Clinical trials: Adverse Reaction
COVID, Drug Effect
Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Adults With Polypharmacy Using Data From Large Medicare and Commercially Insured Populations
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 a health insurance…
- Conditions
- COVID, Drug Effect, Drug Interaction, Adverse Drug Event
- Trial name
- NCT04378881
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Tabula Rasa HealthCare
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
COVID-19, Vaccine Adverse Reaction
National Vaccine Adverse Event Reporting Survey and Etiology
If your serious vaccine-induced adverse event has been entered in the CDC Vaccine Adverse Event Reporting System (VAERS) we are interested in enrolling you for this study in order to log your symptoms.
- Conditions
- COVID-19, Vaccine Adverse Reaction, Vaccine Reaction, Vaccine or Biological Substance, Unspecified Causing Adverse Effects in Therapeutic Use
- Trial name
- NVAERS (NCT05095844)
- Testing
- vaccinated
- Where
- United States
- Volunteers
- 100,000 people
- Sponsor
- Neuroganics LLC
Injection Site Irritation, Injection Site Bruising
Comparison of Subcutaneous Injection of Normal Saline and Bacteriostatic Saline
This is a randomized, double-blind, single-center clinical trial comparing normal saline and bacteriostatic saline subcutaneous injection within a single subject.
- Conditions
- Injection Site Irritation, Injection Site Bruising, Injection Site Discomfort, Benzoic Acid Adverse Reaction
- Trial name
- NCT05109000
- Testing
- Sodium Chloride 0.9% Inj, Bacteriostatic Sodium Chloride 0.9 % INJECTION VIAL (ML)
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jeffrey Alan Klein, MD
Post Operative Hemorrhage, Transfusion Related Complication
Monitoring Noninvasively for Infusion and Transfusion Optimization
This is a multicenter, cluster randomized controlled trial to assess the effects of an optimized intraoperative fluid and blood management strategy on postoperative complications.
- Conditions
- Post Operative Hemorrhage, Transfusion Related Complication, Blood Transfusion Associated Adverse Reactions, Hypovolemia
- Trial name
- NCT04388722
- Testing
- Pulse CO-Oximeter Sensor
- Sponsor
- Masimo Corporation
Premenopause, Iron-deficiency
A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects
A randomized, placebo controlled, parallel group, double blind study to compare the 3-month adherence and efficacy of Active Iron in subjects with or at-risk of iron deficiency and a history of intolerance to oral iron.
- Conditions
- Premenopause, Iron-deficiency, Iron Adverse Reaction, Iron Deficiency Anemia
- Trial name
- NCT04778072
- Testing
- Ferrous sulfate 14mg once daily, Ferrous sulfate 25mg once daily, Ferrous sulfate 25mg twice daily
- Where
- Ireland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Solvotrin Innovations Ltd
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.
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
Hypercholesterolemia, Atherosclerosis
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)
The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.
- Conditions
- Hypercholesterolemia, Atherosclerosis, Statin Adverse Reaction
- Trial name
- NCT03001076
- Testing
- Bempedoic acid, Ezetimibe
- Where
- United States
- Volunteers
- 269 people
- Sponsor
- Esperion Therapeutics, Inc.
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.
- Conditions
- Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, Statin Adverse Reaction
- Trial name
- CLEAR Serenity (NCT02988115)
- Testing
- bempedoic acid
- Where
- 67 sites in United States, Canada
- Volunteers
- 345 people
- Sponsor
- Esperion Therapeutics, 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
Adverse Reaction
Knowledge and Practices of ADR Reporting in LMICs
The reported literature suggests that knowledge about pharmacovigilance is on a lower side and ADR reporting is not common in developing countries.
- Trial name
- NCT04301219
- Where
- Pakistan
- Volunteers
- 1,500 people
- Sponsor
- Getz Pharma
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
Localized Adverse Reaction to Administration of Drug
Intralymphatic eASC Administration in Healthy Volunteers
The objective is to determine the safety, tolerability and feasibility of the inguinal intralymphatic administration of expanded allogeneic adipose-derived stem cells (eASCs)
- Trial name
- NCT01743222
- Testing
- eASC
- Where
- Spain
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Tigenix S.A.U.
Drug-Related Side Effects and Adverse Reactions
A Positron Emission Tomography (PET) Imaging Study to Investigate the Biodistribution and Clearance of an Albumin Binding Domain Antibody (AlbudAb) GSK3128349 in Healthy Male Subjects
GSK3128349 is a small protein molecule (biopharmaceutical) that binds to albumin in the body, and by itself, has no pharmacological action.
- Trial name
- NCT02829307
- Testing
- 89Zr-GSK3128349 1 mg
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neoplasms, Medication Toxicity
Study of Orally-Administered AMXT 1501 Dicaprate in Normal Healthy Volunteers
This is a Phase 1 study, which will assess the safety, PK, and pharmacodynamics (PD) of orally-administered AMXT 1501 dicaprate in normal healthy male volunteers.
- Conditions
- Neoplasms, Medication Toxicity, Tolerance
- Trial name
- NCT03077477
- Testing
- AMXT 1501
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Aminex Therapeutics, Inc.
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.
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
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
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