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A Study of Rapcabtagene Autoleucel in Systemic Lupus Erythematosus (SLE) Patients With Active, Refr1
Novartis Pharmaceuticals
Lupus Erythematosus, Systemic
Lupus Nephritis
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene
autoleucel (administered once following lymphodepletion) versus Standard of Care (SOC) in
patients with systemic lupus erythematosus (SLE) with active, refractory lupus nephritis
(LN). expand
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) versus Standard of Care (SOC) in patients with systemic lupus erythematosus (SLE) with active, refractory lupus nephritis (LN). Type: Interventional Start Date: Sep 2024 |
Contraceptive Efficacy Study of Ovaprene
Daré Bioscience, Inc.
Contraception
This will be a multi-center, single arm, open-label study of Ovaprene, a non-hormonal
intravaginal ring, to investigate the contraceptive effectiveness, safety and
acceptability of Ovaprene. expand
This will be a multi-center, single arm, open-label study of Ovaprene, a non-hormonal intravaginal ring, to investigate the contraceptive effectiveness, safety and acceptability of Ovaprene. Type: Interventional Start Date: Dec 2023 |
Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial
University of Washington
Diverticulitis
The COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is
a pragmatic, patient-level randomized superiority trial of elective colectomy vs. best
medical management for patients with quality of life (QoL) limiting diverticular disease.
A parallel observational cohort w1 expand
The COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is a pragmatic, patient-level randomized superiority trial of elective colectomy vs. best medical management for patients with quality of life (QoL) limiting diverticular disease. A parallel observational cohort will include those who are disinclined to have their treatment choice randomized, but are willing to contribute information about their outcomes. The goal of the COSMID trial is to answer the question: For patients with QoL-limiting diverticular disease, is elective colectomy more effective than best medical management? The hypothesis being tested in the COSMID trial is that patient-reported outcomes (PROs) among patients in the surgery arm will be superior to those in the best medical management arm. Type: Interventional Start Date: Oct 2019 |
Neuromodulation for a Novel OCD Biomarker and Treatment
Boston University Charles River Campus
OCD
Although multiple treatments for OCD exist, slow symptom decrease, high remission, and
significant side effects for some OCD patients limit their efficacy. More research into
the precise neural mechanisms and linked cognitive functions in OCD is also necessary. To
address both concerns, this study1 expand
Although multiple treatments for OCD exist, slow symptom decrease, high remission, and significant side effects for some OCD patients limit their efficacy. More research into the precise neural mechanisms and linked cognitive functions in OCD is also necessary. To address both concerns, this study by Dr. Reinhart and his team will test a new, non-invasive, and well-tolerated neuromodulation method for reducing OCD symptoms, based on reward-related rhythms of the orbitofrontal cortex (OFC; a brain region responsible for reward, decision making and other crucial functions that is affected by OCD). This proposal is based on highly encouraging preliminary data in both subsyndromal and treatment-resistant populations that shows rapid reductions in OCD behaviors that last at least 1-3 months. Using high-definition transcranial alternating current stimulation (HD-tACS) guided by EEG brain wave recordings, the study will test whether repetitive modulation of relevant rhythm activity in the OFC can lead to rapid (within five days) and sustainable (up to three months) OCD symptom reduction. This research aims to increase knowledge of OCD and development of effective treatment with minimal side effects. Type: Interventional Start Date: Jul 2024 |
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve1
Biogen
Lupus Erythematosus, Systemic
In this study, researchers will learn more about a study drug called litifilimab
(BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus
on participants who have active disease and are already taking standard of care
medications. These may include antimalarials, ster1 expand
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: - How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS). Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: - After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. - All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. - Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - There will be a follow-up safety period that lasts up to 24 weeks. - In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks. Type: Interventional Start Date: Jul 2021 |
A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children
BioNTech SE
SARS-CoV-2 Virus
Severe Acute Respiratory Syndrome Coronavirus 2
COVID-19
The purpose of this clinical trial is to learn about the safety, extent of the side
effects, and immune responses of the study vaccine (called variant-adapted BNT162b2
RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies or
substudies based on age group and prior h1 expand
The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 5 sub-studies will receive study vaccine as a shot depending on what group they are in. - Substudy A design: Phase 1 includes participants 6 months through less than 4 years 3 months of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naïve) and will receive 3 doses of study vaccine as their initial series, followed by a fourth dose of study vaccine. Phase 2/3 includes participants 6 months through less than 5 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive 1, 2, or 3 doses of study vaccine, depending on what group they are in. - Substudy B design: includes participants 6 months through less than 5 years of age who have either received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose. - Substudy C design: Phase 1 includes participants 6 months through less than 5 years of age who have received 3 prior doses of BNT162b2 and will receive study vaccine as their fourth dose. - Substudy D design: includes participants 5 through less than12 years of age who have received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose. - Substudy E design: includes participants 2 through less than 12 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive a single dose of study vaccine. Type: Interventional Start Date: Sep 2022 |
CO2 Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy
University of Texas at Austin
Obsessive-Compulsive Disorder
Post Traumatic Stress Disorder
Generalized Anxiety Disorder
Social Anxiety Disorder
Panic Disorder
Anxiety-, obsessive-compulsive and trauma- and stressor-related disorders reflect a
significant public health problem. This study is designed to evaluate the predictive
power of a novel biomarker based on a CO2 challenge, thus addressing the central question
"can this easy-to-administer assay aid c1 expand
Anxiety-, obsessive-compulsive and trauma- and stressor-related disorders reflect a significant public health problem. This study is designed to evaluate the predictive power of a novel biomarker based on a CO2 challenge, thus addressing the central question "can this easy-to-administer assay aid clinicians in deciding whether or not to initiate exposure-based therapy?" Type: Interventional Start Date: Nov 2022 |
Couples Lived Experience
NYU Langone Health
Alzheimer Disease
Dementia of Alzheimer Type
This is a longitudinal study with regular quantitative assessments of all participants
every six months for 3 years. The quantitative portion of the study will recruit couples,
consisting of individuals over the age of 65 who are in a committed relationship. Both
members of the couple must be willi1 expand
This is a longitudinal study with regular quantitative assessments of all participants every six months for 3 years. The quantitative portion of the study will recruit couples, consisting of individuals over the age of 65 who are in a committed relationship. Both members of the couple must be willing to participate at baseline. The assessment is in two parts. In the first part, each member of the couple will be asked the following: demographic information, mental health history, self-reported physical and emotional health, measures of emotional and mental health, personality, relationship and attachment style, social support and self-efficacy. Then each member of the study couple will be asked a series of questions to determine whether they consider themselves a caregiver. If they do, individuals will be asked to respond to additional caregiver questionnaires. Follow-ups will occur every six months for the study couples for a total of three years from the baseline visit. Each visit, the entire assessment except for demographic questions, will be re-administered to each individual in the couple. At the end of each questionnaire battery, individuals will be screened for cognitive impairment and those who are in the middle to advanced stages of dementia will no longer participate. Recruitment will end when 600 individuals (300 couples,150 couples at each site) are enrolled in the longitudinal portion of the study. All study visits will be conducted virtually via Zoom or WebEx video conferencing. Analyses will be conducted to determine the association between changes in dyadic relationship and changes in mental health and cognitive outcomes, to elucidate how relationship characteristics impact health and well-being as perceived by each member of the dyad. Type: Observational Start Date: Apr 2021 |
AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participan1
Eisai Inc.
Preclinical Alzheimer's Disease
Early Preclinical Alzheimer's Disease
The primary purpose of this study is to determine whether treatment with lecanemab is
superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive
Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether
treatment with lecanemab is superior to placebo1 expand
The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). This study will also evaluate the long-term safety and tolerability of lecanemab in participants enrolled in the Extension Phase. Type: Interventional Start Date: Jul 2020 |
Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD
Boston University
Post Traumatic Stress Disorder
Purpose: About 6.4% of the U.S. population suffers from posttraumatic stress disorder
(PTSD). Trauma-focused psychotherapies are generally effective in PTSD, but responses
vary greatly across individuals and PTSD subpopulations. Neurobiological factors impacted
by life experiences, stress, and gene1 expand
Purpose: About 6.4% of the U.S. population suffers from posttraumatic stress disorder (PTSD). Trauma-focused psychotherapies are generally effective in PTSD, but responses vary greatly across individuals and PTSD subpopulations. Neurobiological factors impacted by life experiences, stress, and genetics can affect treatment responses. These factors can alter brain capacities needed to reprocess traumatic memories prevent them from triggering intensely distressing, disruptive, out-of-place responses. For example, during psychotherapy for PTSD, trauma memory activation engages two competing brain processes that affect recovery: "extinction" versus "reconsolidation" of trauma-related emotional, physiological, and behavioral responses. This study tests whether a single intravenous (IV) dose of allopregnanolone (Allo) compared to placebo (which is non-active): 1. promotes consolidation of extinction learning (sub-study 1) or 2. blocks reconsolidation physiological responses triggered by aversive memories (sub-study 2). The study also tests whether Allo compared to placebo affects retention of non-aversive memories. Type: Interventional Start Date: Mar 2022 |
Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiet1
Boston University Charles River Campus
Anxiety Disorders
Cardiovascular Diseases
Anxiety
Health Behavior
The treatment of generalized anxiety disorder (GAD) in an accessible manner represents an
unmet need for those with cardiovascular disease (CVD), given that patients with CVD
experience numerous barriers for in-person treatment engagement. The research plan for
the proposed pilot project will entai1 expand
The treatment of generalized anxiety disorder (GAD) in an accessible manner represents an unmet need for those with cardiovascular disease (CVD), given that patients with CVD experience numerous barriers for in-person treatment engagement. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention (N=5), followed by (2) recruitment and randomization of 90 individuals with a history of acute CVD events and clinical levels of GAD symptoms to dCBT or a waitlist (Control) condition, using a 1.5:1 allocation (dCBT:Control). Type: Interventional Start Date: Feb 2022 |
Web-administered STAIR for Patients on Behavioral Health Waitlists
Boston Medical Center
Post Traumatic Stress Disorder
Posttraumatic stress disorder (PTSD) is a significant public health challenge with
population prevalence rates in the US between 6.1 to 9.2%. There are large racial and
socioeconomic inequities in access to PTSD treatment, as up to half (30-50%) of patients
in safety net clinical settings meet crit1 expand
Posttraumatic stress disorder (PTSD) is a significant public health challenge with population prevalence rates in the US between 6.1 to 9.2%. There are large racial and socioeconomic inequities in access to PTSD treatment, as up to half (30-50%) of patients in safety net clinical settings meet criteria for PTSD, yet only 13% receive any behavioral health treatment. Workforce shortages are one major barrier to accessing care. Additional barriers to care can include heightened mental health stigma and mistrust of health services. Digital mental health interventions (DMHIs) may be suitable within the continuum of care for PTSD in hospital settings, given their potential for rapid-access, scalability, and the high acceptability of DMHI among individuals with high stigma and social needs. Among the available DMHIs for PTSD, the investigators have selected web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), based on emerging scientific evidence and a close collaboration with Boston Medical Center (BMC) users (patients and providers) in a previous pilot study in primary care. The aim of this randomized study is to implement webSTAIR at BMC in the Recovery from Stress and Trauma through Outpatient Care, Research, and Education (RESTORE) Center's subspecialty clinic. Type: Interventional Start Date: Nov 2024 |
Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Cla1
Veracyte, Inc.
Pulmonary Nodule, Solitary
Lung Cancer
The goal of this observational study is to learn how a physician uses the results of the
Percepta® Nasal Swab test to manage people with a newly identified pulmonary nodule.
The main questions it aims to answer are:
- Does the use of the Percepta Nasal swab test reduce the number of invasive1 expand
The goal of this observational study is to learn how a physician uses the results of the Percepta® Nasal Swab test to manage people with a newly identified pulmonary nodule. The main questions it aims to answer are: - Does the use of the Percepta Nasal swab test reduce the number of invasive procedures in people with a low-risk result and whose nodule is benign? - Does the use of the Percepta Nasal swab test decrease the time to treatment in people with a high-risk result and whose nodule is cancer? Participants will be randomly assigned to either a group where the test result is provided to the physician (test arm) or to a group where the test result is not provided (control arm). Researchers will compare management of participants in the two groups. Type: Observational Start Date: Jul 2022 |
Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and1
Novo Nordisk A/S
Alcohol-related Liver Disease
The study will look at the effects of NNC0194-0499, cagrilintide and semaglutide, on
liver damage and alcohol use in participants with alcoholic liver disease. Participants
will get NNC0194-0499, semaglutide, cagrilintide or ''dummy" medicine in different
treatment combinations. Which treatment par1 expand
The study will look at the effects of NNC0194-0499, cagrilintide and semaglutide, on liver damage and alcohol use in participants with alcoholic liver disease. Participants will get NNC0194-0499, semaglutide, cagrilintide or ''dummy" medicine in different treatment combinations. Which treatment participants get is decided by chance. The study will last for about 39 weeks. Type: Interventional Start Date: May 2024 |
Stress Management Intervention Among Breast and Gynecologic Cancer Patients in Viet Nam
Boston University
Breast Cancer
Gynecologic Cancer
Psychological distress is common among Vietnamese cancer patients but often
underestimated and not detected by professionals due to lack of time and overload of
clinical work. Currently no established, evidence-based intervention exists to help
address the mental health needs of cancer patients in1 expand
Psychological distress is common among Vietnamese cancer patients but often underestimated and not detected by professionals due to lack of time and overload of clinical work. Currently no established, evidence-based intervention exists to help address the mental health needs of cancer patients in Viet Nam besides the 'Stronger Together' peer mentoring intervention model that the investigators piloted in 2021-2023. The goal of this 2-arm, parallel, single-blind randomized controlled trial (RCT) is to pilot and evaluate the Vietnamese Self Help Plus (vSH+) stress management intervention among breast and gynecologic cancer patients in Viet Nam. Aim 1- the investigators pilot the adapted vSH+ intervention. After recruitment and screening, participants are randomized into either the intervention (vSH+) or enhanced usual care (EUC) study arms. Participants are invited to attend an in-person informational session (IS) specific to their study arm, where informed consent is obtained. Aim 2- the investigators assess the potential effectiveness of the vSH+ intervention. Quantitative surveys of study outcomes measures are administered at three timepoints: T0 (baseline, in-person, during info-sessions); T1 (1-2 weeks post-intervention, via phone); and T2 (3 months post-intervention, via phone). Aim 3- the investigators conduct a qualitative process evaluation, via in-depth interview (IDIs) and focus group discussions (FGDs), to assess the acceptability and feasibility implementing and scaling up the vSH+ intervention model. Satisfaction surveys will be administered during vSH+ sessions and in-depth interviews (IDIs) will be conducted following the conclusion of the intervention. IDIs wil also be conducted with Facilitators, in addition to evaluation surveys during vSH+ sessions and supportive supervision sessions. Between T1 and T2, the investigators will conduct IDIs with Healthcare Workers and focus group discussions with Caregivers. Type: Interventional Start Date: Nov 2024 |
Study to Learn About the Safety of Fazirsiran and if it Can Help People With Alpha-1 Antitrypsin Li1
Takeda
Alpha1-Antitrypsin Deficiency
The liver produces a protein called alpha-1 antitrypsin (AAT). AAT is normally released
into the bloodstream. In some people, the liver makes an abnormal version of the AAT
protein, called Z-AAT. Making an abnormal version of the AAT protein can result in liver
disease as Z-AAT builds up in liver c1 expand
The liver produces a protein called alpha-1 antitrypsin (AAT). AAT is normally released into the bloodstream. In some people, the liver makes an abnormal version of the AAT protein, called Z-AAT. Making an abnormal version of the AAT protein can result in liver disease as Z-AAT builds up in liver cells, which leads to liver problems such as liver scarring (fibrosis), continuing liver damage (cirrhosis), and eventually endstage liver disease. Fazirsiran is a medicine that reduces the creation of the Z-AAT protein and thus the build-up of this abnormal protein in the liver. People with this type of liver disease who already have mild liver scarring will take part in the study. They will be treated with fazirsiran or a placebo for about 2 years. This study will check the long-term safety of fazirsiran, whether participants tolerate the treatment and if there are any effects on liver scarring. A liver biopsy, a way of collecting a small tissue sample from the liver, will be taken twice during the study. Type: Interventional Start Date: Mar 2024 |
A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Im1
AbbVie
Immunoglobulin Light Chain (AL) Amyloidosis
Immunoglobulin light chain (AL) amyloidosis is the most common form of systemic
amyloidosis. AL amyloidosis has many root causes and is characterized by the
overproduction of AL that are secreted by clonal bone marrow plasma cells. This is a
study to determine adverse events and change in disease a1 expand
Immunoglobulin light chain (AL) amyloidosis is the most common form of systemic amyloidosis. AL amyloidosis has many root causes and is characterized by the overproduction of AL that are secreted by clonal bone marrow plasma cells. This is a study to determine adverse events and change in disease activity in adult participants with AL amyloidosis treated with ABBV-383. ABBV-383 is an investigational drug being developed for the treatment of AL amyloidosis. This study in broken into 2 parts (dose escalation and safety expansion) with 5 arms. During dose escalation (arms 1-3) participants will receive 1 of 3 doses of ABBV-383 to determine the part 2 doses. After completion of the dose escalation portion of the study, the safety expansion (part 2) portion of the study will begin. Two arms (arm 4-5) will begin and participants will receive 1 of 2 doses as determined during the dose escalation portion (part 1). Around 76 adult participants with relapsed/refractory AL amyloidosis will be enrolled at approximately 20 sites across the world. Participants will receive ABBV-383 as an infusion into the vein for up to approximately 2 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during 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 questionnaires. Type: Interventional Start Date: Apr 2024 |
A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Pati1
Eli Lilly and Company
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
The purpose of this study is to assess if adding LY3537982 in combination with standard
of care anti-cancer drugs is more effective than standard of care in participants with
untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study
participation, including follow-up, cou1 expand
The purpose of this study is to assess if adding LY3537982 in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing. Type: Interventional Start Date: Dec 2023 |
Durvalumab With Gemcitabine and Cisplatin for the Treatment of High-Risk Resectable Liver Cancer Be1
National Cancer Institute (NCI)
Resectable Intrahepatic Cholangiocarcinoma
This phase II trial tests how well giving durvalumab with standard chemotherapy,
gemcitabine and cisplatin, before surgery works in treating patients with high risk liver
cancer (cholangiocarcinoma) that can be removed by surgery (resectable). Durvalumab is a
monoclonal antibody that may interfere1 expand
This phase II trial tests how well giving durvalumab with standard chemotherapy, gemcitabine and cisplatin, before surgery works in treating patients with high risk liver cancer (cholangiocarcinoma) that can be removed by surgery (resectable). Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, 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 durvalumab with gemcitabine and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed in patients with high risk resectable cholangiocarcinoma. Type: Interventional Start Date: Jul 2024 |
To Compare the Efficacy and Safety of the HAV With AVF in Female Patients With End-Stage Renal Dise1
Humacyte, Inc.
End Stage Renal Disease (ESRD)
The goal of this clinical trial is to compare the number of catheter-free days (CFD) and
the rate and severity of any dialysis access-related infections between the HAV and AVF
groups over 12 months in patients with end-stage renal disease (ESRD) needing
hemodialysis (HD).
Participants will be str1 expand
The goal of this clinical trial is to compare the number of catheter-free days (CFD) and the rate and severity of any dialysis access-related infections between the HAV and AVF groups over 12 months in patients with end-stage renal disease (ESRD) needing hemodialysis (HD). Participants will be stratified by location of the vascular access (forearm versus upper arm) and by type of AVF creation procedure planned by the surgeon at randomization (1-stage AVF versus 2-stage AVF). The comparator is an upper extremity arterio-venous fistula (AVF) for HD access surgically created per the institution's Standard of Care (SoC). Type: Interventional Start Date: Sep 2023 |
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
Johns Hopkins University
Atrial Fibrillation
REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE
design), controlled trial comparing the current Standard Of Care (SOC) of continuous
Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an
AF-sensing Smart Watch (AFSW) in parti1 expand
REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk. Type: Interventional Start Date: Jul 2023 |
Validating Gulf War Illness Blood Biomarkers
Roskamp Institute Inc.
Gulf War Syndrome
Gulf War Illness
The investigators goals are to identify blood lipids/metabolites that correlate with
cognitive decline in the presence of the APOE ε4 allele among veterans with GWI. To
determine the effect of dietary, medical and biological factors that influence lipid and
metabolites in blood from GW veterans. To1 expand
The investigators goals are to identify blood lipids/metabolites that correlate with cognitive decline in the presence of the APOE ε4 allele among veterans with GWI. To determine the effect of dietary, medical and biological factors that influence lipid and metabolites in blood from GW veterans. To identify blood lipid/metabolite profiles that correlate with bioenergetics deficits and glial activation in the brains of GWI. To validate blood biomarker signatures of GWI using APOE genotyping and blood lipids/metabolites that correlate with the CNS dysfunction in GWI. Type: Observational Start Date: Jun 2022 |
An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated1
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 |
A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With an1
Theratechnologies
HIV Infections
Multi-Antiviral Resistance
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical
trials. This study will expand ibalizumab's clinical data set and allow a better
understanding of the virologic response durability on ARV regimens with or without
ibalizumab in a heterogeneous real-world pati1 expand
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologic response durability on ARV regimens with or without ibalizumab in a heterogeneous real-world patient population. Additional data on the efficacy and safety of ibalizumab and its impact on patient reported outcomes will be captured until study end. Primary Objective: To evaluate the long-term efficacy, safety, and durability of ibalizumab in combination with other ARVs by comparing the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment versus patients not receiving ibalizumab. Secondary Objective: To assess the efficacy of ibalizumab in combination with other antiretrovirals by comparing the virologic, immunologic, clinical and patient reported outcomes of patients before and after they receive ibalizumab treatment. To assess the long-term safety and tolerability of ibalizumab. Other Objectives: To assess risk factors/predictors of virologic and immunologic response. To assess efficacy and safety in special populations that enroll. Type: Observational Start Date: Mar 2022 |
VE202 in Patients with Mild-to-Moderate Ulcerative Colitis
Vedanta Biosciences, Inc.
Ulcerative Colitis
Colitis, Ulcerative
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in
patients with mild to moderate ulcerative colitis (UC). expand
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC). Type: Interventional Start Date: May 2023 |