Condition: Late Life Depression (LLD), Depression - Major Depressive DisorderPhase: PHASE1, PHASE2Sponsor: Andre Russowsky Brunoni
The purpose of this research study is to determine the effectiveness of Transcranial direct current stimulation (tDCS) therapy in the treatment of participants with Late-life depression (LLD).
The study will evaluate feasibility, safety, and tolerability of high-dose (6mA) bilateral tDCS delivered as three daily sessions, 3 times a week, for 3 weeks in older adults (60 y/o and older) with late-life depression.
Condition: Triple Negative Breast CancerPhase: PHASE1, PHASE2Sponsor: Gilead Sciences
The goal of this clinical study is to learn more about the study drug sacituzumab govitecan-hziy (SG) given at an alternative dose and schedule, in participants with triple-negative breast cancer (TNBC).
The primary objectives of this study are to assess the safety and tolerability of SG given at alternate dose and schedule, to assess the effect on objective response rate (ORR) and progression-free survival (PFS).
Condition: End Stage Renal Disease, Hypertension, Extracellular Volume Overload, Intradialytic HypotensionPhase: NASponsor: VA Office of Research and Development
Kidney failure has been recognized as one of the most costly chronic conditions among United States Veterans. Approximately 13,000 Veterans develop kidney failure each year, and most require hemodialysis initiation. Hemodialysis patients suffer significantly increased risk of death and hospitalizations, and excessive body fluid is a major cause of this. While empiric aggressive fluid removal during dialysis is one approach to limit fluid overload, this can cause dangerous decreases in blood pressure during…
Condition: Open Angle Glaucoma (OAG)Phase: NASponsor: Avisi Technologies Inc.
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
Condition: Breast CancerPhase: NASponsor: ARTIDIS AG
This prospective, blinded, single-arm study aims to test the performance of nanomechanical phenotype in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment response compared to the gold standard of histopathological assessment. The study involves patients with suspicious breast lesions who will undergo a breast biopsy procedure indicated by standard of care. The nanomechanical phenotype will be measured on the freshly obtained breast biopsies or tissue from breast surgeries.
Condition: Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Development, Child, Parent-Child RelationsPhase: NASponsor: University of Texas Southwestern Medical Center
This study is being done to see if outcomes for both a premature infant's parents and the infant born prematurely who have spent time in the neonatal intensive care unit (NICU) can be improved through parent cognitive behavioral therapy (CBT) sessions.
Condition: Advanced HR+/HER2- Breast CancerPhase: PHASE1Sponsor: Novartis Pharmaceuticals
The purpose of this study is to evaluate the safety, tolerability and preliminary activity of IEV407 as a single agent and in combination with endocrine therapy (fulvestrant or letrozole) in patients with advanced hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-negative) breast cancer.
Condition: Solid Tumor, Small Cell Lung Cancer (SCLC), High Grade Neuroendocrine Cancer, Small Cell Carcinomas of Non-lung Origin, Non-small Cell Lung Cancer (NSCLC), Prostate Cancer, Ovarian Cancer, Renal Carcinoma (Clear and Non-clear Cell), Head and Neck Squamous Cell Carcinoma (HNSCC), Hepatic Cancer, Gastric Cancer, Triple-negative Breast Cancer (TNBC)Phase: PHASE1Sponsor: Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
The primary purpose of this study is to determine the safety, tolerability, and maximum tolerated dose (MTD) of EXS74539 (REC-4539) in participants with select solid tumors.
Condition: Colorectal Cancer, Epithelial Ovarian Cancer, Gastric Cancer, Invasive Lobular Breast Carcinoma, Pancreatic Ductal AdenocarcinomaPhase: PHASE1, PHASE2Sponsor: Blue Earth Diagnostics
This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of \[18F\]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).
Condition: Emotional Dysregulation, HRV, Adolescent, Family Relationship, DepressionPhase: Not ApplicableSponsor: University of Texas Southwestern Medical Center
This cross-sectional study examines associations among heart rate variability (HRV), emotional dysregulation, and parent-adolescent relationship quality in adolescents with Major Depressive Disorder (MDD). We hypothesize that lower HRV will be linked to greater emotional dysregulation and that more supportive parent-adolescent relationships will correlate with higher HRV. Participants will wear a Fitbit Charge 5 during nighttime sleep for 7 consecutive nights and complete validated measures of emotional regulation…
Condition: Prostate Cancer Castration-resistant Prostate Cancer, Breast Cancer, Colo-rectal Cancer, Lung Cancer (Non-Small Cell), Pancreas Cancer, Duct Cell AdenocarcinomaPhase: PHASE1, PHASE2Sponsor: MBrace Therapeutics
This is a multicenter, open-label FIH, Phase 1a (dose escalation), Phase 1b (dose expansion) and Phase 2 study in patients with advanced metastatic solid tumors refractory to standard treatment.
Condition: Suicidal Ideation, Suicide Attempt, Anxiety, Depression DisordersPhase: NASponsor: University of Texas Southwestern Medical Center
The goal of this pilot study is to test the effectiveness of a novel intervention for young adults (ages 18-27) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and improve mental health recovery by using outpatient services.
The current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medications, anticipated outpatient…
Condition: Elevated Blood Pressure, HypertensionPhase: NASponsor: Zona Health, Inc
The study will be a multi-center, randomized clinical trial to evaluate the safety and efficacy of using the Zona Plus handgrip therapy device compared to the use of an auditory relaxation therapy for treatment of high blood pressure and hypertension in subjects who are not currently taking antihypertensive medications. Half of the study subjects will also be randomized to record blood pressure at home throughout the study.
Condition: Breast Neoplasms, Breast CancerPhase: PHASE2Sponsor: Merck Sharp & Dohme LLC
Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. The main goals of this study are to learn:
* About the safety of the study treatments and if people tolerate them
* If people who receive patritumab deruxtecan, pembrolizumab, and chemotherapy before surgery have fewer cancer cells removed during surgery compared to those who receive only pembrolizumab (pembro) and…
Condition: Heart Failure, DiabetesPhase: NASponsor: University of Texas Southwestern Medical Center
A pragmatic electronic health record (EHR) based randomized controlled trial to evaluate the utility of providing Ultromics EchoGo analysis results and recommendations for HF risk prevention therapies using an EHR embedded clinical decision support tool.
Condition: Type 2 Diabetes, Diabetic Cardiomyopathy, Heart Failure, Cardiometabolic DiseasesPhase: NASponsor: University of Texas Southwestern Medical Center
A pragmatic, randomized clinical trial to evaluate the effect of a heart failure (HF) risk assessment and prevention strategy incorporating HF clinical risk scores (WATCH-DM) with cardiac biomarker (NT-proBNP) paired with a clinical decision support tool to implement an intensive prevention strategy among patients with high risk focused on implementation of evidence-based HF preventive therapies.
Condition: Breast CancerPhase: PHASE2Sponsor: University of Texas Southwestern Medical Center
1\. Efficacy of PULSAR preoperative radiation 2. Evaluate potential of microbubble CEUS as an alternative to operative SLNBx 3. Evaluate potential of OA to evaluate treatment response of pre-operative radiation on the tumor
Condition: AsthmaPhase: PHASE2Sponsor: University of Texas Southwestern Medical Center
Antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs), such as escitalopram are widely used for mood and anxiety disorders. However, they have also been explored, with promising findings, for a variety of disorders outside of psychiatry. Clinical studies of SSRIs in depressed people with asthma were associated with decreased asthma exacerbations and improvement in asthma control. In this study, the number of asthma exacerbations will be assessed as the primary outcome measure in patients…
Condition: Advanced Solid Tumor, Advanced Breast Cancer, Metastatic Breast Cancer, Hormone-receptor-positive Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Hormone Receptor Positive Malignant Neoplasm of Breast, HER2-negative Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast CancerPhase: PHASE1Sponsor: BeOne Medicines
This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.
Condition: Triple Negative Breast Cancer, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Lymphoma, Non-Hodgkin, Mantle Cell Lymphoma, Bladder Cancer, Uveal Melanoma, Recurrent, Cervix Cancer, Carcinoma in Situ, Head and Neck Squamous Cell Carcinoma, Skin Cancer, Metastatic Cancer, Tumor, Solid, Tumor RecurrencePhase: PHASE1Sponsor: OncoNano Medicine, Inc.
A phase 1, multicenter, open label, non-randomized dose escalation and dose expansion study to examine the maximum tolerated dose, (MTD), minimum effective dose (MED) and/or recommended dose for expansion (RDE) of intratumoral ONM-501 as monotherapy and in combination with a PD-1 checkpoint inhibitor in patients with advanced solid tumors and lymphomas.
Condition: Suicide, Suicidal IdeationPhase: NASponsor: Elizabeth Arnold
The overall aim of this study is to reduce suicide among sexual and gender diverse youth ages 18-24 years old. This study will compare the effectiveness of two brief suicide prevention interventions that have been adapted for use with this population to use in primary care via telehealth and will recruit youth from primary care clinics in multiple metropolitan areas. The primary study outcome is suicidal ideation. Each clinic will be randomly assigned to deliver one of the two study interventions.
Condition: Breast Cancer, Gastric Cancer, Gastroesophageal-junction CancerPhase: PHASE1Sponsor: Iksuda Therapeutics Ltd.
This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate, in patients with advanced solid tumors.
Condition: Severe Traumatic Brain Injury, Intracranial HypertensionPhase: NASponsor: Brain Trauma Foundation
The goal of this phase 1 randomized controlled safety and feasibility clinical trial are to determine the safety of external lumbar drainage (ELD) in select patients with severe Traumatic Brain Injury (TBI). The main questions it aims to answer are (i) if ELD is feasible and (ii) safe to perform in severe TBI patients who have radiological evidence of patent basal cisterns and midline shift \<5mm without increasing the risk of neurological worsening or cerebral herniation.
All participants will receive routine…
Condition: Ovarian Neoplasm, Depressive Symptoms, Quality of LifePhase: NASponsor: Baylor College of Medicine
This study will enroll 120 women living with ovarian cancer following completion of initial treatment. Our objective is to test an intervention designed to provide support during the survivorship transition for this population, who live with a high degree of morbidity related to the illness and its treatment as well as a high risk of recurrence. Study participants will be randomly assigned to receive survivorship care using the POSTCare-O process or usual care. The primary outcome is quality of life at 12 weeks…
Condition: Cognitive Decline, Blood Pressure, HypertensionPhase: NASponsor: University of Texas Southwestern Medical Center
The PCOT study is a multi-site randomized trial of patients 70 years or older with high BP. The main goal of the study Preventing Cognitive Decline by Reducing BP Target Trial (PCOT) is to conduct a large pragmatic clinical trial (PCT) to test the hypothesis that patients who receive care with a combination of clinical decision support (CDS) and team-based care delivered in primary care practices will have better blood pressure control and a lower incidence of mild cognitive impairment and dementia than patients…
Condition: Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness, Severe HypoglycemiaPhase: PHASE3Sponsor: Vertex Pharmaceuticals Incorporated
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
Condition: Treatment Resistant Depression, Undergoing Deep Brain Stimulation (DBS) SurgeryPhase: NASponsor: Nader Pouratian
Treatment resistant depression remains a major problem for individuals and society. Surgical procedures may provide relief for some of these patients. The most frequently considered surgical approach is deep brain stimulation (DBS) of a part of the brain called the subcallosal cingulate region. However, the effectiveness and safety is not well established. The investigators will use a novel approach using advanced imaging technique (magnetic resonance tractography) to evaluate the feasibility and safety of this…
Condition: Breast CancerPhase: PHASE2Sponsor: Weill Medical College of Cornell University
Newly diagnosed post-menopausal women with clinical stage II-III, HR+HER2- breast cancer are eligible to a randomized trial, concurrently open at five US academic institutions. Patients receiving 4 months of standard neoadjuvant hormonal therapy with letrozole are randomly assigned to one of 4 arms of a trial testing focal hypo-fractionated RT alone or with immunotherapy combinations.