Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).
This page lists clinical trials related to Drug Reaction from the ClinicalTrials.gov database.
Trial Summary
- Total studies: 50
- Recruiting: 24
- Active, not recruiting: 2
- Completed: 12
- Other: 12
Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.
Recruiting Trials
NCT00414115 — National Active Surveillance Network and Pharmacogenomics of Adverse Drug Reactions in Children
| Status | Recruiting |
| Phase | N/A |
| Sponsor | University of British Columbia |
| Enrollment | 7000 |
| Study Type | OBSERVATIONAL |
| Conditions | Adverse Drug Reaction (ADR) |
The purpose of the study is (1) to identify and collect samples from children and adults who take drugs and have adverse drug reactions AND children and adults who take drugs and do not experience any adverse drug effects; (2) to determine if genetic differences between the two groups contribute to causing the adverse drug reactions; and (3) to develop patient specific drug dosing guidelines to…
NCT03953014 — Pharmacogenetics of Antidepressant-Induced Disinhibition
| Status | Recruiting |
| Phase | N/A |
| Sponsor | University of Calgary |
| Enrollment | 120 |
| Study Type | OBSERVATIONAL |
| Conditions | Obsessive-Compulsive Disorder; Anxiety Disorders; Major Depressive Disorder; Antidepressant Drug Adverse Reaction |
The purpose of this study is to identify pharmacogenetic profiles associated with selective serotonin reuptake inhibitors (SSRI)-induced behavioral disinhibition in children with Major depressive disorder (MDD), anxiety disorders and/or obsessive-compulsive disorder (OCD) that could be used clinically to reduce the incidence of this adverse event and improve health outcomes.
NCT04249375 — Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System
| Status | Recruiting |
| Phase | N/A |
| Sponsor | University of British Columbia |
| Enrollment | 150 |
| Study Type | OBSERVATIONAL |
| Conditions | Adverse Drug Reaction (ADR) |
This project addresses the problem of adverse drug reactions in the three most frequently prescribed therapeutic classes of drugs in children: antibiotics, analgesics, and mental health medications.
We will conduct pilot testing of a pharmacogenomic testing panel and study how the tests and generated test results are utilized and understood by physicians, pharmacists, patients and their families.
NCT04330118 — Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome
| Status | Recruiting |
| Phase | N/A |
| Sponsor | University Hospital, Lille |
| Enrollment | 80 |
| Study Type | OBSERVATIONAL |
| Conditions | Drug Hypersensitivity; DRESS Syndrome |
Drug Hypersensitivity Syndrome or DRESS for “Drug Reaction with Eosinophilia and Systemic Symptoms” is a serious drug allergy which can be life-threatening for patients with serious organ damage. The pathophysiology of DRESS is still not fully understood. In particular, no study has focused on the characterization of eosinophils, while paradoxically eosinophilia is one of the diagnostic criteri…
NCT04659343 — TDM for Optimized Outcome in Patients With mRCC.
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Niels Fristrup |
| Enrollment | 200 |
| Study Type | OBSERVATIONAL |
| Conditions | Kidney Cancer; Renal Cell Carcinoma Metastatic; Drug Toxicity; Drug Side Effect; Drug Mechanism |
| Interventions |
The purpose of this observational study is to assess the role of plasma concentration monitoring of treatment drugs for patients with metastatic renal cell carcinoma (mRCC) in terms of efficacy and side effects. It furthermore holds microbiome characterization of CPI-treated patients.
Furthermore, the investigators examines the role of anti-drug antibodies and receptor polymorphisms in CTLA-4 …
NCT05332262 — A Precision Medicine Approach to Identify Patients Undergoing Elective PCI at Risk of Peri-PCI Myocardial Infarction
| Status | Recruiting |
| Phase | N/A |
| Sponsor | University of Florida |
| Enrollment | 500 |
| Study Type | OBSERVATIONAL |
| Conditions | Coronary Artery Disease |
| Interventions | ; |
Despite the relative safety of PCI with new generation stents, peri-PCI thrombotic complications, including myocardial infarction and myocardial injury, are common in elective PCI, occurring in up to 30% of patients. Importantly, these events are associated with poor prognosis. The risk of peri-PCI myocardial infarction/myocardial injury has been in part attributed to HPR. The aim of this study…
NCT05358535 — Propofol and Etomidate Admixtures Comparisons Trial (PEAC Trial)
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Texas Southwestern Medical Center |
| Enrollment | 200 |
| Study Type | INTERVENTIONAL |
| Conditions | Anesthesia; Propofol Adverse Reaction; Etomidate Adverse Reaction; Anesthesia Complication; Anesthesia; Adverse Effect |
| Interventions | ; |
The purpose of this study is to evaluate the hemodynamics and adverse event profile in comparison between two treatment arms, one using an admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7), and one using an admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2), for anesthesia during endoscopic procedures at the Clements University Hospital (CUH) end…
NCT05512169 — Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia
| Status | Recruiting |
| Phase | N/A |
| Sponsor | University of Geneva, Switzerland |
| Enrollment | 556 |
| Study Type | OBSERVATIONAL |
| Conditions | ALL, Childhood; Pediatric Cancer; Toxicity, Drug; Adverse Drug Event; Relapse Leukemia |
A five-year prospective observational cohort study. The study is focused on observing the relation between static germline variants and therapeutic response in Indian children with acute lymphoblastic leukemia (ALL). The project is an International multicenter setup. This collaborative research project between Switzerland and India includes one main center in Geneva that has conceptualized, des…
NCT06228456 — Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Florida |
| Enrollment | 50 |
| Study Type | INTERVENTIONAL |
| Conditions | Coronary Artery Disease |
| Interventions | ; |
The proposed study aims to assess the antiplatelet effects of more potent oral P2Y12 inhibition with low-dose ticagrelor (60 mg bid) compared with standard of care clopidogrel in patients with a high ABCD-GENE score (≥10). We hypothesize that ticagrelor is associated with better pharmacodynamic effects (i.e., lower platelet reactivity and high platelet reactivity rates) compared with clopidogre…
NCT06554288 — Pharmacogenomic Contributions to Trihexyphenidyl Biotransformation and Response in Children With Dystonic Cerebral Palsy
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Children’s Mercy Hospital Kansas City |
| Enrollment | 40 |
| Study Type | INTERVENTIONAL |
| Conditions | Pediatric Disorder; Genetic Predisposition; Dystonia, Secondary; Dystonia; Cerebral Palsy, Dystonic-Rigid |
| Interventions |
This study looks at how a medicine called trihexyphenidyl works in children with dystonic cerebral palsy. The study aims to understand how trihexyphenidyl is broken down and used in the body of pediatric patients and whether this is impacted by a person’s genetics. Information from this study will also be used to design future clinical trials.
NCT05587361 — Beta-Adrenergic Modulation of Drug Cue Reactivity
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Oklahoma |
| Enrollment | 80 |
| Study Type | INTERVENTIONAL |
| Conditions | Tobacco Use Disorder; Nicotine Dependence; Cigarette Smoking |
| Interventions | ; ; |
This study is designed to investigate the effects of a beta-adrenergic antagonist (Propranolol; 40 mg IR) and nicotine patch (14 mg) administered alone and in combination on neurobiological and behavioral responses to smoking cues in ongoing cigarette smokers. This is a basic experimental study in humans and participants will not take these medications for an extended period or make a cessation…
NCT06575530 — Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Beijing Shijitan Hospital, Capital Medical University |
| Enrollment | 306 |
| Study Type | INTERVENTIONAL |
| Conditions | Effect of Drug; Adverse Drug Event; Mechanical Ventilation Complication; Critical Illness; Surgery |
| Interventions | ; |
A multi-center, prospective, randomized, double-blind, active-controlled, no-inferiority clinical trial conducted across 5 tertiary medical centers in China. The objective of this RCT is to evaluate the sedative efficacy and safety profile of remimazolam besylate compared with dexmedetomidine in patients requiring mechanical ventilation following non-cardiac surgery. The study hypothesized that…
NCT06907784 — PRE-EMPTIVE PHARMACOGENOMICS IN ACUTE CARE SETTINGS WITH HEALTH ECONOMIC EVALUATIONS (PHOENIX TRIAL)
| Status | Recruiting |
| Phase | N/A |
| Sponsor | NHS Greater Glasgow and Clyde |
| Enrollment | 2000 |
| Study Type | INTERVENTIONAL |
| Conditions | Pharmacogenomic Drug Interaction |
| Interventions |
It is known that individuals respond differently to the same medicine with some people benefitting, some experiencing no effect and others suffering side-effects or even coming to harm. Some of the differences in response to medications can be explained by our genes. Genes are short sections of DNA. Each individual has over 20,000 different genes. Genes carry instructions for making the protein…
NCT06406114 — Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Enrollment | 300 |
| Study Type | INTERVENTIONAL |
| Conditions | Drug Allergy; Cephalosporin Allergy; Drug Hypersensitivity; Antibiotic Allergy; Beta Lactam Adverse Reaction |
| Interventions | ; ; |
Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the …
NCT07385131 — Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Enrollment | 300 |
| Study Type | OBSERVATIONAL |
| Conditions | Inflammatory Bowel Disease (IBD); CD - Crohn’s Disease; UC - Ulcerative Colitis |
| Interventions |
This comparative observational cohort clinical study aims to investigate the necessity of premedication for allergy prevention prior to infliximab injection, and is designed to evaluate whether non-routine administration of dexamethasone before intravenous infusion of infliximab yields greater benefits than routine prophylactic medication in patients with moderate-to-severe inflammatory bowel d…
NCT07216846 — The Geriatric Emergency Department Pharmacologic Harm Prevention Project
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Florida Atlantic University |
| Enrollment | 1000 |
| Study Type | INTERVENTIONAL |
| Conditions | Fall; Fall Accident; Poly Pharmacy; Adverse Drug Events; Pharmacogenomic Drug Interaction |
| Interventions |
The goal of this project is to determine whether pharmacogenomic testing (using participants’ DNA) can help optimize medication prescribing and reduce side effects in older adults taking five or more medications.
The main questions it aims to answer are:
- Can DNA-based prescribing reduce medication-related side effects, especially falls and fall-related injuries?
- Does providing pharmacogen…
NCT07323043 — Effect of Tegileridine Versus Sufentanil as Analgesic Components on Opioid-Induced Cough During Anesthesia Induction
| Status | Recruiting |
| Phase | N/A |
| Sponsor | The First People’s Hospital of Lianyungang |
| Enrollment | 190 |
| Study Type | INTERVENTIONAL |
| Conditions | General Anesthetic Drug Adverse Reaction |
| Interventions | ; |
In patients undergoing general anesthesia with planned tracheal intubation , a prospective, randomized, controlled study was conducted to record the occurrence of cough 2 minutes after injection of Sufentanil or Tegilerdine. The cough was graded based on the frequency and duration: Grade I, no cough; Grade II, a single mild cough; Grade III, multiple coughs with duration <1 second; Grade IV, c…
NCT07341139 — Blood Storage Related Mortality and Adverse Effects in Trauma Patients
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Kocaeli City Hospital |
| Enrollment | 300 |
| Study Type | OBSERVATIONAL |
| Conditions | Transfusion Adverse Reaction; Major Trauma; Blood Product Transfusion for All Conditions |
The purpose of this retrospective study is to examine the following factors related to blood storage time in severely injured trauma patients who received large blood transfusions:
- The effect of blood storage time on the patient’s 28-day mortality rate.
- The relationship between storage time and other health problems that the patient may develop (such as heart disease, vascular occlusion,…
NCT07341776 — Steroid Use in Treatment of Allergic Reactions to Food
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Johannes Trueck |
| Enrollment | 160 |
| Study Type | INTERVENTIONAL |
| Conditions | Anaphylactic Reaction; Anaphylaxis; Allergy in Children; IgE Mediated Food Allergy |
| Interventions | ; ; |
In this study, the investigators want to find out whether a specific medication commonly used for severe allergic reactions is really necessary. When children have allergic reactions to foods, they are often given medications to relieve the symptoms. In addition to adrenaline and antihistamines, steroids are frequently administered in German-speaking Switzerland. However, it is unclear whether …
NCT07592234 — Chemokeyp: A Feasibility Study for Realtime Safety Data-Capture for Potential Serious Adverse Drug Events
| Status | Recruiting |
| Phase | N/A |
| Sponsor | St Vincent’s University Hospital, Ireland |
| Enrollment | 100 |
| Study Type | OBSERVATIONAL |
| Conditions | Serious Adverse Events; Patient Safety; Pharmacovigilance; Oncology |
Chemokeyp is a feasibility study testing a secure ED-Oncology interface for patients receiving chemotherapy who may present to unscheduled care with possible treatment-related complications.
Participants are enrolled through Oncology and issued a medical-alert-style wristband with a QR code. If they attend the Emergency Department, staff can scan the QR code, access a generic study landing pag…
NCT07477119 — Linezolid Tolerance During the BPaL Regimen With Dosage Personalization Based on Therapeutic Drug Monitoring (TDM) During Multidrug-Resistant Tuberculosis Treatment
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Marco Schiuma |
| Enrollment | 150 |
| Study Type | INTERVENTIONAL |
| Conditions | Linezolid; Tuberculosis Multi Drug Resistant Active; Therapeutic Drug Monitoring (TDM) |
| Interventions |
Multidrug-resistant tuberculosis (MDR-TB) poses a significant challenge to global public health.
Globally, the World Health Organization (WHO) estimates the number at 400,000 patients with MDR-TB for 2023. Only 44% were diagnosed and put on treatment, the therapeutic success rate of the 2021 cohort is only 68%.
In Guinea, the number of patients with MDR-TB is estimated at 450, and the treatme…
NCT07523633 — Effect of Semaglutide on Cannabis Use in Adults With Cannabis Use Disorder
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Anders Fink-Jensen, MD, DMSci |
| Enrollment | 100 |
| Study Type | INTERVENTIONAL |
| Conditions | Cannabis Use Disorder; Cannabis Use Disorders; Cannabis Abuse; Cannabis Dependence; Cannabis Addiction |
| Interventions | ; |
The HASHTAG Study is investigating whether the medicine semaglutide can help adults with cannabis use disorder (CUD) reduce their cannabis use. Participants will be randomly assigned to receive either semaglutide or a placebo. The first 50 participants will have functional brain scans (fMRI) to investigate how the brain responds to cannabis-related cues. The main outcome after 20 weeks is wheth…
NCT07605806 — Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
| Status | Recruiting |
| Phase | Phase 1 / Phase 2 |
| Sponsor | Johns Hopkins University |
| Enrollment | 25 |
| Study Type | INTERVENTIONAL |
| Conditions | Healthy Volunteer; Hypersensitivity Reactions; Vancomycin |
| Interventions |
The goal of this clinical trial is to investigate biomarkers of non-IgE-mediated immediate hypersensitivity reactions during infusion of intravenous vancomycin. The main question it aims to answer is:
• Identifying novel biomarkers in blood that occur during infusion reaction
Participants will:
- Have allergy skin testing for vancomycin
- Receive an infusion of vancomycin
NCT06997198 — Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Hospitals Cleveland Medical Center |
| Enrollment | 25 |
| Study Type | INTERVENTIONAL |
| Conditions | Tardive Dyskinesia; Intellectual Disability; Developmental Disabilities |
| Interventions |
The primary goal of this study is to investigate the efficacy of deutetrabenazine treatment of TD in this previously untreated patient population. Compare movement disorder deutetrabenazine treatment response in persons with IDD to response seen in patients without IDD treated with deutetrabenazine in other treatment settings (per literature review). Compare global deutetrabenazine treatment re…
Active, Not Recruiting
NCT06822959 — The INTEGRATE Study: Integrated Pharmacogenetics, TDM and Active Pharmacovigilance as Innovative Tools for the Optimisation and Appropriateness of Drug Therapy
| Status | Active, not recruiting |
| Phase | N/A |
| Sponsor | Direzione centrale salute, politiche sociali e disabilità |
| Enrollment | 450 |
| Study Type | OBSERVATIONAL |
| Conditions | Adverse Drug Reaction (ADR) |
| Interventions |
The primary goal of this observational study is to evaluate the feasibility of implementing a multidisciplinary approach based on pharmacogenetics, TDM (Therapeutic Drug Monitoring) and MedReview into the clinical practice in order to optimize the appropriateness of drugs prescription and to minimise the risk of Adverse Drug Reactions (ADRs) in adult cancer patients and in pediatric patients af…
NCT06110156 — Population Health Approach to Optimizing Medications in Older Adults
| Status | Active, not recruiting |
| Phase | N/A |
| Sponsor | Cedars-Sinai Medical Center |
| Enrollment | 100 |
| Study Type | INTERVENTIONAL |
| Conditions | Medication Adverse Effects; Older Adults (65 Years and Older); Polypharmacy; Polypharmacy Patients; Deprescribing |
| Interventions |
This randomized controlled pragmatic pilot study examines the feasibility and acceptability of a population health-based deprescribing intervention that leverages a polypharmacy risk prediction model. It includes four arms (2 intervention and 2 control arms) and uses a parallel arm study design.
Not Yet Recruiting
NCT07374588 — Impact of Medication Education on Adherence and Side Effects
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | Cumhuriyet University |
| Enrollment | 64 |
| Study Type | INTERVENTIONAL |
| Conditions | Schizophrenia; Schizoaffective Disorder; Bipolar Disorder With Psychotic Features; Major Depressive Disorder With Psychotic Features |
| Interventions | ; |
Severe mental disorders such as schizophrenia, bipolar disorder, and psychotic depression often require long-term or lifelong medication treatment. However, many psychiatric patients have difficulty adhering to their prescribed medication regimens due to factors such as lack of information, fear of side effects, and negative experiences with psychotropic medications. Poor treatment adherence is…
NCT07406113 — MEOP - Multidimensional Evaluations in Oncological Psychiatry
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Enrollment | 2000 |
| Study Type | OBSERVATIONAL |
| Conditions | Psychiatric Disorder; Cognition Disorder; Treatment Compliance; Adverse Drug Event; Family Members |
| Interventions |
Cancer is among the leading causes of morbidity and mortality worldwide, profoundly affecting patients’ lives at every level, and its psychological and psychiatric impacts remain a major concern. Psychiatric disorders are frequently observed in cancer patients. Nevertheless, they were also underdiagnosed, with a consequent undermining possible interventions. Still, psychiatric disorders in canc…
NCT06805799 — Stress Reactivity and Mother-Infant Cardiovascular Disease Risk
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | Lifespan |
| Enrollment | 40 |
| Study Type | INTERVENTIONAL |
| Conditions | Maternal Health; Infant Health; Hypertension; Behavioral Medicine; Mindfulness |
| Interventions |
Prenatal Mindfulness training (MT) shows promise as a preventive intervention against hypertensive disorders of pregnancy (HDP) and may reduce risk for offspring cardiovascular disease (CVD). One proposed mechanism of MT to reduced CVD risk is improved self-regulation following stress. Perhaps the most crucial contributor to the development of self-regulation in the first year is the psychophys…
NCT07505134 — Exploring the Influence of Glucagon-like Peptide -1 (GLP-1) Medications on Food Cravings, Food Selection, and Food Intake Following Exposure to Food Advertisements
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | Penn State University |
| Enrollment | 50 |
| Study Type | INTERVENTIONAL |
| Conditions | GLP - 1 |
| Interventions | ; |
The purpose of this randomized control trial is to compare how food cravings, food selection, and food consumption change in response to frequent food advertisements compared to non-food advertisements in adults taking GLP-1 (weight loss) medications. The primary question we aim to answer is: do GLP-1 medications reduce an individual’s vulnerability to external triggers that drive food cravings…
NCT07472348 — Isoniazid-Related Hepatotoxicity in Clinical Practice: Incidence and Predictors
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | ASST Fatebenefratelli Sacco |
| Enrollment | 220 |
| Study Type | OBSERVATIONAL |
| Conditions | Tuberculosis Infection; Tuberculosis Infection, Latent |
| Interventions |
The objective of this observational study is to determine how frequently isoniazid (INH) causes liver injury (hepatotoxicity) in adults treated for tuberculosis (TB) or latent tuberculosis infection (LTBI) and to understand which factors increase this risk. The study also aims to describe how hepatotoxicity is managed in real-world clinical practice and whether treatments such as corticosteroid…
NCT07546357 — AIManage Using an AI-driven CDS and Chatbot
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | NYU Langone Health |
| Enrollment | 16 |
| Study Type | INTERVENTIONAL |
| Conditions | Diabetes; Obesity; Medication Side Effects |
| Interventions |
The objective of this project is to define and test the GenAI-powered Clinical Decision Support (CDS) tool, AIManage, providing a broad range of incretin mimetic medication management services to optimize dose titrations. The study will take place across primary care and obesity medicine clinics at NYUH.
The study is currently conducting formative data collection for tool refinement (Phase 1)….
NCT07645404 — The Effect of Mental Fatigue on Upper Extremity Functional Performance
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | Izmir Bakircay University |
| Enrollment | 16 |
| Study Type | INTERVENTIONAL |
| Conditions | Mental Fatigue |
| Interventions |
Mental fatigue (MF) is known to impair cognitive performance and may negatively affect physical performance. While its effects on lower-extremity functional performance have been investigated, little is known about the influence of MF on upper-extremity physical performance tests commonly used in sports and rehabilitation settings. This randomized crossover study will investigate the effects of…
NCT06734884 — Interest of a Targeted Therapy for the Treatment of a Severe Form of Hypersensitivity to Drug (DRESS Syndrome)
| Status | Not yet recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Lille |
| Enrollment | 96 |
| Study Type | INTERVENTIONAL |
| Conditions | DRESS Syndrome |
| Interventions | ; |
Drug Reaction with eosinophilia and Systemic Symptoms (DRESS) is a rare and severe multiorgan drug reaction whose pathophysiological mechanisms underlying remain unclear, but may involve the role of several immune cells like eosinophils. iIndeed,the number of eosinophils is increased in blood and/or in organs tiisues in at least 50% of patients with DRESS. There is no specific treatment availab…
Enrolling by Invitation
NCT06990126 — The Efficacy and Adverse Reactions of Neotetracycline in the Treatment of GNB Infections
| Status | Enrolling by invitation |
| Phase | N/A |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Enrollment | 300 |
| Study Type | OBSERVATIONAL |
| Conditions | Clinical Efficacy and Safety |
| Interventions |
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.
NCT07595367 — Evaluate the Effectiveness and Safety of BBD-1 Multi-target Immune Enhancement Targeting Agent in the Treatment of Hypersensitivity Reaction (IgA) Vasculitis
| Status | Enrolling by invitation |
| Phase | Phase 2 |
| Sponsor | Qifeng Zhang |
| Enrollment | 30 |
| Study Type | INTERVENTIONAL |
| Conditions | Allergic Reaction (IgA) Vasculitis |
| Interventions |
Hypersensitivity (IgA) vasculitis is a common vascular allergic disease, the cause of which is not yet clear, and may involve infection, immune disorders, heredity and other factors. It belongs to the category of immune diseases. The disease can be divided into simple type, abdominal type, joint type, renal type and mixed type allergic purpura according to the location of the disease. The annua…
Completed Trials
NCT03553251 — Protocol of Reintroduction of Beta-lactams in Children at Low Risk of Anaphylaxis.
| Status | Completed |
| Phase | N/A |
| Sponsor | Nantes University Hospital |
| Enrollment | 195 |
| Study Type | OBSERVATIONAL |
| Conditions | Hypersensitivity; Beta Lactam Adverse Reaction |
The purpose of this study is to establish the rationale for the practice of performing an oral reintroduction test without previous skin tests in children at low risk of IgE-mediated reaction or drug-induced toxidermia, and to confirm the criteria for a drug reintroduction test could be performed without previous skin tests, without subsequent risk of reaction for the child. The primary endpoin…
NCT03771118 — Drug Provocation Test (DPT) to Paracetamol
| Status | Completed |
| Phase | N/A |
| Sponsor | University Hospital, Montpellier |
| Enrollment | 498 |
| Study Type | OBSERVATIONAL |
| Conditions | Drug Hypersensitivity |
Background : Paracetamol (acetaminophen) drug hypersensitivity reactions (DHR) are oonfirmed in about 10% of alleged cases. The diagnosis is made via an empirical drug provocation test (DPT).
Objective: Detect eliciting dose thresholds during Paracetamol DPT in order to suggest optimal step doses and to identify variables and potential risk factors associated with Paracetamol hypersensitivity….
NCT04181775 — Effectiveness of an ADE-related Hospitalization Risk Prediction Tool for Patients (ADE-RED)
| Status | Completed |
| Phase | N/A |
| Sponsor | Methodist Health System |
| Enrollment | 471 |
| Study Type | OBSERVATIONAL |
| Conditions | Adverse Drug Event |
| Interventions |
The rationale for this study is to evaluate the effectiveness of a risk prediction tool for patients who are at high risk for ADEs resulting in hospitalization or ED revisit. The ADE-RED score initiates a PLMR that literature has shown reduces medication discrepancies and ADEs at hospital admission and discharge. No current system identifies patients presenting to the ED that may benefit from P…
NCT03805607 — IV Ketorolac on Platelet Function Post-Cesarean Delivery
| Status | Completed |
| Phase | Phase 4 |
| Sponsor | Beth Israel Deaconess Medical Center |
| Enrollment | 40 |
| Study Type | INTERVENTIONAL |
| Conditions | Analgesia, Obstetrical; Coagulation Defect; Postpartum; Nonsteroidals (NSAIDs)Toxicity; Postpartum Hemorrhage; Postoperative Pain |
| Interventions | ; |
Cesarean delivery has become the most common surgical procedure in the US. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to improve the quality of post-cesarean analgesia and markedly reduce opioid consumption. The effect of NSAIDs on healthy volunteers results in inhibition of platelet aggregation and prolonged bleeding time. However, in the obstetric population, the presence …
NCT07589881 — An Educational Intervention on Medication Adverse Effects in Patients With Resistant Hypertension (HTAR-CSI)
| Status | Completed |
| Phase | N/A |
| Sponsor | Consorci Sanitari Integral |
| Enrollment | 46 |
| Study Type | INTERVENTIONAL |
| Conditions | Resistant Hypertension; Urinary Incontinence; Sexual Disfunction |
| Interventions | ; |
This randomized, single-blind controlled trial evaluates the effectiveness of a nurse-led educational intervention focused on the adverse effects of antihypertensive drugs-specifically sexual dysfunction and urinary incontinence-in patients with resistant hypertension. The intervention aims to improve treatment adherence and blood pressure control. The primary outcome is a reduction of ≥10 mmHg…
NCT04903353 — Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole
| Status | Completed |
| Phase | Phase 4 |
| Sponsor | Vanderbilt University Medical Center |
| Enrollment | 30 |
| Study Type | INTERVENTIONAL |
| Conditions | Weight Gain; Autism Spectrum Disorder; Medication Side Effect |
| Interventions |
This study aims to compare two FDA approved medications (aripiprazole and risperidone) for the treatment of behavioral dysregulation in children with autism spectrum disorders. This trial, done in the context of routine clinical care, will seek to evaluate whether aripiprazole or risperidone is associated with more weight gain in children.
NCT05157191 — Safety of Pediatric COVID-19 Vaccination
| Status | Completed |
| Phase | N/A |
| Sponsor | Duke University |
| Enrollment | 299 |
| Study Type | OBSERVATIONAL |
| Conditions | Pain; Injection Site Reaction; Adverse Drug Event |
| Interventions |
This is a prospective, observational study. During the study, children and adolescents (ages ≥ 5 to < 16) will be followed post administration of mRNA COVID-19 vaccines.
Injection site (local), systemic reaction, and unsolicited adverse event data will be assessed on vaccination day and during the 7 days following each vaccination using either identical web-based or paper diaries, depending o…
NCT06180876 — Effect of Remimazolam on Postoperative Delirium
| Status | Completed |
| Phase | N/A |
| Sponsor | Zhihong LU |
| Enrollment | 264 |
| Study Type | INTERVENTIONAL |
| Conditions | General Anesthetic Drug Adverse Reaction |
| Interventions | ; |
Remimazolam is a novel benzodiazepine with ultra-short onset and offset of its effect. It can be used for general anesthesia. However, classical benzodiazepine such as midazolam was reported to increase the risk of postoperative delirium. Thus, the investigators aim to investigate the effect of remimazolam general anesthesia on postoperative delirium in elderly patients.
NCT05586009 — Comparative Study of Different Doses of Magnesium as a Protective Agent in Nephrotoxicity in Cancer Patients
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | Tanta University |
| Enrollment | 100 |
| Study Type | INTERVENTIONAL |
| Conditions | Cisplatin Adverse Reaction |
| Interventions | ; |
The goal of this [ type of study: intervential study is to compare between different doses of magnesium to prevent cisplatin induced nephrotoxicity.] In 75 participant population with head and neck cancer recieved cisplatin it aims to answer are: • • optimal doses of magnesium as 3 groups each group take 1gm of magnesium then second group take 2gm of magnesium and finally third group take 3gm…
NCT05923983 — DETECT-IP: a Clinical Decision Support System and Intelligent Procedures to Counter Some Adverse Drug Events in Older Hospital Patients
| Status | Completed |
| Phase | N/A |
| Sponsor | University Hospital, Lille |
| Enrollment | 783 |
| Study Type | INTERVENTIONAL |
| Conditions | Patient Acceptance of Health Care; Acute Renal Failure |
| Interventions | ; |
Current evidence shows that computerized decision support systems (CDSS) have shown to be insufficiently effective to prevent adverse drug reactions (ADRs) at large scale (e.g. whole hospital). Several barriers for successful implementation of CDSS have been identified: over-alerting, lack of specificity of rules, and physician interruption during prescription. The effectiveness of CDSS could b…
NCT06888986 — Integration of VR and AR Dementia Prevention Health Education Progrom for Older Adults With Mild Cognitive Impairment
| Status | Completed |
| Phase | N/A |
| Sponsor | National Taiwan Normal University |
| Enrollment | 139 |
| Study Type | INTERVENTIONAL |
| Conditions | Mild Cognitive Impairment (MCI); Dementia; Health Literacy; Self-Efficacy; Attitude to Health |
| Interventions |
The goal of this randomized controlled trial is to evaluate the effectiveness of Virtual Reality (VR)-based cognitive health education for older adults with mild cognitive impairment (MCI) in Taiwan. The study aims to assess whether VR-supported interventions improve cognitive health knowledge, health literacy, and self-management skills among participants.
The primary research questions are: …
NCT06721858 — Effects of Emotion-focused Therapy (EFT) on Mood Awareness and Emotional Reactivity in Bipolar Patients Awareness and Emotional Reactivity
| Status | Completed |
| Phase | N/A |
| Sponsor | Muğla Sıtkı Koçman University |
| Enrollment | 50 |
| Study Type | INTERVENTIONAL |
| Conditions | Therapy, Directly Observed |
| Interventions | ; |
4.503 / 5.000 Bipolar disorder is a serious mood disorder that requires lifelong treatment and is characterized by recurring periods of depression, mania, hypomania or mixed episodes without a specific order, completely normal between episodes or thought to be with minimal symptom levels, has a high mortality and morbidity rate, causes serious deterioration in the quality of life in terms of oc…
Other (Suspended)
NCT05401929 — Transcranial Magnetic Brain Stimulation to Reduce Cannabis Use in Heavy Cannabis Users
| Status | Suspended |
| Phase | N/A |
| Sponsor | Duke University |
| Enrollment | 50 |
| Study Type | INTERVENTIONAL |
| Conditions | Cannabis |
| Interventions | ; |
The growing legalization of cannabis across the U.S. is associated with increases in cannabis use, and accordingly, an increase in the number of individuals with cannabis use problems, including cannabis use disorder (CUD). While there are several medications being investigated as treatment options for CUD, none have been FDA-approved, and there is limited efficacy of traditional behavioral the…
Other (Withdrawn)
NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis
| Status | Withdrawn |
| Phase | N/A |
| Sponsor | Massachusetts General Hospital |
| Enrollment | N/A |
| Study Type | OBSERVATIONAL |
| Conditions | Stevens-Johnson Syndrome; Toxic Epidermal Necrolysis; Drug Reaction |
| Interventions |
This is a prospective, multicenter cohort observational; study to compare treatment outcomes in patients admitted to the hospital with Stevens-Johnsons Syndrome/Toxic Epidermolysis, aiming to assess the utility of medical management. The hypothesis of this study is that one or more treatment options will demonstrate improved patient outcomes. The primary objectives are cessation of progression …