Clinical trials: Patient Safety
Crohn's Disease, Inflammatory Bowel Disease
A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease.
This randomized placebo-controlled double-blind, multi-centre trial will determine the efficacy of the probiotic VSL#3 in the prevention of Crohn's disease development following surgical resection and re-anastomosis.
- Trial name
- NCT00175292
- Testing
- Probiotic - VSL#3
- Where
- 17 sites in Canada
- Volunteers
- 120 people
- Sponsor
- University of Alberta
Alpha Mannosidosis
Dose Finding Study of Recombinant Human Alpha-mannosidase for the Treatment of Patients With Alpha-mannosidosis
This is a single-center, open-label, multiple-dose study of the efficacy and long-term safety of Lamazym for the treatment of patients with alpha-mannosidosis.
- Trial name
- NCT01285700
- Testing
- Lamazym
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Zymenex A/S
Moyamoya Disease, Pediatric
Safety and Efficacy of RIC in Pediatric Moyamoya Disease Patients Treated With Revascularization Therapy
Revascularization surgery has been the standard treatment to prevent ischemic stroke in pediatric Moyamoya disease (MMD) patients with ischemic symptoms.
- Trial name
- RIC-PMD (NCT03546309)
- Testing
- RIC group, Medication group
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Capital Medical University
Fanconi Anemia
Clinical Phase II Trial to Evaluate CD34+ Cells Mobilization and Collection in Patients With Fanconi Anemia for Subsequent Transduction With a Lentiviral Vector Carring FANCA Gene. FANCOSTEM-1
Fanconi anemia (FA) is a congenital disease characterized by bone marrow failure and increased incidence of malignant tumors. The Project pursue the optimization of the collection of hematopoietic progenitor cells for later use…
- Trial name
- NCT02931071
- Testing
- filgrastim, plerixafor
- Where
- 2 sites in Spain
- Volunteers
- 13 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia
The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
The purpose of this study is to determine if FDA approved food safety guidelines are equivalent to a low bacterial diet (the neutropenic diet) with respect to the acquisition of infections during neutropenia in a sample of…
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Non-Hodgkins Lymphoma, Sarcoma
- Trial name
- NCT00726934
- Testing
- Food Safety Guidelines, Neutropenic Diet
- Where
- 6 sites in United States
- Volunteers
- 149 people
- Sponsor
- Indiana University
S. Aureus Bloodstream Infection
Collect Clinical Data in Chinese Patients Received CUBICIN Treatment for Actual Usage in Clinical Practice
This is a Multicenter, observational, non-interventional registry designed to collect clinical data in Chinese patients who have received CUBICIN treatment under condition of actual usage in clinical practice.
- Trial name
- NCT01212601
- Where
- 18 sites in China
- Volunteers
- 203 people
- Sponsor
- AstraZeneca
Cystic Fibrosis
Efficacy Study of IgY (Antibody Against Pseudomonas) in Cystic Fibrosis Patients
The purpose of this study is to prolong the time to reinfection with Pseudomonas aeruginosa after successfully treated acute or intermittent infection.
- Trial name
- PsAer-IgY (NCT01455675)
- Testing
- IgY
- Where
- 42 sites in Austria, Belgium and 7 more
- Volunteers
- 164 people
- Sponsor
- Mukoviszidose Institut gGmbH
Idiopathic Pulmonary Fibrosis
Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Pirfenidone as anti-fibrosis drug developed in recent years demonstrated the potential anti- fibrotic effect, but so far there were no domestic studies about pirfenidone's efficacy and safety evaluation in china.
- Trial name
- IPF (NCT02136992)
- Testing
- Pirfenidone
- Volunteers
- 160 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma
A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients with DIPG
The primary objectives of this trial are to evaluate the safety and tolerability of sonodynamic therapy (SDT) using SONALA-001 and Exablate Type 2.0 device and to determine the maximum tolerated dose (MTD) or recommended phase 2…
- Trial name
- NCT05123534
- Testing
- SONALA-001 (ALA) and MR-Guided Focused Ultrasound device (MRgFUS)
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- SonALAsense, Inc.
Anemia
Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients
The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red…
- Trial name
- ReCePI (NCT03459287)
- Testing
- INTERCEPT, Control
- Where
- 18 sites in United States
- Volunteers
- 581 people
- Sponsor
- Cerus Corporation
Iron Deficiency Anemia
Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044
Evaluating the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients with Iron Deficiency Anemia and an Unsatisfactory Response to Oral Iron under Study Protocol 1VIT17044
- Trial name
- NCT04269707
- Testing
- Ferric carboxymaltose
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- American Regent, Inc.
Pulmonary Hypertension
Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension
This is a clinical research study designed to evaluate an investigational new medication called sitaxsentan for the treatment of pulmonary arterial hypertension (patients with NYHA functional class II, III or IV).
- Trial name
- NCT00034307
- Testing
- sitaxsentan sodium
- Where
- 26 sites in United States, Canada
- Volunteers
- 180 people
- Sponsor
- ICOS-Texas Biotechnology
Contrast Enhanced X-ray Based Examination
A Study, Called UV Population, to Learn More About the Safety of the Study Drug Ultravist, Which is Given to Get Clearer X-ray Pictures, in People of Different Sexes, Races, and From Different Countries/Regions
This is an observational study in which patient data from the past of people who received Ultravist prior to an X-ray based scan are studied.
- Trial name
- NCT05428397
- Testing
- Iopromide (Ultravist, BAY86-4877)
- Where
- Germany
- Volunteers
- 152,233 people
- Sponsor
- Bayer
Attention-Deficit Hyperactivity Disorder(ADHD)
A Trial to Evaluate the Efficacy and Safety of EB-1020 in Pediatric Patients With ADHD
The purpose of this study is to evaluate the efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in pediatric ADHD patients.
- Trial name
- NCT07086313
- Testing
- EB-1020 (Centanafadine) low dose, EB-1020 (Centanafadine) high dose
- Where
- Japan
- Volunteers
- 315 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Mucopolysaccharidosis II
Study of Idursulfase-beta (GC1111) in Hunter Syndrome
This study evaluates the efficacy and safety of three doses of GC1111 in patients with Hunter Syndrome. Participants will be randomized to one of three doses of GC1111 or comparator.
- Trial name
- NCT02663024
- Testing
- idursulfase beta, idursulfase
- Volunteers
- 20 people
- Sponsor
- Green Cross Corporation
Myocardial Infarction
Post Marketing Surveillance to Monitor the Safety and Efficacy of Metalyse® in Korean Patients With Acute Myocardial Infarction
To monitor the safety of Metalyse® in clinical practice in patients with acute myocardial infarction over a period of 6 years as required by Korean authorities, with the following observations: 1.
- Trial name
- NCT02206646
- Testing
- Metalyse
- Volunteers
- 987 people
- Sponsor
- Boehringer Ingelheim
Alpha-Mannosidosis
Interventional Study to Assess Efficacy and Safety of Velmanase Alfa in Patients With Alpha Mannosidosis
Randomized, double-blind, placebo-controlled, parallel group study where subjects will receive velmanase alfa or placebo for 24 weeks.
- Trial name
- SHAMAN (NCT04031066)
- Testing
- Velmanase Alfa
- Sponsor
- Chiesi Farmaceutici S.p.A.
Cystic Fibrosis, Lung Infection
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa
The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second…
- Conditions
- Cystic Fibrosis, Lung Infection, Pseudomonas Aeruginosa
- Trial name
- AIR-CF4 (NCT00712166)
- Testing
- AZLI 75 mg three times daily (TID)
- Where
- 40 sites in United States, Australia and 1 more
- Volunteers
- 160 people
- Sponsor
- Gilead Sciences
Spinal Muscular Atrophy (SMA)
Clinical Trial to Assess the Safety and Efficacy of EXG001-307 in Patients With Spinal Muscular Atrophy
The purpose of this trial is to evaluate safety and efficacy of intrathecal delivery of EXG001-307 as a treatment of spinal muscular atrophy .
- Trial name
- NCT06888661
- Testing
- EXG001-307 injection
- Where
- 2 sites in China
- Volunteers
- 4 people
- Sponsor
- Guangzhou Jiayin Biotech Ltd
Tuberous Sclerosis Complex, Seizures
An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P.
- Trial name
- NCT02544750
- Testing
- GWP42003-P
- Where
- United States
- Volunteers
- 199 people
- Sponsor
- Jazz Pharmaceuticals
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