Clinical trials: Risk Assessment
Hypercholesterolemia, Dyslipidemia
Efficacy/Safety of Rosuvastatin+Ezetimibe in High Risk Patients With Primary Hypercholesterolemia/Mixed Dyslipidemia
The purpose of this study is to determine the non-inferiority between two different FDC (fixed-dose combination), measuring LDL-Cholesterol levels, in high risk patients with primary hypercholesterolemia or mixed dyslipidemia.
- Trial name
- LANCE (NCT01420549)
- Testing
- Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation., Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation.
- Where
- 7 sites in Brazil
- Volunteers
- 129 people
- Sponsor
- Ache Laboratorios Farmaceuticos S.A.
Colorectal Cancer
An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now
The primary objective is to confirm the specificity of a multi-target stool DNA test (mt-sDNA), Cologuard, in an average risk population, ages 45-49.
- Trial name
- NCT03728348
- Testing
- mt-sDNA screening test, Colonoscopy
- Where
- 39 sites in United States
- Volunteers
- 983 people, healthy volunteers welcome
- Sponsor
- Exact Sciences Corporation
Pediatric Obesity
Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors
The purpose of this study is to help overweight or obese children to maintain or reduce their body mass index (BMI) through the home-based parent training program the investigators developed called DRIVE.
- Trial name
- NCT02160847
- Testing
- DRIVE Program
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Georgia State University
Dyslipidemia
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).
- Trial name
- FOURIER OLE (NCT02867813)
- Testing
- Evolocumab
- Where
- 198 sites in United States, Czechia and 5 more
- Volunteers
- 5,035 people
- Sponsor
- Amgen
Arthritis, Rheumatoid
Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients
The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo.
- Trial name
- NCT00124449
- Testing
- Abatacept
- Where
- 48 sites in United States, Australia and 8 more
- Volunteers
- 56 people
- Sponsor
- Bristol-Myers Squibb
Type 2 Diabetes Mellitus
Effect of Efpeglenatide on Cardiovascular Outcomes
Primary Objective: To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk.
- Trial name
- AMPLITUDE-O (NCT03496298)
- Testing
- Efpeglenatide (SAR439977)
- Where
- 353 sites in United States, Argentina and 26 more
- Volunteers
- 4,076 people
- Sponsor
- Sanofi
Cardiovascular Disease (CVD), Hypertension
Veteran Peer Coaches Optimizing and Advancing Cardiac Health
The purpose of this study is to test if having a Veteran peer health coach will improve blood pressure control among Veterans with high blood pressure and at least one other Cardiovascular disease (CVD) risk factor.
- Conditions
- Cardiovascular Disease (CVD), Hypertension, Hyperlipemia, Obesity
- Trial name
- Vet-COACH (NCT02697422)
- Testing
- Community-based peer health coach intervention
- Where
- United States
- Volunteers
- 264 people
- Sponsor
- VA Office of Research and Development
RESPIRATORY SYNCYTIAL VIRUS (RSV)
A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Adults at High Risk of Severe RSV Disease
The purpose of this study is to learn about the safety and immunogenicity of a study vaccine (called RSVpreF) in several adult groups.
- Trial name
- MONET (NCT05842967)
- Testing
- RSVpreF
- Where
- 36 sites in United States
- Volunteers
- 885 people
- Sponsor
- Pfizer
Acute Pain, Dysmenorrhea
Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima
What AE occur in routine clinical practice, what is the incidence of AE and Adverse Drug Reaction, how many patients present with AE symptoms related to a potential liver injury.
- Trial name
- NCT02910167
- Testing
- Hyoscine n-butylbromide, Paracetamol
- Where
- Peru
- Volunteers
- 360 people
- Sponsor
- Boehringer Ingelheim
Thrombocytopenia, MDS
Determination of Safe Dose of Romiplostim (AMG 531) in Patients With Myelodysplastic Syndromes (MDS)
The purpose of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will evaluate the platelet response to romiplostim.
- Conditions
- Thrombocytopenia, MDS, Myelodysplastic Syndromes, Refractory Cytopenias
- Trial name
- NCT00303472
- Testing
- Romiplostim
- Volunteers
- 72 people
- Sponsor
- Amgen
Neoplasms, Prostate
Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men
The purpose of this study is to examine the effect of dutasteride on the inhibition of low-risk, localized prostate cancer progression in men who would otherwise receive no active therapy (expectant management).
- Trial name
- NCT00363311
- Testing
- Dutasteride
- Where
- 82 sites in United States, Canada
- Volunteers
- 302 people
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above
The aim of this study is to demonstrate the non-inferiority (NI) of the immune response and evaluate safety of RSVPreF3 older adults (OA) investigational vaccine in adults 50-59 years of age (YOA), including those who are at…
- Trial name
- NCT05590403
- Testing
- RSVPreF3 OA investigational vaccine
- Volunteers
- 1,544 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Nonalcoholic Steatohepatitis
A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M…
- Trial name
- FORTUNA (NCT05809934)
- Testing
- AZD2693
- Where
- 163 sites in United States, Argentina and 20 more
- Volunteers
- 220 people
- Sponsor
- AstraZeneca
Coronary Heart Disease (CHD)
Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a…
- Trial name
- VESALIUS-CV (NCT03872401)
- Testing
- Evolocumab
- Where
- 852 sites in United States, Argentina and 31 more
- Volunteers
- 12,301 people
- Sponsor
- Amgen
Neuroblastoma
Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients
The purpose of this study was to assess the incidence of human anti-chimeric antibody (HACA) in high-risk neuroblastoma patients treated with Unituxin combination therapy.
- Trial name
- NCT02693171
- Testing
- Dinutuximab
- Where
- 18 sites in United States
- Volunteers
- 13 people
- Sponsor
- United Therapeutics
Burkitt Lymphoma, CD20-Positive Neoplastic Cells Present
Anti-CD20 Radioimmunotherapy Before Chemotherapy and Stem Cell Transplant in Treating Patients With High-Risk B-Cell Malignancies
This phase I/II trial studies the side effects and best dose of anti-cluster of differentiation (CD)20 radioimmunotherapy (RIT), and to see how well it works when given before chemotherapy and stem cell transplant in treating…
- Conditions
- Burkitt Lymphoma, CD20-Positive Neoplastic Cells Present, Diffuse Large B-Cell Lymphoma, Indolent Non-Hodgkin Lymphoma
- Trial name
- NCT02483000
- Testing
- Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein, Autologous Hematopoietic Stem Cell Transplantation, Carmustine
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Fred Hutchinson Cancer Center
Squamous Cell Carcinoma
Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients
Using focus group and cognitive interviews with organ transplant recipients, the investigators developed interactive workbooks: a) prevention by sun protection b) early detection by skin self-examination (SSE).
- Trial name
- SCCs in OTRs (NCT01127737)
- Testing
- Educational Intervention
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Northwestern University
Asthma, Wheezing
A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
This is a retrospective cohort study of children included in a large medical insurance claims database.
- Conditions
- Asthma, Wheezing, Immunosuppression
- Trial name
- NCT00626808
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 321,697 people
- Sponsor
- MedImmune LLC
Pre-Exposure Prophylaxis of HIV Infection
Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF) in preventing HIV infection, in adolescent girls and young women (AGYW).
- Trial name
- PURPOSE 1 (NCT04994509)
- Testing
- Oral Lenacapavir (LEN), Subcutaneous (SC) Lenacapavir (LEN), F/TAF
- Where
- 28 sites in South Africa, Uganda
- Volunteers
- 5,368 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Meningococcal Disease, Meningococcal Meningitis
A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults
The proposed study will evaluate the safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).
- Trial name
- NCT01478347
- Testing
- Recombinant meningococcal B + OMV NZ
- Where
- Italy
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines