Clinical trials: Safety Issues
Drug Effect, Safety Issues
Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia
The goal of this clinical trial is to demonstrate equivalent efficacy and comparable safety of the drug GP40141 (GEROPHARM, Russia) in comparison with the drug Nplate® (Amgen, the Netherlands). the main questions are 1.
- Conditions
- Drug Effect, Safety Issues, Immunogenicity
- Trial name
- NCT06497036
- Testing
- GP404141, Nplate
- Where
- 6 sites in Russia
- Volunteers
- 160 people
- Sponsor
- Geropharm
Safety Issues
Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population
This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in Indonesian Population
- Trial name
- NCT03336593
- Testing
- Quadrivalent Influenza Vaccine, Trivalent Influenza Vaccine
- Where
- 3 sites in Indonesia
- Volunteers
- 810 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues, Injuries
An Interactive Web Platform to Teach Children Hunting, Shooting and Firearms Safety
Firearms injuries present a major pediatric public health challenge, killing >800 children ages 0-15 annually and leading to lifelong disability among >1000 survivors.
- Conditions
- Safety Issues, Injuries, Firearm Injury
- Trial name
- NCT04622943
- Testing
- firearms safety, nutrition
- Where
- United States
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Safety Issues, Immunogenicity
Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)
Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.
- Trial name
- NCT04051268
- Testing
- Vi-DT Typhoid Conjugate Vaccine, PQed Typhoid Conjugate Vaccine, Vi Polysaccharide Vaccine
- Where
- Indonesia
- Volunteers
- 3,071 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Reproductive Issues
The Efficacy and Safety of Female PRP Co-incubation With Sperm During (IUI) Cycles
The investigators hypothesize that infertility patients undergoing IUI who receive female autologous platelet-rich plasma (PRP) co-incubation with husband's sperm would have higher clinical pregnancy rate.
- Trial name
- NCT07615634
- Testing
- non-PRP group (control group), PRP group (intervention group)
- Where
- China
- Volunteers
- 288 people
- Sponsor
- Chinese University of Hong Kong
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
Safety Issues, Pharmacokinetics
Safety and Pharmacokinetics of an Extract of Naringenin
This study evaluates the safety of administering single ascending doses (150, 300, 600, and 900 mg) of a citrus extract of the flavonoid narigenin, and assesses the blood concentrations of naringenin following oral administration…
- Trial name
- Citrus (NCT03582553)
- Testing
- Naringenin
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
Fasting, Gastric Stasis
Residual Gastric Volume After the Ingestion of Supplements Containing Carbohydrates and Whey Protein
Oral supplements (OS) containing carbohydrates are being used 2h before anesthesia. The addition of a nitrogen source would improve these drinks designed for the abbreviation of preoperative fasting.
- Conditions
- Fasting, Gastric Stasis, Perioperative Complication, Safety Issues
- Trial name
- NCT05573854
- Testing
- Gastric emptying after an oral supplement containing carbohydrates and whey protein, Overnight Fast
- Where
- Brazil
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Federal University of Mato Grosso
Safety Issues, Immunogenicity
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants
This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.
- Trial name
- NCT03460405
- Testing
- Vi-DT Vaccine, Vi Polysaccharide Vaccine, IPV Vaccine
- Where
- 2 sites in Indonesia
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues
Safety Evaluation of Porous Silica in Men
The aim of the present study was to determine whether oral dosing, up to 9 grams/day, of porous silica administered as a food additive can be used safely in normal weight and obese male humans, without significant side effects on…
- Trial name
- NCT03667430
- Testing
- Porous silica
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Karolinska Institutet
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, Tolerance
A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144
This is a randomised, double-blind, placebo-controlled, single ascending dose study in healthy volunteer subjects. Each dose level will be investigated with eight 20-50-year-old male subjects (6 on active drug and 2 on placebo).
- Trial name
- NCT04689035
- Testing
- AVLX-144
- Where
- Finland
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Avilex Pharma
Safety Issues
Safety and Efficacy of Bleach Baths in Non Critical Hospitalized Patients
Non critical hospitalized patients were bathed daily with 4 substances: bleach at .005%, bleach at .0125%, clorhexidine 2% and soap and water. 76 patients were enrolled and divided 19 subjects per group.
- Trial name
- NCT04904666
- Where
- Mexico
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
Safety Issues, Efficacy, Self
Trial of Befizal® 200 mg for the Treatment of Leber Hereditary Optic Neuropathy
Study of the efficiency of Béfizal® 200 mg in 14 adult patients with a LHON that occurred for less than 5 years. Patient must have certain specific mutations
- Trial name
- Béfinohl (NCT04561466)
- Testing
- Béfizal
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Hôpital Necker-Enfants Malades
Safety Issues, Effect of Drug
Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients
The aim of this study is evaluating safety and effectiveness of Ovine Enoxaparin Sodium in Non-ST-Segment Elevation Acute Coronary Syndrome (NSTEACS) Patients
- Trial name
- NCT06114641
- Testing
- Enoxaparin sodium injection
- Where
- 3 sites in Indonesia
- Volunteers
- 220 people
- Sponsor
- PT Bio Farma
Safety Issues, Effect of Drug
ADC189 Tablets on Influenza A Virus Infection/Influenza B Virus Infection
The goal of this Phase II/III study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infection/influenza B virus infection.
- Trial name
- ADC (NCT06342921)
- Testing
- 15 mg ADC189, 45 mg ADC189
- Where
- China
- Volunteers
- 749 people
- Sponsor
- Jiaxing AnDiCon Biotech Co.,Ltd
Pharmacokinetics, Safety Issues
A Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab
The aim of the Clinical study is to evaluate the pharmacokinetic and safety profile of a new formulation of Bevacizumab (Zutrab®, Argentinian origin) when compared to two already marketed formulations of Bevacizumab Avastin®…
- Trial name
- NCT03919448
- Testing
- Bevacizumab
- Where
- Argentina
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Laboratorios Richmond S.A.C.I.F.
Opioid; Intoxication, Perception Disturbance (Acute), Acute Pain
Pupillary Unrest in Ambient Light, and Relationship to Opioid-Induced Respiratory Depression
Volunteers will receive a weight-based opioid (remifentanil) infusion for 10 minutes. In the first run, serial pupillary measurements (pupillary unrest, pupil diameter) will be taken at baseline, and at 2.5-minute intervals…
- Conditions
- Opioid; Intoxication, Perception Disturbance (Acute), Acute Pain, Overdose of Opiate, Respiratory Depression
- Trial name
- NCT04301895
- Testing
- Continuous conversational interaction, Remifentanil infusion
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Safety Issues, Effect of Drugs
Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy
To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of cerebral palsy.
- Trial name
- NCT03791372
- Testing
- 0.9% Sodium Chloride, Autologous Umbilical Cord Blood
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Guangdong Women and Children Hospital
Safety Issues
Phase 1 Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer
Phase 1 open label dose ranging study of RH324 in advanced non-small cell lung cancer
- Trial name
- NCT05580172
- Testing
- RH324
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- ReHeva Biosciences,Inc.