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NCT ID: NCT03385551 Completed - Clinical trials for Vulvovaginal Atrophy

Study to Evaluate Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

Start date: December 9, 2019
Phase:
Study type: Observational

This is a study to evaluate the acceptability, efficacy and preferences of 10 of estradiol vaginal tablets vs promestriene vaginal cream

NCT ID: NCT03384979 Completed - Clinical trials for Contrast Agent With Lean Body Weight

Optimization of Contrast Agent Dose in CT With Lean Body Weight

CA_LBW
Start date: December 18, 2017
Phase: Phase 4
Study type: Interventional

This study evaluates the different enhancement using a contrast agent dose in computed tomography based on total body weight or based on lean body weight. Half of participants will receive contrast agent dose based on their total body weight, while the other half will receive a dose based on their lean body weight. Our hypothesis is that if contrast agent is administered not basing on total body weight but on lean body weight it is possible to obtain equal or better quality of enhanced images, a reduction of the variability of contrast enhancement, and also a dose reduction in some patients (overweight ones).

NCT ID: NCT03384940 Completed - Colorectal Neoplasm Clinical Trials

DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)

Start date: February 23, 2018
Phase: Phase 2
Study type: Interventional

The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.

NCT ID: NCT03384654 Completed - Clinical trials for Precursor Cell Lymphoblastic Leukemia-Lymphoma

A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Start date: May 14, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL) and T-cell ALL/LL as measured by the complete response (CR) rate.

NCT ID: NCT03383549 Completed - Clinical trials for Mild Cognitive Impairment

Cognitive and Physical Home-rehabilitation by Information and Communications Technology. Games for Older Adults Active Life (GOAL)

GOAL
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Aging is often associated with pathological pathway such as in Mild Cognitive Impairment (MCI), and that pathway may be associated to a high risk of dementia. Tools for early identification of functional and cognitive decline and effectiveness of treatments in counteracting the loss of functionality to preserve MCI subjects autonomy, have been widely debated in recent years. In literature, the importance of combined cognitive and physical training is also recognized (Karssemeijer E, 2017). Moving from the above mentioned findings and considerations, the aim of GOAL project is to test a newly developed tele-rehabilitation platform to monitor and preserve functional and cognitive abilities in individuals affected by Mild Cognitive Impairment (MCI). Participants will be enrolled and randomly assigned to the tele-rehabilitation (GOAL group) or usual care program (control group). A dedicated application will be developed for the GOAL group. Thanks to the application, the participant will access different contents, such as serious games to train cognitive abilities (Anguera et al,2013) and physical training video lessons to endorse daily activity. Each participant of GOAL group will be provided with a tablet, with the application installed on it, and an internet connection (if needed).

NCT ID: NCT03382639 Completed - Schizophrenia Clinical Trials

A Study to Evaluate 3 Dose Levels of Luvadaxistat of Adults With Negative Symptoms of Schizophrenia

Start date: January 4, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether add-on luvadaxistat is superior to placebo on the Positive and Negative Syndrome Scale Negative Symptom Factor Score (PANSS NSFS).

NCT ID: NCT03382353 Completed - Clinical trials for Lifestyle Risk Reduction

EMuNI Project: Multiple Nonpharmacological Interventions

EMuNI
Start date: January 2016
Phase: N/A
Study type: Interventional

By 2030, the global prevalence of Alzheimer's Disease (AD) is predicted to reach 65.7 million worldwide. Despite extensive research efforts, a cure for AD has not been identified. Recent studies on non-demented individuals have demonstrated the importance of a healthy lifestyle (physical exercise, healthy diet) and non pharmacological interventions (diet supplements) to delay the onset of the cognitive decline (Vemuri P et al., 2012). Given that AD is a multi-factorial disorder, some multi- component interventions at early stages could be the best strategy currently available to delay the AD onset. The aim of this study is to investigate the effects of combined non-pharmacological interventions, at different levels of intensity, on cognitive performance, on basic (hippocampal, brain ventricle volumes and white matter lesions) and advanced magnetic resonance imaging (MRI) markers (Resting-state Functional MRI, Probabilistic Diffusion Tensor Tractography

NCT ID: NCT03380988 Completed - Clinical trials for Type 2 Diabetes Mellitus

Fiber-enriched Buckwheat Pasta and Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease

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

The intervention was preceded by a 1-week run-in period during which participants underwent continuous glucose monitoring (CGM) and filled in a 7-day dietary record to optimize basal infusion rate and insulin-to-glycemic load ratio. The study had a randomized crossover design with each subject studied on 2 occasions at least 1 week apart. Participants were assigned to consume, in random order, two test meals with the same amount of carbohydrates (50g): a meal containing fiber-enriched buckwheat pasta (FBP) or corn pasta (CP), used as control. Over the experimental period, participants underwent CGM, wearing their sensors 7 days/week.

NCT ID: NCT03380429 Completed - Asthma Clinical Trials

A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects

Start date: January 31, 2018
Phase: Phase 4
Study type: Interventional

GlaxoSmithKline (GSK) in collaboration with Propeller Health has developed a sensor, which can clip on to the ELLIPTA® dry powder inhaler (DPI) and monitor the time and date that the ELLIPTA DPI cover is fully opened and closed. Additionally, a sensor will be attached to the rescue medication metered dose inhaler (MDI). The data from both sensors will be fed back to the subject via an application (app) on smart phone and will be reviewed by the subject's health care professional (HCP) via an online dashboard. The sensors, app, dashboard and systems to provide data comprise the CIS. This study will be the first to evaluate the effect of CIS on adherence to maintenance therapy in subjects with uncontrolled asthma. This is an open-label, randomized, parallel group study in asthmatic subjects currently on a fixed dose inhaled corticosteroid (ICS)/long-acting beta 2 agonist (LABA) maintenance therapy. Eligible subjects will receive RELVAR®/BREO® maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers during the run-in period, which may last for up to 3 months. Eligible subjects will then be randomized into five treatment arms depending on whether the data, from RELVAR/BREO ELLIPTA or RELVAR/BREO ELLIPTA and salbutamol MDI, is fed back to the subject or subject and HCP, or not at all. The treatment period for the study is approximately 6 months and there will be a follow-up period one week post last visit. The total duration of a subject in the study will be approximately 9 months. RELVAR, BREO and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.

NCT ID: NCT03380416 Completed - NAFLD Clinical Trials

Effects of a Portfolio Diet on NAFLD in Type 2 Diabetic Patients

MEDEA
Start date: April 4, 2017
Phase: N/A
Study type: Interventional

Patients with type 2 diabetes and non-alcoholic fatty liver disease will be enrolled. According to a parallel design, the participants will be randomized to a Portfolio diet or a monounsaturated fatty acid (MUFA)-rich diet (used as control) for 8 weeks. At the beginning and at the end of the trial, the participants will undergo a MRI spectroscopy to evaluate fatty liver content. Moreover, the participants will undergo a test meal resembling the nutritional composition of the assigned diet to evaluate fasting and postprandial metabolic response.