Clinical trials: Adverse Reaction to Drug
Venous Thromboembolism, Deep Venous Thrombosis
Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery
Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic \& reconstructive surgery patients are among those at highest risk for anticoagulant-associated…
- Conditions
- Venous Thromboembolism, Deep Venous Thrombosis, Pulmonary Embolus, Reconstructive Surgery
- Trial name
- NCT03212365
- Testing
- Fixed dose, Variable dose
- Where
- 2 sites in United States
- Volunteers
- 295 people
- Sponsor
- University of Utah
Patient Readmission, Adverse Drug Event
Regional Data Exchange to Improve Care for Veterans After Non-VA Hospitalization
Among older VA patients who have Medicare coverage, 43% use both VA and non-VA (Medicare-covered) services. VA and non-VA providers are often uninformed about encounters, treatments and test results provided in the other system.
- Conditions
- Patient Readmission, Adverse Drug Event, Cost
- Trial name
- NCT02689076
- Testing
- HIE Notification, Care transitions intervention
- Where
- 2 sites in United States
- Volunteers
- 796 people
- Sponsor
- VA Office of Research and Development
Ototoxicity
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing…
- Trial name
- NCT02819856
- Testing
- SPI-1005 Ebselen 200mg Capsule x1, SPI-1005 Ebselen 200mg Capsule x2, SPI-1005 Ebselen 200mg Capsule x3
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Sound Pharmaceuticals, Incorporated
Local Anesthetic Complication, Local Anesthetic Drug Adverse Reaction
Defining Normal Postoperative Magnetic Resonance Imaging After Total Knee Arthroplasty
The aim of this study was to describe the postoperative "baseline" magnetic resonance imaging (MRI) appearance of the ipsilateral thigh musculature after total knee arthroplasty (TKA).
- Trial name
- NCT04821245
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Benaroya Research Institute
Carcinoid Syndrome
An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome
The purpose of this study was to determine whether monthly deep subcutaneous (s.c.) injections of lanreotide Autogel (Somatuline Depot) were effective and safe in controlling diarrhoea and flushing by reducing the usage of s.c.
- Trial name
- ELECT (NCT00774930)
- Testing
- Lanreotide
- Where
- 54 sites in United States, Brazil and 9 more
- Volunteers
- 115 people
- Sponsor
- Ipsen
Osteosarcoma, Nephrotoxicity
Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy
Osteosarcoma is the most common type of bone cancer in children, adolescents and young adults. Treatment with surgery and a combination of three conventional chemotherapy drugs can cure nearly two-thirds patients with…
- Conditions
- Osteosarcoma, Nephrotoxicity, Ototoxicity
- Trial name
- NCT01848457
- Testing
- Pantoprazole, High-dose methotrexate infusion duration
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Children's Hospital of Philadelphia
Ranitidine Adverse Reaction, Pharmacokinetics
Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration
Ranitidine is an over-the-counter and prescription drug, which decreases the amount of acid secreted by the stomach. Some ranitidine medicines contain an impurity called N-nitrosodimethylamine (NDMA) at low levels.
- Conditions
- Ranitidine Adverse Reaction, Pharmacokinetics, Food-drug Interaction
- Trial name
- NCT04397445
- Testing
- Ranitidine, Low nitrite/NDMA meals, High nitrite/NDMA meals
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
Breast Cancer, Heart Disease
STOP Heart Disease in Breast Cancer Survivors Trial
The purpose of this study is to to examine the effects of atorvastatin, a type of statin, on changes to the heart among women undergoing breast cancer treatment.
- Conditions
- Breast Cancer, Heart Disease, Cardiotoxicity, Myocardial Dysfunction
- Trial name
- STOP (NCT02674204)
- Testing
- Atorvastatin
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Cedars-Sinai Medical Center
Malaria, Falciparum
Study to Compare the Triple ACT AL+AQ With the ACT AL in Cambodia and Vietnam
This study is a multi-centre, open-label randomised trial to assess the efficacy, safety and tolerability of the Triple ACT artemether-lumefantrine+amodiaquine (AL+AQ) compared to the ACT artemether-lumefantrine (AL) in…
- Trial name
- TACT-CV (NCT03355664)
- Testing
- ACT, TACT
- Where
- 4 sites in Cambodia, Vietnam
- Volunteers
- 310 people
- Sponsor
- University of Oxford
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
Adverse Reaction to Drug, Neonatal Disorder
Exploratory Propofol Dose Finding Study In Neonates
The aim of the study is to explore the optimal propofol dose in neonates receiving a single intravenous propofol bolus for endotracheal intubation during (semi-)elective INSURE (intubation-surfactant-extubation) procedure…
- Trial name
- NEOPROP (NCT01621373)
- Testing
- propofol administration
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Hypercholesterolemia, Hydroxy-methylglutaryl-coenzyme A (HMG Co-A) Reductase Inhibitors Adverse Reaction
Genetically Guided Statin Therapy
The purpose of this study is to examine if using genetics can improve statin adherence in patients who should be taking statins but are not because of prior side effects.
- Trial name
- NCT01894230
- Testing
- SLCO1B1*5 allele testing, results reported at randomization, SLCO1B1*5 allele testing, results reported at end of study, Genetic testing for SLCO1B1*5 allele
- Where
- 2 sites in United States
- Volunteers
- 167 people
- Sponsor
- Duke University
Carcinoid Syndrome
Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms
The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.
- Trial name
- TELEPATH (NCT02026063)
- Testing
- Telotristat etiprate
- Where
- 43 sites in United States, Australia and 10 more
- Volunteers
- 124 people
- Sponsor
- Lexicon Pharmaceuticals
Acute Coronary Syndrome, Adverse Reaction to Antiplatelet Agent
Mojito Study (Mashed Or Just Integral Pill of TicagrelOr ? )
The aim of the Mashed Or Just Integral pill of TicagrelOr (MOJITO) study is to evaluate the superiority of Ticagrelor 180 mg LD mashed pill versus Ticagrelor 180 mg LD integral pill both orally administrated in decreasing…
- Trial name
- NCT01992523
- Testing
- Ticagrelor mashed pills, Ticagrelor integral pills
- Where
- 2 sites in Greece, Italy
- Volunteers
- 82 people
- Sponsor
- David Antoniucci
Pain, Quality of Life
Simultaneous RZV and aIIV4 Vaccination
The overall aim of the study is to compare the safety of simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Quadrivalent Influenza Vaccine, Adjuvanted (FLUAD®) versus simultaneous Zoster Vaccine…
- Conditions
- Pain, Quality of Life, Injection Site Reaction, Adverse Drug Event
- Trial name
- NCT05007041
- Testing
- FLUAD® Quadrivalent, Fluzone® High-Dose Quadrivalent, SHINGRIX®
- Where
- 2 sites in United States
- Volunteers
- 267 people, healthy volunteers welcome
- Sponsor
- Duke University
Acute Heart Failure, Diuretics Drug Reactions
Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment
This is a pragmatic, multicenter, interventional, parallel-arm, randomized, open-label trial to investigate whether a diuretic regimen, based on serial assessment of sodium concentration (UNa) on spot urine samples after diuretic…
- Trial name
- DECONGEST (NCT05411991)
- Testing
- UNa measurement after intravenous loop diuretic bolus, Intravenous acetazolamide 500 mg OD, Intravenous bumetanide TID
- Where
- 2 sites in Belgium
- Volunteers
- 107 people
- Sponsor
- Vrije Universiteit Brussel
Polypharmacy
The Adverse Drug Reaction (ADRe) Profile for Polypharmacy
Polypharmacy, the use of multiple or inappropriate medications, has the potential to harm older adults by causing cognitive impairment, falls, and hospitalisations.
- Trial name
- ADRe-p (NCT03955133)
- Testing
- Adverse Drug Reaction ADRe Profile for Polypharmacy
- Where
- United Kingdom
- Volunteers
- 19 people
- Sponsor
- Swansea University
Adverse Drug Reaction
Educational Intervention in Pharmacovigilance for Hospital Health Professionals
Spontaneous reports by health professionals generate the signals in pharmacovigilance. However, the passive method has limitations and the most important of them are the underreporting and the poor quality of data, hindering the…
- Trial name
- EIPhv (NCT02134587)
- Testing
- Multifaceted educational intervention
- Where
- Brazil
- Volunteers
- 203 people
- Sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
Akathisia, Drug-Induced, Antipsychotic Agents
Study of Preladenant for the Treatment of Neuroleptic Induced Akathisia (Study P05145)
This study is designed to evaluate the effectiveness of preladenant in the prevention (Part 1) or treatment (Part 2) of antipsychotic induced akathisia in participants with acute psychosis using the Barnes Akathisia Scale.
- Conditions
- Akathisia, Drug-Induced, Antipsychotic Agents, Movement Disorders
- Trial name
- NCT00693472
- Testing
- Preladenant, Anticholinergic agents or propanolol, Haloperidol
- Volunteers
- 46 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer, Breast Tumors
Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer
The goal of this study is to determine if co-administration of metformin and doxorubicin in breast cancer patients receiving neoadjuvant or adjuvant therapy will reduce the number of patients who develop a significant change in…
- Trial name
- NCT02472353
- Testing
- Metformin, Doxorubicin
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Avera McKennan Hospital & University Health Center