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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... 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 study... 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 Improve Symptoms...
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, steroids,... 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... 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... 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 willing... 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 Participants...
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 placebo... 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 genetics... 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 Anxiety...
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 entail:... 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 |
A Study of Rapcabtagene Autoleucel in Systemic Lupus Erythematosus (SLE) Patients With Active, Refractory...
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 |
Non-Invasive Monitoring Methods in Patients With Acute Brain Injury
Boston Medical Center
Brain Injury, Acute
Life-threatening mass effect (LTME) arises when brain swelling displaces or compresses
crucial midline structures subsequent to acute brain injuries (ABIs) like traumatic brain
injury (TBI), ischemic stroke (IS), and intraparenchymal hemorrhage (IPH), which can
manifest rapidly within hours or more... expand
Life-threatening mass effect (LTME) arises when brain swelling displaces or compresses crucial midline structures subsequent to acute brain injuries (ABIs) like traumatic brain injury (TBI), ischemic stroke (IS), and intraparenchymal hemorrhage (IPH), which can manifest rapidly within hours or more gradually over days. Despite advancements in surgical management, significant gaps in understanding persist regarding optimal monitoring and therapeutic approaches. The current standard for identifying LTME involves neurologic decline in conjunction with radiographic evidence or increased intracranial pressure (ICP) indicating space-occupying mass effect. However, in critically ill patients, reliance on subjective physical exam findings, such as decreased arousal, often leads to delayed recognition, occurring only after catastrophic shifts have already occurred. The goal of this study is to determine the association of non-invasive biomarkers with neurologic deterioration, and to determine whether non-invasive biomarker inclusion improves detection of outcome and decline. The investigators propose to use various non-invasive methods to monitor ICP as adjuncts in detecting deteriorating mass effect. These methods include quantitative pupillometry, radiographic data, laboratory data, and other bedside diagnostic tests available including electroencephalography (EEG), skull vibrations detected via brain4care device, optic nerve sheath diameter assessment (ONSD), and ultrasound-guided eyeball compression. Some of these methods will be measured *only* for the purposes of the research study (such as skull vibrations via brain4care). Other measurements, such as quantitative pupillometry, will represent additional measurements beyond those already being collected for clinical care. This research study is necessary to understand the association of these non-invasive biomarkers with neurological decline and outcomes while considering potential confounding factors. Type: Observational Start Date: Sep 2024 |
Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol...
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 participants... 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 |
Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Jaeb Center for Health Research
Amblyopia
In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per
week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to
treatment with 2 hours of patching per day 7 days per week with respect to change in
amblyopic eye distance VA from randomization... expand
In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks. Type: Interventional Start Date: Jul 2024 |
Study to Learn About the Safety of Fazirsiran and if it Can Help People With Alpha-1 Antitrypsin Liver...
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... 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 Immunoglobulin...
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... 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 |
MAGNITUDE: a Phase 3 Study of NTLA-2001 in Participants with Transthyretin Amyloidosis with Cardiomyopathy...
Intellia Therapeutics
Transthyretin Amyloidosis (ATTR) with Cardiomyopathy
To evaluate the efficacy and safety of a single dose of NTLA-2001 compared to placebo in
participants with ATTR-CM. expand
To evaluate the efficacy and safety of a single dose of NTLA-2001 compared to placebo in participants with ATTR-CM. Type: Interventional Start Date: Dec 2023 |
A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell...
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, could... 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 |
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 type 1 (HIV-1), meaning... 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. To identify subjects with previous... 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 |
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus...
Genentech, Inc.
Adenocarcinoma, Pancreatic Ductal
The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene
cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan,
and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected
pancreatic ductal adenocarcinoma (PDAC)... expand
The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery. Type: Interventional Start Date: Oct 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 participants... 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 |
Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete...
Alliance for Clinical Trials in Oncology
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Early Stage Triple-Negative Breast Carcinoma
The phase III trial compares the effect of pembrolizumab to observation for the treatment
of patients with early-stage triple-negative breast cancer who achieved a pathologic
complete response after preoperative chemotherapy in combination with pembrolizumab.
Immunotherapy with monoclonal antibodies,... expand
The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. 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. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab. Type: Interventional Start Date: Jun 2023 |
A Study of Ripretinib Vs Sunitinib in Patients with Advanced GIST with Specific KIT Exon Mutations Who...
Deciphera Pharmaceuticals, LLC
GIST
This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the
efficacy of ripretinib to sunitinib in participants with GIST who progressed on
first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and
are without KIT exon 9, 13, or 14 mutations.... expand
This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without KIT exon 9, 13, or 14 mutations. Upon disease progression as determined by an independent radiologic review, participants randomized to sunitinib will be given the option to either crossover to receive ripretinib 150 mg QD or discontinue sunitinib. Type: Interventional Start Date: Dec 2023 |
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), to learn if fazirsiran reduces... 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 |