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Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure...
National Heart, Lung, and Blood Institute (NHLBI)
Severe Aplastic Anemia
MDS (Myelodysplastic Syndrome)
Background:
- Stem cell transplants from related donors (allogenic stem cell transplants) can be used
to treat individuals with certain kinds of severe blood diseases or cancers, such as
severe anemia. Allogenic stem cell transplants encourage the growth of... expand
Background: - Stem cell transplants from related donors (allogenic stem cell transplants) can be used to treat individuals with certain kinds of severe blood diseases or cancers, such as severe anemia. Allogenic stem cell transplants encourage the growth of new bone marrow to replace that of the recipient. Because stem cell transplants can have serious complications, researchers are interested in developing new approaches to stem cell transplants that will reduce the likelihood of these complications. - By reducing the number of white blood cells included in the blood taken during the stem cell collection process, and replacing them with a smaller amount of white blood cells collected prior to stem cell donation, the stem cell transplant may be less likely to cause severe complications for the recipient. Researchers are investigating whether altering the stem cell transplant donation procedure in this manner will improve the likelihood of a successful stem cell transplant with fewer complications. Objectives: - To evaluate a new method of stem cell transplantation that may reduce the possibly of severe side effects or transplant rejection in the recipient. Eligibility: - Recipient: Individuals between 4 and 80 years of age who have been diagnosed with a blood disease that can be treated with allogenic stem cell transplants. - Donor: Individuals between 4 and 80 years of age who are related to the recipient and are eligible to donate blood. OR unrelated donors found through the National Marrow Donor Program. Design: - All participants will be screened with a physical examination and medical history. - DONORS: - Donors will undergo an initial apheresis procedure to donate white blood cells. - After the initial donation, donors will receive injections of filgrastim to release bone marrow cells into the blood. - After 5 days of filgrastim injections, donors will have apheresis again to donate stem cells that are present in the blood. - RECIPIENTS: - Recipients will provide an initial donation of white blood cells to be used for research purposes only. - From 7 days before the stem cell transplant, participants will be admitted to the inpatient unit of the National Institutes of Health Clinical Center and will receive regular doses of cyclophosphamide, fludarabine, and anti-thymocyte globulin to suppress their immune system and prepare for the transplant. - After the initial chemotherapy, participants will receive the donated white blood cells and stem cells as a single infusion. - After the stem cell and white blood cell transplant, participants will have regular doses of cyclosporine and methotrexate to prevent rejection of the donor cells. Participants will have three doses of methotrexate within the week after the transplant, but will continue to take cyclosporine for up to 4 months after the transplant. - Participants will remain in inpatient care for up to 1 month after the transplant, and will be followed with regular visits for up to 3 years with periodic visits thereafter to evaluate the success of the transplant and any side effects. Type: Interventional Start Date: Dec 2010 |
A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease
Regulus Therapeutics Inc.
Autosomal Dominant Polycystic Kidney Disease
ADPKD
Polycystic Kidney, Autosomal Dominant
Primary Objectives
- To assess the safety and tolerability of RGLS8429
- To assess the impact of RGLS8429 on ADPKD biomarkers
Secondary Objectives
- To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV)
- To characterize... expand
Primary Objectives - To assess the safety and tolerability of RGLS8429 - To assess the impact of RGLS8429 on ADPKD biomarkers Secondary Objectives - To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV) - To characterize the pharmacokinetic (PK) properties of RGLS8429 - To assess the impact of RGLS8429 on renal function Type: Interventional Start Date: Oct 2022 |
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
University of Michigan
Cardiac Arrest, Out-Of-Hospital
Hypothermia, Induced
Hypoxia-Ischemia, Brain
This is a multicenter trial to establish the efficacy of cooling and the optimal duration of
induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest.
The study team hypothesizes that longer durations of cooling may improve either the
proportion... expand
This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome. Type: Interventional Start Date: Aug 2022 |
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
Iksuda Therapeutics Ltd.
B-cell Non-Hodgkin Lymphoma
Diffuse Large B Cell Lymphoma
Follicular Lymphoma
Mantle Cell Lymphoma
B-cell Lymphoma
This first-in-human study will evaluate the recommended dose for further clinical
development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics
and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with
advanced... expand
This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with advanced B cell non-Hodgkin lymphoma (NHL). Type: Interventional Start Date: Sep 2023 |
A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk...
Geron Corporation
Myelofibrosis
The purpose of the study is to evaluate the overall survival of participants treated with
imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis
(MF) who are relapsed/refractory to Janus Kinase (JAK)-Inhibitor treatment.
expand
The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory to Janus Kinase (JAK)-Inhibitor treatment. Type: Interventional Start Date: Apr 2021 |
Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and...
Merck Sharp & Dohme LLC
Squamous Cell Carcinoma of Head and Neck
This study is designed to assess the safety and efficacy of lenvatinib in combination with
pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and
efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck... expand
This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review. Type: Interventional Start Date: Aug 2020 |
Efficacy and Safety of Erenumab in Pediatric Subjects With Episodic Migraine
Amgen
Migraine
This study will evaluate the efficacy and safety of erenumab in migraine prevention in
children (6 to <12 years) and adolescents (12 to <18 years) with episodic migraine. The study
hypothesis is that in pediatric subjects with episodic migraine, the combined erenumab dose... expand
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with episodic migraine. The study hypothesis is that in pediatric subjects with episodic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP). Type: Interventional Start Date: Jul 2019 |
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
United Therapeutics
PAH
Pulmonary Hypertension
Pulmonary Arterial Hypertension
Hypertension
Connective Tissue Diseases
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of
ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or
PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
expand
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH. Type: Interventional Start Date: Aug 2018 |
Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years
University of Maryland, Baltimore
Atrial Fibrillation New Onset
Screening for Atrial Fibrillation in Elderly Women (SAFE-W) is a pilot study evaluating the
prevalence of atrial fibrillation (Afib) in a rapidly aging segment of the population.
Studies have shown that women with Afib are more likely to be symptomatic, have increased
mortality... expand
Screening for Atrial Fibrillation in Elderly Women (SAFE-W) is a pilot study evaluating the prevalence of atrial fibrillation (Afib) in a rapidly aging segment of the population. Studies have shown that women with Afib are more likely to be symptomatic, have increased mortality from stroke resulting from Afib, and are less likely to receive treatment for Afib. University of Maryland Department of Neurology and Vascular Neurology are recruiting women older than 70 years of age to participate in the study. Type: Interventional Start Date: Jul 2023 |
Trifecta-Kidney cfDNA-MMDx Study
University of Alberta
Kidney Transplant Rejection
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the
Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies.
expand
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies. Type: Observational Start Date: Dec 2019 |
ARrest RESpiraTory Failure From PNEUMONIA
Stanford University
Pneumonia
Hypoxemia
Acute Respiratory Failure
COVID-19 Pneumonia
This research study seeks to establish the effectiveness of a combination of an inhaled
corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory
failure (ARF) in hospitalized patients with pneumonia and hypoxemia.
expand
This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia. Type: Interventional Start Date: Jun 2020 |
Talazoparib and Gemtuzumab Ozogamicin for the Treatment of CD33 Positive Relapsed or Refractory Acute...
Roswell Park Cancer Institute
Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia
This phase I/Ib trial studies the side effects and best dose of talazoparib given together
with gemtuzumab ozogamicin and to see how well they work in treating patients with CD33
positive acute myeloid leukemia that has come back (relapsed) or does not respond to
treatment... expand
This phase I/Ib trial studies the side effects and best dose of talazoparib given together with gemtuzumab ozogamicin and to see how well they work in treating patients with CD33 positive acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). Talazoparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Gemtuzumab ozogamicin is a protein (antibody) combined with a chemotherapy drug which specifically targets acute myeloid leukemia cells expressing a marker (CD33). Adding talazoparib to the gemtuzumab ozogamicin therapy may lead to an increased effectiveness in treatment. Type: Interventional Start Date: Oct 2020 |
Efficacy of a Transcranial Vibrating System for Minimizing Dizziness During Caloric Testing
Otolith Labs
Vestibular Function Tests
Dizziness
Testing for vestibular dysfunction often induces dizziness and nausea, to the point that
testing cannot be completed. The investigators will use a "transcranial vibration system"
that has shown promise in improving comfort during testing for vestibular disorders.
The investigators... expand
Testing for vestibular dysfunction often induces dizziness and nausea, to the point that testing cannot be completed. The investigators will use a "transcranial vibration system" that has shown promise in improving comfort during testing for vestibular disorders. The investigators hypothesize that with this "transcranial vibration system", the dizziness and nausea associated with caloric testing will be significantly reduced, while the clinical measures derived from the test will not be statistically significantly altered. Type: Interventional Start Date: Oct 2018 |
Mechanisms of Palmitoylethanolamide (PEA) to Alter Pain Sensitivity in Knee Osteoarthritis
University of Maryland, Baltimore
Osteoarthritis, Knee
The purposes of this 1-year proof of feasibility and acceptability pilot study are twofold.
First to determine if participants with knee osteoarthritis (KOA) will comply with taking
palmitoylethanolamide (PEA) dietary supplement for 6 weeks and adhere to taking it as
directed.... expand
The purposes of this 1-year proof of feasibility and acceptability pilot study are twofold. First to determine if participants with knee osteoarthritis (KOA) will comply with taking palmitoylethanolamide (PEA) dietary supplement for 6 weeks and adhere to taking it as directed. Second is to gain preliminary data to elucidate mechanisms (protein signatures, inflammatory markers and neurobiological signaling pathways) by which PEA, a lipid-based endocannabinoid, works to alter pain sensitivity in adults with KOA. In the simplest terms possible, we need to provide evidence that PEA changes the protein signature in order to provide evidence to establish mechanism. Type: Interventional Start Date: Mar 2023 |
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD...
University of Maryland, Baltimore
Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
The investigators hypothesize that use of a remote monitoring digital health system that
supports medication taking and monitoring of symptoms will improve adherence, clinical
outcomes, and decrease healthcare utilization compared to standard care in participants with
inflammatory... expand
The investigators hypothesize that use of a remote monitoring digital health system that supports medication taking and monitoring of symptoms will improve adherence, clinical outcomes, and decrease healthcare utilization compared to standard care in participants with inflammatory bowel disease initiating oral or subcutaneous treatment. The investigators are conducting a 12-month, multicenter, randomized, controlled trial to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization. The investigators will address the following specific aims: 1. Compare adherence as measured by the medication possession ratio in participants using a remote monitoring digital health system compared to standard of care. 2. Compare clinical outcomes and healthcare utilization in participants using a remote monitoring digital health system compared to standard of care. Type: Interventional Start Date: Sep 2022 |
DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)
Cellphire Therapeutics, Inc.
Cardiac Surgery
A randomized, parallel group, active comparator-controlled trial to evaluate the
non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in
controlling blood loss in patients undergoing Cardiopulmonary Bypass Surgery.
expand
A randomized, parallel group, active comparator-controlled trial to evaluate the non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in controlling blood loss in patients undergoing Cardiopulmonary Bypass Surgery. Type: Interventional Start Date: Sep 2021 |
Trial of Therapeutic Hypothermia in Patients With ARDS
University of Maryland, Baltimore
Respiratory Distress Syndrome, Adult
Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a
complication of medical and surgical diseases, has a mortality of ~40%, and has no known
treatment other than optimization of support. Data from basic research, animal models, and
retrospective... expand
Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a complication of medical and surgical diseases, has a mortality of ~40%, and has no known treatment other than optimization of support. Data from basic research, animal models, and retrospective studies, case series, and small prospective studies suggest that therapeutic hypothermia (TH) similar to that used for cardiac arrest may be lung protective in patients with ARDS; however, shivering is a major complication of TH, often requiring paralysis with neuromuscular blocking agents (NMBA) to control. Since the recently completed NHLBI PETAL ROSE trial showed that NMBA had no effect (good or bad) in patients with moderate to severe ARDS, the CHILL trial is designed to evaluate whether TH combined with NMBA is beneficial in patients with ARDS. This Phase IIb randomized clinical trial is funded by the Department of Defense to compare TH (core temperature 34-35°C) + NMBA for 48h vs. usual temperature management in patients in 14 clinical centers with the Clinical Coordination Center and Data Coordinating Center at University of Maryland Baltimore. Planned enrollment is 340 over ~3.5 years of the 4-year contract. COVID-19 is considered an ARDS risk-factor and patients with ARDS secondary to COVID-19 pneumonia will be eligible for enrollment. Primary outcome is 28-day ventilator-free days. Secondary outcomes include safety, physiologic measures, mortality, hospital and ICU length of stay, and serum biomarkers collected at baseline and on days 1, 2, 3, 4, and 7. Type: Interventional Start Date: Jun 2021 |
Muscle Capillarization and Sarcopenia
Baltimore VA Medical Center
Sarcopenia
Aging is associated with a loss of muscle mass, termed sarcopenia, that reduces mobility,
decreases physical function and accelerates progression of other age-related disorders. This
study is designed to determine whether increasing skeletal muscle capillarization through... expand
Aging is associated with a loss of muscle mass, termed sarcopenia, that reduces mobility, decreases physical function and accelerates progression of other age-related disorders. This study is designed to determine whether increasing skeletal muscle capillarization through aerobic exercise will enhance muscular adaptations to strength training in older adults with sarcopenia. Type: Interventional Start Date: Nov 2021 |
TMS Related Biomarker Assessments
University of Maryland, Baltimore
Schizophrenia Schizoaffective
Schizophrenia
Patients with schizophrenia spectrum disorder (SSD) will be exposed to active and sham
repetitive transcranial magnetic stimulation (rTMS) in separate sessions. SSD-related
biomarkers will be assessed before and after the rTMS administration.
expand
Patients with schizophrenia spectrum disorder (SSD) will be exposed to active and sham repetitive transcranial magnetic stimulation (rTMS) in separate sessions. SSD-related biomarkers will be assessed before and after the rTMS administration. Type: Interventional Start Date: Jan 2023 |
Dengue 4 Human Infection Model (Dengue CVD 11000; DHIM-4)
University of Maryland, Baltimore
Dengue
The purpose of this research study is to test a weakened form of an experimental dengue virus
challenge at different doses to test if participants develop symptoms or circulating virus in
the blood (called viremia). When volunteers are exposed to dengue on purpose, it is called a... expand
The purpose of this research study is to test a weakened form of an experimental dengue virus challenge at different doses to test if participants develop symptoms or circulating virus in the blood (called viremia). When volunteers are exposed to dengue on purpose, it is called a "challenge" or Dengue Human Infection Model (DHIM). The research team is collecting information about the safety of the challenge and the best dose to use. The information may help us to make a dengue challenge (a DHIM) that will test vaccines to protect people from dengue. Type: Interventional Start Date: Feb 2022 |
Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation
University of Alberta
Liver Dysfunction
INTERLIVER is a prospective observational study of the relationship of the molecular
phenotype of 300 liver transplant biopsies to the histologic phenotype and the clinical
features and outcomes. A segment of a biopsy performed as standard-of-care for indications,
or by center... expand
INTERLIVER is a prospective observational study of the relationship of the molecular phenotype of 300 liver transplant biopsies to the histologic phenotype and the clinical features and outcomes. A segment of a biopsy performed as standard-of-care for indications, or by center protocol, will be used for gene expression study. Type: Observational Start Date: Dec 2017 |
Strengthening Family Coping Resources Open Trials
University of Maryland, Baltimore
Intervention Effectiveness
Practice-based Evidence
Posttraumatic Stress Disorder
Strengthening Families Coping Resources (SFCR) Open Trials completes the second stage of the
National Institute on Drug Abuse's intervention development model by testing a new family,
skills-based intervention involving pre-post evaluation of families participating in
multi-family... expand
Strengthening Families Coping Resources (SFCR) Open Trials completes the second stage of the National Institute on Drug Abuse's intervention development model by testing a new family, skills-based intervention involving pre-post evaluation of families participating in multi-family groups. The purpose of this study is to gather practice-based evidence on the effectiveness of the manualized treatment, on the dynamics involved in the group format, and on implementation fidelity and feasibility. Analyses will involve initial exploration of the following hypotheses: 1) Families will show a significant increase in the constructive use of family coping skills and in general family functioning. 2) The target child will show a reduction in trauma-related symptoms and behavior problems. 3) Parents will show significant reductions in traumatic stress and other symptoms of distress. 4) Families will engage and participate in the treatment. 5) Providers will implement SFCR with fidelity. Other outcomes of interest are the process measures that will be collected to monitor participation in the groups, cultural sensitivity and acceptability, clinician competence, and intervention integrity. Type: Observational Start Date: Feb 2006 |
Ankle Robotics After Stroke
NextStep Robotics Inc.
Foot Drop
Stroke
Hemiparesis
The randomized study (in Phase II of the U44) compares the efficacy and durability of 9 weeks
(18 sessions) of robot-assisted physical therapy (PTR) versus physical therapy (PT) alone on
foot drop as assessed by gait biomechanics (ankle angle at initial contact, peak swing ankle... expand
The randomized study (in Phase II of the U44) compares the efficacy and durability of 9 weeks (18 sessions) of robot-assisted physical therapy (PTR) versus physical therapy (PT) alone on foot drop as assessed by gait biomechanics (ankle angle at initial contact, peak swing ankle angle, number of heel-first strikes - % total steps, gait velocity) and blinded clinician assessment (dorsiflexion active range of motion, ankle muscle strength, assistive device needs). Type: Interventional Start Date: Aug 2020 |
Functional Interval Training for Veterans Exercising Through Telehealth.
VA Office of Research and Development
HIV Infection
Most Veterans living with HIV are 50 years of age or older and can expect to live more than
20 years longer with HIV medication. However, despite this success, Veterans living with HIV
are more likely to have age-related diseases and loss of fitness and muscle that place them... expand
Most Veterans living with HIV are 50 years of age or older and can expect to live more than 20 years longer with HIV medication. However, despite this success, Veterans living with HIV are more likely to have age-related diseases and loss of fitness and muscle that place them at increased risk for disability. This is a major priority for the VHA, the largest provider of HIV care in the United States. The goal of this study is to test a circuit exercise program in Veterans living with HIV that is designed to slowdown the aging process. The exercise program will be widely available by Video Teleconferencing (VTEL) and does not require stationary exercise equipment, making it widely accessible. This research will help reach the goal for Veterans to preserve their quality of life and ability to function independently. Novel findings will strengthen strategies to maintain life-long fitness through a personalized exercise prescription. Type: Interventional Start Date: Mar 2020 |
Sensory-Motor Rehabilitation Post Stroke
University of Maryland, Baltimore
Acute Stroke
Early after stroke, patients often have significant motor impairment and sensory deficit.
Evidence has demonstrated heightened plasticity and significant recovery in the acute phase
(first months) post stroke but there has been a lack of effective and practical protocols and... expand
Early after stroke, patients often have significant motor impairment and sensory deficit. Evidence has demonstrated heightened plasticity and significant recovery in the acute phase (first months) post stroke but there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy.This research study will conduct a randomized clinical trial of an intensive motor-sensory rehabilitation on patients with acute stroke using a wearable rehabilitation robot. The primary aims are to facilitate sensorimotor recovery, reduce ankle impairments, and improve balance and gait functions. This clinical trial will be conducted on the Study and Control groups of acute stroke survivors. Type: Interventional Start Date: Apr 2019 |
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