Clinical trials: High-risk
Influenza
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
The primary objective of the study was to provide sera (collected from participants before vaccination [Blood Sample 1] and after final vaccination [Blood Sample 2]) to the Center for Biologics Evaluation and Research (CBER) for…
- Trial name
- GRC00097 (NCT04109222)
- Testing
- Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation, Fluzone High-Dose vaccine, 2019-2020 formulation
- Where
- 2 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Prostate Cancer
Clinical Data Collection of Patients Treated With High Intensity Focused Ultrasound (HIFU) by the Focal One for Their Prostate Cancer.
The aim of the registry is to gather real-life data to evaluate the clinical performance and safety of medical devices in patients who have been treated with HIFU thank to the Focal One device for their prostate cancer.
- Trial name
- One registry (NCT07645872)
- Where
- 5 sites in France
- Volunteers
- 3,000 people
- Sponsor
- EDAP TMS S.A.
Locally Advanced Cervical Cancer
Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)
This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have…
- Trial name
- eVOLVECervical (NCT06079671)
- Testing
- Volrustomig
- Where
- 205 sites in United States, Brazil and 17 more
- Volunteers
- 800 people
- Sponsor
- AstraZeneca
Immunity
A Clinical Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on Gut Microbiota Composition and Clinical Effectiveness in Infants at High Risk of Developing Allergy
With the rising prevalence of allergic diseases and the subsequent risk of developing other immune-related disorders, primary prevention of allergy has become a major priority.
- Trial name
- TEMPO (NCT03067714)
- Testing
- Infant formula with added synbiotics, Standard infant formula
- Where
- 59 sites in Belgium, Czechia and 11 more
- Volunteers
- 855 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Stable Angina (SA), NSTE-ACS (NSTEMI and UA)
Utilisation of Angiox® in European Practice
The objective of this study is to determine utilisation patterns in patients receiving Angiox® in participating European centres.
- Conditions
- Stable Angina (SA), NSTE-ACS (NSTEMI and UA), STEMI (STE-ACS)
- Trial name
- EURO-vision (NCT01011504)
- Where
- 2 sites in France, Germany
- Volunteers
- 2,019 people
- Sponsor
- The Medicines Company
Cardiovascular Disease With Mention of Arteriosclerosis, Elevated Cholesterol
Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction
The study is to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W [<31 days]) dosing of subcutaneous (SC) LIB003 300 mg administered in patients with CVD or at high risk for CVD…
- Conditions
- Cardiovascular Disease With Mention of Arteriosclerosis, Elevated Cholesterol, Familial Hypercholesterolemia
- Trial name
- LIBerate-OLE (NCT04798430)
- Testing
- lerodalcibep
- Where
- 12 sites in United States, India and 4 more
- Volunteers
- 2,000 people
- Sponsor
- LIB Therapeutics LLC
Asthma
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
This is a randomised, double-blind, parallel group, placebo-controlled study designed to evaluate the efficacy and safety of a fixed 30 mg dose of benralizumab administered subcutaneously for patients with a history of asthma…
- Trial name
- NCT03186209
- Testing
- Benralizumab
- Where
- 79 sites in China, Philippines and 2 more
- Volunteers
- 695 people
- Sponsor
- AstraZeneca
Asthma
Evaluating the Efficacy and Safety of Fluticasone Furoate in the Treatment of Asthma in Adults and Adolescents
A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high…
- Trial name
- NCT01431950
- Testing
- fluticasone furoate, albuterol/salbutamol
- Where
- 40 sites in United States, Argentina and 4 more
- Volunteers
- 238 people
- Sponsor
- GlaxoSmithKline
Nutrition Disorders
Acceptability and Tolerance Study of a Plant-based Tube Feed
This is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 7-day period with a plant based tube feed.
- Trial name
- NCT06209593
- Testing
- Compleat plant protein tube feed
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Société des Produits Nestlé (SPN)
Bronchopulmonary Dysplasia
Safety and Efficacy of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD) - a US Study
PNEUMOSTEM® consists of ex vivo cultured allogeneic, unrelated, human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) and it is intended for use as a cellular therapy product for prevention of Bronchopulmonary…
- Trial name
- NCT02381366
- Testing
- Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Medipost, Inc.
Malignant Glioma
Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma
The objective of this study is to determine the survival status of patients enrolled in study GLI01S (all-case observational study).
- Trial name
- NCT02300506
- Testing
- No intervention
- Where
- 2 sites in Japan
- Volunteers
- 507 people
- Sponsor
- Eisai Co., Ltd.
Neuroblastoma
N2007-01: Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma
RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIBG), may carry radiation directly to tumor cells and not harm normal cells.
- Trial name
- NCT00659984
- Testing
- UltratraceTM Iobenguane I 131 Imaging, UltratraceTM Iobenguane I 131 Therapy
- Where
- 8 sites in United States
- Volunteers
- 15 people
- Sponsor
- Molecular Insight Pharmaceuticals, Inc.
Neuroblastoma
Efficacy and Safety of Ultratrace™ Iobenguane I 131 in Neuroblastoma
This is a multi-center, single arm trial of two doses of 18 mCi/kg of Ultratrace iobenguane I 131 administered to subjects with high-risk neuroblastoma.
- Trial name
- NCT00992173
- Testing
- Ultratrace Iobenguane I 131
- Where
- 21 sites in United States, Canada
- Sponsor
- Molecular Insight Pharmaceuticals, Inc.
Neuroblastoma
Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and…
- Trial name
- NCT03363373
- Testing
- GM-CSF + Naxitamab
- Where
- 20 sites in United States, Canada and 7 more
- Volunteers
- 122 people
- Sponsor
- Y-mAbs Therapeutics
Hepatitis C, Chronic, Hepatitis C
Safety and Efficacy of PegIntron Plus Rebetol in Patients With Chronic Hepatitis C in Japan, Excluding (1) Subjects With HCV Genotype 1 and High Viral Load, and (2) Interferon-naïve Subjects With Low Viral Load (Study P04841)(COMPLETED)
The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C.
- Trial name
- NCT00724230
- Testing
- PegIntron (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- Volunteers
- 505 people
- Sponsor
- Merck Sharp & Dohme LLC
Melanoma
Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)
This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma.
- Trial name
- NCT03553836
- Testing
- Pembrolizumab
- Where
- 159 sites in United States, Australia and 14 more
- Volunteers
- 976 people
- Sponsor
- Merck Sharp & Dohme LLC
Oral Neoplasm
Early Prediction of Oral Cancer by S100A7 Immunohistochemistry Signature-based Assessment
The purpose of this observational study is to evaluate the utility of the S100A7 immunohistochemistry signature-based assessment - STRATICYTE - in determining the risk of progression to cancer of clinically suspicious oral…
- Trial name
- NCT04622462
- Testing
- Standard of Care Histopathology, STRATICYTE Assessment
- Where
- 3 sites in Canada
- Volunteers
- 500 people
- Sponsor
- Proteocyte Diagnostics Inc.
Hyperkalemia
Effect of Patiromer in Children Under 12 Years of Age With High Blood Potassium Levels
A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.
- Trial name
- EMERALD2 (NCT05766839)
- Testing
- Patiromer
- Where
- 37 sites in United States, Australia and 13 more
- Volunteers
- 36 people
- Sponsor
- Vifor Pharma, Inc.
Cardiovascular Diseases, Microvascular Complications
Non-invasive Microvascular Assessment in Individuals at High Risk of Cardiovascular Disease From the SCAPIS2 Study
Microvascular dysfunction, particularly endothelial dysfunction, is increasingly recognized as a key mechanism underlying various cardiovascular diseases (CVD), including heart failure, ischemic heart disease, atherosclerosis…
- Trial name
- NCT07359768
- Where
- Sweden
- Volunteers
- 900 people
- Sponsor
- HJN Sverige AB/Neko Health
Enteral Nutrition, Cancer
2kcal Tube Feed Study
The primary aim of this study is to investigate the effects of a plant-based, high energy, high protein tube feed with and without inclusion of fibre on gastrointestinal tolerance in adult patients who require nutritional support…
- Trial name
- NCT05411848
- Testing
- 2kcal HP PlantBased
- Where
- United Kingdom
- Volunteers
- 42 people
- Sponsor
- Nutricia UK Ltd