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Cefazolin plasma levels and pharmacokinetic parameters during adult cardiac surgery: after implementation of a new protocol for antibiotic prophylaxis.

The primary aim of the study of to investigate time and concentration of cefazolin above the MIC. The main secondary aim is to investigate influence of cardiac surgery and use of CPB on PK parameters of cefazolin. We aim investigate the new dosing…

Timing of inguinal hernia repair in premature infants: A randomized trial

The objective of this study is to determine whether early inguinal hernia repair (prior to discharge home) or late inguinal hernia repair (approximately 5 months after discharge home) is the safer surgical approach for premature infants who are…

A Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis

Primary: - To determine the dose-response relationship for SAR442168 to reduce the number of new active brain lesions. Secondary: - To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging measures.- To evaluate the…

B-FIT! A guideline to individualized exercise in post-polio syndrome

Primary objective:(1) To evaluate the efficacy of the B-FIT aerobic training program on physical fitness of individuals with PPS in the US and the Netherlands.Secondary objective:(2) To evaluate the patient and healthcare professional satisfaction…

The PREDMETH trial: Effectiveness of methotrexate versus prednisone as first-line therapy for pulmonary sarcoidosis - A randomized controlled trial

This study has been transitioned to CTIS with ID 2024-514055-15-00 check the CTIS register for the current data. Primary: • Investigate the effectiveness and tolerability of methotrexate as first-line therapy in patients with pulmonary sarcoidosis…

Early prediction of adalimumab levels with InsightRx

Prediction of adalimumab steady-state levels, based on 2 adalimumab levels in the induction phase of therapy with InsightRx.

Short-term safety, efficacy and mode of action of apremilast in mild to moderate cutaneous pemphigoid: a phase IIa open label single arm study.

Primary Objective: To evaluate the achievement of partial remission by apremilast combined with doxycyclineat week sixteen (t=16). Secondary Objectives: • Complete remission at week sixteen; • Disease control at week six (t=6); • Drug survival;•…

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of OV101 in Pediatric Individuals With Angelman Syndrome (NEPTUNE)

All efficacy study objectives will be assessed in the pediatric AS study population of subjects who are 4 to 12 years old. All safety study objectives will be assessed in the pediatric AS study population of subjects who are 2 to 12 years old.…

The effect of adding biofeedback on heart rate variability to the treatment of
intimate partner violence perpetrators with cognitive behavioral therapy.

The first objective is to investigate whether biofeedback on HRV and voice volume will lead to a larger decrease of IPV compared to treatment as usual (CBT only). Second, to test the premise that IPV perpetrators have trouble self-observing bodily…

Neo-adjuvant Pembrolizumab in dMMR/ POLE-EDM uterine cancer patients: a feasibility study

We aim to establish proof-of-concept for use of pembrolizumab as novel neo-adjuvant therapy in dMMR and POLE-EDM UC. When ICB proves to be feasible as defined in the primary endpoint (see 2.1), we will follow-up with larger studies to determine…

Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients with rare genetic disorders of obesity

Main objective:To explore the impact of setmelanotide on obesity in patients with various specific rare genetic mutations.Secondary objective:To assess the effects of setmelanotide on:* Safety and tolerability-Hunger* Waist circumferenceOptional sub…

A Phase Ib, multicenter, open-label dose escalation and expansion platform study of select immunotherapy combinations in adult patients with triple negative breast cancer

Primary: To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future dosesSecondary:* To characterize the pharmacokinetic profile of each investigational drug within each treatment arm…

Effect of preoperative weight loss with a 14-day low-calorie diet on surgical procedure and outcomes in patients undergoing RYGB surgery.

The primary objective is to evaluate the effect of preoperative weight loss (by means of a 14-day low-calorie diet) on the operative time of the RYGB procedure. The first secondary objective is to evaluate the effect of preoperative weight loss on…

A Randomized, Double Blind, Placebo Controlled, Phase 2a Study to Assess the Clinical Efficacy of ISIS 721744, a Second Generation Ligand Conjugated Antisense Inhibitor of Prekallikrein, in Patients with Hereditary Angioedema

The primary objective of the study is to evaluate the clinical efficacy of antisense inhibitor of prekallikrein (ISIS 721744) in patients with hereditary angioedema (HAE) type 1 (HAE 1), HAE type 2 (HAE 2), or HAE with normal C1-inhibitor (C1-INH).…

Phase 4 Double-blinded, Randomized, Active Comparator-controlled
Clinical Trial to Study the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-
8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2
Years

The current trial aims to demonstrate that sugammadex is generally safe and effective for reversing both moderate and deep block after rocuronium or vecuronium induced NMB in term neonates and young children.

An extension study to evaluate the long-term outcomes of subjects who received treatment for retinopathy of prematurity in Study 20090

This extension study aims to collect long-term data on safety and efficacy in a subject population treated for ROP with aflibercept and/or laser, and to contribute to the clarification of potential effects.

An open-label, multicenter, Phase 1/2 study of radium-223 dichloride in combination with pembrolizumab in participants with stage IV non-small cell lung cancer

The purpose of the study is to determine the safety and assess the efficacy of the combination of radium-223 dichloride and pembrolizumab in participants with stage IV NSCLC with bone metastases who are either treatment naïve or have progressed on…

Randomized, double blind, multicenter extension to CZPL389A2203 dose-ranging study to assess the shortterm and long-term safety and efficacy of oral ZPL389 with concomitant or intermittent use of TCS and/or TCI in adult patients with atopic dermatitis (ZEST Extension)

The purpose of this study is to assess short-term and the long-term safety and efficacy of oral ZPL389 (30 mg once daily (o.d.) and 50 mg o.d.) when used concomitantly or intermittently with topical corticosteroid (TCS) and/or topical calcineurin…

A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled
Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects with Moderate to Severe Atopic Dermatitis.

The objective of this study is to evaluate the efficacy and safety of upadacitinib versus dupilumab for the treatment of adult subjects with moderate to severe atopic dermatitis who are candidates for systemic therapy.

A Phase 2, single-arm study of bempegaldesleukin (NKTR-214) in combination with nivolumab in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients

The primary objective is:• To evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per…