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Showing 20 of 30222 trials
Pilot Study of Mirtazapine for the Dual Tx of Depression and CINV in High-Grade Glioma Pts on TMZ
NCT03935685
Active, positions filled
Conditions Glioma of Brain
Phase PHASE2
Enrollment 120
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Mirtazapine (Remeron)

Primary Outcomes

  • Depression level in glioma patients on temozolomide therapy treated with Mirtazapine
  • Patient Weight Change
  • Frequency and grade of nausea and vomiting in depressed glioma patients on temozolomide therapy treated with Mirtazapine
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Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2019-02-26
Completion: 2030-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of California, Irvine
Principal Investigators:
  • Daniela Bota, MD PHD (PRINCIPAL_INVESTIGATOR) - University of California, Irvine
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Mirtazapine (Remeron)
Study Locations (1 sites)
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California 92868 United States
Eligibility Criteria
Inclusion Criteria: * Understand and voluntarily sign and date an informed consent document prior to any study related assessments/procedures are conducted. * Histologically confirmed diagnosis of glioma * No prior treatment with temozolomide TMZ * Patient will receive temozolomide TMZ therapy as part of their standard treatment. * Males and Females ≥18 years of age at the time of signing the informed consent document. Able to understand consent forms and study materials in English * Willing to use approved methods of contraception for duration of study * Karnofsy Performance Score (KPS) of at least 60 * Patients should have stopped any anti-depressant medications by standard of care at least a month before enrolling in the trial * Willing and able to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: * Prior treatment with other chemotherapy drugs for glioma * Known hypersensitivity to Mirtazapine and 5-HT3 receptor antagonists * Life expectancy of less than three months * Pregnancy or breastfeeding.
Surgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma
NCT03909282
Recruiting
Conditions Ductal Breast Carcinoma in Situ
Phase NA
Enrollment 50
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

  • Lumpectomy
  • Partial breast irradiation prior to surgery

Primary Outcomes

  • Rate of ductal carcinoma in situ (DCIS) pathologic complete response
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2019-03-22
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Stanford University
Principal Investigators:
  • Irene Wapnir, MD (PRINCIPAL_INVESTIGATOR) - Stanford University
Contact Information
Study Contact:
Sinyoung Park
650-721-4485
sinyoung@stanford.edu
Interventions
  • Lumpectomy
  • Partial breast irradiation prior to surgery
Study Locations (1 sites)
Stanford University, Stanford, California 94304 United States
Eligibility Criteria
Inclusion Criteria * Core needle biopsy demonstrating DCIS (ductal carcinoma in situ) of non-palpable, image-detected breast abnormality * Signed and dated IRB-approved written informed consent * Women 18 years of age or older * Mammographic calcifications or MRI non-mass enhancement measuring 4 cm or less in greatest dimension, including multifocal disease * Estrogen receptor positive or negative, progesterone receptor positive, negative or unknown; HER2 positive, negative or unknown DCIS is allowed * Diagnostic needle biopsy within 16 weeks of randomization * Patients must have a biopsy marker placed within the tumor bed confirmed on post biopsy imaging. * Placement of Savi scout optical reflectance marker in tumor bed area as a wireless guide for surgery and for neoRT treatment planning is preferred but not required if anatomic metallic markers are sufficient for radiation planning. Placement does not have to occur before randomization. Additionally, wire localization before surgery is permissible. * Planned lumpectomy. Mastectomy will be acceptable if lumpectomy fails by virtue of involved margins or size of lesion, or patient chooses this approach after randomization * Radiation Oncologist to ascertain feasibility of PBI prior to randomization - based on their estimation that 30% or less of the breast volume will be encompassed in the radiation fields * Patients who had a prior contralateral invasive or non-invasive (DCIS) cancer are eligible * ECOG performance status 0, 1, or 2 * Concurrent foci of atypia or lobular carcinoma in situ in the ipsilateral or contralateral breast are allowed Exclusion Criteria * Invasive carcinoma on core needle biopsy, including microinvasive carcinoma * Radiographic extent of DCIS \>4.0 cm * Mass lesion on breast imaging or palpable tumor * No residual radiographic lesion after diagnostic percutaneous core needle biopsy * Prior history of ipsilateral invasive or noninvasive breast cancer * Pregnant or breastfeeding * Prior ipsilateral breast or chest irradiation * Multicentric or multifocal DCIS, if extent is \> 4cm * Synchronous contralateral invasive or noninvasive breast cancer * Pagets' disease of the breast * Active collagen vascular disease * Positive axillary lymph nodes * Not meeting the described criteria for partial breast irradiation during initial clinical evaluation. * Psychiatric or addictive disorders or other condition, that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with the interpretation of study results * Endocrine therapy is not allowed from the time of study randomization to the completion of surgery unless the endocrine therapy is being continued for a contralateral cancer
PersonaLized neoAdjuvant Strategy ER Positive and HER2 Negative Breast Cancer TO Increase BCS Rate
NCT03900637
Active, positions filled
Conditions Breast Cancer
Phase PHASE2
Enrollment 122
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Leuprorelin acetate
  • Letrozole
  • MammaPrint

Primary Outcomes

  • Conversion Rate
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Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2019-11-08
Completion: 2028-12-31
Eligibility
Age: 19 Years
Sex: FEMALE
Volunteers: false
Enrollment: 122 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Seoul National University Hospital
Principal Investigators:
  • Wonshik Han (PRINCIPAL_INVESTIGATOR) - Seoul National University Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Leuprorelin acetate
  • Letrozole
  • MammaPrint
Study Locations (1 sites)
Seoul National University Hospital, Seoul, South Korea
Eligibility Criteria
Inclusion Criteria: 1. Histopathologically and immunohistochemically confirmed ER+ and HER2- BC patients 2. Stage I-IIIA BC patients with detectable tumor sizes 3. BC patients for whom BCS is not feasible due to tumor sizes or locations (two surgeons at each institution evaluate the infeasibility of BCS) 4. Patients without distant metastasis which were identified pathologically or radiologically 5. Female patients ≥ 19 years * Diagnosis of menopause is defined as no menstruation for 1-year or both ovaries removed surgically 6. ECOG 0-2 7. Patients with adequate bone marrow function * Hemoglobin 10 g/dL, ANC 1,500/mm3, Plt 100,000/mm3 8. Patients with adequate kidney function * serum Cr ≤ 1.5 mg/dL 9. Patients with adequate liver function * Bilirubin: ≤ 1.5 times of upper normal limit * AST/ALT: ≤ 1.5 times of upper normal limit * Alkaline phosphatase: ≤ 1.5 times of upper normal limit 10. Patients who decided to voluntarily participate in this trial with written informed consent Exclusion Criteria: 1. History of treatment for ipsilateral BC or breast carcinoma in situ 2. Confirmed distant metastasis of BC 3. History of cancer other than BC 4. Pregnant (positive pregnancy test within a week of enrollment) or breast-feeding patients 5. Uncontrolled severe infection 6. Psychiatric illness or epilepsy 7. Male BC patients 8. Inability to understand and willingness to sign a written informed consent 9. Mammographic extensive microcalcification 10. Multicentral, Bilateral BC 11. History of chemotherapy or endocrine therapy on contralateral BC for the past 2 years 12. ER- 13. HER2+ 14. Undetectable and unmeasurable primary tumor size
Breast Cancer and Its Relationship With the Microbiota
NCT03885648
Active, positions filled
Conditions Breast Cancer
Phase Not Applicable
Enrollment 150
Locations 1 sites
Compensation paid available
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Metagenomic study of mammary microbiota
  • Metagenomic study of intestinal microbiota
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Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2018-01-01
Completion: 2024-12-31
Eligibility
Age: 25 Years
Sex: FEMALE
Volunteers: true
Enrollment: 150 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Universidad de Granada
Principal Investigators:
  • Luis Fontana, Ph.D. (PRINCIPAL_INVESTIGATOR) - Universidad de Granada
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (1 sites)
Unit of Mammary Pathology, General Surgery Service, University Hospital Campus de la Salud, Granada, 18100 Spain
Eligibility Criteria
Inclusion criteria: * Cases will be women diagnosed and surgically intervened of breast cancer, stages I and II. * Controls will be women surgically intervened of breast augmentation or reduction. Exclusion criteria: 1. For cases: * Women with antecedents of cancer or advanced tumor stage (metastasis). * Women who have received antibiotic treatment 3 months prior to recruitment, or any neoadjuvant therapy. 2. For controls: * Women with oncological, gynecological or endocrine antecedents. * Women who have received antibiotic treatment 3 months prior to recruitment.
MRI Screening Versus SYMptom-directed Surveillance for Brain Metastases Among Patients with Triple Negative or HER2+ MBC
NCT03881605
Active, positions filled
Conditions Breast Neoplasm, Brain Metastases, Tripl...
Phase NA
Enrollment 50
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

  • MRI screening

Primary Outcomes

  • Proportion of eligible patients at the Sunnybrook Odette Cancer Centre (SOCC) who i) agree to enroll in the proposed randomized phase II pilot study, and ii) complete the study protocol.
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2018-11-08
Completion: 2025-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sunnybrook Health Sciences Centre
Collaborators: Harvard University
Principal Investigators:
  • Katarzya J Jerzak, MD MSc FRCPC (PRINCIPAL_INVESTIGATOR) - University of Toronto
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • MRI screening
Study Locations (1 sites)
Sunnybrook Odette Cancer Centre, Toronto, Ontario M4N3M5 Canada
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 2. Triple negative or HER2+ breast cancer (ASCO/CAP guidelines 2018)\* 3. MBC, as defined as distant disease outside of the breast and local/regional lymph nodes. Physicians' clinical judgment will be used to determine the possible need for biopsy in confirming a MBC diagnosis. However, biopsy of a metastatic site is not required for pathologic confirmation of stage IV disease. 4. Diagnosis of metastatic disease within 12 weeks prior to study enrollment. 5. No symptoms of BrM or known asymptomatic BrM at study entry. 6. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may participate. * This will generally be based on the primary cancer but in the event that a metastatic site is biopsied eligibility will be based on the ER, PR and HER2 profile of the metastasis. Exclusion Criteria: 1. Inability to participate in an MRI screening program as determined by the patient and/or physician. This may be on the basis of severe claustrophobia, performance status that limits additional testing, or a metal foreign body that would prevent MRI imaging. 2. Inability to provide informed consent. Notably participants who require translators are allowed to enroll. 3. Creatinine clearance \<30 mL/min using the Cockcroft-Gault equation. 4. Established need for brain imaging apart from the breast cancer diagnosis (e.g surveillance for an aneurysm). 5. ECOG Performance status \>2. 6. Pregnancy. 7. Grade 3+ allergy to Gadavist IV contrast (CTEP Adverse Event Reporting System).
Metastatic Breast Cancer in Austria
NCT03870620
Recruiting
Conditions Breast Cancer, Breast Carcinoma, Breast ...
Phase Not Applicable
Enrollment 5000
Locations 16 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Number of patients with prognostic factors for metastatic breast cancer
  • Number of patients according to molecular subtypes
  • Frequency and tumour characteristics of breast cancer in male patients
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Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2015-06-15
Completion: 2025-06
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 5000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators: Hoffmann-La Roche, Daiichi Sankyo, Pfizer, Novartis, Caris Life Sciences, AstraZeneca, Seagen Inc., Eli Lilly and Company
Principal Investigators:
  • Richard Greil, MD (STUDY_CHAIR) - AGMT gemeinnützige GmbH
Contact Information
Study Contact:
Daniela Wolkersdorfer
+43 662 6404412
d.wolkersdorfer@agmt.at
Interventions
N/A
Study Locations (16 sites)
Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität; Universitätsklinik für Innere Medizin III Salzburg, Salzburg, State of Salzburg 5020 Austria
AKH Wien; Universitätsklinik für Frauenheilkunde: Klin. Abt. f. Allg. Gynäkologie und gynäkologische Onkologie, Vienna, State of Vienna 1090 Austria
Steiermärkische Krankenanstalten- gesellschaft m. b. H. LKH-Univ. Klinikum Graz; Universitätsklinik für Innere Medizin; Klinische Abteilung für Onkologie, Graz, Styria 8036 Austria
Landeskrankenhaus - Universitätskliniken Innsbruck; Universitätsklinik für Frauenheilkunde Innsbruck, Innsbruck, Tyrol 6020 Austria
BKH Kufstein; Innere Medizin: Interne II und onk. Tagesklinik, Kufstein, Tyrol 6330 Austria
Kepler Universitätsklinikum; Univ.-Klinik für Hämatologie und Internistische Onkologie, Linz, Upper Austria 4020 Austria
Ordensklinikum Linz GmbH - Barmherzige Schwestern; Interne I: Medizinische Onkologie und Hämatologie, Linz, Upper Austria 4020 Austria
Pyhrn-Eisenwurzen Klinikum Steyr; Innere Medizin II: Onkologie, Gastroenterologie, Angiologie, Steyr, Upper Austria 4400 Austria
Klinikum Wels-Grieskirchen GmbH; Abteilung für Innere Medizin IV, Wels, Upper Austria 4600 Austria
LKH Feldkirch; Innere Medizin II/ Interne E (Hämatologie und Onkologie), Feldkirch, Vorarlberg 6800 Austria
Eligibility Criteria
Inclusion Criteria: * Histological evidence of breast cancer * Histological and/or radiological evidence of metastases * Metastasis within 10 years of registry initiation * Signed informed consent (if a patient has already died at the time of entry, the entry can be made without a declaration of consent) Exclusion Criteria: * Due to the non-interventional design of the registry there are no specific exclusion criteria.
Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing
NCT03889743
Recruiting
Conditions Asthma, Inflammation
Phase PHASE4
Enrollment 280
Locations 8 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

  • Dexamethasone treatment during 3 days
  • placebo treatment during 3 days

Primary Outcomes

  • time to a new physician-confirmed wheezy episode within 24 months after study entry
  • time to need for a regular controller medication for asthma within 24 months after study entry
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2019-05-08
Completion: 2028-05
Eligibility
Age: 3 Months
Sex: ALL
Volunteers: false
Enrollment: 280 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: St. Olavs Hospital
Collaborators: Turku University Hospital, Karolinska University Hospital, Haukeland University Hospital, University Hospital, Akershus, Helse Stavanger HF, University Hospital of North Norway, Ullevaal University Hospital
Principal Investigators:
  • Geir Bråthen (STUDY_DIRECTOR) - St. Olavs Hospital
Contact Information
Study Contact:
Henrik Døllner, md phd
0047 73559531
henrik.dollner@ntnu.no
Interventions
  • Dexamethasone treatment during 3 days
  • placebo treatment during 3 days
Study Locations (8 sites)
Turku University Hospital, Turku, Finland
Haukeland University Hospital, Bergen, Norway
Akershus University Hospital, Oslo, Norway
Ullevål University Hospital, Oslo, Norway
Stavanger University Hospital, Stavanger, Norway
University Hospital of North Norway, Tromsø, Norway
St Olavs Hospital, Trondheim, Norway
Karolinska Universitetssjukhuset, Stockholm, Sweden
Eligibility Criteria
Inclusion Criteria: * admitted to pediatric acute wards in the participating hospitals in Norway, Finland, Sweden. * referred for first severe wheezing episode, defined as first-time acute breathing difficulty with wheezing ever, appearing less than 7 days from onset of symptoms * one or more of the following:(a) fever, (b) hypoxia (SAT O2 \<= 92%), (c) retractions (inter-, subcostal), (d) prolonged expiration (on auscultation), (e) expiratory rhonchi (on auscultation) * evidence of rhinovirus infection by PCR-test in nasopharyngeal secretions * signed informed consent and expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to ICH GCP, and national/local regulations. Exclusion Criteria: * previous episodes with wheezing, defined as a history of acute breathing difficulty with wheezing in need of treatment at a general practitioner or at hospital, or parental information about similar breathing difficulties * gestational age \<37 weeks * chronic illness other than atopy (eczema), * previous systemic or inhaled corticosteroid treatment, * participation to another trial, * varicella infection or contact during the last 2-3 weeks, * need for intensive care unit treatment during the present infection, except for respiratory support with non-invasive methods (high flow nasal cannula ventilation, CPAP or BiPAP), * any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures). * COVID-19 related disease.
Change of Adipose Tissues and Triglyceride After Bariatric Surgery or Life-style Intervention
NCT03875625
Recruiting
Conditions Non-Alcoholic Fatty Liver Disease, Obesi...
Phase NA
Enrollment 80
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

  • Bariatric surgery
  • Dietitian led life style modification intervention
  • Conventional care (control)

Primary Outcomes

  • Use of modified Dixon Magnetic Resonance Imaging method to measure the response of adipose tissue in different organs following life style modification program or Bariatric surgery
  • Use of modified Dixon Magnetic Resonance Imaging method to measure the response of adipose tissue in different organs following life style modification program or Bariatric surgery 2
  • Use of modified Dixon Magnetic Resonance Imaging method to measure the response of adipose tissue in different organs following life style modification program or Bariatric surgery- 3
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2019-04-01
Completion: 2026-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 80 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Chinese University of Hong Kong
Principal Investigators:
  • Winnie C Chu, MD (PRINCIPAL_INVESTIGATOR) - Chinese University of Hong Kong
Contact Information
Study Contact:
Winnie C Chu, MD
(852) 3505 2299
winniechu@cuhk.edu.hk
Interventions
  • Bariatric surgery
  • Dietitian led life style modification intervention
  • Conventional care (control)
Study Locations (1 sites)
The Chinese University of Hong Kong, Prince of Wale Hospital, Hong Kong, Shatin Hong Kong
Eligibility Criteria
Inclusion Criteria: * BMI ≥ 25-30 kg/m2 * BMI ≥ 30 kg/m2 with Metabolic syndrome * BMI ≥ 35 kg/m2 for morbid obesity Exclusion Criteria: * Other kind of hepatic diseases * Under medications known to affect liver fat * Waist circumference ≥ 150 cm * Weight ≥ 250 kg * MRI contraindications
Photoacoustic Imaging of the Breast in Patients With Breast Cancer and Healthy Subjects
NCT03897270
Recruiting
Conditions Breast Carcinoma, Healthy Subject
Phase NA
Enrollment 400
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

  • Photoacoustic Imaging

Primary Outcomes

  • Identify photoacoustic features of breast malignancies
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2018-10-25
Completion: 2026-08-25
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 400 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Roswell Park Cancer Institute
Collaborators: Susan G. Komen Breast Cancer Foundation
Principal Investigators:
  • Ermelinda Bonaccio (PRINCIPAL_INVESTIGATOR) - Roswell Park Cancer Institute
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Photoacoustic Imaging
Study Locations (1 sites)
Roswell Park Cancer Institute, Buffalo, New York 14263 United States
Eligibility Criteria
Inclusion Criteria: * Women with clinically suspicious or confirmed breast cancer masses (that have not been surgically removed) and will/have already undergo/undergone breast magnetic resonance imaging (MRI). Exclusion Criteria: * Pregnant women (there are no known risks to these procedures, but any unforeseen risks are as yet undetermined, so pregnant women will be excluded by means of a verbal confirmation at time of screening). * Women who have had breast implants in the previous 6 months. * Women who have had lumpectomy * Adults unable to consent. * Individuals who are not yet adults (infants, children, teenagers). * Pregnant women. * Prisoners. * There is no direct benefit of the study to any subject either non-English or English speaker. To facilitate the consent process, we will exclude non-English speaking subjects.
Correlation Study Between Clinical Phenotype and Pathology of Type 2 Diabetic Nephropathy
NCT03865914
Recruiting
Conditions Diabetic Kidney Disease
Phase Not Applicable
Enrollment 2000
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

  • change in eGFR and urine protein from baseline
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: 2017-11-30
Completion: 2030-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 2000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Chinese PLA General Hospital
Collaborators: Beijing Municipal Science & Technology Commission, China-Japan Friendship Hospital, Beijing Friendship Hospital, Beijing Hospital, Fourth Medical Center of PLA General Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Third Medical Center of Chinese PLA General Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, The First Affiliated Hospital of Dalian Medical University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Dongzhimen Hospital, Beijing, Shanghai University of Traditional Chinese Medicine
Principal Investigators:
  • Xiangmei Chen, MD.&Ph.D (PRINCIPAL_INVESTIGATOR) - Chinese PLA General Hospital
Contact Information
Study Contact:
Xiangmei Chen, MD.&Ph.D
+86 010 66935462
xmchen301@126.com
Zheyi Dong, MD.&Ph.D
+86 010 66935462
shengdai26@163.com
Interventions
N/A
Study Locations (1 sites)
Chinese PLA General Hospital, Beijing, Beijing Municipality 100853 China
Eligibility Criteria
Inclusion Criteria: * Age≥18, male or female * Clinical diagnosed as type 2 diabetes mellitus * The presence of renal impairment including: microalbuminuria or overt proteinuria or renal insufficiency * The renal biopsy was performed with complete renal pathological diagnosis * Obtaining the signed informed consent from patients Exclusion Criteria: * The history of the disease was not complete * Clinical diagnosed as other secondary renal diseases * Patients with hereditary kidney disease * Autoimmune diseases * Patients with malignant tumor were expected to survive less than 6 months * Pregnancy and lactation
Preventing Anxiety and Depression in Older Hispanics
NCT03870360
Active, positions filled
Conditions Depression, Anxiety
Phase NA
Enrollment 240
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

  • HOLA Component 1
  • HOLA Component 2
  • HOLA Component 3
  • HOLA Component 4
  • Healthy lifestyles education program

Primary Outcomes

  • Change in risk factors for major depressive disorder (MDD)
  • Change in risk factors for generalized anxiety disorder (GAD)
  • Incidence of generalized anxiety disorder
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: 2022-11-01
Completion: 2026-11-01
Eligibility
Age: 60 Years
Sex: ALL
Volunteers: false
Enrollment: 240 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Miami
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Principal Investigators:
  • Daniel E. Jimenez, Ph.D. (PRINCIPAL_INVESTIGATOR) - University of Miami
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • HOLA Component 1
  • HOLA Component 2
  • HOLA Component 3
  • HOLA Component 4
  • Healthy lifestyles education program
Study Locations (1 sites)
University of Miami, Miami, Florida 33136 United States
Eligibility Criteria
Inclusion Criteria: * Latino (self-identified); * Age 60+; * Subthreshold depression defined as a score ≥ 5 on the Patient Health Questionnaire (PHQ-9), OR subthreshold anxiety as defined as a score ≥ 5 on the GAD-7; * Do not meet criteria for current MDD or GAD as indicated by the Mini International Neuropsychiatric Inventory (MINI); * Voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian or conservator; * Medical clearance for participation in a health promotion intervention by a physician, physician's assistant, or nurse practitioner; * Not taking steroidal or anti-inflammatory medication (including NSAIDs) within 2 weeks of treatment randomization; * Expect to be resident in Miami for the subsequent 2 years. Exclusion Criteria: * Have met criteria for major depressive disorder or generalized anxiety disorder within the past 12 months; * Have met criteria for alcohol or other substance abuse disorders within the past 12 months; * Are currently receiving antidepressant medication or participating in other mental health treatment; * Have a lifetime history of bipolar disorder or other psychotic disorder including major depression with psychotic features; * Have a diagnosis of any neurodegenerative disorder or dementia (Parkinson's disease, Alzheimer's, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a Mini Mental Status Exam (MMSE) score \<24; * Are current tobacco smokers since smoking influences systemic inflammation; * Have contraindications to physical activity outlined in the American College of Sports Medicine standards; * Have high suicide risk, i.e., intent or plan to attempt suicide in the near future (a response of "yes" to questions 3, 4, and/or 5 on the Paykel Questionnaire; * Are unable to complete 10 m walk test; * Currently residing in a nursing or group home; * Have a terminal physical illness expected to result in the death within one year; * Any evidence of current infection; and * Have an acute or severe medical illness that precludes them from safely participating in a health promotion intervention (further defined in the protocol).
Exercise, Hypertension, and Gut Dysbiosis in African Americans
NCT03897777
Active, positions filled
Conditions Hypertension
Phase NA
Enrollment 36
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

  • Exercise Training effect on Hypertension and Gut Dysbiosis

Primary Outcomes

  • Blood Pressure
  • Gut Dysbiosis
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: 2019-06-01
Completion: 2030-06
Eligibility
Age: 30 Years
Sex: ALL
Volunteers: true
Enrollment: 36 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: North Carolina Agriculture & Technical State University
Principal Investigators:
  • Marc Cook, PhD (PRINCIPAL_INVESTIGATOR) - North Carolina Agriculture & Technical State University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Exercise Training effect on Hypertension and Gut Dysbiosis
Study Locations (1 sites)
North Carolina A&T State University, Greensboro, North Carolina 27411 United States
Eligibility Criteria
Inclusion Criteria * Sedentary (regular aerobic exercise frequency ≤2 times per week and duration ≤20 minutes per session; sedentary profession); * 30-50 years of age; * Control normotensive (systolic BP: 90-120 mmHg/diastolic BP: 60-80 mmHg) * Elevated to Stage 1 Hypertension (systolic BP: 120-129 mmHg/diastolic BP: 80-89 mmHg) and/or stage 1 hypertension (systolic BP: 130-159 mmHg/diastolic BP: 90-99 mmHg). Exclusion Criteria Diagnosed with any of the following: * Uncontrolled hypertension, stroke, history of heart attack, heart disease; * Metabolic disease (diabetes mellitus); * Inflammatory diseases (inflammatory bowel disease(s), rheumatoid arthritis, and systemic lupus erythematosus); * Kidney stones or gallbladder problems; * Kidney disease; * Liver disease; * Lung disease; * Cancer within the previous 6 months; (11) pregnant females; * Peripheral vascular disease; * Taking hypertension medications or those known to affect inflammation or metabolic function (anti-inflammatories, statins, thyroid medication) in the past 1 month; * Currently smoking; * Other conditions that would exclude vigorous exercise (\>2mV ST-segment depression or CVD signs and symptoms during the screening graded exercise test).
Impact of Metabolic Health on Sperm Epigenetic Marks in Humans
NCT03860558
Active, positions filled
Conditions Overweight, Type 2 Diabetes Mellitus, Ty...
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

  • Lifestyle Intervention
  • No Intervention

Primary Outcomes

  • Spermatozoa concentration
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: 2018-05-01
Completion: 2026-07-01
Eligibility
Age: 18 Years
Sex: MALE
Volunteers: true
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Joslin Diabetes Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Lifestyle Intervention
  • No Intervention
Study Locations (1 sites)
Joslin Diabetes Center, Boston, Massachusetts 02215 United States
Eligibility Criteria
Inclusion Criteria: * Male, age 18-65 years * Willing and able to provide informed consent and follow all study procedures, including providing sperm specimens 3 months apart. * Type 1 or type 2 diabetes diagnosis confirmed by an endocrinologist (for participants in the diabetes groups) * HbA1c \> 7% (for participants in the diabetes groups) * Overweight (BMI \> 25 kg/m2) (for all groups, to ensure groups are similar) Exclusion Criteria: * Chronic kidney disease stage 4 or 5 (including end-stage renal disease); * Hepatic disease, including serum alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin \< 3.0 g/dL; or serum bilirubin \> 2.0; * Severe diabetic retinopathy; * Congestive heart failure, New York Heart Association (NYHA) class II, III or IV; * History of myocardial infarction, unstable angina or revascularization within the past 6 months; * Active genitourinary infection; * Testicular volume \<12 mL (assessed using Prader orchidometer); * Hypogonadism, defined as total testosterone \<250 ng/dl; * Hyperprolactinemia, defined as prolactin \>18 ng/ml; * Hyperestrogenism, defined as estradiol \>42 pg/ml; * Cryptorchidism; * Cigarette smoking; * Active alcohol abuse or substance abuse; * Cancer (except localized non-melanoma skin cancers) or use of chemotherapy agents within 5 years; * Use of nitrates or guanylate cyclase stimulators; * Use of steroid hormones (including testosterone), other than inhalers for reactive airway disease
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
NCT03887715
Recruiting
Conditions Treatment Resistant Depression
Phase NA
Enrollment 6800
Locations 101 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Vagus Nerve Stimulation (VNS)

Primary Outcomes

  • Montgomery Åsberg Depression Rating Scale (MADRS) Rate of Response
  • Montgomery Åsberg Depression Rating Scale (MADRS) Time to First response
  • Montgomery Åsberg Depression Rating Scale (MADRS) Time to First Remission
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2019-09-26
Completion: 2030-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 6800 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: LivaNova
Principal Investigators:
  • Charles Conway, MD (PRINCIPAL_INVESTIGATOR) - Washington University School of Medicine
Contact Information
Study Contact:
Laura Yates, BSN
281-228-7200
laura.yates@livanova.com
Interventions
  • Vagus Nerve Stimulation (VNS)
Study Locations (101 sites)
University of Alabama at Birmingham, Birmingham, Alabama 35294 United States
UAB Huntsville Regional Medical Center, Huntsville, Alabama 35801 United States
Access Multi Specialty Medical Clinic, Inc, Burlingame, California 94010 United States
CMB Clinical Trials, Colton, California 92324 United States
ATP Clinical Research, Inc., Costa Mesa, California 92626 United States
Kaizen Brain Center, La Jolla, California 92037 United States
Keck Hospital of USC, Los Angeles, California 90033 United States
University of California San Diego, San Diego, California 92103 United States
SF-CARE, Inc., San Rafael, California 94901 United States
Syrentis Clinical Research, Santa Ana, California 92705 United States
Eligibility Criteria
Inclusion Criteria: The patient must be in a major depressive disorder (MDD) episode for ≥ two years or have had at least four episodes of MDD, including the current episode. The patient's depressive illness meets a minimum criterion of four prior failed treatments of adequate dose and duration as measured by a tool designed for this purpose. The patient is experiencing a major depressive episode (MDE) as measured by a guideline recommended depression scale assessment tool on two visits, within a 45-day span prior to implantation of the VNS device. Patients must maintain a stable medication regimen for at least four weeks before device implantation. Exclusion Criteria: Current or lifetime history of psychotic features in any MDE; Current or lifetime history of schizophrenia or schizoaffective disorder; Current or lifetime history of any other psychotic disorder; Current or lifetime history of rapid cycling bipolar disorder; Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder; Current suicidal intent; or Treatment with another investigational device or investigational drugs.
A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients
NCT03833206
Not yet recruiting
Conditions Major Depressive Disorder
Phase PHASE1, PHASE2
Enrollment 12
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • PDC-1421 Capsule

Primary Outcomes

  • Montgomery-Åsberg Depression Rating Scale (MADRS)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Not yet recruiting
Start Date: 2027-01-15
Completion: 2028-02-28
Eligibility
Age: 21 Years
Sex: ALL
Volunteers: false
Enrollment: 12 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: BioLite, Inc.
Collaborators: American BriVision Corporation
Principal Investigators:
  • scott A Irwin, MD/PhD (PRINCIPAL_INVESTIGATOR) - Cedars-Sinai Health System
Contact Information
Study Contact:
Shirley Chiu, Ph.D.
+886-3-657-9631
shirleychiu@bio1st.com
Hsien-Ming Wu, MS
+886-3-657-9631
sonnywu@bioliteinc.com
Interventions
  • PDC-1421 Capsule
Study Locations (1 sites)
Cedars-Sinai Health System, Los Angeles, California 90048 United States
Eligibility Criteria
Eligibility Criteria * 21 to 85 Years of age * Diagnosis of Stage I, II or III cancer * Histologically-proven malignancy * Receiving or within one year of having received cancer treatment with radiation and/or chemotherapy * Montgomery and Åsberg Depression Rating Scale (MADRS) ≥ 20 (moderate to severe depressive symptoms) * Duration of depressive symptoms ≥ 2 weeks by patient report. * No active/acute suicidality requiring immediate care or psychiatric hospitalization * Sufficient English language proficiency to complete all assessments without assistance * Able to swallow pills * No severe anemia, defined as hemoglobin \< 10 g/dL * No history of multiple adverse drug reactions or allergy to study drugs * Not pregnant * No history of head trauma * No history of epilepsy * No other concurrent antidepressant medications Exclusion Criteria * Have a current or previous diagnosis of or history consistent with obsessive-compulsive disorder, posttraumatic stress disorder, bipolar I or II, manic or hypomanic episodes, schizophrenia, major Axis II disorders which might compromise the study, or major depression with psychotic symptoms, as assessed using the MINI International Neuropsychiatric Interview (MINI Plus). * Have a documented history of an intellectual disability. * Use of any antidepressant medication in the last 2 weeks before visit 1 (4 weeks for fluoxetine). * Currently being treated with tamoxifen. * Subjects who were non-responsive to two or more courses of antidepressant medications given at an adequate dosage\* for symptom treatment within four weeks, or by the judgment of the investigator considered to have treatment resistant depression (TRD), or a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or psychosurgery within the last year. * Have a history of any seizure disorder. * Any clinically significant abnormal vital sign, ECG, or laboratory values as determined by the investigator which might interfere with the study. * Have a high suicidal risk as assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). High suicidal risk is indicated by: 1. A positive response to question 4 or 5, indicating endorsement of suicidal ideation with at least some intent to act in the past month; and/or 2. A positive response to part two of question 6, indicating the presence of any suicidal behavior in the past 3 months. * Have a history of substance dependence/abuse\*\* within the past 6 months or a positive drug screen result during the screening period. * Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions. * \* An adequate dosage of the antidepressant medication is defined as the average of the usual dose (mg/day) recommended in American Psychiatric Association (APA) Practice Guideline for the Treatment of Patients with Major Depressive Disorder, Third Edition. E.g. the usual dose of Citalopram is 20-60 mg/day, the adequate dosage is 40 mg/day. * \*\* Tobacco is excluded here, and alcohol abuse is defined as average pure alcohol intake is more than 112 g (for male) or 56 g (for female) per week and/or with Alcohol withdrawal syndrome. Pure alcohol intake =% (Concentration or alcohol content) x c.c. (volume)x 0.79 (density of alcohol). Result of serum ethanol test should be equal to or lower than 10.0 mg/dL to be determined as eligible for the trial. If test result is between 10.1 to 29.9 mg/dL, only one re-test is allowed per subject to meet the criterion. Subject with test result equal to or higher than 30.0 mg/dL is to be excluded.
'ADVANCE' (A Pilot Trial)
NCT03858322
Active, positions filled
Conditions Breast Cancer
Phase PHASE1
Enrollment 41
Locations 5 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Paclitaxel
  • Cyclophosphamide
  • Carboplatin

Primary Outcomes

  • Toxicity and receipt of planned therapy (feasibility)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Active, positions filled
Start Date: 2019-03-21
Completion: 2026-06-30
Eligibility
Age: 70 Years
Sex: ALL
Volunteers: false
Enrollment: 41 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Dana-Farber Cancer Institute
Collaborators: Mayo Clinic
Principal Investigators:
  • Rachel Freedman, MD, MPH (PRINCIPAL_INVESTIGATOR) - Dana-Farber Cancer Institute
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Paclitaxel
  • Cyclophosphamide
  • Carboplatin
Study Locations (5 sites)
City of Hope National Medical Center, Duarte, California 91010 United States
Dana Farber Cancer Institute, Boston, Massachusetts 02115 United States
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) at Milford Regional Medical Center, Milford, Massachusetts 01757 United States
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital, South Weymouth, Massachusetts 02190 United States
Novant Health Oncology Specialists, Winston-Salem, North Carolina 27103 United States
Eligibility Criteria
Inclusion Criteria: * Participants must have histologically or cytologically confirmed breast cancer that is human epidermal growth factor receptor 2 negative (HER2-negative) per the most recent 2018 ASCO CAP guidelines94 * Estrogen Receptor and Progesterone immunohistochemistry (IHC) status must be known; any status is eligible, but this will define in which cohort a patient will enroll: * Additional eligibility for cohort 1: Triple negative disease- defined as IHC staining of \<10% for ER and PR per local pathology review * Additional eligibility for cohort 2: Hormone receptor-positive disease defined as IHC for ER or PR \>/= 10% per local pathology review * Men and women are eligible * Age 70 and older at the time of protocol registration * Non-metastatic, invasive breast cancer (scans are not required to document non-metastatic disease- any staging work-up is up to the treating provider's discretion) * Recommended to have either neoadjuvant chemotherapy or adjuvant chemotherapy per their treating provider. * Any surgery, nodal assessment, radiation, hormonal therapy is left up to the treating provider but should not occur concurrently with study therapy. If any additional chemotherapy is planned by a treating provider, this must occur AFTER all study-related chemotherapy is completed. * Any patient receiving pre-operative hormonal therapy and who is then recommended for adjuvant chemotherapy is eligible, though hormonal therapy should be held during study treatment administration * All study-related chemotherapy must be given prior to surgery if neoadjuvant therapy is planned or adjuvantly if postoperative chemotherapy is planned. For example, giving 6 doses pre-operatively and 6 doses postoperatively is not allowed on study. * There are no restrictions on life expectancy, ECOG Performance Status, or baseline blood values or organ function; Appropriateness of chemotherapy treatment is left up to the treating provider but providers should be ok with the full starting doses of each agent. * Participants must be willing to fill out surveys over time or designate a proxy to answer on their behalf. * Ability to understand and the willingness to sign a written informed consent document. * Patients who do not speak or read English are eligible as long as adequate interpreter services are available or the surveys are available in the preferred language (i.e. PRO surveys are available in many languages) Exclusion Criteria: * Participants who have already received chemotherapy for the current cancer. Prior diagnoses of breast cancers are allowed, provided that the treating provider feels that the current cancer represents a new primary breast cancer and not recurrent disease. * Participants who are receiving any other investigational or anti-cancer agents. Any additional radiation, hormonal therapy or chemotherapy planned should be administered once the study treatments have completed. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide, carboplatin, and paclitaxel. * Prior chemotherapy receipt is allowed in the setting of treatment of other/prior cancers, but no prior carboplatin (cohort 1), cyclophosphamide (cohort 2), or paclitaxel (both cohorts) receipt in the last 2 years is allowed (given toxicity and possible efficacy concerns
Development of Novel Physiological CMR Methods in Health and Disease
NCT03854071
Recruiting
Conditions Heart Failure, Pulmonary Hypertension, M...
Phase NA
Enrollment 135
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

  • intravenous fluid challenge

Primary Outcomes

  • 4D CMR Flow
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2018-07-30
Completion: 2031-01-01
Eligibility
Age: 20 Years
Sex: ALL
Volunteers: true
Enrollment: 135 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Contact Information
Study Contact:
Helen Denney
0114 2269047
H.Denney@nhs.net
Amber Ford
0114 2269047
amber.ford3@nhs.net
Interventions
  • intravenous fluid challenge
Study Locations (1 sites)
Sheffield Teaching Hospitals NHS FT, Sheffield, England S10 2JF United Kingdom
Eligibility Criteria
Inclusion Criteria: * Healthy Volunteers age 20 to 80, recruited from Sheffield Teaching Hospitals staff members * Patients age 20 to 80 with suspected or known heart disease (group 1 to 5) * Capable of giving written informed consent Exclusion Criteria: * Inability to perform the study protocol secondary to severe heart failure requiring IV therapy * Patients recruited in the suspected CAD and acute myocardial infarction arms of the study and in need for detection of ischaemia should not have any past medical history of MI, ACS or cardiomyopathy * Patients with significant valvular heart disease will be excluded from any patient group * Patient with in atrial fibrillation will be excluded * Contraindication to MRI (as per standard MRI screening questionnaire issued to patients prior to clinical MRI procedures)
Intensive Diet and Physical Activity on Diabetes
NCT03839667
Active, positions filled
Conditions Type2 Diabetes, Life Style
Phase NA
Enrollment 326
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

  • intensive diet intervention
  • Enhanced physical activity intervention
  • Standard education

Primary Outcomes

  • change in HbA1C level (%)
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: 2019-01-07
Completion: 2026-03-21
Eligibility
Age: 40 Years
Sex: ALL
Volunteers: false
Enrollment: 326 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Shanghai Jiao Tong University School of Medicine
Principal Investigators:
  • Guang Ning, MD, PhD (PRINCIPAL_INVESTIGATOR) - Shanghai Jiao Tong University School of Medicine
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • intensive diet intervention
  • Enhanced physical activity intervention
  • Standard education
Study Locations (1 sites)
Ruijin hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai Municipality 200025 China
Eligibility Criteria
Inclusion Criteria: 1. Men and women aged 40-70 years; 2. Newly diagnosed type 2 diabetes * Duration of type 2 diabetes ≤ 2 years; * Antidiabetic treatment maintained for at least 6 weeks before recruitment; 3. 7.0%≤ HbA1c \< 9.0%; 4. 25 Kg/m2 ≤ Body mass index (BMI) \<40 Kg/m2; Exclusion Criteria: 1. History consistent with type 1 diabetes; 2. Insulin treatment; 3. Severe cardiovascular disease: * current angina * myocardial infarction within last six months * heart failure * symptomatic periphery vascular disease 4. Uncontrolled hypertension: systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg; 5. Myocardial ischemia indicated by resting ECG; 6. Foot ulcers, peripheral neuropathy or skeletal disorders; 7. Taking high intensity exercise more than 75 minutes or moderate intensity exercise more than 150 minutes per week during the screening phase 8. Average weekly alcohol intake \>140 grams for men and \>70 grams for women; 9. ALT or AST levels more than twice the upper limit of the normal range or active liver diseases; 10. eGFR \<60 ml/min/1.73 m2, or serum creatinine \>1.5 mg/dl for men or 1.3mg/dl for women; or Proteinuria 11. Malignant tumor in active-stage, or in remission stage but less than 5 years from the most recent treatment 12. Hemoglobin concentration \<130 g/l for men or \<120 g/l for women; 13. Past or present confirmed psychiatric illness or drug dependence; 14. History of food allergies; 15. Surgical history of digestive system; 16. Currently taking medications known to affect weight (e.g. anti thyroid drugs, glucocorticoids); 17. Known to have weight-affecting diseases (e.g. malabsorption, functional bowel disease, uncontrolled low sodium/hyperthyroidism, eating disorders); 18. Known to have metabolism-affecting diseases; 19. Known to have infectious diseases within last month; 20. Possible consumption of food or drugs affecting glucose homeostasis or gut microbiota within the last three months; 21. Other acute diseases supported by clinical evidence which may contradict to the interventions; 22. Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control; 23. Currently participating in another intervention study; 24. Failure to obtain informed consent from participant; 25. Any factors judged by the clinic team to be likely to limit adherence to interventions; 26. Any other medical condition judged by the clinic team not eligible for the trial.
Docosahexaenoic Acid (DHA) for Women With Breast Cancer in the Neoadjuvant Setting
NCT03831178
Active, positions filled
Conditions Breast Cancer
Phase PHASE2
Enrollment 76
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Docosahexaenoic acid (DHA)
  • Placebo oral capsule

Primary Outcomes

  • Percent change in Ki67 index from baseline to surgical excision.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2019-08-28
Completion: 2030-09
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 76 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: AHS Cancer Control Alberta
Collaborators: Canadian Institutes of Health Research (CIHR), University of Alberta
Principal Investigators:
  • John Mackey, MD (PRINCIPAL_INVESTIGATOR) - Cross Cancer Institute
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Docosahexaenoic acid (DHA)
  • Placebo oral capsule
Study Locations (1 sites)
Cross Cancer Institute, Edmonton, Alberta T6G 1Z2 Canada
Eligibility Criteria
Inclusion Criteria: 1. Women with invasive (clinical stage I, II and III) breast cancer, for whom neoadjuvant systemic therapy with chemotherapy is recommended prior to surgery. 2. ECOG Performance status of 0 or 1. 3. Hematology and Biochemistry assessments (CBC and differential, PTT, PT/INR, AST, Alk Phos, Bilirubin, and Creatinine) within normal range unless determined not clinically significant by the qualified investigator. 4. Ability to take oral medications. 5. Adequate tissue specimen for diagnosis, biomarkers, and endpoint Ki67 assays. Exclusion Criteria: 1. Patients undergoing surgery prior to chemotherapy. 2. Current or previous (within 2 months) daily use (\>1 day/week) use of omega-3, fish oil, or other supplements or functional foods containing docosahexaenoic acid (at daily doses \> 200 mg). 3. Known allergy to soy or corn. 4. Continued intake of supplements containing Vitamin C, Vitamin E or β-carotene exceeding the DRI, or other anti-oxidant supplements. 5. Symptomatic but untreated cholelithiasis. 6. History of deep venous thrombosis, active thrombophlebitis, pulmonary embolism, stroke, acute myocardial infarction, congestive cardiac failure, untreated hypertension, known inherited hypercoagulable disorder. 7. Diagnosis of any other malignancy within the previous year except for adequately treated basal cell or squamous cell skin cancer. 8. Medically documented history of a psychiatric disorder that would preclude consent 9. Partial or complete loss of vision or diplopia, from ophthalmic vascular disease. 10. Hypersensitivity to DHA or to any ingredient in the formulation or component of the container.
Improving Brain Stimulation Through Imaging
NCT03851380
Active, positions filled
Conditions Depression, Depressive Disorder, Treatme...
Phase Not Applicable
Enrollment 54
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

  • Psychological / Functional Assessment
  • Structural and Functional MRI
  • Transcranial Magnetic Brain Stimulation and MR Image Guidance
  • Transcranial Electrical Stimulation (tES)

Primary Outcomes

  • World Health Organization Disability Assessment Schedule 2.0
  • Veterans RAND 36-Item
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: 2019-09-30
Completion: 2026-05-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 54 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: VA Office of Research and Development
Collaborators: Providence VA Medical Center, Atlanta VA Medical Center
Principal Investigators:
  • Allyson C Rosen, PhD (PRINCIPAL_INVESTIGATOR) - VA Palo Alto Health Care System, Palo Alto, CA
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Psychological / Functional Assessment
  • Structural and Functional MRI
  • Transcranial Magnetic Brain Stimulation and MR Image Guidance
  • Transcranial Electrical Stimulation (tES)
Study Locations (1 sites)
VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto, California 94304-1207 United States
Eligibility Criteria
Inclusion Criteria: Cohort 1: Capacity and willingness to participant in TMS, and fMRI as well as satisfying criteria for diagnosis. * Between 18 and 89 years of age. * Ability to obtain a Motor Threshold (MT) with single pulse TMS * Ability to safely and comfortably undergo an MRI and TMS * Able to read, verbalize, understand and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments * Depression (PHQ-9 \>= 10 and functional impairment present indicated with "difficulty" question OR sufficiently depressed to be enrolled in rTMS therapy) * Confirmed diagnosis of Major Depressive Disorder (MDD) * Can maintain all existing treatments (e.g. psychopharmacology, psychotherapy, etc.,) throughout course of the three sessions (psychological / functional assessments, MRI, and TMS), with modifications only as needed for clinical management * Is a Veteran Cohort 2: * Between 18 and 89 years of age * Ability to safely and comfortably undergo an MRI and tES * Ability to read, verbalize, understand, and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments * Depression (PHQ-9 \>= 10) and endorse that the COVID-19 pandemic has worsened their depression OR have a score on the COVID Stress Scale (CSS) on any item of 3 or greater indicating stressor is "very" or "often" a problem will allow the Veteran to enter the study Exclusion Criteria: * Participants who can not safely and comfortably undergo MRI OR TMS (or TES for Cohort 2) * If their language is not primarily English they may be excluded depending on how dependent the imaging and cognitive tasks are on language * Additionally, participants may be excluded if they do not fully understand the consenting process and cannot communicate sufficiently in English to participate in the therapy (d/t language barrier, etc.) * An example of safety screen details for an MRI is detailed in the Stanford University MRI screening form * MRI exclusions include having any non-removable device or implant that makes scanning unsafe, claustrophobia, and size (e.g. weight, girth) beyond the constraints of the MRI and scanner bed * For TMS the investigators will follow safety guidelines set by Rossi et. al.,2009 * Specifically, the investigators will not include subjects whose Motor Threshold (MT) is greater than 84% of maximum device output because mathematically they would not be able to be safely stimulated using the standard 120% of MT (i.e. the device cannot stimulate more than 100% of its potential output) * The investigators will report these high MT data in our secondary analyses. Additional TMS exclusions include any history or condition that puts patients at risk for a seizure * Pregnant or planning to become pregnant within the next 3 months * Lifetime history of moderate or severe traumatic brain injury, current unstable medical conditions, current (or past if appropriate) significant neurological disorder, or lifetime history of: * seizure disorder * primary or secondary CNS tumors * stroke * cerebral aneurysm * Significant cognitive impairment (Montreal Cognitive Assessment \[MoCA\] \< 16) * Comorbidities (e.g. PTSD) determined not to be the primary diagnosis * Have a lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms * Have a diagnosis of obsessive-compulsive disorder assessed by a study investigator to be causing greater impairment than MDD * Have active suicidal intent or plan in which case Dr. Rosen will determine whether the patient needs to be referred for hospitalization * Presence of any other condition or circumstance that, in opinion of the investigator team, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments Exclusion Criteria for Cohort 2: * Participants who cannot safely and comfortably undergo MRI or TES * Pregnant or lactating female or planning to become pregnant within the next 3 months * Lifetime history of moderate or severe traumatic brain injury or tumor * Significant cognitive impairment (Montreal Cognitive Assessment \[MoCA\] \< 16 OR equivalent score on \[MoCA-BLIND\] and judgement of a clinician that the test is validly reflecting a significant disabling cognitive impairment * Have a lifetime diagnosis of: * schizophrenia * schizoaffective disorder * schizophreniform * delusional disorder * or current psychotic symptoms * Have a diagnosis of obsessive-compulsive disorder or unstable substance use disorder * Presence of actively infections/contagious disease such as the flu or SARS-CoV-2