Clinical trials: Therapeutic Drug Monitoring
Human Immunodeficiency Virus
Efficacy Study of Different Laboratory Management Strategies and Drug Regimens in HIV-infected Children in Africa
The two original objectives were to determine in HIV-infected children initiating antiretroviral therapy (ART): 1. Whether clinically driven monitoring (CDM) will have a similar outcome in terms of disease progression or death as…
- Trial name
- ARROW (NCT02028676)
- Testing
- Clinically Driven Monitoring (CDM), Laboratory plus Clinical Monitoring (LCM), Arm A: ABC+3TC+NNRTI
- Where
- 4 sites in Uganda, Zimbabwe
- Volunteers
- 1,206 people
- Sponsor
- Medical Research Council
Asthma in Children, Medication Adherence
Financial Incentives to Improve Asthma
The aim of this pilot randomised controlled trial is to assess the effectiveness of a short-term financial incentives intervention at bringing about behaviour change, namely short-medium term improvements in inhaled…
- Trial name
- FINA (NCT05322044)
- Testing
- Financial incentives
- Where
- United Kingdom
- Volunteers
- 32 people
- Sponsor
- Imperial College London
HIV/AIDS, Medication Adherence
Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System
Introduction of antiretroviral therapy (ART) has transformed HIV-infection from a fatal to manageable disease but adherence to ART remains critical to optimize outcomes.
- Trial name
- NCT02797262
- Testing
- Proteus digital health feedback (PDHF) system
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- University of California, Los Angeles
Stroke, Medication Adherence
Adherence to Medical Treatments for Telemedicine Patients
This study will test the feasibility of MedRem, a novel medication reminder and tracking system on wearable wrist devices, specifically with the Apple Watch 4.
- Trial name
- NCT04180475
- Testing
- MedRem application
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Adherence, Medication, Risk Behavior
DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence
The researchers are working with a technology company, AiCure, to develop a smartphone app, DOT Diary, which combines two drug adherence strategies.
- Conditions
- Adherence, Medication, Risk Behavior, Pre-Exposure Prophylaxis, HIV Prevention
- Trial name
- NCT03387462
- Testing
- Emtricitabine / Tenofovir Disoproxil Oral Tablet, DOT Diary mobile app
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Public Health Foundation Enterprises, Inc.
Hyperlipidemia, Diabetes
Point-of-Care Testing (POCT) Detection and Management of Metabolic Syndrome in Patients With Mental Illness
The study was a 12-month, multi-centered, quasi-experimental design to assess point-of-care (POCT) screening/monitoring of subjects on antipsychotic agents for metabolic syndrome.
- Conditions
- Hyperlipidemia, Diabetes, Hypertension
- Trial name
- NCT02029989
- Testing
- Glucose and lipids, Glycosylated Hemoglobin A1c, Blood Pressure and Heart Rate
- Where
- United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Drug Abuse
A First Study in Healthy Volunteers of a New Mobile Phone Application Measuring the Eyes Before and After Medication
This is a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data on the medical device Previct Drugs.
- Trial name
- NCT05731999
- Testing
- Previct Drugs
- Where
- Netherlands
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Kontigo Care AB
Medication Adherence
Smart Capsule for Automatic Adherence Monitoring
In pharmacotherapy trials in drug-dependent populations, medication compliance is a significant issue, as rates tend to be low and adherence to medication may predict improved outcomes (Baros et al, 2007; McRae et al, 2004…
- Trial name
- NCT02344238
- Testing
- ID Capsule, Riboflavin, Prompts
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
Inflammatory Bowel Diseases, Colitis, Ulcerative
Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes
The purpose of this study is to determine if a relationship exists between Week 6 vedolizumab therapeutic drug monitoring (TDM) and Week 30 Faecal calprotectin (FCP).
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
- Trial name
- VEDO TDM RWE (NCT04567628)
- Testing
- No Intervention
- Where
- Canada
- Volunteers
- 7,873 people
- Sponsor
- Takeda
Hypertension
Efficacy and Safety of Azilsartan Medoxomil, Once Daily (QD), Co-Administered With Amlodipine in Participants With Essential Hypertension
The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), co-administered with amlodipine in treating individuals with essential hypertension, compared to treatment with amlodipine…
- Trial name
- NCT00591266
- Testing
- Azilsartan Medoxomil and amlodipine, Amlodipine
- Where
- 50 sites in United States
- Volunteers
- 566 people
- Sponsor
- Takeda
Carcinoid Syndrome, Metastatic Nonfunctional Well Differentiated Neuroendocrine Neoplasm
AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm
This pilot trial studies how well telotristat etiprate works in treating participants with well differentiated neuroendocrine neoplasm that has spread to other places in the body and monitored by carbon C 11…
- Trial name
- NCT03453489
- Testing
- Carbon C 11 Alpha-methyltryptophan, Laboratory Biomarker Analysis, Positron Emission Tomography
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute
Hypertension
Efficacy and Safety of Azilsartan Medoxomil in African American Participants With Essential Hypertension
The purpose of this study is to evaluate the effectiveness and safety of azilsartan medoxomil compared to placebo, once daily (QD), in African-American participants with essential hypertension.
- Trial name
- NCT00591253
- Testing
- Azilsartan medoxomil
- Where
- 64 sites in United States, Puerto Rico
- Volunteers
- 413 people
- Sponsor
- Takeda
Uncontrolled Asthma, Young Adults
Medication Adherence With Telehealthcare Medication Therapy Management
Improving Medication Adherence with Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults with Asthma (MATCH) is a multi-center, randomized parallel group study targeted to an…
- Trial name
- MATCH (NCT03978936)
- Testing
- Medication Therapy Management (MTM) Video Telehealthcare, Electronic Adherence Self-Management (EAM)
- Where
- 21 sites in United States
- Volunteers
- 375 people
- Sponsor
- Johns Hopkins University
Dementia, Dementia With Lewy Bodies
Monitoring Anti-Dementia Drugs by Serum Levels
The main objective of the MONANTI study is twofold: Firstly, to determine the serum concentration (SC) the anti-dementia drugs donepezil and memantine in a broadly defined clinical population of patients suffering from dementia…
- Conditions
- Dementia, Dementia With Lewy Bodies, Dementia in Parkinsons Disease, Dementia Alzheimers
- Trial name
- MONANTI (NCT04117178)
- Testing
- Donepezil, Memantine, Measurement of serum level of anti-dementia drug
- Where
- Denmark
- Volunteers
- 132 people
- Sponsor
- Zealand University Hospital
Multiple Sclerosis
Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.
The primary objective of the study is to determine whether a Medication Event Monitoring System (MEMS®) cap with a liquid crystal display (LCD) reader (a "smart" cap) along with additional patient counseling intervention (Arm 3)…
- Trial name
- NCT02343159
- Testing
- dimethyl fumarate, Medication Event Monitoring System (MEMS), Adherence counseling
- Where
- 29 sites in United States
- Volunteers
- 84 people
- Sponsor
- Biogen
Hypertension
Management of Uncontrolled Hypertension (HTN)
In this study, investigators will compare chronotherapy to ABPM. Data collected will include hypertension drug therapy regimen prior to and during the study, timing of medication administration, and dose, along with the patient's…
- Trial name
- NCT02922023
- Testing
- Ambulatory blood pressure monitor (ABPM), Chronotherapy
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Florida
Heart Failure, Heart Failure Hospitalization
Teach-Back Discharge Education to Improve Self-Care and Reduce 30-Day Readmissions in Heart Failure Patients
This study aimed to improve how patients with heart failure understand and manage their condition after leaving the hospital. Many heart failure patients are readmitted within 30 days due to confusion about their discharge…
- Conditions
- Heart Failure, Heart Failure Hospitalization, Readmission, Hospital
- Trial name
- NCT07280208
- Testing
- Teach-Back Discharge Education
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Nova Southeastern University
Substance Use Disorder (SUD)
A Study of a Mobile Phone Application Measuring the Eyes Before and After Medication
This is a post-market clinical follow-up study on an approved CE-marked eHealth system where a mobile phone application is used to measure the pupils and eye measurements to monitor the use of different drug substances.
- Trial name
- NCT06629740
- Testing
- Measurements with a eHealth system
- Where
- Netherlands
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Kontigo Care AB
Type 2 Diabetes Mellitus
A Study to Compare the Use of Diabetes Treatment Support System (BAP0527 and Blood Glucose Meter) in Addition to Daily Practice and Treatment With Daily Practice and Treatment Alone in Patients With Type 2 Diabetes Mellitus
The subjects of this study are patients with type 2 diabetes mellitus. The patients take part in dietetic therapy and exercise therapy, and also receive diabetes education to improve lifestyle habits, but since diet and exercise…
- Trial name
- NCT06156696
- Testing
- BAP0527, Blood Glucose Meter
- Where
- Japan
- Volunteers
- 248 people
- Sponsor
- Astellas Pharma Inc
HIV Infections
SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC
The primary purpose of this study is to: 1. Demonstrate the safety and efficacy of tipranavir/ritonavir (TPV/r) among a racially diverse HIV+ population (males and females) who are three-class (nucleoside reverse transcriptase…
- Trial name
- NCT00440271
- Testing
- tipranavir, ritonavir, Optimized Background Regimen (OBR)
- Where
- 30 sites in United States, Argentina and 5 more
- Volunteers
- 33 people
- Sponsor
- Boehringer Ingelheim