Clinical trials: Drug Reaction
Injection Site Reaction
A Study Comparing the Local Tolerability of Two Subcutaneous Heparins in Healthy Volunteers.
A Phase IV, Randomised, Double-blind, Single-centre clinical trial in healthy male and female participants aged 18 to 55, that was designed to assess and compare the pain intensity at an injection site as well as the duration of…
- Trial name
- NCT03841396
- Testing
- Sodium chloride
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Aspen Global Incorporated
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
Longitudinal Studies, Prospective Studies
Clinical Time and Temporal Dynamics Study (CLIN-TIME)
TH-CLINICAL-TIME is a prospective, longitudinal observational study evaluating how changes in clinical measurements over time may help researchers better understand patient health trajectories and clinically meaningful outcomes.
- Conditions
- Longitudinal Studies, Prospective Studies, Biomarkers, Predictive Value of Tests
- Trial name
- CLIN-TIME (NCT07812831)
- Testing
- No Study-Assigned Intervention
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Truway Health, Inc.
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
History of IgE Dependent Reaction to a Penicillin Product
Evaluation of Skin Testing Reagents for Penicillin Allergy
A self- or parent-reported history of penicillin allergy excludes approximately 10% of the US population from receiving penicillin (Kerr 1994, Kagy, Blaiss 1998, Solensky et al. 2000, Neugut et al. 2001).
- Trial name
- NCT01818336
- Testing
- Penicillin skin test kit
- Where
- 13 sites in United States
- Volunteers
- 481 people, healthy volunteers welcome
- Sponsor
- AllerQuest LLC
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
Acute Coronary Syndrome
Ticagrelor Removal Study Using CytoSorb® 300 mL Device During CPB in Patients Undergoing Emergent Cardiothoracic Surgery
The aim of CyTation is to demonstrate intra-operative removal of ticagrelor by CytoSorb® hemadsorption in patients on ticagrelor undergoing emergent cardiothoracic surgery requiring CPB, using platelet reactivity to adenosine…
- Trial name
- CyTation (NCT04625764)
- Testing
- Blood sampling and analysis
- Where
- 4 sites in Germany, Luxembourg
- Volunteers
- 6 people
- Sponsor
- CytoSorbents Europe GmbH
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
Allergic Reaction (IgA) Vasculitis
Evaluate the Effectiveness and Safety of BBD-1 Multi-target Immune Enhancement Targeting Agent in the Treatment of Hypersensitivity Reaction (IgA) Vasculitis
Hypersensitivity (IgA) vasculitis is a common vascular allergic disease, the cause of which is not yet clear, and may involve infection, immune disorders, heredity and other factors. It belongs to the category of immune diseases.
- Trial name
- NCT07595367
- Testing
- BBD-1 Multi target Immune Enhancement Targeting Agent
- Where
- 2 sites in United States, China
- Volunteers
- 30 people
- Sponsor
- Qifeng Zhang
Injection Site, Injection Site Reaction
Sorrel 25R Injector - Sorrel Clinical Study Protocol
A prospective, open-label, single-center pilot study to evaluate the performance, safety and usability of the investigational SWI Device in healthy volunteers.
- Conditions
- Injection Site, Injection Site Reaction, Injection Site Irritation
- Trial name
- NCT05221333
- Testing
- Sorrel Wearable Injector
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Eitan Medical