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NCT ID: NCT06238154 Completed - Drug Use Clinical Trials

Flurbiprofen Tablet vs Spray In Oral Soft Tissue Wounds

Start date: October 26, 2023
Phase: Phase 4
Study type: Interventional

The amount of active ingredient in tablet form of flurbiprofen is higher than that in the oral spray form. Therefore, based on the hypothesis that the side effects that may occur depending on the dose can be reduced, this clinical study investigated whether tablet and spray form flurbiprofen would have similar effects on postoperative pain in primarily closed soft tissue wounds in the oral region.

NCT ID: NCT06193473 Completed - Clinical trials for Cardiovascular Diseases

Evaluation Of Clinical Pharmacy Services in Patients Receiving Antithrombotic Treatment

Start date: November 30, 2021
Phase: N/A
Study type: Interventional

Clinical pharmacy services aim to enhance patient outcomes and reduce the risk of potential drug-related harm by offering patient-centred pharmaceutical care. In the hospital setting, clinical pharmacists collaborate with physicians as part of a multidisciplinary team to identify and prevent DRPs (Drug-related problems). Clinical pharmacist interventions encompass 'any action initiated by a pharmacist that directly results in patient management or a modification in medication.' The favourable clinical and economic impacts of interventions have been well-established for decades. Clinical pharmacists have played an important role in ensuring the effective and correct use of medicines in many settings. This study aims to investigate the clinical pharmacy services provided by clinical pharmacists to patients receiving antithrombotic therapy. For this study, patients were divided into two groups: a control group and an intervention group. A comprehensive medication review will be conducted by the clinical pharmacist for both the control and intervention groups. Drug-related problems such as drug selection, dose errors, possible drug-drug interactions, and inappropriate drug use, will be identified. In the control group, no interventions will be made by the clinical pharmacist. In the intervention group, solution recommendations for identified and clinically significant issues will be presented to the physician, and the provided services will be documented. Furthermore, the groups will be evaluated for whether there are any hospital readmissions within 1 and 3 months following discharge for the patients.

NCT ID: NCT05849883 Completed - Drug Use Clinical Trials

Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

Start date: December 10, 2020
Phase: N/A
Study type: Interventional

The study was conducted to investigate whether 20 mg omeprazole capsules manufactured by PT. Dankos Farma for PT. Hexpharm Jaya is bioequivalent to its reference product, 20 mg Losec® capsules manufactured by AstraZeneca AB, Sweden, imported by PT. AstraZeneca Indonesia.

NCT ID: NCT05753371 Completed - Drug Use Clinical Trials

Bioequivalence Study of Metformin Hydrochloride 500 mg Film-Coated Tablets in Indonesia Healthy Subject

Start date: February 23, 2022
Phase: N/A
Study type: Interventional

The objective of this present study was to investigate whether Glufor® 500 (metformin hydrochloride 500 mg) film-coated tablets manufactured by PT. Pyridam Farma Tbk is bioequivalent to its reference product, Glucophage® 500 mg film-coated tablets manufactured by PT. Merck Tbk, Indonesia under licensed Merck Sante SAS, France.

NCT ID: NCT05688761 Completed - Drug Use Clinical Trials

Nordic Gastric and Esophageal Tumor Study

NordGETS
Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

This is a population-based case-control study in all 5 Nordic countries from 1994 onwards. All cases with an esophageal or gastric tumor will be compared with 10 times as many population controls, frequency-matched by age, sex, and calendar year, country. This design offers excellent statistical power, length and completeness of follow-up, quality of data on exposures, outcomes and confounders, and control for confounding. The project will include a specific study entitled "Long-term medication with proton pump inhibitors and risk of gastric cancer", which is summarized here: Research question: Medication with proton pump inhibitors (PPI) (e.g., omeprazole and esomeprazole) is one of the most common long-term therapies globally, prompted by its high anti-acidic efficacy and good short-term safety profile. Gastric cancer is the 3rd leading cause of cancer-related mortality globally, responsible for 770,000 deaths each year. There are clear biological mechanisms linking long-term PPI-use with an increased risk of gastric cancer. However, existing research has not been able to provide a definite answer to whether long-term PPI-use is associated with an increased risk of gastric cancer. The reasons are that the literature is hampered by too short follow-up time to assess cancer development, and also insufficient statistical power, lack of population-based design and confounding. With the availability of nationwide complete medication registries in the Nordic countries, the firsts two starting already in 1994 (Denmark and Finland), we can now, by adding registry data from all Nordic countries together, conduct the first study providing a robust and valid answer to this research question. Overarching aim This project aims to clarify if (and if so to what extent) long-term PPI-therapy influences the risk of developing gastric adenocarcinoma. For validation reasons, we will also examine how long-term use of histamine-2-receptor blockers (H2RB) influences the risk of developing gastric adenocarcinoma. These analyses will validate that the findings are specific for PPIs. H2RB are used for the same indications as PPIs, but with a different biological mechanism. Hypothesis We plan to test the hypothesis that long-term use of PPI (but not H2RB) increases the risk of gastric adenocarcinoma. Prerequisites This will be the first project with all prerequisites to provide conclusive answers to the hypotheses above, i.e.: - Long follow-up (up to 28 years) - Complete follow-up (by virtue of the nationwide complete Nordic registries) - Population-based design (which rules out biased selection of cases or controls) - Superior statistical power (all five Nordic countries participate with nationwide data) - High-quality data on exposures, outcomes and confounders (thanks to well-maintained and complete nationwide Nordic health data registries) - Control for confounding factors (available for all participants, both cases and controls)

NCT ID: NCT05609864 Completed - Drug Use Clinical Trials

Drug Wastage : Observational Study in the Operating Rooms of France

GAME-OvBLOC
Start date: April 6, 2023
Phase:
Study type: Observational

Environmental awareness is leading medical field to question its responsibility and possibilities for action. Drug residues can have a major environmental impact as per their bioaccumulation, toxicity and persistence characteristics, depending on where they are discarded. In France, drug residues should be disposed of by incineration, but in practice this is not systematic. Moreover, data on drug wastage in the operating rooms by anesthesia department are rare. The GAME-OvBLOC observational study aim to evaluate drug wastage in the operating rooms by anesthesia department in France and to propose ways of improving health care practices.

NCT ID: NCT05553054 Completed - Drug Use Clinical Trials

Drug Wastage : Observational Study in Intensive Care Units in France

GAME-OVER
Start date: November 8, 2022
Phase:
Study type: Observational

Environmental awareness leads medical field to question its responsibility and possibilities for action. Drug residues can have a major environmental impact as per their bioaccumulation, toxicity and persistence characteristics, depending on where they are discarded. In France, drug residues should be disposed of by incineration, but in practice, this is not systematic. Moreover, data on drug wastage in Intensive Care Units (ICU) are rare. GAME-OVER observational study aims to evaluate drug wastage in ICU in France and to suggest ways to improve health care practices.

NCT ID: NCT05468879 Completed - Drug Use Clinical Trials

Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects

Start date: September 21, 2020
Phase: N/A
Study type: Interventional

The study was conducted toinvestigate whether the bioavailability of 3 mg Glimepiride Tablet Manufactured by PT. Harsen Laboratories was bioequivalent to the reference product, 3 mg Amaryl® Tablet Manufactured by PT. Aventis Indonesia Pharma, Indonesia.

NCT ID: NCT05182203 Completed - Clinical trials for Rheumatoid Arthritis

Safety and Retention Rate of the JAK and TNF Inhibitors in Rheumatoid Arthritis: a Real-life Experience

Start date: March 1, 2022
Phase:
Study type: Observational [Patient Registry]

This study aims to extract data from the Hong Kong Biologics Registry for retention rate of the JAK inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. These real life data are important as they cannot be provided by randomized controlled trials which are limited by the duration of observation and fixed protocols in research settings. Moreover, data will represent our local experience of the JAK inhibitors in Chinese patients with RA. The retention rate and adverse effects of the JAK inhibitors are compared with conventional TNF inhibitors.

NCT ID: NCT04996368 Completed - Drug Use Clinical Trials

A Randomized Comparison of Two Doses of Tranexamic Acid in Open-Heart Surgery

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Perioperative bleeding during cardiac surgery is associated with a higher incidence of reoperation and blood transfusion leading to an increase in morbidity and mortality. Coagulopathy is a major cause of excessive bleeding. It is associated with use of cardiopulmonary bypass which activates the intrinsic and extrinsic coagulation pathway, platelet dysfunction and systemic inflammatory response. Increase in duration of cardiopulmonary bypass correlates directly with increase bleeding during cardiac surgery. Antifibrinolytic agents like tranexamic acid has shown promising result in major surgeries and in trauma patients. Current clinical practice guidelines recommended use of tranexamic acid in cardiac surgery. There are wide variations in dose of tranexamic acid ranging from 10mg/Kg to 100mg/kg. The higher dose of this drug is associated with seizures and thromboembolic events including stroke. The objective is to find out the minimal effective dose of tranexamic acid in open-heart surgery. This is a prospective comparative study among the patients undergoing open heart surgery in Shahid Gangalal National Heart Center, Kathmandu Nepal. The inclusion criteria include patients with age more than 18years, surgery with total cross clamp time more than 60 min. The exclusion criteria are the patients with allergy to tranexamic acid or any of the lysine analogues, history of seizure, chronic homeostasis abnormality, on anticoagulants, severe chronic kidney disease with creatinine clearance less than 30ml/hr, deranged liver function test, total cross clamp time less than 60 min. The sample size was calculated to be 100 including 10% dropout cases. Patients will be randomized into two groups Group H (High dose group) and Group L (Low dose group) with a sealed envelope technique. Low-dose TEA consists of 10 mg/kg bolus administration before incision, followed by1 mg/kg/hr infusion; High-dose TEA consists of a 30 mg/kg bolus followed by a 1mg/kg/hr infusion till the end of surgery. Blood sampling and transfusion will be done as per protocol of Shahid Gangalal National Heart Center. The primary study endpoint was the amount of blood loss during the first 24 hours after surgery. The secondary endpoint was the incidence of overall blood transfusion and hemoglobin concentration on the first postoperative day after surgery. All adverse effects of the drug were noted and were treated as per hospital protocol. Data will be collected using the data collection form (proforma). Collected data will be analyzed by means of spss version 20 for windows. The result will be presented as mean ± SD. The continuous variable will be compared between the two groups by student t test and categorical variables with the chi-square test. A minimum level of significance is maintained at the p-value of <0.05.