Clinical trials: Plasma Concentration, open to volunteers
Cardiovascular Side Effects of Clozapine, Neutropenia Due to Clozapine
Nor)Clozapine Kinetics and Side Effects in Therapy Resistant Schizophrenia and the Optimal Sampling Time for Therapeutic Drug Monitoring
The goal of this observational study is to better understand how clozapine treatment can be tailored as regards minimizing side effects and optimizing efficacy and monitoring.
- Conditions
- Cardiovascular Side Effects of Clozapine, Neutropenia Due to Clozapine, General Side Effects of Clozapine, Constipation Due to Clozapine
- Trial name
- COTTONS (NCT06749041)
- Volunteers
- 60 people
- Sponsor
- GGZ Noord-Holland-Noord
Paroxysmal AF, Treatment Decisions
Comparative Efficacy of 100-, 200-, & 400-mg Amiodarone in Patients With Paroxysmal AF Depending on Plasma Concentration
Amiodarone is a highly effective drug for the treatment and prevention of arrhythmias. In the 1970s and 1980s, numerous experimental and clinical studies comprehensively examined the mechanisms of amiodarone's antiarrhythmic…
- Conditions
- Paroxysmal AF, Treatment Decisions, Therapeutic Drug Monitoring (TDM)
- Trial name
- AMIODETECT (NCT07487714)
- Testing
- Pharmacotherapy with amiodarone 200 mg per day, Treatment with Amiodarone at a dose 100 mg per day, Treatment with Amiodarone at a dose 400 mg per day
- Where
- Russia
- Volunteers
- 80 people
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
Healthy
Lycopene as a Dietary Compliance Biomarker
Rationale: To determine the plasma lycopene concentration before and after an oral intake of lycopene in order to use this measurement as a life style compliance marker.
- Trial name
- NCT07117110
- Testing
- Supplement, Tomato soup
- Where
- Netherlands
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Erasmus Medical Center
Complicated Staphylococcus Aureus (S. Aureus) Infections (CSAI)
Target Attainment of Continuous Infusion Flucloxacillin and Cefazolin Coupled With TDM vs. Standard of Care Treatment in Patients With Complicated S. Aureus Infection
This prospective randomized, controlled interventional pilot trial, aims to compare the achievement of the optimal target concentration with continuously administered flucloxacillin (FLU) or cefazolin (CZO) coupled with TDM and…
- Trial name
- TARGET III (NCT05655091)
- Testing
- FLU or CZO as continuous infusion, standard FLU or CZO intermittent bolus administration
- Where
- Switzerland
- Volunteers
- 36 people
- Sponsor
- University Hospital, Basel, Switzerland
Creatine
Changing in Plasma Concentration of a New Form of Creatine
Creatine is one of the most popular supplements among athletes. Studies have consistently shown that creatine supplementation increases intramuscular creatine concentrations, improving exercise performance and/or enhancing…
- Trial name
- NCT07838805
- Testing
- New Formulation of Creatine (Creamix), Active Comparator: Creatine Monohydrate
- Where
- Italy
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- University of Padova
Renal Impairment, Healthy Volunteers
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
The purpose of this Phase 1, open-label, 2-arm study is to assess the effect of severe RI on PK, safety, and tolerability of rilzabrutinib compared with normal renal function, in male and female participants aged from 18 to 75…
- Trial name
- NCT07853131
- Testing
- rilzabrutinib
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sanofi
Therapeutic Drug Monitoring (TDM), Menopause
Escitalopram Plasma Concentrations in Premenopausal and Postmenopausal Women
This observational cross-sectional case-control study aims to evaluate the effects of menopausal status on escitalopram metabolism in women.
- Conditions
- Therapeutic Drug Monitoring (TDM), Menopause, Depression - Major Depressive Disorder, General Anxiety Disorder
- Trial name
- MENO-ES (NCT07259525)
- Where
- Turkey (Türkiye)
- Volunteers
- 94 people
- Sponsor
- Eskisehir Osmangazi University
Soft Tissue Infections, Mediastinitis
Delafloxacin Plasma and Tissue Concentration in Patients With Skin, Soft Tissue, and Bone and Joint Infections.
The goal of this observational study is to measure how well the antibiotic delafloxacin penetrates into the blood and various body tissues in adult patients over 18 years old.
- Conditions
- Soft Tissue Infections, Mediastinitis, Osteomyelitis/Septic Arthritis, Prosthetic Joint Infection
- Trial name
- DELA-PLAT (NCT07426471)
- Testing
- delafloxacin
- Volunteers
- 20 people
- Sponsor
- IRCCS San Raffaele
Adult Acute Myeloid Leukemia
Relation Between Venetoclax Plasma Concentration and Remission in Adults with Acute Myeloid Leukemia (PREDICLAX)
Background: In combination with hypomethylating drugs, venetoclax has recently changed the therapeutic management of patients with newly diagnosed acute myeloid leukemia (AML) for whom standard induction chemotherapy was not an…
- Trial name
- NCT06045819
- Testing
- Blood sampling for venetoclax drug dosage (venous puncture)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Caen
Postoperative Pain After a Total Knee Arthroplasty
Post-operative Analgesic Effect of Oral Nefopam
Primary knee arthroplasty by total prosthesis is a painful surgery, performed on patients with advanced gonarthrosis (stage III), thus already presenting hyperalgesia and hyperalgesia and allodynia.
- Trial name
- NefPO (NCT04576078)
- Testing
- Oral nefopam
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Hospices Civils de Lyon
Chronic Graft Versus Host Disease
Study to Compare the Plasma Concentration of Belumosudil Given as an Oral Suspension and as a Tablet to Healthy Adult Male Participants
The purpose of this open-label, randomized, cross-over, Phase 1, 2-treatment, 2-period, 2-sequence study is to assess the bioequivalence of belumosudil oral suspension compared with belumosudil tablet in healthy male participants…
- Trial name
- NCT07726914
- Testing
- Belumosudil
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Sanofi
Type 1 Diabetes
Can the Addition of Pioglitazone to SGLT2 Inhibitor in Type 1 Diabetic Patients Amplify the Decrease in HbA1c and Prevent the Increase in Plasma Ketone Concentration?
Previous data from our clinical trial has demonstrated that the combination of dapagliflozin plus pioglitazone cause robust decrease in the plasma glucose concentration without significant increase in plasma ketone concentration…
- Trial name
- NCT06922656
- Testing
- Dapagliflozin (DAPA), Pioglitazone 45 mg
- Where
- 3 sites in Kuwait, Qatar and 1 more
- Volunteers
- 60 people
- Sponsor
- Dasman Diabetes Institute
Infections
Assess the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam (Meropenem/FL058) in China Healthy Adult Participants
The goal of this clinical trial is to evaluate the Epithelial Lining Fluid concentrations and permeability of Intravenous Meropenem-Pralubactam(Meropenem/FL058) in China Healthy Adult Participants.
- Trial name
- NCT07124468
- Testing
- Meropenem-Pralubactam
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Anesthesia, Intravenous, Electroencephalography
Remifentanil Effect on Burst Suppression Ratio
The goal of this clinical trial is to determine whether remifentanil has a facilitating effect on the generation of burst suppression by propofol in adult patients (18-60 years) candidates for elective surgery who require…
- Conditions
- Anesthesia, Intravenous, Electroencephalography, Burst Suppression
- Trial name
- NCT06237101
- Testing
- High dose of remifentanil, Medium dose of remifentanil
- Where
- 2 sites in Chile
- Volunteers
- 20 people
- Sponsor
- University of Chile
Acute Cannabis-induced CNS Depression
Observational Study of THC Concentrations in Acute Cannabis-induced CNS Depression
This observational study is being conducted to determine plasma concentrations of tetrahydrocannabinol (THC) and its metabolites, 11-OH-THC and THC-COOH, in plasma of pediatric patients who visit the emergency department due to…
- Trial name
- NCT06017622
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Anebulo Pharmaceuticals
Bone Fractures
Naringenin Supplementation in Bone Fracture Patients
Fractures of the lower extremities represent a significant proportion of injuries sustained by polytrauma patients, with a notable association with prolonged hospitalization, chronic disability, and impaired physical functioning.
- Trial name
- NCT06612762
- Testing
- The daily ingestion of capsules containing naringenin
- Where
- Iran
- Volunteers
- 70 people
- Sponsor
- Shahid Beheshti University of Medical Sciences
Thiazide-induced Hyponatremia (TIH)
Urinary Prostaglandin as a Potential Predictive Marker for Thiazide-induced Hyponatremia
Thiazides and thiazide-like diuretics are one of the five major classes of antihypertensive drugs. This study is to investigate whether urinary PGE2 concentration at baseline (prior to thiazide initiation) is associated with the…
- Trial name
- PROPHECY (NCT05542056)
- Testing
- Data and biosample collection
- Where
- 3 sites in Spain, Switzerland
- Volunteers
- 232 people
- Sponsor
- University Hospital, Basel, Switzerland
Pain, Postoperative, Pharmacokinetics
Liposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy
The purpose of this study is to assess pharmacokinetics of liposomal bupivacaine (Exparel) after multilevel intercostal injections of this local anesthetic for pain control during and after thoracoscopic surgeries.
- Trial name
- NCT03737292
- Testing
- Exparel, Bupivacaine
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Milton S. Hershey Medical Center
Digestive Cancer, Metastatic Colorectal Cancer
TARGETed Therapy Drug MONITOring in DIGestive Oncology
Targeted therapy drug monitoring in digestive oncology: Dosage of plasma levels of various multikinase inhibitors (MKI) in patients treated for advanced digestive cancer (gastrointestinal stromal tumor (GIST), metastatic…
- Conditions
- Digestive Cancer, Metastatic Colorectal Cancer, Hepatocellular Carcinoma, GIST
- Trial name
- TARGETMONITO (NCT05443087)
- Testing
- Blood sampling to build population pharmacokinetics model
- Where
- 29 sites in France
- Volunteers
- 330 people
- Sponsor
- UNICANCER
Diabetes
Urinary Vitamin C Loss in Diabetic Subjects
Several studies have reported that diabetic subjects have lower plasma vitamin C concentrations than non-diabetic subjects. Although urinary vitamin C loss in diabetic subjects was reported to be increased in two studies, these…
- Trial name
- NCT00071526
- Where
- United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)