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NCT ID: NCT02709395 Completed - Neurogenic Bowel Clinical Trials

Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart

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

This study is designed as an open, prospective, single arm, multicenter study in order to investigate patient satisfaction, perception and compliance for the novel Navina Smart, a transanal irrigation (TAI) system. Approximately 30 male and female subjects who are currently practicing TAI, will be followed during a 4-week period of use of Navina Smart. Observational data on satisfaction, perception, compliance, bowel regimen, TAI therapy and TAI frequency will be collected via patient reported outcome (PRO) questionnaires.

NCT ID: NCT02708498 Completed - Ageing Clinical Trials

Implementation of Knowledge-Based Palliative Care

KUPA
Start date: April 9, 2015
Phase: N/A
Study type: Interventional

The research on ageing during the last couple of decades has increasingly focused on questions regarding the quality of life and life satisfaction of the old people. Yet the research indicates that when it comes to the final stage of life, the end includes unnecessary suffering and the quality of life drops. Palliative care has traditionally been provided successfully to younger persons dying from incurable illnesses while older people dying of multiple morbidities or "old age" has received far less of this type of care. However, sixty percent of all people who died in Sweden in 2010 were at least 80 years old and it is well known that dying among older people often is a prolonged period of suffering. One reason might be that it is more difficult to identify when the final stages of life begins for older persons. The purpose of this project is to implement and evaluate how a knowledge-based model for palliative care in nursing homes affects the quality of life and the participation in the care process for older persons in nursing homes and their next of kin. A second aim is to explore the staff's implementation process of palliative care and the role of the leadership. The final aim is to investigate which factors (barriers and facilitators) that affect the implementation process of this model.

NCT ID: NCT02707640 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)

Start date: August 2013
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled safety and tolerability study of N-acetylcysteine or placebo in participants with mild to moderate idiopathic pulmonary fibrosis (IPF) receiving background pirfenidone therapy.

NCT ID: NCT02706847 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs

SELECT-BEYOND
Start date: March 15, 2016
Phase: Phase 3
Study type: Interventional

The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD. The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.

NCT ID: NCT02702388 Completed - Thyroid Cancer Clinical Trials

A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile

Start date: June 8, 2017
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind study being conducted as a postmarketing requirement to the US Food and Drug Administration (FDA) to evaluate whether there is a lower starting dosage of lenvatinib 24 mg once daily (QD) that provides comparable efficacy but has a better safety profile in participants with radioiodine-refractory differentiated thyroid cancer RR-DTC with radiographic evidence of disease progression within the prior 12 months.

NCT ID: NCT02702037 Completed - Malnutrition Clinical Trials

Older Person's Exercise and Nutrition Study

OPEN
Start date: March 1, 2016
Phase: N/A
Study type: Interventional

The novelty with the OPEN study is to evaluate the effects of the simple sit-to-stand exercise during routine care, in combination with an oral protein-rich supplement, on functional status and independence in frail older persons. In this study we will also explore the experiences among older persons in the intervention group as wells as among staff of promoting the sit-to-stand exercise and nutritional supplement to gain knowledge for implementation as a daily routine in nursing homes across Sweden. Hypothesis The main hypothesis of the OPEN study is that physical exercise performed as a daily routine along with an oral protein-rich supplement, will result in improved functional status and independence in everyday life activities and thereby enhance health-related quality of life in older persons living in nursing homes. The primary outcome measure for functional status will be the number of sit-to-stands that the participant is able to complete in 30 seconds. Specific aims Aim I: To study the effects of the sit-to-stand exercise combined with an oral protein-rich supplement on functional and nutritional status, and health-related quality of life, and the frequency and incidence of falls, pressure ulcers and incontinence in older persons living in nursing homes. Furthermore, the cost effectiveness of the combination of the sit to stand exercise and oral protein-rich supplement vs. the control group will also be examined. Aim II: To describe the older persons' perceptions of daily being offered to conduct the sit-to-stand exercise and to drink the nutritional supplement. Aim III: To describe staff's perceptions of supporting the sit-to-stand exercise and the nutritional supplement with older persons living in nursing homes.

NCT ID: NCT02699879 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Start date: February 16, 2012
Phase: N/A
Study type: Observational

This single arm, post-authorisation study is designed to evaluate the long-term safety of pirfenidone in participants with IPF. The enrolment of participants will be completed within approximately 24 months. Participants will receive pirfenidone according to the physician discretion and will be followed for 2 years. Treating physicians will collect pre-specified data at the baseline and every 3 months thereafter, for the duration of the participants' participation in study.

NCT ID: NCT02699424 Completed - Clinical trials for Relapsed Prostate Cancer

Prospective Evaluation of 68-Ga-prostate Specific Membrane Antigen (PSMA)-Positron Emission Tomograph (PET) and Early Prostatic Specific Antigen (PSA) Kinetics During Salvage Radiotherapy for Personalizing the Management of Men With Relapse of Prostate Cancer After Radical Prostatectomy

PROPER
Start date: March 2016
Phase: N/A
Study type: Interventional

This is an open-label, phase II trial in patients with PSA recurrence after prostatectomy. Patients entering the study will all receive initial 50 Gray (Gy) radiotherapy (25 x 2Gy) to the prostate bed and thereafter be classified as either responders or non-responders depending on PSA response at fifth week of radiotherapy. A 68-Ga- PSMA-PET is done before start of radiotherapy, and analyzed before fifth treatment week in order to identify cancer lesions in patients with poor PSA response. Patients with PSA response after 5 weeks of radiotherapy will not receive any subsequent therapy, whilst patients with poor PSA response may be in need for additional therapy such as radiotherapy to lymph node metastases and/or boost fractions to local recurrence. Patients with more than 3 lymph node metastases or distant metastases will not receive any more radiotherapy, but individualized systemic therapy will be started.

NCT ID: NCT02698020 Completed - Oxidative Stress Clinical Trials

Optimized Oxygen Delivery During General Anesthesia in Newborn Infants

ANOXneo
Start date: November 2015
Phase: N/A
Study type: Interventional

An open randomized control trial investigating the delivery of two levels of inspired oxygen to newborn infants during general anesthesia.

NCT ID: NCT02697630 Completed - Clinical trials for Metastatic Uveal Melanoma

Efficacy Study of Pembrolizumab With Entinostat to Treat Metastatic Melanoma of the Eye

PEMDAC
Start date: February 21, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see if the combination of entinostat and pembrolizumab can be an effective treatment for patients with melanoma of the eye (uveal melanoma) that has spread to other sites of the body (metastatic disease). Pembrolizumab is an antibody that helps the immune system to attack cancer cells. Although pembrolizumab has proven clinical efficacy in treating patients with metastatic cutaneous melanoma, an effect on metastatic uveal melanoma has not been established. Entinostat is a histone deacetylase (HDAC) inhibitor that has effects on both cancer cells and immune regulatory cells, thus potentially enhancing the effects of immunotherapy.