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NCT ID: NCT04594707 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis

STARSCAPE-OLE
Start date: August 30, 2021
Phase: Phase 3
Study type: Interventional

This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).

NCT ID: NCT04594694 Active, not recruiting - Clinical trials for Primary Biliary Cholangitis

Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC

Start date: October 2, 2019
Phase: Phase 2
Study type: Interventional

Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).

NCT ID: NCT04593394 Active, not recruiting - Asthma Chronic Clinical Trials

Inducible Laryngeal Obstruction in Severe Asthma in Severe Asthma

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

The first part will be a comparative cross-sectional study to identify the frequency of ILO and other comorbidites among participants with asthma compared to a group of reference subjects without asthma, matched for age- and gender and race. The second part will be a longitudinally observational study study following participants for one year after the cross-sectional study. The Maat-scores ILO-symptoms and asthma-outcomes longitudinally will be evaluated, .

NCT ID: NCT04593251 Completed - Celiac Disease Clinical Trials

Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis

Start date: September 28, 2020
Phase: Phase 1
Study type: Interventional

This is a single and multiple ascending study to characterize the safety, PK, PD and clinical effect in healthy volunteers and participants with Celiac Disease and Eosinophilic Esophagitis.

NCT ID: NCT04589650 Recruiting - Clinical trials for PIK3CA-related Overgrowth Spectrum (PROS)

Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum

EPIK-P2
Start date: April 19, 2021
Phase: Phase 2
Study type: Interventional

This is a prospective Phase II multi-center study with an upfront 16-week, randomized, double-blind, placebo-controlled period, and extension periods, to assess the efficacy, safety and pharmacokinetics of alpelisib in pediatric and adult participants with PIK3CA-related overgrowth spectrum (PROS).

NCT ID: NCT04588285 Recruiting - Clinical trials for Dementia With Lewy Bodies

Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial

ANeED
Start date: May 4, 2021
Phase: Phase 2
Study type: Interventional

This is a confirmatory investigational medicinal product (IMP) study to investigate the effects on cognition, functional decline and on neuropsychiatric symptoms of the Glucocerebrosidase (GCase) enhancing chaperone ambroxol in participants diagnosed with prodromal and early dementia with Lewybodies (DLB).

NCT ID: NCT04586933 Recruiting - Clinical trials for Rheumatoid Arthritis

Nutrition in Rheumatic Diseases

EROM
Start date: December 10, 2020
Phase: N/A
Study type: Interventional

Background: Patients with inflammatory rheumatic diseases (IRD) are prone to malnutrition for several reasons. The diseases and treatment can cause reduced intake and absorption of nutrients and the inflammatory processes may cause an increased demand for nutrients, especially proteins. Studies report that nutritional status can affect disease activity. Dietary supplement of 3-4 gram omega-3 has shown beneficial effect upon disease activity in patients with IRD. Aim: To investigate whether improved dietary intake with and without supplements of omega-3 will affect disease activity in patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA). Hypothesis 1: A systematic change of diet in line with the Norwegian dietary guidelines, which will result in increased intake of, among other nutrients, omega-3 fatty acids and complete protein, as well as reduced intake of saturated fat and sugar, will improve nutritional status and reduce disease activity. Hypothesis 2: A systematic change of diet (as above), included a high dose of omega-3 will further improve nutritional status and reduce disease activity compared with placebo. Design: A DB-RCT-study will be conducted. All patients will receive individualized dietary guidance by a clinical dietician for 12 weeks, before randomization to supplements of omega-3 or placebo, for 24 weeks. The supplement will be blinded for the participants, researchers and physicians. Clinical implications: The study will investigate the effect of improved diet and nutrition on treatment offered to patients with IRD to provide more evidence-based knowledge, and thus specific dietary guidelines for patients with IRD. In addition, the study might increase the understanding of the role of omega-3 in the pathogenesis of inflammation.

NCT ID: NCT04586868 Recruiting - Psychotic Disorders Clinical Trials

VR-assisted CBT for Adolescents With Psychosis

Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Psychotic disorders typically emerge during late adolescence or early adulthood. Patients, who are diagnosed with a psychotic disorder before turning 18 years, are defined as early onset psychosis patients (EOP). Relative to adult patients, these patients show a worse long-term prognoses. Social impairment present a major barrier towards recovery, and thus and important issue to address in treatment. Cognitive behavioral therapy (CBT) is the recommended psychological treatment for psychotic disorders. As part of the therapy, the patient does an exposure-based training in a social environment. This type of training has several limitations for patients with psychosis. The last decade there has been a growing interest in using virtual reality (VR) to understand and treat various psychological disorders. There is a lack of research on VR-interventions for EOP patients. This study will assess the acceptability, tolerability, feasibility and clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis.

NCT ID: NCT04586855 Completed - Healthy Persons Clinical Trials

Ultrasound Imaging of the Larynx and Diaphragm During NIV and Cough Assist

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

The study examines if diagnostic ultrasound imaging of larynx and diaphragm can be as accurate as transnasal fiberoptic laryngoscopy in visualizing the larynx during NIV and Mechanically Assisted Cough interventions.

NCT ID: NCT04585581 Active, not recruiting - Clinical trials for Gestational Diabetes

Preconception Lifestyle Interventions to Improve Future Metabolic Health (Before the Beginning)

Start date: November 6, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to investigate whether the combination of high intensity exercise and time restricted eating before and during pregnancy can reduce the risk of hyperglycaemia during pregnancy.