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NCT ID: NCT03444220 Completed - Clinical trials for Scleroderma, Systemic

Gut Microbiota Transplantation in Systemic Sclerosis

ReSScue
Start date: January 18, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Systemic Sclerosis (SSc) is a progressive multi-organ disorder with high disease burden. Life expectancy in SSc is reduced by 25-40 years, mainly due to cardiopulmonary and gastro-intestinal (GI) disease involvement; and a very poor response to available treatment. Aiming to improve treatment for SSc, the ReSScue project will determine the therapeutic potential of standardized, cultivated gut microbiome transplantation (GMT), and assess the mechanisms by which this novel intervention strategy works. This approach is rationalized by studies indicating that skewed gut microbiomes could act as major, environmental risk factors in SSc; and thereby be rational targets for therapeutic manipulation. ReSScue is set up as a 4 months randomized double blind trial involving the University Hospital in Oslo. Trial participants will be recruited from the population-based, nationwide SSc cohort. Intervention will be by GMT or placebo. Primary end point is changes in SSc-related GI parameters , while secondary outcomes include safety, explorative clinical parameters, changes in oral, skin and gut microbiomes, and in immune cell phenotypes.

NCT ID: NCT03444181 Active, not recruiting - Alzheimer Disease Clinical Trials

ALzheimer and MUsic THerapy: Effects of Music Lessons on Brain Plasticity, Mood, and Quality of Life in Alzheimer Patients

ALMUTH
Start date: April 11, 2018
Phase: N/A
Study type: Interventional

Music has powerful effects on memory in patients with neurodegenerative diseases. However, although there is anecdotal evidence for beneficial effects of active music interventions in patients with Alzheimer's disease (AD), there is lack of high-quality research investigating this issue, and the cognitive, emotional, and social factors that contribute to potentially beneficial effects of music making in AD patients are largely unknown. In a randomised controlled intervention trial, a cohort of AD patients will undergo twelve months of music lessons specifically tailored for AD patients. Structural and functional magnetic resonance imaging (MRI) will be used to determine changes in brain age (as compared to two control groups), and voxel-based morphometry will be computed to determine contributions of different factors of the music intervention (cognitive, emotional, and social) to plastic changes of brain morphology, and a potential deceleration of brain atrophy. In addition, quality of life of patients. In cooperation with the Bergen municipality, and a strong network of national and international partners, the neurocognitive music therapy will be implemented, involving training of music therapists, and communication of results to patients, patient groups, and therapists.

NCT ID: NCT03443856 Active, not recruiting - Clinical trials for Gastric and Esophagogastric Junction Adenocarcinoma

Postoperative Immunotherapy vs Standard Chemotherapy for Gastric Cancer With High Risk for Recurrence

VESTIGE
Start date: July 17, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of the trial is to investigate if nivolumab plus ipilimumab given as adjuvant treatment improve disease free survival (DFS) in patients with stage Ib-IVa gastric and esophagogastric junction adenocarcinoma and high risk of recurrence (defined by ypN1-3 and/or R1 status) following neoadjuvant chemotherapy and resection. Other study objectives: - To investigate the safety and effect of adjuvant immunotherapy on long term oncologic outcomes and quality of life of patients in the study - To correlate nutritional status assessment on outcomes and quality of life of patients

NCT ID: NCT03440879 Terminated - Prostate Cancer Clinical Trials

Androgen Deprivation Therapy Muscle Protein Metabolism and Blood Glucose

Start date: September 21, 2018
Phase: N/A
Study type: Interventional

Prostate cancer (PCa) patients receiving androgen deprivation therapy (ADT) (e.g., Zoladex), experience troublesome side effects during and after treatment (e.g., loss of lean body mass (LBM) and increased fat mass). Although the negative effects of ADT on muscle mass are well documented, the cellular effects of ADT on muscle tissue are still largely unknown, and studies investigating the mechanisms are highly warranted. Furthermore, understanding the cellular mechanisms through which ADT negatively influences muscle mass and glucose metabolism is important so that appropriate measures can be taken to counteract muscle wasting and comorbidities during ADT. Thus, PCa patients on ADT (Zoladex), along with non-ADT treated PCa patients serving as controls, will be invited to participate in this study, that aims to investigate the influence of ADT on the basal muscle protein turnover, as well as the responses to strength training. Secondary aims are to investigate between-group differences in blood glucose and insulin responses following a meal).

NCT ID: NCT03440190 Recruiting - Obesity, Morbid Clinical Trials

Bariatric Surgery and Pharmacokinetics of Methylphenidate

Start date: January 2, 2018
Phase:
Study type: Observational

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on methylphenidate.

NCT ID: NCT03440177 Recruiting - Obesity, Morbid Clinical Trials

Bariatric Surgery and Pharmacokinetics of Ramipril

Start date: January 2, 2018
Phase:
Study type: Observational

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on ramipril.

NCT ID: NCT03439514 Terminated - Clinical trials for Dilated Cardiomyopathy

A Study of ARRY-371797 (PF-07265803) in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation

REALM-DCM
Start date: April 17, 2018
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled study in patients with dilated cardiomyopathy (DCM) due to a mutation of the gene encoding the lamin A/C protein (LMNA). The study will further evaluate a dose level of study drug (ARRY-371797) that has shown preliminary efficacy and safety in this patient population. After the primary analysis has been performed, eligible patients may receive open-label treatment with ARRY-371797.

NCT ID: NCT03438578 Completed - Pain, Postoperative Clinical Trials

Efficacy Safety Score in Postoperative Management

Start date: March 5, 2018
Phase: N/A
Study type: Interventional

The primary aim of this project is to determine whether postoperative patients may benefit from the Efficacy Safety Score (ESS) as a tool for postoperative clinical decision support, with a special focus on the first 24 hours after discharge from the postoperative care unit.

NCT ID: NCT03437863 Completed - Chronic Disease Clinical Trials

Feasibility of a Mobile Application to Support Reflection and Dialog About Strengths in People With Chronic Illness

Start date: April 18, 2018
Phase: N/A
Study type: Interventional

Self-management of chronic illness can be highly demanding and people need to mobilize their personal strengths in order to live well with their condition. A mobile application was designed in collaboration with people with chronic illness and health care providers with the aims to support awareness of patients' strengths and patient-provider dialogues that include strengths. The aim of the present study is to evaluate with mixed methods the perceived usefulness and usability of the application and potential effects of the application on patients.

NCT ID: NCT03437187 Completed - Cholecystectomy Clinical Trials

The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy

Start date: January 20, 2018
Phase: N/A
Study type: Interventional

The enhanced recovery after surgery and laparoscopic approach is essential after day-case surgery. The patients want to go home early without pain and nausea, and the hospitals need the post-operative capacity for more patients. Many patients have pains, nausea and vomiting postoperatively. Postoperative pain is an expected but undesirable effect after an operation. The aim of the study is to find out if a bilateral quadratus lumborum block has a beneficial effect after a cholecystectomy.