Search Clinical Trials
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Study to Evaluate Safety and Tolerability of CC-91633 (BMS-986397) in Participants With Relapsed or Refractory...
Celgene
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Study CC-91633-AML-001 is a Phase 1, open-label, dose escalation and expansion,
first-in-human (FIH) clinical study of CC-91633 (BMS-986397) in participants with
relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with relapsed
or refractory higher-risk myelodysplastic syndromes... expand
Study CC-91633-AML-001 is a Phase 1, open-label, dose escalation and expansion, first-in-human (FIH) clinical study of CC-91633 (BMS-986397) in participants with relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS). The Dose Escalation part (Part A) of the study will enroll participants with R/R AML and R/R HR-MDS and will evaluate the safety and tolerability of escalating doses of CC-91633 (BMS-986397), administered orally, and determine the maximum tolerated dose (MTD) or preliminary recommended Phase 2 doses (RP2D) and schedule. Throughout the study, final decisions on dose escalation/de-escalation will be made by the safety review committee (SRC). Approximately 60 participants may be enrolled in Part A of the study. The expansion part (Part B) will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development. Approximately 60 response-evaluable subjects per indication (R/R AML or R/R HR-MDS) may be enrolled. Parts A and B will consist of 3 periods: Screening, Treatment, and Follow-up. Type: Interventional Start Date: Dec 2021 |
Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular...
Abiomed Inc.
Left Ventricular Dysfunction
Coronary Artery Disease
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device
during high-risk PCI in patients with reduced left-sided heart function will result in an
improvement in symptoms, heart function and health after a heart procedure compared to
the current standard of care. expand
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care. Type: Interventional Start Date: Apr 2021 |
Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis
Boston Children's Hospital
Graft Vs Host Disease
This is a multicenter randomized, double blind, Phase 2 trial for patients receiving
transplants from 7 of 8 HLA matched donors, in which an extended dosing regimen of
abatacept, and a short-term dosing regimen + placebo, when added to standard calcineurin
inhibitor + methotrexate-based prophylaxis,... expand
This is a multicenter randomized, double blind, Phase 2 trial for patients receiving transplants from 7 of 8 HLA matched donors, in which an extended dosing regimen of abatacept, and a short-term dosing regimen + placebo, when added to standard calcineurin inhibitor + methotrexate-based prophylaxis, will be compared for their ability to improve outcomes in patients with a minimum follow-up of one year post-transplant. All patients will receive 4 doses of abatacept (Days -1, +5, +14, +28). Prior to the fifth dose, patients will be randomly assigned to the 4-dose abatacept arm and receive 4 doses of placebo or 8-dose abatacept arm and receive 4 more doses of abatacept. The primary endpoint of the study will be severe AGVHD-free, severe CGVHD-free, relapse-free survival (SGRFS). The study will end when the last patient has reached 2 years after transplant. Results will first be calculated and the study unblinded when the last patient has reached one year post-transplant. Type: Interventional Start Date: Mar 2022 |
The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis
University of Utah
Autoimmune Encephalitis
Encephalitis
Determine the difference in the modified Rankin score at 16 weeks in participants with
anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis treated with "first-line"
immunomodulatory therapies provided as standard-of-care, and either inebilizumab
(investigational agent) or placebo. expand
Determine the difference in the modified Rankin score at 16 weeks in participants with anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis treated with "first-line" immunomodulatory therapies provided as standard-of-care, and either inebilizumab (investigational agent) or placebo. Type: Interventional Start Date: Mar 2022 |
A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas
Constellation Pharmaceuticals
Advanced Solid Tumor
Diffuse Large B Cell Lymphoma
Lymphoma, T-Cell
Mesothelioma, Malignant
Prostatic Neoplasms, Castration-Resistant
First-in-human, open-label, sequential dose escalation and expansion study of CPI-0209 in
patients with advanced solid tumors and lymphomas. CPI-0209 is a small molecule inhibitor
of EZH2. expand
First-in-human, open-label, sequential dose escalation and expansion study of CPI-0209 in patients with advanced solid tumors and lymphomas. CPI-0209 is a small molecule inhibitor of EZH2. Type: Interventional Start Date: Sep 2019 |
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced...
Janssen Research & Development, LLC
Carcinoma, Non-Small-Cell Lung
The purpose of this study is to confirm the tolerability of recommended Phase 2 dose
(RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the
recommended Phase 2 combination dose of Lazertinib when combined with Amivantamab
(JNJ-61186372) (Phase 1b), to characterize the safety... expand
The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2 combination dose of Lazertinib when combined with Amivantamab (JNJ-61186372) (Phase 1b), to characterize the safety and tolerability of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced non-small cell lung cancer (NSCLC) with documented advanced or metastatic epidermal growth factor receptor (EGFR) mutation (Phase 1b expansion cohorts A, B, C, D and E), to estimate the antitumor activity of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced NSCLC with documented advanced or metastatic EGFR mutation (Phase 1b expansion cohorts A, B, C, and D), to validate the biomarker identified in Phase 1b expansion Cohort D as a predictor of antitumor activity of Lazertinib and Amivantamab combination (Cohort E) or Amivantamab monotherapy (Cohort F) in participants with osimertinib-relapsed, chemotherapy-naïve, EGFR Exon19del or L858R mutated NSCLC, to identify the recommended Phase 2 dose (RP2ChD) of Lazertinib when combined with Amivantamab and standard of care chemotherapy and to determine the tolerability of the Lazertinib, Amivantamab, and platinum-doublet chemotherapy (LACP) combination (Phase 1b LACP combination cohort) and to characterize the safety and tolerability of Lazertinib at the RP2ChD and Amivantamab and standard of care chemotherapy in participants with advanced or metastatic EGFR-mutated NSCLC (Phase 1b LACP combination cohort), to assess 2 potential biomarker strategies to identify participants at increased, or decreased, probability of tumor response with JNJ-61186372 and lazertinib combination in participants with EGFR Exon19del or L858R mutated NSCLC progressed on or after osimertinib (Phase 1b expansion Cohort D). Type: Interventional Start Date: Sep 2019 |
Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
Yale University
Intracerebral Hemorrhage
Atrial Fibrillation
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the
composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in
patients with recent ICH and atrial fibrillation (AF).
Secondary Aim: To determine if apixaban, compared with aspirin, results in... expand
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale. Type: Interventional Start Date: Jan 2020 |
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently...
Merck Sharp & Dohme LLC
Solid Tumors
Hematologic Malignancies
The purpose of this study is to evaluate the long-term safety and efficacy of
pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent
studies who transition into this extension study.
This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up
Phase... expand
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated. Type: Interventional Start Date: Aug 2018 |
Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid...
ModernaTX, Inc.
Solid Tumors
The purpose of this study is to assess the safety, tolerability, and immunogenicity of
mRNA-4157 alone and in combination in participants with solid tumors. expand
The purpose of this study is to assess the safety, tolerability, and immunogenicity of mRNA-4157 alone and in combination in participants with solid tumors. Type: Interventional Start Date: Aug 2017 |
Brain Connectivity in Depression
Brigham and Women's Hospital
Depression
This study originally included 140 subjects with medication-refractory depression
undergoing 10 Hz transcranial magnetic stimulation (10Hz-TMS) to the left dorsal lateral
prefrontal cortex (DLPFC), with the goal of having 60 completers with good quality data.
Subjects were recruited from the TMS clinics... expand
This study originally included 140 subjects with medication-refractory depression undergoing 10 Hz transcranial magnetic stimulation (10Hz-TMS) to the left dorsal lateral prefrontal cortex (DLPFC), with the goal of having 60 completers with good quality data. Subjects were recruited from the TMS clinics at Beth Israel Deaconess Medical Center, Brigham & Women's Hospital, and Butler Hospital. Subjects underwent an hour-long MRI scanning session, an optional DNA-sample collection, up to three 20 minute neuronavigation sessions for marking the site of TMS stimulation, questionnaires, and a behavioral testing battery before and after their TMS treatment course. The task battery included the Emotion Conflict Resolution (ECR) task, Multi-Source Interference Task (MSIT), War Game (Gambling) task, and Associative Learning with Reversal task. Subjects' scores on the Quick Inventory of Depressive Symptomatology (QIDS) and Beck Depression Inventory (BDI) were assessed before and after the TMS course. MRI data was utilized to identify brain regions whose connectivity to the stimulation site co-varies with the aforementioned measures of symptom improvement. This was the only study group until August 30, 2022, and the primary outcome was analyzed for the 10Hz-TMS group. Due to changes in clinical standard of care from 10Hz-TMS to a newer version of TMS termed intermittent theta burst (iTBS), in September 2022 a second group was added to include patients receiving this new form of TMS. This second group included another 100 patients with medication-refractory depression undergoing iTBS to the left dorsal lateral prefrontal cortex (DLPFC), with the intent to have 80 completers. Massachusetts General Hospital was added as a data collection site in lieu of Butler Hospital. Subjects will undergo an hour-long MRI scanning session, up to three 20 minute neuronavigation sessions for marking the site of TMS stimulation, questionnaires, and a behavioral testing battery before and after their TMS treatment course. The task battery will included the Emotion Conflict Resolution (ECR) task, Multi-Source Interference Task (MSIT), Penn Emotion Recognition Test, the Suicide/Death Implicit Association Test, and Associative Learning with Reversal task. Subjects' scores on the Beck Depression Inventory (BDI) were assessed before and after the TMS course. MRI data will be utilized to identify brain regions whose connectivity to the stimulation site co-varies with the aforementioned measures of symptom improvement. Type: Interventional Start Date: Apr 2018 |
Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors
Georgiamune Inc
Melanoma Stage IV
Solid Tumor
GIM-531 is a first-in-class, orally bioavailable small molecule that is being developed
for the treatment of advanced solid tumors as a single agent and rescue therapy. GIM-531
exhibits its primary effect through selective inhibition of regulatory T-cells (Tregs). expand
GIM-531 is a first-in-class, orally bioavailable small molecule that is being developed for the treatment of advanced solid tumors as a single agent and rescue therapy. GIM-531 exhibits its primary effect through selective inhibition of regulatory T-cells (Tregs). Type: Interventional Start Date: May 2024 |
Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes
Tandem Diabetes Care, Inc.
Type1diabetes
The purpose of this study is to collect clinical data to support a 7-day wear of the
Extended Wear Infusion Set (EWIS).
Participants will be asked to:
1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods
2. Perform blood glucose and ketone measurements if continuous... expand
The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS). Participants will be asked to: 1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods 2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour Type: Interventional Start Date: Mar 2024 |
National Liver Cancer Screening Trial
University of Texas Southwestern Medical Center
Carcinoma, Hepatocellular
Liver Cancer
Liver Cirrhosis
Hepatitis B
The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial
comparing ultrasound-based versus biomarker-based screening in 5500 patients with
cirrhosis from any etiology or patients with chronic hepatitis B infection. Eligible
patients will be randomized in a 1:1 fashion to... expand
The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial comparing ultrasound-based versus biomarker-based screening in 5500 patients with cirrhosis from any etiology or patients with chronic hepatitis B infection. Eligible patients will be randomized in a 1:1 fashion to Arm A using semi-annual ultrasound and AFP-based screening or Arm B using semi-annual screening using GALAD alone. Randomization will be stratified by sex, enrolling site, Child Pugh class (A vs. B), and HCC etiology (viral vs. non-viral). Patients will be recruited from 15 sites (mix of tertiary care and large community health systems) over a 3-year period, and the primary endpoint of the phase IV trial, reduction in late-stage HCC, will be assessed after 5.5 years. Type: Interventional Start Date: Dec 2023 |
A Study to Evaluate the Safety and Efficacy of A2B694, a Logic-gated CAR T, in Subjects With Solid Tumors...
A2 Biotherapeutics Inc.
Solid Tumor, Adult
Colorectal Cancer
NSCLC
Non Small Cell Lung Cancer
NSCLC, Recurrent
The goal of this study is to test A2B694, an autologous logic-gated Tmod™ CAR T-cell
product in subjects with solid tumors including colorectal cancer (CRC), pancreatic
cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma
(MESO), and other solid tumors that express... expand
The goal of this study is to test A2B694, an autologous logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express MSLN and have lost HLA-A*02 expression. The main questions this study aims to answer are: Phase 1: What is the recommended dose of A2B694 that is safe for patients Phase 2: Does the recommended dose of A2B694 kill the solid tumor cells and protect the patient's healthy cells Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: Enrollment and Apheresis in BASECAMP-1 (NCT04981119) Preconditioning Lymphodepletion (PCLD) Regimen A2B694 Tmod CAR T cells at the assigned dose Type: Interventional Start Date: Apr 2024 |
Dampening the Reproductive Axis With Continuous Kisspeptin
Stephanie B. Seminara, MD
Reproductive Disorder
PCOS
Polycystic Ovary Syndrome
The goal of this study is to assess response to kisspeptin as well as the baseline
patterns of luteinizing hormone (LH) secretion in individuals with polycystic ovarian
syndrome (PCOS). expand
The goal of this study is to assess response to kisspeptin as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals with polycystic ovarian syndrome (PCOS). Type: Interventional Start Date: Oct 2023 |
Strategy for Improving Stroke Treatment Response
Translational Sciences, Inc.
Ischemic Stroke
SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding
trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal
antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke. expand
SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke. Type: Interventional Start Date: Mar 2024 |
Kisspeptin Administration Subcutaneously to Patients With IHH
Stephanie B. Seminara, MD
Hypogonadotropic Hypogonadism
The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can
stimulate the release of other reproductive hormones in men and women with idiopathic
hypogonadotropic hypogonadism (IHH). The investigators are also examining whether
kisspeptin can help women release eggs from... expand
The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time. Funding Source: FDA OOPD Type: Interventional Start Date: Feb 2023 |
TRAQinform Assessment of Immunotherapy Response
AIQ Solutions
Melanoma
The intent of this study is to evaluate the actionable information output from the
TRAQinform Immuno technology in a prospective, non-interventional clinical study.
Subjects with metastatic melanoma treated with standard of care (SOC) dual-agent
immunotherapy will be enrolled. Subjects will receive... expand
The intent of this study is to evaluate the actionable information output from the TRAQinform Immuno technology in a prospective, non-interventional clinical study. Subjects with metastatic melanoma treated with standard of care (SOC) dual-agent immunotherapy will be enrolled. Subjects will receive SOC immunotherapy monitored for treatment response with FDG PET/CT's at baseline (SOC), after 3-4 weeks of treatment (non-SOC) and 12 at weeks of treatment (SOC). Type: Observational Start Date: Jun 2023 |
Promoting Safety Plan and Coping Strategy Use Among Adults With Suicidal Thoughts
Massachusetts General Hospital
Suicide
The goal of this study is to learn about a new, real-time, smartphone-based intervention
aimed to decrease risk for suicide in adults who have been hospitalized for suicidal
thoughts or behaviors. The main questions the investigators aim to answer are:
- Is a real-time, smartphone-based intervention... expand
The goal of this study is to learn about a new, real-time, smartphone-based intervention aimed to decrease risk for suicide in adults who have been hospitalized for suicidal thoughts or behaviors. The main questions the investigators aim to answer are: - Is a real-time, smartphone-based intervention that promotes the use of safety plans and other coping strategies for suicidal thoughts feasible and acceptable? - Does the real-time intervention result in increased use of safety plans and other coping strategies, and reduce suicidal thoughts? Participants will: - Answer questions about current suicidal thoughts on their smartphone up to 6 times each day while they are in the hospital and during the 4 weeks after they leave the hospital - When they report elevated suicidal thoughts on a smartphone survey, be randomly assigned to receive or not receive automated, interactive reminders to use content from their personalized safety plan or general coping strategies - Answer brief follow-up questions on their smartphone within a couple hours of receiving or not receiving automated reminders - Give feedback on their experience with the real-time intervention Type: Interventional Start Date: Jul 2023 |
TSC Biosample Repository and Natural History Database
National Tuberous Sclerosis Association
Tuberous Sclerosis
Lymphangioleiomyomatosis
The TSC Biosample Repository collects and stores samples of blood, DNA, and tissues that
scientists can request to use in their research. The samples we collect are all linked to
clinical data in the TSC Natural History Database. The TSC Natural History Database
captures clinical data to document... expand
The TSC Biosample Repository collects and stores samples of blood, DNA, and tissues that scientists can request to use in their research. The samples we collect are all linked to clinical data in the TSC Natural History Database. The TSC Natural History Database captures clinical data to document the impact of the disease on a person's health over his or her lifetime. This data may be collected retrospectively or prospectively. Type: Observational [Patient Registry] Start Date: Jan 2016 |
Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
Stephanie B. Seminara, MD
Hypothalamic Amenorrhea
Hypogonadotropic Hypogonadism
The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can
stimulate the release of other reproductive hormones in women with hypothalamic
amenorrhea (HA). The investigators are also examining whether kisspeptin can help women
release eggs from their ovaries. Kisspeptin... expand
The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time. Type: Interventional Start Date: Dec 2022 |
Safety and Efficacy of Oral Belumosudil in Black or African American, American Indian or Alaska Native,...
Kadmon, a Sanofi Company
Chronic Graft Versus Host Disease
The purpose of this study is to measure safety and efficacy of oral belumosudil in Black
or African American, American Indian or Alaska Native, and Native Hawaiian or Other
Pacific Islander male and female participants with cGVHD who have previously been treated
with at least 2 prior lines of systemic... expand
The purpose of this study is to measure safety and efficacy of oral belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander male and female participants with cGVHD who have previously been treated with at least 2 prior lines of systemic therapy aged 12 years and above. The duration of participants participation will be up to 4 weeks for screening, treatment until clinically significant progression of disease, and 4 weeks of safety follow-up, and then long-term follow-up every 12 weeks.1 Cycle = 28 days. Type: Interventional Start Date: Sep 2024 |
TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines...
Pfizer
Breast Cancer
The purpose of this clinical trial is to learn about the safety and effects of the study
medicine (called ARV-471) when given together with other medicines for the potential
treatment of advanced or metastatic breast cancer.
This study is seeking participants who have breast cancer that:
-... expand
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer. This study is seeking participants who have breast cancer that: - is advanced, may have spread to other organs (metastatic) and cannot be fully treated by surgery or radiation therapy - is sensitive to hormonal therapy (it is called estrogen receptor positive); and - is no longer responding to previous treatments This study is divided into separate sub-studies. For Sub-Study A: All participants will receive ARV-471 and a medicine called abemaciclib. ARV-471 will be given by mouth, at home, 1 time a day. Abemaciclib will be given by mouth, at home, 2 times a day. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective. Participants will continue to take ARV-471 and abemaciclib until their cancer is no longer responding, or side effects become too severe. They will have visits at the study clinic about every 4 weeks. Type: Interventional Start Date: Feb 2023 |
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
AtriCure, Inc.
Ischemic Stroke
Systemic Embolism
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority
trial. The objective of this trial is to evaluate the effectiveness of left atrial
appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial
embolism in subjects undergoing cardiac... expand
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke. Type: Interventional Start Date: Jan 2023 |
Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects
Allergy Therapeutics
Peanut Allergy
This phase I clinical trial is designed to evaluate the safety and tolerability of VLP
Peanut in healthy subjects and in subjects with peanut allergy (PA). This clinical trial
will evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and assess the
immunotoxicity profile and the degree... expand
This phase I clinical trial is designed to evaluate the safety and tolerability of VLP Peanut in healthy subjects and in subjects with peanut allergy (PA). This clinical trial will evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and assess the immunotoxicity profile and the degree of reactogenicity (allergenicity) in subjects with PA. This clinical trial will also explore preliminary proof of efficacy of VLP Peanut in subjects with PA. Type: Interventional Start Date: Oct 2022 |
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