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Showing 20 of 29277 trials
Omission of Breast Surgery for Breast Cancer Patients With pCR on MRI and Vacuum-assisted Biopsy After NST (OPTIMIST)
NCT05505357
Recruiting
Conditions Breast Cancer Invasive
Phase NA
Enrollment 533
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Breast surgery omission

Primary Outcomes

  • Disease-Free Survival
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-09-22
Completion: 2031-06
Eligibility
Age: 20 Years
Sex: FEMALE
Volunteers: false
Enrollment: 533 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Seoul National University Hospital
Collaborators: Ministry of Health & Welfare, Korea
Principal Investigators:
  • Han-Byoel Lee (PRINCIPAL_INVESTIGATOR) - Seoul National University Hospital
Contact Information
Study Contact:
Han-Byoel Lee
+82-2-2072-3447
hblee80@gmail.com
Hong-Kyu Kim
+82-2-2072-2980
hkkim4592@gmail.com
Interventions
  • Breast surgery omission
Study Locations (1 sites)
Seoul National University Hospital, Seoul, South Korea
Eligibility Criteria
Inclusion Criteria: * Sex: female * Age: 20 years and older * Patients with no clinical/radiologic distant metastasis * Tumor type: Invasive ductal carcinoma * Tumor subtype: HER2 positive(including luminal B type, triple negative * Extent of disease: initial tumor size ≤ 5cm, cN0-2 * Patients with measurable tumor size * Patients who are expected to achieve pCR after neoadjuvant chemotherapy (MRI size ≤ 1.0 cm AND L-to-B SER ≤ 1.6) * Patients with clip inserted to the primary tumor site before or during neoadjuvant chemotherapy * Patients with informed consent who are competent to make a voluntary decision Exclusion Criteria: * Multifocal lesion (≥2) * Extent of residual microcalcification after neoadjuvant chemotherapy \> 2cm * Bilateral breast cancer or inflammatory breast cancer * Contraindication to radiotherapy * History of previous contralateral breast cancer * Breast cancer patients with distant metastasis * Allergic history to MRI contrast * Male breast cancer * Patients incapable of giving informed consent owing to poor general conditions * Patients with BRCA mutation * Patients willing to receive breast surgery * Patients with a history of cancer diagnosis within 5 years (However, skin cancer other than melanoma and breast carcinoma in situ other than ductal carcinoma in situ can be registered even if 5 years have not passed since the diagnosis)
A Study of Tumor Imaging With Multispectral Optoacoustic Tomography
NCT05488483
Active, positions filled
Conditions Breast Cancer, Melanoma
Phase Not Applicable
Enrollment 12
Locations 4 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Multispectral Optoacoustic Tomography Imaging

Primary Outcomes

  • Number of participants where tumors were visualized
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: 2022-07-27
Completion: 2026-07-27
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 12 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Memorial Sloan Kettering Cancer Center
Principal Investigators:
  • Jan Grimm, MD, PhD (PRINCIPAL_INVESTIGATOR) - Memorial Sloan Kettering Cancer Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Multispectral Optoacoustic Tomography Imaging
Study Locations (4 sites)
Memorial Sloan Kettering Bergen (Consent only ), Montvale, New Jersey 07645 United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only), Commack, New York 11725 United States
Memorial Sloan - Kettering Cancer Center, New York, New York 10021 United States
Helmholtz Institute (Data Analysis Only), Munich, Germany
Eligibility Criteria
Inclusion Criteria: * Participant is a female or male who is 18 years of age or older. * Participant must meet one of the following: * Suspicious breast imaging finding detected on either mammography, ultrasound, or MRI that is visible on ultrasound and therefore recommended for ultrasound-guided breast biopsy (BI-RADS 4 suspicious abnormality; BI-RADS 5, highly suggestive for malignancy) * No previous treatment for breast cancer * Diagnosis of melanoma Exclusion Criteria: * Life expectancy \< 3 months
The Maternal Well-Being Study
NCT05484999
Active, positions filled
Conditions Postpartum Depression, Postpartum Anxiet...
Phase NA
Enrollment 84
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Meals
  • Meals + Social Support
  • Control

Primary Outcomes

  • % of meals delivered to and consumed by subjects
  • perception of the nutritious home delivered meal program
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2022-05-16
Completion: 2025-05-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 84 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Texas Tech University Health Sciences Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Meals
  • Meals + Social Support
  • Control
Study Locations (1 sites)
Texas Tech University Health Sciences Center, Amarillo, Texas 79106 United States
Eligibility Criteria
Inclusion Criteria: * screen positive for food insecurity or qualify for any of the following governmental assistance programs Medicaid, WIC, SNAP, TANF, * speak English, * are between 20-40 completed weeks of pregnancy, * are ages 18 years or older. Exclusion Criteria: * type 1 diabetes * dietary contraindications (e.g., severe food allergy, or inflammatory bowel disease, celiac disease, chronic renal disease, bariatric surgery, short bowel syndrome) * an active eating disorder (self-reported) * hospitalization in the past 12 months for a mental health concern * a history of postpartum psychosis * Individuals with a history of being banned from any social media site will also be excluded.
DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer
NCT05504707
Recruiting
Conditions Triple Negative Breast Cancer, HER2-nega...
Phase PHASE1
Enrollment 30
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • HER2 - primed Dendritic cells
  • HER3 - primed Dendritic cells

Primary Outcomes

  • Maximum Tolerated Dose (MTD)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2022-08-26
Completion: 2026-10
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Collaborators: The Shulas' Foundation
Principal Investigators:
  • Ricardo Costa, MD (PRINCIPAL_INVESTIGATOR) - Moffitt Cancer Center
Contact Information
Study Contact:
Ricardo Costa
813-745-5051
Ricardo.Costa@moffitt.org
Interventions
  • HER2 - primed Dendritic cells
  • HER3 - primed Dendritic cells
Study Locations (1 sites)
Moffitt Cancer Center, Tampa, Florida 33612 United States
Eligibility Criteria
Inclusion Criteria: * A diagnosis of HER2-negative breast cancer. * Diagnosis of HR negative or HR low positive tumor. * Clinical stage T1c, nodal stage N1-N2 or stage T2-4, nodal stage N0-N2 breast cancer. * Participant must be medically and surgically appropriate to undergo neoadjuvant chemotherapy regimen followed by standard of care local therapy as determined by their treating physician. * Age ≥18 years. * ECOG performance status 0 or 1. * Patients must have normal organ and marrow function, as defined below, within 14 days of registration: * \*Absolute neutrophil count (ANC) ≥ 1500/μL * \*Platelets ≥ 75 000/μL * \*Total bilirubin ≤ 1.5 x institutional ULN, except patients with Gilbert's syndrome in whom total bilirubin must be \< 3.0 mg/dL * \*AST/ALT ≤ 3 x institutional ULN * \*Creatinine ≤ 1.5 x institutional ULN * Left ventricular ejection fraction above institutional lower limit of normal (by echocardiogram or MUGA scan). * Female patients of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. Effective methods of contraception must be used throughout the study and for 5 months following the last dose. To show that women do not have childbearing potential, postmenopausal women must be amenorrheic for at least 12 months naturally (and not because of/following chemotherapy) or patients must be surgically sterile. * Ability to understand and the willingness to sign a written informed consent agreement prior to study registration. Exclusion Criteria: * Patients who received prior anthracycline-based chemotherapy for the treatment of any cancer. * Patients with inflammatory breast cancer. * Patients must not be receiving any other investigational agents or active antineoplastic therapies. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune-suppressive treatment, including chronic prolonged systemic corticosteroid use (defined as corticosteroid use lasting one month or more). * Female patients who are pregnant or nursing. * No other prior malignancy is allowed, except for the following: a. adequately treated basal-cell or squamous-cell skin cancer, b. in situ cervical cancer, c. or any other cancer from which the patient has been disease free for at least 3 years. * History of testing positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). * History of positive test for Hepatitis B or Hepatitis C virus indicating acute or chronic infection. * Patients who have received a live attenuated vaccine ≤ 30 days prior to registration. * Unable to comply with the treatment schedule and study procedures for any reason. * Previously treated with breast cancer-directed vaccine therapies in prior 3 months. * Previously treated with any form HER2- or HER3-primed DC1 therapy.
Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy
NCT05472792
Recruiting
Conditions Breast Cancer, Quality of Life
Phase PHASE2
Enrollment 90
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Accelerated Partial Breast Irradiation (APBI)
  • tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene

Primary Outcomes

  • Patient reported outcomes assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
  • Patient reported outcomes assessed by EORTC QLQ-BR45
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2022-05-17
Completion: 2032-04-15
Eligibility
Age: 65 Years
Sex: FEMALE
Volunteers: false
Enrollment: 90 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
Principal Investigators:
  • Dana Casey, MD (PRINCIPAL_INVESTIGATOR) - University of North Carolina, Chapel Hill
Contact Information
Study Contact:
Lori Stravers
+1 919-966-4432
lori_stravers@med.unc.edu
Jessica Buddenbaum
919-966-4432
jessica_buddenbaum@med.unc.edu
Interventions
  • Accelerated Partial Breast Irradiation (APBI)
  • tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene
Study Locations (1 sites)
University of North Carolina, Chapel Hill, North Carolina 27599 United States
Eligibility Criteria
Inclusion Criteria: 1. Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. 2. Women greater than or equal to age 65 years with de novo invasive carcinoma of breast. 3. Pathological T1 (pT1) stage 4. Estrogen receptor (ER)/ Progesterone receptor (PR) positive (greater than or equal to 10% ER and PR by immunohistochemistry \[IHC\] staining) 5. Human epidermal growth factor receptor 2 (HER2) - according to American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) guidelines (0 or 1+ following IHC staining or proven negative by in-situ hybridization \[ISH\]) 6. Grade 1 or 2 overall tumor grade 7. Clinical or pathological N0 8. No lymphovascular space invasion (LVSI) 9. Final surgical margins ≥ 2 mm as per APBI criteria 10. Subjects with completed breast conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). 11. Suitable for APBI as deemed by the treating radiation oncologist 12. Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 13. Enrollment in another clinical trial is allowed if there would be no interference with interventions on this trial Exclusion Criteria: 1. Pre- or post-operative systemic chemotherapy while on this study. 2. Current ongoing treatment with anti-hormonal agents. If previously on anti-hormonal agents and planning to stop, the subject must discontinue within 30 days of randomization. 3. Hormonal replacement therapy (eligible if discontinued within 30 days of randomization). 4. Multifocal or multicentric tumor. 5. Receipt of tissue rearrangement in the lumpectomy cavity. 6. Synchronous bilateral breast cancer. 7. Clinical or imaging evidence of distant metastases. 8. Prior breast or thoracic radiation. 9. Autoimmune conditions with associated radiation risks. 10. Subjects with poor medical risk due to uncontrolled medical conditions that would deem them ineligible for hormonal or radiation therapy.
Impact of 18F-FES PET on the Therapeutic Treatment of Patients With Metastatic Breast Cancer
NCT05486182
Active, positions filled
Conditions Metastatic Breast Cancer
Phase PHASE4
Enrollment 153
Locations 11 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • 18F Fluoroestradiol Radiopharmaceutical with PET/CT

Primary Outcomes

  • To assess the impact of ESTROTEP PET/CT on metastatic breast cancer patients management, initially ER+ and HER2-, in relapse after first-line treatment combining hormone therapy.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Active, positions filled
Start Date: 2022-02-08
Completion: 2026-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 153 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: GE Healthcare
Collaborators: Simbec-Orion Group, Keosys
Principal Investigators:
  • Alexandre Cochet (PRINCIPAL_INVESTIGATOR) - Centre Georges Francois Leclerc
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • 18F Fluoroestradiol Radiopharmaceutical with PET/CT
Study Locations (11 sites)
CGFL, Dijon, 21079 France
CHU Grenoble Alpes, La Tronche, 38700 France
CHU de Limoges - Dupuytren, Limoges, 87000 France
Centre Léon Bérard, Lyon, 69008 France
Institut du Cancer de Montpellier, Montpellier, 34298 France
Hôpital Américain de Paris, Neuilly-sur-Seine, 92200 France
Centre Antoine Lacassagne, Nice, 06189 France
Hôpital Tenon, Paris, 75020 France
Institut Curie, Paris, 75248 France
Institut Curie, Saint-Cloud, 92210 France
Eligibility Criteria
Inclusion Criteria: 1. Female aged at least 18 years old at the time of enrolment 2. Oestrogen-receptor positive primary breast cancer in IHC (ER ≥10%) 3. HER2-negative primary breast cancer (0, 1+, 2+ FISH negative) 4. Metastatic stage with at least one lesion identifiable on the conventional work-up other than a liver lesion 5. Patient relapsing under first-line treatment combining a CDK4/6inhibitor and hormone therapy 6. Patient having undergone an FDG PET/CT during follow-up of first-line treatment for metastatic tumour revealing the relapse or undergoing a baseline FDG PET/CT seeking the relapse during 2nd line staging (according to the recommendations of the Guide to Correct Use (GBU) for medical imaging tests). A period of 2 to 28 days will be respected between the 2 PET/CT scans (FDG/FES). 7. ECOG 0, 1 or 2 8. Life expectancy of at least 12 months 9. Patient registered with a Social Security scheme 10. Patient having signed an informed consent form 11. Patient able to follow the study procedures and fill in the quality of life questionnaires Exclusion Criteria: 1. Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES) 2. Patients as first-line treatment for metastatic cancer or aftersecond-line treatment for metastatic cancer 3. Person presenting a known allergy to one of the components of EstroTep 4. Patients having been treated with a CDK4/6 inhibitor in combination with an SERM or SERD as first-line metastatic therapy 5. atients suffering from severe or known chronic liver or renal failure 6. Patient following a low-sodium diet or having alcohol consumption levels incompatible with the administration of EstroTep, according to the investigator's opinion 7. Woman of childbearing age with no effective means of contraception according to the investigator's opinion 8. Severe intercurrent disease or comorbidity assessed at risk 9. Persons referred to in articles L. 1121-5 to L. 1121-8 and L11222 of the French Public Health Code
Testing a Scalable Model of Care to Improve Patients Access to Mental Health Services After Traumatic Injury
NCT05497115
Recruiting
Conditions Posttraumatic Stress Disorder, Depressio...
Phase NA
Enrollment 350
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Trauma Resilience and Recovery Program

Primary Outcomes

  • Change from Baseline PTSD Checklist for DSM-5 8- item (PCL8-5) at 3-,6-, and 12-month
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-11-04
Completion: 2027-03-31
Eligibility
Age: 16 Years
Sex: ALL
Volunteers: false
Enrollment: 350 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Medical University of South Carolina
Collaborators: George Washington University, Agency for Healthcare Research and Quality (AHRQ)
Principal Investigators:
  • Kenneth Ruggiero, PhD (PRINCIPAL_INVESTIGATOR) - Medical University of South Carolina
Contact Information
Study Contact:
Gabriela Becerra, BS
8439982602
becerra@musc.edu
Hannah Espeleta, PhD
84377957658
espeleta@musc.edu
Interventions
  • Trauma Resilience and Recovery Program
Study Locations (1 sites)
George Washington University Hospital, Washington, Virginia 20037 United States
Eligibility Criteria
Inclusion Criteria: * English- or Spanish-speaking patients ≥ 16 years old who are admitted to George Washington University hospital's trauma center and screen positive on the Injured Trauma Survivors Screen (which indicates risk for development of posttraumatic stress disorder and/or depression) will be included. Exclusion Criteria: * Patients who have a Glasgow Coma Scale score under 13 at hospital admission, moderate to severe cognitive impairment (as measured by the Montreal Cognitive Assessment), active psychosis, or injury that prevents verbal communication (e.g., serious head or spinal cord injury) or is self-inflicted will be excluded. Patients with positive substance use screens via GWU's SBIRT protocol (\~7% of the patient population) will be assessed by the clinical team with reference to severity and recency of substance use problems. We have found at MUSC that a high percentage of patients with SBIRT- positive screens are nevertheless good candidates for TRRP (\>85%), but patients with serious, active substance abuse problems are likely not good candidates for TRRP and therefore will be excluded and referred to a substance use treatment center.
Functional Connectivity Alterations in Suicidal Patients Among Opioid Users
NCT05489042
Recruiting
Conditions Substance Abuse, Suicide, Depression
Phase NA
Enrollment 80
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Repetitive Transcranial Magnetic Stimulation (rTMS)
  • sham rTMS

Primary Outcomes

  • Functional Connectivity between the orbitofrontal cortex (OFC) and dorsal striatum in opioid users or opioid-related patients versus healthy subjects
  • rTMS changes in dorsal striatum responses between those receiving active stimulation versus sham stimulation
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: 2027-03-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 80 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Baylor College of Medicine
Collaborators: American Foundation for Suicide Prevention, National Institute on Drug Abuse (NIDA)
Contact Information
Study Contact:
Hyuntaek Oh, PhD
713-275-5019
hoh@menninger.edu
Taylor Ly
713-275-5594
TLy1@menninger.edu
Interventions
  • Repetitive Transcranial Magnetic Stimulation (rTMS)
  • sham rTMS
Study Locations (1 sites)
The Menninger Clinic, Houston, Texas 77035 United States
Eligibility Criteria
Inclusion Criteria Opioid Use Patients: Each potential subject will be eligible for inclusion in this study only if the specific criteria listed below are met: * Be male or female aged 18-60 years old * Participation in H-22611; * Meets a World Health Organization Alcohol, Smoking and Substance Involvement Screening Test (WHO-ASSIST) score of 4+ in the opioid category; * Has depressive symptoms according to the Patient Health Questionnaire (PHQ)-9; * Has active suicidal thoughts according to Suicide Behaviors Questionnaire-Revised (SBQ-R); * Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures; * Female subjects must be non-nursing and not pregnant at the times of fMRI experiments and rTMS treatment; * Has no contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.); Meets the pre-screening magnetic resonance imaging (MRI) questions provided by the Center for Advanced MR Imaging (CAMRI); * Has no contraindications to TMS (any types of non-removable metal in their head except the mouth, or within 12 inches of the coil, etc.). Inclusion Criteria Healthy Controls: Each potential subject will be eligible for inclusion in this study only if the specific criteria listed below are met: * Be male or female aged 18-60 years old; * No history of severe medical or neurological illnesses per history; * Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures; * Female subjects must be non-nursing and not pregnant at the time of fMRI experiments; * Has no contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.): Meets the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI); * Has no contraindications to TMS (any types of non-removable metal in their head except the mouth, or within 12 inches of the TMS coil, etc.). Exclusion Criteria: Any potential subject who meets any of the following criteria will be excluded from participating in the study if s/he has * In the opinion of the clinician and the research team at admission, be expected to fail to complete the study protocol due to not tolerable to receive rTMS; * Unable to understand the design and requirements of the study; * Unable to sign informed consent for any reason; * Has an unstable medical condition, including Acquired immunodeficiency syndrome (AIDS), acute hepatitis, active TB, unstable cardiac disease, unstable diabetes, hepatic or renal insufficiency; * Female subjects who are pregnant or nursing; * Contraindications to MRI (pacemaker, cochlear implants, metal in the eye, other metal implants, etc.): Do not meet the pre-screening MRI questions provided by the CAMRI; * Contraindications to the noninvasive brain stimulation (NIBS) (any types of non- removable metal in their head except the mouth, or within 12 inches of the coil, etc.) Additional exclusion criteria for the TMS experiments are based on the recommendations described by the international consensus panel on brain stimulation; * Non-English speaking subjects (we do not have the staff and resources to include other languages)
Technology-enabled Management Versus Usual Care for Blood Pressure
NCT05479461
Recruiting
Conditions Hypertension
Phase NA
Enrollment 200
Locations 3 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Digital Hypertension Management System
  • Usual Care

Primary Outcomes

  • Defined Daily Dose (DDD)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-06-13
Completion: 2025-09-15
Eligibility
Age: 30 Years
Sex: ALL
Volunteers: false
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Stanford University
Principal Investigators:
  • Paul J Wang, MD (PRINCIPAL_INVESTIGATOR) - Stanford University
Contact Information
Study Contact:
Paul J Wang, MD
(650) 723-9363
pjwang@stanford.edu
Meg Babakhanian, PhD
818-618-4764
mbabakha@stanford.edu
Interventions
  • Digital Hypertension Management System
  • Usual Care
Study Locations (3 sites)
Stanford Health Care, Palo Alto, California 94305 United States
Morehouse School of Medicine, Atlanta, Georgia 30310 United States
Lake Country Medical Group, Eatonton, Georgia 31024 United States
Eligibility Criteria
Inclusion Criteria: * Age 30-90 yrs. * Smartphone ownership * Office SBP: ≥ 140 mm Hg * ≤ 2 current anti-HTN meds * Able to add or dose-increase at least 2 of the following classes of medications: ACE-I/ARB, diuretic, calcium channel blocker, beta-blocker, mineralocorticoid receptor antagonists (i.e., at least 2 classes are available for addition or dose- increases after excluding intolerant medications and medications currently at maximum dose) * English or Spanish-speakers Exclusion Criteria: * Heart failure with reduced ejection fraction (EF \< 40%) * ESRD (GFR \<15) * Renal replacement therapy * Pregnant * Myocardial infarction or stroke within preceding 6 months * Hospitalization for hypertensive emergency or malignant hypertension within preceding 6 months * Prior solid organ transplantation * At the clinical discretion of the investigators * Enrolled in another clinical study
Family Model DSME in FBOs in the RMI
NCT05502016
Recruiting
Conditions Diabetes Mellitus, Type 2
Phase NA
Enrollment 288
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Family Model Diabetes Self-Management Education and Support
  • Family Model Diabetes Self-Management Education and Support (Wait-list)

Primary Outcomes

  • Glycemic control, measured by change in mean HbA1c (%) from baseline
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-06-30
Completion: 2027-01-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 288 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Arkansas
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigators:
  • Pearl McElfish, PhD (PRINCIPAL_INVESTIGATOR) - University of Arkansas
Contact Information
Study Contact:
Betsy O'Connor, MA
479-713-8000
geoconnor@uams.edu
Brett Rowland, MA
479-713-8000
mbrowland@uams.edu
Interventions
  • Family Model Diabetes Self-Management Education and Support
  • Family Model Diabetes Self-Management Education and Support (Wait-list)
Study Locations (1 sites)
UAMS Institute for Community Health Innovation, Springdale, Arkansas 72764 United States
Eligibility Criteria
Inclusion Criteria: * self-reported Marshallese * 18 years of age or older * have type 2 diabetes (defined as having HbA1c equal to or greater than 6.5%) * have at least one family member willing to take part in the study Exclusion Criteria: * has received diabetes self-management education in the past five years * has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder * plans to move out of the geographic region
The SOAR Study: a Study of Geriatric Assessment and Exercise for Older Adults and Their Support Person
NCT05509751
Active, positions filled
Conditions Lung Cancer, Gastro-intestinal Cancer, G...
Phase NA
Enrollment 60
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • GAM, exercise, health education
  • online chair-based exercise combined with health education

Primary Outcomes

  • Feasability of the study
  • Acceptability of the intervention and the study
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2023-10-01
Completion: 2026-12-01
Eligibility
Age: 65 Years
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Martine Puts
Collaborators: University Health Network, Toronto, Sunnybrook Health Sciences Centre
Principal Investigators:
  • Martine Puts, RN PhD (PRINCIPAL_INVESTIGATOR) - University of Toronto
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • GAM, exercise, health education
  • online chair-based exercise combined with health education
Study Locations (2 sites)
Princess Margaret Cancer Centre, Toronto, Ontario M5G2C4 Canada
Sunybrook Health Sciences Centre, Odette Cancer Centre, Toronto, Ontario Canada
Eligibility Criteria
Inclusion Criteria: 1. Aged 65+ years. 2. Diagnosed with lung, gastrointestinal (GI) , breast, Gynecologic or Genitourinary (GU) cancer or lymphoma who are referred for chemotherapy or immunotherapy and have not received \> 4 weeks of systemic treatment. 4\) Have a physician estimated life expectancy of \>6 months. 5) Be physically inactive (no more than 90 min moderate to vigorous activity per week as per GLTEQ and do not currently meet the recommended physical activity volume of 90 min of aerobic exercise/week). 6\) Able to speak and understand English. 7) Able to give informed consent. 8) Are considered safe to participate in the weekly classes as per their treating oncologist. Eligible support persons are: 1. Identified by the older adult as their support person. 2. Aged 18 years and over. 3. Able to speak and understand English. 4. Able to give informed consent. Exclusion Criteria: 1. Severe neuropsychiatric abnormalities (e.g., moderate-severe dementia) per the treating physician; and 2. Clinic visit with a geriatrician in the previous 12 months (they have already received part of the intervention). 3. Chest tube in-situ. Exclusion criteria support person: Not able to give informed consent.
Risk Factors and Multiomics Study of Chronic Kidney Disease Caused by Metabolic Diseases
NCT05476627
Recruiting
Conditions Chronic Kidney Diseases, Hypertension, D...
Phase Not Applicable
Enrollment 200
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Biomarkers

Primary Outcomes

  • Number of Participants with End Stage Renal Disease
  • Number of Participants with Adverse cardiovascular events
  • Number of Participants with all cause death
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: 2022-07-01
Completion: 2027-07-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Peking Union Medical College Hospital
Principal Investigators:
  • Limeng Chen (PRINCIPAL_INVESTIGATOR) - Peking Union Medical College Hospital
Contact Information
Study Contact:
Yan Liu
+86-15811568692
liuyanpumch@163.com
Interventions
  • Biomarkers
Study Locations (1 sites)
Peking Union Medical College Hospital, Beijing, Beijing Municipality 100730 China
Eligibility Criteria
Inclusion Criteria: * The diagnosis of metabolic diseases were confirmed; * Be able to understand the process of the research; * Volunteer for participation and be able to sign the informed consent. Exclusion Criteria: * Age \<18 yrs or \>80yrs; * Patients with primary and secondary glomerular diseases * Patients with other comorbidities that could affect the volume or the components of the kidney, such as renal cysts, polycystic kidney disease, medullary sponge kidney, hydronephrosis, renal artery stenosis, renal vein thrombosis and/or renal tumors; * Contraindications for MRI examination; * Pregnant or lactation patients; * Patients with unstable vital signs, failure of other organs or dysphoria.
Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World Study
NCT05498675
Recruiting
Conditions Sacubitril/Valsartan, Hypertension, Obes...
Phase Not Applicable
Enrollment 180
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Sacubitril / Valsartan Oral Tablet [Entresto]
  • ACEI/ARB

Primary Outcomes

  • Changes on left ventricular ejection fraction (LVEF)
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: 2021-09-01
Completion: 2027-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 180 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Beijing Friendship Hospital
Principal Investigators:
  • Rongchong Huang, M.D. (PRINCIPAL_INVESTIGATOR) - Beijing Friendship Hospital
Contact Information
Study Contact:
Rongchong Huang, M.D.
+86-13811039417
rchuang@ccmu.edu.cn
Interventions
  • Sacubitril / Valsartan Oral Tablet [Entresto]
  • ACEI/ARB
Study Locations (1 sites)
Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality 100050 China
Eligibility Criteria
Inclusion Criteria: * Patients with essential hypertension * 18-70 years old * No major barriers to provide written consent Exclusion Criteria: * Secondary hypertension, except because of sleep apnea * cardiovascular disease (myocardial infarction, heart failure, stroke or coronary revascularization) within 6 months * Severe concomitant diseases (autoimmune disease, malignancy, late stage of liver diseases, respiratory diseases and digestive diseases) * Unable to understand or comply with the study procedures
Combination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer
NCT05474846
Recruiting
Conditions Sleep, Fatigue, Anxiety, Cancer, Depress...
Phase PHASE2, PHASE3
Enrollment 188
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Melatonin
  • Placebo for Melatonin
  • Melatonin
  • Methylphenidate

Primary Outcomes

  • Pittsburgh Sleep Quality Index (PSQI) questionnaires
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Status: Recruiting
Start Date: 2022-11-21
Completion: 2027-02-28
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 188 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: M.D. Anderson Cancer Center
Principal Investigators:
  • Sriram Yennu, MD (PRINCIPAL_INVESTIGATOR) - MD Anderson
Contact Information
Study Contact:
Sriram Yennu, MD
713-792-6085
syennu@mdanderson.org
Interventions
  • Melatonin
  • Placebo for Melatonin
  • Melatonin
  • Methylphenidate
Study Locations (1 sites)
MD Anderson Cancer Center, Houston, Texas 77030 United States
Eligibility Criteria
Inclusion Criteria: 1. presence of poor sleep quality, defined as Pittsburgh Sleep Quality Index (PSQI) total score ≥ 5, with patients describing poor sleep as being present for a minimum of 2 weeks; 2. ability to communicate in English; 3. cognitively competent to respond appropriately to questions, as measured by the Memorial Delirium Assessment Scale (MDAS) (≤ 13/30); 4. willing and able to sign a written informed consent; 5. life expectancy of ≥ 1 year as assessed by the oncologist or the principal investigator (SY) using the "surprise question," "Would I be surprised if this patient died in the next 12 months?"; and 6. no pain or stable pain (defined as pain ≤ 4 on Edmonton Symptom Assessment Scale (ESAS) or under control and on stable doses of opioids for 1 month). 7. Age 18 years or older 8. be willing to complete in-person or telemedicine follow-up visits with research staff, and able to complete CBT intervention either in person or virtually within Texas. Exclusion Criteria: 1. active use of systemic anti-inflammatory prescription medications including steroids; unless used during or prior to cancer treatment as a prophylaxis (i.e., nausea); 2. known history of psychiatric illness (e.g., schizophrenia, bipolar disorder, major depressive disorder), sleep disorder (e.g., obstructive sleep apnea, narcolepsy, periodic limb movement disorder), obesity hypoventilation syndrome, glaucoma, congenital blindness, self-reported acquired blindness, significant cataracts or retinal disease; and night shift workers. 3. Hospital Anxiety and Depression (HADS) score ≥21, or use of antidepressants, unless the patient is receiving a stable dose for at least 1 month; 4. use of hypnosedative drugs or stimulants; unless on stable doses of hypnosedative drugs or stimulants for at least 1 month; 5. use of monoamine oxidase inhibitors (MOI), tricyclic anti-depressants and anticoagulants; and 6. patients who have bright sunlight exposure for consecutive 30 minutes or more daily in the past month, or prior exposure to BLT, or prior use of MT, MP, or CBT. 7. other medical reason that increases patient risk as determined by PI. 8. For patients participating in the MRI data collection component of the study, we will exclude the participants who meet the following criteria: 1. . Any metallic objects in the body. Metal plates, certain types of dental braces, cardiac pacemakers, ext., that are sensitive to electromagnetic fields contraindicate MRI scans 2. . Claustrophobia 9. Pregnancy as documented in the medical record
My Interprofessional Care Team for Adherence and Research Engagement Disparities
NCT05470439
Active, positions filled
Conditions Medication Adherence, Hypertension
Phase NA
Enrollment 217
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • My Interprofessional Care team for Adherence and Research Engagement (MI-CARE)

Primary Outcomes

  • Objectively measured medication adherence (pill count)
  • Self-reported medication adherence (survey)
  • Blood Pressure
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2023-08-30
Completion: 2026-10-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 217 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Arizona
Collaborators: University of Massachusetts, Amherst
Principal Investigators:
  • Jeannie K Lee, PharmD (PRINCIPAL_INVESTIGATOR) - University of Arizona College of Pharmacy
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • My Interprofessional Care team for Adherence and Research Engagement (MI-CARE)
Study Locations (1 sites)
Caring Health Center, Inc., Springfield, Massachusetts 01103 United States
Eligibility Criteria
Inclusion Criteria: 1. age ≥ 18 years; 2. self-report cultural identity as African-American, or Latino; 3. speak English, or Spanish; 4. have medication-treated hypertension; 5. use ≥5 chronic medications; 6. have hypertension medication adherence \<85%; and 7. able to provide informed consent. Exclusion Criteria: 1. if project staff conclude that a candidate participant is unable to comprehend the informed consent process (because he/she offers an inappropriate response to consent questions); or 2. if the candidate is hostile or unwilling to follow project protocols.
Endothelial Cell Loss in Pseudophakic Patients Receiving a Paul Glaucoma Drainage Device With Its Tube Inserted in the Anterior Versus Posterior Chamber: a Randomized Controlled Trial
NCT05500469
Recruiting
Conditions Glaucoma
Phase NA
Enrollment 200
Locations 1 sites
Compensation compensation available
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Paul glaucoma drainage device (GDD)

Primary Outcomes

  • Change of endothelial cell density (ECD)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-10-20
Completion: 2026-08
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Oogziekenhuis Rotterdam
Contact Information
Study Contact:
Rene Wubbels
+31104023430
r.wubbels@oogziekenhuis.nl
Susan Marinissen
+31104023449
S.Marinissen@oogziekenhuis.nl
Interventions
  • Paul glaucoma drainage device (GDD)
Study Locations (1 sites)
Oogziekenhuis Rotterdam, Rotterdam, 3011BH Netherlands
Eligibility Criteria
Inclusion Criteria: * Age \> 18 years * Informed consent * Pseudophakic * Open angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma or angle closure glaucoma with sufficiently deep anterior chamber * Endothelial image at baseline of fair or good quality Exclusion Criteria: * Iridocorneal endothelial syndrome or posterior polymorphous dystrophy * Eyes with a history of penetrating trauma * Eyes with a history of (intra)ocular surgery other than uncomplicated cataract surgery * Eyes with corneal disease * Synechiae posterior * Pregnant and lactating women
The Effects of Glucagon on Hepatic Metabolism in People With Type 2 Diabetes After Caloric Restriction
NCT05499702
Recruiting
Conditions Type2diabetes
Phase PHASE2
Enrollment 20
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Caloric Restriction
  • Hyperglycemic clamp

Primary Outcomes

  • Rate of leucine oxidation in response to rising glucagon concentrations
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2022-12-15
Completion: 2027-12-31
Eligibility
Age: 25 Years
Sex: ALL
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Adrian Vella
Principal Investigators:
  • Adrian Vella (PRINCIPAL_INVESTIGATOR) - Mayo Clinic
Contact Information
Study Contact:
Jeanette Laugen
5072558110
Laugen.Jeanette@mayo.edu
Interventions
  • Caloric Restriction
  • Hyperglycemic clamp
Study Locations (1 sites)
Mayo Clinic in Rochester, Rochester, Minnesota 55905 United States
Eligibility Criteria
Inclusion Criteria: * We will recruit up to 20 weight-stable, subjects with type 2 diabetes * BMI ≥ 28 Kg/M2 * Diabetes is managed by diet alone or a combination of oral agents Exclusion Criteria: * History of prior upper abdominal surgery e.g. gastric banding, pyloroplasty, vagotomy. * Active systemic illness or malignancy. * Symptomatic macrovascular or microvascular disease. * Contraindications to MRI (e.g. metal implants, claustrophobia). * Hematocrit \< 35% * TSH \< 0.4 or \> 5.5. * Consumption of \> 2 alcohol drinks per day or \> 14 per week or a positive AUDIT questionnaire.
A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer
NCT05509790
Active, positions filled
Conditions Breast Neoplasms
Phase PHASE1
Enrollment 17
Locations 4 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • LY3484356

Primary Outcomes

  • Pharmacokinetics (PK): Plasma Concentration of LY3484356
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: 2022-10-09
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 17 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Eli Lilly and Company
Principal Investigators:
  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) (STUDY_DIRECTOR) - Eli Lilly and Company
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • LY3484356
Study Locations (4 sites)
Wannan Medical College Yijishan Hospital, Wuhu, Anhui 241001 China
Hunan Cancer Hospital, Changsha, Hunan 410013 China
The Third Hospital of Nanchang, Nanchang, Jiangxi 330025 China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality 201315 China
Eligibility Criteria
Inclusion Criteria: * Native Chinese participants must be of an acceptable age to provide informed consent * Have locally advanced (not amenable to curative treatment by surgery) or metastatic disease and be an appropriate candidate for experimental therapy in the judgment of the investigator, after available standard therapies have ceased to provide clinical benefit * Have a diagnosis of ER+, HER2- breast cancer * Female participants have postmenopausal status due either surgical/natural menopause or ovarian suppression * If postmenopausal status is due to ovarian suppression, participants must have a negative serum pregnancy test and agree to use highly effective, medically approved precautions to prevent pregnancy * Have a performance status less than or equal to (≤)1 on the Eastern Cooperative Oncology Group (ECOG) scale * Have adequate organ function * Must be able to swallow capsules/tablets Exclusion Criteria: * Have symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis * Have a serious concomitant systemic disorder * Human immunodeficiency virus (HIV) positive patients are excluded unless they are well controlled on highly active antiretroviral therapy with no evidence of autoimmune deficiency syndrome-defining opportunistic infections within the last 2 years, and cluster of differentiation 4 (CD4) count greater than (\>)350 cells/microliter (μL) * Active hepatitis B or C virus infection * Severe renal impairment, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in clinically significant diarrhea * Have visceral crisis * Have a serious cardiac condition * Have an acute leukemia or other relevant cancers * Females who are pregnant or lactating * Known allergic reaction against any of the components of the study drug
Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction
NCT05490433
Recruiting
Conditions Breast Cancer Classified as TNM Stage 0-...
Phase NA
Enrollment 790
Locations 17 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Robot-assisted Nipple-Sparing Mastectomy (RNSM)
  • Conventional nipple sparing mastectomy(CNSM)

Primary Outcomes

  • 5-year disease-free survival rate(DFS)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-10-26
Completion: 2032-06
Eligibility
Age: 19 Years
Sex: FEMALE
Volunteers: false
Enrollment: 790 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Yonsei University
Principal Investigators:
  • Hyung Seok Park, MD, PhD (PRINCIPAL_INVESTIGATOR) - Yonsei University
Contact Information
Study Contact:
Hyung Seok Park, MD, PhD
82-10-6760-2974
imgenius@yuhs.ac
Interventions
  • Robot-assisted Nipple-Sparing Mastectomy (RNSM)
  • Conventional nipple sparing mastectomy(CNSM)
Study Locations (17 sites)
Samsung Changwon Medical Center, Changwon, South Korea
Keimyung University Dongsan Hospital, Daegu, South Korea
Kyungpook National University Chilgok Hospital, Daegu, South Korea
Yeungnam University Medical Center, Daegu, South Korea
Myongji Hospital, Goyang-si, South Korea
The Catholic University of Korea, Incheon ST. Mary's Hospital, Incheon, South Korea
Kosin University Gospel Hospital, Pusan, South Korea
Chungnam National University Sejong Hospital, Sejong, South Korea
Asan Medical Center, Seoul, South Korea
Gangnam Severance Hospital, Seoul, South Korea
Eligibility Criteria
Inclusion Criteria: * Adult women (≥19 years) scheduled to undergo therapeutic mastectomy for breast cancer who desire immediate breast reconstruction (IBR). * Breast cancer classified as clinical TNM stage 0 to IIIA, based on preoperative evaluation according to the 8th edition of the AJCC anatomic staging system. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Patients scheduled for breast-conserving surgery or deemed ineligible for immediate breast reconstruction (IBR). * Clinical evidence of nipple or skin involvement on preoperative evaluation. * Pregnant or breastfeeding women. * Tumors consisting exclusively of lobular carcinoma in situ (LCIS). * Paget's disease of the breast. * Inflammatory breast cancer. * Male breast cancer. * Clinical stage IIIB-IV disease on preoperative evaluation. * breast size equal to or larger than cup E * History of breast cancer or bilateral breast cancer (including metachronous or synchronous disease). * History of non-breast malignancy, with the exception of non-melanoma skin cancer or papillary/follicular thyroid carcinoma. * Special histologic subtypes of breast tumors (e.g., phyllodes tumor, sarcoma, lymphoma). * Age \>70 years. * American Society of Anesthesiologists (ASA) physical status classification grade ≥4. * Inability to provide informed consent. * History of prior chest radiotherapy. * Patients who have not undergone preoperative testing for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV), which is required for liability insurance coverage.
Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss
NCT05484973
Recruiting
Conditions Alopecia, Chemotherapy-induced Alopecia,...
Phase NA
Enrollment 99
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • AMMA Portalbe Scalp Cooling System

Primary Outcomes

  • Hair Loss
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-11-08
Completion: 2026-09-30
Eligibility
Age: 21 Years
Sex: FEMALE
Volunteers: false
Enrollment: 99 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Cooler Heads Care Inc.
Principal Investigators:
  • Kate Dilligan (PRINCIPAL_INVESTIGATOR) - Cooler Heads Inc.
Contact Information
Study Contact:
Chris Schultz, BS
9715067552
cschultz@ecr-inc.com
Interventions
  • AMMA Portalbe Scalp Cooling System
Study Locations (2 sites)
University of Arizona, Tucson, Arizona 245024 United States
Carle Health, Urbana, Illinois 61801 United States
Eligibility Criteria
Inclusion Criteria: 1. Female patients ≥ 21 years of age 2. Documented diagnosis of breast cancer, stage I, II, or III 3. A planned taxane-containing CT regimen in the adjuvant or neoadjuvant setting with curative intent 4. Concomitant agents may include trastuzumab, pertuzumab, or other CT agents such as cyclophosphamide, or carboplatin Note: Targeted and/or hormonal therapies intended for use after completion of the taxane-containing CT regimen will not be considered part of the study treatment period, and the AMMA PSCS will not be used during the post-CT targeted and/or hormonal therapy period 5. Plan to complete the current CT regimen within six months 6. At least two years out from the last CT causing hair loss with complete recovery of hair 7. Karnofsky17 performance status 80% or greater 8. Willing and able to sign informed consent for this study 9. Willing and able to complete all required study procedures Exclusion Criteria: 1. Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale 2. Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss, others 3. A history of whole brain radiation 4. Plans to use a CT regimen other than those specified in the inclusion criteria; specifically, a regimen not including paclitaxel or docetaxel or a regimen including an anthracycline (AC/T, EC/T, TAC, etc.) 5. Hormone therapy concurrent with CT. Hormone therapy after CT is permitted 6. Current and/or prior use of hair growth products, such as Nutrafol, minoxidil, and Keranique 7. A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up 8. History of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens 9. History of and/or current exposure to other agents, drugs, device, or procedure that may cause hair loss 10. Cold sensitivity 11. Intercurrent life-threatening malignancy 12. Evidence of untreated or poorly controlled hyperthyroidism or hypothyroidism 13. History or current diagnosis of any of the following: Cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia 14. Concurrent hematologic malignancy 15. Participation in any other clinical investigation 16. Concurrent treatment with any investigational agent 17. Any reason the investigator does not believe the patient is a good candidate for the study