Clinical trials: Risk Assessment
High Risk MDS
Phase II Study to Evaluate Overall Response in Patients With Higher Risk Myelodysplastic Syndromes (MDS) Treated With Azacitidine With or Without Deferasirox.
The primary objective of the study is to compare the overall response rate (inclusive of complete response, partial response and hematologic improvement) per IWG 2006 criteria in patients with higher risk MDS treated with…
- Trial name
- NCT02159040
- Testing
- Azacitidine, Azacitidine plus Deferasirox
- Where
- 6 sites in United States
- Volunteers
- 1 people
- Sponsor
- Novartis Pharmaceuticals
Drug Use Disorders, Drug Abuse
Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks
Background: Sixty million American adults suffer from moderate to severe chronic pain. Of these, 5 to 8 million currently use opioids long-term.
- Conditions
- Drug Use Disorders, Drug Abuse, Drug Addiction, Drug Dependence
- Trial name
- CARE (NCT02224508)
- Volunteers
- 1,588 people
- Sponsor
- Kaiser Permanente
Hypercholesterolemia
Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin therapy with or without other lipid modifying therapy in comparison with…
- Trial name
- NCT02107898
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT)
- Where
- 32 sites in Japan
- Volunteers
- 216 people
- Sponsor
- Sanofi
Hypercholesterolemia
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9).
- Trial name
- NCT01644175
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT)
- Where
- 76 sites in United States
- Volunteers
- 316 people
- Sponsor
- Sanofi
Bladder Cancer, Urothelial Carcinoma
A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer
This Phase 2b, single-arm, multicenter study evaluated the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC).
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- OPTIMA II (NCT03558503)
- Testing
- UGN-102
- Where
- 19 sites in United States, Israel
- Volunteers
- 63 people
- Sponsor
- UroGen Pharma Ltd.
Obesity
A Primary Care Behavioral Approach for Addressing Childhood Overweight
The purpose of this study is to determine whether participation in a group-based health education curriculum is superior to receipt of standardized health educational materials for children who are overweight or at risk for…
- Trial name
- NCT00284557
- Testing
- Group-based behavioral intervention
- Volunteers
- 130 people
- Sponsor
- Emory University
Keratolysis
Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit
This is a phase I/II prospective, randomized, multi-center, double-masked, vehicle-controlled clinical trial evaluating the safety and efficacy of corneal collagen cross-linking the keratoprosthesis carrier tissue in subjects who…
- Trial name
- NCT02863809
- Testing
- Riboflavin, Dextran, UVA Light Source
- Where
- 13 sites in United States
- Volunteers
- 76 people
- Sponsor
- Joseph B. Ciolino, MD
Breast Cancer
Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts
We aim to compare the sensitivity of mammography to the sensitivity of Molecular Breast Imaging (a new gamma-camera based breast imaging technology) in women with dense breast tissue who are at increased risk for breast cancer.
- Trial name
- NCT00620373
- Testing
- Molecular Breast Imaging, Conventional Mammography, Technetium (99mTc) sestamibi
- Where
- United States
- Volunteers
- 969 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Smoldering Multiple Myeloma
Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma
The purpose of this study is to determine whether elotuzumab will improve response in patients with high risk smoldering myeloma who have more CD56^dim cells (a marker for the health of the body's immune system)
- Trial name
- NCT01441973
- Testing
- Elotuzumab (BMS-901608; HuLuc63)
- Where
- 12 sites in United States
- Volunteers
- 41 people
- Sponsor
- Bristol-Myers Squibb
Myelodysplastic Syndromes
Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
The purpose of this study is to evaluate the efficacy and safety of imetelstat sodium in transfusion-dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to…
- Trial name
- NCT02598661
- Testing
- Imetelstat Sodium
- Where
- 126 sites in United States, Belgium and 15 more
- Volunteers
- 289 people
- Sponsor
- Geron Corporation
Influenza
High-risk Influenza Vaccine Alert
The purpose of this study is to assess, prospectively, the effect on flu vaccination rates of salient alerts in the electronic health record that indicate a patient's high risk for flu and its complications.
- Trial name
- NCT05492786
- Testing
- Alert, Salient alert features, High-risk Text
- Where
- United States
- Volunteers
- 80,452 people
- Sponsor
- Geisinger Clinic
Physical Inactivity
Intergenerational Behavioral Intervention to Enhance Physical Activity in Older Adults at Risk for Alzheimer's Disease
This is a four-week pilot randomized controlled trial of a behavioral intervention in older adults at risk for Alzheimer's disease. Older participants are a subgroup from the PREVENT-AD longitudinal cohort.
- Trial name
- HABS (NCT06038643)
- Testing
- Motivational behavioural intervention and daily activities monitoring, Active Control
- Where
- Canada
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Douglas Mental Health University Institute
Evaluation Studies, Implementation Research
Implementation of the Begin Exploring Fertility Options, Risks and Expectations (BEFORE) Decision Aid
The Begin Exploring Fertility Options, Risks and Expectations (BEFORE) decision aid was created to support fertility discussions and decision-making for young breast cancer patients in Canada.
- Conditions
- Evaluation Studies, Implementation Research, Decision Aid, Young Adult Cancer
- Trial name
- BEFORE (NCT03629509)
- Testing
- Educational Webinar and Resources
- Where
- Canada
- Volunteers
- 116 people
- Sponsor
- Unity Health Toronto
Breast Cancer
Sunitinib in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer Who Have Tumor Cells in the Bone Marrow
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
- Trial name
- NCT00824538
- Testing
- sunitinib malate, flow cytometry, immunohistochemistry staining method
- Volunteers
- 13 people
- Sponsor
- University of California, San Francisco
Staphylococcal Infections, Surgical Site Infection
Effect of Exeporfinium Chloride (XF-73) Gel on Nasal S.Aureus in Patients at Risk of Post-op Staphylococcal Infection
This study looks at the difference between XF-73 and placebo in reducing the carriage of a bacteria S. aureus in the nose before, during and after heart surgery.
- Trial name
- NCT03915470
- Testing
- XF-73
- Where
- 21 sites in United States, Georgia and 1 more
- Volunteers
- 124 people
- Sponsor
- Destiny Pharma Plc
Prostate Cancer
68Ga-THP-PSMA PET/CT Imaging in High Risk Primary Prostate Cancer or Biochemical Recurrence of Prostate Cancer
This will be an open-labelled, single centre study in the UK. The study group will include 60 patients with three groups of patients being studied.
- Trial name
- PRONOUNCED (NCT03617588)
- Testing
- Gallium-68 THP-PSMA
- Where
- 4 sites in United Kingdom
- Volunteers
- 49 people
- Sponsor
- Theragnostics Ltd
High-Risk Melanoma
Evaluation of the Impact of Adjuvants Accompanying Peptide Immunization in High-Risk Melanoma
This study will evaluate the immunization effects of a vaccine for patients who are at risk for recurrence of their skin cancer. That is, the risk of cancer is higher if melanoma has invaded deep into the skin or lymph nodes.
- Trial name
- NCT00273910
- Testing
- gp100:209-217 (210M), Montanide ISA-51, Imiquimod
- Where
- United States
- Volunteers
- 104 people
- Sponsor
- National Cancer Institute (NCI)
Respiratory Syncytial Virus
A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus
Part A: The purpose is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1345 in children aged 2 to <5 years (Cohort 1) and in children at high risk of respiratory syncytial virus (RSV) disease 5 to <18 years of…
- Trial name
- NCT06097299
- Testing
- mRNA-1345
- Where
- 50 sites in United States, Panama
- Volunteers
- 349 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Hyperlipidemia
Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as…
- Trial name
- MENDEL (NCT01375777)
- Testing
- Evolocumab, Ezetimibe
- Where
- 58 sites in United States, Australia and 3 more
- Volunteers
- 411 people
- Sponsor
- Amgen
Cardiac Disease
Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease
A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care). All children in the study will receive free treatment.
- Trial name
- NCT03395639
- Testing
- Edoxaban, Standard of Care (SOC)
- Where
- 48 sites in United States, Austria and 12 more
- Volunteers
- 168 people
- Sponsor
- Daiichi Sankyo