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Adverse Reaction to Drug clinical trials

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NCT ID: NCT06124417 Completed - Clinical trials for Adverse Reaction to Drug

Efficacy and Safety of Sertraline in the Treatment of Maintenance Hemodialysis Patients With Depression

Start date: January 10, 2022
Phase: Phase 4
Study type: Interventional

Depression is a common mental disorder in patients undergoing maintenance hemodialysis (MHD), which increases the risk of cardiovascular events, hospitalization rates, and mortality, but has not received enough attention from patients and medical staff. Sertraline is a selective serotonin reuptake inhibitor with fewer adverse reactions and higher safety compared to other antidepressants. This study aims to investigate the efficacy and safety of sertraline in patients undergoing MHD with depression. This study used a randomized controlled design and evaluated the depression status of the patients using the Hamilton Depression Scale (HAMD). MHD patients with comorbid depression were recruited and divided into the treatment group and the control group. The treatment group received sertraline for antidepressant therapy, while the control group did not receive any antidepressant medication. To investigate the efficacy and safety of sertraline before and after intervention.

NCT ID: NCT05645302 Recruiting - Clinical trials for Adverse Reaction to Drug

Intensive Monitoring Scheme of Lidocaine Cataplasms

Start date: April 6, 2022
Phase:
Study type: Observational

In this center, retrospective research methods are used to collect data. Patients who had used Lidocaine Cataplasms at least once were included consecutively. Taking the time when the patient first used Lidocaine Cataplasms as the starting time (the study baseline), collect the demographic characteristics of the patient, the medication scheme of Lidocaine Cataplasms and other information, as well as the medication safety and other information from the first medication to the end of medication or discharge (whichever occurs first).

NCT ID: NCT04655794 Recruiting - Clinical trials for Adverse Reaction to Drug

Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment

Start date: April 19, 2018
Phase:
Study type: Observational

The treatment of latent TB with 3HP is an important issue for the prevention of active TB. However, significant proportion of subjects receiving 3HP had adverse reaction. The main purpose of this observation study is to identify subjects who have higher risk to develop adverse reaction. Clinical characteristics and biomarker will be used to predict adverse reaction.

NCT ID: NCT04226443 Completed - Clinical trials for Chronic Kidney Diseases

The Use of Midazolam and Remifentanil During Dialysis Access Procedures

Start date: August 28, 2012
Phase: N/A
Study type: Interventional

BACKGROUND: Sedation and analgesia are related to unexpected adverse events in chronic renal failure patients undergoing arteriovenous fistula placement procedures under monitored anesthesia care (MAC). OBJECTIVE: Our goal was to investigate and compare the sedation and analgesia related effects and adverse effects of continuous intravenous use of midazolam and intermittent bolus doses of midazolam while intravenous remifentanil is used as a rescue medication in patients with chronic renal failure.

NCT ID: NCT02609919 Completed - Clinical trials for Adverse Reaction to Drug

Assessment of Immediate Adverse Reactions From Dotarem in Children Under 2 Years of Age

Start date: January 2016
Phase:
Study type: Observational

Our primary outcome is to assess the safety of Dotarem in children <2 years old up to 24 hours after Dotarem injection. Patients will be monitored for any adverse events that occur for 2 hours following the completion of the MRI exam. The type of event, time of onset, duration of symptoms, intensity of the reaction (mild, moderate, severe), causality (not related, probably related, related, definitely related, unclassifiable), and subsequent outcome (required treatment, favorable outcome, recovery with sequela, or death) will be documented. Parents will be given instruction sheets on who and when to call should any adverse event occur after discharge. Parents will be called by the radiology department the next day to identify any adverse events that occurred during the first 24 hours after discharge from the hospital. Our secondary outcome is to assess image quality of the exam. The pre-contrast images will be compared to the combined pre- and post-contrast images following administration of Dotarem by radiologists who are blinded to the patients' clinical information to assess for improvement of image quality and delineation of structures with contrast.

NCT ID: NCT02520570 Recruiting - Clinical trials for Adverse Reaction to Drug

Post-market Safety Reassessment of Ulinastatin for Injection

Start date: August 2014
Phase:
Study type: Observational

1. Investigate the application of ulinastatin(UTI) in real practice clinic.(eg:population character, usage and dosage, course of treatment,etc ) 2. Analysis the incidence of adverse drug reactions /adverse events of ulinastatin, collect the main clinical manifestations, treatment, outcome, influence factors; provide evidence for improving the recommended medication plan of ulinastatin. 3. Evaluate the safety of ulinastatin , obtain scientific conclusion , and provide evidence for appropriate medication to administration department of health authority.

NCT ID: NCT02447679 Completed - Clinical trials for Recurrent Hepatocellular Carcinoma

Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrence

Start date: August 2010
Phase: Phase 2
Study type: Interventional

This single-centered phase II clinical study is to obtain preliminary information on 1-year recurrence-free survival rate, recurrence-free survival and safety profile of thalidomide in combination with tegafur-uracil in hepatocellular carcinoma after hepatectomy and explore biomarkers(VEGF/bFGF) for thalidomide response.

NCT ID: NCT02353455 Recruiting - Clinical trials for Adverse Reaction to Drug

Cells of Monocytic Origin as Surrogate Markers for Individual Drug Effects and Hepatotoxicity

Start date: March 2013
Phase:
Study type: Observational

Drug metabolism in the liver is subject to large fluctuations (differences between women and men, people of different ethnic backgrounds, children and adults). These large differences are responsible for very different drug effects and side-effects (and especially liver damage caused by drugs) between individuals. Recent scientific findings suggest that blood derived cells can be used to model individual effects of drugs on the liver reflect inter-individual differences. Since liver damage caused by drugs is a diagnosis of exclusion, the aforementioned cells can be used to identify patients that show higher sensitivity to hepatotoxic side-effects and - in case several drugs are involved - identify the causal agent or possible interactions.

NCT ID: NCT02296840 Terminated - Clinical trials for Obstructive Sleep Apnea

Post-operative Pain Control After Pediatric Adenotonsillectomy

Start date: November 2014
Phase: Phase 4
Study type: Interventional

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 children. Post-operative pain following adenotonsillectomy has significant morbidity and may result in prolonged hospital stay or re-admission to the hospital. Post-operative analgesia is most commonly managed with narcotic-containing pain medication. In recent years however, there is evidence that some patients may manifest increased sensitivity to narcotics, resulting in life-threatening respiratory compromise. Though there is a theoretical risk that nonsteroidal anti-inflammatory drugs (NSAIDs) increase bleeding time by disrupting platelet aggregation, evidence of detrimental effects (i.e. increased risk of postoperative bleeding) remains inconclusive for these generally well-tolerated medications. The goal of this study is to determine the incidence of post-operative bleeding and to determine the efficacy of NSAIDs in the management of post-operative pain following pediatric adenotonsillectomy, versus more commonly used narcotic pain medication. The study design will be an initial retrospective study to collect pilot data on the incidence of postoperative hemorrhage and indicators of adequate/inadequate pain control in children age 4 to 17 undergoing adenotonsillectomy. This will be followed by a prospective, randomized, single-blind controlled study in which orally-administered ibuprofen (test intervention) is compared to acetaminophen-hydrocodone (control intervention) in the postoperative period following adenotonsillectomy.

NCT ID: NCT02012712 Completed - Health Behavior Clinical Trials

Personal Health Records and Elder Medication Use Quality

Start date: July 2010
Phase: N/A
Study type: Interventional

Purpose: To examine the impact of a personal health record (PHR) on medication use safety among older adults. Background: Online PHRs have potential as tools to manage health information. We know little about how to make PHRs accessible for older adults and what effects this will have. Methods: A PHR was designed and pretested with older adults and tested in a six-month randomized controlled trial. After completing mailed baseline questionnaires, eligible computer users aged 65 and over were randomized 3:1 to be given access to a PHR (n=802) or serve as a standard care control group (n=273). Follow-up questionnaires measured change from baseline medication use, medication reconciliation behaviors, and medication management problems.