Clinical trials: Safety Issues
Safety Issues
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)
This study is to assess the safety of Vi-DT vaccine in adults and children.
- Trial name
- NCT03109600
- Testing
- Vi-DT (Bio Farma), Vi polysaccharide vaccine, Influenzae vaccine
- Where
- 2 sites in Indonesia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Anesthesia, Airway Morbidity
Preoxygenation Using High Flow Oxygen : Efficacy and Tolerance in Healthy Volunteers
High flow nasal cannula oxygen has been proposed to perform preoxygenation in patients with acute respiratory failure requiring orotracheal intubation in intensive care units.
- Conditions
- Anesthesia, Airway Morbidity, Safety Issues
- Trial name
- PreOx-OHD (NCT03399695)
- Testing
- preoxygenation
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University Hospital, Caen
Safety Issues, Pharmacokinetics
Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects
This is a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects.
- Trial name
- HTL0018318 (NCT03198624)
- Testing
- HTL0018318
- Where
- United Kingdom
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Nxera Pharma UK Limited
Colonoscopy, Safety Issues
Motorized Spiral Colonoscopy Trial: A First Feasibility Trial
The aim of this study is to assess the feasibility and the safety of the Novel Motorized Spiral Endoscope to examine the colon. The study is conceived as proof of concept trial with the primary aim to achieve a cecal intubation…
- Conditions
- Colonoscopy, Safety Issues, Adenoma
- Trial name
- MSCT (NCT03000361)
- Testing
- Motorized Spiral Colonoscopy
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Evangelisches Krankenhaus Düsseldorf
Safety Issues
Safety Analysis of Implantation of Stromal Vascular Fraction
Stromal vascular fraction (SVF) can be isolated from fat (adipose) tissue in an outpatient in-clinic procedure. Platelet rich plasma (PRP) can be isolated from peripheral blood.
- Trial name
- NCT03226093
- Testing
- Stromal Vascular Fraction
- Volunteers
- 676 people
- Sponsor
- Bioheart, Inc.
Safety Issues, Infant Nutrition Disorders
Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT
This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy full-term infants by investigating effects on growth and gastrointestinal tolerance and by identifying any adverse effects.
- Trial name
- NCT03035721
- Testing
- Low protein formula, Standard protein formula
- Where
- Italy
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Recurrent Urinary Tract Infection, Safety Issues
Controlled Human Urine Transfusion for UTI
The primary objective of this pilot study is to investigate the safety and tolerability of controlled human urine transfusion in female patients with recurrent UTI's.
- Trial name
- SHUTUP (NCT03142295)
- Testing
- urine transfusion
- Where
- Netherlands
- Volunteers
- 6 people
- Sponsor
- Leiden University Medical Center
Safety Issues, Tolerance
Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants
This study will examine the safety and tolerability of supplementation with bovine lactoferrin with fructo-oligosaccharide a simple sugar in very low birth weight infants.
- Conditions
- Safety Issues, Tolerance, Very Low Birth Weight Infant
- Trial name
- NCT03163212
- Testing
- Lactoferrin/FOS
- Volunteers
- 20 people
- Sponsor
- University of Virginia
Effect of Drugs, Safety Issues
A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults（Part 2）
This is a single center, open-label, multiple-dose phase 1 clinical trial. This study will determine the pharmacokinetics (PK), pharmacodynamics (PD), safety and side-effect profile of an investigational dexlansoprazole injection…
- Trial name
- NCT03120273
- Testing
- Dexlansoprazole Injection, Lansoprazole Injection
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital of Zhejiang University
Safety Issues, Effect of Drugs
Safety and Efficacy of Autologous Umbilical Cord Blood Mononuclear Cells Transfusion in Neonates
To study the safety and efficacy of Autologous Umbilical Cord Blood Mononuclear Cells transfusion on clinical outcome in preterm infants
- Conditions
- Safety Issues, Effect of Drugs, Neonatal Death
- Trial name
- NCT03053076
- Testing
- Autologous Umbilical Cord Blood Mononuclear Cells Therapy, 0.9% Sodium Chloride
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Guangdong Women and Children Hospital
Safety Issues
A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults (Part 1)
This is a single center, randomized, double-blind, dose-escalation, placebo-controlled phase 1 clinical trial. This study will determine the safety and side-effect profile of an investigational dexlansoprazole injection after…
- Trial name
- NCT03011125
- Testing
- dexlansoprazole injection
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital of Zhejiang University
Morbid Obesity, Sleeve Gastrectomy
Safety of an Early Discharge Protocol After Sleeve Gastrectomy
Evaluate the safety and efficacy of an early discharge protocol (23 hours, overnight stay) after scheduled sleeve gastrectomy.
- Conditions
- Morbid Obesity, Sleeve Gastrectomy, Early Discharge, Safety Issues
- Trial name
- NCT03070457
- Testing
- Early discharge, Conventional protocol
- Where
- Spain
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hospital Universitari de Bellvitge
Safety Issues, Patient Care
Survey of Housestaff Attitudes Toward Patient Care and Safety
Background: The occurrence of medical errors and their deleterious effects on quality of care delivered are widely recognized phenomena in healthcare today.
- Trial name
- NCT00845052
- Where
- United States
- Volunteers
- 674 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University