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NCT ID: NCT02634749 Completed - Infant Development Clinical Trials

OTIS - Optimized Complementary Feeding Study

OTIS
Start date: April 1, 2015
Phase: N/A
Study type: Interventional

Dietary factors during infancy, e.g. high intakes of protein, fast carbohydrates and saturated fat increase the risk of adult obesity, type 2 diabetes and hypertension. However, current dietary recommendations to infants are based on traditions and experiences whereas research is basically lacking. Towards the end of the first year of life the infant will normally become increasingly suspicious towards fruits and vegetables. However, these foods are an important part of healthy eating. When and how these food items should be introduced into the diet of young children is unclear. New Nordic Diet, an initiative from the Nordic Council of Ministers calls for a larger intake of fruits, vegetables, whole grain, fish and game. In adults such diet improves weight and biomarkers of insulin resistance and cardiovascular disease. Since dietary preferences are founded early in life it is logical to introduce such a diet already when the child is starting complementary foods. In a randomized controlled study from 6 mo of age, we want to explore if a Nordic complementary diet with lower protein intake, more vegetable fats and a systematic introduction of fruits and greens will improve body composition, metabolic biomarkers, the composition of faecal microbiota (associated with obesity), cognitive development and the consumption of foods that can lay the foundation for better long-term diet. If the study has the expected results, these will have a direct impact on the dietary habits of Swedish children during infancy and childhood and thus their long-term health.

NCT ID: NCT02632890 Completed - Clinical trials for Rheumatoid Arthritis

Assessment of the Effectiveness of IV and SC Abatacept (Orencia) Patient Alert Cards in Patients With Rheumatoid Arthritis in a Sample of EU Countries

Start date: November 29, 2016
Phase: N/A
Study type: Observational

The purpose of the study is to determine a) if the implementation of abatacept (Orencia®) patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.

NCT ID: NCT02632409 Active, not recruiting - Clinical trials for Various Advanced Cancer

An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer

CheckMate 274
Start date: March 22, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.

NCT ID: NCT02631993 Completed - AML Clinical Trials

Photochemotherapy and Graft-versus-leukemia in Acute-leukemia

Start date: October 2014
Phase: N/A
Study type: Observational

Cure of leukemia after hematopoietic stem cell transplantation (HSCT) is sustained by the anti-leukemic effect of the grafted cells (graft-versus-leukemia (GVL)). However, it is not known whether the tumor-immunity is affected by photochemotherapy (psoralene photosensitization and ultraviolet light radiation) administered to attenuate graft-versus host disease (GVHD). The present study aim to investigate what happens to the GVL after photochemotherapy of aGVHD in a predominantly retrospective setting with 10-years follow-up after HSCT

NCT ID: NCT02631538 Completed - Sjogren's Syndrome Clinical Trials

Safety and Efficacy Study of Subcutaneous Belimumab and Intravenous Rituximab Co-administration in Subjects With Primary Sjogren's Syndrome

Start date: February 17, 2016
Phase: Phase 2
Study type: Interventional

This study is a multi-national, multi-center, double-blind (sponsor open), randomized, placebo-controlled trial in subjects with active primary Sjögren's syndrome designed to understand the safety and tolerability profile of belimumab/ rituximab co-administration and of belimumab monotherapy; and to evaluate whether either co-administration therapy or belimumab monotherapy has a substantive effect on disease activity. This study will consist screening period, double blind treatment period, a general follow-up period and individualized follow-up period. Approximately 70 subjects will be recruited into the study initially. At Day 0, subjects will be randomized 1:2:2:2 to one of the four treatment arms placebo arm, belimumab monotherapy arm, co-administration therapy arm and rituximab monotherapy arm. Once a sufficient number of subjects have completed the Week 24, interim analyses and sample size re-estimation will be conducted. The total number of subjects randomized may increase following sample size re-estimation up to a maximum of 120 recruited into the study. Subjects in all arms will receive investigational product (IP) until Week 52 (completion of the treatment phase). All subjects will enter a 16-week general follow-up period after the Week 52 visit or after discontinuation if a subject discontinues IP and withdraws from the treatment phase visits prior to Week 52. After completing the general follow-up period, subjects with cluster of differentiation (CD)19+ B-cell levels below the lower limit of normal (or less than 90 percent [%] of baseline, if baseline value was below lower limit of normal [LLN]) will enter an individualized safety follow-up phase and return to the clinic for visits every 12 weeks with monthly calls between visits to evaluate subjects for any serious adverse events (SAEs) related to IP or study participation, fatal SAEs, and designated adverse event of special interests (AESIs) (i.e., infections, malignancies, or depression, suicide/self-injury), and to check concomitant medications. The total duration of participation of a subject in this study will be approximately up to a maximum of 2 years (i.e., up to Week 104).

NCT ID: NCT02631512 Completed - Clinical trials for Diabetic Foot Ulcers

Evaluation of Woulgan in Diabetic Foot Ulcer

Start date: October 2015
Phase: Phase 4
Study type: Interventional

The aim of the current study is to support the performance and safety of Woulgan® in the treatment of diabetic foot ulcer in comparison with the commercially available hydrogel Intrasite. Healing and untoward medical events to be evaluated.

NCT ID: NCT02631447 Completed - Metastatic Melanoma Clinical Trials

Sequential Combo Immuno and Target Therapy (SECOMBIT) Study

SECOMBIT
Start date: November 14, 2016
Phase: Phase 2
Study type: Interventional

To evaluate the best sequencing approach with the combination of target agents (LGX818 plus MEK162) and the combination of immunomodulatory antibodies (ipilimumab plus nivolumab) in patients with metastatic melanoma and BRAF V600 mutation.

NCT ID: NCT02631070 Completed - Clinical trials for Myelodysplastic Syndromes

A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes

MEDALIST
Start date: February 9, 2016
Phase: Phase 3
Study type: Interventional

The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in participants with anemia due to the Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate MDS with ring sideroblasts who require red blood cell (RBC) transfusions.

NCT ID: NCT02630875 Completed - Clinical trials for Pediatric Cholestasis

A4250, an IBAT Inhibitor in Pediatric Cholestasis

Start date: August 2015
Phase: Phase 2
Study type: Interventional

This study will evaluate A4250 (IBATinhibitor) as a treatment option in pediatric patients with chronic cholestasis with main emphasis on safety evaluation and on effects on pruritus

NCT ID: NCT02630654 Completed - Clinical trials for Gastroenteropancreatic Neuroendocrine Tumors

Study For Evaluating The Value Of A Multi Biomarker Approach In Metastatic GEP NETs

EXPLAIN
Start date: March 24, 2014
Phase:
Study type: Observational

This exploratory study aims to evaluate the diagnostic, prognostic and response predictive value of a multi biomarker strategy in patients with Gastroenteropancreatic Neuroendocrine Tumors (GEP NETs) originating from the midgut or pancreas. Using a recently developed methodology enabling the evaluation of 92 concomitant cancer biomarkers will provide an interesting approach to solve this question (Lundberg et al 2011).