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NCT ID: NCT04905693 Enrolling by invitation - Clinical trials for Idiopathic Pulmonary Fibrosis

Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

TETON-OLE
Start date: September 6, 2022
Phase: Phase 3
Study type: Interventional

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis.

NCT ID: NCT04881825 Enrolling by invitation - Clinical trials for Short Bowel Syndrome

Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial

EASE SBS 3
Start date: June 16, 2021
Phase: Phase 3
Study type: Interventional

This trial is an extension trial to EASE SBS 2. The study looks at whether glepaglutide is a safe treatment for participants with Short Bowel Syndrome (SBS), as well as how well effectiveness is maintained during long term treatment. Participants in this trial will receive glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.) for approximately 2 years.

NCT ID: NCT04814953 Enrolling by invitation - Clinical trials for Squamous Cell Carcinoma

HRQoL Keratinocyte Carcinomas

Start date: July 1, 2020
Phase:
Study type: Observational

Rationale: Keratinocyte skin cancer is known to influence the HRQoL in a specific way. Derived utility values are required for cost-effectiveness analyses of new interventions. However there is no sensitive tool to capture HRQoL that translates into utilities available. Objective: To document the exact HRQoL in patients with in KC using the generic EQ-5D-5L questionnaire, as well as the TTO, 15D and the BaSQoL questionnaire, and to develop health utilities based on these tools. Study design: Longitudinal observational study (at time 0 and time 0 +12 months). Study population: Patients aged ≥18 years consulting a dermatologist or their GP for diagnosis, treatment or follow-up of a (pre)malignant skin lesion(s).

NCT ID: NCT04761549 Enrolling by invitation - Clinical trials for Adolescent Idiopathic Scoliosis

3D, Dynamic and Mechanically-informed Decision Making in AIS

3D-AIS
Start date: January 19, 2021
Phase: N/A
Study type: Interventional

Adolescent Idiopathic Scoliosis (AIS) is a growth defect of the spine that primarily occurs in prepubertal children between the age of 10 to 14 years, affecting approximately 3% of these otherwise normal children. AIS has been associated with problems related to posture, load-related back pain, as well as aesthetic problems, e.g. the induced asymmetry of the shoulder. Therefore, early diagnosis followed by the appropriate treatment is vital to prevent further curve progression of AIS and minimize the health-related complications of these patients. The current treatment recommendation to stop curve progression for an immature patient with a scoliosis curve between 25 and 40 degrees is to wear a brace. If the curve in the skeletally immature patient is not responding to the brace treatment, dynamic scoliosis correction by vertebral body tethering can be considered when there is still some growth potential left. State-of-the-art guidelines for the selection of fusion levels are currently mainly based on two-dimensional (2D) static radiographic parameters (such as, the Cobb angle and Shoulder balance) and a qualitative assessment of 2D bending or traction radiographs. Several classification systems and algorithms that are based on the 2D static radiographic (X-ray) parameters exist to assist surgeons in determining the appropriate levels to be instrumented. Despite this wide range of classification systems and detailed guidelines available in the literature, spinal fusion does not always yield satisfying 2D radiographic clinical outcome, with revision rates ranging from 3.9% to 22%. Overall, the surgeon is presently not provided with 3D dynamic and mechanical information regarding the deformity of the AIS to guide the decision-making. Obtaining this vital 3D dynamic information regarding the curvature and mechanical behavior of the spine will allow the surgeon to make an evidence-based and well-informed decisions in the treatment of the AIS patient. Consequently, realizing these objectives has the potential to improve patient satisfaction, reduce the postoperative complications and accordingly reduce socio-economic costs associated with AIS treatment. Recent advances in the use of subject specific musculoskeletal models will form the basis to realize this shift from 2D to 3D dynamic in AIS care.

NCT ID: NCT04746378 Enrolling by invitation - Urolithiasis Clinical Trials

PRedictive Accuracy of Initial Stone Burden Evaluation.

PRAISE
Start date: September 9, 2021
Phase:
Study type: Observational

This study is intended to be a prospective registry of patients undergoing any kind of stone treatment that have a pre-operative CT available. This imaging will be used to measure the stone burden in three different ways: in a single dimension (cumulative stone diameter), in two dimensions (surface area) and in three dimensions (volume).The primary purpose is to identify what way of measuring stone burden is most predictive of outcomes after stone treatment such as stone free status, operative time and complications.

NCT ID: NCT04646187 Enrolling by invitation - Crohn Disease Clinical Trials

De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease

FREE
Start date: March 11, 2021
Phase: Phase 4
Study type: Interventional

BACKGROUND/RATIONALE: Treatment outcomes of patients with inflammatory bowel disease (IBD) have improved enormously during the past decade due to the use of anti-tumour necrosis factor (anti-TNF) therapy. As a result, 67 to 91% of paediatric patients and 66% of adult patients is still in sustained remission two years after the initiation of anti-TNF therapy. Prolonged use of anti-TNFs comes with disadvantages such as dose dependent susceptibility to infections and dermatological adverse effects. Preliminary, mostly uncontrolled studies suggest that dose reduction by dosing interval lengthening is a realistic option in a relevant proportion of patients with IBD, provided that intensive follow-up is applied. OBJECTIVE: To evaluate whether a faecal calprotectin (FC) guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD, compared with an unchanged dosing interval.

NCT ID: NCT04545112 Enrolling by invitation - Clinical trials for Multi Vessel Coronary Artery Disease

Xeltis Coronary Artery Bypass Graft (XABG) First in Human (FIH)

XABG-FIH
Start date: October 22, 2020
Phase: N/A
Study type: Interventional

A FIH study to collect preliminary device safety, feasibility and performance data of the XABG in patients with symptomatic coronary artery disease (SCAD), with suitable multi vessel disease (MVD) and selected by the local Heart Team for elective coronary artery bypass grafts surgery of at least 3 bypass grafts (minimally 1 artery and 2 veins or 2 arteries and 1 vein).

NCT ID: NCT04451044 Enrolling by invitation - Clinical trials for Coronary Artery Disease

Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting

DEFINE GPS
Start date: June 17, 2021
Phase: N/A
Study type: Interventional

Multi-center, prospective, randomized controlled study comparing PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and the SyncVision co-registration system, employing an adaptive design study for interim sample size re-estimation.

NCT ID: NCT04421963 Enrolling by invitation - Breast Cancer Clinical Trials

Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib

ROSY-O
Start date: August 4, 2020
Phase: Phase 3
Study type: Interventional

The rationale of the ROSY-O study is to continue to provide study treatment for patients who have participated in a parent study with olaparib and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.

NCT ID: NCT04382807 Enrolling by invitation - Clinical trials for Tinnitus, Subjective

Internet-delivered Group Counseling for Chronic Tinnitus

Start date: May 12, 2020
Phase:
Study type: Observational

In the treatment of chronic tinnitus, psycho-education plays an import role to provide more insights into the symptoms of tinnitus. However, the need for e-health is increasing. As such, it is important to investigate if these psycho-education sessions can be delivered online, with the same efficacy compared to the traditional face-to-face delivery.