Clinical trials: Safety of Intervention
Overweight, Obesity
Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents
In this 3-month pilot study, we will introduce to 40 adolescents "at risk for overweight" (i.e., a BMI/age >85th percentile) a structured meal plan consisting of meal replacements, fruits, vegetables, whole grains, lean protein…
- Trial name
- NCT00207519
- Testing
- weekly behavioral modification group, liquid meal replacements
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Boston Medical Center
Iron-deficiency Anemia, Iron-deficiency
Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study
This pilot study has 2 components: 1) a cross-sectional assessment designed to estimate the prevalence of anaemia leading to donor deferral, the prevalence of iron deficiency (ID) and iron deficiency anaemia (IDA) among…
- Trial name
- BLIS (NCT04949165)
- Testing
- Iron Supplementation
- Where
- Ghana
- Volunteers
- 223 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Children Sedation
Comparison of Chlorpromazine or Pentobarbital Premedications for Pediatric Imaging Procedures
Sedation is often required for pediatric medical imaging procedures to ensure compliance and quality images. Recommendations exist regarding pediatric sedation, but there are currently no guidelines regarding the choice of the…
- Trial name
- PREIMAPED (NCT04350528)
- Testing
- Chlorpromazine or Pentobarbital
- Where
- France
- Volunteers
- 254 people
- Sponsor
- University Hospital, Brest
Rhinitis, Allergic, Perennial and Seasonal
Regulatory AVAMYS Nasal Spray PMS
Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of AVAMYS nasal spray administered in Korean patients according to the prescribing information.
- Trial name
- NCT01001130
- Testing
- fluticasone furoate group
- Where
- South Korea
- Volunteers
- 3,244 people
- Sponsor
- GlaxoSmithKline
Venous Thromboembolism
A Study in Europe Based on Medical Records That Looks at the Safety of Dabigatran in Children Below 2 Years of Age Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot
The study is designed to collect and evaluate Dabigatran Etexilate (DE) safety in the context of routine anticoagulation care provided in the European Union (EU)/European Economic Area (EEA) for children under 2 years of age.
- Trial name
- DaPaR (NCT05536791)
- Testing
- Dabigatran Etexilate (DE)
- Where
- 6 sites in Germany, Netherlands and 2 more
- Sponsor
- Boehringer Ingelheim
Leber's Hereditary Optic Neuropathy (LHON)
Post Authorisation Safety Study With Raxone in LHON Patients
This study is a multicentre, prospective, non-interventional post-authorisation safety study (PASS) of the clinical outcomes for patients with LHON treated with Raxone®. No medication will be provided as part of this study.
- Trial name
- PAROS (NCT02771379)
- Testing
- Idebenone
- Where
- 26 sites in Austria, France and 4 more
- Volunteers
- 229 people
- Sponsor
- Santhera Pharmaceuticals
Hypochondroplasia
An Interventional Study of Infigratinib in Children With Hypochondroplasia
ACCEL2/3 is a Phase 2/3 study. The purpose of the Phase 2 portion of the study (ACCEL2/3) is to evaluate the efficacy and safety of infigratinib in children with hypochondroplasia (HCH) receiving infigratinib at one of two doses…
- Trial name
- HCH (NCT06873035)
- Testing
- infigratinib 0.128 mg/kg/day, infigratinib 0.25 mg/kg/day
- Where
- 24 sites in United States, Australia and 8 more
- Volunteers
- 24 people
- Sponsor
- QED Therapeutics, a BridgeBio company
Patient Safety
Transfer of Standard Operating Procedures in Anesthesiology
Patients safety and high Quality Performance built up the centre of anesthesiology. Standard operating procedures based on the Helsinki declaration may help to increase the Patient safety and decreased adverse Events or…
- Trial name
- QUALI-II (NCT04800796)
- Testing
- Audiovisual
- Where
- Germany
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Johannes Gutenberg University Mainz
Hypothalamic Obesity, Hypothalamic Tumor
Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity
Hypothalamic obesity (HO) refers to the substantial weight gain that often complicates hypothalamic brain tumors. Children with this treatment-recalcitrant form of obesity have excess rates of metabolic sequelae compared to…
- Conditions
- Hypothalamic Obesity, Hypothalamic Tumor, Craniopharyngioma
- Trial name
- NCT06299891
- Testing
- Phentermine / Topiramate Extended Release Oral Capsule [Qsymia]
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Seattle Children's Hospital
Gun Violence Prevention
Distribution and Randomization of Gun Safety Devices to Measure Uptake and Preferences
This study aims to enhance workplace safety by implementing a firearm safety program at Penn Medicine Pennsylvania Hospital (PAH). The option to store firearms securely during visits is offered to firearm owners.
- Trial name
- NCT06682403
- Testing
- Received cable lock as default, Choice between cable lock or lock box
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Respiratory Syncytial Virus Infections
A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV
The purpose of the study is to learn about the safety and amount of sisunatovir in the blood of infants and children up to age 60 months.
- Trial name
- NCT06102174
- Testing
- Active
- Where
- 9 sites in United States, Japan and 1 more
- Volunteers
- 10 people
- Sponsor
- Pfizer
Robotic Surgical Procedures, Spinal Surgery
Clinical Trial for the Application of Robotic System in Spinal Surgery
This randomized controlled study was designed to evaluate the accuracy, safety and clinical outcomes of the robot assisted spinal surgery.
- Conditions
- Robotic Surgical Procedures, Spinal Surgery, Safety
- Trial name
- NCT03512379
- Testing
- TIANJI Robot, Fluoroscopy, Navigation
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Beijing Jishuitan Hospital
Clostridium Difficile
To Determine the Feasibility of a Fidaxomicin Study in Neonates and to Assess C. Difficile (Clostridium Difficile) Involvement in the Pathogenesis
The objective of this multi-center, prospective observational study is to determine the feasibility of a potential interventional study with fidaxomicin.
- Trial name
- DAISY (NCT01533844)
- Where
- 9 sites in France, Germany and 2 more
- Volunteers
- 1 people
- Sponsor
- Astellas Pharma Europe B.V.
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Coronavirus Disease 2019 (COVID-19)
A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People With Weakened Immune Systems or at Increased Risk for Poor Outcomes Who Are Hospitalized Due to Severe COVID-19
A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People with Weakened Immune Systems or at Increased Risk for Poor Outcomes who are Hospitalized Due to Severe COVID-19
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Coronavirus Disease 2019 (COVID-19), Immunocompromised, Hospitalization
- Trial name
- EPIC-HOS (NCT05545319)
- Testing
- Nirmatrelvir, Ritonavir
- Where
- 11 sites in United States, Bulgaria
- Sponsor
- Pfizer
Diabetes, Diabetes Mellitus, Type 1
A Non-interventional, Post Marketing Surveillance (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India
This study is conducted in Asia. The aim of the study is to evaluate long term safety and efficacy of Tresiba® (insulin degludec) in patients with diabetes mellitus in routine clinical practice in India.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Trial name
- NCT02117622
- Testing
- insulin degludec
- Where
- 38 sites in India
- Volunteers
- 1,056 people
- Sponsor
- Novo Nordisk A/S
Menorrhagia, Dysmenorrhea
Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea
The primary objective in this study is collecting post-marketing information on the safety. Thus, it includes information under the routine clinical practice on adverse events (AEs) and adverse drug reactions (ADRs) including…
- Trial name
- J-MIRAI (NCT02475356)
- Testing
- Levonorgestrel IUS (Mirena, BAY86-5028)
- Where
- Japan
- Volunteers
- 601 people
- Sponsor
- Bayer
Salmonella Infections
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants
The purpose of this study is to evaluate the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid…
- Trial name
- NCT07286370
- Testing
- Low dose of iNTS-TCV, Full dose of iNTS-TCV, TYPHIBEV
- Where
- The Gambia
- Volunteers
- 537 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Suicidal Ideation, Suicidal Behaviors
Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study
The goal of this study is to finalize a version of the Safety Planning Intervention suitable for 6-12-year-old children. This intervention provides individuals with strategies to reduce the risk of suicidal behavior.
- Trial name
- NCT07564583
- Testing
- Child - Safety Planning Intervention, C-SPI+ecological momentary assessment
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Columbia University
Hepatitis C, Chronic
Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon
Title Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin with or without Interferon among Pakistani Population: A real life trial Hepatitis Eradication Accuracy Trial of Sofosbuvir (HEATS) Study Design Endpoint…
- Trial name
- HEATS (NCT02804386)
- Testing
- Sofosbuvir
- Where
- Pakistan
- Volunteers
- 573 people
- Sponsor
- PharmEvo Pvt Ltd
Malaria
A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months
The purpose of this study is to evaluate the safety and immunogenicity of reduced antigen doses and alternative vaccination regimes for RTS,S/AS01E in healthy children aged 5-60 months in a malaria-endemic area.
- Trial name
- NCT07036159
- Testing
- RTS,S/AS01E vaccine
- Where
- 2 sites in Rwanda
- Volunteers
- 238 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline