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Study in Parkinson Disease of Exercise
Northwestern University
Parkinson Disease
This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance
treadmill exercise on changes in the Movement Disorder Society-Unified Parkinson Disease
Rating Scale (MDS-UPDRS) Part III score at 12 months among persons with early stage Parkinson
disease.... expand
This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III score at 12 months among persons with early stage Parkinson disease. 370 participants will be randomly assigned to 2 groups: 1)60-65% HRmax or 2)80-85% HRmax 4 times per week. The primary objective is to test whether the progression of the signs of Parkinson's disease is attenuated at 12 months in among persons who have not initiated medication for Parkinson Disease (PD) when they perform high-intensity endurance treadmill exercise. Type: Interventional Start Date: Aug 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 |
Metformin in Alzheimer's Dementia Prevention
Columbia University
Mild Cognitive Impairment
MAP will be a multisite phase II/III 1:1 randomized controlled trial (RCT) of long acting
metformin (reduced mass Glucophage XR) vs. matching placebo in 370 men and women with early
and late aMCI, without diabetes, not treated with metformin, overweight or obese, aged 55
years... expand
MAP will be a multisite phase II/III 1:1 randomized controlled trial (RCT) of long acting metformin (reduced mass Glucophage XR) vs. matching placebo in 370 men and women with early and late aMCI, without diabetes, not treated with metformin, overweight or obese, aged 55 years to 90 years. The RCT will last 24 months and have 5 visits: baseline, 6-months, 12-months, 18-months, and 24-months. The RCT will be preceded by a screening phase followed by randomization and a titration period in which drug/placebo will be titrated from 500 mg a day (one tablet) to 2,000 mg a day (4 tablets), in increments of 500 mg (one tablet) every 10 days. Participants will remain in the RCT on the tolerated dose, and included in analyses on an intent to treat basis. We expect the attrition rate to be 10%/year. Neuropsychological battery, clinical interviews, physical exam, and phlebotomy will be conducted at baseline and every 6 months. Brain MRI will be conducted in approximately half of the participants (186) twice, at baseline, and after the last study visit at month 24. We will also conduct brain amyloid Positron Emission Tomography (PET) using 18F-Florbetaben, and tau PET using 18F-MK6240 in half of the participants at baseline and end of the RCT. The primary clinical outcome of the study will be changes in the Free and Cued Selective Reminding Test. The secondary clinical outcome will be changes in the Alzheimer's Disease Cooperative Study Preclinical Alzheimer's Cognitive Composite. Secondary subclinical outcomes will be changes in cortical thickness AD signature areas, changes in white matter hyperintensity volume, changes in brain amyloid burden, changes in brain tau burden, and changes in plasma biomarkers of amyloid, tau, and neurodegeneration. The data coordinating center and Imaging Core is located at John Hopkins University. The PET coordinating center is located at UC-Berkeley. The Clinical Coordinating and Monitoring Center and the central laboratory will be located at Columbia. The Research pharmacy function will be shared by the University of Rochester, which will dispense randomization kits, and the University of Iowa, which will receive bulk metformin and identical matching placebo from EMD Serono. Type: Interventional Start Date: Mar 2021 |
CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood
Boston Medical Center
Parent-Child Relations
Parenting
Child Development
Child Behavior
Disparities in health begin in early childhood. Early life experiences influence brain
development and have significant implications on future health and developmental outcomes.
Low-income children are at greater risk of developmental delays in large part due to a lack
of... expand
Disparities in health begin in early childhood. Early life experiences influence brain development and have significant implications on future health and developmental outcomes. Low-income children are at greater risk of developmental delays in large part due to a lack of an enriched environment. Disparities in early childhood development increase risk for stunted academic achievement throughout the life course. Primary care is a universal exposure in early childhood and therefore is also a significant entry point for promoting optimal child development. There is a need to provide effective, low-cost, and scalable interventions in primary care to support early childhood development.The CenteringParenting intervention is designed to reduce negative health and developmental outcomes within a model of group routine child health care. To date, there is no evidence of the benefits of the CenteringParenting intervention on school readiness, or improvements in parental behaviors that support optimal developmental milestones and achievement. The intent of this study is to determine the effectiveness of the CenteringParenting intervention on school readiness in early childhood, as measured by language development at 24 months, (in addition to health care utilization, child routine care maintenance, parenting stress, caregiver behaviors and attitudes). Type: Interventional Start Date: Feb 2019 |
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
United Therapeutics
PAH
Pulmonary Hypertension
Pulmonary Arterial Hypertension
Hypertension
Connective Tissue Diseases
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of
ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or
PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
expand
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH. Type: Interventional Start Date: Aug 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.... 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... 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 |
A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma
Takeda
Multiple Myeloma
The main aims of this 3-part study are as follows:
Part 1: To determine any side effects from modakafusp alfa single treatment and how often
they occur. The dose of modakafusp alfa will be increased a little at a time until the
highest dose that does not cause harmful side... expand
The main aims of this 3-part study are as follows: Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found. Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard dose will be administered with one or more selected dose of modakafusp alfa in selected group of participants. Part 3: To find the optimal dose with the more favorable risk-benefit profile of modakafusp alfa. Participants will receive modakafusp alfa at one of two doses which will be given through a vein. Type: Interventional Start Date: Oct 2017 |
Implementing an Intervention to Address Social Determinants of Health in Pediatric Practices
Boston Medical Center
Basic Unmet Material Needs
Patient Satisfaction
Receipt of Community Resources
Provider Referrals
This research project is aimed to assess the implementation, effectiveness, and
sustainability of a pediatric-based intervention aimed at reducing families' unmet material
needs (food, housing, employment, childcare, household utilities, education) in pediatric
practices throughout... expand
This research project is aimed to assess the implementation, effectiveness, and sustainability of a pediatric-based intervention aimed at reducing families' unmet material needs (food, housing, employment, childcare, household utilities, education) in pediatric practices throughout the United States. Type: Interventional Start Date: Oct 2019 |
Alpha-1 Antitrypsin Deficiency Adult Liver Study
St. Louis University
Alpha-1 Antitrypsin Deficiency
The investigators hypothesize that there is liver injury (inflammation, fibrosis, cirrhosis)
in adults with Alpha-1 Antitrypsin Deficiency (AATD), which is asymptomatic,
under-recognized, and undiagnosed. In addition, the investigators believe that the genetic
and environmental... expand
The investigators hypothesize that there is liver injury (inflammation, fibrosis, cirrhosis) in adults with Alpha-1 Antitrypsin Deficiency (AATD), which is asymptomatic, under-recognized, and undiagnosed. In addition, the investigators believe that the genetic and environmental factors that play an important role in the development of alpha-1 antitrypsin (AAT) liver disease, can be identified by comparing a cohort database of clinical disease information to linked biospecimen and DNA samples. Type: Observational [Patient Registry] Start Date: Dec 2013 |
The Longevity Genes in Founder Populations Project
Albert Einstein College of Medicine
Extreme Longevity
We believe extreme longevity is due to specific genes which function to delay aging and
prevent disease. The purpose of our research is to identify the genes/mutations associated
with healthier aging; to understand the biological functions of these genes/mutations; and to... expand
We believe extreme longevity is due to specific genes which function to delay aging and prevent disease. The purpose of our research is to identify the genes/mutations associated with healthier aging; to understand the biological functions of these genes/mutations; and to develop therapies to replicate these preservative genetic activities in individuals who do not have the genetic profile for longevity. Type: Observational Start Date: Jul 1998 |
Consent for Use of Stored Patient Specimens for Future Testing
AIDS Clinical Trials Group
HIV Infections
The purpose of this study is to obtain informed consent to use stored human biological
materials (HBM) (e.g., blood and other tissues) for future studies that may include genetic
testing.
expand
The purpose of this study is to obtain informed consent to use stored human biological materials (HBM) (e.g., blood and other tissues) for future studies that may include genetic testing. Type: Observational Start Date: Feb 2002 |
Records for Alcohol Care Enhancement
Boston Medical Center
Alcohol Use Disorder (AUD)
Unhealthy alcohol use (the spectrum from risky consumption through alcohol use disorder, AUD)
is a leading cause of preventable death in the US (88,424 deaths annually costing $249
billion a year), and alcohol-related health harms (e.g. AUD itself, cirrhosis) are
increasing.... expand
Unhealthy alcohol use (the spectrum from risky consumption through alcohol use disorder, AUD) is a leading cause of preventable death in the US (88,424 deaths annually costing $249 billion a year), and alcohol-related health harms (e.g. AUD itself, cirrhosis) are increasing. Despite high frequency of contacts with the medical system, most people with unhealthy alcohol use do not receive evidence-based interventions due to factors such as stigma, lack of knowledge, challenges with implementing and maintaining tool-based screening, time or prioritization constraints, and more. Electronic health records (EHRs), Best Practice Advisories (BPA) and registries are known and practical tools to improve management and care of chronic disease by aggregating information about the target population, and by assisting the clinician in reminders, decision support, and disease-specific care management. EHRs may help clinicians identify, assess, treat and monitor care when assisted by targeted staff support such as a clinical care manager (CCM) and population health manager (PHM). These support staff help to track outcomes of care and treatments, allowing for increased engagement with the population, and facilitation of care. The study team created a live database/registry of patients with unhealthy alcohol use in the BMC electronic health record (Epic), and updated Epic-based best practice advisories (BPA) and clinical decision support (CDS) (Epic Smart Set) for risky alcohol use and AUD. To improve recognition, management, and overall services provided to patients with AUD, this trial aims to test the impact of these EHR tools (the BPA, CDS, registry and registry-based reporting) for risky alcohol use and AUD by incorporating a population health manager (PHM) and clinical care manager (CCM) to augment reach and support to clinicians, and test the feasibility and effectiveness of leveraging EHRs and targeted supports to improve AUD care. A four-group randomized control trial will be implemented to determine which of four interventions is most effective at increasing rates of initiation and engagement in AUD treatment, as well as other clinical processes and outcomes. The trial will compare the use of the 1) BPA alone (only Epic-based clinician prompting and CDS), 2) BPA + PHM, 3) BPA + CCM, and 4) BPA + PHM + CCM, on the trials' primary, secondary, and exploratory outcomes. Trial results will be assessed by examining outcomes for patients on the clinician's panel. Type: Interventional Start Date: Nov 2022 |
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 |
Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in Zambia
Boston University
HIV
With the advent of universal eligibility for HIV treatment ("treat all") and same-day and
community-based antiretroviral therapy (ART) initiation, retention in care after a patient
has started ART remains the main challenge to achieving optimal outcomes in HIV treatment
programs.... expand
With the advent of universal eligibility for HIV treatment ("treat all") and same-day and community-based antiretroviral therapy (ART) initiation, retention in care after a patient has started ART remains the main challenge to achieving optimal outcomes in HIV treatment programs. Consistently across both time and geography, the highest risk for loss from care is during a patient's first six months after ART initiation, with about quarter of all patients not retained by the end of month 6. One of the reasons for the high attrition from care in this early retention period is that the model of care offered to most newly-initiating and re-initiating patients has barely evolved from its original outlines. Patients in their first six months on ART are generally not eligible for lower-intensity, patient-centered "differentiated service delivery" models that make remaining in care easier for experienced patients. Instead, most early patients must still make multiple clinic visits that include clinical consultations with providers, and most can receive only 1-2 month supplies of medications at a time. This protocol is for the PREFER-Zambia study, an activity of the Retain6 project. Retain6 aims to develop new models of care for patients' first six months on ART. PREFER-Zambia will collect data on patients' characteristics, clinical and non-clinical needs, and preferences for different types of services during their first six months after initiating ART. The investigators will conduct an observational, prospective cohort survey of newly-initiated or re-initiated adult ART patients at a selected set of 12 healthcare facilities in Zambia. Results are expected to inform the design of better models of service delivery for the early treatment period. Type: Observational Start Date: Sep 2022 |
Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
Boston University
HIV
With the advent of universal eligibility for HIV treatment ("treat all") and same-day and
community-based antiretroviral therapy (ART) initiation, retention in care after a patient
has started ART remains the main challenge to achieving optimal outcomes in HIV treatment
programs.... expand
With the advent of universal eligibility for HIV treatment ("treat all") and same-day and community-based antiretroviral therapy (ART) initiation, retention in care after a patient has started ART remains the main challenge to achieving optimal outcomes in HIV treatment programs. Consistently across both time and geography, the highest risk for loss from care is during a patient's first six months after ART initiation, with about quarter of all patients not retained by the end of month 6. One of the reasons for the high attrition from care in this early retention period is that the model of care offered to most newly-initiating and re-initiating patients has barely evolved from its original outlines. Patients in their first six months on ART are generally not eligible for lower-intensity, patient-centered "differentiated service delivery" models that make remaining in care easier for experienced patients. Instead, most early patients must still make multiple clinic visits that include clinical consultations with providers, and most can receive only 1-2 month supplies of medications at a time. This protocol is for the PREFER-South Africa study, an activity of the Retain6 project. Retain6 aims to develop new models of care for patients' first six months on ART. PREFER-South Africa will collect data on patients' characteristics, clinical and non-clinical needs, and preferences for different types of services during their first six months after initiating ART. The investigators will conduct an observational, prospective cohort survey of newly-initiated or re-initiated adult ART patients at a selected set of 18 healthcare facilities in South Africa. Results are expected to inform the design of better models of service delivery for the early treatment period. Type: Observational Start Date: Sep 2022 |
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... 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 |
Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® in the Treatment of Wagner...
PolarityTE
Diabetic Foot
The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of
Wagner grade 2 diabetic foot ulcers.
expand
The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 2 diabetic foot ulcers. Type: Interventional Start Date: Apr 2022 |
Improving Spatial Perception and Speech Understanding in Multitalker Mixtures
Boston University Charles River Campus
Hearing Loss
The purpose of this study is to investigate several approaches for improving spatial
perception and speech intelligibility in multitalker listening situations for hearing-aid
users. The hypotheses are that spatial perception and speech intelligibility will be improved
by (1)... expand
The purpose of this study is to investigate several approaches for improving spatial perception and speech intelligibility in multitalker listening situations for hearing-aid users. The hypotheses are that spatial perception and speech intelligibility will be improved by (1) increased high-frequency audibility, (2) speech envelope enhancement, and/or (3) appropriate sound image externalization. Type: Interventional Start Date: Mar 2022 |
A Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion...
Route 92 Medical, Inc.
Acute Ischemic Stroke
The SUMMIT MAX study is a prospective, randomized, controlled, interventional clinical trial
to evaluate the safety and effectiveness of the Route 92 Medical MonoPoint® Reperfusion
System for aspiration thrombectomy in acute ischemic stroke patients.
expand
The SUMMIT MAX study is a prospective, randomized, controlled, interventional clinical trial to evaluate the safety and effectiveness of the Route 92 Medical MonoPoint® Reperfusion System for aspiration thrombectomy in acute ischemic stroke patients. Type: Interventional Start Date: Dec 2021 |
Pilot Testing PREschooler Care, Community Resources, Advocacy, Referral, Education (PRE-CARE)
Boston Medical Center
Attention Deficit/Hyperactivity Disorder
Inattention
The goal of this proposed study is to pilot test a novel treatment model (PRE-CARE)
addressing unmet social needs for families of preschool-age children with Attention
Deficit/Hyperactivity Disorder (ADHD) symptoms. The investigators will conduct an adaptive,
pilot randomized... expand
The goal of this proposed study is to pilot test a novel treatment model (PRE-CARE) addressing unmet social needs for families of preschool-age children with Attention Deficit/Hyperactivity Disorder (ADHD) symptoms. The investigators will conduct an adaptive, pilot randomized controlled trial (RCT) of the intervention with parents of 60 low-income children age 3-5 (36-71 months) with ADHD symptoms in order to: optimize intervention delivery; field test study logistics (e.g., recruitment, enrollment, randomization, retention); explore putative intervention mechanisms; and obtain estimates of study parameters to plan an appropriately powered RCT of the intervention. The PRE-CARE intervention is adapted from Well Child Care, Evaluation, Community, Resources, Advocacy, Referral, Education (WE CARE), a screening and referral intervention that has been shown to be feasible and effective in addressing the family psychosocial stressors of low-income families seen in pediatric medical homes. Given the negative impact that socioeconomic stressors can have on the health and development of young children with ADHD symptoms, tailored interventions such as PRE-CARE may serve as a vital early intervention strategy to promote long-term well-being. Type: Interventional Start Date: Nov 2021 |
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... 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 |
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... 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 |
Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab...
National Cancer Institute (NCI)
Metastatic Lung Non-Squamous Non-Small Cell Carcinoma
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma
Stage III Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Stage IIIB Lung Cancer AJCC v8
This phase II trial compares cabozantinib alone and the combination of cabozantinib and
nivolumab to standard chemotherapy in the treatment of patients with non-squamous non-small
cell lung cancer (NSCLC). Cabozantinib may stop the growth of tumor cells by blocking some of... expand
This phase II trial compares cabozantinib alone and the combination of cabozantinib and nivolumab to standard chemotherapy in the treatment of patients with non-squamous non-small cell lung cancer (NSCLC). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ramucirumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as docetaxel, gemcitabine hydrochloride, paclitaxel, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cabozantinib alone or in combination with nivolumab may be more effective than standard chemotherapy in treating patients with non-small cell lung cancer. Type: Interventional Start Date: May 2020 |
Gathering Records to Evaluate Antiretroviral Treatment-Malawi ( GREAT )
Boston University
HIV
To achieve global goals for the treatment of HIV, most high-prevalence countries are
experimenting with and scaling up differentiated service delivery models (DSD). A handful of
efforts have been formally described and evaluated in the literature; many others are being
implemented... expand
To achieve global goals for the treatment of HIV, most high-prevalence countries are experimenting with and scaling up differentiated service delivery models (DSD). A handful of efforts have been formally described and evaluated in the literature; many others are being implemented formally or informally under routine care, without a research or evaluation goal. For most countries, however, we have little evidence on the big picture-the proportion of clinics offering alternative models, eligibility criteria and the proportion of patients considered eligible, the number of patients actually participating, health outcomes such as viral suppression, empirical resource utilization compared to traditional care, variations among the models, duration of patient participation, fidelity to model guidelines, effects on clinic efficiency, and sustainability without external donor support. AMBIT is a set of data synthesis, data collection, and data analysis activities aimed at generating information for near- and long-term decision making and creating an approach and platform for ongoing evaluation of differentiated models of HIV treatment delivery in the future. The project will collect and analyze a wide range of existing data sets pertinent to DSD. This protocol is for an analysis of existing medical record data collected by the Ministry of Health, implementing partners, and other completed, ongoing, or new evaluations, trials, and observational studies. Outcomes to be reported include coverage/uptake of DSD, patients' outcomes, and distribution of each model. There will be no study interaction with individual patients, providers, caregivers, or others for this analysis. Type: Observational Start Date: Dec 2019 |
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