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Showing 20 of 30222 trials
ECT with Ketamine Anesthesia Vs High Intensity Ketamine with ECT Rescue for Treatment-Resistant Depression
NCT03272698
Recruiting
Conditions Treatment Resistant Depression, Ketamine
Phase PHASE4
Enrollment 62
Locations 1 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Ketamine
  • ECT

Primary Outcomes

  • Number of treatments required to reach disease remission
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2017-09-01
Completion: 2025-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 62 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Saskatchewan
Collaborators: Royal University Hospital Foundation
Principal Investigators:
  • Jonathan Gamble, MD (PRINCIPAL_INVESTIGATOR) - University of Saskatchewan
Contact Information
Study Contact:
Una Goncin
3066551183
ung039@usask.ca
Interventions
  • Ketamine
  • ECT
Study Locations (1 sites)
Royal University Hospital, Saskatoon, Saskatchewan S7N 0W8 Canada
Eligibility Criteria
Inclusion Criteria: * Montgomery Asberg Depression Rating Scale (MADRS) score of greater than 20) planned for ECT therapy. * Subjects must meet clinical criteria for TRD defined as failure to respond to at least 2 standard-of-care drug therapies of adequate treatment duration. Exclusion Criteria: * Subjects will be ineligible if they cannot provide informed consent * American Society of Anesthesiology physical status score of four or greater * Implanted medical device with electronic parts (e.g. pacemaker, defibrillator, intrathecal pump, spinal cord stimulator, deep brain stimulator) * Schizoaffective disorder * Women of child-bearing potential will be asked to undergo a commercial urine pregnancy screening test. Those who refuse or screen positive will be excluded. * Allergic to any of the study drugs or their carrier components * Any serious physical condition prior to randomization deemed by the attending psychiatrist or consulting anesthetist to be a contraindication to ECT such as cardiovascular disease (including untreated hypertension), respiratory disease, cerebrovascular disease, intracranial hypertension (including glaucoma), or seizures.
Her2-BATS and Pembrolizumab in Metastatic Breast Cancer
NCT03272334
Active, positions filled
Conditions Metastatic Breast Cancer
Phase PHASE1, PHASE2
Enrollment 22
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

  • HER2 BATs with Pembrolizumab

Primary Outcomes

  • Dose Limiting Toxicities (Escalation and Expansion Cohorts)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Active, positions filled
Start Date: 2017-12-29
Completion: 2031-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 22 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: University of Virginia
Collaborators: Merck Sharp & Dohme LLC
Principal Investigators:
  • Patrick Dillon, MD (PRINCIPAL_INVESTIGATOR) - University of Virginia
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • HER2 BATs with Pembrolizumab
Study Locations (1 sites)
Ashley Donihee, Charlottesville, Virginia 22908 United States
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed breast cancer (infiltrating ductal or lobular breast carcinoma) with evidence of measurable metastatic disease. Metastatic disease must be biopsy proven. a. Since histologic type, lymphatic permeation, blood vessel invasion, and degree of anaplasia may be prognostic variables, appropriate slides of the primary lesion will be requested for future review. HER2, estrogen, and progesterone receptor positivity will be recorded. 2. Measurable lesion. Patients are required to have at least one measurable non-bone lesion ≥10 mm that has not been irradiated. a. Measurable metastatic disease documented by radiograph, CT scan, PET/CT, MRI, or physical exam is required. Each subject will be required to have at least one measurable lesion that has not been irradiated with a minimum size in at least one diameter of ≥ 10 mm for liver lesions, lung, skin, and ≥ 15 mm lymph node metastases. Biopsy of recurrent site(s) is not required. 3. Patients must have HER2 status determined by FISH or IHC. HER2 status of positive or negative are both eligible for the study. In order to be eligible for participation in this trial, the patient must also: 4. Be female ≥ 18 years of age 5. Be willing and able to provide written informed consent for the trial. 6. Have a performance status (PS) ECOG 0-1 7. Have a life expectancy ≥ 3 months 8. Be eligible for apheresis, as determined by the Stem Cell Transplant team 9. Demonstrate adequate organ function as defined below, all screening labs should be performed within 10 days prior to apheresis. Absolute lymphocyte count ≥ 500/mm3 Absolute neutrophil count (ANC) ≥1,500 /mcL Platelets ≥ 100,000 / mcL Hemoglobin ≥ 9 g/dL (or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment) BUN ≤ 1.5 X upper limit of normal (ULN) Serum creatinine OR ≤1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN Serum total bilirubin ≤ 1.5 X ULN OR AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases Albumin \>2.5 mg/dL International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy Activated Partial Thromboplastin Time (aPTT) as long as PT or PTT is within therapeutic range of intended use of anticoagulants 10. Female patients of childbearing potential should have a negative urine or serum pregnancy test at screening. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 11. Female patients of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 4.5.2, for the course of the study through 120 days after the last dose of study medication. 12. Patients must have had two or more lines of prior therapy (chemo or hormonal) in the metastatic setting Exclusion Criteria: The patient must be excluded from participating in the trial if the subject: 1. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to leukapheresis. 2. Has a known history of active TB (Bacillus Tuberculosis) 3. Hypersensitivity to PBZ or any of its excipients. 4. Lack of recovery (i.e., ≤ Grade 1 or baseline prior to last line of cancer therapy) from non-laboratory adverse events except ≤ Grade 2 neuropathy 5. Has history of another malignancy within the past 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 6. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to leukapheresis. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. 7. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 8. Has known history of, or any evidence of active, non-infectious pneumonitis. 9. Has an active infection requiring systemic therapy. 10. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 11. Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. 12. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. 13. Has Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) or known history of Hepatitis B (e.g., HBsAg reactive) or Hepatitis C antibody is detected. Note: Patients may be eligible if HCV antibody is detected as long as HCV viral load is undetectable following an FDA approved treatment regimen 14. Has received a live vaccine within 30 days of apheresis. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed. 15. Has a history of significant cardiac disease, including: * History of a recent myocardial infarction (within one year), a past myocardial infarction (more than one year ago) along with current coronary symptoms requiring medications and/or evidence of depressed left ventricular function (LVEF \< 45% by MUGA or ECHO). * Current history of angina/coronary symptoms requiring medications and/or evidence of depressed left ventricular function (LVEF \< 45% by MUGA or ECHO) * Clinical evidence of congestive heart failure requiring medical management (irrespective of ECHO results). 16. Pt may be excluded if, in the opinion of the PI and investigator team, the pt is not capable of being compliant.
CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer
NCT03285412
Active, positions filled
Conditions Breast Cancer
Phase PHASE2
Enrollment 120
Locations 3 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

  • Ribociclib
  • Endocrine therapy

Primary Outcomes

  • ctDNA clearance
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: 2017-12-12
Completion: 2026-10
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Massachusetts General Hospital
Collaborators: Novartis
Principal Investigators:
  • Arielle Medford, MD (PRINCIPAL_INVESTIGATOR) - Massachusetts General Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Ribociclib
  • Endocrine therapy
Study Locations (3 sites)
Massachusetts General Hospital, Boston, Massachusetts 02214 United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215 United States
Mass General/North Shore Cancer Center, Danvers, Massachusetts 01923 United States
Eligibility Criteria
Inclusion Criteria: * Participants must have biopsy proven localized ER+ (≥ 10%), HER2 negative, invasive breast cancer, with pathological stage (including post-neoadjuvant therapy) T1c-T4c, any N, M0, by AJCC 7th edition staging. Invasive breast cancer must be ER+ in ≥10% of the cells and HER2 negative (IHC 0 or 1+ and/or FISH negative with a ratio \<2) by ASCO/CAP guidelines. For IHC 2+, the tumor must be FISH negative with a ratio \<2. PR status must be performed. ER, PR and HER2 measurements should be performed according to institutional (local) guidelines, in a CLIA-approved setting. Evaluation for metastatic disease is not required in the absence of symptoms. Patients must have completed definitive surgery for breast cancer. * Detectable ctDNA * No prior history of other malignancies within past 5 year (besides breast cancer as per 3.1.1). Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin. No concurrent malignancy or other serious medical condition as deemed by the investigator. * Participants may or may not have received (neo)adjuvant chemotherapy, but must be at least 4 weeks after last dose of chemotherapy and/or biological therapy at the time of screening, with no more than grade 1 residual toxicity (except ≤ grade 2 neuropathy or ≤ grade 2 alopecia). * Participants may or may not have received adjuvant radiotherapy, but must be at least 30 days after last dose radiotherapy, with no more than grade 1 residual toxicity at the time of screening. * Pre- and postmenopausal women are eligible. Premenopausal women must have a negative serum or urine pregnancy test. Pregnancy testing does not need to be pursued in female patients who are: age ≥ 60 years; or age \< 60 with intact uterus and amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; or status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. * QTc (Fredericia's formula) \< 470ms. * Must be ≥ 18 years of age. * Prior CDK 4/6 inhibitor is permitted provided it was more than 12 months ago (from consent date). * ECOG performance status 0-1 (Karnofsky ≥70%, see Appendix A) * Patients may enroll within 20 years of breast cancer diagnosis, as long as there is a plan for at least 1 more year of adjuvant endocrine therapy. * Ability to understand and the willingness to sign a written informed consent document. Patient must sign the Informed Consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements. * Currently on adjuvant endocrine therapy (tamoxifen and/or aromatase inhibitor (AI)), i.e prior use of any AI, including letrozole, anastrozole or exemestane, or tamoxifen is allowed. However, tamoxifen use is not allowed during the study with ribociclib. Patients on tamoxifen interested in this trial could be switched to AI on C1D1 or before/during screening. Concurrent GNRH agonist is allowed, and is recommended with AI in pre/peri-menopausal patients. * Patient has adequate bone marrow and organ function as defined by the following laboratory values at screening: * Absolute neutrophil count ≥1.5 × 109/L * Platelets ≥100 × 109/L * Hemoglobin ≥9.0 g/dL * Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication * Serum creatinine \<1.5 mg/dL or creatinine clearance ≥50 mL/min * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2.5 x ULN. * Total bilirubin \< ULN; or total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN in patients with well-documented Gilbert's Syndrome. * Fasting plasma glucose \<140 mg/dL / 7.7 mmol/L.. Exclusion Criteria: * Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * Participants who are receiving any other investigational agents. * Participants with known brain metastases, or any other metastases from cancer. * Participants receiving any medications or substances that are inhibitors or inducers of CYP3A4 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as http://medicine.iupui.edu/clinpharm/ddis/table.aspx; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. * Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). * Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including any of the following: * History of angina pectoris, symptomatic pericarditis, coronary artery bypass graft (CABG) or myocardial infarction within 6 months prior to study entry. * Documented cardiomyopathy. * Left Ventricular Ejection Fraction (LVEF) \<50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) detected during screening. * History of cardiac failure, significant/symptomatic bradycardia, Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome or any of the following: * Known risk to prolong the QT interval or induce Torsade's de Pointes. * Uncorrected hypomagnesemia or hypokalemia. * Systolic Blood Pressure (SBP) \>160 mmHg or \<90 mmHg. * Bradycardia (heart rate \<50 at rest), by ECG or pulse. * On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF \>450 screening ECG (based on a mean of 3 ECGs). * History of hypersensitivity to ribociclib or any of its components. * HIV-positive participants on combination antiretroviral therapy are ineligible. These participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated. * Pregnant women are excluded from this study because the safety of ribociclib is not established in pregnant women. For this reason and because CDK4/6 agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of treatment, and for at least 3 months after the completion of treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential. All WOCBP must have a negative pregnancy test with
Investigation of Tumour Spectrum of Germline Mutations in Breast and Ovarian Cancer Genes.
NCT03246841
Active, positions filled
Conditions Hereditary Breast and Ovarian Cancer, Mu...
Phase NA
Enrollment 7274
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

  • Genetic testing

Primary Outcomes

  • Penetrance estimation of the mutations identified in the gene panel
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2017-09-21
Completion: 2025-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 7274 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: UNICANCER
Collaborators: Institut Curie, Gustave Roussy, Cancer Campus, Grand Paris, Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigators:
  • Olivier CARON, MD (PRINCIPAL_INVESTIGATOR) - Gustave Roussy, Villejuif, France
  • Andrieu Nadine, PhD (PRINCIPAL_INVESTIGATOR) - Institut Curie, Paris, France
  • Severine Eon Marchais, PhD (PRINCIPAL_INVESTIGATOR) - PIGE Institut Curie, Paris, France
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Genetic testing
Study Locations (2 sites)
Gustave Roussy, Paris, France
Institut Curie - PIGE, Paris, France
Eligibility Criteria
Inclusion criteria: Index case eligibility: Any person with an indication for a BRCA1/BRCA2 gene analysis and who has been offered TUMOSPEC panel screening. Age ≥18 years. Family member eligibility: Family members will be eligible if the mutation identified in the Index Case is considered deleterious. Any family member to the first and second decree or a cousin of the Index Case. Family members from both sides of the family will be invited to take part. Age ≥18 years. Exclusion Criteria: People deprived of their civil liberties or who are under judicial protection or guardianship. Patients unable to answer the questionnaire for social or psychological reasons. Children of the index cases, of any age.
Cooperation for Primary Care Patients on Sick Leave for CMD: Care Manager and Workplace Intervention - CO-WORK-CARE
NCT03250026
Active, positions filled
Conditions Depressive Disorder, Anxiety Disorders
Phase NA
Enrollment 349
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

  • Workplace convergence dialogue
  • Care Manager

Primary Outcomes

  • Net and gross sick-leave days
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2017-12-05
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 349 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Göteborg University
Collaborators: Vastra Gotaland Region
Principal Investigators:
  • Cecilia Björkelund, prof (PRINCIPAL_INVESTIGATOR) - Göteborg University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Workplace convergence dialogue
  • Care Manager
Study Locations (1 sites)
Department of Primary Health Care, Sahlgrenska Academy, Gothenburg, Region Västra Götaland 40530 Sweden
Eligibility Criteria
Inclusion Criteria: Patients attending primary care centers with care manager function * aged \>=18 to 67 years * diagnosed with a new (\< 1 month) depression diagnose (F32, F33), anxiety syndrome (F41, F48) or stress related adjustment disorder (F43) * on sick-leave \> 14 days Exclusion Criteria: * Bipolar disorder * psychosis * addiction * other serious mental disorder * suicidal ideation or earlier suicide attempt * cognitive impairment or not speaking/understanding Swedish
Potassium Supplementation in CKD
NCT03253172
Active, positions filled
Conditions Renal Insufficiency, Chronic, Potassium ...
Phase NA
Enrollment 532
Locations 4 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Potassium Chloride
  • Potassium Citrate
  • Placebo

Primary Outcomes

  • Difference in estimated glomerular filtration rate (eGFR)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2017-07-01
Completion: 2026-10-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 532 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Erasmus Medical Center
Collaborators: Dutch Kidney Foundation, University Medical Center Groningen, Leiden University Medical Center, Amsterdam UMC
Principal Investigators:
  • Ewout J Hoorn, MD, PhD (PRINCIPAL_INVESTIGATOR) - Erasmus Medical Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Potassium Chloride
  • Potassium Citrate
  • Placebo
Study Locations (4 sites)
Academic Medical Center Amsterdam, Amsterdam, Netherlands
University Medical Center Groningen, Groningen, Netherlands
Leiden University Medical Center, Leiden, Netherlands
Erasmus MC, Rotterdam, Netherlands
Eligibility Criteria
Inclusion Criteria: * CKD 3b or 4 (45 - 15 ml/min/1.73 m2) * Δ eGFR (as estimated by the CKD-EPI equation) \> 2 ml/min/1.73 m2/year (in preceding ≥ 1 year with at least 3 measurements) * Hypertension (defined as office blood pressure \> 140/90 mmHg or use of anti-hypertensive medication) Exclusion Criteria: * Hyperkalemia (serum potassium \> 5.5 mmol/l) at study visit V0 * Medical reasons to continue dual RAAS-blockade, mineralocorticoid receptor blockers, potassium-sparing diuretics, or oral potassium binders. * Patients with previous history of ventricular cardiac arrhythmia * Patients with a life expectancy \< 6 months * Expected initiation of renal replacement therapy \< 2 years * Incapacitated subjects * Women who are pregnant, breastfeeding or consider pregnancy in the coming 2 years.
Prospective Cohort Study of 4,837 Post-myocardial Infarction Patients (Alpha Omega Cohort)
NCT03192410
Active, positions filled
Conditions Cardiovascular Diseases, Mortality, Type...
Phase Not Applicable
Enrollment 4837
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

  • Dietary intake
  • Lifestyle factors
  • Blood biomarkers
  • Health
  • DNA

Primary Outcomes

  • Cardiovascular mortality
  • All-cause mortality
  • Major cardiovascular events
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: 2002-04
Completion: 2040-01
Eligibility
Age: 60 Years
Sex: ALL
Volunteers: false
Enrollment: 4837 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Wageningen University
Principal Investigators:
  • Johanna M Geleijnse, PhD (PRINCIPAL_INVESTIGATOR) - Wageningen University, Division of Human Nutrition
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Dietary intake
  • Lifestyle factors
  • Blood biomarkers
  • Health
  • DNA
Study Locations (1 sites)
Wageningen University, Division of Human Nutrition, Wageningen, 6700 AA Netherlands
Eligibility Criteria
The Alpha Omega Cohort is a prospective cohort study. The cohort originated from the Alpha Omega Trial, a 40-month intervention study of low doses of n-3 fatty acids (in margarine spreads) and cardiovascular events (NCT00127452). The in/exclusion criteria were defined for the Alpha Omega Trial. Inclusion criteria: * Men and women * Aged 60 through 80 y * Verified clinically diagnosed myocardial infarction up to 10 y before entry into the study * Written informed consent Exclusion criteria: * Living in a nursing home or other institution * Participation in another scientific study * Habitual margarine intake \< 10 g per day * Habitual fish intake \> 150 g per day * Habitual alcohol intake \> 6 drinks per day * Use of fish oil capsules or other supplements containing omega-3 fatty acids * Presence of cancer with \< 1 y of life expectancy * Cognitive impairment, as indicated by the Mini Mental State Examination (score \<= 21) * Unintended weight loss \> 5 kg in the past year * Lack of facilities for cooled margarine storage at home * Inability or unwillingness to comply with study procedures
Obesity, Metabolic Dysregulation and the Airway Epithelium in Asthmatics
NCT03215836
Recruiting
Conditions Asthma, Obesity, Metabolic Syndrome
Phase NA
Enrollment 50
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Bronchoscopy and Nasal Epithelium Brush Sampling

Primary Outcomes

  • Measurement of L-arginine-NO biosynthesis pathways in the airway epithelium in obese and non-asthmatics.
  • Measurement of oxidative stress in the airway epithelium in obese and non-asthmatics.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2017-08-10
Completion: 2029-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Colorado, Denver
Collaborators: National Jewish Health
Principal Investigators:
  • Fernando Holguin, MD, MPH (PRINCIPAL_INVESTIGATOR) - University of Colorado Denver, Anschutz Medical Campus
Contact Information
Study Contact:
Asthma Research
1 (844) 365-0852
asthmaresearch@ucdenver.edu
Interventions
  • Bronchoscopy and Nasal Epithelium Brush Sampling
Study Locations (1 sites)
University of Colorado, Aurora, Colorado 80045 United States
Eligibility Criteria
Inclusion Criteria: For ALL Groups 1. Adequate completion of informed consent process with written documentation 2. Male and female patients, ≥ 18 - 65 years old 3. Smoking history \<10 pack years and no smoking in the last year \*\*Subjects can be included in the study if they are on blood pressure treatment and are on a diet control/exercise only treatment of diabetes. 4. Specific to Asthma Groups i. From all racial/ethnic backgrounds with a diagnosis of asthma based on physician diagnosis for \>6 months 1. Specific to Metabolic Syndrome Group. Metabolic syndrome diagnosis based on having at least any three of: a. Triglycerides ≥ 150 mg/dl; b. High-density lipoproteins (HDL) cholesterol ≤ 50 mg/dl for women and ≤ 40 mg/dl for men; c Fasting blood glucose ≥ 100 mg/dl; d. Waist circumference \> 40 inches males and \> 35 inches females); e. Previously diagnosed hypertension or on antihypertensive medication; f. Blood pressure greater than 130/85 on two consecutive measurements. 2. Specific to Non-Metabolic Syndrome Group a. Baseline pre-bronchodilator forced expiratory volume (FEV1) of 50% or greater of predicted with a 12% or greater bronchodilator (BD) response to 4 puffs of albuterol or PC20 methacholine (16 mg) if no BD response; b. BMI ≥ 30 Metabolic syndrome diagnosis based on having at least any three of: i. Triglycerides ≥ 150 mg/dl; ii. HDL cholesterol ≤ 50 mg/dl for women and ≤ 40 mg/dl for men; iii. Fasting blood glucose ≥ 100 mg/dl; iv. Waist circumference \> 40 inches males and \> 35 inches females); v. Previously diagnosed hypertension or on antihypertensive medication; vi. Blood pressure greater than 130/85 on two consecutive measurements. 3. Specific to Non-Obese Group a. Body Mass Index (BMI) \< 30 b. Specific to Non-Asthma Group i. No history of asthma or any other airway diseases; ii. Pulmonary function test within normal limits; iii. BMI ≥ 30. Exclusion Criteria (all groups): 1. Significant or uncontrolled concomitant medical illness (PI discretion) including, but not limited to heart disease, cancer, diabetes (HbAc1 \> 6.5), renal disease (creatinine \> 2.0) at Visit 0, neurological (brain damage) or psychiatric disorder (diagnosed by a mental health professional of behavioral or mental pattern that may cause suffering or a poor ability to function in life); 2. Chronic renal failure (creatinine \> 2.0) at screening (associated with higher asymmetric dimethylarginine (ADMA) levels); 3. Current statins use (statins lower ADMA levels); 4. On diabetic medications; 5. Positive pregnancy test; 6. Positive urine cotinine and/or urine tetrahydrocannabinol (THC) test; 7. Current or recent (within 30 days) investigational treatment or participation in another interventional research study (including non-pharmacologic interventions); 8. Unable or unlikely to complete study assessments or the study intervention (i.e. bronchoscopy) poses undue risk to patient in the opinion of the investigator. a. Specific to Asthma Groups i. Respiratory tract infection within the last 4 weeks; ii. Oral or systemic corticosteroids (CS) burst within the last 4 weeks; iii. Asthma-related hospitalization within the last 2 months; iv. Asthma-related ER visit within the previous 4 weeks.
Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women
NCT03201861
Recruiting
Conditions Tubular Breast Cancer, Mucinous Breast C...
Phase PHASE3
Enrollment 762
Locations 1 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Paclitaxel, Cisplatin
  • EC to docetaxel or paclitaxel

Primary Outcomes

  • Number of Participants With Disease-Free Survival (DFS) Events
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2017-07-27
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 762 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: RenJi Hospital
Principal Investigators:
  • Jinsong Lu, M.D. (PRINCIPAL_INVESTIGATOR) - Shanghai Jiao Tong University School of Medicine
Contact Information
Study Contact:
Yueyao Du, M.D.
86-21-68385569
jessicayy8629@126.com
Jie Zhang, M.D.
86-21-68385516
doudou090227@163.com
Interventions
  • Paclitaxel, Cisplatin
  • EC to docetaxel or paclitaxel
Study Locations (1 sites)
Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, Shanghai Municipality 200127 China
Eligibility Criteria
Inclusion Criteria: 1. Women aged ≥18 years and ≤70 years 2. Have accepted surgical treatment, histologically confirmed early breast cancer, the pathological types of invasive carcinoma 3. Not received treatment for breast cancer before operation 4. Triple-negative breast cancer confirmed by pathology, or pathology confirmed as the HR positive breast cancer at the same time meet the following conditions: axillary lymph node positive breast cancer, tumor size≥2 cm and Ki - 67 \>20% or tumor size ≥2 cm and grade III or tumor size ≥2cm and aged \<35 years 5. HER2 negative: immunohistochemistry HER2 (1 +) or HER2 (0), or fluorescence in situ hybridization (FISH): not amplified 6. Performance status (PS) 0-1 7. Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count(ANC)≥1.5×109/L, Platelets(PLT)≥100×109/L, Hemoglobin(Hb)≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit , creatinine≤1.5 upper normal limit, bilirubin≤1.5 upper normal limit 8. No obvious main organs dysfunction Exclusion Criteria: 1. metastatic breast cancer 2. Patient is pregnant or breast feeding 3. Any evidence of sense or motor nerve disorders 4. Bilateral Primary Breast Cancer (DCIS in one side not included) 5. Patients with medical conditions taht indicate intolerant to adjuvant chemotherapy, including uncontrolled cardiovascular disease, severe infection 6. Have received chemotherapy because of any malignancy other than breast cancer 7. Known severe hypersensitivity to any drugs in this study
Improving Hypertension Control in CHina and ARGEntina With a Mobile APP-based Telecare System
NCT03206814
Recruiting
Conditions Hypertension,Essential, Hypertension, Un...
Phase NA
Enrollment 480
Locations 8 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Usual care
  • POST-strategy

Primary Outcomes

  • Ambulatory Systolic Blood Pressure
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2021-05-11
Completion: 2025-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 480 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Istituto Auxologico Italiano
Principal Investigators:
  • Gianfranco Parati, MD (PRINCIPAL_INVESTIGATOR) - Istituto Auxologico Italiano
Contact Information
Study Contact:
Gianfranco Parati, MD
+390261911
gianfranco.parati@unimib.it
Paulina Wijnmaalen, MD
+390261911
charge-app@auxologico.it
Interventions
  • Usual care
  • POST-strategy
Study Locations (8 sites)
Private Hospital " Dr Raúl Matera", Bahía Blanca, B8000 Argentina
Argerich Hospital, Buenos Aires, C155 AHD Argentina
General San Martin Hospital of La Plata, La Plata, 1900 Argentina
Spanish Hospital of Mendoza, Mendoza, M5501 Argentina
British Sanatorium of Rosario, Rosario, S2000 Argentina
Shanghai Institute of Hypertension, Shanghai, Huangpu China
Jiangsu Province Official Hospital, Jiangse, 210024 China
Ruijin Hospital North, Shanghai, 200025 China
Eligibility Criteria
Inclusion Criteria: * Male and female subjects; * Age 18-80 years; * Either the patient or another person close to him/her should possess a smartphone compatible with the ESH CARE app and be capable of using it; * Uncontrolled (untreated or treated) hypertension, defined as office BP ≥140/90 mmHg, and Ambulatory 24h ABP ≥130/80 mmHg Exclusion Criteria: * eGFR \<45 mL/min/1.73 m2 (CKD-EPI creatinine equation 2009); * Severe uncontrolled hypertension (i.e. BP ≥200/120 mmHg despite treatment); * Known secondary hypertension; * Orthostatic hypotension (SBP fall \> 20 mmHg on standing); * Unstable clinical conditions or severe disease with short life expectation; * Known atrial fibrillation; * Hepatic disease as determined by either AST or ALT values \> 2 times the upper limit of normal; * History of gastrointestinal surgery or disorders which could interfere with drug absorption * History of malignancy including leukaemia and lymphoma (but not basal cell skin cancer) within the last 5 years; * History of clinically significant autoimmune disorders such as systemic lupus erythematosus; * History of drug or alcohol abuse within the last 5 years; * History of non-compliance to medical regimens and/or patients who are considered potentially unreliable; * Dementia (clinical diagnosis); * Inability or unwillingness to give free informed consent; * Inability to use even simple communication technologies; * Pregnancy or planned pregnancy during study period
Intraoperative Radiation Therapy (IORT) in DCIS
NCT03216421
Active, positions filled
Conditions Breast Cancer, Ductal Carcinoma in Situ
Phase NA
Enrollment 265
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

  • Quality of Life Questionnaires

Primary Outcomes

  • Rate of local recurrence
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2017-09-12
Completion: 2029-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 265 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Columbia University
Principal Investigators:
  • Eileen Connolly, MD (PRINCIPAL_INVESTIGATOR) - Assistant Professor of Radiation Oncology
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Quality of Life Questionnaires
Study Locations (1 sites)
Columbia University Irving Medical Center, New York, New York 10032 United States
Eligibility Criteria
Inclusion Criteria: * Pathologically confirmed DCIS of the breast * Clinical ≤ 3.0 cm unifocal lesion * No clinical or pathological evidence of nodal involvement * Operable DCIS, suitable for breast conserving surgery * Plans to administer irradiation to the breast only * Eastern Cooperative Oncology Group (ECOG) performance status of 0-3, however grade 4 patients may be enrolled at the discretion of the treating radiation oncologist * Must have had a diagnostic mammogram or MRI performed within last 6 months * Women of child-bearing potential must have a negative pregnancy test in accordance to institutional guidelines * Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives, or combination of condom and spermicide) from the time of negative pregnancy test through the radiation treatment period. * English or Spanish speaking * Able to sign informed consent * Amenable to regular follow-up (according to research policies) for at least 5 years. Exclusion Criteria: * Histologic or clinical evidence of invasive breast cancer * Multicentric cancer in the ipsilateral breast as diagnosed by clinical examination, imaging, or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy * Synchronous bilateral breast cancer at the time of diagnosis * Pathologic or imaging evidence of lymph node involvement * Any severe concomitant disease that may limit their life expectancy to less than 5 years. * Prior history of breast cancer or in-field radiation in the ipsilateral breast. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant or breast feeding women
18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients
NCT03168737
Active, positions filled
Conditions Malignant Breast Neoplasm, Malignant Col...
Phase PHASE1
Enrollment 25
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Computed Tomography
  • Fluorine F 18-fluoroazomycin Arabinoside
  • Positron Emission Tomography

Primary Outcomes

  • Relative change of imaging parameters (tumor volume, standardized uptake value [SUV], tumor to muscle ratio [TMR], hypoxic tumor volume [HTV1, HTV2], and total lesion hypoxia [TLH1, TLH2])
  • Incidence of adverse events per Common Terminology Criteria for Adverse Events version 4.03
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: 2017-09-22
Completion: 2027-04-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 25 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Franklin C Wong (PRINCIPAL_INVESTIGATOR) - M.D. Anderson Cancer Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Computed Tomography
  • Fluorine F 18-fluoroazomycin Arabinoside
  • Positron Emission Tomography
Study Locations (1 sites)
M D Anderson Cancer Center, Houston, Texas 77030 United States
Eligibility Criteria
Inclusion Criteria: * Patients with histopathologic diagnosis of a solid tumor. All solid tumors will be considered, but patients with breast, pancreas, and colorectal masses will be prioritized. * Patient must have a solid tumor with a short-axis greater than or equal to 1 cm (by CT, magnetic resonance imaging \[MRI\], ultrasonography or mammography) to allow reliable PET imaging. * A patient who has not received systemic or loco-regional treatment of the tumor within the last month. * Ability of the subject, or the legally authorized representative (LAR) if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, to understand, and the willingness to sign, a written informed consent. * Patients who are not expected to receive cancer therapy before imaging sessions are completed. Exclusion Criteria: * Pregnant or lactating women: pregnant women are excluded from this study because the effects of \[18F\] FAZA in pregnancy are not known. A urine or serum pregnancy test will be performed before accrual after informed consent is obtained. * Lactation should be suspended for at least two days following the administration of \[18F\] FAZA to the mother, because of the unknown but potential risk for adverse events in nursing infants secondary to administration of the radionuclide to a lactating woman. * Subjects with contraindications to the use of \[18F\] FAZA including confirmed allergy. * Patients with a body weight of 400 pounds or more, or a body mass index (BMI) which precludes their entry into the bore of the PET/CT scanner, because the findings will probably be compromised in image quality with CT, PET/CT and MRI. * Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.
Guangzhou Nutrition and Health Study (GNHS)
NCT03179657
Active, positions filled
Conditions Cardiovascular Diseases, Osteoporosis, D...
Phase Not Applicable
Enrollment 5118
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

  • Cardiovascular diseases (change in carotid artery intima-media thickness, and occurrence of cardiovascular diseases)
  • Bone health (change of bone mineral density, and occurrence of osteoporosis and fractures)
  • Nonalcoholic fatty liver disease (NAFLD)
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: 2008-07-01
Completion: 2027-12
Eligibility
Age: 40 Years
Sex: ALL
Volunteers: true
Enrollment: 5118 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Sun Yat-sen University
Principal Investigators:
  • Yuming Chen (PRINCIPAL_INVESTIGATOR) - Sun Yat-sen 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: * Age: 40-80 years (the original GNHS) and 40-85 years (CCFH) at baseline; * Living in Guangzhou for at least five years; * Chinese. Exclusion Criteria: * Had a history of hospital-confirmed diabetes, failure(s) of heart, liver, or kidney, cancer, cardiovascular events, metabolic bone diseases, glucocorticoid use (over 3 mo.) or sexual hormone use (over 6 mo.), spine or hip fractures; On special diet due to a disease or weight control; * Mental and physical disability; * Likely to move to other city within 5 years; * Did not want to attend any one item of the survey or sample collection.
STOP DIABETES - Knowledge-based Solutions
NCT03156478
Recruiting
Conditions Type2 Diabetes, Life Style, Diet Habit, ...
Phase NA
Enrollment 10000
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

  • Digital lifestyle intervention group
  • Combined digital and face-to-face lifestyle intervention group

Primary Outcomes

  • Change in diet
  • Change in total physical activity level
  • Change in plasma glucose levels
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2017-04-10
Completion: 2037-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 10000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Eastern Finland
Collaborators: National Institute of Health and Welfare, Technical Research Centre of Finland, University of Melbourne, University of Konstanz, Karolinska Institutet, Maastricht University, University of Oslo, Danube-University, Flinders University, Cornell University, University of Copenhagen, Roskilde University, University of Manchester, University of York
Principal Investigators:
  • Jussi Pihlajamäki, MD, PhD (PRINCIPAL_INVESTIGATOR) - University of Eastern Finland
Contact Information
Study Contact:
Jussi Pihlajamäki, MD, PhD
+358 50 344 0187
jussi.pihlajamaki@uef.fi
Timo A Lakka, MD, PhD
+358 40 7707 329
timo.lakka@uef.fi
Interventions
  • Digital lifestyle intervention group
  • Combined digital and face-to-face lifestyle intervention group
Study Locations (1 sites)
University of Eastern Finland, Kuopio, Finland
Eligibility Criteria
Inclusion Criteria: * age of 18-70 years * 12 points or more in the Finnish diabetes risk score or previous gestational diabetes or repeated impaired fasting glucose (IFG) (fasting plasma glucose level 6,1 - 6,9 mmol/l) or impaired glucose tolerance (2-hour glucose level 7,8 - 11,0 mmol/l in oral glucose tolerance test) * living in the hospital district of Northern Savo, Päijät-Häme or South Karelia * possibility to use computer, smartphone or tablet with internet connection * having own self-phone number * adequate Finnish language skill Exclusion Criteria: * type 1 or 2 diabetes * pregnancy or breastfeeding * current cancer or less than 6 months from the end of cancer treatment
Palbociclib After CDK and Endocrine Therapy (PACE)
NCT03147287
Active, positions filled
Conditions Metastatic Breast Cancer
Phase PHASE2
Enrollment 220
Locations 22 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

  • Palbociclib
  • Fulvestrant
  • Avelumab

Primary Outcomes

  • Progression-Free Survival (PFS), According to RECIST v1.1 Criteria (Investigator Assessment)
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: 2017-09-05
Completion: 2026-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 220 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Dana-Farber Cancer Institute
Collaborators: Pfizer
Principal Investigators:
  • Erica L Mayer, 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
  • Palbociclib
  • Fulvestrant
  • Avelumab
Study Locations (22 sites)
University of Miami, Miami, Florida 33136 United States
Emory University - Winship Cancer Institute, Atlanta, Georgia 30322 United States
Northwestern University, Chicago, Illinois 60611 United States
Indiana University, Indianapolis, Indiana 46202 United States
The University of Kansas Cancer Center - North, Kansas City, Kansas 64154 United States
The University of Kansas Cancer Center - Overland Park, Overland Park, Kansas 66210 United States
The University of Kansas Cancer Center, Westwood, Kansas 66205 United States
University of Louisville, Louisville, Kentucky 40202 United States
Eastern Maine Medical Center, Bangor, Maine 04401 United States
Boston Medical Center, Boston, Massachusetts 02188 United States
Eligibility Criteria
Inclusion Criteria: -Participants must have histologically confirmed hormone receptor positive (HR+) HER2 negative metastatic or locally recurrent unresectable invasive breast cancer. ER, PR and HER2 measurements should be performed according to institutional guidelines, in a CLIA-approved setting. Cut-off values for positive/negative staining should be in accordance with current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines. -Men and pre- and postmenopausal women are eligible. Ongoing monthly GNRH agonist is required in pre-menopausal women or male participants for at least 4 weeks prior to study entry. -Participants must have radiological or objective evidence of progression on an endocrine and CDK 4/6 inhibitor regimen in the metastatic setting, and/or relapse/progression during or within 12 months of completion of an endocrine and CDK4/6 inhibitor regimen in the adjuvant setting. --Participants must have previously been exposed to CDK4/6 inhibitor therapy in combination with endocrine therapy. Exposure to any prior CDK4/6 inhibitor, (including palbociclib, abemaciclib, and ribociclib) is allowed. Patients may have a line of endocrine therapy after combination endocrine and CDK4/6 inhibitor exposure. --Participants must have remained on prior endocrine and CDK4/6 therapy in the metastatic setting without progression for at least 6 months prior to study entry. --It is not mandatory to have a CDK 4/6 inhibitor containing regimen as the most recent treatment. -Participants may have 0-1 prior lines of cytotoxic chemotherapy in the metastatic setting. -Prior endocrine therapy in the metastatic setting may include any aromatase inhibitor (AI) or tamoxifen, but may not include prior fulvestrant. In the metastatic setting, 1-2 prior lines of endocrine therapy are allowed. -Participants may have received radiotherapy for palliative purpose, but must not be experiencing \> grade 1 treatment related toxicities, and must have completed treatment \> 14 days prior to registration. -Age ≥18 years. Because no dosing or adverse event data are currently available on the use of study agents in participants \<18 years of age, children are excluded from this study. -ECOG performance status 0-1 (see Appendix A). -Participants must have normal organ and marrow function as defined below: -Absolute neutrophil count \> 1,500/µL --Platelets \> 100,000/µL --Hemoglobin \> 9g/dL --Total bilirubin \< 1.5 x institutional upper limit of normal (ULN) (participants with documented Gilbert's disease are allowed total bilirubin up to 1.5X ULN) --AST (SGOT)/ALT (SGPT) \< 2.5 x institutional ULN, or ≤ 5 x ULN for subjects with documented metastatic disease to the liver. --Creatinine \< institutional ULN or creatinine clearance \> 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional ULN. --Baseline QTc \< 480 ms -The effects of palbociclib and avelumab on the developing human fetus are unknown. If, for any reason, a woman should become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately. Women of childbearing age, women who are made postmenopausal through use of GNRH agonists, and men must agree to use adequate contraception for the duration of protocol treatment and for at least 60 days after the last dose of study medication if the risk of contraception exists. -Adequate contraception is defined as one highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and/or partner. -Highly Effective Non-Hormonal Contraception -Methods of birth control which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly are considered highly-effective forms of contraception. -The following non-hormonal methods of contraception are acceptable: --True abstinence when this is in line with the preferred and usual lifestyle of the participant. \[Periodic abstinence (e.g., calendar, ovulation, symptothermal post-ovulation methods) and withdrawal are not acceptable methods of contraception\]. --Male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female participants, the vasectomized male partner should be the sole partner. OR -Effective Non-Hormonal Contraception Alternatively two of the following effective forms of contraception may be used instead: --Placement of non-hormonal intrauterine device (IUD) or intrauterine system (IUS). Consideration should be given to the type of device being used, as there is higher failure rates quoted for certain types, e.g., steel or copper wire. --Condom with spermicidal foam/gel/film/cream/suppository. --Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. --The use of barrier contraceptives should always be supplemented with the use of spermicide. The following should be noted: --Failure rates indicate that, when used alone, the diaphragm and condom are not highly effective forms of contraception. Therefore, the use of additional spermicides does confer additional theoretical contraceptive protection. --However, spermicides alone are ineffective at preventing pregnancy when the whole ejaculate is spilled. Therefore, spermicides are not a barrier method of contraception and should not be used alone. It should be noted that two forms of effective contraception are required. A double barrier method is acceptable, which is defined as condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream /suppository. -Premenopausal women must have a negative serum or urine pregnancy test. Pregnancy testing does not need to be pursued in female participants who are: --Age \> 60 years; or --Age \< 60 with intact uterus and amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; or --Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. -Participant must be able to swallow and retain oral medication. -Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: -Participants who have had endocrine, chemotherapy, and/or biologic therapy within 14 days prior to entering the study or those who have not recovered from any prior treatment-related toxicities (must recover to no more than grade 1. Alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 toxicity not constituting a safety risk based on investigator's judgment are acceptable). -Participants who are receiving concurrent therapy with other investigational agents. -Rapidly progressive, symptomatic, visceral spread of disease placing participant at risk of life-threatening complications in the short term. -Participants with active brain metastases. Stable treated brain metastases are allowed (this includes participants who have documented radiologic stability at least 4 weeks after radiotherapy, and do not require systemic steroids for management of symptoms from CNS metastatic lesions). -Participants who have discontinued prior palbociclib for toxicity, or have needed more than one dose or schedule reduction for toxicity from prior palbociclib therapy. If a participant required a single dose reduction during prior palbociclib therapy and tolerated it well, for example prior dosing at 100 mg qd 3 weeks on 1 week off schedule, than that dose may be selected for this trial. -History of allergic reactions to palbociclib or attributed to compounds of similar chemical or biologic composition to palbociclib. -Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3) -Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes are
Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive Breast Cancer: FDG-PET Response-adapted Strategy.
NCT03161353
Active, positions filled
Conditions Breast Cancer
Phase PHASE2
Enrollment 377
Locations 56 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

  • Perjeta
  • Herceptin
  • Docetaxel
  • Carboplatin
  • Letrozole

Primary Outcomes

  • Evaluate the rate of pCR
  • 3-year iDFS rate
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: 2017-06-26
Completion: 2026-11-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 377 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: MedSIR
Principal Investigators:
  • Antonio Llombart, MD (PRINCIPAL_INVESTIGATOR) - Hospital Arnau de Vilanova
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Perjeta
  • Herceptin
  • Docetaxel
  • Carboplatin
  • Letrozole
Study Locations (56 sites)
Institute Jules Bordet, Brussels, Belgium
CLCC d'Auvergne. Centre Jean Perrin., Clermont-Ferrand, France
Institute de Cancerologie de Laurraine, Nancy, France
Groupe Hospitalier Diaconesses, Paris, France
Hopital Tenon, Paris, France
Hospital Georges Pompidou, Paris, France
Centre Paul Strauss, Strasbourg, France
Institut Claudius Régaud, Toulouse, France
Kliniken Essen Mitte, Essen, Germany
Klinikum der Med. Fakultät Halle, Halle, Germany
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent prior to beginning specific protocol procedures. 2. Female or male patients ≥ 18 years of age. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Histologically proven invasive breast cancer. 5. Operable breast cancer (cT1-3 and/or cN0-2 tumors) (breast cancer TNM classification) 6. Tumor size larger than or equal to 1.5 centimeter (cm) in diameter by magnetic resonance imaging (MRI) or ultrasound with a significant 18F-FDG uptake defined as maximum standarized uptake value (SUVmax: maximum standarized uptake value) ≥1.5 x SUVmean (mean standarized uptake value) liver + 2 SD (standard deviation. Multicentric/multifocal tumors will be allowed only if: 1. Histological confirmation of at least two lesions. 2. All tumors must be HER2-positive. 3. Largest lesion must be larger than or equal to 1.5 cm in diameter by MRI or ultrasound. 7)Centrally confirmed HER2-positive disease according to the 2018 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) criteria. 8)Patient must have known estrogen receptor (ER) and progesterone receptor (PR) status locally determined prior to study entry. Patient has adequate bone marrow, liver, and renal function: 9)Hematological: White blood cell (WBC) count \> 3.0 x 109/L, absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100.0 x109/L, and hemoglobin ≥ 10.0 g/dL (≥ 6.2 mmol/L). 10)Hepatic: total bilirubin ≤ institutional upper limit of normal (ULN) (except for Gilbert's syndrome); alkaline phosphatase (ALP) ≤ 2.5 times ULN; aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 times ULN. 11)Renal: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. 12)Patient must be accessible for treatment and follow-up. Exclusion Criteria: 1. Previous treatment with chemotherapy, anti-HER2 therapy, radiation therapy, or endocrine therapy for invasive breast cancer. 2. cT4 and/or cN3 tumors (TNM breast cancer classification) 3. Bilateral breast cancer. 4. Evidence of metastatic disease by routine clinical assessment chest x-ray, liver ultrasound, and bone scan; or computed tomography (CT) scan of thorax and abdomen and bone scan, except patients with subclinic M1 (metastases) at baseline only according to 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) that will be allowed to be included into cohort C. 5. Known hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances. 6. History of other malignancy within the last five years prior to first dose of study drug administration, except for curatively treated basal and squamous cell carcinoma of the skin and/or in situ cervical carcinoma. 7. Left ventricular ejection fraction (LVEF) below 55% as determined by multiple-gated acquisition (MUGA) scan or echocardiography (ECHO). 8. Uncontrolled hypertension (systolic \> 150 mm Hg and/or diastolic \> 100 mm Hg) despite adequate antihypertensive treatment. 9. Clinically significant cardiovascular disease \[stroke, unstable angina pectoris, or documented myocardial infarction within six months prior to study entry; history of documented congestive heart failure (CHF) (New York Heart Association II-III-IV); symptomatic pericarditis; documented cardiomyopathy; ventricular arrythmias with the exception of benign premature ventricular contractions; conduction abnormality requiring a pacemaker; other arrhythmias not controlled with medication\]. 10. Active uncontrolled infection at the time of enrollment. 11. Current known infection with HIV, hepatitis B virus, or hepatitis C virus. 12. Patients with pulmonary disease requiring continuous oxygen therapy. 13. Previous history of bleeding diathesis. 14. Patient is currently receiving anti-coagulant therapy, chronic treatment with corticosteroids, or another immunosuppressive agent (standard premedication for chemotherapy and local applications are allowed). 15. Major surgical procedure or significant traumatic injury within 14 days prior to randomization or anticipation of need for major surgery within the course of the study treatment. 16. Patient has other concurrent severe and/or uncontrolled medical conditions that would, in the investigator´s judgment, contraindicate her participation in the clinical study. 17. Concurrent participation in other clinical trial, except other translational studies. 18. History of receiving any investigational treatment within 28 days prior to randomization. 19. Pregnant or breast-feeding women or patients not willing to apply highly effective contraception as defined in the protocol. LINGain sub-study: The LINGAIN project intends to include a total of 126 blood samples from PHERGain trial, as follows: 105 from patients treated with trastuzumab and pertuzumab ± endocrine therapy (according to HR status); 21 from patients treated with trastuzumab and pertuzumab + carboplatin and docetaxel.
CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery)
NCT03167905
Active, positions filled
Conditions Depression, Postpartum, Analgesia, Obste...
Phase PHASE2, PHASE3
Enrollment 881
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

  • Epidural delivery system
  • Entonox
  • Meperidine
  • Ultiva
  • Fentanyl

Primary Outcomes

  • The incidence of major postnatal depression in both groups
  • The incidence of (clinically significant, probable) postnatal depression in both groups
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Status: Active, positions filled
Start Date: 2017-06-15
Completion: 2026-12-31
Eligibility
Age: 21 Years
Sex: FEMALE
Volunteers: false
Enrollment: 881 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: KK Women's and Children's Hospital
Principal Investigators:
  • Ban Leong Sng, FANZCA (PRINCIPAL_INVESTIGATOR) - KK Women's and Children's Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Epidural delivery system
  • Entonox
  • Meperidine
  • Ultiva
  • Fentanyl
Study Locations (1 sites)
KK Women's and Children's Hospital, Singapore, 229899 Singapore
Eligibility Criteria
Inclusion Criteria: * Healthy adult (American Society of Anesthesiologists physical status 1 and 2) parturients at term (36 weeks gestation or more) (nulliparous and multiparous); * With a singleton fetus. Exclusion Criteria: * Multiple pregnancies; * Non-cephalic fetal presentation; * Obstetric complications (e.g. pre-eclampsia, uncontrolled hypertension, uncontrolled diabetes); * Elective and urgent caesarean section (not from delivery suite).
Outcome of 15 Versus 5 Fractions in Adjuvant Breast Radiotherapy in Women Over 65 Years
NCT03121248
Active, positions filled
Conditions Breastcancer
Phase NA
Enrollment 144
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

  • WBI 5 fractions
  • WBI 15 fractions
  • LNI 5 fractions
  • LNI 15 fractions
  • SIB 5 fractions if needed

Primary Outcomes

  • Breast retraction (LENTSOMA)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2017-02-15
Completion: 2026-11-15
Eligibility
Age: 65 Years
Sex: FEMALE
Volunteers: false
Enrollment: 144 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: University Hospital, Ghent
Principal Investigators:
  • Liv Veldeman, M.D., PhD (PRINCIPAL_INVESTIGATOR) - Ghent University Hospital, Dept. Radiotherapy-Oncology
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • WBI 5 fractions
  • WBI 15 fractions
  • LNI 5 fractions
  • LNI 15 fractions
  • SIB 5 fractions if needed
Study Locations (1 sites)
Ghent University Hospital, Dept. Radiotherapy-Oncology, Ghent, 9000 Belgium
Eligibility Criteria
Inclusion Criteria: * breast conserving surgery or mastectomy for breast carcinoma * multidisciplinary decision of adjuvant irradiation * absence of distant metastases * informed consent obtained, signed and dated before specific protocol procedures Exclusion Criteria: * History of previous radiation treatment to the same region * Bilateral breast irradiation * Life expectancy of less than 2 years * Planned reconstructive breast surgery * Condition making toxicity evaluation difficult, e.g. skin disorders, pre-existing brachial plexus injury, … * Inability to respect constraints on skin, heart, lungs, esophagus, ribs, brachial plexus or any other organ at risk * Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study * Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits or unlikely to complete the study
Sensory-Mechanical Responses to Eucapneic Voluntary Hyperventilation and Mannitol
NCT03105843
Recruiting
Conditions Asthma, Cough, Cough Variant Asthma
Phase PHASE4
Enrollment 30
Locations 1 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Methacholine (MCh) Challenge Testing
  • Eucapneic Voluntary Hyperventilation (EVH)
  • Mannitol Inhalation Kit

Primary Outcomes

  • Mid expiratory flows
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2022-03-01
Completion: 2026-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Dr. Diane Lougheed
Principal Investigators:
  • M. Diane Lougheed, MD, MSc (PRINCIPAL_INVESTIGATOR) - Department of Medicine, Queen's University
Contact Information
Study Contact:
M. Diane Lougheed, MD, MSc
613-548-2348
diane.lougheed@kingstonhsc.ca
Taylar Wall, RRT
613-549-6666
taylar.wall@kingstonhsc.ca
Interventions
  • Methacholine (MCh) Challenge Testing
  • Eucapneic Voluntary Hyperventilation (EVH)
  • Mannitol Inhalation Kit
Study Locations (1 sites)
Kingston Health Sciences Centre, Kingston, Ontario K7L 2V7 Canada
Eligibility Criteria
Inclusion Criteria: * Individuals aged 18-65 years of age with CVA and individuals with methacholine-induced cough but normal airway sensitivity. The following definitions will be used: 1. CVA: chronic cough (≥8 weeks) is the sole or predominant symptom and positive methacholine challenge (PC20 ≤ 16 mg/mL) and history of cough responding to specific asthma treatment (such as inhaled steroid or 1 week trial of bronchodilator); 2. Methacholine-induced cough but normal airway sensitivity: chronic cough (≥8 weeks) is the sole or predominant symptom and negative methacholine challenges (PC20 \> 16 mg/mL). * Individuals aged 18-65 years of age with no history of asthma or chronic cough. Exclusion Criteria: * an exacerbation necessitating a change in medication, emergency department visit or hospitalizations within the previous 4 weeks * inability to perform acceptable spirometry * medical contraindications to methacholine challenge testing * smoking history in excess of 10 pack years Note: Previous treatment with inhaled or systemic corticosteroids is not an exclusion criterion; medication use will be recorded and examined in the analysis.
Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus
NCT03132129
Recruiting
Conditions Diabetes Mellitus, Type 2, Diabetic Card...
Phase Not Applicable
Enrollment 593
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

  • Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy
  • Transthoracic echocardiography
  • Computed tomography coronary artery calcium scoring
  • Cardiopulmonary exercise testing
  • Manganese-enhanced magnetic resonance imaging (MEMRI)

Primary Outcomes

  • Prevalence of early heart failure in type 2 diabetes
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: 2017-10-24
Completion: 2029-10-31
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: true
Enrollment: 593 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Leicester
Principal Investigators:
  • Gerry P McCann, MD (PRINCIPAL_INVESTIGATOR) - University of Leicester
Contact Information
Study Contact:
Gerry P McCann, MD
01162583402
gpm12@le.ac.uk
Gaurav S Gulsin, MBChB(Hons)
01162583244
gg149@leicester.ac.uk
Interventions
  • Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy
  • Transthoracic echocardiography
  • Computed tomography coronary artery calcium scoring
  • Cardiopulmonary exercise testing
  • Manganese-enhanced magnetic resonance imaging (MEMRI)
Study Locations (1 sites)
University of Leicester, Leicester, United Kingdom
Eligibility Criteria
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * Male or Female, aged ≥18 and ≤75 years. * Diagnosed with Stable type 2 diabetes (determined by: i) formal diagnosis in GP case records, ii) a record of diagnostic oral glucose tolerance test OR glycated haemoglobin level ≥6.5%). Exclusion Criteria: * Angina pectoris or limiting dyspnoea (\>NYHA II), * Major atherosclerotic disease: Symptomatic CAD, history of myocardial infarction, previous revascularisation, stroke/transient ischaemic attack or symptomatic peripheral vascular disease. * Atrial fibrillation or flutter. * Moderate or severe valvular heart disease. * History of heart failure or cardiomyopathy. * Type 1 diabetes mellitus (T1DM). * Low fasting C-peptide levels suggestive of adult-onset T1DM. * Stage III-V renal disease (estimated glomerular filtration rate ≤30ml/min/1.73m2). * Absolute contraindications to CMR. Importantly, patients with subclinical CAD, and other common comorbidities such as obesity and hypertension, will not be excluded from this study. This will enable us to evaluate the contribution of CAD to myocardial dysfunction in diabetes and ensures our study group is representative of the general population with diabetes. Similarly, as mild dyspnoea is extremely common and non-specific participants with mild dyspnoea will be included.