Conflict of Interest
Request Clinical TrialsAssociated Trial(s):
- NCT02034162 - A Double-Blind, Randomized, Multi-Center, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Dose of a 500-mg Chewable Tablet of Mebendazole in the Treatment of Soil-Transmitted Helminth Infections (Ascaris Lumbricoides and Trichuris Trichiura) in Pediatric Subjects
Request Clinical Trials
Data Request StatusStatus: Withdrawn/Closed
Project Title: Operations research and optimization methods in biology and medicine
Background: The study of medical data is essential for students of computer science, particularly for those interested in developing solutions for healthcare. Medical datasets provide a comprehensive picture of various health conditions, treatments, and patient outcomes.
Objective: The objective of this study is to utilise a medical dataset to understand the various factors that impact patient outcomes and to identify areas of improvement in healthcare.
Study Design: The study will be a retrospective analysis of a medical dataset. The dataset will be analysed to understand the demographic and clinical characteristics of the patients and their outcomes.
Participants: The participants will be a sample of patients from the medical dataset, who have received treatment for various health conditions. The sample size will be determined based on the availability of data in the dataset.
Primary Outcome Measure(s): The primary outcome measures will be patient outcomes, such as success in curing from parasites.
Secondary Outcome Measure(s): The secondary outcome measures will be the demographic and clinical characteristics of the patients, including age, gender and other insights from data.
Statistical Analysis: Descriptive statistics will be used to summarise the demographic and clinical characteristics of the patients. Inferential statistics will be used to assess the relationships between the various demographic and clinical factors and the patient outcomes. The analysis will be conducted using Python.
Brief Project Background and Statement of Project Significance:
Background: Parasitic infections are a significant public health concern, affecting millions of people worldwide. While there are existing treatments available, they are often not effective or have significant side effects. The development of new drugs to cure parasitic infections in humans is crucial for improving public health.
Significance: The proposed research project aims to develop a new drug to cure parasites in humans. The drug aims to be effective against a wide range of parasitic infections and have minimal side effects. The successful development of this drug has the potential to improve the lives of millions of people affected by parasitic infections.
Information Gained: The information gained from this work will provide a better understanding of the effectiveness and safety of the new drug. The results of the study can be used to inform the development of future treatments for parasitic infections. The information gained from this work will contribute to the generalizable scientific and medical knowledge in the field and inform public health policies.
Specific Aims of the Project:
Specific Aims: The specific aims of the project are as follows:
Objectives: The main objective of the project is to evaluate the effectiveness and safety of the new drug in curing parasitic infections in humans.
Hypotheses: The following hypotheses will be evaluated in the study:
Hypothesis 1: The new drug will be effective in curing a wide range of parasitic infections in humans.
Hypothesis 2: The new drug will have a lower incidence of side effects compared to existing treatments for parasitic infections.
In summary, the specific aims of the project are to evaluate the effectiveness and safety of the new drug in curing parasitic infections in humans and to test the hypotheses that the drug will be effective and have a lower incidence of side effects.
Study Design: Individual trial analysis
What is the purpose of the analysis being proposed? Please select all that apply.:
Data Source and Inclusion/Exclusion Criteria to be used to define the patient sample for your study:
Age: Participants must be 18 years of age or older.
Diagnosis: Participants must have a confirmed diagnosis of a parasitic infection.
Treatment: Participants must have not received any treatment for the parasitic infection within the past 3 months.
Medical History: Participants must not have any medical conditions that may interfere with the efficacy or safety of the new drug.
Pregnancy: Participants who are pregnant or breastfeeding will be excluded from the study.
Allergies: Participants with a known allergy to any component of the new drug will be excluded from the study.
Current Medications: Participants who are currently taking medications that may interact with the new drug will be excluded from the study.
Previous Treatment: Participants who have previously failed treatment for the parasitic infection will be excluded from the study.
Primary and Secondary Outcome Measure(s) and how they will be categorized/defined for your study:
Primary Outcome Measure: The primary outcome measure of the study is the cure rate of the parasitic infection. The cure rate will be defined as the percentage of participants who have no evidence of the parasitic infection after treatment with the new drug.
Secondary Outcome Measures: The secondary outcome measures of the study are:
Safety: The incidence of adverse events will be recorded and compared between the new drug and existing treatments for parasitic infections.
Tolerability: Participants' satisfaction with the new drug will be assessed through a patient-reported outcome measure.
Time to Cure: The time from the start of treatment to the cure of the parasitic infection will be recorded and compared between the new drug and existing treatments for parasitic infections.
In the final analysis reported in the publication, no changes to the primary and secondary outcome measures are expected. The primary and secondary outcome measures are designed to provide a comprehensive assessment of the effectiveness and safety of the new drug in curing parasitic infections in humans.
Main Predictor/Independent Variable and how it will be categorized/defined for your study: The main independent variable for the study is the new drug used to treat parasitic infections in humans. The new drug will be compared with existing treatments for parasitic infections to evaluate its efficacy and safety in curing the infection. The independent variable (the new drug) will be manipulated to see its effect on the dependent variables (cure rate, incidence of adverse events, patient satisfaction, and time to cure). This study will help to determine whether the new drug is a more effective and safe treatment option for parasitic infections in humans.
Other Variables of Interest that will be used in your analysis and how they will be categorized/defined for your study:
The independent variables are:
Age: Participants' age will be recorded to ensure they meet the inclusion criteria.
Gender: Participants' gender will be recorded to ensure a balanced representation of both genders in the study.
Medical History: Participants' medical history, including any pre-existing conditions or previous treatments for parasitic infections, will be recorded to ensure they meet the inclusion criteria.
Parasite Type: The type of parasitic infection will be recorded to ensure the sample is representative of the types of parasitic infections being treated.
Baseline Parasite Load: The baseline parasite load, measured at the start of the study, will be used to control for the severity of the parasitic infection.
Body Mass Index (BMI): Participants' BMI will be recorded to control for the effect of obesity on the cure rate of the parasitic infection.
Smoking Status: Participants' smoking status will be recorded to control for the effect of smoking on the cure rate of the parasitic infection.
These independent variables will
Statistical Analysis Plan:
Descriptive Analyses: Summarize demographic and clinical characteristics, including age, gender, medical history, parasite type, baseline parasite load, BMI, and smoking status, and the cure rate, incidence of adverse events, patient satisfaction, and time to cure.
Bivariate Analyses: Assess relationship between the new drug and outcome measures (cure rate, adverse events, patient satisfaction, and time to cure) and between subgroups defined by demographic and clinical characteristics.
Multivariable Analyses: Assess relationship between the new drug and outcome measures while controlling for potential confounding effect of demographic and clinical characteristics. Models will include logistic regression for binary outcomes and linear regression for continuous outcomes. Results will be presented in tables and figures and interpreted in the context of study objectives.
No other advanced analyses planned. Results will be assessed for statistical significance (p
Narrative Summary: The proposed study is a clinical trial that aims to evaluate the safety and effectiveness of a drug called mebendazole in treating helminth infections in children. The study is designed to optimize the criteria for evaluating the efficacy and safety of the drug by using a double-blind, randomized, and multi-center design. During the double-blind treatment phase, randomly assigned to receive either mebendazole or a placebo (an inactive substance), and no party will know which treatment they are receiving to reduce the influence of biases and increase the accuracy of the results. The main goal is to analyse data before and after administering drug and optimize chosen criteria.
Project Start: Feb 10st, 2023
Analysis Completion: July 15th, 2023
Manuscript Drafted: July 30th, 2023
First Submission for Publication: Aug 15th, 2023
Results reported to YODA Project: Sep 1st, 2023
Final Study Report: Detailed findings of the study will be reported in a final report, which will be submitted to YODA Project.
Study Manuscript(s): Findings of the study will be published in peer-reviewed scientific journals.
Researchers and clinicians in the fields of parasitology, infectious diseases, and clinical trials
Public health organizations and regulatory agencies
General public interested in the treatment of parasite infections
Expectation for Study Manuscripts:
The study manuscript will present the study design, results, and conclusions in a clear and concise manner suitable for publication in a peer-reviewed journal.
The Lancet Infectious Diseases
New England Journal of Medicine
PLoS Neglected Tropical Diseases
Clinical Infectious Diseases
Journal of Antimicrobial Chemotherapy.