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Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes...
T. John Winhusen, PhD
Opioid-Related Disorders
Drug Addiction
Pregnancy Related
Substance Abuse
Drug Abuse
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder
in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Caretakers of the infants
delivered by MOMs participants will be offered the opportunity to enroll in this sub-study,
which... expand
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Caretakers of the infants delivered by MOMs participants will be offered the opportunity to enroll in this sub-study, which is designed to evaluate the impact of extended-release buprenorphine (BUP-XR), relative to sublingual buprenorphine (BUP-SL), on infant neurodevelopment. The additional data collected in this sub-study will be combined with data from the main MOMs trial. Type: Interventional Start Date: Jun 2021 |
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
T. John Winhusen, PhD
Opioid-Related Disorders
Drug Addiction
Pregnancy Related
Substance Abuse
Drug Abuse
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder
in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be
offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual... expand
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial. It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development). Type: Interventional Start Date: Jul 2020 |
Effects of Nitric Oxide on the Endothelium During Hemolysis.
Massachusetts General Hospital
Endothelial Dysfunction
Hemolysis Intravascular
Cardiovascular Diseases
Cardiovascular Risk Factor
This study is an ancillary (add-on) study to the clinical trial entitled "Effect of Nitric
Oxide in Cardiac Surgery Patients With Endothelial Dysfunction", which has Clinical
Trials.gov identifier NCT02836899. NCT02836899 trial randomizes cardiac surgical patients to
receive... expand
This study is an ancillary (add-on) study to the clinical trial entitled "Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction", which has Clinical Trials.gov identifier NCT02836899. NCT02836899 trial randomizes cardiac surgical patients to receive either Nitric Oxide (NO) or a placebo during and after cardiac surgery. This ancillary study aims to assess the effects of Nitric Oxide on vascular responsiveness and on endothelial function during hemolysis in patients with pre-operative endothelial dysfunction undergoing cardiac surgery requiring prolonged cardiopulmonary bypass. Type: Interventional Start Date: Dec 2018 |
Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement
Dartmouth-Hitchcock Medical Center
Pulmonary Embolism
Venous Thrombosis
PEPPER is a randomized study comparing the three most commonly used anticoagulants in North
America in patients who have elected to undergo primary or revision hip or knee joint
replacement surgery. The anticoagulants being compared are enteric coated aspirin, low
intensity... expand
PEPPER is a randomized study comparing the three most commonly used anticoagulants in North America in patients who have elected to undergo primary or revision hip or knee joint replacement surgery. The anticoagulants being compared are enteric coated aspirin, low intensity warfarin, and rivaroxaban. Type: Interventional Start Date: Dec 2016 |
Telehealth Exercise and Mindfulness for Pain in Osteoarthritis
Boston University Charles River Campus
Knee Osteoarthritis
This is a parallel-arm mixed-methods randomized controlled trial to investigate the
feasibility of telehealth delivered mindful exercise vs. usual exercise interventions for
people with knee osteoarthritis.
expand
This is a parallel-arm mixed-methods randomized controlled trial to investigate the feasibility of telehealth delivered mindful exercise vs. usual exercise interventions for people with knee osteoarthritis. Type: Interventional Start Date: Oct 2022 |
Renal Mechanism of SGLT2 Inhibition
University of Colorado, Denver
Type 2 Diabetes
Diabetic Kidney Disease
Canagliflozin is an oral drug which is currently approved for use in patients with type 2
diabetes by the US Food and Drug Administration (FDA). Canagliflozin acts by increasing salt
and sugar loss in the urine, and has shown to protect heart, kidney, and blood vessel
function... expand
Canagliflozin is an oral drug which is currently approved for use in patients with type 2 diabetes by the US Food and Drug Administration (FDA). Canagliflozin acts by increasing salt and sugar loss in the urine, and has shown to protect heart, kidney, and blood vessel function in patients with type 2 diabetes. However, it is unknown how canagliflozin protects the kidneys from disease. Therefore, this study plans to learn more about how canagliflozin works to protect against diabetic kidney disease in adults with type 2 diabetes. This study will use state-of-the-art kidney imaging, kidney biopsies and detailed testing of kidney function to determine the mechanisms of protection afforded by canagliflozin. Type: Interventional Start Date: Oct 2022 |
Proactive Therapeutic Drug Monitoring Based Adalimumab Therapy Optimization in Patients With Rheumatoid...
Boston Medical Center
Rheumatoid Arthritis
Current standard of care of rheumatoid arthritis (RA) management includes a routine clinical
assessment of disease activity to adjust therapy. For the most part, therapy adjustment for
therapy non-response and/or suboptimal therapy response leads to therapy switch within the... expand
Current standard of care of rheumatoid arthritis (RA) management includes a routine clinical assessment of disease activity to adjust therapy. For the most part, therapy adjustment for therapy non-response and/or suboptimal therapy response leads to therapy switch within the same class of therapy or to a different class of therapy. The lack of objective data to titrate dose of a given therapeutic agent for maximal possible efficacy makes it difficult for providers and payors to titrate dose as needed. Therapeutic drug monitoring (TDM) provides objective data for a proactive and individualized therapy optimization based on serum drug levels and the presence or absence of anti-drug antibodies. Maintaining optimal trough drug concentration is a proven concept of therapeutics. With respect to adalimumab, this approach helps to maximize therapeutic efficacy and prevent anti-adalimumab antibody development. However, lack of drug and disease state specific published data creates a barrier for a wider adoption of TDM into clinical practice. The objective of this single site, open label, randomized, parallel group pilot study is to investigate whether proactive therapeutic drug monitoring based adalimumab dose optimization results in higher rate of achieving and/or maintaining therapeutic goal compared to standard of care in patients with rheumatoid arthritis. Type: Interventional Start Date: Oct 2022 |
Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old, An Exploratory...
Boston Medical Center
Human Papilloma Virus
This study is an open-label nonrandomized exploratory proof of concept and descriptive 4-year
immunogenicity study to assess immunogenicity after administration of a 2-dose regimen of
9-valent human papillomavirus vaccine (9vHPV) vaccine separated by 12 months (months 0, 12).... expand
This study is an open-label nonrandomized exploratory proof of concept and descriptive 4-year immunogenicity study to assess immunogenicity after administration of a 2-dose regimen of 9-valent human papillomavirus vaccine (9vHPV) vaccine separated by 12 months (months 0, 12). Type: Interventional Start Date: Sep 2022 |
Total Joint Arthroplasty (TJA) Weight Loss Study
Boston Medical Center
Osteoarthritis, Hip
Osteoarthritis, Knee
Obesity, Morbid
This is a randomized clinical trial (RCT) to assess the efficacy of bariatric surgery vs
medical weight loss vs. the "usual standard of care" to optimize a morbidly obese patient
with end-stage osteoarthritis of the hip or knee joint for total joint arthroplasty (TJA).
The... expand
This is a randomized clinical trial (RCT) to assess the efficacy of bariatric surgery vs medical weight loss vs. the "usual standard of care" to optimize a morbidly obese patient with end-stage osteoarthritis of the hip or knee joint for total joint arthroplasty (TJA). The study population will include patients with hip or knee joint osteoarthritis and BMI (Body Mass Index) > 40 kg/m2 who are evaluated in the joint arthroplasty clinic at Boston Medical Center. The primary objective of the study is to determine if bariatric surgery or medical weight loss is more effective than the usual standard of care in optimizing a morbidly obese patient with osteoarthritis of the hip or knee joint for TJA. This will be determined by comparing the number of patients within each group who are able to lose weight through either bariatric surgery, medical weight loss, or the usual standard of care to achieve a BMI ≤ 40 kg/m2 to eventually undergo TJA. The secondary objectives of this study are to compare total operative time, postoperative complication rates, readmission rates, percentage of total body weight lost, revision rate, and reoperation rate. The ability of patients within each study arm to maintain a BMI ≤ 40 kg/m2 for up to 2 years after undergoing TJA will also be assessed, as well as their level of satisfaction before and after being in the study. Type: Interventional Start Date: Oct 2022 |
Palliative Care Educator
Tufts Medical Center
Advance Care Planning
Palliative Care
Alzheimer's Disease and Related Dementias
Doctor-patient Communication
Video Decision Aids
The investigators propose to conduct a stepped wedge cluster randomized trial of an advance
care planning (ACP) educator-led intervention among hospitalized patients aged 65 and over,
or any patient with Alzheimer's Disease and Related Dementias (ADRD) and their proxy
decision-makers... expand
The investigators propose to conduct a stepped wedge cluster randomized trial of an advance care planning (ACP) educator-led intervention among hospitalized patients aged 65 and over, or any patient with Alzheimer's Disease and Related Dementias (ADRD) and their proxy decision-makers in the ward and ICU settings of two major hospitals: Boston Medical Center and North Shore University Hospital in New York. Patient outcomes will be abstracted from electronic health records with Natural Language Processing. The effectiveness of the intervention will be evaluated by comparing the following outcomes among 9,000 hospitalized patients (Aim 1): ACP documentation; preferences for resuscitation; palliative care consults; and, hospice use. The investigators will characterize caregiver-centered outcomes of patients with ADRD, including (Aim 2): (1) knowledge, (2) confidence in future care, (3) communication satisfaction, and (4) decisional certainty in 600 caregivers of patients with ADRD admitted to the hospital. COVID-19 poses a unique dilemma for older Americans and patients with ADRD and their caregivers, who must balance their desire to live against the risk of a lonely and potentially traumatic hospital death. Video decision support is a practical, evidence-based, and innovative approach to assist patients facing such choices. If proven effective, this innovative care model can be immediately deployed across the country to improve the quality of care for millions of Americans. Type: Interventional Start Date: Jul 2021 |
Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People With T2 Diabetes
Abbott Diabetes Care
Diabetes Mellitus, Type 2
A multi-center, randomized, prospective, non-significant risk study to compare the impact of
the FreeStyle Libre Flash Glucose Monitoring System with and without a food logging
smartphone application on reducing time above 180 mg/dL in subjects with type 2 diabetes who
are... expand
A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre Flash Glucose Monitoring System with and without a food logging smartphone application on reducing time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen. Type: Interventional Start Date: Apr 2021 |
Evaluating the Effect of Solius UV Light Source in Improving Vitamin D Status
Boston University
Vitamin D Deficiency
Vitamin D Insufficiency
The aim of this study is to evaluate the safety and effectiveness of the Solius
Photobiological System in improving serum levels of 25-hydroxyvitamin D in vitamin D
deficient/ insufficient adults of various skin types.
The invetigators will conduct an double-blinded randomized... expand
The aim of this study is to evaluate the safety and effectiveness of the Solius Photobiological System in improving serum levels of 25-hydroxyvitamin D in vitamin D deficient/ insufficient adults of various skin types. The invetigators will conduct an double-blinded randomized clinical trial in 100 adults to compare the changes in serum 25-hydroxyvitamin D levels between subjects who received and do not receive weekly exposures to Ultraviolet B Radiation (UVB) generated by the Solius Photobiological System for 16 weeks. Type: Interventional Start Date: Feb 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... 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 |
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... 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 |
Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small...
National Cancer Institute (NCI)
Lung Non-Small Cell Carcinoma
Lung Non-Small Cell Squamous Carcinoma
Lung Non-Squamous Non-Small Cell Carcinoma
Stage II Lung Cancer AJCC v8
Stage IIA Lung Cancer AJCC v8
This phase III ALCHEMIST trial tests the addition of pembrolizumab to usual chemotherapy for
the treatment of stage IIA, IIB IIIA or IIIB non-small cell lung cancer that has been removed
by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the... expand
This phase III ALCHEMIST trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB IIIA or IIIB non-small cell lung cancer that has been removed by surgery. 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, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and 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 pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB IIIA or IIIB non-small cell lung cancer. Type: Interventional Start Date: Jun 2020 |
Effectiveness of Transdiagnostic Cognitive Behavioral Therapy for Improving HIV Treatment Outcomes in...
Boston University
HIV/AIDS
Violence
This study will evaluate the impact of the Common Elements Treatment Approach (CETA), an
evidence-based intervention comprised of cognitive-behavioral therapy elements, at improving
HIV treatment outcomes among women with HIV who have experienced intimate partner violence... expand
This study will evaluate the impact of the Common Elements Treatment Approach (CETA), an evidence-based intervention comprised of cognitive-behavioral therapy elements, at improving HIV treatment outcomes among women with HIV who have experienced intimate partner violence (IPV) and have an unsuppressed viral load on HIV treatment. To evaluate CETA, the investigators will conduct a randomized controlled trial of HIV-infected women, with or without their partners, who have experienced IPV and have an unsuppressed viral load to test the effect of CETA in increasing viral suppression and reducing violence. The investigators will also identify mediators and moderators of CETA's effect on retention and viral suppression and assess the cost and cost-effectiveness of CETA vs. active control at increasing the proportion who are retained and virally suppressed by 12 months. Type: Interventional Start Date: Nov 2021 |
Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study
ECOG-ACRIN Cancer Research Group
Anal Basaloid Carcinoma
Anal Canal Cloacogenic Carcinoma
Anal Canal Squamous Cell Carcinoma
Anal Margin Squamous Cell Carcinoma
Stage I Anal Cancer AJCC v8
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation)
therapy works in comparison to standard-dose chemoradiation in treating patients with
early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and
capecitabine,... expand
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type. Type: Interventional Start Date: Nov 2019 |
CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884,...
Ionis Pharmaceuticals, Inc.
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
To evaluate the efficacy of eplontersen compared to placebo in participants with ATTR-CM
receiving available standard of care (SoC). For more information, please visit
https://www.cardio-ttransform.com.
expand
To evaluate the efficacy of eplontersen compared to placebo in participants with ATTR-CM receiving available standard of care (SoC). For more information, please visit https://www.cardio-ttransform.com. Type: Interventional Start Date: Mar 2020 |
Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride...
National Cancer Institute (NCI)
AIDS-Related Lymphoma
Ann Arbor Stage II Diffuse Large B-Cell Lymphoma
Ann Arbor Stage III Diffuse Large B-Cell Lymphoma
Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma
This phase I trial studies the side effect and best dose of ibrutinib in combination with
rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin
hydrochloride in treating patients with human immunodeficiency virus (HIV)-positive stage
II-IV... expand
This phase I trial studies the side effect and best dose of ibrutinib in combination with rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride in treating patients with human immunodeficiency virus (HIV)-positive stage II-IV diffuse large B-cell lymphomas. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib and etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride may work better in treating patients with HIV-positive diffuse large B-cell lymphomas. Type: Interventional Start Date: Nov 2017 |
JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer
University of Texas Southwestern Medical Center
Non-Small Cell Lung Cancer
To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC
expand
To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC Type: Interventional Start Date: Jul 2015 |
Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA
NRG Oncology
Epstein-Barr Virus Infection
Stage II Nasopharyngeal Carcinoma
Stage III Nasopharyngeal Carcinoma
Stage IVA Nasopharyngeal Carcinoma
Stage IVB Nasopharyngeal Carcinoma
There are two study questions we are asking in this randomized phase II/III trial based on a
blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally
advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard
concurrent... expand
There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and 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. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer. Type: Interventional Start Date: Apr 2014 |
Amped-PD: Amplifying Physical Activity Through Music in Parkinson Disease
Boston University Charles River Campus
Parkinson Disease
Regular, habitual exercise is a critical component of the long-term management of Parkinson
disease (PD). However, PD-specific motor (e.g. slow and diminished movements, variable step
timing) and non-motor (e.g. depression, apathy) problems collectively hinder physical
activity.... expand
Regular, habitual exercise is a critical component of the long-term management of Parkinson disease (PD). However, PD-specific motor (e.g. slow and diminished movements, variable step timing) and non-motor (e.g. depression, apathy) problems collectively hinder physical activity. Rhythmic auditory stimulation (RAS) is a rehabilitation technique that employs coupling of auditory cues with movement. Walking with RAS has been shown to benefit walking rhythmicity, quality, and speed. These walking benefits make RAS advantageous in promoting moderate intensity walking activity -- an important health-objective in the management of PD. However, the therapeutic potential of RAS in self-directed walking programs has not been examined. In this pilot, we will utilize a breakthrough digital therapeutic that delivers music-adaptive RAS to alleviate PD-specific problems by regulating stepping patterns. Using music as a substrate for cue delivery, this digital therapeutic leverages gait benefits from RAS along with enjoyment of music listening, thus making it a viable and engaging modality that will yield habits of regular walking. Habits are automatically recurring psychological dispositions that emerge from repeated behaviors. The investigators posit that music cues provide recurring contextual cues that automatically evoke habitual response of exercise, thus has the potential to prompt regular physical activity. This study will enroll 44 individuals with mild-to-moderate PD. The experimental intervention, "Amped-PD", is a 6-week, user-managed community-based walking program that utilizes music-adaptive RAS that progressively increases walking intensities. This study will examine if Amped-PD (Experimental Intervention) is more effective than a standard-of-care walking program (Active-Control Intervention) in improving physical activity based on moderate intensity walking, and in improving motor deficits related to quality of walking in individuals with mild-to-moderate PD. This study will also examine whether the resultant habits formed from each intervention matter in relation to training-related changes in physical activity. Type: Interventional Start Date: Aug 2022 |
Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced...
Alliance for Clinical Trials in Oncology
Metastatic Pancreatic Neuroendocrine Tumor
Unresectable Pancreatic Neuroendocrine Carcinoma
This phase II trial compares capecitabine and temozolomide to lutetium Lu 177 dotatate for
the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body
(advanced) or are not able to be removed by surgery (unresectable). Chemotherapy drugs, such... expand
This phase II trial compares capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or are not able to be removed by surgery (unresectable). Chemotherapy drugs, such as capecitabine and temozolomide, 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. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. The purpose of this study is to find out whether capecitabine and temozolomide or lutetium Lu 177 dotatate may kill more tumor cells in patients with advanced pancreatic neuroendocrine tumors. Type: Interventional Start Date: Mar 2022 |
CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted...
ECOG-ACRIN Cancer Research Group
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Invasive Breast Carcinoma
This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating
further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer
who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after... expand
This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as 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. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment. Type: Interventional Start Date: Feb 2020 |
Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal...
Alliance for Clinical Trials in Oncology
Colorectal Adenocarcinoma
This phase III trial studies how well vitamin D3 given with standard chemotherapy and
bevacizumab works in treating patients with colorectal cancer that has spread to other parts
of the body. Vitamin D3 helps the body use calcium and phosphorus to make strong bones and
teeth.... expand
This phase III trial studies how well vitamin D3 given with standard chemotherapy and bevacizumab works in treating patients with colorectal cancer that has spread to other parts of the body. Vitamin D3 helps the body use calcium and phosphorus to make strong bones and teeth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, oxaliplatin, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving vitamin D3 with chemotherapy and bevacizumab may work better in shrinking or stabilizing colorectal cancer. It is not yet known whether giving high-dose vitamin D3 in addition to chemotherapy and bevacizumab would extend patients' time without disease compared to the usual approach (chemotherapy and bevacizumab). Type: Interventional Start Date: Sep 2019 |
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