Clinical trials: Risk Management
Renal Transplantation
Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients
The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g.
- Trial name
- NCT00154297
- Testing
- Everolimus (RAD001)
- Where
- Switzerland
- Volunteers
- 139 people
- Sponsor
- Novartis Pharmaceuticals
Sarcopenia, Gait Disorders in Old Age
A Double-blind, Placebo-controlled, Randomized INTerventional Clinical Trial (SARA-INT)
The main objective of the study is to evaluate the effect of two daily doses of BIO101 versus placebo on mobility function as measured by gait speed using the 400MW test.
- Conditions
- Sarcopenia, Gait Disorders in Old Age, Muscle Weakness
- Trial name
- SARA-INT (NCT03452488)
- Testing
- BIO101
- Where
- 22 sites in United States, Belgium
- Volunteers
- 233 people
- Sponsor
- Biophytis
Gastric Ulcer
A Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers
Primary: To demonstrate that PA32540 causes fewer gastric ulcers in subjects at risk for developing aspirin-associated gastric ulcers compared to enteric coated (EC) aspirin 325 mg.
- Trial name
- NCT00961350
- Testing
- PA32540, EC Aspirin 325
- Where
- United States
- Volunteers
- 530 people
- Sponsor
- POZEN
Tumor Lysis Syndrome, Cancer
Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
This is a randomized, multi-center, open-label, parallel group study with three arms: Rasburicase alone Rasburicase followed by Allopurinol Allopurinol alone The primary objective is to compare the adequacy of control of plasma…
- Conditions
- Tumor Lysis Syndrome, Cancer, Hyperuricemia
- Trial name
- NCT00230178
- Testing
- Rasburicase (SR29142), Allopurinol
- Where
- 15 sites in United States
- Volunteers
- 280 people
- Sponsor
- Sanofi
Antithrombin Deficiency, Congenital
Assess Incidence of Deep Vein Thrombosis(DVT)Following Administration of Recombinant Human Antithrombin (rhAT) to Hereditary Antithrombin(AT) Deficient Patients in High Risk Situations.
Patients with hereditary antithrombin (AT) deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures.
- Trial name
- rhAT (NCT00056550)
- Testing
- Recombinant Human Antithrombin (rhAT)
- Where
- 11 sites in United States, France and 4 more
- Volunteers
- 14 people
- Sponsor
- rEVO Biologics
Engagement, Patient, Mood
SimpleC Wellness Platform With Social Robot Interaction
This implementation study will be conducted to test a Socially-Assistive Robot (SAR) system for residents in an Assisted Living environment. The goal of the SAR system is to enhance social engagement and connectedness.
- Conditions
- Engagement, Patient, Mood, Quality of Life, Aging
- Trial name
- NCT05296239
- Testing
- SimpleC Wellness Platform with Social Robot Interaction
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- SimpleC, LLC
Severe Hypertriglyceridemia (sHTG)
Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis
The primary objective is to determine the change in Triglyceride (TG) levels following 12 weeks of repeated Intravenous (IV) doses of evinacumab.
- Trial name
- NCT03452228
- Testing
- evinacumab
- Where
- 17 sites in United States, Canada and 2 more
- Volunteers
- 52 people
- Sponsor
- Regeneron Pharmaceuticals
COVID-19
COVID-19 Administration of Single-Dose Subcutaneous Anti- Spike(s) SARS-CoV-2 Monoclonal Antibodies Casirivimab and Imdevimab in High-Risk Pediatric Participants Under 12 Years of Age
The primary objective of the study is to characterize the concentrations of casirivimab+imdevimab in serum over time after a single subcutaneous (SC) administration The secondary objectives of the study are: To assess the safety…
- Trial name
- NCT04992273
- Testing
- casirivimab+imdevimab
- Where
- 7 sites in United States
- Volunteers
- 7 people
- Sponsor
- Regeneron Pharmaceuticals
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
Pneumococcal Infections
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)
This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal disease and to 2) describe the safety…
- Trial name
- NCT03547167
- Testing
- V114, Prevnar 13™, PNEUMOVAX™23
- Where
- 78 sites in United States, Australia and 5 more
- Volunteers
- 1,515 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia, Coronary Arteriosclerosis
Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)
This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe 10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian population with primary hypercholesterolemia.
- Trial name
- NCT00319449
- Testing
- Ezetimibe, Atorvastatin 10 mg
- Volunteers
- 22 people
- Sponsor
- Organon and Co
Atrial Fibrillation, Heart Failure
Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure
The purpose of this study is to characterize the feasibility and impact of a diagnostic tool that may help clinicians identify when patients are at higher risk of visiting the hospital for a heart failure event.
- Trial name
- IDENTIFY-HF (NCT01486316)
- Testing
- Reveal XT® Insertable Cardiac Monitor, Heart Failure Risk Status Diagnostic
- Where
- 11 sites in United States
- Volunteers
- 24 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Myelodysplastic Syndrome, Transfusional Iron Overload
Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study
The objective of the study is to evaluate and compare the frequency and severity of GI adverse events in different dose administration regimens.
- Trial name
- MACS1574 (NCT01326845)
- Testing
- Deferasirox
- Where
- 10 sites in France, Italy and 2 more
- Volunteers
- 12 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma
Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600)
Patients with malignant melanoma who had undergone surgery will receive adjuvant treatment with high-dose Intron A for one year.
- Trial name
- NCT00723710
- Testing
- Intron A (interferon alfa-2b; SCH 30500)
- Volunteers
- 299 people
- Sponsor
- Merck Sharp & Dohme LLC
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections
This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis (CT)…
- Conditions
- Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection, Mycoplasma Genitalium Infection
- Trial name
- NCT06369220
- Testing
- cobas® liat CT/NG/MG nucleic acid test, Standard of Care (SOC): Clinician's Standard Practice
- Where
- 4 sites in United States
- Volunteers
- 331 people
- Sponsor
- Hoffmann-La Roche
Gastric Ulcer
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at…
- Trial name
- NCT00527787
- Testing
- PN400 (VIMOVO), Naproxen
- Where
- United States
- Volunteers
- 434 people
- Sponsor
- POZEN
HIV Infections, Dyslipidemias
Efprezimod Alfa (CD24Fc, MK-7110) Administration to Decrease Low-Density Lipoprotein (LDL) and Inflammation in Human Immunodeficiency Virus (HIV) Patients (CALIBER) (MK-7110-003)
This is a phase 2, randomized, double-blinded, placebo-controlled clinical trial. The intervention drug will be efprezimod alfa (intravenous [IV] infusion).
- Trial name
- CALIBER (NCT03960541)
- Testing
- Efprezimod alfa (human CD24 extracellular domain and human IgG1 Fc fusion protein), Saline Solution
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Metabolic Diseases, Hyperlipidemias
Safety and Efficacy Study of ISIS 301012 (Mipomersen) Administration in High Risk Statin Intolerant Subjects
The purpose of this study is to determine safety and efficacy of mipomersen (ISIS 301012) in the reduction of total cholesterol, low density lipoprotein cholesterol (LDL-C), and apolipoprotein B (apoB) in high risk subjects…
- Conditions
- Metabolic Diseases, Hyperlipidemias, Metabolic Disorder, Hypercholesterolemia
- Trial name
- ASSIST (NCT00707746)
- Testing
- mipomersen
- Where
- Netherlands
- Volunteers
- 34 people
- Sponsor
- Kastle Therapeutics, LLC
Gastric Ulcer
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at…
- Trial name
- NCT01129011
- Testing
- PN400 (VIMOVO), Naproxen
- Volunteers
- 420 people
- Sponsor
- POZEN
Contrast Media
Primovist / Eovist in Renally Impaired Patients
Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to participate.
- Trial name
- PERI (NCT00908596)
- Testing
- Gadoxetic acid disodium (Primovist, BAY86-4873)
- Where
- 47 sites in United States, Australia and 7 more
- Volunteers
- 357 people
- Sponsor
- Bayer