Clinical trials: Chronic Diseases in Children
Hepatic Failure, Hepatic Impairment
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects
The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.
- Conditions
- Hepatic Failure, Hepatic Impairment, Chronic Hepatitis C Infection With Hepatic Coma
- Trial name
- NCT01846455
- Testing
- 2.0mg Buprenorphine/0.5mg Naloxone, Promethazine
- Where
- 3 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Chronic Kidney Disease, Bacterial Infection
Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease
The purpose of this study is to: 1. Study the pharmacokinetics and safety of daptomycin in children on hemodialysis (HD) and peritoneal dialysis (PD). 2. Determine urine, HD and PD clearance of daptomycin.
- Trial name
- NCT01012089
- Testing
- Daptomycin
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Oklahoma
Cerebral Palsy, Hemiplegia
Constraint-induced Movement Therapy (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegic Cerebral Palsy
A randomized control trial of bimanual training. The protocols have been developed at Columbia University to be child friendly and draws upon our experience since 1997 with constraint-induced movement therapy in children with…
- Conditions
- Cerebral Palsy, Hemiplegia, Children, Pediatric
- Trial name
- NCT00305006
- Testing
- Constraint-Induced Movement Therapy (CIMT), Hand-Arm Bimanual Intensive Therapy (HABIT)
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Teachers College, Columbia University
Cerebral Palsy, Physical Activity
Effects of Hippotherapy on Physical Fitness and Attention in Cerebral Palsy
This research analyzes whether hippotherapy improves the physical activity, cardiopulmonary fitness, and attention in children with cerebral palsy and whether this enhances their general health and quality of life.
- Conditions
- Cerebral Palsy, Physical Activity, Attention Disorder
- Trial name
- NCT03870893
- Testing
- hippotherapy
- Where
- South Korea
- Volunteers
- 47 people
- Sponsor
- Samsung Medical Center
Turner Syndrome, Renal Insufficiency, Chronic
Study to Define Optimal IGF-1 Monitoring in Children Treated With NutropinAq
The main purpose of this study is to establish an optimal monitoring regimen in NutropinAq treated children, using newly developed capillary blood spot IGF-1 measurement technology.
- Conditions
- Turner Syndrome, Renal Insufficiency, Chronic, Pituitary Diseases, Dwarfism
- Trial name
- OPTIMA (NCT00234533)
- Testing
- Somatropin (rDNA origin)
- Where
- 45 sites in Belgium, Czechia and 12 more
- Volunteers
- 251 people
- Sponsor
- Ipsen
Spastic Cerebral Palsy
Short Term Follow-up of a Botulinum Toxin Intervention in Children With Spastic Cerebral Palsy
This study investigates the effect of integrated Botulinum Neurotoxin A (BoNT) treatment on morphologic muscle and tendon properties, spasticity, joint stiffness, joint range of motion, muscle strength, gait and gross motor…
- Trial name
- NCT05126693
- Testing
- Botulinum Toxin treatment combined with a post-BoNT intensive physical therapy period guided by individualized treatment goals.
- Where
- Belgium
- Volunteers
- 61 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Hypertension, Chronic Kidney Diseases
Assessing the Feasibility of N-of-1 Trials in Children With Hypertension and Chronic Kidney Disease
The purpose of this study to test whether n-of-1 trial-guided clinical decision-making improves blood pressure control in hypertensive children with chronic kidney disease (CKD) and end-stage renal disease (ESRD).
- Trial name
- NCT04591171
- Testing
- n-of-1 trial guided clinical decision making
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- The University of Texas Health Science Center, Houston
Bone Marrow Failure Syndrome, Thalassemia
Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation
In this study, the investigators test 2 dose levels of thiotepa (5 mg/kg and 10 mg/kg) added to the backbone of targeted reduced dose IV busulfan, fludarabine and rabbit anti-thymocyte globulin (rATG) to determine the minimum…
- Conditions
- Bone Marrow Failure Syndrome, Thalassemia, Sickle Cell Disease, Diamond Blackfan Anemia
- Trial name
- NCT03513328
- Testing
- Thiotepa--single daily dose, Thiotepa--escalated dose
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Florida
Osteoporosis
An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids
This study was designed to evaluate the efficacy and safety of zoledronic acid compared to placebo in osteoporotic children treated with glucocorticoids
- Trial name
- NCT00799266
- Testing
- Zoledronic acid
- Where
- 12 sites in Australia, Canada and 4 more
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Cerebral Palsy
A Study of UCB and MSCs in Children With CP: ACCeNT-CP
The main purpose of this study is to estimate change in motor function 12 months after treatment with a single dose of allogeneic umbilical cord blood (AlloCB) or repeated doses of umbilical cord tissue-derived mesenchymal…
- Trial name
- ACCeNT-CP (NCT03473301)
- Testing
- Infusion of allogeneic umbilical cord blood, Infusion of MSCs
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- Joanne Kurtzberg, MD
Chronic Kidney Disease Stage 3 and 4
Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children Aged 10-16 With Chronic Kidney Disease (CKD)
Part 1: To determine the safety, tolerability, and pharmacokinetics of a single dose of 3 μg paricalcitol capsules in children ages 10 to 16 years with moderate to severe chronic kidney disease (CKD Stages 3 and 4).
- Trial name
- NCT01020487
- Testing
- Paricalcitol
- Volunteers
- 47 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Heart Failure
Developing a Non-invasive Cardiac Functional Health Status Measurement Device
This is a single-center, non-randomized study.Enrolled patients will be placed on a tilt table and a stress test will be performed in a total of 4 different positions. Their blood pressure will be measured at each position.
- Trial name
- NCT01877343
- Testing
- CVInsight(TM)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Florida
Cerebral Palsy
Validity of Bispectral Index Monitoring During Deep Sedation
During Intramuscular botulinum toxin injections for children with cerebral palsy, immobility is essential to inject botulinum toxin to the right muscle.
- Trial name
- NCT02096549
- Where
- South Korea
- Volunteers
- 20 people
- Sponsor
- Yeungnam University College of Medicine
Chronic Hepatitis C, Hepatitis C Virus
A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)
The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of ABT-493 and ABT-530 in adults with genotype 1 HCV.
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, Compensated Cirrhosis
- Trial name
- NCT01995071
- Testing
- ABT-493, ABT-530, ABT-450/r/ABT-267, ABT-333
- Volunteers
- 89 people
- Sponsor
- AbbVie
Chronic Hepatitis C
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir
The purpose of this study is to evaluate the safety and tolerability of AL-335 in combination with odalasvir (ODV) with or without simeprevir (SMV) in participants with genotype (GT)1 or GT2 or GT3 chronic hepatitis C (CHC)…
- Trial name
- NCT02569710
- Testing
- AL-335, Odalasvir (ODV), Simeprevir (SMV)
- Where
- 11 sites in Mauritius, Moldova and 2 more
- Volunteers
- 161 people
- Sponsor
- Alios Biopharma Inc.
Spastic Cerebral Palsy
Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy
Aquatic intervention had been applied in children with neuromotor impairment for years, yet there has been little progress toward objective identifications of therapy goals, interventions, and outcomes.
- Trial name
- NCT01049581
- Testing
- aquatic therapy
- Where
- Taiwan
- Volunteers
- 27 people
- Sponsor
- Chang Gung Memorial Hospital
Hepatitis C, Chronic
BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120…
- Trial name
- NCT01830127
- Testing
- Ribavirin, BI 207127 high dose, Faldaprevir
- Where
- 19 sites in United States, Germany and 2 more
- Volunteers
- 35 people
- Sponsor
- Boehringer Ingelheim
Hepatitis C Virus Infection
Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants…
- Trial name
- NCT02994056
- Testing
- SOF/VEL, RBV
- Where
- 12 sites in United States, France
- Volunteers
- 32 people
- Sponsor
- Gilead Sciences
Leukemia
A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib
The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL)…
- Trial name
- NCT00777036
- Testing
- Dasatinib
- Where
- 174 sites in United States, Argentina and 16 more
- Volunteers
- 133 people
- Sponsor
- Bristol-Myers Squibb
Wheezing, Reactive Airway Disease
A Study of the Pharmacokinetics, Safety and Tolerability of Single Doses of VR647 Inhalation Suspension Administered Using the VR647 Inhalation System in Children With Wheezing, Reactive Airway Disease or Mild Asthma
The primary objective of this study is to evaluate budesonide levels in the blood following inhalation of single doses of VR647 Inhalation Suspension in children with wheezing, reactive airway disease or mild asthma using a…
- Conditions
- Wheezing, Reactive Airway Disease, Mild Asthma
- Trial name
- NCT03421730
- Testing
- VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System, 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- Vectura Limited