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NCT ID: NCT03157557 Completed - Lifestyle Clinical Trials

Multidisciplinary Lifestyle-enhancing Treatment for People With Severe Mental Illness in Sheltered Housing Facilities

Start date: July 19, 2017
Phase: N/A
Study type: Interventional

Introduction and rationale: Unhealthy eating habits and lack of physical activity are risk factors for many diseases (including metabolic syndrome) and contribute to a shortened lifespan of 15-30 years in people with severe mental illness (SMI). Literature, mainly including short-term hospitalized or outpatients, show strong positive effects of activation on both physical and mental health. However, studies in long-term care are limited. In recent years, implementation of a lifestyle enhancing treatment intervention in clinical settings in "GGz Centraal" has demonstrated to be effective. The question is whether this kind of lifestyle intervention in sheltered housing is applicable and effective. Objectives: This research aims to develop an appropriate lifestyle intervention for patients living in sheltered housing services of GGz Centraal, based on input of patients and directly involved. Does applying this lifestyle treatment result in a positive effect in health and quality of life of patients and what is the influence of contextual factors, personal- and disease characteristics? Study design: In this intervention study, we use an experimental design. Municipal locations are paired based on the number of participants to generate equal cluster sizes. These paired clusters are randomly allocated to the control or intervention arm by means of a random number generator by an independent person (not involved in this project). At the start of the lifestyle treatment patients in the experimental and control group are invited to participate in the baseline screening. After twelve months, following a post-test on all outcome measures. Treatment intervention: The intervention in this study consists of formulating a lifestyle intervention, by patients and directly involved, aimed at enhancing a more active and healthier lifestyle . After formulation of the plan (based on psycho education, nutrition and physical activity), it wil be executed for a twelve month period. Hypothesis: Hypotheses is that lifestyle enhancing treatment is associated with improved metabolic health, quality of life and reduced use of medication. Furthermore we expect that movement disorders and disease severity will be negative related in becoming more active.

NCT ID: NCT03156738 Completed - Healthy Clinical Trials

A Clinical Study to Investigate How Safe and Tolerable the Study Drug MT-2990 is and How MT-2990 is Taken up by the Body in Healthy Volunteers

Start date: May 17, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and immunogenicity of MT-2990 in healthy male subjects.

NCT ID: NCT03156491 Completed - Clinical trials for Recurrent Miscarriages

Maternal Embryo Interaction in Recurrent Miscarriages

MEER
Start date: June 2010
Phase: N/A
Study type: Observational

Background of the study: The etiology of recurrent miscarriage (RM, defined as three or more consecutive miscarriages without any proven maternal or fetal cause), remains undiagnosed in more than 50% of cases. In these cases it is generally considered that a disturbance in the normal mother-embryo interactions is a causal factor. This disturbance may be based on a dysregulation of embryo invasiveness and/or decidual acceptance (e.g. altered decidualization; endometrial changes in preparation for the acceptance of a putative pregnancy). Moreover, dysfunctional maternal immune regulatory natural killer (NK) cells, implicated in tolerance induction and trophoblast invasion,may also underlie the occurrence of RM. The Selection Failure hypothesis for RM suggests that super-receptive endometrium (possibly due to increased embryo invasiveness and/or decidual acceptance and/or dysregulated immune cell function) may allow 'poor quality' embryos to implant and present as a clinical pregnancy before miscarrying. Fundamental knowledge on mechanisms of embryo implantation, decidual function and maternal immune reactivity in successful pregnancies has accumulated over the past 5 years. This study aims to investigate whether dysregulation of (one of) these mechanisms may underlie RM. Objective of the study: To test The Selection Failure hypothesis by assessing A) the degree of embryo invasiveness and decidual acceptance (the quality of decidualization, endometrium-embryo communication and endometrial stromal cell (ESC) migration) and B) the angiogenic capacity of decidual NK (dNK) cells, in order to elucidate the pattern of the mother-embryo equilibrium in women with RM.

NCT ID: NCT03156218 Recruiting - PaO2/FiO2 Ratio Clinical Trials

The Effect of FiO2 on PaO2/FiO2 Ratio

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

The PaO2/FiO2 ratio is frequently used to determine the severity of lung injury in mechanically ventilated patients. However, several mathematical models have shown that PaO2/FiO2 ratio depends on FiO2. The relationship is complex and depends on numerous physiological variables, including shunt fraction, and arterio-venous oxygen difference. The nonlinear relation between PaO2/FiO2 and FiO2 underlines the limitations describing the intensity of hypoxemia using PaO2/FiO2 and is thus of major importance for the clinician. Surprisingly, this relationship has only been assessed mathematically. Obviously, the accuracy of the mathematical relationship depends on the input variables used. The current study is designed to assess the PaO2/FiO2 vs FiO2 relation in mechanically ventilated patients without ARDS (n =10) and with mild or moderate ARDS (n =10). In order to explain the dependency of the PaO2/FiO2 on FiO2, shunt fraction and alveolar - arterial oxygen difference ((A-a)DO2) will be determined in these patients.

NCT ID: NCT03155997 Active, not recruiting - Breast Cancer Clinical Trials

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

monarchE
Start date: July 12, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.

NCT ID: NCT03154333 Terminated - Clinical trials for Epidermolysis Bullosa Simplex

Safety and Efficacy of Diacerein 1% Ointment for Subjects With Epidermolysis Bullosa Simplex (EBS)

Start date: June 1, 2017
Phase: Phase 2
Study type: Interventional

Epidermolysis bullosa simplex (EBS) is a rare genetic skin disease characterized by fragility of the skin and mucous membranes resulting in painful blisters and erosions after minor trauma. The purpose of this study is to compare the efficacy of diacerein 1% ointment to vehicle ointment when applied once-daily for 8 weeks in subjects with EBS.

NCT ID: NCT03153475 Active, not recruiting - Clinical trials for Revision Total Knee Arthroplasty

ATTUNE Revision System in the Revision Total Knee Arthroplasty Population

Start date: May 30, 2017
Phase: N/A
Study type: Interventional

Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in revision total knee arthroplasty.

NCT ID: NCT03153449 Recruiting - Clinical trials for Primary Knee Arthroplasty

ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population

Start date: September 19, 2017
Phase: N/A
Study type: Interventional

Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in complex primary total knee arthroplasty.

NCT ID: NCT03152734 Completed - Mortality Clinical Trials

Periinterventional Outcome Study in the Elderly

POSE
Start date: October 1, 2017
Phase:
Study type: Observational

The POSE study will predict critical stages and outcome in a large sample of all surgical and non-surgical interventional patients ≥80 years of age in Europe.

NCT ID: NCT03152552 Terminated - Clinical trials for Diabetes Mellitus and Heart Failure

A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure

Start date: July 25, 2017
Phase: Phase 2
Study type: Interventional

This was a dose-finding study to evaluate the efficacy, safety and tolerability of 3 different doses of LIK066 compared to placebo or empagliflozin in T2DM patients with heart failure