Clinical trials: Risk Assessment
- Condition Risk Assessment
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
SARS-CoV Infection, Covid19
A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2
This is a phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants and adolescent participants.
- Trial name
- NCT04611802
- Testing
- SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
- Where
- 154 sites in United States, Mexico and 1 more
- Volunteers
- 33,000 people, healthy volunteers welcome
- Sponsor
- Novavax
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD).
- Trial name
- NCT02476994
- Testing
- Clinolipid, Intralipid
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Baxter Healthcare Corporation
Suicidality
A Study to Assess the Validation and Mapping of the Suicide Ideation and Behavior Assessment
The main purpose of this cross-sectional study is to generate data to support the psychometric properties of the Suicide Ideation and Behavior Assessment Tool (SIBAT) and validate its use in participants at imminent risk of…
- Trial name
- NCT03085108
- Testing
- No Intervention
- Where
- 4 sites in United States
- Volunteers
- 130 people
- Sponsor
- Janssen Scientific Affairs, LLC
Pressure Ulcers
A Pilot Study of the Envision® Surface
This study is to evaluate the clinical safety and effectiveness of the Envision® surface.
- Trial name
- NCT00405834
- Testing
- Envision® Patient Support System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Hill-Rom
Renal Insufficiency
Evaluation of the Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents (GBCA)
The objective of this long term study is to prospectively evaluate the incidence of NSF in patients with severe CKD or kidney failure including patients undergoing dialysis (stages 4 and 5 i.e., with an eGFR below 30)who have not…
- Trial name
- NCT00773409
- Where
- United States
- Volunteers
- 405 people
- Sponsor
- Bracco Diagnostics, Inc
ACUTE LYMPHOBLASTIC LEUKEMIA
A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL
This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and <18 years)…
- Trial name
- NCT05748171
- Testing
- Inotuzumab ozogamicin, ALLR3
- Where
- 65 sites in Austria, Belgium and 13 more
- Volunteers
- 100 people
- Sponsor
- Pfizer
HIV Preexposure Prophylaxis
Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Are at High Risk for HIV-1 Infection (MK-8591-024)
The main purpose of the study is to evaluate the safety and tolerability of oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP) in cisgender men who have sex with men (MSM) and transgender women (TGW) who…
- Trial name
- Impower-024 (NCT04652700)
- Testing
- ISL, FTC/TDF, FTC/TAF
- Where
- 25 sites in United States, Brazil and 5 more
- Volunteers
- 494 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Candidiasis, Candidemia
Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection
In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down.
- Trial name
- NCT00739934
- Testing
- voriconazole (Vfend)
- Where
- 14 sites in United States
- Volunteers
- 40 people
- Sponsor
- Pfizer
Acute Lymphoblastic Leukaemia, Acute Myeloid Leukaemia
Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression
The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of orally administered AZD3632 in participants with advanced haematologic…
- Conditions
- Acute Lymphoblastic Leukaemia, Acute Myeloid Leukaemia, Higher-risk Myelodysplastic Syndromes
- Trial name
- MOMENTUM (NCT07155226)
- Testing
- AZD3632, Posaconazole
- Where
- 30 sites in United States, Australia and 7 more
- Volunteers
- 85 people
- Sponsor
- AstraZeneca
Opioid-related Disorders, Opioid Addiction
ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning
Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency Department visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02866266
- Testing
- Retrospective database review
- Volunteers
- 183,452 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Cardiomyopathies, Cardiac Arrest
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
WILLEM is a multi-center, prospective and retrospective cohort study. The study will assess the performance of a cloud-based and AI-powered ECG analysis platform, named Willem™, developed to detect arrhythmias and other abnormal…
- Conditions
- Cardiomyopathies, Cardiac Arrest, Cardiac Arrhythmias, Sudden Cardiac Death
- Trial name
- WILLEM (NCT05890716)
- Testing
- AI-powered ECG analysis to detect cardiac arrhythmic episodes
- Where
- 13 sites in Netherlands, Spain
- Volunteers
- 5,342 people, healthy volunteers welcome
- Sponsor
- Idoven 1903 S.L.
Graft Failure
Study to Investigate the Pharmacokinetics, Pharmacodynamics and Assess the Efficacy and Safety to Support Dose Selection of Emapalumab in Pre-empting Graft Failure in Patients at High Risk After HSCT.
This study is designed as an open-label, single arm, proof of concept study in order to determine the appropriate emapalumab dosing regimen neutralizing IFNγ in patients at risk of GF.
- Trial name
- NCT04731298
- Testing
- Emapalumab
- Where
- 5 sites in Australia, Canada and 1 more
- Volunteers
- 2 people
- Sponsor
- Swedish Orphan Biovitrum
Pharmacokinetics
A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents
This study is designed to collect additional pharmacokinetic and safety data of voriconazole in immunocompromised adolescents receiving intravenous and oral voriconazole.
- Trial name
- NCT00556998
- Testing
- Voriconazole
- Where
- 9 sites in United States
- Volunteers
- 26 people
- Sponsor
- Pfizer
Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia
A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301)
LATITUDE: A Phase 3, Randomized, Open-Label, 3-Cohort, 2-Period, 2- Sequence, Crossover Trial to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Arsenic Trioxide Versus Intravenous Arsenic Trioxide for Consolidation…
- Conditions
- Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia, Acute Promyelocytic Leukemia With PML-RARA, Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA
- Trial name
- LATITUDE (NCT07296445)
- Testing
- Oral ATO, IV Arsenic Trioxide, all-trans retinoic acid (ATRA)
- Volunteers
- 120 people
- Sponsor
- SDK Therapeutics, Inc.
Retinopathy of Prematurity (ROP)
Safety, PK and PD of FLQ-101 in Premature Neonates
The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.
- Trial name
- tROPhy-1 (NCT07093255)
- Testing
- FLQ-101
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- FELIQS INC.
Diabetes, Diabetes Mellitus, Type 1
An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes
This study is conducted in the United States of America (USA). The aim of the study is to assess longitudinal variation of immune biomarkers in subjects at risk for development of type 1 diabetes (T1D).
- Trial name
- NCT01846312
- Testing
- No treatment given
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Fibrosing Colonopathy
Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)
This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of…
- Trial name
- NCT01652157
- Testing
- ULTRESA, PANCREAZE, CREON
- Where
- 123 sites in United States
- Volunteers
- 17 people
- Sponsor
- AbbVie
Amblyopia
Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
Objective: Prospective evaluation of GoCheckKids™, a smartphone application ('App') as a photo screening device in a pediatric population to detect amblyopia risk factors (ARFs) Method: Photorefraction images are captured using…
- Trial name
- NCT03119675
- Testing
- GoCheck Kids (iOS), GoCheck Kids (Windows)
- Volunteers
- 358 people
- Sponsor
- Gobiquity Mobile Health
Pre-Exposure Prophylaxis of HIV Infection
Pre-Exposure Prophylaxis Study of Lenacapavir in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People at Risk for HIV Infection
The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) in preventing HIV infection, in participants ≥ 16 years of age who have condomless receptive anal sex with partners assigned male at birth…
- Trial name
- PURPOSE 2 (NCT04925752)
- Testing
- Oral Lenacapavir (LEN), F/TDF, Sub-cutaneous (SC) Lenacapavir (LEN)
- Where
- 93 sites in United States, Argentina and 6 more
- Volunteers
- 3,292 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Dermatitis, Allergic Contact, Infectious Diseases
Incidence of Allergic Manifestations and Infectious Episodes in Healthy Term Infants at Risk for Dysbiosis
This study will evaluate the incidence of allergic manifestations (the first of which is atopic dermatitis) and infectious diseases in children fed with an infant formula under real conditions of use.
- Trial name
- SOPRANO (NCT04182425)
- Testing
- Infant formula
- Where
- France
- Volunteers
- 334 people, healthy volunteers welcome
- Sponsor
- Bledina