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NCT ID: NCT03299686 Completed - Asthma Clinical Trials

Study to Assess the Efficacy and Safety of CJM112 in Patients With Inadequately Controlled Severe Asthma

Start date: November 6, 2017
Phase: Phase 2
Study type: Interventional

An unmet medical need exists for patients with moderate and severe asthma who continue to demonstrate symptoms despite being on standard of care medications, and are not eligible for other biologic therapies developed or in development for T2-high(allergic/eosinophilic) asthma. The purpose of this study was to determine if CJM112, an anti-IL-17A antibody, displayed the clinical efficacy and safety profile to support further development in patients with inadequately controlled moderate to severe asthma with low IgE and low circulating eosinophil levels.

NCT ID: NCT03293550 Completed - Delirium Clinical Trials

Can a New EEG Based Tool Predict Post-operative Delirium and Cognitive Dysfunction?

Start date: December 31, 2017
Phase:
Study type: Observational

As the population ages and medical progress is made, many elderly patients that previously would not have been candidates for surgery are now undergoing operations. In this group of older patients, brain dysfunction after anesthesia and surgery is well recognized and categorized into two distinct clinical entities; Post-operative cognitive delirium (POD) and post-operative cognitive dysfunction (POCD). Delirium is an acute and fluctuating deterioration in attention accompanied by either a change in cognition or arousal and is often diagnosed by criteria established in the Confusion Assessment Method (CAM). Delirium can present as hypoactive (decreased alertness, motor activity and anhedonia), as hyperactive (agitated and combative) or as mixed forms. Age and the type of operation are the major risk factors. Post-operative cognitive dysfunction (POCD) is a term used to describe subtle changes in cognition, such as memory and executive function. The most commonly seen problems are memory impairment and impaired performance on intellectual tasks. In severe cases, it can lead to inability to perform daily living functions. It was previously found that the presence of cognitive dysfunction 3 months after non-cardiac surgery was associated with an increased mortality. The mechanisms leading to cognitive impairment after anesthesia and surgery are not yet fully clear. The risk factors are related to patient characteristics, type of operation and anesthetic management. Despite its limitations over-anesthesia as monitored by BIS was at-least correlative with POD. Therefore it is hopeful that an even more precise evaluation of the level of anesthesia will improve POD prediction (and thereby prevention) even further. On the other hand the measure of depth of anesthesia by itself does not provide sufficient prediction for POCD. In POCD a major role has been assigned to hippocampal damage. The investigators have recently demonstrated that temporary hippocampal interruptions are manifested by interhemispheric desynchronization, which are recognized by our new algorithm, which monitors electrophysiological markers of attention and of perception. The investigators have developed a unique algorithm for analyzing EEG based on the concept of monitoring perception and attention and their interhemispheric synchronization. The aims of this proof of concept study are: (i) to find-out whether interhemispheric desynchronization of attentional processes is associated with POCD; (ii) to find out whether the level of anesthesia, is linked primary to POD and secondary to POCD.

NCT ID: NCT03290781 Completed - Ulcerative Colitis Clinical Trials

An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis

FIGARO UC 303
Start date: April 4, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

NCT ID: NCT03285776 Completed - Clinical trials for Developmental Coordination Disorder

Reliability and Validity of a Computerized Tool to Assess Proprioception Among Children With Coordination Disorders

Start date: December 5, 2017
Phase:
Study type: Observational

Coordination disorders are common among children that arrive to child development services. Children with coordination disorders have impaired proprioceptive sensation and motor planning. It is important to carry out a comprehensive assessment of these children in order to design an appropriate and effective treatment. There is a lack of an objective and standard assessment tools for proprioception and motor planning. Technology based assessment tools might offer a solution, as they enable automated and accurate measurement. The purpose of this study is to examine the validity and reliability of a new diagnostic computerized kit, which was developed for assessment of proprioception and motor planning among children with coordination disorders. The hypothesis includes: 1. Examine the construct validity of the new diagnostic computerized kit (the known group procedure). Whether there is a difference in the outcomes between children with typical development and children with coordination disorders. 2. Examine the construct validity of the new diagnostic computerized kit outcomes - correlation with the following associated variables: (a) motor skills; (b) sensory function; (c) participation in daily activities. 3. Examine of test-retest reliability of the new diagnostic computerized kit. Whether the outcomes are stable in repeated measurements. The participants will include fifty children between the ages of 5 to 7 years: 25 children with coordination disorders (study group), and 25 children with typical development (control group). Each child will arrive for an evaluation meeting that includes: (a) the new diagnostic computerized kit; (b) standard and routine tests for motor skills (Movement Assessment Battery for Children-2-MABC-2, and two sub-test of the Beery-Buktenica developmental test of visual-motor integration- Beery VMI). In addition, the children's parents will complete two questionnaires: (a) Sensory Processing Measurement (SPM) for sensory function assessment; (b) Participation in Childhood Occupations Questionnaire (PICO-Q) for daily participation assessment. After two weeks, ten children from the control group will be evaluated once again by the new diagnostic computerized kit for examine test-retest reliability.

NCT ID: NCT03284424 Completed - Clinical trials for Squamous Cell Carcinoma

Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629)

Start date: October 26, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in adult participants with recurrent or metastatic(R/M) cutaneous Squamous Cell Carcinoma (cSCC) or locally advanced (LA) unresectable cSCC that is not amenable to surgery and/or radiation and/or systemic therapies.

NCT ID: NCT03283085 Completed - Ulcerative Colitis Clinical Trials

A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

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

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)

NCT ID: NCT03279081 Completed - Crohn's Disease Clinical Trials

Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)

ADMIRE-CD-II
Start date: September 15, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the combined remission of complex perianal fistulas, defined as the clinical assessment at Week 24 of closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections greater than (>) 2 centimeter (cm) (in at least 2 dimensions) confirmed by blinded central magnetic resonance imaging (MRI) assessment at Week 24.

NCT ID: NCT03277690 Completed - Clinical trials for Endogenous Cushing's Syndrome

A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.

Start date: September 26, 2017
Phase: Phase 3
Study type: Interventional

This is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration study in subjects with endogenous Cushing's Syndrome (CS) previously treated with single-arm, open-label levoketoconazole that will assess efficacy, safety, tolerability, and pharmacokinetics of levoketoconazole.

NCT ID: NCT03277105 Completed - Multiple Myeloma Clinical Trials

A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma

Start date: October 27, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).

NCT ID: NCT03276689 Completed - Neuropathic Pain Clinical Trials

'Fix the Dysfunction' Concept for Mechanism-based Pharmacological Treatment of Neuropathic Pain by Drug

0381-16
Start date: October 19, 2017
Phase: N/A
Study type: Interventional

Introduction Treatment of neuropathic pain has been a goal of numerous research projects for the last half century, with overall disappointing results. These poor achievements are in contrast with substantial advancements in the understanding of pain mechanisms, and numerous molecules developed to tackle them. The need to better identify patients likely to respond to treatment comes from the neuropathic pain experts in regards to the pharmacological domain. The basic assertion of this project is that the pain modulation profile is altered in pain patients toward a pro-nociceptive mode, and that the specific single or multiple dysfunctions of pain modulation that underlie this pro-nociceptivity should be targeted by therapeutic lines that can reverse the modulation back toward eu-nociceptivity. The aim of this amendment is to demonstrate that pain treatment efficacy for painful diabetic neuropathy can be optimized by individualizing pharmacological treatment choice along 'fix the dysfunction' concept