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NCT ID: NCT03678987 Completed - Systemic Sclerosis Clinical Trials

Mycophenolate Mofetil Pharmacokinetics in Systemic Sclerosis

MMFSSC
Start date: September 13, 2018
Phase:
Study type: Observational

Drug of investigation: Mycophenolate mofetil (MMF), given orally as a tablet twice daily. Dosage of drug: This study recruits patients who have been prescribed a steady dose of MMF in the range between 1000 and 3000 mg daily by their physician. Design: This is an open-label PK study. Disease studied: Systemic sclerosis (SSC, scleroderma). Variables assessed: Estimated AUC0-12 for MMF. Gastrointestinal manifestations of SSc. Concomitant medication. Study population: Inclusion criteria: Diagnosis of SSC fulfilling the 2013 classification criteria for this disease. Participant should have been prescribed a stable dose of MMF tablets, taken twice daily, for at least 3 months prior to the study. Exclusion criteria: Failure to comply with study protocol. Limited access to repeated venous puncture. Recipient of organ transplant. Pulmonary arterial hypertension. Number of participants: The study aims at the inclusion of 35 subjects. Primary objective: To investigate the PK of orally ingested MMF in SSC. Secondary objectives: 1. To investigate how SSC manifested in the gastrointestinal (GI) tract may alter the PK of MMF. 2. To investigate how the PK of MMF in SSc is altered by medications often used in SSC, i.e. proton pump inhibitors (PPI), NSAID and calcium channel blockers.

NCT ID: NCT03677284 Active, not recruiting - Dementia Clinical Trials

Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia

MTD
Start date: September 30, 2018
Phase: N/A
Study type: Interventional

Sweden, like most countries, is undergoing population ageing. This is accompanied by an epidemiologic transition of equal importance, leading to a greater number of people than ever before affected by dementia. Dementia affects thinking, memory, behavior and ability to perform everyday activities, including daily time management. Time orientation and daily management has been shown to influence well-being in older people. There is evidence suggesting that time assistive products can have positive effects on the well-being of both primary users and informal care givers, but this is not sufficient to provide evidence-based guidance for effective interventions, nor to develop innovative and effective solutions. In order to contribute to the development and use of affordable and appropriate innovative assistive products and services for older people with mild or moderate dementia, the purposes of this project are to investigate and model the relationship between the use of time assistive products by older people with dementia, their daily time management and their well-being, and to devise strategies for the acceptance and use of such products by older people with dementia and informal caregivers. A mixed longitudinal approach will be used to attain the first purpose, while the second purpose will be accomplished by applying a qualitative method. Women and men aged 65 or older diagnosed with early or moderate dementia (n=74), and their significant others will be eligible for inclusion. Cooperation with researchers in India and Japan will generate a set of core data, which allows for cross-cultural comparisons of factors related to daily time management and well-being. The three-year project started September 2017, the main study in September 2018. This project can be expected to contribute important knowledge that can advance the effectiveness of cornerstone social policies such as support for ageing in place and healthy and active ageing, and the reduction of social exclusion of older people.

NCT ID: NCT03676686 Completed - Tinea Pedis Clinical Trials

Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis

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

A prospective, open post-market clinical investigation that will enroll male and female subjects diagnosed with foot fungus and at least one of the following conditions: heal cracks, calluses and/or dry feet. The investigation population will consist of 48 subjects fulfilling the eligibility criteria for the clinical investigation. The subjects will all be treated with the study product, Nåva Foot Cream. The duration of the investigation is estimated to 6 months, including a 2-month recruitment period and 2-month follow up period.

NCT ID: NCT03676283 Completed - Palliative Care Clinical Trials

Increasing Preparedness Through a Website

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Partners of patients with advanced cancer often take a great responsibility for the patient's care. They are often unprepared for a situation where they are faced both with the role as caregivers and with the patient's impending death. This project holds significant research questions on how to implement a web-based intervention and make it easily available to all those in need and prevent negative consequences related to caregiving and the loss of a partner. The project will study the effects of using a website for support and information. Instruments for measuring outcomes will be available both on paper or electronically. To obtain data for the main outcomes, preparedness for caregiving and for death, 200 partners will be recruited and receive access to the website. Preparedness for caregiving will be measured at baseline and four weeks later (pre- and post-intervention. Further, sem-structured interviews will be performed. Preparedness for death will be measured eight weeks after the patient's death. Because current trends point towards increased levels of home-care, web-based interventions could be a way to reach more partners in a more cost-effective way.

NCT ID: NCT03675464 Recruiting - Obesity Clinical Trials

Study of Human Adipose Tissue (LOSHAT)

LOSHAT
Start date: September 20, 2018
Phase:
Study type: Observational

The investigators will study the influence of initial fat cell size/number and adipose function (in particular lipolysis) on weight development over very long time periods (years). By comparing investigations of fat biopsies or blood samples obtained at baseline, the investigators will determine the association between adipose morphology/function and changes in weight or development of metabolic complications (e.g. metabolic syndrome, glucose intolerance, type 2 diabetes, dyslipidemia and hypertension).

NCT ID: NCT03675308 Active, not recruiting - Psoriatic Arthritis Clinical Trials

A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy

KEEPsAKE 1
Start date: March 25, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in participants with moderately to severely active psoriatic arthritis (PsA).

NCT ID: NCT03674190 Withdrawn - Disc Disease Lumbar Clinical Trials

A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement

Start date: September 4, 2018
Phase: N/A
Study type: Interventional

Total lumbar disc replacement has previously been compared to posterior fusion of the lumbar spine, showing some favor towards total disc replacement. The study aims to compare total disc replacement to anterior fusion, sparing the muscles of the back and thus comparing the two different methods using the same surgical approach.

NCT ID: NCT03674112 Completed - Clinical trials for HER2-Positive Early Breast Cancer

A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer

PHranceSCa
Start date: December 19, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase II, randomized, multicentre, multinational, open-label, cross-over study in adult patients who have completed neoadjuvant chemotherapy with neoadjuvant pertuzumab and trastuzumab and have undergone surgical treatment of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. The study will consist of two adjuvant treatment periods: a treatment cross-over period and a treatment continuation period. It will evaluate participant-reported preference for a subcutaneously administered fixed-dose combination formulation (FDC SC) of pertuzumab and trastuzumab compared with intravenously (IV) administered pertuzumab and trastuzumab formulations. The study will also evaluate participant-reported satisfaction with pertuzumab and trastuzumab FDC SC and health-related quality of life outcomes; healthcare professionals' perceptions of time/resource use and convenience of pertuzumab and trastuzumab FDC SC compared with pertuzumab and trastuzumab IV formulations; as well as the safety and efficacy of each study regimen.

NCT ID: NCT03674099 Recruiting - Multiple Sclerosis Clinical Trials

Imatinib for Multiple Sclerosis (MS) Relapses

Start date: October 1, 2018
Phase: Phase 2
Study type: Interventional

To investigate if treatment with Imatinib results in a better outcome than standard care in form of Methylprednisolone(MP) after MS-associated relapses.

NCT ID: NCT03673501 Active, not recruiting - Clinical trials for Gastrointestinal Stromal Tumors

A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib

INTRIGUE
Start date: February 8, 2019
Phase: Phase 3
Study type: Interventional

This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of ripretinib to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to ripretinib 150 mg once daily (continuous dosing for 6 week cycles) or sunitinib 50 mg once daily (6 week cycles, 4 weeks on, 2 weeks off).