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VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
Vedanta Biosciences, Inc.
Ulcerative Colitis
Colitis, Ulcerative
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients
with mild to moderate ulcerative colitis (UC).
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A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC). Type: Interventional Start Date: May 2023 |
Assessment of Dapagliflozin on Vascular Health in Patients With Type 2 Diabetes
Boston University
Diabetes Mellitus, Type 2
Endothelial Dysfunction
Patients with Type 2 Diabetes Mellitus (T2DM) have changes in blood vessel health that can
lead to a higher chance of developing heart attacks or strokes. New medications for T2DM
including dapagliflozin, which is a Sodium-Glucose Cotransporter-2 inhibitor (SGLT2)
inhibitor,... expand
Patients with Type 2 Diabetes Mellitus (T2DM) have changes in blood vessel health that can lead to a higher chance of developing heart attacks or strokes. New medications for T2DM including dapagliflozin, which is a Sodium-Glucose Cotransporter-2 inhibitor (SGLT2) inhibitor, may help protect the heart and blood vessels. The overarching objective of this mechanistic study is to learn how a Sodium-Glucose Cotransporter-2 (SGT2) inhibitor, dapagliflozin, impacts vascular health in patients with Type 2 Diabetes Mellitus (T2DM). The investigators will compare the changes in vascular health to changes in endothelial cell (EC) phenotype including non-coding RNA (ncRNA) to develop evidence supporting the mechanism of cardiovascular benefit of SGLT2 inhibitors. This study will provide novel information regarding the mechanism of effects of novel treatments for endothelial function and vascular health in patients with T2DM to reduce cardiovascular (CV) risk. The research aims to assess the: - effects of dapagliflozin on EC phenotype. - impact of dapagliflozin on vasodilator function and additional measures of vascular health including arterial stiffness and circulating markers of vascular health. Type: Interventional Start Date: May 2022 |
Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced/Metastatic...
National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Refractory Malignant Solid Neoplasm
Triple-Negative Breast Carcinoma
Unresectable Malignant Solid Neoplasm
This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination
with binimetinib in treating patients with solid tumors that carry RAS alterations and that
have spread to other places in the body (advanced/metastatic) or cannot be removed by surgery... expand
This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with binimetinib in treating patients with solid tumors that carry RAS alterations and that have spread to other places in the body (advanced/metastatic) or cannot be removed by surgery (unresectable). ZEN003694 is an oral medication with potential anticancer activity. It is an inhibitor of a family of proteins called bromodomain and extra-terminal (BET) which play important role during development and cellular growth. ZEN003694 may stop the growth of tumor cells that produce BET. Binimetinib is in a class of medications called kinase inhibitors. It works by blocking the action proteins called MEK1 and MEK2, that signal cancer cells to multiply. It may help keep cancer cells from growing and spreading. There is pre-clinical evidence that using ZEN003694 and binimetinib together may shrink or stabilize cancers studied in this trial. There are two parts of this study; dose escalation and dose expansion. In the dose escalation part of this study, different people will get different doses of the study drugs ZEN003694 and binimetinib. In the dose expansion part of this study, the highest dose with manageable side effects will be given to additional people. This will help to understand the side effects that may happen with this drug combination. Type: Interventional Start Date: Aug 2022 |
Haiti Community Health Workers (CHW) Adaptation
Boston Medical Center
Heart Failure
Evidence-based interventions to improve linkage and outcomes for heart failure (HF) patients
requires input from stakeholders: patients, community health workers (CHWs), healthcare
staff, and health system administrators.
In this research the investigators will assess a... expand
Evidence-based interventions to improve linkage and outcomes for heart failure (HF) patients requires input from stakeholders: patients, community health workers (CHWs), healthcare staff, and health system administrators. In this research the investigators will assess a CHW intervention designed to improve linkage to care for HF patients. This intervention was systematically adapted for use in rural Haiti in a prior study using the Assessment, Decisions, Administration, Production, Topical Experts, Integration, Training staff, Testing (ADAPT-ITT) framework. The ADAPT-ITT framework provides 8 sequential phases to adapt interventions and programs to new target audiences. It has been applied successfully to the adaptation of several interventions for HIV among under-resourced communities leading to randomized clinical trials. With the first 6 steps of the ADAPT-ITT framework completed in a prior study, this protocol outlines the training and testing of the adapted CHW intervention. In addition to assessing the feasibility, appropriateness, and acceptability of the adapted intervention through participants' feedback, the investigators will assess its efficacy in improving HF outcomes. The proposed intervention is targeted at both the patient domain - through improved peer support - and health system domain - by improving health system navigation. Type: Interventional Start Date: Jan 2023 |
GWICTIC: NAC Mechanistic Study in Gulf War Veterans
Nova Southeastern University
Gulf War Syndrome
This mechanistic study will test if NAC affects chronic oxidative stress and depletion of
antioxidants in GWI participants. Blood specimen collection and neuroimaging will be used to
determine whether NAC affects serum glutathione (GSH) concentration and oxidative stress in... expand
This mechanistic study will test if NAC affects chronic oxidative stress and depletion of antioxidants in GWI participants. Blood specimen collection and neuroimaging will be used to determine whether NAC affects serum glutathione (GSH) concentration and oxidative stress in the CNS when compared to placebo. Type: Interventional Start Date: Nov 2023 |
Fenofibrate for Prevention of DR Worsening
Jaeb Center for Health Research
Diabetic Retinopathy
This randomized trial will evaluate the effect of fenofibrate compared with placebo for
prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes with
mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline.
In addition... expand
This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline. In addition to evaluating efficacy, this study aims to evaluate the feasibility of a model for ophthalmologists to prescribe or collaborate with a primary care provider such as an internist/endocrinologist to prescribe and monitor the drug safely. If this study demonstrates that fenofibrate is effective for reducing the onset of proliferative diabetic retinopathy (PDR) or and the results are adopted by the community of retina specialists, a new strategy to prevent vision threatening complications of diabetes could be widely adopted. Widespread use of an oral agent effective at reducing worsening of DR would decrease the numbers of patients who undergo more invasive and much more expensive treatment for DR and who are consequently at risk for side effects that adversely affect visual function. This study will also assess the relationship of glycemic variability, as measured by continuous glucose monitoring with DR outcomes. Ancillary studies will characterize functional and structural outcomes in this cohort. Type: Interventional Start Date: Mar 2021 |
Pomalidomide Treatment in Patients With Kaposi Sarcoma
National Cancer Institute (NCI)
Skin Kaposi Sarcoma
This phase II trial studies the effect of pomalidomide in treating patients with Kaposi
sarcoma. Pomalidomide is a cancer fighting drug that stops the growth of blood vessels,
stimulates the immune system, and may kill cancer cells.
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This phase II trial studies the effect of pomalidomide in treating patients with Kaposi sarcoma. Pomalidomide is a cancer fighting drug that stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells. Type: Interventional Start Date: Mar 2022 |
Scalable Communication Modalities for Returning Genetic Research Results
Boston University
Hereditary Breast and Ovarian Cancer
Lynch Syndrome
Efforts to examine the utility of alternate modalities for genetic results disclosure has
widespread implications for how precision medicine research might yield direct health
benefits for study participants. This study will examine the efficacy of an online
self-guided program... expand
Efforts to examine the utility of alternate modalities for genetic results disclosure has widespread implications for how precision medicine research might yield direct health benefits for study participants. This study will examine the efficacy of an online self-guided program to return genetic results to a racial minority cohort population. Study results will provide empirical evidence on the effectiveness of alternate modalities for genetic results return, inform ongoing efforts to establish scalable approaches for effective return of genetic research results, and increase access to personal health information among African American women. Type: Interventional Start Date: Mar 2023 |
Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive...
National Cancer Institute (NCI)
Extensive Stage Lung Small Cell Carcinoma
This phase II/III trial compares the effect of adding radiation therapy to the usual
maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already
received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has
spread... expand
This phase II/III trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to atezolizumab may extend the time without extensive small cell lung cancer growing or spreading compared to atezolizumab alone. Type: Interventional Start Date: Jan 2021 |
An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination...
Boston Medical Center
HPV Infection
The goal of this study is to explore and evaluate whether a 2-dose schedule of Gardasil 9
among young and mid-adult women 16-45 years of age is generally safe and immunogenic, with an
antibody response that is not inferior to that observed of a 3-dose schedule of Gardasil 9... expand
The goal of this study is to explore and evaluate whether a 2-dose schedule of Gardasil 9 among young and mid-adult women 16-45 years of age is generally safe and immunogenic, with an antibody response that is not inferior to that observed of a 3-dose schedule of Gardasil 9 among women aged 16-26 years old. The investigators thought that having a 2-dose vaccination regimen for individuals 16 to 45 would provide a more robust dataset than those of 27 to 45 years old. Type: Interventional Start Date: Dec 2020 |
Study to Evaluate Sacituzumab Govitecan in Combination With Talazoparib in Patients With Metastatic Breast...
Massachusetts General Hospital
Breast Cancer
This research is studying the effect of Antibody-Drug Conjugate Sacituzumab Govitecan in
Combination with the Poly (Adenosine Diphosphate [ADP]-Ribose) Polymerase (PARP) Inhibitor
Talazoparib in Patients with Metastatic Triple-Negative Breast Cancer.
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This research is studying the effect of Antibody-Drug Conjugate Sacituzumab Govitecan in Combination with the Poly (Adenosine Diphosphate [ADP]-Ribose) Polymerase (PARP) Inhibitor Talazoparib in Patients with Metastatic Triple-Negative Breast Cancer. Type: Interventional Start Date: Oct 2019 |
Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
Yale University
Intracerebral Hemorrhage
Atrial Fibrillation
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite
outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with
recent ICH and atrial fibrillation (AF).
Secondary Aim: To determine if apixaban, compared... expand
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale. Type: Interventional Start Date: Jan 2020 |
Nutrition in Patient With Critical Limb Ischemia
Boston Medical Center
Critical Limb Ischemia
Malnutrition
Nutritional Supplements
A prospective pilot study examining nutritional supplements among vascular surgery patients
with Critical Limb Ischemia (CLI). CLI patients have a high rate of malnutrition and has the
potential to benefit greatly from nutritional intervention. The investigators plan to
evaluate... expand
A prospective pilot study examining nutritional supplements among vascular surgery patients with Critical Limb Ischemia (CLI). CLI patients have a high rate of malnutrition and has the potential to benefit greatly from nutritional intervention. The investigators plan to evaluate nutrition and functional status of patients by assessing objective lab values and the use of the hand grip strength test. Providing perioperative nutritional supplements to patients has potentially improved their nutritional status, which in turn may improve the patient's clinical status after surgery. Type: Interventional Start Date: Oct 2018 |
Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy...
National Cancer Institute (NCI)
Oropharyngeal p16INK4a-Negative Squamous Cell Carcinoma
Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7
Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
This phase II/III trial studies how well radiation therapy works when given together with
cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with
high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous
cell).... expand
This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. 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. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab. Type: Interventional Start Date: Mar 2013 |
Mobile App-based Approach for Reducing Pain and Hazardous Drinking: a Pilot Study
Boston University Charles River Campus
Alcohol Drinking
Chronic Pain
Chronic pain and heavy drinking are common co-occurring conditions among patients presenting
to primary care settings. Given their impact on functioning and medical outcomes, there would
be considerable benefit to developing an accessible, easily utilized, integrative approach to... expand
Chronic pain and heavy drinking are common co-occurring conditions among patients presenting to primary care settings. Given their impact on functioning and medical outcomes, there would be considerable benefit to developing an accessible, easily utilized, integrative approach to reduce alcohol use and pain that can be readily incorporated into the health care settings. The objective of this study is to test a modified version of a smartphone-based intervention for reducing pain and alcohol use among individuals experiencing chronic pain who engage in heavy drinking. The primary goal is to test the feasibility and acceptability of implementing this intervention in a sample that includes participants from rural areas and providing initial data on the utility of the intervention. Type: Interventional Start Date: Feb 2024 |
Ti-Mesh Frame Comparison for Alveolar Bone Augmentation
Boston University
Tooth Loss
This research compares a chairside Titanium Mesh frame fabrication used during bone grafting
procedures with the use of a computer-aided design/computer-assisted manufacture (CAD-CAM)
Titanium Mesh frame. In addition, a novel method of measuring soft tissue thickness will be... expand
This research compares a chairside Titanium Mesh frame fabrication used during bone grafting procedures with the use of a computer-aided design/computer-assisted manufacture (CAD-CAM) Titanium Mesh frame. In addition, a novel method of measuring soft tissue thickness will be tested using an Optical scanner at various times during the sequence of surgeries. The device used for shaping is a very thin, perforated titanium metal sheet with numerous small perforations (referred to as Micromesh). The construction of this device is usually accomplished chairside at the time of the surgery with custom cutting and shaping done using cues from the geometry of the surgical defect. An alternative approach will be tested where the mesh is pre-designed using digital information provided by a special xray and an optical scan device which takes a digital impression of the tooth and soft tissue surface. A digitally designed frame can then be printed using CAD-CAM software prior to surgery. This should reduce surgical time. A randomized control trial of 30 patients needing 3-D bone augmentation will be conducted comparing chairside fabrication of Ti-MESH or TEST- CAD-CAM designed and preprinted Ti-MESH to investigate these objectives: 1. Compare the operative times required for placement and removal of two different Ti-MESH frame fabrications 2. Compare post-op wound healing -Ti MESH exposure rates, bone production (volume, contour, and quality) and soft tissue thickness changes during the 1-year study period. Type: Interventional Start Date: Jan 2024 |
A Randomized Trial Evaluating Control-IQ Technology in Adults With Type 2 Diabetes
Tandem Diabetes Care, Inc.
Type 2 Diabetes Treated With Insulin
A randomized controlled trial (RCT) to assess the safety and efficacy of use of Control-IQ
technology in adults with type 2 diabetes using basal-bolus insulin therapy.
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A randomized controlled trial (RCT) to assess the safety and efficacy of use of Control-IQ technology in adults with type 2 diabetes using basal-bolus insulin therapy. Type: Interventional Start Date: Jun 2023 |
Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung...
SWOG Cancer Research Network
Recurrent Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab
versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is
stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a... expand
This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs 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. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy. Type: Interventional Start Date: Mar 2023 |
Full-Time Occlusion Therapy for Intermittent Exotropia in Children
Jaeb Center for Health Research
Intermittent Exotropia
Determine whether full-time patching is more effective than observation for improving
distance control of IXT after 3 months of treatment (on-treatment outcome).
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Determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome). Type: Interventional Start Date: Nov 2022 |
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening...
LimFlow, Inc.
Critical Limb Ischemia
Chronic Limb-Threatening Ischemia
Peripheral Arterial Disease
A prospective, single-arm, multi-center study designed to gather additional information on
the LimFlow System.
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A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System. Type: Interventional Start Date: Dec 2022 |
Cognitive Processing Therapy (CPT) Memory Support (MS) Study
Boston University
PTSD
The efficacy of psychological interventions for posttraumatic stress disorder (PTSD) is
likely limited by the difficulty participants have learning and remembering important therapy
content. Accordingly, the present study will examine the utility of integrating a Memory
Support... expand
The efficacy of psychological interventions for posttraumatic stress disorder (PTSD) is likely limited by the difficulty participants have learning and remembering important therapy content. Accordingly, the present study will examine the utility of integrating a Memory Support (MS) intervention into Cognitive Processing Therapy (CPT), an empirically supported and widely disseminated treatment for PTSD. MS was designed to integrate techniques aimed at facilitating encoding, consolidation, and retrieval of new learning into existing treatments, and has been shown to improve outcomes when integrated into cognitive therapy for depression. A pilot randomized controlled trial (n=52) comparing CPT with Memory Support (CPT+MS) to CPT-alone will be conducted. Study participants will be adults diagnosed with PTSD. The primary aim of the trial will be to determine if CPT+MS will lead to greater memory and learning of therapy content relative to CPT-alone, and to establish the acceptability and feasibility of integrating MS into CPT. Secondary aims include a preliminary examination of treatment efficacy, as indicated by the magnitude of changes in PTSD symptoms between conditions, and target validation, as indicated by associations between memory and learning of therapy content and treatment response. Exploratory analyses will examine several indicators of baseline memory-related cognitive functioning as predictors of memory and learning of therapy content, providing preliminary data to inform future research on personalized application of MS. Results of the trial will advance scientific knowledge about methods for optimizing memory and learning as a mechanism for improving PTSD treatment outcomes. Type: Interventional Start Date: Jan 2023 |
EndovaSCular TreAtment to imProve outcomEs for Medium Vessel Occlusions (ESCAPE-MeVO Trial)
Dr. Michael D Hill
Acute Ischemic Stroke
Stroke occurs when a blood clot causes a blockage in a blood vessel (artery) within the
brain. This type of stroke is called an ischemic stroke and carries a high risk of disability
or death. Stroke must be treated very fast. Any delay of even 10 minutes can result in the... expand
Stroke occurs when a blood clot causes a blockage in a blood vessel (artery) within the brain. This type of stroke is called an ischemic stroke and carries a high risk of disability or death. Stroke must be treated very fast. Any delay of even 10 minutes can result in the difference between an independent and a disabled outcome, and in some cases between life and death. Endovascular therapy (EVT) or Thrombectomy is a procedure to remove the blood clot (thrombus) from a blood vessel to reopen it (recanalization). Patients are likely to benefit from a thrombectomy procedure when it is performed in a larger blood vessel. Currently it is not known if thrombectomy procedure will benefit the patients presenting with the stroke that has been caused by a blood clot in a medium sized blood vessel (medium vessel occlusion, MeVO). This trial will enrol patients diagnosed with acute stroke due to a clot in the medium sized vessel. The patients will be randomized within 12 hours of their symptom onset to either standard of care or standard of care plus thrombectomy procedure. The participation will last for 12 months Escape MeVO coordinating centre is located at the University of Calgary. There will be up to 75 sites. We will be recruiting a total of 530 patients. Type: Interventional Start Date: Apr 2022 |
Conversation Group Treatment for Aphasia: Does it Work?
Boston University Charles River Campus
Aphasia, Acquired
The proposed research will test the efficacy of group conversation treatment for people with
aphasia and explore whether the effects of treatment differ as a result of the following
factors:
1. Group size: Do large groups of 6-8 people with aphasia or dyads of 2 people... expand
The proposed research will test the efficacy of group conversation treatment for people with aphasia and explore whether the effects of treatment differ as a result of the following factors: 1. Group size: Do large groups of 6-8 people with aphasia or dyads of 2 people with aphasia demonstrate different levels of improvement with this treatment? 2. Group composition: Do effects of conversation group treatment differ if the groups include members with similar or different types of aphasia? 3. Aphasia severity: Do effects of conversation group treatment differ if the individuals within the group have mild-moderate or moderate-severe profiles of aphasia? Treatment sessions will occur in groups of 6-8 people with aphasia or with 2 people with aphasia. During treatment sessions, discourse will be facilitated on a focused set of every day topics, such as current events or travel. Linguistic and multi modal cueing hierarchies will be tailored to individual client goals and used to maximize communication success. The prediction is that conversation treatment is an effective method for improving communication in people with aphasia, but that specific benefits may differ based on variables such as group size, group composition, and aphasia severity. The results will help inform best practices for aphasia treatment and refine a hypothesized model about the mechanisms underlying conversation treatment. Type: Interventional Start Date: Apr 2022 |
Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That...
NRG Oncology
Metastatic Lung Small Cell Carcinoma
Metastatic Malignant Neoplasm in the Brain
Recurrent Lung Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8
This phase III trial compares the effect of stereotactic radiosurgery to standard of care
memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of
the brain) for the treatment of small cell lung cancer that has spread to the brain.
Stereotactic... expand
This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine. Type: Interventional Start Date: Mar 2021 |
Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II
Butler Hospital
Opioid Use
Chronic Pain
Phase 2 - Multiphase Optimization Strategy (MOST) Optimization Phase:
1. To conduct a factorial experiment that will allow us to evaluate the impact of each of
the 4 intervention components on yoga dosage received. We will enroll a total n=192. All
participants... expand
Phase 2 - Multiphase Optimization Strategy (MOST) Optimization Phase: 1. To conduct a factorial experiment that will allow us to evaluate the impact of each of the 4 intervention components on yoga dosage received. We will enroll a total n=192. All participants will receive the core yoga intervention, with random assignment to the four intervention components outlined above. 2. Use results from Phase 2 to choose an efficient combination of intervention components that, together with standard yoga classes, maximizes yoga dosage. 3. Examine mechanisms by which components are hypothesized to work. Type: Interventional Start Date: Feb 2022 |
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