Clinical trials: Serious Adverse Events
Neoplasms, Chemotherapy-induced Nausea and Vomiting
Serious Gaming for Chemotherapy-induced Nausea and Vomiting
The purpose of this study is to examine the effectiveness of a technology-based intervention for managing nausea and vomiting in older adults with cancer.
- Trial name
- NCT05838638
- Testing
- eSSET-CINV
- Where
- 2 sites in United States
- Volunteers
- 610 people
- Sponsor
- University of Central Florida
Retinal Detachment, Achilles Tendon
A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events
The purpose of this study is to evaluate whether there is an increased risk of achilles tendon rupture (ATR), retinal detachment (RD) or aortic aneurysm and dissection (AAD) following exposure to fluoroquinolone (FQ) or other…
- Conditions
- Retinal Detachment, Achilles Tendon, Aneurysm, Dissecting
- Trial name
- NCT03479736
- Testing
- Oral Fluoroquinolones (FQ), Other Antibiotics, Febrile Illness Not Treated with Antibiotics Will be Analyzed as an Exposure
- Where
- United States
- Volunteers
- 117,911 people
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteer Study
Safety Study of CZ10 in Healthy Volunteers
A randomized, double-blind, placebo-controlled, parallel group, dose escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and initial effectiveness of a novel intravenous CT contrast…
- Trial name
- NCT06708767
- Testing
- Contrast Media
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Nextrast, Inc.
Hypertension
Post Marketing Surveillance (PMS) Study to Assess Safety and Efficacy of Micardis in Patients With Essential Hypertension
The objective of this PMS study was to monitor and assess the safety of Micardis tablets in patients with hypertension over a period of 6 years
- Trial name
- NCT02245464
- Testing
- Telmisartan
- Volunteers
- 13,066 people
- Sponsor
- Boehringer Ingelheim
Unexpected Hospital Mortality, Death, Sudden, Cardiac
Prevention of Serious Adverse Events in Acute Care Hospitals by Afferent Limb and Response Method Intervention - the ALARM Intervention Study.
1. Summary Growing evidence suggests that a significant proportion of in-hospital patient deaths occur after serious adverse events (SAE's).
- Conditions
- Unexpected Hospital Mortality, Death, Sudden, Cardiac, Unplanned Intensive Care Unit Admission
- Trial name
- ALARM (NCT01949025)
- Testing
- ALARM intervention
- Where
- Belgium
- Volunteers
- 69,656 people, healthy volunteers welcome
- Sponsor
- Universiteit Antwerpen
Infections, Papillomavirus
Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study
This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in…
- Trial name
- NCT01190189
- Testing
- GSK580299 (Cervarix)
- Where
- 28 sites in United States, Canada
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neoplasms, Rectal
A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea
The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30…
- Trial name
- NCT03671369
- Testing
- Safety data collection (following routine vaccination) by a continuous surveillance method.
- Where
- 29 sites in South Korea
- Volunteers
- 670 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Obesity
Antibiotic-related Serious Adverse Events in Obese Patients Treated for Bone and Joint Infection
It exists recommendations to get an optimal antibiotic treatment for bone and joint infection and prescription of antibiotics in the bone and joint infections on material meets certain obligations: the micro-organism must be…
- Trial name
- NCT02861092
- Where
- France
- Volunteers
- 76 people
- Sponsor
- Hospices Civils de Lyon
HIV Infections, Gonorrhea
Cellulose Sulfate (CS) Gel and HIV in Nigeria
This is a Phase 3, multi-center, randomized, placebo-controlled trial to determine the effectiveness and safety of the 6% cellulose sulfate (CS) vaginal gel for the prevention of HIV infection.
- Conditions
- HIV Infections, Gonorrhea, Chlamydia Infections
- Trial name
- NCT00120770
- Testing
- Cellulose Sulfate Vaginal Gel (Microbicide)
- Where
- 2 sites in Nigeria
- Volunteers
- 2,160 people, healthy volunteers welcome
- Sponsor
- FHI 360
HIV Infections
Fuzeon (Enfuvirtide) Early Access Program for Patients With HIV-1 Infection
This study will determine the safety and tolerability of Fuzeon (enfuvirtide) used together with other treatments for HIV infection in patients with advanced HIV disease. Fuzeon is an antiretroviral drug.
- Trial name
- NCT00050856
- Testing
- Enfuvirtide T/20/Ro 29,9800, HIV-1 Infusion Inhibitor
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chronic Kidney Disease (CKD), Elderly
Sertraline and the Risk of Serious Adverse Events
The goal of this population-based cohort study is to assess the safety of initiating a new outpatient prescription of 50 mg/day of Sertraline, a higher dose, compared to 25 mg/day, a lower dose, in adults aged 65+ with low kidney…
- Conditions
- Chronic Kidney Disease (CKD), Elderly, Outpatient
- Trial name
- NCT07387120
- Testing
- Sertraline 50 mg, Sertraline 25 mg
- Where
- Canada
- Volunteers
- 6,893 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Soft Tissue Sarcoma, Lung Metastases
Surveillance AFter Extremity Tumor surgerY
Following treatment for a primary extremity sarcoma, patients remain at risk for the development of local and systemic disease recurrence.
- Trial name
- SAFETY (NCT03944798)
- Testing
- Frequency: Every 3 Months, Frequency: Every 6 Months, Imaging Modality: Chest Radiograph (CXR)
- Where
- 35 sites in United States, Argentina and 12 more
- Volunteers
- 310 people
- Sponsor
- McMaster University
Serious Adverse Events, Patient Safety
Chemokeyp: A Feasibility Study for Realtime Safety Data-Capture for Potential Serious Adverse Drug Events
Chemokeyp is a feasibility study testing a secure ED-Oncology interface for patients receiving chemotherapy who may present to unscheduled care with possible treatment-related complications.
- Conditions
- Serious Adverse Events, Patient Safety, Pharmacovigilance, Oncology
- Trial name
- NCT07592234
- Where
- Ireland
- Volunteers
- 100 people
- Sponsor
- St Vincent's University Hospital, Ireland
Chronic Kidney Disease (CKD), Elderly
Citalopram and the Risk of Serious Adverse Events
This population-based cohort study aims to evaluate the safety of initiating a new outpatient prescription of citalopram at 20 mg/day (higher dose) compared to 10 mg/day (lower dose) in adults aged 65 years and older with reduced…
- Conditions
- Chronic Kidney Disease (CKD), Elderly, Outpatient
- Trial name
- NCT07399795
- Testing
- Citalopram 10 MG, Citalopram 20 MG
- Where
- Canada
- Volunteers
- 7,110 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
HIV
HPTN 073 Black Men Who Have Sex With Men (MSM) Pre-Exposure Prophylaxis (PrEP)
Black men who have sex with men (MSM) Pre-Exposure Prophylaxis (PrEP) Study with Client Centered Care Coordination (C4) Component.
- Trial name
- NCT01808352
- Testing
- Observational
- Where
- 3 sites in United States
- Volunteers
- 226 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
Immunodeficiencies, Primary Immunodeficiencies (PID)
V-IMMUNE: A Novel Immunoglobulin Therapy for Immunodeficiency
This is a phase III, non-randomized clinical trial (VIP Study) designed to assess the safety and efficacy of V-IMMUNE®, a 5% human normal immunoglobulin preparation, in approximately 50 patients with primary immunodeficiency…
- Conditions
- Immunodeficiencies, Primary Immunodeficiencies (PID), Agammaglobulinemia
- Trial name
- VIP (NCT06954441)
- Testing
- Intravenous immunoglobulin (IVIG)
- Where
- Brazil
- Volunteers
- 50 people
- Sponsor
- On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.
Adverse Drug Reactions
A Pharmacovigilance Study for AdimFlu-S (A/H1N1) Influenza Vaccine in Pregnant Women
This was a retrospective cohort study of pregnant women who had received the AdimFlu-S (A/H1N1) influenza vaccine during gestation period. Eligibility into the study was confirmed by chart review.
- Trial name
- NCT01354730
- Volunteers
- 398 people, healthy volunteers welcome
- Sponsor
- Adimmune Corporation
Cardiac Surgery, Heart Surgery
Novel Venous Cannula Trial
This is a prospective, open-label, single-arm, single-center clinical investigation designed to evaluate the safety and performance of a Novel Venous Cannula during on-pump cardiac surgery requiring transfemoral venous…
- Conditions
- Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass, Minimally Invasive Surgical Procedures
- Trial name
- NCT07087639
- Testing
- Self-expanding Venous Cannula
- Where
- Italy
- Volunteers
- 42 people
- Sponsor
- Eurosets S.r.l.
Graves Disease
Effective Iodide Therapy for Untreated Patients With Graves' Hyperthyroidism Avoiding Thionamide Drugs With Many Side Effects
As the drug treatment of Graves' hyperthyroidism, Plummer reported the effectiveness of excess iodide in 1923 and iodide was used as the therapy for Graves' hyperthyroidism starting from the 1930s.
- Trial name
- NCT04686006
- Testing
- Potassium Iodide
- Volunteers
- 504 people
- Sponsor
- Kyushu University
Chronic Renal Failure (CRF), Graft Failure
Renal Transplantation in the Elderly - nEverOld Study
An exploratory study of the efficacy and safety of a regimen consisted of Everolimus plus low tacrolimus for the immunosuppression in renal transplantation in the elderly.
- Conditions
- Chronic Renal Failure (CRF), Graft Failure, Transplant; Failure, Kidney, Renal Transplant Rejection
- Trial name
- NCT01631058
- Testing
- Everolimus
- Where
- 2 sites in Brazil
- Volunteers
- 90 people
- Sponsor
- University of Sao Paulo General Hospital