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Therapeutic drug monitoring in tocilizumab-treated rheumatoid arthritis patients: Pilot study of a double-blind randomised controlled trial

To evaluate the feasibility of the study after 20 weeks of follow-up, which includes the evaluation of the dose-reduction algorithm in tocilizumab-treated patients with RA.

A randomized controlled trial evaluating the additional effect of topical coal tar to a topical corticosteroid regimen in patients aged >16 years of age with moderate-severe atopic dermatitis

To evaluate the additional effect of coal tar treatment to a corticosteroid regimen in adults (aged >16 years of age) with moderate to severe atopic dermatitis, based on the percentage change in Eczema Area and Severity Index (EASI) at week 2…

Neurotoxic adverse effects of morphine and oxycodone in continuous subcutaneous infusion for treatment of pain in terminal patients with diminished renal function: a Randomized Controlled Trial.

The primary objective of this study is to compare the prevalence of delirium between oxycodone and morphine, administered by CSCI, for the treatment of pain in dying patients with a diminished renal function.The secondary objective is to compare the…

Bilateral vs. unilateral transcranial magnetic stimulation of the primary motor cortex to treat chronic orofacial pain: a pilot study with a randomized controlled design

In 2016, Henssen et al. discuss that orofacial pain may be conducted in a bilateral fashion, inducing activation of both thalami [1]. For this reason, bilateral stimulation of the motor cortex is thought to induce a stronger analgesic effect…

The effect of Opioids on P2Y12 Receptor Inhibition in patients with ST-Elevation Myocardial Infarction who are pre-treated with crushed Ticagrelor.

Primary Objective: The aim of the study is to show that STEMI patients who are pre-treated with crushed ticagrelor and paracetamol have a higher level of platelet inhibition after primary PCI than patients pre-treated with crushed ticagrelor who are…

A randomized controlled pilot study comparing the efficacy of topical coal tar to topical corticosteroids in children aged 1 to < 16 years with moderate-severe atopic dermatitis.

To evaluate efficacy of topical treatment with coal tar compared to topical treatment with corticosteroids in children aged 1 to &lt;16 years with moderate to severe AD, based on the percentage change in Eczema Area and Severity Index (EASI) at…

The effect of pelvic floor muscle training on bowel symptoms after low anterior resection for rectal cancer.

The proportion of successful patients, defined as an improvement in LARS category, will be 25% larger in the experimental group than in the control group (in which 10 % improvement is assumed).

A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn*s disease patients in sustained steroid-free remission on combination therapy.

To assess the effect of two withdrawal strategies over two years in patients with stable remission for more than 8 months on combination therapy with infliximab and antimetabolites, and demonstrate that continued combination of infliximab and…

An open label, randomised, parallel group clinical study to evaluate the effect of the Connected Inhaler System (CIS) on adherence to Relvar/Breo ELLIPTA therapy, in asthmatic subjects with poor control (study 207040)

Primary:To compare the effect of 6 months use of the CIS on adherence to ELLIPTA maintenance therapy when both the subject and the HCP are supplied with data from the maintenance sensor versus no data supplied to the subject and HCP (Arm 1 vs Arm 5…

Pediatric Ards Neuromuscular blockade (PAN) study: Life-threatening acute respiratory failure in children: to breathe or not to breathe spontaneously, that's the question. A multicentre, randomised, double-blind, placebo controlled study.

To test the hypothesis that early use of neuromuscular blocking agents for 48 hours in paediatric patients younger than 5 years of age with moderate-to-severe paediatric acute respiratory distress syndrome will lead to at least a 20% reduction in…

Bioequivalence study of CRUshed Sofosbuvir/velpAtasvir compareD to the wholE tablet (CRUSADE-1)/Hep-NED004

Primary objective:To assess the bioequivalence of SOF/VEL as a crushed (test) tablet compared to a whole (reference) tablet in patients treated with SOF/VELSecondary objective:To evaluate the safety and tolerability of crushed SOF/VEL tablets in…

A study to characterize the humoral and cellular response following simultaneous immunization with a neo-antigen (KLH) and a recall antigen (tetanus) in healthy volunteers

Investigation of the immune response following immunization with Immucothel/Alhydrogel with or without tetanus. Per efficacy endpoint, the following parameters will be explored:(a) Response size;(b) Inter-individual variability of the response;(c)…

MORphine use in the Fascia Iliaca Compartment block with UltraSound

The main study endpoint will be the mean preoperative morphine use per hour in patients with and without FICB with levobupivacaine, guided by ultrasound. Secondary parameters will include the pain scores reported by the numerical rating scale both…

Pharmacokinetics of single-dose dOLutegravir in HIV-serOnegative sub-jects with severe hepatic impairment compared to matched controls (POLO).

The aim of the POLO study is to evaluate pharmacokinetics and safety of a single-dose of dolutegravir in patients with severe hepatic impairment (Child-Pugh score * 10) and compare these to matched controls.

Ketanserin effects on Peripheral Temperature and Lactate

To determine the effects of a continuous ketanserin infusion on peripheral temperature and lactate clearance in critically ill patients with either a high lactate or a high deltaT.

A randomized, placebo-controlled, evaluator-blinded, study to assess the anti-inflammatory effects of topical erythromycin and clindamycin in patients with inflammatory facial acne

* To evaluate the effects of topically applied erythromycin and clindamycin in patients with facial AV* To explore skin and faecal microbiota in patients with AV;* To evaluate the effects of topically applied erythromycin and clindamycin on skin and…

A 24-week treatment, multi-center, randomized, double-blind, double-dummy, parallel group study to compare Umeclidinium/Vilanterol, Umeclidinium, and Salmeterol in subjects with chronic obstructive pulmonary disease (COPD)

Primary:To compare the effect of UMEC/VI (62.5/25 mcg once daily) with UMEC (62.5 mcg once daily) on lung functionSecondary:To compare UMEC/VI, UMEC with salmeterol (50 mcg twice daily) on patient reported outcomes and on other COPD efficacy…

Esophageal HILZO Covered self-expandable metal stent for palliation of malignant dysphagia: A Safety and Feasibility Study

The main objective of this study is to evaluate the safety and efficacy of placement of the esophageal HILZO Covered stent with the TTS method in patients with non-operable malignant obstruction of the esophagus or esophagogastric junction,…

Pharmacokinetic Profile of Ropivacaïne after Periarticular Local Infiltration Analgesia for Primary Total Knee Arthroplasty without the use of a Tourniquet.

The primary objective of this study is to describe the pharmacokinetic profile of total and unbound plasma concentrations of ropivacaine, when used for LIA in TKA surgery without tourniquet.

Pharmacokinetics of posaconazole given as a single intravenous dose to obese subjects: Dosing Obese with Noxafil® Under a Trial (DONUT).

Primary objective:To determine the effect of obesity (BMI &gt; 35 kg/m2) on the pharmacokinetics of posaconazole and develop a dosing regimen for obese patients. Secondary objective:• To describe the pharmacokinetics of the augmented dose of 400…