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NCT ID: NCT03781999 Active, not recruiting - Fitness Clinical Trials

The Effect of a Combination of Orange- and Pomegranate Actives on Physical Fitness in Elderly People

Start date: June 25, 2018
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine the effect of daily supplementation of a combined orange- and pomegranate extract for a period of 4 weeks on physical fitness compared to placebo. In this crossover study, participants will daily receive either a placebo or Actiful®, a supplement containing 500 mg orange extract and 200 mg pomegranate actives, for 4 weeks followed by a wash-out period of 4 to 8 weeks. Subsequently, the second intervention period of 4 weeks (active product or placebo) will take place. The product and placebo will be supplied in capsules that participants can ingest with a glas of water (daily, prior to breakfast).

NCT ID: NCT03756272 Active, not recruiting - Postmenopausal Clinical Trials

Stellate Ganglion Block to Reduce Hot Flushes

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure

NCT ID: NCT03743272 Active, not recruiting - Cirrhosis Clinical Trials

Repeatability and Reproducibility of Multiparametric MRI

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

This study aims to prospectively assess the repeatability and reproducibility of iron-corrected T1 (cT1), T2*, and hepatic proton density fat fraction (PDFF) quantification with multiparametric MRI using the LiverMultiScan™ (LMS, Perspectum Diagnostics, Oxford, UK) protocol across different field strengths, scanner manufacturers and models.

NCT ID: NCT03727724 Active, not recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Afatinib and Cetuximab in Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Positive Non-small-cell Lung Cancer

AFACET
Start date: December 4, 2018
Phase: Phase 2
Study type: Interventional

This is a single arm open-label multi-center phase II study, investigating disease control rate after 18 weeks of treatment with afatinib/cetuximab combination therapy in patients with advanced non-small cell lung cancer (NSCLC) harboring an EGFR exon 20 insertion.

NCT ID: NCT03720314 Active, not recruiting - Clinical trials for Irritable Bowel Syndrome

Microbiota Profiling in IBS

IBSQUtrition
Start date: September 6, 2018
Phase:
Study type: Observational

This study investigates differences in microbiota profiles and metabolite levels between mild and severe IBS patients, compared to matched healthy controls. Two fecal samples, with one month in between, will be analyzed. Secondary parameters such as dietary intake, quality of life and stool pattern will be assessed.

NCT ID: NCT03710967 Active, not recruiting - Neuropathic Pain Clinical Trials

Bilateral TMS vs. Unilateral TMS

biTMSvsuniTMS
Start date: May 1, 2018
Phase: N/A
Study type: Interventional

Rationale: In 2016, Henssen et al. discuss that orofacial pain may be conducted in a bilateral fashion, inducing activation of both thalami [1]. For this reason, bilateral stimulation of the motor cortex is thought to induce a stronger analgesic effect compared to unilateral motor cortex stimulation by transcranial magnetic stimulation. Objective: To investigate the superiority of bilateral transcranial magnetic stimulation (TMS) over unilateral TMS of the motor cortex Study design: Double-blind, randomized controlled trial Study population: Patients that suffer from chronic orofacial pain and have not been treated (yet) with any form of neuromodulation. Intervention (if applicable): One group receives bilateral TMS whereas the other group receives unilateral TMS for one month. After one month, the groups switch treatment protocol. Main study parameters/endpoints: Modification in intensity of pain as measured using the VAS, the influence the relief of pain with regard to quality of life and daily activities using the McGill Pain Questionnaire. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Time investment of patients.

NCT ID: NCT03702530 Active, not recruiting - Clinical trials for Necator Americanus Infection

Immunisation, Treatment and Controlled Human Hookworm Infection

ITCHHI
Start date: December 17, 2018
Phase: N/A
Study type: Interventional

24 healthy volunteers will be immunized with three times 50 L3 larvae or placebo followed by treatment with albendazol and subsequently challenged with twice 50 L3 larvae.

NCT ID: NCT03665168 Active, not recruiting - Palliative Medicine Clinical Trials

A Multidimensional Strategy to Improve Quality of Life of Patients With Multiple Symptoms and Palliative Care Needs

MuSt-PC
Start date: September 1, 2018
Phase:
Study type: Observational

A nationwide, cross-sectional study, to determine the prevalence of symptoms of patients in the palliative phase in various care settings will be performed within a set period of two weeks in September 2018 and two weeks in November 2018. The participating settings will be selected by a total of seven coordinators, one for each consortium of palliative care in the Netherlands. To identify common combinations of symptoms and for multidimensional screening the Utrecht Symptom Diary-4 Dimensional (USD-4D) and Utrecht Symptom Diary (USD), a Dutch instrument based on the Edmonton Symptom Assessment Scale, will be used. The current protocol focuses on the cross-sectional study.

NCT ID: NCT03610035 Active, not recruiting - Amyloidosis Clinical Trials

A Study of NPT189 in Healthy Subjects

Start date: July 24, 2018
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the safety and tolerability of single dose of NPT189 in healthy volunteers. The study will also evaluate the pharmacokinetic characteristics of NPT189.

NCT ID: NCT03607903 Active, not recruiting - Pain Clinical Trials

Adalimumab Microneedles in Healthy Volunteers

Start date: July 11, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Adalimumab (Humira, AbbVie) is a highly effective treatment for a variety of auto-immune/auto-inflammatory diseases including juvenile idiopathic arthritis (JIA). Adalimumab works by binding to tumor necrosis factor alpha (TNF), hereby preventing its interaction with the TNF receptor. In the presence of complement, adalimumab can also lyse TNF-expressing cells. Adalimumab is administered via subcutaneous injection, which has the major drawback of being perceived as unpleasant and painful, especially during long term use for both adults and children. As subcutaneous administration may therefore eventually jeopardize treatment adherence, there is a clear need for less invasive alternatives to administer highly effective biological drugs such as adalimumab. Microneedles may be a potential alternative for invasive drug administration. Microneedles are currently widely investigated for the administration of various vaccines. The experience with administration of biological drugs is rather limited. The sparse available data suggests similar pharmacokinetics of adalimumab when administered either subcutaneous or intradermal in healthy volunteers. Moreover, the first studies report good tolerability of microneedles. However, no systematic studies have been performed yet i) to investigate pain, acceptability, and local tolerability for intradermal versus subcutaneous adalimumab administration ii) to evaluate safety, PK and immunogenicity for intradermal versus subcutaneous adalimumab and iii) to explore the usability of optical coherence tomography, clinical photography, thermal imaging and laser speckle contrast imaging in the evaluation of intradermal injections. This study will directly compare the pain perception and hence acceptability of a single dose (40 mg) of adalimumab administered subcutaneously (SC) versus intradermally (ID) via microneedles in healthy adult volunteers. Furthermore, the pharmacokinetic profile, pharmacodynamics, the immunogenicity and the tolerability will be assessed. This study will enable bridging to a future study in children and adolescents with JIA, in which the suitability of microneedles for the administration of adalimumab in pediatric patients will be examined. The overarching aim of these studies is to make administration of biologicals in children as pain free as possible.