Clinical trials: Adverse Reaction to Drug
Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome
Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis
To test the ability of palifermin (a recombinant human keratinocyte growth factor) to decrease mucocutaneous injury and to promote epithelial repair in Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome-Toxic Epidermal…
- Trial name
- NCT02037347
- Testing
- Palifermin
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Brett King
Seizures
Pathogenesis of Adverse Drug Reactions
The purpose of the study is to examine the individual metabolic profiles of pediatric patients receiving carbamazepine or valproate therapy, in an attempt to determine identities of the reactive metabolites or, alternatively, the…
- Trial name
- NCT00224952
- Testing
- No intervention; Urine Collection
- Where
- 3 sites in United States
- Volunteers
- 274 people
- Sponsor
- Children's Mercy Hospital Kansas City
Graft vs Host Disease, Congenital Aniridia
Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation
The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination with Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely.
- Conditions
- Graft vs Host Disease, Congenital Aniridia, Chemical Burns, Stevens-Johnson Syndrome
- Trial name
- NCT02945176
- Testing
- ARGOS-IO system
- Where
- 2 sites in Germany
- Volunteers
- 13 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Complications of Surgical and Medical Care: General Terms, Adverse Reaction to Drug
The Thai Surgical Intensive Care Study (Thai-SICU Study)
The study observed the 28 days mortality of 9 participated University base surgical intensive care unit (SICU) as well as the occurrence of adverse events in SICU.
- Conditions
- Complications of Surgical and Medical Care: General Terms, Adverse Reaction to Drug, Sequelae of External Causes of Morbidity and Mortality, Critical Illness
- Trial name
- THAI-SICU (NCT01354197)
- Where
- 9 sites in Thailand
- Volunteers
- 4,652 people
- Sponsor
- Royal College of Anesthesiologists of Thailand
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
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
Idiopathic Parkinson's Disease, Drug Induced Dyskinesia
Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease
The study will involve an eighteen-week, double-blind, placebo-controlled parallel designed comparison between add-on topiramate and add-on placebo to stable treatment with amatadine in the treatment of Parkinson's disease (PD)…
- Trial name
- TOP-DYSK (NCT01789047)
- Testing
- Topiramate, Amantadine
- Where
- 5 sites in United States
- Volunteers
- 42 people
- Sponsor
- Rush University Medical Center
Drug Hypersensitivity
Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions
Severe skin adverse drug reactions can result in death. Toxic epidermal necrolysis (TEN) has the highest mortality (30-35%); Stevens-Johnson syndrome and transitional forms correspond to the same syndrome, but with less extensive…
- Trial name
- NCT01276314
- Testing
- anti- TNF-a, Prednisolone
- Where
- Taiwan
- Volunteers
- 135 people
- Sponsor
- Chang Gung Memorial Hospital
Brain and Central Nervous System Tumors, Drug/Agent Toxicity by Tissue/Organ
Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
- Conditions
- Brain and Central Nervous System Tumors, Drug/Agent Toxicity by Tissue/Organ, Lymphoma, Thrombocytopenia
- Trial name
- NCT00074165
- Testing
- Rituxan, Cyclophosphamide, Etoposide
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- OHSU Knight Cancer Institute
Carcinoid Syndrome
Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO
The primary objective of the study is to estimate the proportion of carcinoid syndrome (CS) patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO).
- Trial name
- RELAX (NCT03223428)
- Testing
- Xermelo
- Where
- United States
- Volunteers
- 223 people
- Sponsor
- TerSera Therapeutics LLC
Aging, Benzodiazepine Sedative Adverse Reaction
Optimizing Electronic Health Record Prompts With Behavioral Economics to Improve Prescribing for Older Adults
Prescribing of potentially unsafe medications for older adults is extremely common; benzodiazepines and sedative hypnotics are, for example, key drug classes frequently implicated in adverse health consequences for vulnerable…
- Conditions
- Aging, Benzodiazepine Sedative Adverse Reaction, Anticholinergic Adverse Reaction, Adverse Drug Event
- Trial name
- NUDGE-EHR (NCT04284553)
- Testing
- Order Entry, Open Encounter, Follow-up booster Alert
- Where
- United States
- Volunteers
- 216 people
- Sponsor
- Brigham and Women's Hospital
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
Carcinoid Syndrome, Carcinoid
Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome.
- Conditions
- Carcinoid Syndrome, Carcinoid, Carcinoid Tumor, Carcinoid Tumor of Ileum
- Trial name
- NCT05361668
- Testing
- Randomized: 40 mg Paltusotine, Randomized: 80 mg Paltusotine
- Where
- 35 sites in United States, Argentina and 5 more
- Volunteers
- 36 people
- Sponsor
- Crinetics Pharmaceuticals Inc.
Cardiotoxicity, Breast Cancer
PROactive Evaluation of Function to Avoid CardioToxicity
This study is intended to evaluate the ability of an intramyocardial strain analysis package with cardiac MRI to assist in the early detection and management of cardiotoxicity from therapeutics used to treat cancer.
- Conditions
- Cardiotoxicity, Breast Cancer, Lymphoma, Sarcoma
- Trial name
- PROACT (NCT03862131)
- Testing
- MyoStrain®
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Washington University School of Medicine
Adverse Drug Events
Pharmacists and Pharmacy Technicians to Improve Admission Medication History Accuracy
We tested two interventions to improve the accuracy of medication histories obtained at hospital admission. The interventions target elderly and chronically ill patients prone to erroneous medication histories and resultant…
- Trial name
- NCT02026453
- Testing
- Pharmacist obtains admission medication history, Pharmacy technician obtains admission medication history
- Volunteers
- 306 people
- Sponsor
- Cedars-Sinai Medical Center
Urologic Diseases, Antibacterial Drug Adverse Reaction
Audit-and-feedback to Improve Antimicrobial-prescribing Among Urologists
Antimicrobial resistance is one of today''s most urgent public health problems. An important strategy to slow the spread of antimicrobial resistance is the promotion of judicious antimicrobial use.
- Trial name
- NCT04196777
- Testing
- Audit-and-feedback
- Where
- 3 sites in United States
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- Iowa City Veterans Affairs Medical Center
Aspirin Exacerbated Respiratory Disease (AERD)
Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease
The primary objective of the study is to determine the safety of oral ifetroban compared to placebo as measured by a > 20% decrease in FEV1 compared to baseline following a dose of Investigational Medicinal Product (IMP) (Study…
- Trial name
- NCT02216357
- Testing
- Ifetroban, Oral Capsule
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Cumberland Pharmaceuticals
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
Kidney Transplant; Complications, Toxicity
Effect of Tacrolimus Formulation on Neurological Side Effects in Older Kidney Transplant Recipients
Previous studies have shown that elderly patients experience higher trough levels of tacrolimus and are more sensitive to the effects of medications, they experience higher occurrence and severity of such medication related…
- Conditions
- Kidney Transplant; Complications, Toxicity, Drug Toxicity, Neurotoxicity
- Trial name
- NCT03461445
- Testing
- Envarsus, IR Tacrolimus
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- University of California, Davis