![](/assets/img/rmlogo.png)
Search Clinical Trials
The BU-CTSI is a center of expertise providing tools, services and resources to clinical investigators, maximizing the impact of discoveries & speeding the translation of research into improved patient care
Sponsor Condition of Interest |
---|
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, may help protect the heart... 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 |
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 CHW intervention designed... 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 the CNS when compared to... 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 |
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. expand
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 to return genetic results... 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 outside of the lung... 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 among women aged 16-26... 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. expand
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 |
VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions
AIDS Malignancy Consortium
Anal Intraepithelial Neoplasia
High Grade Squamous Intraepithelial Neoplasia
HIV Positivity
Human Papillomavirus-16 Positive
Human Papillomavirus-18 Positive
This phase II trial studies the use of human papillomavirus (HPV) deoxyribonucleic acid
(DNA) plasmids therapeutic vaccine VGX-3100 (VGX-3100) and electroporation in treating
patients with human immunodeficiency virus (HIV)-positive high-grade anal lesions.
Vaccines made from DNA may help the body... expand
This phase II trial studies the use of human papillomavirus (HPV) deoxyribonucleic acid (DNA) plasmids therapeutic vaccine VGX-3100 (VGX-3100) and electroporation in treating patients with human immunodeficiency virus (HIV)-positive high-grade anal lesions. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells. Electroporation helps pores in your body's cells take in the drug to strengthen your immune system's response. Giving VGX-3100 and electroporation together may work better in treating patients with high-grade anal lesions. Type: Interventional Start Date: Sep 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). Specialized radiation... 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 |
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 tested using an Optical... 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 |
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 monoclonal antibody that... 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). expand
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 |
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 (MS) intervention into... 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 |
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 with
aphasia demonstrate... 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 |
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 will receive the core... 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 |
Social Media and Risk Reduction Teaching-Enhanced Reach
Boston University
Breastfeeding
SUID
SIDS
This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS)
recommendations and improve rates of initiation and duration of partial and exclusive
breastfeeding (BF) through direct education of mothers using Mobile Health (mHealth)
technologies (ex. text messaging). expand
This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF) through direct education of mothers using Mobile Health (mHealth) technologies (ex. text messaging). Type: Interventional Start Date: Jan 2022 |
A Randomized Trial to Evaluate Sequential vs Simultaneous Patching
Jaeb Center for Health Research
Amblyopia
A randomized trial to determine whether simultaneous treatment with spectacles and
patching has an equivalent VA outcome compared with sequential treatment, first with
spectacles alone followed by patching (if needed), for previously untreated amblyopia in
children 3 to <13 years of age. expand
A randomized trial to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to <13 years of age. Type: Interventional Start Date: Dec 2020 |
Improving Medical Decision Making for Older Patients With End Stage Renal Disease
Tufts Medical Center
Renal Disease, End Stage
Palliative Care
Decision Aids
The overall objective of this study is to reduce the burden of chronic kidney disease
(CKD) and its consequences for an aging U.S. population. To accomplish this, the
investigators propose to conduct a multi-center randomized trial of an advance care
planning (ACP) video intervention (vs. usual care)... expand
The overall objective of this study is to reduce the burden of chronic kidney disease (CKD) and its consequences for an aging U.S. population. To accomplish this, the investigators propose to conduct a multi-center randomized trial of an advance care planning (ACP) video intervention (vs. usual care) among older patients with CKD. Type: Interventional Start Date: Jun 2021 |
Leadership, Engagement, and Youth Activism Program With Mindfulness (LEAP)
Boston University Charles River Campus
Adolescent Behavior
Mental Health Wellness 1
The current study tests the feasibility and effectiveness of a youth intervention
designed to provide meaningful leadership opportunities and to address barriers to
equity, through the acquisition of civic leadership and development skills as well as
mindfulness practice, LEAP-M: Leadership, Engagement,... expand
The current study tests the feasibility and effectiveness of a youth intervention designed to provide meaningful leadership opportunities and to address barriers to equity, through the acquisition of civic leadership and development skills as well as mindfulness practice, LEAP-M: Leadership, Engagement, and youth Activism Program with Mindfulness. The goal of our proposal is to determine whether the Leadership, Engagement, and youth Activism Program with Mindfulness.(LEAP-M) curriculum, which was developed with youth of color, is a feasible and effective intervention for fostering civic leadership, civic development, and wellbeing. We seek to understand whether LEAP-M can support wellbeing for youth of color as a strategy to combat structural racism at the school- and neighborhood-levels, increase youth mental, emotional, and behavioral (MEB) health and decrease health disparities in youth of color. Type: Interventional Start Date: Dec 2023 |
Validating Gulf War Illness Blood Biomarkers
Roskamp Institute Inc.
Gulf War Syndrome
Gulf War Illness
The investigators goals are to identify blood lipids/metabolites that correlate with
cognitive decline in the presence of the APOE ε4 allele among veterans with GWI. To
determine the effect of dietary, medical and biological factors that influence lipid and
metabolites in blood from GW veterans. To... expand
The investigators goals are to identify blood lipids/metabolites that correlate with cognitive decline in the presence of the APOE ε4 allele among veterans with GWI. To determine the effect of dietary, medical and biological factors that influence lipid and metabolites in blood from GW veterans. To identify blood lipid/metabolite profiles that correlate with bioenergetics deficits and glial activation in the brains of GWI. To validate blood biomarker signatures of GWI using APOE genotyping and blood lipids/metabolites that correlate with the CNS dysfunction in GWI. Type: Observational Start Date: Jun 2022 |
Physical Activity for PLWH and Unhealthy Drinking
Boston University
HIV
Physical Inactivity
Unhealthy Alcohol Use
Brief Summary: Alcohol use disorder (AUD) is a significant and costly public health
problem that affects one-third of the U.S. population in their lifetime. Specifically,
unhealthy alcohol use is common among persons living with HIV (PLWH) and increases the
risk of developing negative outcomes. Antiretroviral... expand
Brief Summary: Alcohol use disorder (AUD) is a significant and costly public health problem that affects one-third of the U.S. population in their lifetime. Specifically, unhealthy alcohol use is common among persons living with HIV (PLWH) and increases the risk of developing negative outcomes. Antiretroviral therapy (ART) has shown increasing life expectancy and decreased HIV-related deaths, leading to a growing older adult HIV population. Yet, HIV accelerates the aging process and increases the risk for numerous chronic health conditions that compromise physical and mental health functioning and quality of life. Thus, PLWH continue to have shorter life expectancies relative to the general population and these multimorbidities explain this increased risk. In this context, unhealthy alcohol use among PLWH can further increase the risk for negative outcomes. Physical activity (PA) interventions can be used as an effective way to address unhealthy alcohol use among PLWH. Previous PA interventions have shown low generalizability and high loss to follow-up. Therefore, an intervention that is home-based, including lifestyle physical activity (LPA) with mobile health-delivered components is designed following the physical activity (PA) paradigm. Participants in this randomized controlled trial will be assigned to one of two study arms -- either the LPA or Fitbit Only intervention - both lasting 12-weeks. Both study arms will utilize a Fitbit to track daily step counts. In addition to utilizing a Fitbit, the LPA arm will receive 7 LPA sessions with a trained interventionist to assist in adding LPA to the participant's routine. The Fitbit only arm will receive only brief check-in phone calls and only related to assisting with any Fitbit functioning issues. Follow-up assessments will take place at 3 and 6 months. Type: Interventional Start Date: Feb 2023 |
Telehealth for Pain and Unhealthy Drinking Among PLWH
Boston University
HIV
Chronic Pain
Unhealthy Alcohol Use
This randomized controlled trial is a between-groups design to compare the Motivational
and Cognitive Behavioral Management for Alcohol and Pain (MCBMAP) Intervention to a Brief
Advice and Information Control condition.
Two-hundred and fifty participants who have HIV with moderate or greater chronic... expand
This randomized controlled trial is a between-groups design to compare the Motivational and Cognitive Behavioral Management for Alcohol and Pain (MCBMAP) Intervention to a Brief Advice and Information Control condition. Two-hundred and fifty participants who have HIV with moderate or greater chronic pain will be randomized for the trial. Recruitment will take place through digital media. A unique feature of this intervention trial is that most of the procedures will be conducted remotely which will minimize barriers of transportation and time for participants. Consent and baseline assessment will be completed remotely. Following baseline assessment, participants will complete two weeks of ecological momentary assessment (EMA) to assess alcohol use, chronic pain, physical function and mechanisms of behavior change for alcohol and pain management. Following the two-week phase, participants will be randomly assigned to either the intervention or control condition and meet the interventionist through videoconferencing. Participants will complete outcome assessment measures at 3- and 6-months post-baseline. Following the 3-month outcome assessment, participants will complete another two weeks of EMA. Type: Interventional Start Date: Mar 2023 |
5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer
Boston University
Superficial Basal Cell Carcinoma
Squamous Cell Carcinoma in Situ
The investigators will compare the application of two different creams for the treatment
of low-risk skin cancers-superficial basal cell carcinoma (sBCC) and squamous cell
carcinoma in situ (SCCis). 5-Fluorouracil cream is currently FDA approved for the
treatment of superficial basal cell carcinoma... expand
The investigators will compare the application of two different creams for the treatment of low-risk skin cancers-superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). 5-Fluorouracil cream is currently FDA approved for the treatment of superficial basal cell carcinoma and is routinely used by dermatologists across the country and at Boston Medical Center (BMC) for SCCis. The normal treatment regimen is 4 weeks of the 5-fluorouracil cream for both skin cancers. The application of a compounded cream consisting of 1:1 ratio 5-fluorouracil with calcipotriene will be tested. This combination cream has been shown to clear pre-skin cancers called actinic keratoses and prevent future skin cancers from developing. This combination cream for 7-14 days to see if this shorter treatment course provides clearance of the 2 types of skin cancer. This combination cream is successfully used in this manner to treat other subtypes of related skin cancers. This will be a pilot study with The primary endpoint for this pilot randomized single blinded clinical trial will be the response to treatment (yes versus no). The lesions will be assessed clinically for clearance of cancer, as would normally be done and is consistent with how comparable studies have assessed clearance. Participants will be followed closely afterwards for three years with visits at 6 months, which does not vary from standard practice. If the lesions are not clear of cancer or equivocal clinically, the lesions will be re-biopsied and normal standard of care procedure will take place. Type: Interventional Start Date: Oct 2022 |
Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric...
Vertex Pharmaceuticals Incorporated
Proteinuric Kidney Disease
The purpose of this study is to evaluate the efficacy, safety, tolerability, and
pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein
L1 (APOL1)-mediated proteinuric kidney disease. expand
The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease. Type: Interventional Start Date: Mar 2022 |
- Previous
- Next