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Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent...
Glioblastoma Multiforme
The purpose of this study is to assess the safety and tolerability of VBI-1901 in
subjects with recurrent malignant gliomas (glioblastoma, or GBM). expand
The purpose of this study is to assess the safety and tolerability of VBI-1901 in subjects with recurrent malignant gliomas (glioblastoma, or GBM). Type: Interventional Start Date: Dec 2017 |
Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction
Peripheral Nerve Injuries
This study is a registry of general use of Avance Nerve Graft and is intended to evaluate
the uses, response rates, and safety of Avance Nerve Graft in the real-life clinical
setting. Optional addendums 1 and 2 included in the protocol are intended to establish
comparative groups and focused subgroups... expand
This study is a registry of general use of Avance Nerve Graft and is intended to evaluate the uses, response rates, and safety of Avance Nerve Graft in the real-life clinical setting. Optional addendums 1 and 2 included in the protocol are intended to establish comparative groups and focused subgroups within the registry. Type: Observational Start Date: Nov 2008 |
Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter...
Valvular Heart Disease
The vast majority of cardiac rehabilitation eligible individuals do not participate in
center based cardiac rehabilitation (CBCR). While steps to encourage participation in
CBCR are important, many individuals will still not participate for a variety of reasons.
This randomized controlled trial is... expand
The vast majority of cardiac rehabilitation eligible individuals do not participate in center based cardiac rehabilitation (CBCR). While steps to encourage participation in CBCR are important, many individuals will still not participate for a variety of reasons. This randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients undergoing transcatheter heart valve interventions (THVIs). After a brief roll-in period, participants not intending to participate in CBCR are randomized to one of three groups: (1) control, (2) HBCR mobile health intervention with hands-off delivery, and (3) HBCR mobile health intervention with interactive delivery. Participants in the intervention groups (hands-off/interactive delivery) will also be randomized to continue the intervention for 12 weeks or 24 weeks. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on clinical events, physical activity, quality of life, and other outcomes. Those who intend to participate in CBCR will be followed in a registry. Type: Interventional Start Date: Dec 2023 |
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
Anatomic Stage I Breast Cancer
Anatomic Stage II Breast Cancer
Anatomic Stage III Breast Cancer
Invasive Breast Lobular Carcinoma
This phase II trial tests how well neratinib prior to the primary treatment (neoadjuvant)
works in treating patients with stage I-III HER2 mutated lobular breast cancers.
Neratinib is in a class of medications called kinase inhibitors. It works by blocking the
action of an abnormal protein that signals... expand
This phase II trial tests how well neratinib prior to the primary treatment (neoadjuvant) works in treating patients with stage I-III HER2 mutated lobular breast cancers. Neratinib 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. This helps slow or stop the spread of cancer cells. Giving neratinib in addition to normal therapy may work better in treating cancer than the endocrine therapy patients would normally receive. Type: Interventional Start Date: Sep 2024 |
SGC Stimulation, Perioperative Vascular Reactivity, and Organ Injury in Cardiac Surgery
Endothelial Dysfunction
Vascular Diseases
Kidney Injury
Brain Disease
Vascular Inflammation
The goal of this mechanistic clinical trial is to learn about the effects of medications
called soluble guanylyl cyclase stimulators on vascular function and markers of kidney
and brain injury in patients having heart surgery. The main questions it aims to answer
are:
1. Does soluble guanylyl... expand
The goal of this mechanistic clinical trial is to learn about the effects of medications called soluble guanylyl cyclase stimulators on vascular function and markers of kidney and brain injury in patients having heart surgery. The main questions it aims to answer are: 1. Does soluble guanylyl cyclase stimulation improve blood vessel function compared to placebo? 2. Does soluble guanylyl cyclase stimulation decrease markers of kidney injury and brain injury compared to placebo? Participants will be randomized to a soluble guanylyl cyclase stimulator called vericiguat or placebo, and researchers will compare vascular function and markers of brain and kidney injury to see if vericiguat improves vascular function and reduces markers of injury. This will provide important information to determine the underlying reasons that patients have some kidney and brain function problems after having heart surgery. Type: Interventional Start Date: May 2023 |
A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With Select Solid Tumors
Colorectal Cancer
Gastric Cancer
HER2-negative Breast Cancer
Non-small Cell Lung Cancer
Squamous Cell Carcinoma of Head and Neck
The goal of this clinical trial is to evaluate the safety of TOS-358 in adults with
select solid tumors who meet study enrollment criteria. The main questions it aims to
answer are:
1. what is the maximum tolerated dose and recommended dose for phase 2?
2. how safe and tolerable is TOS-358... expand
The goal of this clinical trial is to evaluate the safety of TOS-358 in adults with select solid tumors who meet study enrollment criteria. The main questions it aims to answer are: 1. what is the maximum tolerated dose and recommended dose for phase 2? 2. how safe and tolerable is TOS-358 at different dose levels when taken orally once or twice per day? Type: Interventional Start Date: Feb 2023 |
Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy
Refractory Epilepsy
Focal Seizure
Seizures, Focal
Seizures
Epilepsy in Children
This is a multiple site, randomized, double blinded parallel-group controlled study. The
purpose of this study is to evaluate efficacy, safety, and tolerability of repeated,
daily sessions with the STARSTIM device, which delivers transcranial cathodal direct
current stimulation (tDCS). Subjects will... expand
This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will be treated with STARTSTIM or sham device for 10 sessions over a 2-week period. The subjects will be followed for an additional 10 weeks post treatment. Quality of Life questionnaires and adverse events will be collected and evaluated. Type: Interventional Start Date: Oct 2021 |
SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
Hemophilia A With Inhibitor
Hemophilia B With Inhibitor
Phase IV multi-center, US-centric, open-label, safety study enrolling participants with
Hemophilia A or B with inhibitors12 years of age and older, who are either on long term
prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding
event (BE), or who are not on prophylactic... expand
Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A or B with inhibitors12 years of age and older, who are either on long term prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding event (BE), or who are not on prophylactic treatment who may need to control a BE. Type: Interventional Start Date: Jun 2021 |
A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With...
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... 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 Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE...
Plasma Cell Myeloma
RISS Stage I Plasma Cell Myeloma
RISS Stage II Plasma Cell Myeloma
This phase III trial compares the combination of four drugs (daratumumab, bortezomib,
lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab,
lenalidomide and dexamethasone). Bortezomib may stop the growth of cancer cells by
blocking some of the enzymes needed for cell... expand
This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab, lenalidomide and dexamethasone). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on daratumumab, lenalidomide, and dexamethasone. Type: Interventional Start Date: Feb 2021 |
Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly...
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... 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 |
INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia...
Anemia
Post-essential Thrombocythemia Myelofibrosis
Post-polycythemia Vera Myelofibrosis
This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and
tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in
combination with ruxolitinib in participants with MF who are transfusion-dependent or
presenting with symptomatic anemia. This study... expand
This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and expansion. Type: Interventional Start Date: Mar 2021 |
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children...
Coronavirus Infection (COVID-19)
Pulmonary Arterial Hypertension
Urinary Tract Infections in Children
Hypertension
Pain
The study investigators are interested in learning more about how drugs, that are given
to children by their health care provider, act in the bodies of children and young adults
in hopes to find the most safe and effective dose for children. The primary objective of
this study is to evaluate the PK... expand
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider. Type: Observational Start Date: Mar 2020 |
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer...
Bladder Adenocarcinoma
Bladder Clear Cell Adenocarcinoma
Bladder Mixed Adenocarcinoma
Bladder Neuroendocrine Carcinoma
Bladder Small Cell Neuroendocrine Carcinoma
This phase II trial studies how well cabozantinib works in combination with nivolumab and
ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from
where it first started (primary site) to other places in the body. Cabozantinib may stop
the growth of tumor cells by blocking... expand
This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone. Type: Interventional Start Date: May 2019 |
Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative...
CD20 Positive
Mantle Cell Lymphoma
This randomized phase III trial studies rituximab after stem cell transplant and to see
how well it works compared with rituximab alone in treating patients with in minimal
residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal
antibodies, such as rituximab, may interfere... expand
This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma. Type: Interventional Start Date: Mar 2018 |
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients...
Childhood Extracranial Germ Cell Tumor
Extragonadal Embryonal Carcinoma
Germ Cell Tumor
Malignant Germ Cell Tumor
Malignant Ovarian Teratoma
This phase III trial studies how well active surveillance help doctors to monitor
subjects with low risk germ cell tumors for recurrence after their tumor is removed. When
the germ cell tumor has spread outside of the organ in which it developed, it is
considered metastatic. Drugs used in chemotherapy,... expand
This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, 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. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors. Type: Interventional Start Date: May 2017 |
Study on Basal Joint Arthritis Prospective
Osteoarthrosis of the Carpometacarpal Joint of the Thumb
The data in this prospective registry will be used 1) to define which surgical and
nonoperative techniques are most effective at providing pain relief, restoring function,
are cost effective, and patients are satisfied with their outcomes; and 2) to design
focused clinical questions regarding the... expand
The data in this prospective registry will be used 1) to define which surgical and nonoperative techniques are most effective at providing pain relief, restoring function, are cost effective, and patients are satisfied with their outcomes; and 2) to design focused clinical questions regarding the optimal treatment of basal joint arthritis of the thumb in future randomized controlled trials. There are no interventions or changes in patient care associated with this study. Type: Observational Start Date: Mar 2007 |
The R4R Advance Care Planning Pilot Study
Advance Care Planning
Affordable housing residents continue to experience multi-faceted insecurity and advance
care planning (ACP) challenges even after obtaining secure housing, resulting in
significant inequities in quality of care during times of cognitive incapacity. To
promote proactive planning for affordable housing... expand
Affordable housing residents continue to experience multi-faceted insecurity and advance care planning (ACP) challenges even after obtaining secure housing, resulting in significant inequities in quality of care during times of cognitive incapacity. To promote proactive planning for affordable housing residents, this proposal is for a pilot study to test a novel trauma-informed care adapted advance care planning intervention with the following aims: to test initial efficacy of the intervention on ACP outcomes (Aim 1) and determine resident perceptions of intervention acceptability, appropriateness, and feasibility and perceived implementation barriers and facilitators (Aim 2). These data will support the development of a larger scale study of ACP interventions within a resiliency-based hub model to comprehensively support whole-person care and proactive planning for times of cognitive incapacity. Type: Interventional Start Date: May 2024 |
Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
Single Ventricle Heart Disease
This study will evaluate the clinical efficacy and safety of udenafil, an orally
administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of
adolescent who have had the Fontan procedure. expand
This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure. Type: Interventional Start Date: Oct 2023 |
Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic...
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 closure... 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 at 12 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 |
MoVE Trial: Motivational Strategies to Empower African Americans to Improve Dialysis Adherence
End Stage Renal Disease on Dialysis
MoVE Trial is a randomized clinical trial designed to rigorously test the impact of a
behavioral intervention (culturally tailored motivational interviewing - (MOVE))
delivered by trained health coaches, on hemodialysis treatment non-adherence. It is a a
two-arm, parallel group randomized clinical... expand
MoVE Trial is a randomized clinical trial designed to rigorously test the impact of a behavioral intervention (culturally tailored motivational interviewing - (MOVE)) delivered by trained health coaches, on hemodialysis treatment non-adherence. It is a a two-arm, parallel group randomized clinical trial with 24-week follow-up. It involves completion of surveys by patients enrolled in the study. It also involves participation in motivational interviewing sessions by patients who are randomized to the intervention (MI). Type: Interventional Start Date: Oct 2023 |
Right Ventricle Lipid in Pulmonary Arterial Hypertension (PAH)
Idiopathic Pulmonary Arterial Hypertension
Heritable Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension Associated With Connective Tissue Disease
The investigators propose to study the relationship between right ventricle (RV)
steatosis and RV function, exercise capacity, and outcomes in humans with pulmonary
arterial hypertension (PAH) and to identify potential drivers of lipid accumulation. expand
The investigators propose to study the relationship between right ventricle (RV) steatosis and RV function, exercise capacity, and outcomes in humans with pulmonary arterial hypertension (PAH) and to identify potential drivers of lipid accumulation. Type: Observational Start Date: Jan 2023 |
Nasotracheal Intubation With VL vs DL in Infants Trial
Intubation Complication
Intubation; Difficult or Failed
Hypoxia
Hypoxemia
Anesthesia Intubation Complication
Nasotracheal Intubation with Videolaryngoscopy versus Direct Laryngoscopy in Infants
(NasoVISI) Trial is a prospective randomized multicenter study. The study will be
conducted at 8 centers in the United States. It is expected that approximately 700
subjects enrolled to product 670 evaluable subjects.The... expand
Nasotracheal Intubation with Videolaryngoscopy versus Direct Laryngoscopy in Infants (NasoVISI) Trial is a prospective randomized multicenter study. The study will be conducted at 8 centers in the United States. It is expected that approximately 700 subjects enrolled to product 670 evaluable subjects.The randomization is 1:1 naso tracheal intubation with the Storz C-Mac Video Videolaryngoscopy (VL) or the Standard Direct Laryngoscope (DL). The primary objective is to compare the nasotracheal intubation (NTI) first attempt success rate using VL vs. DL in infants 0-365 days of age presenting for cardiothoracic surgery and cardiac catheterizations. Type: Interventional Start Date: Jun 2022 |
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
Stroke
Patent Foramen Ovale
The objective of this study is to investigate whether percutaneous PFO closure with the
Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore®
Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke,
and device/procedure related Serious... expand
The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE). Type: Interventional Start Date: Apr 2022 |
SELUTION4BTK Trial
Peripheral Arterial Disease
Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities
This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION
SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of
peripheral arterial disease (PAD) in the BTK arteries in CLTI patients. expand
This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients. Type: Interventional Start Date: May 2022 |
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