Clinical trials: Adverse Effects
Adverse Drug Reaction
Educational Intervention in Pharmacovigilance for Hospital Health Professionals
Spontaneous reports by health professionals generate the signals in pharmacovigilance. However, the passive method has limitations and the most important of them are the underreporting and the poor quality of data, hindering the…
- Trial name
- EIPhv (NCT02134587)
- Testing
- Multifaceted educational intervention
- Where
- Brazil
- Volunteers
- 203 people
- Sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
Antidepressants Causing Adverse Effects in Therapeutic Use
Pharmacogenomic Testing in Primary Care
This is a 6-month randomized, wait-listed, controlled pilot trial conducted in 6 department of family medicine (DFM) clinics at the University of Michigan (UM).
- Trial name
- NCT03270891
- Testing
- PGx test
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- University of Michigan
Drug Toxicity
MW151-101: First-in-human Study of MW151
MW01-2-151SRM (=MW151), a small molecule, is being developed for the treatment of cognitive disorders. The development program is based on nonclinical evidence that MW151 improves neurocognitive outcomes in animal models of…
- Trial name
- NCT04120233
- Testing
- MW151, 10mg, MW151, 20mg, MW151, 40mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Linda Van Eldik
Anesthesia; Adverse Effect, Congenital Heart Disease
The Effect of Anesthesia on Neurodevelopmental Outcome (NDO)
The purpose of this study is to assess whether the type of anesthesia, narcotic-based versus inhalational anesthesia administered during cardiopulmonary bypass (CPB) surgery contributes to the wide variation in neurologic…
- Conditions
- Anesthesia; Adverse Effect, Congenital Heart Disease, Neurodevelopmental Disorders
- Trial name
- NDO (NCT03882788)
- Testing
- Isoflurane, Fentanyl (high dose), Fentanyl (low dose)
- Where
- United States
- Volunteers
- 153 people
- Sponsor
- Stanford University
Olfactory Disorder, Anosmia
Smell Changes & Efficacy of Nasal Theophylline
This study evaluates the efficacy and safety of nasal theophylline irrigation in treating smell loss related to a viral respiratory infection.
- Conditions
- Olfactory Disorder, Anosmia, Viral Infection, Theophylline Causing Adverse Effects in Therapeutic Use
- Trial name
- SCENT (NCT03990766)
- Testing
- Theophylline, Saline Nasal
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Washington University School of Medicine
Adverse Effect, Atherosclerosis, Coronary
Effect of Pioglitazone on Insulin Resistance, Atherosclerosis Progression and Clinical Course of Coronary Heart Disease
Pioglitazone, a medication of thiazolidinedione group, is capable of triggering the peroxisome proliferator-activated receptors (PPAR-γ).
- Conditions
- Adverse Effect, Atherosclerosis, Coronary, Insulin Resistance Syndrome
- Trial name
- EFFORT (NCT03011775)
- Testing
- Pioglitazone 15 mg Tablet, Isosorbide Dinitrate 10Mg Tablet, Acetylsalicylic Acid 75Mg Tablet
- Where
- Ukraine
- Volunteers
- 43 people
- Sponsor
- Ukrainian Medical Stomatological Academy
Polypharmacy
The Adverse Drug Reaction (ADRe) Profile for Polypharmacy
Polypharmacy, the use of multiple or inappropriate medications, has the potential to harm older adults by causing cognitive impairment, falls, and hospitalisations.
- Trial name
- ADRe-p (NCT03955133)
- Testing
- Adverse Drug Reaction ADRe Profile for Polypharmacy
- Where
- United Kingdom
- Volunteers
- 19 people
- Sponsor
- Swansea University
Epinephrine Causing Adverse Effects in Therapeutic Use
Cardiovascular Effects of Racemic Epinephrine Pellets
The primary aim of this study was to determine if topical racemic epinephrine pellets affect heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP) or mean arterial pressure (MAP) in children receiving…
- Trial name
- NCT04688346
- Testing
- HemeRX epinephrine pellets
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- University of Washington
Adverse Effects in the Use of the OsteoProbe System
Open Label Study Using OsteoProbe System
Prospective, Single Center, Open Label Clinical Study. The purpose of the study is to collect safety data associated with the use of the OsteoProbe System.
- Trial name
- OP (NCT04628221)
- Testing
- OsteoProbe System
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Active Life Scientific, Inc.
Pain, Quality of Life
FLUAD® vs. Fluzone® High-Dose Study
The overall aim of the study is to compare safety and immunogenicity of inactivated influenza vaccine (IIV), adjuvanted (FLUAD®) versus High-Dose inactivated influenza (Fluzone® High-Dose) vaccine in persons ≥65 years (20% aged…
- Conditions
- Pain, Quality of Life, Injection Site Reaction, Side Effect of Drug
- Trial name
- NCT03183908
- Testing
- FLUAD®, Fluzone® High-Dose
- Where
- 4 sites in United States
- Volunteers
- 757 people, healthy volunteers welcome
- Sponsor
- Duke University
Breast Cancer, Hormone Changes
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as triptorelin, may protect normal ovarian cells from the side effects of…
- Conditions
- Breast Cancer, Hormone Changes, Drug Toxicity
- Trial name
- NCT00090844
- Testing
- triptorelin
- Where
- 9 sites in United States
- Volunteers
- 49 people
- Sponsor
- University of South Florida
Drug-Related Side Effects and Adverse Reactions, Adverse Drug Events
The Secure Messaging for Medication Reconciliation Tool (SMMRT) Trial
Medication discrepancies, defined as unintentional differences found between patients' medical records and patients' reports of the medication they are taking, occur frequently after hospital discharge, predisposing to adverse…
- Trial name
- SMMRT (NCT02482025)
- Testing
- SMMRT
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- VA Office of Research and Development
Adverse Effect of MRI on an Implanted Pacemaker Lead, Adverse Effect of MRI on an Implanted Pacemaker
Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead
The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI…
- Trial name
- NCT01576016
- Testing
- Accent MRI system (lead safety), Accent MRI system (with MRI scan)
- Where
- 70 sites in United States, Australia and 3 more
- Volunteers
- 950 people
- Sponsor
- Abbott Medical Devices
Oxygen Deficiency, Desaturation of Blood
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Procedures
THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) refers to the use of high-flow nasal cannula to augment the ability to oxygenate and ventilate a patient under general anesthesia.
- Conditions
- Oxygen Deficiency, Desaturation of Blood, Hypoventilation, Anesthesia; Adverse Effect
- Trial name
- NCT03430206
- Testing
- High-flow nasal cannula
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Stanford University
Latent Tuberculosis, Human Immunodeficiency Virus
Doravirine, Rifapentine and Isoniazid Interaction
Drug therapy for persons living with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) co-infected with latent tuberculosis infection (LTBI) is complex.
- Conditions
- Latent Tuberculosis, Human Immunodeficiency Virus, Rifamycins Causing Adverse Effects in Therapeutic Use, Drug Interaction Potentiation
- Trial name
- DORIIS (NCT03886701)
- Testing
- Doravirine (DOR), Rifapentine (RPT), Isoniazid (INH)
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Walter K. Kraft
Adverse Effects in the Therapeutic Use of Plasma Substitutes
Octaplas Pediatric Plasma Exchange Trial
To assess the safety and tolerability of octaplas™ in the pediatric population by monitoring serious adverse drug reactions, adverse drug reactions (ADRs), thrombotic events (TEs), thromboembolic events (TEEs) and by measuring…
- Trial name
- Octaplas (NCT01938378)
- Testing
- Octaplas™
- Where
- 8 sites in United States
- Volunteers
- 41 people
- Sponsor
- Octapharma
Adverse Drug Events, Adverse Drug Reactions
Pharmacogenetic Testing Among Home Health Patients
Patients meeting eligibility criteria will be randomized into two groups, one receiving pharmacogenetic testing and the other not receiving pharmacogenetic testing.
- Conditions
- Adverse Drug Events, Adverse Drug Reactions, Drug Interaction Potentiation, Drug Metabolism, Poor, CYP2D6-RELATED
- Trial name
- NCT02378220
- Testing
- Pharmacogenetic testing
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Genelex Corporation
Hepatitis C, Chronic
An Observational Study of the Safety of Direct-acting Antivirals in Patients With Hepatitis C
The investigators will assess whether patients with the Hepatitis C virus (HCV) who are prescribed direct-acting antiviral (DAA) medications experience higher rates of adverse events than patients with HCV who are untreated.
- Trial name
- NCT03423641
- Testing
- Direct Acting Antivirals
- Volunteers
- 33,808 people
- Sponsor
- Kaiser Permanente
Nasopharyngeal Carcinoma, Adverse Effect of Radiation Therapy
Effect of Bevacizumab on Radiation-induced Brain Necrosis in Patients With Nasopharyngeal Carcinoma
Bevacizumab may have a better effect on brain necrosis caused by radiotherapy.This randomized trial aims to investigate whether bevacizumab may alleviate radiation-induced brain necrosis in patients with nasopharyngeal carcinoma.
- Conditions
- Nasopharyngeal Carcinoma, Adverse Effect of Radiation Therapy, Brain Necrosis
- Trial name
- BRAIN (NCT01621880)
- Testing
- bevacizumab, Corticosteroid
- Where
- China
- Volunteers
- 112 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Drug-Related Side Effects and Adverse Reactions
A Positron Emission Tomography (PET) Imaging Study to Investigate the Biodistribution and Clearance of an Albumin Binding Domain Antibody (AlbudAb) GSK3128349 in Healthy Male Subjects
GSK3128349 is a small protein molecule (biopharmaceutical) that binds to albumin in the body, and by itself, has no pharmacological action.
- Trial name
- NCT02829307
- Testing
- 89Zr-GSK3128349 1 mg
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline