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Showing 20 of 29714 trials
A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
NCT04895709
Recruiting
Conditions Cervical Cancer, Gastric/Gastroesophagea...
Phase PHASE1, PHASE2
Enrollment 1109
Locations 47 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

  • BMS-986340
  • BMS-936558-01
  • Docetaxel
  • Pumitamig

Primary Outcomes

  • Incidence of adverse events (AEs)
  • Incidence of serious adverse events (SAEs)
  • Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Recruiting
Start Date: 2021-05-27
Completion: 2031-08-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1109 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Bristol-Myers Squibb
Principal Investigators:
  • Bristol-Myers Squibb (STUDY_DIRECTOR) - Bristol-Myers Squibb
Contact Information
Study Contact:
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.
Interventions
  • BMS-986340
  • BMS-936558-01
  • Docetaxel
  • Pumitamig
Study Locations (47 sites)
Community Cancer Institute, Clovis, California 93611 United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California 90033 United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California 92663 United States
University of Iowa, Iowa City, Iowa 52242 United States
John Theurer Cancer Center, Hackensack, New Jersey 07601 United States
Local Institution - 0006, New York, New York 10032 United States
Local Institution - 0002, New York, New York 10065 United States
Providence Cancer Center Oncology and Hematology Care- Eastside, Portland, Oregon 97213 United States
Local Institution - 0063, Nashville, Tennessee 37067 United States
Vanderbilt University Medical Center, Nashville, Tennessee 37232 United States
Eligibility Criteria
Inclusion Criteria * Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable. * Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Radiographically documented progressive disease on or after the most recent therapy. * Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated. * Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant. Exclusion Criteria * Women who are pregnant or breastfeeding. * Primary central nervous system (CNS) malignancy. * Untreated CNS metastases. * Leptomeningeal metastases. * Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment. * Active, known, or suspected autoimmune disease. * Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment. * Prior organ or tissue allograft. * Uncontrolled or significant cardiovascular disease. * Major surgery within 4 weeks of study drug administration. * History of or with active interstitial lung disease or pulmonary fibrosis. * Other protocol-defined inclusion/exclusion criteria apply.
Coronary Artery Calcification in Type 2 Diabetes Mellitus (USCAC Study)
NCT04889053
Recruiting
Conditions Type 2 Diabetes, Vascular Calcification,...
Phase Not Applicable
Enrollment 1400
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • The prevalence and incidence rate of CAC in T2DM
Interested in this trial?
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Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2021-06-01
Completion: 2030-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1400 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of South China
Principal Investigators:
  • Liu Jianghua, PhD (STUDY_CHAIR) - The First Affiliated Hospital of University of South China
Contact Information
Study Contact:
Liu Jianghua, PhD
(+86)13407340909
jianghua990@126.com
Fu Chenxiao, PhD
(+86)13469116604
nhfyllwyh@163.com
Interventions
N/A
Study Locations (1 sites)
The First Affiliated Hospital of University of South China, Hengyang, China
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years old * Type 2 diabetes is diagnosed according to WHO diagnostic criteria * Low dose prospectively triggered sequential dual-source CT coronary angiography can be performed at baseline investigation * Those subjects are able to understand the purpose and procedure of this study and sign the informed consent voluntarily Exclusion Criteria: * Those have received coronary artery stenting or coronary artery bypass grafting * Those with severe lung (respiratory failure), liver (ALT or AST 3 times normal value or bilirubin increase), renal dysfunction\[GFR \< 45ml/(min.1.73m2) or dialysis patients * Malignant tumor * Mental illness or mental retardation * Pregnant or lactating women or those with fertility planning * Concomitant diseases (hyperparathyroidism, sarcoidosis, amyloidosis) affecting calcium balance and soft tissue calcification * Contraindications of contrast agents * Based on the judgment of the researcher, the compliance is poor and the study could not be completed according to the requirements
PET/MR Pre- and Post Radiotherapy for Cardiopulmonary Dysfunction Evaluation
NCT04901884
Recruiting
Conditions Pulmonary Hypertension
Phase NA
Enrollment 40
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

  • PET/MR with 18F-FDG

Primary Outcomes

  • Change of FDG uptake of heart
  • Change of FDG uptake of lungs
  • Change of the heart function
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2021-06-01
Completion: 2026-06-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Health Network, Toronto
Principal Investigators:
  • Patrick Veit-Haibach, MD (PRINCIPAL_INVESTIGATOR) - University Health Network, Toronto
Contact Information
Study Contact:
Patrick Veit-Haibach, MD
416-340-4800
Patrick.Veit-Haibach@uhn.ca
Andrew Hope, MD
416-946-2124
Andrew.Hope@rmp.uhn.ca
Interventions
  • PET/MR with 18F-FDG
Study Locations (1 sites)
University Health Network, Toronto, Ontario M5G 2M9 Canada
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Biopsy or otherwise clinically proven thoracic malignant mass which is intended to be treated with radio(chemo)therapy * Intention to treat with radio(chemo)therapy with incidental cardiac irradiation of at least 25Gy. * A negative urine or serum pregnancy test within the two week interval immediately prior to imaging, in women of child-bearing age. * Ability to provide written informed consent to participate in the study (for all components of the trial: imaging with cardiac PET/MR, blood sampling for plasma metabolomics and circulating DNA). Exclusion Criteria: * Contraindication for MR as per current institutional guidelines. * Contraindication for Gadolinium injection as per current institutional guidelines. * Inability to lie supine for at least 45 minutes. * Any patient who is pregnant or breastfeeding. * Any patient with known hypersensitivity to 18F-FDG.
Effects of White Button Mushroom on Inflammation in Obese Postmenopausal Women at High Risk of Breast Cancer
NCT04913064
Recruiting
Conditions Breast Carcinoma
Phase NA
Enrollment 26
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

  • Questionnaire Administration
  • White Button Mushroom Extract

Primary Outcomes

  • Relative change in levels of circulating myeloid-derived suppressor cells (MDSCs) within the peripheral blood mononuclear (PBMC) compartment
  • Relative change in immune cell composition within the peripheral blood mononuclear (PBMC) compartment
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2021-07-27
Completion: 2027-01-12
Eligibility
Age: 21 Years
Sex: FEMALE
Volunteers: true
Enrollment: 26 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Lisa D Yee (PRINCIPAL_INVESTIGATOR) - City of Hope Medical Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Questionnaire Administration
  • White Button Mushroom Extract
Study Locations (1 sites)
City of Hope Medical Center, Duarte, California 91010 United States
Eligibility Criteria
Inclusion Criteria: * This study will be conducted in postmenopausal women who have increased risk of breast cancer and high BMI \>= 30 kg/m\^2 * The study population will consist of women with a relative risk of developing breast cancer that is at least \> 2 x that of the general population for their age group based on any of the following: * Have a known genetic mutation associated with hereditary breast cancer (including BRCA1, BRCA2, p53, etc.) * One or more first degree relatives with breast cancer, with at least one under the age of 60 * Two or more second degree relatives with breast cancer, with at least one under the age of 50 * Prior biopsy diagnosing atypical lobular hyperplasia, atypical ductal hyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ in the last 10 years * Have a Gail Risk Assessment (which is based on age, race, age of menarche, age of first live birth, number of first degree relatives with breast cancer, number of breast biopsies, and presence of high risk histology on any biopsies) that is considered high risk compared to the general population i.e. 5 year Gail \>= 1.7 * Prior diagnosis of T1 or T2 breast cancer \>= 5 years, without antiestrogen therapy for \> six months when applicable * ELIGIBILITY CRITERIA FOR HIGH RISK PATIENTS FOR THE CLINICAL TRIAL * Body mass index (BMI) \>= 30 (Asian BMI \>= 25 kg/m\^2) * Postmenopausal, defined as continuous absence of menstruation for 12+ months, status post bilateral oophorectomy, or status post hysterectomy with follicle stimulating hormone (FSH) in menopausal range * Bilateral mammogram within the 12 months prior to study enrollment that is read as not suspicious for breast cancer (American College of Radiology \[ACR\] class I-III). Subjects with a class IV mammogram may be entered once they have had a negative biopsy. In cases of bilateral mastectomy, documentation that the patient has been continuously without evidence of disease for 5 years will suffice * Serum creatinine of 1.5 X upper limit of institutional norm or less * Total bilirubin of 1.5 X upper limit of institutional norm or less * ALT and aspartate aminotransferase (AST) of less than 2 X upper limit of institutional norm or less * Hemoglobin of 9.0 gm/dL or more * Platelets of 100,000/mm\^3 or more * Total white blood cell (WBC) of 3500/mm\^3 * Absolute neutrophil count (ANC) of 1500/mm\^3 or more * Must be willing to have about 40-50 ml of blood (approximately 8-10 teaspoons) drawn at 0 and 3 months * Must be able to swallow pills * This study will assess WBM powder in postmenopausal women of 21 years of age or older. Younger women are unlikely to be postmenopausal * Participants will have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * The effects of WBM on the developing fetus are unknown. Pregnant and women with childbearing potential are not eligible to participate in this study of postmenopausal women at high risk of breast cancer * All subjects must have the ability to understand and the willingness to sign a written informed consent. Participants must be aware of their increased breast cancer risk and willingly consent after being informed of the investigational nature of the intervention, alternatives, potential benefits, side-effects, risks, and discomforts * Prior therapies, including chemoprevention or adjuvant therapies, must have been completed for 6 or more months prior to study entry. Prior use of mushroom or mushroom chemical-containing supplements must have been completed within 3 months of study entry Exclusion Criteria: * Active malignancy within the past 5 years with the exception of non-melanoma skin cancer or carcinoma in situ of the cervix. NOTE: If there is a history of prior malignancy, the participant must not be receiving other specific treatment, i.e., other hormonal therapy, for their cancer * Ongoing chemotherapy, radiation therapy, or other cancer-related treatment * History of a bleeding tendency or current use of Coumadin or other anticoagulants * Concurrent use of hormone-modifying medications including systemic hormone replacement therapy (local vaginal preparations are permitted), selective estrogen receptor modifiers (SERMs), aromatase inhibitors (Ais), or gonadotropic-releasing hormone (GnRH) modifiers within 3 months of randomization * Concurrent use of immunosuppressant medications * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation that would limit compliance with study requirements * Chronic use of any herbal or dietary supplement containing mushrooms within the 3 months prior to entry on the study * Treatment with other investigational agents * Premenopausal status * Known sensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to WBM or * Subjects on a standing regimen of full dose aspirin (\>= 325 mg/day), nonsteroidal anti-inflammatory drugs (NSAIDs) or NSAID-containing products * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Web-Based Symptom Monitoring and Self-Management Portal (YES) for Adolescent and Young Adult Breast Cancer Survivors
NCT04906200
Active, positions filled
Conditions Anatomic Stage 0 Breast Cancer AJCC v8, ...
Phase NA
Enrollment 400
Locations 3 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Best Practice
  • Internet-Based Intervention
  • Survey Administration

Primary Outcomes

  • Efficacy of the Young, Empowered & Strong (YES) intervention in improving quality of life (QOL)
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: 2021-06-28
Completion: 2026-12-31
Eligibility
Age: 15 Years
Sex: FEMALE
Volunteers: false
Enrollment: 400 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Ohio State University Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI), Dana-Farber Cancer Institute, Columbia University
Principal Investigators:
  • Michelle Naughton, PhD (PRINCIPAL_INVESTIGATOR) - Ohio State University Comprehensive Cancer Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Best Practice
  • Internet-Based Intervention
  • Survey Administration
Study Locations (3 sites)
Dana Farber Cancer Institute, Boston, Massachusetts 02215 United States
Columbia University Medical Center, New York, New York 10032 United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio 43210 United States
Eligibility Criteria
Inclusion Criteria: * Female * Age 15-39 years at diagnosis of a stage 0-III breast cancer * Within 3 years of breast cancer diagnosis * No known evidence of breast cancer recurrence (local or distant) or second primary breast cancer * No prior history of new other malignancy since their breast cancer diagnosis (other than non-melanoma skin cancer) * Able to speak, understand and read English * Cognitively able to complete the study requirements * Ability to access medical records from treating hospital * Willing to provide cell phone number and/or email address, and willing to receive email and/or text messages from the study team either with their own smartphone or one provided by the study team if they do not have their own to use * Pregnant survivors are also eligible for this protocol, given that fertility and pregnancy are important AYA issues Exclusion Criteria: * Individuals under age 15 or over age 42 * Stage IV or metastatic breast cancer * Males with breast cancer are not being recruited to this protocol. In the AYA age group, only a miniscule proportion of breast cancers occur in males. For this reason, the YES portal intervention materials have been targeted for young women
Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen
NCT04891237
Recruiting
Conditions Rhinitis, Allergic, Rhinoconjunctivitis,...
Phase PHASE3
Enrollment 180
Locations 32 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • 10,000 MG01 + 10,000 T517
  • 30,000 MG01 + 10,000 T517
  • Placebo

Primary Outcomes

  • CSMS: Combined Symptoms and Medication Score
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2021-06-14
Completion: 2027-01
Eligibility
Age: 12 Years
Sex: ALL
Volunteers: false
Enrollment: 180 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Inmunotek S.L.
Principal Investigators:
  • Irán Sánchez (STUDY_CHAIR) - Private Site
Contact Information
Study Contact:
Miguel Casanovas
912908942
mcasanovas@inmunotek.com
Raquel Caballero
607600638
rcaballero@inmunotek.com
Interventions
  • 10,000 MG01 + 10,000 T517
  • 30,000 MG01 + 10,000 T517
  • Placebo
Study Locations (32 sites)
Cedt de Tarancón, Tarancón, Cuenca 16400 Spain
Hospital Universitario Principe de Asturias, Alcalá de Henares, Madrid 28805 Spain
Centro Médico Iza, Tres Cantos, Madrid 28760 Spain
Hospital Infanta Elena, Valdemoro, Madrid 28342 Spain
Hospital Clínico Universitario Virgen de Arrixaca, El Palmar, Murcia 30120 Spain
Private Practice, Albacete, 02003 Spain
Hospital Ntra. Sra. de Sonsoles, Ávila, 05004 Spain
Clinica Dermatologica Y Alergia, Badajoz, 06001 Spain
Hospital Quironsalud Clideba, Badajoz, 06011 Spain
Hospital Universitario Dexeus, Barcelona, 08028 Spain
Eligibility Criteria
Inclusion Criteria: 1. Subject who has signed the informed consent. 2. Subjects of both sexes aged between 12 and 65 years. 3. Subjects with confirmed clinical history of inhalational allergy (rhinitis and / or moderate-severe intermittent or persistent rhinoconjunctivitis according to the ARIA classification with or without intermittent or persistent controlled mild-moderate asthma according to the GEMA 5.0 classification caused by grass and olive allergy. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent 4. Subjects with a positive prick test (higher papule diameter ≥ 5 mm) to a standardized extract of pollen from grasses (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or one of the components of the mixture and an olive extract. 5. Specific IgE (CAP or Immulite) against a mixture of grasses or against one of the components of the mixture of grasses, preferably Phleum pratense and olive or one of the molecular components of allergenic sources with a value \> 3,5 KU / L. 6. Women of childbearing age (from menarche) should submit a urine pregnancy test with a negative result at the time of joining the trial. 7. Women of childbearing potential, and men participating in the trial, should commit to using an appropriate method of contraception. Medically acceptable methods of contraception are intrauterine devices placed at least 3 months in advance, surgical sterilization (for example, tubal ligation), barrier methods, or the use of oral contraceptives. 8. Subjects capable of complying with the dosage regimen. 9. Subjects who have a smartphone to record symptoms and medication. 10. Subjects with a negative prick test to coestational pollens. In the case specific IgE is available, the result should be \<3,5 kU/L and without relevant symptomatology 11. Subjects with a negative prick test to other aeroallergens (dust mites, epitheliums and fungus). In the case specific IgE is available, the result should be \<3,5 kU/L and without relevant symptomatology Exclusion Criteria: 1. Subjects polysensitized to other aeroallergens with the exception of epithelia with occasional exposure and symptoms 2. Subjects polysensitized to other aeroallergens with the exception non-seasonal pollens with grasses and olive 3. Subjects who have received prior immunotherapy in the preceding 5 years to any aeroallergens. 4. Subjects in which immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee. 5. Subjects with severe or uncontrolled persistent asthma, with an FEV1 \<70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial. Likewise, subjects with intermittent or persistent rhinitis / rhinoconjunctivitis with severe symptoms in which the suspension of oral or systemic antihistamine treatment is contraindicated. 6. Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test. 7. Subjects under treatment with ß-blockers. 8. Clinically unstable subjects at the time of enrolment in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.). 9. Subjects with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburns, active psoriasis with lesions in areas where skin tests will be performed, or a history of hereditary angioedema. 10. Subjects who have any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HT, heart disease, etc.). 11. Subjects with some other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multiple operations, kidney disease,). 12. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies. 13. Subject whose condition prevents him / her from offering cooperation and who has severe psychiatric disorders. 14. Subjects with a known allergy to other investigational drug components other than the allergen. 15. Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis. 16. Subjects who are direct relatives of the researchers. 17. Pregnant or lactating women.
Mindful Moms Randomized Control Trial
NCT04886856
Recruiting
Conditions Depression
Phase NA
Enrollment 200
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

  • Mindful Moms
  • Prenatal Education

Primary Outcomes

  • Change in Depressive symptom severity
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2021-10-15
Completion: 2026-06-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Virginia Commonwealth University
Collaborators: National Institute of Nursing Research (NINR)
Principal Investigators:
  • Patricia Kinser, PhD (PRINCIPAL_INVESTIGATOR) - Virginia Commonwealth University
Contact Information
Study Contact:
Patricia Kinser, PhD
804-828-9140
kinserpa@vcu.edu
Christine Aubry, RN
aubrych@vcu.edu
Interventions
  • Mindful Moms
  • Prenatal Education
Study Locations (1 sites)
Virginia Commonwealth University, Richmond, Virginia 23298 United States
Eligibility Criteria
Inclusion Criteria: 1. pregnant woman at 12-26 weeks gestation at baseline visit; 2. defined as minority (e.g., Black/ African American, Hispanic/ Latino, Native American, etc) and/or annual household income at qualification level for Women, Infants, \& Children \[WIC\] benefits in Virginia and/or educational attainment ≤high school education; 3. ≥age 18; 4. current depressive symptoms, as defined by a score ≥7 on the Edinburgh Postnatal Depression Scale (EPDS); 5. able to read, write, and understand English; 6. has not been told by a healthcare provider to avoid physical activity; 7. has not engaged in a consistent (once/week or more) yoga-based practice during the current pregnancy. Exclusion Criteria: Does not meet the inclusion criteria above.
Breast Fractionation Study - Standard Versus Investigational Fractionation Trial - Nodal Radiation
NCT04909125
Active, positions filled
Conditions Breast Cancer, Post Mastectomy
Phase NA
Enrollment 132
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

  • Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy

Primary Outcomes

  • Fatigue
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: 2021-06-01
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 132 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Royal North Shore Hospital
Collaborators: Northern Sydney and Central Coast Area Health Service
Principal Investigators:
  • Susan Carroll, MBBS FRANZCR (PRINCIPAL_INVESTIGATOR) - Radiation Oncology Department, Royal North Shore Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy
Study Locations (1 sites)
Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital, St Leonards, New South Wales 2065 Australia
Eligibility Criteria
Inclusion Criteria: * Age 18 years and older * ECOG performance status 0-2 * Ability to understand and willingness to sign a written informed consent document * Stage pT1-3, pN0-3, M0 histologically proven breast cancer no matter the status of ER/PR/HER2 receptor testing * Managed with either mastectomy or breast conserving surgery * Suitable for radiation therapy to the breast/chest wall and regional lymph nodes * Neoadjuvant and adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 therapy is accepted * Neoadjuvant radiotherapy (reverse sequencing) accepted * Breast implants and expanders are accepted * Patients with connective tissue disease are allowed if the treating radiation oncologist finds radiation therapy indicated * Life expectancy minimum 10 years * Patients with non-breast malignancies are accepted if the patient has been disease free for five years and/or has a low risk of recurrence as estimated by the treating radiation oncologist (to be determined at initial patient appointment) Exclusion Criteria: * Prior radiotherapy to the ipsilateral breast or chest wall * Pregnancy or lactation * Radiosensitivity syndrome * Permanent pacemaker/defibrillator within radiotherapy field * Oncoplastic surgery where boost volume unacceptable (clinician discretion) * Conditions indicating that the patient cannot go through radiation therapy or follow up, or a condition where the treating oncologist thinks the patient should not participate in the trial (for example, language barriers)
Single Fraction Accelerated Partial Breast Irradiation vs. Five Fraction Accelerated Partial Breast Irradiation for Low-risk Stage 0 and I Breast Carcinoma
NCT04849871
Active, positions filled
Conditions Breast Carcinoma, Breast Cancer, Stage 0...
Phase NA
Enrollment 134
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

  • External Beam Accelerated Partial Breast Irradiation

Primary Outcomes

  • Proportion of patients who are free of breast cancer in the treated breast (IBTR)
  • Feasibility of treatment regimen as measured by the ability to complete accrual to the trial in 3 years
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: 2021-08-12
Completion: 2029-08-06
Eligibility
Age: 50 Years
Sex: FEMALE
Volunteers: false
Enrollment: 134 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Washington University School of Medicine
Collaborators: The Foundation for Barnes-Jewish Hospital
Principal Investigators:
  • Imran Zoberi, M.D. (PRINCIPAL_INVESTIGATOR) - Washington University School of Medicine
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • External Beam Accelerated Partial Breast Irradiation
Study Locations (1 sites)
Washington University School of Medicine, St Louis, Missouri 63110 United States
Eligibility Criteria
Inclusion Criteria: * AJCC 7th Edition stage 0 or I (TisN0 ≤ 2 cm or T1N0) histologically confirmed carcinoma of the breast, treated with partial mastectomy. Axillary sampling is required only for cases of invasive cancers. Tumor size is determined by the pathologist. Clinical size may be used if the pathologic size is indeterminate. Patients with invasive cancer must have no positive axillary lymph nodes with at least 6 axillary lymph nodes as assessed by axillary ultrasound, axillary sampling, or axillary sentinel node procedure. * Negative histologic margins of partial mastectomy or re-excision specimen. The posterior margin is always considered widely negative if the partial mastectomy extended to the pectoralis fascia and there is no tumor on ink. Margins generally are positive if there is invasive or noninvasive tumor at the inked resection margin, close but negative if the tumor is within 2 mm of the inked margin and negative if the tumor is at least 2 mm away from the inked edge.\[42\] * Invasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular histologies, or mixed histologies (lesions ≤ 2 cm) that are estrogen and/or progesterone receptor positive and do not exhibit HER2/neu gene amplification OR ductal carcinoma in situ (lesions ≤ 2 cm) that are estrogen and/or progesterone receptor positive. * Neoadjuvant hormone therapy, chemotherapy, or biologic therapy is not allowed prior to APBI, but adjuvant hormone therapy may have been started after surgery. Planned chemotherapy or biologic therapy must not start for at least 4 weeks after the completion of APBI. * Good candidate for treatment per protocol in the judgment of the PI and/or treating physician following simulation. * Postmenopausal status. * Age ≥ 50 years at diagnosis. * Able to understand and willing to sign IRB-approved written informed consent document. * All radiation therapy must be planned for delivery at BJH or a BJH/Siteman satellite location with the following stipulations: F\_APBI may be delivered at any Siteman location. S\_APBI treatment must occur at the main Siteman location at BJH and will be delivered on a Viewray Unit, the Varian Edge unit, or the Varian Halcyon unit. Pre and post treatment care is allowed at any Siteman center. Exclusion Criteria: * Presence of distant metastases. * Nonepithelial breast malignancies such as sarcoma or lymphoma. * Proven multicentric carcinoma (tumors in different quadrants of the breast, or tumors separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy. * Histologically confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor. * Prior non-hormonal therapy for the present breast cancer, including radiation therapy or chemotherapy. * Diagnosis of systemic lupus erythematosis, scleroderma, or dermatomyositis. * Diagnosis of a coexisting medical condition which limits life expectancy to \< 2 years. * Paget's disease of the nipple. * Skin involvement, regardless of tumor size. * Unsatisfactory breast for APBI as determined by the treating physician. For example, if there is little breast tissue remaining between the skin and pectoralis muscle after surgery, treatment with APBI is technically problematic. * Partial mastectomy so extensive that the cosmetic result is fair or poor prior to APBI as determined by the treating physician. * Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation. * Time between final definitive breast surgical procedures to APBI simulation is greater than 8 weeks.
Promoting Resilience in Stroke Survivor-carepartner Dyads (ReStoreD)
NCT04845542
Active, positions filled
Conditions Stroke, Depression, Anxiety, Coping Skil...
Phase NA
Enrollment 400
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

  • ReStoreD

Primary Outcomes

  • PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form
  • PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form
  • PROMIS Emotional Distress, Anxiety and Depression Scale-Short Form
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: 2022-07-20
Completion: 2027-08-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 400 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Utah
Principal Investigators:
  • Alexandra L Terrill, PhD (PRINCIPAL_INVESTIGATOR) - University of Utah
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • ReStoreD
Study Locations (1 sites)
University of Utah, Salt Lake City, Utah 84108 United States
Eligibility Criteria
Inclusion Criteria: * Community-dwelling cohabitating couple where one partner has a had an ischemic or hemorrhagic stroke * The stroke must have occurred between 3 months and 3 years prior to enrollment * The adult couple must have been living together since before the stroke and for at least 6 months prior to enrollment * One or both partners must report some anxiety and/or depressive symptoms * Participants must be able to read, understand, and follow instructions, and be able to provide their own consent Exclusion Criteria: • Either dyad partner has significant aphasia (difficulties with speech), visual, psychiatric, and/or significant cognitive impairment that would limit their ability to participate in the intervention in a meaningful way
Phase III Study :SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative
NCT04842617
Active, positions filled
Conditions Hormone Receptor Positive,Human Epiderma...
Phase PHASE3
Enrollment 5274
Locations 1 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • SHR6390
  • placebo

Primary Outcomes

  • IDFS(Invasive Disease-Free Survival)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Active, positions filled
Start Date: 2021-04-30
Completion: 2031-10-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 5274 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • SHR6390
  • placebo
Study Locations (1 sites)
Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality 200032 China
Eligibility Criteria
Inclusion Criteria: 1. Postmenopausal or premenopausal/perimenopausal female patients aged ≥18 years and ≤75 years old. 2. Pathological examination diagnosed as invasive breast cancer with HR+ and HER2-. 3. Underwent radical resection of breast cancer. 4. The score of ECOG was 0 - 1. 5. Fertile women must have a negative serum pregnancy test within 7 days before randomization, and be willing to use acceptable non hormonal contraceptive measures. 6. With my consent and informed consent, I am willing and able to comply with the planned visit, study treatment plan, laboratory examination and other test procedures. Exclusion Criteria: 1. This Pathological examination diagnosed as HER2-positive breast cancer. 2. The history of any malignant tumor other than breast cancer within 5 years before randomization. 3. At the same time participate in other anti-tumor therapy clinical trials (including endocrine therapy or immunotherapy, etc.). 4. In the 6 months before randomization, the following conditions occurred: myocardial infarction, severe/unstable angina pectoris, , etc 5. Inability to swallow, intestinal obstruction, or other factors that affect the administration and absorption of the drug. 6. There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, as well as patients who the investigator believes are not suitable for participating in this study.
Long-term Observation of Participants With Mood Disorders
NCT04877977
Recruiting
Conditions Depression, Suicide Risk
Phase Not Applicable
Enrollment 1000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Score on Beck Depression Inventory (suicide item removed)
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: 2021-08-17
Completion: 2028-10-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 1000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: National Institute of Mental Health (NIMH)
Principal Investigators:
  • Elizabeth D Ballard, Ph.D. (PRINCIPAL_INVESTIGATOR) - National Institute of Mental Health (NIMH)
Contact Information
Study Contact:
Elizabeth D Ballard, Ph.D.
(301) 435-9399
elizabeth.ballard@nih.gov
Interventions
N/A
Study Locations (1 sites)
National Institutes of Health Clinical Center, Bethesda, Maryland 20892 United States
Eligibility Criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Participants who signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers over a year ago. 2. Age 18 years or older 3. Able to provide informed consent online using study website or over the telephone 4. Able to read and write English EXCLUSION CRITERIA: None.
De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)
NCT04852887
Recruiting
Conditions Stage I Breast Cancer
Phase PHASE3
Enrollment 1670
Locations 832 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
  • Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)

Primary Outcomes

  • Time to invasive or noninvasive IBTR.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2021-06-23
Completion: 2041-07
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: false
Enrollment: 1670 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: NRG Oncology
Collaborators: National Cancer Institute (NCI)
Contact Information
Study Contact:
Director Department of Regulatory Affairs
412-339-5300
langerj@nrgoncology.org
Norman Wolmark, MD
Interventions
  • Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
  • Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
Study Locations (832 sites)
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama 35233 United States
University of South Alabama Mitchell Cancer Institute, Mobile, Alabama 36688 United States
Kingman Regional Medical Center, Kingman, Arizona 86401 United States
Cancer Center at Saint Joseph's, Phoenix, Arizona 85004 United States
Mayo Clinic Hospital in Arizona, Phoenix, Arizona 85054 United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205 United States
Kaiser Permanente-Anaheim, Anaheim, California 92806 United States
Kaiser Permanente-Deer Valley Medical Center, Antioch, California 94531 United States
Mission Hope Medical Oncology - Arroyo Grande, Arroyo Grande, California 93420 United States
PCR Oncology, Arroyo Grande, California 93420 United States
Eligibility Criteria
Inclusion Criteria: * • The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry/Step 1 and, for patients treated in the U.S., authorization permitting release of personal health information. * The patient must have an ECOG performance status of 0 or 1. * The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. (Patients with margins positive for LCIS are eligible without additional resection.) * The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination. * Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection). * The following staging criteria must be met postoperatively according to AJCC 8th edition criteria: * By pathologic evaluation, primary tumor must be pT1 (less than or equal to 2 cm). * By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible.) * Oncotype DX Recurrence Score of less than or equal to 18 on diagnostic core biopsy or resected specimen. \*\* For patients with a T1a tumor (less than or equal to 0.5 cm in size) or patients at Canadian provinces or approved international sites where Oncotype DX Recurrence Score testing would not be covered, who do not already have an Oncotype DX Recurrence Score at pre-entry/Step 1, a specimen (unstained blocks or slides) must be sent to the Genomic Health centralized laboratory. Tumor size sample must be greater than or equal to 0.2 cm for analysis. \*\*\* The Oncotype RS can be run on the biopsy core or surgical specimen. The patient cannot have initiated endocrine therapy prior to tissue collection. * An Oncotype RS is required for eligibility, however, for a patient whose tumor has already had a MammaPrint test completed as part of usual care when being considered for enrollment and is in the binary "Low" category will meet this eligibility criteria and an Oncotype RS does not need to be performed. * The tumor must have been determined to be ER and/or PgR positive assessed by current ASCO/CAP Guideline Recommendations for hormone receptor testing. Patients with greater than or equal to 1% ER or PgR staining by IHC are considered positive. * The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines. * Patients may be premenopausal or postmenopausal at the time of pre-entry/Step 1. For study purposes, postmenopausal is defined as: * Age 56 or older with no spontaneous menses for at least 12 months prior to pre-entry/Step 1; or a documented hysterectomy; or * Age 55 or younger with no spontaneous menses for at least 12 months prior to pre-entry/Step 1 (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or Documented bilateral oophorectomy. * The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry/Step 1 must be no more than 70 days. * The patient must have recovered from surgery with the incision completely healed and no signs of infection. * Bilateral mammogram or MRI within 6 months prior to pre-entry/Step 1. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients must be intending to take endocrine therapy for a minimum 5 years duration (tamoxifen or aromatase inhibitor). The specific regimen of endocrine therapy is at the treating physician's discretion. Exclusion Criteria: * • Definitive clinical or radiologic evidence of metastatic disease. * pT1 mi and pT2 - pT4 tumors including inflammatory breast cancer. * Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease. * Patient had a mastectomy. * Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor. * Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign. * Non-epithelial breast malignancies such as sarcoma or lymphoma. * Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible.) * Paget's disease of the nipple. * Any history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated or not treated. (Patients with synchronous or previous ipsilateral LCIS are eligible.) * Synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible.) * Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re- excision, the patient is eligible.) * Treatment plan that includes regional nodal irradiation. * Any treatment with radiation therapy, chemotherapy, or biotherapy, administered for the currently diagnosed breast cancer prior to pre-entry/Step 1. * History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to pre-entry/Step 1. * Current therapy with any endocrine therapy such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention. \*\* Patients are eligible for BR007 if they receive a short course of preoperative endocrine therapy of less than 6 weeks duration (prior to randomization/Step 2) for this diagnosis after the core biopsy (and can continue postoperatively if: * the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18, AND * the patient had not initiated endocrine therapy prior to core biopsy tissue collection. \*\*\* This does not apply to adjuvant endocrine therapy recommended for this diagnosis which may start any time after surgery including prior to registration (Pre-entry/Step 1). * Patients intending to continue on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible. Patients that discontinue oral, transdermal, or subdermal estrogen replacement prior to registration are eligible. * Prior breast or thoracic RT for any condition. * Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma. * Pregnancy or lactation at the time of pre-entry/Step 1 or intention to become pregnant during treatment. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to pre-entry/Step 1.) * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of study therapy or that may affect the interpretation of the results or render the patient at high risk from treatment complications. * Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results. * Use of any investigational product within 30 days prior to p
Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast Cancer
NCT04871516
Active, positions filled
Conditions Anatomic Stage 0 Breast Cancer AJCC v8, ...
Phase NA
Enrollment 103
Locations 11 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Quality-of-Life Assessment
  • Questionnaire Administration
  • Radiation Boost
  • Therapeutic Surgical Procedure
  • Whole Breast Irradiation

Primary Outcomes

  • Change in wound status from baseline every 3-6 months after WBI to access incidence of grade 3 or more wound complications after breast conserving surgery.
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: 2021-05-18
Completion: 2028-01-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 103 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Rutgers, The State University of New Jersey
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Bruce G Haffty (PRINCIPAL_INVESTIGATOR) - Rutgers Cancer Institute of New Jersey
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Quality-of-Life Assessment
  • Questionnaire Administration
  • Radiation Boost
  • Therapeutic Surgical Procedure
  • Whole Breast Irradiation
Study Locations (11 sites)
Clara Maass Medical Center, Belleville, New Jersey 07109 United States
RWJBarnabas Health-Trinitas Hospital and Comprehensive Care, Elizabeth, New Jersey 07202 United States
The Cancer Institute of New Jersey Hamilton, Hamilton, New Jersey 08690 United States
RWJBarnabas Health Jersey City Medical Center, Jersey City, New Jersey 07302 United States
RWJBarnabas Health - Monmouth Medical Center Southern Campus, Lakewood, New Jersey 08701 United States
Cooperman Barnabas Medical Center (Saint Barnabas Medical Center), Livingston, New Jersey 07039 United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey 08903 United States
Rutgers New Jersey Medical School, Newark, New Jersey 07101 United States
RWJBarnabas Health - Newark Beth Israel Medical Center, Newark, New Jersey 07112 United States
Robert Wood Johnson University Hospital Somerset, Somerville, New Jersey 08876 United States
Eligibility Criteria
Inclusion Criteria: * Breast cancer patients with biopsy proven invasive cancer * Clinically and radiographically node negative * No indication of metastatic disease * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Synchronous bilateral invasive cancer allowed * Negative serum pregnancy test within one month from the radiation therapy (RT) boost delivery * Willingness to participate in the clinical trial and adhere to the study protocol * Individuals of all races, genders and ethnic groups are eligible for this trial Exclusion Criteria: * Need for neoadjuvant chemotherapy * Inflammatory breast cancer (cT4) * Multicentric tumor * Prior ipsilateral breast or thoracic RT * Contraindication for baseline magnetic resonance imaging (MRI) * Contraindication for surgery * Distant metastatic disease * Other synchronous cancer (besides bilateral breast) * Contraindication to radiation therapy (presence of scleroderma or other collagen vascular disease) * Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
Taurine Effect on Glycemic, Lipidic and Inflammatory Profile in Individuals With Type 2 Diabetes
NCT04874012
Recruiting
Conditions Diabetes Mellitus, Type 2
Phase PHASE2
Enrollment 94
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

  • Active comparator Taurine
  • Placebo Comparator

Primary Outcomes

  • HbA1c
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2021-06-12
Completion: 2025-12
Eligibility
Age: 30 Years
Sex: ALL
Volunteers: false
Enrollment: 94 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Hospital de Clinicas de Porto Alegre
Principal Investigators:
  • Beatriz D Schaan, PhD (PRINCIPAL_INVESTIGATOR) - Hospital de Clínicas de Porto Alegre
Contact Information
Study Contact:
Beatriz D Schaan, PhD
55 51 3359-8000
bschaan@hcpa.edu.br
Rosane Gomez, PhD
55 51 33082823
rogomez@hcpa.edu.br
Interventions
  • Active comparator Taurine
  • Placebo Comparator
Study Locations (1 sites)
Hospital de Clínicas, Porto Alegre, Rio Grande do Sul 90630090 Brazil
Eligibility Criteria
Inclusion criteria * Female and male individuals, with clinical diagnosis of DM2 for at least 6 months; * Age over 30 years; * BMC equal to or above 18.5 kg/m2, without weight change in the last 3 months; * HbA1c between 7.5% and 10.5%. Exclusion criteria * Use of herbal supplements, antioxidants, and multivitamins in the last 3 months; * Pregnancy or lactation; * Chronic renal failure with glomerular filtration rate calculated by MDRD \< 30 mL/h; * Myocardial infarction in the last than 6 months * Current neoplasia; * Chronic use of glucocorticoids; * Bariatric surgery.
Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
NCT04874038
Recruiting
Conditions Post-mastectomy Pain Syndrome, Breast Ca...
Phase PHASE3
Enrollment 1602
Locations 17 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Lidocaine 20mg/ml
  • Placebo

Primary Outcomes

  • Development of persistent pain 3-months after breast cancer surgery
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2021-09-22
Completion: 2026-11-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1602 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Health Network, Toronto
Collaborators: Canadian Institutes of Health Research (CIHR)
Principal Investigators:
  • James Khan, MD (PRINCIPAL_INVESTIGATOR) - University Health Network, Toronto
  • PJ Devereaux, MD.PhD (PRINCIPAL_INVESTIGATOR) - Population Health Research Institute
  • Ian Gilron, MD (PRINCIPAL_INVESTIGATOR) - Kingston Health Sciences Centre
Contact Information
Study Contact:
James Khan
416-340-4800
James.Khan@medportal.ca
Nour Ayach
416-340-4800
Nour.Ayach@uhn.ca
Interventions
  • Lidocaine 20mg/ml
  • Placebo
Study Locations (17 sites)
Foothills Medical Centre, Calgary, Alberta Canada
Sturgeon Community Hospital, Edmonton, Alberta Canada
Eastern Health- Health Sciences Centre, St. John's, Newfoundland and Labrador Canada
IWK, Halifax, Nova Scotia Canada
Juravinski Hospital, Hamilton, Ontario Canada
North York General Hospital, North York, Ontario Canada
The Ottawa Hospital, Ottawa, Ontario Canada
Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario Canada
Humber River Hospital, Toronto, Ontario Canada
Mount Sinai Hospital, Toronto, Ontario Canada
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years old 2. Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation) Exclusion Criteria: 1. Previous breast surgery within 6 months of index surgery 2. Undergoing any autologous flap procedure during index surgery 3. Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery 4. Documented hypersensitivity or allergy to lidocaine 5. Surgery not planned to be performed under general anesthesia and/or planned use of regional or neuraxial anesthetic techniques before surgery (i.e., epidural, paravertebral, serratus plane block, pectoralis or modified pectoralis block) 6. History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker 7. Known cirrhotic liver disease 8. Pregnant 9. Unlikely to comply with follow-up (e.g. no fixed address, language difficulties that would impede valid completion of questionnaires, plans to move out of town)
TRIple Negative Breast Cancer Markers In Liquid Biopsies Using Artificial Intelligence
NCT04874064
Recruiting
Conditions Breast Cancer
Phase Not Applicable
Enrollment 130
Locations 3 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Liquid Biopsy

Primary Outcomes

  • Develop signatures of good and poor outcome as well of tumor response to chemotherapy in TNBCs by integrating multidimensional profiling of both tumor and liquid biopsies making use of Artificial Intelligence (AI) tools
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: 2019-12-05
Completion: 2027-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 130 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Jewish General Hospital
Collaborators: Exactis Innovation
Principal Investigators:
  • Mark Basik, Dr (PRINCIPAL_INVESTIGATOR) - Study Principal Investigator
Contact Information
Study Contact:
Adriana Aguilar, PhD
514-340-8222
nanaaguilar@gmail.com
Josiane Lafleur, MSc
514-340-8222
josiane.lafleur.jgh@gmail.com
Interventions
  • Liquid Biopsy
Study Locations (3 sites)
St. Joseph's Health Care London, London, Ontario N6A 4V2 Canada
The Ottawa Hospital Cancer Center, Ottawa, Ontario K1H 8L6 Canada
Jewish General Hospital, Montreal, Quebec H3T 1E1 Canada
Eligibility Criteria
Inclusion Criteria: * Triple negative (ER negative, PR negative and Her2 negative as defined by local standards). ER \<10% is acceptable. * Patients who have completed a minimum of 8 weeks of neoadjuvant chemotherapy. * A cohort of TNBC patients who are awaiting surgery that have clinical or radiological evidence of residual tumor prior to surgery. This evaluation will be made at the discretion of the treating physician. OR A second cohort of TNBC patients will be recruited after surgery, in which pathological evaluation has demonstrated the presence of residual tumor post-surgery. * Patients who can come to the clinic for standard of care follow-up within 6 weeks post-surgery and in the next 6 months after surgery. * Patients who are willing to provide serial blood samples. * Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study. Exclusion Criteria: * Clinical or radiological evidence of metastatic disease. * Patient with a recurrence of breast cancer. * Patients who have not had neoadjuvant chemotherapy or less than 8 weeks of neoadjuvant chemotherapy. * Patient who received radiotherapy treatment prior to surgery. * Patients who are not capable of signing or understanding the informed consent form. * Known infection with HIV or hepatitis.
Engineered TILs/CAR-TILs to Treat Advanced Solid Tumors
NCT04842812
Recruiting
Conditions Liver Cancer, Lung Cancer, Breast Cancer...
Phase PHASE1
Enrollment 40
Locations 1 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

  • TILs and CAR-TILs targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2/6, ROR1, GD1, or B7-H3

Primary Outcomes

  • Safety of TILs/CAR-TILs treatment in advanced solid cancers
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2021-01-01
Completion: 2035-01-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University
Collaborators: Guangdong Zhaotai InVivo Biomedicine Co. Ltd.
Principal Investigators:
  • Zhenfeng Zhang, MD, PhD (PRINCIPAL_INVESTIGATOR) - Second Affiliated Hospital of Guangzhou Medical University
Contact Information
Study Contact:
Zhenfeng Zhang, MD, PhD
+862039195966
zhangzhf@gzhmu.edu.cn
Bingjia He, MD
+862039195965
464677938@qq.com
Interventions
  • TILs and CAR-TILs targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2/6, ROR1, GD1, or B7-H3
Study Locations (1 sites)
Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510260 China
Eligibility Criteria
Inclusion Criteria: 1. Patients with advanced cancers that failed to current available therapies; 2. Life expectancy \>12 weeks; 3. Adequate heart, lung, liver, kidney functions; 4. Available for tumor biopsy or cancerous effusions; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. Exclusion Criteria: 1. Had accepted gene therapy before; 2. Severe virus infection such as HBV, HCV, HIV, et al; Known HIV positivity; 3. Active infectious disease related to bacteria, virus, fungi, et al; 4. Other severe diseases that the investigators consider not appropriate; 5. Pregnant or lactating women; 6. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day); 7. Other conditions that the investigators consider not appropriate.
Decreasing Cardiovascular Risk for Patients With Diabetes
NCT04874116
Active, positions filled
Conditions Diabetes Mellitus, Type 2
Phase NA
Enrollment 378
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

  • Office Guidelines Applied to Practice (Office-GAP) + Mobile text messaging
  • Mobile text messaging

Primary Outcomes

  • Change in Medication adherence
  • Change in Medication adherence
  • Change in Medication Adherence
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: 2021-05-26
Completion: 2026-09-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 378 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Michigan State University
Collaborators: University of Michigan
Principal Investigators:
  • Adesuwa Olomu, MD, MS (PRINCIPAL_INVESTIGATOR) - Michigan State University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Office Guidelines Applied to Practice (Office-GAP) + Mobile text messaging
  • Mobile text messaging
Study Locations (1 sites)
Ingham Healthcare center, Lansing, Michigan 48742 United States
Eligibility Criteria
Inclusion Criteria: Patients: aged \>18 at participating Federally Qualified Health Care centers (FQHCs) and; 1) have a diagnosis of Type 2 diabetes (T2DM) with HbA1c \>8, with or without CVD; 2) patient should be taking at least one prescribed medication for BP or cholesterol management 3) able to provide informed consent 4) able to read and speak English (grade 6 reading level); 5) have a cell phone with texting (provided by our study for any enrolled patient who does not have one). Exclusion Criteria: 1\) medical record documentation of cognitive impairment, dementia or psychosis 2) plans to leave the area prior to study completion 3) participating in another cellphone program.
TCM as an Adjuvant Treatment in Breast Cancer Patients
NCT04843865
Recruiting
Conditions Breast Cancer, Musculoskeletal Pain
Phase NA
Enrollment 30
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

  • Chinese Herbs

Primary Outcomes

  • Feasibility of the study (Adherence)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-04-22
Completion: 2024-12
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Universiti Tunku Abdul Rahman
Principal Investigators:
  • Yang Mooi Lim (PRINCIPAL_INVESTIGATOR) - Universiti Tunku Abdul Rahman (UTAR)
Contact Information
Study Contact:
Chin Long Poo
0178853596
athrunjoe@gmail.com
Interventions
  • Chinese Herbs
Study Locations (1 sites)
Tung Shin Hospital, Bukit Bintang, Kuala Lumpur 55100 Malaysia
Eligibility Criteria
Inclusion Criteria: * Postmenopausal women as determined by cessation of menses for at least 1 year or FSH\>20 mIU/mL * Histology confirmed stage 2 to 3 hormone-receptor positive breast cancer patient * Currently taking letrozole for at least 1 month * Reported ongoing musculoskeletal pain or stiffness, which started or worsened after initiation of letrozole * Had a baseline average pain score over the past week on the Brief Pain Inventory Short Form (BPI-SF) of ≥4 points on a scale of 0 to 10. * Completed all indicated surgery, chemotherapy and radiation therapy * Agreed to take prescribed Chinese herbs * No evidence of distant metastasis * Follow-up for the duration of the study * No acute disease in the past month * Able to communicate to practitioner and interviewer * Willing to give informed consent Exclusion Criteria: * Pregnant or nursing woman or woman of childbearing potential without effective method of birth control. * Patients who default subsequent follow-up/ has irregular follow-up. * Patients who directly involved in other study at the same time. * History of non-compliance to medical regime and patients who are unwilling or unable to comply with the protocol. * Bedridden and/ or cancer metastasis to bone/ lung. * Concurrent infection requiring intravenous antibiotics * History of allergy to Chinese herbs * Had previously received Chinese herbs for their AI-induced musculoskeletal symptoms * Had received Chinese herbs within one month prior to study entry * Current use of steroids or narcotics for pain relief within the past 2 weeks * Subjects with acute onset of a chronic illness or with acute disease in the past month or had pre-existing chronic diseases * Patients with concomitant severe illness or metastatic disease (poorly controlled hypertension, hypothyroidism, diabetes mellitus, liver diseases, osteoarthritis, rheumatoid arthritis, gout or neuropathic arthropathy, autoimmune or inflammatory joint disease, bone fracture, stroke)