Clinical trials: Drug Monitoring
Autism Spectrum Disorder
Safety and Pharmacokinetics of Antipsychotics in Children 2: Studying TDM in an RCT
The aim of this study is to test whether therapeutic drug monitoring of risperidone in children with autism spectrum disorder and comorbid behavioral problems is able to reduce metabolic side effect burden, while retaining…
- Trial name
- SPACe2:STAR (NCT05146245)
- Testing
- Therapeutic Drug Monitoring, Risperidone plasma level
- Where
- Netherlands
- Volunteers
- 140 people
- Sponsor
- Erasmus Medical Center
Malaria
Monitoring Pregnant Women for Antimalarial Drug Resistance
Annually, malaria affects an estimated 229 million people, causing 409,000 deaths (WHO 2019) mostly in Africa. Despite a substantial decline in malaria-related maternal and child deaths in recent years, progress in controlling…
- Trial name
- MIRANDA (NCT05072613)
- Testing
- Malaria screening
- Where
- Democratic Republic of the Congo
- Volunteers
- 6,833 people, healthy volunteers welcome
- Sponsor
- University of Oxford
HIV Infections
Dose Reduction of Lopinavir in Children
To study the pharmacokinetics of low-dose and standard dose, lopinavir/ritonavir in ARV PI naive HIV-1 infected Thai children. To study clinical and immunological efficacy after 48 weeks of lopinavir/ritonavir in PI naïve HIV-1…
- Trial name
- NCT00887120
- Testing
- Lopinavir/ritonavir standard dose According to WHO simplified dosing table, Lopinavir/ritonavir low dose ( 70% of WHO recommended dosing table)
- Where
- Thailand
- Volunteers
- 24 people
- Sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
Lupus Nephritis
Concentration-controlled Therapy of Mycophenolate Mofetil (MMF) in Proliferative Lupus Nephritis
To evaluate therapeutic response to MMF treatment in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis.
- Trial name
- NCT01042457
- Testing
- Mycophenolate mofetil
- Where
- Thailand
- Volunteers
- 24 people
- Sponsor
- Chulalongkorn University
Opioid Prescribing, Prescription Drug Misuse
E-mails to Nudge Safer and Better-Informed Prescribing of Risky Drugs
This study will test e-mails to encourage engagement with the Minnesota prescription monitoring program (PMP/PDMP) and will evaluate the effect of these e-mails on PMP/PDMP use and controlled substance prescribing.
- Trial name
- NCT06443385
- Testing
- PDMP Legal Mandate E-mail, PDMP Clinical Benefit E-mail
- Where
- United States
- Volunteers
- 7,872 people, healthy volunteers welcome
- Sponsor
- Columbia University
Non-valvular Atrial Fibrillation (NVAF), Venous Thromboembolism (VTE)
Precision Antithrombotic Therapy
The goal of this observational study is to systematically analyze the relationship between trough/peak concentrations of novel oral anticoagulants (NOACs) and antiplatelet drugs with clinical events, aiming to provide high-level…
- Conditions
- Non-valvular Atrial Fibrillation (NVAF), Venous Thromboembolism (VTE), MI(Myocardial Infarction), Ischemic Stroke
- Trial name
- NCT07654634
- Testing
- Not applicable- observational study
- Where
- China
- Volunteers
- 5,000 people
- Sponsor
- The Third Xiangya Hospital of Central South University
Catheter Related Blood Stream Infections
Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter
The goal of this study is to verify whether extensive flushing of the port catheter in patients with catheter related blood stream infection will lead to correct vancomycin trough levels, taken via the port catheter and compared…
- Trial name
- NCT03720132
- Testing
- Extensive flushing of the port catheter
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Pediatric Hematopoietic Stem Cell Transplantation, Malignant Disorders
Treosulfan Therapeutic Drug Monitoring in Pediatric Hematopoietic Stem Cell Transplant Recipients
One of the major challenges to improve the outcome of hematopoietic stem cell transplantation (HSCT) is the reduction of toxicity and non-relapse mortality caused by the pre-transplant conditioning regimen, while maintaining…
- Conditions
- Pediatric Hematopoietic Stem Cell Transplantation, Malignant Disorders, Non-malignant Disorders
- Trial name
- NCT06861257
- Where
- 10 sites in Italy
- Volunteers
- 70 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Methicillin-resistant Staphylococcal Infections
Comparison of Two Dosage Adjustment Strategies of Vancomycin in Children
Vancomycin is the standard first-line treatment for MRSA infections and a first-line empiric therapy. The relationship between exposure to vancomycin and efficacy is admitted but because of an important intersubject variability…
- Trial name
- OPTIBAYE (NCT02694458)
- Testing
- Early vancomycin monitoring and bayesian dosage adjustment, usual vancomycin dose and monitoring strategy
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Ulcerative Colitis (UC), IBD-unclassified (IBD-U)
Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease
Inflammatory Bowel Diseases (IBD), which include Crohn's disease (CD), ulcerative colitis (UC), and the unclassified form referred to as indeterminate colitis, are most commonly diagnosed during adolescence and early adulthood.
- Trial name
- TDMpIBD (NCT06954311)
- Where
- 10 sites in Austria
- Volunteers
- 120 people
- Sponsor
- Medical University Innsbruck
Upper Respiratory Tract Infection;, Acute Tracheobronchitis
A Registry Study on Reduning（a Chinese Medicine Injection）Used in Hospitals in China
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in January 2013.
- Trial name
- NCT01824719
- Where
- China
- Volunteers
- 3,000 people
- Sponsor
- China Academy of Chinese Medical Sciences
Crohn Disease
Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease
Crohn's disease (CD) is a condition that causes inflammation (swelling, redness) of the lining and wall of the small intestine, large intestine, or both.
- Trial name
- CAMEO (NCT05781152)
- Testing
- Anti-TNF therapy
- Where
- 26 sites in United States, Canada
- Volunteers
- 1,270 people
- Sponsor
- Connecticut Children's Medical Center
Acute Lymphoblastic Leukemia
TDM of Asparaginase in ALL2008
Asparaginase is a cornerstone in the treatment of ALL. In most contemporary protocols like in NOPHO ALL2008 prolonged asparaginase treatment has been implemented.
- Trial name
- NCT04843514
- Where
- 2 sites in Denmark
- Volunteers
- 765 people, healthy volunteers welcome
- Sponsor
- Aarhus University Hospital
Lymphatic Filariasis Elimination by Mass Drug Administration, Monitoring and Evaluation of Mass Drug Administration for Lymphatic Filariasis
East New Britain Province Monitoring & Evaluation
While tremendous progress towards elimination of lymphatic filariasis (LF) has been made in the 20 years since the 1997 Fiftieth World Health Assembly, it is unlikely the goal of eliminating LF as a public health problem by 2020…
- Conditions
- Lymphatic Filariasis Elimination by Mass Drug Administration, Monitoring and Evaluation of Mass Drug Administration for Lymphatic Filariasis, Acceptability of Mass Drug Administration for Lymphatic Filariasis
- Trial name
- ENBP M&E (NCT04124250)
- Testing
- Observational
- Where
- Papua New Guinea
- Volunteers
- 12,930 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Crohn Disease, Ulcerative Colitis
Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease
This is a comparative pragmatic trial in patients with UC and CD on maintenance treatment with IFX. All IBD patients from cohort A with maintenance IFX treatment at a referral IBD clinic are prospectively included between June…
- Trial name
- NCT04775732
- Testing
- infliximab therapeutic drug monitoring
- Where
- 2 sites in Belgium
- Volunteers
- 187 people
- Sponsor
- Imelda GI Clinical Research Center
Musculoskeletal System Disease
Clinical and Biomolecular Assessment for the Monitoring of Patients Undergoing Regenerative Medicine Treatments with Orthobiologics
the aim is to improve the evaluation of the outcomes of regenerative medicine treatments performed in the regenerative medicine centers involved in the study.
- Trial name
- NCT04711551
- Testing
- PRP and related devices to abtain platelet concentrate from whole blood, medullary and adipose tissue and related devices
- Where
- 2 sites in Italy
- Volunteers
- 2,000 people
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
HIV-1-infection, Antiretroviral Therapy
HIV Transmission in the Era of Scaling up Antiretroviral Therapy in Ethiopia
The goal of this observational study is to understand patterns of HIV transmission in a high-prevalence area in Ethiopia, and to compare viral genetic information in people with HIV who are newly diagnosed and have not been…
- Trial name
- THESA (NCT05652400)
- Testing
- Exposure to antiretroviral therapy
- Where
- Ethiopia
- Volunteers
- 2,200 people
- Sponsor
- Lund University
Melanoma, Lung Cance
Intensive Medicines Monitoring Study of Toripalimab Monoclonal Injection (Tuoyi) .
This study was a prospective, single-arm, multi-channel, multicenter, non-interventional real-world study to evaluate the safety and efficacy of Toripalimab injection in the treatment of unresectable or metastatic melanoma with…
- Conditions
- Melanoma, Lung Cance, Breast Cancer
- Trial name
- NCT04234620
- Testing
- Toripalimab injection
- Where
- 25 sites in China
- Volunteers
- 800 people
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
Invasive Fungal Infections, Lung Transplantation
Isavuconazole Therapeutic Drug Monitoring in Transplant Recipients
Isavuconazole is an antifungal medicine used to prevent or treat serious fungal infections in people who have received a solid organ transplant (mainly lung, and also kidney or liver) or a hematopoietic stem cell (bone marrow)…
- Conditions
- Invasive Fungal Infections, Lung Transplantation, Hematopoietic Stem Cell Transplantation (HSCT), Kidney Transplantation
- Trial name
- TRIM-1 (NCT07716878)
- Testing
- Isavuconazole
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Zhibin Xu
Sickle Cell Disease
Optimizing the Management of Sickle Cell Patients on Hydroxyurea: The Value of Therapeutic Pharmacological Monitoring
Brief Summary: * A short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public. Limit: 5000 characters.
- Trial name
- OPTIMDREP (NCT06464458)
- Testing
- management on hydroxyurea by therapeutic pharmacological monitoring
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Strasbourg, France