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NCT ID: NCT03690206 Completed - Clinical trials for Short Bowel Syndrome

Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)

EASE SBS 1
Start date: October 4, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome. Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

NCT ID: NCT03689972 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration

Start date: November 27, 2018
Phase: Phase 3
Study type: Interventional

Part 1: The primary objective is to evaluate the efficacy of natalizumab extended interval dosing (EID) (every 6 weeks [Q6W]) in participants who have previously been treated with natalizumab standard interval dosing (SID) (every 4 weeks [Q4W]) for at least 12 months, in relation to continued Q4W treatment. The secondary objectives is to evaluate relapse-based clinical efficacy measures, disability worsening, additional Magnetic resonance imaging (MRI)-lesion efficacy measures and safety of Q6W in participants who have previously been treated with natalizumab Q4W for at least 12 months, in relation to continued Q4W treatment. Part 2: The primary objective is to evaluate participant preference for subcutaneous (SC) versus intravenous (IV) route of natalizumab administration. The secondary objectives is to evaluate treatment satisfaction, drug preparation and administration time, safety and immunogenicity, efficacy and characterize pharmacokinetic (PK) and pharmacodynamic (PD) drug preparation and administration time of SC versus IV routes of natalizumab administration.

NCT ID: NCT03688854 Completed - Stress Clinical Trials

The Role of Short Chain Fatty Acids in Microbiota-gut-brain Axis

SCFA-AP
Start date: January 4, 2018
Phase: N/A
Study type: Interventional

The role of short chain fatty acids (SCFA) in the microbiota-gut-brain axis is examined in a sample of healthy volunteers. SCFA are the major products of bacterial fermentation of dietary fiber in the colon, and are hypothesised to mediate the bidrectional communication between the gut and the residing microbiota on the one hand, and the central nervous system on the other hand. We perform a 1-week intervention with SCFA and measure their effects on a range of affective outcomes in healthy male volunteers.

NCT ID: NCT03688620 Completed - Influenza, Human Clinical Trials

Enhanced Safety Surveillance of GlaxoSmithKline's (GSK's) Quadrivalent Seasonal Influenza Vaccines During the 2018/19 Influenza Season

Start date: October 5, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this study is to comply with the European Medicines Agency (EMA) guidance on enhanced safety surveillance for seasonal influenza vaccines in the European Union (EU) and aims to assess adverse events of interest (AEIs) experienced within 7 days post vaccination with GSK's quadrivalent seasonal influenza vaccine (AlphaRix Tetra in Belgium; Influsplit Tetra in Germany, Fluarix Tetra in Spain). This study may help to inform decisions regarding future influenza vaccine safety surveillance for influenza vaccines in Europe.

NCT ID: NCT03688555 Completed - Clinical trials for Bilateral Nasal Polyposis

A Study to Evaluate the Effect of ACT-774312 in Subjects With Bilateral Nasal Polyposis

Start date: October 19, 2018
Phase: Phase 2
Study type: Interventional

The study will evaluate the effect of ACT-774312 on the nasal polyps and will assess the safety and tolerability of ACT-774312 in the patients with bilateral nasal polyposis

NCT ID: NCT03687749 Completed - Lymphedema Clinical Trials

Presentation of First Time Attenders at Lymphedema Clinics

Start date: February 1, 2017
Phase:
Study type: Observational

The first aim of this research project is to identify what factors motivate patients to seek assessment for early lymphedema and further, to gain insight into the signs and symptoms of developing lymphedema and the concurrent physical measurements. The second aim is to identify other sensory signs and symptoms and changes in body perception which may be perceived by the patient as reflective of lymphedema, and to identify to which degree they contribute to the patients' motivation to seek referral to lymphedema clinics.

NCT ID: NCT03685929 Completed - Pressure Ulcer Clinical Trials

Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis

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

This study aims to identify differences and similarities between superficial pressure ulcers (category II and III) and incontinence-associated dermatitis (category IIA) at tissue level. Skin biopsies will be obtained from 30 patients with pressure ulcers (n = 10), incontinence-associated dermatitis (n = 10), and combined lesions (n = 10). The results from the histopathologic examination will be compared with the clinical diagnosis by wound care experts, which will be based on photographs and relevant patients' characteristics.

NCT ID: NCT03684096 Completed - Breast Cancer Clinical Trials

Effect of Non-estrogenic Pollen Extract PCC-100 on Hot Flushes

Start date: October 15, 2018
Phase: N/A
Study type: Interventional

Many postmenopausal women have vasomotor symptoms during adjuvant hormonal treatment for breast cancer. PCC-100 is a pollen extract used for alleviation of postmenopausal symptoms. In a randomised, double blinded study pollen extract PCC-100 will be used to treat vasomotor complaints in postmenopausal women under adjuvant hormonal treatment and also in menopausal women without a history of breast cancer.

NCT ID: NCT03684044 Completed - Influenza Clinical Trials

Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza

Start date: January 8, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in hospitalized patients with influenza.

NCT ID: NCT03683576 Completed - Asthma Clinical Trials

GB001 in Adult Subjects With Moderate to Severe Asthma

Start date: October 22, 2018
Phase: Phase 2
Study type: Interventional

A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance therapy in adults with moderate to severe asthma and an eosinophilic phenotype with respect to asthma worsening at the end of 24 weeks of treatment.