Clinical trials: Safety Issues
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
Critical Incident, Safety Issues
Critical Incident During Anaesthesia
A multicenter study in Ukrainian hospitals on compliance with the requirements for responding to critical cases in the operating room, and the availability of relevant documentation and checklists.
- Trial name
- NCT05435287
- Where
- Ukraine
- Volunteers
- 92 people
- Sponsor
- Bogomolets National Medical University
Occupational Stress, Health Behavior
Corrections Work's Adverse Effects and a Total Worker Health Program to Enhance Well-being
Conduct a quasi-experimental pre-post study of a mindfulness-enhanced, web/app-enabled, scalable Total Worker Health (TWH) program among higher stress Corrections Professionals.
- Conditions
- Occupational Stress, Health Behavior, Safety Issues, Mental Health Wellness 1
- Trial name
- NCT05608889
- Testing
- Total Worker Health Mindfulness Enhanced Program
- Where
- 2 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Kerry Kuehl
Efficacy, Self, Safety Issues
First-Line Treatment Induced With mFOLFOX6 and HLX04 Regimen, Following Combined With Serplulimab in MSS Initially Unresectable Metastatic Colorectal Cancer
This is a prospective, multi-center, randomized controlled clinical intervention study, aiming to explore the effectiveness and safety of mfolfox6 and hlx04 regimens combined with slulimumab as first-line treatment for MSS-type…
- Conditions
- Efficacy, Self, Safety Issues, Colo-rectal Cancer
- Trial name
- NCT06491355
- Testing
- mfolfox6 and hlx04 regimen and Serplulimab, mfolfox6 and hlx04 regimen
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Sir Run Run Shaw Hospital
Premature Ejaculation, Erectile Dysfunction
The Safety of Dapoxetine/Tadalafil Combination Therapy
The purpose of this study is to evaluate the safety and efficacy of Dapoxetine/Tadalafil 30/20 mg film-coated tablet in the treatment of men with premature ejaculation and erectile dysfunction.
- Conditions
- Premature Ejaculation, Erectile Dysfunction, Safety Issues
- Trial name
- NCT03177746
- Testing
- Dapoxetine/Tadalafil 30/20 mg film coated tablet
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Neutec Ar-Ge San ve Tic A.Ş
Glaucoma, Glaucoma Surgery
Vienna Preserflo Cohort Study
The Vienna Preserflo Microshunt Cohort Study is an observational study with a prospective postoperative examination in all glaucoma patients who had received a Preserflo Microshunt (PMS) as standalone procedure or in combination…
- Conditions
- Glaucoma, Glaucoma Surgery, Post-Op Complication, Efficacy, Self
- Trial name
- NCT04541524
- Testing
- Santen Preserflo Microshunt
- Where
- Austria
- Volunteers
- 70 people
- Sponsor
- Medical University of Vienna
Safety Issues, Tolerance
Safety and Tolerability of 2 Dietary Supplement Beverages Designed to Maintain Healthy Blood Pressure.
This study is designed to evaluate the safety and tolerability of two distinct dietary supplement beverage formulations designed to maintain normal blood pressure.
- Trial name
- NCT06442293
- Testing
- Treatment 1, Treatment 2
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- USANA Health Sciences
Rheumatic Disease, HIV Infections
COVID-19 CoronaVac in Patients With Autoimmune Rheumatic Diseases and HIV/AIDS
Patients with chronic rheumatic diseases (such as systemic lupus erythematosus [SLE], rheumatoid arthritis [RA], ankylosing spondylitis [AS], juvenile idiopathic arthritis [JIA], poly/dermatomyositis [PM/DM], systemic sclerosis…
- Conditions
- Rheumatic Disease, HIV Infections, AIDS, Safety Issues
- Trial name
- CoronavRheum (NCT04754698)
- Testing
- CoronaVac
- Where
- Brazil
- Volunteers
- 2,196 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Safety Issues
Safety and Efficacy of Longan and Lingzhi Mushroom Syrup on Immune and Inflammatory Responses in Healthy Volunteers
This study aimed to preliminarily determine safety and efficacy of longan and lingzhi mushroom syrup on immune and inflammatory responses.
- Trial name
- NCT04728009
- Testing
- Longan and lingzhi mushroom syrup
- Where
- Thailand
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
Safety Issues
NOPARK Open Label Extension Study
This protocol describes the NOPARK Open Label Extension Study. The NOPARK Open Label Extension study is an optional extension of the clinical phase II NOPARK study.
- Trial name
- NCT05546567
- Testing
- Nicotinamide Riboside
- Where
- Norway
- Volunteers
- 400 people
- Sponsor
- Haukeland University Hospital
Safety Issues
Safety of Cream Containing Sericin and Turmeric in Healthy Volunteers
The object of this study was to evaluate safety of cream containing sericin and turmeric in healthy volunteers.
- Trial name
- NCT05869357
- Testing
- cream containing 2.5% sericin and 2%turmeric, cream containing 5%sericin and 2%turmeric, cream containing 10%sericin and 2%turmeric
- Where
- Thailand
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
Safety Issues
A Phase I Clinical Study of Hemay808
This is a first-in-human study in health volunteers. The purpose is the local tolerability and systemic safety of Hemay808, which is an ointment made of a novel small molecule Hemay028.
- Trial name
- NCT04100642
- Testing
- Hemay808
- Where
- China
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Tianjin Hemay Pharmaceutical Co., Ltd
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
Safety Issues
Safety of Cell-free Adipose Tissue Product in Healthy Volunteers
The study is a randomized, double blinded, bilaterally controlled trial.The aim is to evaluate the short- and mid term safety of cell-free adipose tissue product.
- Trial name
- SAFETY (NCT05518084)
- Testing
- Liponovo tissue product
- Where
- Finland
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Linio Biotech Oy
Diabetes Mellitus, Renal Insufficiency
Empagliflozin in Renal Transplant Recipients
This is a single-center, prospective, controlled, double-blind, randomized study. A total of 50 renal transplant recipients diagnosed with post-transplantation diabetes mellitus (PTDM) will be included more than 1 year after…
- Conditions
- Diabetes Mellitus, Renal Insufficiency, Safety Issues
- Trial name
- EMPA-RenalTx (NCT03157414)
- Testing
- Empagliflozin
- Where
- Norway
- Volunteers
- 49 people
- Sponsor
- Oslo University Hospital
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
Cancer Pediatric, Neutropenia
Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
This study aims to demonstrate the safety of intracutaneous needles in pediatric cancer patients. For this, a two-year retrospective study will be carried out to determine the incidence of adverse effects related to acupuncture…
- Conditions
- Cancer Pediatric, Neutropenia, Thrombocytopenia, Bacteremia
- Trial name
- ACUSAFE2021 (NCT05585463)
- Testing
- acupuncture
- Where
- Spain
- Volunteers
- 460 people
- Sponsor
- Fundació Sant Joan de Déu
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
Safety Issues
Dexmedetomidine for Sedation Undergoing Bronchoscopy
Several sedatives or analgesics can be used to achieve appropriate levels of sedation for endoscopic procedures. Dexmedetomide is notable for providing sedation without respiratory depression.
- Trial name
- NCT04169685
- Testing
- bronchoscopy
- Where
- Taiwan
- Volunteers
- 80 people
- Sponsor
- Kaohsiung Medical University
Safety Issues, Efficacy, Self
DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease
This study aims to compare the mid- and long-term outcomes between paclitaxel-coated balloon and primary selective stenting in the treatment of TASC C/D femoropopliteal artery occlusive disease.
- Trial name
- NCT05517291
- Testing
- paclitaxel-coated balloon angioplasty or bare mental stents implantation
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Peking Union Medical College Hospital