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NCT ID: NCT04170322 Not yet recruiting - Surgery Clinical Trials

Comparing Pvc or Silicone Gastric Calibration Tube During Sleeve Gastrectomy

Start date: August 2020
Phase: N/A
Study type: Interventional

Time from 40 Fr gastric calibration tube introduction on surgical request till first stapling is measured as introduction time. Problems to advance are noted A note is made If change to other type of gastric tube is needed

NCT ID: NCT04170101 Not yet recruiting - Muscle Injury Clinical Trials

RCT Deep vs Moderat NMB on Surgical Conditions During THP

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

A clinical deep NMB might relax the anterior muscles of the upper leg better than a moderate/superficial block giving a better exposure for the surgeon with less muscle trauma by traction to expose the hip. a continuous deep NMB (group A) versus a non deep NMB (group B) having a moderate to superficial block imitating common practice today as control group. Primary objectives are surgical exposure and Secondary objectives are Muscle damage creatine kinase changes, C-reactive protein (CRP), first time leaving bed postoperative, post operative pain as measured by opioid use postoperative at 24h, with a control of max VAS score during first 24 hour, length of hospital stay (LOS), number of adverse events using the Dindo-Clavien surgical complication score, QoR15 measured at 24h on the ward.

NCT ID: NCT04147871 Not yet recruiting - Cystinuria Clinical Trials

Study Evaluating Patients With Cystinuria and Efficacy and Safety Exploratory Study in the Youngest Children

Start date: March 1, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

This is a multicenter, randomized, controlled versus placebo, double-blinded, 4 parallel arms, dose-ranging main study, to evaluate the efficacy, safety and tolerability, and acceptability of repeated doses of ADV7103, after 7 days of treatment, in patients with cystinuria, and an efficacy and safety exploratory study in the youngest children.

NCT ID: NCT04142463 Not yet recruiting - Oncologic Disorders Clinical Trials

Collaborative Network to Take Responsibility for Oral Anticancer Therapy 2

CONTACT-2
Start date: October 2019
Phase: N/A
Study type: Interventional

In 2015, the research team of KU Leuven and UGent started a pilot project supported by Kom op Tegen Kanker, called CONTACT-1. This multicentre before-after study aims at developing, implementing and evaluating a care pathway for patients treated with oral anticancer drugs (OACD) in four oncology centres in Flanders (AZ Groeninge Kortrijk, AZ Imelda Bonheiden, AZ Maria Middelares Gent, AZ Turnhout). Preliminary results from CONTACT-1 have shown that re-organisation of care processes, and better interdisciplinary collaboration and communication, are highly needed, and that working towards a care pathway is an appropriate method to achieve this. However, the development and implementation of the care pathway in each hospital was difficult and needed intensive coaching by the research team. Moreover, we have currently no insight in the impact of the care pathway on defined outcomes, neither on the sustainability of the implemented care pathway. In CONTACT-2, we will expand the development and implementation of a care pathway to 10 additional oncology centres in Flanders. In contrast to CONTACT-1, the CONTACT-2 oncology centres will take the lead in the development, implementation and evaluation of the care pathway, supported by the research team en by the CONTACT-Toolkit. This toolkit was developed based on the experiences from CONTACT-1 and international guidelines on the implementation of care pathways/complex interventions. Similar to CONTACT-1, we hypothesise that the implementation of a care pathway will improve the level of self-management and the quality of patient-centred care, and will increase adherence, patient satisfaction and health-related quality of life. Next, we hypothesise that the care pathway will improve counselling practice, interdisciplinary collaboration, self-efficacy and self-confidence of healthcare professionals (HCP). The impact of a care pathway on the above outcomes in patients as well as in HCPs will be investigated by means of various assessments, that have been selected by the research team based on their experiences from CONTACT-1. Moreover, we hypothesize that the development and implementation process will be more efficient in the CONTACT-2 oncology centres, who will need less intensive support of the research team, due to the CONTACT-Toolkit. A process evaluation will be conducted to test this last hypothesis. Further in-depth analysis of the impact of the care pathway, combined with a thorough process evaluation, should eventually lead to insight in the crucial factors for sustainable implementation of a care pathway, as well as to definite conclusions on its impact for patients and HCPs. Throughout CONTACT-2, the CONTACT-toolkit will be further elaborated, optimised and digitised based on the experiences of the research team and feedback from the CONTACT-2 oncology centres. The toolkit will enable a nation-wide and sustainable implementation of similar care pathways for patients treated with OACD.

NCT ID: NCT04095741 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Characteristics of Autism Spectrum Disorder in Minors With Anorexia Nervosa in Remission

Start date: October 1, 2019
Phase:
Study type: Observational

With this investigation, researchers wil look for a link between the appearance of anorexia nervosa and autism spectrum disorders in minors. Previous studies made clear already that patients with anorexia nervosa show elevated characteristics of autism spectrum disorder, when being meassured in adults and in patients in the acute fase of their anorexia nervosa. The purpose of this invenstigation is to see if their is also an elevated incidence of characteristics of autism spectrum disorder in minors with anorexia nervosa in remission.

NCT ID: NCT04041388 Not yet recruiting - Clinical trials for Maxillary Hypoplasia

Maxillary Segment Tipping During Transpalatal Distraction

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The investigator proposes a multi-centre study to investigate tipping of teeth, bringing into consideration the height of the osteotomy line and the height and placement of the transpalatal distractor as possible factors. If tipping occurs depending on these factors, the investigator could identify the situations that cannot be straightened by the orthodontist and provide another course of action for these specific patients.

NCT ID: NCT04016506 Not yet recruiting - Child, Only Clinical Trials

Epidemiology, Management and Complications Related to Pancreatic Trauma in Children

PANC-TRAUMA
Start date: September 15, 2019
Phase:
Study type: Observational

The aim of this study is to better evaluate the treatment and development of children and adolescents who have had a pancreatic trauma and who are being followed in Belgian hospitals.

NCT ID: NCT03905109 Not yet recruiting - Crohn Disease Clinical Trials

Safety Evaluation of ABX464 in Patients With Moderate to Severe Active Crohn's Disease

Start date: April 15, 2020
Phase: Phase 2
Study type: Interventional

This Phase IIa study is a 16-week, double-blind, placebo-controlled, randomized study aiming at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in subjects with moderate to severe active Crohn's Disease who have inadequate response, loss of response, or intolerance to prior amino-salicylates, immunosuppressant treatment, biologics, and/or corticosteroid treatment, and followed by a 4 weeks period of follow-up after the last study drug intake.

NCT ID: NCT03864575 Not yet recruiting - Metastatic Cancer Clinical Trials

An Open Label Phase II Study Combining Nivolumab and Celecoxib in Patients With Advanced " Cold " Solid Tumors

NICE-COMBO
Start date: August 15, 2019
Phase: Phase 2
Study type: Interventional

This is an open-label study to evaluate the safety and the anti-tumor activity of the combination of nivolumab and celecoxib. The total numbers of participants to be enrolled will be up to 68 participants, depending on the investigated dose of celecoxib during the safety run-in phase.

NCT ID: NCT03848598 Not yet recruiting - Tendinopathy Clinical Trials

Is There a Mechanistic Reason for the Response or Non-response to Isometric Exercise in Tendinopathy?

Start date: August 2019
Phase:
Study type: Observational

In early phase tendinopathy, isometric exercises are seen as ideal to provide pain relief to patients. This approach is mainly based on a paper by Rio et al (2016), where they found that isometric exercises of a certain load magnitude and time (5 repetitions of 45 second hold at 70% of maximum) gave 100% pain relief for 45 minutes in patients with patellar tendinopathy. This then helps patients to perform their more heavy load exercises during rehabilitation, which would otherwise be too painful. Unfortunately, the study of Rio et al only consisted of 6 participants, and recent papers have contradicted the findings. In Achilles tendinopathy, plantar fasciopathy and lateral elbow tendinopathy, the pain relief was not consistently present, with "responders" and "non-responders" being found in these studies. Also, a study yet to be published (poster at conference), replicating Rio et al, also found a heterogeneous response, debunking the "one size fits all" approach that seemed to work. However, in our understanding, isometric exercises do have a crucial role in early tendinopathy management, but the way the exercise is performed, in which position, what magnitude of load, time under tension, … has an important influence. The same protocol (5 repetitions of 45 second hold at 70% of maximum) might lead to big inter-individual differences. Therefore, there might be a mechanistic reason why some patients respond, and others do not. Fortunately, the P.I. of this current trial application has recently optimized an ultrasound-based method to quantify local tendon deformation during exercises. The main purpose of this trial is therefore to evaluate the local tendon deformation pattern of patients with tendinopathy during isometric exercises and evaluate whether there is an interindividual difference in pattern between "responders" and "non-responders".