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Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
BeiGene
Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma (MCL)
Relapsed Mantle Cell Lymphoma
The study consists of two parts. Part 1 determines the safety and tolerability of
BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended
Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma.
Part 2 evaluates efficacy of BGB-11417 monotherapy... expand
The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1. Type: Interventional Start Date: Sep 2022 |
A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent...
Shanghai Henlius Biotech
Limited-Stage Small Cell Lung Cancer
This study is a randomized, double-blind, multicenter, phase III clinical study to
compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent
radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage
Small Cell Lung Cancer. expand
This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer. Type: Interventional Start Date: May 2022 |
Medication Adherence Program
Tulane University
Hypertension
Medication Adherence
Behavior and Behavior Mechanisms
Randomized controlled trial testing the efficacy of the Supporting Tailored Adaptive
change and Reinforcement for Medication Adherence Program (STAR-MAP), a health coaching
approach that aims to improve antihypertensive medication adherence, blood pressure
control, and quality of life. Participants... expand
Randomized controlled trial testing the efficacy of the Supporting Tailored Adaptive change and Reinforcement for Medication Adherence Program (STAR-MAP), a health coaching approach that aims to improve antihypertensive medication adherence, blood pressure control, and quality of life. Participants (n=402) >=40 years old with a diagnosis of hypertension, uncontrolled blood pressure, and low antihypertensive medication adherence will be recruited through a statewide health insurer, Blue Cross Blue Shield of Louisiana, and randomized to receive either interactive health coaching sessions with medication reminder tools (intervention) or medication reminder tools only (control) over one year. Data will be collected from participants at baseline, 6 months, 12 months, and 24 months using questionnaires, physical measurement (height, weight, blood pressure), a computer-based single-category implicit association test, and laboratory analysis of antihypertensive medication urinary metabolites. Type: Interventional Start Date: Mar 2022 |
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 superiority of inhaled treprostinil against
placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52. expand
Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52. Type: Interventional Start Date: Jun 2021 |
S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration
SWOG Cancer Research Network
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 + Daratumumab/rHuPH20.... 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: Aug 2019 |
Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
Eledon Pharmaceuticals
Kidney Transplant Rejection
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in
patients undergoing kidney transplantation. expand
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation. Type: Interventional Start Date: Aug 2023 |
Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
ECOG-ACRIN Cancer Research Group
Breast Screening
This randomized phase III trial studies digital tomosynthesis mammography and digital
mammography in screening patients for breast cancer. Screening for breast cancer with
tomosynthesis mammography may be superior to digital mammography for breast cancer
screening and may help reduce the need for... expand
This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment. Type: Interventional Start Date: Sep 2017 |
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. expand
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 |
Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
Icahn School of Medicine at Mount Sinai
NAS
This study examines the effects of 6 different music therapy interventions on outcomes
for neonates diagnosed with Neonatal Abstinence Syndrome. expand
This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome. Type: Interventional Start Date: Nov 2017 |
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 surgery. 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 |
A Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy...
Hemab ApS
Glanzmann Thrombasthenia
The goal of this clinical trial is to Investigate the Safety, Tolerability,
Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Participants with
Glanzmann Thrombasthenia.
The main questions it aims to answer are:
- Parts A, B, and C: To determine the safety and tolerability of... expand
The goal of this clinical trial is to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Participants with Glanzmann Thrombasthenia. The main questions it aims to answer are: - Parts A, B, and C: To determine the safety and tolerability of HMB-001 - Part A: To establish the dose level(s) and dosing interval(s) of HMB-001 to be investigated in Parts B and C - Parts B and C: To estimate the ability of HMB-001 to prevent the number and severity of bleeds Part A will assess differing singular doses of HMB-001 in small groups of participants. The dose administered to a newly enrolled participant (or groups of participants) may only increase if analysis of data from previous dosing shows it is safe to do so. The planned duration of participation in Part A is approximately 6 months, which consists of a Screening Period, an optional Run-in Observation Period, and a follow-up period of 8 weeks. Part B is similar to Part A as it involves testing different dose levels of HMB-001 in small groups of participants. However, in Part B, HMB-001 is given multiple times over a 3-month period, either weekly, every 2 weeks, or every 4 weeks. Part B consists of a Screening Period, a Run-in Observation Period, a 3-month Treatment Period, and a Safety Follow-up following the last dose of HMB-001. Part C is open to participants from Part B and consists of approximately a 9-month Treatment Period and a Safety Follow-up following the last dose of HMB-001. Type: Interventional Start Date: Dec 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 is expected. This is... 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 impact of catheter ablation on... 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 |
Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women
Harvard School of Public Health (HSPH)
Antiretroviral Toxicity
SMARTT will estimate the incidence of conditions and diagnoses potentially related to in
utero exposure to antiretroviral therapy and/or exposure in the first two months of life
among children born of HIV-infected mothers. expand
SMARTT will estimate the incidence of conditions and diagnoses potentially related to in utero exposure to antiretroviral therapy and/or exposure in the first two months of life among children born of HIV-infected mothers. Type: Observational Start Date: Mar 2007 |
Promoting Color Brave Conversations in Families
Tulane University
Racism
Child Development
Parents
The objective of this research is to evaluate a multi-module "color brave" app-based
intervention for parents of children in K-2nd grade, that guides them in how to initiate
and proactively engage their children in productive, critical discussions around
race/racism and anti-racism. This study will... expand
The objective of this research is to evaluate a multi-module "color brave" app-based intervention for parents of children in K-2nd grade, that guides them in how to initiate and proactively engage their children in productive, critical discussions around race/racism and anti-racism. This study will recruit a national sample of parents and their K-2nd grade children. The impact of the intervention will be tested using a rigorous randomized wait-list controlled trial design. The design of the intervention is based on research indicating that among children, positive intergroup contact with outgroup members, including vicarious engagement, can prevent or reduce anti-outgroup bias, in particular, when contact is based on common goals, cooperation rather than competition, and supported by external authorities. To evaluate the effectiveness of the program, a mixed-methods design will be utilized involving collection of a broad range of outcome measures through online questionnaire surveys, one-on-one interviews with parents and children, and parent-child dyadic interviews. Type: Interventional Start Date: Mar 2023 |
Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis
GID BIO, Inc.
Osteoarthritis, Knee
This study is a pivotal study to evaluate the efficacy and safety of a single injection
of autologous adipose-derived SVF produced using the GID SVF-2 device system for
treatment of pain with concomitant improvement in function associated with osteoarthritis
of the knee joint. expand
This study is a pivotal study to evaluate the efficacy and safety of a single injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of pain with concomitant improvement in function associated with osteoarthritis of the knee joint. Type: Interventional Start Date: Oct 2020 |
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 of acute rejection.... 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 |
Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary...
Pliant Therapeutics, Inc.
Idiopathic Pulmonary Fibrosis
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the
efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary
fibrosis (BEACON-IPF). expand
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF). Type: Interventional Start Date: Nov 2023 |
IDEAL: Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels...
Gilead Sciences
Primary Biliary Cholangitis
To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in
Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance
to Ursodeoxycholic Acid (UDCA) expand
To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA) Type: Interventional Start Date: Sep 2023 |
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart...
Novo Nordisk A/S
Cardiovascular Disease
This study will look at the effects of CagriSema on cardiovascular events (for example
heart attack and stroke) in people living with cardiovascular disease. Participants will
either get CagriSema or a dummy medicine (also called "placebo") which has no effect on
the body. Which treatment participants... expand
This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with cardiovascular disease. Participants will either get CagriSema or a dummy medicine (also called "placebo") which has no effect on the body. Which treatment participants will get will be decided by chance. Participant's chance of getting CagriSema or placebo is the same. Participants will inject the study medicine once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for up to 4.5 years. Type: Interventional Start Date: Mar 2023 |
LITES Task Order 0005 Prehospital Airway Control Trial (PACT)
Jason Sperry
Trauma Injury
Airway Control
The Prehospital Airway Control Trial (PACT) is a proposed 5 year, open label,
multi-center, stepped-wedge randomized trial comparing airway management strategies of
prehospital trauma patients. The initial airway attempt will be randomized to either
usual care (control) or a supraglottic airway management... expand
The Prehospital Airway Control Trial (PACT) is a proposed 5 year, open label, multi-center, stepped-wedge randomized trial comparing airway management strategies of prehospital trauma patients. The initial airway attempt will be randomized to either usual care (control) or a supraglottic airway management approach (intervention). The primary outcome will be 24 hour survival, with secondary outcomes to include survival to hospital discharge, expected clinical adverse events, airway management performance, ICU length of stay, ventilator days, incidence of ARDS, and incidence of ventilator associated pneumonia. Subjects will be enrolled across approximately 17 prehospital agencies at select LITES Network sites and will enroll a total of 2,009 subjects. Type: Interventional Start Date: Apr 2021 |
To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients...
Shanghai Henlius Biotech
Extensive Stage Small Cell Lung Cancer
This is a randomized, open-label study of Serplulimab plus chemotherapy
(Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously
untreated US patients with ES-SCLC.
Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows:
- Arm A (Serplulimab):... expand
This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: - Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide) - Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide) Type: Interventional Start Date: Nov 2022 |
Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove...
SWOG Cancer Research Network
Metastatic Clear Cell Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v8
This phase III trial compares the effect of adding surgery to a standard of care
immunotherapy-based drug combination versus a standard of care immunotherapy-based drug
combination alone in treating patients with kidney cancer that has spread to other places
in the body (metastatic). Immunotherapy... expand
This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer. Type: Interventional Start Date: Mar 2021 |
Academic-Community EPINET (AC-EPINET)
Indiana University
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders
Major Depression with Psychotic Features
Bipolar Disorder with Psychotic Features
The investigators propose to examine the effects of CSC services delivered via TH
(CSC-TH) versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes
in a 12-month, randomized trial. expand
The investigators propose to examine the effects of CSC services delivered via TH (CSC-TH) versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes in a 12-month, randomized trial. Type: Interventional Start Date: Mar 2022 |
Atrial Fibrosis Progression in Sleep Apnea Patients: A Pilot Study
Tulane University
Atrial Fibrillation
Obstructive Sleep Apnea
The investigators hypothesize that Obstructive Sleep Apnea (OSA) is an independent risk
factor for atrial fibrosis development. The investigators aim to prove the presence and
progression of atrial fibrosis on Delayed Enhancement Magnetic Resonance Imaging (DE-MRI)
in OSA patients without atrial fibrillation... expand
The investigators hypothesize that Obstructive Sleep Apnea (OSA) is an independent risk factor for atrial fibrosis development. The investigators aim to prove the presence and progression of atrial fibrosis on Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) in OSA patients without atrial fibrillation (AF). The investigators will also investigate the correlation between OSA metrics (nocturnal oxygen saturation and Apnea Hypopnea Index (AHI)) and degree of fibrosis at baseline and its progression. Type: Interventional Start Date: Jul 2021 |
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