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Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A1
Pulmonary Arterial Hypertension
The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly
called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy)
versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in
participants who are newly diagnose1 expand
The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high risk of disease progression. Type: Interventional Start Date: Mar 2022 |
Effect of Raised Head of the Bed on Lying Blood Pressure in Autonomic Failure
Supine Hypertension
Autonomic Failure
Many persons with autonomic failure often have high blood pressure when lying down
(supine hypertension). This study is exploring the impact of decreased venous return to
the heart (achieved by raising the head of the bed) to lessen supine blood pressure. If
decreased venous return to the heart is1 expand
Many persons with autonomic failure often have high blood pressure when lying down (supine hypertension). This study is exploring the impact of decreased venous return to the heart (achieved by raising the head of the bed) to lessen supine blood pressure. If decreased venous return to the heart is effective at lowering supine blood pressure, these approaches may be utilized to treat supine hypertension non-pharmacologically. Raising the head of the bed decreases the amount of blood returning to the heart due to the effects of gravity. In this case, the decreased blood return to the heart may decrease blood pressure. Type: Interventional Start Date: Aug 2020 |
Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in P1
Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
In this observational study researcher want to learn more about the effectiveness of drug
VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine
use in patients with TRK fusion cancer which is locally advanced or spread from the place
where it started to other plac1 expand
In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months. Type: Observational Start Date: Apr 2020 |
Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension
Pediatric Pulmonary Hypertension
The investigators' central hypothesis is that early combination therapy with two
PAH-specific oral therapies that have been shown to be well tolerated in the pediatric
population, sildenafil and bosentan, will result in better World Health Organization
(WHO) functional class at 12 months after init1 expand
The investigators' central hypothesis is that early combination therapy with two PAH-specific oral therapies that have been shown to be well tolerated in the pediatric population, sildenafil and bosentan, will result in better World Health Organization (WHO) functional class at 12 months after initiation of PAH treatment than therapy with sildenafil alone. Type: Interventional Start Date: Aug 2022 |
Automated Abdominal Binder for Orthostatic Hypotension
Orthostatic Hypotension
Autonomic Failure
Pure Autonomic Failure
Multiple System Atrophy
The automated inflatable abdominal binder is an investigational device for the treatment
of orthostatic hypotension (low blood pressure on standing) in patients with autonomic
failure. The purpose of this study is to determine safety and effectiveness of the
automated abdominal binder in improving1 expand
The automated inflatable abdominal binder is an investigational device for the treatment of orthostatic hypotension (low blood pressure on standing) in patients with autonomic failure. The purpose of this study is to determine safety and effectiveness of the automated abdominal binder in improving orthostatic tolerance in these patients. Type: Interventional Start Date: Mar 2018 |
NATIENS: Optimal Management and Mechanisms of SJS/TEN
Stevens-Johnson Syndrome
Toxic Epidermal Necrolyses
The North American Therapeutics in Epidermal Necrolysis Syndrome (NATIENS) study is a
multicenter double-blind randomized controlled assessment of two arms - one of systemic
immunomodulatory therapy (etanercept) and one of supportive care deemed to be the current
standard of care. We will leverage1 expand
The North American Therapeutics in Epidermal Necrolysis Syndrome (NATIENS) study is a multicenter double-blind randomized controlled assessment of two arms - one of systemic immunomodulatory therapy (etanercept) and one of supportive care deemed to be the current standard of care. We will leverage the opportunity of this controlled design to collect multiples samples with an aim to discover new genetic and biological markers for prevention and early diagnosis and define cellular and molecular mechanisms to facilitate discovery of promising treatment strategies. This study has been preceded by a planning phase to ensure testing and development of harmonized supportive care infrastructure and operating procedures across sites. Type: Interventional Start Date: Mar 2023 |
Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
Rheumatic Joint Disease
Continuation of the CARRA Registry as described in the protocol will support data
collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will
form the basis for future CARRA studies. In particular, this observational registry will
be used to answer pressing questions abo1 expand
Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions. Type: Observational [Patient Registry] Start Date: Jul 2015 |
Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With D1
Diabetic Foot Ulcer
The purpose of this clinical trial is to evaluate the safety and effectiveness of the
treatment with the COMS One device in subjects with refractory diabetic foot ulcers
(DFUs). The prospective randomized, double-blinded, sham-controlled trial is designed to
demonstrate superiority of wound closure1 expand
The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). The prospective randomized, double-blinded, sham-controlled trial is designed to demonstrate superiority of wound closure of the COMS One device to a sham-control device through 24 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs. Type: Interventional Start Date: Jun 2023 |
Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA
Obstructive Sleep Apnea
Polysomnography (PSG) and drug-induced sleep endoscopy (DISE) are widely used diagnostic
studies for assessing obstructive sleep apnea (OSA) severity and collapse patterns of the
upper airway anatomy during sleep. Hypoglossal nerve stimulation (HNS) therapy for
obstructive sleep apnea suffers from1 expand
Polysomnography (PSG) and drug-induced sleep endoscopy (DISE) are widely used diagnostic studies for assessing obstructive sleep apnea (OSA) severity and collapse patterns of the upper airway anatomy during sleep. Hypoglossal nerve stimulation (HNS) therapy for obstructive sleep apnea suffers from variable response at the level of the soft palate. The Investigators propose a study examining the physiologic effect of ansa cervicalis stimulation (ACS) alone and in combination with HNS during PSG and DISE. Type: Interventional Start Date: Nov 2022 |
Tiragolumab and Atezolizumab for the Treatment of Relapsed or Refractory SMARCB1 or SMARCA4 Deficie1
Atypical Teratoid/Rhabdoid Tumor
Epithelioid Sarcoma
Kidney Medullary Carcinoma
Malignant Solid Neoplasm
Poorly Differentiated Chordoma
This phase I/II trial studies how well tiragolumab and atezolizumab works when given to
children and adults with SMARCB1 or SMARCA4 deficient tumors that have either come back
(relapsed) or do not respond to therapy (refractory). SMARCB1 or SMARCA4 deficiency means
that tumor cells are missing the1 expand
This phase I/II trial studies how well tiragolumab and atezolizumab works when given to children and adults with SMARCB1 or SMARCA4 deficient tumors that have either come back (relapsed) or do not respond to therapy (refractory). SMARCB1 or SMARCA4 deficiency means that tumor cells are missing the SMARCB1 and SMARCA4 genes, seen with some aggressive cancers that are typically hard to treat. Immunotherapy with monoclonal antibodies, such as tiragolumab and atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Type: Interventional Start Date: Nov 2022 |
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard C1
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Metastatic Head and Neck Squamous Cell Carcinoma
Metastatic Hypopharyngeal Squamous Cell Carcinoma
Metastatic Laryngeal Squamous Cell Carcinoma
Metastatic Lip and Oral Cavity Carcinoma
This phase II/III compares the standard therapy (chemotherapy plus cetuximab) versus
adding bevacizumab to standard chemotherapy, versus combination of just bevacizumab and
atezolizumab in treating patients with head and neck cancer that has spread to other
places in the body (metastatic or advance1 expand
This phase II/III compares the standard therapy (chemotherapy plus cetuximab) versus adding bevacizumab to standard chemotherapy, versus combination of just bevacizumab and atezolizumab in treating patients with head and neck cancer that has spread to other places in the body (metastatic or advanced stage) or has come back after prior treatment (recurrent). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Cisplatin and carboplatin are in a class of chemotherapy medications known as platinum-containing compounds. They work by killing, stopping, or slowing the growth of cancer cells. Docetaxel is in a class of chemotherapy medications called taxanes. It stops cancer cells from growing and dividing and may kill them. The addition of bevacizumab to standard chemotherapy or combination therapy with bevacizumab and atezolizumab may be better than standard chemotherapy plus cetuximab in treating patients with recurrent/metastatic head and neck cancers. Type: Interventional Start Date: Mar 2023 |
A Study of Evorpacept (ALX148) in Patients with Advanced HER2+ Gastric Cancer (ASPEN-06)
Gastric Cancer
Gastroesophageal Junction Adenocarcinoma
Gastric Adenocarcinoma
A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab,
and Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma. expand
A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma. Type: Interventional Start Date: Jan 2022 |
Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial
Hemorrhagic Shock
Traumatic Injury
Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma
centers designed to determine the efficacy and safety of low titer whole blood
resuscitation as compared to standard of care resuscitation in patients at risk of
hemorrhagic shock and to appropriately characterize t1 expand
Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma centers designed to determine the efficacy and safety of low titer whole blood resuscitation as compared to standard of care resuscitation in patients at risk of hemorrhagic shock and to appropriately characterize the hemostatic competency of whole blood relative to its age. Type: Interventional Start Date: Apr 2022 |
Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Pa1
Neurogenic Orthostatic Hypotension
Autonomic Failure
Pure Autonomic Failure
Multiple System Atrophy
Parkinson Disease
The purpose of this study is to learn more about the effects of abdominal compression and
the medication midodrine, two interventions used for the treatment of orthostatic
hypotension (low blood pressure on standing), on hemodynamic markers of cardiovascular
risk. The study will be conducted at the1 expand
The purpose of this study is to learn more about the effects of abdominal compression and the medication midodrine, two interventions used for the treatment of orthostatic hypotension (low blood pressure on standing), on hemodynamic markers of cardiovascular risk. The study will be conducted at the Vanderbilt University Medical Center and consists of a screening and 2 testing days, one with abdominal compression and one with midodrine. The total length of the study will be about 5 days. Type: Interventional Start Date: Nov 2020 |
A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients1
HER2-positive Breast Cancer
Invasive Carcinoma of the Breast
Breast Cancer
Node Negative Breast Cancer
Micrometastasis Breast Cancer
This research study is studying a combination of HER2-directed therapies (trastuzumab and
pertuzumab) and hormonal therapy as a treatment after surgery for hormone receptor
positive breast cancer.
The study drugs involved in this study are:
- A combination of trastuzumab and pertuzumab given a1 expand
This research study is studying a combination of HER2-directed therapies (trastuzumab and pertuzumab) and hormonal therapy as a treatment after surgery for hormone receptor positive breast cancer. The study drugs involved in this study are: - A combination of trastuzumab and pertuzumab given as an injection under the skin (PHESGO) - Hormonal (endocrine) Treatment Type: Interventional Start Date: Jan 2021 |
Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Ne1
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
This phase III trial compares the effect of usual treatment of chemotherapy and steroids
and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab.
Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability
of cancer cells to grow and spread. The i1 expand
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care. Type: Interventional Start Date: Jan 2021 |
MitraClip REPAIR MR Study
Mitral Valve Regurgitation
The objective of this randomized controlled trial (RCT) is to compare the clinical
outcome of MitraClip™ device versus surgical repair in patients with severe primary MR
who are at moderate surgical risk and whose mitral valve has been determined to be
suitable for correction by MV repair surgery b1 expand
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team. Type: Interventional Start Date: Jul 2020 |
A Study of Oral Nuvisertib (TP-3654) in Patients with Myelofibrosis
Myelofibrosis
This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess
safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in
patients with intermediate or high-risk primary or secondary MF. expand
This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF. Type: Interventional Start Date: Dec 2019 |
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma
Low Grade Glioma
Metastatic Low Grade Astrocytoma
Metastatic Low Grade Glioma
This phase III trial compares the effect of selumetinib versus the standard of care
treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed
or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality
called BRAFV600E mutation and is not1 expand
This phase III trial compares the effect of selumetinib versus the standard of care treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality called BRAFV600E mutation and is not associated with systemic neurofibromatosis type 1. Selumetinib works by blocking some of the enzymes needed for cell growth and may kill tumor cells. Carboplatin and vincristine are chemotherapy drugs that work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. The overall goal of this study is to see if selumetinib works just as well as the standard treatment of CV for patients with LGG. Another goal of this study is to compare the effects of selumetinib versus CV in subjects with LGG to find out which is better. Additionally, this trial will also examine if treatment with selumetinib improves the quality of life for subjects who take it. Type: Interventional Start Date: Jan 2020 |
Activity Monitoring in Pulmonary Hypertension
Pulmonary Hypertension
This is a prospective, longitudinal, observational study of free-living activity trackers
and patient reported outcomes to test the hypothesis that daily activity will have
stronger prognostic value than 6MWD in patients with pulmonary hypertension after 12
weeks. expand
This is a prospective, longitudinal, observational study of free-living activity trackers and patient reported outcomes to test the hypothesis that daily activity will have stronger prognostic value than 6MWD in patients with pulmonary hypertension after 12 weeks. Type: Observational Start Date: Oct 2019 |
A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis1
Low Grade Glioma
Neurofibromatosis Type 1
Visual Pathway Glioma
This phase III trial studies if selumetinib works just as well as the standard treatment
with carboplatin/vincristine (CV) for subjects with NF1-associated low grade glioma
(LGG), and to see if selumetinib is better than CV in improving vision in subjects with
LGG of the optic pathway (vision nerve1 expand
This phase III trial studies if selumetinib works just as well as the standard treatment with carboplatin/vincristine (CV) for subjects with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves). Selumetinib is a drug that works by blocking some enzymes that low-grade glioma tumor cells need for their growth. This results in killing tumor cells. Drugs used as chemotherapy, such as carboplatin and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether selumetinib works better in treating patients with NF1-associated low-grade glioma compared to standard therapy with carboplatin and vincristine. Type: Interventional Start Date: Jan 2020 |
Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refrac1
Advanced Malignant Solid Neoplasm
Ann Arbor Stage III Non-Hodgkin Lymphoma
Ann Arbor Stage IV Non-Hodgkin Lymphoma
Histiocytic Sarcoma
Juvenile Xanthogranuloma
This Pediatric MATCH screening and multi-sub-study phase II trial studies how well
treatment that is directed by genetic testing works in pediatric patients with solid
tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at
least one line of standard systemic thera1 expand
This Pediatric MATCH screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas. Type: Interventional Start Date: Jul 2017 |
Home-Based Cardiac Rehabilitation for Patients With Heart Failure
Heart Failure With Preserved Ejection Fraction
Heart Failure With Reduced Ejection Fraction
Cardiovascular Diseases
The vast majority of individuals with heart failure do not participate in center based
cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important,
many individuals will still not participate for a variety of reasons. This pilot
randomized controlled trial is evaluating1 expand
The vast majority of individuals with heart failure do not participate in center based cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important, many individuals will still not participate for a variety of reasons. This pilot randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients with heart failure. After a brief roll-in period, participants are randomized to one of two groups: (1) control or (2) HBCR mobile health intervention. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on physical activity, quality of life, clinical events, and other outcomes. Type: Interventional Start Date: Aug 2024 |
Safety and Efficacy Study of Intracystic TARA-002 for the Treatment of Lymphatic Malformations in P1
Lymphatic Malformation
This is a Phase 2a/b single arm open label study to evaluate the safety, reactogenicity,
and efficacy of intracystic injection of TARA-002 in participants 6 months to less than
18 years of age for the treatment of macrocystic and mixed cystic lymphatic
malformations. The Phase 2a safety lead-in, ag1 expand
This is a Phase 2a/b single arm open label study to evaluate the safety, reactogenicity, and efficacy of intracystic injection of TARA-002 in participants 6 months to less than 18 years of age for the treatment of macrocystic and mixed cystic lymphatic malformations. The Phase 2a safety lead-in, age de-escalation study is designed to establish the safety of TARA-002 in older participants 6 years to less than 18 years before proceeding to younger participants 2 years to less than 6 years, then 6 months to less than 2 years. The Phase 2b is an expansion study in which enrollment of participants will be initiated after safety has been established in each cohort during the Phase 2a safety lead-in study. Each participant will receive up to 4 injections of TARA-002 spaced approximately 6 weeks apart. Type: Interventional Start Date: Oct 2023 |
Comparison of Chemotherapy Before and After Surgery Versus After Surgery Alone for the Treatment of1
Stage II Gallbladder Cancer AJCC v8
Stage IIA Gallbladder Cancer AJCC v8
Stage IIB Gallbladder Cancer AJCC v8
Stage III Gallbladder Cancer AJCC v8
Stage IIIA Gallbladder Cancer AJCC v8
This phase II/III trial compares the effect of adding chemotherapy before and after
surgery versus after surgery alone (usual treatment) in treating patients with stage
II-III gallbladder cancer. Chemotherapy drugs, such as gemcitabine and cisplatin, work in
different ways to stop the growth of tum1 expand
This phase II/III trial compares the effect of adding chemotherapy before and after surgery versus after surgery alone (usual treatment) in treating patients with stage II-III gallbladder cancer. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before surgery may make the tumor smaller; therefore, may reduce the extent of surgery. Additionally, it may make it easier for the surgeon to distinguish between normal and cancerous tissue. Giving chemotherapy after surgery may kill any remaining tumor cells. This study will determine whether giving chemotherapy before surgery increases the length of time before the cancer may return and whether it will increase a patient's life span compared to the usual approach. Type: Interventional Start Date: Feb 2021 |
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