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Safe Accelerated Venetoclax Escalation in CLL
Dana-Farber Cancer Institute
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
This research study is trying to determine which patients with newly diagnosed or
relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma
(SLL), as grouped by their risk for tumor lysis syndrome (TLS), are able to safely
tolerate an accelerated, daily venetoclax dose ramp-up... expand
This research study is trying to determine which patients with newly diagnosed or relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), as grouped by their risk for tumor lysis syndrome (TLS), are able to safely tolerate an accelerated, daily venetoclax dose ramp-up rather than the standard approved schedule (5-week dose ramp-up). The name of the study drug involved in this study is: - Venetoclax The following drugs may also be included in some participants treatment regimen: - Obinutuzumab - Rituximab Type: Interventional Start Date: Apr 2021 |
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children...
Duke University
Coronavirus Infection (COVID-19)
Pulmonary Arterial Hypertension
Urinary Tract Infections in Children
Hypertension
Pain
The study investigators are interested in learning more about how drugs, that are given
to children by their health care provider, act in the bodies of children and young adults
in hopes to find the most safe and effective dose for children. The primary objective of
this study is to evaluate the PK... expand
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider. Type: Observational Start Date: Mar 2020 |
Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative...
ECOG-ACRIN Cancer Research Group
CD20 Positive
Mantle Cell Lymphoma
This randomized phase III trial studies rituximab after stem cell transplant and to see
how well it works compared with rituximab alone in treating patients with in minimal
residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal
antibodies, such as rituximab, may interfere... expand
This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma. Type: Interventional Start Date: Mar 2018 |
A Ph 2 Study of Glofitamab Alone or in Combination With Polatuzumab Vedotin or Atezolizumab in Richter's...
Christine Ryan
Chronic Lymphocytic Leukemia
Richter's Transformation
This research is being done to evaluate Glofitamab by itself or in combination with
Polatuzumab Vedotin or Atezolizumab as possible treatments for Chronic Lymphocytic
Leukemia (CLL) that has transformed into Richter's Transformation (RT).
The names of the study drugs involved in this research study... expand
This research is being done to evaluate Glofitamab by itself or in combination with Polatuzumab Vedotin or Atezolizumab as possible treatments for Chronic Lymphocytic Leukemia (CLL) that has transformed into Richter's Transformation (RT). The names of the study drugs involved in this research study are: - Glofitamab (a T-cell bispecific humanized monoclonal antibody) - Obinutuzumab (a humanized glycoengineered type II anti-CD20 monoclonal antibody) - Polatuzumab vedotin (an antibody-drug conjugate) - Atezolizumab (a humanized immunoglobulin monoclonal antibody) - Tocilizumab (a recombinant, humanized, anti-human monoclonal antibody) Type: Interventional Start Date: Jan 2024 |
Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and...
Massachusetts General Hospital
Coronary Artery Disease
The goal of this double-blind randomized controlled trial is to determine how treatment
with high intensity statin, low-dose colchicine, and their combination modulates
progression and composition of coronary atherosclerosis in individuals with high
polygenic risk for coronary artery disease. expand
The goal of this double-blind randomized controlled trial is to determine how treatment with high intensity statin, low-dose colchicine, and their combination modulates progression and composition of coronary atherosclerosis in individuals with high polygenic risk for coronary artery disease. Type: Interventional Start Date: Dec 2023 |
Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular...
Massachusetts General Hospital
Hematologic Malignancy
Blood Cancer
Lymphoma
Leukemia
Multiple Myeloma
The goal of this study is to determine whether a palliative care intervention (PEACE) can
improve the quality of life and experiences of participants with Lymphoma, Leukemia, or
Multiple Myeloma receiving adoptive cellular therapy (ACT). After completion of an open
pilot, participants will be randomly... expand
The goal of this study is to determine whether a palliative care intervention (PEACE) can improve the quality of life and experiences of participants with Lymphoma, Leukemia, or Multiple Myeloma receiving adoptive cellular therapy (ACT). After completion of an open pilot, participants will be randomly assigned into one of two study intervention groups. The names of the study intervention groups involved in this study are: - Palliative care (PEACE) plus usual oncology care - Usual care (standard oncology care) Participation in this research study is expected to last for up to 2 years. It is expected that about 90 people will take part in this research study. Type: Interventional Start Date: Dec 2022 |
Deferoxamine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury
Brigham and Women's Hospital
Acute Kidney Injury
Multiple lines of evidence support a central role of iron in causing acute kidney injury
(AKI), including the finding that prophylactic administration of iron chelators
attenuates AKI in animal models. Patients undergoing cardiac surgery may be particularly
susceptible to iron-mediated kidney injury... expand
Multiple lines of evidence support a central role of iron in causing acute kidney injury (AKI), including the finding that prophylactic administration of iron chelators attenuates AKI in animal models. Patients undergoing cardiac surgery may be particularly susceptible to iron-mediated kidney injury due to the profound hemolysis that often occurs from cardiopulmonary bypass. The investigators will test in a phase 2, randomized, double-blind, placebo-controlled trial whether prophylactic administration of deferoxamine decreases the incidence of AKI following cardiac surgery. Type: Interventional Start Date: Apr 2021 |
Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder
Stony Brook University
Bipolar Disorder
Bipolar Disorder Type 1
The goal of this clinical trial is to test how specific components of diet affect brain
function and behavior for individuals with bipolar. The main question it aims to answer
is how glucose and ketones each affect the brain's response to risk and reward.
Participants will be asked to provide blood... expand
The goal of this clinical trial is to test how specific components of diet affect brain function and behavior for individuals with bipolar. The main question it aims to answer is how glucose and ketones each affect the brain's response to risk and reward. Participants will be asked to provide blood (to assess baseline measures of how the body uses energy), and then to receive two MRI scan sessions, on separate days. During each MRI scan session, participants will play three games, from which they can win money, before and after drinking glucose (on one day) or ketones (on the other day). Investigators will compare individuals with and without bipolar to test whether the two groups differ in how their brains use energy, and to test how the brain's use of energy affects behavior. Type: Interventional Start Date: Jan 2024 |
A Study to Test How Well Different Doses of BI 3706674 Are Tolerated by People With Advanced Cancer in...
Boehringer Ingelheim
Solid Tumor, KRAS Mutation
This study is open to adults with advanced cancer in the stomach and oesophagus. This is
a study for people for whom previous treatment was not successful or no treatment exists.
In this study, BI 3706674 is given to humans for the first time.
The purpose of this study is to find a suitable dose... expand
This study is open to adults with advanced cancer in the stomach and oesophagus. This is a study for people for whom previous treatment was not successful or no treatment exists. In this study, BI 3706674 is given to humans for the first time. The purpose of this study is to find a suitable dose of BI 3706674 that people with advanced cancer can tolerate when taken alone. Another purpose is to check whether BI 3706674 can make tumours shrink. BI 3706674 blocks growth signals and may prevent the tumour from growing. Participants take BI 3706674 as a tablet when starting treatment. Different doses of BI 3706674 are tested during this study. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. Doctors record any unwanted effects and regularly check the general health of the participants. Type: Interventional Start Date: Oct 2023 |
Enhancing Modulation Effects of Baduanjin Through Neuromodulation for Knee OA
Massachusetts General Hospital
Knee Osteoarthritis
This study will combine brain imaging and neuromodulation tools to investigate the
underlying neurobiological mechanisms of exercises. The findings will enhance our
understanding of the mechanisms underlying mind-body exercise and facilitate the
development of new pain management approaches. expand
This study will combine brain imaging and neuromodulation tools to investigate the underlying neurobiological mechanisms of exercises. The findings will enhance our understanding of the mechanisms underlying mind-body exercise and facilitate the development of new pain management approaches. Type: Interventional Start Date: Mar 2024 |
Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
SOFIE
Gastrointestinal Cancers
Cholangiocarcinoma
Gastric Cancer
Colorectal Cancer
Pancreatic Ductal Adenocarcinoma
Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy
of [18F]FAPI-74 to detect FAP expressing cells in patients diagnosed with
gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma,
gastric, pancreatic and colorectal cancer. The [18F]FAPI-74... expand
Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of [18F]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer. The [18F]FAPI-74 PET scan will be acquired in patients with proven GI cancers after initial staging using institutional standard methods. The PET scan results will be compared to FAP immunohistochemistry (as the primary objective) and histopathology (as the secondary objective) of the biopsied or resected tissues. Type: Interventional Start Date: Apr 2023 |
Mirdametinib + BGB-3245 in Advanced Solid Tumors
SpringWorks Therapeutics, Inc.
Advanced Solid Tumor
A Phase 1/2a open-label, multicenter, dose escalation and expansion study of mirdametinib
in combination with BGB-3245 in adult participants with histologically confirmed,
advanced (American Joint Committee on Cancer (AJCC) Stage III or IV) metastatic or
unresectable solid cancer that is refractory... expand
A Phase 1/2a open-label, multicenter, dose escalation and expansion study of mirdametinib in combination with BGB-3245 in adult participants with histologically confirmed, advanced (American Joint Committee on Cancer (AJCC) Stage III or IV) metastatic or unresectable solid cancer that is refractory to or has progressed during or after at least 1 line of appropriate prior systemic anti-cancer therapy including chemotherapy, immunotherapy, or appropriate targeted therapy, or for which there is no treatment available, or prior standard of care therapy was not tolerated. Type: Interventional Start Date: Feb 2023 |
Positive Emotions Following Acute Cardiac Events
Massachusetts General Hospital
Acute Coronary Syndrome
Physical Inactivity
The focus of this study is to test the efficacy of a 12-week, remotely delivered,
positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice
weekly text messages for a total of 24 weeks (with interactive, algorithm-driven,
goal-focused text messages in the final 12 weeks),... expand
The focus of this study is to test the efficacy of a 12-week, remotely delivered, positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice weekly text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks), compared to post-acute coronary syndrome (ACS) treatment as usual, in a randomized trial of 280 post-ACS patients with low baseline physical activity. Type: Interventional Start Date: Sep 2022 |
Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1)
Kite, A Gilead Company
Multiple Myeloma
A Phase II study of anitocabtagene-autoleucel (formerly CART-ddBCMA) for patients with
relapsed or refractory multiple myeloma. Anitocabtagene-autoleucel is a BCMA-directed
CAR-T cell therapy. expand
A Phase II study of anitocabtagene-autoleucel (formerly CART-ddBCMA) for patients with relapsed or refractory multiple myeloma. Anitocabtagene-autoleucel is a BCMA-directed CAR-T cell therapy. Type: Interventional Start Date: Aug 2022 |
(VELA) Study of BLU-222 in Advanced Solid Tumors
Blueprint Medicines Corporation
Advanced Solid Tumors
HR+ Breast Cancer
CCNE1 Amplification
HER2-negative Breast Cancer
Ovarian Cancer
This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the
safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer
activity of BLU-222, a selective inhibitor of CDK2. expand
This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-222, a selective inhibitor of CDK2. Type: Interventional Start Date: Apr 2022 |
A Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve...
REDNVIA Co., Ltd.
Calcific Aortic Valve Disease
This is an adaptive Phase 2/3 multicenter, double-blind, placebo-controlled, randomized,
parallel, 3 arm study to evaluate the efficacy and safety of DA-1229 compared to placebo
in patients with calcific aortic valve disease with mild to moderate aortic stenosis.
There are 3 arms in this study to... expand
This is an adaptive Phase 2/3 multicenter, double-blind, placebo-controlled, randomized, parallel, 3 arm study to evaluate the efficacy and safety of DA-1229 compared to placebo in patients with calcific aortic valve disease with mild to moderate aortic stenosis. There are 3 arms in this study to which patients will be randomized in a ratio of 1:1:1 to receive the DA-1229 or placebo orally once daily for a period of 104 weeks . the 3 arms are: placebo, DA-1229 5mg GroupDA-1229 10 mg Group. The study will have three phases: Screening Period (up to 4 weeks), Treatment Period (104 weeks), and Follow-Up Period (2-4 weeks). Total Study Duration is112 Weeks. Type: Interventional Start Date: Jun 2022 |
ViTAA Registry Pre- and Post-Operative Monitoring for Endovascular Aortic Aneurysm Repair and Serial...
ViTAA Medical Solutions
Abdominal Aortic Aneurysms
This is a Prospective Registry study to collect imaging and clinical data both on
patients with aortic aneurysm disease undergoing serial monitoring and on patients pre
and post-endovascular repair, using ViTAA (The Sponsor) aortic mapping technology. expand
This is a Prospective Registry study to collect imaging and clinical data both on patients with aortic aneurysm disease undergoing serial monitoring and on patients pre and post-endovascular repair, using ViTAA (The Sponsor) aortic mapping technology. Type: Observational [Patient Registry] Start Date: Dec 2021 |
Glycemic Observation and Metabolic Outcomes in Mothers and Offspring
Northwestern University
Gestational Diabetes
Pregnancy Related
The overarching goal of Glycemic Observation and Metabolic Outcomes in Mothers and
Offspring (GO MOMs) is to perform a comprehensive, longitudinal description of maternal
glycemia over the course of pregnancy and to evaluate how glucose levels throughout
pregnancy relate to traditional third trimester... expand
The overarching goal of Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs) is to perform a comprehensive, longitudinal description of maternal glycemia over the course of pregnancy and to evaluate how glucose levels throughout pregnancy relate to traditional third trimester gestational diabetes mellitus (GDM) screening and perinatal outcomes. Type: Observational Start Date: Apr 2021 |
US IDE Study of the Contour NEurovasCular Systemâ„¢ for IntraCranial Aneurysm Repair
Cerus Endovascular, Ltd
Aneurysm, Intracranial
The purpose of this trial is to gather data on the safety and effectiveness of the
Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular,
intracranial aneurysms for submission to FDA in support of a premarket approval
application for the device. expand
The purpose of this trial is to gather data on the safety and effectiveness of the Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular, intracranial aneurysms for submission to FDA in support of a premarket approval application for the device. Type: Interventional Start Date: Aug 2021 |
Transcranial Direct Current Stimulation (tDCS) in Pediatric Obsessive Compulsive Disorder (OCD)
Massachusetts General Hospital
Obsessive-Compulsive Disorder
Pediatric Psychiatric Disorder
In this study, the investigators aim to understand the role of transcranial direct
current stimulation (tDCS) in modulating aberrant neurocognitive processes implicated in
pediatric patients with obsessive compulsive disorder (OCD). expand
In this study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in modulating aberrant neurocognitive processes implicated in pediatric patients with obsessive compulsive disorder (OCD). Type: Interventional Start Date: Jan 2021 |
A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients
University of Pennsylvania
End Stage Renal Disease
The Transplanting Hepatitis C Kidneys into Negative KidnEy Recipients [THINKER-NEXT]
study will include adult kidney transplant candidates without hepatitis C virus (HCV)
infection on the transplant waiting list who will consent to kidney transplantation from
a deceased donor infected with HCV, followed... expand
The Transplanting Hepatitis C Kidneys into Negative KidnEy Recipients [THINKER-NEXT] study will include adult kidney transplant candidates without hepatitis C virus (HCV) infection on the transplant waiting list who will consent to kidney transplantation from a deceased donor infected with HCV, followed by treatment with a direct acting antiviral. The one-year allograft function and one-year risk of CMV infection will be compared between THINKER-NEXT kidney transplant recipients and matched recipients who received hepatitis C uninfected kidney transplants (these patients are called Transplant Cohort). The survival rate of patients opting-in for offers of kidneys from HCV-viremic donors will be compared to the survival rate of matched comparators from the kidney transplant waitlist who did not consent to receive offers of a HCV-viremic kidney. Lastly, renal pathologic findings will be compared among HCV-viremic donors and HCV-negative comparator donors. Type: Interventional Start Date: Jun 2021 |
Quality of Pediatric Resuscitation in a Multicenter Collaborative
Children's Hospital of Philadelphia
Cardiac Arrest
Cardiopulmonary Arrest
This is a prospective, observational, multi-center cohort study of pediatric cardiac
arrests.
The purpose of the study is to determine the association between chest compression
mechanics (rate, depth, flow fraction, compression release) and patient outcomes. In
addition, the investigators will... expand
This is a prospective, observational, multi-center cohort study of pediatric cardiac arrests. The purpose of the study is to determine the association between chest compression mechanics (rate, depth, flow fraction, compression release) and patient outcomes. In addition, the investigators will determine the association of post cardiac arrest care with patient outcomes. Type: Observational Start Date: May 2016 |
Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma
Children's Oncology Group
Ganglioneuroblastoma
Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
This research trial studies biomarkers in tumor tissue samples from patients with newly
diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from
patients with cancer in the laboratory may help doctors identify and learn more about
biomarkers related to cancer. expand
This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. Type: Observational Start Date: Nov 2000 |
International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry & Pregnancy Sub-registry
Genzyme, a Sanofi Company
Gaucher Disease
Cerebroside Lipidosis Syndrome
Glucocerebrosidase Deficiency Disease
Glucosylceramide Beta-Glucosidase Deficiency Disease
The ICGG Gaucher Registry is an ongoing, international multi-center, strictly
observational program that tracks the routine clinical outcomes for patients with Gaucher
disease, irrespective of treatment status. No experimental intervention is involved;
patients in the Registry undergo clinical assessments... expand
The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Gaucher disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician. The objectives of the Registry are: - To enhance understanding of the variability, progression, identification, and natural history of Gaucher disease, with the ultimate goal of better guiding and assessing therapeutic intervention. - To assist the Gaucher medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. - To characterize the Gaucher disease population. - To evaluate the long-term effectiveness of imiglucerase and of eliglustat. Gaucher Pregnancy Sub-registry: The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Gaucher disease during pregnancy, regardless of whether they receive disease-specific therapy. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician.If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected. Type: Observational [Patient Registry] Start Date: Apr 1991 |
Communication Intervention for Fecal Ostomy Surgery
Massachusetts General Hospital
Surgery
Colostomy Stoma
Ileostomy - Stoma
In this study the investigators will evaluate the acceptability of a communication
intervention for fecal ostomy surgery (CI-oSurg) to address the needs of adults who are
undergoing fecal ostomy surgery. The investigators will recruit 24 patients and 4
clinicians (surgical nurses, wound ostomy nurses).... expand
In this study the investigators will evaluate the acceptability of a communication intervention for fecal ostomy surgery (CI-oSurg) to address the needs of adults who are undergoing fecal ostomy surgery. The investigators will recruit 24 patients and 4 clinicians (surgical nurses, wound ostomy nurses). At least half of patients are 65 years or older to understand the unique needs of older adults recovering from fecal ostomy surgery that might impact intervention acceptability. Questionnaires will be administered at two time-points for patient participants: upon study start and 4 weeks after exposure to the intervention. Type: Interventional Start Date: Mar 2024 |
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