Clinical trials: Safety Issues
Reproductive Issues, Male Infertility
Efficacy and Safety of a New Sperm Capacitation Method
Prospective, multicenter research study with a split-sample design on semen samples, without intervention, to evaluate the efficacy and safety of HyperSperm, a new sperm capacitation method, in 300 semen samples with various…
- Conditions
- Reproductive Issues, Male Infertility, Asthenozoospermia, Oligozoospermia
- Trial name
- HyperSperm01 (NCT06742437)
- Testing
- Standard sperm preparation, HyperSperm
- Where
- 4 sites in Spain
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Fecundis Lab SL
Drug Drug Interaction, Safety Issues
Possible Effects of Propylthiouracil, Riociguat and Perphenazine on Circulation of Healthy Volunteers
This trial is part of the Horizon 2020 project, REPO-TRIAL, on in-silico, mechanism-based drug repurposing in high unmet-medical-need indications.
- Trial name
- REPO-STROKE1 (NCT04776499)
- Testing
- Propylthiouracil, Riociguat, Perphenazine
- Where
- Germany
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Maastricht University
Pharmacokinetics, Safety Issues
A Clinical Study With Adalimumab Biosimilar
The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) [Test Product] vs.
- Trial name
- NCT06291948
- Testing
- Humira® (adalimumab) AC Pen [Reference Product], Adalimumab Richmond [Test Product]
- Where
- Argentina
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Laboratorios Richmond S.A.C.I.F.
Safety Issues
MIST3: Active Patient Safety Reporting
This study will seek to describe and understand adverse events (AE) severity ratings.
- Trial name
- MIST3 (NCT04161677)
- Where
- United States
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Parker University
Infant Development, Safety Issues
Safety of Bifidobacterium Breve PS1 for Infants
The objective of this work was the characterization of the probiotic potential of Bifidobacterium breve PS1, a strain originally isolated from human milk.
- Trial name
- NCT05973812
- Testing
- Infant formula supplemented with Bifidobacterium breve PS1, Infant formula NOT supplemented with Bifidobacterium breve PS1
- Where
- 3 sites in Spain
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Universidad Complutense de Madrid
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
Effect of Drugs, Safety Issues
Remifemin Preventing the Climacteric Symptoms in Breast Cancer
LHRH-a is an important hormone treatment in breast cancer especially in high-risk hormone receptor-positive patients or hormone receptor-negative but needing ovarian function protecting.
- Trial name
- NCT03339882
- Testing
- Remifemin
- Where
- China
- Volunteers
- 85 people
- Sponsor
- Zhejiang Cancer Hospital
Safety Issues, Medical Device
Innovative Device for Intravenous Administration
The prevention of catheter-related complications is nowadays an important topic of research. Flushing the catheters is considered an important clinical procedure in preventing malfunction and several complications such as…
- Trial name
- SeringaDUO (NCT04046770)
- Testing
- Drug administration and Flushing procedure using Double-Chamber Syringe, Drug administration and Flushing procedure using Classic Syringe
- Volunteers
- 146 people
- Sponsor
- Escola Superior de Enfermagem de Coimbra
Safety Issues, Tolerability
SB17170 Phase1 Trial in Healthy Volunteer
This clinical trial aims to learn about the safety, tolerability, and pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults.
- Conditions
- Safety Issues, Tolerability, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT05795192
- Testing
- SB17170
- Where
- South Korea
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- SPARK Biopharma
Safety Issues, Chronic Kidney Disease
Care Coordination/Home Telehealth to Safeguard Care in CKD
Home telehealth monitoring of veterans with chronic kidney disease, with a disease management protocol and safety-specific decision support, will increase the detection of adverse safety events, and in turn, reduce the need for…
- Trial name
- CCHT in CKD (NCT03038126)
- Testing
- CCHT, Usual care
- Where
- United States
- Volunteers
- 137 people
- Sponsor
- University of Maryland, Baltimore
Safety Issues;Effect of Drugs
Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Autism Spectrum Disorder
To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of autism spectrum disorder.
- Trial name
- NCT04768816
- Testing
- 0.9% Sodium Chloride, Autologous Umbilical Cord Blood
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Guangdong Women and Children Hospital
Safety Issues
SVF Combined With Functional Self-assembling Peptide Nanofiber Hydrogels in the Treatment of Spinal Cord Injury
Traumatic spinal cord injury (SCI) is a severe medical problem experienced by people worldwide with high mortality and long term morbidity.
- Trial name
- NCT05967325
- Testing
- Stromal Vascular Fraction (SVF) combined with Functional self-assembling peptide nanofiber hydrogels
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Kunming Tongren Hospital
Aging
Safety and Feasibility of Dasatinib and Quercetin in Adults at Risk for Alzheimer's Disease
The purpose of this pilot study is to demonstrate the safety and feasibility of administering intermittent doses of Dasatinib and Quercetin (D+Q) in older adults at risk of Alzheimer's disease (AD).
- Trial name
- STAMINA (NCT05422885)
- Testing
- Dasatinib, Quercetin
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Lewis Lipsitz
Safety Issues, Anticoagulant Toxicity
Clinical Pharmacist Anticoagulant Stewardship
Initiative to improve direct anticoagulant utilization involving programmatic review by clinical pharmacists in collaboration with multidisciplinary team.
- Trial name
- NCT03527615
- Testing
- Clinical Pharmacist Medication Review
- Where
- Israel
- Volunteers
- 4,000 people
- Sponsor
- Hadassah Medical Organization
Safety Issues
Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates
This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.
- Trial name
- NCT03462108
- Testing
- Rotavirus (Bio Farma) Vaccine
- Where
- 4 sites in Indonesia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues, Tolerance
Phase1 First in Human Ascending Dose Study to Evaluate the Safety and Tolerability of FC-12738 in Health Adults
A Phase I, Randomized, Double-Blind, Placebo-Controlled, First-in-human, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of retro enversio (RT) thymopentin in Healthy Adult…
- Trial name
- NCT05978908
- Testing
- FC-12738, Saline
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Neurodegenerative Disease Research Inc
Radiotherapy Side Effect, Chemotherapy Effect
Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）
To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma.
- Conditions
- Radiotherapy Side Effect, Chemotherapy Effect, Oesophageal Carcinoma, Effect of Drugs
- Trial name
- NCT04027543
- Testing
- Neoadjuvant chemoradiotherapy, Oesophagectomy, Neoadjuvant chemotherapy
- Where
- 3 sites in United States, China
- Volunteers
- 423 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Safety Issues
Paracetamol Hypothermia Children
Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia
- Trial name
- NCT04608669
- Testing
- Paracetamol
- Where
- Lebanon
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Saint George Hospital
Safety Issues
A Phase 1 Study of the Safety and Tolerability of ICM20 in Adults
A Phase 1 Non-Randomized Open Label Study of Oral ICM20
- Trial name
- NCT05523596
- Testing
- ICM20, Benznidazole
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- IC-MedTech Corporation
Safety Issues
Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever
This is a randomized study to evaluate the safety and feasibility of early de-escalation of empirical antibiotics treatment in neutropenic fever patients undergoing hematopoietic stem cell transplantation (HSCT).
- Trial name
- NCT04270786
- Testing
- Early de-escalation, Standard
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine