Search Clinical Trials
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A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease...
Agios Pharmaceuticals, Inc.
Sickle Cell Disease
This clinical trial is a Phase 2/3 study that will determine the recommended dose of
mitapivat and evaluate the efficacy and safety of mitapivat in sickle cell disease by testing
how well mitapivat works compared to placebo to increase the amount of hemoglobin in the
blood... expand
This clinical trial is a Phase 2/3 study that will determine the recommended dose of mitapivat and evaluate the efficacy and safety of mitapivat in sickle cell disease by testing how well mitapivat works compared to placebo to increase the amount of hemoglobin in the blood and to reduce or prevent the occurrence of sickle cell pain crises. In addition, the long-term effect of mitapivat on efficacy and safety will be explored in an open-label extension portion. Type: Interventional Start Date: Feb 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 |
Oxbryta® Product Registry An Observational Study Designed to Evaluate the Effect of Oxbryta in Individuals...
Pfizer
Sickle Cell Disease
This registry is an observational study designed to evaluate the effect of Oxbryta in
individuals with SCD in a real-world setting.
expand
This registry is an observational study designed to evaluate the effect of Oxbryta in individuals with SCD in a real-world setting. Type: Observational [Patient Registry] Start Date: Nov 2021 |
Digital Health Weight Management Among Public Housing Residents
Tufts Medical Center
Weight Change, Body
Obesity
This research will test the efficacy of a weight management intervention through a
three-group randomized trial: mHealth only, mHealth+Community Health Worker (CHW) support,
versus control group, among residents of Boston's public housing developments. The mHealth
group consists... expand
This research will test the efficacy of a weight management intervention through a three-group randomized trial: mHealth only, mHealth+Community Health Worker (CHW) support, versus control group, among residents of Boston's public housing developments. The mHealth group consists of a 1-year text messaging program to promote diet and physical activity behavior changes and the CHW support consists of monthly phone counseling delivered by a CHW to support the text messaging program. Our hypothesis is that the mHealth+CHW group will be more effective in bringing about weight loss compared to mHealth alone or the assessment only control group. The findings are expected to inform future health promotion efforts among residents in public housing developments. Type: Interventional Start Date: Sep 2021 |
Genetic Epidemiology of Rotator Cuff Tears: The cuffGEN Study
University of Texas Southwestern Medical Center
Rotator Cuff Tears
Rotator cuff tear is one of the most common reasons to seek musculoskeletal care, and cuff
repair is one of the fastest growing ambulatory surgery procedures. However, the etiology of
cuff tears, reasons for variability treatment success, and causes of FI are poorly
understood.... expand
Rotator cuff tear is one of the most common reasons to seek musculoskeletal care, and cuff repair is one of the fastest growing ambulatory surgery procedures. However, the etiology of cuff tears, reasons for variability treatment success, and causes of FI are poorly understood. A large-scale genome-wide association studies (GWAS) using imaging-verified rotator cuff tear cases and controls can address limitations in rigor of prior research and assess the genetic basis of FI and functional outcomes of cuff tear treatments. Primary Objective: To conduct a case-control GWAS of imaging-verified symptomatic rotator cuff tear in approximately 3000-6000 individuals and replicate findings in an independent set of 3000-6000 or more imaging-verified individuals to identify common variants in several genetic loci that increase risk for rotator cuff tears. Hypothesis: Common variants in several genetic loci increase risk for rotator cuff tears. Secondary Objectives: 1. To perform an imputed transcriptome-wide association study (TWAS) to identify and prioritize gene targets associated with rotator cuff tear by integrating GWAS summary statistics and gene-expression weights from muscle and adipose tissue available in the GTEx project. Hypothesis: Genetically predicted gene expression of multiple genes in muscle and adipose tissue are associated with rotator cuff tear. 2. To identify if single nucleotide polymorphisms (SNPs) associated with rotator cuff tear and their genetic risk score (GRS) predict improved pain and function as measured by American Shoulder and Elbow Surgeons Standardized Form (ASES) and other outcome measures. Hypothesis: Select SNPs and GRS predict ASES outcome. 3. To identify genetic variants associated with Fatty Infiltration (FI) in patients with cuff tears in a two stage GWAS of imaged rotator cuffs and to prioritize gene targets through an imputed-TWAS in muscle and adipose tissue. Hypothesis: Multiple genetic variants are associated with FI and some exert their influence by altering gene expression in the muscle and adipose tissue. Type: Observational Start Date: Mar 2021 |
Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)
Novo Nordisk A/S
Non-alcoholic Steatohepatitis
Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known
medicine, which is already used by doctors to treat type 2 diabetes in many countries.
Participants will either get semaglutide or a dummy medicine - which treatment participants
get is... expand
Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance. Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week. The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day. Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period. Type: Interventional Start Date: Apr 2021 |
A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in...
Horizon Therapeutics Ireland DAC
Diffuse Cutaneous Systemic Sclerosis
Sclerosis, Systemic
This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial.
Participants will be screened within 6 weeks prior to the Baseline (Day 1) Visit.
Approximately 300 participants who meet the trial eligibility criteria will be randomized on
Day 1 in a... expand
This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial. Participants will be screened within 6 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks. The trial will include up to a 42-day Screening Period and a 52-week Double-blind Treatment Period. Participants will take their first dose of trial drug at the clinic and will participate in trial visits at Week 4 and every 6 weeks thereafter until Week 52. All participants who complete the Double-blind Treatment Period (Week 52) will be eligible to enter a 52-week extension trial (HZNP-HZN-825-302, NCT05626751). Participants not entering the extension trial will participate in a Safety Follow-up Visit 4 weeks after the last dose of trial drug. Type: Interventional Start Date: Apr 2021 |
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 |
T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive...
Alliance for Clinical Trials in Oncology
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in
preventing breast cancer from coming back (relapsing) in patients with high risk, HER2
positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a
chemotherapy... expand
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone. Type: Interventional Start Date: Jan 2021 |
Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and...
Merck Sharp & Dohme LLC
Squamous Cell Carcinoma of Head and Neck
This study is designed to assess the safety and efficacy of lenvatinib in combination with
pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and
efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck... expand
This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review. Type: Interventional Start Date: Aug 2020 |
Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer
Alliance for Clinical Trials in Oncology
Pancreatic Adenosquamous Carcinoma
Resectable Pancreatic Adenocarcinoma
Pancreatic Cancer
This phase III trial compares perioperative chemotherapy (given before and after surgery)
versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer
that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as
fluorouracil,... expand
This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, 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. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly). Type: Interventional Start Date: Jul 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 |
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 IIIA 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... 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 |
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 |
Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat...
Boston University
Tuberculosis, Multidrug-Resistant
Multidrug-resistant tuberculosis (MDR-TB) is tuberculosis (TB) that is resistant to at least
isoniazid and rifampicin, the two most important anti-TB drugs. It occurs in 3.6% of newly
diagnosed TB patients in the world and 17% of patients who have been previously treated. In... expand
Multidrug-resistant tuberculosis (MDR-TB) is tuberculosis (TB) that is resistant to at least isoniazid and rifampicin, the two most important anti-TB drugs. It occurs in 3.6% of newly diagnosed TB patients in the world and 17% of patients who have been previously treated. In 2017, approximately 600,000 people were estimated to have acquired MDR-TB. However, only 25% of persons with MDR-TB were diagnosed and started on treatment, reflecting inadequate diagnostic capacity and lack of TB treatment capacity. In this multicenter, randomized, partially blinded, four-arm, phase 2 study, the investigators will examine the efficacy and safety of an all-oral regimen of bedaquiline, delamanid, levofloxacin, linezolid, and clofazimine given for 16, 24, 32 or 40 weeks Type: Interventional Start Date: Jun 2022 |
Screening for Cardiac Amyloidosis With Nuclear Imaging for Minority Populations
Mathew S. Maurer
Amyloid Cardiomyopathy, Transthyretin-Related
In this study, the investigators will recruit a cohort of elderly Black and Hispanic patients
with heart failure to define the number of patients who have cardiac amyloidosis by utilizing
highly sensitive heart imaging and blood tests. The investigators will also explore
differences... expand
In this study, the investigators will recruit a cohort of elderly Black and Hispanic patients with heart failure to define the number of patients who have cardiac amyloidosis by utilizing highly sensitive heart imaging and blood tests. The investigators will also explore differences in genetics and sex as they relate to heart failure disease progression in cardiac amyloidosis. Type: Observational Start Date: May 2019 |
Maternal Newborn Health Registry
NICHD Global Network for Women's and Children's Health
Pregnancy Outcome Trends in Low-resource Geographic Areas
The primary purpose of this population-based study is to quantify and understand the trends
in pregnancy outcomes in defined low-resource geographic areas over time, in order to provide
population-based data on stillbirths, neonatal and maternal mortality.
expand
The primary purpose of this population-based study is to quantify and understand the trends in pregnancy outcomes in defined low-resource geographic areas over time, in order to provide population-based data on stillbirths, neonatal and maternal mortality. Type: Observational Start Date: May 2008 |
Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)
Gilead Sciences
HIV-1-infection
The goal of this clinical study is to learn how safe and effective it is to switch to an oral
therapy of Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) from Cabotegravir + Rilpivirine
(CAB+RPV) in participants living with virologically suppressed human immunodeficiency virus... expand
The goal of this clinical study is to learn how safe and effective it is to switch to an oral therapy of Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) from Cabotegravir + Rilpivirine (CAB+RPV) in participants living with virologically suppressed human immunodeficiency virus type 1 (HIV-1), meaning participants with HIV RNA levels below detectable levels. The primary objective of this study is to assess the safety of switching to B/F/TAF in virologically suppressed participants unable/unwilling to continue on CAB+RPV intramuscular (IM) injections or wishing to switch to oral therapy through Week 12. Type: Interventional Start Date: Dec 2023 |
Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
Columbia University
Lumbar Spinal Stenosis
Cardiac Amyloidosis
ATTR Amyloidosis Wild Type
ATTR Gene Mutation
ATTRV122I Amyloidosis
Primary objective:
To identify older adults with transthyretin cardiac amyloidosis (ATTR-CA) early in the course
of the illness, at a time when disease modifying therapies are most effective.
The specific aims of this epidemiologic investigation include:
1.... expand
Primary objective: To identify older adults with transthyretin cardiac amyloidosis (ATTR-CA) early in the course of the illness, at a time when disease modifying therapies are most effective. The specific aims of this epidemiologic investigation include: 1. To identify subjects with previous lumbar spinal stenosis (LSS) Surgery who have evidence of transthyretin (TTR) amyloid deposits in spinal specimens and could be at risk for ATTR cardiac amyloidosis. 2. To evaluate for ATTR-CA among those with localized TTR in the spinal tissue. The study will also explore the following: 1. The prevalence of amyloid in lumbar spinal stenosis specimens by Congo Red staining. 2. The prevalence of TTR deposits among subjects with amyloid as determined by mass spectrometry. 3. Evaluation of a novel artificial intelligence technique for that can identify amyloid histologically with standard H&E staining. 4. Difference in ATTR-CA prevalence between subjects with TTR and indeterminate amyloid deposits in subject's spine by myocardial uptake of technetium pyrophosphate scan (Tc99-PYP). Type: Observational Start Date: Sep 2023 |
The Society for Obstetric Anesthesia and Perinatology Research Network General Anesthesia Registry
Yale University
Cesarean Delivery
General Anesthesia
The SOAP registry is a prospective, multicenter, electronic registry. The goal is to
investigate the indications, mode of airway management, predisposing factors, and obstetric
and anesthetic outcomes of pregnant patients who receive general anesthesia for cesarean
delivery.... expand
The SOAP registry is a prospective, multicenter, electronic registry. The goal is to investigate the indications, mode of airway management, predisposing factors, and obstetric and anesthetic outcomes of pregnant patients who receive general anesthesia for cesarean delivery. Type: Observational Start Date: Feb 2024 |
Support Via Online Social Networks to Promote Safe Infant Care Practices
University of Virginia
Breastfeeding
Infant Death
Sudden Infant Death Syndrome Without Mention of Autopsy
This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS)
recommendations and improve rates of initiation and duration of partial and exclusive
breastfeeding (BF); and reduce Black/White disparities in these practices through the use of
private... expand
This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF); and reduce Black/White disparities in these practices through the use of private Facebook groups providing a) evidence-based education through videos and other multi-media supporting best practices and b) an online community and social network of other pregnant WIC clients and new parents. Type: Interventional Start Date: Mar 2024 |
Translation of Robotic Apparel for Alleviating Low Back Pain
Boston University Charles River Campus
Low Back Pain
This is a NIAMS-sponsored clinical trial being conducted through the NIH Helping to End
Addition Long-term (HEAL) Initiative's Back Pain Consortium (BACPAC) Research Program. This
is a single-arm controlled trial with individuals aged 18-70 with low back pain (LBP). This
study... expand
This is a NIAMS-sponsored clinical trial being conducted through the NIH Helping to End Addition Long-term (HEAL) Initiative's Back Pain Consortium (BACPAC) Research Program. This is a single-arm controlled trial with individuals aged 18-70 with low back pain (LBP). This study investigates the effect(s) of augmenting physical therapy (PT) interventions with the use of an experimental wearable soft robotic device ('exosuit'). Type: Interventional Start Date: Mar 2024 |
Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and...
Takeda
Alpha1-Antitrypsin Deficiency
The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis)
compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening
in the liver, to get information on how fazirsiran affects the body (called
pharmacodynamics),... expand
The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), to test how well fazirsiran works compared with a placebo in improving measures of liver scarring including imaging and liver biomarkers (substances in the blood that the body normally makes and help show if liver function is improving, staying the same, or getting worse) as well as to check for side effects in participants treated with fazirsiran compared with those who received placebo. Participants will either receive fazirsiran or placebo. Liver biopsies, a way of collecting a small tissue sample from the liver, will be taken twice during this study. Type: Interventional Start Date: Mar 2023 |
Event-Related Potential (ERP) Components in Clinical Diagnosis
Boston University
Alzheimer Disease
Dementia, Mild
Mild Cognitive Impairment
In this study, the investigators will use a novel electroencephalogram (EEG) system that
participants will wear during a single in-person research session to investigate whether ERPs
are now ready for validation as a tool clinicians can easily implement to increase diagnostic... expand
In this study, the investigators will use a novel electroencephalogram (EEG) system that participants will wear during a single in-person research session to investigate whether ERPs are now ready for validation as a tool clinicians can easily implement to increase diagnostic accuracy and confidence. This EEG will not be used to treat, cure, mitigate or diagnosis any disease and there will be no safety or efficacy data collected about the machine for any purpose including support of FDA submission. The investigators will compare the ERP data to that of neuropsychological testing in order to determine the degree of correlation between these two measures. Questionnaires on cognition, mood, and fluency will be administered prior to the EEG to establish a baseline. ERP data from the EEG session will be compared with the results of the neuropsychological battery in order to determine whether the implementation of ERPs in the existing workflow of clinicians can aid in diagnostic accuracy, thus altering clinical management. Type: Observational Start Date: Mar 2023 |
An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid...
Ionis Pharmaceuticals, Inc.
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
The purpose of this study is to evaluate the safety and tolerability of extended dosing with
eplontersen in participants with ATTR-CM.
expand
The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM. Type: Interventional Start Date: Nov 2022 |
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