Search Clinical Trials
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EMPOWER 3: Improving Palliative Care Health Literacy and Utilization
Tulane University
Cancer
Neoplasm Malignant
Through this award, Michael Hoerger, PhD, MSCR, a psychologist at the Tulane Cancer Center in
Louisiana, will lead a study called EMPOWER 3 designed to test an educational intervention to
help patients understand palliative care, use it, and feel better emotionally and physically.... expand
Through this award, Michael Hoerger, PhD, MSCR, a psychologist at the Tulane Cancer Center in Louisiana, will lead a study called EMPOWER 3 designed to test an educational intervention to help patients understand palliative care, use it, and feel better emotionally and physically. Participants will be adults with serious cancer diagnoses. Participants will be randomized into two groups. Patients in the control group will get enhanced usual care, meaning standard cancer care and several additional healthcare-related brochures. Patients in the intervention group will get enhanced usual care plus an educational video developed by the investigators and other materials designed to increase understanding and use of palliative care. Family members of patients in the intervention group may also attend if desired. The investigators will track participants' understanding of palliative care, attitudes toward palliative care, symptoms over 6 months of follow-up, and palliative care utilization. Type: Interventional Start Date: Mar 2021 |
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial...
Boehringer Ingelheim
Lung Diseases, Interstitial
This study is open to adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs).
People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the
study. If they already take nintedanib, they can continue treatment throughout the study.... expand
This study is open to adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study. If they already take nintedanib, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with PF-ILD. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine. Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects. Type: Interventional Start Date: Oct 2022 |
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis...
Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis
This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF).
People can join the study if they are 40 years or older. If they already take nintedanib or
pirfenidone for their IPF, they can continue treatment throughout the study. The purpose of... expand
This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with IPF. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine. Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects. Type: Interventional Start Date: Sep 2022 |
A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft...
Equillium
Graft Versus Host Disease
GVHD
Acute-graft-versus-host Disease
Acute GVHD
aGVHD
This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo
as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement,
in combination with corticosteroids
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This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids Type: Interventional Start Date: Apr 2022 |
A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia...
Loxo Oncology, Inc.
Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic
Leukemia, B-cell
Small Lymphocytic Lymphoma
The purpose of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305)
to ibrutinib in participants with CLL/SLL. Participants may or may not have already had
treatment for their cancer. Participation could last up to six years.
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The purpose of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL. Participants may or may not have already had treatment for their cancer. Participation could last up to six years. Type: Interventional Start Date: Jul 2022 |
A Study Evaluating Tocilizumab in Pediatric Patients Hospitalized With COVID-19
Hoffmann-La Roche
COVID-19
This is a single-arm, open-label study to assess the pharmacokinetics, pharmacodynamics,
safety, and exploratory efficacy of tocilizumab (TCZ) for the treatment of pediatric patients
from birth to less than 18 years old hospitalized with COVID-19 and who are receiving
systemic... expand
This is a single-arm, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and exploratory efficacy of tocilizumab (TCZ) for the treatment of pediatric patients from birth to less than 18 years old hospitalized with COVID-19 and who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Type: Interventional Start Date: Jun 2022 |
A Study to Learn About the Study Medicine (Elranatamab) Either Alone or in Combination With Dexamethasone...
Pfizer
Multiple Myeloma
The purpose of Part 1 and Part 2 is to evaluate the safety of a step-up dosing approach
(starting with low doses followed by higher doses) of the study medicine (elranatamab) in
participants with multiple myeloma that has come back after responding to treatment or has
not... expand
The purpose of Part 1 and Part 2 is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). The purpose of Part 3 of the study is to evaluate the safety and efficacy of elranatamab in combination with dexamethasone during the first 6 cycles followed by elranatamab monotherapy. This study will also look at the safety and efficacy of different doses of elranatamab, as well as different intervals between doses. Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every week. The frequency of clinic visits for injections may then decrease over time. Participation will be at least two years. Type: Interventional Start Date: Oct 2021 |
Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal...
AVEO Pharmaceuticals, Inc.
Renal Cell Carcinoma
This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in
subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy,
one of which was an Immune Checkpoint Inhibitor (ICI).
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This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI). Type: Interventional Start Date: Sep 2021 |
Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus...
Merck Sharp & Dohme LLC
RSV Infection
This study aims to evaluate the safety and tolerability of clesrovimab compared to
palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).
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This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs). Type: Interventional Start Date: Nov 2021 |
A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based...
Janssen Vaccines & Prevention B.V.
Respiratory Syncytial Viruses
Lower Respiratory Tract Disease
The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the
active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription
Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower
Respiratory... expand
The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above. Type: Interventional Start Date: Jul 2021 |
Mogamulizumab Q4week Dosing in Participants With R/R CTCL
Kyowa Kirin, Inc.
Cutaneous T-Cell Lymphoma, Relapsed
Cutaneous T-Cell Lymphoma Refractory
This is an open-label, multicenter, Phase 2 study to evaluate the safety and tolerability of
mogamulizumab given Q4W following initial weekly induction in adult participants with
relapsed/refractory MF and SS subtypes of CTCL. The study is composed of a 28-day Screening
Period... expand
This is an open-label, multicenter, Phase 2 study to evaluate the safety and tolerability of mogamulizumab given Q4W following initial weekly induction in adult participants with relapsed/refractory MF and SS subtypes of CTCL. The study is composed of a 28-day Screening Period during which participants are screened for entry into this study, followed by a treatment period of up to 2 years from Cycle 1 Day 1. Type: Interventional Start Date: Aug 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... 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. 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 explosion of 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. 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) 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. Type: Observational Start Date: Sep 2020 |
Evaluating Effectiveness and Long Term Safety of Damoctocog Alfa Pegol in Patients, Who Have Been Diagnosed...
Bayer
Hemophilia A
The aim of the HEM-POWR study is to understand better how Damoctocog alfa pegol (Jivi) is
used to treat people with Hemophilia A in day-to-day life, how well the treatment is
tolerated and how satisfied patients and physicians are with the treatment.
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The aim of the HEM-POWR study is to understand better how Damoctocog alfa pegol (Jivi) is used to treat people with Hemophilia A in day-to-day life, how well the treatment is tolerated and how satisfied patients and physicians are with the treatment. Type: Observational Start Date: Oct 2019 |
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
C. R. Bard
Open Midline Laparotomy
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the
time of midline fascial closure compared to primary suture closure in preventing a subsequent
incisional hernia in subjects at risk for incisional hernia after open midline laparotomy... expand
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery. Type: Interventional Start Date: Dec 2019 |
Molecular Assessment and Profiling of Liver Transplant Recipients
CareDx
Liver Transplantation
Biomarkers
The objective of this protocol is to conduct longitudinal and prospective studies of liver
transplant recipients, using a multimodality approach, akin to that used in kidney
transplantation. The primary aim will compare the clinical outcomes of LiverCare
post-transplant surveillance... expand
The objective of this protocol is to conduct longitudinal and prospective studies of liver transplant recipients, using a multimodality approach, akin to that used in kidney transplantation. The primary aim will compare the clinical outcomes of LiverCare post-transplant surveillance in liver transplant with standard of care consisting of liver function tests, DSA measurements, drug level monitoring, and 'for cause' biopsy. The protocol will assess the correlation between clinical events (e.g. rejection, recurrent disease, biliary obstruction), dd-cfDNA levels, gene expression profiling, ability to assess microchimerism, develop predictive analytics, infectious disease diagnoses and finally examine graft histology. Type: Observational Start Date: May 2021 |
Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
United Therapeutics
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-301 is designed to evaluate the safety and efficacy of inhaled treprostinil in
subjects with idiopathic pulmonary fibrosis (IPF) over a 52-week period.
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Study RIN-PF-301 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF) over a 52-week period. Type: Interventional Start Date: Jun 2021 |
Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
Janssen Research & Development, LLC
Warm Autoimmune Hemolytic Anemia
The main purpose of this study is to evaluate the efficacy and safety of M281 in participants
with warm autoimmune hemolytic anemia (wAIHA).
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The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA). Type: Interventional Start Date: Oct 2019 |
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Center for International Blood and Marrow Transplant Research
Hematologic Malignancies
Inherited Disorders of Metabolism
Inherited Abnormalities of Platelets
Histiocytic Disorders
Acute Myelogenous Leukemia (AML or ANLL)
This study is an access and distribution protocol for unlicensed cryopreserved cord blood
units (CBUs) in pediatric and adult patients with hematologic malignancies and other
indications.
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This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications. Type: Observational Start Date: Oct 2011 |
S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration
Southwest Oncology Group
Multiple Myeloma
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step
2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2
(first randomization). Patients are randomized between Lenalidomide for 2 years and
Lenalidomide... expand
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years. Type: Interventional Start Date: Jun 2019 |
INSPIRE Trial for Skin and Soft Tissue Infections
Harvard Pilgrim Health Care
Skin and Soft Tissue (SST) Infection
The INSPIRE Skin and Soft Tissue Infection trial is a cluster-randomized controlled trial of
HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with
real-time, precision medicine computerized physician order entry (CPOE) smart prompts
providing... expand
The INSPIRE Skin and Soft Tissue Infection trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill adult admitted with skin and soft tissue infection is infected with a resistant pathogen. Note: enrolled "subjects" represent 102 individual HCA Healthcare hospitals that have been randomized into 92 clusters. Hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff. Type: Interventional Start Date: Aug 2022 |
INSPIRE Trial for Abdominal Infections
Harvard Pilgrim Health Care
Abdominal (ABD) Infection
The INSPIRE Abdominal Infection Trial is a cluster-randomized controlled trial of HCA
Healthcare hospitals comparing routine empiric antibiotic stewardship practices with
real-time, precision medicine computerized physician order entry (CPOE) smart prompts
providing the probability... expand
The INSPIRE Abdominal Infection Trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill adult admitted with abdominal infection is infected with a resistant pathogen. Note: enrolled "subjects" represent 102 individual HCA Healthcare hospitals that have been randomized into 92 clusters. Hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff. Type: Interventional Start Date: Aug 2022 |
Factor IX as Adjunctive Therapy to Emicizumab (EMIX)
Tulane University
Hemophilia A
This trial will enroll patients with severe hemophilia A. Experiments will be run in vitro by
spiking patients' blood with different molecules (currently used and theoretically proposed
as adjunctive therapy to emicizumab), therefore no more than minimal direct risk to patients... expand
This trial will enroll patients with severe hemophilia A. Experiments will be run in vitro by spiking patients' blood with different molecules (currently used and theoretically proposed as adjunctive therapy to emicizumab), therefore no more than minimal direct risk to patients is expected. This is a pilot preclinical study. Type: Interventional Start Date: Aug 2022 |
The CoAGulation Biomarkers and Atrial Fibrillation (COAG-AF) Pilot Study
Tulane University
Atrial Fibrillation
The aim of the Correlation Of CoAGulation-Atrial Fibrillation (COAG-AF) study is to prove
that an increase in pro-thrombotic biomarkers in AF is associated with an increase in AF
burden.
Secondary objectives of the study are the following:
- To investigate the... expand
The aim of the Correlation Of CoAGulation-Atrial Fibrillation (COAG-AF) study is to prove that an increase in pro-thrombotic biomarkers in AF is associated with an increase in AF burden. Secondary objectives of the study are the following: - To investigate the impact of catheter ablation on serum pro-thrombotic biomarkers in patients with AF. - To correlate coagulation biomarkers with imaging features such as, the degree of fibrosis found on Late Gadolinium Enhancement Magnetic Resonance Imaging (LGE-MRI) scans, which is a part of standard of care. - To determine baseline values of coagulation and pro-thrombotic biomarkers in the AF population and compare those baseline values with the general population values. - To compare central and peripheral thrombotic biomarkers in patients with atrial fibrillation. Type: Observational Start Date: Sep 2021 |
TruGraf® Long-term Clinical Outcomes Study
Transplant Genomics, Inc.
Kidney Transplant Rejection
This is a prospective, multi-center, observational study. Subjects will have OmniGraf™
(TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition
subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical
suspicion... expand
This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period. Type: Observational Start Date: Sep 2020 |
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... 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 |