Clinical trials: Risk Management
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
Superficial Esophageal Cancer
A Study to Evaluate the Esophageal Stenosis Inhibition Effects of CLS2702C/CLS2702D After Endoscopic Submucosal Dissection (ESD) in Patients With Superficial Esophageal Cancer in the Steroid Administration Risk Group
The purpose of this study is to evaluate the efficacy and safety of esophageal epithelial regenerative treatment by the transplantation of the product, CLS2702C, to the esophageal wound site after extensive ESD for superficial…
- Trial name
- NCT04689594
- Testing
- CLS2702C/CLS2702D
- Where
- Japan
- Volunteers
- 1 people
- Sponsor
- CellSeed Inc.
Prostate Cancer
Focal ExAblate MR-Guided Focused Ultrasound Treatment for Management of Organ-Confined Intermediate Risk Prostate Cancer
This study is intended to show that ExAblate™ MRgFUS is a safe procedure that can significantly postpone or eliminate the need of patients with organ confined intermediate risk prostate cancer to undergo a definitive treatment…
- Trial name
- NCT02968784
- Testing
- ExAblate MRgFUS
- Where
- 4 sites in Canada, China and 1 more
- Volunteers
- 53 people
- Sponsor
- InSightec
Diabetes Mellitus, Type 2, Cardiovascular Diseases
Clinical Utility of a Genomic Predictor Test on the Management of Cardiorenal Complications of Type 2 Diabetes
The goal of this pragmatic trial is to provide Real World Evidence (RWE) on the impact of the result of a polygenic risk prediction test of cardiorenal complications of T2D, so that more patients at high risk of these…
- Conditions
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Diabetic Nephropathy Type 2
- Trial name
- GENOCORDIA (NCT06586203)
- Testing
- Polygenic Risk Score
- Where
- 2 sites in Canada
- Volunteers
- 2,714 people
- Sponsor
- Optithera
Cisplatin Induced Hearing Loss
Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss
This is a multicenter, Phase 2 study to assess the feasibility, safety and efficacy of OTO-104 given by intratympanic administration in subjects at risk for ototoxicity from cisplatin chemotherapy regimens in the treatment of…
- Trial name
- NCT02997189
- Testing
- OTO-104
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Otonomy, Inc.
Diabetes Mellitus, Type 1, Autoimmune Diseases
Study to Evaluate the Safety and Feasibility of Diamyd® in Individuals at Risk for Type 1 Diabetes
A 2-arm randomized Phase II Open Label Study to evaluate the safety and feasibility of intralymphatic administration of Diamyd® (Diamyd) also known as retogatein in individuals at risk of Type 1 diabetes carrying the HLA DR3-DQ2…
- Conditions
- Diabetes Mellitus, Type 1, Autoimmune Diseases, Prevention
- Trial name
- NCT05683990
- Testing
- Diamyd
- Where
- Sweden
- Volunteers
- 5 people
- Sponsor
- Diamyd Medical AB
Longitudinal Studies, Prospective Studies
Clinical Time and Temporal Dynamics Study (CLIN-TIME)
TH-CLINICAL-TIME is a prospective, longitudinal observational study evaluating how changes in clinical measurements over time may help researchers better understand patient health trajectories and clinically meaningful outcomes.
- Conditions
- Longitudinal Studies, Prospective Studies, Biomarkers, Predictive Value of Tests
- Trial name
- CLIN-TIME (NCT07812831)
- Testing
- No Study-Assigned Intervention
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Truway Health, Inc.
Oral Mucositis Due to Radiation, Radiation Dermatitis
Feasibility and Safety of CareMin650 in Patients at Risk of or Suffering From Oral Mucositis and/or Radiation Dermatitis
The main objective of the present study is to investigate the feasibility, safety and tolerability of CareMin650 in patients with 1) head \& neck cancer at high risk of or suffering from oral mucositis and/or radiation dermatitis…
- Trial name
- SafePBM (NCT03988556)
- Testing
- Photobiomodulation using CareMin650 at 6 Joules (curative intent), Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)
- Where
- 5 sites in France
- Volunteers
- 72 people
- Sponsor
- NeoMedLight
Hypertension, Hypercholesterolemia
Caduet vs Usual Care in Subjects With Hypertension and Additional Risk Factors
To investigate whether a Caduet based treatment strategy might result in greater reduction in total cardiovascular risk as compared to usual care in subjects with hypertension and additional risk factors.
- Trial name
- CRUCIAL (NCT00407537)
- Testing
- Amlodipine besylate/atorvastatin calcium single pill combination
- Where
- 125 sites in Costa Rica, Croatia and 18 more
- Volunteers
- 1,531 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Cytochrome P450 CYP2D6 Enzyme Deficiency, Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant
Drug & Gene Interaction Risk Analysis With & Without Genetic Testing Among Patients Undergoing MTM
This randomized controlled trial will evaluate whether the use of pharmacogenetic testing through a Medication Therapy Management (MTM) program has a beneficial impact on drug therapy problems.
- Conditions
- Cytochrome P450 CYP2D6 Enzyme Deficiency, Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Ultrarapid Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Extensive Metabolizer Due to Cytochrome P450 CYP2D6 Variant
- Trial name
- NCT02428660
- Testing
- Pharmacogenetic testing, Software-based drug & gene interaction risk analysis, MTM
- Where
- United States
- Volunteers
- 341 people
- Sponsor
- Genelex Corporation
Migraine Disorders, Refractory Migraine
EMBRACE Study: Enduring Migraine Benefit From Responsive Artery Coil Embolization
This single-site, open-label pilot study evaluates the safety, feasibility, and potential durability of the TEMMA procedure (Targeted Embolization for Migraine Management), an endovascular treatment strategy targeting meningeal…
- Conditions
- Migraine Disorders, Refractory Migraine, Chronic Migraine
- Trial name
- EMBRACE (NCT07313800)
- Testing
- TEMMA Endovascular Treatment
- Where
- United States
- Sponsor
- Cortex Neurovascular
Type 2 Diabetes, Metabolic Syndrome
Clinical Study on the Effect of a Synbiotic on Body Fat Mass
In this trial the effect of a synbiotic consisting of the three different strains of Lactobacillus fermentum and acacia gum (gum arabic) on body fat mass, body weight, long-term glycemia, insulin resistance and other risk factors…
- Conditions
- Type 2 Diabetes, Metabolic Syndrome, Obesity, Abdominal, Obesity, Visceral
- Trial name
- NCT04754464
- Testing
- synbiotic, microcrystalline cellulose
- Where
- 2 sites in Austria, Germany
- Volunteers
- 120 people
- Sponsor
- Slimbiotics GmbH
Osteoporosis
Improving Management of Patients at High Risk for Osteoporotic Fractures (0000-038)
The purpose of this study is to assess the impact of disease management interventions on percent receiving a bone densitometry test and percent appropriately prescribed a medication for osteoporosis.
- Trial name
- NCT00139438
- Testing
- Disease Management Assessment
- Volunteers
- 4,266 people
- Sponsor
- Merck Sharp & Dohme LLC
Cardiovascular Risk Factors, Cardiovascular Diseases
Management of Cardiovascular Risk Factors
This practical experience should report a retrospective collection of data regarding cardiovascular risk factors of cardiovascular diseases.
- Trial name
- NCT00848380
- Where
- 36 sites in Switzerland
- Volunteers
- 1,492 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Heart Failure, Congestive
FUSION I Assesses Safety and Tolerability of Two Doses of NATRECOR (Nesiritide) Administered to Patients With Worsening Congestive (Decompensated) Heart Failure Who Are Concurrently Receiving Their Usual Cardiac Medications and Are at High Risk for Hospitalization.
The purpose of this study is to assess the safety and tolerability of two doses of nesiritide (a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) when administered…
- Trial name
- NCT00270361
- Testing
- nesiritide, usual long term cardiac medications
- Volunteers
- 214 people
- Sponsor
- Scios, Inc.
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
Type 2 Diabetes Mellitus
Telemonitoring System Study in Participants With Type 2 Diabetes Mellitus (MK-0000-347)
The primary goal is to evaluate whether a home telehealth system that enables the participant to monitor their body weight, blood glucose values and blood pressure values, associated with remote educational support and feedback…
- Trial name
- NCT02194608
- Testing
- Home telehealth system
- Volunteers
- 500 people
- Sponsor
- Merck Sharp & Dohme LLC
Bladder Neoplasms
Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-refractory Patients With Non-muscle Invasive Bladder Cancer
The purpose of this study is to determine the efficacy and safety of intravesical Mycobacterial Cell Wall-DNA Complex (MCC) in patients with non-muscle invasive transitional cell carcinoma (papillary tumors and/or carcinoma in…
- Trial name
- NCT00406068
- Testing
- Mycobacterial cell wall-DNA complex
- Where
- 31 sites in United States, Canada
- Volunteers
- 129 people
- Sponsor
- Bioniche Life Sciences Inc.
Hypercholesterolemia
Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR)
The purpose of this study is to compare the efficacy and safety of rosuvastatin with simvastatin and atorvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia
- Trial name
- SOLAR (NCT00654173)
- Testing
- Rosuvastatin, Simvastatin, Atorvastatin
- Volunteers
- 4,444 people
- Sponsor
- AstraZeneca
Fungus Diseases
PROPHESSOR: AmBisome in Antifungal Primary Prophylaxis Treatment of High Risk Patients Undergoing Allogeneic Stem Cell Transplantation
This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome® loading dose regimen, in a weekly administration schedule during the initial phase of allogeneic stem-cell transplant and in case of…
- Trial name
- NCT00326157
- Testing
- AmBisome
- Where
- Italy
- Volunteers
- 34 people
- Sponsor
- Gilead Sciences