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Showing 20 of 27412 trials
Effects of Mouthwashes on the Oral Microbiome and Systemic Health
NCT07356271
Not yet recruiting
Conditions Hypertension
Phase EARLY_PHASE1
Enrollment 200
Locations 0 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

OVERVIEW While antimicrobial mouthwashes are proven to be clinically effective for management of certain oral microbial diseases, recent studies suggest tha, in addition to targeting bacteria responsible for gum diseases such as gingivitis and periodontitis, they may harm healthy bacteria and disturb the balance and protective role of the oral microbiome (dysbiosis). Most findings on the oral microbiome and mouthwashes involve chlorhexidine use, demonstrating that it may induce dysbiosis and compromise the host oral microenvironment . A recent study completed in 2025 has shown that CPC mouthwash can also inhibit nitrate synthesis in the mouth. However there remains a need for further research on other agents used in mouthrinses, such as hydrogen peroxide, essential oils, to determine whether their clinical effectiveness in managing oral disease is accompanied by changes to the oral microbiome. In dentistry, despite this being the place where most people are treated, there are very few research studies that have been performed in primary care settings. Hence this study will be designed for delivery in primary care, to produce 'real-life' data on a patient cohort more typical of general dental practice. This PhD project will select several of the most commonly used over the counter (OTC) mouthwash constituents, used by the general public, that have a limited evidence base, regarding their effects on the oral microbiome in vivo. . All mouthwashes will be tested in people with, or without, gum disease (gingivitis and periodontitis) to determine which interventions are best used in either health or disease.

Design

Study type: Interventional Phases: Early Phase1 Allocation: Randomized Intervention model: Parallel Primary purpose: Prevention Masking/blinding: Triple

Interventions / Regimen

  • Drug: Use of mouthwashes — Population This study aims to recruit up to 200 participants over a period of 3 years on a part-time basis. Recruitment will be carried out through three sites: (i) the University of Plymouth campus population (as successfully used in earlier studies such as Bescos et al., 2020), (ii) the Peninsula Dental School / Peninsula Dental Social Enterprise (PDSE) triage patient clinics (non-NHS clinics), and (iii) the Southside Dental Practice, a private primary care practice located in Southsea, Portsmouth. Sample size was calculated using G\*Power software, which showed that usually 20-30 participants per group are enough, depending on whether the focus is clinical outcomes, blood markers, or microbiome changes. For this project, the main outcome is clinical effectiveness, measured through changes in plaque and bleeding scores. The PDSE clinics collectively see around 400 patients per day across their sites, providing a large and diverse pool of potential participants. In compariso

Primary Outcomes

  • effect of mouthwashes on oral microbiome (three years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: Not yet recruiting
Start Date: 2026-02-01
Completion: 2029-03-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Plymouth
Principal Investigators:
  • zoe Brookes, PhD (STUDY_DIRECTOR) - University of Plymouth
Contact Information
Study Contact:
mimoza cana-bishop, MSc
+447903995399
mimoza.cana-bishop@plymouth.ac.uk
Zoe Brookes, PhD
441752586828
zoe.brookes@plymouth.ac.uk
Interventions
  • Drug: Use of mouthwashes — Population This study aims to recruit up to 200 participants over a period of 3 years on a part-time basis. Recruitment will be carried out through three sites: (i) the University of Plymouth campus population (as successfully used in earlier studies such as Bescos et al., 2020), (ii) the Peninsula Dental School / Peninsula Dental Social Enterprise (PDSE) triage patient clinics (non-NHS clinics), and (iii) the Southside Dental Practice, a private primary care practice located in Southsea, Portsmouth. Sample size was calculated using G\*Power software, which showed that usually 20-30 participants per group are enough, depending on whether the focus is clinical outcomes, blood markers, or microbiome changes. For this project, the main outcome is clinical effectiveness, measured through changes in plaque and bleeding scores. The PDSE clinics collectively see around 400 patients per day across their sites, providing a large and diverse pool of potential participants. In compariso
Eligibility Criteria
* Inclusion \& Exclusion All individuals aged 18 years and older will be eligible to take part in this study. Exclusion will apply to individuals who: Are current smokers, due to the well-documented impact of smoking on oral and systemic health. Have a known diagnosis of hypertension, diabetes, or cancer, as these systemic conditions may influence oral microbiome and inflammatory responses. Have taken a course of antibiotics within the last three months, since antibiotics are known to disrupt microbial balance and may confound the interpretation of oral microbiome data. Report allergies to essential oils or to milk proteins, as these ingredients may be present in the study mouthwash and could trigger adverse reactions. In addition, participants who have never previously used a mouthwash will be excluded. This is a precautionary measure designed to avoid even the minimal possibility of adverse responses.
Integrated Approach in Frail Older People with Atrial Fibrillation
NCT06775028
Recruiting
Conditions Atrial Fibrillation (AF), Hypertension, ...
Phase NA
Enrollment 1250
Locations 50 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

The study will verify if a structured multidisciplinary approach (called iABC), aimed to improve the appropriate management of elderly AF patients with multimorbidity (the i-ABC group), would provide a clear evidence of an improvement in clinical conditions and quality of life compared to usual clinical care. The i-ABC group in AFFIRMO will follow the ABC pathway, focused on three domains: avoid stroke with anticoagulation (with optimized VKA or label-adherent DOAC use); better symptom management; and optimized management of associated cardiovascular and non cardiovascular comorbidities. The study will be conducted in Bulgaria, Denmark, Italy, Romania, Serbia and Spain .

Design

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

Interventions / Regimen

  • Other: iABC platform use — The novel platform (iABC) that will be used in AFFIRMO will consist of an educational program, a healthy or functional diet/physical activity, guideline-adherent drug treatments, periodic (re)assessment.

Primary Outcomes

  • Impact of iABC on all cause unplanned hospitalization (12 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-04-11
Completion: 2026-01-31
Eligibility
Age: 65 Years
Sex: ALL
Volunteers: false
Enrollment: 1250 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Heart Care Foundation
Collaborators: Aalborg University, University of Belgrade, Universidad de Murcia, Carol Davila University of Medicine and Pharmacy, Plovdiv Medical University, University of Liverpool
Contact Information
Study Contact:
Aldo P Maggioni, MD
+390555101211
affirmo@heartcarefoundation.it
Interventions
  • Other: iABC platform use — The novel platform (iABC) that will be used in AFFIRMO will consist of an educational program, a healthy or functional diet/physical activity, guideline-adherent drug treatments, periodic (re)assessment.
Study Locations (50 sites)
MHAT Haskovo AD-Cardiology, Haskovo, Bulgaria
SHATS Sveti Georgi - Pernik-Cardiology, Pernik, Bulgaria
MBAL Sv. Ivan Rilski-Cardiology, Plovdiv, Bulgaria
UMBAL Sveti Georgi EAD-Clinic of Cardiology, Plovdiv, Bulgaria
UMHAT Pulmed Plovdiv-Cardiology, Plovdiv, Bulgaria
Acibadem City Clinic Tokuda Hospital-Dept of Electrophysiology Clinic of Cardiology, Sofia, Bulgaria
Acibadem City Clinic UMBAL Cardiovascular Center-CARDIOLOGY, Sofia, Bulgaria
National Heart Hospital-ICCU, Sofia, Bulgaria
Herlev Hospital-Department of Cardiology, Herlev, Denmark
North Denmark Regional Hospital-Department of Cardiology, Hjørring, Denmark
Eligibility Criteria
Inclusion Criteria: * Outpatients of both sexes with age ≥65 years; * First diagnosed, paroxysmal, persistent, long-standing persistent or permanent AF, confirmed as per guideline-recommended diagnostic criteria for AF, e.g. with electrocardiogram (ECG) or Holter monitoring; * ≥1 additional long-term comorbidity, thus fulfilling the definition of multimorbidity: hypertension (treated with at least 2 antihypertensive drugs), coronary artery disease (CAD), peripheral artery disease, heart failure, stroke/TIA, diabetes mellitus, COPD, CKD. Exclusion Criteria: * Mechanical prosthetic heart valve or moderate/severe mitral stenosis; * Patient unwilling to be enrolled and sign written informed consent; * Patient unable to understand the study and attend the follow-up; * Serious diseases with a life expectancy inferior to 12 months; * Patients included in other interventional studies. Only for sites randomized to the iABC group: \- Patient without a device suitable for iABC use.
Duke Cardiometabolic Prevention Clinic's Impact on High-risk Cardiovascular Patients With Uncontrolled Risk Factors
NCT07117695
Not yet recruiting
Conditions ASCVD, Hyperlipidemia, Hypertension
Phase NA
Enrollment 150
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This project is studying whether a team-based specialty clinic can help people with type 2 diabetes and heart disease better manage their blood pressure and cholesterol. The clinic includes coordinated care from heart doctors, kidney doctors, diabetes specialists, and liver doctors. The study will compare two groups of patients: one receiving usual care from their primary care provider, and one referred to the Duke Cardiometabolic Prevention Clinic for multidisciplinary care. The main goals are to find out if this clinic improves blood pressure and cholesterol control over 12 months, increases use of recommended heart medications, and reduces hospital visits and other healthcare use. Participants will be randomly assigned to one of the two groups. Those referred to the clinic will: 1) Meet with a cardiologist for an initial evaluation. 2) Be referred to other specialists (such as endocrinology, nephrology, or hepatology) based on their needs. 3) Receive ongoing, coordinated care from a team of specialists working together to improve their heart and metabolic health.

Design

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

Interventions / Regimen

  • Other: Referral to the Duke Cardiometabolic Prevention Clinic — Patients who are referred to the cardiometabolic prevention clinic within the intervention arm will be evaluated first by a cardiology provider (as each patient has a history of ASCVD). On this initial visit, the cardiology provider will assess the patient's risk factor profile - to identify the presence of co-morbid conditions or uncontrolled risk factors. The need for additional referrals to other clinicians within the cardiometabolic clinic will specifically outlined criteria. These referrals will be offered to the patient and facilitated after the first visit. Preventive care will follow routine, evidence-based care. Clinicians within the cardiometabolic prevention clinic will meet bi-weekly to discuss enrolled patients, thus every individual in the intervention arm will receive coordinated, multi-specialty care.

Primary Outcomes

  • Change in LDL-C (Baseline, 12 months after enrollment)
  • Change in Systolic Blood Pressure (Baseline, 12 months after enrollment)
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: 2026-10-02
Completion: 2028-02-27
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Duke University
Collaborators: Barnhill Family Foundation
Principal Investigators:
  • Neha J Pagidipati, MD, MPH (PRINCIPAL_INVESTIGATOR) - Duke University
Contact Information
Study Contact:
Sarah Burns, MSCR
910-272-7239
sarah.durden@duke.edu
Interventions
  • Other: Referral to the Duke Cardiometabolic Prevention Clinic — Patients who are referred to the cardiometabolic prevention clinic within the intervention arm will be evaluated first by a cardiology provider (as each patient has a history of ASCVD). On this initial visit, the cardiology provider will assess the patient's risk factor profile - to identify the presence of co-morbid conditions or uncontrolled risk factors. The need for additional referrals to other clinicians within the cardiometabolic clinic will specifically outlined criteria. These referrals will be offered to the patient and facilitated after the first visit. Preventive care will follow routine, evidence-based care. Clinicians within the cardiometabolic prevention clinic will meet bi-weekly to discuss enrolled patients, thus every individual in the intervention arm will receive coordinated, multi-specialty care.
Study Locations (1 sites)
Duke University Medical Center, Durham, North Carolina 27710 United States
Eligibility Criteria
Inclusion Criteria: 1. Adults ≥ 18 years of age 2. Prior history of cardiovascular disease (prior history of CAD, MI, ischemic stroke, PVD, any arterial revascularization) 3. Type 2 Diabetes 4. Uncontrolled sBP AND LDL-C within the preceding 3 months: * SBP \> 150mmHg on at least 1 occasion in last 3 months, AND * LDL \> 130mg/dL in last 3 months * NOTE: If there are not enough patients with the above inclusion criteria available for enrollment, then we will expand the criteria to include patients with uncontrolled sBP and LDL-C within the last 6 months. Exclusion Criteria: 1. Currently or previously established with providers in the Duke Cardiometabolic Prevention Clinic (Pagidipati, Shah, McGarrah, Blazing, Kelsey) 2. History of advanced dementia 3. Referred to hospice/on hospice 4. Lives outside of Durham County, Orange County, Wake County, Person County or Granville County 5. End Stage Renal Disease (those on dialysis or with EGFR \<20) 6. History of cardiac transplant/Listed for Cardiac Transplant/Followed by Advanced Heart Failure 7. Pregnant/Planning to become pregnant during study period
Pulmonary Hypertension Institutional Registry at Hospital Italiano de Buenos Aires
NCT01501838
Recruiting
Conditions Hypertension, Pulmonary Arterial
Phase Not Applicable
Enrollment 200
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to create a registry of patients with Pulmonary Hypertension who received medical care in the Hospital Italiano of Buenos Aires.

Design

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

Primary Outcomes

  • Pulmonary Hypertension prevalence (1 year)
  • Pulmonary Hypertension incidence (1 year)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2017-01-01
Completion: 2031-06-01
Eligibility
Age: 17 Years
Sex: ALL
Volunteers: false
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Hospital Italiano de Buenos Aires
Principal Investigators:
  • Ignacio M Bluro, MD (PRINCIPAL_INVESTIGATOR) - Hospital Italiano de Buenos Aires
Contact Information
Study Contact:
Ignacio M Bluro, MD
+541149590200
ignacio.bluro@hospitalitaliano.org.ar
Interventions
N/A
Study Locations (1 sites)
Hospital Italiano de Buenos Aires, Buenos Aires, Buenos Aires 1181 Argentina
Eligibility Criteria
* Inclusion Criteria: 1. Diagnosed with PAH WHO group 1 (2022 ESC/ESR guidelines criteria) as the presence of a mean pulmonary artery pressure (mPAP) greater than 20 mmHg at rest with pulmonary arterial wedge pressure (PAWP) \>15 mmHg and pulmonary vascular resistance (PVR) \>2 WU, according to the 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. 2. Included in the institutional registry of PAH of Hospital Italiano de Buenos Aires 3. Aged ≥18 years at the index date. * Exclusion Criteria History of lung transplantation surgery previously the baseline period
Impact of Intensive Treatment of SBP on Brain Perfusion, Amyloid, and Tau (IPAT Study)
NCT05331144
Active, positions filled
Conditions Cognitively Normal Older Adults, Hyperte...
Phase PHASE2
Enrollment 180
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to determine if intensive lowering of systolic blood pressure (SBP), using FDA approved medications (antihypertensive), reduces Alzheimer's Disease pathology (i.e., excessive brain amyloid and tau protein deposition) in older adults at high risk for memory decline or dementia.

Design

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

Interventions / Regimen

  • Drug: Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine) — Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine) will be used to treat high blood pressure. Additional antihypertensive medications may be used if needed.
  • Other: PCP — Participants will follow their PCP's recommendations for BP control.

Primary Outcomes

  • Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) (Baseline, 24 months)
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: 2022-10-25
Completion: 2028-08-31
Eligibility
Age: 60 Years
Sex: ALL
Volunteers: false
Enrollment: 180 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Rong Zhang
Collaborators: National Institute on Aging (NIA), Texas Health Resources, Michigan State University
Principal Investigators:
  • Rong Zhang, PhD (PRINCIPAL_INVESTIGATOR) - University of Texas Southwestern Medical Center
  • Wanpen Vongpatanasin, MD (PRINCIPAL_INVESTIGATOR) - University of Texas Southwestern Medical Center
  • David Zhu, PhD (PRINCIPAL_INVESTIGATOR) - Michigan State University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine) — Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine) will be used to treat high blood pressure. Additional antihypertensive medications may be used if needed.
  • Other: PCP — Participants will follow their PCP's recommendations for BP control.
Study Locations (1 sites)
University of Texas Southwestern Medical Center, Dallas, Texas 75390 United States
Eligibility Criteria
Inclusion Criteria: * Age 60-85, all races/ethnicities, and both sexes are eligible; * Mini-Mental State Exam (MMSE) ≥ 26 to exclude gross dementia; based on clinical judgment, may be rescreened in ≥ 7 days; * Individuals with SBP ≥ 130 and SBP ≤ 180 if on 0 or 1 antihypertensive medications; ≥130 and ≤170 on up to 2 medications; ≥130 and ≤160 on up to 3 medications; ≥130 and ≤150 on up to 4 medications. Those on antihypertensives are eligible. If an individual, not treated for hypertension (HTN), has a SBP ≥ 125 mmHg, consider rescreening after 24 hours; * Willingness to be randomized into the treatment groups and ability to return to clinic for follow-up visits over 24 months; * Fluency in English or Spanish or both, adequate visual and auditory acuity to allow neuropsychological testing; * Participants must have a regular healthcare provider. Exclusion Criteria: * Clinically documented history of stroke, focal neurological signs or other major cerebrovascular diseases based on clinical judgment or MRI/CT scans such as evidence of infection, infarction, or other brain lesions; * Diagnosis of AD or other type of dementia, or significant neurologic diseases such as Parkinson's disease, seizure disorder, multiple sclerosis, history of severe head trauma or normal pressure hydrocephalus; * Evidence of severe major depression (GDS ≥ 12, may be rescreened after 12 weeks or longer if evidence of reactive depression or temporary mood disturbances) or clinically significant psychopathology, (e.g., psychosis and schizophrenia); if hospitalized in past year, can be rescreened in 6 months; or presence of a major psychiatric disorder that in the investigator's opinion, could interfere with adherence to research assessments or procedures. * Unstable heart disease based on clinical judgment (e.g., heart attack/cardiac arrest, cardiac bypass procedures within previous 6 months and congestive heart failure), or other severe medical conditions; * History of atrial fibrillation and evidence on ECG with any of the following: active symptoms of persistent palpitation, dizziness, history of syncope, chest pain, dyspnea, orthopnea, shortness of breath at rest, or paroxysmal nocturnal dyspnea within the past 6 months; resting heart rate of \< 30 or \> 110 bpm; taking class I or III antiarrhythmic drugs including flecainide, propafenone, dronedarone, sotalol, dofetilide, and amiodarone; or clinical concerns for safely participating in lowering blood pressure. * Systolic BP equal or greater than 180 mmHg and/or diastolic BP equal or greater than 110 mmHg, may be rescreened in 1 week. * Orthostatic hypotension, defined as the third standing SBP \< 100mmHg, may be rescreened after 2 weeks; * History of significant autoimmune disorders such as systemic lupus erythematosus, rheumatoid arthritis or polymyalgia rheumatica; * Significant history of alcoholism or drug abuse within the last five years; * Uncontrolled diabetes mellitus, defined as hemoglobin A1C \> 7.5%, or requiring insulin treatment; * Regularly smoking cigarettes within the past year; * Pacemaker or other medical device of metal that precludes performing MRI; * Women with a potential for pregnancy, lactation/childbearing (2 year post-menopausal or surgically sterile to be considered not childbearing potential); * Participant enrolled in another investigational drug or device study, either currently or within the past 2 months; * Severe obesity with BMI \> 40 ; clinical judgment should be applied in all cases to assess patient safety and anticipated compliance; * Allergy to angiotensin receptor blockers (ARBs), i.e., drugs that have a suffix "-sartan"; allergy to amlodipine; * Abnormal screening laboratory tests (e.g., liver ALT and AST \> 3 x ULN, GFR \< 30 or Hct \< 28%); may be rescreened after 2 weeks or longer; * A medical condition likely to limit survival to less than 3 years; * Participant has any condition(s) judged by the study investigator to be medically inappropriate, risky or likely to cause poor study compliance. For example: 1. Plans to move outside the clinic catchment area in the next 2 years; 2. Significant concerns about participation in the study from spouse, significant other, or family members; 3. Lack of support from primary health care provider; 4. Residence too far from the study clinic site such that transportation is a barrier including persons who require transportation assistance provided by the study clinic funds for screening or randomization visits; 5. Residence in a nursing home; persons residing in an assisted living or retirement community are eligible if they meet the other criteria; 6. Other medical, psychiatric, or behavioral factors that, in the judgment of the site PI or clinician, may interfere with study participation or the ability to follow the study Protocol. 7. Couples or significant partners who live together cannot be enrolled or participate simultaneously in the study.
Dietary Strategies for Remission of Type 2 Diabetes
NCT04943926
Recruiting
Conditions Diabetes Mellitus, Type 2, Overweight an...
Phase NA
Enrollment 600
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

In this project, the investigators will perform a multicenter randomised controlled trial to determine whether advice to consume a moderate, whole food-based low-carbohydrate high-fat (LCHF) ad libitum diet (CarbCount program) can produce and maintain equal remission rates of type 2 diabetes (T2D) as a nutritionally complete very-low-calorie formula diet followed by a energy-restrictive (i.e., calorie counting) diet (DiRECT principles). Within the principles of each approach, the dietary goals and change will be adjusted according to individual needs/capabilities conducive to long-term adherence. Furthermore, the investigators aim to determine whether the rate of diet-induced remission is reflected in/can be predicted by baseline or diet-induced changes in glucose variability (e.g., time-in-range measured by continuous glucose monitoring) and other factors such as anthropometric changes and genetic susceptibility. Each center will also conduct locally-lead standalone mechanistic research, including analyses of intra-abdominal/hepatic fat accumulation, adipose tissue biopsies and/or measurements of energy metabolism. Additionally, changes in medication use, nutritional status, cardiovascular disease risk, as well as adverse events, will be monitored.

Design

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

Interventions / Regimen

  • Other: Energy restricted diet — Nutritional complete formula diet followed by an energy restricted diet
  • Other: Low carbohydrate high fat diet — Very low-carbohydrate high-fat ketogenic diet (VLCHF) diet followed by a low-carbohydrate high-fat diet (LCHF)

Primary Outcomes

  • Diabetes remission (15 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-01-04
Completion: 2040-12-31
Eligibility
Age: 24 Years
Sex: ALL
Volunteers: false
Enrollment: 600 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Bergen
Collaborators: Karolinska Institutet, University of Glasgow, University of Copenhagen, Technical University of Munich
Contact Information
Study Contact:
Simon N Dankel, PhD
+4794308637
Simon.Dankel@uib.no
Kristin Amundsen, MSc
+4797171257
k.amundsen@uib.no
Interventions
  • Other: Energy restricted diet — Nutritional complete formula diet followed by an energy restricted diet
  • Other: Low carbohydrate high fat diet — Very low-carbohydrate high-fat ketogenic diet (VLCHF) diet followed by a low-carbohydrate high-fat diet (LCHF)
Study Locations (1 sites)
Department of Clinical Science, Bergen, Vestland 5021 Norway
Eligibility Criteria
Inclusion Criteria: * HbA1c ≥48 mmol/mol (with or without medical treatment) * Less than 10 years since the diagnosis of T2D * BMI ≥27 kg/m2 (≥25 kg/m2 for Asians) Exclusion Criteria: * Treatment with insulin \>25 IU * HbA1c concentration of 12% or more (≥108 mmol/mol) * Insulin to C-peptide ratio \<0.8 (indicative of insulin deficiency) * Myocardial infarction within the previous 6 months, and severe or unstable heart failure or other severe diseases including cancer, psychiatric/eating disorders, severe depression and substance abuse
Improving Hypertension Control in Safety-Net Settings: The Boston Hypertension Equity Alliance in Treatment
NCT06948838
Recruiting
Conditions Hypertension, Hypertension Complicated
Phase NA
Enrollment 16895
Locations 7 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

High blood pressure (BP) or hypertension (HTN) affects over 100 million individuals in the US, increasing the risk of adverse outcomes, including stroke, myocardial infarction (MI), and chronic kidney disease (CKD). Effective therapies include non-pharmacologic approaches and multiple medication classes. Successful HTN management requires ongoing patient engagement for BP monitoring and treatment intensification. Reaching this goal is challenging, and many patients with HTN do not have controlled BP. Using a collaborative partnership between patients, clinicians, health system and public health stakeholders, and the research team the investigators plan to overcome barriers to widespread implementation of evidence-based health system strategies to improve BP control in a large, urban, primary care-based safety-net setting for diverse populations experiencing disparities in HTN-related outcomes.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Sequential Primary purpose: Health Services Research Masking/blinding: None

Interventions / Regimen

  • Behavioral: RBPM — Standardized blood pressure measurement and treatment protocols in clinical practice.
  • Other: MII — Team-based interventions including multiple evidence-proven interventions such as clinician decision support, monitoring medication non-adherence, use of combination pills, and formulary modifications.

Primary Outcomes

  • Systolic blood pressure (SBP) improvement (Baseline, every 3 months up to 54 months)
  • Interventions received (Baseline, 54 months)
  • Patient activation (Baseline, 18 months, 30 months, 36 months, 42 months, 54 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-09-08
Completion: 2029-09
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 16895 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Boston Medical Center
Collaborators: Patient-Centered Outcomes Research Institute, Boston Healthcare for the Homeless Program (BHCHP), Boston Medical Center General Internal Medicine primary care (BMC GIM), Boston Medical Center Family Medicine Primary Care (BMC FM), NeighborHealth Center Family Medicine at Maverick Street (NH FM), NeighborHealth Center Internal Medicine at Gove Street (NH IM), NeighborHealth South End (NH South End), Manet Community Health Center (Maner CHC), Mattapan Community Health Center (Mattapan), Greater Roslindale Medical and Dental Center (GRMDC), Boston University School of Public Health (BUSPH), BUSPH Biostatistics and Epidemiology Data Analytics Center (BEDAC)
Principal Investigators:
  • Michael Fischer, MD MS (PRINCIPAL_INVESTIGATOR) - Boston Medical Center, Internal Medicine
  • Cheryl Clark, MD ScD (PRINCIPAL_INVESTIGATOR) - Institute for Health Equity Research, Evaluation & Policy, MA League of CHCs
Contact Information
Study Contact:
Michael Fischer, MD MS
(617) 414-7288
Michael.Fischer@bmc.org
Justine Scott, MPH
(617) 414-7288
Justine.Scott@bmc.org
Interventions
  • Behavioral: RBPM — Standardized blood pressure measurement and treatment protocols in clinical practice.
  • Other: MII — Team-based interventions including multiple evidence-proven interventions such as clinician decision support, monitoring medication non-adherence, use of combination pills, and formulary modifications.
Study Locations (7 sites)
Boston Healthcare for the Homeless (BHCHP), Boston, Massachusetts 02118 United States
Boston Medical Center Family Medicine, Boston, Massachusetts 02118 United States
Boston Medical Center, General Internal Medicine primary care, Boston, Massachusetts 02118 United States
Neighborhood Health, Boston, Massachusetts 02118 United States
Mattapan Community Health Center, Boston, Massachusetts 02126 United States
Manet Community Health Center, Quincy, Massachusetts 02169 United States
Greater Roslindale Medical and Dental Center (GRMDC), Roslindale, Massachusetts 02131 United States
Eligibility Criteria
Inclusion Criteria: * Adult (age\>18) patients receiving primary care at one of the 9 participating sites, with primary care provider (PCP) visit in the preceding year * Presence of HTN defined by one or more of: 1) diagnosis included on active problem list, 2) active HTN medications in prior year, 3) 3 separate elevated BP measurements * Uncontrolled HTN defined as systolic blood pressure (SBP)\>140 Exclusion Criteria: * Not meeting the inclusion criteria
Hemodynamic Effects of Inhaled Iloprost in PH-COPD (HOLLYWOOD)
NCT07263958
Not yet recruiting
Conditions Pulmnary Hypertension, COPD, Pulmonary H...
Phase NA
Enrollment 15
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Study Title: A Clinical Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension in Patients With Chronic Obstructive Pulmonary Disease (HOLLYWOOD) The goal of this clinical study is to learn if the inhaled drug iloprost is effective and safe for treating pulmonary hypertension (PH) in adult patients who have severe or very severe Chronic Obstructive Pulmonary Disease (COPD). The main questions it aims to answer are: Does inhaled iloprost reduce the pressure and resistance in the lung's blood vessels (measured as Pulmonary Vascular Resistance - PVR)? Does inhaled iloprost improve participants' ability to exercise, measured by how far they can walk in 6 minutes? What are the side effects and medical problems that participants experience while taking inhaled iloprost? Researchers will assess changes in participants' health by comparing measurements taken before they start taking inhaled iloprost to measurements taken after 12 weeks of treatment. There is no placebo group in this study. Participants in this study will: Use an inhaler to take iloprost 6 to 9 times every day for 12 weeks. Visit the clinic for checkups at the beginning of the study and after the 12-week treatment period. Undergo tests including an exercise capacity test (the 6-minute walk test) and heart pressure measurements (hemodynamic tests) before and after the treatment period.

Design

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

Interventions / Regimen

  • Drug: Iloprost is a synthetic molecule with pharmacological action — Ventavis® is the commercial brand name for inhaled iloprost in Brazil.

Primary Outcomes

  • Change from Baseline in Pulmonary Vascular Resistance (PVR) in Wood Units (WU) (Baseline and 12 weeks)
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: 2025-12-10
Completion: 2026-12-20
Eligibility
Age: 40 Years
Sex: ALL
Volunteers: false
Enrollment: 15 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Sao Paulo General Hospital
Contact Information
Study Contact:
Caio JC Fernandes, PhD
+55 11 2661-1548
caio.cesar@hc.fm.usp.br
Interventions
  • Drug: Iloprost is a synthetic molecule with pharmacological action — Ventavis® is the commercial brand name for inhaled iloprost in Brazil.
Eligibility Criteria
Inclusion Criteria: * Age 40 years or older. * Established diagnosis of severe or very severe Chronic Obstructive Pulmonary Disease (COPD), corresponding to GOLD stage 3 or 4. * Symptomatic Group 3 Pulmonary Hypertension (PH) confirmed by Right Heart Catheterization (RHC) with the following hemodynamic profile at rest: * Mean Pulmonary Artery Pressure (mPAP) \> 35 mmHg. * Pulmonary Vascular Resistance (PVR) \> 5 Wood Units (WU). * Pulmonary Capillary Wedge Pressure (PCWP) ≤ 15 mmHg. * Capable of providing written informed consent. Exclusion criteria: * History of hypersensitivity to iloprost or other prostacyclin analogs. * Pregnancy or breastfeeding.
GLAUcoma Diagnostic and Imaging Analysis (GLAUDIA) Study
NCT07210216
Not yet recruiting
Conditions Glaucoma Open-Angle Primary, Ocular Hype...
Phase Not Applicable
Enrollment 60
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

This observational study aims to identify early diagnostic markers of glaucomatous damage by combining functional and structural assessments. Patients with primary open-angle glaucoma and ocular hypertension will undergo comprehensive ophthalmological evaluation, including visual field testing and multimodal imaging of the optic nerve and retina. Both retrospective and prospective data will be collected. The main objective is to define new diagnostic paradigms for detecting early glaucomatous changes and to improve the accuracy of current clinical practice in glaucoma management.

Design

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

Primary Outcomes

  • Prevalence of early glaucomatous damage detected by multimodal imaging (Baseline to 24 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2025-10
Completion: 2028-06
Eligibility
Age: 40 Years
Sex: ALL
Volunteers: Not specified
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Eligibility Criteria
Inclusion Criteria: * Age between 40 and 90 years. * Best-corrected visual acuity ≥ 0.1 LogMAR (≥ 8/10). * For primary open-angle glaucoma (POAG): * IOP ≥ 21 mmHg with normal visual field and/or normal optic nerve head/RNFL, or * Suspicious optic nerve head (excavation), or * Reproducible glaucomatous visual field defect. * POAG patients stratified by visual field mean deviation (MD): -3 to -10 dB (S1-S2 Brusini classification). Exclusion Criteria: * Best-corrected visual acuity worse than 0.1 LogMAR (\< 8/10). * Ocular surgery in the last 6 months (except uncomplicated cataract extraction). * Previous vitreoretinal surgery for macular pathologies (e.g., macular pucker, macular hole) or retinal detachment. * High myopia (\> -3 diopters). * Optic disc anomalies not attributable to glaucoma (tilted disc, papillary drusen, other morphological/functional anomalies). * Severe motor disability preventing proper positioning for tests. * Cognitive impairment reducing test reliability.
Registry Study on "Control Nocturnal Hypertension to Reach the Target "
NCT04137549
Recruiting
Conditions Nocturnal Hypertension
Phase Not Applicable
Enrollment 4500
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

Ambulatory blood pressure monitoring (ABPM) is a major innovation in the history of hypertension diagnosis. In clinical practice, the most well established indication for using ABPM is to identify patients who have high BP readings in the office but normal readings during usual daily activities outside of this setting or vice versa, and to identify varying 24-h BP profiles. However, in recent years, there has been increasing interest in BP values during sleep, and nocturnal BP is now recognized to be superior to daytime BP in predicting fatal and nonfatal cardiovascular events (stroke, myocardial infarction, and cardiovascular death), especially in medicated patients. The current direction in the management of hypertension is toward earlier and lower BP control for 24 hours, including the nocturnal and morning periods. Therefore, it may be of great significance to pay attention to the management of nocturnal blood pressure so as to reduce the increased cardiovascular risks. Information of nocturnal hypertensive patients defined by ABPM was prospectively registered nationwide, and then to investigate whether there was difference in cardiovascular prognosis according to the control of ambulatory nocturnal blood pressure.

Design

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

Primary Outcomes

  • The occurrence time of fatal and non-fatal cardiovascular events. (From date of enrollment until date of first documented event assessed up to 3 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2019-12-01
Completion: 2026-12-31
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: false
Enrollment: 4500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Shanghai Institute of Hypertension
Contact Information
Study Contact:
Yan Li, MD,PhD
0086-021-64370045
liyanshcn@163.com
Interventions
N/A
Study Locations (1 sites)
Ruijin Hospital, Shanghai, Shanghai Municipality 200025 China
Eligibility Criteria
Inclusion Criteria: * Age 50-79 years old * Clinical diagnosed hypertension with the use of antihypertensive drugs * Nocturnal hypertension ( nocturnal systolic blood pressure ≥ 130 mmHg and/or nocturnal diastolic blood pressure ≥ 80 mmHg) * A 24-hour ambulatory blood pressure monitoring was performed with validated equipment. * Willing to provide information about disease history and blood biochemical test data within 6 months. * Sign the informed consent Exclusion Criteria: * Without antihypertensive drug use * Hospitalized hypertension patients * Non-compliant patient
A Study to Find and Confirm Blood-based Markers (Called Proteins) That May Show Early Heart Changes in Women With Preeclampsia, Even Before Symptoms Appear, and the Use of Heart Ultrasound (Echocardiography) to Look at Patterns of How the Heart Changes During Pregnancy in Women With Preeclampsia
NCT07463898
Recruiting
Conditions Cardiovascular Biomarkers, Preeclampsia ...
Phase Not Applicable
Enrollment 172
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

The goal of this study is to find and confirm blood-based markers (called proteins) that may show early heart changes in women with preeclampsia, even before symptoms appear. It will also use heart ultrasound (echocardiography) to look at patterns of how the heart changes during pregnancy in women with preeclampsia. The main questions it aims to answer are: * Do these blood markers relate to heart changes on ultrasound? * How may they help predict future health problems for the mother? Participants will: * Complete a 20-minute survey that will include taking your baseline demographic information, clinical information/medical history, asking about pre-existing health conditions, including measuring your height, weight, and blood pressure. * Have transthoracic echocardiography (TTE) performed at 12 - 16 weeks gestation and again at 28 - 32 weeks gestation. * Provide a blood sample for these protein measurements. These samples will be collected at intake (12 - 16 weeks gestation) and again at 28 - 32 weeks gestation.

Design

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

Interventions / Regimen

  • Other: No Intervention: Observational Cohort — This is an observational study, and there is no intervention.

Primary Outcomes

  • Proteomic markers and cardiac-preE phenotypes (At 12-16 weeks gestation and at 28-32 weeks gestation)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2026-04-24
Completion: 2027-12
Eligibility
Age: 13 Years
Sex: FEMALE
Volunteers: true
Enrollment: 172 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Washington University School of Medicine
Collaborators: Vanderbilt University Medical Center, University of Abuja Teaching Hospital
Contact Information
Study Contact:
Zainab Mahmoud, MD, MSc
314-415-0009
zmahmoud@wustl.edu
Cecilia Nartey, MBChB, MPH
314-528-1082
c.nartey@wustl.edu
Interventions
  • Other: No Intervention: Observational Cohort — This is an observational study, and there is no intervention.
Study Locations (1 sites)
University of Abuja Teaching Hospital, Abuja, Nigeria
Eligibility Criteria
Inclusion Criteria: * • Pregnant women who are up to 20 weeks pregnant * Able to consent to participate in the study * Are enrolled in the ENHANCE-CVH study * Willing to undergo echocardiography and blood draws Exclusion Criteria: * • Known cardiac disease (e.g., cardiomyopathy, coronary artery disease \[CAD\]) * Sickle cell disease * Pulmonary arterial hypertension * Pulmonary embolism * Inability to provide informed consent * Acute Illness * Malignancy
Effects of Coffee Versus Hibiscus Tea Consumption During Prolonged Sitting on Blood Pressure and Heart Rate
NCT07159152
Not yet recruiting
Conditions Hypertension
Phase NA
Enrollment 30
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

Modern lifestyles often involve long periods of sitting, which can increase the risk of heart problems, obesity, and other health issues. Diet also plays a key role in heart health. Coffee and hibiscus tea are two common beverages, but their effects during prolonged sitting are not well understood. This study will examine how drinking coffee versus hibiscus tea affects blood pressure, heart rate, and heart rate variability in men and women during extended periods of sitting. Participants (30 in total: 15 women and 15 men) will take part in a randomized crossover study, meaning each person will try both beverages at different times. Data will be collected using questionnaires, body measurements, and devices to measure heart rate, blood pressure, and heart rate variability. The goal is to better understand how these drinks influence heart health during sedentary behavior.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Crossover Primary purpose: Prevention Masking/blinding: None

Interventions / Regimen

  • Dietary Supplement: Coffee — Participants will consume 3 cups of Arabica coffee (Guatemalan origin), providing a total of 400 mg of caffeine. Each cup is prepared with 6% coffee grounds per 100 mL of water, brewed at 90°C for 6 minutes using an electric drip coffee maker, yielding 100.8 mg caffeine per 100 mL. Immediately following coffee consumption, participants will engage in uninterrupted sitting for 3 hours. Blood pressure, heart rate, and other study questionnaires will be measured at baseline (before coffee), 1 hour after coffee intake, and hourly during the 3-hour sitting period.
  • Dietary Supplement: Hibiscus drink — Participants will consume 3 servings of hibiscus leaves tea per day, each serving containing 1.25 g of dried hibiscus leaves, totaling 3.75 g per session. The tea will be prepared by steeping the leaves in 240 mL of boiling water (100°C) for 10 minutes. Immediately after consuming the hibiscus tea, participants will engage in uninterrupted sitting for 3 hours. Blood pressure, heart rate, and other study questionnaires will be measured at baseline (before tea), 1 hour after tea intake, and hourly during the 3-hour sitting.

Primary Outcomes

  • Systolic and diastolic blood pressure (Blood pressure will be recorded at five standardized time points: prior to consumption of coffee or hibiscus tea, one hour post-consumption, and following one, two, and three hours of prolonged sitting.)
  • Heart Rate (Heart rate measurements will be performed at multiple time points during each visit: prior to beverage consumption, one hour post-consumption, and after one, two, and three hours of prolonged sitting.)
  • NN Intervals (NN Intervals measurements will be performed at multiple time points during each visit: prior to beverage consumption, one hour post-consumption, and after one, two, and three hours of prolonged sitting.)
  • RMSSD (RMSSD measurements will be performed at multiple time points during each visit: prior to beverage consumption, one hour post-consumption, and after one, two, and three hours of prolonged sitting.)
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: 2025-09-01
Completion: 2026-03-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: King Saud University
Collaborators: Princess Nourah Bint Abdulrahman University
Principal Investigators:
  • Hadeel M Almalki, BSc (PRINCIPAL_INVESTIGATOR) - Princess Nourah Bint Abdulrahman University
Contact Information
Study Contact:
Abdullah B Alansare, PhD
+966555061381
aalansare@ksu.edu.sa
Mohanad S AlJubairi, MSc
+966553899006
MSAljabiri@pnu.edu.sa
Interventions
  • Dietary Supplement: Coffee — Participants will consume 3 cups of Arabica coffee (Guatemalan origin), providing a total of 400 mg of caffeine. Each cup is prepared with 6% coffee grounds per 100 mL of water, brewed at 90°C for 6 minutes using an electric drip coffee maker, yielding 100.8 mg caffeine per 100 mL. Immediately following coffee consumption, participants will engage in uninterrupted sitting for 3 hours. Blood pressure, heart rate, and other study questionnaires will be measured at baseline (before coffee), 1 hour after coffee intake, and hourly during the 3-hour sitting period.
  • Dietary Supplement: Hibiscus drink — Participants will consume 3 servings of hibiscus leaves tea per day, each serving containing 1.25 g of dried hibiscus leaves, totaling 3.75 g per session. The tea will be prepared by steeping the leaves in 240 mL of boiling water (100°C) for 10 minutes. Immediately after consuming the hibiscus tea, participants will engage in uninterrupted sitting for 3 hours. Blood pressure, heart rate, and other study questionnaires will be measured at baseline (before tea), 1 hour after tea intake, and hourly during the 3-hour sitting.
Study Locations (1 sites)
Princess Nourah University Lifestyle Center, Riyadh, 80200 Saudi Arabia
Eligibility Criteria
Inclusion Criteria: * Age between 18 and 35 years. * Normal to elevated blood pressure (systolic \<130 mmHg and diastolic \<80 mmHg) and normal resting heart rate (60-100 bpm), ensuring selection of healthy adults and minimizing confounding factors. * Generally healthy, without chronic or acute medical conditions, to reduce external influences on study outcomes. * Physically inactive, not meeting current physical activity guidelines, as the study targets sedentary individuals. Exclusion Criteria: * Known allergy or hypersensitivity to hibiscus or coffee, as participants will consume these beverages during the study. * Current use of medications that could influence blood pressure, heart rate, or heart rate variability, including antihypertensive, chronotropic, or vasoactive drugs. * Any medical condition or health issue that may interfere with safe participation or affect study measurements.
Arlington Longitudinal Optimal Healthy Aging Study (ALOHA)
NCT07180147
Active, positions filled
Conditions Alzheimer Disease (AD), Cardio Vascular ...
Phase Not Applicable
Enrollment 500
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

The Arlington Longitudinal Optimal Healthy Aging (ALOHA) Study is a community-based research project led by the Marymount University Center for Optimal Aging (MCOA). The study is designed to help older adults in the Washington, D.C., Maryland, and Virginia (DMV) area maintain independence, mobility, wellbeing and brain health as they age. Adults aged 50 years and older will receive a comprehensive health assessment at the study site, Center for Optimal Aging- ALOHA Lab at Marymount University (MU) Ballston Campus in Arlington, Virginia. The assessment includes physical and cognitive testing, health and medical history, lifestyle surveys, and biometric measures such as blood pressure, grip strength, body composition by the InBody system, balance and gait speed. Participants will receive their results in a personalized "Health Passport," which summarizes findings and provides tailored recommendations to help manage modifiable health risk factors-such as those linked to Alzheimer's disease, cardiovascular disease, frailty syndrome, and depression. Participants will return annually for up to 5 years to repeat assessments and receive updated health and wellness recommendations. The study will track changes in health over time and explore the impact of the Health Passport on health behaviors, functional independence, and quality of life. ALOHA will also evaluate the cultural appropriateness of the Health Passport for diverse populations in Northern Virginia. The program incorporates an interprofessional research model, engaging researchers from multiple health professions to work alongside older adults, supporting both participants' wellness and optimal aging.

Design

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

Primary Outcomes

  • Change in adherence to Health Passport recommendations-Physical/Cardiovascular Health (HPAI-PC) (Baseline and 12 months (with annual re-testing up to 5 years, per protocol).)
  • Change in adherence to Health Passport recommendations-Cognitive, Sleep, and Mental Health (HPAI-CSM) (Baseline and 12 months (with annual re-testing up to 5 years, per protocol).)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2025-05-01
Completion: 2031-07-30
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: true
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Marymount University
Collaborators: Potomac Health Foundations
Principal Investigators:
  • Patricia C Heyn, PhD, FGSA, FACRM (PRINCIPAL_INVESTIGATOR) - Office of Research, Marymount University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (1 sites)
Center for Optimal Aging, Marymount University, Arlington, Virginia 22201 United States
Eligibility Criteria
Inclusion Criteria: * Age 50 years or older at time of enrollment * Residing in the Washington, District of Columbia (DC)., Maryland, or Virginia metropolitan areas * Community-dwelling (living independently or with minimal assistance) * Able to participate in physical and cognitive assessments * Able to provide informed consent * Willing to return for annual follow-up assessments for up to 5 years Exclusion Criteria: * Diagnosis of dementia or significant cognitive impairment that prevents informed consent or participation in assessments * Severe physical disability or medical condition that precludes participation in study assessments (e.g., unstable cardiac condition, severe mobility limitation) * Current diagnosis of a terminal illness with life expectancy less than 12 months * Residing in a long-term care facility or nursing home at time of enrollment * Inability to communicate in English or Spanish (study materials available in these languages only) * Participation in another interventional trial that could confound study results
Long-term Survival and Influencing Factors of Patients With Pulmonary Arterial Hypertension and Diabetes
NCT07082933
Not yet recruiting
Conditions Pulmonary Arterial Hypertension (PAH)
Phase Not Applicable
Enrollment 5000
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

This is a multicenter retrospective cohort study on pulmonary arterial hypertension. It is expected to collect data from no less than 5,000 patients to compare the long-term overall survival of patients with and without diabetes, and analysis the risk factors of the overall survival .

Design

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

Interventions / Regimen

  • Other: Standard medical treatment — Standard medical treatment

Primary Outcomes

  • Overall Survival (10 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2025-08-01
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 5000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Xijing Hospital
Principal Investigators:
  • Yue Zhang, Doctor (PRINCIPAL_INVESTIGATOR) - Department of Health Management, Xijing Hospital, Air Force Medical University
Contact Information
Study Contact:
Yue Zhang, Doctor
0086+13022957751
zhangy718@foxmail.com
Interventions
  • Other: Standard medical treatment — Standard medical treatment
Eligibility Criteria
Inclusion Criteria: * Individuals aged 18 to 80 years with full capacity for civil conduct. * Patients diagnosed with pulmonary hypertension by community-level and/or higher-level medical institutions. Exclusion Criteria: * Patients with malignant tumors. * Other physical conditions judged by the researchers as making the patients ineligible to participate in the clinical study.
Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer
NCT06318897
Recruiting
Conditions Stage 1 cT1b-T1cN0M0, Triple Negative Br...
Phase PHASE2
Enrollment 28
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

To look at the effectiveness of the combination of pembrolizumab, carboplatin, and paclitaxel in participants with stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer.

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Carboplatin — Given by IV
  • Drug: Paclitaxel — Given by IV
  • Drug: Pembrolizumab — Given by IV
  • Drug: Doxorubicin — Given by IV
  • Drug: Cyclophosphamide — Given by IV

Primary Outcomes

  • Safety and adverse events (AEs) (Through study completion; an average of 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: 2024-05-29
Completion: 2027-09-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 28 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: M.D. Anderson Cancer Center
Principal Investigators:
  • Oluchi Oke, MD (PRINCIPAL_INVESTIGATOR) - M.D. Anderson Cancer Center
Contact Information
Study Contact:
Oluchi Oke, MD
(832) 729-8362
oukaegbu@mdanderson.org
Interventions
  • Drug: Carboplatin — Given by IV
  • Drug: Paclitaxel — Given by IV
  • Drug: Pembrolizumab — Given by IV
  • Drug: Doxorubicin — Given by IV
  • Drug: Cyclophosphamide — Given by IV
Study Locations (1 sites)
MD Anderson Cancer Center, Houston, Texas 77030 United States
Eligibility Criteria
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participants must have histologically confirmed ER negative, PR negative and HER2-negative (TNBC) defined as ER\<10%, PR\<10%, and HER2 negative (per 2018 ASCO CAP guidelines). All pathology will be confirmed at the MD Anderson Houston Campus. Participants with tumors designated as HER2 equivocal (per ASCO CAP guidelines) are eligible if in view of treating physician patient is not considered a candidate for HER2-targeted therapy. Participants with weakly ER or PR positive disease, defined as ER and/or PR between 1-9% by immunohistochemistry, are eligible if the treating physician considers the participants not eligible for adjuvant endocrine therapy. 2. AJCC 8 anatomic tumor Stage 1 T1b-T1c, N0, M0. All participants with clinically suspicious nodes must undergo core or fine needle biopsy per standard clinical practice to pathologically assess at least 1 suspicious index node. Participants with suspicious nodes that are biopsy negative will be eligible. 3. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of Stage 1 T1b-T1cN0M0 TNBC will be enrolled in this study. 4. Male participants: A male participant must agree to use a contraception as detailed in Appendix 2 of this protocol during the treatment period and for at least 120 days, corresponding to time needed to eliminate any study treatment(s) (e.g. 5 terminal half-lives for pembrolizumab and/or any active comparator/combination) plus an additional 90 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity at any dose after the last dose of study treatment and refrain from donating sperm during this period. 5. Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix 2), not breastfeeding, and at least one of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 OR 2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the treatment period and for at least 120 days (corresponding to time needed to eliminate any study treatment(s) (pembrolizumab and/or any active comparator/combination) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity after the last dose of study treatment. 6. Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible. 7. The participant provides written informed consent for the trial. 8. Archival tumor tissue sample or newly obtained \[core, incisional or excisional\] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. 9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (appendix 3). Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention. 10. Have adequate organ function as defined in the following table (Table 3). Specimens must be collected within 10 days prior to the start of study intervention. 11. Non-English speaking participant can enroll in the study as long as they speak a language for which interpretation can be provided by a licensed interpreter either in person or virtually. 12. Criteria for known HIV positive participants. 1. Participants with HIV are eligible if they have well-controlled HIV with negative viral load on ART and must not have had any AIDS-defining opportunistic infections within the past 12 months from initiation of C1D1 study treatment. 2. HIV screening tests are not required unless: i. Known history of HIV ii. As mandated by local health authority 13. Criteria for known Hepatitis B and C positive participants Hepatitis B and C screening tests are not required unless: * Known history of HBV or HCV infection * As mandated by local health authority 13.1 Hepatitis B positive Participants * Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. * Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. 13.2 Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. * Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization. Table 3 Adequate Organ Function Laboratory Values System Laboratory Value Hematological Absolute neutrophil count (ANC) = ≥1500/µL Platelets = ≥100 000/µL Hemoglobin = ≥9.0 g/dL or ≥5.6 mmol/La Renal Creatinine OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl) = ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN Hepatic Total bilirubin = ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN AST (SGOT) and ALT (SGPT) = ≤2.5 × ULN (≤5 × ULN for participants with liver metastases) Coagulation International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) = ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal. a Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks. b Creatinine clearance (CrCl) should be calculated per institutional standard. Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 1. Stage 2, 3 or 4 Triple negative breast cancer 2. Hormone Receptor positive and/or Human Epidermal Growth factor 2 (HER 2) positive breast cancer 3. A WOCBP who has a positive urine pregnancy test within 72 hours prior to dose of study drug (see Appendix 2). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 4. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137). 5. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks to allocation of therapy. 6. Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted. 7. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. 8. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. 9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of
Clinical Study to Evaluate Debio0123 + Sacituzumab Govitecan Combination in TNBC or HR+/HER2- Advanced Breast Cancer
NCT06612203
Active, positions filled
Conditions Advanced Breast Cancer
Phase PHASE1, PHASE2
Enrollment 76
Locations 7 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The WIN-B is an international, multicenter, single-arm, phase Ib/II study to evaluate the safety and activity of the Debio 0123 and Sacituzumab govitecan combination therapy in patients with pre-treated advanced/metastatic TNBC or HR+/HER2- breast cancer. Phase Ib will explore if the addition of increasing doses of Debio 0123 to Sacituzumab govitecan is safe and active in pre-treated advanced/metastatic TNBC and HR+/HER2- breast cancer patients. The Debio 0123's recomendad phase 2 doses (RP2D) obtained during phase Ib will then be administered in combination with Sacituzumab govitecan in phase II of the study.

Design

Study type: Interventional Phases: Phase1, Phase2 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Debio 0123 and Sacituzumab govitecan — Debio 0123 will be administered orally during 6 days of each 21-day cycle in combination with 10 mg/kg of Sacituzumab govitecan administered intravenously on D1 and D8 of each 21-day cycle until documented disease progression, death, unacceptable toxicity, or discontinuation from the study treatment for any other reason, whichever occurs first.

Primary Outcomes

  • Phase Ib - Debio 0123's recommended phase II dose (RP2D) when administered in combination with Sacituzumab govitecan in patients with TNBC or HR+/HER2- metastatic breast cancer. (Baseline up to 42 days.)
  • Phase II - Efficacy in terms of objective response rate (ORR) as per RECIST v.1.1 in each cohort. (Approximately 9 months from baseline.)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Active, positions filled
Start Date: 2025-01-17
Completion: 2027-10
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 76 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: MedSIR
Collaborators: Debiopharm International SA, Gilead Sciences
Principal Investigators:
  • Tim Robinson, BMBS, PhD (PRINCIPAL_INVESTIGATOR) - University of Bristol, Bristol, England (UK)
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Debio 0123 and Sacituzumab govitecan — Debio 0123 will be administered orally during 6 days of each 21-day cycle in combination with 10 mg/kg of Sacituzumab govitecan administered intravenously on D1 and D8 of each 21-day cycle until documented disease progression, death, unacceptable toxicity, or discontinuation from the study treatment for any other reason, whichever occurs first.
Study Locations (7 sites)
Hospital Universitari Dexeus, Barcelona, Spain
Hospital Universitario Clínico San Cecilio de Granada, Granada, Spain
Hospital Beata María Ana, Madrid, Spain
Hospital Universitario Virgen de la Victoria, Málaga, Spain
Hospital Arnau de Vilanova de Valencia, Valencia, Spain
Beatson West of Scotland Cancer Center, Glasgow, United Kingdom
Barts Health NHS Trust, London, United Kingdom
Eligibility Criteria
Inclusion Criteria: 1. Patient must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures. 2. Female or male patients ≥ 18 years of age at the time of signing ICF. 3. Unresectable locally recurrent or metastatic breast cancer documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent. 4. Histologically confirmed TNBC or HR+/HER2- breast cancer as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. Note: Patients must have known HR and HER2 status locally determined on the most recent analyzed biopsy or FFPE tumor block prior to study entry. 5. All patients must have been previously treated with taxanes regardless of disease stage (adjuvant, neoadjuvant, or advanced), unless contraindicated for a given patient. 6. Refractory to at least one, and no more than two, prior standard of care chemotherapy regimens for unresectable locally advanced or metastatic breast cancer. Earlier adjuvant or neoadjuvant therapy for more limited disease will be considered as one of the required prior regimens if the development of unresectable locally advanced or metastatic disease occurred within a 12-month period after completion of chemotherapy. 7. HR+/HER2- breast cancer patients must be refractory to at least 1 prior anti-cancer hormonal treatment for advanced disease and must have resistance to CDK4/6 inhibitor defined as: * Disease progression while on, or within 12 months after the end of this treatment in the (neo)adjuvant setting. * Disease progression to this treatment during advanced disease. 8. For phase Ib: evaluable disease according to RECIST v.1.1; for phase II: measurable disease according to RECIST v.1.1. 9. Patients with bone-only metastatic disease will be allowed to participate only if they have at least one measurable soft-tissue component ≥10 mm. 10. Patients with brain metastasis must have an MRI scan of the brain performed and have had stable CNS disease for at least 4 weeks before entry into the trial. Note: low dose corticosteroids for the treatment of brain metastases are permitted provided the dose is stable for 4 weeks. 11. Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks or fresh tumor biopsy at baseline and after detection of disease progression. 12. Able to provide liquid biopsy at the established time points. 13. ECOG performance status of 0-1. 14. Patient must have adequate bone marrow, liver, and renal function. 15. Resolution of all acute toxic effects of prior anti-cancer therapy to grade ≤ 1 as determined by the US National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v.5.0) (except for alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion). 16. Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 14 days before study treatment initiation. In addition, they must agree to use one highly effective method of birth control from the time of screening until 7 months after the last dose of study treatments. Female patients must refrain from egg cell donation and breastfeeding during this same period. 17. Male patients who are sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening until 4 months after the last administration of the study drug. Male patients must not donate or bank sperm during the same time period. 18. Patient must be accessible for treatment and follow-up visits. Exclusion Criteria: 1. Current participation in another therapeutic clinical trial, except other translational studies. 2. Investigational anti-cancer therapy, chemotherapy or radiotherapy with curative intent within 21 days prior to first dose of study treatment. Note: Palliative radiation (e.g., for pain relief) is allowed up to 1 week prior to study treatment start. 3. Treatment with monoclonal antibodies/biologics within 28 days prior to first dose of study treatment. 4. Has previously been treated with a TROP2-directed antibody-drug conjugate (ADC) or WEE-1 inhibitor in any setting. 5. Has previously been treated with topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase 1 inhibitor in any setting. Note: for phase Ib, prior treatment with topoisomerase 1 inhibitors or ADC-containing a topoisomerase 1 inhibitor in any setting must be specifically evaluated on a case-by-case basis by the Medical Monitor. 6. Patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions \[pleural, pericardial, and/or peritoneal\] and pulmonary lymphangitis). 7. Known active uncontrolled or symptomatic central nervous system (CNS) metastases and/or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Note: Patients with ≤ 20 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks. 8. History of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. 9. Has a concurrent malignancy or malignancy within 5 years of study enrollment with the exception of carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required. 10. Active autoimmune disease that has required systemic treatment in past 2 years or is receiving systemic steroid therapy (e.g., dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment, or any diagnosis of immunodeficiency. 11. Known allergy or hypersensitivity reaction to any of the investigational medicinal products (Debio 0123 and Sacituzumab govitecan) or their incorporated substances. 12. Major surgical procedure or significant traumatic injury within 14 days before the first dose of study treatment or anticipation of need for major surgery within the course of the study treatment. 13. Clinically relevant cardiovascular/cerebrovascular disease and/or cardiac dysfunction or conduction abnormalities. 14. Concomitant use of a drug with a known risk of TdP/QTc prolongation or of any drug(s) described in the prohibited medications section of the protocol. If such a drug has been used by the participant, a wash-out period of at least 5 half-lives of the drug must occur before first administration of study treatment. 15. Concomitant use of a drug or herbal product that is an inhibitor or inducer of CYP enzymes, or of any drug(s) (such as proton pump inhibitors, H2 receptor antagonists, etc.) described in the prohibited medications section of the protocol. If such a drug has been used by the participant, a wash-out period of at least 5 half-lives of the drug must occur before first administration of study treatment. 16. Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol. 17. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study. 18. Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative
T-DXd With or Without Neratinib for HER2 Positive Breast Cancer With Brain Metastasis
NCT07152782
Not yet recruiting
Conditions Breast Cancer With Brain Metastasis, HER...
Phase PHASE2
Enrollment 202
Locations 0 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

A phase II, open-label, multicenter, randomized controlled trial exploring the efficacy and safety of Trastuzumab Deruxtecan combined with or without Neratinib in HER2-positive breast cancer with brain metastasis

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Neratinib — Neratinib, as an irreversible pan-HER tyrosine kinase inhibitor (TKI), holds a unique position in the treatment of HER2-positive breast cancer. From a molecular perspective, Neratinib irreversibly binds to the intracellular kinase domains of HER1 (EGFR), HER2, and HER4 through covalent bonds, comprehensively blocking signal transduction of the HER family. This mechanism of action is markedly different from reversible TKIs such as lapatinib. Neratinib's irreversible binding characteristic allows for a more sustained inhibition of target activity, maintaining anti-tumor effects even after drug plasma concentrations have decreased. This feature is particularly important for HER2-positive breast cancer, which requires continuous suppression of proliferative signals.
  • Drug: Trastuzumab Deruxtecan — Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate (ADC) composed of an anti-HER2 monoclonal antibody (trastuzumab), a cleavable linker, and a topoisomerase I inhibitor (an exatecan derivative). It targets and binds to HER2-positive tumor cells, internalizes, and releases cytotoxic drugs to induce DNA damage and apoptosis. It also has a "bystander effect" that can kill neighboring tumor cells with low HER2 expression, enhancing anti-tumor activity. T-DXd has shown significant efficacy in HER2-positive advanced breast cancer, with key clinical trials (such as DESTINY-Breast03) confirming that its progression-free survival (PFS) and overall survival (OS) are superior to traditional second-line treatments, with a median PFS reaching 28.8 months. Additionally, for HER2-low-expressing (IHC 1+ or 2+/ISH-) metastatic breast cancer (in the DESTINY-Breast04 study), T-DXd can extend PFS and OS, becoming the first targeted therapy to alter the survival outcomes of such patients

Primary Outcomes

  • Progression Free Survival(PFS) (24 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Not yet recruiting
Start Date: 2025-11
Completion: 2029-11
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 202 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fudan University
Contact Information
Study Contact:
Zhimin Shao, Professor
08664175590 Ext. 88807
zhimingshao@yahoo.com
Guantian Lang, Doctor
08664175590 Ext. 65277
langguantian@126.com
Interventions
  • Drug: Neratinib — Neratinib, as an irreversible pan-HER tyrosine kinase inhibitor (TKI), holds a unique position in the treatment of HER2-positive breast cancer. From a molecular perspective, Neratinib irreversibly binds to the intracellular kinase domains of HER1 (EGFR), HER2, and HER4 through covalent bonds, comprehensively blocking signal transduction of the HER family. This mechanism of action is markedly different from reversible TKIs such as lapatinib. Neratinib's irreversible binding characteristic allows for a more sustained inhibition of target activity, maintaining anti-tumor effects even after drug plasma concentrations have decreased. This feature is particularly important for HER2-positive breast cancer, which requires continuous suppression of proliferative signals.
  • Drug: Trastuzumab Deruxtecan — Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate (ADC) composed of an anti-HER2 monoclonal antibody (trastuzumab), a cleavable linker, and a topoisomerase I inhibitor (an exatecan derivative). It targets and binds to HER2-positive tumor cells, internalizes, and releases cytotoxic drugs to induce DNA damage and apoptosis. It also has a "bystander effect" that can kill neighboring tumor cells with low HER2 expression, enhancing anti-tumor activity. T-DXd has shown significant efficacy in HER2-positive advanced breast cancer, with key clinical trials (such as DESTINY-Breast03) confirming that its progression-free survival (PFS) and overall survival (OS) are superior to traditional second-line treatments, with a median PFS reaching 28.8 months. Additionally, for HER2-low-expressing (IHC 1+ or 2+/ISH-) metastatic breast cancer (in the DESTINY-Breast04 study), T-DXd can extend PFS and OS, becoming the first targeted therapy to alter the survival outcomes of such patients
Eligibility Criteria
Inclusion Criteria: \- Participants must meet all of the following inclusion criteria in order to be enrolled in this study: 1. Female, aged 18-70 years old. 2. ECOG score ranges from 0 to 1. 3. Expected survival period is greater than 12 weeks. 4. Histologically confirmed invasive HER2 positive breast cancer (HER2 IHC+++or FISH/CISH positive, all samples need to be verified by the pathology department of the research center). 5. Tumor staging: recurrent or metastatic breast cancer; Patients with local recurrence need to be confirmed by the researcher that radical surgical resection cannot be performed. 6. The subject has at least one lesion (measurable and/or unmeasurable) that has not received radiation therapy in the past. 7. MRI or CT shows brain metastasis and meets one of the following conditions: i) Untreated brain parenchymal metastases detected through imaging screening; Ii) Stable or progressive brain parenchymal metastases that have undergone previous local treatment and meet one of the following conditions: 1. Stable imaging for ≥ 4 weeks; 2. New brain parenchymal metastases detected by MR or CT. 8. Transfer treatment ≤ 2 lines, and did not receive T-DXd or nalatinib. 9. The main organ functions are basically normal, meeting the following conditions: 1. The standard for blood routine examination should meet: HB ≥ 90g/L (no blood transfusion within 14 days); ANC≥1.5×109/L;PLT≥75×109/L; 2. Biochemical tests must meet the following standards: TBIL ≤ 1.5 × ULN (upper limit of normal value); ALT and AST ≤ 3 × ULN; If there is liver metastasis, ALT and AST should be ≤ 5 × ULN; Serum Cr ≤ 1.5 × ULN, endogenous creatinine clearance rate ≥ 30mL/min (Cockcroft Gault formula). 10. Prior to enrollment, the use of mannitol and hormone therapy is allowed, but the medication dosage should be stable for at least one week without the need for an increase. 11. Female participants with fertility agreed to take effective contraceptive measures until 3 months after the last use of medication. 12. The subjects voluntarily joined this study, signed informed consent forms, had good compliance, and cooperated with follow-up. Exclusion Criteria: \- Subjects with any of the following conditions are not eligible for inclusion in this study: 1. Transfer treatment exceeding 2 lines, or previous use of T-DXd or nalatinib. 2. Meningeal metastasis. 3. Brain metastases that require emergency intervention treatment, or brain metastases that require treatment with more than 3mg/d dexamethasone or equivalent drugs. 4. A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmia. 5. Due to ongoing grade ≥ 2 adverse reactions caused by previous treatments (excluding hair loss). 6. Pregnancy period. 7. Other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin. 8. Unable to swallow, chronic diarrhea, and intestinal obstruction, there are multiple factors that affect medication intake and absorption. 9. There is a third interstitial fluid accumulation that cannot be controlled by drainage or other methods (such as a large amount of pleural fluid and ascites). 10. Participated in clinical trials of other anti-tumor drugs within 4 weeks prior to the first use of the investigational drug. 11. Long term unhealed wounds or fractures with incomplete healing. 12. Known subjects with active HBV or HCV infection. 13. Active primary immunodeficiency, known to be HIV positive. 14. Uncontrolled infections requiring intravenous injection of antibiotics, antiviral drugs, or antifungal drugs. 15. A history of non communicable ILD/pneumonia requiring steroids, currently suffering from ILD/pneumonia, or unable to rule out suspected ILD/pneumonia through imaging during screening. 16. Lung standard: 1. Pulmonary specific comorbidities with clinically significant diseases, including but not limited to any potential pulmonary diseases (such as pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive pulmonary disease, pleural effusion, etc. within 3 months of recruitment). 2. Any autoimmune disease, connective tissue disease, or inflammatory disease (such as rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.). There are records or suspicions of lung involvement during screening. For participants participating in the study, all detailed information about the disease should be recorded in the CRF. 3. Previous complete lung resection surgery. 17. Individuals with allergies, or those with a known history of allergies to the components of this medication regimen, or subjects who are allergic to other monoclonal antibodies. Researchers believe that substance abuse or medical conditions may interfere with participants' participation in clinical studies or the evaluation of clinical study results.
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
NCT07696754
Not yet recruiting
Conditions Breast Cancer, Breast Neoplasms, Sentine...
Phase NA
Enrollment 30
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study tests whether special imaging goggles can help surgeons find lymph nodes that may be left behind during breast cancer surgery. The goggles show a fluorescent dye (indocyanine green, ICG) that is given during the operation and collects in lymph nodes. In breast cancer surgery, the surgeon removes lymph nodes from the armpit (axilla) to check whether the cancer has spread. Some nodes can be difficult to see and may remain after the surgeon believes the removal is complete. This study looks at whether the goggles can reveal such remaining nodes after the surgeon has declared the axillary surgery finished. Thirty patients having breast cancer surgery with removal of the axillary lymph nodes will take part. After the surgeon states the planned removal is complete, the surgeon will briefly re-examine the area using the goggles and the ICG signal. If additional glowing tissue is seen, the surgeon will decide-using normal surgical judgment-whether it is safe and appropriate to remove it. Any tissue removed this way is examined under the microscope to determine whether it is a lymph node and whether it contains cancer. The study measures how often this additional examination finds cancer-containing nodes that would otherwise have remained, where these nodes are located, whether the finding changes the cancer stage, and how much extra time the examination takes. The study also records any side effects. The results will help determine whether this approach should be studied in a larger trial.

Design

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

Interventions / Regimen

  • Device: Augmented-reality ICG fluorescence second-look imaging — A wearable augmented-reality system displaying combined color and near-infrared fluorescence, with a handheld laser/white-light illuminator, used to re-examine the axillary field for residual ICG-fluorescent tissue after the surgeon declares the dissection complete. Indocyanine green is administered intraoperatively per protocol.

Primary Outcomes

  • Patient-level rate of clinically significant events (CSE) (From intraoperative second-look review to final histopathology (up to approximately 2 weeks after surgery))
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: 2026-07-10
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Ss. Cyril and Methodius University of Skopje
Collaborators: University of Illinois at Urbana-Champaign
Contact Information
Study Contact:
Borislav Kondov, MD
+38972539003
borislav.kondov@medf.ukim.edu.mk
Magdalena Bogdanovska Todorovska, MD
+389709602221
magdalena.todorovska@medf.ukim.edu.mk
Interventions
  • Device: Augmented-reality ICG fluorescence second-look imaging — A wearable augmented-reality system displaying combined color and near-infrared fluorescence, with a handheld laser/white-light illuminator, used to re-examine the axillary field for residual ICG-fluorescent tissue after the surgeon declares the dissection complete. Indocyanine green is administered intraoperatively per protocol.
Study Locations (1 sites)
University Clinic for Thoracic and Vascular Surgery, Faculty of Medicine, UKIM, Skopje, 1000 North Macedonia
Eligibility Criteria
Inclusion Criteria: * Histologically proven breast cancer * Age 18 years or older * Undergoing radical surgery (mastectomy or quadrantectomy) with complete axillary lymph node dissection * Provides written informed consent Exclusion Criteria: * Pregnancy * Neoadjuvant chemotherapy * Prior breast surgery * Iodine or seafood allergy * Indocyanine green (ICG) allergy * Declines or is unable to provide informed consent
A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors
NCT03845166
Active, positions filled
Conditions Neoplasm Malignant, Renal Cell Carcinoma...
Phase PHASE1
Enrollment 325
Locations 86 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with advanced solid tumors.

Design

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

Interventions / Regimen

  • Drug: XL092 — oral doses of XL092
  • Drug: Atezolizumab — Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once every 3 weeks (q3w)
  • Drug: Avelumab — Supplied as 200 mg/10 mL vials; administered as an 800 mg IV infusion once every 2 weeks (q2w)

Primary Outcomes

  • Dose-Escalation Stage: MTD/recommended dose for XL092 (Up to 24 months)
  • Cohort-Expansion Stage: Objective Response Rate (ORR) (Up to 24 months)
  • Cohort-Expansion Stage (except Cohort H): Progression-Free Survival (PFS) (Up to 24 months)
  • Cohort-Expansion Stage (Cohort H only): Overall Survival (OS) (Up to 24 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Active, positions filled
Start Date: 2019-03-20
Completion: 2027-05-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 325 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Exelixis
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: XL092 — oral doses of XL092
  • Drug: Atezolizumab — Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once every 3 weeks (q3w)
  • Drug: Avelumab — Supplied as 200 mg/10 mL vials; administered as an 800 mg IV infusion once every 2 weeks (q2w)
Study Locations (86 sites)
Exelixis Clinical Site #6, Duarte, California 91010 United States
Exelixis Clinical Site #49, La Jolla, California 92093 United States
Exelixis Clinical Site #7, Los Angeles, California 90025 United States
Exelixis Clinical Site #84, Los Angeles, California 90095 United States
Exelixis Clinical Site #66, San Francisco, California 94158 United States
Exelixis Clinical Site #71, Stanford, California 94305 United States
Exelixis Clinical Site #15, Lake Mary, Florida 32746 United States
Exelixis Clinical Site #24, Miami, Florida 33136 United States
Exelixis Clinical Site #11, Atlanta, Georgia 30322 United States
Exelixis Clinical Site #80, Atlanta, Georgia 30342 United States
Eligibility Criteria
Inclusion Criteria: * Cytologically or histologically confirmed solid tumor that is inoperable locally advanced, metastatic, or recurrent. * Dose-escalation (single-agent and combination therapy): Subjects with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective. * Expansion Cohort A (ccRCC): Subjects with previously treated advanced RCC with clear cell histology (including those with a sarcomatoid component) who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease. * Expansion Cohorts B and E (nccRCC): Subjects with previously treated advanced RCC with non-clear cell histology who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease. * Expansion Cohorts C and F (HR+ BC): Subjects with breast cancer that is hormone receptor positive (ER+ and/or PR+) and negative for human epidermal growth factor receptor 2 (HER-2) and who have radiographically progressed during or following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease. * Expansion Cohorts D and G (mCRPC): Subjects with metastatic CRPC (adenocarcinoma of the prostate). Neuroendocrine differentiation and other features permitted if adenocarcinoma is the primary histology. * Expansion Cohort H (CRC): Subjects with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum, KRAS/NRAS wild-type (confirmed via local testing report) and determined NOT to have microsatellite instability high (MSI-high) or mismatch repair deficient (dMMR) by local testing, who received the following standard of care chemotherapy regimens as prior therapy for metastatic CRC: * Fluoropyrimidine, irinotecan and oxaliplatin, with or without an anti-VEGF monoclonal antibody (bevacizumab) * Anti-EGFR monoclonal antibody (cetuximab or panitumumab) * BRAF inhibitor (in combination with cetuximab +/- binimetinib) for subjects with BRAF V600E mutations * Expansion Cohorts: Subjects must have measurable disease per RECIST 1.1. * Tumor tissue material: * Subjects in the non-biomarker cohort provide archival, if available, or fresh tumor tissue if it can be safely obtained. * Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs), including immune-related adverse events (irAEs), related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. * Adequate organ and marrow function. * Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception. * Female subjects of childbearing potential must not be pregnant at screening. Exclusion Criteria: * Prior treatment with XL092 (all cohorts), prior treatment with PD-L1/PD-1 targeting immune checkpoint inhibitor (Cohorts E, F, G, and H only), or prior treatment with regorafenib and/or TAS-102 (Cohort H only). * Receipt of any type of small molecule kinase inhibitor within 2 weeks before first dose of study treatment. * Receipt of any type of anticancer antibody, systemic chemotherapy, or hormonal anticancer therapy within 4 weeks before first dose of study treatment. * Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible. * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. * Uncontrolled, significant intercurrent or recent illness. * Concomitant use of certain medications. * Corrected QT interval calculated by the Fridericia formula (QTcF) \> 450 ms for males and \> 470 ms for females. Single ECGs are no longer permitted. * Pregnant or lactating females. * Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy. Additional Exclusion Criteria for XL092 + Atezolizumab Combination Therapy Cohorts ONLY: * Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment. * Administration of a live, attenuated vaccine within 30 days before first dose of study treatment. Additional Exclusion Criteria for XL092 + Avelumab Combination Therapy Cohorts ONLY: * Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. * Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.
Instagram and Podcast Intervention for Breast Cancer Awareness and Screening
NCT07673588
Recruiting
Conditions Breast Cancer, Breast Cancer Screening
Phase NA
Enrollment 180
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

Breast cancer is the most common cancer among women worldwide. This randomized controlled trial aims to evaluate the effect of an Instagram- and podcast-based intervention on women's breast cancer awareness, health beliefs, and breast cancer screening behaviors among women aged 20-39 years.

Design

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

Interventions / Regimen

  • Other: Instagram-Based Breast Cancer Awareness Intervention — Participants will follow the "Breast Health Academy" Instagram account and receive an 8-week Instagram-based breast cancer awareness intervention. Educational breast cancer awareness and screening content will be shared as posts and stories on Mondays, Wednesdays, and Saturdays. Reminder stories encouraging breast self-examination (BSE), such as "Do not forget to perform your monthly BSE" and "Remember to perform BSE this week," will be shared on Tuesdays, Thursdays, and Sundays. Stories will also be saved as highlights. No content will be shared on Fridays, and all posts and stories will be published at the same time each day.
  • Other: Instagram-Podcast-Based Breast Cancer Awareness Intervention — Participants will follow the "Breast Health Academy Plus" Instagram account and receive an 8-week Instagram- and podcast-based breast cancer awareness intervention. Educational breast cancer awareness and screening content will be shared as posts and stories on Mondays, Wednesdays, and Saturdays. Reminder stories encouraging breast self-examination (BSE) will be shared on Tuesdays, Thursdays, and Sundays and saved as highlights. In addition, one educational podcast episode developed for the intervention will be delivered weekly via Instagram direct message every Friday. All content will be provided at the same time each day throughout the intervention period.

Primary Outcomes

  • Breast Cancer Awareness Scale (Assessments will be performed at baseline and Week 8.)
  • Champion's Health Belief Model Scale in Breast Cancer Screening (Assessments will be performed at baseline and Week 8.)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-07-06
Completion: 2026-12-31
Eligibility
Age: 20 Years
Sex: FEMALE
Volunteers: true
Enrollment: 180 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Ankara University
Principal Investigators:
  • Baise Bicav (PRINCIPAL_INVESTIGATOR) - Yüksek İhtisas University
  • Zehra Bicav (PRINCIPAL_INVESTIGATOR) - Yüksek İhtisas University
  • Sevinç Kutlutürkan (STUDY_DIRECTOR) - Ankara University
Contact Information
Study Contact:
Baise BİCAV
0 312 329 10 10
baisebicav@gmail.com
Zehra BİCAV
0 312 329 10 10
Interventions
  • Other: Instagram-Based Breast Cancer Awareness Intervention — Participants will follow the "Breast Health Academy" Instagram account and receive an 8-week Instagram-based breast cancer awareness intervention. Educational breast cancer awareness and screening content will be shared as posts and stories on Mondays, Wednesdays, and Saturdays. Reminder stories encouraging breast self-examination (BSE), such as "Do not forget to perform your monthly BSE" and "Remember to perform BSE this week," will be shared on Tuesdays, Thursdays, and Sundays. Stories will also be saved as highlights. No content will be shared on Fridays, and all posts and stories will be published at the same time each day.
  • Other: Instagram-Podcast-Based Breast Cancer Awareness Intervention — Participants will follow the "Breast Health Academy Plus" Instagram account and receive an 8-week Instagram- and podcast-based breast cancer awareness intervention. Educational breast cancer awareness and screening content will be shared as posts and stories on Mondays, Wednesdays, and Saturdays. Reminder stories encouraging breast self-examination (BSE) will be shared on Tuesdays, Thursdays, and Sundays and saved as highlights. In addition, one educational podcast episode developed for the intervention will be delivered weekly via Instagram direct message every Friday. All content will be provided at the same time each day throughout the intervention period.
Study Locations (1 sites)
Ankara, Ankara, Turkey (Türkiye)
Eligibility Criteria
Inclusion Criteria: * Women aged 20-39 years * Able to read and write Turkish * Turkish citizens * Have an active Instagram account and access it at least once daily * No previous diagnosis of cancer * Willing to participate and provide informed consent Exclusion Criteria: * No access to a smartphone with the Instagram application * Visual, hearing, or cognitive impairment that may prevent participation in the intervention Withdrawal Criteria: * Failure to complete the assigned podcast sessions during the intervention period * Participant request to withdraw from the study at any time