Clinical trials: High Cardiovascular Risk
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or…
- Trial name
- NCT01240902
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR)
- Where
- 45 sites in United States
- Volunteers
- 1,453 people
- Sponsor
- Medtronic Cardiovascular
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations
Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk Hematologic Malignancies
This phase II trial studies reduced-intensity conditioning before donor stem cell transplant in treating patients with high-risk hematologic malignancies.
- Conditions
- Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations, Acute Myeloid Leukemia With Inv(3) (q21.3;q26.2); GATA2, MECOM, Acute Myeloid Leukemia With t(6;9) (p23;q34.1); DEK-NUP214
- Trial name
- NCT01760655
- Testing
- Fludarabine phosphate, Busulfan, Total-Body Irradiation
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Intracranial Aneurysm, Brain Edema
Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients
This is a prospective, randomized controlled trial to determine if using FloTrac/EV1000 system in neurosurgical patients undergoing craniotomies for aneurysm repair or tumor resection complicated by cerebral edema, or complex…
- Conditions
- Intracranial Aneurysm, Brain Edema, Scoliosis, Surgery
- Trial name
- NCT02701582
- Testing
- Phenylephrine, Epinephrine, Albumin
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- NYU Langone Health
Respiratory Syncytial Virus Infections
Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
The SYNAGIS Registry was carried out in order to gather comprehensive real-world data on the use of palivizumab in children at high risk for serious respiratory syncytial virus (RSV) disease.
- Trial name
- NCT01155193
- Volunteers
- 30,804 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic…
- Trial name
- PII A (NCT01314313)
- Testing
- TAVR Implantation with SAPIEN XT, SAVR Implantation
- Where
- 57 sites in United States, Canada
- Volunteers
- 2,032 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
RESPOND Post Market Study
The purpose of the RESPOND post market study is to collect real world clinical and device performance outcomes data with the Lotus Valve System used in routine clinical practice to demonstrate that the commercially available…
- Trial name
- RESPOND (NCT02031302)
- Testing
- Lotus Valve System
- Where
- 41 sites in Colombia, Finland and 11 more
- Volunteers
- 1,064 people
- Sponsor
- Boston Scientific Corporation
Kaposiform Hemangioendothelioma (KHE), Kasabach-Merritt Syndrome
A Study to Compare Vincristine to Sirolimus for Treatment of High Risk Vascular Tumors
In this research study we want to learn more about which treatment works better for patients diagnosed with a vascular tumor called Kaposiform Hemangioendothelioma (KHE) or other high risk vascular tumors such as Tufted Angioma…
- Conditions
- Kaposiform Hemangioendothelioma (KHE), Kasabach-Merritt Syndrome, Tufted Angioma
- Trial name
- NCT02110069
- Testing
- Vincristine, Sirolimus
- Where
- 7 sites in United States
- Volunteers
- 4 people
- Sponsor
- Boston Children's Hospital
Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission
Haploidentical Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancer
This phase II trial studies how well giving fludarabine phosphate, cyclophosphamide, tacrolimus, mycophenolate mofetil and total-body irradiation together with a donor bone marrow transplant works in treating patients with…
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Trial name
- NCT00049504
- Testing
- cyclophosphamide, fludarabine phosphate, tacrolimus
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Fred Hutchinson Cancer Center
Infant,Premature, Bronchopulmonary Dysplasia
L-citrulline and Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia
Bronchopulmonary dysplasia (BPD) is a chronic lung disease that affects up to 35% of very low birth weight infants (VLBW < 1500 g).
- Conditions
- Infant,Premature, Bronchopulmonary Dysplasia, Pulmonary Hypertension
- Trial name
- NCT03542812
- Testing
- L-Citrulline
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- University of Utah
B-Cell Prolymphocytic Leukemia, Hypodiploidy
Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia
This phase II trial studies autologous peripheral blood stem cell transplant followed by donor bone marrow transplant in treating patients with high-risk Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma, or chronic…
- Conditions
- B-Cell Prolymphocytic Leukemia, Hypodiploidy, Loss of Chromosome 17p, Plasma Cell Leukemia
- Trial name
- NCT01008462
- Testing
- Allogeneic Bone Marrow Transplantation, Allogeneic Hematopoietic Stem Cell Transplantation, Autologous Hematopoietic Stem Cell Transplantation
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Fred Hutchinson Cancer Center
Obesity
Study of Serum Markers for Cardiovascular Risk in Obese Youth and Impact of Lifestyle and Medication Intervention
In Protocol #2, we will select 30 obese pubertal and 30 obese prepubertal subjects with an abnormal cytokine profile (i.e. fibrinogen and/or hsCRP concentration greater than or equal to 2 Standard Deviations (SD) above the mean…
- Trial name
- NCT00139477
- Testing
- Metformin, Dietary modification with caloric restriction, Establishment of exercise protocol
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Nemours Children's Clinic
Cardiovascular Disease, Hypercholesterolemia
Low Fat Vegan or American Heart Association Diets & Cardiovascular Risk in Obese 9-18 y.o. With Elevated Cholesterol
The purpose of this study is to investigate the short-term effects of a reduced fat plant-based diet on biomarkers of inflammation, oxidative stress and cardiovascular risk.
- Conditions
- Cardiovascular Disease, Hypercholesterolemia, Obesity, Fatty Liver
- Trial name
- NCT01817491
- Testing
- American Heart Association Diet, Reduced Fat Vegan Diet
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- The Cleveland Clinic
Endocarditis
Early Surgery Versus Conventional Treatment in Infective Endocarditis
There have been no prospective clinical studies in infective endocarditis comparing early surgery with the conventional treatment strategy based on current guidelines.
- Trial name
- EASE (NCT00750373)
- Testing
- Valve surgery with removal of vegetations
- Where
- 2 sites in South Korea
- Volunteers
- 76 people
- Sponsor
- Asan Medical Center
Multiple Myeloma, Lymphocytic Leukemia, Chronic
Study of Low-Intensity Conditioning for Allogeneic Stem Cell Transplant
The purpose of this study is to determine whether a reduced intensity conditioning regimen for stem cell transplant with donor cells will allow the donor cells to be effective without causing health problems.
- Conditions
- Multiple Myeloma, Lymphocytic Leukemia, Chronic, Lymphoma, Low-Grade
- Trial name
- NCT00143845
- Testing
- Reduced intensity conditioning, Rapid immunosuppressive taper, Prophylactic donor leukocyte infusions
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- University of Michigan Rogel Cancer Center
Coronary Artery Disease Risk High
FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study
This pilot study seeks to compare the change in energy expenditure and fitness levels of patients seen in the Children's Hospital Preventive Cardiology program receiving standard of care provider exercise counseling to similar…
- Trial name
- NCT01394705
- Testing
- BodyMedia
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Preeclampsia, Obstetric Labor Complications
Pravastatin to Prevent Preeclampsia
This study is a double-blind randomized placebo-controlled trial of 1,550 high-risk women to assess whether daily treatment with pravastatin administered early in pregnancy reduces the rate of a composite outcome of preeclampsia…
- Conditions
- Preeclampsia, Obstetric Labor Complications, Hypertension in Pregnancy
- Trial name
- Pravastatin (NCT03944512)
- Testing
- Pravastatin
- Where
- 12 sites in United States
- Volunteers
- 102 people
- Sponsor
- The George Washington University Biostatistics Center
Critical Aortic Stenosis
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.
- Trial name
- PARTNER (NCT00530894)
- Testing
- Edwards SAPIEN Transcatheter Heart Valve, Surgical Valve Replacement, medical management and/or balloon aortic valvuloplasty
- Where
- 26 sites in United States, Canada and 1 more
- Volunteers
- 1,057 people
- Sponsor
- Edwards Lifesciences
Severe Aortic Stenosis
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted very high risk and high risk for aortic…
- Trial name
- NCT01531374
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 45 sites in United States
- Volunteers
- 2,777 people
- Sponsor
- Medtronic Cardiovascular
Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
This pilot phase II trial studies how well giving donor T cells after donor stem cell transplant works in treating patients with hematologic malignancies.
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Trial name
- NCT01839916
- Testing
- therapeutic allogeneic lymphocytes, laboratory biomarker analysis
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- University of Chicago