Clinical trials: High Risk Medications
Coronary Artery Disease
Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk
This study is designed to investigate whether scoring balloon (non-slip element, NSE) predilation compared to non-compliant (NC) balloon predilation for de novo lesion in patients with high bleeding risk and planning to receive…
- Trial name
- PREPARE-NSE (NCT03817801)
- Testing
- NSE balloon, NC balloon
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Chronic Diseases in Children
Food as Medicine Study
The Food as Medicine (FAME) intervention aims to improve dietary quality in lower income, primarily ethnic minority youth through food navigation that bridges clinical care and community food resources.
- Trial name
- FAME (NCT07162350)
- Testing
- Food Navigation
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Parkland Health and Hospital System
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
Birth Defects, Pregnancy Complications
UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)
This is a prospective, observational, exposure-registration and follow-up study of women and their offspring exposed to Keppra® (levetiracetam) and Keppra XR® at the time of conception (i.e., any time from the first day of the…
- Conditions
- Birth Defects, Pregnancy Complications, Epilepsy, Seizures
- Trial name
- NCT00345475
- Where
- United States
- Volunteers
- 516 people
- Sponsor
- UCB Pharma
High Risk MC4R Genotype, Low Risk MC4R Genotype
1/2-MC4R Genotype and Pediatric Antipsychotic Drug- Induced Weight Gain
We will conduct a 12-week, randomized open label study, comparing usual care (UC) antipsychotic treatment (aripiprazole, quetiapine, risperidone) with ziprasidone (ZIP) in children and adolescents aged 13-18 years old.
- Conditions
- High Risk MC4R Genotype, Low Risk MC4R Genotype, One Week or Less Antipsychotic Lifetime Exposure
- Trial name
- NCT01844700
- Testing
- Ziprasidone, aripiprazole, quetiapine, or risperidone
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Northwell Health
Buprenorphine, Naloxone
Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)
The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic…
- Conditions
- Buprenorphine, Naloxone, Opiate-related Disorders, Opiate Dependence
- Trial name
- OPUS R (NCT00723697)
- Testing
- buprenorphine
- Volunteers
- 1,307 people
- Sponsor
- Indivior Inc.
Malignant Glioma
A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
This phase I/II trial tests the safety, side effects, and best dose of selinexor given in combination with standard radiation therapy in treating children and young adults with newly diagnosed diffuse intrinsic pontine glioma…
- Trial name
- NCT05099003
- Testing
- Biopsy Procedure, Magnetic Resonance Imaging, Radiation Therapy
- Where
- 129 sites in United States, Australia and 2 more
- Volunteers
- 132 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Modulation of Breast Cancer Risk Biomarkers by High Dose Vitamin D
The overall goal of this project is to determine if high dose vitamin D3 given to premenopausal women at high risk for development of breast cancer, who initially have insufficient levels of 25-hydroxy vitamin D (<30 ng/ml), will…
- Trial name
- NCT01166763
- Testing
- vitamin D3
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Carol Fabian, MD
Substance Use, Stress
Automating Peer Learning to Reduce Alcohol Use and Related Deviant Behavior in Secondary School
Deviant peer affiliation is one of the most important predictors of alcohol use in adolescence. These affiliations arise when socially marginalized youth self-aggregate and reinforce alcohol use and other deviant activity (i.e.…
- Conditions
- Substance Use, Stress, Relation, Interpersonal, Bullying
- Trial name
- PeerLearning (NCT04478240)
- Testing
- PeerLearning.net
- Where
- United States
- Volunteers
- 924 people, healthy volunteers welcome
- Sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
Childhood Posterior Fossa Ependymoma
Testing Safe Doses of Anti-Cancer Medicines, 5-Flurouracil (5-FU) and Tretinoin (ATRA), Added to the Usual Cancer Treatment of Ependymoma
This phase I/II trial tests the safety, side effects best dose and how well giving fluorouracil and tretinoin along with standard of care radiation therapy works for the treatment of high risk posterior fossa ependymoma that has…
- Trial name
- NCT07848568
- Testing
- Biospecimen Collection, Echocardiography Test, Fluorouracil
- Volunteers
- 70 people
- Sponsor
- Children's Oncology Group
Adolescent Dysmenorrhea
Adolescent Dysmenorrhea : Prevalence, Severity, Experience and Management in the Use of Medication in High School Girls in Ille-et-Vilaine
Dysmenorrhea or painful menstruation is a common symptom of menses. Dysmenorrhea is defined as a painful, cramping sensation in the lower abdomen or back associated with menstrual periods and is classified into primary and…
- Trial name
- DAPsvs (NCT04007471)
- Testing
- Anonymous survey
- Where
- France
- Volunteers
- 979 people, healthy volunteers welcome
- Sponsor
- Rennes University Hospital
PICU, Nurses
Smart Mind Maps in Promoting Safe Administration of High-Alert Medications
In PICU setting, drug administration, monitoring, and prescribing errors made up most cases (54%) of MEs . Emphasizes these issues requires a multifaceted approach, including staff training, creation of innovative cognitive…
- Trial name
- HAMs- PICU (NCT07320196)
- Testing
- smart mind mapsde
- Volunteers
- 70 people
- Sponsor
- Mansoura University
Asthma
A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications
The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp…
- Trial name
- NCT01576718
- Testing
- Fp MDPI, Flovent Diskus, albuterol/salbutamol
- Where
- 300 sites in United States, Australia and 17 more
- Volunteers
- 889 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Bipolar Disorder, Bipolar I Disorder
Children's Bipolar Network Treatment Trial I
This is a naturalistic treatment and follow-up study of youth with bipolar spectrum disorders (BSDs) across four US sites of The Childhood Bipolar Network (CBN).
- Conditions
- Bipolar Disorder, Bipolar I Disorder, Bipolar II Disorder, Other Specified Bipolar and Related Disorder
- Trial name
- CBN (NCT05427123)
- Testing
- Medication or psychosocial treatment
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- University of California, Los Angeles
Solid Tumor
Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence
Most pediatric patients with solid tumors respond to initial high-dose, intensive therapy and complete treatment in remission. High-risk patients however, frequently have recurrent disease which is then treated with ad hoc…
- Trial name
- Metronomic (NCT02446431)
- Testing
- Bevacizumab, Cyclophosphamide, Valproic Acid
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Miller Children's & Women's Hospital Long Beach
Osteosarcoma, Survival
Comparison of MAPI+Camrelizumab Versus API+Apatinib Versus MAPI in Patients With a Poor Response to Preoperative Chemotherapy for Newly Diagnosed High-grade Osteosarcoma
Treatment strategies for high-grade osteosarcoma with multidrug chemotherapy and resection result in 3-year event-free survival of 60-70%.
- Conditions
- Osteosarcoma, Survival, Chemotherapy Effect, Toxicity, Drug
- Trial name
- MAPAC (NCT04351308)
- Testing
- MAPI chemotherapy, Apatinib Mesylate, Camrelizumab
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Peking University People's Hospital
Substance Use (Drugs, Alcohol), Health Risk Behaviors
Pilot of a Drug Education Curriculum for Middle and High School Students
The goal of this pilot study is to measure the feasibility, sustainability, and acceptability of a drug education curriculum (IDECIDE) in middle and high students who have endorsed past-month substance use.The main question it…
- Conditions
- Substance Use (Drugs, Alcohol), Health Risk Behaviors, Youth, Adolescent Behavior
- Trial name
- iDECIDE (NCT07918963)
- Testing
- iDECIDE
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Osteosarcoma, Nephrotoxicity
Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy
Osteosarcoma is the most common type of bone cancer in children, adolescents and young adults. Treatment with surgery and a combination of three conventional chemotherapy drugs can cure nearly two-thirds patients with…
- Conditions
- Osteosarcoma, Nephrotoxicity, Ototoxicity
- Trial name
- NCT01848457
- Testing
- Pantoprazole, High-dose methotrexate infusion duration
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Children's Hospital of Philadelphia
Epilepsy
Acute Recording of Stereotyped High-Frequency Oscillations
Overall, this study will investigate the functional utility of stereotyped HFOs by capturing them with a new implantable system (Brain Interchange - BIC of CorTec), which can sample neural data at higher rates >=1kHz and deliver…
- Trial name
- NCT05439655
- Testing
- Brain Interchange System
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Mayo Clinic
High Grade Osteosarcoma, Localized Osteosarcoma
A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma
This phase II/III trial tests the safety, side effects, and best dose of the drug cabozantinib in combination with standard chemotherapy, and to compare the effect of adding cabozantinib to standard chemotherapy alone in treating…
- Conditions
- High Grade Osteosarcoma, Localized Osteosarcoma, Metastatic Osteosarcoma, Secondary Osteosarcoma
- Trial name
- NCT05691478
- Testing
- Bone Scan, Cabozantinib S-malate, Cisplatin
- Where
- 202 sites in United States, Australia and 2 more
- Volunteers
- 1,122 people
- Sponsor
- National Cancer Institute (NCI)