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Showing 20 of 30222 trials
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
NCT03065335
Recruiting
Conditions Healthy Volunteer, Major Depressive Diso...
Phase PHASE1
Enrollment 150
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

  • Ketamine
  • Placebo
  • Cobot TS MV robotic arm for TMS
  • NeurOptics PLRTM-30000 Pupillometer

Primary Outcomes

  • To demonstrate more robust neuropharmacodynamic effects measured by neuropharmacodynamic imaging (fMRI+EEG and MEG) of ketamine 0.5 mg/kg as compared to placebo administered over 40 minutes.
  • Ketamine Metabolites Substudy: To determine if ketamine metabolites cross the blood brain barrier and enter the brain during ketamine IV administration.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2017-05-25
Completion: 2028-01-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: National Institute of Mental Health (NIMH)
Principal Investigators:
  • Carlos A Zarate, M.D. (PRINCIPAL_INVESTIGATOR) - National Institute of Mental Health (NIMH)
Contact Information
Study Contact:
Adilah M Kirton
(301) 549-0315
adilah.meredith-kirton@nih.gov
Interventions
  • Ketamine
  • Placebo
  • Cobot TS MV robotic arm for TMS
  • NeurOptics PLRTM-30000 Pupillometer
Study Locations (1 sites)
National Institutes of Health Clinical Center, Bethesda, Maryland 20892 United States
Eligibility Criteria
* INCLUSION CRITERIA: Inclusion Criteria: All Subjects (Main Study) 1. 18 to 65 years of age. 2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document. 3. All subjects must have undergone a screening assessment under either protocol 01-M-0254, "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers" or protocol 17-M-0181 ("Recruitment and Characterization of Research Volunteers for NIMH Intramural Studies"). 4. Agree to be hospitalized Additional Inclusion Criteria: Patients with MDD (Main Study) 1. At the initial study enrollment, subjects must have fulfilled DSM-IV or DSM-5 criteria for Major Depression, single episode or recurrent. Subjects must be experiencing a current major depressive episode of at least 2 weeks duration. 2. At the initial screening and beginning of Phases II and III, subjects must have a baseline score on the MADRS \>= 20 and YMRS of \< 12. 3. Current or past history of lack of response to one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial. Ketamine Metabolites Substudy Inclusion Criteria: Healthy Volunteers 1. 18 to 65 years of age. 2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document. 3. All subjects must have undergone a screening assessment under either protocol 01-M-0254 "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers") or 17-M-0181 ("Recruitment and Characterization of Research Volunteers for NIMH Intramural Studies"). 4. Agree to be hospitalized. EXCLUSION CRITERIA: Additional Exclusion Criteria: Patients with MDD (Main Study) 1. Current diagnosis of Bipolar Disorder including Bipolar I, Bipolar II, or Bipolar NOS diagnoses. 2. Current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5. 3. Subjects with a history of DSM-IV or DSM-5 drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months. In addition, subjects who currently are using drugs (except for caffeine or nicotine) must not have used illicit substances or known drugs of abuse in the 2 weeks prior to screen and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines or stimulants) urine test at screening. 4. Treatment with a reversible MAOI within two weeks prior to Phase II. 5. Subjects who, in the investigator s judgment, pose a current serious suicidal or homicidal risk. Exclusion Criteria: All Subjects (Main Study) 1. Pregnant or nursing women or women who plan to become pregnant. Women who are able to get pregnant must be willing to use at least one form of effective birth control during the entire period of study participation (or until last clinical labs and rating) and have a negative pregnancy test that was obtained no more than 24 hours prior to MRI and infusion of ketamine. 2. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, coronary artery disease, atherosclerotic ischemic stroke, and atrial fibrillation), endocrinologic, neurologic, immunologic, or hematologic disease. 3. Clinically significant abnormal laboratory tests. 4. Subjects with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold. History of seizure (regardless of age or etiology), history of epilepsy in self or first-degree relatives, stroke, brain surgery, head injury, or known structural brain lesion will be excluded from the TMS procedures. 5. Treatment with any other concomitant medication 14 days prior to Phase II. An exception of this would be necessary for those who are taking Fluoxetine or Aripiprazole. Prior to Phase II, treatment with Fluoxetine must be discontinued for at least 5 weeks and treatment with Aripiprazole must be discontinued for at least 3 weeks. 6. Any use of opioid medication in the past 3 months 7. Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip) (for subjects doing imaging component of the study only). 8. Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications. 9. Subjects who have hearing loss that has been clinically evaluated and diagnosed 10. Participants who are uncomfortable in small closed spaces (have claustrophobia), unable to lie comfortably supine for up to 90 minutes, and would feel uncomfortable in the MRI machine (for subjects doing imaging component of the study only). 11. Positive HIV test 12. Weight \> 119 kg 13. \[for participants undergoing NPU Threat Test with Auditory Startle\] Known history of hearing loss Additional Exclusion Criteria: Healthy Volunteers (Main Study) 1\. Current or past history of any DSM-IV or DSM-5 Axis I disorder based on clinical assessment and confirmed by a structured diagnostic interview (SCID). Ketamine Metabolites Substudy Exclusion Criteria: Healthy Volunteers 1. Current or past history of any DSM-IV or DSM-5 Axis I disorder based on clinical assessment and confirmed by a structured diagnostic interview (SCID). 2. Current (within the past 3 months) or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine) 3. Pregnant or nursing women or women who plan to become pregnant. Women who are able to get pregnant must be willing to use at least one form of effective birth control during the 4-days of the study participation (or until last clinical labs and rating) and have a negative pregnancy test that was obtained no more than 24 hours prior to infusion of ketamine. 4. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, coronary artery disease, atherosclerotic ischemic stroke, and atrial fibrillation), endocrinologic, neurologic, immunologic, or hematologic disease. 5. Clinically significant abnormal laboratory tests. 6. Subjects with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold. 7. Treatment with any other concomitant medication. 8. Any use of opioid medication in the past 3 months 9. Positive HIV test 10. Weight \> 119 kg 11. Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip) (for subjects doing neuroimaging component of the study only). 12. Participants who are uncomfortable in small closed spaces (have claustrophobia), unable to lie comfortably supine for up to 90 minutes, and would feel uncomfortable in the MRI machine (for subjects requiring clinical MRI scans for safety and/or structural MRI scans for MEG coregistration).
Managing Cancer and Living Meaningfully (CALM) Adapted to Italian Cancer Care Setting
NCT03068013
Recruiting
Conditions Depression, Anxiety, Quality of Life
Phase NA
Enrollment 171
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

  • CALM
  • SPI

Primary Outcomes

  • PHQ - depression
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2018-10-11
Completion: 2024-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 171 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Università degli Studi di Ferrara
Collaborators: Princess Margaret Hospital, Canada, University Health Network, Toronto
Principal Investigators:
  • Luigi Grassi, M.D. (STUDY_CHAIR) - Istituto di Psichiatria. Università degli Studi di Ferrara
  • Rosangela Caruso, M.D., PhD (PRINCIPAL_INVESTIGATOR) - Istituto di Psichiatria. Università degli Studi di Ferrara
Contact Information
Study Contact:
Luigi Grassi, M.D.
+39 0532 236409
luigi.grassi@unife.it
Rosangela Caruso, M.D., PhD
+39 340 6053409
rosangela.caruso@unife.it
Interventions
  • CALM
  • SPI
Study Locations (1 sites)
Università di Ferrara, Ferrara, Emilia-Romagna 44100 Italy
Eligibility Criteria
Inclusion Criteria: 1. 18 years of age or more 2. fluency in Italian language; 3. no cognitive impairment; 4. confirmed or working diagnosis of "wet" stage IIIB (those not treated with curative intent) or IV lung cancer; any stage of pancreatic or stage IV GI cancer, stage III or IV ovarian and fallopian tube cancers, or other stage IV gynecological cancer; and stage IV breast, genitourinary, sarcoma, melanoma or endocrine cancers (expected survival of 12-18 months); a score ≥10 at the Patient Health Questionnaire (PHQ9) or ≥ 20 at the Death and Dying Distress Scale (DDAS). - Exclusion Criteria: 1. communication difficulties; 2. inability to commit to the required 6 sessions (i.e., too ill to participate, lack of transportation, etc.); 3. actively seeing a psychotherapist, and
Ribociclib and Bicalutamide in AR+ TNBC
NCT03090165
Active, positions filled
Conditions Triple Negative Breast Cancer
Phase PHASE1, PHASE2
Enrollment 37
Locations 6 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

  • ribociclib
  • ribociclib
  • Bicalutamide

Primary Outcomes

  • Phase I: Maximum Tolerated Dose
  • Phase II: Clinical benefit rate (CBR) of treatment combination
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: 2018-05-07
Completion: 2026-10
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 37 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Kari Wisinski
Collaborators: Novartis, Big Ten Cancer Research Consortium, University of Wisconsin, Madison
Principal Investigators:
  • Kari Wisinski, MD (PRINCIPAL_INVESTIGATOR) - University of Wisconsin, Madison
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • ribociclib
  • ribociclib
  • Bicalutamide
Study Locations (6 sites)
University of Illinois Cancer Center, Chicago, Illinois 60612 United States
Michigan State University, Lansing, Michigan 48910 United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey 08903 United States
University of Rochester Medical Center, Rochester, New York 14642 United States
Penn State Cancer Institute, Hershey, Pennsylvania 17033 United States
University of Wisconsin, Madison, Wisconsin 53792 United States
Eligibility Criteria
Individuals from populations who are underrepresented in clinical research (e.g., racial and ethnic minorities, women, individuals from rural/frontier communities, older individuals) will be enrolled with a goal of ensuring that all eligible patients are given the opportunity to participate in novel clinical trials and that research findings can be generalizable to the entire population. Androgen Receptor (AR) positivity definitions -Phase I: Metastatic or unresectable AR+ triple-negative breast cancer (TNBC); AR positivity defined as IHC staining of \>0% of tumor nuclei. OR -Phase II: Metastatic or unresectable AR+ triple-negative breast cancer (TNBC); AR positivity defined as IHC staining of ≥10% of tumor nuclei. Inclusion Criteria for Phase I and II study. In addition to being AR positive as defined in protocol, subjects must also meet all of the following applicable inclusion criteria. * Histological or cytological confirmed, metastatic or unresectable triple-negative breast cancer (TNBC). TNBC will be defined as expression of ER\<10%, PR\< 10% and HER2 negative either by IHC (0, 1+ are negative, 2+ equivocal) or in situ hybridization method (ratio \<2.0 is negative). * 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. * Up to 3 prior line of systemic therapy for metastatic disease is allowed. Combination therapy will be considered 1 line. * Age ≥ 18 years at the time of consent. * ECOG Performance Status of 0, 1 or 2 within 28 days prior to registration. * Life expectancy of \> 12 weeks as determined by the treating physician. * Measurable disease according to RECIST 1.1 within 28 days prior to registration. * No active central nervous system (CNS) metastatic disease. NOTE: Subjects with CNS involvement must meet ALL of the following to be eligible: * At least 28 days from prior definitive treatment of their CNS disease by surgical resection, stereotactic body radiation therapy (SBRT) or whole brain radiation treatment (WBRT) at the time of registration * AND asymptomatic and off systemic corticosteroids and/or enzyme-inducing anti-epileptic medications for brain metastases for \>14 days prior to registration. * Prior cancer treatment must be completed at least 14 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤grade 1 or to baseline prior to initiation of that therapy. * Screening rate-corrected QT interval (QTc) must be \<450msec and a resting heart rate of at least 50-90 bpm via a standard 12-lead ECG within 28 days prior to registration. * Demonstrate adequate bone marrow and organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration. * Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), or they are naturally postmenopausal for at least 12 consecutive months, or her male partner has had a vasectomy at least 6 months prior to screening (The sterilized male partner must be her only sexual partner.). * Females of childbearing potential and males must be willing to abstain from heterosexual activity or must agree to use adequate contraception (hormonal or barrier method) for the duration of study participation and for 3 weeks after discontinuation of study treatment. * As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study. * Able to swallow bicalutamide and ribociclib tablets. Exclusion Criteria: * Prior therapy with AR antagonists including but not limited to bicalutamide, enzalutamide, abiraterone and orteronel. * Prior therapy with any CDK 4/6 inhibitors with the exception of participation in a window or preoperative study for Stage I-III operable breast cancer.. * Active infection requiring systemic therapy. * Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study). * Known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least three years. * Treatment with any investigational drug within 14 days prior to registration or within 5 half-lives of the investigational product, whichever is longer. Immunotherapies such as PD-L1 or PD-1 inhibitors only require a 14 day window, regardless of half-life. Investigational imaging agents are not included in this definition and are allowed. * Subject who has received radiotherapy \<14 days prior to registration, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia and any adverse events deemed by the investigator to be unlikely to interfere with the study drug safety). * Subject has had major surgery within 14 days prior to registration or has not recovered from major side effects of the surgery (tumor biopsy is not considered as major surgery). * Known hypersensitivity to any of the excipients of ribociclib or bicalutamide. * Any 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). * Known history of HIV infection (testing not mandatory). * Any concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate subject participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.). * Subjects with any of the following conditions are excluded: * Serious or non-healing wound, ulcer, or bone fracture. * History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess within 28 days prior to registration. * Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to registration. * Any history of arterial or venous thrombosis/thromboembolic event, including pulmonary embolism within the past 12 months prior to registration. * History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to registration. * Symptomatic congestive heart failure (New York Heart Association III-IV) or documented current cardiomyopathy with left ventricular ejection fraction (LVEF) \<50% * Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia) or clinically significant, complete left bundle branch block, high-grade AV block (e.g. bifascicular block, Mobitz type II and third-degree AV block). * Any episode of atrial fibrillation in the prior 12 months. * Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome. * Concomitant use of medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued (within 5 half-lives or 7 days prior to starting study drug) or replaced by safe alternative medication. See ManualDocuments/Info tab of the EDC for list of medications. * Systolic blood pressure (SBP) \>160 mmHg or \<90 mmHg at screening. * Currently receiving any known strong inducers or inhibitors of CYP3A4/5 which cannot be discontin
The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
NCT03059069
Recruiting
Conditions Type2 Diabetes With Depressive Mood
Phase PHASE4
Enrollment 60
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

  • Chonline Alphoscerate
  • Placebo Oral Tablet

Primary Outcomes

  • changes in Hamilton Depression Rating Scale (HDRS)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2016-06-01
Completion: 2025-06-30
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Yonsei University
Contact Information
Study Contact:
Bong-Soo Cha, MD, Ph.D
82-2-2228-5457
bscha@yuhs.ac
Interventions
  • Chonline Alphoscerate
  • Placebo Oral Tablet
Study Locations (1 sites)
Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center, Seoul, 03722 South Korea
Eligibility Criteria
Inclusion Criteria: * Type 2 diabetic patients * Age ≥ 50 * Glycemic control: HbA1c ≤ 10.0% * 10 ≤ Beck Depression Inventory (BDI) \<30 points * Participants who can undergo contraception in case of being in childbearing period * Understands the study procedure, alternatives, and risks and voluntarily agrees to participate by giving written informed concent Exclusion Criteria: * Type 1 diabetes, Secondary diabetes, gestational diabetes * Ongoing dementia treatment or anti-depressive disorder medication * Uncontrolled psychiatric disorder * BDI ≥ 30 points * Heavy alcoholics * Underlying chronic liver disease (hemochromatosis, liver cell carcinoma, autoimmune liver disease, liver cirrhosis, chronic viral hepatitis) * Allergy or hypersensitivity to target medication or any of its components * Renal failure, moderate or severe renal impairment (estimated glomerular filtration rate \< 30 mL/min/1.73 m2), or ongoing dialysis * Abnormal liver function (AST/ALT \> x3 upper normal limit) * History of alcohol or drug abuse in the previous 3 months * Premenopausal women who are nursing or pregnant * Human immunodeficiency virus (HIV) or human immunodeficiency virus (AIDS) * chronic pancreatitis or pancreatic cancer
ADAPT - A Patient Registry of the Real-world Use of Orenitram®
NCT03045029
Active, positions filled
Conditions Pulmonary Arterial Hypertension
Phase Not Applicable
Enrollment 300
Locations 41 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Oral treprostinil

Primary Outcomes

  • Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients
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: 2017-07-18
Completion: 2027-03
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: United Therapeutics
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Oral treprostinil
Study Locations (41 sites)
University of California - San Francisco, Fresno, California 94143 United States
University of Southern California - Keck Medical Center, Los Angeles, California 90033 United States
Paloma Medical Group, San Juan Capistrano, California 92675 United States
Santa Barbara Pulmonary Associates, Santa Barbara, California 93105 United States
Harbor UCLA Medical Center, Torrance, California 90502 United States
Aurora Denver Cardiology Associates, Aurora, Colorado 80012 United States
Pueblo Pulmonary Associates, Pueblo, Colorado 81003 United States
Lung Associates PA, Bradenton, Florida 34208 United States
University of Florida Clinical Research Center, Gainesville, Florida 32610 United States
St. Vincent's Lung, Sleep, and Critical Care Specialists, Jacksonville, Florida 33204 United States
Eligibility Criteria
INCLUSION CRITERIA Patients are eligible for the registry if: 1. The patient voluntarily gives informed consent to participate in the study. 2. The patient must be at least 18 years of age or older. 3. The patient is prescribed Orenitram (per the package insert indication), and plans to initiate therapy with this medication or has been receiving Orenitram for 182 or fewer days. 4. The patient agrees to dosing, prostacyclin-related AE of interest record keeping, survey participation during designated time periods, and recording any medication changes, use, for the duration of the study. 5. The patient has the ability to answer surveys and use the diary in English. 6. The patient must have an email address and be willing to access the PRO Portal. EXCLUSION CRITERIA Patients are ineligible for the registry if: 1. The patient has previously received Orenitram for more than 182 days. 2. The patient is currently participating in an investigational drug or device study or has participated in a clinical study with an investigational product other than Orenitram in PAH within
Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
NCT02986087
Recruiting
Conditions Congenital Diaphragmatic Hernia, Pulmona...
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

  • Fetal Tracheal Occlusion

Primary Outcomes

  • Change lung growth on prenatal imaging
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2016-11
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Children's Hospital Medical Center, Cincinnati
Principal Investigators:
  • Kurt Schibler, MD (STUDY_CHAIR) - CCHMC Oversight Data Safety Monitoring Committee
Contact Information
Study Contact:
Foong-Yen Lim, MD
(513) 636-6259
Foong-Yen.Lim@cchmc.org
Jose Peiro, MD, PhD
(513) 803-4563
Jose.Peiro@cchmc.org
Interventions
  • Fetal Tracheal Occlusion
Study Locations (1 sites)
Cincinnati Children's Hospital Medical Center (CCHMC), Cincinnati, Ohio 45229 United States
Eligibility Criteria
Inclusion Criteria: * Isolated CDH with liver up * Severe pulmonary hypoplasia with ultrasound O/E LHR \<25% at the time of surgery * Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days * Moderate pulmonary hypoplasia with ultrasound O/E LHR \<30% and liver-up at the time of surgery * Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category * Maternal age greater than or equal to 18 years * Gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate category * Normal karyotype or FISH * Normal fetal echocardiogram * Singleton pregnancy * Willing to remain in the greater Cincinnati area for remainder of pregnancy * Family considered and decline option of termination of the pregnancy at less than 24 weeks 0 days * Family meets psychosocial criteria Exclusion Criteria: * Patient \< 18 years old * Multi-fetal pregnancy * Rubber latex allergy * Preterm labor, cervix shortened (\<15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa * Bilateral CDH, isolated left sided CDH with an O/E \> 30% * Additional fetal anomaly by ultrasound, MRI, or echocardiogram * Chromosomal abnormalities * Maternal contraindications to fetoscopic surgery or severe maternal condition in pregnancy * Incompetent cervix with or without a cerclage * Placental abnormalities known at time of enrollment * Maternal HIV, Hepatits B, Hepatitis C * Maternal uterine anomaly * No safe or technically feasible fetoscopic approach to balloon placement * Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
NCT02969798
Recruiting
Conditions Diabetes Mellitus, Type 2, Impaired Gluc...
Phase NA
Enrollment 700
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

  • Dapagliflozin
  • Saxagliptin
  • Pioglitazone
  • Metformin

Primary Outcomes

  • Beta cell function
  • Insulin sensitivity
  • Glucose tolerance status
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2014-01-01
Completion: 2027-07
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 700 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: The University of Texas Health Science Center at San Antonio
Collaborators: American Diabetes Association, AstraZeneca, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigators:
  • Ralph A DeFronzo, MD (PRINCIPAL_INVESTIGATOR) - The University of Texas Health Science Center at San Antonio
Contact Information
Study Contact:
Ralph A DeFronzo, MD
210-567-6691
defronzo@uthscsa.edu
Monica Palomo, BS
210-567-6710
palomom@uthscsa.edu
Interventions
  • Dapagliflozin
  • Saxagliptin
  • Pioglitazone
  • Metformin
Study Locations (1 sites)
The University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229 United States
Eligibility Criteria
Inclusion Criteria: * NGT subjects will serve as controls and will be matched in age, gender, ethnicity, and BMI to IGT and IFG subjects 1. Male or female subjects between the ages of 18 and 65 years of age, inclusive, at Screening. 2. FPG \< 100 mg/dl and 2-h PG \< 140 mg/dl 3. BMI = 24-40 kg/m2; 4. Stable body weight (±4lbs) over the preceding 3 months 5. Subjects with no evidence of major organ system disease as determined by physical exam, history, and screening laboratory data 6. Females of childbearing potential with a negative pregnancy test at Screening and Treatment visits, using one of the following forms of contraception for the duration of participation in the study (i.e., until Follow-up 7-14 days post last dose): * Oral contraceptive * Injectable progesterone * Subdermal implant * Spermicidal foam/gel/film/cream/suppository * Diaphragm with spermicide * Copper or hormonal containing IUD * Sterile male partner vasectomized \> 6 month pre-dosing. 7. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 8. Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures. Exclusion Criteria: 1. Recent (i.e., within three (3) months prior to Screening) evidence or medical history of unstable concurrent disease such as: documented evidence or history of clinically significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, immunological, or clinically significant neurological disease. 2. Subjects with a family history of diabetes in a first degree relative 3. BMI of less than 24 or greater than 40 kg/m2 4. Unstable body weight (change of greater than ±4lbs over the preceding 3 months 5. Subjects participating in an excessively heavy exercise program 6. Subject with a feeding/sleeping schedule different from a daytime feeding/night time sleeping schedule 7. Subjects taking medications known to alter glucose metabolism (with the exception of metformin and/or pioglitazone) or which effect brain neurosynaptic function are excluded. 8. Subjects with evidence of major organ system disease as determined by physical exam, history, and screening laboratory data 9. Pregnant subjects or subjects unwilling to use birth control during their study enrollment 10. Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to Screening. 11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study 12. Subjects with hematuria will be excluded. 13. Subjects with evidence or prior history of heart failure will be excluded 14. Subjects with family history of pancreatic, bladder, and breast cancer will be excluded. 15. Subjects with history of pancreatitis will be excluded. 16. Subjects with eGFR \< 60 ±5 ml/min.1.73m2 will be excluded. 17. Subjects with elevated serum creatinine (\>1.5 mg/dl males/1.4 mg/dl females) will be excluded. 18. Subjects with a history of orthostatic hypotension (\>15/10 mmHg) will be excluded. 19. Subjects with liver enzymes (ALT, AST) \>3-fold above upper normal limit will be excluded. 20. Subjects with a history of hypersensitivity to pioglitazone, dapagliflozin, or Saxagliptin will be excluded.
: Vascular Function in Health and Disease
NCT02966665
Recruiting
Conditions Chronic Obstructive Pulmonary Disease, P...
Phase PHASE1
Enrollment 420
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

  • Maximum Exercise Tests
  • BH4, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid and L-Ascorbate
  • BQ-123
  • Fexofenadine, Ranitidine
  • Angiotensin-II, Valsartan

Primary Outcomes

  • Change in Limb Blood Flow
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2008-09
Completion: 2026-08
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 420 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Russell Richardson
Principal Investigators:
  • Russell Richardson, Ph.D. (PRINCIPAL_INVESTIGATOR) - George E Wahlen VA Medical Center
Contact Information
Study Contact:
Maydeen Ogara
801-584-2522
maydeen.ogara@hsc.utah.edu
Interventions
  • Maximum Exercise Tests
  • BH4, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid and L-Ascorbate
  • BQ-123
  • Fexofenadine, Ranitidine
  • Angiotensin-II, Valsartan
Study Locations (1 sites)
George E Wahlen VA Medical Center, Salt Lake City, Utah 84132 United States
Eligibility Criteria
Inclusion Criteria: * Healthy Young Volunteers: 18-30 years of age with no diseases or conditions that would affect their participation in the study * Healthy Older Controls: volunteers 65 years of age or older with no diseases or conditions that would affect their participation in the study * Coronary Angiography subjects: patients undergoing routine coronary angiography * Chronic Obstructive Pulmonary Disease subjects: patients diagnosed with mild to moderate COPD * Pulmonary Arterial Hypertension subjects: patients with idiopathic or heritable Group 1 pulmonary arterial hypertension * Heart Failure subjects: patients with Class I, II or III New York Heart Association symptoms of Heart Failure * Hypertension subjects: patients diagnosed with chronic high blood pressure Exclusion Criteria: * Severe COPD (use of supplemental oxygen, or have a one-second forced expiratory volume of less than 30% predicted) * History of myocardial infarction * History of percutaneous coronary revascularization * History of coronary artery bypass grafting * Unstable angina pectoris * History of variant angina * Ejection fraction \< 50% * Significant renal disease (Glomerular Filtration Rate \< 50 mL/min/1.73m2) * Subjects whose medical care or safety may be at risk from undergoing a Magnetic Resonance Imaging examination (e.g. pacemaker, metal implants, certain types of heart valves) * Subject is pregnant * Subject has physical ailments (other than COPD, PAH, HF, or hypertension) that would prevent them from study participation in the judgment of the investigator
Hypofractionated Radiation Therapy for Patients With Breast Cancer Receiving Regional Nodal Irradiation
NCT02958774
Active, positions filled
Conditions Breast Cancer
Phase NA
Enrollment 388
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

  • Hypofractionated Radiation Therapy

Primary Outcomes

  • Lymphedema Rate
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: 2017-10-23
Completion: 2029-03-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 388 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: University of Kansas Medical Center
Principal Investigators:
  • Shane Stecklein, MD, PhD (PRINCIPAL_INVESTIGATOR) - University of Kansas Medical Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Hypofractionated Radiation Therapy
Study Locations (1 sites)
University of Kansas Medical Center, Kansas City, Kansas 66160 United States
Eligibility Criteria
Inclusion Criteria: * Karnofsky Performance Status 50% - 100% * Diagnosis of stage II or III node-positive breast cancer (NOTE: Stages include: T4a-cNany, T3N1, TxN2.) OR T3N0 node-negative breast cancer. * For patients with TxN1 disease, one of the following criteria must be met: Grade 3; ≤ 45 years of age at time of screening for this study; extensive Lymphovascular Space Invasion (LVSI); 3 lymph nodes positive; hormone-negative disease; positive lymph nodes after chemotherapy; or extracapsular extension * Prior surgery and chemotherapy allowed, no prior radiation to the target area (breast or chest and nodes). NOTE: Radiation should occur 3-12 weeks after last chemotherapy or surgery, whichever comes last. * Women of child-bearing potential (WOCP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Exclusion Criteria: * Diagnosis of inflammatory breast cancer * Previously diagnosed malignancy excluding basal or squamous cell carcinoma of the skin (unless disease-free for 5 years or more) * Diagnosis of scleroderma * Diagnosis of lupus * Diagnosis of active dermatomyositis * Diagnosis of metastatic disease * Pregnant or nursing
Detecting Post-surgical Respiratory Compromise and Prompting Patients to Self-rescue: An Early Feasibility Study
NCT02962557
Active, positions filled
Conditions Anesthesia
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

  • NM3, Phillips Medical, Wallingford CT: verbal prompts to breathe with an optional shoulder shake

Primary Outcomes

  • Oxygen saturation measured by pulse oximetry (SpO2)
  • Breath promoting success rate
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: 2017-10-01
Completion: 2027-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Utah
Principal Investigators:
  • Ken B Johnson, MD (PRINCIPAL_INVESTIGATOR) - University of Utah
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • NM3, Phillips Medical, Wallingford CT: verbal prompts to breathe with an optional shoulder shake
Study Locations (1 sites)
University of Utah, Salt Lake City, Utah 84112 United States
Eligibility Criteria
Inclusion Criteria: Patients that meet the following criteria will be invited to participate in this study: 1. Patients who undergo surgical procedures associated with a post operative hospital stay of at least 24 hours. 2. Patients with known or suspected obstructive sleep apnea (OSA). Known OSA will be defined as a sleep hypopnea study within the last 10 years that is consistent with OSA. Suspected OSA will be defined as a patient with a screening questionnaire (STOP-Bang) score of 5-8 (A score consistent with a high risk of OSA). The STOP-Bang questionnaire is a built in component of the anesthesia preopreative evaluation in EPIC. OR 3. Patients who will undergo surgical procedures associated with significant post operative pain and require opioid analgesics to manage pain. Sample procedures include major extremity surgery, spine surgery, abdominal surgery, and chest surgery that require a post operative in patient hospital stay. Nurses who meet the following criteria will be invited to participate in this study: PACU nurses who are in charge of caring for consented patients. Exclusion Criteria: 1. Patients who are discharged home on the day of surgery. 2. Vulnerable populations including pregnant women, prisoners, and people requiring legally authorized representative for consent 3. There are no exclusion criteria for PACU Nurses
Chronotype of Patients With Diabetes and Effect on Glycaemic Control
NCT02973412
Recruiting
Conditions Diabetes Mellitus, Type 1, Diabetes Mell...
Phase Not Applicable
Enrollment 3447
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • HBA1C level (%) measured from a blood sample
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: 2016-12-07
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 3447 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Leicester
Collaborators: University Hospitals, Leicester
Principal Investigators:
  • Andrew Hall (PRINCIPAL_INVESTIGATOR) - Sleep Consultant
Contact Information
Study Contact:
Sahar Khodabakhsh, PhD
0116258
sahar.khodabakhsh@uhl-tr.nhs.uk
Interventions
N/A
Study Locations (1 sites)
Leicester Diabetes Centre, Leicester General Hospital, Leicester, LE5 4PW United Kingdom
Eligibility Criteria
Inclusion Criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. T1DM or established T2DM (\>6months since diagnosis) 3. Male or Female 4. Aged 18-75 years inclusive 5. BMI less than or equal to 45kg/m² inclusive 6. No known sleep disorders except Obstructive Sleep Apnoea (OSA) 7. On any glucose-lowering therapy (T1DM or T2DM) or lifestyle modification for management of T2DM 8. Good command of the English language Exclusion Criteria: 1. Participant is unwilling or unable to give informed consent 2. Anyone without a good command of the English language 3. Anyone \<18 years of age and \>75 years of age 4. BMI greater than 45 kg/m² 5. A regular cannabis user i.e. weekly use 6. Have a terminal illness 7. A known sleep disorder that is not OSA 8. Regular use of the following medicines i.e. Weekly use: (Wakefulness promoting agents Modafinil, Amphetamine derivatives, Methylphenidate; Sedatives including benzodiazepines, Z-drugs (zopiclone, zolpidem \& zaleplon); Melatonin, including Circadin and melatonin analogues; Clonazepam and other drugs for nocturnal movement disorders).
TARGET BP I Clinical Trial
NCT02910414
Active, positions filled
Conditions Hypertension
Phase PHASE3
Enrollment 300
Locations 5 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

  • Dehydrated alcohol
  • Peregrine System Kit (Sham Procedure)

Primary Outcomes

  • Change in mean systolic ABPM
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Active, positions filled
Start Date: 2019-07-22
Completion: 2026-05
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 300 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Ablative Solutions, Inc.
Principal Investigators:
  • David Kandzari, MD (PRINCIPAL_INVESTIGATOR) - Piedmont Heart Institute
  • Michael Weber, MD (PRINCIPAL_INVESTIGATOR) - SUNY Downstate Medical
  • Atul Pathak, MD (PRINCIPAL_INVESTIGATOR) - Clinique Pasteur
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Dehydrated alcohol
  • Peregrine System Kit (Sham Procedure)
Study Locations (5 sites)
Cardiology PC, Birmingham, Alabama 35211 United States
Piedmont Heart Institute, Atlanta, Georgia 30309 United States
NC Heart and Vascular Research, Raleigh, North Carolina 27607 United States
Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157 United States
UT Southwestern Medical Center, Dallas, Texas 75390 United States
Eligibility Criteria
Inclusion Criteria: 1. Has 3 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥150 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg when receiving 2 to 5 antihypertensive medications. 2. Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings Exclusion Criteria: 1. Subject has renal artery anatomy abnormalities. 2. Subject has an estimated glomerular filtration rate (eGFR) of ≤45 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or is on chronic renal replacement therapy. 3. Subject has documented sleep apnea. 4. Subject has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association \[NYHA\] Class III or IV), chronic atrial fibrillation, and known primary pulmonary hypertension (\>60 mmHg pulmonary artery or right ventricular systolic pressure). 5. Subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only). 6. Subject is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed. 7. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.
Safety Study of MELK Inhibitor to Treat Patients With Advanced Breast Cancer and Triple Negative Breast Cancer
NCT02926690
Recruiting
Conditions Relapsed/Refractory Locally Advanced or ...
Phase PHASE1
Enrollment 70
Locations 8 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

  • OTS167PO

Primary Outcomes

  • MTD
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2017-05-29
Completion: 2027-09
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 70 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: OncoTherapy Science, Inc.
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • OTS167PO
Study Locations (8 sites)
Norwalk Hospital, Norwalk, Connecticut 06856 United States
Emory University, Winship Cancer Institute, Atlanta, Georgia 30322 United States
Kapi'olani Medical Center for Women & Children, Honolulu, Hawaii 96826 United States
Dartmouth Cancer Center/Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756 United States
Weill Cornell Medicine | NewYork-Presbyterian, New York, New York 10065 United States
Memorial Sloan Kettering Cancer Center, New York, New York 11065 United States
MD Anderson Cancer Center, Houston, Texas 77030 United States
Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin 53226 United States
Eligibility Criteria
Inclusion Criteria: Dose Escalation and Dose Expansion Cohorts Patients must meet all of the following criteria to be eligible for participation in the study: 1. Female patients, ≥ 18 years of age at the time of obtaining informed consent. 2. Patients with a documented (histologically- or cytologically-proven) breast cancer that is locally advanced or metastatic. 3. Patients with a malignancy that is either relapsed/refractory to standard therapy or for which no standard therapy is available. 4. Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor. 5. Patients with measurable or non-measurable disease according to the Response Evaluation Criteria In Solid Tumor (RECIST, v1.1). 6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (see APPENDIX B: Performance Status Evaluation). 7. Life expectancy of greater than or equal to 3 months. 8. Resolution of all chemotherapy-related or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (less than or equal to Grade 2). 9. Patients who are either not of childbearing potential or who agree to use a medically effective method of contraception during the study and during 3 months after the last dose of study drug. (See Appendix H: Forms of contraception). 10. Patients with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol. Dose expansion Cohort - TNBC 1. Patients with conditions as follows: * ER \<10%, PR \<10% by IHC assay; And * HER2 negative based on ASCO CAP guideline 2. Patients with measurable disease according to the response evaluation criteria in TNBC (RECIST, v1.1) 3. Patients with measurable disease that can be easily accessed for biopsy. 4. Relapsed (recurrence or disease progression after achieving a documented clinical response to first- or second-line treatment) or refractory (disease progression while receiving first line or second line treatment). In the case of TNBC, prior initial therapy with at least one known active regimen for TNBC including, but not limited to, any combination of anthracyclines, taxanes, platinum agents, Ixabepilone, and/or cyclophosphamide is required. Exclusion Criteria: Dose Escalation and Dose Expansion Cohorts Patients meeting any of the following criteria are ineligible for participation in the study. 1. Women who are pregnant or lactating. Women of child-bearing potential (WOCBP) not using adequate birth control see Appendix H: Forms of contraception. 2. Patients with known central nervous system (CNS) or leptomeningeal metastases not controlled by prior surgery, radiotherapy or requiring corticosteroids to control symptoms, or patients with symptoms suggesting CNS involvement for which treatment is required. 3. Patients with primary brain tumors. 4. Patients with any hematologic malignancy. This includes leukemia (any form), lymphoma, and multiple myeloma. 5. Patients with any of the following hematologic abnormalities at baseline. (Patients may have received a red blood cell product transfusion prior to study, if clinically warranted.): * Absolute neutrophil count (ANC) \< 1,500 per mm3 * Platelet count \< 100,000 per mm3 * Hemoglobin \< 8.0 gm/dL 6. Patients with any of the following serum chemistry abnormalities at baseline: * Total bilirubin ≥ 1.5 × the ULN for the institution value * AST or ALT ≥ 3 × the ULN for the institution value (≥ 5 × if due to hepatic involvement by tumor) * Creatinine ≥ 1.5 × ULN for the institution value (or a calculated creatinine clearance \< 60 mL/min/1.73 m2\* ) 7. Patients with a significant active cardiovascular disease or condition, including: * Congestive heart failure (CHF)requiring therapy * Need for antiarrhythmic medical therapy for a ventricular arrhythmia * Severe conduction disturbance * Unstable angina pectoris requiring therapy * QTc interval \> 450 msec (males) or \> 470 msec (females) * QTc interval ≤ 300 msec * History of congenital long QT syndrome or congenital short QT syndrome * LVEF \< 50% as measured by echocardiography or MUGA scan * Uncontrolled hypertension (per the Investigator's discretion) * Class III or IV cardiovascular disease according to the New York Heart Association's (NYHA) Functional Criteria (see APPENDIX C: New York Heart Association's Functional Criteria). * Myocardial infarction (MI) within 6 months prior to first study drug administration 8. Patients with a known or suspected hypersensitivity to any of the components of OTS167. 9. Patients with a known history of human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). 10. Patients with any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever \> 38ºC within 1 week prior to first study drug administration. 11. Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure within 4 weeks prior to first study drug administration. 12. Patients with any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluation of the safety of the study drug. 13. Patients with a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies. 14. Patients with the inability or with foreseeable incapacity, in the opinion of the Investigator, to comply with the protocol requirements. 15. Any anti-neoplastic agent or monoclonal antibody therapy for the primary malignancy (standard or experimental) within 2 weeks prior to first study drug administration. 16. Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment. If acute symptoms of radiation have fully resolved, the extent and timing of radiotherapy for eligibility can be discussed between Investigator and Sponsor. 17. Patients requiring surgery for the primary or metastatic primary malignancy. 18. Herbal preparations or related over the counter (OTC) preparations/supplements containing herbal ingredients within 1 week prior to first study drug administration and during study. 19. Systemic hormonal therapy which is not related to breast cancer treatment (standard or experimental) within 1 week prior to first study drug administration and during study. The following therapies are allowed: * Hormonal therapy (e.g., Megace) for appetite stimulation * Nasal, ophthalmic, inhaled, and topical glucocorticoid preparations * Oral replacement glucocorticoid therapy for adrenal insufficiency * Low-dose maintenance steroid therapy for other conditions (excluding steroid tapers for brain edema/metastases/radiation) * Hormonal contraceptive therapy (for WOCBP must be combined with non-hormonal contraceptive equivalent to a double-barrier method) 20. Any other investigational treatments during study. This includes participation in any medical device or therapeutic intervention clinical trials. Dose expansion Cohort - TNBC 21. Patients with only lesions that cannot be accessed for biopsy.
Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy
NCT02945579
Recruiting
Conditions Estrogen Receptor Negative, HER2 Positiv...
Phase NA
Enrollment 120
Locations 8 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Undergo EBRT
  • Laboratory Biomarker Analysis
  • Quality-of-Life Assessment
  • Questionnaire Administration
  • Partial Breast Irradiation

Primary Outcomes

  • Ipsilateral breast tumor recurrence-free survival (IBT-RFS)
  • Overall survival
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2017-01-20
Completion: 2028-01-31
Eligibility
Age: 30 Years
Sex: FEMALE
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Henry M Kuerer (PRINCIPAL_INVESTIGATOR) - M.D. Anderson Cancer Center
Contact Information
Study Contact:
Henry Kuerer
713-745-5043
hkuerer@mdanderson.org
Interventions
  • Undergo EBRT
  • Laboratory Biomarker Analysis
  • Quality-of-Life Assessment
  • Questionnaire Administration
  • Partial Breast Irradiation
Study Locations (8 sites)
MD Anderson Cancer Center - Banner, Gilbert, Arizona 85234 United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida 32207 United States
Queen's Medical Center, Honolulu, Hawaii 96813 United States
Mayo Clinic, Rochester, Minnesota 55905 United States
Cooper Hospital Univ Med Ctr, MD Anderson at Cooper Voorhees, Voorhees Township, New Jersey 08103 United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina 28203 United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania 15232 United States
M D Anderson Cancer Center, Houston, Texas 77030 United States
Eligibility Criteria
Inclusion Criteria: * Cohort A1 and A2 • Conditions for patient eligibility: Patients on this portion of the study can receive radiation treatment at any MD Anderson Cancer Center or any outside hospital and may be enrolled prior to, during, or following neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below: 1. Pathologically confirmed unicentric invasive breast cancer defined as radiologic clinical stage T1 or T2 (≤ 5 cm), N0 or N1 (≤ 4 abnormal axillary nodes on initial ultrasound), clinical stage M0. 2. HER2 positive (IHC 3+ and or FISH amplified) or triple receptor negative (TN, ER/PR\&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 10% HER2 negative (IHC 1+ or 2+ FISH non-amplified) receiving any standard routine clinical NST regimen. 3. Patient desires breast conserving therapy. 4. Age 40 years or older. This age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of IBTR presumably due to underlying biologic differences \[124, 125\]. 5. Female sex. 6. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer. 7. Patient must have an initial nodal ultrasound that does not demonstrate more than four suspicious lymph nodes, any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present. 8. Patient understands that the breast lesion size on final breast imaging must be less than or equal to 2 cm prior to the biopsy procedure being performed on study and if the biopsy shows residual carcinoma the patient will be taken off study. * Cohort B1 and B2 • Conditions for patient eligibility: Patients on this portion of the study will be limited to receive radiation treatment at MD Anderson Cancer Center or other approved locations and must be enrolled prior to any neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below: 1. ER and/or PR positive, HER2 negative 2. Clinical stage T1N0M0, unicentric non-lobular breast cancer, no lymphovascular space invasion, 3. At least 40 years of age. 4. Oncotype ≤ 25 if age ≥ 50 years 5. Oncotype 0-20 and tumor size ≤ 1.5cm if age 40-49 years. 6. Patient agrees to take anti-estrogen therapy and is interested in breast conservation 7. Female sex. 8. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer. 9. No history of prior radiation to the area of the breast that would require protocol-mandated treatment * Cohort C • Conditions for patient eligibility: Patients on this portion of the study can receive surgical treatment at any MD Anderson Cancer Center or any outside hospital and may be enrolled prior to or following neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below: 1. Pathologically confirmed invasive breast cancer defined as radiologic clinical stage T1 or T2 (≤ 5 cm), N0, clinical stage M0 and HER2 positive (IHC 3+ and or FISH amplified) receiving any standard routine clinical NST regimen containing her-2 directed therapy OR Pathologically confirmed invasive breast cancer defined as radiologic clinical stage T1 (≤ 2 cm), N0, clinical stage M0 and triple negative, receiving any standard routine clinical NST regimen. 2. For cohort C patients participating in the optional pretreatment biopsy, the patient should be able undergo biopsy or surgery of the primary tumor site of suspected or proven invasive breast cancer and should be planned to receive neoadjuvant systemic therapy. 3. Patient desires breast conserving therapy. 4. Age 30 years or older if HER2 positive. Age 50 or older if HER2 negative (triple negative). 5. Female sex. 6. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer. 7. Patient must have an initial nodal ultrasound that does not demonstrate suspicious lymph nodes; any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present. 8. Patient must have no evidence of residual invasive tumor or DCIS on pathologic review of the lumpectomy surgical specimen 9. Patient must have no evidence of metastatic disease or isolated tumor cells involving the lymph nodes on pathologic review of the lymph node surgical specimen. If treatment effect in the nodes is noted on the pathology report, the investigators would generally discourage enrollment on this protocol. 10. Unifocal disease or limited multifocal disease that can be excised in a single lumpectomy specimen * Cohort D (MD Anderson Houston patients only) * Conditions for patient eligibility: Patients on this portion of the study meet all eligibility requirements for cohort C, but have not enrolled onto the study to omit radiation. Patients in Cohort D can be identified at the time of diagnosis or prior to lumpectomy. They are not required to participate in one of the treatment arms of the study, but can ultimately choose to move to an omission Cohort at a later time point. 3.5.1 Patients with triple negative or her-2 positive tumor who are amenable to breast conserving treatment and have received or are planned for neoadjuvant systemic therapy prior to surgery are eligible for Cohort D. 3.5.2 Eligible patients in cohort D who have undergone optional ARTIDIS biopsies of the primary breast tumor at the time of diagnosis, prior to starting neoadjuvant therapy, or following completion of systemic therapy, at the time of surgery, may later move to Cohort A or C if they meet all eligibility requirements and ultimately desire surgery or radiation omission Exclusion Criteria: 1. Radiologic evidence for a stage T3 or clinical stage T4 breast cancer in Cohort A1/A2/C; radiologic evidence for a stage T2-T3 or clinical stage T4 breast cancer in Cohort B1/B2. 2. Clinical or pathologic evidence for distant metastases. 3. Prior diagnosis of invasive or ductal carcinoma in situ breast cancer in the ipsilateral breast. 4. Clinical evidence of progression of disease \&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;20% in the breast or new evidence of nodal metastases. 5. Patient is known to be pregnant. 6. Patient is participating in a NST protocol in which surgical excision of the breast and or lymph nodes are required in Cohort A1/A2/B1/B2.
Carboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer
NCT02876107
Active, positions filled
Conditions Breast Carcinoma, Breast Lump, Edema, Er...
Phase PHASE2
Enrollment 42
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

  • Carboplatin
  • Laboratory Biomarker Analysis
  • Paclitaxel
  • Panitumumab

Primary Outcomes

  • Complete pathologic response
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: 2016-10-06
Completion: 2027-10-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 42 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI), Amgen
Principal Investigators:
  • Azadeh Nasrazadani (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
  • Carboplatin
  • Laboratory Biomarker Analysis
  • Paclitaxel
  • Panitumumab
Study Locations (1 sites)
M D Anderson Cancer Center, Houston, Texas 77030 United States
Eligibility Criteria
Inclusion Criteria: * Patients must have histological confirmation of breast carcinoma * Patients must have invasive breast cancer (IBC), confirmed according to international consensus criteria: * Onset: Rapid onset of breast erythema, edema, and/or peau d'orange, and/or warm breast, with or without an underlying breast mass * Duration: History of such findings no more than 6 months * Extent: Erythema occupying at least 1/3 of whole breast * Pathology: Pathologic confirmation of invasive carcinoma * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Patients must have negative HER2 expression on immunohistochemistry (IHC) (defined as 0 or 1+) or fluorescence in situ hybridization (FISH) analysis; if HER2 is 2+, negative HER2 expression must be confirmed by FISH (HER2/cep17 ration \< 2, and/or copy number less than 6); ER and PgR expression should be less than 10% * Patients have left ventricular ejection fraction (LVEF) \>= 50% by multigated acquisition scan (MUGA) or echocardiogram before study randomization * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L * Platelet count \>= 100 x 10\^9/L * Hemoglobin \>= 9.0 g/dL * Aspartate aminotransferase (AST) =\< 3.0 x upper limit of normal (ULN) * Alanine aminotransferase (ALT) =\< 3.0 x ULN * Alkaline phosphatase (ALP) =\< 2.5 x ULN * Total bilirubin =\< 1.5 x ULN * Creatinine (Cr) =\< 1.5 mg/dL x ULN * Creatinine clearance (CrCl) \>= 50 mL/min calculated by the Cockroft-Gault * Patients have the ability and willingness to sign written informed consent * Patients of childbearing potential (women who are postmenopausal for \< 1 year, not surgically sterilized, or not abstinent), have a negative urine pregnancy test, and agree to the consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile before the female subject's entry into the study and is the sole sexual partner for that female subject; intrauterine device, oral contraception, or barrier methods, including diaphragm or condom with a spermicide Exclusion Criteria: * Stage IV disease, if the metastatic sites are not amendable for local therapy (i.e. radiation and/or surgery), and are not candidates for breast surgery will not be eligible * History of radiotherapy for current breast cancer diagnosis * History of recent malignancies \< 5 years (except for cured non-melanomatous skin cancer or cured cervical carcinoma in situ) * Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection * History of extensive interstitial lung disease, e.g., pneumonitis or pulmonary fibrosis or any evidence of extensive interstitial lung disease on baseline chest computed tomography (CT) scan * Other known other significant medical or psychiatric condition that would make assessment of toxicity or efficacy difficult * 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 * Patients with a peripheral neuropathy \> grade 1 * Patients with a history of New York Heart Association class 3 or 4 heart failure, or history of myocardial infarction, unstable angina, or cerebrovascular accident (CVA) within 6 months of protocol registration * Patients have a history of prior therapy with carboplatin * Patients have received a cumulative dose of doxorubicin of greater than 360 mg/m\^2 or epirubicin of greater than 640 mg/m\^2 * Patients have had prior radiotherapy for primary breast carcinoma or axillary lymph nodes * Patients have history of diagnosed interstitial lung disease
PREgnancy and FERtility Registry
NCT02895165
Recruiting
Conditions Breast Neoplasms, Pregnancy, Fertility P...
Phase Not Applicable
Enrollment 1000
Locations 23 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Rate of patients interested in the available strategies for fertility preservation
  • Rate of patients undergoing the different strategies for fertility preservation
  • Type of strategies for fertility preservation proposed by oncologists
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: 2012-11
Completion: 2032-11
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 1000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Collaborators: Clinical Research Technology S.r.l.
Contact Information
Study Contact:
Lucia Del Mastro, MD
+390105558908
lucia.delmastro@hsanmartino.it
Interventions
N/A
Study Locations (23 sites)
Ospedale Cardinal Massaia, Asti, Asti Italy
Presidio Ospedaliero 'Antonio Perrino', Brindisi, BR 72100 Italy
AOU di Cagliari Strada, Monserrato, Cagliari Italy
Azienda Ospedaliera S. Croce e Carle, Cuneo, CN 12100 Italy
Arcispedale S. Anna - A.O.U. di Ferrara, Cona, FE 44124 Italy
Irccs Aou San Martino - Ist, Genoa, GE 16132 Italy
Ospedale Vito Fazzi, Lecce, LE 73100 Italy
Ospedale Unico Versilia, Lido di Camaiore, LU 55041 Italy
Azienda Ospedaliera Carlo Poma, Mantua, MN 46100 Italy
Ospedale 'Guglielmo da Saliceto', Piacenza, PC 29121 Italy
Eligibility Criteria
Inclusion Criteria: * breast cancer diagnosis * age between18 and 45 years (only for PREFER-FERTILITY) * have not received any radiation or chemotherapy for cancer before enrolment (only for PREFER-FERTILITY) * absence of metastatic disease (only for PREFER-FERTILITY) * diagnosis of breast cancer during pregnancy or within 1 year from the end of pregnancy or pregnancy after prior diagnosis and treatment for breast cancer (only for PREFER-PREGNANCY) * informed consent Exclusion Criteria: * inability to provide written informed consent * stage IV disease at diagnosis (only for PREFER-FERTILITY) * serious psychiatric disorders
A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal Carcinoma of Breast
NCT02897700
Recruiting
Conditions Breast Cancer
Phase PHASE1
Enrollment 300
Locations 3 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

  • Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate
  • cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM)
  • Placebo

Primary Outcomes

  • Incidence of treatment-emergent adverse events
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2013-01
Completion: 2027-12
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Shanghai Jiao Tong University School of Medicine
Collaborators: Shanghai 10th People's Hospital, China-Japan Union Hospital, Jilin University, Ganzhou City People's Hospital
Principal Investigators:
  • Yu Sun, Ph.D (PRINCIPAL_INVESTIGATOR) - Shanghai Jiao Tong University School of Medicine
Contact Information
Study Contact:
Yu Sun, Ph.D
86-21-54923302
sunyu@sibs.ac.cn
Interventions
  • Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate
  • cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM)
  • Placebo
Study Locations (3 sites)
Ganzhou City People's Hospital, Ganzhou, Jiangxi 341000 China
China-Japan Union Hospital, Jilin University, Changchun, Jilin 130033 China
Shanghai 10th People's Hospital, Tongji University School of Medicine, Shanghai, 200072 China
Eligibility Criteria
Inclusion Criteria: * Patients ≥ 18 years of age with histologically proven infiltrating ductal carcinoma of breast * no severe major organ dysfunction * Patients must have adequate hematopoietic function as evidenced by: white blood cells (WBC) ≥ 3,000/μl absolute neutrophil count (ANC) ≥ 1,500/μl Platelet count ≥ 100,000/μl hemoglobin (HGB) ≥ 10 g/dl and not transfusion dependent * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10% above upper limit of normal * Individuals of child-bearing potential must have a negative serum or urine pregnancy test within 72 hours of Cycle 1 Day 1. * World Health Organization (WHO) performance status of 0 or 1 * No prior or concurrent cancer-associated chemotherapy, no initiation of new hormonal therapy * Hormone receptor (estrogen receptor (ER), progesterone receptor (PR), epidermal growth factor receptor 2 (Her2)) status not specified * Menopausal status not specified * Patients or their legal representatives must be willing and able to provide written informed consent * A Clinical Stage ≥ I subtype A (IA) (T1a, N0, M0) of Beast Cancer but without diagnosed distant metastasis (according to the 1997 revision of the International Union Against Cancer-PrimaryTumor, Regional Nodes and Metastasis (TNM) staging system) as determined by a preoperative evaluation that included a chest computed tomography (CT) scan and/or X-ray mammography. Exclusion Criteria: * Age \< 18 * Severe major organ dysfunction * WHO performance status of \>1 * Prior cancer chemotherapy * Stage IV * Patients with symptomatic central nervous system (CNS) metastases from breast cancer * Patients with a history of another invasive malignancy within the last 3 years * History of loss of consciousness or transient ischemic attack within 12 months before study treatment initiation. * Patients who have known active HIV, Hepatitis B, or Hepatitis C infections. * Patients with any other condition which in the opinion of the investigator would preclude participation in the study.
Immunotherapy in High-risk Ductal Carcinoma in Situ (DCIS)
NCT02872025
Active, positions filled
Conditions Carcinoma, Intraductal, Noninfiltrating
Phase EARLY_PHASE1
Enrollment 42
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

  • Pembrolizumab
  • Intralesional mRNA 2752

Primary Outcomes

  • Maximum tolerated dose (MTD)
  • Number of participants with Dose-limiting toxicities (DLTs)
  • Percentage of patients who demonstrate an increase (baseline vs. post intralesional injection) in intralesional CD8+ T cells
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: Active, positions filled
Start Date: 2016-12-12
Completion: 2026-03-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 42 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Laura Esserman
Collaborators: Merck Sharp & Dohme LLC, ModernaTX, Inc.
Principal Investigators:
  • Laura Esserman, MD (PRINCIPAL_INVESTIGATOR) - University of California, San Francisco
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Pembrolizumab
  • Intralesional mRNA 2752
Study Locations (1 sites)
University of California, San Francisco, San Francisco, California 94143 United States
Eligibility Criteria
Inclusion Criteria: 1. Plan on having surgical treatment to remove the lesion 2. Have at least 2 of the following high-risk features associated with DCIS - high-grade (grade II-III), palpable mass, hormone receptor negative (less than 1%), Her2 positive, young age (less than 45 years old), and large size (greater than 5 cm) and abundant T cell infiltration. 3. Participants with extensive DCIS and a small component of invasive disease are eligible as long as the extent of invasive disease is 10% or less of the total burden of disease. 4. Participants with a history of tamoxifen and/or aromatase inhibitor use for treatment or prevention are eligible but should discontinue these medications at least 2 weeks prior to starting this trial 5. Be willing and able to provide written informed consent/assent for the trial. 6. Be \>=18 years of age on day of signing informed consent. 7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 8. Demonstrate adequate organ function (all screening labs should be performed within 3 months of treatment initiation): * Absolute Neutrophil Count (ANC) \>=1,500/microliter (mcL). * Platelets \>=100,000/mcL. * Hemoglobin \>=9 g/dL or \>=5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment). * Serum creatinine \<=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 * Direct bilirubin \<= ULN for subjects with total bilirubin levels \> 1.5 ULN. * Aspartate aminotransferase (AST) / serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) / serum glutamic-pyruvic transaminase (SGPT) \<= 2.5 X ULN. * Albumin \>=2.5mg/dL. * International Normalized Ratio (INR) or Prothrombin Time (PT) \<=1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants. * Activated Partial Thromboplastin Time (aPTT) \<=1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants. 9. A female participants is eligible to participate if not pregnant, not breast feeding, and at least one of the following applies: 1. Not a person of childbearing potential (WOCBP) OR 2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 90 days .corresponding to time needed to eliminate any study treatment plus 30 days (a menstruation cycle) after the last dose of study treatment. * Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (Reference Section 5.7.2). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year. 10. A male participant must agree to use a contraception during the treatment period and for at least 90 days corresponding to time needed to eliminate any study treatment plus an additional 120 days (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period. Exclusion Criteria: 1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. 2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 3. Has hormone positive DCIS (HR+) that is not Her2+. 4. Has invasive breast cancer. This does not include DCIS with \<10% invasive component and a clinically node negative disease. 5. Has a known history of active Bacillus Tuberculosis (TB) 6. Hypersensitivity to mRNA-2752 for mRNA-2752 monotherapy and combination therapy and hypersensitivity to immune check point inhibitor for the combination therapy or any of its excipients. 7. 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. 8. 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. 9. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. 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. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 12. Is pregnant or breastfeeding, or expecting to conceive or father 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. 13. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 14. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen (HBsAg) reactive) or known active Hepatitis C virus (HCV) (defined as HCV RNA \[qualitative\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority. 15. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer
NCT02883062
Active, positions filled
Conditions Invasive Breast Carcinoma, Stage II Brea...
Phase PHASE2
Enrollment 67
Locations 14 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

  • Atezolizumab
  • Biospecimen Collection
  • Carboplatin
  • Lumpectomy
  • Mastectomy

Primary Outcomes

  • Change in Tumor Infiltrating Lymphocyte (TIL) Percentage
  • Pathologic Complete Response (pCR) 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: 2017-08-02
Completion: 2026-09-11
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 67 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: National Cancer Institute (NCI)
Principal Investigators:
  • William E Gillanders (PRINCIPAL_INVESTIGATOR) - Yale University Cancer Center LAO
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Atezolizumab
  • Biospecimen Collection
  • Carboplatin
  • Lumpectomy
  • Mastectomy
Study Locations (14 sites)
Mayo Clinic Hospital in Arizona, Phoenix, Arizona 85054 United States
Mayo Clinic in Arizona, Scottsdale, Arizona 85259 United States
University of California Davis Comprehensive Cancer Center, Sacramento, California 95817 United States
Mayo Clinic in Florida, Jacksonville, Florida 32224-9980 United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland 21287 United States
Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters, Missouri 63376 United States
Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri 63141 United States
Washington University School of Medicine, St Louis, Missouri 63110 United States
Siteman Cancer Center-South County, St Louis, Missouri 63129 United States
Siteman Cancer Center at Christian Hospital, St Louis, Missouri 63136 United States
Eligibility Criteria
Inclusion Criteria: * Patients must have histologically confirmed new diagnosis of breast cancer * Estrogen receptor (ER) and progesterone receptor (PR) \< Allred score of 3 or =\< 5% positive staining cells in the invasive component of the tumor (provided the patient is being treated as triple negative breast cancer) * Human epidermal growth factor receptor 2 (HER2) negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining 0 or 1+ according to National Comprehensive Cancer Network (NCCN) guidelines * Clinical stage T2-T4c, any N, M0 primary tumor by American Joint Committee on Cancer (AJCC) 7th edition clinical staging * Eligible for neoadjuvant chemotherapy * No prior therapy for this disease * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Leukocytes \>= 2,500/mcL * Absolute neutrophil count \>= 1,500/mcL * Platelets \>= 150,000/mcL * Hemoglobin \>= 10 g/dL * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =\< 3 x ULN may be enrolled) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 3 x ULN * Alkaline phosphatase =\< 2.5 x ULN * Creatinine clearance \>= 30 mL/min/1.73 m\^2 by Cockcroft-Gault * International normalized ratio (INR) =\< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose) * Activated partial thromboplastin time (aPPT) =\< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose) * Administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 180 days after the last dose of paclitaxel; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Ability to understand and the willingness to sign an Institutional Review Board (IRB) approved written informed consent document Exclusion Criteria: * Known metastatic disease * Invasive cancer in the contralateral breast * Patients with a previous history of non-breast malignancy are eligible only if they meet the following criteria for a cancer survivor: (1), and (2) * Has undergone potentially curative therapy for all prior malignancies * Has been considered disease-free for at least 1 year (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix) * Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation * Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1 * Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to cycle 1, day 1 * Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled * The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed * Patients taking bisphosphonate therapy for symptomatic hypercalcemia; use of bisphosphonate therapy for other reasons (e.g., osteoporosis) is allowed * Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins * History of allergic reactions attributed to compounds of similar chemical or biologic composition to other agents used in study * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease * Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen \[HBsAg\] test and a positive anti-HBc \[antibody to hepatitis B core antigen\] antibody test) are eligible * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA) * History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis * Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible * Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible * Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: * Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations * Rash must cover less than 10% of body surface area (BSA) * Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%) * No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation \[PUVA\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids) * History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted * Patients with active tuberculosis (TB) are excluded * Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia * Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1 * Received oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible * Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study with the exception of the planned breast cancer surgery that is part of the trial design * Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab * Influenza vaccination should be given during influenza season only (approximately October to March); patients must not receive live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study * Pati
Institut Paoli Calmettes Lymphoma Database
NCT02869542
Recruiting
Conditions Lymphoma
Phase Not Applicable
Enrollment 16000
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

  • Data collection

Primary Outcomes

  • Survival of patients
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: 2000-01
Completion: 2030-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 16000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Institut Paoli-Calmettes
Contact Information
Study Contact:
Dominique Genre, MD
0033491223778
drci.up@ipc.unicancer.fr
Lilian Laborde
0033491223778
labordel@ipc.unicancer.fr
Interventions
  • Data collection
Study Locations (1 sites)
Institut Paoli-Calmettes, Marseille, Bouches-du Rhône 13009 France
Eligibility Criteria
Inclusion Criteria: * Hodgkin or non-hodgkin lymphoma Exclusion Criteria: * Non applicable