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A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
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Amgen
Antineutrophil Cytoplasmic Antibody-associated Vasculitis
The primary objective of this study is to evaluate the long-term safety of avacopan in
participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). expand
The primary objective of this study is to evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Type: Interventional Start Date: Feb 2024 |
Mobile Apps for Preschool Parents (MAPP) Study
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Pamela Hull
Obesity, Childhood
Nutrition, Healthy
Physical Inactivity
Sleep, Inadequate
The purpose of Mobile Apps for Preschool Parents (MAPP) Study is to test the
effectiveness of two mobile applications for parents of preschool aged children: 1) an
app focused on child and family nutrition and wellness, and 2) an app focused on parents
reading to their children. expand
The purpose of Mobile Apps for Preschool Parents (MAPP) Study is to test the effectiveness of two mobile applications for parents of preschool aged children: 1) an app focused on child and family nutrition and wellness, and 2) an app focused on parents reading to their children. Type: Interventional Start Date: Aug 2024 |
A Precision Medicine Approach to Target Engagement for Emotion Regulation
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Matthew Southward
Emotional Regulation
Depression
Anxiety
Borderline Personality Disorder
Obsessive-Compulsive Disorder
The proposed study is designed to first test whether teaching people personalized or
standardized emotion regulation skills leads to greater decreases in daily negative
emotion intensity. Second, using data from an initial sample, the investigators will
prospectively assign an independent sample of1 expand
The proposed study is designed to first test whether teaching people personalized or standardized emotion regulation skills leads to greater decreases in daily negative emotion intensity. Second, using data from an initial sample, the investigators will prospectively assign an independent sample of participants to receive their predicted optimal or non-optimal skills to determine if it is feasible and efficacious to match participants to the most appropriate training condition. Results of these studies may identify the mechanisms by which emotion regulation interventions impact emotional functioning and allow for the development of personalized, evidence-based, and scalable emotion regulation interventions. Type: Interventional Start Date: Sep 2023 |
A Study of Rapcabtagene Autoleucel in Systemic Lupus Erythematosus (SLE) Patients With Active, Refr1
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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 |
Impact of Plant Diet for Diabetes Prevention
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Jean L. Fry
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
The primary purpose of this study is to determine the sex-specific metabolic and
molecular response, among adults with prediabetes, when moving from a Western Diet to
plant-based diet. expand
The primary purpose of this study is to determine the sex-specific metabolic and molecular response, among adults with prediabetes, when moving from a Western Diet to plant-based diet. Type: Interventional Start Date: Oct 2024 |
Hyperbaric Oxygen Brain Injury Treatment Trial
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Hennepin Healthcare Research Institute
Traumatic Brain Injury
The purpose of this innovative adaptive phase II trial design is to determine the optimal
combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate
improvement in the outcome of severe TBI patients in a subsequent phase III trial. expand
The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial. Type: Interventional Start Date: Jun 2018 |
Evaluation of K9 in Subjects with Diabetic Macular Edema (DME)
Michelle Abou-Jaoude
Diabetic Macular Edema
A non-randomized study evaluating the safety of an orally administered inflammasome
inhibitor, K9, for the treatment of diabetic macular edema (DME). expand
A non-randomized study evaluating the safety of an orally administered inflammasome inhibitor, K9, for the treatment of diabetic macular edema (DME). Type: Interventional Start Date: Mar 2025 |
Opioid Drug Interaction Study
Shanna Babalonis, PhD
Drug Interactions
Drug Kinetics
This study will examine the effects of doses of opioid/placebo and doses of
alprazolam/placebo, alone and in combination. The primary outcomes are pharmacodynamic
measures (subjective ratings of drug liking and other abuse-related effects;
physiological outcomes) and pharmacokinetic outcomes (from1 expand
This study will examine the effects of doses of opioid/placebo and doses of alprazolam/placebo, alone and in combination. The primary outcomes are pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) and pharmacokinetic outcomes (from blood samples) to determine the interaction effects of these compounds. Type: Interventional Start Date: Mar 2025 |
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newl1
NovoCure GmbH
Glioblastoma
This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of
Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ)
chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ
and placebo in newly diagnosed Gliobla1 expand
This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS). Type: Interventional Start Date: Feb 2025 |
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fib1
United Therapeutics
Progressive Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil
in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. expand
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. Type: Interventional Start Date: Oct 2023 |
A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin,1
Novartis Pharmaceuticals
Extensive Stage Small Cell Lung Cancer
This study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in
combination with carboplatin, etoposide and atezolizumab in this setting and to assess
preliminary efficacy of this combination treatment versus the combination of carboplatin,
etoposide, and atezolizumab.The stud1 expand
This study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The study will be essential to assess a new potential therapeutic option in participants with this aggressive cancer type. Type: Interventional Start Date: Jul 2022 |
Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma
Ruta Arays
Metastatic Melanoma
BRAF Gene Mutation
This is a phase 1 dose-escalation study of nilotinib in combination with fixed-dose
dabrafenib and trametinib regimen for patients with metastatic or unresectable melanoma
carrying a BRAF V600 mutation and have relapsed on a BRAF/MEK inhibitor therapy. The goal
is to assess the toxicity and tolerab1 expand
This is a phase 1 dose-escalation study of nilotinib in combination with fixed-dose dabrafenib and trametinib regimen for patients with metastatic or unresectable melanoma carrying a BRAF V600 mutation and have relapsed on a BRAF/MEK inhibitor therapy. The goal is to assess the toxicity and tolerability and determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of the combination of nilotinib with dabrafenib and trametinib or with encorafenib and binimetinib. Additionally, this study will assess pharmacokinetic parameters of dabrafenib and nilotinib when used in combination. Type: Interventional Start Date: Jun 2022 |
Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
Celgene
Neoplasms
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for
all pediatric and adult participants exposed to Gene-modified (GM) T cell therapy
participating in a previous Celgene sponsored or Celgene alliance partner sponsored
study.
Participants who received at least1 expand
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Participants who received at least one GM T cell infusion will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol. Type: Interventional Start Date: Jul 2018 |
Functional Incremental Stepping in Place Test (F-IST) Validation
University of Kentucky
Intensive Care Medicine
Acute Care Medical
The purpose of this multi-site prospective study is to assess validity of a new step test
called Functional-Incremental Stepping-in-place- Test (F-IST) compared to gold-standard
cardiopulmonary exercise testing (CPET) and to physical function and health perception,
respectively. The investigators w1 expand
The purpose of this multi-site prospective study is to assess validity of a new step test called Functional-Incremental Stepping-in-place- Test (F-IST) compared to gold-standard cardiopulmonary exercise testing (CPET) and to physical function and health perception, respectively. The investigators will also assess test-retest reliability of the F-IST. The investigators hypothesize that the F-IST will have high validity and test-retest reliability to be used in field testing environments such as the ICU. Type: Observational Start Date: Jul 2024 |
A Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab in First-line Treatment of1
Rakuten Medical, Inc.
Recurrent Head and Neck Squamous Cell Carcinoma
The goal of this clinical trial is to learn if ASP-1929 photoimmunotherapy (PIT) in
combination with pembrolizumab works to treat recurrent squamous cell cancer of the head
and neck (HNSCC) with no distant metastases. It will also learn about the safety of
ASP-1929 PIT in combination with pembroliz1 expand
The goal of this clinical trial is to learn if ASP-1929 photoimmunotherapy (PIT) in combination with pembrolizumab works to treat recurrent squamous cell cancer of the head and neck (HNSCC) with no distant metastases. It will also learn about the safety of ASP-1929 PIT in combination with pembrolizumab. Researchers will compare ASP-1929 PIT in combination with pembrolizumab to pembrolizumab alone or pembrolizumab plus chemotherapy (carboplatin or cisplatin, plus 5-fluorouracil or paclitaxel or docetaxel) according to physician's choice (control arm). The overall primary study hypothesis being tested is whether ASP-1929 PIT plus pembrolizumab combination treatment improves the overall survival (OS) of the population defined by the inclusion/exclusion criteria over the control arm. Type: Interventional Start Date: Dec 2024 |
A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)
Janssen Research & Development, LLC
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory
Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are:
- can a dose of JNJ-90009530 be determined that is safe and well tolerated by
patients.
- will JNJ-90009530 help patients1 expand
The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are: - can a dose of JNJ-90009530 be determined that is safe and well tolerated by patients. - will JNJ-90009530 help patients achieve a response and for how long? Type: Interventional Start Date: Nov 2023 |
Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
Medtronic Cardiovascular
Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)
Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)
The purpose of this trial is to generate clinical evidence related to key performance
outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder
Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are
randomized and imaging collected at all foll1 expand
The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint. Type: Interventional Start Date: Jan 2023 |
Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage
Delta-Fly Pharma, Inc.
Leukemia, Myeloid, Acute
Phase III, multicenter, randomized study with two arms (1:1 ratio) enrolling patients
with AML relapsed/refractory after 2, 3, or 4 prior induction regimens:
Experimental arm: DFP-10917 14-day continuous intravenous (IV) infusion at a dose of 6
mg/m²/day followed by a 14-day resting period per 28-1 expand
Phase III, multicenter, randomized study with two arms (1:1 ratio) enrolling patients with AML relapsed/refractory after 2, 3, or 4 prior induction regimens: Experimental arm: DFP-10917 14-day continuous intravenous (IV) infusion at a dose of 6 mg/m²/day followed by a 14-day resting period per 28-day cycles. Control arm: Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens), depending on the patient's prior induction treatment. Type: Interventional Start Date: Nov 2019 |
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
Zachary Warriner
Rib Fractures
This is a prospective, randomized, non-blinded study comparing CINB plus medical therapy
versus standard medical care (non-steroidals and opioids intravenous/oral inpatient and
oral outpatient) alone for patients with multiple rib fractures. The objective of this
study is to analyze the effect of c1 expand
This is a prospective, randomized, non-blinded study comparing CINB plus medical therapy versus standard medical care (non-steroidals and opioids intravenous/oral inpatient and oral outpatient) alone for patients with multiple rib fractures. The objective of this study is to analyze the effect of continuous intercostal nerve block (CINB) in the treatment of patients admitted to the adult trauma service with rib fractures. The effectiveness of CINB as adjunctive treatment will be compared to standard medical therapy involving nonsteroidal and intravenous/oral opioid medications. Type: Interventional Start Date: Feb 2025 |
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Children's Hospital of Philadelphia
Failed or Difficult Intubation, Sequela
Intubation; Difficult
Intubation Complication
Advanced airway interventions are common high risk, high stakes events for children in
intensive care units (ICU) and emergency departments (ED), with risk for life and health
threatening consequences. expand
Advanced airway interventions are common high risk, high stakes events for children in intensive care units (ICU) and emergency departments (ED), with risk for life and health threatening consequences. Type: Observational Start Date: Mar 2010 |
Suvorexant and Alcohol
University of Kentucky
Alcohol Use Disorder
This research will translate findings from preclinical research and provide the initial
clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other
alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study
will also provide basic science1 expand
This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans. Type: Interventional Start Date: Jun 2024 |
A Study of EP0031 in Patients With Advanced RET-altered Malignancies
Ellipses Pharma
Advanced Solid Tumor
The aim of this study is to assess the safety, side effects and effectiveness of EP0031
in patients with advanced RET-altered malignancies expand
The aim of this study is to assess the safety, side effects and effectiveness of EP0031 in patients with advanced RET-altered malignancies Type: Interventional Start Date: Sep 2022 |
Regulation of Mucosal Healing in Inflammatory Bowel Disease
Terrence A Barrett
Inflammatory Bowel Diseases
The objective of the current study is to compare non-healing colonic ulcers in patients
with inflammatory bowel disease (IBD) with iatrogenic colonic ulcers (biopsy sites) in
healthy control patients and patients with rheumatoid or psoriatic arthritis. Patients
will be biopsied at baseline and agai1 expand
The objective of the current study is to compare non-healing colonic ulcers in patients with inflammatory bowel disease (IBD) with iatrogenic colonic ulcers (biopsy sites) in healthy control patients and patients with rheumatoid or psoriatic arthritis. Patients will be biopsied at baseline and again at a follow-up visit in a "biopsy of the biopsy" approach. These biopsies will be used to reveal patterns about gene expression and mitochondrial function during ulcer healing. Type: Interventional Start Date: Apr 2021 |
Evaluation of K9 in Subjects with Thyroid Eye Disease (TED)
Peter Timoney
Thyroid Eye Disease
The objective of this clinical trial is to evaluate the plasma pharmacokinetics of K9 in
healthy subjects (Cohort 1) and the safety and treatment efficacy of K9 in patients with
active Thyroid Eye Disease (Cohort 2). Participants will receive study medication one
time or for up to 4 weeks. Particip1 expand
The objective of this clinical trial is to evaluate the plasma pharmacokinetics of K9 in healthy subjects (Cohort 1) and the safety and treatment efficacy of K9 in patients with active Thyroid Eye Disease (Cohort 2). Participants will receive study medication one time or for up to 4 weeks. Participants will have blood drawn and/or complete eye exams and questionnaires. The planned duration of this study is 6 weeks. Type: Interventional Start Date: Nov 2024 |
Abatacept in Immune Checkpoint Inhibitor Myocarditis
Massachusetts General Hospital
Myocarditis Acute
Cancer
The primary aim is to test whether abatacept, as compared to placebo, is associated with
a reduction in major adverse cardiac events (MACE) among participants hospitalized with
myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE,
is a composite of first occurren1 expand
The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure. Type: Interventional Start Date: Jun 2022 |