Clinical trials: Adverse Drug Event
Urinary Tract Infections
Diagnosis, Antibiotic Prescribing Practices and Outcomes of cUTI in an Outpatient Setting
This prospective, multicenter, comparative cohort observational study is to determine if Guidance® UTI pathway compared to traditional diagnostic pathways reduces the rates of empiric antibiotic therapy, adverse events, and…
- Trial name
- NCT05091931
- Where
- 2 sites in United States
- Volunteers
- 3,308 people
- Sponsor
- Pathnostics
Hepatitis C
Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy
An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan
- Trial name
- NCT03071133
- Where
- Japan
- Volunteers
- 344 people
- Sponsor
- Bristol-Myers Squibb
Major Depressive Disorder (MDD)
A Study to Assess Adverse Events of Fosigotifator (ABBV-CLS-7262) in Adults With Major Depressive Disorder
Major depressive disorder (MDD; depression) is a mood disorder that causes a continued feeling of sadness and loss of interest. It is a common and serious illness that can cause both emotional and physical symptoms such as…
- Trial name
- NCT06618118
- Testing
- Fosigotifator
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- AbbVie
Lymphoma, T-cell, Peripheral, Lymphoma, T-cell, Cutaneous
A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
The primary purpose of the study is to investigate the incidence of adverse drug reactions (ADRs) (ADR of special interest: capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic…
- Trial name
- NCT05137847
- Testing
- Remitoro
- Where
- 3 sites in Japan
- Volunteers
- 118 people
- Sponsor
- Eisai Inc.
Pharmacogenomic Testing for Medication Management
Reduction of Adverse Drug Events and Readmissions
Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known with genetic variation.
- Trial name
- RADAR-PGX (NCT02738047)
- Where
- United States
- Volunteers
- 280,000 people, healthy volunteers welcome
- Sponsor
- ClinLogic LLC
Drug Reactions
Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes
This study will help determine which types of drugs that may interact with Lu AF35700
- Trial name
- NCT03195946
- Testing
- Lu AF35700, Midazolam, Cocktail of CYP450 substrates
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Overactive Bladder
Drug Use-Results Survey of Betanis Tablets in Japan
This study is to determine the following information. 1. The occurrence of adverse drug reactions in clinical settings. 2. Factors potentially impacting safety, effectiveness, and other aspects.
- Trial name
- NCT01919047
- Testing
- Betanis
- Where
- 8 sites in Japan
- Volunteers
- 10,711 people
- Sponsor
- Astellas Pharma Inc
Parkinson's Disease, Dyskinesia
Capturing Parkinson's Disease Medication Side Effects During Daily Activities
The purpose of the study is to test whether body-worn wireless motion sensors can measure dyskinesias (involuntary movements caused by medications) in individuals with Parkinson disease (PD) independent of voluntary activity…
- Trial name
- NCT01429207
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Great Lakes NeuroTechnologies Inc.
Opioid-induced Constipation
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
The research objective is to characterize the risk of a major adverse cardiovascular event (MACE) among new users of naldemedine versus new users of lubiprostone and new users of naloxegol as comparator opioid induced…
- Trial name
- NCT03720613
- Testing
- Naldemedine, Lubiprostone, Naloxegol
- Where
- United States
- Volunteers
- 34,532 people
- Sponsor
- BioDelivery Sciences International
Healthy Volunteer
A Study to Evaluate Adverse Events, How the Drug is Tolerated, and How the Drug Moves Through the Body of Intravenous Infusions of ABBV-8736 in Adult Healthy Volunteers
The objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity following multiple intravenous (IV) ascending doses of ABBV-8736 in healthy adult participants.
- Trial name
- NCT07141199
- Testing
- ABBV-8736
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AbbVie
Atrial Fibrillation, Deep Vein Thrombosis
Association Between Genetic Variant Scores and Warfarin Effect
Study objective is to determine whether there is an association between genetic variant risk scores and clinical outcomes (percent time in therapeutic range, time to reach therapeutic international normalized ratio (INR), INR ≥…
- Conditions
- Atrial Fibrillation, Deep Vein Thrombosis, Intracardiac Thrombus, Pulmonary Embolism
- Trial name
- AWARE1 (NCT03894878)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Cipherome, Inc.
Drug Side Effects
Pharmacogenomics Registry to Assess Clinical Utility
The PREACT Registry aims to see whether data from Pharmacogenomic Testing (PGx) can help healthcare providers manage patient medication regimens and assess if the testing has an effect on reducing medication side effects…
- Trial name
- PREACT (NCT02374840)
- Volunteers
- 340,778 people
- Sponsor
- Companion Dx Reference Lab, LLC
Healthy Volunteer, Psoriasis
A Study to Evaluate How the Study Drug Moves Through the Body, Adverse Events, and How the Body Tolerates ABBV-547 Injections
The purpose of this study is to assess how safe, effective, and tolerable ABBV-547 is in adult participants in the United States and Japan. There will be 2 parts to this study.
- Trial name
- NCT07232004
- Testing
- ABBV-547
- Where
- 20 sites in United States, Japan
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- AbbVie
Tumor Infiltrating Lymphocytes, Safety
A Study of GC101 TIL in Advanced Melanoma (BZ)
20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail is expected to be finished in 20 months.
- Conditions
- Tumor Infiltrating Lymphocytes, Safety, Melanoma, Efficacy
- Trial name
- MIZAR-002 (NCT06120712)
- Testing
- GC101 TIL
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Shanghai Juncell Therapeutics
Epilepsy
Adverse Event Scale in Patients With Epilepsy (aEscape) - A European Survey for Physicians With Epilepsy Patients
The purpose of the survey is to explore through a structured interview and patient examination the rate and distribution of neurological and systemic adverse effects related to antiepileptic treatment.
- Trial name
- NCT00394927
- Where
- 53 sites in Austria, Czechia and 5 more
- Volunteers
- 1,000 people
- Sponsor
- UCB Pharma
Drug Reaction to Analgesic Nos
Phase I Pharmacokinetic Study of RX0041-2
This Phase I study is to examine the systemic pharmacokinetics of RX0041-002 following acute, topical, intranasal administration to healthy male and female volunteers.
- Trial name
- NCT02667106
- Testing
- RX0041-2
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pharmaceutical Project Solutions, Inc.
Pharmacogenetic Analysis to Reduce Events.
Medication Optimisation for Reducing Events in a Private Practice Setting
Using a prospective study design of two three month periods (before and after genotyping) in which the patients will self-monitor their health status and possible medical events it is hypothesized that it will be shown that…
- Trial name
- MORE (NCT00653653)
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- Awenydd GmbH
Bipolar Disorder
Utility of the Pharmacogenetic Information Provided by NEUROPHARMAGEN in the Treatment of Bipolar Depressionwith Bipolar Depression
Evaluation of the impact of the genetic variation of individual genes on the therapeutic response and side effects profile in a cohort of well-characterized patients with bipolar depression, using NEUROPHARMAGEN.
- Trial name
- NCT04923204
- Testing
- Pharmacogenomic-testing with NEUROPHARMAGEN
- Where
- Spain
- Volunteers
- 76 people
- Sponsor
- AB Biotics, SA
Ovarian Cancer
A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous (IV) ABBV901 Moves Through the Body Alone or in Combination With Other Anticancer Drugs in Adult Participants With Ovarian Cancer
Ovarian cancer (OC) is a lethal disease. The purpose of this study is to assess the safety, pharmacokinetics and efficacy of ABBV901, alone or in combination with other anticancer drugs, in participants with ovarian cancer.
- Trial name
- NCT07278336
- Testing
- ABBV-901, Bevacizumab, Carboplatin
- Where
- 27 sites in United States, Australia and 6 more
- Volunteers
- 285 people
- Sponsor
- AbbVie
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