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A Study to Learn About How Well Riociguat Works, How Safe it is and How it is Used Under Real World Conditions...
Bayer
Pulmonary Arterial Hypertension
Pulmonary arterial hypertension (PAH) is a type of high blood pressure in the arteries that
carry blood from the heart to the lungs. PAH occurs when the openings in the blood vessels of
the lungs get smaller and smaller. These smaller openings can be caused by the following:... expand
Pulmonary arterial hypertension (PAH) is a type of high blood pressure in the arteries that carry blood from the heart to the lungs. PAH occurs when the openings in the blood vessels of the lungs get smaller and smaller. These smaller openings can be caused by the following: - The walls of the arteries tightening - The walls of the arteries becoming stiff and narrow from an overgrowth of cells The increased pressure in the pulmonary arteries strains the right side of the heart and it begins to fail, causing difficulty breathing and other symptoms. As PAH progresses, symptoms get worse. There is no cure for PAH, but several medications like endothelin receptor antagonists (ERAs), prostacyclin analogues (PCAs) and riociguat, a soluable guanylate cyclase stimulator, are available to help slow the progression of changes in the pulmonary arteries and help reduce symptoms. Riociguat can be taken together with ERAs and PCAs. In this study, the researchers want to learn about how well riociguat works, how safe it is when patients take it in 1 of these ways: - alone - with ERA - with PCA - with ERA and PCA The dosage for each patient will be decided by their doctor. The researchers will review information collected from the patients who have decided with their doctor to start riociguat treatment for their PAH. The study will include about 500 patients in the United States who are at least 18 years old. All of the patients will have either just started taking riociguat or will have been taking it for less than 3 months No investigational products will be administered in this study. Patients will be treated with the Standard of Care (SOC) for PAH. The SOC is the currently appropriate treatment in accordance with scientific evidence and agreed upon in collaboration between medical experts for PAH. There will be no study-mandated visits or treatments. The patients will be in the study for up to 2 years. During this time, they will visit their doctor every 3 to 6 months as part of the Standard of Care. At these visits, the patients will answer questions about their PAH symptoms and whether they have any medical problems. They will also do exercise tests to see how well they are able to breathe and how tired they get while exercising. The doctors will perform other usual examinations which are part of the Standard of Care such as echocardiograms (images of the heart to show how the heart is working) and a right heart catheters (to measure the pressures in the heart) and will take the usual blood and urine samples. Type: Observational Start Date: Jul 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 |
Safety And Efficacy Study Of Intravenous (IV) Administration Of Elezanumab To Assess Change In Upper...
AbbVie
Spinal Cord Injury (SCI)
Acute Spinal Cord Injury (SCI) is a rare injury that leads to permanent neuromotor impairment
and sudden disability. Approximately 25,000 people experience cervical SCI in the United
States, Europe, and Japan every year. The purpose of this study is to see if elezanumab is... expand
Acute Spinal Cord Injury (SCI) is a rare injury that leads to permanent neuromotor impairment and sudden disability. Approximately 25,000 people experience cervical SCI in the United States, Europe, and Japan every year. The purpose of this study is to see if elezanumab is safe and assess change in Upper Extremity Motor Score (UEMS) in participants with acute traumatic cervical SCI. Elezanumab is an investigational drug being developed for the treatment of SCI. Elezanumab is a monoclonal antibody, that binds to an inhibitor of neuronal regeneration and neutralizes the inhibitor, thus potentially promoting neuroregeneration. This study is "double-blinded", which means that neither trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Participants 18-75 years of age with a SCI will be enrolled. Approximately 54 participants will be enrolled in the study in approximately 49 sites worldwide. Participants will receive intravenous (IV) doses of elezanumab or placebo within 24 hours of injury and every 4 weeks thereafter through Week 48 for a total of 13 doses. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Sep 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 |
Gathering Records to Evaluate Antiretroviral Treatment-Zambia (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, there is 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 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 |
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... 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 |
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
Icahn School of Medicine at Mount Sinai
Atrial Fibrillation
Stroke
Bleeding
The primary objective of this study is to evaluate the effectiveness (prevention of
thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to
background antiplatelet therapy in patients who develop new-onset post-operative atrial
fibrillation... expand
The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey. Type: Interventional Start Date: Dec 2019 |
Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite
Harvard School of Public Health (HSPH)
HIV/AIDS
This is a prospective cohort study designed to define the impact of HIV infection and
antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition
to adulthood.
expand
This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition to adulthood. Type: Observational Start Date: Nov 2017 |
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: Mar 2018 |
Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
CHDI Foundation, Inc.
Huntington's Disease
Enroll-HD is a longitudinal, observational, multinational study that integrates two former
Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and
Australasia-while also expanding to include sites in Latin America. More than 20,000
participants... expand
Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 20,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more. Type: Observational [Patient Registry] Start Date: Jul 2012 |
Responders to Rhythmic Auditory Stimulation in Individuals Post-Stroke and Older Adults
Boston University Charles River Campus
Stroke
Old Age
Stroke is among the leading causes of long-term disability worldwide. Post-stroke neuromotor
impairments are heterogeneous, yet often result in reduced walking ability characterized by
slow, asymmetric, and unstable gait patterns. Rhythmic Auditory Stimulation (RAS) is an... expand
Stroke is among the leading causes of long-term disability worldwide. Post-stroke neuromotor impairments are heterogeneous, yet often result in reduced walking ability characterized by slow, asymmetric, and unstable gait patterns. Rhythmic Auditory Stimulation (RAS) is an emerging rehabilitation approach that leverages auditory-motor synchronization to retrain neuromotor control of walking. Indeed, walking with RAS can enhance walking rhythmicity, gait quality, and speed. RAS is a potentially valuable tool for walking rehabilitation after stroke; however, despite extensive research evidence on the overall benefits of RAS in people with chronic stroke, the notable variability in the walking characteristics of individual patients is likely to influence the effectiveness of RAS intervention, and thus requires study. Furthermore, beyond stroke-related factors, age-related changes may also affect how well individuals post-stroke respond to RAS. This study aims to recruit 24 individuals post-stroke and 20 older adults to evaluate the effects of stroke- and age-related neuromotor impairment on RAS intervention. Each study participant will complete two six-minute walk tests: one without RAS (baseline) and the other with RAS delivered using a metronome. The investigators hypothesize that post-stroke individuals will, on average, exhibit a positive response to RAS intervention (i.e., walk farther and with greater gait automaticity (i.e., reduced stride time variability), with the degree of response predicted by specific baseline characteristics. Furthermore, the investigators anticipate that these walking enhancements will be accompanied by improvements in gait biomechanics and a reduction in the metabolic cost of walking. The investigators hypothesize that older adults will exhibit similar, but attenuated, effects of RAS. Type: Interventional Start Date: Sep 2023 |
The INSTITUT Study
Boston Medical Center
Tuberculosis, Pulmonary
Undernutrition
Undernutrition is a leading global risk factor of tuberculosis (TB) and a prevalent
comorbidity associated with TB. In Benin, the National TB Program systematically provides
nutritional support to all persons with TB (PWTB), distributing prepared foods to
hospitalized patients... expand
Undernutrition is a leading global risk factor of tuberculosis (TB) and a prevalent comorbidity associated with TB. In Benin, the National TB Program systematically provides nutritional support to all persons with TB (PWTB), distributing prepared foods to hospitalized patients and food baskets during outpatient care. In Togo, the PWTB population is similar to that of Benin; however, Togo does not have a systematic program in place to provide nutritional support to these patients. The investigators will perform a prospective cohort analysis using anonymized TB patient data from the National TB Programs of Benin and Togo. Participants enrolled in Benin will receive nutritional support from the hospital while those enrolled in Togo will not. Participants in Togo who do not receive nutritional support will serve as a control. Unfavorable outcomes in both groups such as treatment failure, death, or relapse will be compared. The results from this study should help to shape TB programs in the future by incorporating nutritional support. Type: Observational Start Date: Sep 2023 |
A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer
NuCana plc
Colorectal Cancer
Colorectal Neoplasms
Colorectal Adenocarcinoma
Colorectal Cancer Metastatic
Neoplasm, Colorectal
This is a randomized, open-label, dose/schedule optimization study comparing
NUC-3373/leucovorin (LV)/irinotecan plus bevacizumab (NUFIRI-bev) to 5-FU/LV/irinotecan plus
bevacizumab (FOLFIRI-bev) for the treatment of patients with unresectable metastatic
colorectal cancer.... expand
This is a randomized, open-label, dose/schedule optimization study comparing NUC-3373/leucovorin (LV)/irinotecan plus bevacizumab (NUFIRI-bev) to 5-FU/LV/irinotecan plus bevacizumab (FOLFIRI-bev) for the treatment of patients with unresectable metastatic colorectal cancer. A total of 171 patients will be randomized 1:1:1 to either NUFIRI-bev on a weekly NUC-3373 schedule, NUFIRI-bev based on an alternate weekly NUC-3373 schedule, or FOLFIRI bev on an alternate weekly schedule. The main objectives are to assess and compare the efficacy and safety of the 3 regimens. Pharmacokinetics will be assessed on the 2 NUFIRI arms. Type: Interventional Start Date: Apr 2023 |
Longitudinal Spatial Frequency Domain Imaging Study
Boston University
Systemic Scleroderma
Scleroderma (SSc) is an autoimmune disease characterized by fibrosis (or collagen deposition)
of the skin and internal organs. The extent of skin fibrosis is an important predictor of
internal organ complications and increased mortality. Currently imprecise and subjective... expand
Scleroderma (SSc) is an autoimmune disease characterized by fibrosis (or collagen deposition) of the skin and internal organs. The extent of skin fibrosis is an important predictor of internal organ complications and increased mortality. Currently imprecise and subjective methods that varies amongst different doctors for the same patient are available to quantify skin fibrosis in patients, by "pinching" their skin and assessing how thick it is; this is the method used to determine the modified Rodnan skin score (mRSS). Skin thickness and the amount of fibrosis can change over time due to disease progression or in response to therapy. In this research, longitudinal measurements will be taken to determine if spatial frequency domain imaging (SFDI) can detect changes in skin thickness that occur over time in response to therapy or from disease progression in scleroderma patients. This study will compare SFDI with other clinical outcome assessments of skin thickness and fibrosis in scleroderma patients including mRSS, skin biopsy histology, scleroderma skin patient reported outcome (SSPRO), ultrasound, and durometry (durometer measures skin hardness). SFDI information will also be compared with capillaroscopy (allows for non-invasive imaging of the nailfold capillaries) if available from the electronic medical record. If SFDI correlates well with other clinical outcome assessments, it may be used in the future as a rapid, non-invasive tool for monitoring disease activity in scleroderma patients. Type: Interventional Start Date: Feb 2023 |
Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX)...
Alliance for Clinical Trials in Oncology
Locally Advanced Rectal Carcinoma
Stage II Rectal Cancer AJCC v8
Stage III Rectal Cancer AJCC v8
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course
chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs,
such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX
(leucovorin,... expand
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) 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. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer. Type: Interventional Start Date: Dec 2022 |
A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction...
Eli Lilly and Company
Heart Failure
Heart Failure With Preserved Ejection Fraction
The main purpose of this study is to assess the efficacy and safety of LY3540378 in adults
with worsening heart failure with preserved ejection fraction
expand
The main purpose of this study is to assess the efficacy and safety of LY3540378 in adults with worsening heart failure with preserved ejection fraction Type: Interventional Start Date: Feb 2023 |
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 |
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening...
LimFlow, Inc.
Critical Limb Ischemia
Chronic Limb-Threatening Ischemia
Peripheral Arterial Disease
A prospective, single-arm, multi-center study designed to gather additional information on
the LimFlow System.
expand
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System. Type: Interventional Start Date: Dec 2022 |
EPIC-Peds: A Study to Learn About the Study Medicine Called PF-07321332 (Nirmatrelvir)/Ritonavir in Patients...
Pfizer
COVID-19
The purpose of this clinical trial is to learn about the safety, pharmacokinetics
(pharmacokinetics helps us understand how the drug is changed and eliminated from your body
after you take it), and efficacy (how well a study treatment works in the study) of the study
medicine... expand
The purpose of this clinical trial is to learn about the safety, pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it), and efficacy (how well a study treatment works in the study) of the study medicine (called nirmatrelvir/ritonavir) for potential treatment of coronavirus disease 2019 (COVID-19). The study medicine will be given to patients under 18 years of age with COVID-19 that are not hospitalized but are at risk for severe disease. Type: Interventional Start Date: Mar 2022 |
Understanding the Long-term Impact of COVID-19 in Adults (RECOVER)
NYU Langone Health
SARS-CoV2 Infection
This is a combined retrospective and prospective, longitudinal, observational meta-cohort of
individuals who will enter the cohort with and without SARS-CoV-2 infection and at varying
stages before and after infection. Individuals with and without SARS-CoV-2 infection and with... expand
This is a combined retrospective and prospective, longitudinal, observational meta-cohort of individuals who will enter the cohort with and without SARS-CoV-2 infection and at varying stages before and after infection. Individuals with and without SARS-CoV-2 infection and with or without Post-Acute Sequelae of COVID-19 (PASC) symptoms will be followed to identify risk factors and occurrence of PASC. This study will be conducted in the United States and subjects will be recruited through inpatient, outpatient, and community-based settings. Study data including age, demographics, social determinants of health, medical history, vaccination history, details of acute SARS-CoV-2 infection, overall health and physical function, and PASC symptom screen will be reported by subjects or collected from the electronic health record using a case report form at specified intervals. Biologic specimens will be collected at specified intervals, with some tests performed in local clinical laboratories and others performed by centralized research centers or banked in the Biospecimen Repository. Advanced clinical examinations and radiologic examinations will be performed at local study sites with cross-site standardization. Type: Observational Start Date: Oct 2021 |
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 |
Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced/Metastatic...
National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Refractory Malignant Solid Neoplasm
Triple-Negative Breast Carcinoma
Unresectable Malignant Solid Neoplasm
This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination
with binimetinib in treating patients with solid tumors that carry RAS alterations and that
have spread to other places in the body (advanced/metastatic) or cannot be removed by surgery... expand
This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with binimetinib in treating patients with solid tumors that carry RAS alterations and that have spread to other places in the body (advanced/metastatic) or cannot be removed by surgery (unresectable). ZEN003694 is an oral medication with potential anticancer activity. It is an inhibitor of a family of proteins called bromodomain and extra-terminal (BET) which play important role during development and cellular growth. ZEN003694 may stop the growth of tumor cells that produce BET. Binimetinib is in a class of medications called kinase inhibitors. It works by blocking the action proteins called MEK1 and MEK2, that signal cancer cells to multiply. It may help keep cancer cells from growing and spreading. There is pre-clinical evidence that using ZEN003694 and binimetinib together may shrink or stabilize cancers studied in this trial. There are two parts of this study; dose escalation and dose expansion. In the dose escalation part of this study, different people will get different doses of the study drugs ZEN003694 and binimetinib. In the dose expansion part of this study, the highest dose with manageable side effects will be given to additional people. This will help to understand the side effects that may happen with this drug combination. Type: Interventional Start Date: Aug 2022 |
A Study to Assess the Long-Term Safety and Efficacy of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx...
Ionis Pharmaceuticals, Inc.
Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
The purpose of this study is to evaluate the safety and tolerability of extended dosing with
Eplontersen in participants with hereditary transthyretin-mediated amyloid polyneuropathy
(hATTR-PN).
expand
The purpose of this study is to evaluate the safety and tolerability of extended dosing with Eplontersen in participants with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN). Type: Interventional Start Date: Jan 2022 |
A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis
Prothena Biosciences Ltd.
Light Chain (AL) Amyloidosis
A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care
compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.
expand
A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis. Type: Interventional Start Date: Aug 2021 |
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