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Showing 20 of 29277 trials
Identifying and Treating Depression in the Orthopaedic Trauma Population
NCT05976347
Recruiting
Conditions Depression
Phase PHASE4
Enrollment 100
Locations 1 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

  • Fluoxetine 20 MG
  • Duloxetine 30 MG
  • Observation

Primary Outcomes

  • Depressive Symptom Scores
  • Depressive Symptom Scores
  • Depressive Symptom Scores
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2025-06-25
Completion: 2027-05
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Wake Forest University Health Sciences
Principal Investigators:
  • Meghan K Wally, PhD (PRINCIPAL_INVESTIGATOR) - Wake Forest University Health Sciences
Contact Information
Study Contact:
Erica Grochowski, MPH
704-403-4980
Erica.Grochowski@advocatehealth.org
Interventions
  • Fluoxetine 20 MG
  • Duloxetine 30 MG
  • Observation
Study Locations (1 sites)
Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157 United States
Eligibility Criteria
Inclusion Criteria: * Patients presenting to an Orthopaedic trauma clinic for the first time following operative extremity fracture or any pelvis fracture * A score of greater than or equal to 5 on the Patient Health Questionnaire-9 (PHQ-9) at first post- operative visit * Age 18 or older * Speak English or Spanish Exclusion Criteria: * Currently taking medication to treat depression * Contraindication/allergy to one of the study medications * Bipolar disorder of psychotic disorder * Endorse suicidal ideation
Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery
NCT05973864
Recruiting
Conditions Triple Negative Breast Neoplasms
Phase PHASE2
Enrollment 220
Locations 20 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

  • Pembrolizumab injection
  • Capecitabine tablets
  • Local radiotherapy

Primary Outcomes

  • 2-year Invasive Disease-free survival (iDFS)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2025-03-11
Completion: 2028-08
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 220 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: UNICANCER
Principal Investigators:
  • Delphine LOIRAT, MD PhD (PRINCIPAL_INVESTIGATOR) - Institut Curie Paris
  • Jean-Yves PIERGA, MD (PRINCIPAL_INVESTIGATOR) - Institut Curie Paris
Contact Information
Study Contact:
Telma ROQUE, PhD
+33 (0) 1 80 50 12 92
cappa@unicancer.fr
Sylvie Mijonnet, PhD
+33 (0) 1 44 23 04 65
s-mijonnet@unicancer.fr
Interventions
  • Pembrolizumab injection
  • Capecitabine tablets
  • Local radiotherapy
Study Locations (20 sites)
CHU Amiens Picardie_Site Sud, Amiens, 80054 France
Institut Sainte Catherine, Avignon, 84918 France
Centre Hospitalier de la Côte Basque, Bayonne, 64109 France
CHU Jean Minoz, Besançon, France
Polyclinique Bordeaux Nord Aquitaine, Bordeaux, 33077 France
Centre François Baclesse, Caen, 14000 France
Centre Georges-François Leclerc, Dijon, France
CHD Vendee, La Roche-sur-Yon, France
Centre Oscar Lambret, Lille, France
Centre Léon Bérard, Lyon, 69008 France
Eligibility Criteria
• CRITERIA FOR EXPERIMENTAL ARM : Inclusion criteria (for experimental arm): Patients eligible for this study must meet ALL of the following criteria: 1. Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent; 2. Subject ≥18 years of age on day of signing informed consent form (ICF); 3. Histologically proven TNBC defined as follows: 1. HER2 negativity (ASCO/CAP criteria) 2. AND less than 10% of cells stained by immunohistochemistry (IHC) for ER and PgR; 4. TNBC patients previously treated by standard neoadjuvant chemotherapy with a minimum of 6 cycles of immunochemotherapy containing pembrolizumab, per standard of care (and pembrolizumab label) and anthracyclines and/or taxanes (with/without carboplatin). Other drugs may be acceptable following discussion with the sponsor (with the exclusion of capecitabine); 5. Complete resection of the breast tumor(s) (and of any invaded lymph node); 6. No complete pathological response, defined as RCB Class I, II or III (per local assessment); 7. Available representative formalin-fixed paraffin-embedded (FFPE) tumor block from surgery specimen with its histological report; 8. Eastern Cooperative Oncology Group (ECOG) Performance Status \<2; 9. Adequate organ and bone marrow function. All screening lab tests should be performed within 28 days before inclusion; 10. Resolution to at least grade 1 of all acute toxicities from previous therapies including immune-related toxicity due to pembrolizumab, except alopecia and grade 2 immune-related endocrinopathies controlled by hormone replacement which are allowed; 11. Minimal/maximal period for prior treatments (i.e. minimal delay from last dose of prior treatment to C1D1): breast surgery (the wound must have healed prior to C1D1) ≥2 weeks (maximum 10 weeks); last pembrolizumab injection ≥3 weeks; 12. Women of child-bearing potential must have a negative serum pregnancy test within 7 days before C1D1; 13. Women of child-bearing potential and male patients must agree to use 1 effective form of contraception from the time of the negative pregnancy test up to 6 months after the last dose of study drugs; 14. Patient should be able and willing to comply with study visits and procedures as per protocol; 15. Patients must be affiliated to a Social Security System (or equivalent). Non-inclusion criteria (for experimental arm): Patients eligible for this study must not meet ANY of the following criteria: 1. Radiological or clinical evidence of metastatic disease documented by imaging or clinical examination performed during screening period; 2. Has received capecitabine or other ICI than pembrolizumab in the NAC regimen; 3. Has a known additional malignancy, excepted skin basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer or previously treated malignancy with no evidence of disease for ≥2 years; 4. Presents a contraindication to continue pembrolizumab treatment as per respective SmPC including known hypersensitivity; 5. Previous immune-related adverse event of any grade due to pembrolizumab that led to permanent discontinuation of pembrolizumab; 6. Presents a contraindication to capecitabine treatment as per SmPC (See EMA website for most recent edition of SmPC); 7. Complete DPD (Dihydropyrimidine Dehydrogenase) deficiency (a systematic screening of DPD deficiency must be performed); 8. Patient with active infection ; 9. Patients with history of uncontrolled or symptomatic cardiac disease ; 10. Patients having received brivudine within 4 weeks prior to inclusion; 11. Require the use of one of the following forbidden treatments during the study treatment period: * Any investigational anticancer therapy other than the protocol specified treatment; * Any concurrent chemotherapy, immunotherapy, biologic for cancer treatment, other than the ones stated in the protocol; 12. Pregnant women or women who are breast-feeding; 13. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons; 14. Persons deprived of their liberty or under protective custody or guardianship; 15. Participation in another therapeutic trial within the 30 days prior to randomization. * CRITERIA FOR STANDARD OF CARE TREATED EXTERNAL COHORT Inclusion criteria (for standard of care treated external cohort) : Patients eligible for this cohort must meet ALL of the following criteria: 1. Patient information prior to study entry and non-opposition to data collection 2. Subject ≥18 years of age ; 3. Histologically proven TNBC defined as follows: 1. HER2 negativity (ASCO/CAP criteria) 2. AND less than 10% of cells stained by immunohistochemistry (IHC) for ER and PgR; 4. TNBC patients previously treated by standard neoadjuvant chemotherapy with a minimum of 6 cycles of immunochemotherapy containing pembrolizumab, per standard of care (and pembrolizumab label) and anthracyclines and/or taxanes (with/without carboplatin). Other drugs may be acceptable following discussion with the sponsor (with the exclusion of capecitabine); 5. Complete resection of the breast tumor(s) (and of any invaded lymph node); 6. No complete pathological response, defined as RCB Class I, II or III (per local assessment); 7. Patient should have received at least one injection of pembrolizumab as post-surgery treatment (concomitantly or after radiotherapy). Non-exclusion criteria (for standard of care treated external cohort) : Patients eligible for this study must not meet ANY of the following criteria: 1. Radiological or clinical evidence of metastatic disease documented by imaging or clinical examination after surgery. 2. Has received capecitabine or other ICI than pembrolizumab in the NAC regimen; 3. Has a known additional malignancy, excepted skin basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer or previously treated malignancy with no evidence of disease for ≥2 years; 4. Any investigational anticancer therapy (chemotherapy, immunotherapy, biologic for cancer treatment) other than pembrolizumab only as adjuvant treatment.
A Study of Pulmonary Hypertension Peripheral Limitations
NCT05968859
Active, positions filled
Conditions Pulmonary Arterial Hypertension, Healthy
Phase NA
Enrollment 45
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

  • Aerobic Training
  • Leg Training

Primary Outcomes

  • Change in skeletal muscle O2 diffusive conductance (Dm) during supine cycle exercise
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2024-01-02
Completion: 2026-09
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 45 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Mayo Clinic
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigators:
  • Yogesh Reddy, M.B.B.S (PRINCIPAL_INVESTIGATOR) - Mayo Clinic
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Aerobic Training
  • Leg Training
Study Locations (1 sites)
Mayo Clinic in Rochester, Rochester, Minnesota 55905 United States
Eligibility Criteria
Inclusion Criteria: 1. Pulmonary Arterial Hypertension (PAH) Subjects: 1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2. NYHA Class II-IV 3. LVEF ≥ 40 % within the preceding year. 4. No hospitalizations due to heart failure in the preceding 30 days. 5. No recent initiation of pulmonary vasodilator in the last 60 days 6. Pulmonary arterial hypertension by right heart catheterization (Mean PA pressure ≥ 20 mmHg with PVR\>2 Wood units) with no evidence of heart failure with preserved ejection fraction (exercise PCWP \<25 mm Hg). 7. Symptomatic PAH patients with plan to undergo exercise RHC for reassessment of exertional symptoms 2. Healthy Controls: 1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2. No known diagnosis of heart failure Exclusion Criteria: * Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening. * Planned coronary, carotid, or peripheral artery revascularization. * Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, anemia, or more than moderate mitral or aortic heart valve disease). * Wheelchair bound or orthopedic inability to exercise * Chronic hypoxemia with inability to exercise without oxygen supplementation (PAH Subjects) or need for oxygen supplementation (Healthy Controls) * Skeletal muscle myopathy * History of rhabdomyolysis * Participation in any clinical trial of an approved or non-approved device for the treatment of pulmonary hypertension within 30 days before screening. * Receipt of any investigational medicinal product within 30 days before screening * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. * Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator. * Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.
Understanding CARdiac Events in Breast Cancer
NCT05921279
Recruiting
Conditions Breast Cancer, Cardiotoxicity, Cardiomyo...
Phase Not Applicable
Enrollment 100
Locations 4 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • The number of participants with successful application of guideline-directed Cardio-Oncology assessments and surveillance.
Interested in this trial?
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Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2023-01-14
Completion: 2026-07
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: National University of Ireland, Galway, Ireland
Collaborators: HRB Clinical Research Facility Galway, CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland
Principal Investigators:
  • Osama Soliman, MBBCh, PhD (PRINCIPAL_INVESTIGATOR) - NUIG
  • Aoife Lowery, MBBCh, PhD (PRINCIPAL_INVESTIGATOR) - NUIG
  • Michael Kerin, MD, PhD (PRINCIPAL_INVESTIGATOR) - NUIG
Contact Information
Study Contact:
Osama Soliman, MBBCh, PhD
+35391493781
osama.soliman@nuigalway.ie
Aoife Lowery, MBBCh, PhD
aoife.lowery@nuigalway.ie
Interventions
N/A
Study Locations (4 sites)
Galway University Hospital, Galway, H91 T861 Ireland
Galway Clinic, Galway, Ireland
Mayo University Hospital, Mayo, Ireland
Sligo General Hospital, Sligo, Ireland
Eligibility Criteria
Inclusion Criteria: * Women aged ≥ 18 years * Ability to read and understand English * Breast Cancer Stage I- III planned to receive systemic chemotherapy Exclusion Criteria: * Patients not for systemic chemotherapy with curative intent * Patients who are unable to co-operate with the study protocol * Patients who are unable to give informed consent
Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer
NCT05929768
Recruiting
Conditions Anatomic Stage I Breast Cancer AJCC v8, ...
Phase PHASE3
Enrollment 2400
Locations 963 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

  • Biospecimen Collection
  • Carboplatin
  • Cyclophosphamide
  • Docetaxel
  • Doxorubicin

Primary Outcomes

  • Breast cancer event-free survival (BC-EFS)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2023-09-15
Completion: 2033-04
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 2400 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Priyanka Sharma (PRINCIPAL_INVESTIGATOR) - SWOG Cancer Research Network
Contact Information
Study Contact:
Alicia Aranda
210-614-8808
aaranda@swog.org
Dana Sparks
210-614-8808
dsparks@swog.org
Interventions
  • Biospecimen Collection
  • Carboplatin
  • Cyclophosphamide
  • Docetaxel
  • Doxorubicin
Study Locations (963 sites)
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama 35233 United States
Anchorage Associates in Radiation Medicine, Anchorage, Alaska 98508 United States
Anchorage Radiation Therapy Center, Anchorage, Alaska 99504 United States
Alaska Breast Care and Surgery LLC, Anchorage, Alaska 99508 United States
Alaska Oncology and Hematology LLC, Anchorage, Alaska 99508 United States
Alaska Women's Cancer Care, Anchorage, Alaska 99508 United States
Anchorage Oncology Centre, Anchorage, Alaska 99508 United States
Katmai Oncology Group, Anchorage, Alaska 99508 United States
Providence Alaska Medical Center, Anchorage, Alaska 99508 United States
Fairbanks Memorial Hospital, Fairbanks, Alaska 99701 United States
Eligibility Criteria
Inclusion Criteria: * Participants must have histologically confirmed estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative breast cancer (TNBC) defined as ER \< 5%, PR \< 5%, and HER2 negative (per 2020 American Society of Clinical Oncology \[ASCO\] College of American Pathologists \[CAP\] guidelines) * NOTE: Participants with weakly ER or PR positive disease, defined as ER and/or PR between 1-4% by immunohistochemistry, are eligible if adjuvant endocrine therapy is not recommended/planned by the treating physician * Participants must have American Joint Committee on Cancer (AJCC) 8 anatomic tumor clinical stage either * T2-T4, N0, M0 or * T1-T3, N1-2, M0 * Note: All participants with clinically suspicious nodes must undergo core needle biopsy or fine needle biopsy per standard clinical practice to pathologically confirm nodal status * Participants must have breast and axillary imaging with mammogram and/or ultrasound and/or magnetic resonance imaging (MRI) within 49 days prior to randomization * Note: Participants with bilateral invasive breast cancer are eligible if both breast cancers are ER-negative, PR-negative, and HER2-negative provided they meet the other eligibility criteria * Participants must not have T4/N+, any N3, or inflammatory breast cancer * Participants must not have metastatic disease (M1) * Participants must not have received prior systemic therapy or radiation therapy with curative intent for the current breast cancer * Participants must not have had previous definitive ipsilateral breast surgery for the current breast cancer * Participants must not have current or anticipated use of other investigational agents while participating in this study * Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition as study agents * Participants must not have severe hypersensitivity (\>= grade 3) to pembrolizumab or any of its excipients * Participants must not have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137) * Participants must not be currently participating in or have participated in a study of an investigational agent or used an investigational device within 28 days prior to randomization * Participants must be \>= 18 years old * Participants must have Zubrod performance status of 0-2 * Participants with evidence of peripheral neuropathy must have it at =\< grade 1, by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0, within 28 days prior to randomization * Participants must have a complete medical history and physical exam within 28 days prior to randomization * Hemoglobin \>= 9.0 g/dL or \>= 5.6 mol/L (within 28 days prior to randomization) * (Criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks) * Leukocytes \>= 3 x 10\^3/uL (within 28 days prior to randomization) * Absolute neutrophil count \>= 1.5 x 10\^3/uL (within 28 days prior to randomization) * Platelets \>= 100 x 10\^3/uL (within 28 days prior to randomization) * Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN), OR direct bilirubin =\< IULN for participants with total bilirubin \> 1.5 x IULN (unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional IULN) (within 28 days prior to randomization) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x institutional upper limit of normal (ULN) (within 28 days prior to randomization) * Participants must have a serum creatinine =\< the IULN OR calculated creatinine clearance \>= 50 mL/min/1.73m\^2 using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration * Participants must have adequate cardiac function. Participants must have left ventricular ejection fraction \>= 50% as assessed by either echocardiography (ECHO) or multigated acquisition scan (MUGA) assessed within 28 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must be class 2B or better * Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization * Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated * Note: No testing for Hepatitis B is required unless mandated by local health authority * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated * Note: No testing for hepatitis C is required unless mandated by local health authority * Participants with history of diabetes must not have uncontrolled diabetes in the opinion of the treating investigator * Participants must not have uncontrolled hypertension in the opinion of the treating investigator * Participants must not have had a major surgery within 14 days prior to randomization. Participants must have fully recovered from the effects of prior major surgery in the opinion of the treating investigator * Participants must not have severe or active infections within 14 days prior to Randomization, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia * Participants must not have a diagnosis of immunodeficiency and be receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization * Participants must not have active autoimmune disease that has required systemic treatment in 2 years prior to randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment * Participants must not have a history of (non-infectious) pneumonitis that required steroids, or has current (non-infectious) pneumonitis * Participants must not have received a live vaccine within 30 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed * Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen * Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potentia
Circadian Intervention to Improve Cardiometabolic Health
NCT05943626
Recruiting
Conditions Cardiometabolic Syndrome, Type 2 Diabete...
Phase NA
Enrollment 20
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

  • Circadian Intervention

Primary Outcomes

  • Insulin sensitivity change 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: 2023-06-13
Completion: 2026-03
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Utah
Contact Information
Study Contact:
Christopher M Depner, PhD
801-581-2275
christopher.depner@utah.edu
Interventions
  • Circadian Intervention
Study Locations (1 sites)
College of Health Research Complex--University of Utah, Salt Lake City, Utah 84112 United States
Eligibility Criteria
Inclusion Criteria: 1. Age: 18-45 years old; equal numbers of men and women 2. Body mass index (BMI): 25.0-34.9 kg/m2, 3. Sleep Habits: habitual self-reported average total sleep time (TST) \<6.5 hours per night for prior 6 months Exclusion Criteria: 1. Clinically diagnosed sleep disorder or major psychiatric illness 2. Evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease) 3. Use of prescription drugs or substances known to influence sleep or glucose metabolism 4. Shift-work: current or history of within last year 5. Weight change: \>10% of body weight over prior six months 6. Experiencing menopause or post-menopausal 7. Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program 8. Currently pregnant or planning to become pregnant, or currently lactating. 9. Currently smoking 10. Alcohol intake \>3 drinks per day or \>14 drinks per week
OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-stage Triple-negative Breast Cancer
NCT05949021
Active, positions filled
Conditions Triple Negative Breast Cancer (TNBC)
Phase PHASE2
Enrollment 30
Locations 8 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

  • Combination of liposomal doxorubicin

Primary Outcomes

  • Disease-Free Survival (DFS) Rate
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2023-10-07
Completion: 2027-09-30
Eligibility
Age: No restriction
Sex: FEMALE
Volunteers: false
Enrollment: 30 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Mridula George, MD
Principal Investigators:
  • Mridula George, MD (PRINCIPAL_INVESTIGATOR) - Cancer Institute of New Jersey Rutgers
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Combination of liposomal doxorubicin
Study Locations (8 sites)
RWJBarnabas Health - Trinitas hospital and Comprehensive Center, Elizabeth, New Jersey 08755 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
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey 08903 United States
RWJBarnabas Health - Robert Wood Johnson University Hospital, New Brunswick, New Jersey 08903 United States
RWJBarnabas Health - Newark Beth Israel Medical Center, Newark, New Jersey 07112 United States
University Hospital-Newark, Newark, New Jersey 07112 United States
RWJBarnabas Health - Community Medical Center, Toms River, New Jersey 08755 United States
Eligibility Criteria
Inclusion Criteria: * Newly diagnosed early stage triple negative breast cancer (TNBC) with a primary tumor size less than 2.5cm and nodal disease of N0/N1mi on final surgical pathology. * Patients who have completed primary surgical treatment. * Estrogen receptor (ER) expression of 20% or less, progesterone receptor (PgR) expression of 20% or less, and human epidermal growth factor receptor 2 (HER2) status 0-2+ by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) result of 2.0 or less. * Participants with a history of prior cancers are allowed if there is no evidence of disease within the last five years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Baseline left ventricular ejection fraction (LVEF) greater than 50% (most recent measurement within the last 5 years). * No prior history of treatment with anthracycline-based chemotherapy. * Adequate bone marrow function: * Absolute neutrophil count (ANC) greater than or equal to 1500/uL. * Platelet count greater than or equal to 100,000/uL. * Hemoglobin level greater than or equal to 9.0 g/dL. * Adequate hepatic function: * Total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN). * Aspartate aminotransferase (AST) levels (also known as serum glutamic-oxaloacetic transaminase, SGOT) less than or equal to 5 times the ULN. * Alanine aminotransferase (ALT) levels (also known as serum glutamic-pyruvic transaminase, SGPT) less than or equal to five times the ULN. * Participants with biliary obstruction must have restored biliary flow through the placement of an endoscopic common bile duct stent or percutaneous drainage. * Adequate renal function, with a creatinine level less than 1.5 times the institutional ULN or a calculated creatinine clearance greater than or equal to 50 mL/min using the Cockcroft-Gault formula. * Ability to understand the nature of the study protocol and provide written informed consent. * Willingness and ability to comply with scheduled visits and treatment plans. Exclusion Criteria: * Participants with stage III-IV breast cancer. * Uncontrolled hypertension, defined as systolic blood pressure greater than 190 mm Hg or diastolic blood pressure greater than 100 mm Hg. * Active liver disease. * Any condition, including the presence of laboratory abnormalities that, in the investigator's opinion, would place the participant at an unacceptable risk if they were to participate in the study. * Pre-existing sensory neuropathy greater than grade 1. * Clinically significant cardiac disease, such as congestive heart failure, symptomatic coronary artery disease, and uncontrolled cardiac arrhythmias, or a history of myocardial infarction within the last six months. * Presence of a serious non-healing wound, ulcer, or bone fracture. * Participants with uncontrolled and/or active infection with HIV, Hepatitis B, or Hepatitis C. * Participants with a history of allergy or hypersensitivity to any of the study drugs. * Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
HIIT Following Breast Cancer Chemotherapy
NCT05913713
Recruiting
Conditions Breast Cancer
Phase NA
Enrollment 158
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

  • 12-week Intervention Period
  • 12-week Observation Period

Primary Outcomes

  • Change in brachial FMD
  • Change in cardiac function (global longitudinal strain)
  • Percent completed vs. planned exercise frequency
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-03-07
Completion: 2026-05-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 158 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Florida
Collaborators: National Institute on Aging (NIA)
Principal Investigators:
  • Demetra Christou, PhD (PRINCIPAL_INVESTIGATOR) - University of Florida
Contact Information
Study Contact:
Demetra Christou, PhD
352-294-1746
ddchristou@ufl.edu
Interventions
  • 12-week Intervention Period
  • 12-week Observation Period
Study Locations (1 sites)
Integrative Cardiovascular Physiology Laboratory, University of Florida, Gainesville, Florida 32611 United States
Eligibility Criteria
Inclusion Criteria: * female patients based on biological sex * 18 to 85 years of age * diagnosis of primary, invasive, non-metastatic, stages I-III breast cancer * completed chemotherapy for breast cancer (anthracycline, alkylating agent and/or taxane) more than 6 months but less than 18 months prior to study enrollment. Adjuvant endocrine therapy for breast cancer (e.g., ovarian suppression, SERMs, SERDs, AIs), CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy, and bisphosphonates are allowed within 6 months of study enrollment and during study participation * absence of contraindications to exercise or to participate in study * study clinician approval Exclusion Criteria: * do not meet inclusion criteria * scheduled to receive surgery or radiation therapy during the intervention period * any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent) * lymphedema stage ≥2 prior to study enrollment * are pregnant * current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)
Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH
NCT05937854
Recruiting
Conditions Chronic Obstructive Pulmonary Disease, P...
Phase PHASE2
Enrollment 126
Locations 5 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

  • Tadalafil
  • Placebo

Primary Outcomes

  • severity of patient-reported dyspnea
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-04-01
Completion: 2029-03-01
Eligibility
Age: 35 Years
Sex: ALL
Volunteers: false
Enrollment: 126 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: VA Office of Research and Development
Collaborators: VA Boston Healthcare System, Atlanta VA Medical Center, VA Eastern Colorado Health Care System, VA Nebraska Western Iowa Health Care System
Principal Investigators:
  • Sharon I Rounds, MD (PRINCIPAL_INVESTIGATOR) - Providence VA Medical Center, Providence, RI
Contact Information
Study Contact:
Sharon I Rounds, MD
(401) 273-7100
sharon.rounds@va.gov
Ronald H Goldstein, MD
(857) 203-6578
Ronald.Goldstein@va.gov
Interventions
  • Tadalafil
  • Placebo
Study Locations (5 sites)
Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora, Colorado 80045 United States
Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur, Georgia 30033-4004 United States
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA, Boston, Massachusetts 02130-4817 United States
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE, Omaha, Nebraska 68105-1850 United States
Providence VA Medical Center, Providence, RI, Providence, Rhode Island 02908-4734 United States
Eligibility Criteria
Inclusion Criteria: 1. Outpatients with COPD, defined as airflow limitation with post-bronchodilator obstruction on baseline visit spirometry, identified by FEV1/FVC \< 70% or \< the lower limit of normal (5th percentile of a normal population based on Global Lung Function Initiative reference equations), OR any emphysema on chest CT noted in a clinical radiology report confirmed by study investigator review. 2. Eligible subjects must have PH documented as follows: 1. Main Pulmonary Artery/Ascending Aorta (PA/A) diameter \> 0.90 on clinically available CT scans within 12 months OR 2. Main Pulmonary Artery diameter \> 30.8mm on clinically available CT scans within 12 months OR 3. outpatient echocardiography done within 6 months of enrollment demonstrating PA sys \> 34 mmHg OR 4. Mean Pulmonary Artery Pressure \> 20 on Right Heart Catheterization done within 6 months of enrollment and when Veteran is clinically stable. 3. Eligible subjects must be dyspneic, as quantitated by a score of at least 20 on the baseline UCSD Shortness of Breath Questionnaire, assessed at the time of the baseline visit. 4. Treatment with at least one long-acting bronchodilator for at least 4 weeks, assessed at the time of the baseline visit by chart review and patient interview. 5. Age 35-89 Years 6. Women of childbearing potential must meet one of the following criteria for the previous three months AND must have a negative pregnancy test on the day of testing. If more than 36 hours since the participant's last pregnancy test, they will be tested again at the study visit. 1. have been using a contraceptive measure (an intrauterine device (IUD), a contraceptive implant, oral contraceptives, barrier methods, or abstinence) 2. have a male partner with a vasectomy 3. have a tubal ligation procedure or a medical diagnosis (such as infertility) or therapies/procedures that precludes pregnancy (such as cancer treatments or endometrial ablation) 4. are in a same-sex relationship 5. have a male partner not capable of fathering children because of congenital anomalies, other surgery, or medical treatment 7. Women who are not considered to be of childbearing potential who have been surgically sterilized (for example: removal of ovaries or fallopian tubes, or hysterectomy) or are post-menopausal (no menstrual period for more than 6 months). Exclusion Criteria: 1. Diagnosis of PH in the following subgroups of the updated WHO Clinical Classification: 1. Group 1 (Idiopathic, heritable, drug- or toxin-induced, Pulmonary Arterial Hypertension associated with connective tissue disease, congenital heart disease) 2. Group 2 (left atrial hypertension) 3. Group 3 PH not attributable to COPD 4. Group 4 (chronic thromboembolic PH) or other forms of PH not associated with primary lung disease. 2. Systemic hypotension in the ambulatory setting (at least 3 reproducible measurements of systolic BP \<89 mmHg, recorded by a health care provider over 1 week). 3. Moderate or severe hepatic impairment (Child-Pugh B and C). 4. Severe renal insufficiency (GFR \<30 ml/min/1.73 m2) 5. Echocardiography within 6 months showing greater than moderate aortic stenosis (aortic valve area \<1.0 cm2), greater than moderate mitral regurgitation, or diastolic dysfunction (Any two of the following: Average E/e' \>14, Septal e' velocity \< 7 or lateral e' velocity \<10, LA volume index \> 34 ml/m2). LVEF \< 50%. Any aortic or mitral valve replacement. 6. Any acute or chronic impairment (other than dyspnea) that limits ability to comply with the study requirements. 7. Current unstable angina, myocardial infarction or stroke within 6 months. 8. Requirement for nitrate therapy for any clinical indication. 9. Active prescription for a PDE-5 inhibitor or other pulmonary vasodilator other than oxygen as a PH treatment. 10. History of the following retinal disorders: retinitis pigmentosa, non-arteritic anterior ischemic optic neuropathy, or crowded optic disc noted on ophthalmology examinations recorded in CPRS. 11. Contraindications: PDE-5i allergy, penile anatomical deformations, sickle cell anemia, multiple myeloma, leukemia, bleeding disorders, active peptic ulcer disease, retinitis pigmentosa or other retinal disorders listed above. In accordance with 38 USC 7332, this information will be kept confidential and will not be disclosed in presentations, publications, or any other dissemination of the study results, or to anyone outside of the IRB-approved study team. 12. Use of any of the following: rifampin, systemic anti-fungal azole agents, protease inhibitors, phenobarbital, dilantin. 13. Pregnant, possibly pregnant by report, or if breastfeeding. If found to be pregnant at the study visit, the study visit will not be conducted. 14. Pulmonary veno-occlusive disease 15. Hypoxia (reproducible ambulatory SaO2 \< 90% on supplemental oxygen at rest recorded by a health care provider over 1 week). 16. Diagnosis of Obstructive Sleep Apnea without a prescription for treatment. 17. Newly prescribed (less than 4 weeks duration) bronchodilator or diuretic therapy or new enrollment in pulmonary rehabilitation at the time of Baseline. 18. Students, VA employees, persons with impaired decision making, illiterate and non-English speakers, and terminally ill patients. 19. COPD or CHF exacerbation within the past 4 weeks. 20. On-going therapy with doxazosin. Women of childbearing potential must have a documented negative pregnancy test and must be using adequate contraception during the study and for 9 months afterward. Monthly pregnancy tests will be done, and compliance with contraception use will be documented at the telephone and clinic visits. Should a female become pregnant at any time during the study, the study medication will be discontinued. Doxazosin use will be defined as current active prescription and usage of Doxazosin or planned trial (pending prescription) of Doxazosin for treatment of benign prostatic hypertrophy, systemic hypertension, or other indication. A list of alpha-1 antagonists (ex. prazosin, doxazosin, tamulosin, terazosin, etc.) will be included in the patient study medication handout to prompt the patient to avoid any new usage of these drugs during the trial period. On-going therapy with doxazosin is an exclusion criterion due to greater risk of hypotension.
Changing Tactics? Optimizing ECT in Difficult-to-treat Depression
NCT05923801
Recruiting
Conditions Depression
Phase NA
Enrollment 196
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

  • switch to BT electrode position
  • continue with RUL electrode position

Primary Outcomes

  • Change form baseline Depressive Symptom Severity
  • Change form baseline Depressive Symptom Severity
  • 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: 2023-06-01
Completion: 2026-06-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 196 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Universitaire Ziekenhuizen KU Leuven
Collaborators: Universiteit Antwerpen, AZ Sint-Jan AV, General Hospital Groeninge
Principal Investigators:
  • Pascal Sienaert, MD, PhD (PRINCIPAL_INVESTIGATOR) - UPC KU Leuven
Contact Information
Study Contact:
Pascal Sienaert, MD,PhD
+322 758 05 11
pascal.sienaert@upckuleuven.be
Interventions
  • switch to BT electrode position
  • continue with RUL electrode position
Study Locations (1 sites)
UPC Kortenberg, Kortenberg, Belgium
Eligibility Criteria
Inclusion Criteria: * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures * Age 18 or older * Diagnosis of major depressive disorder (DSM-5 296.21-30) or bipolar disorder, depressed (DSM-5 296.51-54; 296.84). Exclusion Criteria: * Contra-indication for general anesthesia * Non-Dutch speaking * Diagnosis of schizoaffective disorder or schizophrenia * Diagnosis of substance use disorder in the past six months * Diagnosis of neurocognitive disorder or intellectual disability alongside a MoCA score \<23 * Previous ECT course in the past three months * Participation in an interventional Trial with an investigational medicinal product or device * Pregnancy
To Evaluate the Efficacy and Safety of Envlo Tablet or Envlomet SR Tablet in Patients With Type II Diabetes Mellitus
NCT05926414
Active, positions filled
Conditions Diabetes Mellitus, Type 2
Phase Not Applicable
Enrollment 15000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Enavogliflozin
  • Enavogliflozin

Primary Outcomes

  • change in HbA1c
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: 2023-09-21
Completion: 2025-12-31
Eligibility
Age: 19 Years
Sex: ALL
Volunteers: false
Enrollment: 15000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Daewoong Pharmaceutical Co. LTD.
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Enavogliflozin
  • Enavogliflozin
Study Locations (1 sites)
NaRi Kim, Seoul, South Korea
Eligibility Criteria
Inclusion Criteria: 1. an adult male and female over 19 years of age 2. A person who is a type 2 diabetic and is planed to take Envlo Tab or Envloment SR Tab for the first time according to the medical judgment of the Investigator based on the permit 3. A person who voluntarily participates in the observational study and agrees in writing to comply with the subject's precautions during the study period after hearing and understanding the detailed explanation of the characteristics of the observational study and the drug to be studied Exclusion Criteria: 1. Persons with diabetes other than type 2 diabetes (type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.) 2. A person who is prohibited from administering in accordance with the permission of Envlo Tab.'s * Patients who overreact to Envlo Tab. or Envlo Tab. components and have a history of it * eGFR (estimated global filtration rate) patients below 30 mL/min/1.73 m2, end-stage renal disease or on dialysis * Patients with moderate and severe liver failure (AST or ALT \> 3x normal upper limit, Total Bilirubin \> 2x normal upper limit, hepatitis or liver failure) * Class III or IV by classification of the New York Heart Association (NYHA) 3. Patients with unstable weight due to treatment or other treatments (surgery, diet, etc.) with obesity or weight loss medication within 3 months of Enrollment 4. Pregnant women and lactating women 5. A person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices 6. A person who is deemed inappropriate to participate in this observational study based on the judgment of other investigators
Reducing Blood Pressure in Patients With High Cardiovascular Risk
NCT05937685
Recruiting
Conditions Myocardial Infarction, Hypertension, Str...
Phase NA
Enrollment 546
Locations 4 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • BP REACH Intervention

Primary Outcomes

  • Systolic blood pressure (SBP) mmHG
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-09-01
Completion: 2026-07
Eligibility
Age: 35 Years
Sex: ALL
Volunteers: false
Enrollment: 546 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Southern California
Collaborators: University of California, Los Angeles, University of California, Irvine
Principal Investigators:
  • Alejandra Casillas, MD (PRINCIPAL_INVESTIGATOR) - University of California, Los Angeles
  • Amytis Towfighi, MD (PRINCIPAL_INVESTIGATOR) - University of Southern California
Contact Information
Study Contact:
Monica Ayala-Rivera
(323) 442-0934
ayalariv@usc.edu
Interventions
  • BP REACH Intervention
Study Locations (4 sites)
Rancho Los Amigos National Rehabilitation Center, Downey, California 90242 United States
LA General Medical Center, Los Angeles, California 90033 United States
Olive View Medical Center, Sylmar, California 91342 United States
Harbor UCLA Medical Center, Torrance, California 90502 United States
Eligibility Criteria
Inclusion Criteria: * Patients of LA General Medical Center, Rancho Los Amigos, Olive Medical Center or Harbor-UCLA Medical Center with ischemic stroke, hemorrhagic stroke, or myocardial infarction * English or Spanish speaking * Systolic blood pressure (SBP) ≥ 130 mm Hg Exclusion Criteria: * Age \< 35 years * SBP \< 130 mm Hg * Only speaks a language other than English or Spanish * Cannot provide informed consent due to dementia or aphasia
Effect of Metformin, a Drug Used to Treat Diabetes, vs Placebo
NCT05949008
Active, positions filled
Conditions NIDDM, Obesity
Phase PHASE4
Enrollment 150
Locations 1 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Metformin Extended Release (ER) Oral Tablet
  • Placebo

Primary Outcomes

  • Number of participants who achieve body weight reduction ≥5% from baseline
  • Change in total body weight from baseline
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: 2023-11-22
Completion: 2028-07-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of California, Los Angeles
Principal Investigators:
  • Vijiya Surampudi, MD (PRINCIPAL_INVESTIGATOR) - University of California, Los Angeles
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Metformin Extended Release (ER) Oral Tablet
  • Placebo
Study Locations (1 sites)
UCLA Center for Human Nutrition, Los Angeles, California 90024 United States
Eligibility Criteria
Inclusion Criteria: * Male or female, age ≥ 18 years at the time of signing informed consent. * Body Mass Index (BMI) ≥ 27 kg/m2 * Waist circumference \>40" for men, and \>35" for women Exclusion Criteria: * A self-reported change in body weight \> 5 kg (11 lbs) within 90 days before screening irrespective of medical records * Diagnosed with T2D (HbA1c \>7.5 (53 mmol/mol) * Current use of insulin or oral medication of metformin, SU, SGLT2i, glitazone, DPP4 or GLP-1 agonist injections as single agent therapy or combination oral agents. * Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of \< 45 mL/min/1.73 m2 (\< 60 ml/min/1.73 m2 in subjects treated with SGLT2i) according to CKDEPI creatinine equation as defined by KDIGO 201242 by the central laboratory at screening * History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months (History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable). * History or lactic acidosis * Liver problems * Congestive heart failure * History of alcoholism * Recent surgery * Heart attack, severe infection or stroke * Any unstable medical conditions or terminal diagnosis * Pregnancy or lactation * Allergy and intolerance to metformin
Exploring Clinical Study Experiences of People With Depression
NCT05937932
Not yet recruiting
Conditions Depression
Phase Not Applicable
Enrollment 500
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

  • Number of patients who decide to participate in a depression clinical trial
  • Rate of patients who remain in depression clinical trial to trial completion
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2024-07
Completion: 2026-07
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Power Life Sciences Inc.
Principal Investigators:
  • Michael B Gill (STUDY_DIRECTOR) - Power Life Sciences Inc.
Contact Information
Study Contact:
Michael B Gill
4159004227
bask@withpower.com
Interventions
N/A
Study Locations (1 sites)
Power Life Sciences, San Francisco, California 94107 United States
Eligibility Criteria
Inclusion Criteria: * Patient has self-identified as planning to enroll in a clinical trial * Patient has been diagnosed with depression * Patient is a minimum of 18 years or older Exclusion Criteria: * Patient does not understand, sign, and return consent form * Inability to perform regular electronic reporting * Patient is pregnant
Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT
NCT05931302
Active, positions filled
Conditions Lobular Breast Carcinoma
Phase NA
Enrollment 40
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

  • 68Ga-FAPI-46 PET scan

Primary Outcomes

  • Number of positive tumor lesions, i.e. confirmed by additional imaging, histopathology/biopsy or response to treatment (on imaging or clinical assessment)
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: 2023-11-16
Completion: 2026-11
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators: Institut Curie, Centre Antoine Lacassagne
Principal Investigators:
  • Florent Hugonnet, MD (STUDY_DIRECTOR) - Centre Hospitalier Princesse Grace
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • 68Ga-FAPI-46 PET scan
Study Locations (1 sites)
Centre Hospitalier Princesse Grace, Monaco, 98000 Monaco
Eligibility Criteria
Inclusion Criteria: * Age greater than or equal to 18 years * ECOG from 0 to 2 * Histological diagnosis of Lobular Carcinoma of the breast based on a breast biopsy * Patient naïve to any treatment for lobular breast carcinoma * Women of childbearing age should have an adequate method of contraception * Patient having voluntarily accepted to participate in the study and signed the informed consent * Minimum tumor stage IIA * Sufficient histological material in the biopsy or the surgical specimen, if the biopsy is insufficient Exclusion Criteria: * PET scan contraindications: severe claustrophobia, unbalanced diabetes during 18F-FDG PET scans (fasting capillary blood sugar ≥ 11 mmol) * Hormone therapy started * 18F-FDG PET scan \> 21 days * Pregnant women, parturients and nursing mothers * Persons deprived of liberty by a judicial or administrative decision * Persons admitted to a health or social establishment for purposes other than research * Adults who are the subject of a legal protection measure or who are unable to express their consent
Ultrahypofractionation and Normal Tissue Toxicity
NCT05912231
Active, positions filled
Conditions Breast Cancer, Breast Cancer Female, Bre...
Phase NA
Enrollment 60
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

  • Accelerated Proton Beam Radiation Therapy (PBT)
  • Accelerated Photon Radiation Therapy (XRT)

Primary Outcomes

  • Change in Myocardial Fibrosis from Baseline in Proton Beam Radiation Therapy (PBT)
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: 2023-08-15
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Massachusetts General Hospital
Collaborators: National Cancer Institute (NCI), American Society of Clinical Oncology
Principal Investigators:
  • Rachel Jimenez, MD (PRINCIPAL_INVESTIGATOR) - Massachusetts General Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Accelerated Proton Beam Radiation Therapy (PBT)
  • Accelerated Photon Radiation Therapy (XRT)
Study Locations (1 sites)
Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02215 United States
Eligibility Criteria
Inclusion Criteria: * ≥18 years of age * Non-metastatic Breast Cancer patients who are scheduled to receive conventional left-sided or bilateral breast/chest wall RT inclusive of treatment to the internal mammary lymph nodes (IMNs) * Prior chemotherapy is permitted * Ability to understand and the willingness to sign a written informed consent document * No contraindication to MRI * Patients with right-sided breast cancer or patients with left-sided patients not requiring treatment to the IMNs, but where cardiac anatomy is determined to be unfavorable by the study PI, will be considered eligible. Exclusion Criteria: * Person who is pregnant or breastfeeding. * Patients receiving any other investigational agent will not be excluded from study eligibility, unless the patient is already enrolled in an interventional study evaluating cardiac toxicity. No cytotoxic therapy or radiotherapy may be used during radiation therapy. * Contra-indication to gadolinium contrast (e.g., chronic kidney disease) * Contra-indication to radiotherapy (e.g., scleroderma, p53 mutation)
Real Life Study of Biologicals in Patients With Severe CRSwNP
NCT05938972
Recruiting
Conditions Chronic Rhinosinusitis With Nasal Polyps
Phase Not Applicable
Enrollment 180
Locations 1 sites
Compensation reimbursement available
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Mepolizumab

Primary Outcomes

  • Clinical characteristics
  • Clinical characeristics
  • Local nasal immunity
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: 2022-03-01
Completion: 2030-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 180 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospital, Ghent
Principal Investigators:
  • Philippe Gevaert, Prof. Dr. (PRINCIPAL_INVESTIGATOR) - University Hospital, Ghent
Contact Information
Study Contact:
Manon Blauwblomme, Masters
+32 09 332 23 98
manon.blauwblomme@ugent.be
Philippe Gevaert, Prof. Dr.
Interventions
  • Mepolizumab
Study Locations (1 sites)
Ghent University Hospital, Ghent, 9000 Belgium
Eligibility Criteria
Inclusion Criteria: Patients must meet the following criteria to be eligible for the enrolment in the study: * Signed informed consent form (ICF), * Age between 18 and 80 years at time of signing ICF, * Able to comply with the study protocol, in the investigator's judgment, * In group one: patients with severe allergic and/or eosinophilic asthma, defined by being currently treated with a biological (SoC) OR starting treatment with a biological (SoC). * In group two: patients with CRSwNP with or without asthma, defined by starting treatment with a biological (SoC) and fulfill the criteria for reimbursement of a biological therapy Exclusion Criteria: Patients who do not meet the reimbursement criteria of a biological therapy cannot participate in the study.
Remotely Delivered, Community-Aligned Weight Loss Interventions Among Breast Cancer Survivors, ¡Vida! Trial
NCT05930483
Recruiting
Conditions Anatomic Stage I Breast Cancer AJCC v8, ...
Phase NA
Enrollment 640
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

  • ¡Vida! program
  • ¡Vida! Plus [¡Vida! + Experiential Learning (EL)]
  • Health Coaching
  • Mailed Toolkits

Primary Outcomes

  • Body weight (kg) percent change
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-04-08
Completion: 2028-03-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 640 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fred Hutchinson Cancer Center
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Heather Greenlee (PRINCIPAL_INVESTIGATOR) - Fred Hutch/University of Washington Cancer Consortium
Contact Information
Study Contact:
Jenny Whitten-Brannon
206-667-5625
jwhitten@fredhutch.org
Interventions
  • ¡Vida! program
  • ¡Vida! Plus [¡Vida! + Experiential Learning (EL)]
  • Health Coaching
  • Mailed Toolkits
Study Locations (1 sites)
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington 98109 United States
Eligibility Criteria
Inclusion Criteria: * Biologically female * Age \>= 18 years * Self-identifies Hispanic/Latina * Able to read and write in Spanish and/or English * Previous diagnosis of stage I-III BC within the past 5 years * No evidence of current, recurrent, or metastatic disease * 60 days post treatment, including chemotherapy, radiation therapy, and cancer-related surgery (NOTE: current allowed therapies include endocrine therapy, CDK4/6 inhibitors (e.g. palbociclib,ribociclib, abemaciclib), HER2-directed therapies (e.g., trastuzumab, neratinib), and monoclonal antibodies (e.g., pertuzumab, pembrolizumab); surgery for breast reconstruction is allowed during the trial) * Body mass index (BMI) \>= 27 kg/m\^2 initially assessed via self-reported height and weight and confirmed prior to randomization via a tape measure and Bluetooth-enabled scale * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Willingness to participate in all study activities * Access to phone for study contacts * Access to internet to participate in the online program and to be able to sync study devices * Successful completion of at-home baseline assessments prior to randomization Exclusion Criteria: * Body mass index (BMI) \< 27 kg/m\^2 at time of baseline data collection * Diabetic with current use of insulin or sulfonylurea medications (note: current use of metformin is allowed) * Use of glucagon-like peptide-1 (GLP1) receptor agonist medications reported at baseline * Current use of cytotoxic chemotherapy medications (e.g., capecitabine) or drug-antibody conjugates (e.g., trastuzumab emtansine \[T-DM1\], trastuzumab deruxtecan \[T-DXd\]) * Major comorbidities or physical limitations that would preclude from healthy weight loss, reducing energy intake or engaging in PA * Pregnant, breastfeeding, or planning to become pregnant during the study period * Use of exogenous hormones for gender affirmation * For stool sample collection only: Self-reported use of oral or intravenous antibiotics, antifungals, or anti-parasitics during the past 6 months * For stool sample collection only: Presence of self-reported ileostomy or colostomy * For stool sample collection only: Presence of self-reported inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis) * Anticipated major surgical procedure (e.g., hysterectomy) within 3 months after study registration. Breast reconstruction is allowed during study participation. * Concurrent enrollment in another weight loss or physical activity trial
A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC
NCT05918133
Active, positions filled
Conditions TNBC
Phase PHASE1, PHASE2
Enrollment 42
Locations 8 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

  • PM8002
  • nab-paclitaxel

Primary Outcomes

  • Objective Response Rate
  • Treatment related adverse events (TRAEs)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Active, positions filled
Start Date: 2022-07-01
Completion: 2026-10-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 42 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Biotheus Inc.
Principal Investigators:
  • Wu Jiong (PRINCIPAL_INVESTIGATOR) - Fudan University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • PM8002
  • nab-paclitaxel
Study Locations (8 sites)
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality China
Affiliated Cancer Hospital of Harbin Medical University, Harbin, Heilongjiang China
Jiangsu Province Hospital, Nanjing, Jiangsu China
Nanchang Third Hospital, Nanchang, Jiangxi China
The first ward of breast Surgery, Shandong Cancer Hospital, Jinan, Shandong China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality China
Yibin Second People's Hospital, Yibin, Sichuan China
Tian Jin Medicial University Cancer Institute&Hospital, Tianjin, Tianjin Municipality China
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily participate in clinical research; fully understand the study and voluntarily sign the informed consent; willing to follow and have the ability to complete all trial procedures; 2. Male or female, aged 18 to 75 years (including boundary value); 3. Unresectable locally advanced or metastatic breast cancer confirmed by histology or cytology, ER, PR, HER-2 are all negative. Negative ER and PR were defined as: IHCER \< 1%, IHCPR \< 1%. HER-2 negative is defined as: IHCHER-2 (-) or (1+), HER-2 (2+) must be tested by FISH and the result is negative. 4. Patients who have not received systemic treatment for advanced TNBC in the past are allowed to use taxane anti-tumor therapy in the previous neoadjuvant and/or adjuvant treatment stage, but must meet the end time of taxane neoadjuvant and/or adjuvant treatment Recurrence/metastasis interval ≥ 12 months; 5. Sufficient organ function; 6. The Eastern Cooperative Oncology Group (ECOG) score of physical status is 0-1; 7. Expected survival period ≥ 12 weeks; 8. According to the RECIST1.1 standard, the subject has at least one measurable tumor lesion. Exclusion Criteria: 1. History of severe allergic diseases, allergic history of serious drugs (including unlisted test drugs) or known allergic to any component of this test drug; 2. Previously received any antibody or inhibitor therapy targeting PD-1/PD-L1 or VEGF; 3. There is meningeal metastasis, uncontrollable or symptomatic central nervous system (CNS) metastasis; 4. Those who have active infection and currently need intravenous anti-infection treatment; 5. At present, there are uncontrollable pleural effusion, pericardium effusion and abdominal effusion; 6. Before the start of the study and treatment, fever of unknown cause \> 38.5°C (according to the researcher's judgment, fever caused by tumor can be included in the group); 7. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 8. Known history of alcohol abuse, psychotropic substance abuse or drug abuse; 9. Have a clear history of neurological or mental disorders, such as epilepsy, dementia and schizophrenia; 10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); 11. Syphilis nonspecific antibody test is positive (such as TRUST and PRP) or syphilis specific antibody test is positive (such as TPPA) \[it is acceptable that "Syphilis specific antibody test" is positive but "Syphilis nonspecific antibody test" is negative for more than one year\]; 12. Active tuberculosis, or a history of tuberculosis infection in the past but failed to control after treatment; 13. Active hepatitis B (HBsAg positive and HBV-DNA ≥1 1000 IU/ml) can be controlled by antiviral drugs (HBV-DNA \< 1000 IU/ml). Active hepatitis C (HCV-RNA \> detection limit of research center); 14. According to the researcher's judgment, the subject's basic illness may increase the risk of receiving the study drug, or confuse the explanation of the toxic reaction and AE; 15. It is expected that any other form of anti-tumor drug treatment will be required during the study; 16. Women who are pregnant or breastfeeding.
Patient Reported Outcomes Study Using Electronic Monitoring System for Advanced or Metastatic Solid Cancer
NCT05931445
Active, positions filled
Conditions Breast Cancer, Lung Cancer, Colorectal C...
Phase NA
Enrollment 500
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

  • e-PRO monitoring

Primary Outcomes

  • Overall Survival (OS)
  • HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) global health status score
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: 2021-01-26
Completion: 2027-03-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Comprehensive Support Project for Oncology Research
Principal Investigators:
  • Hironobu Minami (PRINCIPAL_INVESTIGATOR) - Kobe University Graduate School
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • e-PRO monitoring
Study Locations (1 sites)
Kobe University Graduate School, Kobe, Hyōgo 650-0017 Japan
Eligibility Criteria
Inclusion Criteria: 1. Unresectable, advanced, metastasized, or relapsed solid tumors (Breast Cancer, Lung Cancer, Colorectal Cancer, Liver Cancer, Stomach Cancer, Endometrial Cancer, Ovarian Cancer, or Squamous Cell Carcinoma of the Head and Neck) 2. Expected to be able to undergo treatment or observation for at least 6 months at the study site 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2 4. Receiving systemic anticancer mono- or combination pharmacotherapy (e.g., cytotoxic anticancer agents, molecularly targeted drugs, and immune checkpoint inhibitors) at enrollment or scheduled to begin such therapy within 1 month from the date of enrollment (In principle, patients should be receiving pharmacotherapy on an out-patient basis.) 5. Capable of using electronic device (includes cases needing some assistance) 6. Aged 18 years or older at informed consent 7. Written consent for the study personally obtained from the subject Exclusion Criteria: 1. Has undergone four or more regimens of pharmacotherapy for advanced, metastasized, or relapsed solid tumors\*Notes 1, 2 2. Currently participating in a study where PRO is tracked and the results are passed on to a physician 3. The following are exclusion criteria for individual types of cancer 1) Breast cancer * Scheduled to receive or currently receiving endocrine therapy (including endocrine therapy in combination with other agents) for hormone receptor-positive breast cancer * Scheduled to receive or currently receiving first regimen of anti-HER2 therapy for HER2-positive disease 2) Liver cancer * Hepatic function of Child-Pugh B/C 4. Undergoing or scheduled to undergo radiation therapy for curative purposes 5. Deemed otherwise unsuitable for the study by the investigator or sub-investigator * Notes: 1. If the disease has relapsed during perioperative adjuvant chemotherapy or within 24 weeks after adjuvant chemotherapy, the adjuvant chemotherapy will be considered as the first regimen of adjuvant chemotherapy. 2. Does not include endocrine therapy for breast cancer.