Clinical trials: Serious Adverse Events
Pemphigus, Auto-immune Thrombocytopenic Purpura
The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders
The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for various auto-immune diseases.
- Conditions
- Pemphigus, Auto-immune Thrombocytopenic Purpura, Hemolytic Auto-immune Anaemia, Cold Agglutinin Disease
- Trial name
- RITAI (NCT00960713)
- Testing
- Rituximab (MABTHERA® or RITUXAN®).
- Where
- France
- Volunteers
- 35 people
- Sponsor
- University Hospital, Toulouse
Oral Anticancer Therapy.
Impact of Clinical Pharmacy Consultations in Patients With Cancer Treated With Oral Anti-cancer Therapies on the Rate of Serious Adverse Events
The improvement of the care pathway of oncology patients through Clinical Pharmacy activities for outpatients (such as pharmaceutical consultation) should be implemented and evaluated.
- Trial name
- PharmaOnco (NCT02733965)
- Testing
- Pharmaceutical Consultations, No Pharmaceutical Consultations
- Where
- France
- Volunteers
- 190 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
The Study Goal is to Assess the Introduction of Sustainable Family Planning/Reproductive Health Information and Services Through, Land O' Lakes-supported Dairy Cooperatives
Family Planning Through Dairy Cooperatives
This observational study will assess a model for providing family planning through quarterly events organized by dairy cooperatives supported by Land O'Lakes in Kenya.
- Trial name
- NCT01226433
- Where
- Kenya
- Volunteers
- 319 people, healthy volunteers welcome
- Sponsor
- FHI 360
Total Knee Arthroplasty, Knee Arthroplasty
Risk of Serious Adverse Events Following Unsupervised vs Supervised Rehabilitation After Knee Arthroplasty
SUMMARY Background: After knee arthroplasty (KA), rehabilitation is widely recommended, yet its clinical effectiveness-especially the need for supervision-has been challenged.
- Conditions
- Total Knee Arthroplasty, Knee Arthroplasty, Unicompartmental Knee Arthroplasty
- Trial name
- SAFE-T (NCT07067060)
- Volunteers
- 40,000 people
- Sponsor
- Copenhagen University Hospital, Hvidovre
Sexually Transmitted Diseases
Madagascar Female Condom Study
The study was designed to measure the effects of male and female condom promotion on STI prevalence and reported condom use by sex workers and their partners.
- Trial name
- NCT00272974
- Testing
- Clinic-based counseling
- Where
- 2 sites in Madagascar
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- FHI 360
This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy
Third Line Highly Active Antiretroviral Therapy (HAART) in HIV-infected Children
This is an observational cohort study of virologic and immunologic outcome after at least 48 weeks of third line antiretroviral therapy. Upto 150 children at 8 Thai sites will be enrolled.
- Trial name
- NCT01225406
- Testing
- Tenofovir
- Where
- 9 sites in Thailand
- Volunteers
- 56 people
- Sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
Pregnancy Prevention
Continuous Use of COCs
The primary objective is to determine if continuous COC use leads to higher continuation rates over 12 months of follow up than use of the standard 28-day COC regimen.
- Trial name
- NCT00570440
- Testing
- Oral contraceptives--ethinyl estradiol, levonorgestrel
- Where
- 2 sites in Dominican Republic, Nicaragua
- Volunteers
- 362 people, healthy volunteers welcome
- Sponsor
- FHI 360
Schizophrenia, Serious Mental Illness
Cross-Sectional Iloperidone IVGTT
This study aims to utilize state of the art procedures such as the frequently sampled intravenous glucose tolerance test (FSIVGTT), Bergman's Minimal Model Analysis, lipoprotein analysis, and DEXA scans to demonstrate that a…
- Conditions
- Schizophrenia, Serious Mental Illness, Metabolic Syndrome, Insulin Resistance
- Trial name
- NCT01686815
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Massachusetts General Hospital
COVID-19 Disease
A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 to Prevent Clinical Deterioration in Patients With Moderate or Severe COVID-19 Infection
A Phase II Randomized, double-blind, Placebo-controlled Study to Evaluate the safety and efficacy of exosomes overexpressing CD24 to prevent clinical deterioration .The study population will include patients with moderate or…
- Trial name
- NCT04969172
- Testing
- Exosomes overexpressing CD24
- Where
- Israel
- Volunteers
- 155 people
- Sponsor
- Eli Sprecher, MD
Chronic Kidney Disease (CKD), Older Adults (65 Years and Older)
Trazodone 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 trazodone (>75-150 mg/day), compared to a lower dose (25-75 mg/day) is associated…
- Trial name
- NCT07381101
- Testing
- Trazodone HCl
- Where
- Canada
- Volunteers
- 31,459 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Prevention of In-hospital Adverse Events
Electronically Recorded National Early Warning Scores, Pain Scores and PONV Scores Among Hospitalized Patients
National early warning score (NEWS) enables early detection of patient deterioration in hospital floors. However, there is limited data on the prognostic value of NEWS among actual general ward patients.
- Trial name
- NCT04055350
- Where
- Finland
- Volunteers
- 30,000 people
- Sponsor
- Tampere University Hospital
HIV Infections
Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV
This Phase 2a study involving Tenofovir Disoproxil Fumarate (TDF) will provide extended safety data for high-risk men. Secondarily, the study will assess the feasibility of conducting the trial and evaluate the preliminary…
- Trial name
- NCT00122512
- Testing
- Tenofovir Disoproxil Fumarate
- Where
- Malawi
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- FHI 360
Patient Centered Care, Postoperative Care
Outreach: A Programme for Timely Treatment of Critically Ill Patients in a University Hospital
The identification of patients with potential early organ failure is the key in preventing admission or readmission to a critical care facility.
- Conditions
- Patient Centered Care, Postoperative Care, Critical Illness
- Trial name
- NCT00306345
- Testing
- Outreach
- Where
- Netherlands
- Volunteers
- 1,500 people
- Sponsor
- Radboud University Medical Center
Chronic Kidney Disease (CKD), Elderly
Escitalopram 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 10mg/day of Escitalopram (higher dose) compared to 5 mg/day (lower dose) in adults over the age of 65 with low…
- Conditions
- Chronic Kidney Disease (CKD), Elderly, Outpatient
- Trial name
- NCT07274241
- Testing
- Escitalopram
- Where
- Canada
- Volunteers
- 12,145 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Cardiovascular Events, MACE
Tezspire Cardiac Events PASS
The aim of this study is to evaluate the risk of serious adverse cardiovascular events in adolescent and adult patients with severe asthma taking tezepelumab compared to a population receiving standard of care treatment for…
- Trial name
- TRESPASS (NCT06951867)
- Testing
- Tezepelumab
- Where
- 4 sites in United States, Denmark and 2 more
- Volunteers
- 16,640 people
- Sponsor
- AstraZeneca
Infections, Papillomavirus
The 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 HPV vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the…
- Trial name
- NCT01249365
- Testing
- GSK580299 (Cervarix)
- Where
- 15 sites in Australia, Portugal and 2 more
- Volunteers
- 199 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Contraceptive Usage
A Prospective Observational Study of the Performance of Zarin in Kenya
This will be a non-comparative prospective observational study of women using Zarin as a primary method of contraception in Kenya.
- Trial name
- NCT01334190
- Where
- Kenya
- Volunteers
- 602 people, healthy volunteers welcome
- Sponsor
- FHI 360
Acquired Bleeding Disorder, Intracerebral Haemorrhage
Factor VIIa in Acute Intracerebral Haemorrhage
This trial is conducted in Japan. The purpose of this trial is to evaluate the safety and preliminary efficacy of Activated Recombinant Factor VII (NN-007) in patients with acute intracerebral haemorrhage.
- Trial name
- NCT00266006
- Testing
- eptacog alfa (activated)
- Where
- Japan
- Volunteers
- 90 people
- Sponsor
- Novo Nordisk A/S
Emergencies
Prediction Of Serious Adverse Event in Emergency Department With dysKAlemia, Retrospective Study
Dyskalemia, hypo- and hyperkalemia are common in the emergency department and are associated with increased morbidity and mortality.
- Trial name
- PODKA-R (NCT05788523)
- Where
- France
- Volunteers
- 500 people
- Sponsor
- Centre Hospitalier Régional Metz-Thionville
Chronic Kidney Disease (CKD)
Tamsulosin and the Risk of Serious Adverse Events
This is a population-based cohort study assessing whether initiating a higher dose of tamsulosin (0.8 mg/day) compared to a lower dose (0.4 mg/day) in older adults with advanced chronic kidney disease (CKD) (an estimated…
- Trial name
- NCT07274228
- Testing
- Tamsulosin
- Where
- Canada
- Volunteers
- 14,000 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's