Clinical trials: Drug Reaction
CVI - Common Variable Immunodeficiency
A Study to Evaluate the Benefit of RUCONEST® in Subjects Who Experience ADRs Related to IVIG Infusions
Patients receiving intravenous immunoglobulin (IVIG) therapy for primary immunodeficiency and neurologic conditions may experience adverse drug reactions (ADRs). The mechanism of the ADR is unknown.
- Trial name
- NCT03576469
- Testing
- C1-esterase inhibitor [recombinant] (C1-INH-R)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- IMMUNOe Research Centers
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
Tumor Infiltrating Lymphocytes, Safety
A Phase I Study of GC101 TIL in Advanced Solid Tumors
20-60 participants are expected to be enrolled for the Phase I clinical trial which is further divided into two parts: a "3+3" dose escalation study and an expanded enrollment study.
- Conditions
- Tumor Infiltrating Lymphocytes, Safety, Advanced Solid Tumor, Immunotherapy
- Trial name
- MIZAR-001 (NCT05417750)
- Testing
- TIL therapy
- Where
- China
- Volunteers
- 43 people
- Sponsor
- Shanghai Juncell Therapeutics
Acute Postoperative Pain, Tramadol Adverse Effect
Prospective Pharmacogenetic Cohort Study of CYP2D6 Metabolizer Phenotype, Analgesic Failure, and Adverse Effects in Postoperative Patients Receiving Tramadol by Elastomeric Infusion Pump
This prospective pharmacogenetic cohort will enroll postoperative patients receiving a standardized tramadol-containing elastomeric analgesia pump.
- Conditions
- Acute Postoperative Pain, Tramadol Adverse Effect, Pharmacogenetic Variation
- Trial name
- NCT07810816
- Testing
- Standardized Tramadol Elastomeric Analgesia Pump, CYP2D6 Genotyping and Metabolizer Phenotype Assignment
- Where
- Colombia
- Volunteers
- 200 people
- Sponsor
- Research Inc
Injection Site Reaction
Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products
The objective of this study is to identify and assess in vivo tissue responses after injection with various biostimulatory products at various timepoints.
- Trial name
- NCT06093815
- Testing
- Injection
- Where
- Spain
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Merz North America, Inc.
Adverse Drug Event, Side Effects of Drugs
Safety and Tolerability of Krill Powder Supplement in Slightly Overweight People With Moderately Elevated Blood Pressure
The aim of this study was to systematically collect data on safety and tolerability of krill powder in humans and simultaneously gain efficacy data by measuring the risk factors for cardiovascular disease.
- Trial name
- NCT03112083
- Testing
- Nutritional counseling A, Nutritional counselling B
- Where
- Finland
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Olympic Seafood AS
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
Atrial Fibrillation, Atrial Flutter
Strategy of Early Detection and Active Management of Supraventricular Arrhythmia With Telecardiology (SETAM)
This study investigates if the early detection and treatment of supraventricular arrhythmia (SVA) may help to prevent the progression of the arrhythmia and improve the clinical outcome.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Atrial Tachycardia
- Trial name
- SETAM (NCT01108692)
- Testing
- Telecardiology
- Where
- 57 sites in France
- Volunteers
- 602 people
- Sponsor
- Biotronik France
Parkinson Disease
A Study of Equfina® on the Incidences of Adverse Drug Reactions in Participants With Parkinson's Disease (Including Participants With Hepatic Impairment)
The purpose of the study is to investigate the incidences of psychiatric symptoms (example, hallucinations), somnolence and sudden onset of sleep, dyskinesia, and retinal degeneration-related events during treatment with Equfina…
- Trial name
- NCT04724109
- Testing
- Equfina
- Where
- 2 sites in Japan
- Volunteers
- 1,088 people
- Sponsor
- Eisai Co., Ltd.
Tumor Associated Lymph Node T Cell, Advanced Solid Tumor
A Phase I Trial of Tumor-Associated Lymph Node T-Cell Injection With Advanced Malignant Solid Tumors
A Phase I clinical trial of the safety and tolerability of tumor-associated lymph node T cell injection in patients with advanced malignant solid tumors, including but not limited to melanoma, head and neck tumors, cervical…
- Conditions
- Tumor Associated Lymph Node T Cell, Advanced Solid Tumor, Immunotherapy, Serplulimab Injection
- Trial name
- NCT06716619
- Testing
- Tumor Associated Lymph node T cell, Serplulimab Injection
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Guangzhou FineImmune Biotechnology Co., LTD.
Relapsing-Remitting Multiple Sclerosis (RRMS)
Brimonidine Tartrate for the Treatment of Injection Related Erythema
The primary objective of this study is to evaluate the Injection Related Erythema (IRE) mitigation effect of a single administration of brimonidine tartrate in comparison with a vehicle gel (placebo).
- Trial name
- BRITE (NCT02568111)
- Testing
- peginterferon beta-1a, brimonidine tartrate, Vehicle Gel
- Sponsor
- Biogen
Drug Hypersensitivity
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase.
- Trial name
- NCT00198419
- Testing
- Vitrase
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Bausch & Lomb Incorporated
COVID, Drug Effect
Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Frail Elderly Adults With Polypharmacy
This retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the Medication Risk Score (MRS) in elderly people enrolled…
- Conditions
- COVID, Drug Effect, Drug Interaction, Adverse Drug Event
- Trial name
- NCT04339634
- Testing
- Simulation of Repurposed Drugs for COVID-19
- Where
- United States
- Volunteers
- 12,873 people
- Sponsor
- Tabula Rasa HealthCare
Atrial Fibrillation
Study to Learn More About the Benefits and Side-effects of Drugs Rivaroxaban and Apixaban Compared to the Drug Warfarin for Stroke Prevention in Patients With Rapid and Irregular Heartbeat Which is Not Due to a Heart-valve Fault (Non-valvular Atrial Fibrillation) in the UK Routine Clinical Practice
This population-based study will identify patients with rapid and irregular heartbeat which is not due to a fault with the heart valves (non-valvular atrial fibrillation) who initiate rivaroxaban, apixaban or warfarin as…
- Trial name
- SiERRA UK (NCT03847181)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Apixaban (Eliquis), Warfarin
- Where
- United Kingdom
- Volunteers
- 45,164 people
- Sponsor
- Bayer
Mucopolysaccharidosis II
A Study to Test the Possibility of Cross Reaction Induced by the Idursulfase Drug to GSK2788723
Study IDS116406 will be a non-interventional, phlebotomy study in Hunter Syndrome patients who are currently being treated with idursulfase, an enzyme replacement therapy, and in at least a single patient who is naïve to…
- Trial name
- NCT01602601
- Testing
- Idursulfase, GSK2788723
- Where
- Japan
- Volunteers
- 10 people
- Sponsor
- GlaxoSmithKline
Acute Lymphoblastic Leukemia, Pediatric, Adverse Drug Event
Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia
This is a retrospective biobank study evaluating the impact of novel genetic variants in a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients.
- Trial name
- NCT04770922
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Cipherome, Inc.
Coronary Artery Disease (CAD)
Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI)
To determine the efficacy of prasugrel versus clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting…
- Trial name
- TRIGGER-PCI (NCT00910299)
- Testing
- Prasugrel, Clopidogrel
- Where
- 27 sites in United States, Germany
- Volunteers
- 423 people
- Sponsor
- Eli Lilly and Company
Adverse Drug Events, Adverse Drug Reactions
YouScript IMPACT Registry
This multicenter observational study aims to investigate the benefits of providing pharmacogenetic testing with the YouScript Personalized Prescribing System which includes a clinical decision support tool and individualized…
- Conditions
- Adverse Drug Events, Adverse Drug Reactions, Drug Interaction Potentiation, Drug Metabolism, Poor, CYP2D6-RELATED
- Trial name
- IMPACT (NCT02191358)
- Where
- 7 sites in United States
- Volunteers
- 800 people
- Sponsor
- Genelex Corporation
Liver Transplantation, Transplantation Immunology
A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Liver Transplant Recipients.
The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF and steroid withdrawal in de novo Liver transplant recipients
- Conditions
- Liver Transplantation, Transplantation Immunology, Host vs Graft Reaction
- Trial name
- NCT00720408
- Testing
- Prograf-XL, Prograf, MMF
- Where
- 4 sites in Taiwan
- Volunteers
- 48 people
- Sponsor
- Astellas Pharma Inc
Leishmaniasis; American, Cutaneous, Drug Side Effect
Phase 2 Trial to Evaluate 18-Methoxycoronaridine Efficacy, Safety and Tolerability in Cutaneous Leishmaniasis Patients
It is a randomized phase II clinical study, unicentre aimed to evaluate the tolerability, safety and efficacy of 18-Methoxyoronaridine as a candidate of tegumentary leishmaniasis treatment.
- Trial name
- NCT03084952
- Testing
- 18-Methoxycoronaridine, Glucantime
- Volunteers
- 52 people
- Sponsor
- Infan Industria Quimica Farmaceutica Nacional