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Showing 20 of 28375 trials
Clinical Study of Chemotherapy and Immunotherapy Combined With Lactobacillus Johnsonii in Patients With Multiple Irresectable Solid Tumors
NCT07191405
Not yet recruiting
Conditions Immunotherapy, Chemotherapy
Phase NA
Enrollment 156
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

  • oral Lactobacillus johnsonii (1×10¹¹ CFU, twice daily)
  • Placebo

Primary Outcomes

  • Progression-Free Survival (PFS)
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: 2025-09-18
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 156 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Information
Study Contact:
Liangjing Wang Vice President of the Second Affiliated Hospital
86-571-89713734
wangljzju@zju.edu.cn
Interventions
  • oral Lactobacillus johnsonii (1×10¹¹ CFU, twice daily)
  • Placebo
Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent. 2. Age 18-75 years. 3. Histologically confirmed unresectable/metastatic tumors: EGFR/ALK wild-type adenocarcinoma non-small cell lung cancer (NSCLC) PD-L1+ (CPS≥1) triple-negative breast cancer (TNBC) HER2- gastric/gastroesophageal adenocarcinoma 4. ≥1 measurable lesion (RECIST v1.1). 5. Progression after PD-1/PD-L1 inhibitor therapy (defined as: * ≥2 doses administred. * Radiographic progression per RECIST/iRECIST/irRECIST, confirmed ≥4 weeks later. * Progression within 12 weeks of last PD-1/PD-L1 dose. 6. Adequate organ function. 7. ECOG performance status 0-1. 8. Negative pregnancy test (urine/serum β-HCG) for women of childbearing potential. Exclusion Criteria: * 1\. Prior allogeneic transplantation (cells, tissues, or solid organs). 2. History of immune-related adverse events (irAEs) from immunomodulators (e.g., PD-1/PD-L1 or CTLA-4 inhibitors) leading to permanent discontinuation or Grade 3/4 severity. 3\. Recent anticancer therapy (chemotherapy/immunotherapy/biologics/experimental drugs) within: \<5 half-lives of the drug or \<21 days before starting study treatment (whichever is shorter). Exceptions: Stable hormone therapy (e.g., for prostate/breast/ovarian cancer). 4\. Concomitant corticosteroid use (\>10 mg prednisone/day or equivalent) within 7 days prior to treatment, unless for physiological replacement (≤10 mg/day) or non-immunosuppressive purposes (e.g., inhaled/topical steroids). 5\. Severe cardiac dysfunction, including: NYHA Class III-IV heart failure, symptomatic coronary artery disease, severe ventricular arrhythmias, myocardial infarction/unstable angina within 6 months. 6\. Active autoimmune disease requiring systemic treatment (immunosuppressants/corticosteroids) in the past 2 years, except: Hormone replacement (thyroxine, insulin, physiologic corticosteroids). 7\. Active severe infection requiring systemic therapy. 8. Antibiotic use completed within 2 weeks before the first dose. 9. Psychiatric or substance abuse disorders compromising protocol compliance. 10. Live vaccines administered within 28 days before treatment. 11. Active HIV or hepatitis (A/B/C) infection. 12. History of steroid-requiring (non-infectious) pneumonitis or current active pneumonitis. 13\. Other malignancies requiring active treatment or progressing within 2 years (exceptions: Non-melanoma skin cancer, cervical/prostate carcinoma in situ). 14\. Pregnancy or lactation. 15. Known intolerance/allergy to study drugs. 16. Other conditions deemed unsuitable by investigators.
Acupuncture for Anxiety/Depression in Patients With Breast Cancer
NCT07183813
Not yet recruiting
Conditions Anxiety Depression, Breast Cancer, Acupu...
Phase NA
Enrollment 360
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

  • Electroacupuncture group
  • Sham electroacupuncture

Primary Outcomes

  • The change from baseline in the total score of Hospital Anxiety and Depression Scale (HADS).
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: 2025-09-15
Completion: 2026-12-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 360 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Contact Information
Study Contact:
Yuanjie Sun
+8618810337542
puzhisun@163.com
Shuai Gao
+8613128205732
gaoshuai980314@163.com
Interventions
  • Electroacupuncture group
  • Sham electroacupuncture
Study Locations (1 sites)
Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China
Eligibility Criteria
Inclusion Criteria: 1. Female, aged 18 to 70 years old; 2. Meeting the diagnostic criteria for breast cancer and at TMN I-III; 3. Having completed specialized active treatment for at least one month; 4. With an ECOG score of 0-2; 5. Mild to moderate anxiety and/or depression; 6. Voluntarily joining this study and signing the informed consent form. Exclusion Criteria: 1. Starting to take or change the regimen of anti-anxiety and/or -depression disorder medication within one month before enrolment; 2. Received psychological intervention or physical therapy one month before enrolment or planning to use in the next 5 months; 3. With diagnosis of anxiety and/or depression disorder prior to the diagnosis of breast cancer; 4. Patients with suicidal tendencies, bipolar disorder and psychotic symptoms; 5. Patients with severe anxiety and/or depression; 6. Patients received acupuncture treatment within one month before enrolment; 7. Participating in other clinical studies on the treatment of anxiety and/or depression; 8. Combined with severe underlying diseases; 9. Patients with severe skin ulcers; 10. Pregnant or lactating patients; 11. Poor compliance.
Effect of Linvemastat in Patients With Partially Controlled Asthma (syMMPonia)
NCT07191535
Not yet recruiting
Conditions Asthma (Diagnosis), Pulmonary Function, ...
Phase PHASE2
Enrollment 135
Locations 0 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

  • linvemastat
  • Placebo

Primary Outcomes

  • The mean change in trough FEV1 assessed by central spirometry
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: 2027-03-01
Completion: 2028-09-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 135 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Foresee Pharmaceuticals Co., Ltd.
Collaborators: QPS Holdings LLC
Principal Investigators:
  • Bassem Elmankabadi, MD (STUDY_DIRECTOR) - Foresee Pharmaceuticals
Contact Information
Study Contact:
Bassem Elmankabadi, MD
+1 562-310-8718
Bassem.elmankabadi@foreseepharma.com
Yisheng Lee
408-823-4807
yisheng.lee@foreseepharma.com
Interventions
  • linvemastat
  • Placebo
Eligibility Criteria
Inclusion Criteria: * Patients aged 18 - 85 years at the time of signing informed consent * Patient is able to provide written informed consent. * Documented physician´s diagnosis of Type 2 high asthma, as per the Global Initiative for Asthma (GINA) 2023 guideline 2023 at Screening. * Patients with existing treatment with at least low to medium doses of ICS therapy in combination with LABA as a second controller for at least 90 days and a stable/optimized dose ≥30 days prior to Day 1. Patients on triple therapy with a long-acting muscarinic antagonist (LAMA) will be excluded. * An ACQ score ≥ 1.5 at Screening. * Patients with a pre-bronchodilator FEV1 value of 40% to 80% of the patient's predicted value at Screening. * Patients must have experienced at least once, within 2 years prior to Screening, one of the following asthma exacerbation events: Treatment with a systemic steroid (oral or parenteral) for worsening asthma. Hospitalization or emergency medical care visit for worsening asthma. * Males with a partner of childbearing potential must use a condom for the duration of study treatment and at least 96 hours after discontinuing the study drug. * Female patients of childbearing potential (including those \< 1 year post-menopausal) must use a highly effective method of contraception per Clinical Trial Facilitation Group (CTFG) recommendation during the conduct of the study and for 30 days after the last dose of study drug. Highly effective contraceptive measures for female patients of childbearing potential include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable. intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner (when partner is the sole sexual partner of the female patient and when the partner has received medical assessment of the surgical success), sexual abstinence. * Women not of childbearing potential are defined as: Post-menopausal women (defined as at least 12 months with no menses without an alternative medical cause); in women \<45 years of age, a high follicle-stimulating hormone (FSH) level in the post-menopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy; OR Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to Screening OR Have a congenital or acquired condition that prevents childbearing. Exclusion Criteria: * Pregnant or breastfeeding. * Current smoker (including vaping) or cessation of smoking within the 6 months prior to Day 1, or \> 10 pack-year history of smoking. * Participation in another clinical trial of an investigational agent within 3 months (small molecule) / 6 months (biologics) or 5 half-lives (if known) of the agent, whichever is longer, prior to randomization. * Evidence of COVID-19 infection at Screening, as judged by the Investigator. * Advanced congestive heart failure \[New York Heart Association (NYHA) class 3 or 4\]. * Known hypersensitivity to any component of the formulation of linvemastat or any component of the excipient. * Live or messenger ribonucleic acid (mRNA) vaccination within 2 weeks before Day 1 or inoculation with a live or mRNA vaccine is planned during study participation. * History of solid organ transplant. * Anti-immunoglobulin E (IgE) therapy \[e.g., omalizumab (Xolair®)\] within 130 days prior to Screening or any other biologic therapy \[including anti-TSLP, anti-IL-4/4R or IL-5/5R monoclonal antibodies (mAb)\] or systemic immunosuppressant (e.g., methotrexate) to treat inflammatory disease or autoimmune disease (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis) and other diseases, within 2 months or 5 half-lives prior to Screening, whichever is longer. * Evidence of active tuberculosis (TB) infection at Screening, as judged by the Investigator. * Active acute or chronic psychiatric illness that, in the opinion of the Investigator, may prevent from complying with study instructions. * Known positive history of malignancy within 5 years of Screening (with the exception of basal cell skin cancer, carcinoma in-situ of the cervix, or low-risk prostate cancer after curative therapy). * Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) infection at Screening. * Concurrent emphysema. * Use of any therapeutics that are strong inhibitors and inducers of CYP3A4 or CYP2C8 \[e.g., rifampicin, ketoconazole, phenytoin, ritonavir, macrolide antibiotics (e.g., telithromycin), and carbamazepine\]. * History of liver dysfunction, including patients with moderate (Child-Pugh B) or severe (Child-Pugh C) impairment or disordered coagulation. * Abnormal ECG: ventricular arrhythmias (non-sustained ventricular tachycardia \[VT\], multifocal or frequent premature ventricular contractions, clinically significant bundle branch block or axis deviation \[as assessed by PI\], or abnormal Q waves). In the case of a corrected QT interval using Fridericia's formula (QTcF) interval \>450 ms (men) or \>480 ms (women; patients with bundle branch block) or PR (P to QRS) interval outside the range of 120 to 220 ms, the assessment may be repeated once for eligibility determination at Screening or Baseline. * Known uncontrolled hypertension or diabetes at the discretion of the Investigator. * Any condition that required hospitalization (except for asthma exacerbation) within the 3 months prior to Day 1 or is likely to require so during the study. * Clinically significant abnormalities in the Screening physical examination, medical history, vital signs, ECG, or clinical laboratory tests that are not known to be due to concurrent asthma in the opinion of the Investigator and Medical Monitor should preclude the patient's participation in the clinical study. * The following laboratory parameters are excluded: 1. Hemoglobin (Hg) \<10 g/dL (100 g/L) 2. White blood cells (WBC) \< 3000/μL (\< 3000/mm3). African American patients who are known to have low WBC of \< 3000/μL but ≥ 1500/μL will be eligible. 3. Platelet count \< 70,000/μL (70,000/mm3) 4. Serum creatinine \> 1.5 x upper limit of normal (ULN) 5. Glomerular filtration rate ≤ 60 mL/min/1.73 m2 or evidence of acute kidney injury or history of severe hypersensitivity reactions to gadolinium-based contrast agents 6. Serum total bilirubin \> 1.5 ULN 7. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 x ULN or serum alkaline phosphatase \> 2 x ULN
Tirzepatide in Idiopathic Intracranial Hypertension Trial
NCT07191873
Not yet recruiting
Conditions Idiopathic Intracranial Hypertension (II...
Phase PHASE4
Enrollment 60
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

  • Tirzepatide
  • Tirzepatide Placebo

Primary Outcomes

  • Change in intracranial pressure in Idiopathic Intracranial Hypertension (IIH) patients
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Not yet recruiting
Start Date: 2026-08
Completion: 2028-08
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Duke University
Collaborators: Eli Lilly and Company
Principal Investigators:
  • Alexa N Bramall, MD (PRINCIPAL_INVESTIGATOR) - Duke University
Contact Information
Study Contact:
Alexa N Bramall, MD
919-660-1754
alexa.bramall@duke.edu
Beth Perry, RN
919-681-2695
beth.perry@duke.edu
Interventions
  • Tirzepatide
  • Tirzepatide Placebo
Study Locations (1 sites)
Duke University Medical Center, Durham, North Carolina 27710 United States
Eligibility Criteria
Inclusion Criteria: 1. Signs and symptoms of increased intracranial pressure: 1. headaches, tinnitus, visual obscurations, papilledema; 2. absence of localizing findings on neurological examination (except for VI nerve palsy); 3. no secondary causes identified on imaging, e.g., hydrocephalus, space- occupying lesion; 4. elevated lumbar puncture (LP) opening pressure (OP) ≥25 cm H2O in lateral decubitus position with legs extended (\>= (≥ 20cm H2O if one of the following is present: pulse synchronous tinnitus, abducens palsy, Frisen grade II papilledema, transverse venous sinus stenosis, partially empty sella or enlarged optic nerve sheath on magnetic resonance imaging (MRI); 5. the patient is awake and alert. 2. BMI ≥30 kg/m2 3. Age 18-60 years of age 4. Unilateral or bilateral papilledema 5. Able to provide informed consent 6. Women of child-bearing age must use birth control (non-oral contraceptive method or add a barrier method of contraception). Exclusion Criteria: 1. Previous bariatric surgery 2. Prior intervention for high ICP including optic nerve sheath fenestration (ONSF), venous stenting and/or shunting 3. Taking another GLP-1 agonist, another drug that can interfere with the GLP-1 agonist, or any other anti-obesity medication 4. History of pancreatitis, personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2), history of gallbladder disease, ulcerative colitis, Crohn's disease, or history of hypersensitivity reaction in response to the drug 5. Pregnancy or planning a pregnancy in the next 12 months or currently breastfeeding 6. Other disorders causing visual loss and/or anomalous optic nerve 7. Taking another medication to lower ICP in IIH (if previously taking another medication for ICP must be off this medication for at least 30 days prior to enrollment) 8. No change in headache medications in the past 60 days 9. Venous sinus thrombosis on magnetic resonance venography (MRV) 10. Papilledema Frisen Grade III, IV or fulminant IIH 11. Mean perimetric deviation ≤ -7 dB 12. CSF contents outside of normal limits 13. Uncontrolled hypertension (≥140mmHg/90 mmHg) 14. Anemia (hemoglobin \[Hgb\] ≤ 8.0g/dL) 15. Diagnosed sleep apnea with continuous positive airway pressure (CPAP) use 16. Exposure to a drug, substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis such as lithium, vitamin A, various cyclines 17. eGFR \< 30 ml/min/1.73m2 18. Type II diabetes
Intervention Effect of Temporal Interference Stimulation (TIS) on Depressive Disorder
NCT07191392
Recruiting
Conditions Depressive Disorder, Temporal Interferen...
Phase NA
Enrollment 60
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Temporal Interference Stimulation (TIS)
  • Sham temporal interference stimulation (TIS)

Primary Outcomes

  • face-word assciative memory task score
  • Change in Hamilton Depression Rating Scale (HAMD) Score
  • Change in the Patient Health Questionnaire-15 (PHQ-15) scale
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-09-01
Completion: 2026-06
Eligibility
Age: 12 Years
Sex: ALL
Volunteers: true
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: The Second Hospital of Anhui Medical University
Contact Information
Study Contact:
Yanghua Tian, PhD
0551 6599 7278
zylykd@163.com
Interventions
  • Temporal Interference Stimulation (TIS)
  • Sham temporal interference stimulation (TIS)
Study Locations (2 sites)
Anhui Medical University, Hefei, Anhui China
Anhui Mental Health Center, Hefei, Anhui China
Eligibility Criteria
Inclusion Criteria: * the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for depression, and HAMD\>17, BSS\>6, PHQ-15\>5. * the age ranged from 18 to 65 years old, and the length of education was more than 5 years. * the visual acuity or corrected visual acuity is normal, right-handed, can cooperate with the completion of various experimental tests. Exclusion Criteria: * accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on. * accompanied by other neurological diseases, such as stroke, epilepsy and so on. pregnant and lactating women. * accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective
Preeclampsia and Defective Placentation in Oocyte Donation: Importance of HLA-C and KIR
NCT07178652
Not yet recruiting
Conditions Preeclampsia (PE) Risk, Oocyte Donation
Phase Not Applicable
Enrollment 2325
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Preeclampsia development.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2025-09
Completion: 2029-08
Eligibility
Age: No restriction
Sex: FEMALE
Volunteers: false
Enrollment: 2325 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Universitair Ziekenhuis Brussel
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Eligibility Criteria
Inclusion Criteria: * Every live birth delivery post oocyte donation (mother, child, donor). Exclusion Criteria: * Unknown HLA-C/KIR typing of acceptor, donor or offspring (resumlts of all 3 parties must be present to participate.
IH, Brain Health, and T2D
NCT07173543
Recruiting
Conditions Type 2 Diabetes, Aging
Phase NA
Enrollment 80
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

  • Intermittent Hypoxia 1 (IH1)
  • Intermittent Hypoxia 2 (IH2)
  • SHAM - normoxia

Primary Outcomes

  • Internal Carotid Artery (ICA) shear-mediated dilation
  • Cerebral blood flow responsiveness
  • Cognitive function testing
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-09-22
Completion: 2028-06-30
Eligibility
Age: 60 Years
Sex: ALL
Volunteers: true
Enrollment: 80 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Darren P Casey
Collaborators: American Diabetes Association
Contact Information
Study Contact:
Darren Casey, PHD
13193841009
darren-casey@uiowa.edu
Interventions
  • Intermittent Hypoxia 1 (IH1)
  • Intermittent Hypoxia 2 (IH2)
  • SHAM - normoxia
Study Locations (1 sites)
University of Iowa, Iowa City, Iowa 52242 United States
Eligibility Criteria
For 30 patients with documented Type 2 diabetes Inclusion Criteria: * Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures. * Age is \> or = 60 and \< or = 85 years of age * Documented Type 2 diabetes * Scoring 26 or higher on the MoCA test Exclusion criteria: * diagnosis of type 2 diabetes \< 1 year prior to enrollment * HbA1c \<6.5% or \>10.0% * body mass index \> 40 kg/m 2 * incident cardiovascular events in the last year (heart attack, stroke) * symptomatic coronary artery disease and/or heart failure * uncontrolled hypertension * obstructive sleep apnea * pulmonary disease * dementia * renal impairment with creatinine clearance (eGFR) of \<60 ml/min * smoking or history of smoking within past one year 30 nondiabetic control subjects will also be studied. Inclusion criteria: * Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures. * Age is \> or = 60 and \< or = 85 years of age * Scoring 26 or higher on the MoCA test Exclusion criteria: * Diagnosis of diabetes (Type 1 or Type 2) * body mass index \> 40 kg/m2 * incident cardiovascular events in the last year (heart attack, stroke) * symptomatic coronary artery disease and/or heart failure * uncontrolled hypertension * obstructive sleep apnea * pulmonary disease * dementia * renal impairment with creatinine clearance (eGFR) of \<60 ml/min * smoking or history of smoking within past one year
Study to Evaluate HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
NCT07193459
Recruiting
Conditions Type 2 Diabetes
Phase PHASE3
Enrollment 360
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

  • HDM1002 200 mg
  • HDM1002 400 mg
  • Placebo

Primary Outcomes

  • Change From Baseline in HbA1c at Week 40
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2025-08-12
Completion: 2027-02-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 360 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • HDM1002 200 mg
  • HDM1002 400 mg
  • Placebo
Study Locations (1 sites)
Peking University People's Hospital, Beijing, Beijing Municipality 100000 China
Eligibility Criteria
Inclusion Criteria: 1. Male or female subjects between 18 and 75 years of age (inclusive). 2. Have been diagnosed with type 2 diabetes mellitus (T2DM) for at least 10 weeks based on the World Health Organization, and meet the following conditions:a) had been treated with diet and exercise for at least 10 weeks prior to signing ICF; b) Not been treated with any hypoglycemic drugs within 10 weeks prior to signing ICF. 3. HbA1c ≥7.5% and ≤10.5% at screening as assessed by the local laboratory, and HbA1c ≥7.5% and ≤10.5% prior to randomization as assessed by the specified central laboratory. 4. Having a body mass index (BMI) of 22.5 to 40.0 kg/m2, inclusive. 5. Female participants of childbearing potential and male participants must agree to use highly effective contraception method from the day of signing the ICF and until 30 days (female) or 90 days (male) after the final dose administration. 6. Able to understand and comply with protocol requirements, agree to maintain the same dietary and exercise habits throughout the trial, be willing to complete the trial in strict compliance with the clinical trial protocol and provide written informed consent. Exclusion Criteria: 1. Diagnosed with type 1 diabetes mellitus (including latent autoimmune diabetes in adults), special types of diabetes or gestational diabetes mellitus 2. Evidence of acute complications of diabetes (e.g., diabetic ketoacidosis, diabetic lactosidosis, or hyperosmolar nonketotic coma) within 6 months prior to signing ICF. 3. Have a known self or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia or multiple endocrine neoplasia type II (MEN2) 4. History of acute or chronic pancreatitis or pancreatic injury, or any high-risk factor which may lead to pancreatitis; or have symptomatic gallbladder disease that requires treatment during the trial (subjects with prior cholecystectomy can be enrolled if deemed eligible by the investigator) 5. Have had dysphagia, or any condition or disease possibly affecting gastric emptying or nutrients absorption in the opinion of the investigator, such as history of surgery affecting gastric emptying, gastroesophageal reflux disease, pyloric obstruction, irritable bowel syndrome, etc. 6. Have had any of the following within 3 months prior to screening: * Unstable angina; * Heart failure (New York Heart Association, class III or IV); * Myocardial infarction (MI); * Coronary artery bypass grafting or percutaneous coronary intervention; * Uncontrolled severe arrhythmias (including: ventricular tachycardia, ventricular fibrillation, atrial fibrillation, second to third degree atrioventricular block, sick sinus node syndrome, pre-excitation syndrome, etc.); * Cerebrovascular accident 7. Have a history of proliferative diabetic retinopathy and/or diabetic maculopathy that requires treatment, or evidence of other severe retinopathy that requires treatment during the study. 8. Have a known history of liver disease, including: acute or chronic active liver disease (except non-alcoholic steatohepatitis) such as active hepatitis B, hepatitis C; or primary biliary cholangitis. 9. Those who have used the following drugs within 14 days before randomization or within 5 half-lives (whichever is longer), or who need to use the following drugs for a long time during the trial, are excluded: strong or moderate inhibitors of cytochrome P450 enzyme (CYP) 3A4, strong inducers of CYP3A4, strong inhibitors of P-gp, strong inducers of P-gp, inhibitors of OATP1B1 or OATP1B3, or narrow therapeutic index drugs that are CYP2C8, CYP3A4, UGT1A1, P-gp, OATP1B1 or OATP1B3 substrates. 10. Use of any glucose-lowering medication within 10 weeks prior to signing ICF, including but not limited to: α-glucosidase inhibitors (e.g., acarbose), thiazolidinediones, and dipeptidyl peptidase-4 inhibitors (DPP-4i) inhibitors, glucose kinase activators, sodium-glucose cotransporter-2 inhibitors (SGLT-2i) ,with the exception of short-term insulin therapy due to a concomitant illness, stress, or perioperative period (cumulative duration ≤ 14 days). 11. Having used a Glucagon-like peptide-1 (GLP-1) analogue within 3 months prior to signing the ICF; or previous discontinuation of a GLP-1 analogue due to safety/tolerability or lack of efficacy. 12. Pregnancy or lactation. 13. Subjects with a known hypersensitivity to GLP-1 receptor agonists (GLP-1RA), or a history of severe drug allergies. 14. Enrolled in or participated in any other clinical study of drugs or medical devices within 3 months (or within 5 half-lives, whichever is longer) prior to signing the ICF (except for subjects who signed written informed consent without any intervention of investigational product or medical devices). 15. Any other condition considered by the investigator which is not suitable for participating in this study.
MSC Exosome Therapy for Post-Preeclampsia Endothelial Dysfunction
NCT07183384
Recruiting
Conditions Preeclampsia, Postpartum, Endothelial In...
Phase PHASE1, PHASE2
Enrollment 80
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Mesenchymal Stem Cell-Derived Exosomes
  • Placebo (Sterile Saline Solution)

Primary Outcomes

  • Change in Endothelial Function Biomarker (miR-126-3p)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Recruiting
Start Date: 2024-07-01
Completion: 2026-09-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 80 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Universitas Padjadjaran
Collaborators: Hasan Sadikin General Hospital, Dr Cipto Mangunkusumo General Hospital, Dr. Sardjito Hospital, Yogyakarta
Principal Investigators:
  • Akhmad Y Pramatirta, M.D., Ph.D (PRINCIPAL_INVESTIGATOR) - Dr. Hasan Sadikin Central General Hospital
Contact Information
Study Contact:
Prima N Fauziah, S.Si., M.Si.
+62 85721368609
primanandafauziah@gmail.com
Nurul Azizah, S.Tr.Keb.
+62 81312971480
nurul19012@mail.unpad.ac.id
Interventions
  • Mesenchymal Stem Cell-Derived Exosomes
  • Placebo (Sterile Saline Solution)
Study Locations (1 sites)
Dr. Hasan Sadikin Central General Hospital, Bandung, West Java 40161 Indonesia
Eligibility Criteria
Inclusion Criteria: * Postpartum * Confirmed diagnosis of preeclampsia in the last pregnancy * Postpartum period of first week and second week * Able to provide informed consent Exclusion Criteria: * History of chronic hypertension prior to pregnancy * Major cardiovascular disease history * Active systemic infection * Endothelial Injury history * Active smoking status including vape, alcohol, drug addiction.
Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes
NCT07173712
Not yet recruiting
Conditions Type 2 Diabetes
Phase PHASE4
Enrollment 324
Locations 0 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

  • CSII
  • Insulin glargine /lixisenatide Fixed Ratio Combination
  • Insulin Degludec and Insulin Aspart Injection
  • Insulin Glargine (HOE901 - U300)
  • Metformin

Primary Outcomes

  • Proportion of subjects with optimal glycemic control
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Not yet recruiting
Start Date: 2026-03-15
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 324 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Yanbing Li
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • CSII
  • Insulin glargine /lixisenatide Fixed Ratio Combination
  • Insulin Degludec and Insulin Aspart Injection
  • Insulin Glargine (HOE901 - U300)
  • Metformin
Eligibility Criteria
Inclusion Criteria: 1. Diagnosed with type 2 diabetes mellitus (T2DM) with a disease duration of \>1 year and \<15 years. 2. On a stable dose of at least one oral antidiabetic drug (OAD) for ≥3 months. 3. HbA1c at screening: \>8.0% if on a single OAD; \>7.5% if on more than one OAD (centralized laboratory testing, or results from medical centers participating in the National Glycohemoglobin Standardization Program). 4. Age 18-70 years. 5. Body mass index (BMI) 20-35 kg/m². 6. Able and willing to comply with study requirements, including continuous glucose monitoring, self-monitoring of blood glucose, lifestyle management, and insulin-based glycemic management. 7. Agreement to use effective contraception during the study. 8. Willingness to provide written informed consent. Exclusion Criteria: 1. Diagnosis of type 1 diabetes mellitus or other specific types of diabetes. 2. Receipt within 3 months prior to screening of premixed insulin therapy and/or basal-bolus insulin therapy and/or basal insulin plus OAD therapy for ≥7 cumulative days; or receipt within 1 year prior to screening of intensive insulin therapy (insulin pump or multiple daily injections); or receipt within 3 months prior to screening of GLP-1 receptor agonists; or inability to tolerate protocol-specified doses. 3. Known hypersensitivity or intolerance to study medications. 4. Acute diabetic complications (including diabetic ketoacidosis, hyperosmolar hyperglycemic state, or lactic acidosis). 5. Severe microvascular complications: proliferative diabetic retinopathy; albumin excretion rate (AER) \>300 mg/g or proteinuria \>0.5 g/day; uncontrolled painful diabetic neuropathy or significant autonomic neuropathy. Severe macrovascular complications: hospitalization for acute cerebrovascular accident, acute coronary syndrome, peripheral artery disease requiring intervention or amputation within the previous 12 months; unstable angina, myocardial infarction, uncontrolled arrhythmia, or severe heart failure (New York Heart Association \[NYHA\] class ≥III). 6. Persistent blood pressure \>180/110 mmHg, or uncontrolled above 160/110 mmHg within 1 week. 7. Estimated creatinine clearance \<45 mL/min/1.73 m² (calculated by CKD-EPI formula); alanine aminotransferase ≥2.5 × upper limit of normal (ULN); or total bilirubin ≥1.5 × ULN. 8. Hemoglobin \<100 g/L or requiring regular blood transfusions. 9. Use within 12 weeks prior to screening of medications affecting glycemic control for \>1 cumulative week, including oral/intravenous glucocorticoids, growth hormone, estrogen/progestins, high-dose diuretics, or antipsychotics. Exceptions: low-dose diuretics used for antihypertensive purposes (HCTZ \<25 mg/day, indapamide ≤1.5 mg/day) and physiological thyroid hormone replacement therapy. 10. Uncontrolled endocrine disorders. 11. History or family history of medullary thyroid carcinoma, or history of multiple endocrine neoplasia syndrome type 2 (MEN2). 12. Psychiatric illness or communication disorders. 13. Systemic infection, severe comorbid conditions, malignancy, or chronic diarrhea. 14. Pregnancy, lactation, or women of childbearing potential unwilling to use contraception during the study. 15. Uncooperative participants, inability to comply with follow-up, or judged by investigators as unlikely to complete the study. 16. Any other condition deemed unsuitable by investigators, including history of acute pancreatitis, rapidly progressing gallstones, or chronic cholecystitis.
Online Transdiagnostic Group CBT for Postpartum Depression and Anxiety
NCT07162129
Active, positions filled
Conditions Postpartum Depression (PPD), Postpartum ...
Phase NA
Enrollment 48
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

  • Cognitive Behavioral Therapy for Postpartum Depression (PPD) and Anxiety

Primary Outcomes

  • Number of participants recruited in recruitment period
  • Number of participants who complete all data collection procedures
  • Number of participants who complete study (retention)
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: 2025-09-09
Completion: 2026-09
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 48 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: McMaster University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Cognitive Behavioral Therapy for Postpartum Depression (PPD) and Anxiety
Study Locations (1 sites)
McMaster University, Hamilton, Ontario L8S 4L8 Canada
Eligibility Criteria
Inclusion Criteria: * ≥18 years old * have an infant \<12 months at recruitment * fluent in written/spoken English * have an EPDS score ≥10 and/or a GAD-7 score≥10 * live in Ontario, Canada Exclusion Criteria: * does not meet diagnostic criteria for bipolar, psychotic, borderline personality and current substance use disorders
Randomized Controlled Trial Testing the Efficacy of Transcranial Magnetic Stimulation by Accelerated & High-dose Theta-burst, Functional Imaging Guided, in the Treatment of Depression in Elderly Subjects With Cognitive Impairment
NCT07188753
Not yet recruiting
Conditions Treatment Resistant Depression, Elderly ...
Phase NA
Enrollment 186
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

  • transcranial magnetic stimulation by accelerated & high-dose theta-burst, functional imaging guided, i

Primary Outcomes

  • To determine the effect of aiTBS, as compared to sham stimulation, on depressive symptoms at one-month visit (35+/-3 days after the last day of treatment).
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: 2025-12-15
Completion: 2031-12-15
Eligibility
Age: 65 Years
Sex: ALL
Volunteers: false
Enrollment: 186 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Rennes University Hospital
Principal Investigators:
  • Jean-Marie BATAIL, M.D.,Ph.D. (PRINCIPAL_INVESTIGATOR) - C. H. GUILLAUME REGNIER RENNES
  • Bruno MILLET, PH-PD (PRINCIPAL_INVESTIGATOR) - APHP- LA PITIE
  • Ghina HARIKA GERMANEAU, MD (PRINCIPAL_INVESTIGATOR) - Centre Hospitalier Henri Laborit
Contact Information
Study Contact:
Jean-Marie BATAIL, M.D.,Ph.D.
0299333937
jm.batail@ch-guillaumeregnier.fr
Kristell COAT
0299282555
kristell.coat@chu-rennes.fr
Interventions
  • transcranial magnetic stimulation by accelerated & high-dose theta-burst, functional imaging guided, i
Eligibility Criteria
Inclusion Criteria: 1. Male or female, of ages ≥ 65 years at the time of screening 2. Currently diagnosed with either Major Depressive Disorder (MDD) and meets criteria for a current Major Depressive Episode (MDE) according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5). 3. Patients that don't meet the treatment response criteria according to antidepressant treatment history form (ATHF) for whom a switch to another ATD is required. 4. rTMS/iTBS naïve. 5. Access to ongoing psychiatric care before and after completion of the study. 6. Access to clinical rTMS after completion of the study. 7. In good general health, as evidenced by medical history (i.e. any ongoing serious and vital medical condition). 8. Having signed a free, informed and written consent 9. Patients that have a valid health insurance and are affiliated to or beneficiary of a social security system. 10. Montgomery and Asberg Depression Rating Scale (MADRS) score of ≥ 20 at screening. 11. MoCA total score ≤ 26. 12. Comply with eligibility criteria checklist (Appendix 3) Exclusion Criteria: 1. Major cognitive disorder according to DSM-5 criteria. 2. The presence or diagnosis of prominent (primary) anxiety disorder, personality disorder, or dysthymia. 3. Bipolar Affective Disorder I \& II and primary psychotic disorders. 4. Autism Spectrum disorder or Intellectual Disability. 5. A diagnosis of obsessive-compulsive disorder (OCD). 6. Current moderate or severe substance use disorder (according to DSM-5 criteria) or demonstrating signs of acute substance withdrawal. 7. Any history of ECT (greater than 8 sessions) without meeting response criteria. 8. No recent (during the current depressive episode) or concurrent use of a rapid acting antidepressant agent (i.e., ketamine or a course of ECT). 9. History of significant neurologic disease, including Parkinson's or Huntington's disease, brain tumor, unexpected seizure/epilepsy disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma (having caused a coma and/or requiring specific hospital care, and/or with abnormal brain imaging). 10. Untreated or insufficiently treated dysthyroidism (TSH range 0.4-4mUI/l). 11. Treatment with another investigational drug or other intervention within the study period. 12. Any other condition deemed by the PI to interfere with the study or increase risk to the participant. 13. Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion). 14. Contraindications to Magnetic Resonance Imaging (MRI) (ferromagnetic metal in their body). 15. Participants taking certain psychoactive medications will be assessed for safety by the PI, due to potential for increase of seizure risk (e.g., clozapine) and change in cortical excitability (e.g. anticonvulsant, benzodiazepines). A maximum daily dose of 2mg lorazepam equivalent will be accepted. 16. Persons referred in articles L.1121-5 to L.1121-8 and L.1122-2 of the Public Health Code: Pregnant women, women in labour and breastfeeding mothers Person deprived of liberty for judicial or administrative decision, adult person under legal protection (any form of public guardianship). 17. Mini Mental Status Examination (MMSE) score \< 21. 18. Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation). 19. Current mania or psychosis. 20. Endorses clinically significant explicit suicidal cognitions (score ≥ 6 on the Beck Suicide Scale \[BSS\] self-report). 21. Any current substance abuse that is clinically elicited or based on urine/breathalyzer screening deemed by the PI to be critical from a safety standpoint. 22. Depth-adjusted aiTBS treatment dose \> 65% maximum stimulator output (MSO).
Group Cognitive Behavioural Therapy for Paternal Perinatal Depression
NCT07166237
Active, positions filled
Conditions Perinatal Depression, Fathers
Phase NA
Enrollment 48
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

  • Cognitive Behavioral Therapy for Paternal Perinatal Depression

Primary Outcomes

  • Number of participants recruited in recruitment period
  • Number of participants who complete all data collection procedures
  • Number of participants who complete study (retention)
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: 2025-09-09
Completion: 2026-09
Eligibility
Age: No restriction
Sex: MALE
Volunteers: false
Enrollment: 48 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: McMaster University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Cognitive Behavioral Therapy for Paternal Perinatal Depression
Study Locations (1 sites)
McMaster University, Hamilton, Ontario L8S 4L8 Canada
Eligibility Criteria
Inclusion Criteria: * Non-birthing individuals identifying as fathers-to-be (i.e., have a pregnant partner) or fathers with an infant \<18 months at recruitment, be fluent in written/spoken English, have an EPDS score ≥9 and live in Ontario Exclusion Criteria: * Free of bipolar, psychotic, borderline personality and current substance use disorders
Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study
NCT07179939
Not yet recruiting
Conditions HER2-positive Breast Cancer
Phase PHASE2
Enrollment 288
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

  • Trastuzumab rezetecan
  • Pyrotinib
  • Dalpiciclib
  • Trastuzumab
  • ET: Letrozole/ Anastrozole/ Exemestane/ Fulvestrant/ Leuprorelin/ Goserelin.

Primary Outcomes

  • PFS
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: 2025-09-10
Completion: 2031-12-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 288 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fudan University
Collaborators: Jiangsu HengRui Medicine Co., Ltd., Chinese PLA General Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Trastuzumab rezetecan
  • Pyrotinib
  • Dalpiciclib
  • Trastuzumab
  • ET: Letrozole/ Anastrozole/ Exemestane/ Fulvestrant/ Leuprorelin/ Goserelin.
Study Locations (1 sites)
Fudan University, Shanghai, China
Eligibility Criteria
Inclusion Criteria: To be eligible to participate in this trial, an individual must meet ALL the following criteria: 1. Patient must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures. 2. Female patients ≥ 18 years of age at the time of signing ICF. 3. Breast Cancer Requirements: 1. Histologically or cytologically confirmed HER2-positive(IHC 3+ or ISH+) unresectable locally advanced or metastatic breast cancer (Note: Patients eligible for curative-intent treatment are excluded). 2. Documented hormone receptor (HR) status. 3. No prior systemic anti-tumor therapy for recurrent/metastatic disease (≤1 line of endocrine therapy is permitted\*). 4. For patients who received (neo)adjuvant therapy: \>12 months between the end of systemic treatment (excluding endocrine therapy) and recurrence/metastasis. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 5. Adequate Organ Function. 6. Pregnancy and Contraception: Women of childbearing potential (WOCBP) must agree to use highly effective contraception from screening until7 months after the last dose of study treatment and must refrain from breastfeeding. Exclusion Criteria: An individual who meets ANY of the following criteria will be excluded from participation in this trial: 1. Known active CNS metastases not treated with surgery or radiotherapy, except for those who have achieved stable disease for ≥1 month after treatment and have discontinued corticosteroids for \>2 weeks. 2. Received major cancer-related surgery, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biologic therapy, or investigational drug therapy within 4 weeks prior to the first dose of study treatment. 3. Previous treatment with antibody-drug conjugates containing exatecan derivative topoisomerase I inhibitors. 4. Presence of clinically significant cardiovascular conditions, including: 1. Severe/unstable angina 2. Symptomatic congestive heart failure (NYHA class ≥II) 3. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention 4. Myocardial infarction within 6 months before the first dose 5. Has a history of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. 6. Known substance abuse or any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation.
Study Aiming to Compare the Plasma Exposure of the Payload (Free-DXd) in Patients Treated by T-DXd for Locally Advanced or Metastatic Breast Cancer According to Their BMI.
NCT07195344
Recruiting
Conditions Locally Advanced or Metastatic Breast Ca...
Phase PHASE4
Enrollment 210
Locations 11 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

  • Pharmacokinetics blood samples

Primary Outcomes

  • Primary Outcome Measure
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2025-10-15
Completion: 2029-10
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 210 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Institut Claudius Regaud
Collaborators: Ligue contre le cancer, France
Contact Information
Study Contact:
Florence DALENC, MD, Prof
+33531155104
dalenc.florence@iuct-oncopole.fr
Interventions
  • Pharmacokinetics blood samples
Study Locations (11 sites)
Institut de Cancérologie de l'Ouest - Site Angers, Angers, France
Centre Georges François Leclerc, Dijon, France
Centre Oscar Lambret, Lille, France
Institut Paoli Calmettes, Marseille, France
CHU de Nîmes, Nîmes, France
Institut Curie - Site Paris, Paris, France
Centre Eugène Marquis, Rennes, France
Institut de Cancérologie de l'Ouest - Site Saint Herblain, Saint-Herblain, France
Centre Paul Strauss, Strasbourg, France
IUCT-O, Toulouse, France
Eligibility Criteria
Inclusion Criteria: 1. Women (or men) aged ≥ 18 years on the day of signing the informed consent with histologically proven breast cancer. 2. Metastatic or locally advanced breast cancer with overexpression/amplification HER2 (IHC +++ or ++ and positive-hybridation in situ) or low HER2 expression (IHC + or ++ and negative-hybridation in situ) and may be ultra-low (in first line, in case of approval). 3. Patient eligible for Trastuzumab-Deruxtecan (T-DXd). 4. Concomitant administration of pertuzumab may be accepted in case of approval in first line for HER2- overexpressed/amplified locally advanced or metastatic breast cancer. 5. Female subjects of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the first dose of study treatment. 6. Female subjects of childbearing potential must be willing to follow at least one method of contraception or be surgically sterile, or abstain from heterosexual activity for the duration of the study and until 7 months after the last dose of study treatment. Subjects of childbearing potential are those who have not been surgically sterilized and who had menstruation in the last 12 months. Note: Abstinence is acceptable if it is the subject's usual lifestyle and preferred method of contraception. 7. Male subjects must agree to use at least one method of contraception for the duration of the study and until 4 months after the last dose of study treatment. Note: Abstinence is acceptable if it is the subject's usual lifestyle and preferred method of contraception. 8. Signed written informed consent. 9. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol. 10. Patient affiliated to a Social Health Insurance in France. Exclusion Criteria: 1. Peripheral venous access making blood samples difficult. 2. Patients unable to receive T-DXd treatment at a dose of 5.4 mg/kg in cycle 1 (whatever the reason) 3. Patients with known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 4. Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study. 5. Patient pregnant, or breast-feeding. 6. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure. 7. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice). 8. Concurrent participation in an experimental drug study. 9. Patient with a known history of hypersensitivity to the active substance of T-DXd or to any of the excipients listed in the SmPC of T-DXd. 10. Patient with severe hepatic impairment defined by TGO and/or TGP \> 5 x ULN and Total bilirubin \> 1.5 x ULN.
What is the Role of the Exposome in Pulmonary Hypertension
NCT07172334
Not yet recruiting
Conditions Pulmonary Arterial Hypertension (PAH), C...
Phase Not Applicable
Enrollment 150
Locations 10 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Questionnaires
  • Samples

Primary Outcomes

  • To compare the exposome assessed based on the concentration of 190 environmental toxins, drugs and medications of interest in the hair and urine of patients newly diagnosed with PAH or CTEPH
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2027-01
Completion: 2029-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Poitiers University Hospital
Contact Information
Study Contact:
Etienne-Marie JUTANT, MD-PhD
+335 49 44 33 49
etienne-marie.jutant@chu-poitiers.fr
Céline ABONNEAU, Project manager
Interventions
  • Questionnaires
  • Samples
Study Locations (10 sites)
Bordeaux University Hospital, Bordeaux, France
Brest University Hospital, Brest, France
Le Kremlin Bicetre Hospital, Le Kremlin-Bicêtre, France
Lille University Hospital, Lille, France
Louis Pradel Hospital, Lyon, France
Nancy University Hospital, Nancy, France
Poitiers University Hospital, Poitiers, France
Saint Etienne University Hospital, Saint-Etienne, France
New Civil Hospital, Strasbourg, France
Larrey Hospital, Toulouse, France
Eligibility Criteria
Inclusion Criteria: * Consent signed by the participant * Age ≥ 18 years * Free subject, under no legal protection * Good understanding of the French language, allowing to answer the questionnaires * Patients with pre-capillary PH confirmed by cardiac catheterization (PAPm \> 20mmHg, PCP ≤ 15 mmHg, RVP \> 2UW) having had the right diagnostic cardiac catheterization within one year (≤1 year) : * Cases: Patients with PAH without associated pathology: idiopathic or heritable, or with features of venous/capillary involvement, according to the clinical classification of PH * Controls: Patients with chronic thromboembolic PH (CTEPH, class 4), according to the clinical classification of PH. Exclusion Criteria: * Patients classified as HTP groups 2, 3 or 5 * Patients with a diagnosis of PAH associated with a connective tissue disease, HIV, portal hypertension, congenital heart disease, bilharzia, or a drug or toxic cause considered certain according to the international classification (Aminorex, Benfluorex, Carfilzomib, Dasatinib, Dexfenfluramine, Fenfluramine, Methamphetamines, Mitomycin C, adulterated rapeseed oil) * Patients with signs of right heart failure requiring amines and/or intensive care hospitalization at time of visit (may be included at a later visit) * Patients refusing hair sampling or having no hair \> 2 cm to allow sampling * Patients benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection, and patients in emergency situations
Efficacy and Safety of Treprostinil in Intermediate-Risk Pulmonary Arterial Hypertension
NCT07177703
Not yet recruiting
Conditions Pulmonary Arterial Hypertension (PAH)
Phase PHASE2
Enrollment 32
Locations 0 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

  • Treprostinil

Primary Outcomes

  • Change From Baseline in Right Ventricular Stroke Volume (RVSV)
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: 2025-10-31
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 32 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Shanghai Zhongshan Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Treprostinil
Eligibility Criteria
Inclusion Criteria: * Signed the informed consent form. * Age between 18 and 75 years, inclusive. * Diagnosed with Pulmonary Arterial Hypertension (PAH, WHO Group 1) of the following etiologies:Idiopathic;Heritable;Drug or toxin-induced (excluding amphetamine-induced PAH);Associated with repaired congenital systemic-to-pulmonary shunts (repair performed ≥1 year prior);Associated with connective tissue disease;Associated with HIV infection; * Has undergone a right heart catheterization (RHC) within 6 months of the baseline visit. * Baseline RHC demonstrates the following hemodynamics:Mean pulmonary arterial pressure (mPAP) \> 20 mmHg;Pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg;Pulmonary vascular resistance (PVR) \> 2 Wood units; * WHO Functional Class II, III, or IV. * Risk stratification according to 2022 ESC/ERS guidelines is either intermediate-risk at initial diagnosis or low- to intermediate-risk during follow-up. * Patient is on a stable dose of an endothelin receptor antagonist (ERA) and/or a phosphodiesterase-5 inhibitor (PDE-5i) or a soluble guanylate cyclase (sGC) stimulator for at least 30 days prior to baseline; OR, if treatment-naïve, is willing to initiate one of these therapies in addition to the study drug. Exclusion Criteria: * Age \< 18 years. * Diagnosis of Pulmonary Hypertension belonging to WHO Groups 2, 3, 4, or 5. * Patients undergoing dialysis. * Severe hepatic impairment (Child-Pugh Class C). * Use of any prostacyclin-pathway drugs (epoprostenol, treprostinil, iloprost, beraprost, or selexipag) within 30 days prior to the baseline visit. * Presence of implanted metallic devices that would interfere with Cardiac - - - Magnetic Resonance (CMR) imaging, such as defibrillators, neurostimulators, cochlear implants, permanent infusion devices, implanted pumps, or certain plates/screws. * In the investigator's judgment, the patient is unable to complete or comply with study requirements. * Refusal to sign the informed consent form or refusal to participate in follow-up visits. * Participation in any other clinical trial involving an investigational drug, device, or procedure within 30 days prior to the baseline visit.
Diet and Progression of CKD in Patients With Type 2 Diabetes Mellitus
NCT07169786
Not yet recruiting
Conditions CKD Stage 1-4, Diet Pattern Analysis, Ty...
Phase Not Applicable
Enrollment 160
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Evaluation of the influence of dietary pattern on the progression of chronic kidney disease among patients with type 2 Diabetes Milletus
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2025-10
Completion: 2028-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: Not specified
Enrollment: 160 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Mariam Emeel Haleem Naseem
Contact Information
Study Contact:
Mariam Emeel Haleem
+201273939432
Mariam.17289970@med.aun.edu.eg
Salah Abdelazeem Argoon
+201064559917
argoons@yahoo.com
Interventions
N/A
Eligibility Criteria
Inclusion Criteria: * • Adults aged above 18 years * Diagnosed with type 2 diabetes mellitus according to ADA criteria. * Diagnosed with chronic kidney disease stages 1-4 (eGFR 15-90 mL/min/1.73 m²) for at least 3 months. * Willing and able to provide informed consent Exclusion Criteria: * • Patients with end-stage renal disease (CKD stage 5 or on dialysis). * History of kidney transplantation. * Acute kidney injury within the past 3 months. * Pregnant or lactating women. * Patients with severe comorbid conditions (e.g., active malignancy, severe heart failure). * Use of medications known to significantly affect renal function (other than standard antihypertensive or antidiabetic therapy).
"Mon Parcours de Vie" Localized Breast Cancer: Announcement, Support, Information on the Disease and Treatments. Pilot Study to Assess the Value of Written Information Documents.
NCT07165756
Recruiting
Conditions Localized Breast Cancer
Phase Not Applicable
Enrollment 60
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

  • Acceptability rate
  • Variation in the anxiety score
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: 2025-09-09
Completion: 2026-11-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Institut de Cancérologie de Lorraine
Contact Information
Study Contact:
Jean-Louis MERLIN
+33 3 83 59 84 00
jl.merlin@nancy.unicancer.fr
Denise BECHET
+33 3 83 59 86 79
d.bechet@nancy.unicancer.fr
Interventions
N/A
Study Locations (1 sites)
Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, 54519 France
Eligibility Criteria
Inclusion Criteria: * Patient with localized breast cancer consulting for medical treatment (chemotherapy+/- immunotherapy+/anti-HER2 targeted therapy) * Diagnosis of invasive breast cancer for which there is an indication for local and medical treatment. * WHO ≤ 1 * Patient has understood, signed and dated the consent form * Patient affiliated to the social security system Exclusion Criteria: * Patient with metastatic breast cancer * History of other cancer * Patient unable to read or speak French * Persons deprived of liberty or under guardianship (including curatorship).
Exploring Blood Cell Function and Oxidative Stress to Improve Diagnosis and Treatment in Pre-Capillary Pulmonary Hypertension
NCT07176260
Recruiting
Conditions Pre-capillary Pulmonary Hypertension
Phase Not Applicable
Enrollment 120
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Patients with pre-Capillary pulmonary hypertension

Primary Outcomes

  • Blood Cell Mitochondrial Function and Respiration and Oxidative Stress Markers
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: 2025-09
Completion: 2026-06
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospital, Strasbourg, France
Principal Investigators:
  • Marianne RIOU (PRINCIPAL_INVESTIGATOR) - Hôpitaux Universitaires de Strasbourg
Contact Information
Study Contact:
Marianne RIOU
+ 33 3 69 55 11 45
marianne.riou@chru-strasbourg.fr
Interventions
  • Patients with pre-Capillary pulmonary hypertension
Study Locations (1 sites)
Hôpitaux Universitaires de Strasbourg - Service Physiologie explorations fonctionnelles, Strasbourg, Bas-Rhin 67000 France
Eligibility Criteria
Inclusion Criteria: * Adult patients (≥18 years) diagnosed with pre-capillary pulmonary hypertension confirmed by right heart catheterization * Patients classified according to the international clinical classification: * Group 1: Pulmonary arterial hypertension (PAH) * Group 3: Pulmonary hypertension associated with chronic respiratory diseases and/or hypoxia * Group 4: Chronic thromboembolic pulmonary hypertension (CTEPH) * Patients scheduled for routine clinical follow-up and/or right heart catheterization at the study center. * Ability and willingness to provide informed consent for participation and data analysis. Exclusion Criteria: * Postcapillary pulmonary hypertension (pulmonary arterial wedge pressure \>15 mmHg). * Conditions precluding safe blood sampling (e.g., severe anemia, coagulopathy). * Patients already enrolled in interventional clinical trials that could interfere with mitochondrial or oxidative stress measurements * Patients unable or unwilling to provide informed consent * Pregnancy or breastfeeding