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NCT ID: NCT03682835 Completed - Healthy Clinical Trials

Effect of POCO on Gastric Function in HV

POCO
Start date: October 13, 2017
Phase: N/A
Study type: Interventional

This study aims to investigate changes in gastric motility (including gastric accommodation), nutrient volume tolerance, gastric emptying and gastrointestinal hormones in healthy volunteers after an acute intake of a combination of peppermint oil and caraway oil, compared to placebo. In addition, the effect of a combination of peppermint oil and caraway oil on appetite-related sensations and upper gastrointestinal symptoms will be assessed. Gastric emptying rate will be assessed using a 13C breath test. Intragastric pressure (IGP) will be measured using high-resolution manometry in fasted state and during intragastric infusion of a nutrient drink (350 mL or until full satiation). Appetite-related sensations and gastrointestinal symptoms were rated during IGP measurements. Blood samples were collected to assess peptide hormone levels.

NCT ID: NCT03682705 Completed - Clinical trials for Rheumatoid Arthritis (RA)

A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis

Start date: October 8, 2018
Phase: Phase 2
Study type: Interventional

This was a phase 2 study to evaluate the safety and efficacy of elsubrutinib (ELS) and ABBV-599 (ELS plus upadacitinib [UPA]) vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs (bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to severely active RA and to define optimal dose for further development.

NCT ID: NCT03682159 Completed - Clinical trials for Edema/Prevention & Control

The Effect of Manual Lymphatic Drainage on Swelling After Orthognathic Surgery - a Qualitative and 3D Facial Analysis.

Start date: September 2016
Phase: N/A
Study type: Interventional

Introduction / background Orthognathic surgery is an operation in which one or both jaws are fixed in a more favorable position performed by an osteotomy. In this way, large skeletal differences between the upper and lower jaw can be corrected surgically. The aim is to obtain a good and stable occlusion as well as to improve the facial aesthetics off the patient, where this would not be possible without surgery. These surgical procedures are accompanied by swelling of the face that can last for several days. The swelling is often considered unpleasant by the patients. The post-operative application of ice on the face can reduce the swelling. Also, performing manual lymphatic drainage (MLD) at the head and neck region would have a positive effect on the swelling after the operation. Manual lymphatic drainage is a kind of gentle massage performed by physiotherapists to reduce swelling in a faster way after surgery. This therapy is performed during the first days after the surgery and lasts about 30 minutes per session. There is still insufficient evidence to be whether or not this technique offers added value for patients undergoing jaw surgery. Goal The aim of this study is to investigate whether or not manual lymphatic drainage provides added value for patients undergoing jaw surgery. The facial swelling will be studied as the primary outcome variable. Other postoperative discomforts associated with orthognathic surgery are the secondary outcome variables. This study may or may not justify performing MLD and ensure that it is included in a postoperative protocol. Methodological approach The investigators would like to measure and compare the swelling in the face in an objective way between patients who received manual lymphatic drainage (intervention group) and patients who did not undergo manual lymphatic drainage (control group) The control group receives the standard postoperative care that is applied at the University Hospital Ghent. The intervention group also receives the same postoperative cares, as well as 5 MLD sessions during the first postoperative week (1st, 2nd, 3rd, 4th, 7th postoperative day).The objective measurement of the swelling can be done on the basis of a laser scan that can create 3D images of the face. For this, the patient should take a natural head position at rest and have a relaxed facial expression. This technique of imaging is non-invasive and there is no x-ray radiation involved! The 3D images are taken at the following times: 3 days, 1 week, 2 weeks, 1 month, 3 months and 6 months after the operation. Together with the scans, the patients were asked to fill in a questionnaire to frame the subjective postoperative discomfort associated with orthognathic surgery. The change in swelling can be analyzed on the basis of specific measurements on the 3D images as well as by recording surface changes. The last 3D image is used as a reference to superimpose the other 3D images as there is no longer any swelling on this 3D image. After analyzing these data, it can be assessed to what extent manual lymphatic drainage offers an advantage to reduce swelling after orthognathic surgery.

NCT ID: NCT03681093 Completed - Nasal Polyps Clinical Trials

Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma

THUNDER
Start date: March 26, 2019
Phase: Phase 3
Study type: Interventional

A Phase 3b Proof-of-Concept study to evaluate the ability of fevipiprant 150 mg and 450 mg, compared with placebo, as add-on to nasal spray standard-of-care (SoC), in reducing endoscopic nasal polyp score in adult (≥ 18 years) patients with nasal polyposis and concomitant asthma.

NCT ID: NCT03680807 Completed - Clinical trials for Osteo Arthritis Knee

Power Production in Older Adults With Knee Osteoarthritis

Start date: September 1, 2018
Phase:
Study type: Observational

Knee osteoarthritis is an important cause of functional disabilities at old age. Previous research has demonstrated that individuals with knee osteoarthritis have reduced knee-extensor strength in comparison to healthy individuals. However, rapid power production declines more than strength as a consequence of ageing and is more predictive of functional capacity. However, limited research has investigated whether individuals with knee osteoarthritis have reduced ability to develop strength and power rapidly on top of reduced maximal strength capacities, which is the primary aim of the current study.

NCT ID: NCT03679884 Completed - Insomnia Disorder Clinical Trials

Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

Start date: October 9, 2018
Phase: Phase 3
Study type: Interventional

Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep

NCT ID: NCT03679637 Completed - Stroke, Acute Clinical Trials

Tablet-based Aphasia Therapy in the Acute Phase After Stroke

Start date: September 28, 2018
Phase: N/A
Study type: Interventional

As aphasia is one of the most common and disabling disorders following stroke, in many cases resolving in long-term deficits, it is now thought that intensive aphasia therapy is effective, even in the chronic phase following stroke. However, as intensive aphasia rehabilitation is difficult to achieve in clinical practice, tablet-based aphasia therapies are explored to further facilitate language recovery. Although there is mounting evidence that computer-based treatments are effective, it is also important to assess the feasibility, usability and acceptability of these technologies, especially in the acute phase post stroke. The investigators assume that tablet-based aphasia therapy is a feasible treatment option for patients with aphasia in the acute phase following stroke. The researchers also believe that the specific app that will be used in therapy is user-friendly and that it will be well accepted by this specific patient population.

NCT ID: NCT03678454 Completed - Clinical trials for Chronic Myeloid Leukemia

Iclusig® (Ponatinib) in Clinical Practice for the Treatment of Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia in Belgium

Start date: February 3, 2017
Phase:
Study type: Observational

This prospective registry is initiated to follow up on the use of Iclusig® in patients with CML or Ph+ ALL in routine practice in Belgium.

NCT ID: NCT03677427 Completed - Breast Cancer Clinical Trials

Comparing 5 and 15 Fractions for Whole Breast Irradiation After Breast Conserving Surgery

YO-HAI5
Start date: October 16, 2017
Phase: N/A
Study type: Interventional

Adjuvant radiotherapy after breast-conserving surgery for breast cancer reduces the risk of locoregional relapse and ensures better overall survival. In recent years it has been found that hypofractionation in which the number of radiation sessions is reduced with a higher dose per session offers advantages for breast irradiation. Randomized studies showed that moderate hypofraction regimens in 15 or 16 fractions have the same effect in tumor control and toxicity, although the total dose is lower than the traditional 50 Gy in 25 fractions. In a randomized study from the United Kingdom (START-B trial) even a better disease-free survival was seen with 15 sessions than with 25 sessions and the long-term side effects were also less with the short schedule. This project proposes a clinical trial with an accelerated radiotherapy schedule in 5 sessions. It is expected that the accelerated schedule of 5 sessions over 12 days will have a number of radiobiological benefits: since a higher dose per session is given over a shorter period of time, it is expected that tumor control and survival will be higher. By reducing the total treatment time, the total dose is reduced, which may result in fewer radiation-related side effects and thus improve the quality of life. Apart from these radiobiological benefits, the shorter radiotherapy program reduces the number of treatment days from 15 to 5. This is not only more comfortable for the patients, but also increases the treatment capacity of the radiotherapy department. This opens up a possibility for the use of more complex techniques with fewer side effects such as radiation in the prone position. This project includes a randomized study comparing the accelerated schedule in 5 sessions with a hypofraction schedule of 15 sessions in patients who are irradiated on the entire breast after breast-saving surgery. The primary endpoint is chest retraction (loss of volume) 2 years after radiotherapy.

NCT ID: NCT03677336 Completed - Infertility Clinical Trials

Oral Dydrogesterone (OD) Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in IVF/ICSI

Start date: May 1, 2019
Phase: Phase 4
Study type: Interventional

Female inability to conceive a child. The purpose of this prospective randomized, double-blinded, double dummy, two-arm cross-over study is to investigate the difference on histological, transcriptional and immunological level in endometrium between 3x10mg Dydrogesterone oral tablets and 3x200 mg Micronized progesterone intravaginal capsules for the luteal support in egg cell donors. Beside that, the pharmacokinetics, the impact on the peripheral immunology (by blood sampling) and the microbiota (by genital swabs) will be investigated.