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Condition of Interest |
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Quantitation of Glymphatic Functioning in Sleep and Meditative States
Parkinson Disease
Sleep
This involves development and application of magnetic resonance imaging (MRI) methods for
visualizing hemodynamic and metabolic relationships in healthy volunteers with advanced
meditation experience. expand
This involves development and application of magnetic resonance imaging (MRI) methods for visualizing hemodynamic and metabolic relationships in healthy volunteers with advanced meditation experience. Type: Interventional Start Date: Feb 2021 |
Clinical Outcomes of the ALPS Proximal Humerus Plating System
Proximal Humeral Fracture
The purpose of this study is to document the performance and clinical outcomes of the
A.L.P.S® Proximal Humerus Plating System.
Specific Aims:
- Conduct physical assessments measuring shoulder strength and range of motion,
physician assessment of radiographs
- Obtain patient-reported1 expand
The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System. Specific Aims: - Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs - Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions - Document revisions, complications, and adverse events Type: Observational Start Date: Aug 2017 |
Inherited CAncer REgistry
Cancer
The purpose of the Inherited CAncer REgistry (ICARE) Initiative is to provide individuals
interested in participating in studies focused on inherited cancer predisposition the
opportunity to enroll in a research registry. Efforts through the registry include, but
are not limited to, contribution of1 expand
The purpose of the Inherited CAncer REgistry (ICARE) Initiative is to provide individuals interested in participating in studies focused on inherited cancer predisposition the opportunity to enroll in a research registry. Efforts through the registry include, but are not limited to, contribution of data to observational studies, targeted gene-specific studies, and education and outreach efforts for both participants and recruiting healthcare providers. Participants are given the opportunity to learn about and participate in other efforts for which they may be eligible. All participants and recruiting healthcare providers receive educational newsletters twice per year which contain research and clinical updates in the field of cancer genetics. Providers who recruit patients can also access monthly web-based genetics case conferences which focus on different topics each month and are generally attended by a guest expert who provides background information on the topic as well as comments on the case presentations. Participation in ICARE involves completion of an informed consent form, baseline questionnaire, follow-up questionnaires every two years, and medical record/tumor releases, as applicable. There is no cost to participate and all correspondence can be facilitated through phone, email, or mail. Enrollment can be completed either through a traditional paper-based consenting method (i.e. postal mail) or through the online enrollment option available on the ICARE website (InheritedCancer.net). If you are a patient interested in learning more or a provider interested in recruiting to ICARE, please visit our website where you may complete an online contact form requesting a study team member contact you. Type: Observational [Patient Registry] Start Date: Feb 2017 |
Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
Huntington's Disease
Enroll-HD is a longitudinal, observational, multinational study that integrates two
former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North
America and Australasia-while also expanding to include sites in Latin America. More than
30,000 participants have now enrolled int1 expand
Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more. Type: Observational [Patient Registry] Start Date: Jul 2012 |
Use of Hand-held Dynamometry to Obtain Objective Measures of Lower Extremity Force Production With1
Chronic Stroke
Weakness, Muscle
This study wants to know if using handheld dynamometry (HHD) to test leg strength in
persons who have had a stroke, will reduce mistakes and give therapists better
information to use for therapy. This study will collect normal values of leg muscle peak
force production, cumulative peak force produc1 expand
This study wants to know if using handheld dynamometry (HHD) to test leg strength in persons who have had a stroke, will reduce mistakes and give therapists better information to use for therapy. This study will collect normal values of leg muscle peak force production, cumulative peak force production, and sustained peak force production in patients with chronic stroke. Type: Observational Start Date: Jun 2023 |
Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
Chronic Graft-versus-Host-Disease
Leukemia
Allogeneic Hematopoietic Stem Cell Transplantation
Blood Cancer
Non-Malignant Hematologic and Lymphocytic Disorder
This study will validate a previously developed pediatric prognostic biomarker algorithm
aimed at improving prediction of risk for the later development of chronic
graft-versus-host disease (cGvHD) in children and young adults undergoing allogeneic
hematopoietic stem cell transplant.
By developing1 expand
This study will validate a previously developed pediatric prognostic biomarker algorithm aimed at improving prediction of risk for the later development of chronic graft-versus-host disease (cGvHD) in children and young adults undergoing allogeneic hematopoietic stem cell transplant. By developing an early risk stratification of patients into low-, intermediate-, and high-risk for future cGvHD development (based upon their biomarker profile, before the onset of cGvHD), pre-emptive therapies aimed at preventing the onset of cGvHD can be developed based upon an individual's biological risk profile. This study will also continue research into diagnostic biomarkers of cGvHD, and begin work into biomarker models that predict clinical response to cGvHD therapies. Type: Observational Start Date: Nov 2020 |
Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer
Lung Cancer
RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high
risk of cancer for laboratory studies may help doctors learn more about changes that may
occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at molecular predictors o1 expand
RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at molecular predictors of cancer in patients at high risk of lung cancer. Type: Observational Start Date: Dec 2003 |
Providing Access to the Visual Environment
Vision Impairment
Providing Access to the Visual Environment is a pediatric low vision grant which has the
ability to provide comprehensive, interdisciplinary low vision rehabilitation services to
every child in Tennessee with a vision impairment. Children, ages 3-21, with
best-corrected vision of 20/50 or worse in1 expand
Providing Access to the Visual Environment is a pediatric low vision grant which has the ability to provide comprehensive, interdisciplinary low vision rehabilitation services to every child in Tennessee with a vision impairment. Children, ages 3-21, with best-corrected vision of 20/50 or worse in the better seeing eye are prescribed optical devices to improve their visual functioning and trained to use the devices. Type: Observational Start Date: Jul 2001 |
Clinical and Genetic Evaluation of Individuals With Undiagnosed Disorders Through the Undiagnosed D1
Genetic Disease
Without an explanation for severe and sometimes life-threatening symptoms, patients and
their families are left in a state of unknown. Many individuals find themselves being
passed from physician to physician, undergoing countless and often repetitive tests in
the hopes of finding answers and insig1 expand
Without an explanation for severe and sometimes life-threatening symptoms, patients and their families are left in a state of unknown. Many individuals find themselves being passed from physician to physician, undergoing countless and often repetitive tests in the hopes of finding answers and insight about what the future may hold. This long and arduous journey to find a diagnosis does not end for many patients- the Office of Rare Diseases Research (ORDR) notes that 6% of individuals seeking their assistance have an undiagnosed disorder. In 2008, the National Institutes of Health (NIH) Undiagnosed Diseases Program (UDP) was established with the goal of providing care and answers for these individuals with mysterious conditions who have long eluded diagnosis. The NIH UDP is a joint venture of the NIH ORDR, the National Human Genome Research Institute Intramural Research Program (NHGRI-IRP), and the NIH Clinical Research Center (CRC) (1-3). The goals of the NIH UDP are to: (1) provide answers for patients with undiagnosed diseases; (2) generate new knowledge about disease mechanisms; (3) assess the application of new approaches to phenotyping and the use of genomic technologies; and (4) identify potential therapeutic targets, if possible. To date, the UDP has evaluated 3300 medical records and admitted 750 individuals with rare and undiagnosed conditions to the NIH Clinical Center. The NIH UDP has identified more than 70 rare disease diagnoses and several new conditions. The success of the NIH UDP prompted the NIH Common Fund to support the establishment of a network of medical research centers, the Undiagnosed Diseases Network (UDN), for fiscal years 2013-2020. The clinical sites will perform extensive phenotyping, genetic analyses, and functional studies of potential disease-causing variants. The testing performed on patients involves medically indicated studies intended to help reach a diagnosis, as well as research investigations that include a skin biopsy, blood draws, and DNA analysis. In addition, the UDN will further the goals of the UDP by permitting the sharing of personally identifiable phenotypic and genotypic information within the network. By sharing participant information and encouraging collaboration, the UDN hopes to improve the understanding of rare conditions and advance the diagnostic process and care for individuals with undiagnosed diseases. Type: Observational Start Date: Sep 2015 |
A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate1
Crohn's Disease
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in
participants with moderately to severely active Crohn's disease. Study 1's primary
hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the
proportion of participants achieving clinica1 expand
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Type: Interventional Start Date: Jun 2024 |
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilep1
Generalized Epilepsy
The purpose of this study is to determine whether BHV-7000 is effective in the treatment
of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an
additional open-label extension (OLE) phase. expand
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase. Type: Interventional Start Date: Jun 2024 |
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and1
Osteogenesis Imperfecta
The primary objective of this study is to evaluate the effect of romosozumab treatment
for 12-months compared with bisphosphonate(s) on the number of clinical fractures at
12-months; the number of any fractures at 12-months and change in lumbar spine bone
mineral density (BMD) Z-score at 6-months. expand
The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months. Type: Interventional Start Date: Apr 2024 |
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
Immunization; Infection
Transplantation Infection
Influenza
Influenza virus is a significant pathogen in pediatric solid organ transplant (SOT)
recipients. However, these individuals respond poorly to standard-dose (SD) inactivated
influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor
immune responses in SOT recipients: (1 expand
Influenza virus is a significant pathogen in pediatric solid organ transplant (SOT) recipients. However, these individuals respond poorly to standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. One study compared HD-IIV vs. SD-IIV in adult SOT recipients and noted that HD-IIV was safe and more immunogenic; however, the median post-transplant period was 38 months. A phase I pediatric study comparing a single dose of HD-IIV vs. SD-IIV was safe with higher immunogenicity, but the study was limited by small sample size and median post-transplant vaccine administration was 26 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV one month apart compared to one-dose of SD-IIV revealed modestly increased immunogenicity when given at a median of 18 months post-transplant. Therefore, these studies lack both evaluation in the early post-transplant period and substantive pediatric populations. Additionally, the administration of two-doses of HD-IIV in the same influenza season has not been evaluated in pediatric SOT recipients. Thus, the optimal immunization strategy for pediatric SOT recipients less than 24 months post-transplant is unknown. In addition, immunologic predictors and correlates of influenza vaccine immunogenicity in pediatric SOT recipients have not been well-defined. The central hypothesis of our proposal is that pediatric SOT recipients 1-23 months post-transplant who receive two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have similar safety but higher Hemagglutination Inhibition (HAI) geometric mean titers (GMTs) to influenza antigens compared to pediatric SOT recipients receiving two doses of SD-QIV. Type: Interventional Start Date: Sep 2024 |
Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Doc1
Metastatic Salivary Gland Carcinoma
Recurrent Salivary Gland Carcinoma
Stage III Major Salivary Gland Cancer AJCC v8
Stage IV Major Salivary Gland Cancer AJCC v8
Unresectable Salivary Gland Carcinoma
This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus
trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-postive salivary gland cancer
that has come back (recurrent), that has spread from where it first started (primary
site) to other places in the body,1 expand
This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-postive salivary gland cancer that has come back (recurrent), that has spread from where it first started (primary site) to other places in the body, or cannot be removed by surgery (unresectable). This trial is also testing how well trastuzumab deruxtecan works in treating patients with HER2-low recurrent or metastatic salivary gland cancer. Trastuzumab is a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by body's immune system. Trastuzumab emtansine contains trastuzumab, linked to a chemotherapy drug called emtansine. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers emtansine to kill them. Trastuzumab deruxtecan is a monoclonal antibody called traztuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors and delivers deruxtecan to kill them. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Trastuzumab emtansine may work better compared to usual treatment of chemotherapy with docetaxel and trastuzumab or trastuzumab deruxtecan in treating patients with recurrent, metastatic or unresectable salivary gland cancer. Type: Interventional Start Date: Mar 2023 |
Dose-Ranging Study of the Efficacy and Safety of TAK-101 for Prevention of Gluten-Specific T Cell A1
Celiac Disease
The main aim of the study is to assess if TAK-101 can reduce gluten related symptoms and
immune activation in adult participants with celiac disease (CeD) on a gluten-free diet
(GFD).
Participants will receive TAK-101 and/or placebo through the vein on Day 1 and Day 8. All
participants will receiv1 expand
The main aim of the study is to assess if TAK-101 can reduce gluten related symptoms and immune activation in adult participants with celiac disease (CeD) on a gluten-free diet (GFD). Participants will receive TAK-101 and/or placebo through the vein on Day 1 and Day 8. All participants will receive active treatment at Week 24. Type: Interventional Start Date: Jun 2022 |
The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immu1
Respiratory Syncytial Virus Infection
Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract
infections (LRTIs) in infants and young children. It is also a leading cause of mortality
in children <5 years of age worldwide. Until recently, no Food and Drug Administration
(FDA)-approved vaccines were available t1 expand
Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract infections (LRTIs) in infants and young children. It is also a leading cause of mortality in children <5 years of age worldwide. Until recently, no Food and Drug Administration (FDA)-approved vaccines were available to prevent RSV infection. The only prophylactic product for RSV prevention recommended for infants was the monoclonal antibody palivizumab, but administration was limited to those with extreme prematurity, chronic lung disease, or hemodynamically significant congenital heart disease. However, in 2023, the FDA approved two products designed to prevent RSV lower respiratory tract disease (LRTD) in all infants: an active RSV vaccine based on the prefusion F protein (RSVpreF, ABRYSVO, Pfizer) administered during pregnancy, and a passive, long-acting monoclonal antibody (nirsevimab-alip [henceforth referred to as nirsevimab], BEYFORTUS, AstraZeneca) administered to infants at birth or at the start of their first RSV season. Both products were evaluated in Phase 3 pivotal clinical trials and have high efficacy in preventing LRTD caused by RSV in infants. Although there is no established correlate of protection against RSV, antibodies have been associated with protection across multiple studies. The clinical development plan for the products did not include comprehensive evaluations of the magnitude and durability of the immune response, nor were the two products tested in a single trial. This study is a prospective, randomized, open-label Phase 4 study with the primary objective of evaluating the magnitude and durability of RSV-specific neutralizing antibodies in infants through 12 months of life following either maternal RSV vaccination, infant nirsevimab administration, or both products combined. Type: Interventional Start Date: Sep 2024 |
Volatility in Paranoia (VIP) Trial: An RCT of Changes in Volatility With Psychotherapy
Schizophrenia Disorders
The goal of this clinical trial is to learn whether learning and belief updating change
in response to the treatment of persecutory delusions, in individuals with
schizophrenia-spectrum disorders.
The main questions are:
1. do prior expectations about environmental volatility reduce following e1 expand
The goal of this clinical trial is to learn whether learning and belief updating change in response to the treatment of persecutory delusions, in individuals with schizophrenia-spectrum disorders. The main questions are: 1. do prior expectations about environmental volatility reduce following effective psychotherapeutic treatment of delusions? 2. does corresponding brain activity related to volatility change with effective treatment of delusions? Participants will: 1. engage in CBTp or TAU + phone check-ins for 16 weeks 2. complete assessments at 4 timepoints over the course of 6 months 3. complete an MRI when possible Type: Interventional Start Date: Jan 2025 |
A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Place1
Generalized Myasthenia Gravis
The study is a randomized, double-blind, placebo-controlled, multicenter, Phase III
study, to evaluate efficacy, safety and tolerability of iptacopan in patients with AChR+
gMG who are on stable SOC treatment. Participants who meet the eligibility criteria will
be randomized in a ratio of 1:1, to r1 expand
The study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate efficacy, safety and tolerability of iptacopan in patients with AChR+ gMG who are on stable SOC treatment. Participants who meet the eligibility criteria will be randomized in a ratio of 1:1, to receive either iptacopan or matching placebo, for 6 months (180 days) while continuing on a stable SOC treatment. The randomization will be stratified based on region. Type: Interventional Start Date: Jul 2024 |
A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Mu1
Non-Muscle Invasive Bladder Neoplasms
The purpose of this study is to compare disease free survival (DFS) in participants with
recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC)
within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or
are unfit for Radical Cystectomy (RC)1 expand
The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy. Type: Interventional Start Date: Apr 2024 |
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilep1
Focal Epilepsy
The purpose of this study is to determine whether BHV-7000 is effective in the treatment
of refractory focal epilepsy. expand
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy. Type: Interventional Start Date: Mar 2024 |
Observational Study to Characterize Biomarkers and Disease Progression in Participants With Methyl1
Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome
The purpose of the study is to prospectively assess longitudinal changes in biomarkers
(MECP2, potential biomarkers of target engagement and disease activity) in cerebrospinal
fluid (CSF) and blood; characterize longitudinal changes in performance on clinical
scales (clinician-reported measures of1 expand
The purpose of the study is to prospectively assess longitudinal changes in biomarkers (MECP2, potential biomarkers of target engagement and disease activity) in cerebrospinal fluid (CSF) and blood; characterize longitudinal changes in performance on clinical scales (clinician-reported measures of neurodevelopment and functioning) and caregiver-reported outcome assessments (communication, gastrointestinal, social-emotional-adaptive behavioral measures); evaluate longitudinal changes in caregiver-reported health-related quality-of-life measures; and assess the frequency, type, and severity of seizures over time. Type: Observational Start Date: Oct 2023 |
Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy
HIV I Infection
Transgender women (TW) are a key population and priority for HIV treatment. More research
is needed to develop evidence-based clinical guidance when it comes to choosing
antiretroviral treatment (ART) regimens for TW on feminizing hormonal therapy (FHT).
Concerns about ART interacting with FHT and1 expand
Transgender women (TW) are a key population and priority for HIV treatment. More research is needed to develop evidence-based clinical guidance when it comes to choosing antiretroviral treatment (ART) regimens for TW on feminizing hormonal therapy (FHT). Concerns about ART interacting with FHT and decreasing its effectiveness can lead to decreased ART adherence and increased viral loads. The GET IT RiGHT trial aims to address concerns about drug-drug interactions (DDIs) between ART and FHT while providing access to hormonal therapy to TW living with HIV. Data suggest that access to FHT improves adherence to HIV treatment and decreases treatment interruptions. This is an open-label, non-randomized, 3-group trial of adult TW and other individuals identifying as female or transfeminine but with male sex assigned at birth living with HIV. Participants will be on ART at entry and receive study-supplied 17-β estradiol for FHT for 48 weeks. The primary objectives of the study are to 1) assess whether TW continue to achieve therapeutic concentrations of ART while receiving FHT for 48 weeks and 2) assess whether serum estradiol concentrations on FHT (across a range of estradiol doses) vary between boosted and un-boosted ART regimens. Type: Interventional Start Date: Jan 2024 |
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Pos1
Oligometastatic Prostate Cancer (OMPC)
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu)
vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer
(OMPC) progressing after definitive therapy to their primary tumor. The data generated
from this study will provide evidence for t1 expand
The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT). Type: Interventional Start Date: Mar 2024 |
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
Heart Failure NYHA Class II
Heart Failure NYHA Class III
Heart Failure
This is a prospective, multi-center, open label, randomized control clinical trial
evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in
NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial).
The study contains of 5 arms:
NYHA II Cohort - To demonstrate s1 expand
This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial). The study contains of 5 arms: NYHA II Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients, where patients have daily access to PAP data. - Treatment Arm (Group 1) - Active Control Arm (Group 2) - Crossover Arm (Group 3) NYHA III Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class III HF patients, where patients have daily access to PAP data, including a randomized sub-study to evaluate a clinician-directed patient self-management strategy. Type: Interventional Start Date: Nov 2023 |
Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old1
Locally Advanced Extraskeletal Myxoid Chondrosarcoma
Locally Advanced Leiomyosarcoma
Locally Advanced Liposarcoma
Locally Advanced Undifferentiated Pleomorphic Sarcoma
Locally Advanced Unresectable Soft Tissue Sarcoma
This phase II trial compares the effect of immunotherapy with ipilimumab and nivolumab
alone to their combination with cabozantinib in treating patients with soft tissue
sarcoma that has spread from where it first started to nearby tissue, lymph nodes, or
distant parts of the body (advanced). Immun1 expand
This phase II trial compares the effect of immunotherapy with ipilimumab and nivolumab alone to their combination with cabozantinib in treating patients with soft tissue sarcoma that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply and may also prevent the growth of new blood vessels that tumors need to grow. By these actions it may help slow or stop the spread of cancer cells. Adding cabozantinib to the combination of ipilimumab and nivolumab may be better in stopping or slowing the growth of tumor compared to ipilimumab and nivolumab alone in patients with advanced soft tissue sarcoma. Type: Interventional Start Date: Oct 2023 |
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