Clinical trials: Serious Adverse Events
Nursing Caries, Critical Care
Analysis of Factors Related to Occurrence of Serious Adverse Events During Nursing in Intensive Care Units
Patients who are hospitalized in intensive care unit (ICU) require basic nursing care to improve patient hygiene, to promote comfort, to prevent pressure ulcer, and foot or hand's retractations.
- Trial name
- NURSIE (NCT03475238)
- Testing
- Nursing care
- Where
- 26 sites in Belgium, France and 2 more
- Volunteers
- 262 people
- Sponsor
- French Society for Intensive Care
Acute Renal Failure, Kidney Disease
Prevention of Serious Adverse Events Following Angiography
The purpose of this research study is to compare the effectiveness of intravenous isotonic sodium bicarbonate with intravenous isotonic sodium chloride and oral N-acetylcysteine (NAC) with oral placebo for the prevention of…
- Conditions
- Acute Renal Failure, Kidney Disease, Coronary Artery Disease
- Trial name
- PRESERVE (NCT01467466)
- Testing
- IV isotonic saline, IV isotonic bicarbonate, N-acetylcysteine
- Where
- 54 sites in United States, Australia and 2 more
- Volunteers
- 5,177 people
- Sponsor
- VA Office of Research and Development
Drug-Related Side Effects and Adverse Reactions
Investigation of Serious Adverse Events Following Vaccination Against Yellow Fever: Emphasis on Genetic Basis and Biological Markers
It concerns an investigation aiming to investigate genetic biological(s) marker(s) which allow to identify individuals who have risk of serious adverse events to the yellow fever vaccine.
- Trial name
- NCT03938597
- Where
- Brazil
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Anticoagulants, Thromboembolism
Influence of ABCB1 Polymorphisms on Plasma Concentrations of New Oral Anticoagulants in Case of Serious Adverse Events
Vitamin K antagonists were hampered by several disadvantages, such as the need for frequent monitoring. In this context, new oral anticoagulants (NOACs) have been developed and are now available on the market.
- Conditions
- Anticoagulants, Thromboembolism, Hemorrhage
- Trial name
- Pgp NACO (NCT02103101)
- Testing
- Measurement of Plasma Concentrations of NOACs, Identification of ABCB1 polymorphisms coding for P-gp
- Where
- France
- Volunteers
- 68 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Contraception
Assessing Preference for 3 Female Condoms: A Comparative Evaluation of the PATH Woman's Condom, FC2 and the Reddy 6
Evaluation of preference for three female condoms (FC).
- Trial name
- NCT01452503
- Testing
- Path Women's Condom, FC2 female condom, Reddy 6 female condom (V-Amour)
- Where
- South Africa
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- FHI 360
Diabetes Mellitus, Type 2
Malignancy Meta Analysis for BRL49653
Observational analyses of data from population registeries have suggested that metformin may be associated with a decreased prevalence of malignancy.
- Trial name
- NCT01195259
- Testing
- allocation of treatment with metformin or rosiglitazone
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Glioblastoma, Glioblastoma Multiforme
The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)
Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival.
- Conditions
- Glioblastoma, Glioblastoma Multiforme, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme of Brain
- Trial name
- RECSUR (NCT06283927)
- Testing
- Re-resection, Temozolomide, Lomustine
- Where
- 8 sites in United States, Belgium and 3 more
- Volunteers
- 464 people
- Sponsor
- Jasper Gerritsen
Assess the Effects of a the 90-day Oral TS Study Regimen on PSA, IPSS, Haemoglobin and Haematocrit, and to Assess Adverse and Serious Adverse Events.
The Effect of 90-day Oral Testosterone Therapy in Chinese Males With Type 2 Diabetes (T2DM)
The study hypothesis is that treatment with oral Testosterone according to the study regimen will improve glycemic control in T2DM Chinese males in Singapore as indicated by a reduction in HbA1c levels at study day 90.
- Trial name
- OTEST (NCT01510847)
- Testing
- Andriol Testocaps
- Where
- 12 sites in Singapore
- Volunteers
- 19 people
- Sponsor
- Singapore Clinical Research Institute
Vaccine-induced Thrombotic Thrombocytopenia Syndrome, Guillain-Barre Syndrome
Gene Sequencing as a Strategy for Identifying Genetic Factors Associated With Serious Adverse Events After Covid-19 Vaccines in Use in Brazil
This protocol proposes to investigate genetic factors that may be involved in the pathogenesis of adverse events of interest with selected covid-19 vaccines: vaccine-induced immune thrombotic thrombocytopenia, and neurological…
- Conditions
- Vaccine-induced Thrombotic Thrombocytopenia Syndrome, Guillain-Barre Syndrome, Acute Disseminated Encephalomyelitis, Transverse Myelitis
- Trial name
- NCT05630313
- Where
- Brazil
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
HIV
Male Engagement in PMTCT Services
The study employs a quasi-experimental design in 8 public health centers in southwest Uganda offering care and treatment (C\&T) services.
- Trial name
- NCT01903889
- Testing
- clinic based intervention, clinic and community based intervention
- Where
- 7 sites in Uganda
- Volunteers
- 3,806 people, healthy volunteers welcome
- Sponsor
- FHI 360
Contraception
A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan
This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan.
- Trial name
- NCT01463254
- Where
- Pakistan
- Volunteers
- 724 people, healthy volunteers welcome
- Sponsor
- FHI 360
Bleeding as Complication to Anticoagulation Therapy
Reporting of Adverse Events in Patients Treated With New Oral Anticoagulants
Serious adverse events in patients treated with new oral anticoagulants are underreported.
- Trial name
- NCT02107651
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Hvidovre University Hospital
Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM)
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
Non-ischemic cardiomyopathies (NICM) represent a heterogeneous group of pathologies characterized by absence of obstructive disease of the epicardial coronary vessels and distinct structural and functional changes of the…
- Conditions
- Non-ischemic Cardiomyopathy, Dilated Cardiomyopathy (DCM), Hypertrophic Cardiomyopathy (HCM), Restrictive Cardiomyopathy
- Trial name
- AINICM (NCT06607471)
- Testing
- Support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation, Support treatment, cardiac medical treatment, aetiology-specific treatment
- Where
- Italy
- Volunteers
- 15,000 people
- Sponsor
- Scientific Institute San Raffaele
Long-term and Permanent Contraceptive Methods
A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar
This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar.
- Trial name
- NCT01200576
- Where
- Madagascar
- Volunteers
- 621 people, healthy volunteers welcome
- Sponsor
- FHI 360
Chronic Kidney Disease
Serotonin Norepinephrine Reuptake Inhibitors and the Risk of Serious Adverse Events
This is a population-based retrospective, new-user design, active comparator cohort study assessing whether initiating a new outpatient prescription of high-dose serotonin norepinephrine reuptake inhibitors (SNRIs)-venlafaxine…
- Trial name
- NCT07531173
- Testing
- Venlafaxine or duloxetine
- Volunteers
- 8,688 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Infections, Papillomavirus
Safety Evaluation of a Human Papillomavirus (HPV) Vaccine in Healthy Female Control Subjects From the GSK HPV 023 Study
This phase IIIb study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in the HPV-023 (NCT00518336) study and received a placebo in the HPV-001 (NCT00689741)…
- Trial name
- NCT01418937
- Testing
- CervarixTM (GSK580299)
- Where
- 5 sites in Brazil
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Kidney Disease
Nortriptyline and the Risk of Serious Adverse Events
This is a population-based retrospective, new-user, active comparator cohort study assessing whether initiating a new outpatient prescription of high-dose nortriptyline (>10-150 mg/day), compared with low-dose (10 mg/day), is…
- Trial name
- NCT07527481
- Testing
- Nortriptyline Hydrochloride
- Volunteers
- 5,000 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
HIV Infection, HIV Infections
Integration of Family Planning and HIV Services in Tanzania
HIV positive women and couples have broad reproductive health needs that are not always met within HIV services. The integration of family planning (FP) services into Tanzania's HIV Care and Treatment Clinics (CTC) will address…
- Trial name
- NCT00941876
- Testing
- Facilitated Referral
- Where
- Tanzania
- Volunteers
- 864 people
- Sponsor
- FHI 360
Prevention of Inappropriate Therapies and MACCE. Single-chamber ICD
Prevention of Inappropriate Therapies and MACCE With a Single Chamber ICD With DX Floating Dipole Atrial Detection
Prevention of inappropriate therapies and serious adverse cardiac and cerebrovascular events with a single chamber implantable defibrillator with DX floating dipole atrial detection
- Trial name
- PREVENT-DX (NCT04344704)
- Testing
- Single chamber DAI device with floating atrial dipole
- Where
- 16 sites in Spain
- Volunteers
- 462 people
- Sponsor
- Trialance SCCL
General Surgery
The GUARDIAN Pilot Trial
The treatments will be: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg, delayed resumption of chronic antihypertensive medications, and a target ward MAP ≥80 mmHg (tight pressure management)…
- Trial name
- GUARDIAN (NCT04789733)
- Testing
- Tight pressure management, Routine pressure management
- Where
- China
- Volunteers
- 80 people
- Sponsor
- The Cleveland Clinic