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A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases
NCT06764940
Recruiting
Conditions HER2-negative Breast Cancer Patients Wit...
Phase PHASE2
Enrollment 120
Locations 17 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

  • Utidelone
  • Utidelone in combination with capecitabine
  • Utidelone in combination with capecitabine
  • Utidelone in combination with capecitabine

Primary Outcomes

  • Intracranial Objective Response Rate (IC-ORR) evaluated by investigator according to RECIST 1.1 criteria.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2025-07-14
Completion: 2027-07-15
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Biostar Pharma, Inc.
Contact Information
Study Contact:
Simon Guan
+86 10 67864938
simon.guan@biostar-pharma.com
Interventions
  • Utidelone
  • Utidelone in combination with capecitabine
  • Utidelone in combination with capecitabine
  • Utidelone in combination with capecitabine
Study Locations (17 sites)
City of Hope--Duarte, Duarte, California 91010 United States
Cancer & Blood Research Center, LLC, Los Alamitos, California 90720 United States
Univ. of California Los Angeles, Los Angeles, California 90095 United States
FOMAT Medical Research (Network), Oxnard, California 93030 United States
Scripps Health, San Diego, California 92121 United States
University Of Colorado Hospital - Anschutz Cancer Pavilion, Aurora, Colorado 80045 United States
Biosresearch Partner, Hialeah, Florida 33013 United States
D&H Cancer Research Center, Margate, Florida 33063 United States
Augusta University, Augusta, Georgia 30912 United States
Robert H. Lurie Comprehensive Cancer Center Northwestern University, Chicago, Illinois 60611 United States
Eligibility Criteria
Inclusion Criteria: 1. Have histologically confirmed HER2-negative metastatic breast cancer. HER2-negative defined as immunohistochemical (IHC) score of 0 or 1+, or IHC2+ with negative HER2 expression on in situ hybridization (ISH). 2. Based on screening contrast-enhanced brain MRI, patients must have at least one measurable intracranial lesion according to RECIST 1.1 (≥1.0 cm in size) . 3. Male or female aged ≥18 years. 4. ECOG PS 0 or 1. 5. Have a life expectancy of at least 3 months. 6. Have adequate baseline hematologic parameters. 7. Have adequate hepatic and renal function. 8. ≤ 3 prior lines of chemotherapy in advanced or metastatic setting. 9. Women of childbearing potential, unless hysterectomy or oophorectomy or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives \[any hormonal method in conjunction with a secondary method\], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile \[at least 6 months prior to study drug administration\] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 6 months following the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. Investigator will discuss with patient on the above points and the patient agreement will be documented in the source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol. In case of Male patients: Either patient partners or patients themselves must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 6 months following the last dose. 10. Patients must be able to follow the study visit schedule, and must be able of sign and give informed consent in accordance with institutional review board. Exclusion Criteria: 1. Leptomeningeal metastasis confirmed by MRI and/or cerebrospinal fluid cytology. 2. Any intracranial lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or possible treatment-related edema may pose risk to patient (e.g. brain stem lesions). 3. Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases notwithstanding CNS-directed therapy. 4. Had evidence of intracranial hemorrhage within 3 months before study treatment. 5. Had evidence of hemoptysis within 6 months before study treatment. Or bleeding or evidence of coagulopathy within 4 weeks before study treatment. 6. Undergone major surgical procedures within 4 weeks or not fully recovered from surgery before study treatment. 7. Patients who have received anti-tumor therapies less than 2 weeks before the first dose of investigational product, including endocrine therapy, chemotherapy, radiotherapy, biotherapy, targeted therapy, immunotherapy or antibody-drug conjugate therapy. 8. Persistent toxicities caused by previous antitumor therapy (excluding alopecia), not yet improved to CTCAE v5.0 grade ≤ 1 or baseline. 9. Patients with neuropathy\> grade 1. 10. Known hypersensitivity to any components of the investigational product. 11. Known deficiency of dihydropyrimidine dehydrogenase (DPD). 12. This applies only to the combination cohort and does not apply to the monotherapy cohort. For patients with previous capecitabine treatment, the prior use of capecitabine meets any of the following criteria: A) The best response during prior capecitabine combination therapy or monotherapy is Progressive Disease (PD); B) Have received capecitabine treatment within 6 months prior to the first study treatment. 13. Patients who are pregnant (positive pregnancy test) or lactating. 14. Patients with other malignancies over the past 5 years, except for inactive tumors with good prognosis, including resected basal cell and squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, or papillary thyroid cancer. 15. Patients who are particpating in other interventional studies or who are receiving other study treatments (patients who have discontinued other investigational treatments and are in follow-up are eligible for enrollement in this study). 16. Known active or uncontrolled hepatitis B infection, active syphilis, or HIV infection that is not well controlled; or positive for hepatitis B virus based on the evaluation of results of tests for hepatitis B (HBsAg, anti-HBs, anti-HBc, or HBV DNA) infection at screening. 17. With a history of severe or uncontrolled diseases. 18. Autoimmune diseases requiring treatment with systemic glucocorticoids. 19. Not able to perform contrast-enhanced brain MRI or known contraindications to MRI gadolinium contrast, such as cardiac pacemaker, shrapnel, or eye foreign body. 20. Patients with a history of other systemic severe diseases or abnormal laboratory findings that would, in the Investigator's judgment, be inappropriate for this study.
Effect of a Specific Hand Intervention in Women With Arthralgia Secondary to Hormone Therapy Following Breast Cancer.
NCT06746376
Not yet recruiting
Conditions Arthralgia
Phase NA
Enrollment 32
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

  • Occupational Therapy

Primary Outcomes

  • Brief Pain Inventory (BPI)
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: 2025-04-01
Completion: 2025-11-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 32 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Universidad Europea de Madrid
Principal Investigators:
  • Vanesa Abuín-Porras, PhD (PRINCIPAL_INVESTIGATOR) - Universidad Europea de Madrid
Contact Information
Study Contact:
Vanesa Abuín-Porras, PhD
+34 676566073
vanesa.abuin@universidadeuropea.es
Nuria Muñoz-Bermúdez, PT
+34 676566073
nuria.muñoz@universidadeuropea.es
Interventions
  • Occupational Therapy
Study Locations (1 sites)
Universidad Europea de Madrod, Villaviciosa de Odón, Spain
Eligibility Criteria
Inclusion Criteria Experiencing hand arthralgia as a result of hormone therapy (aromatase inhibitors or tamoxifen) following breast cancer. Ability to communicate pain levels effectively. Ability to follow simple instructions to participate in the intervention and assessments. Exclusion Criteria Participants requiring any medication changes during the study period that could influence pain levels (increase or decrease). Concurrent physiotherapy or occupational therapy specifically targeting the hand during the study. Pre-existing diagnosis of arthritis or osteoarthritis in the hand before starting hormone therapy. Presence of systemic diseases associated with hand arthralgia. Neurological conditions affecting hand movement.
Influence of Menstrual Cycle Phases on the Glycemic Control of Aerobic or HIIT Exercise in Adult Women With Type 1 Diabetes
NCT06729242
Recruiting
Conditions Diabetes Mellitus, Type I, Menstruation
Phase NA
Enrollment 40
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Aerobic session
  • HIIT session

Primary Outcomes

  • Mean interstitial glucose
  • Glycemic variability
  • Time spent at each glucose range
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-01-10
Completion: 2026-06
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Valencia
Collaborators: European Regional Development Fund
Contact Information
Study Contact:
Rodrigo Martín-San Agustín, Dr.
0034963983855
rodrigo.martin@uv.es
Interventions
  • Aerobic session
  • HIIT session
Study Locations (1 sites)
University of Valencia, Valencia, Select One 46010 Spain
Eligibility Criteria
Inclusion Criteria: Age between 18-45 years T1D with a diabetes duration for more than 2 years Glycated hemoglobin (HbA1c) \< 8.5% (\<69 mmol mol-1) Stable insulin regimen in the past 6 months with less than 20% change in total insulin daily dose Multiple daily injections or insulin pump Weekly physical activity of 90 min or more, but no practicing any sport as amateur or professional. Exclusion Criteria: Clinical conditions or use of medications (other than insulin) known to affect glycemic control (e.g., oral/parenteral steroids or metformin, among others).
Bioequivalence Study of Paclitaxel for Injection (Albumin Bound) in Subjects With Breast Cancer
NCT06765590
Recruiting
Conditions Breast Cancer
Phase NA
Enrollment 24
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

  • T, 260 mg/m2, paclitaxel for injection (albumin-bound)
  • R, 260 mg/m2, paclitaxel for injection (albumin bound).

Primary Outcomes

  • Maximum observed concentration of paclitaxel (Cmax)
  • Area under the concentration-time curve from time zero to infinite time of paclitaxel (AUC 0-inf)
  • Area under the concentration-time curve from time zero to the last time of paclitaxel (AUC 0-t)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-03-12
Completion: 2026-10-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 24 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd
Collaborators: The First Hospital of Jilin University, The First Affiliated Hospital of Bengbu Medical University, Chongqing Traditional Chinese Medicine Hospital, The First Affiliated Hospital of Henan University of Science and Technology, Qianfoshan Hospital
Contact Information
Study Contact:
Chun Wan
02886021875
chun.wan3717@huiyupharma.com
Interventions
  • T, 260 mg/m2, paclitaxel for injection (albumin-bound)
  • R, 260 mg/m2, paclitaxel for injection (albumin bound).
Study Locations (1 sites)
The First Affiliated hospital of Hennan University of Science & Technology, Luoyang, Henan 471003 China
Eligibility Criteria
Inclusion Criteria: 1. Subjects voluntarily participate in the study and sign the informed consent forms (ICFs); 2. Patients with breast cancer confirmed by histopathology and/or cytology who meet one of the following conditions: ① with metastatic breast cancer that does not respond to combination chemotherapy or recurrent breast cancer within 6 months after adjuvant chemotherapy, and an anthracycline anticancer drug should be used in the previous chemotherapy unless clinically contraindicated; ② investigators determine that subjects are candidates for albumin-bound paclitaxel by reference to the treatment guidelines (NCCN Guidelines and CSCO Guidelines for breast cancer); 3. Aged 18-75 years old (both inclusive), males or females; body mass index (BMI) ≥17 (BMI = weight (kg)/height (m2)); 4. The ECOG score is 0-2; 5. The expected survival time is ≥3 months; 6. Subjects have no plans to become pregnant and voluntarily use non-pharmacologic contraception (such as total abstinence, condom, contraceptive ring, vasectomy, etc.) or other highly effective contraceptive methods, and have no plans to donate eggs or sperm throughout the trial and within 6 months after the last dose; 7. Subjects with the laboratory test results as follows: hemoglobin (Hb) ≥80 g/L (no blood transfusion within 14 days), absolute neutrophil count (ANC) ≥1.5 \* 109/L, platelet count (PLT) ≥100 \* 109/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times the upper limit of normal value (for patients without liver metastasis) or ≤5 times the upper limit of normal value (for patients with liver metastasis); total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (for patients without liver metastasis) or ≤3 times the upper limit of normal value (for patients with liver metastasis); serum creatinine clearance ≥60 mL/min \[formula: Ccr: (140 - age) \* body weight (kg) \* 0.85 (if female)/0.818 \* Scr (μmol/L)\]; international normalized ratio (INR) ≤1.5 times the upper limit of normal value; 8. Subjects are able to communicate well with the investigator and understand and comply with the requirements of the study. Exclusion Criteria: 1. Subjects with allergic constitution (excluding mild asymptomatic seasonal allergies), or who are known (or suspected) to be allergic to or have a specific reaction to the active ingredient paclitaxel or excipients, albumin; 2. Subjects who have received radiotherapy, chemotherapy, immunotherapy and endocrinotherapy within 4 weeks before the administration of the investigational drug and still respond to the treatment; 3. Subjects who have suffered from serious illness of cardio-cerebral vascular system, lung, liver, kidney, gastrointestinal tract, endocrine system, immune system, skin, musculoskeletal system and nervous system or psychiatric disorders within 3 months before screening and are considered unsuitable for enrollment by the investigator; 4. Subjects who have undergone major surgery or suffered from fracture within 4 weeks prior to screening, or plan to undergo major surgery during the study; 5. Subjects who have received treatment with other investigational drugs within 4 weeks before the study; 6. Subjects who have used substrates, inducers or inhibitors of CYP2C8 or CYP3A4 enzymes (including but not limited to ketoconazole and other imidazole antifungal agents, verapamil, diazepam, quinidine, dexamethasone, cyclosporine, teniposide, etoposide, vincristine, testosterone, 17-α diethylstilbestrol, retinoic acid, quercetin, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, nelfinavir, rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine, etc.) in concomitant medications within 4 weeks prior to the first dose of the investigational drug or fail to suspend medications during the study (except for stable dosing at steady state, i.e. the dosing regimen remains unchanged); 7. Subjects who have consumed special diet (foods that affect the activity of CYP3A4 or CYP2C8 enzyme, such as grapefruit, pomelo, mango, etc.), exercised vigorously or with other factors that may affect drug absorption, distribution, metabolism and excretion within 48 hours before the administration of the investigational drug; 8. Subjects who have received therapy with the granulocyte colony-stimulating factor (G-CSF) within 2 weeks before screening; 9. Subjects with grade 2 or higher sensory neuropathy/peripheral neuropathy at screening; 10. Subjects who have experienced myocardial infarction (within 6 months before the study), severe or unstable angina, and grade III-IV heart failure according to the New York Heart Association (NYHA) Classification, or underwent coronary or peripheral artery bypass grafting; 11. Subjects with poorly controlled hypertension (with the systolic blood pressure of \>160 mmHg and/or diastolic blood pressure of \>100 mmHg under regular medication); 12. Subjects who have bleeding tendency or are receiving thrombolytic or anticoagulant therapy or have donated or lost more than 400 mL of blood within 3 months before the administration of the investigational drug; 13. Subjects with clinically significant 12-lead ECG abnormalities, who are considered unsuitable for enrollment by the investigator; 14. Subjects with a history of alcohol (drinking more than 14 units of alcohol per week within 6 months prior to the first dose: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), drug abuse (using narcotic drugs or psychotropic drugs for non-medical purposes) or addiction to drugs, who smoked more than 5 cigarettes per day within 3 months prior to screening, or who could not stop smoking or drinking during the period from signing the ICFs to completing the bioequivalence study; 15. Subjects with positive results of hepatitis B surface antigen (HBsAg), HBV DNA, hepatitis C core antibody (HCV-cAg), HCV RNA, HIV antibody, treponema pallidum antibody, or rapid plasma reagin (RPR) test; 16. Pregnant or lactating women; 17. Other conditions judged inappropriate for participation by the investigator.
Intermittent Theta Burst Stimulation in Fibromyalgia Syndrome
NCT06746922
Recruiting
Conditions Fibromyalgia, Transcranial Magnetic Stim...
Phase NA
Enrollment 30
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

  • Intermittent theta-burst stimulation
  • Sham Intermittent theta-burst stimulation

Primary Outcomes

  • Change from baseline in the Numeric Rating 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: 2025-03-13
Completion: 2027-04-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Izmir Katip Celebi University
Contact Information
Study Contact:
Ayhan ASKIN, Professor
902322444444
ayhan.askin@ikc.edu.tr
Ezgi Ayan, MD
902322444444
ezgiugurlu45@icloud.com
Interventions
  • Intermittent theta-burst stimulation
  • Sham Intermittent theta-burst stimulation
Study Locations (1 sites)
Izmir Katip Çelebi University Atatürk Training and Research Hospital, Izmir, Karabaglar 35290 Turkey (Türkiye)
Eligibility Criteria
Inclusion Criteria: * Being between the ages of 18-65 * Being diagnosed with fibromyalgia syndrome (according to 2016 criteria) * Average pain intensity of NRS ≥ 4/10 * Fibromyalgia treatment was stable for the last 3 months and no treatment change was planned during the study Exclusion Criteria: * Having a clinical condition that would constitute a contraindication for TMS (metallic implant, cardiac pacing, pregnancy, epilepsy, head trauma, history of cranial operation...) * Presence of malignancy * Systemic rheumatologic diseases * Major orthopedic problems limiting activities of daily living (gait disturbance or fracture sequelae limiting joint mobility, prostheses, nerve-tendon injuries) * Serious neurological diseases (increased intracranial pressure, presence of space-occupying lesions in the brain, history of epilepsy, presence of cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, history of previous head trauma causing loss of consciousness) * Alcohol or drug addiction * History of major depression/personality disorder or psychosis * Having received TMS treatment before * Taking benzodiazepine, gabapentin/pregabalin or anticonvulsant medications that have the potential to interfere with intermittent theta burst stimulation treatment or have taken them within the last 4 weeks * Pregnant or planning pregnancy or breastfeeding
Telemedicine Education for Caregivers and Asthma Control in Children
NCT06753214
Recruiting
Conditions Uncontrolled Asthma, Telemedicine-Based ...
Phase NA
Enrollment 64
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

  • Telemedicine-Based Education
  • Standard Care (in control arm)

Primary Outcomes

  • The improvement of asthma control
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-06-05
Completion: 2026-06
Eligibility
Age: 4 Years
Sex: ALL
Volunteers: false
Enrollment: 64 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Can Tho University of Medicine and Pharmacy
Principal Investigators:
  • Nghia Quang Bui, MD, PhD (STUDY_CHAIR) - Can Tho University of Medicine and Pharmacy
  • Ly Cong Tran, MD, MSc (STUDY_DIRECTOR) - Can Tho University of Medicine and Pharmacy
  • Thang Hoang Le, MD (PRINCIPAL_INVESTIGATOR) - Can Tho University of Medicine and Pharmacy
Contact Information
Study Contact:
Thang Hoang Le, MD
+84962024776
hoangthang0899@gmail.com
Ly Cong Tran, MD, MSc
+84397938208
tcly@ctump.edu.vn
Interventions
  • Telemedicine-Based Education
  • Standard Care (in control arm)
Study Locations (1 sites)
Can Tho Children's Hospital, Can Tho, 900000 Vietnam
Eligibility Criteria
Inclusion Criteria: * Pediatric asthma patients diagnosed according to the GINA guidelines, classified as having uncontrolled asthma, are managed and followed up for at least 1 month at the pediatric asthma unit of the outpatient department. Exclusion Criteria: * Pediatric patients who do not cooperate or are unable to complete the Childhood Asthma Control Test questionnaire. * Caregivers who cannot complete the questionnaires related to the assessment of asthma control and associated factors. * Pediatric patients who have siblings participating in the study. * Patients currently participating in another clinical study (excluding non-interventional studies or registries). * Failure to return for a second visit within 6 months following enrollment.
Ketogenic Metabolic Therapy in Schizophrenia, Bipolar Disorder, Major Depressive Disorder: Deep Omic Profiling
NCT06748950
Not yet recruiting
Conditions Schizophrenia, Schizophrenia and Related...
Phase NA
Enrollment 120
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

  • LCHF Ketogenic Diet
  • Diet-as-Usual (DAU)

Primary Outcomes

  • WHO-5 Well-being Index
  • Functioning Assessment Short Test (FAST)
  • Quality of Life Scale (QIDS)
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: 2025-07
Completion: 2028-07
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Stanford University
Principal Investigators:
  • Shebani Sethi, MD, ABOM (PRINCIPAL_INVESTIGATOR) - Stanford University
  • Michael Snyder, PhD (PRINCIPAL_INVESTIGATOR) - Stanford University
Contact Information
Study Contact:
Study Coordinator
(650) 725-0169
jessili@stanford.edu
Interventions
  • LCHF Ketogenic Diet
  • Diet-as-Usual (DAU)
Study Locations (1 sites)
Stanford University, Palo Alto, California 94304 United States
Eligibility Criteria
Inclusion Criteria: 1. diagnosed with bipolar disorder (BD), major depressive disorder (MDD), and or schizophrenia 1. For individuals diagnosed with bipolar disorder (BD): * Meet DSM V criteria for BD (any subtype) * Not mild * \>40 on BPRS * clinically stable (with no hospitalization for past 3 months) 2. For individuals diagnosed with major depressive disorder (MDD): * Not mild * PHQ-9 \> 10 * clinically stable (with no hospitalization for past 3 months) 3. For individuals diagnosed with schizophrenia: * Meet DSM V criteria for schizophrenia (any subtype) * Not mild * \>40 on BPRS * clinically stable (with no hospitalization for past 3 months) 2. Participants may currently be on a stable and adequate dose of SSRI antidepressant therapy or other psychiatric medication. Concurrent hypnotic therapy (e.g., with zolpidem, zaleplon, melatonin, or trazodone) will be allowed if the therapy has been stable for at least four weeks prior to screening and if it is expected to remain stable. Participants may be switched from other classes of medication to another medication class by their psychiatrist or primary care doctor, but need to be stable enough to enroll and adhere to study procedures. 3. willing and able to give informed consent for participation in English. 4. live within the United States. \-------------------------------------------------------------------------------- Exclusion Criteria: 1. has started the ketogenic diet or was in ketosis within 3 months of wanting to enroll 2. pregnant or nursing 3. insulin dependent 4. comorbidity of developmental delay 5. in a current severe mood or psychotic state when entering the study that would prohibit compliance with study visits or dietary programs. 6. any one who has been hospitalized or taken clozapine at doses above 550mg over the past 3 months 7. inability to complete baseline measurements 8. severe renal or hepatic insufficiency 9. cardiovascular dysfunction, including diagnosis of: * Congestive heart failure * Angina * Arrhythmias * Cardiomyopathy * Valvular heart disease 10. active substance abuse with illicit drugs or alcohol and/or current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine or cannabis dependence 11. active suicidal and considered at significant risk for suicide during course of study 12. participation in any clinical trial- within the past month or concurrent to study participation- with an investigational drug/device and/or intervention that may interfere with study participation/evaluation of results 13. mild BPRS at screening or baseline visits 14. history of TBI 15. any other medical condition that may make diet intervention dangerous as determined by the study medical team (e.g. anorexia nervosa) or assessed by study team to have insufficient control over their food intake to adhere to study diets. 16. any medical condition that physicians or the PI believe would interfere with study participation or evaluation of results 17. history of familial hypercholesterolemia
E-Mindfulness Approaches for Living After Breast Cancer
NCT06748222
Recruiting
Conditions Breast Cancer, Depression
Phase PHASE3
Enrollment 402
Locations 364 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

  • Mindfulness (MAPs) Live Online
  • Mindfulness (MAPs) Digital App
  • Meditation Only Control Group

Primary Outcomes

  • Self-reported depressive symptoms measured-post intervention in the Mindful Awareness Practices (MAPs) live online (LO) and the meditation only (MO) groups
  • Self-reported depressive symptoms measured-post intervention in the Mindful Awareness Practices (MAPs) App and the meditation only (MO) groups
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2025-06-27
Completion: 2030-02-28
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 402 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: NRG Oncology
Collaborators: National Cancer Institute (NCI)
Contact Information
Study Contact:
Director Regulatory Affairs
412-339-5300
langerj@nrgoncology.org
Norman Wolmark, MD
Interventions
  • Mindfulness (MAPs) Live Online
  • Mindfulness (MAPs) Digital App
  • Meditation Only Control Group
Study Locations (364 sites)
Mayo Clinic Hospital in Arizona, Phoenix, Arizona 85054 United States
Mercy Hospital Fort Smith, Fort Smith, Arkansas 72903 United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro, Jonesboro, Arkansas 72401 United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205 United States
Kaiser Permanente-Anaheim, Anaheim, California 92806 United States
Kaiser Permanente-Deer Valley Medical Center, Antioch, California 94531 United States
AIS Cancer Center at San Joaquin Community Hospital, Bakersfield, California 93301 United States
Kaiser Permanente-Baldwin Park, Baldwin Park, California 91706 United States
Kaiser Permanente-Bellflower, Bellflower, California 90706 United States
Marshall Cancer Center, Cameron Park, California 95682 United States
Eligibility Criteria
Inclusion Criteria: * The participant or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for participants treated in the U.S., authorization permitting release of personal health information. * The participant must have been greater than or equal to 18 or less than or equal to 50 years of age at the time of breast cancer diagnosis. * The participant must have a first-time diagnosis of non-metastatic breast cancer which is Stage 0, I, II, or III. * The participant must have a score of greater than or equal to 5 and less than or equal to 14 on the Patient Health Questionnaire-8 item (PHQ-8). * Participants must have completed all primary breast cancer treatments at least 6 months prior to and no more than 5 years prior to registration. Note: Primary treatments include surgery, radiation therapy, adjuvant chemotherapy, targeted therapies (e.g., PARP (poly-ADP ribose polymerase) inhibitors, CDK4/6 inhibitors, TDM-1, pertuzumab, or immunotherapy). (Participants may still be taking adjuvant therapy with trastuzumab or adjuvant endocrine therapy or completing minor reconstructive surgery.) * Participant must be able to understand, speak, read, and write in English or Spanish. * Participant must be willing to participate in a 6-week program to receive training in mindfulness. * Participant must be able to use a smartphone, tablet, or other digital device. * Sex assigned at birth must be female. Exclusion Criteria: * Patient Health Questionnaire-8 item (PHQ-8) score of less than 5 or greater than 14 . * Any history or current evidence of recurrent or metastatic breast cancer. * Current or past history of another cancer. Participants with a history of only non-melanoma skin cancer or in situ cervical cancer without chemotherapy treatment would be eligible. * Currently pregnant or planning to become pregnant in the near future. * Participants who are enrolled in other cancer control or behavioral intervention trials that require frequent assessments or training activities.
Nature-based Virtual Reality Intervention for Depression in Alzheimer's Disease
NCT06732128
Recruiting
Conditions Alzheimer Disease, Depression
Phase NA
Enrollment 50
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

  • nature-based virtual reality applications and videos
  • nature-based videos

Primary Outcomes

  • Tolerability of nature-based virtual reality
  • Feasibility of nature-based virtual reality
  • Acceptability of nature-based virtual reality
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-01-06
Completion: 2025-11-11
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Centre for Addiction and Mental Health
Collaborators: St. Mary's Research Center, Canada
Principal Investigators:
  • HARMEHR SEKHON, PhD (PRINCIPAL_INVESTIGATOR) - CAMH and McGill/St. Mary's Research Centre
  • Eric Brown, MD (PRINCIPAL_INVESTIGATOR) - CAMH and UofT
Contact Information
Study Contact:
Ashnie Sukhu, BSc
(416) 535-8501
ashnie.sukhu@camh.ca
Interventions
  • nature-based virtual reality applications and videos
  • nature-based videos
Study Locations (1 sites)
Centre for Addictions and Mental Health (CAMH), Toronto, Ontario L5V 2X3 Canada
Eligibility Criteria
Inclusion Criteria: * Clinical diagnosis of mild to early-moderate stage AD (including mixed dementia with AD) using the Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. Criteria * Age of 50 years or older * Medical stability to participate in the trial * Patient Health Questionnaire score 5-14 * Investigator judgement on whether the participant is comfortable with technology * Access to WiFi and a smart device for connecting on WebEx and downloading the Fitbit and Muse applications * Have someone available to be present during all sessions Exclusion Criteria: * Unstable medical or psychiatric condition, including substance use based on an investigator opinion * Visual or hearing impairments that would impair participation * Patient Health Questionnaire score 15-27 and/or score of 1 or 2 in section E question 1 of the Cornell Scale for Depression in Dementia * Any other reason, which will make the study participation intolerable for the participant in the opinion of the study investigator
A Study of BL0175 Injection in Postmenopausal Female Adults With HR-positive, Locally Advanced or Metastatic Cancer
NCT06738966
Recruiting
Conditions Breast Cancer, Ovarian Cancer, Endometri...
Phase PHASE1
Enrollment 9
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

  • BL0175

Primary Outcomes

  • Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2025-03-10
Completion: 2027-12-26
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 9 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Shanghai Best-Link Bioscience, LLC
Contact Information
Study Contact:
Guat Hoon Ong
+65 9726 6883
gho@zhangjiang-bio.com
Interventions
  • BL0175
Study Locations (2 sites)
The First Hospital of Jilin University, Changchun, Jilin 130000 China
Jinan Central Hospital, Jinan, Shandong 250000 China
Eligibility Criteria
Inclusion Criteria: 1. Volunteer to participate in the study, be able to understand the requirements of a clinical study, and willingness to sign a written informed consent form. 2. Age ≥ 18 years. 3. HR-positive, HER2-negative (characterized by the absence of HER2 expression and the presence of ER and/or PR expression) locally advanced or metastatic breast cancer (histological or cytological proven diagnosis) in postmenopausal women with disease progression during or following endocrine therapy, or HR-positive, locally advanced or metastatic ovarian cancer or endometrial cancer in postmenopausal women that progressed during or following prior standard of care therapy. 4. Patients with at least one measurable or evaluable lesion: At least one lesion (measurable and/or non-measurable) that can be accurately assessed by CT/MRI/plain x-ray at baseline and follow up visit. Note: Measurable lesions cannot be selected from the following sites in principle: having received prior radiotherapy or having received other local therapy. If a target lesion at a site that has received prior radiotherapy or other local therapy is the only optional lesion, the progression of the lesion shall be confirmed by the investigator. 5. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening. 6. Life expectancy period ≥ 12 weeks. Exclusion Criteria: 1. Patients with symptomatic central nervous system (CNS) metastases or carcinomatous meningitis. Note: patients with treated CNS metastases may participate in this study if the patient has completed radiotherapy or surgery for CNS metastases ≥ 4 weeks prior to study entry, and if the patient is neurologically stable ≥ 2 weeks after radiotherapy or surgery treatment (no new neurologic deficits from brain metastasis on screening clinical examination, no new findings on CNS imaging, and corticosteroids were not required within 2 weeks prior to enrollment). 2. Patients who have a history of another primary malignancy (with the exception of participants with cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of uterine cervix). A patient who has had no evidence of disease from another primary cancer for 3 or more years is allowed to participate in the study. 3. Patients whose pericardial effusion, pleural effusion or ascites remain uncontrollable after intervention. 4. Patients with a history of allogeneic transplantation of organs, bone marrow or stem cell. 5. A history of allergic or adverse response(s) to fulvestrant, or prone to allergic reactions (such as: prone to angioedema, urticaria, asthma, rash, etc.). 6. Patients who have impaired cardiac function or clinically significant cardiac diseases, including any of the following: * New York Heart Association class III-IV for cardiac insufficiency or left ventricular ejection fraction \< 50% (if the LVEF data is available). * Patients with poorly controlled arrhythmia: QTc interval \> 480 ms calculated by Fridericia's formula, or congenital syndrome of prolonged QT interval. * Any of the following within 6 months prior to the enrollment: myocardial infarction, severe or unstable angina, congestive heart failure, cerebrovascular accident (including transient ischemic attack), symptomatic pulmonary embolism or other clinically significant thromboembolic disease, or coronary artery bypass graft. * Clinically symptomatic bradycardia as assessed by the investigator. * Patients with other clinically significant cardiovascular disease who were assessed as unsuitable for this study by the investigator. 7. Patients who have a known diagnosis of Human Immunodeficiency Virus (HIV) infection or HIV antibody test positive in screening. 8. Patients with active hepatitis C or chronic hepatitis B at screening ("active hepatitis" defined as HCV RNA level ≥ 200 IU/mL for hepatitis C or HBV DNA level ≥ 2000 IU/mL for hepatitis B at screening). In addition, eligible hepatitis B or hepatitis C patients must agree to antiviral treatment according to the treatment guidelines. 9. Active infections requiring antibiotic intravenous therapy within 1 weeks prior to enrollment. 10. Moderate or severe hepatic impairment (Child-Pugh class B or C). 11. Patients who have not sufficient baseline organ function and whose laboratory data meet the following criteria at enrollment \[No transfusion of blood products (including platelets or red blood cells) or use of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days prior to screening\]: * Absolute Neutrophil Count (ANC) \< 1.5×109/L. * Total bilirubin \> 1.5×ULN. * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3×ULN without liver metastases or primary liver cancer. AST or ALT \> 5×ULN if the patient has documented liver metastases. * Hemoglobin \< 90 g/L. * Platelets \< 100×109 /L. * Creatinine clearance \< 30 mL/min. 12. Prior to first dose of the investigational product, received an antitumor drug or investigational drug at the following time intervals: * Chemotherapy, targeted small molecule therapy or radiotherapy (except palliative radiotherapy and the radiotherapy area do not include the proposed target lesion) ≤ 14 days. The wash-out period for TKI drugs is more than 5 half-lives could enroll for their shorter half-life. * Immunotherapy or cell therapy (i.e. chimeric antigen receptor T cell therapy) ≤ 28 days; Other cell therapy must be discussed with the investigators to determine eligibility. * Monoclonal antibodies ≤ 28 days for anticancer therapy. * Anti-tumor Chinese medicine which approved by the agency ≤ 14 days. * Immunosuppressive therapy for any reason ≤ 7 days. * Fulvestrant ≤ 250 days (5 half-lives). * All other investigational drugs or devices ≤ 28 days or 5 half-lives before the first dosing administration (whichever is shorter). 13. Bleeding constitution (e.g., diffuse intravascular coagulation \[DIC\], clotting factor deficiency), or long-term anticoagulant therapy (excluding antiplatelet therapy and low doses of warfarin and low molecular weight heparin). 14. Severe vascular embolism events requiring medical or surgical intervention. 15. Active autoimmune diseases that require systemic treatment (i.e. use of immunomodulators, corticosteroids, or immunosuppressive drugs). Note: Participants with hyperthyroidism/hypothyroidism could participate. Note: Hormone replacement therapy and symptomatic therapy (e.g., levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered a form of systemic therapy and are permitted. 16. Those who have received systemic corticosteroids within 4 weeks prior to administration of BL0175 or active control (low doses of corticosteroids are excluded, such as ≤ 20 mg prednisone daily or equivalent). 17. Those who underwent major surgery within 4 weeks before enrollment, or plan to undergo major surgery during the study. 18. Has not recovered from the toxic effects of prior treatment (including prior immunotherapy) and/or complications of surgical intervention to CTCAE v5.0 ≤ 1. Note: Participants with stable chronic AE (≤ grade 2) that are not expected to resolve on their own (e.g., peripheral neuropathy and alopecia) are allowed. 19. Those who are determined disqualified to join clinical studies by investigator for other causes.
Scaling Up Community-based Noncommunicable Disease Research Into Practice in Pokhara Metropolitan City of Nepal
NCT06740708
Active, positions filled
Conditions Hypertension, Type 2 Diabetes Mellitus (...
Phase NA
Enrollment 2100
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

  • SCALE-NCD

Primary Outcomes

  • Systolic blood pressure (mmHg)
  • Fasting Plasma glucose
  • Participants Who Have Achieved Smoking cessation
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: 2025-04-28
Completion: 2029-02-28
Eligibility
Age: 40 Years
Sex: ALL
Volunteers: false
Enrollment: 2100 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Johns Hopkins Bloomberg School of Public Health
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigators:
  • Dinesh Neupane, PhD (PRINCIPAL_INVESTIGATOR) - Johns Hopkins University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • SCALE-NCD
Study Locations (1 sites)
Pokhara Metropolitan City, Pokhara, Gandaki Nepal
Eligibility Criteria
Inclusion Criteria: 1. Meeting at least one of the following three conditions * Hypertensive, defined as * BP≥140/90 mmHg at two separate measurements * Type 2 diabetes, defined as * Fingerprick glucose≥100 mg/dL, and plasma fasting glucose ≥126 mg/dL, and HbA1c≥6.5 * Current smoker, defined as * Ever smoked ≥100 cigarettes in lifetime, and * Currently smokes every day. 2. Registered on the voter list in Pokhara. 3. Not planning to migrate outside of Pokhara during the study period Exclusion Criteria: 1. Blood pressure ≥180/120 mmHg or 2. Blood glucose \>250 mg/dL or \<54 mg/dL 3. Diagnosed with secondary hypertension by health professionals 4. Diagnosed with other diabetes besides type 2 by health professionals 5. Presenting with acute symptoms that may require hospitalizations, which includes but not limited to: * Nausea, vomiting, diarrhea * Abdominal pain * Polyuria, polydipsia, polyphagia * Loss of motor or sensory function * Altered mental status. * Chest pain, chest tightness * Dyspnea, shortness of breath * Fever 6. Diagnosed as terminally ill by a health professional, defined as life expectancy of 6 months or less. 7. Pregnant or intend to be pregnant
Partners in Control, Phase II: Using Remote Monitoring Technology With Community Health Workers to Support Hypertension Management for Latinx Patients
NCT06730230
Recruiting
Conditions Hypertension
Phase NA
Enrollment 300
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

  • Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) Support

Primary Outcomes

  • Change in systolic blood pressure
  • Change in diastolic blood pressure
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-02-10
Completion: 2027-05-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: NYU Langone Health
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Principal Investigators:
  • Devin Mann, MD (PRINCIPAL_INVESTIGATOR) - NYU Langone Health
Contact Information
Study Contact:
Devin Mann, MD
212-263-8313
Devin.Mann@nyulangone.org
Tiffany Martinez
646-501-2505
Tiffany.Martinez@nyulangone.org
Interventions
  • Remote Patient Monitoring (RPM)-enabled Community Health Worker (CHW) Support
Study Locations (1 sites)
NYU Langone Health, New York, New York 10016 United States
Eligibility Criteria
Inclusion Criteria: 1. Self-identify as Latinx 2. Be fluent in English or Spanish 3. Be age 18 years or older 4. Receiving care at one of the 10 safety-net primary care clinics 5. Have uncontrolled HTN documented in the electronic health record (EHR) on at least two visits in the past year (defined as an average BP ≥ 140/90 mmHg) 6. Have been prescribed at least one anti-hypertensive medication and be non-adherent to their medications, defined as adherence \<80% in the preceding 12 months, as determined by prescription orders obtained from the clinic EHR. Exclusion Criteria: 1. Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks) 2. Participation in other hypertension-related clinical trials 3. Have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR) 4. Plan to discontinue care at the clinic within the next 15 months
Establishing Mobile Transcranial Magnetic Stimulation
NCT06748209
Recruiting
Conditions Treatment Resistant Major Depression
Phase PHASE4
Enrollment 30
Locations 1 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Left prefrontal Transcranial Magnetic Stimulation (TMS)
  • FDA cleared TMS for treating depression

Primary Outcomes

  • Percent of depression responders
  • Improvement in Depression Symptoms
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2025-05-10
Completion: 2028-03-01
Eligibility
Age: 22 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Medical University of South Carolina
Principal Investigators:
  • Mark George, MD (PRINCIPAL_INVESTIGATOR) - Medical University of South Carolina
Contact Information
Study Contact:
Mark S George, MD
8438765142
GEORGEM@MUSC.EDU
Alexandra Herron, BA
herronal@musc.edu
Interventions
  • Left prefrontal Transcranial Magnetic Stimulation (TMS)
  • FDA cleared TMS for treating depression
Study Locations (1 sites)
Medical Univerity of South Carolina, Charleston, South Carolina 29425 United States
Eligibility Criteria
Inclusion Criteria: * Adult (22-80 years old) * Have treatment-resistant depression as defined by the e-Mini, and the antidepressant treatment history form (ATHF short). * Be able to read and communicate in English. * Able to provide their own consent. * Access to a computer with videoconferencing ability for initial consent and telescreen. Exclusion Criteria: * Patients with unstable medical conditions that might make TMS unsafe. This includes current poorly controlled seizures. * Ferromagnetic metal in the head. * Pregnant. * Currently active substance abuse except tobacco.
Reproductive Health in Breast Cancer Survivor
NCT06756802
Active, positions filled
Conditions Breast Cancer
Phase Not Applicable
Enrollment 22000
Locations 4 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • to describe pregnancies (number, origin and outcome) after stage 1 to 3 breast cancer in women aged 18 to 40 at diagnosis, according to age at diagnosis and treatment received.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2025-12-01
Completion: 2029-07-11
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 22000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Institut Cancerologie de l'Ouest
Collaborators: UNICANCER
Principal Investigators:
  • Aliette DEZELLUS, MD (PRINCIPAL_INVESTIGATOR) - INSTITUT DE CANCEROLOGIE DE L'OUEST
  • Marie ROBERT, MD (PRINCIPAL_INVESTIGATOR) - INSTITUT DE CANCERORLOGIE DE L'OUEST
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (4 sites)
Centre Oscar Lambret, Lille, 59000 France
Centre Leon Berard, Lyon, 69000 France
Institut Curie, Paris, 75000 France
Institut de Cancerologie de L'Ouest, Saint-Herblain, 44805 France
Eligibility Criteria
Exposed cohort (Breast cancer patient) Inclusion Criteria: * Patients aged between 18 and 50 at the time of diagnosis of breast cancer * Diagnosed with stage 1 to 3 breast cancer between 01/01/2010 and 31/12/2018 * Patients treated in one of the identified ConSoRe partner centres (CLB, ICO, COL, IC) Exclusion Criteria: * Diagnosis of metastatic breast cancer (stage 4) * Patients opposed to the use of their data for research purposes Unexposed cohort (data from the SNDS) : Population derived from the SNDS, among women not diagnosed with breast cancer, of the same ages (same year of birth) and the same geographical area (same département of residence) as the exposed population.
Explore Association Models Between Environmental Hormones andBreast Cancer
NCT06765395
Active, positions filled
Conditions Breast Diseases, Breast Adenocarcinoma
Phase Not Applicable
Enrollment 687
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

  • established an association model between environmental hormones and breast cancer
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2023-03-20
Completion: 2025-03-31
Eligibility
Age: 20 Years
Sex: FEMALE
Volunteers: true
Enrollment: 687 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Pei-Hung Liao
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (1 sites)
National Taipei university of Nursing and health science, Taipei, Peitou 112 Taiwan
Eligibility Criteria
Inclusion Criteria: * (1) patients aged 20 years or above; (2) patients with breast cancer. Exclusion Criteria: * non-patients with breast cancer
Inflammation's Impact on Heart Disease and Diabetes
NCT06752018
Recruiting
Conditions Inflammation, Obesity and Type 2 Diabete...
Phase Not Applicable
Enrollment 250
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Gastric bypass

Primary Outcomes

  • Whole blood ROS prooduction
  • Whole blood ROS production
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: 2025-01-30
Completion: 2030-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 250 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Aarhus
Principal Investigators:
  • Emma Börgeson, Dr., PhD, MSc (PRINCIPAL_INVESTIGATOR) - University of Aarhus
Contact Information
Study Contact:
Emma Börgeson, MSc
+45 9352 2984
emma.borgeson@biomed.au.dk
Interventions
  • Gastric bypass
Study Locations (1 sites)
Steno Diabetes Center Aarhus, Aarhus, 8200 Denmark
Eligibility Criteria
Inclusion Criteria: * Individuals willing and able to give appropriate oral and written informed consent * Men and women over 18 years of age. * Correct body mass index (BMI) (Lean controls: 18.5-24.9 kg/m2. Obese gastric bypass patients: 35-50 kg/m2) Exclusion Criteria: * The individual does not follow instructions given in the research study. * Pregnancy. * Significant gastrointestinal problems. * Use of tobacco. * The individual consumed alcohol within two days prior to the study visit * Active cancer within 5 years. * Use of dietary supplements that impact the inflammatory resolution process (e.g., fish oils), and the person is not willing to discontinue the use of the supplements 1 week prior to the visits. * Underlying cardiometabolic disease, or medication related to such disease (e.g., blood pressure medication, insulin to treat diabetes, etc.). * Underlying inflammatory disease, or medication related to such disease. * The individual states that they have increased bleeding tendency or are using anti-coagulant (blood-thinning) medication. * For obese patients only: The individual has lost more than 8% of his/her body weight since their clinical referral for surgery or has lost more than 3% of his/her body weight in the 4 months leading up to surgery.
The Effect of Exercise on the Brain in Type 2 Diabetes
NCT06734546
Recruiting
Conditions Type 2 Diabetes
Phase NA
Enrollment 75
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

  • Exercise intervention

Primary Outcomes

  • Neurometabolite levels
  • Changes in arterial spin labelling measured by means of magnetic resonance imaging (MRI)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-11-08
Completion: 2027-08
Eligibility
Age: 30 Years
Sex: ALL
Volunteers: false
Enrollment: 75 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Hasselt University
Collaborators: Universitaire Ziekenhuizen KU Leuven, Jessa Hospital, Research Foundation Flanders
Principal Investigators:
  • Dominique Hansen, Full professor (PRINCIPAL_INVESTIGATOR) - Hasselt University
  • Koen Cuypers, Assistant professor (PRINCIPAL_INVESTIGATOR) - Hasselt University
Contact Information
Study Contact:
Dominique Hansen, Full Professor
+3211292126
dominique.hansen@uhasselt.be
Jitske Vandersmissen, PhD student
+3211268387
jitske.vandersmissen@uhasselt.be
Interventions
  • Exercise intervention
Study Locations (1 sites)
Hasselt University, Hasselt, Limburg 3500 Belgium
Eligibility Criteria
Inclusion Criteria: * type 2 diabetes * no insulin therapy * 30-75 years old * physically inactive Exclusion Criteria: * MRI contraindications * psychological disorders * exogenous insulin therapy * history of coma, transient ischemic attack, head trauma, brain tumor, stroke, epilepsy, and other central nervous system diseases that could cause dementia or presence of dementia before T2DM * suffering from any disease with significant impact on exercise intervention participation such as: chronic heart disease (e.g. valve insufficiency ≥ grade 2) or significant arrhythmias, cardiac events less than one year ago (myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention), clinical heart failure (oedema, shortness of breath), percutaneous coronary intervention less than one year ago, chronic obstructive pulmonary disease (COPD), cerebrovascular or peripheral vascular disease * severe hypertension (\>160/110 mmHg) * ongoing cancer, severe neuropathy (limiting exercise participation) * renal disease (GRF \<45 ml/min/1,73 m2) * inability to regularly participate in the exercise intervention * pregnancy * breastfeeding
Acceptability and Feasibility of an In-person 8-week Mindfulness-Based Cognitive Therapy Program Among Undergraduates
NCT06757842
Recruiting
Conditions Depression/Anxiety
Phase NA
Enrollment 45
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

  • Mindfulness in Students

Primary Outcomes

  • Acceptability Assessment
  • Feasibility Assessment: Number of participants recruited
  • Feasibility Assessment: Recruitment time for completion
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-10-01
Completion: 2026-03-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 45 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Universidad de los Andes, Chile
Contact Information
Study Contact:
Jorge E Gaete, MD, PhD
+56226181000
jgaete@uandes.cl
Valentina Romo
+56984038329
vromo@miuandes.cl
Interventions
  • Mindfulness in Students
Study Locations (1 sites)
Universidad de los Andes, Santiago, Santiago Metropolitan 7620086 Chile
Eligibility Criteria
Inclusion Criteria: * Undergraduate students at the Universidad de los Andes. * Aged 18 or older. * Capable of reading and speaking Spanish. * With a score on the PHQ-9 depression scale between 0 and 14. * Have participated in an informational meeting about the study and the implications of the intervention. * Availability to attend 1 weekly session of 90 minutes for 8 consecutive weeks, and time to practice mindfulness exercises at home for at least 15 minutes daily during the intervention period. Exclusion Criteria: * With a PHQ-9 score greater than or equal to 15. * With active suicidality, defined as score ≥ 3 in Columbia suicide severity scale. * Currently undergoing psychiatric treatment for a severe condition, understood as: psychotic disorders and/or substance abuse. * History of hospitalization for psychiatric conditions in the last 2 years. * History of having participated in a previous MBI course, such as: MBCT, MBSR, MMB, among others. * History of sexual abuse in their lifetime.
Effects of Pilate Training Versus Moderate Intensity Continous Training in Hypertensive Patients
NCT06762262
Active, positions filled
Conditions Prehypertension
Phase NA
Enrollment 52
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

  • Moderate-Intensity continuous training

Primary Outcomes

  • 6 MWT
  • VO2 max
  • Borg Dyspnea Scale
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2024-04-20
Completion: 2025-04-30
Eligibility
Age: 45 Years
Sex: ALL
Volunteers: false
Enrollment: 52 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Riphah International University
Principal Investigators:
  • Sumera Nassser, Mphill (STUDY_CHAIR) - Riphah International University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Moderate-Intensity continuous training
Study Locations (1 sites)
Sheikh Zaid Hospital, Quetta, Balochistan oooo Pakistan
Eligibility Criteria
Inclusion Criteria: * Participants must be between 45 to 70 years old * Gender: Male and Female both * Chronic, mild-to moderate, and stable (\>1 year duration) hypertension (systolic blood pressure * \[SBP\] between 140-179 mm Hg and diastolic blood pressure \[DBP\] between 90-109 mm Hg). * Single antihypertensive medication will be recruited. * Participants have sedentary life style. * Smokers, alcoholic, diabetic, and other cardiac problems (controlled) would be included. Exclusion Criteria: * Patients with Permanent atrial fibrillation * Patients with COPD * Patients with Heart surgery * Patients with presence of symptomatic congestive heart failure * Smokers, alcoholic, diabetic, and other cardiac, renal, and respiratory disease patients (uncontrolled) would be excluded. * Participants with no history of psychiatry or psychological disorders or abnormalities.
Preoperative Radiation Therapy and Immediate Breast Reconstruction
NCT06739655
Recruiting
Conditions Breast Neoplasms, Breast Carcinoma, Brea...
Phase NA
Enrollment 180
Locations 6 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Preoperative radiotherapy
  • Postoperative radiotherapy
  • Immediate breast reconstruction
  • Immediate or delayed breast reconstruction

Primary Outcomes

  • Patient's satisfaction with breasts.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-02-20
Completion: 2038-02-20
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 180 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Cancer Research Antwerp
Collaborators: Ziekenhuis aan de Stroom, Iridium netwerk
Principal Investigators:
  • Melanie Machiels, MD, PhD (PRINCIPAL_INVESTIGATOR) - Iridium netwerk
Contact Information
Study Contact:
Tom Quisenaerts, MD
+3234433759
Tom.quisenaerts@zas.be
Interventions
  • Preoperative radiotherapy
  • Postoperative radiotherapy
  • Immediate breast reconstruction
  • Immediate or delayed breast reconstruction
Study Locations (6 sites)
Universitair Ziekenhuis Antwerpen (UZA), Edegem, Antwerpen 2650 Belgium
Ziekenhuis aan de stroom, Wilrijk, Antwerpen 2610 Belgium
AZ Klina, Brasschaat, Antwerp 2930 Belgium
CHU Namur, Namur, Namur 5000 Belgium
Universitair Ziekenhuis Gent (UZGent), Ghent, Oost Vlaanderen 9000 Belgium
AZ Groeninge, Kortrijk, West Vlaanderen 8500 Belgium
Eligibility Criteria
Screening assessments, including review of all study eligibility criteria must be completed before enrolment and randomisation. Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria: 1\. Women ≥18 years with histopathologically confirmed breast cancer who: 1.a. require SSM/NSM for any reason (e.g. extensive disease) 1.b. require postoperative radiation therapy of at least the chest wall 1. c. have a wish for a breast reconstruction 2. An Eastern Cooperative Oncology Group (ECOG) performance status grade ≤ 2 3. Participant is able and willing to provide written informed consent, which includes compliance with and ability to undergo all study procedures, and attend the scheduled follow-up visit(s) per protocol. Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study: 1. A previous history of breast cancer or irradiation of the chest wall for any other indication, on the other side (ipsilateral). A bilateral SSM/NSM + reconstruction (e.g. in case of a contralateral prophylactic SSM/NSM), or previous contralateral breast cancer disease/treatment, do not fall under this criterium and are thus allowed. 2. Collagen synthesis disease 3. Ongoing pregnancy 4. Actively breastfeeding 5. Smoking at time of inclusion (a history of smoking is allowed but needs to be registered in the eCRF). No interval between smoking cessation and study inclusion is defined, but the reconstructive surgeon needs to be willing to operate the patient using autologous tissue transfer. This generally translates to a smoking cessation of \>3months preoperatively. 6. BMI \> 35 kg/m2 7. cT4d tumour, metastatic disease or any reason making SSM/NSM not indicated