Clinical trials: Adverse Drug Events
Recurrent Tonsillitis, Obstructive Sleep Apnea
Post-operative Pain Control After Pediatric Adenotonsillectomy
Adenotonsillectomy is one of the most common surgical procedures performed in the pediatric population in the United States. It is generally a well-tolerated procedure with post-operative bleeding risk ranging from 3-5% in…
- Conditions
- Recurrent Tonsillitis, Obstructive Sleep Apnea, Sleep Disordered Breathing, Adverse Reaction to Drug
- Trial name
- NCT02296840
- Testing
- Ibuprofen, Hydrocodone-Acetaminophen
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Emory University
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
Target Drug-related Adverse Events
Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens
The purpose of this study is to determine whether the addition of selective pharmacogenomic (PGx) testing as determined by Urine Drug Testing (UDT) adds a clinical benefit as evidenced by a reduction in Target Drug-related…
- Trial name
- SPHERE (NCT02625155)
- Testing
- Urine diagnostic testing as SOC, drug regimen changes per SOC, Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results
- Where
- United States
- Volunteers
- 14,000 people, healthy volunteers welcome
- Sponsor
- InSource Diagnostics
Patients on Anti-hypertensive Medication
Impact of a Procedure for the Information and Active Participation of the Patient in the Primary Care Prescription of Antihypertensives
Adverse drug events (ADEs) are responsible for 3.6% of the hospitalisations in France. 50% of these ADEs could be preventable. Cardiovascular drugs are frequently involved in ADEs.
- Trial name
- InPAct (NCT01610817)
- Testing
- InPAct : Information for Participating Actively in cardiovascular treatment
- Where
- France
- Volunteers
- 1,100 people
- Sponsor
- Hospices Civils de Lyon
Simvastatin Adverse Reaction, Pharmacogenomics
A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction
Adverse reactions of simvastatin are mostly slight and transient, however, the incidence of simvastatin-induced hepatic impairment and myopathy are obviously higher in Chinese population than other racial groups.
- Conditions
- Simvastatin Adverse Reaction, Pharmacogenomics, Accurate Medication
- Trial name
- NCT03261908
- Testing
- detection of genotype
- Where
- China
- Volunteers
- 2,200 people
- Sponsor
- Cui Yimin
Clinical Efficacy and Safety
The Efficacy and Adverse Reactions of Neotetracycline in the Treatment of GNB Infections
A multicenter, retrospective, real-world stduy . Subjects with composite criteria were teated with eravacycline ,and 100 cases ,Tigecycline and 300 cases were to be enrolled.
- Trial name
- NCT06990126
- Testing
- bronchoscope
- Where
- China
- Volunteers
- 300 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Obesity; Drug
Nutritional Therapy to Incretin-based Anti-obesity Medications in the Management of Gastrointestinal Adverse Events
The goal of the study is to evaluate the effect of nutrition intervention on gastrointestinal symptoms, treatment discontinuation rate, nutritional parameters (e.g., dietary intake and eating habits), anthropometric measures…
- Trial name
- NCT06431308
- Testing
- nutritional intervention
- Where
- 3 sites in Israel
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Ariel University
Hypnotic Withdrawal
The Impact of a Pharmacist Intervention on Post-discharge Hypnotic Drug Discontinuation in Geriatric Inpatients
This study investigated whether a multifaceted approach was associated with hypnotic drug discontinuation at one month after discharge
- Trial name
- NCT05521971
- Testing
- multifaceted pharmacist-led intervention, Usual care group
- Volunteers
- 173 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Weight Gain, Autism Spectrum Disorder
Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole
This study aims to compare two FDA approved medications (aripiprazole and risperidone) for the treatment of behavioral dysregulation in children with autism spectrum disorders.
- Conditions
- Weight Gain, Autism Spectrum Disorder, Medication Side Effect
- Trial name
- NCT04903353
- Testing
- Comparison of Risperidone and Aripiprazole
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Ovarian Cancer
A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous (IV) ABBV901 Moves Through the Body Alone or in Combination With Other Anticancer Drugs in Adult Participants With Ovarian Cancer
Ovarian cancer (OC) is a lethal disease. The purpose of this study is to assess the safety, pharmacokinetics and efficacy of ABBV901, alone or in combination with other anticancer drugs, in participants with ovarian cancer.
- Trial name
- NCT07278336
- Testing
- ABBV-901, Bevacizumab, Carboplatin
- Where
- 27 sites in United States, Australia and 6 more
- Volunteers
- 285 people
- Sponsor
- AbbVie
Safety Surveillance, Adverse Drug Events
Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.
This registry aims to monitor the safety of Qizhi Tongluo Capsules and to identify the potential risk factors for its adverse drug reactions.
- Conditions
- Safety Surveillance, Adverse Drug Events, Adverse Drug Reactions, Severe Adverse Events
- Trial name
- NCT04479553
- Testing
- Qizhi Tongluo Capsules
- Where
- 14 sites in China
- Volunteers
- 30,000 people
- Sponsor
- Zhong Wang
Best Possible Medication History
Best Possible Medication History at USB
This pilot project investigates the use of a structured medication history (Best Possible Medication History, BPMH) in patients (primarily admitted at the emergency department of University Hospital Basel) after transfer to a…
- Trial name
- bpmh@USB (NCT03851328)
- Testing
- BPMH structured interview
- Where
- Switzerland
- Volunteers
- 160 people
- Sponsor
- University Hospital, Basel, Switzerland
Adverse Drug Events
Eliminating Risk of Preventable Adverse Drug Events at the Hospital-community Interface of Care
This initiative aims to decrease the risk of medication errors at the hospital-community interface as well as health system utilization following hospital discharge by implementing a pharmacist-led medication reconciliation in…
- Trial name
- CMR (NCT01164137)
- Testing
- Medication Reconciliation
- Where
- Canada
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Westview Physician Collaborative
Multiple Sclerosis
VIGIP-SEP2: Training of Patients by Nurses on ADR Reporting by RRMS Patient Via an App
The patient's reporting of adverse drug reactions (ADRs) is recognized as being of interest for post-marketing safety monitoring, but is still underdeveloped in France, with an average lower than the European average.
- Trial name
- VIGIP-SEP2 (NCT04116424)
- Testing
- nurse training of the patient, neurologist accompaniement
- Where
- France
- Volunteers
- 46 people
- Sponsor
- University Hospital, Caen
Fall, Congestive Heart Failure
Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges: Pilot Phase
Polypharmacy is common among older adults in the United States and is associated with harms such as adverse drug reactions and higher costs of care.
- Conditions
- Fall, Congestive Heart Failure, Chronic Kidney Failure, Adverse Drug Event
- Trial name
- NCT03791580
- Testing
- Commitment nudge, Justification nudge
- Where
- United States
- Sponsor
- RAND
Adverse Drug Reactions, Clinical Decision Support
Multi-Agent Collaborative ADR Prediction With Human-Machine Decision Comparison
This study develops a multi-agent collaborative prediction model to forecast adverse drug reactions using real-world clinical medical records.
- Trial name
- NCT07808866
- Testing
- Retrospective medical record data analysis only, no clinical intervention
- Where
- 2 sites in China
- Volunteers
- 20,000 people
- Sponsor
- Peking University Third Hospital
Cancer;Cardiovascular;Adverse Events, Cancer
Multicenter Prospective Observational Study of Cardiotoxicity in Patients Receiving Targeted Cancer Therapies
This study will prospectively monitor cancer patients receiving chemotherapy (including molecular targeted therapies) for cardiovascular adverse events using biomarkers and imaging.
- Trial name
- NCT07058454
- Where
- China
- Volunteers
- 5,000 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Adverse Drug Reactions
A Pharmacovigilance Study for AdimFlu-S (A/H1N1) Influenza Vaccine in Pregnant Women
This was a retrospective cohort study of pregnant women who had received the AdimFlu-S (A/H1N1) influenza vaccine during gestation period. Eligibility into the study was confirmed by chart review.
- Trial name
- NCT01354730
- Volunteers
- 398 people, healthy volunteers welcome
- Sponsor
- Adimmune Corporation
Adverse Drug Event
Ametop - Friend and Foe A Prospective Study of the Incidence of Adverse Reactions With Ametop
Ametop was introduced into the formulary as it was deemed more efficacious for intravenous cannulation compared to EMLA. However, the incidences of adverse reactions seemed to be higher compared to other studies.
- Trial name
- NCT02750137
- Testing
- Tetracaine
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- KK Women's and Children's Hospital
Older Adults (65 Years and Older)
Quantifying the Attentive Behaviors of Older Adults During Over-the-counter Drug Selection
Per-capita consumption of medication is higher in older adults than any other sector of the population. In fact, it has been estimated that although older adults comprise 13% of the population they take 34% of all prescriptions…
- Trial name
- NCT02188134
- Where
- United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Michigan State University