Clinical trials: Adverse Drug Reaction (ADR)
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
Thrombosis, Deep Vein, Pulmonary Embolism
A Study of Adverse Events and Suspected Adverse Drug Reactions of Patients Under Treatment of Apixaban for Venous Thomboembolism (VTE) Treatment
Number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with apixaban, according to therapeutic indications approved in Mexico.
- Trial name
- NCT03812835
- Sponsor
- Pfizer
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
Adverse Drug Event, Effect of Drug
Research on Human Insulin rDNA Safety and Efficacy in Patients With Type 2 Diabetes Mellitus
Objective: To evaluate the safety and efficacy of Human Insulin rDNA (Insuget) in patients with Type II Diabetes Mellitus. Study Design: Open-label, prospective, observational, single arm, multi-center, post-marketing…
- Conditions
- Adverse Drug Event, Effect of Drug, Type 2 Diabetes Treated With Insulin
- Trial name
- RISE (NCT05161741)
- Testing
- Insulin
- Where
- Pakistan
- Volunteers
- 238 people
- Sponsor
- Getz Pharma
Cytochrome P450 CYP2D6 Enzyme Deficiency, Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant
Drug & Gene Interaction Risk Analysis With & Without Genetic Testing Among Patients Undergoing MTM
This randomized controlled trial will evaluate whether the use of pharmacogenetic testing through a Medication Therapy Management (MTM) program has a beneficial impact on drug therapy problems.
- Conditions
- Cytochrome P450 CYP2D6 Enzyme Deficiency, Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Ultrarapid Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Extensive Metabolizer Due to Cytochrome P450 CYP2D6 Variant
- Trial name
- NCT02428660
- Testing
- Pharmacogenetic testing, Software-based drug & gene interaction risk analysis, MTM
- Where
- United States
- Volunteers
- 341 people
- Sponsor
- Genelex Corporation
Adverse Drug Event, Drug Drug Interaction
Implementation of a Pharmacist-led Pharmacogenomic Clinical Service
Tabula Rasa HealthCare (TRHC), doing business as CareKinesis, is the first national pharmacy that provides science-based medication risk identification and mitigation technologies and services.
- Conditions
- Adverse Drug Event, Drug Drug Interaction, Pharmacogenomics, Elderly
- Trial name
- NCT04984538
- Testing
- Pharmacogenomic Testing
- Where
- United States
- Sponsor
- Tabula Rasa HealthCare
Advanced Solid Tumor, Tumor Associated Lymph Node T Cell
Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors
A total of 17 to 23 participants are anticipated to be enrolled in the Phase I clinical trial, which is further divided into two distinct parts: one part involves single-agent cell therapy, while the other entails a combination…
- Conditions
- Advanced Solid Tumor, Tumor Associated Lymph Node T Cell, Immunotherapy
- Trial name
- TAL-T (NCT06302062)
- Testing
- Tumor Associated Lymph node T cell, cyclophosphamide, IL-2
- Where
- China
- Volunteers
- 23 people
- Sponsor
- Guangzhou FineImmune Biotechnology Co., LTD.
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.
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
Genetics of Drug Metabolism
Utility of PharmacoGenomics for Reducing Adverse Drug Effects
UPGRADE aims to see whether data from Pharmacogenomic Testing (PGx) can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug reactions, hospitalizations and emergency…
- Trial name
- UPGRADE (NCT02081872)
- Where
- 41 sites in United States
- Volunteers
- 279,000 people
- Sponsor
- Companion Dx Reference Lab, LLC
Drug-Related Side Effects and Adverse Reactions
DOAC ADRs Retrospective Study
This retrospective study's objective is to evaluate if Cipherome's algorithm could have predicted the serious adverse drug reactions (ADRs) experienced by patients while on direct oral anti-coagulants (DOACs).
- Trial name
- NCT04247919
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Cipherome, Inc.
Hypertension
Lacidipine in Medical Practice in Patients With Mild to Moderate Essential Hypertension
In order to confirm the proposed metabolic effect of lacidipine these follow-up study was to provide long-term data on its impact on liver function, glucose homoeostasis and lipid metabolism.
- Trial name
- NCT02177331
- Testing
- Lacidipine
- Volunteers
- 53 people
- Sponsor
- Boehringer Ingelheim
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.
Genetics of Drug Metabolism
Diagnosing Adverse Drug Reactions Registry
This multicenter Registry is to assess whether the use of pharmacogenomic data results in a meaningful change in a subject's drug or dose regimen.
- Trial name
- DART (NCT01970709)
- Where
- 49 sites in United States
- Volunteers
- 250,000 people
- Sponsor
- Renaissance RX
Drug Reaction to Analgesic Nos
Topical Anesthetic for Procedures Through the Nose
To determine if RX0041-002 is a safe and effective topical anesthetic.
- Trial name
- NCT02667054
- Testing
- RX0041 4%, RX0041 8%
- Where
- 2 sites in United States
- Volunteers
- 648 people
- Sponsor
- Pharmaceutical Project Solutions, Inc.
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
Genetics of Drug Metabolism
Pharmacogenomic Testing Of the Elderly To Reduce Morbidity
The goal of the POETRY Registry is to determine whether data from Pharmacogenomic (PGx) Testing for elderly and disabled patients can help physicians manage patient medication regimens and assess if the testing has an effect on…
- Trial name
- POETRY (NCT02095769)
- Where
- 8 sites in United States, Puerto Rico
- Volunteers
- 280,000 people
- Sponsor
- General Genetics Corporation
Cerebral Stroke, Thrombosis, Deep Vein
A Study of Adverse Events and Suspected Adverse Drug Reactions in Patients Under Apixaban for Prevention of Stroke and Systemic Embolism With Non-Valvular Atrial Fibrillation and Venous Thromboembolic Events in Patients Who Have Undergone Elective Hip or Knee Replacement Surgery
To characterize and analyze the number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with Apixaban, according to therapeutic indications approved in Mexico.
- Conditions
- Cerebral Stroke, Thrombosis, Deep Vein, Pulmonary Embolism
- Trial name
- NCT03804125
- Sponsor
- Pfizer
COVID, Drug Effect
Assessment of Mortality Rates in COVID-19 Infected Populations Treated With Repurposed Medications
This retrospective cohort study will include eligible patients that received a positive COVID-19 test and filled a new prescription for one of the repurposed medications (including hydroxychloroquine, chloroquine, with or without…
- Conditions
- COVID, Drug Effect, Drug Interaction, Risk Reduction
- Trial name
- NCT04432350
- Where
- United States
- Sponsor
- Tabula Rasa HealthCare
Adverse Reaction to Drug
Post-market Safety Reassessment of Ulinastatin for Injection
1. Investigate the application of ulinastatin(UTI) in real practice clinic.(eg:population character, usage and dosage, course of treatment,etc ) 2.
- Trial name
- NCT02520570
- Testing
- ulinastatin
- Where
- China
- Volunteers
- 10,000 people
- Sponsor
- Techpool Bio-Pharma Co., Ltd.