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Showing 20 of 30222 trials
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
NCT03424005
Recruiting
Conditions Metastatic Breast Cancer
Phase PHASE1, PHASE2
Enrollment 1132
Locations 47 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

  • Capecitabine
  • Atezolizumab
  • Ipatasertib
  • SGN-LIV1A
  • Bevacizumab

Primary Outcomes

  • Objective Response Rate (ORR)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Recruiting
Start Date: 2018-03-30
Completion: 2030-09-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1132 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Hoffmann-La Roche
Collaborators: Gilead Sciences, Pfizer
Principal Investigators:
  • Clinical Trials (STUDY_DIRECTOR) - Hoffmann-La Roche
Contact Information
Study Contact:
Reference Study ID Number: CO40115 https://forpatients.roche.com/ No attachments to email below.
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Interventions
  • Capecitabine
  • Atezolizumab
  • Ipatasertib
  • SGN-LIV1A
  • Bevacizumab
Study Locations (47 sites)
City of Hope, Duarte, California 91010 United States
University of California San Diego Medical Center, La Jolla, California 92093 United States
Stanford Cancer Institute, Stanford, California 94305 United States
Rocky Mountain Cancer Center - Longmont, Longmont, Colorado 80501 United States
H. Lee Moffitt Cancer Center and Research Inst., Tampa, Florida 33612 United States
Metro-Minnesota Community Oncology Research Consortium, Saint Paul, Minnesota 55101-2502 United States
Renown Regional Medical Center, Reno, Nevada 89502-1576 United States
Hackensack Univ Medical Center, Hackensack, New Jersey 07601 United States
Regional Cancer Care Associates, LLC, Howell Township, New Jersey 07731 United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey 08901 United States
Eligibility Criteria
Inclusion Criteria Patients must meet all of the following criteria to qualify for Stage 1 (all cohorts) and to qualify for Stage 2 (2L CIT-naïve cohort): * Age \>/= 18 years at the time of signing Informed Consent Form * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 * Able to comply with the study protocol, in the investigator's judgment * Metastatic or inoperable locally advanced adenocarcinoma of the breast * Measurable disease (at least one target lesion) according to RECIST v1.1 * Life expectancy \>/= 3 months, as determined by the investigator * Tumor accessible for biopsy, unless archival tissue is available * Availability of a representative tumor specimen that is suitable for biomarker analysis via central testing * Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from breastfeeding and donating eggs, as outlined for each specific treatment arm * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm Exclusion Criteria Exclusion Criteria for Stage 1 * Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, CD40 agonists or interleukin-2 (IL-2) or IL-2-like compounds * Biologic treatment (e.g., bevacizumab) within 2 weeks prior to initiation of study treatment, or other systemic treatment for TNBC within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment * Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study * Eligibility only for the control arm Exclusion Criteria for Stage 1 (both cohorts) and Stage 2 (2L CIT-naïve cohort) * Adverse events from prior anti-cancer therapy that have not resolved to Grade \</= 1 or better with the exception of alopecia of any grade and Grade \</= 2 peripheral neuropathy * Treatment with investigational therapy within 28 days prior to initiation of study treatment * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) * Uncontrolled tumor-related pain * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * History of leptomeningeal disease * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. * Active tuberculosis * Severe infection within 4 weeks prior to initiation of study treatment * Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment * Significant cardiovascular disease * Prior allogeneic stem cell or solid organ transplantation * History of malignancy other than breast cancer within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death * Pregnancy or breastfeeding, or intention of becoming pregnant during the study
A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression
NCT03423680
Recruiting
Conditions Depression, Bipolar
Phase PHASE3
Enrollment 390
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

  • Abilify 2, 5, 10, 15mg (Tablet)
  • Placebo of Abilify 2, 5, 10, 15mg (Tablet)

Primary Outcomes

  • Mean change in the Montgomery-Åsberg Depression Rating Scale total score
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2018-02-22
Completion: 2025-12
Eligibility
Age: 19 Years
Sex: ALL
Volunteers: false
Enrollment: 390 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Contact Information
Study Contact:
Hoyoung Lee
82-2-3287-9238
hoyounglee@otsuka.co.kr
Interventions
  • Abilify 2, 5, 10, 15mg (Tablet)
  • Placebo of Abilify 2, 5, 10, 15mg (Tablet)
Study Locations (1 sites)
Seounl National University Hospital, Seoul, South Korea
Eligibility Criteria
Inclusion Criteria: * Patients aged ≥ 19 and \< 70 years at the time of informed consent * Patients who are able to understand information required for providing a consent * Patients who have received a mood stabilizer (lithium or valproic acid) * Patients with bipolar I or II disorder accompanied by major depressive episode * Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 20 at both the screening and baseline visits Exclusion Criteria: * Patients diagnosed with bipolar I or II disorder with mania, mixed or psychotropic features * Patients considered to have a high risk of suicide during the study period by the investigator based on current psychotic symptom and the patient's past medical history
Air Pollution, Asthma and Circadian Clocks
NCT03406351
Active, positions filled
Conditions Asthma, Healthy
Phase Not Applicable
Enrollment 20
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Observational

Primary Outcomes

  • Difference in expression levels of miR-142-3p in induced sputum from asthmatics versus controls
Interested in this trial?
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Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2018-01-15
Completion: 2028-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Pennsylvania
Principal Investigators:
  • Garret FitzGerald, MD (PRINCIPAL_INVESTIGATOR) - University of Pennsylvania
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Observational
Study Locations (1 sites)
University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104 United States
Eligibility Criteria
Inclusion Criteria: 1. \>18 years of age, 2. Physician's diagnosis of asthma, 3. Prescribed an inhaled-steroid-containing medication for asthma (ensuring the patient is believed to have at least moderate reversible airways obstruction by their physician), 4. severe persistent asthma according to the NHLBI Guidelines, 5. evidence of reversible airflow obstruction: (a) forced expiratory volume in 1 second (FEV1) \<80% predicted at the time of or within 3 years of screening, and (b) improvement with bronchodilator: either (i) an increase of ≥15% and 200mL in FEV1 with asthma treatment over the previous 3 years or (ii) after 4 puffs of albuterol by MDI (or 2.5 mg by nebulizer), an increase in FEV1 or FVC ≥12% and 200 mL in FEV1 within 30 min at screening, 6. Own a smartphone. Exclusion Criteria: 1. Severe psychiatric or cognitive problems (obvious mania, schizophrenia, significant mental retardation) making study conduct impossible. Formal psychiatric evaluations are outside of the scope; however, research coordinators will be trained to identify such cases followed by review of the PI. Patients can be referred to mental health facilities. 2. Past diagnosis of gastroesophageal reflux disease or obstructive sleep apnea, 3. Transmeridian travel across ≥2 time zones in the past month, 4. Planned transmeridian travel across more than ≥2 time zones during the planned study activities; 5. Use of oral or intravenous antibiotics in the past 6 months, 6. Episodes of bronchospasm in response to ultrasonic nebulizer treatment (to induce sputum collection non-invasively), 7. Any contraindication listed below in the separate paragraph "Contraindications for the use of CorTemp® Disposable Temperature Sensors"; 8. Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening; 9. \> 2 drinks of alcohol per day; 10. Use of illicit drugs; 11. Smoking; 12. Pregnant or nursing; 13. Avoid over-the-counter NSAID use 2 weeks prior to 48 hour session \& during 48 hour session (Visit 3, Visit 4 \& Visit 5); 14. Avoid Alcohol use 2 weeks prior to the 48 hour session and during the 3 day session (Visit 3, Visit 4 \& Visit 5); 15. Vitamins use 1 week prior to and during the 48 hour session. 16. BMI \> 30.
Accelerated iTBS for Post Partum Depression
NCT03417960
Recruiting
Conditions Post Partum Depression
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

  • iTBS

Primary Outcomes

  • Determine feasibility and tolerability of accelerated iTBS for postpartum depression. The investigators hope to retain >80% of recruited patients (feasibility) and reach a full treatment dose of 120%rMT in >80% of enrolled women (tolerability).
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2018-01-24
Completion: 2027-08-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Medical University of South Carolina
Contact Information
Study Contact:
Lisa McTeague, PhD
843-792-8274
mcteague@musc.edu
Interventions
  • iTBS
Study Locations (1 sites)
Medical University of South Carolina, Charleston, South Carolina 29425 United States
Eligibility Criteria
Inclusion Criteria: 1. Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments. 2. Participants must be over the age of 18. 3. Participants must meet criteria for post-partum depression: a) onset of symptoms in the first year postpartum 4. Participants must have a HRSD17 greater than or equal to 14 at baseline. Exclusion Criteria: 1. Participants must not be pregnant. 2. Participants must not meet moderate or severe use disorder of any substance with the exception of Tobacco Use Disorder. 3. Participants must not have current psychotic symptoms. 4. Participants must not have a history of dementia or other cognitive impairment. 5. Participants must not have active suicidal ideation requiring hospitalization or a suicide attempt within the past 3 months. 6. Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the neck, history of seizure, any known brain lesion). 7. Participants must not have any unstable general medical conditions. 8. Participants must not have had eclampsia during pregnancy.
Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies, MERIT Study
NCT03408353
Recruiting
Conditions Breast Carcinoma
Phase Not Applicable
Enrollment 10000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Biospecimen Collection
  • Mammography
  • Questionnaire Administration

Primary Outcomes

  • Creation of a repository of blood specimens and database of imaging, clinical data, health measurements, and questionnaire data
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: 2017-09-15
Completion: 2027-04-30
Eligibility
Age: 25 Years
Sex: FEMALE
Volunteers: true
Enrollment: 10000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Jessica W Leung (PRINCIPAL_INVESTIGATOR) - M.D. Anderson Cancer Center
Contact Information
Study Contact:
Jessica Leung
713-745-4555
jwleung@mdanderson.org
Interventions
  • Biospecimen Collection
  • Mammography
  • Questionnaire Administration
Study Locations (1 sites)
M D Anderson Cancer Center, Houston, Texas 77030 United States
Eligibility Criteria
Inclusion Criteria: * Willingness to participate in the study and ability to provide informed consent * Willingness to complete a questionnaire and to provide a blood sample at the initial visit and at follow up annual visits * Undergoing a screening mammogram at participating sites. Subjects undergoing routine annual diagnostic mammograms or CEM as part of a screening study are also eligible. Exclusion Criteria: * Current or recent (within the prior 6 months) history of breast feeding * Personal history of breast cancer (ductal breast carcinoma in situ \[DCIS\] or invasive breast cancer) * Personal history of any other cancer (excluding in-situ, stage 0, and non-melanoma skin cancers and other pre-cancerous conditions) treated within the last 5 years.
Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer
NCT03379428
Active, positions filled
Conditions Breast Neoplasms, Malignant Neoplasm of ...
Phase PHASE1, PHASE2
Enrollment 34
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

  • Trastuzumab
  • Ibrutinib 560 mg
  • Ibrutinib 840 mg
  • Ibrutinib 420 mg

Primary Outcomes

  • Phase I: Maximum Tolerated Dose
  • Phase II: Clinical Benefit Rate
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: 2017-11-29
Completion: 2025-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 34 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: US Oncology Research
Collaborators: AbbVie, Pharmacyclics LLC.
Principal Investigators:
  • Joyce O'Shaughnessy, MD (PRINCIPAL_INVESTIGATOR) - US Oncology Research/McKesson Specialty Health
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Trastuzumab
  • Ibrutinib 560 mg
  • Ibrutinib 840 mg
  • Ibrutinib 420 mg
Study Locations (1 sites)
10 sites incl TX, WA, VA, and NV, Dallas, Texas 75246 United States
Eligibility Criteria
Inclusion Criteria: * 1\. Female, Age ≥ 18 years * 2\. Histologic or cytologic confirmation of HER2-amplified breast cancer according to most recent biopsy (local testing permitted) * a. HER2-amplified status is defined as a HER2/CEP17 ratio ≥2 or an average of ≥6 HER2 gene copies per cell by in situ hybridization (ISH) according to the 2013 American Society of Clinical Oncology (ASCO)/CAP guidelines * 3\. Measurable or evaluable metastatic disease by RECIST (v1.1). * 4\. Progression of disease on or ≤6 months of completing prior TDM1 therapy * 5\. ≤ 4 prior chemotherapy regimens for MBC (Phase I portion) or ≤ 3 prior chemotherapy regimens for MBC (Phase II portion) * 6\. Adequate hematologic function independent of transfusion and growth factor support for ≤7 days prior to screening, with the exception of pegylated G-CSF (pegfilgrastim) and darbepoetin which require discontinuation at least 14 days prior to screening, defined as: * Absolute neutrophil count \>1500 cells/mm3 (0.75 x 10\^9/L). * Platelet count \>100,000 cells/mm3 (50 x 10\^9/L). * Hemoglobin \>9.0 g/dL. * 7\. Adequate hepatic and renal function defined as: * Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤5.0 x upper limit of normal (ULN) if liver metastases, or ≤3 x ULN in the absence of liver metastases. * Alkaline phosphatase \<2.5 x ULN, unless bone metastases are present and in the absence of liver metastases * Estimated Creatinine Clearance ≥30 ml/min (Cockcroft-Gault) * Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, such as hemolysis) * 8\. Prothrombin time (PT)/international normalized ratio (INR) \< 1.5xULN and PTT (aPTT) \< 1.5x ULN * 9\. Left Ventricular Ejection Fraction (LVEF) ≥ 50% at baseline as determined by either ECHO or multiple gated acquisition scan (MUGA) and within normal limits per institutional guidelines * 10\. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * 11\. Negative urine/serum pregnancy test within 72 hours before starting study medications for women of childbearing potential * 12\. Women of childbearing potential who agree to use two highly effective methods of birth control (e.g., some intrauterine devices \[IUD\], diaphragm with spermicide, condom with spermicide, sterilized partner, or complete abstinence) for the duration of the study and for 30 days after the last dose of study drug o Note: Women are considered postmenopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms), or if they have undergone surgical sterilization * 13\. Signed informed consent obtained prior to any screening procedures. * 14\. Signed Patient Authorization Form (HIPAA) obtained prior to any screening procedures. Exclusion Criteria: * 1\. Uncontrolled or untreated central nervous system metastases, defined as clinical or radiologic evidence of progression of brain metastases or clinical signs of leptomeningeal disease 1. Patients with treated brain metastases are eligible provided they do not have clinical or radiologic evidence of disease progression and have been off of dexamethasone for ≥2 weeks prior to first dose of study drugs 2. Brain MRI at baseline required for patients with known brain metastases at study entry * 2\. Chemotherapy ≤ 21 days prior to first administration of study treatment * 3\. History of other malignancies, except: * Malignancy treated with curative intent and with no known active disease present for ≥3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician. * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. * Adequately treated carcinoma in situ without evidence of disease. * 4\. Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration days\] \[ \> 14 days\] of \>5 mg/day of prednisone) ≤28 days of the first dose of study drug. * 5\. Vaccinated with live, attenuated vaccines ≤4 weeks of first dose of study drug. * 6\. Recent infection requiring systemic treatment that was completed ≤14 days before the first dose of study drug. * 7\. Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4), grade 0 or 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia. * 8\. Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia. * 9\. History of stroke or intracranial hemorrhage ≤6 months prior to first dose of study drug. * 10\. Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV). Patients who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded. * 11\. Any uncontrolled active systemic infection. * 12\. Major surgery ≤ 4 weeks of first dose of study drug. * 13\. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk. * 14\. Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization. * 15\. Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction. * 16\. Concomitant use of warfarin or other Vitamin K antagonists. * 17\. Receipt of a strong cytochrome P450 (CYP) 3A inhibitor within 7 days prior to the first dose of ibrutinib or requirement for continuous treatment with a strong CYP3A inhibitor. * 18\. Chronic liver disease with hepatic impairment Child-Pugh class B or C. * 19\. Lactating or pregnant. * 20\. Unwilling or unable to participate in all required study evaluations and procedures. * 21\. Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations).
Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients
NCT03393845
Active, positions filled
Conditions Breast Cancer
Phase PHASE2
Enrollment 47
Locations 5 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

  • Pembrolizumab
  • Fulvestrant

Primary Outcomes

  • Clinical Benefit Ratio (CBR)
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: 2018-01-29
Completion: 2027-09-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 47 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Nancy Chan, MD
Collaborators: Merck Sharp & Dohme LLC
Principal Investigators:
  • Nancy Chan (PRINCIPAL_INVESTIGATOR) - Rutgers Cancer Institute of New Jersey
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Pembrolizumab
  • Fulvestrant
Study Locations (5 sites)
Michigan State University, Breslin Cancer Center, Lansing, Michigan 48910 United States
University of Nebraska Medical Center, Omaha, Nebraska 68198 United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey 08903 United States
New York University Clinical Cancer Center, New York, New York 10016 United States
University of Wisconsin, Madison, Wisconsin 53705 United States
Eligibility Criteria
Inclusion Criteria: Subject must meet all of the following applicable inclusion criteria to participate in this study: * Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. * Men \[29\] and women ≥ 18 years of age at the time of informed consent. NOTE: Both pre- and post-menopausal women are eligible. Patients who are premenopausal should either undergo bilateral oophorectomy or receive ovarian suppression according to institutional standards. Male patients will be treated as premenopausal females and receive a GnRH agonist. * ECOG Performance Status of 0 or 1 within 28 days prior to registration. * Histologic or cytologic diagnosis of metastatic breast cancer. * Has received no more than two lines of prior therapy for advanced non-resectable/metastatic disease. Prior lines can can be either chemotherapy or hormonal therapy. Prior or current fulvestrant is allowed. Combination therapy is considered as one regimen. * Tumor is estrogen receptor positive (ER+) and/or (PR+), HER-2 negative (HER2-). ER and PR positivity is defined as \>1%. HER-2 negative is defined as by IHC (0, 1+) or FISH. HER2 positive test result includes: Single-probe average HER2 copy number ≥6.0 signals/cell; Dual-probe HER2/CEP17 ratio ≥2.0 with an average HER2; copy number ≥4.0 signals/cell; Dual-probe HER2/CEP17 ratio ≥2.0 with an average HER2copy number \<4.0 signals/cell; or Dual-probe HER2/CEP17 ratio \< 2.0 with an average HER2 copy number ≥6.0 signals/cell. Equivocal findings for IHC as 2+ should be reflexed to FISH. Equivocal results by FISH may be considered with approval from the Sponsor-Investigator. * Measurable disease based on RECIST 1.1 within 28 days prior to registration. Except in patients with bone-only disease, in the absence of measurable disease, evaluable bone lesion is allowed. NOTE: Bone-only disease is the sole non-measurable disease site allowed and biopsy is required. Measurable disease is required in all other cases. * Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. NOTE: Subjects for whom newly-obtained fresh tissue samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor-Investigator. * Normal cardiac function as determined by treating physician per institutional standards via echocardiogram (ECHO) performed within 28 days prior to registration. * Prior chemotherapy must be completed at least 28 days prior to registration or at least 14 days prior to registration for targeted therapy. * Prior hormonal therapy or radiation therapy must be completed at least 14 days prior to registration. If subject is currently receiving fulvestrant, it may continue without interruption as per standard of care. * The subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤ Grade 1 or baseline. NOTE: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. NOTE: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to study registration, as determined by the enrolling physician. * Demonstrate adequate organ function as defined in the table below; all screening labs will be performed within 28 days of study registration. * Hematological * Absolute Neutrophil Count (ANC): ≥ 1500/mm3 * Platelets: ≥100,000 / mcL * Hemoglobin (Hgb): ≥ 9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment) * Renal ---Serum creatinine OR Measured or calculateda creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≤1.5 × upper limit of normal (ULN) OR ≥30 mL/min for subjects with creatinine levels \> 1.5 × institutional ULN * Hepatic * Serum total bilirubin: ≤ 1.5 X ULN OR * Direct bilirubin ≤ ULN for subjects with total bilirubin levels: \> 1.5 ULN * AST (SGOT) and ALT (SGPT): ≤ 2.5 × ULN * Albumin: \>2.5 mg/dL * Coagulation ---International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT): ≤1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants aCreatinine clearance will be calculated per institutional standard. * Females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to study registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. NOTE: Females are considered of childbearing potential unless: they are postmenopausal; are surgically sterile; or they have a congenital or acquired condition that prevents childbearing. See the protocol for definitions. NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. * Females and males of reproductive potential must be willing to abstain from heterosexual activity which could result in pregnancy or agree to use an adequate method of contraception as outlined in the protocol. Hormonal contraceptives are contraindicated in this population and are not allowed. Contraception will begin from the time of informed consent through 120 days after the last dose of study drug(s). Exclusion Criteria: * Is currently receiving an investigational agent or has received an investigational agent or used an investigational device within 28 days of study registration. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger. NOTE: 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. * Has a known history of active TB (Bacillus Tuberculosis). NOTE: TB testing is not required. * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). NOTE: HIV testing is not required. * Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). NOTE: Hepatitis B and Hepatitis C testing is not required. * Hypersensitivity to pembrolizumab or any of its excipients. * Has received prior chemotherapy within 28 days prior to study registration or has received prior hormonal/targeted therapy within 14 days prior to study registration * More than two lines of chemotherapy or more than two lines of hormonal therapy excludes participation. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * 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 trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. * Has known history of non-infectious pneumonitis/interstitial lung disease that required stero
Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery
NCT03408717
Active, positions filled
Conditions Breast Cancer, Chronic Pain, Acute Pain,...
Phase Not Applicable
Enrollment 220
Locations 2 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Questionnaires
  • Mechanical Temporal Summation assessment
  • Pain threshold assessment

Primary Outcomes

  • Persistent pain at 4 months after surgery
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: 2018-01-03
Completion: 2026-12-31
Eligibility
Age: 21 Years
Sex: FEMALE
Volunteers: false
Enrollment: 220 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: KK Women's and Children's Hospital
Collaborators: Duke University
Principal Investigators:
  • Ban Leong Sng, FANZCA (PRINCIPAL_INVESTIGATOR) - KK Women's and Children's Hospital
  • Ashraf Habib, MBBCh, FRCA (PRINCIPAL_INVESTIGATOR) - Duke University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Questionnaires
  • Mechanical Temporal Summation assessment
  • Pain threshold assessment
Study Locations (2 sites)
Duke University Medical Center, Durham, North Carolina 27710 United States
KK Women's and Children's Hospital, Singapore, 229899 Singapore
Eligibility Criteria
Inclusion Criteria: * Aged between 21 - 80 year old; * Healthy and/or have systemic medical conditions as reviewed by anaesthetist for surgery (ASA 1-3); * Undergoing breast cancer surgery. Exclusion Criteria: * History of intravenous drug or opioid abuse; * Current chronic daily treatment with corticosteroids (excluding inhaled steroids); * Previous history of chronic pain syndrome; * Obstetric patients.
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
NCT03412877
Recruiting
Conditions Endocrine Tumors, Non-Small Cell Lung Ca...
Phase PHASE2
Enrollment 285
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Cyclophosphamide
  • Fludarabine
  • Aldesleukin
  • Individual Patient TCR-Transduced PBL
  • Pembrolizumab (KEYTRUDA(R))

Primary Outcomes

  • Response rate
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2018-09-06
Completion: 2029-03-23
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 285 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: National Cancer Institute (NCI)
Principal Investigators:
  • Steven A Rosenberg, M.D. (PRINCIPAL_INVESTIGATOR) - National Cancer Institute (NCI)
Contact Information
Study Contact:
NCI SB Immunotherapy Recruitment Center
(866) 820-4505
IRC@nih.gov
Interventions
  • Cyclophosphamide
  • Fludarabine
  • Aldesleukin
  • Individual Patient TCR-Transduced PBL
  • Pembrolizumab (KEYTRUDA(R))
Study Locations (1 sites)
National Institutes of Health Clinical Center, Bethesda, Maryland 20892 United States
Eligibility Criteria
* INCLUSION CRITERIA: * Metastatic, solid cancer that can be measured, and falls into one of five cohorts: (1) gastrointestinal and genitourinary cancers; (2) breast, ovarian, and other solid cancers; (3) non-small cell lung cancer (NSCLC); (4) endocrine tumors including neuroendocrine tumors; and, (5) multiple myeloma that includes measurable solid tumors (plasmacytomas). Participants with multiple myeloma are potentially eligible only if they have measurable multiple myeloma as defined in Section 16.7 after plasmacytoma resection. Note: NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinomas. * Documented diagnosis of cancer. * Refractory to approved standard systemic therapy. Specifically: * Participants with metastatic colorectal cancer must have received oxaliplatin or irinotecan. * Participants with breast and ovarian cancer must be refractory to first- line treatment and refractory to or have refused second-line treatments. * Participants with NSCLC must have received at least one platinum-based chemotherapy regimen and at least one FDA-approved targeted treatment (when appropriate). * Participants with endocrine tumors including neuroendocrine tumors must be refractory to first-line therapy (e.g., lanreotide, octreotide) and must be refractory or have refused second-line treatments such as everolimus, sunitinib, or 177 Lu-Dotatate, if indicated. * Participants with multiple myeloma must have received at least four prior lines of therapy that included at least one exposure to an immunomodulatory drug such as lenalidomide, a proteosome inhibitor, an anti-CD38 antibody treatment, and an autologous stem cell transplant. * Participants with three (3) or fewer brain metastases that are \< 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment for the participant to be eligible. Participants with surgically resected brain metastases are eligible. * Age greater than or equal to 18 years and less than or equal to 72 years. * Clinical performance status of ECOG 0 or 1. * Participants of both sexes must be willing to practice birth control from the time of enrollment on this study and for and 12 months after the last dose of combined chemotherapy for individuals of child-bearing potential (IOCBP) and four months after treatment for participants who can father a child. * Individuals of child-bearing potential must be willing to undergo a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus. NOTE: Certain malignancies may secrete hormones that produce false positive pregnancy tests. Serial blood testing (e.g. HCG measurements) and/ or ultrasound may be performed for clarification. * Serology: * Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who are HIV seropositive may have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.) * Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then participant must be tested for the presence of antigen by RT-PCR and be HCV RNA negative. * Hematology: * ANC \> 1000/mm\^3 without the support of filgrastim * WBC greater than or equal to 2500/mm\^3 * Platelet count greater than or equal to 80,000/mm\^3 * Hemoglobin \> 8.0 g/dL. Subjects may be transfused to reach this cut-off. * Chemistry: * Serum ALT/AST less than or equal to 5.0 x ULN * Serum creatinine less than or equal to 1.6 mg/dL. * Total bilirubin less than or equal to 2.0 mg/dL, except in participants with Gilbert's Syndrome, who must have a total bilirubin less than or equal to 3.0 mg/dL. * Participants must have completed any prior systemic therapy at the time of enrollment. Note: Participants may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to grade 1 or less. In addition, participants with multiple myeloma may receive bridging therapy during the time between study enrollment and start of study therapy. This may be necessary due to the long time needed for cell production on this study. After bridging therapy and within 14 days of protocol treatment start, participants with multiple myeloma must still have measurable multiple myeloma. * For Cohort 3: More than two weeks must have elapsed since any prior palliation for major bronchial occlusion or bleeding at the time the patient receives the preparative regimen, and patient s toxicities must have recovered to a grade 1 or less. * Ability of subject to understand and the willingness to sign a written informed consent document. * Willing to sign a durable power of attorney. * Subjects must be co-enrolled on protocol 03-C-0277. EXCLUSION CRITERIA: * Participants who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant. * Concurrent systemic steroid therapy. * Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses. * For Cohort 3: Any major bronchial occlusion or bleeding not amenable to palliation. * Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS). * History of major organ autoimmune disease. * For Arm 2: Grade 3 or 4 major organ irAEs following treatment with anti-PD-1/PD-L1, including but not limited to myocarditis and pneumonitis. Note: Participants with grade 3 or 4 major organ irAEs may be enrolled on Arm 1 if all other eligibility criteria are met. * Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities.) * History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin. * For Cohorts 1, 2, 4. or 5: Clinically significant participant history which in the judgment of the Principal Investigator (PI) would compromise the participants ability to tolerate high-dose aldesleukin. Note: At the discretion of the PI, participants enrolled in Cohort 3 may receive low-dose aldesleukin. * History of coronary revascularization or ischemic symptoms. * For select participants with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%. * For select participants with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50% predicted. * Participants who are receiving any other investigational agents.
The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer
NCT03414658
Active, positions filled
Conditions Breast Cancer
Phase PHASE2
Enrollment 100
Locations 17 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

  • Vinorelbine
  • Trastuzumab
  • Avelumab
  • Utomilumab

Primary Outcomes

  • Progression Free Survival
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: 2018-06-21
Completion: 2027-05-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Adrienne G. Waks
Collaborators: Pfizer, Breast Cancer Research Foundation, Johns Hopkins University
Principal Investigators:
  • Adrienne Waks, MD, PhD (PRINCIPAL_INVESTIGATOR) - Dana-Farber Cancer Institute
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Vinorelbine
  • Trastuzumab
  • Avelumab
  • Utomilumab
Study Locations (17 sites)
University of Alabama at Birmingham, Birmingham, Alabama 35249 United States
University of California San Francisco, San Francisco, California 94158 United States
Georgetown University Medical Center, Washington D.C., District of Columbia 20007 United States
University of Chicago Medical Center, Chicago, Illinois 60637 United States
Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202 United States
Johns Hopkins University, Baltimore, Maryland 21287 United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02115 United States
Dana-Farber Cancer Institute, Boston, Massachusetts 02215 United States
Memorial Sloan-Kettering Cancer Center, New York, New York 10065 United States
Montefiore Medical Center, The Bronx, New York 10467 United States
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years or older * Histologically confirmed breast adenocarcinoma that is unresectable loco-regionally advanced or metastatic * HER2-positive (immunohistochemistry score 3+) or ERBB2- amplification (Ratio ERBB2/centromeres ≥ 2.0 or mean gene copy number ≥ 6) on primary tumor or of metastatic or unresectable loco-regional biopsy. * Measurable disease per RECIST v1.1 (see Section 11) * Patients must have previous treatment with ado-trastuzumab emtansine (Kadcyla, T-DM1) in any setting. Patients must have previously received trastuzumab and pertuzumab in the metastatic setting or within 12 months of neoadjuvant/adjuvant treatment. * Patient must have progressed on their most recent line of therapy. Progression must have been demonstrated by radiological or clinical assessment. * Left ventricular ejection fraction (LVEF) ≥ 50% * Willingness and availability to submit FFPE tissue for central confirmation of HER2 positivity and central assessment of PD-L1 status. This can be from archival tissue from unresectable loco-regional or metastatic disease obtained ≤ 1 year prior to enrollment or new tissue material from a recently obtained surgical or diagnostic biopsy. Tissue obtained for the biopsy must not have been previously irradiated. If a patient does not have any available archival tissue ≤ 1 year old and the treating investigator does not feel that it would be safe to perform a fresh biopsy, the requirement for a fresh biopsy may be waived after discussion with the Principal Investigator. * Written informed consent for screening and trial participation procedures including biological material transfer and handling. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Hematopoietic status: * Absolute neutrophil count ≥ 1.0 × 109/L, * Platelet count ≥ 100 × 109/L, * Hemoglobin ≥ 9 g/dL * Hepatic status: * Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (\< 2 × ULN) is allowed. * AST and ALT ≤ 2.5 × ULN; if the patient has liver metastases, ALT and AST must be ≤ 5 × ULN. * Renal status: * Creatinine ≤ 1.5 ×ULN or creatinine clearance \> 60 ml/min * Proteinuria \< 1 g/day * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulant. * If female of childbearing potential, must have a negative pregnancy test within 7 days of initiating treatment. Childbearing potential is defined by: those who have not been surgically sterilized and/or have had a menstrual period in the past year. * Participants of childbearing potential (as defined above) must be willing to use effective contraception during treatment and up to 7 months after stop of trial treatment. Acceptable methods of contraception are intrauterine devices, bilateral tubal occlusion, vasectomized, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed. * Must not be breastfeeding/lactating. Exclusion Criteria: * Prior therapy with any anti-PD-1, anti-PD-L1, L2, anti-4-1BB (CD137), or anti-CTLA4 therapy * Known Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) * Positive for Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA \[qualitative\]). * History of interstitial lung disease * Active central nervous system metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth (patients with history of CNS metastases or spinal cord compression are eligible if they are clinically stable for at least 4 weeks before first dose of investigational product and do not require high-dose steroid treatment). * History of clinically significant or uncontrolled cardiac disease, including congestive heart failure (New York Heart Association functional classification ≥3), angina, myocardial infarction or ventricular arrhythmia. * Previous severe hypersensitivity reaction to treatment with another monoclonal antibody. * Active infection requiring systemic therapy. * Chronic systemic therapy with immunosuppressive agents including corticosteroids. * Active autoimmune disease or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the trial. Patients with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the trial. * Concurrent disease or condition that would make the patient inappropriate for trial participation or any serious medical disorder that would interfere with the patient's safety. * No uncontrolled hypertension (≥180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen. * Chemotherapy, radiotherapy, and/or biological cancer therapy within 3 weeks prior to the first trial dose or has not recovered to CTCAE v.4 grade 1 or better from adverse events (except alopecia). * Unresolved or unstable, serious adverse events from prior administration of another investigational drug. * Live vaccines within 30 days prior to the first dose of trial therapy and during trial treatment.
Probiotics to Prevent Relapse After Hospitalization for Bipolar Depression
NCT03349528
Active, positions filled
Conditions Bipolar Depression
Phase PHASE2
Enrollment 80
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Probiotic Supplement
  • Inert Compound

Primary Outcomes

  • Time to Relapse
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: 2018-12-11
Completion: 2027-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 80 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sheppard Pratt Health System
Principal Investigators:
  • Faith Dickerson, PhD, MPH (PRINCIPAL_INVESTIGATOR) - Sheppart Pratt Health System
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Probiotic Supplement
  • Inert Compound
Study Locations (1 sites)
Sheppart Pratt Health System, Towson, Maryland 21204 United States
Eligibility Criteria
Inclusion Criteria: * Age 18-65 (inclusive) * Capacity for written informed consent * Currently (or within the last 3 weeks) admitted to a Sheppard Pratt inpatient or day hospital program for symptoms of a depressive episode and a diagnosis Bipolar Disorder I or II, most recent episode depressed per Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5), the diagnosis of which is confirmed with the Structured Clinical Interview for DSM-5 Disorders (SCID-5) * Proficient in the English language * Available to come to Sheppard Pratt Towson for study visits after hospital discharge Exclusion Criteria: * Depressive symptoms better accounted for by a diagnosis of Major Depressive Disorder, Schizoaffective disorder, Schizophrenia, or disorder(s) other than Bipolar Disorder I or II * DSM-5 diagnosis of intellectual disability or comparable diagnosis determined by previous version of the DSM * Substance- or medically-induced mood symptoms at time of Visit 1/Baseline visit * DSM-5 diagnosis of a moderate or severe substance use disorder, except for caffeine or tobacco, within three months prior to the Visit 1/Baseline visit * History of IV drug use * Any clinically significant or poorly controlled medical disorder as determined by the principal investigator and/or the study physician (e.g., HIV infection or other immunodeficiency condition, uncontrolled diabetes, congestive heart failure) * A serious medical condition that affects brain or cognitive functioning (e.g., epilepsy, serious head injury, concussion involving loss of consciousness, brain tumor, or other neurological disorder) * Pregnant, planning to become pregnant, or breastfeeding during the study period * Documented celiac disease * Participated in any investigational drug trial in the 30 days prior to the Visit 1/Baseline visit * Receipt of Electroconvulsive therapy (ECT) in the 30 days prior to the Visit 1/Baseline visit or planned ECT after hospital discharge
rTMS Response Trajectories in Depression
NCT03348761
Recruiting
Conditions Depression
Phase NA
Enrollment 70
Locations 1 sites
Compensation Up to $800
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • rTMS group

Primary Outcomes

  • Montgomery-Ashberg Depression Rating Scale
  • Montgomery-Ashberg Depression Rating Scale
  • Montgomery-Ashberg Depression Rating Scale
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2015-08-04
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 70 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Chinese University of Hong Kong
Principal Investigators:
  • Sau Man S Chan (PRINCIPAL_INVESTIGATOR) - Chinese University of Hong Kong
Contact Information
Study Contact:
The Department of Psychiatry
852-2607-6027
psychiatry@cuhk.edu.hk
Helene J Hopman
852-5597-1622
hjhopman@link.cuhk.edu.hk
Interventions
  • rTMS group
Study Locations (1 sites)
Department of Psychiatry, CUHK, Hong Kong, 852 Hong Kong
Eligibility Criteria
Inclusion Criteria: * right-handed * meet the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition (DSM-IV) criteria for major depressive disorder * at least moderate episode or with a score of \>20 on Montgomery-asberg Depression Rating Scale (MADRS) and \>18 on Hamilton Depression Rating Scale(HDRS) 17-item; * has failed to respond adequately to at least one full course (\>6 weeks) of antidepressant medication or medication intolerant. Exclusion Criteria: * significant head trauma * active abuse of alcohol or illegal substances * current psychotic symptoms * suicide ideation/recent suicide attempts * other DSM-IV Axis I and II psychiatric diagnosis * neurological disorders and contraindications to fMRI (e.g. pace makers, metal implants, pregnancy) or rTMS, or having undergone electroconvulsive therapy in the preceding year.
Mindfulness as a Method of Improving the Well-being, Quality of Life and Health of Primary School Pupils
NCT03327714
Active, positions filled
Conditions Anxiety, Depression
Phase NA
Enrollment 1750
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Mindfulness and compassion

Primary Outcomes

  • Effect of mindfulness on change in anxiety and depression in children, grade 3-9, as measured by the Beck Depression Inventory for Youth and the Beck Anxiety Inventory for Youth.
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: 2016-10-12
Completion: 2039-06-30
Eligibility
Age: 6 Years
Sex: ALL
Volunteers: true
Enrollment: 1750 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Lund University
Collaborators: Region Skane
Principal Investigators:
  • Jan Sundquist, PhD, MD (PRINCIPAL_INVESTIGATOR) - Center for Primary Health Care Research, Institution of Clinical Sciences, Malmö, Sweden
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Mindfulness and compassion
Study Locations (1 sites)
Center for Primary Health Care Research, Malmö, 20502 Sweden
Eligibility Criteria
Inclusion Criteria: * School pupils in grade 0-9 Exclusion Criteria: * No exclusion criteria
MOther-Child Interaction Assessment TRAINING for Pediatricians
NCT03300713
Active, positions filled
Conditions Child Behavior Disorders, Mother-child R...
Phase NA
Enrollment 3504
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

  • MOCITRAINING program
  • usual follow-up

Primary Outcomes

  • Frequency of pathological Alarm Distress BaBy (ADBB) scores
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: 2017-12-02
Completion: 2026-12
Eligibility
Age: 23 Days
Sex: ALL
Volunteers: false
Enrollment: 3504 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospital, Lille
Collaborators: Ministry of Health, France
Principal Investigators:
  • Renaud Jardri, MD, PhD (PRINCIPAL_INVESTIGATOR) - University Hospital, Lille
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • MOCITRAINING program
  • usual follow-up
Study Locations (1 sites)
CHU, Lille, France
Eligibility Criteria
Inclusion Criteria: * Each child will be included WITH his biological mother at the first-month visit after birth. * Age: 1 month + / - 15 days (child), accompanied by his biological mother * Mother able to read French; * Signed consent letter after complete information of parents about the MOCITRAINING study, its principle, advantages and disadvantages. Exclusion Criteria: * Preterm babies. * Children from a twin or multiple pregnancy. * Children with somatic diagnosis explaining the presence of digestive, sleeping or interactional disorders. * Refusal to participate after clear information about the study; * Refusal to sign the consent letter; * Refusal to be informed of a diagnostic hypothesis; * Participants not covered by the Social Security system; * Participants incapable of consenting or under legal protection (guardianship or curatorship).
Positron Emission Tomography (PET) Imaging With Zirconium-89 (89Zr)-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness
NCT03321045
Recruiting
Conditions Breast Cancer
Phase EARLY_PHASE1
Enrollment 10
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

  • [89Zr]-Df-Trastuzumab
  • PET/MRI Imaging

Primary Outcomes

  • Investigate the use of [89Zr]-Df-Trastuzumab as a HER2 imaging agent
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: Recruiting
Start Date: 2017-11-21
Completion: 2028-10
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 10 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Alabama at Birmingham
Principal Investigators:
  • Suzanne E Lapi, PhD (PRINCIPAL_INVESTIGATOR) - University of Alabama at Birmingham
Contact Information
Study Contact:
Denise Jeffers, PharmD
205-975-6469
charlottejeffers@uabmc.edu
Sebastian Eady, BS
2059962636
smeady@uabmc.edu
Interventions
  • [89Zr]-Df-Trastuzumab
  • PET/MRI Imaging
Study Locations (1 sites)
The Kirklin Clinic, Birmingham, Alabama 35249 United States
Eligibility Criteria
Inclusion Criteria: * Be at least 18 years of age. * Diagnosis of HER2 positive breast cancer as defined by to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 guidelines: Immunohistochemistry (IHC) 3+ OR Single prove In situ hybridization (ISH) with average HER2 copy number \>= 6 OR dual probe ISH with both average HER2 copy number \>= 4 AND HER2 to CEP17 ratio \>=2 * Patients eligible for radiation therapy or systemic therapy using a regimen containing at least one anti-HER2 agent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 and 1 * Ejection fraction greater than 50% by echocardiogram or multiple-gated acquisition (MUGA) scans Exclusion Criteria: * Inability to provide informed consent * Pregnancy * Inability to lie still for the imaging study * Weight over 350 lbs., due to the scanner bore size * Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
Effects of Compression Stockings in Asthma Symptoms at Night
NCT03303586
Recruiting
Conditions Asthma
Phase NA
Enrollment 40
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Compression Stockings
  • Control

Primary Outcomes

  • Effect of wearing compression stockings on reducing rostral fluid shift during sleep and its effect in airway narrowing
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2017-02-21
Completion: 2026-08-31
Eligibility
Age: 20 Years
Sex: ALL
Volunteers: true
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Health Network, Toronto
Principal Investigators:
  • Azadeh Yadollahi (PRINCIPAL_INVESTIGATOR) - Scientist
Contact Information
Study Contact:
Cristina O Francisco
416 597 3422
cristina.francisco@uhn.ca
Interventions
  • Compression Stockings
  • Control
Study Locations (1 sites)
Toronto Rehabilitation Institute (TRI), Toronto, Ontario M5G 2A2 Canada
Eligibility Criteria
Inclusion Criteria: non-smokers or former smokers (\<10 pack/year) Exclusion Criteria: uncontrolled hypertension
Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients
NCT03303846
Active, positions filled
Conditions Healthy Subject
Phase NA
Enrollment 344
Locations 5 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Magnetic Resonance Imaging
  • Biospecimen Collection
  • Laboratory Biomarker Analysis

Primary Outcomes

  • Incidence of triple-negative breast cancer (invasive and/or ductal carcinoma in situ [DCIS]) within the 12-month period of the study
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: 2017-10-13
Completion: 2026-11-20
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 344 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Victoria Seewaldt, MD (PRINCIPAL_INVESTIGATOR) - City of Hope Medical Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Magnetic Resonance Imaging
  • Biospecimen Collection
  • Laboratory Biomarker Analysis
Study Locations (5 sites)
City of Hope Medical Center, Duarte, California 91010 United States
University of Southern California, Los Angeles, California 90033 United States
Duke University, Durham, North Carolina 27705 United States
Ohio State University, Stefanie Spielman Comprehensive Breast Center, Columbus, Ohio 43212 United States
University of Wisconsin, Madison, Wisconsin 537192 United States
Eligibility Criteria
Inclusion Criteria: * Women who are undergoing screening breast MRI as per standard of care for high-risk breast cancer screening * Willing to donate left-over tissue if patient undergoes a breast biopsy and/or breast surgery * Willing to have about 40 mL of blood (approximately 3 tablespoons) drawn * Documented informed consent of the participant Exclusion Criteria: * Allergy or intolerance to gadolinium * Inability to undergo breast MRI (e.g. claustrophobia) * Participants with active cancer diagnosis (exception: skin cancer, biopsy-proven atypical lobular, ductal hyperplasia and/or lobular carcinoma in situ) * Previous diagnosis of stage 4 cancer * Participants who have received cytotoxic chemotherapy within 1 year prior to screening breast MRI * Participants who have received endocrine therapy within 1 year prior to screening breast MRI * Participants who have received breast radiation within 1 year prior to screening breast MRI * Radiation to both breasts * Pregnant and/or lactating within 1 year prior to screening breast MRI * Receives screening breast MRIs at an outside facility other than the consenting institution
Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy
NCT03315364
Active, positions filled
Conditions Recurrent or Metastatic Breast Cancer
Phase PHASE2, PHASE3
Enrollment 549
Locations 51 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

  • Oral paclitaxel
  • Paclitaxel injection

Primary Outcomes

  • [Phase II] Objective Response Rate (ORR)
  • [Phase III] Progression Free Survival (PFS)
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: 2017-12-18
Completion: 2028-11-30
Eligibility
Age: 19 Years
Sex: ALL
Volunteers: false
Enrollment: 549 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Daehwa Pharmaceutical Co., Ltd.
Principal Investigators:
  • Sung-bae Kim, M.D., Ph.D (PRINCIPAL_INVESTIGATOR) - Asan Medical Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Oral paclitaxel
  • Paclitaxel injection
Study Locations (51 sites)
Oncology Complex Center - Burgas'' Ltd., Medical Oncology Department, Burgas, 8000 Bulgaria
Multi-profile Hospital for Active Treatment Uni Hospital Ltd. Medical Oncology Department, Panagyurishte, 4500 Bulgaria
Medical Center Nadezhda Clinical" Ltd.,, Sofia, 1330 Bulgaria
Anhui Cancer Hospital, Hefei, Anhui China
Cancer Hospital Chinese Academy Of Medical Sciences, Beijing, Beijing Municipality China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong China
The First Affiliated Hospital Of Hainan Medical College, Haikou, Hainan China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang China
Tianjin Cancer Hospital, Zhengzhou, Henan China
Jiangsu Cancer Hospital, Nanjing, Jiangsu China
Eligibility Criteria
Key inclusion/exclusion criteria * Histologically or cytologically confirmed to have recurrent, or metastatic breast cancer. * Measurable disease (revised RECIST, version 1.1). * Hormone receptor (ER/PR) positive or negative, HER2 negative. * Subjects were eligible for the study regardless of their previous lines of endocrine therapy. * No prior chemotherapy is allowed in metastatic disease. * Subjects who administrated the last dose of taxane class drug ≥12months ago as from the first administration day. * ECOG performance status ≤1. * Neuropathy grade \<2. * Subjects with central nervous system metastasis should be excluded.
Improving Quality of Life for Patients With Breast Cancer Invading the Chest Wall: A Prospective Registry For Patients Undergoing Full Thickness Chest Wall Resection
NCT03265379
Recruiting
Conditions Breast Cancer
Phase Not Applicable
Enrollment 104
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • FACT-B and Brief Pain Inventory

Primary Outcomes

  • differences in Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores
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: 2017-08-22
Completion: 2030-08-22
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 104 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Health Network, Toronto
Principal Investigators:
  • Shaf Keshavjee (PRINCIPAL_INVESTIGATOR) - University Health Network, Toronto
Contact Information
Study Contact:
Jennifer Lister, BSc CCRP
416-340-4857
Jennifer.Lister@uhn.ca
Interventions
  • FACT-B and Brief Pain Inventory
Study Locations (1 sites)
University Health Network (Toronto General Hospital and Princess Margaret Cancer Centre), Toronto, Ontario M5G 2C4 Canada
Eligibility Criteria
Inclusion Criteria: 1. \>18 years of age 2. Breast cancer with invasion of the chest wall (ribs, para-costal soft tissue, intercostal muscle or soft-tissue) that is: 1. Radiologically proven on cross-sectional imaging 2. Histologically proven 3. Medically fit for surgery 4. \>1 year disease-free interval (between initial treatment and recurrence) for patients with local recurrence Exclusion Criteria: 1. Medically inoperable due to co-morbidity or other contraindication to surgery 2. Technically unresectable disease 3. Ineligible for chemotherapy 4. ECOG performance status \>2 5. Patient refusal
Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)
NCT03288025
Active, positions filled
Conditions Pulmonary Arterial Hypertension, Insulin...
Phase NA
Enrollment 34
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

  • Nutrition and Exercise

Primary Outcomes

  • Insulin Sensitivity
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: 2017-09-27
Completion: 2026-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 34 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: The Cleveland Clinic
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigators:
  • Raed Dweik, MD (PRINCIPAL_INVESTIGATOR) - The Cleveland Clinic
  • Gustavo Heresi, MD (PRINCIPAL_INVESTIGATOR) - The Cleveland Clinic
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Nutrition and Exercise
Study Locations (1 sites)
Cleveland Clinic Foundation, Cleveland, Ohio 44195 United States
Eligibility Criteria
Inclusion Criteria: * Age range between 18-75 years old * Group 1 PAH, including idiopathic, heritable, drugs and toxin induced, and PAH associated with connective tissue disease, HIV infection and congenital heart disease * NYHA Class II or III * ≥ 1 PAH-targeted therapy with a stable dose for ≥ 2 months * Stable dose of diuretics and rate of supplemental oxygen for the preceding 2 months Exclusion Criteria: * Decompensated Right Heart Failure * NYHA Class IV * Syncope within the previous 3 months * Cardiac Arrhythmia (except for controlled atrial fibrillation or flutter) * Baseline supplemental O2 \> 4 LPM * Portal Hypertension * Pulmonary hypertension due to Lung Disease and Hypoxia * Pulmonary Hypertension due to Left Heart Disease * Chronic Thromboembolic Pulmonary Hypertension * Pulmonary Hypertension associated with systemic diseases such as hematological disorders and sarcoidosis * Type 2 Diabetes * Evidence of cardiac ischemia on a graded exercise test