indicated. * Patients with history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable or unquantifiable HCV ribonucleic acid (RNA) 12 weeks or longer after definitive treatment completion. * Patients must be able to understand and willing to sign a written informed consent document * Any adverse events subjects have experienced from prior therapy must have resolved to =\< grade 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 Exclusion Criteria: * Patients who within 3 weeks prior to study enrollment who have received chemotherapy, investigational agents, or radiation * Patients with active brain metastases or leptomeningeal metastases are excluded from this clinical trial because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However, patients with treated brain metastases are eligible if there is no magnetic resonance imaging (MRI) evidence of progression for 6 months after treatment is complete and within 28 days prior to the first dose of trial drug. Patients requiring immunosuppressive doses of systemic corticosteroids (\> 10mg/day prednisone equivalent) for palliation are excluded * Patients with a history of another invasive malignancy \< 3 years prior to enrollment (patients with non-melanoma skin cancers, carcinoma in situ of the breast or cervix are eligible) * History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study * Uncontrolled intercurrent illness including, but not limited to, ongoing active infection that requires systemic treatment with ongoing antibiotics (eligible if can stop antibiotics on day of enrollment), unexplained fever (temperature \> 38.1˚celcius \[C\]) within 7 days of initial treatment, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that in the opinion of the primary investigator would prohibit the patient from complying with study requirements * Patients with bone metastases who have initiated denosumab or a bisphosphonate therapy within 28 days prior to or after cycle 1 day 1 due to the potential for flu-like symptoms and mild cytokine release syndrome with the initial dose. However, continuation of prior therapy is allowed * Patients should have no evidence of being immunocompromised as listed below: * Active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to an autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger in the opinion of the primary investigator * Altered immune function that in the judgement of the PI that may affect a patient's ability to adequately engage the immune system and respond to the immunotherapy agents being administered, including but not limited to: inflammatory bowel disease; active infectious enteritis; eosinophilic enteritis; lupus erythematous; ankylosing spondylitis; scleroderma; multiple sclerosis. These criteria do not include all disease with an immune-related component but are not autoimmune in nature or have a primary alteration in the general immune function that may interfere with the vaccine mechanism of action, for example celiac disease * Immunosuppressive therapy post-organ transplant * Concurrent use of chronic use of systemic steroids, except for physiologic doses of systemic steroids for replacement, defined as 10mg of prednisone per day or equivalent, or local (topical, nasal, ophthalmic or inhaled) steroid use or prior concomitant use with chemo
Repurposing Valsartan May Protect Against Pulmonary Hypertension
NCT06053580
Recruiting
Conditions Pulmonary Arterial Hypertension, Right H...
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

  • Valsartan 40 mg
  • Placebo

Primary Outcomes

  • Six-minute walk distance
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-02-28
Completion: 2027-07-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Washington
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigators:
  • Peter Leary, MD, PhD (PRINCIPAL_INVESTIGATOR) - University of Washington
Contact Information
Study Contact:
Laurie Hogl, RRT
206.543.8334
lalnaser@uw.edu
Nancy Liston, MS
206.543.8334
nmliston@uw.edu
Interventions
  • Valsartan 40 mg
  • Placebo
Study Locations (1 sites)
University of Washington Medical Center, Seattle, Washington 98195 United States
Eligibility Criteria
Inclusion Criteria: 1. Male or female, age 18 to 80 2. WHO Group 1 Pulmonary Arterial Hypertension 3. NYHA Functional Class II, III, or IV at screening (Appendix 2 for Functional Class Decision Aid) 4. Right heart catheterization within five years demonstrating a mean pulmonary arterial pressure of ≥25 mmHg, occlusion pressure of ≤15 mmHg, and resistance ≥ 3 wood units 5. Participants with a right heart catheterization within five years demonstrating a mean pulmonary arterial pressure of ≥ 25 mmHg and occlusion pressure of 15 - 20 mmHg will be considered for inclusion if the pulmonary vascular resistance ≥ 9 wood units and they are being treated with pulmonary arterial hypertension specific therapy 6. Able to walk with/without a walking aid for a distance of at least 50 meters Exclusion Criteria: 1. Pregnant or lactating 2. Non-group 1 pulmonary hypertension or veno-occlusive disease 3. History of interstitial lung disease, unless subject has collagen vascular disease and has pulmonary function testing conducted within 12 months demonstrating a total lung capacity or vital capacity of ≥ 60 % 4. Has received or will receive an investigational drug, device, or study within 30 days or during the course of study 5. ACE-inhibitor, ARB or ARNI use within 30 days of randomization. 6. Left sided myocardial disease as evidenced by left ventricular ejection fraction \< 40% 7. Any other clinically significant illness or abnormal laboratory values (measured during the Screening period) that, in the opinion of the Investigator, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data 8. Anticipated survival less than 1 year due to concomitant disease 9. Allergy or angioedema with ACE-inhibitor use 10. Potassium \>5mEq/L or sCr \>2mg/dL at screening 11. SBP \<90mmHg at screening
Dapansutrile in Diabetes and Diabetes-Related Complications - Dapan-Dia
NCT06047262
Recruiting
Conditions Diabetes Mellitus, Type 2
Phase PHASE2
Enrollment 300
Locations 6 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

  • Dapansutrile
  • Placebo

Primary Outcomes

  • Change in HbA1c in blood of patients for dapansutrile compared to placebo
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-07-09
Completion: 2028-07-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Marc Donath
Collaborators: European Union, State Secretariat for Education Research and Innovation, Switzerland, Olatec Therapeutics, Inc., Departement Klinische Forschung Universität Basel, CTU Kantonsspital Baden
Principal Investigators:
  • Marc Y. Donath, Prof. (STUDY_CHAIR) - Kantonsspital Baden, Switzerland
Contact Information
Study Contact:
Marc Y. Donath, Prof.
+41 61 265 50 78
marc.donath@umontreal.ca
Markus Veit
+41 56 486 25 14
markus.veit@ksb.ch
Interventions
  • Dapansutrile
  • Placebo
Study Locations (6 sites)
CHU de Liege, Liège, 4000 Belgium
Hopital Lariboisiere, Paris, Île-de-France Region 75010 France
Hopital Bichat, Paris, Île-de-France Region 75018 France
Deutsches Zentrum für Diabetesforschung Düsseldorf, Düsseldorf, Nordrhein-Westphalen 40225 Germany
University Hospital Basel, Basel, Basel 4031 Switzerland
Kantonsspital Olten, Olten, Canton of Solothurn 4600 Switzerland
Eligibility Criteria
Inclusion Criteria: * Diagnosis of type 2, Diabetes mellitus as defined by the criteria of the American Diabetes Association (ADA) Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (see Appendix 1) and recognized by the World Health Organization (WHO, 2019), for at least 3 months prior to the Baseline Visit/Day 1 * HbA1c value of ≥ 7.7% to ≤ 11.0% at the Screening Visit. * High-sensitivity C-reactive protein (hsCRP) ≥ 1.5 mg/L at the Screening Visit. * Body mass index (BMI) ≥25 to ≤ 40 kg/m2 at the Screening Visit * Acceptable overall medical condition to safely participate in the study and complete all study procedures (particularly with regard to cardiovascular, renal, and hepatic conditions), in the opinion of the Investigator Exclusion Criteria: * Diagnosis of type 1 diabetes mellitus * HbA1c value of ≤ 7.5% or ≥ 10.5% at the Baseline Visit/Day 1, as determined at point of care (local laboratory) * Use of thiazolidinediones (glitazones), pramlintide, or short-acting insulin/insulin analogues (as bolus or premixed insulin) within 12 weeks prior to the Screening Visit * Less than 80% compliance in taking investigational medicinal product by pill count during the Run-In Period, as assessed at the Baseline Visit/Day 1 * Significant weight loss (\> 5 kg) in the 12 weeks prior to the Screening Visit * Systolic blood pressure (BP) ≥ 160 mmHg, diastolic BP ≥ 100 mmHg, or resting heart rate (HR) ≥ 100 beats/minute at the Screening Visit * Previous myocardial infarction, any cardiac surgery
PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.
NCT06059469
Recruiting
Conditions TNBC - Triple-Negative Breast Cancer
Phase PHASE2
Enrollment 20
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

  • Ga-PSMA PET/CT

Primary Outcomes

  • Assess PSMA expression in progressive metastatic TNBC patients
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2022-05-30
Completion: 2025-12
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Jules Bordet Institute
Contact Information
Study Contact:
Géraldine Gebhart, MD
025413095
geraldine.gebhart@hubruxelles.be
Loubna Taraji, Ms
025413781
loubna.taraji@hubruxelles.be
Interventions
  • Ga-PSMA PET/CT
Study Locations (1 sites)
Institut Jules Bordet, Brussels, Belgium
Eligibility Criteria
Inclusion Criteria: * Written informed consent in accordance with institutional guidelines and obtained prior to any study procedure * Women with ≥ 18 years-old * Eastern Cooperative Oncology Group Performance Status of 0 to 2 * Confirmed diagnosis of progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT (performed within 2 weeks) or Brain MRI in case of progressive brain metastases (performed within 4 weeks) prior to PSMA PET/CT. * Radiolabelled PSMA PET/CT has to be performed before the next treatment line initiation Exclusion Criteria: * Pregnant or lactating patients * Other active neoplastic disease * Treatment by another molecule that is the object of investigation within 30 days * Skin only metastatic disease * Patients with a significant medical, neuro-psychiatric, or surgical condition, which, in the investigator's opinion, may interfere with completion of the study
EMBRACE: Exercising Together
NCT06049355
Recruiting
Conditions Breast Carcinoma, Prostate Carcinoma
Phase PHASE2
Enrollment 400
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

  • Exercise Intervention
  • Biospecimen Collection
  • Educational Intervention

Primary Outcomes

  • Physical functioning
  • Anxiety
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-04-18
Completion: 2028-09-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 400 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: OHSU Knight Cancer Institute
Collaborators: Oregon Health and Science University, National Cancer Institute (NCI)
Principal Investigators:
  • Kerri Winters-Stone (PRINCIPAL_INVESTIGATOR) - OHSU Knight Cancer Institute
Contact Information
Study Contact:
Carolyn Guidarelli
503-494-0444
exercise@ohsu.edu
Interventions
  • Exercise Intervention
  • Biospecimen Collection
  • Educational Intervention
Study Locations (1 sites)
OHSU Knight Cancer Institute, Portland, Oregon 97239 United States
Eligibility Criteria
Inclusion Criteria: * INTERVENTION (SURVIVORS) INCLUSION * Histologically confirmed prostate cancer or breast cancer without evidence of metastatic disease * Confirmed by review of the electronic medical record (EMR) and subsequently recorded in Survivor Health History. In cases where the EMR isn't clear, their Oregon Health \&amp; Science University (OHSU) provider will be contacted for confirmation. For non-OHSU patients, we'll initially collect their cancer health history by a self-report questionnaire and confirm when we receive the survivor's outside medical record (through a signed Release of Information) * Scheduled to receive radiation therapy for curative intent * Confirmed by review of the EMR and subsequently recorded in Survivor Health History. In cases where the EMR isn't clear, their OHSU provider will be contacted for confirmation/ For non-OHSU patients, we'll initially collect their cancer health history by a self-report questionnaire and confirm when we receive the survivor's outside medical record (through a signed Release of Information) * Co-residing with an intimate partner or spouse who is willing to participate * Confirmed by self-report on the Demographic Questionnaire * INTERVENTION (SURVIVORS AND PARTNERS) INCLUSION * 18 years of age and older * For survivors: confirmed by review of the date of birth as documented in the Electronic Medical Record (EMR) and subsequently recorded in Survivor Health History. For non-OHSU patients, we'll collect their age by self-report on the Survivor Health History * For partners: confirmed by self-report on the Health History Questionnaire * \&lt; 2 structured strength training sessions for less than 30 minutes per week in the last month * Confirmed by self-report on Health History Questionnaire * Home internet sufficient for videoconferencing * Confirmed by staff review of Internet Connectivity Screening Guide with the participants and outcome recorded in a CRF * Signed informed consent * Confirmed by completion of e-Consent in REDCap * Willing to be randomized into either study arm and adhere to study protocol * Confirmed verbally with the participant and response documented in the Participant Tracking database * IMPLEMENTATION INCLUSION * Be one of these key stakeholders: patient, spouse/partner, healthcare providers, or administrator * Verbal informed consent following receipt of an Information Sheet Exclusion Criteria: * INTERVENTION (SURVIVORS AND PARTNERS) EXCLUSION * Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent * In the event of a suspected undeclared cognitive impairment, it will be confirmed by physician clearance or professional opinion of the Principal Investigator, Kerri Winters-Stone * A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise. Specific contraindications include the following: poorly controlled diabetes, recent cardiac event, neuromuscular disease, untreated orthostatic hypertension, recent surgery, acute hernia, acute rheumatoid arthritis, severe memory disorders, severe balance disorder, inability to ambulate without a walker or wheelchair, inability to stand for 3 minutes, severe hearing or vision problem * Confirmed by a combination of reviewing the EMR, self-report on the Health History Questionnaire, Charlson Comorbidity Index questionnaire, and/or by physician clearance. If in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible. For Spouse/Partner: must answer \&#39;No\&#39; to American College of Sports Medicine pre-participation screening questions. If spouse/partner answers \&#39;Yes\&#39; to either question they may be required to obtain physician clearance prior to becoming eligible. Physician clearance may also be requested at the discretion of the principal investigator.
A Study of Mental Health Care in People With Cancer
NCT06037954
Recruiting
Conditions Breast Cancer, Colorectal Cancer, Lung C...
Phase NA
Enrollment 130
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

  • Questionnaires
  • Interviews
  • 30-minute telephone or videoconference sessions

Primary Outcomes

  • Refusal rates
  • Attrition rates
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-09-07
Completion: 2026-09
Eligibility
Age: 65 Years
Sex: ALL
Volunteers: false
Enrollment: 130 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: Weill Medical College of Cornell University
Principal Investigators:
  • Kelly McConnell, PhD (PRINCIPAL_INVESTIGATOR) - Memorial Sloan Kettering Cancer Center
Contact Information
Study Contact:
Kelly McConnell, PhD
646-888-0026
mcconnek@mskcc.org
Christian Nelson, PhD
646-888-0030
Interventions
  • Questionnaires
  • Interviews
  • 30-minute telephone or videoconference sessions
Study Locations (1 sites)
Memorial Sloan Kettering Cancer Center, New York, New York 10065 United States
Eligibility Criteria
Inclusion Criteria: Patients * Per medical record and/or self-report, diagnosed with breast, colorectal, lung, or prostate cancer at age 65 years or older * Per medical record and/or self-report, undergoing active cancer treatment (e.g., radiation, chemotherapy, immunotherapy, surgery) or within six months of completing treatment * Score of ≥5 on the Patient Health Questionnaire-9 (PHQ-9) * Per self-report, fluent in English\*\* \*\* Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify English fluency necessary for participation in the study: 1. How well do you speak English? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused) 2. What is your preferred language for healthcare? (must respond English) Providers * Per self-report, works in oncology, nursing, social work, psychology, or psychiatry * Per self-report, currently works in oncology at least 50% of the time * Per self-report, provided cancer care for at least three years at time of consent * Per self-report, fluent in English Exclusion Criteria: Patients * Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration scores of ≥ 11 * Per research staff judgment and/or self-report, too ill or weak to complete study procedures * Per medical record and/or self-report, receiving hospice care at the time of enrollment * Per medical record and/or self-report, currently enrolled in mental health treatment Providers * N/A
Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma
NCT06044051
Recruiting
Conditions Asthma in Children, Asthma
Phase NA
Enrollment 100
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

  • Blood sample
  • Expectoration
  • Nasopharyngeal swab

Primary Outcomes

  • description of microbiomes from bronchoalveolar fluids
  • description of microbiomes from nasopharyngeal samples
  • description of microbiomes from sputum samples
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-09-26
Completion: 2026-09-26
Eligibility
Age: No restriction
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospital, Rouen
Principal Investigators:
  • PETAT Hortense (PRINCIPAL_INVESTIGATOR) - University Hospital, Rouen
Contact Information
Study Contact:
David Mallet
02 32 88 82 65
secretariat.DRC@chu-rouen.fr
Interventions
  • Blood sample
  • Expectoration
  • Nasopharyngeal swab
Study Locations (1 sites)
Rouen University Hospital, Rouen, France
Eligibility Criteria
Inclusion Criteria: * Infants less than 24 months old * Follow-up by a pneumo-pediatrician for severe asthma in infants * Requiring etiological investigations and assessment of severity in day hospitalization, including bronchial fibroscopy (HAS 2009) * Parent informed of the research and having signed consent Exclusion Criteria: * Prematurity \<32 WA * Congenital heart disease with significant left to right shunt * Chronic respiratory disease other than infant asthma (cystic fibrosis, bronchiolitis obliterans) * Antibiotic therapy in progress or administered the seven days preceding the date of inclusion (day hospitalization) * Refusal of bronchial fibroscopy
Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints
NCT06032377
Recruiting
Conditions Insomnia
Phase NA
Enrollment 275
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • cognitive behavioral therapy for sleep, anxiety, and depression
  • education about healthy nutrition habits and communication in older age

Primary Outcomes

  • Insomnia severity index
  • Subjective cognitive impairment based on cognitive failure questionnaire
  • Objective cognitive performance based on a composite score for executive functions from the CANTAB
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-11-15
Completion: 2026-12
Eligibility
Age: 60 Years
Sex: ALL
Volunteers: true
Enrollment: 275 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Contact Information
Study Contact:
Thien Thanh Dang-Vu, MD PhD
+1 (514) 340-3540
tt.dangvu@concordia.ca
Rebecca Robillard, PhD
+1 (613) 722-6521
rebecca.robillard@uottawa.ca
Interventions
  • cognitive behavioral therapy for sleep, anxiety, and depression
  • education about healthy nutrition habits and communication in older age
Study Locations (2 sites)
The Royal's Institute of Mental Health Research (IMHR), Ottawa, Ontario K1Z7K4 Canada
Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de l'Île-de-Montréal. CCSMTL - IUGM, Montreal, Quebec H3W 1W5 Canada
Eligibility Criteria
Inclusion * age 60 years or older at the time of enrolment * Sleep Condition Indicator, SCI ≤ 16 and/or meeting DSM-V criteria based on the symptoms assessed by the SCI * subjective cognitive complaints (self-report version of Everyday Cognition scale (ECog), score ≥ 2 on any item) * ability to read and understand French or English * ability to use a smartphone or tablet, and access to home internet connection * If on hypnotic or psychotropic medication (including cannabis), being on stable dosage for at least 2 months prior to study entry * Score on the STOP-BANG questionnaire \< 3 corresponding to participants with low risk of obstructive sleep apnea Exclusion * located outside of Québec or Ontario * current hospitalization or planned major surgery * uncorrected severe hearing or vision impairment * reported diagnosis of major neurocognitive disorder or mild cognitive impairment (MCI) * performance suggestive of major neurocognitive disorder or MCI on T-MoCA \< 17 * reported diagnosis of schizophrenia or bipolar disorder * reported diagnosis or positive screen on the MINI for psychotic or bipolar disorders * high suicidal risk, as assessed by the modified Columbia-Suicide Severity Rating Scale * reported diagnosis or positive screening (apnea-hypopnea index \>30 on a level 3 home sleep apnea test) for another untreated sleep disorder (e.g., sleep disordered breathing (OSA), REM sleep behavior disorder (RBD), restless legs syndrome (RLS); individuals with treated and controlled OSA (residual apnea-hypopnea index \<30 and good therapeutic compliance) or RLS will not be excluded * current shift work * currently receiving CBT, having received CBTi in the past * frequent alcohol consumption having an impact on functionning (\>10 glasses/week and having a significant impact on functionning) * illicit drugs use (more than once a month) Additional exclusion criteria for neuroimaging * psychotropic (including hypnotic) medication in the past 2 weeks * contraindications for MRI (e.g., pacemaker, metallic implant, claustrophobia) * unable or unwilling to come to one of the participating MRI centers (Montreal, Ottawa) * medical conditions likely to affect sleep; in particular: * current neurological disorder (e.g., epilepsy with any seizure in the past year, concussion in the past 3 months, multiple sclerosis, Parkinson's disease) * past history of brain lesion (e.g., brain hemorrhage, brain tumor, any condition having required brain surgery) * major surgery (i.e., requiring general anesthesia) in the past 3 months * untreated thyroid disorder * chronic pain syndrome self-reported as interfering with sleep (e.g., migraine, fibromyalgia, rheumatoid arthritis) * recent and severe infection in the past 3 months (e.g., pneumonia, kidney infection) * active cancer or treated cancer with post-cancer treatment for less than 2 years Inclusion/exclusion criteria for good sleepers Twenty-five good sleepers without cognitive complaint will be recruited as controls for the MRI session following the same criteria described above, except that SCI ≥ 17, not meeting the diagnostic criteria for chronic insomnia as assessed by the insomnia module of the SCID and no subjective cognitive complaint.
Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer
NCT06035679
Recruiting
Conditions Breast Cancer Female
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

  • Pyrotinib and Trastuzumab

Primary Outcomes

  • tpCR
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-08-17
Completion: 2026-11-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Youzhi Zhu
Principal Investigators:
  • zhu youzhi (STUDY_CHAIR) - First Affiliated Hospital of Fujian Medical University
Contact Information
Study Contact:
zhu youzhi
17759120588
zhu@fjmu.edu.cn
Interventions
  • Pyrotinib and Trastuzumab
Study Locations (1 sites)
The First Affiliated Hospital of Fujan Medical University, Fuzhou, Fujian China
Eligibility Criteria
Inclusion Criteria: 1. Female patients aged 18-75 years; 2. Her2-positive breast cancer confirmed by pathology; 3. invasive breast cancer confirmed by histology, Tumor stage: early stage (T1c-3, N0-1, M0) or locally advanced stage (T2-4, N2, N3, M0); 4. ECOG PS: 0-1 score; 5. Plan to undergo the final surgical removal of breast cancer, i.e. breast conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND) 6. Normal function of major organs means that the following criteria are met: (1) Blood test neutrophil (ANC) \>=1.5x10\^9/L; Platelet count (PLT) \>=90x10\^9/L; Hemoglobin (Hb) \>=90g/L; (2) Total bilirubin (TBIL) \<=1.5 upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<=1.5xULN; Alkaline phosphatase \<=2.5xULN; Urea nitrogen (BUN) and creatinine (Cr) \<=1.5xULN; (3) Left ventricular ejection fraction (LVEF) \>=55%; (4) The QT interval (QTcF) corrected by Fridericia method was less than 470msec in 12-lead ECG; 7. For women who have not undergone menopause or surgical sterilization: consent to abstinence or use an effective contraceptive method (during treatment and for at least 7 months after the last dose in the study treatment); 8. Volunteer to participate in this study, sign the informed consent, have good compliance and be willing to cooperate with follow-up. Exclusion Criteria: 1. Known allergic history of the drug components of this protocol; 2. Previous or co-existing other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 3. Participated in clinical trials of other antitumor drugs within four weeks; 4. Stage IV (metastatic) breast cancer; 5. Multiple factors affecting oral medication (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction); 6. A history of congestive heart failure (CHF) or uncontrolled heart disease (angina, arrhythmia, hypertension); 7. Patients with active infection and severe mental illness; 8. Pregnant or lactating patients; 9. Patients with allergies or known history of allergies to the drug components of this protocol; A history of immunodeficiency, including being HIV positive, or having other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 10. Concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or interfere with the patient's completion of the study.
Glaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma
NCT06057051
Recruiting
Conditions Glaucoma
Phase NA
Enrollment 245
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

  • iStent Infinite

Primary Outcomes

  • Mean Diurnal Intraocular Pressure (IOP) 12-Month reduction ≥ 20% from Baseline
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-09-01
Completion: 2027-08
Eligibility
Age: 35 Years
Sex: ALL
Volunteers: false
Enrollment: 245 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Glaukos Corporation
Contact Information
Study Contact:
Dari Parizadeh
949-481-0575
dparizadeh@glaukos.com
Kerry Stephens
949-481-8057
kstephens@glaukos.com
Interventions
  • iStent Infinite
Study Locations (1 sites)
Glaukos Investigator Site, Cincinnati, Ohio 45242 United States
Eligibility Criteria
Inclusion Criteria: * Diagnosis of primary open-angle glaucoma * Phakic or pseudophakic * Age 35 years or older Exclusion Criteria: * Traumatic, uveitic, neovascular, angle-closure glaucoma or * glaucoma associated with vascular disorders * Active corneal inflammation or edema * Retinal disorders not associated with glaucoma
Chimeric Receptor T Cells With Trastuzumab in HER2+ Advanced Breast Cancer and Other Solid Tumors
NCT06027983
Not yet recruiting
Conditions HER2+ Advanced Breast Cancer, Other Soli...
Phase PHASE1, PHASE2
Enrollment 36
Locations 0 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Chimeric receptor T-cells + Trastuzumab
  • Fludarabine and Cyclophosphosphamide

Primary Outcomes

  • Time to treatment failure
  • Progression-free survival
  • Duration of tumour response
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Not yet recruiting
Start Date: 2026-11-01
Completion: 2027-12-31
Eligibility
Age: 21 Years
Sex: ALL
Volunteers: false
Enrollment: 36 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: National University Hospital, Singapore
Principal Investigators:
  • Soo Chin Lee (PRINCIPAL_INVESTIGATOR) - National University Hospital, Singapore
Contact Information
Study Contact:
Soo Chin Lee
+65 6908 2222
soo_chin_lee@nuhs.edu.sg
Interventions
  • Chimeric receptor T-cells + Trastuzumab
  • Fludarabine and Cyclophosphosphamide
Eligibility Criteria
Inclusion Criteria: Patients may be included in the study only if they meet all of the following criteria: * Age ≥ 21 years. * Histologically confirmed diagnosis of HER2-positive cancer defined by immunohistochemistry (IHC) to be HER2 IHC3+ or HER2 IHC2+ and FISH positive. If immunohistochemistry is not available, FISH method is acceptable. The HER2 positivities by FISH is determined as FISH amplification ratio positive by institutional guidelines. Tumor subtype for each phase include : * Phase I: HER2-positive breast or gastric cancer or other treatment-refractory HER2-positive solid tumors * Phase II : HER2-positive breast carcinoma * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Has measurable or evaluable disease based on RECIST 1.1 criteria * Estimated life expectancy of at least 12 weeks. * Prior lines of therapy: * HER2-positive breast cancer - patient must have failed at least two lines of anti-HER2 based therapy for advanced/metastatic cancer. Patients with documented relapse while receiving or within 6 months of completion of adjuvant or neoadjuvant trastuzumab for HER2-positive breast cancer will be considered as 1 prior line of therapy. * HER2-positive gastric cancer - patient must have failed at least one line of anti-HER2 based therapy. * Other refractory HER2-positive solid tumors (non-breast, non-gastric) - have no standard therapies or have failed or unable to tolerate standard therapies * Has recovered from acute toxicities from prior anti-cancer therapies * Left ventricular ejection fraction ≥50% * Adequate organ function including the following: o Bone marrow: Absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 109/L Platelets ≥ 100 x 109/L Haemoglobin ≥ 8 x 109/L o Hepatic: Bilirubin ≤ 1.5 x upper limit of normal (ULN), ALT or AST≤ 2.5x ULN, (or ≤5 X with liver metastases) o Renal: Creatinine ≤ 1.5x ULN * Signed informed consent from patient or legal representative. * Able to comply with study-related procedures. * Specific to cohorts 3, 4 and 5 : Patients who have a history of VTE are eligible if as long as they are receiving therapeutic/prophylactic doses of anticoagulation. Exclusion Criteria: Patients will be excluded from the study for any of the following reasons: * Treatment within the last 30 days with any investigational drug. * Concurrent administration of any other tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy. * Major surgery within 28 days of study drug administration. * Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy. * Pregnancy. * Breast feeding. * Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator. * Active bleeding disorder or bleeding site. * Non-healing wound. * Poorly controlled diabetes mellitus. * Second primary malignancy that is clinically detectable at the time of consideration for study enrolment. * Symptomatic brain metastasis. * History of significant neurological or mental disorder, including seizures or dementia, * History of autoimmune disease or use of gamma immunoglobulin * Unable to comply with study procedures
A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors
NCT06043466
Recruiting
Conditions Colorectal Cancer, Esophagus Cancer, Gas...
Phase PHASE1
Enrollment 30
Locations 2 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • CEA-targeted CAR-T cells

Primary Outcomes

  • To determine the dose range and DLT of C-13-60 cells for CEA positive advanced malignant solid tumors [Safety and Tolerability]
  • To obtain the maximum tolerable dose of C-13-60 cells [Safety and Tolerability]
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2023-08-11
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Chongqing Precision Biotech Co., Ltd
Collaborators: Zhejiang University
Principal Investigators:
  • Ying Yuan, M.D (PRINCIPAL_INVESTIGATOR) - Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Weijia Fang, M.D (PRINCIPAL_INVESTIGATOR) - Zhejiang University
Contact Information
Study Contact:
Ying Yuan, M.D
13858193601
yuanying1999@tom.com
Weijia Fang, M.D
13758211655
weijiafang@zju.edu.cn
Interventions
  • CEA-targeted CAR-T cells
Study Locations (2 sites)
The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang China
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years old, male or female; 2. Patients with advanced malignant solid tumors confirmed by histology or pathology, including colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer, non-small cell lung cancer, breast cancer, and cholangiocarcinoma; 3. Progression or intolerance occurs after receiving systematic standard therapy according to guidelines,(systemic therapy including but not limited to systemic chemotherapy, molecular targeting, etc.) and is not suitable for surgery or local therapy (including ablative therapy, interventional therapy, and radiation therapy), among which colorectal cancer needs to receive at least third-line therapy failure or intolerance or inapplicability. Esophageal, gastric, non-small cell lung, breast, and cholangiocarcinoma require at least second-line treatment failure or intolerance or inadequacy, and pancreatic cancer require at least first-line treatment failure or intolerance or inadequacy: 1. Advanced colorectal cancer: progression or intolerance or inadequacy after third-line standard therapy including cetuximab ± Irinotecan/regorafenib /fruquintinib/trifluridine; 2. Advanced or metastatic esophageal cancer/esophagogastric junction cancer: patients with esophageal cancer who progress or are intolerant or inapplicable after second-line therapy including PD-1 MAB /PD-L1 mab; Patients with esophagogastric junction cancer progressed or were intolerant or inapplicable after second-line therapy including taxane or irinotecan or PD-1 /PD-L1 monoclonal antibody; For HER-2 positive patients, trastuzumab containing system therapy should fail or be intolerable or not applicable; 3. Advanced/metastatic gastric cancer: the combination of PD-1 MAB /PD-L1 MAB and chemotherapy has been developed or is not tolerated or suitable; For HER-2 positive patients, systemic treatment containing trastuzumab should fail or be intolerable or inapplicable. 4. Patients with advanced, metastatic, or recurrent non-small cell lung cancer who have received systemic treatment progression or intolerance, including: Patients with positive driver genes (EGFR, ALK, ROS1, BRAF, NTRK, MET, RET) should receive targeted therapy failure or drug resistance (squamous cell carcinoma does not require driver gene testing). In addition, patients with EGFR-positive driver gene who are resistant to first-line EGFR-Tkis and who are positive for EGFR T790M mutations need to be treated with third-generation EGFR-TKI (such as Osimertinib, almonertinib, or furmonertinib) after failure or resistance. For patients with positive ALK fusion and drug resistance after first-line crizotinib treatment, second-line treatment with ceritinib or alectinib should fail or be resistant; Patients with PD-L1 expression (PD-L1 TPS≥1%) should undergo immune checkpoint inhibitor treatment failure or intolerance; In patients with negative driver genes, the disease progresses or becomes intolerable after chemotherapy with platinum-containing regiments-such as Camrelizumab, Pembrolizumab, Tislelizumab, Sintilimab or Atezolizumab combined with pemetrexed 5. Advanced, metastatic breast cancer: HER-2 positive patients need to have received anti-HER-2 therapy, hormone receptor positive patients need to receive endocrine therapy and other standard treatments have failed or are intolerable or not applicable, and rescue chemotherapy for those who have failed/are intolerable or triple-negative breast cancer (including: Gemcitabine + cisplatin/carboplatin, albumin paclitaxel/other taxoid drugs + cisplatin/carboplatin) fail or are not tolerated or suitable; 6. Locally advanced or metastatic pancreatic cancer: advanced or intolerant or inappropriate after at least first-line treatment, including: Gemcitabine + albumin-bound paclitaxel/cisplatin/erlotinib/capecitabine/tegafur/Nimotuzumab, or FOLFIRINOX (oxaliplatin + irinotecan +LV+5-FU), or mFOLFIRINOX (oxaliplatin + irinotecan + calcium folinate +5-FU); 7. Advanced cholangiocarcinoma: progression or intolerance or inapplicability after at least second-line therapy (mFOLFOX); Remarks: Chemotherapy failure is defined as disease progression or intolerable toxicity during treatment or within 3 months after the last dose; If patients cannot receive the above treatment for economic reasons, those whose benefits outweigh the risks of inclusion in the study can be enrolled. 4. Subjects with positive CEA (IHC score 3+) in tumor tissue samples (paraffin sections or fresh tissue specimens or puncture biopsy samples) within 3 months before screening; If the immunohistochemical results of the tumor samples are more than 3 months from the time of screening, the patient needs to re-biopsy; If the tumor specimens are not available or the amount is too small for immunohistochemical detection of CEA, the CEA positive can be confirmed by re-staining of previous tissue specimens, and the peripheral blood serum CEA≥2.0×ULN can be included in the group. 5. Have at least one evaluable target lesion according to RECIST 1.1 criteria; 6. Colorectal cancer, esophageal cancer, non-small cell lung cancer, breast cancer, stomach cancer, cholangiocarcinoma ECOG 0 \~ 1 score, pancreatic cancer ECOG 0 \~ 2 score; 7. Expected survival time is more than 12 weeks; 8. No serious mental disorders; 9. Unless otherwise stated, the subject's vital organ functions shall meet the following conditions: 1. Blood routine: white blood cells \> 3.5×109/L, neutrophils \> 1.8×109/L, lymphocytes \&gt; 0.5 ×109/L, platelet \> 80×109/L, hemoglobin \> 90g/L; 2. Cardiac function: Echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram; 3. Renal function: serum creatinine ≤2.0×ULN; 4. Liver function: ALT and AST≤3.0×ULN (patients with liver tumor infiltration can be relaxed to ≤5.0 ×ULN); 5. Total bilirubin ≤2.0×ULN (Gilbert syndrome ≤3.0×ULN; The patients with liver tumor infiltration can be enlarged to ≤5.0×ULN); 6. Blood oxygen saturation in non-oxygen state \&gt; 92%. 10. Have the criteria for simple or intravenous blood collection, and no other contraindications for cell collection; 11. The subject agrees to use a reliable and effective method of contraception (excluding safe period contraception) for 1 year from signing the informed consent to receiving the C-13-60 cell infusion. Including but not limited to: abstinence, can inhibit ovulation implantable progesterone contraceptive; Intrauterine device (IUD); Intrauterine hormone release system; Spousal vasectomy; Combined hormonal contraceptives (oral, vaginal, and transdermal) that inhibit ovulation; Progesterone contraceptives (oral or injectable) that inhibit ovulation; Male subjects who have sex with fertile women must consent to the use of a barrier method of contraception (e.g., condom plus spermicidal foam/gel/film/emulsion/suppository). At the same time, the subject should promise not to donate eggs (egg cells, oocytes) or sperm for assisted reproduction within 1 year after the cell infusion. 12. The patient or his/her guardian agrees to participate in the clinical trial and signs the ICF, indicating that he/she understands the purpose and procedure of the clinical trial and is willing to participate in the study. Exclusion Criteria: 1. People who have received CAR-T therapy or other gene-modified cell therapy; 2. Patients with BMS with clinical symptoms or lesions located in key parts of the brain at the time of screening, patients with BMS without clinical symptoms or lesions located in non-critical parts of the brain should be evaluated by researchers or specialists to gain more than the risk. 3. Received any of the following medications or treatments before screening: 1. Received other investigational drugs or treatments that are not on the market within 4 weeks prior to screening; 2. Received live attenuated vaccine within 4 weeks prior to screening; 3. Received radioactive i
Effect of Vagal Nerve Stimulation on Gastric Motor Functions
NCT06038929
Recruiting
Conditions Depression, Epilepsy
Phase NA
Enrollment 16
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Vagal nerve stimulant

Primary Outcomes

  • Gastric emptying T1/2
  • Gastric accommodation
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-09-01
Completion: 2027-12-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 16 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Mayo Clinic
Collaborators: University of Minnesota
Principal Investigators:
  • Michael Camilleri (PRINCIPAL_INVESTIGATOR) - Mayo Clinic
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Vagal nerve stimulant
Study Locations (2 sites)
University of Minnesota, Minneapolis, Minnesota 55455 United States
Mayo Clinic in Rochester, Rochester, Minnesota 55905 United States
Eligibility Criteria
General criteria 1. Participant must be at least 18 years old. 2. Participant must have the capacity to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization. 3. Participant is diagnosed with drug Resistant Epilepsy and previously underwent implantation of VNS. and/or 4. Participant is diagnosed with treatment-refractory depression and previously underwent implantation of VNS. 5. Participant has completed the REVEAL CSP and has been stabilized by their care team on a stable VNS setting 6. Apart from epilepsy or depression, participant should be medically and neurologically stable. 7. Participant is able to complete regular office visits and telephone appointments including the imaging session in accordance with the study protocol requirements. 8. Participant that is of childbearing potential must be adequately protected from conception or willing to use an acceptable method of birth control over the entire study duration (acceptable birth control includes abstinence, barrier methods, hormonal methods, sterilization and fertility awareness). 9. Participant must be enrolled in an active health insurance plan that will cover the costs associated with standard health care services and injuries. Exclusion Criteria: GENERAL criteria 1. Participant has a prior implantable stimulation device other than a VNS device for the clinical indication of refractory focal Epilepsy or for depression. 2. Participant currently uses or during the study is expected to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy. 3. Participant has a diagnosis of Substance Use Disorder as defined by DSM-5 without sustained remission of 12 months or longer. 4. Patient participated in another drug or device trial within the preceding 30 days (other than REVEAL studies). 5. Participant has been hospitalized for a psychiatric condition within the preceding 6 months or has had a history of psychosis within the preceding two years (excluding post-ictal psychosis). 6. Participant has experienced unprovoked status epilepticus in the preceding year. 7. Participant is not able or willing to use their dominant arm, or either upper arm circumference is greater than 50 cm. 8. Any other clinical reasons deemed by the investigators of the study for which the participant would not be an appropriate candidate for the study, such as peripheral vascular disease, Raynaud's phenomenon, orthostatic hypotension (OH), postural orthostatic tachycardia syndrome (POTS), uncontrolled obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), or uncontrolled diabetes or pregnancy 9. Participant with vocal cord paralysis 10. Participant cannot speak and read English. 11. Participant is pregnant. 12. Prohibited Therapy During Study Period: We will exclude patients on immunosuppressants, beta blockers, anticholinergics, and clonidine. Consultation with primary providers and amending some of these therapies may be allowed only if clinically indicated. In that case, participants will have to be stable on their new medication for at least one month prior to implant. 13. A body weight of over 350 pounds or 159 kilograms due to equipment limitations used in the measurements of gastric accommodation and emptying. 14. An inability to eat eggs whether due to an allergy, intolerance, or strong dislike. The gastric emptying test meal contains eggs that are labeled with radioisotope. Other food substitutions for the toast, butter and milk may be made only if prior approval is given by Dr. Camilleri. 15. Any other factor that may impact participant safety or compliance as per PI. Since participants with pVNS will be recruited from the CSP study at U Minnesota, it is important to specify the inclusion and exclusion criteria for participants with drug-resistant epilepsy or drug-resistant depression who entered the CSP study: Inclusion Criteria for Participants With Major Depressive Disorder That Have a Previously Implanted VNS Device 1. Participant must be at least 18 years old. 2. Participant must have the capacity to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization. 3. Participant must be enrolled in an active health insurance plan that will cover the costs associated with standard health care services and injuries. 4. Participant must have been previously implanted with a VNS device for the clinical indication of Major Depressive Disorder (MDD). 5. Participant must have a score on the baseline administration of the Montgomery-Åsberg Depression Rating Scale (MADRS) of ≥ 22. 6. Participant must be able and willing to complete the evaluations and procedures described in the study protocol. 7. Participant must be able and willing to follow the stipulations regarding concomitant medications and excluded medications described in section 5.3 of the study protocol. 8. Participant that is of childbearing potential must be adequately protected from conception or willing to use an acceptable method of birth control over the entire study duration (acceptable birth control includes abstinence, barrier methods, hormonal methods, sterilization and fertility awareness). Exclusion Criteria for Participants With Major Depressive Disorder That Have a Previously Implanted VNS Device 1. Participant has a prior implantable stimulation device, other than a VNS device for the clinical indication of Major Depressive Disorder (MDD). 2. Participant currently uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy. 3. Participant is judged by the investigator to be acutely suicidal (e.g. has made specific plans or preparations to commit suicide or as indicated by the Sheehan Suicidality Tracking Scale) within the last 30 days prior to study enrollment. 4. Participant has made a suicide attempt within the previous 6 months from study enrollment. 5. Participant has a history of one or more schizophrenia-spectrum or other psychotic disorders including schizophrenia, schizoaffective disorder, delusional disorder, or a current or lifetime major depressive episode that includes psychotic features (commonly referred to as psychotic depression) according to the MINI criteria. 6. Participant has a history of significant borderline or severe personality disorder as determined by clinical judgment. 7. Participant has an active primary diagnosis of obsessive-compulsive, eating, or post-traumatic stress disorder based on the MINI criteria. 8. Participant has a diagnosis of Substance Use Disorder as defined by DSM-5 without sustained remission of 12 months or longer. 9. Participant has a presence of any type of dementia, major neurocognitive disorder, or cognitive or psychiatric deficit as determined by clinical judgment. 10. Participant has a history of rapid cycling bipolar disorder I or II. 11. Participant currently receives treatment with another investigational device or investigational drug other than the REVEAL study (or a REVEAL ancillary project or sub-study) or has participated in another drug or device trial within the preceding 30 days before enrollment. 12. Participant is not able or willing to use their dominant arm, or either upper arm circumference is greater than 50 cm. 13. Participant does not speak English. 14. Participant is pregnant. 15. Any other clinical reasons deemed by the investigators of the study for which the participant would not be an appropriate candidate for the study, such as peripheral vascular disease, Raynaud's phenomenon, orthostatic hypotension (OH), postural orthostatic tachycardia syndrome (POTS), uncontrolled obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), or uncontrolled diabetes. Inclusion Criteria for Participants With Drug Resistant Epilepsy That Have a Previously Implanted VNS Device 1. Participant must be at least 18 years old. 2. Participan
Biobanking for Biomarkers In Respiratory Disease, Allergic Diseases and/or Mast Cell Disorders
NCT06037967
Recruiting
Conditions Allergic Diseases, Asthma, Mast Cell Dis...
Phase Not Applicable
Enrollment 3200
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Biobanking for Biomarkers In Respiratory Disease, Allergic diseases and/or mast cell disorders
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: 2024-02-28
Completion: 2038-06
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 3200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospital, Toulouse
Principal Investigators:
  • Laurent GUILLEMINAULT, MD (PRINCIPAL_INVESTIGATOR) - University Hospital, Toulouse
Contact Information
Study Contact:
Laurent GUILLEMINAULT, MD
05 67 77 17 51
guilleminault.l@chu-toulouse.fr
Interventions
N/A
Study Locations (1 sites)
Laurent GUILLEMINAULT, Toulouse, 31059 France
Eligibility Criteria
Inclusion Criteria: * patients with a positive prick test or specific IgE regardless of the allergen * patients suspected of allergic pathology defined by the need to carry out a prick test or specific IgE or a food or drug reintroduction test as part of the treatment * patients with systemic or cutaneous mastocytosis according to the international classification8 * patients with mast cell activation syndrome according to the international classification8 * patients with familial hyper-alpha tryptasemia on the presence of variation in the number of copies of the alpha allele of the TPSAB1 gene * patients with asthma of any severity * people affiliated or beneficiaries of a social security scheme * patients able to receive and understand the information on the study and their participation and having freely consented to it in writing before any collection of samples or data necessary for the research (no restriction of rights by the judicial authorities and mastery of the French language). Exclusion Criteria: * patients under legal protection, guardianship or curatorship * pregnant or breastfeeding women
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
NCT06059638
Recruiting
Conditions Hypertension, Hypertension, Systolic, Hy...
Phase NA
Enrollment 500
Locations 131 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
  • Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated

Primary Outcomes

  • Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months
  • Freedom from Unanticipated Serious Adverse Device Effects (USADE)
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: 2029-08
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Orchestra BioMed, Inc
Collaborators: Medtronic
Principal Investigators:
  • David Kandzari, MD (PRINCIPAL_INVESTIGATOR) - Piedmont Heart Institute
  • Andrea Russo, MD (PRINCIPAL_INVESTIGATOR) - Cooper University
Contact Information
Study Contact:
Hans-Peter Stoll, MD, PhD
646-956-2161
hpstoll@orchestrabiomed.com
Angela Stagg
astagg@orchestrabiomed.com
Interventions
  • Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
  • Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
Study Locations (131 sites)
HonorHealth, Scottsdale, Arizona 85258 United States
Adventist Health Glendale, Glendale, California 91206 United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California 92633 United States
Stanford, Redwood City, California 94063 United States
Scripps Clinic, San Diego, California 92121 United States
Sutter Valley Hospitals, San Francisco, California 94109 United States
South Denver Cardiology, Denver, Colorado 80210 United States
Colorado Heart and Vascular, Golden, Colorado 80401 United States
Intermountain Health Lutheran Hospital, Golden, Colorado 80401 United States
UCHealth Medical Center of the Rockies, Loveland, Colorado 80538 United States
Eligibility Criteria
Inclusion Criteria: 1. Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performed within 30 days prior to a planned implant of a Medtronic Astra/Azure dual-chamber pacemaker system or at any time thereafter 2. On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug 3. Office SBP ≥135 mmHg and \<180 mmHg 4. Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg Exclusion Criteria: 1. LVEF \<50% 2. NYHA Class III-IV 3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months 4. Myocardial infarction (MI) within 3 months 5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months 6. Permanent atrial fibrillation 7. Mitral valve regurgitation greater than or equal to grade 3 8. Aortic stenosis with a valve area less than 1.5 cm2 9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy) 10. Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant