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Showing 20 of 29277 trials
Acupuncture for Hot Flashes in Patients With Hormone Receptor-positive Breast Cancer.
NCT05460819
Not yet recruiting
Conditions Hot Flashes, Breast Cancer, Acupuncture
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

  • Acupuncture treatment
  • Sham Acupuncture treatment

Primary Outcomes

  • Change in cancer therapy functional assessment
  • Change in acupuncture efficacy expectation assessment
  • Change of functional connectivity of whole brain
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2022-08-01
Completion: 2027-07-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 90 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Nanjing University of Traditional Chinese Medicine
Collaborators: Xi'an Jiaotong University
Principal Investigators:
  • Lijun Bai, phd (STUDY_DIRECTOR) - Xi'an Jiaotong University
Contact Information
Study Contact:
Lijun Bai, phd
0086-15129034948
bailijun@xjtu.edu.cn
Interventions
  • Acupuncture treatment
  • Sham Acupuncture treatment
Study Locations (1 sites)
Jiangsu Province Hospital of Traditional Chinese Medcine, Nanjing, Jiangsu 210029 China
Eligibility Criteria
Inclusion Criteria: * Aged 18-75 years old; * Adjuvant hormone therapy (eg, tamoxifen and/or aromatase inhibitors) with or without ovarian function suppression has been administered for at least 4 weeks and is currently on treatment; * Vasomotor syndrome for at least 6 weeks; * Premenopausal or postmenopausal patients; * Patients with persistent hot flashes for at least 4 weeks and with a frequency of more than 14 hot flashes per week (2 times per day) in the week before inclusion in the study, the weekly average hot flash composite score is 3-4; * Patients after surgery and after chemotherapy (if any); * Eastern Cooperative Oncology Group score of 0-1 points. * Sign the informed consent and voluntarily participate in this clinical observation. Exclusion Criteria: * Tumor metastases, undergoing chemoradiotherapy or planning surgery; * Pharmacological intervention for hot flashes with hot flash treatment drugs such as selective serotonin reuptake inhibitors (SSRIs) and/or anticonvulsants for at least 4 weeks prior to study initiation; * Unstable heart disease or myocardial infarction within 6 months prior to study start; * Started or changed adjuvant hormone therapy within the past week, or who planned to start or change adjuvant hormone therapy in the past 14 weeks; * Seizures of unknown likelihood or history of seizures; * Have used acupuncture for hot flashes within 6 months prior to the start of the study; * Pregnant or breastfeeding patients; * Apparent uncontrolled infection; * Mental illness or family history; neurological disorder or family history.
SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer
NCT05445908
Active, positions filled
Conditions Triple-negative Breast Cancer and HR+/HE...
Phase PHASE2
Enrollment 175
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

  • SKB264
  • KL-A167

Primary Outcomes

  • Incidence and severity of adverse events (AEs)
  • Objective Response Rate (ORR)
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: 2022-08-17
Completion: 2027-09
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 175 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • SKB264
  • KL-A167
Study Locations (2 sites)
Hunan Cancer Hospital, Changsha, Hunan 410031 China
Jiangsu Province Hospital, Nanjing, Jiangsu 210029 China
Eligibility Criteria
Inclusion Criteria: 1. Males or females aged ≥ 18 and ≤ 75 years at the time of signing the informed consent form (ICF); 2. Histological and/or cytological diagnosis of TNBC or HR+/HER2- BC based on pathology reports on recent biopsy samples or other pathological samples (central laboratory confirmation is not required); 3. Patients have not received prior systemic chemotherapy for locally advanced, recurrent and metastatic disease; 4. Ability to provide fresh or archival tumor tissue for biomarker testing and analysis; 5. Patients with at least one measurable lesion per RECIST v1.1 criteria, and patients with only skin or bone lesions cannot be enrolled; 6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with an expected survival of ≥ 12 weeks; 7. Adequate organ and bone marrow function; 8. Patients must recover from all toxicities due to prior treatment (recovery to ≤ Grade 1 based on CTCAE v5.0 assessment, or meeting the inclusion criteria in the protocol) with the exception of alopecia and vitiligo; 9. Female subjects of childbearing potential and male patients with partners of childbearing potential who use effective medical contraception during the study treatment period and for 6 months after the end of dosing (see Appendix for specific contraceptive measures); 10. Patients voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures. Exclusion Criteria: 1. History of other malignancies; 2. Patients with a history of central nervous system (CNS) metastases or current CNS metastases. 3. Imaging (CT or MRI) shows that the tumor has invaded large blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study; 4. Received any systemic immune-stimulatory agents within 4 weeks prior to the first dose of study; Received any traditional Chinese medicine for approved anti-tumor indications within 2 weeks prior to the first dose of study; 5. Received other clinical investigational drugs within 4 weeks or major surgery within 4 weeks prior to the first dose of the study treatment; 6. Patients who required systemic corticosteroids (\> 10 mg/day prednisone or equivalent; low-dose corticosteroids are allowed, such as ≤10 mg/day prednisone or equivalent, if the dose is stable for 4 weeks), or other immunosuppressive therapy within 2 weeks prior to the first dose. Steroids are allowed as prophylaxis for hypersensitivity reactions; 7. Patients who occurred arteriovenous thrombosis within 6 months prior to the first dose of study treatment,Such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism, etc. 8. Prior treatment with a TROP2-targeted drug or checkpoint inhibitor ; 9. Serious or uncontrolled cardiac disease or clinical symptoms requiring treatment; 10. Patients with (noninfectious) interstitial lung disease (ILD) or history of pneumonia requiring steroid therapy; patients with serious pulmonary function impairment due to lung disease; 11. Uncontrolled systemic disease as judged by the investigator, included uncontrolled hypertension, uncontrolled diabetes, pesence of pleural effusion, pericardial effusion, or ascites that is clinically symptomatic or requires repeated drainage; 12. Active autoimmune disease requiring systemic treatment within the past 2 years; 13. Active hepatitis B or hepatitis C; known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); positive syphilis antibody test; 14. Known hypersensitivity to the study drug or any of its components, or severe allergic reactions to other monoclonal antibodies; 15. Pregnant or lactating women; 16. Any patient whose condition deteriorates rapidly during the screening process prior to the first dose, such as severe changes in performance status, unstable pain requiring adjustment of analgesic therapy, etc; 17. Other circumstances that, in the opinion of the investigator, are not appropriate for participation in this study.
Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression
NCT05450432
Recruiting
Conditions Major Depressive Disorder
Phase PHASE4
Enrollment 100
Locations 1 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Ketamine
  • Esketamine

Primary Outcomes

  • Feasibility - Retention
  • Feasibility - Drop-out Rates
  • Tolerability - Cognitive Function and Side Effects
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2022-10-13
Completion: 2026-06-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Massachusetts General Hospital
Collaborators: American Foundation for Suicide Prevention
Contact Information
Study Contact:
Cristina Cusin, MD
617-724-5510
mghketamindstudy@partners.org
Catherine Schuessler, BS
617-643-7690
mghketamindstudy@partners.org
Interventions
  • Ketamine
  • Esketamine
Study Locations (1 sites)
Massachusetts General Hospital, Boston, Massachusetts 02114 United States
Eligibility Criteria
Inclusion Criteria: 1. Inpatient at a psychiatric unit (or MGH medical unit, awaiting transfer to psychiatry). 2. Male and female, 18-70 years of age, inclusive, at screening. 3. Diagnosis of MDD, single or recurrent, and currently experiencing a major depressive episode (MDE) at least eight weeks in duration, prior to screening, according to the criteria defined in the Diagnosis and Statistical manual of Mental Disorders, Fifth Edition (DSM-5). The diagnosis of MDD will be made by a site psychiatrist and supported by the Mini-International Neuropsychiatric Interview (MINI). 4. Suicidal ideation determined by a minimum score of 1 on item 12 of the QIDS-C assessment and based on admission to the inpatient unit for suicidal thoughts or behaviors. 5. In good general health, as ascertained by medical history. If needed to verify health status, the investigator may order/conduct physical examination (PE) (including measurement of supine and standing vital signs), clinical laboratory evaluations, or ECG. 6. A status of non-childbearing potential or use of an acceptable form of birth control per the following specific criteria: 1\. Non-childbearing potential (e.g., physiologically incapable of becoming pregnant, i.e., permanently sterilized (status post hysterectomy, bilateral tubal ligation), or is post-menopausal with her last menses at least one year prior to screening); or 2. Childbearing potential, and meets the following criteria: 1. Childbearing potential, including women using any form of hormonal birth control, on hormone replacement therapy started prior to 12 months of amenorrhea, using an intrauterine device (IUD), having a monogamous relationship with a partner who has had a vasectomy, or is sexually abstinent. 2. Negative urinary pregnancy test at screening, confirmed by a negative urinary pregnancy test prior to receiving study treatment. 3. Willing and able to continuously use a method of birth control during the course of the study (implants, injectable or patch hormonal contraception, oral contraceptives, IUD, double-barrier contraception, sexual abstinence). The form of birth control will be documented at screening. 7\. Access to a mobile phone or computer with internet connection. 8. Ability to read, understand and provide written and dated informed consent prior to screening. 9\. Must have a provider to manage psychiatric medication, such as a psychiatrist, nurse practitioner, primary care physician, etc., either prior to admission or at discharge from the inpatient unit. Exclusion Criteria: 1. Any history of previous treatment with IV ketamine. 2. Pregnant or breastfeeding. 3. Subject of childbearing potential who is not willing to use birth control during the study. 4. Unstable medical illness, i.e., severe liver or kidney disease, uncontrolled hypertension, uncontrolled hyperthyroidism 5. Current diagnosis of a moderate to severe substance use disorder (excluding mild or moderate alcohol or cannabis use disorder which will be permitted), within the last six months prior to screening based on DSM-5 criteria. 6. History of bipolar disorder, or any psychotic symptoms in the current or previous depressive episodes. 7. An Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant to their MDD at any time within six months prior to screening (i.e., eating disorder, OCD, PTSD). 8. Currently receiving ECT treatment. 9. Currently receiving frequent or high dose benzodiazepines, opiates, barbiturates, or other CNS depressant medications, based on an increased risk of sedation in combination with ketamine. 10. Has dementia, delirium, amnestic, or any other primary cognitive disorder. 11. Has a clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results according to a licensed physician on the study staff. 12. Inability to consent to or comply with the study procedures. 13. Other medical issues: 1. Hypertension, (SBP ≥160 mmHg or DBP ≥100 mHg) at Screening - untreated 2. Recent myocardial infarction (within one year) 3. Lifetime history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder (e.g., Alzheimer's or Parkinson's Disease), epilepsy, mental retardation, or any other disease/procedure/accident/intervention which, according to the screening done by a licensed physician, is deemed associated with significant injury to or malfunction of the CNS, or history of significant head trauma within the past 2 years 4. Thyroid stimulating hormone (TSH) outside of the normal limits and clinically significant as determined by the Investigator. 5. Any other clinically significant abnormal laboratory result (determined as such by the Investigator and/or medical monitor) at the time of the screening. 6. Patients with diabetes mellitus fulfilling any of the following criteria: 1\. Unstable diabetes mellitus defined as glycosylated hemoglobin (HbA1c) \>8.5% at screening. 2\. Admitted to hospital for treatment of diabetes mellitus or diabetes mellitus- related illness in the past 12 weeks. g. Patients with a history of narrow angle glaucoma - untreated 14. Inability to comply with ketamine clinic safety procedures, including having reliable escorts to and from visits.
Treatment of Advanced or Metastatic Triple-negative Breast Cancer With Adoptive Therapy of PD1+ TILS
NCT05451784
Recruiting
Conditions Metastatic Triple-Negative Breast Carcin...
Phase PHASE1, PHASE2
Enrollment 20
Locations 4 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

  • PD1+ TILs (NUMARZU-001) product infusion

Primary Outcomes

  • Incidence of grade 3-5 adverse event (AE)
  • Overall response rate (ORR)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Recruiting
Start Date: 2022-07-20
Completion: 2027-09-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fundacio Clinic Barcelona
Collaborators: SOLTI Breast Cancer Research Group
Principal Investigators:
  • Aleix Prat (STUDY_CHAIR) - Hospital Clinic
  • Laura Angelats (STUDY_CHAIR) - Hospital Clinic
Contact Information
Study Contact:
Tomás Pascual
+ 34 933 436 302
tomas.pascual@gruposolti.org
Laura Angelats
LANGELATS@clinic.cat
Interventions
  • PD1+ TILs (NUMARZU-001) product infusion
Study Locations (4 sites)
Hospital Universitari Vall d'Hebrón, Barcelona, 08035 Spain
Hospital Clinic de Barcelona, Barcelona, 08036 Spain
Hospital 12 de Octubre, Madrid, 28041 Spain
Clínica universidad de Navarra, Pamplona, 31008 Spain
Eligibility Criteria
Eligibility criteria for Part #1 (Molecular pre-screening: Determination of PD1 by mRNA analysis from an archival FFPE tumor sample): Participants are eligible to be included in the study only if all of the following criteria apply: 1. Age ≥ 18 years. 2. Estimated life expectancy of ≥6 months. 3. Histologically confirmed diagnosis of unresectable or metastatic breast cancer. 4. Histologically confirmed diagnosis of advanced triple-negative breast cancer (based on the most recently analyzed biopsy from locally recurrent or metastatic site, local laboratory) meeting the following criteria: HER2-negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+, and ER and PgR expressions \<10% as determined locally by IHC assay as per most recent ASCO/CAP guidelines. 5. Patients could have received a maximum of 5 lines of prior standard of care chemotherapy in the inoperable/metastatic setting. 6. Patients must not have history of other malignancy within the past 3 years with the following exceptions: adequately treated non-melanoma skin cancer without evidence of disease at the time of enrollment; adequately treated cervical carcinoma in situ without evidence of disease at the time of enrollment; adequately treated breast ductal carcinoma in situ without evidence of disease at the time of enrollment; prostatic intraepithelial neoplasia without evidence of prostate cancer at the time of enrollment; adequately treated superficial or in-situ carcinoma of the bladder without evidence of disease at the time of enrollment. 7. Subject likely to be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge. 8. Absence of psychiatric or physiologic history, substance abuse, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. 9. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 10. Pregnant or breastfeeding women will NOT be eligible. 11. Subject has known sensitivity to any of the products or components to be administered during dosing will NOT be eligible. 12. NOT having an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or sponsor staff directly involved in this trial, unless prospective institutional review board (IRB)/independent ethics committee (IEC) approval (by chair or designee) is given allowing an exception to this criterion for a specific subject 13. Patients must NOT have undergone prior allogeneic hematopoietic stem cell transplantation 14. Patients with a history or evidence of symptomatic autoimmune will NOT be eligible: glomerulonephritis, vasculitis, or other symptomatic autoimmune diseases, or active autoimmune disease or syndrome that has required systemic treatment in the past 2 years (ie, with the use of disease-modifying agents, corticosteroids or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 15. Absence of active bacillus tuberculosis history. 16. Absence of a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required. 17. Absence of a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required. 18. To be able to provide either a newly obtained tumor biopsy (preferred) or archival tumor tissue of an FFPE tumor block. The tumor tissue should be of good quality based on total and viable tumor content and must be evaluated centrally for gene expression analysis prior to enrollment in Part #2. Eligibility criteria for Part #2 (Pre-Screening Phase: Selection, isolation and partial expansion of PD1+ TILs from a fresh tumor sample): Participants are eligible to be included in the study only if all the previous and the following criteria apply: 1. Patients will be eligible for Part #2 if they have a PD-1 mRNA expression above the 20th percentile in the FFPE tumor sample analyzed in Part 1. 2. At least 1 resectable target lesion 3. Patients must NOT have clinically active cerebral metastases. Carcinomatous meningitis is not allowed regardless of clinical stability. Eligibility criteria for Part #3 (Screening and treatment Phase: Complete expansion of PD1+TILs. Treatment of patients with PD1+ TILs infusion): Participants are eligible to be included in the study only if all of the previous and the following criteria apply. For being included in this section, the following criteria must apply: 1. PD1+ TILs selection in Part #1 and successful partial expansion of tumor sample in Part #2 2. Treatment-related toxicities (except alopecia and neuropathy G2) must ≤ Grade 1 at the time of allocation according to CTCAE version 5.0. 3. All patients must have received two or more prior systemic therapies, including at least one of them for advanced disease and an ADC. A maximum of five chemotherapy-based lines are permitted in the metastatic setting. Prior treatment should be discontinued 28 days or 5 half-lives, whichever is shorter, before day 1 of NMA-LD. 4. Measurable disease according to RECIST 1.1 criteria. 5. Adequate organ function determined within 28 days prior to enrollment. 6. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to enrollment. 7. For patients ≥ 60 years or patients who have a history of ischemic heart disease, chest pain, or clinically significant atrial and/or ventricular arrhythmias, a cardiac stress tests must be performed showing normal LVEF, NYHA functional classification \< class 1 and if any wall movement abnormalities, they must be reversible. 8. Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either ECHO or MUGA 9. Patients must not be currently receiving treatment with another investigational device or drug study. No other investigational procedures (of any kind) are permitted while participating in this study. 10. Systemic steroid therapy is not permitted (patients who require replacement therapy for adrenal insufficiency may be enrolled if the steroid treatment dose does not exceed 10 mg of prednisone or equivalent). 11. Patients with evidence of clinically significant immunosuppression will NOT be eligible. 12. Patients with evidence of (non-infectious) pneumonitis that required steroids or current pneumonitis will NOT be eligible.
Preoperative Irradiation for Stage I Breast Cancer
NCT05464667
Active, positions filled
Conditions Breast Cancer
Phase NA
Enrollment 15
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

  • Radiation Therapy (RT)

Primary Outcomes

  • Maximum tolerated dose (MTD)
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: 2023-07-07
Completion: 2030-01-09
Eligibility
Age: 50 Years
Sex: FEMALE
Volunteers: false
Enrollment: 15 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Parul Barry
Principal Investigators:
  • Parul Barry, MD (PRINCIPAL_INVESTIGATOR) - UPMC Hillman Cancer Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Radiation Therapy (RT)
Study Locations (1 sites)
UPMC Magee Womens Hospital - Radiation Oncology, Pittsburgh, Pennsylvania 15213 United States
Eligibility Criteria
Inclusion Criteria: 1. Pathologically confirmed diagnosis of breast cancer within 90 days from breast biopsy. NOTE: The day of biopsy is Day "0" 2. Patient biologically of the female sex 3. Must meet ALL the following criteria: 3.1. Age ≥ 50 years 3.2. Clinical size ≤ 3 cm (invasive) or ≤ 4 cm (DCIS) based on results of dedicated breast imaging. 3.3. All invasive subtypes and DCIS 3.4. ER positive, HER2/neu negative 3.5. No LVSI 3.6. Clinically negative lymph nodes based on results of dedicated breast imaging 4. The gross tumor should be \>1cm from the chest wall and the skin surface 5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 within 90 days prior to registration 6. Patients of child-bearing age should have either a negative urine or serum pregnancy test within 14 days of study entry. 7. Patients of child-bearing age should be non-pregnant and non-lactating. They should use a medically acceptable form of contraception during RT. 8. Patients must have signed this study's informed consent prior to study entry. Exclusion Criteria: 1. Clinically staged breast cancer that does not meet all of the criteria delineated in Inclusion criteria 3. 2. Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry 3. Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix, melanoma in situ) unless disease free for a minimum of 5 years prior to study entry 4. Non-epithelial breast malignancies such as sarcoma or lymphoma. 5. Two or more documented breast cancers within the index breast or bilateral breast cancer. 6. Suspicious unresected microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign. 7. Paget's disease of the nipple. 8. Male breast cancer. 9. Evidence of distant metastases. 10. Clinical regional lymph node involvement. 11. Prior RT to the region of the breast that would result in overlap of RT fields. 12. Intention to administer concurrent chemotherapy for current breast cancer. 13. Severe, active co-morbidity, defined as follows: 13.1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months 13.2. Transmural myocardial infarction within the last 6 months 13.3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 13.4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration 13.5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol 13.6. Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients. 14. Active connective tissue disorders/collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma. 15. Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent. 16. Unable to delineate tumor on pre-RT MRI and CT simulation scan.
The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study
NCT05464095
Recruiting
Conditions Pulmonary Arterial Hypertension
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

  • mHealth Intervention
  • Usual Care

Primary Outcomes

  • Change in Quality of Life as measured by the Short Form Survey (SF-36)
  • Change in Quality of Life as measured by the emPHasis-10
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-01-01
Completion: 2027-08-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Vanderbilt University Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigators:
  • Evan Brittain, MD (PRINCIPAL_INVESTIGATOR) - Vanderbilt Medical Center
Contact Information
Study Contact:
Alisha Lindsey, RT
615-322-3412
alisha.lindsey@vumc.org
Evan Brittain, MD
615-322-2318
evan.brittain@vumc.org
Interventions
  • mHealth Intervention
  • Usual Care
Study Locations (1 sites)
Vanderbilt University Medical Center, Nashville, Tennessee 37232 United States
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 or older. * Diagnosed with idiopathic, heritable, or associated (connective tissue disease, drugs, or toxins) pulmonary arterial hypertension (PAH), or PAH due to simple congenital heart disease (i.e. atrial septal defect). * WHO functional class I-III * Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed. * Forced vital capacity \>65% predicted with no or minimal interstitial lung disease based on reviews of imaging studies by PI and medical monitor. Exclusion Criteria: * Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity. * Pregnancy * Diagnosis of PAH etiology other than idiopathic, heritable, or associated. * Functional class IV heart failure * Requirement of \> 2 diuretic adjustment in the prior three months. * Preferred form of activity is not measured by an activity tracker (swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading).
Safety Assessment of T4090 Eye Drops in Ocular Hypertensive or Glaucomatous Patients.
NCT05389267
Active, positions filled
Conditions Glaucoma, Ocular Hypertension
Phase PHASE1, PHASE2
Enrollment 120
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

  • Kinezodianone R hydrochloride
  • Placebo

Primary Outcomes

  • Ocular and systemic adverse events
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: 2022-07-05
Completion: 2024-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Laboratoires Thea
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Kinezodianone R hydrochloride
  • Placebo
Study Locations (1 sites)
Dr EL-HARAZI, Glendale, California 91204 United States
Eligibility Criteria
Inclusion Criteria: * Informed consent dated and signed. * Both eyes diagnosed open-angle glaucoma or ocular hypertension Exclusion Criteria: * History of trauma, infection, clinically significant inflammation within the previous 6 months * Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s) * Pregnancy or breast-feeding
Phase I Human Analytics (HALO) Study
NCT05423860
Recruiting
Conditions Cardiovascular Diseases, Cancer, Dementi...
Phase Not Applicable
Enrollment 2000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • no interventions will be performed (observational)

Primary Outcomes

  • Prostate cancer Gleason score
  • Prostate cancer ISUP grade group
  • Prostate cancer staging parameters
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: 2022-03-16
Completion: 2037-03
Eligibility
Age: 45 Years
Sex: MALE
Volunteers: false
Enrollment: 2000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: HALO Diagnostics
Collaborators: HALO Affiliate Sites
Principal Investigators:
  • Christopher R. Hancock, MD (PRINCIPAL_INVESTIGATOR) - HALO Diagnostics
  • Erik W. Peterson, BS (STUDY_DIRECTOR) - HALO Diagnostics
Contact Information
Study Contact:
Christopher R Hancock, MD,MBA
760-776-8989
chris.hancock@halodx.com
Erik W Peterson
414-745-5773
ERIK.PETERSON@HALODX.COM
Interventions
  • no interventions will be performed (observational)
Study Locations (1 sites)
Desert Medical Imaging, Indian Wells, California 92210 United States
Eligibility Criteria
Inclusion Criteria: Treatment Naïve patients: * Male, 45 years of age or older. * Diagnosis of prostate adenocarcinoma. * Clinical stage T1c or T2a. * Gleason score of 7 (3+4 or 4+3) or less. * Three or fewer biopsy cores with prostate cancer. * PSA density not exceeding 0.375. * One, two, or three tumor suspicious regions identified on multiparametric MRI. * Negative radiographic indication of extra-capsular extent. * Karnofsky performance status of at least 70. * Estimated survival of 5 years or greater, as determined by treating physician. * Tolerance for anesthesia/sedation. * Ability to give informed consent. * At least 6 weeks since any previous prostate biopsy. * MR-guided biopsy confirmation of one or more MRI-visible prostate lesion(s) with Gleason score of 7 (3+4 or 4+3) or less. Salvage candidates will be accepted upon physician referral. Exclusion Criteria: * Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI. * Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater * History of other primary non-skin malignancy within previous three years. * Diabetes * Smoker
Acute Efficacy and 6 Months Follow up After Electroconvulsive Therapy
NCT05388461
Recruiting
Conditions Depressive Disorder
Phase Not Applicable
Enrollment 600
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

  • electroconvulsive therapy

Primary Outcomes

  • Change of Montgomery and Åsberg Depression Rating Scale (MADRS) score from pretreatment at posttreatment; MADRS range 0 - 60, with higher scores indicating more severe depression)
  • Change of Mini Mental State Examination (MMSE-NR) score from pretreatment at posttreatment; MMS-E range 0-30 with lower scores indicating more severe cognitive impairment
  • Change of Beck depression inventory (BDI) score from pretreatment at posttreatment; BDI range 0-63, with higher scores indicating more severe depression
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: 2013-03-13
Completion: 2028-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 600 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Haukeland University Hospital
Collaborators: Helse Stavanger HF
Contact Information
Study Contact:
Ute Kessler, PhD
ute.kessler@helse-bergen.no
Interventions
  • electroconvulsive therapy
Study Locations (2 sites)
Haukeland University Hospital, Bergen, 5021 Norway
Stavanger University Hospital, Stavanger, Norway
Eligibility Criteria
Inclusion Criteria: * Patients treated with ECT for major depression (F31.3-5, F32, F33) at Haukeland University Hospital or Stavanger University Hospital after 2013, * written consent to enrolment into the Regional Register for neurostimulation. Exclusion Criteria: * ECT performed on other indications than major depression. * No consent to the register.
Family-Centered Treatment for Depression in Hispanic Youth
NCT05407051
Active, positions filled
Conditions Depression, Family Research, Teen Depres...
Phase NA
Enrollment 41
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

  • Family Centered Treatment
  • Treatment as Usual

Primary Outcomes

  • Change in Patient Health Questionnaire-9
  • Change in Generalized Anxiety Disorder-7
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2022-09-30
Completion: 2024-10-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 41 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: MetroHealth Medical Center
Principal Investigators:
  • Brittany Myers, PhD (PRINCIPAL_INVESTIGATOR) - MetroHealth Systems
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Family Centered Treatment
  • Treatment as Usual
Study Locations (1 sites)
MetroHealth Medical Center, Cleveland, Ohio 44109 United States
Eligibility Criteria
Inclusion Criteria: * Teens 12+ seen in pediatric Hispanic clinic will be screened using the Patient Health Questionnaire -9 for depression as a part of standard clinic protocols. Parents of teens 12+ who screen positive for depression who also screen positive for mental health concerns may be included in the study. Parents who participate in the initial survey but who do NOT screen positive for any of their own mental health concerns will be given a list of mental health referrals and crisis numbers but will not be eligible to participate in the rest of the study or any follow-up calls. Parents or legal guardians may be included in the study if their teen is over the age of 12, being seen in the pediatric Hispanic clinic, screens positive for depression during pediatric visit, and if parents then screen positive for any mental health concern during the initial survey. Exclusion Criteria: * Adults unable to consent * Pregnant women * Prisoners
Machine Learning to Reduce Hypertension Treatment Clinical Inertia
NCT05406336
Not yet recruiting
Conditions Hypertension
Phase NA
Enrollment 50
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Predicted uncontrolled BP status (yes/no) at follow up visit, derived using a machine learning algorithm

Primary Outcomes

  • Vignette #1 - antihypertensive medication treatment intensification
  • Vignette #2 - antihypertensive medication treatment intensification
  • Vignette #3 - antihypertensive medication treatment intensification
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2025-04-25
Completion: 2025-07-31
Eligibility
Age: 20 Years
Sex: ALL
Volunteers: true
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Temple University
Principal Investigators:
  • Gabriel Tajeu, DrPH (PRINCIPAL_INVESTIGATOR) - University of Alabama at Birmingham
Contact Information
Study Contact:
Gabriel Tajeu, DrPH
2055312258
gtajeu@uab.edu
Interventions
  • Predicted uncontrolled BP status (yes/no) at follow up visit, derived using a machine learning algorithm
Eligibility Criteria
Inclusion Criteria: practicing primary care clinicians who see patients (i.e., internal medicine, family medicine, attending physicians, nurse practitioners) will be eligible to participate - Exclusion Criteria: \-
Brain Stimulation for Severe Depression
NCT05393622
Recruiting
Conditions Depression Severe
Phase NA
Enrollment 20
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • INTRACALVARIAL PREFRONTAL CORTICAL STIMULATION (IpCS) IN SEVERE TREATMENT-RESISTANT DEPRESSION

Primary Outcomes

  • Change in depression symptoms
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-07-28
Completion: 2027-12
Eligibility
Age: 21 Years
Sex: ALL
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Inner Cosmos Inc
Collaborators: Washington University School of Medicine, Massachusetts General Hospital
Principal Investigators:
  • Eric Lenze, MD (PRINCIPAL_INVESTIGATOR) - Washington University School of Medicine
Contact Information
Study Contact:
Arthur Gribetz
+1 917 732 2102
arthur@innercosmos.io
Interventions
  • INTRACALVARIAL PREFRONTAL CORTICAL STIMULATION (IpCS) IN SEVERE TREATMENT-RESISTANT DEPRESSION
Study Locations (2 sites)
Massachusetts General Hospital, Boston, Massachusetts 02114 United States
Washington University in St Louis School of Medicine, St Louis, Missouri 63110 United States
Eligibility Criteria
Inclusion Criteria: To be eligible for this study, a subject must meet all the following inclusion: 1. Subject has a diagnosis of chronic (≥ two years) or recurrent (multiple prior episodes) depression and is currently experiencing a major depressive episode as defined by DSM V criteria. 2. Subject meets a pre-treatment baseline threshold with MADRS score of \>/=20 3. Subject has not had an sustained response to two or more adequately dosed antidepressant treatments from at least two different antidepressant treatment classes in the current depressive episode according to the Antidepressant Treatment History Form (ATHF) (Gaynes, 2020). 4. The subject has completed all baseline testing to determine eligibility for the implant surgery (approximately 3 \& 2 weeks prior to expected date for implant surgery, CT \& MRI brain scans and cognitive testing). 5. Female subject is not pregnant, agrees to use adequate birth control, or is not capable of becoming pregnant (e.g. post-menopausal, no uterus, ligation of fallopian tubes, surgical removal of ovaries) 6. Subject is between the ages of 21 and 80. 7. Subject is able to complete the evaluations needed for this study including the high resolution CT and MRI brain imaging scans. 8. Subject is able to provide written informed consent and has signed the consent form for participation in this study. Exclusion Criteria: The presence of any of the following will exclude a subject from the study: 1. The IpCS would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the patient. 2. Subject is expected to require full body magnetic resonance imaging (MRI) during the clinical study. 3. Subject is judged by the investigator to be acutely suicidal (e.g., within the 30 days prior to the IpCS implant, the subject has made a suicide attempt or gesture or has made specific plans or preparation to commit suicide). 4. Subject has a history of schizophrenia, schizoaffective disorder, or other psychotic disorder, or a current major depressive episode that includes psychotic features (commonly referred to as psychotic depression) according to the DSM V criteria. 5. Subject has a neurological disorder like Epilepsy, Dementia, Delirium, Amnestic disorder, and cognitive impairment. 6. Subject has a history of brain injury that resulted in cognitive impairment. 7. Subject has history of bony disorders (changes in bone density may impact the safe and effective use of the device as well a device implantation). 8. Female subjects with a positive urine pregnancy test. 9. Subject is taking a MAO inhibitor drug e.g., Isocarboxazid (Marplan), Phenelzine (Nardil), Selegiline (Emsam), or Tranylcypromine (Panate) that may pose risk for general anesthesia. The Coordinator will Identify MAOI drug and discuss with PI. 10. Subject and/or Subject's psychiatrist DISAGREES with holding constant the subject's ongoing pharmacotherapy for 4 months following enrollment. 11. Presence of hyperostosis frontalis interna (operationally defined, frontal bone thickening of \>20mm), as determined by CT scan of the head, at the proposed site of the electrode implantation 5.3 Prohibited Therapy During Study Period No drug is prohibited, with the exception of Monoamine oxidase inhibitors (MAOIs) if they are posing a risk for general anesthesia. If a subject presents on a MAOI, this will be brought to the PI's attention for discussion with the anesthesiologist. Subjects will follow study protocol of IpCS-D. In brief, after enrolling in the IpCS-D study, all subjects will have their ongoing pharmacotherapy held constant for four months. After the 4 months, all drugs for treating mood disorders are allowed.
Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve
NCT05397106
Active, positions filled
Conditions Hydrocephalus, Hydrocephalus in Children...
Phase Not Applicable
Enrollment 160
Locations 9 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • CODMAN CERTAS Plus Programmable Valve

Primary Outcomes

  • Precise Device Placement: Maintaining Integrity and Functionality at 30 Days Post-Deployment
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: 2023-01-24
Completion: 2029-01-24
Eligibility
Age: No restriction
Sex: ALL
Volunteers: false
Enrollment: 160 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Integra LifeSciences Corporation
Principal Investigators:
  • Sherese Fralin, MSN, FNP, PhD (STUDY_DIRECTOR) - Integra LifeSciences
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • CODMAN CERTAS Plus Programmable Valve
Study Locations (9 sites)
University Hospital Leuven, Leuven, Belgium
AZ Delta - Roeselare, Roeselare, Belgium
Klinikum Dortmund Wirbelsäulenchirurgie, Dortmund, Germany
Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf, Düsseldorf, 40225 Germany
Universitätsklinikum Essen, Essen, Germany
Freiburg University Hospital, Freiburg im Breisgau, Germany
Katharinenhospital - Neurochirurgische Klinik Stuttgart, Stuttgart, Germany
Hospital12 de Octubre, Madrid, Spain
Canton Hospital St. Gallen, Sankt Gallen, Switzerland
Eligibility Criteria
Inclusion Criteria: 1. Patient and/or legally authorized representative has agreed to participate in the study by signing the EC-approved consent form, where applicable. 2. Patients (of any age) who underwent or who plan to have a surgical procedure utilizing one of the Codman CERTAS Plus Programmable Valves. 3. Patient (legally designated representative) is willing to comply with the study protocol timelines \& requirements. 4. For patients who have had the Codman CERTAS Plus Programmable Valve implanted prior to study enrollment, have available data from implantation to the current time. Exclusion Criteria: 1. Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as a revision procedure. 2. Patient's planned shunt has distal drainage to the heart. 3. Patient has ventriculitis, peritonitis or meningitis. 4. Patient has sepsis. 5. Patient has a history of poor wound healing. 6. Patient has symptoms pertaining to a skin infection at or near the site of any incisions; an ear infection on either side; a respiratory tract infection; or a urinary tract infection that, in the Investigator's opinion is clinically significant and might compromise the outcome of this study. 7. Patient has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant. 8. Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this study. 9. Patient is currently enrolled in another drug or device trial or has been previously entered in this trial. 10. Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator. 11. Patients with known hypersensitivity to rifampin or clindamycin hydrochloride. This criterion applies for patients to be treated with the BACTISEAL Catheters (included in some models of the valve) only.
Caribbean and South America Team-based Strategy to Control Hypertension
NCT05405920
Active, positions filled
Conditions Hypertension, Blood Pressure
Phase NA
Enrollment 1280
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Team-based Care Strategy for Hypertension Control
  • Enhanced Usual Care

Primary Outcomes

  • Net difference in mean change of systolic blood pressure
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: 2023-02-01
Completion: 2026-08-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1280 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Tulane University
Collaborators: National Institutes of Health (NIH), Universidad de Santander, The University of The West Indies
Principal Investigators:
  • Jiang He, MD, PhD (PRINCIPAL_INVESTIGATOR) - Tulane University
  • Marshall Tulloch-Reid, MBBS, DSc (PRINCIPAL_INVESTIGATOR) - The University of The West Indies
  • Patricio López-Jaramillo, MD, PhD (PRINCIPAL_INVESTIGATOR) - Universidad de Santander
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Team-based Care Strategy for Hypertension Control
  • Enhanced Usual Care
Study Locations (2 sites)
20 primary care clinics in Colombia, Santander, Colombia
20 primary care clinics in Jamaica, Kingston, Jamaica
Eligibility Criteria
Inclusion criteria for clinics: * Serving \>300 hypertensive patients during the previous year * Clinic visits and BP medications are free of charge to patients * Not sharing physicians, nurses, pharmacists, or community health workers (CHWs) with other clinics Inclusion criteria for participants: * Men or women aged ≥ 21 years who receive primary care from participating clinics * Average untreated BP ≥140/90 mm Hg among individuals without a history of clinical cardiovascular disease (CVD), chronic kidney disease (CKD), or diabetes; average untreated BP ≥130/80 mm Hg among individuals aged ≥65 years or those with clinical CVD, CKD, or diabetes; or average treated BP ≥130/80 mm Hg from six BP readings at two screening visits * Not pregnant or planning to become pregnant in the next 18 months * Able and willing to give informed consent * No plans to change primary care clinic in the next 18 months * Not an immediate family member of staff at the primary care clinic
Study to Evaluate the Effect of Improving Systolic BP and LDL-C Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab
NCT05411887
Active, positions filled
Conditions Hyperlipidemias, Hypertension
Phase Not Applicable
Enrollment 2845
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

  • Rosuvastatin, Olmesartan Medoxomil

Primary Outcomes

  • absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C)
  • absolute change and rate of change in systolic and diastolic blood pressure
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: 2022-06-20
Completion: 2025-12-31
Eligibility
Age: 19 Years
Sex: ALL
Volunteers: false
Enrollment: 2845 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Daewoong Pharmaceutical Co. LTD.
Principal Investigators:
  • JaeWon Oh (PRINCIPAL_INVESTIGATOR) - Severance Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Rosuvastatin, Olmesartan Medoxomil
Study Locations (1 sites)
Severance Hospital, Seoul, South Korea
Eligibility Criteria
Inclusion Criteria: 1. men and women over the age of 19 2. Patients who signed a written consent form to participate in the study 3. Patients who are eligible for Olostar tablet prescription according to domestic permission Exclusion Criteria: 1. A person who falls under "2. Do not administer to the following patients" among the precautions for use in the user manual 2. Patients in hospital (hospitals only; nursing care facilities can be recruited) 3. A person who has been administered the study target drug or is being administered at the time of recruitment within 6 months based on the date of the study contract
To Improve Depressive Symptoms Using a Web-App
NCT05405803
Recruiting
Conditions Depression
Phase NA
Enrollment 300
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

  • Web-App based Lifestyle Physical Activity Promotion Program
  • The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelines

Primary Outcomes

  • Change in Center for Epidemiologic Studies Depression Scale-Korean (CESD-K)
  • Change in Acculturation Stress Scale (ASS)
  • Change in Social Readjustment Rating Scale (SRRS)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-12-12
Completion: 2026-10
Eligibility
Age: 40 Years
Sex: FEMALE
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Texas at Austin
Collaborators: National Institute of Nursing Research (NINR)
Principal Investigators:
  • Eun-Ok Im, PhD, MPH (PRINCIPAL_INVESTIGATOR) - The University of Texas at Austin
Contact Information
Study Contact:
Wonshik Chee, PhD
512-232-2121
wpapp.help@austin.utexas.edu
Interventions
  • Web-App based Lifestyle Physical Activity Promotion Program
  • The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelines
Study Locations (1 sites)
The University of Texas at Austin, Austin, Texas 78712 United States
Eligibility Criteria
Inclusion Criteria: * self-reported midlife Korean-American women * aged 40 to 60 years * whose parents and grandparents are of Korean descent; * who can read and write English or Korean; * who currently reside in the United States; * who are sedentary (without any disabilities preventing physical activity); * who are online through computers or mobile devices; * have experienced depressive symptoms during the past two weeks (1 to 10 on the Patient Health Questionnaire \[PHQ-9\],which is equivalent to the cut-point of minimal to moderate depression. Exclusion Criteria: * major signs or symptoms suggestive of pulmonary or CVD * history of a myocardial infarction, stroke, or Type I diabetes mellitus * blood pressure higher than 160/100 mm Hg * Use of beta-blockers, diltiazem, or verapamil
A Study for the Adjuvant Treatment of Breast Cancer
NCT05420467
Recruiting
Conditions Breast Cancer
Phase PHASE4
Enrollment 2413
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

  • Docetaxel
  • Carboplatin
  • Trastuzumab
  • Pertuzumab
  • Nab paclitaxel

Primary Outcomes

  • 5-year DFS
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2022-07-10
Completion: 2027-12-20
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 2413 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Information
Study Contact:
Yiding CHEN
13605719519
ydchen@zju.edu.cn
Huihui CHEN
571-87784527
huihuicyj@zju.edu.cn
Interventions
  • Docetaxel
  • Carboplatin
  • Trastuzumab
  • Pertuzumab
  • Nab paclitaxel
Study Locations (1 sites)
2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang 310000 China
Eligibility Criteria
Inclusion Criteria: 1. Female patients aged ≥18 years; 2. Histopathologically or cytologically confirmed breast cancer patients with the following characteristics:1. stage I to III breast cancer; 2. operable primary lesion with no evidence of distant metastasis (M0); 3. known hormone receptor status (estrogen receptor \[ER\], progesterone receptor \[PR\]) and HER2 status with known Ki67 expression levels; (ER/PR positive defined as stained cells \>1%, HER2 positive defined as IHC 3+ or IHC 2+ with a positive FISH test); 4. Triple-negative breast cancer (TNBC): ER/PR negative, HER2 negative; tumor \>2cm or lymph node metastasis with clear postoperative pathological evidence; Luminal breast cancer: ER\>1%, HER2 negative, postoperative pathological evidence definite lymph node metastasis (different adjuvant chemotherapy regimens depending on whether the lymph nodes are N1 or N2-3); HER2-positive breast cancer: HER2-positive, regardless of ER/PR status; (the above classification determines enrollment and adjuvant therapy, and does not represent the corresponding molecular typing definition); 5. Patients who have undergone breast cancer resection and systemic intrathoracic lymph node dissection; surgical resection is R0 resection; patients who need postoperative adjuvant chemotherapy as judged by the investigator; 6. Start of adjuvant therapy within 21 days of the time of surgery is appropriate ; 7. ECOG physical fitness score of 0-1 with an expected survival of \>6 months ; 8. Patients have not been treated with a paclitaxel regimen prior to enrolment ; 9. Adjuvant chemotherapy should not be performed concurrently with endocrine therapy drugs such as tamoxifen/aromatase inhibitors or postoperative radiotherapy; 10. Women of childbearing age must have taken reliable contraceptive measures, or performed a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and be willing to use appropriate contraceptives during the trial and 8 weeks after the last dose of the trial drug; 11. Electrocardiogram (ECG) and echocardiography must confirm normal cardiac function within 3 months prior to randomization. Left ventricular ejection fraction (LVEF) must be ≥55% for patients receiving anthracycline-containing chemotherapy regimens and targeted therapy ; 12. Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal; AST and ALT ≤3 times the upper limit of normal; total bilirubin ≤1.5 times the upper limit of normal, or ≤2.5 times the upper limit of normal when the patient has Gilbert's syndrome ; 13. Bone marrow function: neutrophils≥1.5×109/L, platelets≥100×109/L, hemoglobin≥90g/L; 14. Able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits during the study period; 15. Subjects have the ability to understand, agree and sign the Informed Consent Form (ICF) for the study prior to initiating any protocol-related procedures; subjects have the ability to express consent (if applicable). Exclusion Criteria: 1. Advanced and/or inoperable patients with distant metastasis confirmed by imaging evidence or pathology; 2. Other malignant tumors have occurred in the past 5 years, except for skin cancers of cured cervical carcinoma in situ and non-melanoma; 3. Pregnant or breastfeeding women; patients with childbearing potential who are unwilling or unable to take effective contraceptive measures; 4. The molecular status of ER/PR and HER2 and Ki67 cannot be determined; 5. Patients with CNS metastases or \> grade 1 peripheral neuropathy; 6. Severe cardiovascular disease: Grade II or higher myocardial ischaemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥ 470 ms); Grade III-IV cardiac insufficiency according to NYHA criteria, or cardiac ultrasound indicating a left ventricular ejection fraction (LVEF) of \<50%; 7. Patients with hypertension that cannot be reduced to the normal range after antihypertensive medication (systolic blood pressure\>140 mmHg, diastolic blood pressure\>90 mmHg); 8. Received major surgical operations or suffered severe traumatic injury, fracture or ulcer within 4 weeks of enrollment; 9. Patients with severe myelosuppression at screening; 10. Patients with severe liver dysfunction (Child's Class III) or renal dysfunction at screening ; 11. Arterial/venous thrombotic events such as cardiovascular and cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction, myocardial infarction), deep vein thrombosis and pulmonary embolism, that occurred within 6 months before randomization; 12. Patients with hypersensitivity to any of the components of albumin paclitaxel, epirubicin, cyclophosphamide, docetaxel, trastuzumab, and pertuzumab; 13. Patients with psychiatric disorders; 14. Subjects who are participating in another clinical study or whose first dose was administered less than 4 weeks (or 5 half-lives of the study drug) from the end of the previous clinical study (last dose) ; 15. The investigator judges other situations that may affect the clinical research and the judgment of the research results and are not suitable for inclusion in the research.
Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes.
NCT05401357
Recruiting
Conditions Glaucoma, Open-Angle, Ocular Hypertensio...
Phase PHASE3
Enrollment 168
Locations 9 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Test - Bimatoprost 0.01% Ophthalmic Solution
  • Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)

Primary Outcomes

  • Mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2022-06-29
Completion: 2022-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 168 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Amneal Pharmaceuticals, LLC
Collaborators: CBCC Global Research
Contact Information
Study Contact:
Ilesh Changela, MBBS; MD
+91-79-67778300
ilesh@amnealindia.com
Interventions
  • Test - Bimatoprost 0.01% Ophthalmic Solution
  • Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)
Study Locations (9 sites)
Eye Research Foundation Inc., Newport Beach, California 92663 United States
North Bay Eye Associates, Inc., Petaluma, California 94954 United States
Volusia Eye Associates, New Smyrna Beach, Florida 32169 United States
Clayton Eye Clinical Research, LLC, Morrow, Georgia 30260 United States
Coastal Research Associates, LLC, Roswell, Georgia 30076 United States
Toyos Clinic, Nashville, Tennessee 37215 United States
Keystone Research, Austin, Texas 78731 United States
Houston Eye Associates, North Loop, Houston, Texas 77008 United States
Cheyenne Eye Clinic & Surgery Center, Cheyenne, Wyoming 82001 United States
Eligibility Criteria
Inclusion Criteria: * Subjects willing and able to provide voluntary informed consent and to follow protocol requirements. * Male or females aged ≥18 years. * Subjects having body mass index (BMI) ≥18.50 kg/m2. * Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. * Subjects requiring treatment of both eyes and able to discontinue the use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period. * Adequate washout period prior to baseline of any ocular hypotensive medications as per the table below (to minimize potential risk to subjects due to intraocular pressure (IOP) elevations during the washout period, the Investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor in place of a sympathomimetic, alpha-agonist, beta-adrenergic blocking agent, or prostaglandin; however, all the subjects must have discontinued their ocular hypotensive medications for the minimum washout period. * Baseline (Day 0/hour 0) IOP ≥22 mm Hg and \<35 mm Hg in each eye, * Subjects' IOP is likely to be controlled with monotherapy as per the Investigator's discretion. * Baseline best corrected visual acuity equivalent to Snellen acuity of 20/100 or better in each eye, using a logarithmic visual acuity chart for testing at 10 feet (3 meters). * Women of childbearing potential (defined as women physiologically capable of becoming pregnant unless they are using an effective method of contraception during the dosing of the study drug) practicing any of the following acceptable methods of contraception: 1. Oral or parenteral (injection, patch, or implant) hormonal contraception which has been continuously used for at least 1 month prior to first dose of study medication 2. Intrauterine device (IUD) or intrauterine system (IUS) 3. Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent) 4. Male sterilization (at least 6 months prior to screening, should be the sole male partner for that subject) 5. Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation 6. Total abstinence; partial abstinence is not acceptable * No history of addiction to any recreational drug or drug dependence or alcohol addiction. Exclusion Criteria: * Female who are pregnant, lactating or planning a pregnancy. * Contraindication or known hypersensitivity to Bimatoprost, related class of drugs, or any of the excipients of formulation. * Current or past history of severe hepatic or renal impairment. * Current or history within 2 months prior to baseline of any other significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye (Note: stable myopia, strabismus, and cataracts as per the Investigator's discretion will be allowed provided that the other inclusion/exclusion criteria are met). * Current corneal abnormalities that would prevent accurate IOP readings with Goldmann applanation tonometer. * Functionally significant visual field loss in the Investigators' opinion. * Subject with corneal grafts. * Subject has contraindication to pupil dilation * Use at any time prior to baseline of an intraocular corticosteroid implant * Use of contact lens within 1 week prior to baseline * Use within 2 weeks prior to baseline of 1) a topical ophthalmic corticosteroid or 2) a topical corticosteroid * Use within 1 month prior to baseline of 1) a systemic corticosteroid or 2) high dose salicylate therapy defined as 325 mg/day and taken on 3 consecutive days. * Use within 6 months prior to baseline of intravitreal or subtenon injection of an ophthalmic corticosteroid * Underwent within 6 months prior to baseline any other intraocular surgery (e.g., cataract surgery). * Underwent within 12 months prior to baseline any refractive surgery, filtering surgery, or laser surgery for IOP reduction (e.g., laser trabeculoplasty). * Amblyopia - only one sighted eye. * Subjects with a history of IOP previously uncontrolled on bimatoprost monotherapy * Significant ocular surface findings (e.g., hyperemia or irritation, mild or greater) in either eye found on gross macroscopic or slit lamp examination * Severe retinal disease or other severe ocular pathology, such as glaucomatous damage with a cup/disk ratio greater than 0.8 (not including physiological cupping in the Investigators' opinion) or split fixation * Chronic use of any systemic medication that may affect IOP with less than 3 months stable dosing regimen (i.e., sympathomimetic agents, beta-adrenergic blocking agents, alpha-agonists, alpha-adrenergic blocking agents, calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.) * Central Corneal thickness (CCT) \<450 microns or \>650 microns * Known history or presence of any uncontrolled systemic disease (e.g., cardiovascular disease, hypertension, diabetes mellitus, hepatic impairment, etc.) * History of recurrent ocular seasonal allergies within the past 2 years * Any other medical condition or serious intercurrent illness that, in the Investigator's opinion, may make it undesirable for the subject to participate in the study and would limit adherence to the study requirements * Participation in any clinical study within 90 days before the first dose of the study drug * Subjects with documented history of positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection * Subjects with positive urine pregnancy test * Subjects with confirmed novel coronavirus infection (COVID-19).
Moving Forward Together 4
NCT05409664
Active, positions filled
Conditions Breast Cancer, Physical Inactivity
Phase NA
Enrollment 68
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

  • Physical activity adoption
  • Self monitoring

Primary Outcomes

  • Accelerometer measured moderate-to-vigorous activity
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2022-11-10
Completion: 2026-01-31
Eligibility
Age: 21 Years
Sex: FEMALE
Volunteers: true
Enrollment: 68 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of South Carolina
Collaborators: University of Colorado, Denver, Brown University, InquisitHealth, Inc.
Principal Investigators:
  • Bernardine M. Pinto, PhD (PRINCIPAL_INVESTIGATOR) - University of South Carolina
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Physical activity adoption
  • Self monitoring
Study Locations (1 sites)
University of South Carolina, Columbia, South Carolina 29208 United States
Eligibility Criteria
Participants: Inclusion Criteria: * Diagnosed in the past 5 years with Stage 0-3 breast cancer * Able to read and speak English * Ambulatory * Sedentary (\<30 minutes of vigorous-intensity physical activity, \<90 min of moderate-intensity physical activity in the past 6 months) * Able to walk unassisted * Access to a smartphone with Bluetooth and internet Exclusion Criteria: * Stage 4 cancer * Medical or psychiatric problem that may interfere with protocol adherence Peer Mentor Coaches: Inclusion criteria: * Current peer coach (at least one year) * Have a valid email address, telephone access, and access to a tablet/computer * Willing to participate in group training * Willing to be supervised using platform * Currently exercise for at least 60 min/week of moderate-intensity activity
The Effect of Myofascial Chain Release Techniques on Shoulder Joint Range of Motion in Breast Cancer Survivors
NCT05386628
Recruiting
Conditions Breast Cancer Survivors
Phase NA
Enrollment 48
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

  • conventional physiotherapy
  • Manual lymphatic drainage
  • Myofascial relasing

Primary Outcomes

  • measurement of tissue stiffness (N/m)
  • measurement of passive muscle tone (Hz)
  • measurement of creep of tissue
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-08-15
Completion: 2025-07-15
Eligibility
Age: 30 Years
Sex: FEMALE
Volunteers: false
Enrollment: 48 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Istanbul Medeniyet University
Contact Information
Study Contact:
Nilüfer Kablan, PhD
+905067638556
niluferkablan@yahoo.com
Gülser Cinbaz, MSc
+905558503576
gulser.cinbaz@gmail.com
Interventions
  • conventional physiotherapy
  • Manual lymphatic drainage
  • Myofascial relasing
Study Locations (1 sites)
İstanbul Medeniyet University, Istanbul, Turkey (Türkiye)
Eligibility Criteria
Inclusion Criteria: * Women between the ages of 30-60 * Having breast surgery within 2 years * Not have received conservative treatment for shoulder rehabilitation in the last 6 months * Having limitation of movement of the shoulder joint due to breast surgery Exclusion Criteria: * Not having agreed to participate in the study * Having undergone radical mastectomy surgery * Having connective tissue disease * Presence of brachial plexus paresis/plegia * Presence of radiogenic fibrosis * Presence of additional orthopedic (scoliosis, etc.), neurological (multiple sclerosis, stroke, etc.) and rheumatological diseases (ankylosing spondylitis, rheumatoid arthritis, etc.) that will affect upper extremity functions * Presence of active metastases * Having undergone reconstruction surgery * Continuation of radiotherapy (must have ended at least 3 months ago) or chemotherapy applications * Having had a bilateral mastectomy * To develop lymphedema in the arm-trunk * Use of muscle relaxants * Patients with severe chemotherapy side effects (hyperesthesia, nausea, skin changes, weakness, etc.)