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TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC trial): study protocol for a randomized controlled trial KU Leuven

Toon Van Gorp
BACKGROUND: Cervical intraepithelial neoplasia (CIN) is the premalignant condition of cervical cancer. Whereas not all high grade CIN lesions progress to cervical cancer, the natural history and risk of progression of individual lesions remain unpredictable. Therefore, high-grade CIN is currently treated by surgical excision: large loop excision of the transformation zone (LLETZ). This procedure has potential complications, such as acute ...

An educational programme for patients with psoriasis and atopic dermatitis: a prospective randomized controlled trial Ghent University

Jessica Bostoen, Stefanie Bracke, STEFANIE DE KEYSER, Jo Lambert
Background:  Patient education as an addition to standard treatment, with the aim of affecting care through courses is a relatively new concept in dermatology. Here we introduce a randomized controlled trial (RCT) with regard to a previously described 12 week educational programme for chronic skin diseases. Objective:  The primary objective of the RCT was to measure the effect of an educational programme on disease severity and quality of life ...

Evaluating newly approved drugs in combination regimens for multidrug-resistant tuberculosis with fluoroquinolone resistance (endTB-Q): study protocol for a multi-country randomized controlled trial Institute of Tropical Medicine

Praharshinie Rupasinghe, S. B. Patil, M. Tamirat, K Khazhidinov, Elisa Ardizzoni, M. Atger, A Austin, E. Baudin, M Bekhit, S Bektasov, et al.

BACKGROUND: Treatment for fluoroquinolone-resistant multidrug-resistant/rifampicin-resistant tuberculosis (pre-XDR TB) often lasts longer than treatment for less resistant strains, yields worse efficacy results, and causes substantial toxicity. The newer anti-tuberculosis drugs, bedaquiline and delamanid, and repurposed drugs clofazimine and linezolid, show great promise for combination in shorter, less-toxic, and effective regimens. To date, ...

Role of cerebral hypoperfusion in multiple sclerosis (ROCHIMS): study protocol for a proof-of-concept randomized controlled trial with bosentan Vrije Universiteit Brussel KU Leuven

Stéphanie Hostenbach, Ayla Pauwels, Veronique Michiels, Hubert Raeymaekers, Anne-Marie Van Binst, Chris Baeken, Annick Van Merhaegen-Wieleman, Peter Van Schuerbeek, Jacques De Keyser, Miguel D'Haeseleer, et al.

Background: Axonal degeneration is related to long-term disability in patients with multiple sclerosis (MS). The underlying mechanism remains ill understood but appears to involve axonal energetic dysfunction. A globally impaired cerebral blood flow (CBF) has been observed in the normal-appearing white matter (NAWM) of patients with MS, which is probably related to astrocytic overexpression of endothelin-1 (ET-1). Cerebral hypoperfusion has ...

Evaluating newly approved drugs for multidrug-resistant tuberculosis (endTB): study protocol for an adaptive, multi-country randomized controlled trial Institute of Tropical Medicine

L. Guglielmetti, Elisa Ardizzoni, M. Atger, E. Baudin, E. Berikova, M. Bonnet, E. Chang, Sandrine Cloez, J. M. Coit, J Cox, et al.

BACKGROUND: Treatment of multidrug- and rifampin-resistant tuberculosis (MDR/RR-TB) is expensive, labour-intensive, and associated with substantial adverse events and poor outcomes. While most MDR/RR-TB patients do not receive treatment, many who do are treated for 18 months or more. A shorter all-oral regimen is currently recommended for only a sub-set of MDR/RR-TB. Its use is only conditionally recommended because of very low-quality ...

Comments on "Effectiveness of sustained natural apophyseal glides in females with cervicogenic headache: A randomized controlled trial" Hasselt University

Christophe Demoulin, Annick TIMMERMANS, Stephanie Grosdent, Lieven Danneels
Dear Editor, After having read the conclusion of the systematic review of Bini et al. who recommended to conduct additional trials on the effectiveness of manual therapy in patients with cervicogenic headache [1], we read with interest the study by Kashif et al. [2] who investigated the effect of sustained natural apophyseal glides (SNAGs) in similar patients. Besides the fact that this study is not really original as the experimental protocol ...

Pulmonary rehabilitation to improve physical capacity, dyspnea, and quality of life following pulmonary embolism (the PeRehab study): study protocol for a two-center randomized controlled trial Hasselt University

Stacey Haukeland-Parker, Oyvind Jervan, Hege Holmo Johannessen, Jostein Gleditsch, Knut Stavem, Kjetil Steine, Martijn A. SPRUIT, Rene Holst, Mazdak Tavoly, Frederikus A. Klok, et al.
BackgroundRecently, a large group of patients with persistent dyspnea, poor physical capacity, and reduced health-related quality of life (HRQoL) following pulmonary embolism (PE) has been identified and clustered under the name "post pulmonary embolism syndrome" (PPS). These patients seem good candidates for pulmonary rehabilitation. The aim of the study is to explore whether a pulmonary rehabilitation program can improve physical capacity, ...

Hidden blood loss in direct anterior total hip arthroplasty: a prospective, double blind, randomized controlled trial on topical versus intravenous tranexamic acid. KU Leuven

Stijn Ghijselings
BACKGROUND: Despite a plethora of literature reporting on the use of tranexamic acid (TXA) in total hip arthroplasty (THA), little is available on its effect on post-operative hidden blood loss and even less on its use in the direct anterior approach (DAA), which is gaining popularity. MATERIALS AND METHODS: This study was designed as a prospective, double blind, single centre, randomized controlled trial. Sixty patients were allocated to ...

The FINISH-3 Trial: A Phase 3, International, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps in Intraoperative Surgical Hemostasis KU Leuven Ghent University

Baki Topal
BACKGROUND: This Phase 3, international, randomized, single-blind, controlled trial (FINISH-3) compared the efficacy and safety of Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, vs gelatin sponge alone for use as a hemostat for surgical bleeding in 4 indications (ie, spinal, hepatic, vascular, soft tissue dissection). STUDY DESIGN: Adults with mild to moderate surgical bleeding ...

Preoperative Nonsteroidal Anti-inflammatory Drug or Steroid and Outcomes after Trabeculectomy A Randomized Controlled Trial Hasselt University Vrije Universiteit Brussel KU Leuven

Christophe Breusegem, Leigh Spielberg, Rita Van Ginderdeuren, Evelien Vandewalle, Charlotte Renier, Sara Van de Veire, Steffen FIEUWS, Thierry Zeyen, Ingeborg Stalmans
Purpose: To investigate the benefit of preoperative treatment with either topical nonsteroidal anti-inflammatory drug (NSAID) or steroid in terms of clinical outcomes following trabeculectomy. Design: Prospective, randomized placebo-controlled trial. Participants: Sixty-one patients. Methods: Between July 2005 and October 2007, 61 consecutive medically uncontrolled glaucoma patients scheduled for first-time trabeculectomy were randomized to 1 of ...