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Showing 20 of 27881 trials
The Establishment of Hong Kong Diabetes Steatotic Liver Disease Register
NCT07437157
Recruiting
Conditions Metabolic Dysfunction-Associated Steatot...
Phase Not Applicable
Enrollment 1000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • No intervention (observational study)

Primary Outcomes

  • All-cause mortality
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Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-06-11
Completion: 2027-02-28
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 1000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Chinese University of Hong Kong
Contact Information
Study Contact:
Alice Pik Shan Kong, MD
+852 3505 2648
alicekong@cuhk.edu.hk
Interventions
  • No intervention (observational study)
Study Locations (1 sites)
Department of Medicine and Therapeutics, The Chinese University of Hong Kong (CUHK), Ward 3M, Diabetes and Endocrine Research Centre, 3/F Day Treatment Block and Children Wards (Old Block), Prince of Wales Hospital, Hong Kong, New Territories 99977 Hong Kong
Eligibility Criteria
Inclusion Criteria: * T2DM. * Aged ≥ 18 years. * Able and willing to give Informed written consent. Exclusion Criteria: * Type 1 diabetes. * Terminal illness such as malignancy with limited life expectancy. * Any condition, as judged by the investigators, as ineligible to participate in this study.
Integrating Systematic Data of Medicine to Explore the Solution for Healthy Aging (ISDHA) Phase 4
NCT07414680
Not yet recruiting
Conditions Sleep Disturbance, Cognitive Change, Agi...
Phase Not Applicable
Enrollment 250
Locations 2 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • The brain volume of local Taiwanese aged over 40 years old
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Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2026-03-01
Completion: 2028-12-31
Eligibility
Age: 40 Years
Sex: ALL
Volunteers: true
Enrollment: 250 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Chang Gung Memorial Hospital
Collaborators: Chang Gung University
Contact Information
Study Contact:
JI-TSENG FANG, Professor
+886-3-3281200
fangjits@cgmh.org.tw
Interventions
N/A
Study Locations (2 sites)
Taipei Chang Gung Memorial Hospital, Taipei, 105 Taiwan
Taoyuan Chang Gung Memorial Hospital, Taoyuan, 333 Taiwan
Eligibility Criteria
Inclusion Criteria: * Willing to sign a written participant consent form. * Males or females aged 40 or above who have participated in the "Integrated Systematic Geriatric Medical Information to Explore Solutions for Healthy Aging (Pilot Project)," the "Integrated Systematic Geriatric Medical Information to Explore Solutions for Healthy Aging" master planner, or the "Integrated Systematic Medical Information to Explore Solutions for Healthy Aging" project (not subject to exclusion criteria). * Males or females aged 40-59 who have participated in health checkups for employees of Chang Gung Memorial Hospital, Formosa Plastics Group, or Chang Gung University. * Those with a medical record of more than one year at Chang Gung Memorial Hospital. * Those who have resided in Taiwan for more than 180 days in the past year. Exclusion Criteria: * Individuals with severe organ abnormalities, such as: heart failure (NYHA Fc ≥ III), chronic obstructive pulmonary disease (hospitalization/emergency room visit or medication adjustment within the past month due to disease worsening), decompensated cirrhosis, hemodialysis, or currently undergoing cancer treatment. * Individuals with a history of severe autoimmune diseases. * Individuals with a preliminary cognitive and mental assessment score of \<26 on the Mini-Mental State Examination (MMSE) or ≥5 on the Generalized Depression Scale (GDS). * Individuals (who agree to undergo brain MRI) who are deemed unsuitable for MRI after evaluation (e.g., those with pacemakers, cochlear implants, or spatial phobia). * Individuals who have taken antibiotics within the past month. * Individuals whose hearing, vision, or cognitive impairments affect communication. * Individuals unable to stand or walk (with a walking aid) or with unsteady gait when walking. * Those who have undergone follow-up outpatient assessments that may affect cognitive function, including but not limited to stroke, Parkinson's syndrome, Parkinson's dementia, epilepsy, brain tumor, or a history of mental illness such as schizophrenia, severe depression, bipolar disorder, alcohol or drug abuse, or a history of loss of consciousness due to severe head trauma. * Those currently diagnosed with depression and undergoing treatment. * Those with a past medical history confirming dementia, depression, etc.. * Those deemed unsuitable by a physician.
Phase I Study of SYS6043 in Patients With Advanced/Metastatic Solid Tumors
NCT07424547
Recruiting
Conditions Cancer, Solid Tumor Cancer, Advanced Met...
Phase PHASE1
Enrollment 386
Locations 5 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

  • SYS6043

Primary Outcomes

  • Assessment of the MTD and/or RP2D (recommended Phase II dose) (Phase 1a).
  • Incidence of Treatment-Emergent Adverse Events and dose-limiting toxicities (DLTs) [Safety and Tolerability] of SYS6043 during the study (Phase 1a)
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Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2026-03-03
Completion: 2030-04
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 386 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Conjupro Biotherapeutics, Inc.
Contact Information
Study Contact:
Director, Clinical Operations
609-356-0210
clinicaltrials.gov@cspcus.com
Regulatory Operations Manager
609-356-0210
clinicaltrials.gov@cspcus.com
Interventions
  • SYS6043
Study Locations (5 sites)
BRCR Global, Plantation, Florida 33322 United States
Florida Clinical Trials Group, Plantation, Florida 33322 United States
NEXT Oncology Austin, Austin, Texas 78758 United States
NEXT Oncology San Antonio, San Antonio, Texas 78229 United States
NEXT Oncology Virginia, Fairfax, Virginia 22031 United States
Eligibility Criteria
Inclusion Criteria: Major: * Aged ≥18 years old (on the date of signing the ICF). * Advanced/unresectable or metastatic solid tumors confirmed by histology or cytology, disease recurrence or progression during or after systemic standard of care, and should be intolerant of or have no available standard of care therapy. * Have at least one measurable lesion, according to the Response Evaluation Criteria in Solid Tumors (RECIST V1.1). Participants with metastatic castration-resistant prostate cancer (mCRPC) who have only metastases to bone will be evaluated through discussion with the sponsor's medical monitor, before determining whether they can be enrolled. * Expected life expectancy of ≥ 3 months. * ECOG performance status of 0-1 and no worsening of the score within 28 days prior to enrollment. * LVEF ≥ 50% as shown by ECHO or MUGA within 28 days prior to enrollment. Exclusion Criteria: Major: * Prior B7-H3 targeted therapy. * Previously received drug therapy with topoisomerase inhibitor antibody-drug conjugate (e.g., trastuzumab deruxtecan). * Symptomatic congestive heart failure (CHF) (New York Heart Association \[NYHA\] Class II-IV) or a history of severe arrhythmia requiring treatment. * History of myocardial infarction or unstable angina within 6 months prior to enrollment. * Based on the results of three 12-lead electrocardiogram (ECG) examinations, the mean QT interval (QTcF) corrected by the Fridericia formula for both males and females is prolonged to \>470 ms. * Unable or unwilling to discontinue concomitant medications known to prolong the QT interval. * History of interstitial lung disease (e.g., ILD/non-infectious pneumonia requiring glucocorticoid treatment in the past), or currently have interstitial lung disease, or are suspected to have such diseases through imaging examinations during screening. * History of underlying lung disorders, including but not limited to pulmonary embolism within 3 months prior to the start of study treatment, severe asthma, severe COPD, restrictive pulmonary disease, and other clinically significant lung injuries or requiring supplemental oxygen. * Any autoimmune diseases, connective tissue disorders, or inflammatory diseases involving the lungs recorded or suspected during screening (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.). * Presence of uncontrolled infection requiring intravenous injection of antibiotics, antiviral drugs, or antifungal drugs. * Active and clinically significant bacterial, fungal, viral infection, or Hepatitis C infection at screening (HCV antibodies test positive and HCV-RNA levels higher than the lower limit of quantification or 1000 copies/mL (whichever is lower); HIV antibody positive or syphilis antibody positive (with confirmation).. * HBsAg positive and HBV-DNA above the lower limit of quantification or 1,000 copies/mL (500 IU/mL) (whichever is lower). Liver tumor: For participants with liver metastases and HBV infection, HBV DNA must be \<2000 IU/mL before the first dose. Participants who are HBsAg-positive and/or HBV DNA-positive should receive at least 2 weeks of anti-Hepatitis B virus treatment prior to the first dose and be willing to continue treatment during the study. * Lactating women (women who are willing to temporarily discontinue breastfeeding will also be excluded), or women confirmed to be pregnant by pregnancy test within 7 days prior to enrollment. * Presence of spinal cord compression or clinically active brain metastasis, and/or meningeal metastases, defined as untreated, symptomatic, or requiring corticosteroids or anticonvulsants.
De-escalation of Neoadjuvant Treatment (Paclitaxel + HP) in Early HER2+ Breast Cancer
NCT07421141
Active, positions filled
Conditions Breast Cancer, HER2-positive Breast Canc...
Phase PHASE2
Enrollment 186
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

  • Paclitaxel
  • trastuzumab
  • Pertuzumab
  • Docetaxel
  • carboplatin

Primary Outcomes

  • Pathological Complete Response (pCR) Rate
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2023-09-01
Completion: 2028-12-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 186 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: National Medical Research Radiological Centre of the Ministry of Health of Russia
Principal Investigators:
  • Larisa Bolotina, MD, PhD (PRINCIPAL_INVESTIGATOR) - P.A. Hertsen Moscow Oncology Research Institute
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Paclitaxel
  • trastuzumab
  • Pertuzumab
  • Docetaxel
  • carboplatin
Study Locations (1 sites)
P.A. Hertsen Moscow Oncology Research Institute, Moscow, 125284 Russia
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed invasive breast carcinoma. * HER2-positive status defined as IHC 3+ or FISH amplification (ratio \>= 2.0). * Clinical Stage IIA-IIB (cT1-T2 N0-N1, cT3 N0, M0). * Operable disease planned for surgical resection. * ECOG performance status 0-1. * Left Ventricular Ejection Fraction (LVEF) \>= 50% by Echocardiography. * Adequate bone marrow, hepatic, and renal function. * Signed informed consent form. Exclusion Criteria: * Metastatic disease (Stage IV). * Prior systemic therapy for breast cancer (chemotherapy, immunotherapy, or anti-HER2 therapy). * Serious cardiac history (congestive heart failure, unstable angina, myocardial infarction within 6 months). * Other synchronous or metachronous malignancies within 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix). * Pregnancy or breastfeeding. * Known hypersensitivity to study drugs.
A Study of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy
NCT07423117
Not yet recruiting
Conditions Metastatic Castration-resistant Prostate...
Phase PHASE1
Enrollment 102
Locations 0 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

  • ITC-6146RO

Primary Outcomes

  • Phase 1a (Dose Escalation) Incidence of Adverse Events (AEs)
  • Phase 1b (Dose Expansion) Incidence of AEs
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Not yet recruiting
Start Date: 2026-02-06
Completion: 2029-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 102 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: IntoCell, Inc
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • ITC-6146RO
Eligibility Criteria
Inclusion Criteria: 1. Adult males and females aged ≥ 19 years (Korea) or ≥ 18 years (United States) 2. Patients must be individuals who have voluntarily agreed to participate in the study after receiving a detailed explanation and fully understanding the nature of the clinical trial, and who have provided written informed consent. 3. Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease 4. Patients must have at least one evaluable or measurable lesion based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1). However, for patients with prostate cancer, eligibility will be determined based on Prostate Cancer Working Group 3 (PCWG3) 5. Patients who have received standard therapies and have no remaining clinically available approved treatment options. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 7. Estimated life expectancy of ≥ 3 months Exclusion Criteria: 1. Inability to comply with study and follow-up procedures 2. Patients with a prior history of anticancer therapy before the first dose 3. History of another active malignancy within the past 3 years 4. Patients with central nervous system metastases, leptomeningeal disease, or spinal cord compression. 5. Patients who are currently participating in a clinical trial or have participated in a clinical trial involving a medical device or investigational product within 28 days prior to the first administration of ITC-6146RO 6. Has prior treatment with duocarmycin-containing agents 7. Pregnancy, lactation, or breastfeeding 8. Known Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV) infection with active disease exception of the following conditions. 9. Tuberculosis with active disease 10. Active infection necessitating systemic therapy 11. Prior allogenic bone marrow transplantation or solid organ transplantation 12. History of autoimmune disease, treatment with systemic immunosuppressive medications 13. Patients with clinically significant pulmonary disease
Interest of Adaptated Physical Activity (APA) on the K Recovery Constant, Reflecting the Rate of Muscle Oxygenation Recovery in Menopausal Women Suffering From Depression
NCT07417709
Not yet recruiting
Conditions Depression - Major Depressive Disorder, ...
Phase NA
Enrollment 52
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

  • APA
  • CCATTP

Primary Outcomes

  • K recovery constant
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: 2026-02
Completion: 2028-11
Eligibility
Age: 40 Years
Sex: FEMALE
Volunteers: false
Enrollment: 52 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Centre Hospitalier Universitaire de Besancon
Principal Investigators:
  • Djamila BENNABI, MD PhD (PRINCIPAL_INVESTIGATOR) - CHU de Besançon
Contact Information
Study Contact:
Karine CHARRIERE, PhD
+33 3 81 21 89 99
kcharriere@chu-besancon.fr
Interventions
  • APA
  • CCATTP
Study Locations (1 sites)
CHU de Besançon, Besançon, France
Eligibility Criteria
Inclusion Criteria: * Menopaused women aged ≥ 40 years old, * Suffering from a major depressive episode according to international Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V) * Presenting a score ≥11 on the 16-item Quick Inventory of Depressive Symptomatology Clinician Rating (QIDS-C16) depression scale * With a stabilized teatment by antidepressors since at least 4 weeks Exclusion Criteria: * Medical contraindication for physical activity (cardio-vascular pathology, and/or previous cardiac disease) * Asthma or other unstabilized condition impairing the ability to perform physical exertion * Adipose tissue thickness measured on the forearm \> 12 mm causing muscle oxygenation measurement by NIRS to be non contributive
Ventilation and Perfusion in Asthmatics
NCT07426458
Recruiting
Conditions Asthma
Phase PHASE4
Enrollment 40
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

  • Albuterol Sulfate
  • Albuterol-Budesonide

Primary Outcomes

  • Change in Regional Ventilation
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2026-04-27
Completion: 2028-04
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Miami
Collaborators: Australian Lung Health Initiative Pty Ltd
Principal Investigators:
  • Trishul Siddharthan, MD (PRINCIPAL_INVESTIGATOR) - University of Miami
Contact Information
Study Contact:
Maria McCoy
305-243-2568
mcm456@med.miami.edu
Sonia Dipti Meena Velmurugan, MS
305-243-2568
sxm3597@med.miami.edu
Interventions
  • Albuterol Sulfate
  • Albuterol-Budesonide
Study Locations (1 sites)
University of Miami - Converge Miami, Miami, Florida 33136 United States
Eligibility Criteria
Inclusion Criteria: * Physician diagnosis of asthma * Baseline Forced Expiratory Volume in 1 Second (FEV1) \< 80% of predicted, with reversibility (10%) on post-bronchodilator spirometry * Adults, 18-75 years of age * Long-term inhaled controller medication consisting of or including an Inhaled corticosteroids (ICS) at a steady dose for at least 3 months before enrollment Exclusion Criteria: * Current cigarette smoking or a past history of \>10 pack-year smoking * Current nicotine vaping * Pregnant and breast-feeding women * Respiratory infection within 4 weeks of proposed study date * Forced Expiratory Volume in 1 Second (FEV1) \< 50% * Inhaled corticosteroids (ICS)/fast-acting beta agonist (FABA) intolerance * Use of beta-blockers * Use of systemic glucocorticosteroids or oral methyl-xanthines within 30 days of planned study visit.
MBM and taVNS for Low Back Pain and Depressive Symptoms
NCT07415941
Recruiting
Conditions Chronic Low Back Pain
Phase NA
Enrollment 66
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

  • MBM
  • VNSM

Primary Outcomes

  • Change in pain intensity and interference
  • Change in depressive symptoms
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-01-30
Completion: 2027-12-31
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: false
Enrollment: 66 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Florida State University
Contact Information
Study Contact:
Jie Chen
18506450657
jc22db@fsu.edu
Interventions
  • MBM
  • VNSM
Study Locations (1 sites)
Florida State University, Tallahassee, Florida 32306 United States
Eligibility Criteria
Inclusion Criteria: 1. aged 50 to 85 years old 2. intact cognition (examined by the Mini-Mental State Exam, ≥ 24) 3. experiencing moderate low back pain daily or almost every day at least the previous three months (≥3 out of 10 on numeric rating scale \[NRS\]) 4. experiencing elevated depressive symptoms with the patient health questionnaire (PHQ-9) total score ranging between 5 to 19 5. able to speak and read English 6. not intent to change medication regimens for pain throughout the trial. Exclusion Criteria: 1. serious underlying illness (e.g., malignant neoplasms), 2. other psychosis, 3. elevated suicide risk as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS) score \> 2, 4. function limitation precluded the meditation practice, 5. participated meditation program before, 6. any other conditions/contraindications that prohibit the application of taVNS including but not limited to any current or past history of cardiovascular disorders, recent ear trauma, and metal implants above the level of the neck, 7. no access to the internet.
A Study of STX-1150 in Participants With Elevated Low-Density Lipoprotein Cholesterol (LDL-C)
NCT07428473
Recruiting
Conditions Elevated LDL-C and High Cholesterol
Phase PHASE1
Enrollment 64
Locations 2 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

  • STX-1150

Primary Outcomes

  • Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
  • Incidence and Severity of Serious Adverse Events (SAEs)
  • Incidence and Severity of Adverse Events of Special Interest (AESI)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2026-06
Completion: 2028-12-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 64 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Monash University
Collaborators: Scribe Therapeutics Inc.
Principal Investigators:
  • Stephen Nicholls, MBBS, FRACP, PhD (STUDY_CHAIR) - VHI
Contact Information
Study Contact:
Domenic Sacca
+61 423245187
domenic.sacca@monash.edu
Raeda Mustafa
+61 477581540
raeda.mustafa@monash.edu
Interventions
  • STX-1150
Study Locations (2 sites)
Monash Health/ Victorian Heart Hospital (VHH), Clayton, Victoria 3168 Australia
New Zealand Clinical Research (NZCR), Christchurch, Christchurch 8011 New Zealand
Eligibility Criteria
Inclusion Criteria: * Elevated serum LDL-C with or without LDL-C lowering medication * Willing and able to give informed consent before initiation of any study-related procedures and willing to comply with all required study procedures Exclusion Criteria: * Patients with history of an ASCVD event \</= 6 months. * Any uncontrolled or serious disease, or any medical or surgical condition that may interfere with participation * Diagnosis of familial hypercholesterolemia * Active or history of liver disease * Previous treatment with PCSK9-inhibitor or other prior treatment within a specified timeframe * Clinically significant abnormal laboratory values
A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity
NCT07438444
Recruiting
Conditions Diabetes Mellitus, Type 2, Obesity, Over...
Phase PHASE4
Enrollment 344
Locations 21 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

  • Tirzepatide

Primary Outcomes

  • Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2026-02-27
Completion: 2027-10
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 344 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Eli Lilly and Company
Principal Investigators:
  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) (STUDY_DIRECTOR) - Eli Lilly and Company
Contact Information
Study Contact:
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
317-615-4559
LillyTrials@Lilly.com
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Interventions
  • Tirzepatide
Study Locations (21 sites)
B. J. Medical College & Civil Hospital, Ahmedabad, 380 016 India
V.S. General Hospital, Ahmedabad, 380006 India
Gujarat Endocrine Center, Ahmedabad, 380052 India
Jawahar Lal Nehru Medical College, Ajmer, 305001 India
Motilal Nehru Medical College Hospital, Allahābād, 211002 India
Lifecare Hospital and Research Centre, Bengaluru, 560092 India
AIIMS, Bhubaneshwar, Bhubaneswar, 751019 India
Sri Ramachandra MedicaL College & Research Institute, Chennai, 600116 India
Kovai Diabetes Speciality Center and Hospital, Coimbatore, 641009 India
Apollo Excelcare Hospital, Guwahati, 781033 India
Eligibility Criteria
Inclusion Criteria: Participants with Type 2 Diabetes: * Have had type 2 diabetes for at least one year * Insulin naive * Have HbA1c ≥7.5% and ≤10% at screening * Have body mass index (BMI) ≥23 kilograms per square meter (kg/m2) Participants with Obesity or Overweight without Type 2 Diabetes: * Have a BMI * Greater than or equal to 30 kg/m2 OR * Greater than or equal to 27 kg/m2 AND previously diagnosed with at least one of the following weight-related comorbidities: high blood pressure, lipid disorder, obstructive sleep apnea, heart disease Exclusion Criteria: Participants with Type 2 Diabetes: * Have type 1 diabetes * Have had any of the following heart conditions within 6 months prior to screening: * heart attack * stroke * hospitalization due to heart failure * Have New York Heart Association Functional Classification Class III or IV congestive heart failure (CHF) * Have type 2 diabetes along with morbid obesity and being considered for bariatric surgery or any other procedure intended for weight loss Participants with Obesity or Overweight without Type 2 Diabetes: * Have type 1 diabetes or type 2 diabetes * Have a self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) within 3 months prior to screening * Have a prior or planned surgical treatment for obesity * Have had any of the following heart conditions within 6 months prior to screening: * heart attack * stroke * hospitalization due to heart failure * Have New York Heart Association Functional Classification Class III or IV CHF * Have taken any medications or alternative remedies for weight loss within 3 months prior to screening
POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes.
NCT07433192
Recruiting
Conditions Type 2 Diabetes Mellitus
Phase Not Applicable
Enrollment 300
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

  • Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (glycated hemoglobin)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2026-03-02
Completion: 2027-09-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: Not specified
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Servier Russia
Principal Investigators:
  • Marina Shestakova (PRINCIPAL_INVESTIGATOR) - Endocrinology Research Centre
Contact Information
Study Contact:
Ekaterina Erina
+7 495 9370700
ekaterina.erina@servier.com
Interventions
N/A
Study Locations (1 sites)
GBUZ hospital, Anapa, Russia
Eligibility Criteria
Inclusion Criteria: * Men and women aged 18 years and older. * Patients with type 2 diabetes. * Written informed consent of the patient to participate in the study. * No conditions that require emergency medical aid. * Treatment with luseogliflozin started 7 to 30 days prior to the inclusion visit as part of routine clinical practice and in accordance with the SmPC approved in the Russian Federation. * Presence of data on the parameters of interest (HbA1c, eGFR, BP, body weight), dated no later than 15 days from the date the treatment with luseogliflozin was started Exclusion Criteria: * Patients cannot be included in this study if they meet at least one of the following exclusion criteria: * Known hypersensitivity to luseogliflozin or other components of Lusefi®. * Type 1 diabetes. * Decompensated type 2 diabetes. * Pregnancy, breastfeeding, or planned pregnancy during the study and at least two months after the study. * Severe renal failure (eGFR \<30 mL/min/1.73 m2), end-stage chronic kidney disease (CKD) or dialysis, as the treatment is predicted to be ineffective in this population of patients. * Diabetic ketoacidosis, diabetic coma or precoma. * Severe infections, pre- and postoperative period, or severe injury. * Any suspected or confirmed malignant neoplasm, including a history of malignancy within ≤5 years prior to screening, excluding successfully treated basal cell carcinoma and squamous cell carcinoma of the skin or in situ cervical cancer. * Urinary tract infection (confirmed or suspected). * Other concomitant disorders considered by the investigator to affect the natural progression of the disease and significantly impact the treatment results. * Predictable unwillingness of the patient to adhere to the treatment regimen and/or cooperate with the investigator. * Participation of the patient in another clinical study within 3 months (6 months for biological medicinal products) prior to the inclusion visit or during this study.
Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer
NCT07408089
Recruiting
Conditions Breast Cancer, Metastatic Breast Cancer,...
Phase PHASE1
Enrollment 96
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

  • BBI-940
  • Fulvestrant

Primary Outcomes

  • Rate of dose limiting toxicities (DLTs) in each BBI-940 monotherapy dose escalation cohort.
  • Incidence of treatment emergent adverse events (TEAEs) in each dose group and overall as assessed by CTCAE version 5.0.
  • Incidence of study treatment discontinuation and/or interruption by dose group and overall.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2026-02-25
Completion: 2029-05-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 96 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Boundless Bio, Inc.
Principal Investigators:
  • Robert C. Doebele, MD, PhD (STUDY_DIRECTOR) - Boundless Bio, Inc.
Contact Information
Study Contact:
Angela Pietrofeso
1-619-821-1090
clinicaltrials@boundlessbio.com
Rebecca Reynolds
1-619-821-1090
clinicaltrials@boundlessbio.com
Interventions
  • BBI-940
  • Fulvestrant
Study Locations (8 sites)
The START Center for Cancer Research, Los Angeles, California 90025 United States
The START Center for Cancer Research, Lake Success, New York 11042 United States
NEXT Oncology, Austin, Texas 78758 United States
University of Texas Southwestern Medical Center, Dallas, Texas 75390 United States
NEXT Oncology, Houston, Texas 77054 United States
NEXT Oncology, San Antonio, Texas 78229 United States
The START Center for Cancer Care, San Antonio, Texas 78229 United States
NEXT Oncology, Fairfax, Virginia 22031 United States
Eligibility Criteria
Key Inclusion Criteria * Adults with locally advanced or metastatic breast cancer, including estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) disease or triple-negative breast cancer with luminal androgen receptor subtype (TNBC-LAR; androgen receptor expression ≥10% by immunohistochemistry), as applicable by study part. * Prior treatment with standard therapies known to provide clinical benefit, appropriate for disease subtype and study part, including endocrine therapy with CDK4/6 inhibition for ER+/HER2- disease. * Measurable disease per RECIST v1.1, except for participants enrolled in Part 1A. * Molecular eligibility as applicable by study part, including absence of an ESR1 mutation (Part 2A) or presence of FGFR1 amplification (Part 2B), based on prior local testing. * Availability of archival or newly obtained formalin-fixed, paraffin-embedded (FFPE) tumor tissue suitable for protocol-specified biomarker analyses. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate hematologic, hepatic, renal, and coagulation function per protocol-defined laboratory criteria. * Estimated life expectancy of at least 12 weeks. * Ability to swallow oral medication and provide written informed consent. Key Exclusion Criteria * Prior exposure to an inhibitor or degrader of Kinesin. * Known hypersensitivity to study intervention(s) or excipients. * Receipt of recent anticancer therapy within protocol-defined washout periods. * Other active malignancy likely to interfere with study assessment. * Baseline QTcF \>470 msec or congenital long QT syndrome. * Clinically significant pulmonary embolism within 6 weeks prior to first dose. * Major surgery within 4 weeks or minor surgery within 2 weeks prior to first dose. * Active infection requiring systemic therapy within 2 weeks prior to first dose. * Pregnant or breastfeeding, or planning conception or gamete donation during the study or required post-treatment period. * Prior solid organ transplant or allogeneic stem cell transplant with protocol-defined exceptions. * Failure to recover to CTCAE Grade ≤1 (or baseline) from prior anticancer therapy, with protocol-specified exceptions. * Any serious or uncontrolled medical, laboratory, or psychiatric condition that could compromise safety or study integrity. * Other exclusion criteria as specified in the study protocol.
Ultrasonographical Assessment of Airway Indices in Pregnancy
NCT07423741
Recruiting
Conditions Airway Assessment
Phase Not Applicable
Enrollment 180
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Sperficial ultrasonographic airway assessemt
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: 2024-12-15
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 180 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: South Valley University
Contact Information
Study Contact:
Zeinab M Sayed, MD
01009071365
zeinab5aton@gmail.com
Interventions
N/A
Study Locations (1 sites)
Qena University, Qina, Qena Governorate 83511 Egypt
Eligibility Criteria
Inclusion Criteria: * -normotensive pregnant * pre-eclamptic patients. * nonpregnant females in child bearing period . Exclusion Criteria: * Patients excluded were women at \<32 weeks' gestation or with Eclampsia . * height \<150 cm, body mass index (BMI) \>30 kg/m2 . * predicted airwy difficulty due to any other cause as neck swelling , facial deformity and prominent teeth.
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
NCT07405606
Not yet recruiting
Conditions Major Depressive Disorder (MDD), Alcohol...
Phase PHASE2
Enrollment 30
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

  • Psilocybin 25 mg
  • Placebo

Primary Outcomes

  • Adherence
  • Montgomery-Asberg Depression Rating Scale (MADRS)
  • Hamilton Depression Rating Scale (HAMD-17)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Not yet recruiting
Start Date: 2026-03
Completion: 2028-06
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Centre for Addiction and Mental Health
Contact Information
Study Contact:
Bernard Le Foll
+14165358501
bernard.lefoll@camh.ca
Esther Kim
+14165358501
esther.kim@camh.ca
Interventions
  • Psilocybin 25 mg
  • Placebo
Study Locations (1 sites)
Centre for Addiction and Mental Health, Toronto, Ontario Canada
Eligibility Criteria
Inclusion Criteria: * Be between the ages of 18-65 * Must be deemed to have capacity to provide informed consent; * Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent; * Stated willingness to comply with all study procedures; * Be deemed in health compatible with the study procedures according to study physician; * Ability to take oral medication and be willing to adhere to the PAT regimen; * Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation; * Fulfil Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5) criteria for a primary diagnosis of current single or recurrent episodes of MDD of at least moderate severity but without psychotic features and a comorbid AUD diagnosis (moderate or severe) using the SCID-5; * A score of at least 14 on the Hamilton Depression Rating Scale for Depression (HAMD); * Participants should not be interested in initiating standard pharmacotherapies for MDD or AUD. The need to start/resume standard pharmacotherapies will be reassessed at Week 6. * Individuals who are willing to and tapered off current antidepressant or IMAOs, antipsychotic and anti-alcohol/anti-craving medications for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and for the duration of the study and whose physician confirms that it is safe for them to do so; * Individuals who are willing to and have tapered off current inhibitors of 5'-diphospho-glucuronosyltransferase (UGT)1A9 and 1A10, aldehyde dehydrogenase inhibitors (ALDHs) and alcohol dehydrogenase inhibitors (ADHs) for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and for the duration of the study and whose physician confirms that it is safe for them to do so; * Agreement to adhere to Lifestyle Considerations (section 4.5) throughout study duration. Exclusion Criteria: * Pregnant as assessed by a urine pregnancy test at Screening (V1) and Baseline (V2) or individual's that intend to become pregnant during the study or are breastfeeding; * Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history, uncontrolled hypertension (over 160/100 mmHG), low or labile blood pressure, recent myocardial infarction, cardiac arrhythmic, severe coronary artery disease, or moderate to severe renal or hepatic impairment. * Diagnosis of cirrhosis, AST or ALT elevations \> 3x upper limit of normal; significant abnormal liver function that would preclude administration of psilocybin based on the judgement of the QI (assessed notably by bilirubin, albumin, alkaline phosphatase, GGT, and INR functions) * Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder; obsessive-compulsive disorder, psychotic disorder (unless substance induced or due to a medical condition), bipolar I or II disorder, paranoid personality disorder, borderline personality disorder, or neurocognitive disorder as determined by medical history and the SCID-5 clinical interview; * Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I or II disorder as determined by the family medical history form and discussions with the participant; * Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) score \> 9, or any other indication that the participant may experience medically complicated withdrawal from alcohol, such as a score of ≥4 in the Prediction of Alcohol Withdrawal Severity Scale. * Use benzodiazepines (with the exception of use of up to 2mg of lorazepam equivalent per day for insomnia and anxiety if it is not taken within 12 hours before the psilocybin dose (Week 2). * Have a DSM-5 diagnosis of substance use disorder (excluding alcohol, cannabis, tobacco and caffeine) within the preceding 6 months; * Presence of baseline prolonged QTc (more than 0.45 seconds for males and 0.47 seconds for females) or Torsade de Pointes as measured by the ECG or a history of long QTc syndrome or related risk factors; * Use of aldehyde dehydrogenase (ALDH) inhibitors and UDG modulators; * Use of hallucinogens in the past 5 years; or total hallucinogen use ≥10 times) * Current suicidality risk as indicated during the conduct of the Columbia Suicide Severity Rating Scale (C-SSRS) with concurrence after a study physician's evaluation if the response to C-SSRS questions 1 or 2 is "yes") * Any other clinically significant physical illness including chronic infectious diseases or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in the study. * Participants that are responding to anti-alcohol or anti-craving medications
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015-3 and BR1015-2 Under Fed Conditions
NCT07421414
Not yet recruiting
Conditions Essential Hypertension
Phase PHASE1
Enrollment 48
Locations 0 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

  • BR1015-A
  • BR1015-3
  • BR1015-2

Primary Outcomes

  • AUCt of Fimasartan
  • AUCt of Indapamide
  • Cmax of Fimasartan
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Not yet recruiting
Start Date: 2026-04-19
Completion: 2026-06-17
Eligibility
Age: 19 Years
Sex: ALL
Volunteers: true
Enrollment: 48 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Boryung Pharmaceutical Co., Ltd
Contact Information
Study Contact:
Soo Hee Kim
02-708-8000
shkim0127@boryung.co.kr
Interventions
  • BR1015-A
  • BR1015-3
  • BR1015-2
Eligibility Criteria
Inclusion Criteria: * Subjects with a body mass index (BMI) of more than 18.0 kg/m² and less than 30.0 kg/m² at the screening visit. * Subjects who provide written informed consent voluntarily after receiving and understanding sufficient explanation regarding the purpose and procedures of the clinical trial, the characteristics of the investigational product, and the expected adverse events. * Subjects who agree to use a highly effective method of contraception, excluding hormonal contraceptives, from the time of signing the written informed consent form until 14 days after the last administration of the investigational product, and who agree not to donate sperm or ova during this period. This requirement applies to the subject and, as applicable, to their spouse or sexual partner in order to prevent pregnancy. Exclusion Criteria: * Subjects who have taken drugs that induce or inhibit metabolizing enzymes, such as barbiturates, within 30 days prior to the first administration of the investigational product, or who have taken any prescription drugs, over-the-counter drugs (OTC), herbal medicines, or dietary supplements within 10 days prior to the first administration that may interfere with the conduct of the study (however, participation may be allowed considering the pharmacokinetics and pharmacodynamics, including potential interactions with the investigational product and the half-life of concomitant drugs). * Subjects with a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs (except for simple appendectomy or hernia surgery). * Subjects who have participated in other clinical trials (including bioequivalence studies) and received investigational products within 6 months prior to the first administration of this study. For this criterion, the 6-month period is counted from the last administration date of the investigational product in the previous study. * Subjects who are unable to discontinue consumption of foods that may affect the absorption, distribution, metabolism, or excretion of the investigational product (e.g., raw grapefruit, grapefruit juice, or foods containing grapefruit) from 48 hours prior to the first administration of the investigational product until the collection of the last pharmacokinetic blood sample. * Subjects who, for reasons other than those specified in the inclusion and exclusion criteria above, are judged by the principal investigator (or a sub-investigator delegated by the principal investigator) to be unsuitable for participation in the clinical trial. * Female subjects who are pregnant, suspected of being pregnant, or currently lactating.
ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar
NCT07425639
Recruiting
Conditions Chronic Spontaneous Urticaria (CSU), All...
Phase Not Applicable
Enrollment 225
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Omalizumab

Primary Outcomes

  • Maintenance of disease control and/or remission 12 months after initiation of biosimilar treatment.
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: 2025-10-02
Completion: 2028-09
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 225 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Celltrion HealthCare France
Contact Information
Study Contact:
Salim BENKHALIFA, MD
+33 1 71 25 27 00
rollyn-oma@sanoia.com
Interventions
  • Omalizumab
Study Locations (1 sites)
CHU Montpellier, Montpellier, France
Eligibility Criteria
Inclusion Criteria: * Be an adult (aged 18 years or older at the time of inclusion) receiving specialist care and diagnosed with one of the following conditions: Severe asthma, Chronic Spontaneous Urticaria * Have been treated for at least 6 months prior to inclusion with the reference omalizumab for the relevant condition (Severe asthma or Chronic Spontaneous Urticaria). * Have been stable for at least 3 months according to the prescribing physician, with the disease controlled or in clinical remission based on the disease-specific activity score: Severe asthma: ≤ 1 course of oral corticosteroids per year related to disease worsening, without hospitalization, and ACQ \< 1.5 and FEV1 ≥ 80% of the patient's most recent values/ Chronic Spontaneous Urticaria : UCT ≥ 12 * For whom the specialist physician has decided to switch to OMLYCLO® (biosimilar developed and marketed by Celltrion) on the day of patient inclusion (shared medical decision independent of the study). * Be able to start treatment within a maximum of 60 days following inclusion. * Have an email address. * Have a mobile phone number. * Be able to understand and complete questionnaires in French. * Not object to participating in the study. * Be affiliated with a French Social Security scheme or be a beneficiary of such a scheme Exclusion Criteria: * Patients under guardianship or trusteeship, or otherwise deprived of liberty. * Pregnant women or women of childbearing potential with a desire to become pregnant during treatment with OMLYCLO®. * Patients who, at the time of inclusion, are participating in a clinical trial or another clinical study that prohibits simultaneous participation in other studies. * Contraindication to the study products.
Immune Tumor Stroma Factors and Pathologic Complete Response After Neoadjuvant Chemotherapy in Early Breast Cancer
NCT07407244
Active, positions filled
Conditions Breast Cancer
Phase NA
Enrollment 268
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

  • Neoadjuvant Chemotherapy

Primary Outcomes

  • Pathological Complete Response (pCR)
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: 2017-03-01
Completion: 2026-02-28
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 268 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Institute of Oncology Ljubljana
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Neoadjuvant Chemotherapy
Study Locations (1 sites)
Institute of Oncology Ljubljana, Ljubljana, 1000 Slovenia
Eligibility Criteria
Inclusion Criteria: * Female patients with early breast cancer * Planned neoadjuvant chemotherapy (NACT) * Availability of tumor tissue sample (biopsy) before treatment * Ability to provide blood sample(s) * Signed informed consent Exclusion Criteria: * Male breast cancer * Patients without neoadjuvant chemotherapy * Inability or refusal to provide informed consent * Insufficient biological material for analysis
ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer
NCT07423611
Not yet recruiting
Conditions Breast Cancer
Phase PHASE2
Enrollment 388
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

  • Aromatase inhibitor (± ovarian suppression) plus Ribociclib
  • 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy

Primary Outcomes

  • ctDNA negativity rate
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Not yet recruiting
Start Date: 2026-10-01
Completion: 2030-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 388 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fudan University
Contact Information
Study Contact:
Keda Yu, MD, PhD
86-21-64175590-88808
yukeda@fudan.edu.cn
Wenjia Zuo, MD
+86-18017312648
wenjiaz07@126.com
Interventions
  • Aromatase inhibitor (± ovarian suppression) plus Ribociclib
  • 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy
Study Locations (1 sites)
Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality 200032 China
Eligibility Criteria
Inclusion Criteria: 1. Signed and dated Patient Informed Consent Form (PICF) obtained prior to any trial-specific screening procedure 2. Patient is female with known menopausal status at the time of randomization 3. Patient is ≥ 18 and ≤70 years-old at the time of PICF signature. 4. Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis 5. Patient has breast cancer that is positive for ER and/or PgR as determined on the most recently analyzed tissue sample 6. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample). 7. Patient after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories: 1\) T0-2N1, 2) T3-4N0, 3) T2N0 meeting the following criteria: 1. histological Grade 3, 2. histological Grade 2 with Ki-67 proliferation index ≥20% or/and high genomic risk 8. Eligible to adjuvant chemotherapy per investigator's decision (Based on clinicopathological findings or genomic assay results) 9. ECOG Performance Status of 0 or 1 10. ctDNA-MRD negative within 4 weeks post-surgery 11. Adequate hematological, renal, and hepatic function Exclusion Criteria: 1. Prior neoadjuvant or adjuvant systemic treatment (including chemotherapy, targeted therapy, or endocrine therapy) for breast cancer 2. Bilateral breast cancer 3. Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery 4. Patient has other active malignancies within the past 2 years 5. Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial 6. Patient has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments 7. Patient has not recovered from clinical and laboratory acute toxicities related to prior anticancer therapies to a NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 5.0 Grade ≤ 1 at day of randomization 8. Participation in other studies involving investigational drug(s) within 30 days prior to randomization or within 5 half-lives of the investigational drug(s) (whichever is longer), or participation in any other type of medical research judged not to be scientifically or medically compatible with this trial
Investigating the Impact of GLP-1 RA Therapy on Osteosarcopenia in Older Female Adults With Diabetes
NCT07428746
Not yet recruiting
Conditions Diabetes Mellitus, Type 2
Phase PHASE3
Enrollment 20
Locations 1 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

  • Semaglutide

Primary Outcomes

  • Change in handgrip strength
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Not yet recruiting
Start Date: 2026-04
Completion: 2028-11
Eligibility
Age: 65 Years
Sex: FEMALE
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Emory University
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigators:
  • Thaer Idrees, MD, FSSCI (PRINCIPAL_INVESTIGATOR) - Emory University
Contact Information
Study Contact:
Thaer Idrees, MD, FSSCI
404-251-5357
thaer.idrees@emory.edu
Jaafer Zaino
jaafer.zaino@emory.edu
Interventions
  • Semaglutide
Study Locations (1 sites)
Grady Memorial Hospital, Atlanta, Georgia 30303 United States
Eligibility Criteria
Inclusion Criteria: * Postmenopausal women aged 65 years or older * Has type 2 diabetes * Body Mass Index (BMI) ≥27 kg/m² to max 40kg/m2 (inclusive) * Hemoglobin A1c between 7-10% within 3 months of the first visit. * Willingness and ability to comply with all study procedures, including fasting requirements for certain visits. * No osteoporosis confirmed on DEXA scan within 12 months * Able to provide informed consent and participate in all study assessments Exclusion Criteria: * Patients with type 1 diabetes mellitus or other types of diabetes that are not T2D * eGFR \<30 ml/min in the last 3 months * Patients with a history of treatment with anti-osteoporosis agents * Documented primary or secondary osteoporosis on a DEXA scan within the last 12 months, or are on osteoporosis therapies * Documented presence of prosthesis or devices in the spine or hip * Previous fragility fracture * Males * Moderate to severe gastroesophageal reflux disease based on patient history. * Inability to comply with the treatment protocol or to understand the consent form. * Aspartate aminotransferase (AST) \> 3 times normal or alanine aminotransferase (ALT) \> 3 times the normal * Subjects with uncontrolled thyroid or parathyroid disease that may influence the study results. * Personal or family history of medullary thyroid carcinoma. * Personal or family history of multiple endocrine neoplasia type 2 syndrome. * Personal history of gastroparesis, celiac disease, hypogonadism, severe COPD, hypopituitarism, or Cushing's disease * Personal history of severe diabetic retinopathy. * Known serious hypersensitivity, including anaphylaxis and angioedema, to semaglutide or any of its excipients. * Any of the following drugs or treatments were used within 6 months before screening: treated with GLP-1RA, GIP analogues, pioglitazones or DPP-4 inhibitors * Concomitant treatment with GLP-1 receptor agonist therapy * Long-term intravenous, oral and intra-articular administration of high dose corticosteroids within 2 months before screening (more than 7 days in a row) * Use of weight control drugs or surgery that can lead to weight changes during the last 6 months before screening, or are currently in the weight loss plan and are not in the maintenance stage * Incarcerated individuals
A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer
NCT07406542
Not yet recruiting
Conditions Recurrent or Metastatic Breast Cancer
Phase PHASE3
Enrollment 400
Locations 0 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

  • SYS6010
  • Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine)

Primary Outcomes

  • PFS
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Not yet recruiting
Start Date: 2026-04-01
Completion: 2030-04-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 400 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.
Contact Information
Study Contact:
Clinical Trials Information Group officer
031169085587
ctr-contact@cspc.cn
Interventions
  • SYS6010
  • Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine)
Eligibility Criteria
Inclusion Criteria: 1. Age 18 to 75 years inclusive, no gender restrictions. 2. Histopathologically confirmed breast cancer at an unresectable recurrent or metastatic stage, requiring: a) HER2-negative; b) EGFR-positive expression. 3. Subjects must have received 1 to 2 lines of systemic chemotherapy regimens during the unresectable advanced or metastatic stage. 4. At least one measurable lesion confirmed by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Brain metastases are evaluated only as non-target lesions. Patients with skin lesions only are ineligible. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 6. Expected survival ≥3 months. 7. Adequate major organ function status within 7 days prior to first study drug administration. 8. Subjects must agree to use effective contraception from informed consent signing until the protocol-specified time after last dose; females must not be lactating and males must refrain from sperm donation during this period. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first study drug administration. Female subjects must not be lactating. 9. Voluntarily participate in this clinical study, understand the research procedures, and be able to sign a written informed consent form. Exclusion Criteria: 1. Presence of cancerous meningitis, spinal cord compression, or active central nervous system metastases. Active central nervous system metastases are specifically defined as untreated, symptomatic, or requiring corticosteroids/anticonvulsants to control related symptoms; except for cases stable for at least one month following treatment for brain metastases and having discontinued corticosteroids/anticonvulsants for \>2 weeks. 2. Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (including clinically significant recurrence requiring additional intervention within 2 weeks prior to enrollment). 3. History of other malignancies within 3 years prior to first use of study drug, except for: cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, papillary thyroid carcinoma, and cervical carcinoma in situ 4. Prior treatment with topoisomerase I inhibitors (including ADCs) 5. Prior treatment with EGFR-targeted ADCs or monoclonal antibodies 6. Known hypersensitivity to any component of SYS6010 or to humanized monoclonal antibody products 7. Adverse events from prior antitumor therapy not recovered to ≤ Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 (excluding Grade 2 alopecia, asymptomatic laboratory abnormalities, etc., deemed safe by the investigator). 8. Patients with inadequate washout periods for prior medications or treatments, as specified in the protocol, prior to the first administration of the study drug. 9. History of severe cardiovascular or cerebrovascular disease. 10\. Clinically significant pulmonary impairment due to pulmonary complications. 11. History of interstitial lung disease (ILD)/non-infectious pneumonia requiring glucocorticoid therapy, current ILD/non-infectious pneumonia, or inability to exclude ILD/non-infectious pneumonia based on imaging at screening. 12\. Subjects with active inflammatory bowel disease, gastrointestinal obstruction, active peptic ulcer, recent (within 4 weeks) gastrointestinal bleeding, gastrointestinal perforation, or severe gastrointestinal conditions such as abdominal abscess (excluding those with a history of resolved conditions). 13\. Severe infection within 4 weeks prior to first use of the investigational drug, including but not limited to: bacteremia requiring hospitalization, severe pneumonia, active tuberculosis infection, or requiring oral or intravenous antibiotic, antifungal, or antiviral therapy due to infection within 2 weeks prior to first dosing (except for prophylactic use). 14\. Uncontrolled diabetes (fasting blood glucose ≥10 mmol/L and/or HbA1c ≥8%). 15. Active hepatitis B, active hepatitis C virus infection, or active syphilis infection. 16\. Human immunodeficiency virus (HIV) infection diagnosed as acquired immunodeficiency syndrome (AIDS). 17.Other conditions deemed unsuitable for participation in this clinical trial by the investigator (e.g., uncontrolled psychiatric disorders or anticipated poor compliance).