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Wrist Cooling for Hot Flashes Clinical Trial
Boston University
Hot Flashes
This pilot randomized double blind controlled crossover study aims to determine the
impact of two wrist cooling devices on symptom control of hot flashes in adult men and
adult women experiencing hot flashes. The participants will record during the first two
weeks of the study all of their hot flashes... expand
This pilot randomized double blind controlled crossover study aims to determine the impact of two wrist cooling devices on symptom control of hot flashes in adult men and adult women experiencing hot flashes. The participants will record during the first two weeks of the study all of their hot flashes and severity of their hot flashes in a diary. The participants will be randomly assigned to wear one of the two wrist cooling devices that have an identical appearance at different times in the study. They will wear the first assigned device for weeks 3 and 4. They will record in their diary the severity of their hot flashes while using the device. For weeks 5 and 6 they will be ask to use a second device and record in their diary the severity of their hot flashes with the use of the device. The devices will be attached to the wrist like a watch. When activated, one device will turn on a cooling fan with the cooling plate being active for up to 5 minutes, and the other device will turn on a cooling fan only for up to 5 minutes without the cooling plate being active. Type: Interventional Start Date: Mar 2023 |
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 radiosurgery is a... 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: Jun 2021 |
Testing Tumor Tissue and Blood to Help Select Personalized Treatments for Patients With Suspected Lung...
Lung Cancer Mutation Consortium
NSCLC
This collaborative screening protocol, developed by the Lung Cancer Mutation Consortium
(LCMC) and supported by the Thoracic Surgery Oncology Group (TSOG), is designed to
determine the feasibility of comprehensive molecular profiling to detect actionable
oncogenic drivers in patients with suspected... expand
This collaborative screening protocol, developed by the Lung Cancer Mutation Consortium (LCMC) and supported by the Thoracic Surgery Oncology Group (TSOG), is designed to determine the feasibility of comprehensive molecular profiling to detect actionable oncogenic drivers in patients with suspected early stage lung cancers scheduled to undergo biopsies to establish the diagnosis of lung cancer. The primary purpose of this testing is to determine the presence of 12 oncogenic drivers (mutations in EGFR, BRAFV600E , MET exon 14, KRAS G12C and HER2, rearrangements in ALK, RET, NTRK, EGFR exon 20 insertion and ROS1, and amplification of MET and HER2) that can serve as targets making patients eligible for upcoming targeted neoadjuvant therapy trials. The ultimate goal is to use this information from the screening process to select the optimal neoadjuvant therapy and wherever possible enroll patients onto separate neoadjuvant therapy trials with genomically matched treatments or other appropriate trials if no actionable driver mutation is detected. Thoracic Surgery Oncology Group (TSOG) is a network of surgeons within North American Thoracic Surgery Academic Centers aligned with the goal of enhancing patient care through administration of multi-site trials focused on recent advances in lung cancer. TSOG has aligned with the LCMC4 sites to enroll the LCRF-LEADER screening trial. TSOG's involvement will be essential in trial enrollment and ultimate interpretation of the multimodal clinical and translational data collected as part of this study. We estimate we will detect an actionable oncogenic driver in 33% of cases. The remaining 66% of patients will represent a cohort identified by their care teams as candidates for other potential neoadjuvant therapies which may include checkpoint inhibitors such as atezolizumab, durvalumab, nivolumab, and pembrolizumab or other novel agents. The targeted therapy treatment trials will be conducted independently of the LCRF-LEADER screening trial, evaluating for efficacy. If none of the 10 oncogenic drivers are detected, the patient will be offered participation in any clinical trial of neoadjuvant therapy available at their treating institution or standard of care therapy. For patients not enrolled on a targeted treatment trial, circulating tumor DNA in blood (ctDNA) will be collected at 3 time points: before neoadjuvant treatment, after neoadjuvant treatment but before surgery, and after surgery. This initiative will be correlated with various clinical outcomes. Prespecified clinical data will be collected for correlation with these circulating biomarkers. Type: Observational Start Date: Jun 2022 |
A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)
Forma Therapeutics, Inc.
Sickle Cell Disease
This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of
etavopivat and test how well etavopivat works compared to placebo to improve the amount
of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when
the blood vessels become blocked and... expand
This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of etavopivat and test how well etavopivat works compared to placebo to improve the amount of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when the blood vessels become blocked and cause pain). Type: Interventional Start Date: Mar 2021 |
PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort
Michael J. Fox Foundation for Parkinson's Research
Parkinson Disease
The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational,
multi-center natural history study to assess progression of clinical features, digital
outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD)
progression in study participants with manifest... expand
The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability. Type: Observational Start Date: Jul 2020 |
MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study
Boston Medical Center
Opioid-use Disorder
Neonatal Abstinence Syndrome
Pregnancy, High Risk
Alcohol Use Disorder
This is a multi-center prospective comparative cohort study examining the safety,
efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with
opioid use disorder. Pregnancy, delivery, and maternal and infant outcomes to 12 months
post-delivery will be examined and compared... expand
This is a multi-center prospective comparative cohort study examining the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with opioid use disorder. Pregnancy, delivery, and maternal and infant outcomes to 12 months post-delivery will be examined and compared with a cohort treated with buprenorphine/naloxone. Type: Observational Start Date: Dec 2018 |
Multi-Center Development of a Novel Diagnostic Test for Alzheimer's Disease
Boston University
Alzheimer Disease
Mild Cognitive Impairment
In this multi-center study, the investigators plan to develop a simple blood-based test
for early detection of Alzheimer's disease (AD). The test is based on a single injection
of Pramlintide, an amylin analogue and FDA-approved drug currently used for treatment of
diabetes. The investigative team... expand
In this multi-center study, the investigators plan to develop a simple blood-based test for early detection of Alzheimer's disease (AD). The test is based on a single injection of Pramlintide, an amylin analogue and FDA-approved drug currently used for treatment of diabetes. The investigative team has provided evidence in humans with full-blown AD and AD-relevant mouse models that a single injection of Pramlintide transiently renders the blood brain barrier (BBB) more permeable to Amyloidbeta (Aß) peptides, allowing their efflux from the brain compartment into the blood. This Aß efflux causes a corresponding transient elevation of blood levels of Aß, the magnitude of which the applicants believe is proportional to the brain amyloid load as determined by AV-45 PET. The measured difference in the level of plasma Aß taken just before and a short time after injection should reveal the magnitude of the transient increase in blood Aß levels. Supportive preliminary data comes from later stage (full-blown) AD patients with more in-depth background studies in Tg2576 and 5X Familial Alzheimer's Disease (FAD) mouse models. If successful for use as an early AD (i.e., at the Mild Cognitive Impairment [MCI] stage) biomarker, this could be a game-changer for both early AD diagnostics and clinical trials aimed at identifying and testing the efficacy of drugs useful for treatment of AD at early stages. If Pramlintide is effective in releasing mobile pools of Aß from the brain into the blood, this could also have some therapeutic potential, with the goal of reducing brain amyloid load. Three groups of particpants will be studied: 1) amnestic MCI with or without positive AD imaging pathology, 2) probable AD with positive imaging AD pathology, and 3) controls who have normal cognition and do not have memory complaints. Type: Interventional Start Date: Feb 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 nutrition and functional... 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 |
Culturally Adapted Group Cognitive Behavior Therapy (CaGCBT-SUDs) for Substance Use Disorders and Their...
National University of Modern Languages
Treatment
Waitlist
Pakistan is facing a massive rise in drug abuse. According to recent estimates, there are
6.7 million drug abusers, of which 4.25 million are drug dependents who need long-term
treatments in residential setups. Despite these shocking statistics, there is a severe
lack of evidence-based treatment,... expand
Pakistan is facing a massive rise in drug abuse. According to recent estimates, there are 6.7 million drug abusers, of which 4.25 million are drug dependents who need long-term treatments in residential setups. Despite these shocking statistics, there is a severe lack of evidence-based treatment, preventive measures, and drug indictment policies. Consequently, the number of drug dependents continues to increase at an alarming rate of 40,000 per year, making Pakistan one of the most drug-affected countries in the world. The ever-increasing rise in drug abuse can be devastating for a country such as Pakistan where the youth population (aged <30 years) makes up a substantial 64% of the total population. It not only affects the individual's physical and mental health but also casts devastating effects on the psycho-social and economic aspects of their lives. Adults with Substance Use Disorders (SUDs) usually come across aggravated interpersonal and family problems, loss of productivity and unemployment, poverty and crimes, overall financial problems, deaths, and accidents. Furthermore, it also destroys the norms, morality, worth, and dignity of the person's well-being and effectiveness in the growth of society. Numerous studies in Pakistan showed a lack of evidence-based treatment altogether for adults suffering from SUDs. Thus, effective interventions for SUDs that also meet the clinical reality of open treatment groups are much needed to reduce the treatment gap. Further, the implementation of evidence-based approaches like Cognitive Behavior Therapy (CBT) has an advantage with SUDs clients who are motivated. The proposed project aims at the cultural adaptation of CBT-based group intervention for adults with substance use disorders (SUDs) in Pakistan by employing a Quasi-Experimental research design, followed by Randomized Control Trials to test its effectiveness in Pakistan. Type: Interventional Start Date: Dec 2022 |
The Impact of Prehabilitation
Boston Medical Center
Post Operative Complications
While numerous studies have assessed the promising impacts of prehabilitation, there is a
lack of prehabilitation research within lower socioeconomic patient populations. Often
for prehabilitation studies, patients are heavily involved in full scale exercise and
nutrition programs weeks before the... expand
While numerous studies have assessed the promising impacts of prehabilitation, there is a lack of prehabilitation research within lower socioeconomic patient populations. Often for prehabilitation studies, patients are heavily involved in full scale exercise and nutrition programs weeks before the scheduled procedure. In underserved populations, programs such as these are often not feasible due to lack of transport, resources, and other barriers to healthcare. The investigators seek to evaluate the effectiveness of inexpensive interventions in lower socioeconomic populations. The investigators hypothesize that barriers to prehabilitation are environmental and that prehabilitation interventions tailored for lower socioeconomic (SES) populations will improve time to discharge, mobility, and in turn, readmission rates. The participants for this clinical trial will be seen four times: initially at the preoperative surgical clinic (6-8 weeks prior to surgery), 1-2 days preop at a pre-procedure clinic, postoperative in the inpatient setting (as soon as the participant is able to ambulate during their hospital stay), and in the postoperative surgical clinic at the postoperative visit. Patients will be within the general surgery, colorectal, and surgical oncology departments at Boston Medical Center (BMC). The anticipated sample size is 60 participants (30 in the intervention/prehabilitation arm and 30 in the control/usual care arm). Participants in the intervention arm will participate in a mobility and step tracking intervention aimed at improving postoperative outcomes. The control group will follow routine standard of care at BMC for preoperative and postoperative care. Type: Interventional Start Date: May 2024 |
Improving Memory in Alzheimer's Disease With Noninvasive Brain Stimulation
Boston University Charles River Campus
Alzheimer Disease
The investigators will evaluate the theory that Alzheimer's disease-related memory
impairment derives from the inefficient orchestration of rhythmic activity at the level
of large-scale cortical networks. The results as expected to elucidate AD-related
pathophysiology and set groundwork for the development... expand
The investigators will evaluate the theory that Alzheimer's disease-related memory impairment derives from the inefficient orchestration of rhythmic activity at the level of large-scale cortical networks. The results as expected to elucidate AD-related pathophysiology and set groundwork for the development of drug-free interventions for improving memory in AD and related dementias. Type: Interventional Start Date: Dec 2023 |
TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer
Dana-Farber Cancer Institute
Breast Cancer
Early-stage Breast Cancer
High Risk Breast Carcinoma
In this research study, investigators are testing if a dose-increasing strategy for
abemaciclib will have less side effects and be better tolerated than the standard dosage
of abemaciclib for participants with early-stage high-risk hormone receptor positive
breast cancer.
The names of the study... expand
In this research study, investigators are testing if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer. The names of the study drugs involved in this study are: - Abemaciclib (CDK4 and CDK6 inhibitor) - Tamoxifen (Selective estrogen receptor modulator) - Anastrozole/Letrozole (Non-steroidal aromatase inhibitors) - Exemestane (steroidal aromatase inhibitor) - LHRH (Gonadotropin-releasing hormone agonist, or Luteinizing hormone-releasing hormone agonist) Type: Interventional Start Date: Oct 2023 |
Prehospital Telemedicine Feasibility/Acceptability Pilot
Boston Medical Center
Respiratory Distress Syndrome
Teleconsultation, or the use of video telecommunications technology to deliver expert
recommendations for care remotely, has been used to improve the safety and quality of
emergency care for children in hospital-based acute care settings by providing real-time
access to remote pediatric physician... expand
Teleconsultation, or the use of video telecommunications technology to deliver expert recommendations for care remotely, has been used to improve the safety and quality of emergency care for children in hospital-based acute care settings by providing real-time access to remote pediatric physician experts. Whether extending teleconsultation as a patient safety intervention to emergency medical systems (EMS) outside hospitals can similarly benefit sick and injured children in the community is unknown. Advances in mobile technology have made teleconsultation more accessible and affordable for EMS systems. However, this intervention has been underutilized by EMS partially due to the lack of prehospital research supporting its efficacy for pediatric applications. In prior simulation studies, the investigators found high intervention acceptance among key stakeholder groups (pediatric emergency physicians and paramedics), and demonstrated that it was feasible to integrate video communication into prehospital clinical workflows involving critical care delivery in high-risk pediatric scenarios. These initial simulation studies were conducted in a controlled prehospital setting in static ambulances using infant simulator manikins to minimize risk to children and providers. Demonstrating feasibility and acceptability with real children in moving ambulances is the next step to build the necessary evidence base to support future planned prehospital efficacy trials with children. The investigators hypothesize that remote respiratory assessment of children by medical control physicians (expert physicians) using a mobile teleconsultation platform is acceptable to users (physicians and transport providers), and technically feasible in real transports. Type: Interventional Start Date: Jun 2024 |
Support Via Online Social Networks to Promote Safe Infant Care Practices
University of Virginia
Breastfeeding
Infant Death
Sudden Infant Death Syndrome Without Mention of Autopsy
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); and reduce Black/White disparities in these practices through the use
of private Facebook groups providing... 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); and reduce Black/White disparities in these practices through the use of private Facebook groups providing a) evidence-based education through videos and other multi-media supporting best practices and b) an online community and social network of other pregnant WIC clients and new parents. Type: Interventional Start Date: Mar 2024 |
Treatment for Antepartum Posttraumatic Stress Disorder/PTSD Study
Boston University
PTSD
The majority of women with perinatal posttraumatic stress disorder (PTSD) do not receive
mental health treatment despite the documented associations between PTSD and adverse
pregnancy outcomes; this is likely due to workforce shortages, lack of data on the
effectiveness of existing evidence-based... expand
The majority of women with perinatal posttraumatic stress disorder (PTSD) do not receive mental health treatment despite the documented associations between PTSD and adverse pregnancy outcomes; this is likely due to workforce shortages, lack of data on the effectiveness of existing evidence-based treatment for PTSD in usual care obstetrics settings, and patient-level barriers to engagement such as stigma. The proposed study is a randomized controlled trial, which will examine the effectiveness of a brief evidence-based treatment for PTSD (i.e., Written Exposure Therapy) during pregnancy and the non-inferiority of delivery of this treatment by community health workers vs. delivery by mental health clinicians. Type: Interventional Start Date: Mar 2023 |
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). expand
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 |
VIGOR: Virtual Genome Center for Infant Health
Boston Children's Hospital
Genetics Disease
Genetics/Birth Defects
Genetic Predisposition to Disease
This study will provide rigorous evaluation of implementing a virtual genome center into
community clinical settings without highly specialized resources, thereby offering
generalizable insights as to how best to implement genomic medicine at scale and for
other age groups. This intervention has great... expand
This study will provide rigorous evaluation of implementing a virtual genome center into community clinical settings without highly specialized resources, thereby offering generalizable insights as to how best to implement genomic medicine at scale and for other age groups. This intervention has great potential to address disparities in genomic medicine among low-income and underrepresented minority (URM) populations and will enhance capacity for providers and health systems to utilize highly specialized genomic techniques in their communities. The goal of this study is to achieve equitable access to state-of-the-art genomic medical care to sick newborns in community centers that predominately care for low-income and racial/ethnic minority populations through the creation of a virtual genome center (VIGOR). VIGOR will provide a venue for physician and family education, genomic expert consultation, reanalysis of unsolved sequencing data, and access to cutting edge therapeutic innovation, thereby facilitating institutionalization of genomic best practices in community settings, and not just highly specialized referral centers. Type: Observational Start Date: Mar 2022 |
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
Hennepin Healthcare Research Institute
Substance Use Disorders
Opioid Use Disorder, Severe
Opioid Use Disorder, Moderate
This study is a multi-site, cluster randomized, two group implementation trial comparing
a low- versus high-intensity implementation strategy for supporting hospital-based opioid
use disorder treatment (HBOT) in community hospital settings where medication for opioid
use disorder (MOUD) treatment... expand
This study is a multi-site, cluster randomized, two group implementation trial comparing a low- versus high-intensity implementation strategy for supporting hospital-based opioid use disorder treatment (HBOT) in community hospital settings where medication for opioid use disorder (MOUD) treatment has not been implemented. Type: Interventional Start Date: Oct 2021 |
Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for the Treatment of Relapsed or Refractory...
National Cancer Institute (NCI)
AL Amyloidosis
This phase I/Ia trial finds the best dose and side effects of venetoclax given in
combination with ixazomib citrate and dexamethasone in treating patients with light chain
amyloidosis that has come back (relapsed) or does not respond to treatment (refractory)
and who have an abnormal genetic change... expand
This phase I/Ia trial finds the best dose and side effects of venetoclax given in combination with ixazomib citrate and dexamethasone in treating patients with light chain amyloidosis that has come back (relapsed) or does not respond to treatment (refractory) and who have an abnormal genetic change [translocation t(11;14)]. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ixazomib citrate is in a class of medications called proteasome inhibitors. It works by helping to kill cancer cells. Anti-inflammatory drugs such as dexamethasone reduce inflammation by lowering the body's immune response and are used with other drugs in the treatment of some types of cancer. Combination therapy with venetoclax, ixazomib citrate and dexamethasone may be effective in treatment of relapsed or refractory light chain amyloidosis. Type: Interventional Start Date: Aug 2022 |
VR Smoking Cessation During a Dental Hygiene Visit
Boston University
Smoking Cessation
The goal of this randomized controlled trial (RCT) is to test whether a smoking cessation
induction intervention delivered during a dental cleaning appointment increases the
utilization of evidence-based treatments (EBTs) for smoking cessation within 7 months
post-dental cleaning appointment.
Approximately... expand
The goal of this randomized controlled trial (RCT) is to test whether a smoking cessation induction intervention delivered during a dental cleaning appointment increases the utilization of evidence-based treatments (EBTs) for smoking cessation within 7 months post-dental cleaning appointment. Approximately 400 cigarette smokers who are scheduled for a dental cleaning appointment at the Boston University Goldman School of Dental Medicine (BUGSDM) patient treatment center will be recruited and enrolled. Participants will be randomized to either the intervention or control group Type: Interventional Start Date: Jan 2021 |
Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage...
ECOG-ACRIN Cancer Research Group
Advanced Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8
Clinical Stage IV Cutaneous Melanoma AJCC v8
Melanoma of Unknown Primary
Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
This phase II trial investigates how well biomarkers on PET/CT imaging drive early
discontinuation of anti-PD-1 therapy in patients with stage IIIB-IV melanoma that cannot
be removed by surgery (unresectable). Anti-PD-1 therapy has become a standard therapy
option for patients with unresectable melanoma.... expand
This phase II trial investigates how well biomarkers on PET/CT imaging drive early discontinuation of anti-PD-1 therapy in patients with stage IIIB-IV melanoma that cannot be removed by surgery (unresectable). Anti-PD-1 therapy has become a standard therapy option for patients with unresectable melanoma. This trial is being done to determine if doctors can safely shorten the use of standard of care anti-PD1 therapy for melanoma by using biomarkers seen on PET/CT imaging and tumor biopsy. Type: Interventional Start Date: Feb 2021 |
EXHIT ENTRE Comparative Effectiveness Trial
Hennepin Healthcare Research Institute
Substance Use Disorder
Opioid Use Disorder, Moderate
Opioid Use Disorder, Severe
This study is a multi-site open-label randomized comparative effectiveness trial of a
28-day formulation of extended-release buprenorphine (XR-BUP) versus treatment as usual
(TAU) for hospitalized patients with a moderate or severe opioid use disorder (OUD) seen
by an addiction consultation service... expand
This study is a multi-site open-label randomized comparative effectiveness trial of a 28-day formulation of extended-release buprenorphine (XR-BUP) versus treatment as usual (TAU) for hospitalized patients with a moderate or severe opioid use disorder (OUD) seen by an addiction consultation service (ACS) and agreeing to initiate a medication for OUD (MOUD). Participants will be randomly assigned to XR-BUP or TAU to be received within 72 hours of anticipated hospital discharge. Follow up will occur at approximately 34, 90, and 180 days following hospital discharge. Type: Interventional Start Date: Aug 2021 |
Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients...
Weill Medical College of Cornell University
Amyloid
AL Amyloidosis
Refractory AL Amyloidosis
This study will test the hypothesis that in patients with previous daratumumab exposure,
combination therapy of daratumumab, pomalidomide, and dexamethasone (DPd) will yield
higher complete remission (CR) rates in relapsed/refractory amyloidosis than historical
pomalidomide/dexamethasone treatment. expand
This study will test the hypothesis that in patients with previous daratumumab exposure, combination therapy of daratumumab, pomalidomide, and dexamethasone (DPd) will yield higher complete remission (CR) rates in relapsed/refractory amyloidosis than historical pomalidomide/dexamethasone treatment. Type: Interventional Start Date: Apr 2021 |
Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
Brown University
Maternal Depression
Within a research network of Head Start centers in Massachusetts, an efficacy trial of a
stepped-care intervention (SCI) to address maternal depression, using intervention
components that both prevent depression and help those in major depressive episode (MDE)
engage with care, will be conducted.... expand
Within a research network of Head Start centers in Massachusetts, an efficacy trial of a stepped-care intervention (SCI) to address maternal depression, using intervention components that both prevent depression and help those in major depressive episode (MDE) engage with care, will be conducted. Both the prevention and engagement components of the model have strong, supportive randomized trial evidence for both their efficacy and safety; but they have yet to be synthesized and tested within a coordinated intervention, applicable to a broad population base. Stepped-care interventions are commonly used in mental health service projects, in which the intensity or type of service is calibrated to the severity of illness. Type: Interventional Start Date: Aug 2023 |
Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
ECOG-ACRIN Cancer Research Group
Breast Screening
This randomized phase III trial studies digital tomosynthesis mammography and digital
mammography in screening patients for breast cancer. Screening for breast cancer with
tomosynthesis mammography may be superior to digital mammography for breast cancer
screening and may help reduce the need for... expand
This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment. Type: Interventional Start Date: Sep 2017 |
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