Clinical trials: Adverse Drug Reactions
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
Influenza
Post-authorisation Safety Study (PASS) of Influenza Vaccine in United Kingdom (UK)
The purpose of this study is to conduct a pilot study to explore the potential use of routinely collected data in General Practitioner (GP) practices to conduct enhanced safety surveillance of seasonal influenza vaccines in the…
- Trial name
- NCT02567721
- Testing
- Vaccine safety surveillance
- Where
- United Kingdom
- Volunteers
- 11,530 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Palmar-Plantar Erythrodysesthesia Syndrome
Safety and Efficacy Placebo Controlled Study of ATH008 Cream in PPES Patients Secondary to Capecitabine
The aim of this study is to evaluate the safety and efficacy of ATH008 cream in patients with Palmar-Plantar Erythrodysesthesia Syndrome (PPES) secondary to capecitabine therapy.
- Trial name
- NCT01316406
- Testing
- ATH008
- Where
- 26 sites in Belgium, Germany and 2 more
- Volunteers
- 122 people
- Sponsor
- Advancell - Advanced In Vitro Cell Technologies, S.A.
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
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
Akathisia, Drug-Induced, Dyskinesia, Drug-Induced
Study of Preladenant for the Treatment of Antipsychotic Induced Movement Disorders in Participants With Schizophrenia (Study P04628)
This study was designed to determine if preladenant (SCH 420814, MK-3814) can reduce drug-induced involuntary movements in participants with schizophrenia or schizoaffective disorder.
- Conditions
- Akathisia, Drug-Induced, Dyskinesia, Drug-Induced, Parkinsonian Disorders
- Trial name
- NCT00686699
- Testing
- Preladenant
- Volunteers
- 11 people
- Sponsor
- Merck Sharp & Dohme LLC
Carcinoid Syndrome
Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome
Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment of the symptoms of carcinoid syndrome.
- Trial name
- NCT00884715
- Testing
- Octreotide
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Parkinson Disease, Dyskinesia, Medication-Induced
Efficacy, Safety and Pharmacokinetic Study of CPL500036 in Patients with Levodopa Induced Dyskinesia
The aim of the study is to determine potential anti-dyskinetic properties of CPL500036 (PDE10A inhibitor) in Parkinson disease patients suffering from levodopa Induced dyskinesia.
- Trial name
- NCT05297201
- Testing
- CPL500036 - low dose, CPL500036 - high dose
- Where
- 16 sites in Poland, Ukraine
- Volunteers
- 105 people
- Sponsor
- Celon Pharma SA
Parkinson Disease, Dyskinesia, Drug-Induced
Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy
This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia (randomized 1:1 to receive active or placebo) for 12 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day).
- Conditions
- Parkinson Disease, Dyskinesia, Drug-Induced, Dyskinesias
- Trial name
- NCT04857359
- Testing
- Dipraglurant
- Where
- 41 sites in United States
- Volunteers
- 25 people
- Sponsor
- Addex Pharma S.A.
Drug Hypersensitivity
A Study to Assess the Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood of Children, Teenagers and Adults
The aim of this study is to find out whether TAK-880 creates hypersensitivity reactions compared to Gammagard S/D by testing blood taken from participants who have a higher risk of becoming hypersensitive to immunoglobulin…
- Trial name
- NCT05269082
- Testing
- No intervention
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Takeda
Parkinson Disease, Dyskinesia, Medication-Induced
AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia
This is a randomized, double-blind, placebo-controlled, crossover, proof-of-concept Phase 2 study to test efficacy and safety of AV-101 (L-4-chlorokynurenine) in Parkinson's Disease subjects with levodopa-induced dyskinesia.
- Conditions
- Parkinson Disease, Dyskinesia, Medication-Induced, L-Dopa Causing Adverse Effects in Therapeutic Use
- Trial name
- NCT04147949
- Testing
- AV-101
- Volunteers
- 20 people
- Sponsor
- VistaGen Therapeutics, Inc.
Hand Foot Skin Syndrome
Topical Cosmetic Products for Hand and Foot Syndrome
The aim of the study is to evaluate the efficacy of a dermocosmetic protocol in reducing the main cutaneous side effects that occur in palmar-plantar erythrodysesthesia syndrome in subjects with a tumor diagnosis, undergoing…
- Trial name
- NCT06586073
- Testing
- cosmetic products
- Where
- Italy
- Volunteers
- 53 people
- Sponsor
- Dermophisiologique s.r.l
Hypersensitivity Reactions
Post-market Safety Study of LUMISIGHT
This study is a prospective, multi-center, observational post-market safety study evaluating the incidence of anaphylaxis and hypersensitivity reactions associated with LUMISIGHT (pegulicianine) administration in adults with…
- Trial name
- NCT07572162
- Where
- 2 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Lumicell, Inc.
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.
Polypharmacy Patients
Assessment of a Novel Algorithm System for Polypharmacy Patient Medication Safety and Consultation
The aim of this study is to determine if insights based on the analysis of historical data of multidrug patients' electronic health records, by a novel system and algorithm, is noninferior to a clinical pharmacist analysis and…
- Trial name
- NCT05589870
- Testing
- Multi-drug analysis of polypharmacy treatment
- Where
- Israel
- Volunteers
- 91 people
- Sponsor
- MDI Health
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
Drug-Related Side Effects and Adverse Reactions, Treatment Failure
DOAC ADRs Retrospective Study on Genetic Variations
The purpose of this study is to see if the participant's genetic profile and clinical factors (age, drug dose, etc.) affect drug outcomes (i.e.
- Trial name
- DARES1 (NCT04580589)
- Where
- United States
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Cipherome, Inc.
Carcinoid Syndrome
Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome
The purpose of the protocol is to assess the efficacy and safety of BIM 23A760 on patient's overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with carcinoid syndrome after 24 weeks of…
- Trial name
- CAMPANULA (NCT01018953)
- Testing
- BIM 23A760
- Where
- 54 sites in Austria, Belgium and 16 more
- Volunteers
- 8 people
- Sponsor
- Ipsen
Breast Cancer, Cognitive Symptoms
Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment
The investigators hypothesize that continuous active interaction with environments that are demanding to sensory, cognitive, and motor systems, together with imbedded rewards for successful performance, will help improve memory…
- Conditions
- Breast Cancer, Cognitive Symptoms, Memory Disorders
- Trial name
- NCT00387062
- Testing
- Computer-based Cognitive Training
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Posit Science Corporation
Malignant Carcinoid Syndrome
Comparison of Lanreotide Autogel® and Sandostatin LAR Depot in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome
The aim of this study is to compare the efficacy and safety of lanreotide Autogel and Sandostatin LAR Depot, to see whether these two 28-day prolonged release formulations produce a similar clinical response in patients with…
- Trial name
- NCT00092287
- Testing
- lanreotide Autogel (somatostatin analogue), Sandostatin long acting release (LAR) Depot (somatostatin analogue)
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Ipsen