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Showing 20 of 28810 trials
Monitoring of Brain Metabolites Using Proton and Deuterium MR Techniques
NCT06705010
Not yet recruiting
Conditions Aging, Brain Metabolic Disorder, Carotid...
Phase NA
Enrollment 140
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

  • Application of new pulse sequence package SIGNATURES2023 to healthy controls
  • Application of new pulse sequence package SIGNATURES2023 to 4 groups of patients (pilot)

Primary Outcomes

  • 3D spatial resolved Deuterium metabolite imaging (DMI)
  • 3D spatial resolved SLOW-EPSI MRSI metabolite mapping
  • 3D spatial resolved 3D DMI and 3D SLOW-EPSI MRSI mapping in Alzheimer's disease (AD) patient group
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2025-04-01
Completion: 2028-03-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 140 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Insel Gruppe AG, University Hospital Bern
Principal Investigators:
  • Johannes Slotboom, PhD (PRINCIPAL_INVESTIGATOR) - University Hospital / Inselspital /University Bern / 3010 Bern / Switzerland
Contact Information
Study Contact:
Johannes Slotboom, PhD
+41316327469
johannes.slotboom@insel.ch
Piotr Radojewski, MD
+41316641467
piotr.radojewski@insel.ch
Interventions
  • Application of new pulse sequence package SIGNATURES2023 to healthy controls
  • Application of new pulse sequence package SIGNATURES2023 to 4 groups of patients (pilot)
Study Locations (1 sites)
Translational Imaging Center / Sitem, Bern, 3010 Switzerland
Eligibility Criteria
General Inclusion Criteria (applicable to all groups): 1. Signed informed consent by the participant. 2. Ability to lie still in the MR scanner for at least one hour. 3. No current or lifetime history of drug or alcohol abuse. 4. No medications that interfere with cognition. 5. Normal or corrected-to-normal vision. Disease-Specific Inclusion Criteria: I. Type 2 Diabetes Patients group (PG-IV-2H-DM): * Diagnosis of Type 2 diabetes according to the ADA classification. * Treatment with lifestyle modification and/or non-insulin agents. II. High-Grade Carotid Stenosis Patient Group (PG-IV-1H-HGCS): * ≥50% stenosis of the carotid artery. III. Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD) Patients (PG-IV-2H-AD/MCI): * Diagnosis of Mild Cognitive Impairment (MCI) or early Alzheimer's disease (AD). * Age range between 60-80 years. * Fluent in German. * Normal or corrected-to-normal vision and hearing. * Ability to understand the research and provide informed consent. Exclusion Criteria: 1. Under 18 years of age. 2. Claustrophobia. 3. Pregnancy or current state of lactation. 4. Active implants (e.g., pacemakers, neuro-stimulators). 5. Passive ferromagnetic implants. 6. Passive non-ferromagnetic metallic implants \> 4 cm in a region covered by the active radio frequency (RF) coils. 7. Large tattoos inside a region covered by the active RF coils. 8. Known or suspected non-compliance. 9. Underweight \<30 kg body weight. 10. Body mass index (BMI) \> 30. 11. Overweight \>135 kg 12. Persons with extreme big head circumference or extreme astigmatism, which cannot be corrected by MR-compatible eyeglasses. 13. Persons not able to understand the informed consent form. 14. Not agreeing with the institute's policy to inform the subject on incidental findings discovered during the examination. 15. Visual and auditory acuity impairing neuropsychological testing (if relevant). 16. Diabetes or glucose intolerance according to WHO recommendations (excluded in the diabetes patient group). 17. Evidence of overt heart or renal disease. 18. Evidence of gastrointestinal tract disease. 19. Cognitive impairment (Mini-mental state examination score \<26/30, CDR score \>0, memory complaints) (excluding AD, MCI groups). 20. Smoking. 21. Current or life-time drug or alcohol abuse 22. Untreated dyslipidemia, hypertension, or thyroid disease. 23. Antidepressant medications with anticholinergic properties. 24. Regular use of narcotic agents more than two doses per week within 4 weeks of screening. 25. Antiparkinsonian medications used within 4 weeks of screening. 26. Enrollment in any investigational drug studies within 4 weeks of screening. 27. Immunomodulating or oncological treatment. 28. Cardiac implantable electronic devices (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. 29. Metallic intraocular foreign bodies: patients who have ever welded without eye protection or had facial injuries involving metal must have an orbit x-ray reviewed by a radiologist before MRI. 30. Implantable neurostimulation systems. 31. Cochlear implants/ear implants. 32. Drug infusion pumps (insulin delivery, analgesic drugs, or chemotherapy pumps). 33. Catheters with metallic components (e.g., Swan-Ganz catheter). 34. Metallic fragments (e.g., bullets, shotgun pellets, shrapnel). 35. Cerebral artery aneurysm clips. 36. Magnetic dental implants. 37. Tissue expanders. 38. Artificial limbs. 39. Non-removable hearing aids. 40. Non-removable piercings. 41. Implantable cardiocerter defibrillators 42. Cardiac resynchronization therapy devices 43. Fever (temperature \> 37.5°C measured prior to MRI). 44. Volunteers taking amphetamines or sedatives
The Association Between Plasma Metabolites and the Risk, Efficacy and Prognosis in Early Breast Cancer
NCT06698679
Recruiting
Conditions Breast Cancer
Phase Not Applicable
Enrollment 1000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • No intervention

Primary Outcomes

  • Cohort 1 : Different Plasma Metabolites
  • Cohort 2: Different Plasma Metabolites
  • Cohort 3: Different Plasma Metabolites
Interested in this trial?
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Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-11-15
Completion: 2031-10-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 1000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Shengjing Hospital
Contact Information
Study Contact:
Liu Hua, Ph. D
15140067366
20242027@cmu.edu.cn
Liu Cai Gang, Ph. D
15140067366
20242027@cmu.edu.cn
Interventions
  • No intervention
Study Locations (1 sites)
Shengjing Hospital of China Medical University, Shenyang, Liaoning 110004 China
Eligibility Criteria
Inclusion Criteria: * Cohort 1 Control Group: women without breast cancer or other malignancies. Case Group: patients with histologically confirmed carcinoma in situ or invasive breast cancer; no prior treatment; no distant metastasis; and not associated with other malignant tumor diseases. * Cohort 2 Pathologically diagnosed as breast cancer; Treatment niave patients; To receive standard neoadjuvant therapy; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) . * Cohort 3 Patients who have been discharged after breast cancer treatment. Exclusion Criteria: * Histologically undiagnosed breast cancer. Breast cancer with distant metastases. Combined with other malignant tumors. Participants must not have participated in other clinical trials within the past month, unless those trials are observational or non-interventional in nature.
Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer
NCT06687291
Recruiting
Conditions Gastroesophageal Cancer (GC), Postoperat...
Phase Not Applicable
Enrollment 130
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Incidence of postoperative delirium
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: 2025-02-13
Completion: 2027-11-11
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 130 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Karolinska Institutet
Collaborators: Region Stockholm
Principal Investigators:
  • Maria Lampi, PhD (PRINCIPAL_INVESTIGATOR) - Karolinska Institutet
Contact Information
Study Contact:
Marcus Nömm, PhD-student
0733765652
marcus.nomm@ki.se
Maria Lampi, PhD
0852483721
maria.lampi@ki.se
Interventions
N/A
Study Locations (1 sites)
Karolinska University Hospital, Huddinge, Huddinge, 14157 Sweden
Eligibility Criteria
Inclusion Criteria: * Patients diagnosed with esophageal or gastric cancer, treated with (or without) chemotherapy and surgery. * Age ≥18 at the time for inclusion. * Participate on a voluntary basis and can (for any reason) end its participation during the study. * Capable of giving informed consent. Exclusion Criteria: * Patients with preoperative cognitive dysfunction such as dementia. * Patients who are inoperable due to metastases. * Patients unable to communicate due to severely impaired hearing and/or - seeing. * Patients with ongoing drug and/or alcohol abuse. * Patients who cannot give informed consent.
Investigation of the Effects of Complex Decongestive Physiotherapy on Sleep Quality and Quality of Life in Women With Breast Cancer Related Lymphedema
NCT06697158
Recruiting
Conditions Breast Cancer Related Lymphedema
Phase NA
Enrollment 31
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

  • Physiotherapy and rehabilitation

Primary Outcomes

  • Sleep Quality
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-01-01
Completion: 2027-03-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 31 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Abant Izzet Baysal University
Contact Information
Study Contact:
Elif DUYGU, PhD
+905052539010
elifduygu@ibu.edu.tr
Zeynep DURU, MSc
+905344095717
zeyneppdduru@gmail.com
Interventions
  • Physiotherapy and rehabilitation
Study Locations (2 sites)
Bolu Abant Izzet Baysal University, Bolu, 14030 Turkey (Türkiye)
Bolu Abant Izzet Baysal University, Bolu, 14030 Turkey (Türkiye)
Eligibility Criteria
Inclusion Criteria: * Participants must be aged between 18 or 85 years, * with a diagnosis of unilateral lymphedema in the upper extremity following breast cancer surgery * stage 2 lymphedema confirmed by a doctor * voluntary consent to participate in the study. Exclusion Criteria: * refusal to participate in the study * development of lymphedema due to primary causes, presence of bilateral upper extremity lymphedema * active soft tissue infection in the lymphedematous arm * mental or cognitive disorders * inability to communicate or cooperate * acute deep vein thrombosis, arterial insufficiency in the upper extremity, systemic diseases that could cause edema other than lymphedema (e.g., renal failure, liver failure, heart failure) * use of sleep medications or antidepressants
Investigating the Combined Effects of Protein, Blueberries, and Exercise on Cardiovascular Health and Frailty in Older Nova Scotians
NCT06693271
Recruiting
Conditions Cardiovascular Disease, Frailty
Phase NA
Enrollment 240
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

  • intervention of protein, blueberries
  • Exercise training

Primary Outcomes

  • Functional Fitness
  • Echocardiography
  • Inflammatory Markers
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-12-15
Completion: 2028-12-31
Eligibility
Age: 65 Years
Sex: ALL
Volunteers: false
Enrollment: 240 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Nova Scotia Health Authority
Collaborators: Dalhousie University
Contact Information
Study Contact:
Scott A Grandy, PhD
902-494-4303
Scott.Grandy@Dal.Ca
Interventions
  • intervention of protein, blueberries
  • Exercise training
Study Locations (1 sites)
QEII Health Sciences Centre, Dickson Building, Halifax, Nova Scotia B3H 2Y9 Canada
Eligibility Criteria
Inclusion Criteria: * Must be 65 years of age or above * Must be willing to participate in a low to moderate exercise program Exclusion Criteria: * Medical and cognitive conditions that prevent participation in the intervention * Allergies and or dislike of blueberries and/or protein powder
Immune Mechanisms of Antipsychotic Treatment Response
NCT06687694
Recruiting
Conditions Psychosis
Phase Not Applicable
Enrollment 500
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Peripheral Immune Phenotype
Interested in this trial?
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Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-08-06
Completion: 2031-07
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: King's College London
Collaborators: South London and Maudsley NHS Foundation Trust, University of Oxford, McPin Foundation, Francis Crick Institute
Contact Information
Study Contact:
Thomas Pollak (Chief Investigator), PhD
+442078485288
IMATStudy@kcl.ac.uk
Amy Aldridge (Project Manager)
+442078485288
IMATStudy@kcl.ac.uk
Interventions
N/A
Study Locations (1 sites)
South London and Maudsley NHS Foundation Trust, London, United Kingdom SE5 8AB United Kingdom
Eligibility Criteria
Inclusion Criteria Participants with psychosis symptoms: * Age 18-65 * Currently experiencing psychosis symptoms warranting treatment by secondary care mental health services, as confirmed by a psychiatrist involved in their treatment. * Psychosis symptoms likely to be attributable to a disorder represented by ICD codes F20-F39, in the opinion of the treating clinical team. * Due to start or change to a new regular antipsychotic medication. (Participants who are initiating antipsychotic treatment for the first time, transitioning to a different antipsychotic medication, or resuming a formerly prescribed antipsychotic medication that was discontinued for a minimum of two weeks may be recruited.) Control Participants * Age 18-65 * No active autoimmune disorder. * No history of psychosis symptoms. Exclusion Criteria Participants with psychosis symptoms: * Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance. * Currently taking or having taken in the last four weeks any medication known to grossly affect the production or function of immune cells (e.g. corticosteroids, methotrexate, cyclophosphamide, mycophenolate mofetil, rituximab or other monoclonal antibody therapies). * Inability to have blood tests. Control participants: * Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance. * Currently taking or having taken in the last four weeks any medication known to grossly affect the production or function of immune cells (e.g. corticosteroids, methotrexate, cyclophosphamide, mycophenolate mofetil, rituximab or other monoclonal antibody therapies). * Inability to have blood tests. Optional lumbar puncture only: * Significant lower spinal deformity (such as spina bifida), injury (such as stenosis) or previous lower spinal surgery. * Antiplatelet or anticoagulant therapy within the 14 days prior to Lumbar Puncture procedure. * Known or suspected clotting disorder. * Clinically significant abnormality in full blood count. * Known or suspected raised intracranial pressure, assessed by study clinician. * Known or suspected allergy to local anaesthetic agent or an ingredient of the anaesthetic solution. * History of chronic or recurrent headaches, in the opinion of the investigator.
Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder
NCT06695767
Recruiting
Conditions Major Depressive Disorder, Epilepsy
Phase NA
Enrollment 16
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

  • Neurobehavioral therapy

Primary Outcomes

  • Enrollment rate
  • Retention rate
  • Session attendance rate (proportion of sessions attended)
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-12-19
Completion: 2025-04-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 16 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: The University of Texas Health Science Center, Houston
Principal Investigators:
  • Melissa Fadipe, MSN, APRN, FNP-C (PRINCIPAL_INVESTIGATOR) - The University of Texas Health Science Center, Houston
Contact Information
Study Contact:
Melissa Fadipe, MSN, APRN, FNP-C
(713) 825-7237
Melissa.F.Fadipe@uth.tmc.edu
Jennifer Beauchamp
(713) 500-2114
Jennifer.E.Beauchamp@uth.tmc.edu
Interventions
  • Neurobehavioral therapy
Study Locations (2 sites)
Michael E. DeBakey VA Medical Center, Houston, Texas 77030 United States
The University of Texas health Science Center at Houston, Houston, Texas 77030 United States
Eligibility Criteria
Inclusion Criteria: * English speaking veterans * has home internet access * has access to and familiarity in using a computer or tablet at least weekly * Asymptomatic patients with chronic conditions * has access to a mobile device with Short Message Service (SMS) text and picture capability * has an active clinical diagnosis of major depressive disorder based on the International Classification of Diseases, 10th version (ICD-10) * has an ICD-10 diagnosis of epilepsy with at least one seizure documented within the last five years Exclusion Criteria: * pregnancy * Veterans that have current suicidal ideation * have active psychosis; and have an ICD-10 diagnosis of psychogenic non-epileptic seizures or conversion disorder.
Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes
NCT06706284
Recruiting
Conditions Spinal Cord Injuries, Type 2 Diabetes
Phase PHASE4
Enrollment 50
Locations 2 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Semaglutide Injectable Product
  • Placebo

Primary Outcomes

  • Glucose tolerance
  • Insulin action
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2025-04-11
Completion: 2029-03-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Marzieh Salehi
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigators:
  • Marzieh Salehi, MD (PRINCIPAL_INVESTIGATOR) - The University of Texas Health Science Center at San Antonio
Contact Information
Study Contact:
Marzieh Salehi, MD
210-567-6691
salehi@uthscsa.edu
Andrea Hansis-Diarte, MPh
210 567 3208
hansisdiarte@uthscsa.edu
Interventions
  • Semaglutide Injectable Product
  • Placebo
Study Locations (2 sites)
University Health - Texas Diabetic Institute, San Antonio, Texas 78207 United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229 United States
Eligibility Criteria
Inclusion Criteria: 1. Male and female subjects aged 18-70 years (inclusive) at screening 2. More than one year after spinal cord injury 3. Levels if injury C2-L2 with Asia Impairment Scale A, B, C or D. 4. Provision of signed and dated written informed consent prior to any study specific procedures 5. Diagnosed with T2DM with glucose control managed with diet and metformin monotherapy where no significant dose changes (increase or decrease ≥ 50%) have occurred in the three months prior to screening 6. HbA1c 6.0-9.0% at screening 7. BMI \> 22 kg/m2 at screening 8. Female subjects of childbearing potential must have a negative pregnancy test at screening and randomization, and must not be lactating 9. Females of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from screening and must agree to continue using such precautions through to the end of the study. It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Exclusion Criteria: 1. History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study and/or any subject unable or unwilling to follow study procedures. 2. Any subject who has received another investigational product as part of a clinical study within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening 3. Taking mirabegron or other glucose altering medications 4. Taking steroids within the past 1 year 5. Significant anemia (hemoglobin\<11g/dL) 6. History of gastric outlet obstruction or chronic diarrhea 7. History of a chronic neurological illness other than SCI (i.e.; MS, etc) 8. Any subject who has received any of the following medications within the specified time-frame prior to the start of the study * Herbal preparations or drugs licensed for control of body weight or appetite (eg, orlistat, bupropion-naltrexone, phentermine-topiramate, phentermine, lorcaserin) within a year prior to the start of the study * Pioglitazone, SGLT2 or DPPIV inhibitors, GLP-1RA within the last 60 days at the time of screening 9. Severe allergy/hypersensitivity to any of the proposed study treatments, excipients, acetaminophen 10. Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus (T1DM) or diabetic ketoacidosis, or if the subject has been treated with daily SC insulin within 90 days prior to screening. 11. Significant inflammatory bowel disease or other severe disease or surgery affecting the upper GI tract (including weight-reducing surgery and procedures) which could affect the interpretation of safety and tolerability data. Prior history of bariatric surgery is not considered exclusion given the ample evidence of safety of use of GLP-1R therapy in this population. 12. Acute or chronic pancreatitis 13. Significant hepatic disease (except for metabolic dysfunction-associated steatohepatitis \[MASH\] or metabolic dysfunction-associated steatotic liver disease \[MASLD\]) without portal hypertension or cirrhosis) and/or subjects with any of the following results at screening: Aspartate transaminase (AST) ≥ 3 × upper limit of normal (ULN) Alanine transaminase (ALT) ≥ 3 × ULN Total bilirubin ≥ 2 × ULN 14. Impaired renal function defined as estimated glomerular filtration rate (eGFR) \< 45 mL/minute/1.73m2 at screening (GFR estimated according to Modification of Diet in Renal Disease (MDRD) using MDRD Study Equation IDMS-traceable \[SI units\]) 15. Unstable angina pectoris, myocardial infarction, transient ischemic attack (TIA) or stroke within 3 months prior to screening, or subjects who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 6 months or who are due to undergo these procedures at the time of screening 16. Severe congestive heart failure (New York Heart Association Class III or IV) 17. Basal calcitonin level \> 50 ng/L at screening or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia 18. History of neoplastic disease within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or in situ cervical cancer 19. History of HIV infection or other immune compromised disease; and history of organ transplantation 20. Substance dependence or history of alcohol abuse and/or excess alcohol intake 21. Patients on ketogenic diet
Neuroscience of Psychotherapy for Depression
NCT06696001
Recruiting
Conditions Depression
Phase NA
Enrollment 45
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Psychoeducation
  • Behavioral Activation

Primary Outcomes

  • Inter-brain phase synchronization in Alpha frequency band via Phase Locking Value
  • Inter-brain phase synchronization in Theta frequency band via Phase Locking Value
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-04-11
Completion: 2026-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 45 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of North Carolina, Chapel Hill
Collaborators: Foundation of Hope, North Carolina
Principal Investigators:
  • Flavio Frohlich (PRINCIPAL_INVESTIGATOR) - Carolina Center for Neurostimulation
Contact Information
Study Contact:
Flavio Frohlich
(919) 966-4584
flavio_frohlich@med.unc.edu
Zachary Stewart
zachary_stewart@med.unc.edu
Interventions
  • Psychoeducation
  • Behavioral Activation
Study Locations (1 sites)
Carolina Center for Neurostimulation, Chapel Hill, North Carolina 27516 United States
Eligibility Criteria
Inclusion Criteria for participants/clients: * Between ages 18 and 30 * Full-time student status (undergraduate, graduate, and professional) * Experience mild to moderate depressive symptoms as determined by the Beck Depression Inventory (score: 14-28) * Capacity to understand study procedures (informed consent) * Ability to speak and understand English * Willingness to comply with study procedures Inclusion Criteria for therapists: * Ages 18 or older * Qualification to administer therapy (decided by the Principal Investigator) * Capacity to understand the study procedures (informed consent) * Speak and understand English * Willingness to comply with study procedures Exclusion Criteria for participants/clients: * Active, Current Suicidal ideation as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past month * Past suicidal attempt (lifetime) * Recently initiated psychotherapy (past month) * Elevated psychosis risk based on self-report prodromal questionnaire - brief version (PQ-B) or self-reported diagnosis of psychotic disorder by mental health provider * Positive screen for autism spectrum disorder based on the self-report autism quotient (AQ-10) or self-reported diagnosis of autism spectrum disorder by mental health provider, * Daily intake of benzodiazepine of \>20 mg diazepam milligram equivalent * Inability to give informed, voluntary, written consent to participate * Inability to effectively communicate in English as determined by interaction with study personnel * Anything else that in the assessment of the study team is not conducive to the successful completion of the study requirements. There are no exclusion criteria for therapists
IMproving PAtient UndeRstanding of GEP TEst Results: Phase 4
NCT06703567
Recruiting
Conditions Breast Cancer
Phase NA
Enrollment 82
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

  • Standard Policy
  • Standard Policy + GEP Information Film

Primary Outcomes

  • GEP Knowledge Evaluation
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-09-06
Completion: 2025-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 82 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: European Institute of Oncology
Principal Investigators:
  • Gabriella Pravettoni, MD (PRINCIPAL_INVESTIGATOR) - European Istitute of Oncology
Contact Information
Study Contact:
Gabriella Pravettoni, MD
+39 0257489731
gabriella.pravettoni@ieo.it
Mara Negri
+39 0257489536
mara.negri@ieo.it
Interventions
  • Standard Policy
  • Standard Policy + GEP Information Film
Study Locations (1 sites)
European Institute of Oncology, Milan, 20141 Italy
Eligibility Criteria
Inclusion Criteria: * First presentation of early stage breast cancer with all known disease surgically removed * Estrogen Receptor (ER) positive and Human Epidermal growth factor Receptor 2 (HER-2) negative * No clear decision on whether chemotherapy should be given as adjunct based on current prognostic criteria * Consented to GEP testing * Able to give full informed consent to IMPARTER study * Good comprehension of the Italian language * Access to internet connection and devices (e.g. smart phone, tablet, laptop or desktop computer) Exclusion Criteria: * Other breast cancer diagnosis (e.g. Ductal carcinoma in situ, Metastatic) * Unable to give fully informed consent * Under 18 years of age * Unable to understand and speak Italian * No access to internet connection or devices
Studying the Senescent T Cell Features and Its Relationship with the Chemotherapy Efficacy in Young TNBC
NCT06684054
Not yet recruiting
Conditions T-Cell Dysfunction, Chemotherapy Effect,...
Phase Not Applicable
Enrollment 30
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • docetaxel, anthracycline, cyclophosphamide

Primary Outcomes

  • pCR
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: 2025-01-01
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Contact Information
Study Contact:
Wang
0086-15850582852
njmuwangwei@163.com
Interventions
  • docetaxel, anthracycline, cyclophosphamide
Eligibility Criteria
Inclusion Criteria: 1. Female, age≤40 years old, 2. Invasive breast cancer confirmed by pathology, immunohistochemistry showed TNBC (ER-, PR-, HER2-), 3. Indications for neoadjuvant chemotherapy according to guidelines: tumor diameter \> 2cm or with axillary lymph node metastasis or desiring breast-conserving surgery but should obtain negative surgical margins through neoadjuvant chemotherapy. Exclusion Criteria: 1. Stage IV patients or a history of other malignancies, 2. Having microbial infection or autoimmune disease have not been cured or having HBV, HIV infection, 3. Having surgery 3 months before enrollment, 4. Patients with insufficient clinicopathological data, 5. Does not meet the indications for neoadjuvant chemotherapy or is unwilling to cooperate.
AYLo - AutoimmunitY and Loss of y
NCT06696027
Recruiting
Conditions Giant Cell Arteritis (GCA), Polymyalgia ...
Phase Not Applicable
Enrollment 500
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Single nucleotide polymorphisms (SNP)
  • 3'mRNA sequencing
  • Enzyme-linked immunosorbent assay (ELISA) and Legendplex Array
  • Flow Cytometry
  • Laboratory assessment

Primary Outcomes

  • Quantification of the fraction of hematopoietic cells exhibiting mLOY.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-11-15
Completion: 2026-07
Eligibility
Age: 50 Years
Sex: MALE
Volunteers: true
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Bonn
Contact Information
Study Contact:
Simon Michael Petzinna, MD
0049 151 382 337 07
Simon_Michael.Petzinna@ukbonn.de
Valentin Sebastian Schäfer, MD
0049 228 287 17000
valentin.schaefer@ukbonn.de
Interventions
  • Single nucleotide polymorphisms (SNP)
  • 3'mRNA sequencing
  • Enzyme-linked immunosorbent assay (ELISA) and Legendplex Array
  • Flow Cytometry
  • Laboratory assessment
Study Locations (1 sites)
Department of Rheumatology, Bonn, North Rhine-Westphalia 53127 Germany
Eligibility Criteria
Inclusion Criteria: * Male * \> 50 years * Diagnosis of arthritis (RA, PsA), collagen diseases (SLE, systemic sclerosis, Sjögren's syndrome, mixed connective tissue diseases), vasculitis (eGPA, GPA, MPA, IgG4-related disease, GCA, PMR), sarcoidosis, COPD, ILD or asthma bronchiale confirmed by the treating physician. Exclusion Criteria: * Female * \< 50 years Inclusion Criteria (Healthy controls): * Male * \> 50 years Exclusion Criteria (Healthy controls): * Female * \< 50 years * autoimmune, rheumatological diease * pulmonary precondition
Role of MDCT in Grading of Esophageal Varices
NCT06707298
Not yet recruiting
Conditions MDCT Esoghageal Varices
Phase Not Applicable
Enrollment 70
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

  • Comparison between CT and endscopy in esophageal varices
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2024-12
Completion: 2026-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 70 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Assiut University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Eligibility Criteria
Inclusion Criteria: -Cirrhotic patients with portal hypertension undergoing upper GI endoscopy. Exclusion Criteria: -Contraindication to contrast:( severe renal insufficiency, allergy to contrast agents). -Previous history of upper GI endoscopy with intervention (band ligation or sclerotherapy).- * Pregnancy. * Patients with previous transjagular intrahepatic portosystemic shunt (TIPS). * Patients with contraindication to endoscopy (severe cardiopulmonary conditions, coma "unless the patient is intubated", and cardiac arrhythmias)
The Effect of Healthy Nutrition and Functional Foods Education Based on the Health Promotion Model for Individuals With Type 2 Diabetes on Healthy Lifestyle Behaviors and Self-Efficacy in Diabetes: Randomized Controlled Study
NCT06721546
Active, positions filled
Conditions Type 2 Diabetes Mellitus (T2DM)
Phase NA
Enrollment 86
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

  • Nursing interventions
  • reminder messages
  • Telephone counseling

Primary Outcomes

  • Healthy Lifestyle Behavior Scale-II
  • Self-Efficacy Scale for Diabetes Management in Diabetes Patients
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: 2024-03-15
Completion: 2024-11-30
Eligibility
Age: 30 Years
Sex: ALL
Volunteers: false
Enrollment: 86 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Necmettin Erbakan University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Nursing interventions
  • reminder messages
  • Telephone counseling
Study Locations (1 sites)
Karaman education and research hospital, Karaman, Merkez Turkey (Türkiye)
Eligibility Criteria
Inclusion Criteria: * Participant aged 30-64 years * Those diagnosed with Type 2 Diabetes for at least 6 months * Not diagnosed with psychiatric and neurological diseases diagnosed by a doctor, * Having basic diabetes knowledge, * At least primary school graduate * Individuals who volunteered to participate in the research, * Smartphone and internet access, Exclusion Criteria: * Those who do not meet the inclusion criteria, * Those who have a condition that prevents them from receiving education (physical, mental, vision and hearing, etc.) * Those who have previously received functional food education, * Those who are pregnant, * Those with cancer, * Those with acute or chronic kidney disease, * Those with known food allergies.
Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer
NCT06693024
Recruiting
Conditions HER2-positive Breast Cancer
Phase Not Applicable
Enrollment 2806
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

  • neratinib

Primary Outcomes

  • invasive disease free survival
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: 2019-01-01
Completion: 2031-12-31
Eligibility
Age: No restriction
Sex: ALL
Volunteers: false
Enrollment: 2806 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Shu Wang
Principal Investigators:
  • shu wang, doctor (PRINCIPAL_INVESTIGATOR) - Peking University People's Hospital
Contact Information
Study Contact:
yuan peng, doctor
86+13671287670
13671287670@163.com
Interventions
  • neratinib
Study Locations (1 sites)
Peking University People's Hospital, Beijing, Beijing Municipality 100044 China
Eligibility Criteria
Inclusion Criteria: * 1\) Patients with HER2 positive breast cancer who were diagnosed by core needle biopsy/operation in Peking University People's hospital; * 2\) The patients were treated in our hospital and underwent radical resection with hospitalization records; * 3\) Received standard anti-HER2 neoadjuvant/adjuvant therapy (trastuzumab, trastuzumab combined with pertuzumab, T-DM1) * 4\) Has signed and agreed to participate in the PKUPH breast disease cohort study. Exclusion Criteria: * 1\) Lack of clinical and pathological data (such as imaging data and pathological data); * 2\) Patients with metastatic breast cancer or bilateral breast cancer; * 3\) Failure to perform radical surgery
Assessing the Impact of VR-Based Observational Mindfulness Meditation on Stress Reduction in Adults
NCT06704282
Not yet recruiting
Conditions Stress, Anxiety, Depression
Phase NA
Enrollment 34
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

  • VR Mindfulness Meditation Program

Primary Outcomes

  • Reduction in Perceived Stress Levels
  • Changes in Emotional State
  • Participant Satisfaction with Intervention
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: 2024-11-25
Completion: 2025-02-23
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 34 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Penn State University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • VR Mindfulness Meditation Program
Study Locations (1 sites)
Penn State Univercity, Erie, Pennsylvania 16563 United States
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 years and older. Exclusion Criteria: * Those with visual or hearing impairments that prevent interaction with VR content.
Pyrotinib in HER2-positive Early Breast Cancer
NCT06718335
Not yet recruiting
Conditions HER2-positive Breast Cancer
Phase NA
Enrollment 156
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

  • Pyrotinib

Primary Outcomes

  • Event Free Survival(EFS)
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: 2024-12-30
Completion: 2029-12-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 156 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Nie Jianyun
Contact Information
Study Contact:
Nie Jian Yun, Ph.D
13608815577
njyvip@sina.com
Interventions
  • Pyrotinib
Eligibility Criteria
Inclusion Criteria: 1. Women aged ≥18 years and ≤75 years with newly treated breast cancer; 2. Pathological examination confirmed HER2 positive (immunohistochemistry staining +++ or immunohistochemistry staining ++ and Fluorescence in situ hybridization positive); 3. Patients with invasive breast cancer diagnosed histologically plus imaging as early (T1c-3, N0-1, M0) or locally advanced (T2-3, N2, or N3, M0); 4. Eastern Cooperative Oncology Group score 0\~1; 5. Plan to undergo the final surgical removal of breast cancer, i.e. breast conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND); 6. If the major organs function normally, the following criteria are met: (1) The standard of blood routine examination should meet: absolute neutrophil count(ANC) ≥1.5×109/L; blood platelet (PLT) ≥90×109/L; Hb ≥90g/L; (2) Biochemical examination should meet the following criteria: total bilirubin(TBIL)≤ upper limit of normal value (ULN); alanine aminotransferase(ALT) and AST≤1.5 times the upper limit of normal (ULN); Alkaline phosphatase ≤2.5 times the upper limit of normal (ULN); blood urea nitrogen(BUN)and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (CockcroftGault formula); (3) Color Doppler ultrasonography and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) Fridericia calibrated QT interval (QTcF) for 18-lead ECG \<470 ms; 7. For female patients who are not menopausal or have not been surgically sterilized: consent to abstinence or use of an effective contraceptive method during treatment and for at least 7 months after the last dose in the study treatment; 8. Volunteer to join the study and sign the informed consent. Exclusion Criteria: 1. Known allergic history of the drug components of this protocol; 2. Previously received antitumor therapy or radiation therapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma); 3. Has undergone major non-breast cancer related surgery within 4 weeks, or has not fully recovered from such surgery; 4. Stage IV (metastatic) breast cancer patients; 5. Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug; 6. Serious heart disease or discomfort that cannot be treated; 7. Suffering from mental illness or psychotropic substance abuse, unable to cooperate; 8. Pregnant or lactating women; 9. Patients with severe liver and kidney function diseases and blood system diseases; 10. Those who were not considered suitable for inclusion by the researchers included: history of drug abuse, history of use of blood products, anticoagulant drugs and immunological drugs within the past year; Patients with poor compliance and refusal to cooperate with treatment; Patients with severe high blood pressure, diabetes and other doctors deemed unsuitable for joining the study.
A Master Trial Assessing the Technical Feasibility of First-In-Human Real-Time Image Guided Radiation Therapy Methods
NCT06708221
Not yet recruiting
Conditions Cancer
Phase NA
Enrollment 40
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Real-Time Image Guided Radio Therapy (IGRT)

Primary Outcomes

  • Successful application of Real-Time IGRT
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: 2027-06
Completion: 2030-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Sydney
Collaborators: Medical Research Future Fund
Principal Investigators:
  • Paul Keall (PRINCIPAL_INVESTIGATOR) - University of Sydney
Contact Information
Study Contact:
Shona Silvester
+61 2 86271185
shona.silvester@sydney.edu.au
Interventions
  • Real-Time Image Guided Radio Therapy (IGRT)
Study Locations (1 sites)
Peter MacCallum Cancer Centre, Melbourne, Victoria 3000 Australia
Eligibility Criteria
Inclusion Criteria: * Patients 18 years or older to be treated with curative radiation therapy * Patients with brain, breast, head and neck, kidney, liver, lung, pancreas, prostate or spine cancer * ECOG performance status 0-2 * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Pregnancy, * Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements or severe psychiatric illness/social situation * Additional inclusion and exclusion criteria may apply to a specific sub-study
A Study to Assess Adverse Events and Change in Disease Activity of Oral Icalcaprant in Adult Participants With Bipolar I or II Disorder
NCT06696755
Recruiting
Conditions Bipolar I Disorder, Bipolar II Disorder
Phase PHASE2
Enrollment 195
Locations 33 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

  • Icalcaprant
  • Placebo for Icalcaprant

Primary Outcomes

  • Change from Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale) total score
  • Number of Participants with Adverse Events (AEs)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2026-02-03
Completion: 2027-11
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 195 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: AbbVie
Principal Investigators:
  • ABBVIE INC. (STUDY_DIRECTOR) - AbbVie
Contact Information
Study Contact:
ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com
Interventions
  • Icalcaprant
  • Placebo for Icalcaprant
Study Locations (33 sites)
University of Alabama - Huntsville Regional Medical Campus /ID# 272951, Huntsville, Alabama 35801 United States
Chandler Clinical Research Trials /ID# 274500, Chandler, Arizona 85224 United States
Del Sol Research Management - East Tanque Verde Road - Tucson /ID# 279767, Tucson, Arizona 85715 United States
Sanro Clinical Research Group /ID# 279462, Bryant, Arkansas 72022 United States
Advanced Research Center /ID# 272828, Anaheim, California 92805 United States
Collaborative Neuroscience Research - Garden Grove /ID# 271917, Garden Grove, California 92845 United States
Catalina Research Institute /ID# 272831, Montclair, California 91763 United States
Excell Research /ID# 272854, Oceanside, California 92056 United States
Pacific Neuropsychiatric Specialists - Orange /ID# 273118, Orange, California 92868 United States
Schuster Medical Research Institute /ID# 272848, Sherman Oaks, California 91403 United States
Eligibility Criteria
Inclusion Criteria: * Participants with a diagnosis of bipolar I or II according to the DSM-5-TR without psychotic features, confirmed by the MINI 7.0.2, and currently experiencing an MDE beginning at least 4 weeks prior to consent and not exceeding 12 months prior to Screening. * Body Mass Index (BMI) is \>= 18.0 to ≤\<= 35.0 kg/m\^2. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG. * CGI-S-BP score of ≥ 4 for depression and overall bipolar illness at screening (Visit 1) and baseline (Visit 2). * YMRS total score \<= 12 at screening (Visit 1) and baseline (Visit 2). * Participants on treatment with a single mood stabilizer (lithium, valproate, or lamotrigine), maintained at a stable dose for \>= 28 days prior to screening. Current mood stabilizer dose must remain unchanged for the duration of the study. * If taking lithium or valproate, participant must have a therapeutic blood level at screening of lithium (0.4 - 1.2 mg/dL) or valproate (50 - 125 mg/dL). * If taking lamotrigine, participant should be taking a dose within the FDA accepted range (50-400 mg/day, target dose is 200 mg/day) and investigator clinical judgment determines that the dose the participant is taking is likely to prevent onset of mood episodes. Exclusion Criteria: * History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class. * History of or active medical conditions(s) that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the subject's well-being. This includes any unstable condition, history or evidence of malignancy (other than treated basal or squamous cell carcinoma), or any significant hematologic, endocrine, cardiovascular, respiratory, renal, hepatic, gastrointestinal, or neurological disorder (if there is a history of such disease but the condition has been stable for more than 1 year, does not require treatment with prohibited medications, and is judged by the investigator not to interfere with the participant's participation in the study, the participant may be included in the study).
PIK3CA Mutational Status Assessment
NCT06706570
Recruiting
Conditions Breast Cancer Metastatic
Phase Not Applicable
Enrollment 100
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

  • Evaluation of PIK3CA mutational status: a path towards a "tailored" diagnostic approach.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-11-06
Completion: 2030-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: European Institute of Oncology
Principal Investigators:
  • Nicola Fusco, MD (PRINCIPAL_INVESTIGATOR) - Istituto Europeo di Oncologia
Contact Information
Study Contact:
Nicola Fusco, MD
00390294372079
nicola.fusco@ieo.it
francesca lombardi, biologist
00390257489425
francesca.lombardi@ieo.it
Interventions
N/A
Study Locations (1 sites)
European Institute of Oncology, Milan, MI 20141 Italy
Eligibility Criteria
Inclusion Criteria: * Participant has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory. * Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing. * Participants should be at advanced or metastatic setting prior to treatment. * Written informed consent must be signed and dated by the patient and the investigator prior to inclusion. * Patients must be accessible for follow-up. Exclusion Criteria: • patients already treated with different treatments like chemotherapy, hormone therapy etc