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Showing 20 of 29277 trials
Parenting Skills Group for Mothers With Postpartum Depression
NCT05772897
Recruiting
Conditions Postpartum Depression
Phase NA
Enrollment 750
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

  • Circle of Security Parenting program

Primary Outcomes

  • Change in methylation of OXTR receptor gene rs53576
  • Changes in Beck Depression Inventory, Second Edition (BDI-II) Score
  • Changes Postpartum Depression Screening Scale (PDSS) Score
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-08-03
Completion: 2035-06-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 750 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Colorado, Denver
Principal Investigators:
  • Sunny Stophaeros, MS (PRINCIPAL_INVESTIGATOR) - sunny.stophaeros@ucdenver.edu
Contact Information
Study Contact:
Sunny Stophaeros, MS
9253392971
sunny.stophaeros@ucdenver.edu
Caroline R Harrison, MPH
caroline.harrison@cuanschutz.edu
Interventions
  • Circle of Security Parenting program
Study Locations (1 sites)
University of Colorado Denver, Denver, Colorado 80204 United States
Eligibility Criteria
Inclusion Criteria: * Mothers aged 18-50 years old with infants aged 3-14 months old * Mothers who are experiencing symptoms of depression and mothers who are not experiencing symptoms of depression (non-depressed controls) are encouraged to participate. (please note that mothers who are experiencing active depression and who are not already being treated under the care of a qualified healthcare provider (i.e. through therapy or psychopharmacological intervention) will be referred for such treatment prior to being enrolled in the study. This study is not a replacement for professional management of depression or other mental health symptoms. Exclusion Criteria: * Mothers with severe psychopathology (such as bipolar disorder, schizophrenia, personality disorders, among others) * Infants with major medical problems that may interfere with a mother's ability to participate in and benefit from the intervention
Novel MRI Techniques on Evaluation of Lymphedema
NCT05804643
Recruiting
Conditions Lymphedema of Upper Limb
Phase Not Applicable
Enrollment 210
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

  • Diffusion magnetic resonance imaging

Primary Outcomes

  • change from baseline circumference of both arms at 3 months after lymphaticovenous anastomosis
  • change from baseline volume of both arms at 3 months after lymphaticovenous anastomosis
Interested in this trial?
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Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2023-04-10
Completion: 2026-12
Eligibility
Age: 20 Years
Sex: ALL
Volunteers: true
Enrollment: 210 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: National Taiwan University Hospital
Collaborators: National Health Research Institutes, Taiwan
Principal Investigators:
  • Li-Wei Kuo, Ph.D. (PRINCIPAL_INVESTIGATOR) - National Health Research Institutes, Taiwan
Contact Information
Study Contact:
Yeefan Lee, MD
+886-972653172
yeefanlee@ntu.edu.tw
Interventions
  • Diffusion magnetic resonance imaging
Study Locations (1 sites)
National Taiwan university hospital, Taipei, Taiwan
Eligibility Criteria
Inclusion Criteria: * adults with breast cancer related lymphedema Exclusion Criteria: * children younger than 20 years old * pregnancy * patients who have absolute contraindications regarding MRI scanning: 1. The cardiac implantable electronic device (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices. 2. Metallic intraocular foreign bodies. 3. Implantable neurostimulation systems 4. Cochlear implants/ear implant: bone-anchored hearing aid (BAHA) cochlear implant type can be scanned on a 1.5-tesla scanner only after the patient removes the battery. Cochlear implant wrapping scheduling must take place before the patient's MRI appointment. 5. Drug infusion pumps (insulin delivery, analgesic drugs, or chemotherapy pumps): If possible, the patient has to remove the device. 6. Catheters with metallic components (Swan-Ganz catheter) 7. Metallic fragments such as bullets, shotgun pellets, and metal shrapnel 8. Cerebral artery aneurysm clips 9. Magnetic dental implants 10. Tissue expander 11. Artificial limb 12. Hearing aid
A Study of Vericiguat in People With Breast Cancer and Cancer Therapy-Related Cardiac Dysfunction
NCT05806138
Active, positions filled
Conditions Breast Cancer, Cardiac Dysfunction
Phase PHASE2
Enrollment 21
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Vericiguat
  • Optimal medical therapy

Primary Outcomes

  • change in CRF (measured by VO2peak)
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: 2023-07-17
Completion: 2028-07-17
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 21 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: Merck Sharp & Dohme LLC
Principal Investigators:
  • Anthony Yu, MD, MS (PRINCIPAL_INVESTIGATOR) - Memorial Sloan Kettering Cancer Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Vericiguat
  • Optimal medical therapy
Study Locations (1 sites)
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York 10065 United States
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Biopsy proven breast cancer (stage I-IV) * Cancer treatment related cardiac dysfunction (CTRCD), established by an absolute decrease in LVEF ≥ 10% from baseline/pre-treatment to \< 53% and attributable to prior cardiotoxic cancer treatment, per the clinical investigator. * Able to complete an acceptable baseline CPET, in the absence of high-risk ECG findings or other inappropriate response to exercise as determined by the PI, as defined by any of the following criteria: * Achieving a plateau oxygen consumption, concurrent with an increase in power output; * A respiratory exchange ratio ≥ 1.00; * Attainment of maximal predicted heart rate, as defined by a peak heart rate within 10bpm of the age predicted maximal heart rate (220 - Age\[years\]); or if on a beta-blocker, 164 - (age \* 0.7) * Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale. * Willing to use highly effective contraceptive measures if of child-bearing potential or if the patient's sexual partner is a woman of child-earing potential while receiving study drug and for 30 days after the last dose of study drug: * Female subjects should be using highly effective contraceptive measures, and must have a negative pregnancy test (within 6 months prior to study enrollment) and not be breast-feeding prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: * Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments * Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the postmenopausal range for the institution * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation. * Male subjects should be willing to use barrier contraception °Willing and able to comply with the requirements of the protocol. Exclusion Criteria: * Systolic blood pressure \< 90 mmHg * Concurrent or anticipated use of a long-acting nitrate or NO donor (e.g., nitroglycerin, isosorbide dinitrate, isosorbide 5-mononitrate, pentaerythritol tetranitrate, nicorandil or transdermal NTG patch, or molsidomine). * Concurrent or anticipated use of a phosphodiesterase inhibitor (e.g., vardenafil, tadalafil, or sildenafil). * Cardiac comorbidity, including any of the following: * Hypertrophic cardiomyopathy, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac sarcoidosis, or amyloid cardiomyopathy * Uncontrolled arrhythmia * Uncorrected congenital cardiac disease * Acute coronary syndrome, percutaneous coronary intervention, or coronary artery bypass graft surgery within 3 months prior to randomization. * Symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke within 3 months prior to randomization. * Cardiac transplantation * Valvular heart disease requiring surgery or intervention * Non-cardiac comorbidity, including any of the following: * eGFR \< 15ml/min/1.73m\^2 (based upon CKD-EPI, Cockroft-Gault, etc.) * Severe hepatic insufficiency (e.g., Child-Pugh C) * Severe pulmonary disease, such as requiring continuous home oxygen or interstitial lung disease * Other medical disorder or condition that in the opinion of the investigator would impair the subject's ability to participate or complete the study * Subjects must not have any of the following absolute contraindications to cardiopulmonary exercise testing: * Acute myocardial infarction (within 30 days of any planned study procedures) * Unstable angina * Uncontrolled arrhythmias causing symptoms or hemodynamic compromise, * Symptomatic severe aortic stenosis * Recurrent syncope * Active endocarditis * Acute myocarditis or pericarditis * Acute pulmonary embolus or pulmonary infarction (within 3 months of any planned study procedures) * Thrombosis of lower extremities (within 3 months of any planned study procedures) * Suspected dissecting aneurysm * Uncontrolled asthma * Pulmonary edema * Room air desaturation at rest ≤85% * Respiratory failure * Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) * Mental impairment leading to inability to cooperate. * Current alcohol and/or drug abuse * Any other condition or intercurrent illness (e.g., symptomatic weight-bearing bone metastases or limited life expectancy \< 6-9 months) that, in the opinion of the investigator, makes the participant a poor candidate for the trial
Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program
NCT05789446
Recruiting
Conditions Chronic Stress, Anxiety, Depression
Phase NA
Enrollment 360
Locations 5 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Building a Strong Identity and Coping Skills

Primary Outcomes

  • Anxiety
  • Depression
  • Suicide Risk Markers
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-02-01
Completion: 2029-05-31
Eligibility
Age: 11 Years
Sex: ALL
Volunteers: true
Enrollment: 360 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Penn State University
Principal Investigators:
  • Martha E Wadsworth, PhD (PRINCIPAL_INVESTIGATOR) - Penn State University
Contact Information
Study Contact:
Martha E Wadsworth, PhD
814-865-2878
mew27@psu.edu
Dara Babinksi, PhD
dbabinski@pennstatehealth.psu.edu
Interventions
  • Building a Strong Identity and Coping Skills
Study Locations (5 sites)
Pennsylvania Psychiatric Institute, Harrisburg, Pennsylvania 17110 United States
Penn State Health Medical Group - Psychiatry and Behavioral Health, Hershey, Pennsylvania 17033 United States
Penns Valley Area School District, Spring Mills, Pennsylvania 16875 United States
Dr. Edwin L. Herr Clinic, State College, Pennsylvania 16802 United States
Penn State Psychological Clinic, State College, Pennsylvania 16802 United States
Eligibility Criteria
Inclusion Criteria: * Children ages 11-14 at intake * Family income at or below 200% federal poverty level * Child speaks English * Parent speaks English or Spanish Exclusion Criteria: * Intellectual disability * Autism spectrum disorder * High suicidal risk (score of 17 or more on the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid)) * Severe depression (score of 19 or more on Patient health questionnaire (PHQ).
Effects of Semaglutide on Intracranial Blood Flow and Brain-Barrier Permeability in Type-2 Diabetes
NCT05780905
Recruiting
Conditions Diabetes Mellitus, Type 2, Stroke (CVA) ...
Phase PHASE4
Enrollment 50
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

  • Semaglutide Auto-Injector
  • Placebo

Primary Outcomes

  • Intracranial blood flow (IBF)
  • bloodbrain barrier Ktrans
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2024-01-11
Completion: 2026-12-31
Eligibility
Age: 40 Years
Sex: ALL
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Washington
Collaborators: Novo Nordisk A/S
Principal Investigators:
  • Francis Kim, MD (PRINCIPAL_INVESTIGATOR) - University of Washington
Contact Information
Study Contact:
Francis Kim, MD
206-744-8305
fkim@u.washington.edu
Interventions
  • Semaglutide Auto-Injector
  • Placebo
Study Locations (1 sites)
University of Washington - Harborview Medical Center, Seattle, Washington 98104 United States
Eligibility Criteria
Inclusion Criteria: 1. Men and women 40-65 years of age 2. Subjects with type-2 diabetes \>= 3 years and HbA1C 7%-10% with blood sugar control medications including insulin, metformin, sulfonylureas, or SGLT2 inhibitors 3. Medically stable 4. Has not received any investigational drug in the past 6 months 5. Willing to participate and sign informed consent. Exclusion Criteria: 1. Contraindication to MRI or contrast agent 2. eGFR\<45 mL/min/1.73m2 (eGFR is a measurement of kidney function) 3. Currently treated with glucagon-like peptide-1 receptor antagonist (same drug class as study intervention) 4. Unable to perform home-glucose monitoring 5. Currently need more than 100 units of insulin daily 6. Uncontrolled hypertension with systolic blood pressure (SBP)\>180 mmHg or diastolic blood pressure (DBP)\>100 mmHg 7. LDL-C\>130 mg/dL or not on stable statin therapy in the past 6 months 8. Treatment with pioglitazone in the past 3 months 9. History of pancreatitis 10. History of myocardial infarction, stroke or transient ischemic attack 11. History or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) 12. Hypersensitivity to semaglutide or any of the product components 13. Participating in other clinical trial 14. Women of child-bearing potential (ie, those who are not chemically or surgically sterilized or who are not post-menopausal) who have a positive pregnancy test at enrollment or who are breastfeeding or who plan to become pregnant in the next 15 months.
Reversibility of Brain Glucose Transport in Type 2 Diabetes Mellitus (T2DM)
NCT05776563
Recruiting
Conditions Diabetes Mellitus, Type 2
Phase NA
Enrollment 24
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

  • Nutrition visits
  • Intensification of diabetes regimen
  • Continuous glucose monitor (CGM)

Primary Outcomes

  • Brain glucose concentration in the occipital cortex week 0
  • Brain glucose concentration in the occipital cortex week 12
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-07-19
Completion: 2027-05-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 24 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Yale University
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigators:
  • Elizabeth Sanchez Rangel, MD (PRINCIPAL_INVESTIGATOR) - Yale University
Contact Information
Study Contact:
Elizabeth Sanchez Rangel, MD
203-785-6430
elizabeth.sanchezrangel@yale.edu
Interventions
  • Nutrition visits
  • Intensification of diabetes regimen
  • Continuous glucose monitor (CGM)
Study Locations (1 sites)
Yale New Haven Hospital (YNHH) Research Unit (HRU), New Haven, Connecticut 06520 United States
Eligibility Criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18-60 * medical history for Type 2 diabetes * HbA1c \> 7.5%, BMI ≥18 kg/m2 * Be willing to adhere to the intensification of their diabetes regimen Exclusion Criteria: * Creatinine \> 1.5 mg/dL * Hgb \< 10 mg/dL, hematocrit of 37 % for males participants and 33 % for female participants * ALT \>3 x ULN * untreated thyroid disease, * uncontrolled hypertension * known neurological disorders * untreated psychiatric disorders * malignancy * bleeding disorders * current or recent steroid use in last 3 months * illicit drug use * for women: pregnancy, actively seeking pregnancy, or breastfeeding * inability to enter MRI/MRS (as per standard MRI safety guidelines).
Grouping Immune-modulation With Cryoablation (LOGIC) for Breast Cancers
NCT05806385
Not yet recruiting
Conditions Triple Negative Breast Cancer
Phase PHASE1, PHASE2
Enrollment 36
Locations 0 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

  • Cryoablation
  • Cryoablation combined with PD1 Inhibitor

Primary Outcomes

  • Rate of Complete Pathological Response
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Not yet recruiting
Start Date: 2026-03
Completion: 2029-06
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 36 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Texas Tech University Health Sciences Center
Contact Information
Study Contact:
Rakhshanda Layeequr Rahman, MD
806-743-2289
rakhshanda.rahman@ttuhsc.edu
Sharda Singh, PHD
806-743-1540
sharda.singh@ttuhsc.edu
Interventions
  • Cryoablation
  • Cryoablation combined with PD1 Inhibitor
Eligibility Criteria
Inclusion Criteria: * Females * Stage I/II Cancer * Age range 18 - 90 years * Diagnoses: Invasive carcinoma, ER -, PR-, HER2- (triple negative) * Radiology findings: Unifocal disease visible on ultrasound Exclusion Criteria: * Additional primary cancer * Inflammatory breast cancer * History of autoimmune disease * History of chronic immunosuppression * Prior immunotherapy * Recent vaccination (within 4 wks.) * Prior radiation therapy * Prior investigational agent therapy within last 1 year * Pregnancy at the time of diagnosis and/ or treatment * Breast feeding
Understanding the Role of Doulas in Supporting People With PMADs
NCT05763537
Recruiting
Conditions Maternal Health, Pregnancy, Delivery, Ob...
Phase NA
Enrollment 75
Locations 1 sites
Compensation compensation available
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Standard Doula Care Plus PMAD Intervention
  • Standard Doula Care

Primary Outcomes

  • The Childbirth Self-Efficacy Inventory (CBSEI)
  • Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 1 month postpartum
  • Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 3 months postpartum
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-11-26
Completion: 2026-07-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 75 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Montana
Contact Information
Study Contact:
Jessica L Liddell, PhD
4357576780
jessica.liddell@mso.umt.edu
Interventions
  • Standard Doula Care Plus PMAD Intervention
  • Standard Doula Care
Study Locations (1 sites)
University of Montana, Missoula, Montana 59812 United States
Eligibility Criteria
Inclusion Criteria: * Participants must be over the age of 18 * Currently pregnant and between 13 and 26 gestational weeks at the time of enrollment * Live in a HRSA-designated rural area of Montana Exclusion Criteria: * They are under the age of 18 * Not currently pregnant * Not between 13-26 gestational weeks at the time of enrollment * If they do not live in a HRSA-designated rural are of Montana.
FUSCC Refractory TNBC Platform Study (FUTURE2.0)
NCT05749588
Recruiting
Conditions Triple-negative Breast Cancer
Phase PHASE2
Enrollment 120
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

  • A1: SHR-A1811
  • A2: SHR-A1811 with Camrelizumab with famitinib
  • B1: TROP2 ADC
  • B2: TROP2 ADC with Camrelizumab
  • C1: SHR-A1811

Primary Outcomes

  • Overall response rate (ORR)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2023-03-30
Completion: 2028-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fudan University
Principal Investigators:
  • Zhimin Shao, M.D. (PRINCIPAL_INVESTIGATOR) - Fudan University
Contact Information
Study Contact:
Zhimin Shao, M.D.
+86-021-64175590
zhimingshao@yahoo.com
Yin Liu, M.D.
+86-021-64175590
liuyinfudan@163.com
Interventions
  • A1: SHR-A1811
  • A2: SHR-A1811 with Camrelizumab with famitinib
  • B1: TROP2 ADC
  • B2: TROP2 ADC with Camrelizumab
  • C1: SHR-A1811
Study Locations (1 sites)
Fudan University Shanghai Cancer Center, Shanghai, 200032 China
Eligibility Criteria
Inclusion Criteria: 1. Female aged ≥18 years; 2. TNBC invasive breast cancer confirmed by histology (specific definition: ER \<1% positive tumor cells by immunohistochemistry are defined as ER negative, PR \<1% positive tumor cells are defined as PR negative, HER2 0-1+ or HER2 ++ but negative by FISH without amplification was defined as HER2 negative); Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer; 3. Progression after at least one prior therapeutic regimens for advanced/metastatic TNBC 4. At least one measurable lesion according to RECIST 1.1 (conventional CT scan ≥20 mm, spiral CT scan ≥10 mm, measurable lesion has not received radiotherapy); 5. The functions of the main organs are basically normal and meet the following conditions: i. Blood routine examination criteria shall meet: HB ≥90 g/L (no blood transfusion within 14 days); The ANC acuity 1.5 x 10\^9 /L; PLT acuity 75 x 10\^9 /L; ii. Biochemical tests should meet the following criteria: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3×ULN; If liver metastases were present, ALT and AST≤ 5×ULN; Serum Cr ≤1×ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula); 6. They have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks before the start of the study, and have recovered from the acute toxicity of previous treatment (if surgery was performed, the wound has healed completely); No peripheral neuropathy or grade I peripheral neurotoxicity; 7. ECOG score ≤1, and life expectancy ≥3 months; 8. Fertile female subjects were required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last use of the study drug; 9. Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up. Exclusion Criteria: 1. Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were used in the first 3 weeks of treatment, except bisphosphonate (which can be used for bone metastasis); 2. Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol); 3. A history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmia within the last 6 months; 4. Persistent grade 1 or higher adverse reactions caused by previous treatments. The exception to this is hair loss or something the researchers don't think should be ruled out. Such cases should be clearly documented in the investigator's notes; 5. Underwent major surgery (except minor outpatient procedures, such as placement of vascular access) within 3 weeks of the first course of trial treatment; 6. Pregnant or lactating patients; 7. Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years.
Prevention of Renal Failure in People Followed for Type 2 Diabetes in General Practice
NCT05749679
Not yet recruiting
Conditions Renal Insufficiency and Diabetes Mellitu...
Phase NA
Enrollment 360
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • training and audit
  • Routine care

Primary Outcomes

  • Change in annual glomerular filtration rate (GFR) slope
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-07
Completion: 2027-07
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: false
Enrollment: 360 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospital, Lille
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • training and audit
  • Routine care
Eligibility Criteria
Inclusion Criteria: * Patient consulting his or her investigating general practitioner * 50 years old or more * type 2 diabetic for more than 5 years, with a GFR lower than 90 ml/mn and higher than 45 ml/mn (stage 2 and 3a of renal failure) and a nephron loss calculated on the average of the two previous years, higher than 3 ml/mn/year * a microalbuminuria \> 30 mg/gr of creatinuria. * Having declared the investigator as the treating physician Exclusion Criteria: * Patient under 50 years of age Patients who do not agree to the use of their data (refusal of consent) or are unable to give consent (dementia, other) Patients with other types of diabetes Patients with renal failure other than diabetic or hypertensive glomerulopathy Patients unable to give consent Patients who do not understand the French language Patients with less than 3 months of planned follow-up Patients with a barrier to follow-up Patients undergoing dialysis, transplantation
Improving Hypertension Control in Rheumatoid Arthritis
NCT05760898
Recruiting
Conditions Hypertension, Rheumatoid Arthritis
Phase NA
Enrollment 25
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

  • Blood pressure intervention arm

Primary Outcomes

  • Intervention feasibility as measured by participant accrual rates
  • Intervention feasibility as measured by participant retention
  • Intervention feasibility as measured by adherence to blood pressure monitoring
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-01-16
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 25 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Duke University
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Contact Information
Study Contact:
Isaac Smith, MD
919-613-2243
isaac.smith063@duke.edu
Interventions
  • Blood pressure intervention arm
Study Locations (1 sites)
Duke Health System, Durham, North Carolina 27710 United States
Eligibility Criteria
Inclusion Criteria: * 18 years old or older * Uncontrolled hypertension * History of rheumatoid arthritis * Receive both primary care and rheumatology care from Duke Health System Exclusion Criteria: * Age less than 18 years old * Healthy volunteers without rheumatoid arthritis and hypertension * Do not receive both primary care and rheumatology care from Duke Health System * Cognitive impairment with lack the capacity to consent to study participation * Pregnant women * Prisoners
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)
NCT05757791
Recruiting
Conditions Major Depressive Disorder
Phase PHASE2
Enrollment 16
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

  • Empagliflozin

Primary Outcomes

  • Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2023-03-17
Completion: 2026-05
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 16 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: NYU Langone Health
Collaborators: American Society of Clinical Psychopharmacology
Principal Investigators:
  • Dan V Iosifescu, MD, MMSc (PRINCIPAL_INVESTIGATOR) - NYU Langone Health
Contact Information
Study Contact:
Dan V Iosifescu, MD, MMSc
(646) 754-5156
dan.iosifescu@nyulangone.org
David T Liebers, MD, MPhil, MPP
212-263-7419
david.liebers@nyulangone.org
Interventions
  • Empagliflozin
Study Locations (1 sites)
NYU Langone Health, New York, New York 10016 United States
Eligibility Criteria
Inclusion Criteria: * Provide written informed consent, as approved by the NYU Institutional Research Ethic Board (IRB). * Patients ages 18-65; * Current/acute Major Depressive Disorder (MDD) diagnosis, per MINI psychiatric interview; * At least moderate severity of depression (Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 20 at initial screen); Exclusion Criteria: * DSM-5 diagnosis of Bipolar disorders, Cyclothymia, Schizoaffective disorder, Schizophrenia; any psychotic disorder or affective psychosis; * Subjects that have had more than two failures of adequate anti-depressant trials in the current MDD episode; * Subjects on psychotropic medications other than SSRIs, NDRIs, SNRIs, or mirtazapine (occasional use of sleep agents, equivalent to lorazepam 1 mg or zolpidem 10 mg, will be allowed); * Those that have previously been on SGLT2 inhibitors; * A significant history of non-adherence to treatments; * History of neurologic / seizure disorder; * A significant history of non-adherence to treatments; * History of dementia/cognitive dysfunction (MOCA \< 22); * A primary diagnosis of a personality disorder, in the opinion of the screening clinician; * DSM-5 substance use disorder (drug/alcohol) active within the past 12 months, or positive urine toxicology at screening; * History of diabetic ketoacidosis; * History of recurrent genital mycotic infection; * GFR \<45; * HgA1c.\>8.0% * History of an allergic reaction to an SGLT2 inhibitor. * Pregnancy or lactation (women of reproductive age, ie \<50 years old, should be on licensed hormonal or barrier method contraception). * Any known pancreatic disease resulting in insulin deficiency (T1D, history of pancreatitis, pancreatic surgery); * History of liver or kidney disease; * Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE.
Effects of Berberine on Preventing Cardiovascular Disease and Diabetes Mellitus
NCT05749874
Active, positions filled
Conditions PreDiabetes, Abdominal Obesity, Hyperten...
Phase PHASE4
Enrollment 2024
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

  • Berberine plus lifestyle intervention
  • Placebo plus lifestyle intervention

Primary Outcomes

  • The distribution of glycemic status at 1 year after randomization
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: 2023-10-31
Completion: 2026-12-31
Eligibility
Age: 40 Years
Sex: ALL
Volunteers: false
Enrollment: 2024 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: China National Center for Cardiovascular Diseases
Principal Investigators:
  • Jing Li, PhD (PRINCIPAL_INVESTIGATOR) - National Center for Cardiovascular Diseases
  • Haibo Zhang, MD (PRINCIPAL_INVESTIGATOR) - National Center for Cardiovascular Diseases
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Berberine plus lifestyle intervention
  • Placebo plus lifestyle intervention
Study Locations (1 sites)
Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases, Beijing, China
Eligibility Criteria
Inclusion Criteria: * Participants aged ≥40 years old * Participants with prediabetes, defined as glycated hemoglobin (HbA1c) between 5.7% and 6.4% * Participants with body mass index\>25kg/m2, or abdominal obesity (i.e., waist circumference ≥85 cm in female or waist circumference ≥90 cm in male) * Participants with established atherosclerosis cardiovascular diseases (ASCVD), or with at least two cardiovascular risk factors: (a) hypertension (b) aged ≥45(male) / 55 (female), (c) current smoker, (d) HDL-C\<1mmol/L or TG≥2.3mmol/L * Participants with established ASCVD required LDL-C≤70 mg/dL (1.8mmol/L) for participants with ASCVD or receiving optimized LDL-C-lowering therapy (at least moderate-intensity statin therapy, unless contraindicated or intolerant) Exclusion Criteria: * Participants with FPG≥7.0 mmol/L, diagnosed with diabetes or taking oral glucose-lowering drugs * Participants diagnosed with acute coronary syndrome, stroke, transient ischemic attack, or undergoing cardiac surgery or cardiac intervention (i.e., implantation of cardiac closure devices, cardiac resynchronization therapy, or catheter ablation), percutaneous coronary intervention or valvuloplasty/other cardiac valve repair or implantation surgery within the 3 months before randomization * Participants who plan to perform coronary and/or non coronary revascularization surgery, or cardiac surgery within 6 months after randomization * Participants diagnosed with heart failure or left ventricular ejection fraction\<40%, severe cardiac valvular disease, cardiomyopathy, congenital heart disease * Conditions known to interfere with the accuracy of HbA1c measurement, including rheumatoid arthritis, hemolytic anemia, aplastic anemia, hemoglobinopathies, splenomegaly, splenectomy, vitamin B12 deficiency, alcoholism, long-term high-dose aspirin use, or chronic use of anesthetics or hydroxyurea * Recipients of major organ transplants (e.g., lung, liver, heart, bone marrow, kidneys, etc.) * Participants diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency * Participants taking berberine or drug containing berberine in the past 1 month * Participants with any adverse reaction to berberine * Participants with severe constipation, diarrhea, and/or severe chronic intestinal diseases (e.g., ulcerative colitis, Crohn's disease, irritable bowel syndrome, etc.) * Participants who plan to have weight loss surgery, plan to take or currently taking drugs for weight loss * Participants with active liver diseases, or alanine aminotransferase (ALT) / aspartate aminotransferase (AST) \> 3 times upper limit of normal * Estimated glomerular filtration rate (eGFR) \< 45 ml/(min×1.73m2) * Women who are pregnant or breastfeeding, or those who plan to be pregnant during the trial * Participants with malignant tumors, or other serious diseases with life expectancy of less than 3 years * Participants with mental disorders, cognitive disorders, or other serious diseases that could affect study participation * Participants who participated or have been participating other trials during the last 3 months * Any other conditions that may hinder the compliance to the study intervention or follow-up visit
SGLT2 Inhibitors on Clinical Outcomes and Left Ventricular Remodeling in Type 2 Diabetic Patients with Acute Myocardial Infarction, a Prospective, Multi-center Registry Study
NCT05770687
Recruiting
Conditions Myocardial Infarction, Diabetes Mellitus...
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

Interventions / Regimen

  • SGLT2 inhibitor

Primary Outcomes

  • Major adverse cardiac and cerebrovascular events
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: 2020-08-01
Completion: 2026-12-31
Eligibility
Age: 19 Years
Sex: ALL
Volunteers: false
Enrollment: 1000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Kiyuk Chang
Collaborators: Seoul St. Mary's Hospital, Uijeongbu St. Mary Hospital, Incheon St.Mary's Hospital, Daejeon St. Mary's hospital, Bucheon St. Mary's Hospital, St Vincent's Hospital, Yeouido St. Mary's Hospital, Sejong General Hospital, Pusan National University Hospital, Andong Hospital, Chungnam National University Hospital, St. Carollo General Hospital, Pusan National University Yangsan Hospital, Kyungpook National University Hospital, Jeju National University Hospital, Korea University Anam Hospital, Inje University
Principal Investigators:
  • Kiyuk Chang, MD, PhD (PRINCIPAL_INVESTIGATOR) - Seoul St. Mary's Hospital
Contact Information
Study Contact:
Kiyuk Chang, MD, PhD
82-2-2258-1139
kiyuk@catholic.ac.kr
Interventions
  • SGLT2 inhibitor
Study Locations (1 sites)
Seoul St. Mary's Hospital, Seoul, South Korea
Eligibility Criteria
Inclusion Criteria: * Acute myocardial infarction who were treated with percutaneous coronary intervention * Type 2 diabetes mellitus * Started SGLT2 inhibitors \<1 month before/after PCI Exclusion Criteria: * Type 1 diabetes mellitus * Insulin / GLP-1 analogue users * Previous users of SGLT2 inhibitors * Pregnancy
Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer
NCT05746325
Recruiting
Conditions Anatomic Stage IV Breast Cancer AJCC v8,...
Phase NA
Enrollment 5
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

  • Digital Photography
  • Lumbar Puncture
  • Magnetic Resonance Imaging
  • Medical Device Usage and Evaluation
  • Biospecimen Collection

Primary Outcomes

  • Incidence of significant toxicity of tumor treating fields (TTFs)
  • Feasibility of TTFs - completion of at least 28 days of TTF therapy
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-04-07
Completion: 2027-03-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 5 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Mayo Clinic
Principal Investigators:
  • Wendy J. Sherman, MD (PRINCIPAL_INVESTIGATOR) - Mayo Clinic
Contact Information
Study Contact:
Clinical Trials Referral Office
855-776-0015
mayocliniccancerstudies@mayo.edu
Interventions
  • Digital Photography
  • Lumbar Puncture
  • Magnetic Resonance Imaging
  • Medical Device Usage and Evaluation
  • Biospecimen Collection
Study Locations (1 sites)
Mayo Clinic in Florida, Jacksonville, Florida 32224-9980 United States
Eligibility Criteria
Inclusion Criteria: * Age \>= 18 * Prior tissue diagnosis of breast cancer or lung cancer * Confirmed diagnosis of leptomeningeal metastases (LM) with positive cerebrospinal fluid (CSF) cytology for malignancy and meningeal enhancement (type 1A, 1B, and 1C) * Radiographic evidence on MRI of leptomeningeal enhancement within the cervical, thoracic or lumbar spine on spinal MRI * Life expectancy of at least 6 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3 * Recovery from any neurotoxic effects of prior therapy * Platelet count greater than 25 x 10\^9/L * Absolute neutrophil count (ANC) greater than 0.5 x 10\^9/L * Patients must have adequate liver function, total bilirubin \< 2.5 mg/dL, unless elevated total bilirubin is due to elevated indirect bilirubin from known Gilbert's disease, aspartate aminotransferase (AST) =\< 3.5 times upper limits of normal; adequate renal function \[calculated estimated glomerular filtration rate (eGFR) \>= 30 mL/min/ body surface area (BSA)\] * Patients or legal medical representative must provide written informed consent * Patients must have suitable body habitus for placement of transducer arrays * Patients must be willing to wear the device for at least 18 hours a day (averaged over monthly) * Patients must be willing to return for the scheduled evaluations and perform the required assessments * Patients are without other disease or situation which would significantly compromise adequate assessment of safety and feasibility of the TTF * Patient willing to start a study treatment with TTF =\< 14 days from registration Exclusion Criteria: * Concomitant therapy: * Must not be receiving concurrent high-dose methotrexate (\>= 3 g/m\^2), high dose thiotepa, or high-dose cytarabine (\>= 3 g/m\^2). Any other systemic chemotherapy, targeted treatment, hormonal or immunotherapy directed at the primary systemic malignancy is permitted * Must not have received radiation therapy (RT) to the brain or spinal cord within 2 weeks of initiation of TTF * Must be at least 1 week from cessation of any prior intrathecal chemotherapy * Women of childbearing age who are pregnant or lactating. (Male and female patients who are fertile must be willing to use an effective means of birth control to avoid pregnancy) * Patients with uncontrolled or untreated infection including active hepatitis, and human immunodeficiency virus (HIV) * Patients receiving any other investigational agents and must not have received any other investigational agent within 14 days prior to registration. The 14-day period should be extended if the investigational agent is known to have delayed toxicity * Patients known to be allergic to the hydrophilic gel utilized for transducer attachment * Patients with surgical hardware within the planned area of treatment in the spine (e.g., titanium rods, screws, fixation devices)
Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab
NCT05760612
Recruiting
Conditions Early-stage Breast Cancer, HER2-positive...
Phase PHASE3
Enrollment 300
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

  • Trastuzumab and neratinib
  • Trastuzumab and Pertuzumab

Primary Outcomes

  • Invasive disease free survival, IDFS
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2023-03-14
Completion: 2028-11-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact Information
Study Contact:
Chang Gong
13925089353
gchang@mail.sysu.edu.cn
Interventions
  • Trastuzumab and neratinib
  • Trastuzumab and Pertuzumab
Study Locations (1 sites)
Sun Yat-sen University Sun Yat-sen Memorial Hospital, Guangzhou, China
Eligibility Criteria
Inclusion Criteria: 1. Female patients aged 18-70 years; 2. Eastern Cooperative Oncology Group performance status of 0 or 1; 3. Clinical stage at initial diagnosis (per the 8th edition of the American Joint Committee on Cancer Staging Manual): cT1-4/N1-3/M0 (cT1mi/N0 or cT1a-b/N0 are eligible), meeting the criteria for neoadjuvant therapy as per NCCN 2022 guidelines; 4. Histologically confirmed hormone receptor-positive (estrogen receptor ≥1% and/or progesterone receptor ≥1%) and HER2-positive (immunohistochemistry 3+ or fluorescence in situ hybridization-positive) invasive breast cancer; 5. Completion of ≥4 cycles of neoadjuvant therapy with trastuzumab and pertuzumab, without recurrence or metastatic disease prior to adjuvant treatment; residual cancer burden class 0 or I after neoadjuvant therapy; time from initial surgery to randomization ≤12 weeks; 6. Adequate organ function within 2 weeks prior to screening (without transfusion or use of growth factors): * Absolute neutrophil count ≥1.5 × 10⁹/L; * Platelet count ≥90 × 10⁹/L; * Hemoglobin ≥90 g/L; * Total bilirubin ≤1.5 × upper limit of normal (ULN); * Alanine aminotransferase and aspartate aminotransferase ≤1.5 × ULN; 7. Post-neoadjuvant therapy echocardiography showing left ventricular ejection fraction (LVEF) ≥50% during screening, with an absolute decrease of ≤15% compared to pre-chemotherapy values; if no pre-chemotherapy LVEF assessment is available, LVEF must be ≥55% during screening; 8. Life expectancy ≥6 months; 9. For premenopausal or non-sterilized female patients: agreement to abstain from sexual activity or use effective non-hormonal contraception during study treatment and for 8 weeks after the last dose; 10. Willingness to participate voluntarily, provide signed informed consent, demonstrate good compliance, and cooperate with follow-up. Exclusion Criteria: 1. History of local or regional breast cancer recurrence; 2. Clinical stage IV (metastatic) breast cancer; 3. Bilateral breast cancer; 4. History of other malignant tumors within the past 5 years, except for curatively treated cervical carcinoma in situ, basal cell carcinoma, or cutaneous squamous cell carcinoma; 5. Prior treatment with pyrotinib, lapatinib, neratinib, or other tyrosine kinase inhibitors; trastuzumab emtansine; or any antitumor biological or immunotherapy; 6. Concurrent participation in another clinical trial involving antitumor therapy, including endocrine therapy, bisphosphonate therapy, or immunotherapy; 7. Significant cardiac disease, including: * Heart failure or systolic dysfunction (LVEF \< 50%); * Poorly controlled arrhythmias (e.g., atrial tachycardia, significant ventricular arrhythmia, or high-grade atrioventricular block); * Angina requiring antianginal medication; * Clinically significant valvular heart disease; * Electrocardiographic evidence of transmural myocardial infarction; * Poorly controlled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg) despite medication; 8. Impaired drug absorption due to dysphagia, intestinal obstruction, or other gastrointestinal disorders; 9. History of neurological or psychiatric conditions that may compromise compliance or informed consent; 10. Chronic gastrointestinal disorders with predominant diarrhea; 11. Known hypersensitivity to any study drug components; history of immunodeficiency (e.g., HIV positivity, congenital or acquired immunodeficiency disorder), or prior organ transplantation; 12. Pregnancy, lactation, or positive pregnancy test at baseline in women of childbearing potential; 13. Severe comorbidities that may interfere with treatment, including active infections (e.g., hepatitis B, hepatitis C, tuberculosis, syphilis) or any other condition deemed by the investigator to render the patient unsuitable for trial participation.
Prevalence of Mental Health Issues in Endurance Athletes.
NCT05768841
Recruiting
Conditions Depression, Anxiety, Mental Health Issue
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

Interventions / Regimen

  • mental health issues

Primary Outcomes

  • Number of participants with mental health issues
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: 2023-03-15
Completion: 2025-09-30
Eligibility
Age: 16 Years
Sex: ALL
Volunteers: true
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Ultra Sports Science Foundation
Collaborators: Hospital Universitario del Vinalopo, Universidade do Porto, University of South Africa
Principal Investigators:
  • Volker Scheer, Prof (PRINCIPAL_INVESTIGATOR) - Ultra Sports Science Foundation
Contact Information
Study Contact:
Volker Scheer, Prof
+33 4 25 36 79 54
contact@ultrasportsscience.org
Interventions
  • mental health issues
Study Locations (1 sites)
Ultra Sports Science Foundation, Pierre-Bénite, 69310 France
Eligibility Criteria
Inclusion Criteria: * endurance athletes (marathon runners, ultramarathon runners and triathletes) * over the age of 16 * all genders * recreational athletes (non- elite) * elite athletes (professional, international, college level) Exclusion Criteria: * athletes that that are not competing or have not competed in an official endurance race * athletes that are younger than 16 years of age.
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma
NCT05748600
Active, positions filled
Conditions Eosinophilic Asthma, Asthma; Eosinophili...
Phase PHASE3
Enrollment 600
Locations 335 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

  • Dexpramipexole Dihydrochloride
  • Placebo

Primary Outcomes

  • Change in pre-BD FEV₁ from baseline
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: 2023-01-30
Completion: 2025-12
Eligibility
Age: 12 Years
Sex: ALL
Volunteers: false
Enrollment: 600 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Areteia Therapeutics
Principal Investigators:
  • Mona Bafadhel, MD (PRINCIPAL_INVESTIGATOR) - Guy's and St Thomas' NHS Foundation Trust
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Dexpramipexole Dihydrochloride
  • Placebo
Study Locations (335 sites)
Research Site 40001-487, Chandler, Arizona 85224 United States
Research Site 40001-462, Peoria, Arizona 85381 United States
Research Site 40001-322, Surprise, Arizona 85378 United States
Research Site 40001-374, Bakersfield, California 93301 United States
Research Site 40001-227, Encinitas, California 92024 United States
Research Site 40001-349, Huntington Beach, California 92647 United States
Research Site 40001-485, Inglewood, California 06410 United States
Research Site 40001-440, La Palma, California 90623 United States
Research Site 40001-357, Lancaster, California 93534 United States
Research Site 40001-089, Los Angeles, California 90048 United States
Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent form and assent form, as appropriate. 2. Male or female ≥12 years of age at Screening Visit 1. Sites in Poland will only include participants aged ≥18 years. Asthma-related criteria 3. Documented physician diagnosis of asthma for ≥12 months prior to Screening Visit 1. 4. Participants requiring at a minimum daily low dose inhaled corticosteroids (ICS; ≥100 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per GINA 2021), plus one or more additional daily maintenance asthma controller medications, eg, long-acting β2 agonist (LABA), leukotriene antagonist, theophylline, long-acting muscarinic antagonists, cromolyn/nedocromil. Note: In Poland, this will instead include participants requiring a minimum daily medium dose ICS (≥500 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per GINA 2021). Use of daily ICS must be for at least 12 weeks prior to Screening Visit 1 and the doses of all controller medications must be stable for at least 4 weeks prior to Screening Visit 1. 5. Pre-BD FEV1 ≥40% and \<80% (\<90% for participants 12 to 17 years of age) of predicted at Screening Visit 2. 6. Bronchodilator reversibility, at Screening Visit 2, as evidenced by ≥12% and ≥200 mL improvement in FEV1, 15 to 30 minutes following inhalation of 400 μg (four puffs) of albuterol/salbutamol (≥12% and ≥160 mL for ages 12 to 17).Participants who do not meet the bronchodilator reversibility inclusion criterion but have ≥10% and ≥160 mL reversibility, may repeat the reversibility spirometry assessment once during the Screening Period, at an unscheduled visit at least 7 days prior to baseline. 7. ACQ-6 ≥1.5 at Screening Visit 2. 8. Eosinophil count of ≥0.30x10⁹/L at Screening Visit 1. If the initial value is between 0.250x10⁹/L to 0.299x10⁹/L, then this may be repeated once at an unscheduled visit (prior to Screening Visit 2). General medical history 9. Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Screening and Baseline visits. 10. WOCBP must use either of the following methods of birth control, from Screening Visit 1 through the End of Study Visit: 1. A highly effective form of birth control (confirmed by the investigator). Highly effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective intrauterine device (IUD), IUD/intrauterine system (IUS), Levonorgestrel Intrauterine system, or oral contraceptive. Or 2. Two protocol acceptable methods of contraception in tandem. * Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of the Baseline Visit without an alternative medical cause. The following age specific requirements apply: 3. Women \<50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone levels in the postmenopausal range. 4. Women ≥50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment. least 7 days prior to baseline. Exclusion Criteria: Asthma-related criteria 1. A participant who experiences a severe asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization prior to the Screening Visit 1 up to and including the Baseline Visit. Participants who experience an asthma exacerbation during the Screening/Run-in Period may remain in screening and proceed with study visits 14 days after they have completed their course of oral steroids or returned to their pre-Screening visit maintenance dose of oral steroids and the investigator considers participant has returned to baseline status. 2. Current diagnosis of diseases which may confound interpretation of this study's findings such as allergic bronchopulmonary aspergillosis, eosinophilic granulomatosis with polyangiitis, eosinophilic gastrointestinal diseases, or hypereosinophilic syndrome, or lung diseases (eg, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis). 3. Respiratory infection: Upper or lower respiratory tract, sinus, or middle ear infection within the 4 weeks before Screening Visit 1. Prohibited medications/procedures 4. Treatment with a biologic investigational drug in the last 5 months prior to Screening Visit 1. Treatment with non-biologic investigational drugs in the previous 30 days or five-half-lives prior to Screening Visit 1, whichever is longer. Treatment with GSK3511294 (long acting anti-interleukin-5) in the past 12 months. 5. Treatment with any of the following monoclonal antibody therapies within 120 days prior to Baseline: benralizumab, dupilumab, mepolizumab, reslizumab, omalizumab, tezepelumab, or tralokinumab. 6. Treatment with pramipexole (Mirapex®) within 30 days of Baseline. 7. Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days prior to Screening Visit 1. 8. Bronchial thermoplasty procedure in the past 12 months prior to Screening Visit 1 or planned during the study period. General medical history 9. Weight \<40 kg at Screening Visit 2. 10. Current smoking within 12 months prior to Screening Visit 1 or a smoking history of \>10 packyears. Smoking includes tobacco, vaping, and/or marijuana use. 11. Known or suspected alcohol or drug abuse. 12. Uncontrolled severe hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to the Baseline Visit despite antihypertensive therapy. 13. History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the 5 years prior to the Baseline Visit. 14. History of human immunodeficiency virus (HIV) infection or chronic infection with hepatitis B or C. 15. A helminth parasitic infection diagnosed within 24 weeks prior to Screening Visit 1, that has not been treated with or has failed to respond to standard of care therapy. 16. Medical or other condition likely to interfere with participant's ability to undergo study procedures, adhere to visit schedule, or comply with study requirements. 17. Known or suspected noncompliance with medication. 18. Unwillingness or inability to follow the procedures outlined in the protocol. Clinical safety labs 19. Absolute neutrophil count \<2.000x10⁹/L at Screening Visit 1 or Screening Visit 2.. 20. Renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2 at Screening Visit 2 (using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula \[Levey et al, 2009\] for age ≥18 years at screening; using the Bedside Schwartz \[Schwartz and Work, 2009\] eGFR formula for age \<18). 21. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), \>3x the upper limit of normal (ULN), or total bilirubin \>2x ULN at Screening Visit 2 confirmed by a repeat abnormal measurement of the relevant value(s), at least 1 week apart. Cardiac safety 22. History of New York Heart Association class IV heart failure or last known left ventricular ejection fraction \<25%. 23. History of major adverse cardiovascular event (MACE) within 3 months prior to the Baseline Visit. 24. History of cardiac arrhythmia within 3 months prior to the Baseline Visit that is not controlled by medication or via ablation. 25. History of long QT syndrome. 26. Correc
Influence of Nutrition in Depression Treatment (INDEPT)
NCT05745194
Recruiting
Conditions Major Depressive Disorder - MDD
Phase NA
Enrollment 190
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Promotion of adherence to the MedDiet

Primary Outcomes

  • Changes in symptoms of MDD
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-06-05
Completion: 2025-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 190 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA
Collaborators: University of Lisbon, Instituto Politécnico de Leiria, Fundação para a Ciência e a Tecnologia
Principal Investigators:
  • Maria João Heitor, PhD (PRINCIPAL_INVESTIGATOR) - Instituto de Saúde Ambiental, Faculdade de Medicina da Universidade de Lisboa, Portugal
Contact Information
Study Contact:
Nuno Sousa-Santos, BSc
00351913295919
nunoneto@edu.lisboa.pt
Cátia Clara, BSc
00351965053469
study.indept@gmail.com
Interventions
  • Promotion of adherence to the MedDiet
Study Locations (2 sites)
Hospital de Beatriz Ângelo - Hospital de Loures, EPE, Loures, Lisbon District 2674-514 Portugal
Centro Hospitalar de Leiria - Hospital Santo André, Leiria, 2410-197 Portugal
Eligibility Criteria
Inclusion Criteria: 1. Aged between 18-70 years old 2. Able to understand and provide informed consent 3. Able to read and write 4. Have a diagnosis of MDD (according to ICD-10 F32.0; F32.1; F32.2; F32.9; F33.0; F33.1; F33.2; F33.9 criteria) 5. Score on the Beck Depression Inventory-II scale (BDI-II) \> 13; 6. Elevated biomarkers of inflammation (CRP \> 3mg/l or IL-6 ≥ 2pg/ml ) 7. Able to follow a MedDiet without impeditive physical or religious limitations, allergies or intolerances 8. Being under pharmacological treatment for depressive disorder Exclusion Criteria: 1. Diagnosis of autoimmune diseases, thyroid dysfunction or cancer 2. Diagnosis of bipolar disorder, psychotic disorders, eating disorders 3. Self-reported acute infection 2 weeks prior to the blood sample collection 4. Pregnancy or lactation 5. Glucocorticoid medication 6. Prescribed with NMDA Receptor Antagonists 7. Under treatment with brain stimulation techniques for the depressive episode 8. Currently participating in another intervention targeting diet, physical exercise, or MDD treatment
SBAT for Health Equity
NCT05744869
Not yet recruiting
Conditions Asthma in Children
Phase NA
Enrollment 300
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • SBAT Implementation
  • Usual Care

Primary Outcomes

  • Percentage of children on DOT
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-08-01
Completion: 2030-12-31
Eligibility
Age: 4 Years
Sex: ALL
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Rochester
Collaborators: Michigan State University, Virginia Polytechnic Institute and State University, University at Buffalo
Contact Information
Study Contact:
Jill S Halterman, MD, MPH
5852755798
Jill_halterman@urmc.rochester.edu
Maria Fagnano, MPH, MS
5852758220
maria_fagnano@urmc.rochester.edu
Interventions
  • SBAT Implementation
  • Usual Care
Eligibility Criteria
Inclusion Criteria: * Physician-diagnosed asthma, with persistent symptoms or poor control based on NHLBI criteria * Age \>4 and \<12 years * Attending school in Rochester City School District * Caregiver \>18 years, and is able to understand and speak English or Spanish Exclusion Criteria: * Caregiver inability to speak and understand English or Spanish. (\*Participants unable to read will be eligible, and all instruments will be given verbally.) * Having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures. * In foster care or other situations in which consent cannot be obtained from a guardian. Based on our prior studies, fewer than 10% of subjects are expected to be excluded based on these criteria.