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AlloSure Lung Assessment and Metagenomics Outcomes Study
CareDx
Lung Transplant Infection
Lung Transplant; Complications
Lung Transplant Failure and Rejection
ALAMO is a prospective, multi-center, perspective, registry of patients receiving
LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap) for surveillance post-transplant.
This study aims to evaluate the diagnostic performance characteristics of AlloSure Lung
(dd-cfDNA) to detect a spectrum of rejec1 expand
ALAMO is a prospective, multi-center, perspective, registry of patients receiving LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap) for surveillance post-transplant. This study aims to evaluate the diagnostic performance characteristics of AlloSure Lung (dd-cfDNA) to detect a spectrum of rejection (ACR, AMR) and allograft infection (Bacterial, Viral, Fungal, Mycobacterial, Parasitic). Type: Observational [Patient Registry] Start Date: Oct 2021 |
A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in C1
Epizyme, Inc.
Relapsed/Refractory Follicular Lymphoma
Follicular Lymphoma
Refractory Follicular Lymphoma
The participants of this study would have relapsed/refractory follicular lymphoma.
Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the
disease has come back after a period of improvement after that follows a treatment
regimen and 'refractory' when treatment no l1 expand
The participants of this study would have relapsed/refractory follicular lymphoma. Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after a period of improvement after that follows a treatment regimen and 'refractory' when treatment no longer works. Stage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3. Stage 1 of the study is completed. Stages 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo (dummy drug) in combination with other drug treatment. Type: Interventional Start Date: Jun 2020 |
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progr1
Alliance for Clinical Trials in Oncology
Intracranial Meningioma
Recurrent Meningioma
NF2 Gene Mutation
This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor
GSK2256098, and capivasertib work in treating patients with meningioma that is growing,
spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098,
capivasertib, and abemaciclib may stop the1 expand
This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Type: Interventional Start Date: Sep 2015 |
Post-Cardiac Surgery Acute Kidney Injury Prevention by Administration of Proton Pump Inhibitor (P21
The University of Texas Health Science Center, Houston
Acute Kidney Injury
The central hypothesis of this research study is that perioperative administration of the
proton pump inhibitor (PPI) pantoprazole could reduce the development of acute kidney
injury (AKI) following cardiac surgery by activation molecular pathways for kidney
protection. The investigators propose a1 expand
The central hypothesis of this research study is that perioperative administration of the proton pump inhibitor (PPI) pantoprazole could reduce the development of acute kidney injury (AKI) following cardiac surgery by activation molecular pathways for kidney protection. The investigators propose a single-center, randomized, controlled, single-blinded trial to determine whether perioperative intravenous administration of pantoprazole will reduce the incidence of AKI, some molecules that can be detected the urine, and major adverse kidney events (MAKE) at day 30 postoperatively, compared to famotidine after cardiac surgery. The specific aims of the study will be achieved by randomizing a group of 400 patients to receive pantoprazole (study) or famotidine (control) for 3 days perioperatively. Our study population will include any adult patients (aged over 18 years) scheduled for cardiac surgery requiring a cardiopulmonary bypass machine. Type: Interventional Start Date: Jan 2025 |
DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestatio1
Ohio State University
Gestational Diabetes Mellitus
Pregnancy, High Risk
This is a non-inferiority patient-centered and pragmatic comparative-effectiveness
pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up
through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized
to oral metformin versus injectable in1 expand
This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin. This study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum. Type: Interventional Start Date: Aug 2024 |
StrokeNet Thrombectomy Endovascular Platform
Medical University of South Carolina
Ischemic Stroke
STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the
care of patients with acute ischemic stroke (AIS) due to large (LVO) or medium vessel
occlusions (MVO). expand
STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the care of patients with acute ischemic stroke (AIS) due to large (LVO) or medium vessel occlusions (MVO). Type: Interventional Start Date: Jan 2025 |
Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disor1
The University of Texas Health Science Center, Houston
Cocaine Use Disorder
The purpose of this study is to assess effects of intermittent theta burst stimulation
(iTBS) to left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex
(dmPFC) compared to sham on electrophysiological indices of reward sensitivity and
motivated attention in adults with cocain1 expand
The purpose of this study is to assess effects of intermittent theta burst stimulation (iTBS) to left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex (dmPFC) compared to sham on electrophysiological indices of reward sensitivity and motivated attention in adults with cocaine use disorder. Type: Interventional Start Date: Nov 2024 |
Autologous Adipose-Derived Mesenchymal Stem Cells for Chronic Traumatic Brain Injury
Hope Biosciences
Traumatic Brain Injury
The global objective of this study is to establish the safety and investigate the
potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences
adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional
outcomes, and neuroinflammation after traumati1 expand
The global objective of this study is to establish the safety and investigate the potential treatment effect of an intravenous infusion of HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) on brain structure, neurocognitive/functional outcomes, and neuroinflammation after traumatic brain injury. Type: Interventional Start Date: Apr 2024 |
A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolesc1
Amgen
Atopic Dermatitis
The primary objective of this study is to describe the long-term safety and tolerability
of rocatinlimab in participants with moderate-to-severe AD. expand
The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD. Type: Interventional Start Date: May 2023 |
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage1
NRG Oncology
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
This phase III trial compares the effect of sentinel lymph node mapping to standard lymph
node dissection in reducing the risk of swelling in the legs (lymphedema) in patients
undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection
removes lymph nodes around the ute1 expand
This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes. Sentinel lymph node mapping uses a special dye and camera to look for cancer that may have spread to nearby lymph nodes. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs. Type: Interventional Start Date: Dec 2022 |
Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of1
Genelux Corporation
Platinum-resistant Ovarian Cancer
Platinum-refractory Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
High-grade Serous Ovarian Cancer
The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the
safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab
compared to the Active Comparator Arm with Physician's Choice of chemotherapy and
bevacizumab in women diagnosed with pla1 expand
The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant/refractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer). This Phase III trial builds on the efficacy and safety data reported in the previous Phase II VIRO-15 trial with promising objective response rate and progression-free survival observed in heavily pre-treated patients with platinum-resistant/refractory ovarian cancer. The phase II results also showed that the intra-peritoneal route of delivery was efficient in generating tumor cell killing and immune activation, and led to clinical reversal of platinum-resistance or refractoriness in this difficult-to-treat patient population. Type: Interventional Start Date: Aug 2022 |
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Ri1
NRG Oncology
Ovarian Carcinoma
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy
and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for
individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal
of fallopian tubes, and bilateral salp1 expand
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations. Type: Interventional Start Date: Sep 2020 |
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
Impulse Dynamics
Heart Failure
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized,
single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of
care. Patients to be included will have NYHA functional class III symptoms and a left
ventricular ejection fraction of 251 expand
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45% Type: Observational [Patient Registry] Start Date: Jan 2020 |
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Edwards Lifesciences
Degenerative Mitral Valve Disease
Mitral Regurgitation
Mitral Insufficiency
Functional Mitral Regurgitation
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve
Repair System in patients with degenerative mitral regurgitation (DMR) who have been
determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in
patients with functional mitral regurgitat1 expand
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT) Type: Interventional Start Date: Nov 2018 |
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Se1
Medtronic Cardiovascular
Mitral Valve Regurgitation
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All
subjects enrolled with receive the study device. expand
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device. Type: Interventional Start Date: Oct 2017 |
A New At-home Telerehabilitation Care Service Delivery Model for Stroke Survivors in the Rio Grande1
The University of Texas Health Science Center, Houston
Stroke
The purpose of this study is to investigate the feasibility of a mobile
telerehabilitation software for post-acute stroke care for Rio Grande Valley (RGV) stroke
survivors with community health worker (CHW) at-home support and to estimate the
functional health, mental health (depression), and careg1 expand
The purpose of this study is to investigate the feasibility of a mobile telerehabilitation software for post-acute stroke care for Rio Grande Valley (RGV) stroke survivors with community health worker (CHW) at-home support and to estimate the functional health, mental health (depression), and caregiver burden outcomes of this new CHW-supported, at-home rehabilitation service delivery model and to identify salient barriers to and facilitators of adopting and delivering the new rehabilitation delivery model to further disseminate the model in real-world communities. Type: Interventional Start Date: Mar 2025 |
A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis
Takeda
Plaque Psoriasis
The main aim of this study is to check the side effects of TAK-279 and how well it is
tolerated in participants with moderate-to-severe plaque psoriasis.
All participants will be assigned to study treatments of TAK-279 and will be treated with
TAK-279 if the participants meet the study rules.
Par1 expand
The main aim of this study is to check the side effects of TAK-279 and how well it is tolerated in participants with moderate-to-severe plaque psoriasis. All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules. Participants will be in the study for up to 217 weeks, including up to 35 days for the screening period, 52 weeks (Part A) up to 156 additional weeks (Part B) study treatment and 4 weeks follow up period. During the study, participants will visit their study clinic multiple times. Type: Interventional Start Date: Sep 2024 |
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With A1
argenx
Active Idiopathic Inflammatory Myopathy
Myositis
Dermatomyositis
Polymyositis
Immune-Mediated Necrotizing Myopathy
This study's purpose is to measure the treatment response from efgartigimod PH20 SC
compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM).
Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing
myopathy (IMNM), or certain other subtypes o1 expand
This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome [ASyS]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/. Type: Interventional Start Date: Oct 2022 |
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 |
FIH Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilep1
Neurona Therapeutics
Mesial Temporal Lobe Epilepsy
This clinical trial is designed to test whether a single image-guided intracerebral
administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects
with drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), with or without
mesial temporal sclerosis (MTS), is safe1 expand
This clinical trial is designed to test whether a single image-guided intracerebral administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects with drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), with or without mesial temporal sclerosis (MTS), is safe (frequency of adverse events) and effective (seizure frequency). NRTX-1001 comprises human interneurons that secrete a neurotransmitter, gamma-aminobutyric acid (GABA). Type: Interventional Start Date: Jun 2022 |
Advancing Discussions Using a Video-based Support Tool About End-of-life Care
The University of Texas Health Science Center, Houston
Traumatic Injury
The purpose of this study is to evaluate the effectiveness and implementation
considerations of a video aid to improve communication and patient-centered outcomes in
older injured adults expand
The purpose of this study is to evaluate the effectiveness and implementation considerations of a video aid to improve communication and patient-centered outcomes in older injured adults Type: Interventional Start Date: Mar 2025 |
Helix Research Network
Helix, Inc
Genetic Predisposition to Disease
Genetics Disease
The Helix Research Network ("HRN") is a network of academic, public, and/or private
healthcare organizations that are committed to advancing medical research and improving
human health through large-scale genomics research and acceleration of the integration of
genomic and other omics data into cli1 expand
The Helix Research Network ("HRN") is a network of academic, public, and/or private healthcare organizations that are committed to advancing medical research and improving human health through large-scale genomics research and acceleration of the integration of genomic and other omics data into clinical care. Type: Observational Start Date: Sep 2021 |
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
American Thrombosis and Hemostasis Network
Hematologic Disorder
Bleeding Disorder
Connective Tissue Disorder
Hemophilia
Thrombosis
In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN)
clinical studies, the number of new therapies for all congenital and acquired hematologic
conditions, not just those for bleeding and clotting disorders, is increasing
significantly. Some of the recently FDA-approved1 expand
In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN) clinical studies, the number of new therapies for all congenital and acquired hematologic conditions, not just those for bleeding and clotting disorders, is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have yet to demonstrate long-term safety and effectiveness beyond the pivotal trials that led to their approval. In addition, results from well-controlled, pivotal studies often cannot be replicated once a therapy has been approved for general use.(1,2,3,4) In 2019 alone, the United States Food and Drug Administration (FDA) has issued approvals for twenty-four new therapies for congenital and acquired hematologic conditions.(5) In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.(6) With this increase in potential new therapies on the horizon, it is imperative that clinicians and clinical researchers in the field of non-neoplastic hematology have a uniform, secure, unbiased, and enduring method to collect long-term safety and efficacy data. ATHN Transcends is a cohort study to determine the safety, effectiveness, and practice of therapies used in the treatment of participants with congenital or acquired non-neoplastic blood disorders and connective tissue disorders with bleeding tendency. The study consists of 7 cohorts with additional study "arms" and "modules" branching off from the cohorts. The overarching objective of this longitudinal, observational study is to characterize the safety, effectiveness and practice of treatments for all people with congenital and acquired hematologic disorders in the US. As emphasized in a recently published review, accurate, uniform and quality national data collection is critical in clinical research, particularly for longitudinal cohort studies covering a lifetime of biologic risk.(7) Type: Observational Start Date: Sep 2020 |
Sleep for Stroke Management and Recovery Trial
University of Michigan
Ischemic Stroke
Sleep Apnea
Sleep Apnea, Obstructive
Stroke
CPAP
The purpose of this study is to determine whether treatment of obstructive sleep apnea
(OSA) with positive airway pressure starting shortly after acute ischemic stroke (1)
reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after
the event, and (2) improves stroke ou1 expand
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke. Type: Interventional Start Date: May 2019 |
APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
APrevent Biotech GmbH
Paralysis, Unilateral, Vocal Cord
This is a prospective, 2-part, multi-center, open-label, non-randomized clinical trial to
assess safety and effectiveness of APrevent® VOIS Implants for the treatment of patients
with Unilateral Vocal Fold Paralysis (UVFP). In total 30 evaluable patients are planned
to be enrolled. expand
This is a prospective, 2-part, multi-center, open-label, non-randomized clinical trial to assess safety and effectiveness of APrevent® VOIS Implants for the treatment of patients with Unilateral Vocal Fold Paralysis (UVFP). In total 30 evaluable patients are planned to be enrolled. Type: Interventional Start Date: Nov 2019 |
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