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Showing 20 of 29714 trials
China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype
NCT04974151
Recruiting
Conditions Hypertension, MTHFR 677 TT Genotype
Phase PHASE4
Enrollment 24000
Locations 20 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Amlodipine besylate
  • Amlodipine besylate And Folic Acid
  • 5-methyltetrahydrofolate (5-MTHF)
  • Amlodipine placebo
  • Amlodipine folic acid placebo

Primary Outcomes

  • First ischemic stroke
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2024-08-22
Completion: 2029-06-30
Eligibility
Age: 45 Years
Sex: ALL
Volunteers: false
Enrollment: 24000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Shenzhen Ausa Pharmed Co.,Ltd
Collaborators: Peking University First Hospital, Second Affiliated Hospital of Nanchang University, The First People's Hospital of Lianyungang, The Affiliated Hospital Of Guizhou Medical University, Lianyungang Oriental Hospital, Tengzhou Central People's Hospital, The First Affiliated Hospital of Bengbu Medical University, Shenzhen Prospective Medical Technology Co., LTD, Weinan Central Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Loudi Central Hospital, Yancheng First People's Hospital, TAIHE country people's hospital, First Affiliated Hospital of Gannan Medical University, Yangjiang People's Hospital, Deyang People's Hospital, Bozhou people's hospital, Chizhou people's hospital, Lianyungang Second People's Hospital, The Affiliated Hospital Of Southwest Medical University, Chengdu Fifth People's Hospital
Principal Investigators:
  • Jianping Li, MD, PhD (PRINCIPAL_INVESTIGATOR) - Peking University First Hospital
Contact Information
Study Contact:
Minqing Tian, PhD
86-18818680849
tianminqing@163.com
Interventions
  • Amlodipine besylate
  • Amlodipine besylate And Folic Acid
  • 5-methyltetrahydrofolate (5-MTHF)
  • Amlodipine placebo
  • Amlodipine folic acid placebo
Study Locations (20 sites)
First Affillated Hospital of Bengbu Medical University, Bengbu, Anhui 233004 China
Bozhou People's Hospital, Bozhou, Anhui China
Chizhou People's Hospital, Chizhou, Anhui China
Taihe County People's Hospital, Fuyang, Anhui China
Peking University First Hospital, Beijing, Beijing Municipality China
Yangjiang People's Hospital, Yangjiang, Guangdong China
The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou China
The First Affiliated Hospital of Hunan University of Medicine, Huaihua, Hunan China
Loudi Central Hospital, Loudi, Hunan China
Lianyungang Oriental Hospital, Lianyungang, Jiangsu 222042 China
Eligibility Criteria
Inclusion Criteria: 1. Men and women, aged ≥45 and \<75 years. 2. Hypertension: Previously diagnosed with primary hypertension and has been taking antihypertensive medication within the past two weeks; OR has not been taking antihypertensive medications within the last two weeks, but meets the following criteria for hypertension: SBP≥140 mmHg and/or DBP≥90 mmHg (average of at least 2 measurements each time) at two separate (not on the same day) clinical visits. 3. MTHFR 677 TT genotype (based on the test results from the central laboratory during the screening period or a previous official test report from a laboratory with medical testing qualifications). 4. Voluntarily participates and has given signed informed consent. Randomized-treatment phase inclusion criteria: 1. Good compliance during the run-in period, and unlikely to discontinue treatment; 2. No stroke or cardiovascular events during the run-in period; 3. The participant voluntarily agrees to continue the study. Exclusion Criteria: 1. Previously diagnosed secondary hypertension; 2. Previously diagnosed stroke; 3. Previously diagnosed myocardial infarction; 4. Previously diagnosed heart failure; 5. Previously diagnosed atrial fibrillation; 6. Cardio-cerebral-kidney revascularization and/or other large arterial stent; 7. Currently on dialysis, or diagnosed with stage 4-5 chronic kidney disease, or eGFR \<30 mL/ min/1.73m²; 8. Known to have congenital (such as aortic stenosis) or acquired organic heart disease; 9. Known to have any of the following severe diseases or conditions: 1. Digestive system: i. Previously diagnosed with any form of viral hepatitis that is currently still in the active phase; ii. Abnormal liver function test before enrollment (any of ALT, AST, GGT, TBIL, DBIL test 3 times higher than normal, or ALB≤30g/L); iii. Subtotal gastrectomy and/or gastrojejunostomy; 2. Respiratory system: previously diagnosed with pulmonary heart disease; 3. Presence of malignant tumors or other severe diseases; 4. Presence of long-term gastrointestinal symptoms such as ; anorexia, decreased appetite, nausea, and abdominal bloating; 5. Previously diagnosed with vitamin B12 deficiency and/or its related diseases. 10. Participant, at the investigator's discretion, is assessed to be unsuitable for the study, for reasons including but not limited to the presence of abnormal laboratory results, or clinical conditions; 11. Prior history of significant intolerance due to adverse reactions resulting from usage of amlodipine or other CCBs, valsartan or other ARBs, indapamide or other similar diuretics, metoprolol tartaric acid or other beta-blockers, or any drugs or health products containing folate or folic acid; 12. Regular consumption of folic acid or vitamin B compounds, or other compounds containing folic acid in the past 3 months; 13. The presence of any of the following conditions that could negatively influence a participant's ability to consent or participate in the trial: 1. Dementia; 2. Severe mental disorders; 3. Inability to express informed consent; 4. Unlikely to complete the study follow-up as specified by the protocol, or plans to relocate outside of the study area in the near future; 5. History of poor compliance when taking antihypertensive medications or is expected to have poor compliance during the study; 14. Refusal to participate, or inability to modify current drug regimen; 15. Women who are pregnant or breastfeeding; or subjects of childbearing potential who are unwilling or unable to use effective contraception during the study period. 16. Within one month prior to the first visit, having participated in any clinical trial for a drug that has not yet been officially approved by the state or is not currently approved for sale; or currently participating in any clinical trial that could potentially impact the results of this study (medication use, drug efficacy, drug interaction, etc.).
Effects of Pregnancy-Specific Anxiety on Placental Inflammatory and Oxidative Stress Response and Birth Outcomes
NCT04993742
Active, positions filled
Conditions Placental Dysfunction, Prenatal Stress
Phase NA
Enrollment 150
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

  • MOMS Intervention

Primary Outcomes

  • Explore associations between prenatal maternal psychosocial measures of anxiety depression with immunological, oxidative stress, and hormonal biomarker changes found in maternal serum with and without the M-O-M-S™ support intervention.
  • Explore associations between prenatal maternal psychosocial measures of anxiety depression with immunological, oxidative stress, and hormonal biomarker changes found in placental tissue with and without the M-O-M-S™ pregnancy intervention.
  • Explore associations between prenatal maternal psychosocial measures of anxiety and depression to histopathology changes in placental tissue with and without the M-O-M-S™ intervention.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2019-11-26
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators: 59th Medical Wing, Brooke Army Medical Center, University of the Incarnate Word, Uniformed Services University of the Health Sciences
Principal Investigators:
  • Tony T Yuan, PhD (PRINCIPAL_INVESTIGATOR) - Uniformed Services University of the Health Sciences
  • Robert O Brady, MD (PRINCIPAL_INVESTIGATOR) - 59 Medical Wing
  • Karen L Weis, 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
  • MOMS Intervention
Study Locations (1 sites)
Joint Base San Antonio, San Antonio, Texas 78236 United States
Eligibility Criteria
Inclusion Criteria: * All Active Duty and DoD beneficiary gravid women, * 18 years of age or older, * Receiving prenatal care at BAMC, * English speaking Exclusion Criteria: * Military dependent daughters * VA beneficiaries
Diabetes Medical Nutrition Therapy in Southeastern African American Women
NCT04971889
Active, positions filled
Conditions Type 2 Diabetes
Phase NA
Enrollment 291
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Diabetes MNT
  • Motivational Interviewing

Primary Outcomes

  • HbA1c
  • Change from Baseline HbA1c
  • Change from Baseline HbA1c
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: 2021-08-03
Completion: 2026-01-31
Eligibility
Age: 21 Years
Sex: FEMALE
Volunteers: false
Enrollment: 291 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Meharry Medical College
Collaborators: Patient-Centered Outcomes Research Institute, Matthew Walker Comprehensive Health Center, Vanderbilt University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Diabetes MNT
  • Motivational Interviewing
Study Locations (2 sites)
Matthew Walker Comprehensive Health Center, Nashville, Tennessee 37208 United States
Meharry Medical College, Nashville, Tennessee 37208 United States
Eligibility Criteria
Inclusion Criteria: * African American * Female * Clinical diagnosis of type 2 diabetes for at least 6 months * At risk for development and/or progression of diabetes complications (HbA1c ≥ 7.0% AND either systolic blood pressure ≥130, LDL cholesterol ≥ 100, or BMI ≥ 30). Exclusion Criteria: --Observed or diagnosed psychotic disorders
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
NCT05006976
Active, positions filled
Conditions Musculoskeletal Disorder, Anxiety Disord...
Phase NA
Enrollment 1180
Locations 5 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • NSAC health only
  • NSAC health + MBW

Primary Outcomes

  • Functional recovery: status, plan and prognosis for employment versus sickness absence
  • Functional recovery: sickness absence self-report
  • Functional recovery: sickness absence registry data
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2021-09-06
Completion: 2033-01-12
Eligibility
Age: 23 Years
Sex: ALL
Volunteers: false
Enrollment: 1180 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Nordlandssykehuset HF
Collaborators: University Hospital of North Norway, Opptreningssenteret i Finnmark (Alta, Norway), Helgeland Hospital Trust, Finnmarkssykehuset HF (Kirkenes, Norway), UiT The Arctic University of Norway
Principal Investigators:
  • Arnstein Mykletun, PhD (PRINCIPAL_INVESTIGATOR) - UiT The Arctic University of Norway
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • NSAC health only
  • NSAC health + MBW
Study Locations (5 sites)
Helse I Arbeid Nordlandssykehuset, Bodø, Nordland 8092 Norway
Helse I Arbeid Helgelandssykehuset, Sandnessjøen, Nordland 8800 Norway
Opptreningssenteret i Finnmark, Alta, Troms Og Finnmark 9510 Norway
Helse I Arbeid Finnmarkssykehuset, Kirkenes, Troms Og Finnmark 9915 Norway
Helse I Arbeid Universitetssykehuset Nord-Norge, Tromsø, Troms Og Finnmark 9019 Norway
Eligibility Criteria
Inclusion Criteria: * For the study, the single inclusion criteria is that the patient is offered a consultation or treatment at the NSAC (Norwegian: HiA). Exclusion Criteria: * Aged younger than 23 years at time of referral. The NSACs have guidelines that describe eligibility for treatment, and excludes patients that are either too healthy for the measure, too sick for the measure, not relevant diagnosis or otherwise not considered being in the target group for the measure.
Scalp Cooling in MBC
NCT04986579
Recruiting
Conditions Metastatic Breast Cancer, Chemotherapy-i...
Phase PHASE2
Enrollment 120
Locations 2 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

  • Paxman Scalp Cooling System
  • Eribulin
  • Sacituzumab govitecan
  • Trastuzumab deruxtecan

Primary Outcomes

  • Hair Loss Rate
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2021-10-07
Completion: 2030-06-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Dana-Farber Cancer Institute
Collaborators: Paxman Coolers Limited, AstraZeneca, Eisai Inc., Daiichi Sankyo, Gilead Sciences
Principal Investigators:
  • Elahe Salehi, DNP, ANP-BC (PRINCIPAL_INVESTIGATOR) - Dana-Farber Cancer Institute
Contact Information
Study Contact:
Elahe Salehi, DNP, ANP-BC
617-632-3800
elahe_salehi@dfci.harvard.edu
Interventions
  • Paxman Scalp Cooling System
  • Eribulin
  • Sacituzumab govitecan
  • Trastuzumab deruxtecan
Study Locations (2 sites)
Brigham and Women's Hospital, Boston, Massachusetts 02115 United States
Dana Farber Cancer Institute, Boston, Massachusetts 02115 United States
Eligibility Criteria
Inclusion Criteria: * Men and women with a diagnosis of metastatic invasive breast cancer with a ECOG PS≤2 * Participant is ≥ 18 years old. * Hair present at baseline. * One of the following full dose chemotherapy regimens must be planned for at least 4 cycles: * Sacituzumab govitecan (IMMU-132) 10 mg/kg administered intravenously on days 1 and 8 of each 21-day cycle * Trastuzumab deruxtecan 5.4 mg/kg administered intravenously once every 3 weeks * Eribulin 1.4 mg/m2 administered intravenously on days 1 and 8 of each 21-day cycle * The Paxman Scalp Cooling System must be initiated with the first dose of therapy in participants that elect to participate in the scalp cooling group. Exclusion Criteria: * Known hematological malignancies (i.e. leukemia or lymphoma) * Known scalp metastases. * Baseline alopecia (defined CTCAE 5.0 grade \> 0, see Appendix B) * Subjects with cold agglutinin disease or cold urticaria. * Subjects who are scheduled for bone marrow ablation chemotherapy. * Personal history of migraines, cluster or tension headaches as defined as actual medical diagnosis by a physician and/ or prescribed medications. If personal history of migraines was related to a past medical problem that is now resolved, the subject may go on study at the discretion of the Principal Investigator. * Subjects who have lichen planus or lupus. * Participants who are receiving any additional anti-cancer agents
Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
NCT05008276
Recruiting
Conditions Type 2 Diabetes Mellitus, Diabetic Kidne...
Phase Not Applicable
Enrollment 100
Locations 2 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Aminohippurate Sodium Inj 20%
  • Iohexol Inj 300 MG/ML
  • Dextran 40

Primary Outcomes

  • Effective renal plasma flow (ERPF)
  • Glomerular Filtration Rate (GFR)
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: 2021-09-27
Completion: 2027-12-01
Eligibility
Age: 8 Years
Sex: ALL
Volunteers: true
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Petter Bjornstad
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Seattle Children's Hospital, University of Colorado, Denver
Principal Investigators:
  • Petter Bjornstad, MD (PRINCIPAL_INVESTIGATOR) - University of Washington - Medicine Diabetes Institute
Contact Information
Study Contact:
Petter Bjornstad, MD
(206) 616 3543
pettermb@uw.edu
Interventions
  • Aminohippurate Sodium Inj 20%
  • Iohexol Inj 300 MG/ML
  • Dextran 40
Study Locations (2 sites)
Children's Hospital Colorado, Aurora, Colorado 80045 United States
Seattle Children's Hospital, Seattle, Washington 98102 United States
Eligibility Criteria
Inclusion Criteria: * HbA1c ≥6.0% for untreated high-risk group * BMI ≥ 85th %ile for high-risk group * Normal HbA1c ≤5.6% for control group * Type 1 diabetes (T1D) Antibody negative Exclusion Criteria: * History of Chronic kidney disease (CKD) or acute kidney injury (AKI) * Metabolic disorder prohibiting safe fasting * Iodine or penicillin allergy * Pregnancy * Thrombophilia * MRI contraindications * Hormone therapy
Inspiratory Muscle Strength Training for Lowering Blood Pressure and Improving Endothelial Function in Postmenopausal Women: Comparison With "Standard of Care" Aerobic Exercise
NCT05000515
Recruiting
Conditions Aging, Blood Pressure, Endothelial Dysfu...
Phase NA
Enrollment 90
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

  • High-resistance inspiratory muscle strength training
  • Aerobic exercise

Primary Outcomes

  • Change from baseline in casual systolic and diastolic blood pressure at 3 months
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-04-19
Completion: 2027-02-28
Eligibility
Age: 50 Years
Sex: FEMALE
Volunteers: true
Enrollment: 90 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Colorado, Boulder
Principal Investigators:
  • Douglas R Seals, PhD (PRINCIPAL_INVESTIGATOR) - University of Colorado, Boulder
Contact Information
Study Contact:
Daniel H Craighead, PhD
303-492-3010
imststudy@colorado.edu
Narissa P McCarty, MS
303-492-2485
imststudy@colorado.edu
Interventions
  • High-resistance inspiratory muscle strength training
  • Aerobic exercise
Study Locations (1 sites)
Integrative Physiology of Aging Laboratory, Boulder, Colorado 80309 United States
Eligibility Criteria
Inclusion Criteria: * Postmenopausal women (\>12 months of amenorrhea) * Estrogen deficient (no hormone therapies within the previous 12 months) * Age 50 years and older * Ability to provide informed consent * Willing to accept random assignment to condition * Resting systolic blood pressure of 120 mmHg or greater * Body mass index \<40 kg/m2 * Weight stable in the prior 3 months (\<2 kg weight change) and willing to remain weight stable throughout study * No change in blood pressure medications or other medications (prescription or dosing) in the prior 3 months and willing to maintain current medication regimen * Free from clinical disease with the exception of hypertension Exclusion Criteria: * Younger than age 50 years * Early menopause (menopause before age 45 years) * Having had a hysterectomy * History of uncontrolled hypertension (systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>120 mmHg) * Current smoker * Alcohol dependence or abuse * Abnormal blood pressure response to exercise (drop in systolic blood pressure below resting levels or systolic blood pressure \>260 mmHg or diastolic blood pressure \>115 mmHg) * Regular vigorous aerobic/endurance exercise (\>4 bouts/week, \>30 min/bout at a workload \>6 METS)
Treatment Interrupts Depression Early
NCT05002309
Recruiting
Conditions Depression
Phase PHASE2
Enrollment 100
Locations 2 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

  • Cognitive-Behavioural Therapy
  • Antidepressant medication

Primary Outcomes

  • Severity of depressive symptoms
  • Severity of depressive symptoms
  • Proportion of time spent depression free
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2021-12-02
Completion: 2028-12-31
Eligibility
Age: 12 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Nova Scotia Health Authority
Principal Investigators:
  • Rudolf Uher, MD, PhD (PRINCIPAL_INVESTIGATOR) - Nova Scotia Health Authority
Contact Information
Study Contact:
Rudolf Uher, MD, PhD
902-473-7209
uher@dal.ca
Jill Cumby, RN, MN
902-473-1781
jill.cumby@nshealth.ca
Interventions
  • Cognitive-Behavioural Therapy
  • Antidepressant medication
Study Locations (2 sites)
Nova Scotia Health, Halifax, Nova Scotia B#H 2E2 Canada
Centre intégré universitaire de santé et de services sociaux de l'Ouest-de-l'Île-de-Montréal / Centre de Recherche Douglas (Montreal West Island IUHSSC / Douglas Research Center), Montreal, Quebec H4H 1R3 Canada
Eligibility Criteria
Inclusion Criteria: * Age 12-25 years * Diagnosis of major depressive disorder, onset of the major depressive disorder within the last 12 months. Depression considered the most significant problem in need of treatment. * An additional inclusion criterion for entering Stage 1 (active intervention) is a minimum moderate depression severity (CDRS-R≥40; MADRS≥20) that justifies the need for treatment. Individuals who fulfill general inclusion criteria but are below the depression severity threshold for active intervention will still be eligible to participate in follow-up assessments. * Verbal ability sufficient to participate in psychological treatment. Exclusion Criteria: * Personal history of a manic or hypomanic episode, diagnosis of a psychotic disorder, pervasive developmental disorder or autism spectrum disorder, intellectual disability, mental disorders secondary to neurological or other medical condition, active substance use disorder. * Previous trial of any treatment for major depressive disorder lasting 4 weeks or longer, current use of antipsychotic, antidepressant or mood-stabilizer medication. * Recent (past 6 weeks) change in any psychotropic medication (including stimulants, hypnotics, anxiolytics) or receipt of 4 of more sessions of cognitive-behavioural therapy. * Pregnancy or breastfeeding. If participants become pregnant or learn of pregnancies during the study, we will consult with Dr. Tanya Tulipan and jointly make the best decision for the participant with the option to either continue or end study treatment. * No one will be excluded based on sex, gender, race, ethnicity, or living arrangements.
Subpectoral Plexus Block With Multi-level TPVB for Surgical Anesthesia During Primary Breast Cancer Surgery
NCT04933266
Recruiting
Conditions Breast Cancer
Phase NA
Enrollment 100
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

  • Subpectoral plexus block (low dose)
  • Subpectoral plexus block (High dose)

Primary Outcomes

  • Proportion of patients requiring intraoperative ketamine
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-03-15
Completion: 2026-03-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Chinese University of Hong Kong
Principal Investigators:
  • Manoj K Karmakar, MD (PRINCIPAL_INVESTIGATOR) - Chinese University of Hong Kong
Contact Information
Study Contact:
Ayla Wong, RN, BN
3505 6157
aylawong@cuhk.edu.hk
Interventions
  • Subpectoral plexus block (low dose)
  • Subpectoral plexus block (High dose)
Study Locations (1 sites)
North District Hospital, Sheung Shui, New Territories Hong Kong
Eligibility Criteria
Inclusion Criteria: * scheduled for mastectomy, modified radical mastectomy or breast conservative surgery with lymph node biopsy and with or without axillary dissection Exclusion Criteria: * local skin site infection * coagulopathy * history of allergy to local anesthetics
Evaluating 6-months of HER2-targeted Therapy in Patients With HER2 Positive Early-stage Breast Cancer That Achieve a Pathological Complete Response to Neoadjuvant Systemic Therapy
NCT04928261
Active, positions filled
Conditions Breast Cancer
Phase PHASE4
Enrollment 52
Locations 1 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Trastuzumab

Primary Outcomes

  • Multiple site activation
  • Medical oncologist active participation
  • Enrolment of at least 50 participants across all sites within 9 months of the fourth site accruing its first participant
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Active, positions filled
Start Date: 2021-12-13
Completion: 2028-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 52 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Ottawa Hospital Research Institute
Principal Investigators:
  • Sharon McGee, MD (PRINCIPAL_INVESTIGATOR) - Ottawa Hospital Research Institute
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Trastuzumab
Study Locations (1 sites)
The Ottawa Hospital Cancer Centre, Ottawa, Ontario K1H8M2 Canada
Eligibility Criteria
Inclusion Criteria: * Early-stage (I-III, i.e. non-metastatic) as per AJCC 8th edition, ER/PR positive or negative, HER2-positive as per 2018 American Society of Clinical Oncology/College of American Pathologists human epidermal growth factor receptor 2 (HER2) testing in breast cancer guidelines. * Treated with neoadjuvant chemotherapy and HER2 targeted therapy preoperatively with a pathological complete response (pCR) defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy at surgery. Must have received less than 6 months of HER2 targeted therapy * Able to provide verbal consent and complete questionnaires in English or French Exclusion Criteria: * Residual invasive disease following neoadjuvant therapy, or metastatic disease * Contraindication to further HER2-targeted therapy following completion of neoadjuvant treatment * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol
Extended Effects of Cannabis Abstinence on Clinical Symptoms and Cognition in Depression
NCT04935619
Recruiting
Conditions Cannabis Use, Major Depressive Disorder,...
Phase NA
Enrollment 52
Locations 1 sites
Compensation Up to $300
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Contingency Reinforcement
  • Non-Contingency Reinforcement

Primary Outcomes

  • Changes in Depressive Symptomology from Baseline to Week 4
  • Changes in Anxious Symptomology from Baseline to Week 4
  • Changes in Sleep Symptomology from Baseline to Week 4
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2021-07-21
Completion: 2027-08-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 52 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Centre for Addiction and Mental Health
Principal Investigators:
  • Tony P George, MD., FRCPC (PRINCIPAL_INVESTIGATOR) - CAMH
Contact Information
Study Contact:
Maryam Sorkhou, HBSc
4165358501
maryam.sorkhou@mail.utoronto.ca
Interventions
  • Contingency Reinforcement
  • Non-Contingency Reinforcement
Study Locations (1 sites)
Centre for Addiction and Mental Health, Toronto, Ontario M5T 1R8 Canada
Eligibility Criteria
Inclusion Criteria: * All participants must be between the ages 18-55 * Meet SCID for DSM-5 diagnostic criteria for cannabis use disorder, moderate to severe * Meet SCID for DSM-5 diagnostic criteria for Major Depressive Disorder * Be an outpatient receiving a stable dose of antidepressant medication for at least three months (to ensure stability of depressive symptoms * Have a Hamilton Depression Rating Scale (HDRS-17) at baseline assessment in the range of 12-25.. * Have a Full-Scale IQ ≥ 80 as determined by the WTAR * Be a non-treatment seeking cannabis user * Evidence of sufficient motivation and effort as measured by a Test of Memory Malingering (TOMM) score ≥ 45. Exclusion Criteria: * Meets criteria for substance use disorder of alcohol or other illicit substances within the past 6 months (with the exception of cannabis, nicotine, or caffeine) * Positive urine screen for illicit substances other than cannabis, nicotine, or caffeine * Current suicidal or homicidal ideation * Psychotic disorder diagnosis (e.g. schizoaffective disorder, major depression with psychotic features) as determined by the SCID * Treatment seeking for cannabis use * Meet SCID for DSM-5 diagnostic criteria for Bipolar Disorder * Head Injury\> 5 minutes LOC * Exceed upper and lower cut-offs on HSRD-17 (See Inclusion Criteria)
Effect of Nitrate on Red Blood Cell Function in Type 2 Diabetes
NCT04917471
Recruiting
Conditions Type 2 Diabetes
Phase NA
Enrollment 20
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

  • Beet root juice
  • Placebo juice

Primary Outcomes

  • Percentage recovery of left ventricular function
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2021-06-01
Completion: 2025-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Karolinska Institutet
Principal Investigators:
  • John Pernow (PRINCIPAL_INVESTIGATOR) - Karolinska Institutet
Contact Information
Study Contact:
John Pernow
+46704848361
john.pernow@ki.se
Interventions
  • Beet root juice
  • Placebo juice
Study Locations (1 sites)
Karolinska Institutet, Karolinska University Hospital, Stockholm, 17176 Sweden
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes Exclusion Criteria: Acute coronary syndrome Vegetarian diet Impaired renal function Absolute indication for proton pump inhibitor Ongoing treatment with organic nitrate Heart failure (ejection fraction \<35%) Any condition that interferes with the possibility to fulfill the study protocol
Mother-Infant Cohort Study in Malaysia and China
NCT04919265
Recruiting
Conditions Gut Microbiota, Gastrointestinal Symptom...
Phase Not Applicable
Enrollment 200
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

  • No intervention - mother-infant cohort study

Primary Outcomes

  • Breastmilk microbiome
  • Gut microbiome
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: 2022-06-03
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Universiti Putra Malaysia
Collaborators: Guilin University of Technology, China, National Engineering Center of Dairy for Maternal and Child Health, Beijing
Principal Investigators:
  • Wan Ying Gan, PhD (PRINCIPAL_INVESTIGATOR) - Universiti Putra Malaysia
  • Tie Min Jiang (PRINCIPAL_INVESTIGATOR) - Guilin University of Technology
  • Li Jun Chen, PhD (STUDY_DIRECTOR) - Beijing Sanyuan Foods Co Ltd
Contact Information
Study Contact:
Shiang Yen Eow, PhD student
017-6803715
cescvin423@hotmail.com
Wan Ying Gan, PhD
012-3564352
wanying@upm.edu.my
Interventions
  • No intervention - mother-infant cohort study
Study Locations (1 sites)
Private hospital, Kajang, Selangor 43000 Malaysia
Eligibility Criteria
Inclusion Criteria: * Pregnant women aged between 18 and 45 years old * Pregnant women who attend the antenatal check-up at the selected clinics/hospitals * Pregnant women with the gestational age of less than 12 weeks * Pregnant women who plan to attend post-natal check-ups for at least one year at the same clinic/hospital Exclusion Criteria: * Pregnant women who are diagnosed with immune deficiency * Pregnant women who have a multiple pregnancy and preterm delivery (\<37 weeks) * Pregnant women who plan to move out of the study area in the next one year * Pregnant women with fetal/newborn with congenital abnormalities
Stem Cell Strategies for the Treatment of Chronic Asthma
NCT04883320
Active, positions filled
Conditions Asthma
Phase Not Applicable
Enrollment 15
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • The overall aim of this proposal is to determine the effects of adult stem cell products on asthmatic respiratory epithelium.
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: 2016-08-31
Completion: 2025-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 15 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospitals of North Midlands NHS Trust
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (1 sites)
University Hospitals of North Midlands NHS Trust, Stoke-on-Trent, Staffordshire ST4 6QG United Kingdom
Eligibility Criteria
Inclusion Criteria: Men or women, age (18-70 years old), II. Lifelong never-smokers or ex-smokers (\< 10 pack years). (1 pack year= 20 cigarettes/day for 1 year). III. Must be competent to give written informed consent. IV. Female participants of child bearing potential must have a negative urine pregnancy test prior to bronchoscopy. V Potential participants must meet the safety criteria to have a Spirometry test where necessary. vi Must meet the safety criteria to have a bronchoscopy. Asthmatic participants: VI. Have a physician diagnosis of asthma. VII. All asthma patients will have either bronchodilator reversibility of ≥12% or 200 mL at screening, or historic data confirming bronchodilator reversibility or bronchial hyperreactivity to methacholine (PC20). Those without prior confirmed reversibility will have bronchodilator reversibility testing to salbutamol at screening and the asthma control questionnaire (ACQ) administered. Where reversibility to salbutamol is inconclusive a methacholine challenge will be performed. VIII. Must have stable disease with no recent flare-ups (within 4 weeks). IX. Oxygen saturations whilst breathing room air must be \> 90% (a measure of how well the lungs are providing oxygen to the body). X. When blowing forcefully into a tube (forced expiratory volume or FEV), the patient must be able to blow out at least one litre of air in the first second (FEV1 \> 1Litre). Non-asthmatic participants: XI. Have no physician diagnosis of asthma. XII. Have no evidence of any long term lung condition or any other disabling condition and they must not have had a chest infection in the preceding 4 weeks. Exclusion Criteria: I. Significant smoking history (\>10 pack year). II. Significant lung co-morbidities III. Patient unable to give informed consent IV. History of myocardial infarction within the preceding 6 weeks V. Any subject with asthma who requires home oxygen will not be included for safety reasons
A Study of Attention and Memory Processes in Breast Cancer Survivors
NCT04883398
Active, positions filled
Conditions Breast Cancer Survivors
Phase Not Applicable
Enrollment 65
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • test early attentional deficits
  • abnormal event-related potential (ERP) during initial learning
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: 2021-05-06
Completion: 2027-05
Eligibility
Age: 50 Years
Sex: FEMALE
Volunteers: true
Enrollment: 65 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: Baruch College City University of New York
Principal Investigators:
  • James Root, PhD (PRINCIPAL_INVESTIGATOR) - Memorial Sloan Kettering Cancer Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (1 sites)
Memorial Sloan Kettering Cancer Center, New York, New York 10065 United States
Eligibility Criteria
Inclusion Criteria: For All Paricipants: * As per medical record or self-report, female * As per medical record or self-report, age 50-70 * Score of \< 11 on the Blessed Orientation-Memory-Concentration Test (BOMC) * English fluent (as per self reported fluency of "well" or "very well", and having a reasonable comprehension of the study conversation in the opinion of the research staff/preference of English language for healthcare)\*\* * As per medical record or self-report, if currently taking psychoactive medications (excluding gabapentin and including but not limited to antidepressants and anxiolytics) on a daily basis, dose must have been stable at least two months prior to enrollment For Survivors: * As per medical record or self-report, AJCC stages 0-3 breast cancer * As per medical record or self-report, at least 1-year post-treatment for breast cancer (including surgery, and chemotherapy, with or without radiation * As per medical record or self-report, current endocrine therapy For Healthy Controls: * As per self-report, if currently taking psychoactive medications (including but not limited to antidepressants and anxiolytics), dose must have been stable at least two months prior to enrollment. * As per self report, no history of cancer except non-melanoma/basal cell skin cancer/squamous cell skin carcinoma Exclusion Criteria: For All Participants: * As per medical record or self-report, diagnosis of neurodegenerative disorder that affects cognitive function (e.g. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, Dementia, Seizure Disorders, etc.) * As per medical record or self report, history of stroke or head injury resulting in a structural lesion on neuropsych imaging, persistent cognitive difficulties impacting work or daily life, or required cognitive rehabilitation * As per medical record or self report, a diagnosis of a Schizophrenia Spectrum Disorder, substance use disorder, Bipolar Disorder or Schizotypal personality disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, and Attenuated Psychotic Disorder * As per medical record or self-report, visual or auditory impairment that would preclude ability to complete the assessments (e.g. history of significant macular degeneration or being unable to correct hearing with hearing aides) * As per medical record or self-report, use of methotrexate (Amethopterin, Rhematrex, Trexall) or rituximab (Rituxin) for rheumatoid arthritis, psoriasis or Crohn's disease, or cyclophosphamide (Cytoxan, Neosar) for Lupus * As per medical record or self-report, participation in a conflicting research study (i.e. another neurocognitive study utilizing HVLT and BVMT tasks.) For Survivors only: * As per medical record or self-report, history of another type of cancer or prior breast cancer diagnosis except non-melanoma/basal cell skin cancer/squamous cell skin carcinoma * As per medical record or self-report, disease recurrence. For Healthy Controls only: * As per medical record or self-report, history of treatment using radiation, chemotherapy, and/or Tamoxifen or Aromatase-inhibitors
Contrast-enhanced Spectral Mammography (CESM) Breast Cancer Screening
NCT04904757
Recruiting
Conditions Mammographic Breast Density, Mammography
Phase NA
Enrollment 210
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

  • Contrast-enhanced spectral mammography (CESM)

Primary Outcomes

  • Evaluate the patient experience during a screening CESM
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2019-09-19
Completion: 2023-06
Eligibility
Age: 40 Years
Sex: FEMALE
Volunteers: true
Enrollment: 210 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Virginia
Contact Information
Study Contact:
Kathy L Repich, RN
4342434540
klr3b@virginia.edu
Matthew M Miller, MD
MM5CA@hscmail.mcc.virginia.edu
Interventions
  • Contrast-enhanced spectral mammography (CESM)
Study Locations (1 sites)
UVA Breast Care Center, Charlottesville, Virginia 22911 United States
Eligibility Criteria
Inclusion Criteria: * • Female * 40 to 69 years * Previous normal mammogram (BI-RADS 1 or 2) showing heterogeneous or extremely dense breast tissue within last 24 months * Scheduled for screening mammogram as part of the patient's clinical care Exclusion Criteria: * • No mammogram within last 24 months * Fatty or scattered fibroglandular tissue on last mammogram * History of allergy to iodinated contrast * History of renal disease or renal function abnormalities * Pregnant women * History of diabetes * History of paraproteinemia syndromes such as multiple myeloma * History of collagen vascular disease * History of vascular disease (coronary artery disease, myocardial infarction, carotid disease, peripheral vascular disease, or known visceral artery disease) * Previously identified as high risk for breast cancer (\>20% lifetime risk) * Asthma * Sickle Cell Anemia * Currently on Dialysis
Inspiratory Muscle Strength Training in Chronic Kidney Disease
NCT04911491
Recruiting
Conditions Chronic Kidney Diseases, Hypertension, A...
Phase NA
Enrollment 108
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

  • IMST
  • Sham Training

Primary Outcomes

  • Change in Casual Systolic Blood Pressure
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-03-01
Completion: 2026-07-01
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: false
Enrollment: 108 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Colorado, Denver
Collaborators: University of Colorado, Boulder, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigators:
  • Kristen Nowak, PhD, MPH (PRINCIPAL_INVESTIGATOR) - University of Colorado, Denver
  • Michel Chonchol, MD (PRINCIPAL_INVESTIGATOR) - University of Colorado, Denver
Contact Information
Study Contact:
Kristen Nowak, PhD, MPH
303-724-4842
Kristen.Nowak@cuanschutz.edu
Emily Andrews
303-724-7790
Interventions
  • IMST
  • Sham Training
Study Locations (1 sites)
University of Colorado - Anschutz Medical Campus, Aurora, Colorado 80045 United States
Eligibility Criteria
Inclusion Criteria: * Aged 50 years or older; women must be post-menopausal * Chronic kidney disease stage 3 or 4 (estimated glomerular filtration rate with the 4 CKD-EPI 2021 race-free equation: 20-59 mL/min/1.73m\^2; stable renal function in the past 3 months) * History of inadequately controlled hypertension (systolic blood pressure 120-159 mmHg on two separate days) and on a stable antihypertensive regimen for the past 6 weeks * Weight stable in the prior 3 months (\<2 kg weight change) and willing to remain weight stable throughout the study. Participants using glucagon-like peptide-1 receptor agonists or planning to start them during the study are excluded unless they have achieved weight stability for at least 3 months prior to enrollment. * Ability to provide informed consent Exclusion Criteria: * Patients with advanced chronic kidney disease requiring chronic dialysis * Significant pulmonary disorders including: chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, or uncontrolled asthma * History of spontaneous pneumothorax, collapsed lung due to traumatic injury that has not fully healed, burst eardrum that has not fully healed, or other conditions of the eardrum * Significant co-morbid conditions with a life expectancy of \< 1 year * History of severe congestive heart failure (i.e., ejection fraction \<35%) * History of hospitalization within the last month * Albuminuria (albumin to creatinine ratio \> 2200 mg/g * Current smoker * Immunosuppressant agents taken in the past 12 months. Steroids used for the treatment of gout are acceptable; however, patients should not be using steroids within 2 weeks (or 14 days) prior to the vascular testing (rationale: may confound vascular testing) * Known malignancy * Inability to cooperate with or clinical contraindication for magnetic resonance imaging including: severe claustrophobia, implants, devices, or non-removable body piercings (these individuals can participate in the study but are excluded from the MRI procedure) * Illicit drug use or alcohol dependence/abuse, which in the opinion of the investigators, would prohibit compliance with the study intervention
Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation
NCT04890613
Recruiting
Conditions Advanced Solid Tumor
Phase PHASE1
Enrollment 52
Locations 8 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

  • CX-5461

Primary Outcomes

  • Determination of Recommended Phase 2 Dose (RP2D)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2021-09-08
Completion: 2027-03
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 52 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Senhwa Biosciences, Inc.
Principal Investigators:
  • Jason Huang, MD (STUDY_DIRECTOR) - Senhwa Biosciences
Contact Information
Study Contact:
Hylee Lee
886-2-889119856
hylee@senhwabio.com
Jenny Chen
jennychen@senhwabio.com
Interventions
  • CX-5461
Study Locations (8 sites)
University of California, Los Angeles, Santa Monica, California 90404 United States
H. Lee Moffitt Cancer Center and Research Institute Hospital, Tampa, Florida 33612-9497 United States
Dana Farber Cancer Institute, Boston, Massachusetts 02215 United States
Memorial Sloan-Kettering Cancer Center, New York, New York 10065 United States
Ohio State University-James Cancer Hospital and Solove Research Institute, Columbus, Ohio 43202 United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania 15232 United States
Princess Margaret Cancer Centre, Toronto, Ontario M5G 1X6 Canada
Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec H2X 0C2 Canada
Eligibility Criteria
Inclusion Criteria: Main study cohort: 1. Histologically or cytologically confirmed malignancy of the pancreas, prostate, breast, or ovary. 2. Documented evidence of pathogenic or likely pathogenic somatic or germline mutation in BRCA1/2 and/or PALB2, and/or any genetic alterations listed below as indicated in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory report. The report must be submitted to and approved by study sponsor prior to registration. Other HRD-associated mutations could be eligible if prior approval by the sponsor is granted. ATM, ATR, BARD1, BRCA1, BRCA2, BRIP1, CCNE1, CHEK1, CHEK2, CDK12, CREBBP, FANCA, FANCI, FANCL, FANC2, FANCB, FANCC, FANCD2, FANC family\*, MRE11A, MYC, NBN, NCL, PALB2, RAD50, RAD51B, RAD51C, RAD51D, RAD54L, SLFN11, PTIP, MLL3, MLL4, EZH2, CtIP(RBBP8), MUS81, CDH4, DYNLL11, TOPBP1, NBS1, CDC25A, CDC25C, RAD17, WEE1 \* In addition to the genes already specified, the "FANC family" genes may also include the following: FANCE, FANCF, FANCG, FANCM, FANCP, FANCQ/ERCC4/XPF, FANCR/RAD51, FANCT/UBE2T, FANCU/XRCC2, FANCV/REV7/MAD2L2, and FANCW/RFWD3. Exploratory cohort: 1. Histologically confirmed ovarian, fallopian tube or primary peritoneal cancer, with a high grade serous or high grade endometrioid histology subtype. 2. Documented evidence of pathogenic or likely pathogenic germline mutation or a clinically actionable somatic mutation in BRCA1 and/or other HRD-associated mutation, as indicated in a CLIA-certified laboratory report. The report must be submitted to and approved by study sponsor prior to registration. 3. Meet one of the following criteria: 1. Platinum Sensitive with no evidence of disease progression within 6 months of the last dose of platinum-based chemotherapy (n=10 patients); OR 2. Platinum Resistant with disease progression within 6 months of the last dose of a platinum-based chemotherapy. All participants: 1. Age ≥ 18 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 within 14 days of registration. 3. Radiographically documented disease progression within 28 days of registration and evaluable as per RECIST v1.1. 4. Patient must have measurable disease as per RECIST v1.1. 5. Patients must have adequate bone marrow, renal and hepatic function per local laboratory reference ranges as follows within 14 days of registration: 1. Absolute Neutrophil Count ≥ 1.5 x 10\^9/L 2. Platelets ≥ 100 x 10\^9/L 3. Hemoglobin ≥ 9 g/dL (blood transfusion ≤ 7 days of screening not permitted). 4. Calculated creatinine clearance \> 51mL/min (Cockcroft-Gault formula) 5. AST/ALT ≤ 2.5× the upper limit of normal (ULN). Subjects with liver metastasis may have AST, ALP, and ALT ≤ 5.0 X ULN. 6. Bilirubin ≤ 1.5×ULN. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of haemolysis or hepatic pathology), who will be allowed only at the discretion of the Study Investigator. 7. INR/PT and aPTT ≤1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants. 8. Albumin ≥3.0 g/dL 6. Patients are willing to undergo tumour biopsy pre-treatment and at time of progression on treatment. If a biopsy at the time of progression on prior therapy is available and can be submitted to the Central Lab for this study, this procedure does not need to be repeated. Patients who consent but have tumour that is not amenable to safe biopsy will be allowed to enter the trial and continue therapy as per protocol if this has been addressed and permission is granted from the sponsor prior to registration. 7. Life expectancy of greater than 3 months from the date of registration. 8. Able to provide written informed consent. 9. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 10. Female patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration. (Note: a negative urine/serum pregnancy test is required on Cycle 1, Day 1 prior to treatment unless the screening pregnancy test was done within 48hrs of registration). 11. Female patients of childbearing potential and male patients who are sexually active must agree to practice true abstinence or at least two effective methods of contraception (ie: condoms with spermicide, hormonal methods such as oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs), non-hormonal IUDs, such as ParaGard, bilateral tubal ligation, vasectomy, complete abstinence) within 14 days prior to registration, and agree to continue using such precautions while on treatment with CX-5461 (including dose interruptions) and for 6 months following the last dose of CX-5461. 12. There is no minimum or maximum number of lines of prior therapy and prior PARP inhibitor therapy is allowed. 13. Patient is clinically stable at the time of entering the study. Exclusion Criteria: 1. For pancreatic cancer; non-adenocarcinoma histology is excluded from this study. 2. Patients with malignant bowel obstruction. 3. Untreated, unstable brain or meningeal metastases or tumor. Patients with radiological evidence of stable brain metastases are eligible provided that they are asymptomatic and either do not require corticosteroids or have been treated with corticosteroids, with clinical and radiological evidence of stabilization at least 10 days after discontinuation of steroids. 4. Unresolved toxicity \> CTCAE grade 1 from previous anti-cancer therapy (including radiotherapy) except hematological toxicity, Grade 1 or 2 neuropathy, and alopecia. 5. Any evidence of severe or uncontrolled diseases such as but not limited to active infection, unstable or uncompensated respiratory, cardiac, neurological, hepatic, renal disease or psychiatric illness/social situations, which in the opinion of the investigator, would limit compliance with study requirements. 6. Treatment with an investigational (non-registered - other than PARP inhibitor) agent within 30 days and treatment with PARP inhibitor within 14 days prior to the first dose of study medication. 7. Immuno-compromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV), patients with known active hepatitis (i.e., hepatitis B or C). Note: Patients with a prior history of treated HBV infection who are antigen-negative or patients with a prior history of treated HCV infection who are HCV RNA-undetectable may be enrolled. Patients who are known to be serologically positive for human immunodeficiency virus (HIV) can enroll if their CD4+ T-cell (CD4+) counts ≥ 350 cells/uL. 8. Patients who have had recent (within 14 days of registration, or until any wound has completely healed) major thoracic or abdominal surgery prior to study start, or a surgical incision that is not fully healed. 9. No concurrent systemic anti-cancer therapy, biological therapy or other novel agent is to be permitted. Palliative radiotherapy may be allowed. If radiotherapy is required due to disease progression, patient will be considered off study. If radiotherapy is be used to treat non-target lesions and patients may benefit from continuing on study treatment, CX-5461 may re-commence 14 days after completion of radiotherapy. Any continuation on study treatment must be discussed with and approved by study sponsor. 10. Patients may be potentially eligible where the current tissue diagnosis is confirmed histologically from biopsy of a target lesion, and the patient has had no evidence of active second malignancy which requires treatment or would confound interpretation of safety, tolerability and efficacy of CX-5461. These cases must be discussed with the medical monitor prior to confirm eligibility. 11. Presen
The OPUS YOUNG Trial. Early Intervention Versus Treatment as Usual for Adolescents With First-episode Psychosis
NCT04916626
Active, positions filled
Conditions Schizophrenia, Schizotypal Disorder, Del...
Phase NA
Enrollment 284
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

  • OPUS YOUNG
  • Treatment as Usual

Primary Outcomes

  • Personal and Social Performance Scale (PSP)
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: 2021-05-06
Completion: 2026-03
Eligibility
Age: 12 Years
Sex: ALL
Volunteers: false
Enrollment: 284 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Principal Investigators:
  • Anne K Pagsberg, PhD (PRINCIPAL_INVESTIGATOR) - Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • OPUS YOUNG
  • Treatment as Usual
Study Locations (1 sites)
Mental Health Services in the Capital Region, Denmark, Hellerup, 2900 Denmark
Eligibility Criteria
Inclusion Criteria: 1. Between 12 and 17 years of age (both inclusive) at trial inclusion. 2. First-episode psychosis within F2 spectrum (F20 schizophrenia, F21 Schizotypal disorder, F22 delusional disorder, F23 acute and transient psychotic disorders, F25 schizoaffective disorders, F28/29 other or un-specified non-organic psychosis) or depression with psychotic symptoms (F32.3, F33.3) or substance-induced psychosis (F1X.5) according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10). 3. Maximum 12 months since first prescription of antipsychotic treatment on the indication psychosis. 4. Speak and understand Danish. 5. Written informed consent from parents or legal caretakers. Participants who reach age 18 years during the trial will be asked to give personal written informed consent to continue their study participation. Exclusion Criteria: 1. A diagnosis of mental retardation of at least moderate severity defined as an intelligence quotient (IQ)of 49 or below (F71, F72, F73 according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10). 2. Currently compulsory admission and/or treatment according to Danish legislation
Improving Care for Rural Patients With Solid Tumors
NCT04916990
Recruiting
Conditions Lung Cancer, Head and Neck Cancer, Thyro...
Phase NA
Enrollment 320
Locations 14 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • CARES Intervention

Primary Outcomes

  • Time to care
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-09-01
Completion: 2027-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 320 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Colorado, Denver
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Evelinn Borrayo, PhD (PRINCIPAL_INVESTIGATOR) - University of Colorado, Denver
Contact Information
Study Contact:
Jennifer V Gonzalez, MS
3037246278
jennifer.villalobosgonzalez@cuanschutz.edu
Tatiana Gerena, MPH
303-724-5439
tatiana.gerena@cuanschutz.edu
Interventions
  • CARES Intervention
Study Locations (14 sites)
University of Colorado Hospital, Aurora, Colorado 80045 United States
Memorial Hospital Central, Colorado Springs, Colorado 80909 United States
Memorial Hospital North, Colorado Springs, Colorado 80920 United States
Poudre Valley Hospital, Fort Collins, Colorado 80524 United States
SCL- St. Mary's Medical Center, Grand Junction, Colorado 81501 United States
VA Western Colorado Health Care System, Grand Junction, Colorado 81501 United States
Greeley Campus, Greeley, Colorado 80634 United States
Highlands Ranch Hospital, Highlands Ranch, Colorado 80129 United States
Medical Center of the Rockies, Loveland, Colorado 80538 United States
San Juan Cancer Center, Montrose, Colorado 81401 United States
Eligibility Criteria
Inclusion Criteria Assessed During Screening: 1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. Male and female adults over 18 years old 4. English or Spanish speaking 5. Receives cancer treatment at UCH- Aurora, UCH-Highlands Ranch, UCHealth North, UCHealth South- UCHealth Memorial Hospital, UCHealth Parkview Hospital, San Juan Cancer Center, RMCC-Pueblo, SCL-St. Mary's, or Parkview Medical Center. 6. Resides in any of the rural counties served by the UCH-Aurora, UCH-Highlands Ranch, UCHealth North, UCHealth South- UCHealth Memorial Hospital, UCHealth Parkview Hospital, San Juan Cancer Center, RMCC-Pueblo, SCL-St. Mary's, VA, Huntsman Cancer Institute, or Parkview Medical Center with Rural-Urban Continuum Codes (RUCC) codes 4-9. 7. Diagnosed with lung cancer (LC): small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), using incident LC diagnosis according to the International Classification of Diseases for Oncology \[ICD-O\] codes: C34.0, C34.1, C34.2, C34.3, C34.8, C34.9, and C33.9, and other lung cancer variants 8. Stage of diagnosis for SCLC (limited vs. extensive), NSCLC (Stages 0, I, II, IIA, IIIB, IV), according to the American Joint Committee on Cancer Staging \[AJCC\] Tumor Node Metastasis \[TNM\] stages: I-IV) 9. Will receive the following types of breast, bladder, cervix, colon, rectum, lung, head-and-neck cancer treatments (surgery, radiation therapy, chemotherapy, or a combination of those modalities, including neoadjuvant and adjuvant therapy) 10. Diagnosed with head and neck cancer (HNC) using head and neck squamous cell carcinoma (HNSCC) ICD-O codes for the oral cavity (including lip; codes C00.0-C00.6, C00.8, C00.9, C02.0-C02.3, C02.8, C0.2.9, C03.0, C03.1, C03.9-C04.1, C04.8-C05.0, C06.0-C06.2, C06.8, and C06.9), the oropharynx (codes C01.9, C02.4, C05.1, C05.2, C5.8, C5.9, C09.0, C09.1, C09.8-C10.4, C10.8, C10.9, C14.0, C14.2, and C14.8), the hypopharynx (codes C12.9-C13.2, C13.8, and C13.9), and the larynx (codes C32.0- C32.3 and C32.8-C32.9) and histology codes for squamous cell carcinoma (SCC) or its variants (codes 8032, 8050, 8052, 8070-8075, and 8083-8084), and salivary gland cancer (code C07 and variants), and other head and neck cancer variants 11. Stage of diagnosis for HNC (Stages I, II, III, IV) according to the AJCC's TNM stages I-IV 12. Diagnosed with malignant neoplasm of thyroid gland, ICD-10 code: C73, and other thyroid cancer variants 13. Diagnosed with BC using malignant neoplasm of breast ICD-O codes for connective tissue of the breast, codes: C50.0, C50.1, C50.2, C50.3, C50.4, C50.5, C50.6, C50.8, C50.9, and other breast cancer variants. 14. Diagnosed with CC using malignant neoplasm of cervix uteri ICD-O codes: C53.0, C53.1, C53.8, C53.9 and other cervical cancer variants. 15. Diagnosed with CRC using colon and rectum malignant neoplasm ICD-O codes for colon (codes: C18, C18.1, C18.2, C18.3, C18.4, C18.5, C18.6, C18.7, C18.8, C18.9) and rectum (code C20), and other colon and rectum cancer variants. 16. Diagnosed with BLC using malignant neoplasm of ICD-O codes: C67.9 and other bladder cancer varients. Inclusion Criteria Confirmed via Baseline Survey: 17. Rural and medically underserved, defined as meeting the following criteria: * Rural: Resides in a rural county with a RUCC code 4-9 AND, * Underserved population who come from counties meeting any of the "health professional shortage areas" OR "Medically Underserved Areas/Populations" AND/OR 18. Uninsured: No health insurance (public or private insurance) AND/OR 19. Underinsured: (c.1) Public insurance (e.g., Medicaid, Medicare Part B exclusive, VA) (c.2) 10% or more of annual income is spent on out-of-pocket medical expenses Exclusion Criteria Assessed During Screening: 1. Children under 18 years old 2. Individuals who do not speak English or Spanish 3. Individuals not receiving cancer treatment at UCH (Aurora, Highlands Ranch, UCHealth North, UCHealth Memorial Hospital), San Juan Cancer Center, RMCC-Pueblo, St. Mary's or Parkview Medical Center. 4. Diagnosed with primary cancer other than breast, bladder, cervix, colon, rectum, lung, and/or head-and-neck cancer or other type of cancer not listed in the inclusion criteria. 5. Diagnosed with a type of breast, bladder, cervix, colon, rectum, lung, and/or head-and-neck cancer listed under inclusion criteria but will not be treated at one of the collaborating hospital sites, 6. Has already initiated curative treatment for the current episode of cancer. Exclusion Criteria Assessed via Baseline Survey: 7. Individuals from vulnerable populations (e.g., inmates or on probation, homeless\*, and pregnant\*) 8. Decisionally-challenged with cognitive or personality impairment, suicidal ideation or intoxication (alcohol or drugs) at the time of consent or endorsed in baseline survey that interfere with ability to participate in the study. 9. Unable to hear (not including individuals who can hear with an auditory aid).\* 10. Likely inability to track the individual over time (e.g. no permanent address at the time of consent) \*Individuals who become homeless, pregnant, or lose their hearing or permanent address after they have consented and/or assigned to study condition may remain in the study until completion