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NCT ID: NCT02207634 Completed - Dyslipidemia Clinical Trials

Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects

EBBINGHAUS
Start date: September 10, 2014
Phase: Phase 3
Study type: Interventional

This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.

NCT ID: NCT02205359 Completed - Clinical trials for Heart Failure With Left Bundle Branch Block

AdaptResponse Clinical Trial

Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).

NCT ID: NCT02205047 Active, not recruiting - Clinical trials for Malignant Neoplasm of Stomach

Neoadjuvant Study Using Trastuzumab or Trastuzumab With Pertuzumab in Gastric or Gastroesophageal Junction Adenocarcinoma

INNOVATION
Start date: July 15, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out whether either trastuzumab or the combination of trastuzumab and pertuzumab with standard chemotherapy shows more activity against gastro-oesophageal adenocarcinoma than standard chemotherapy given before and after surgery and it can be safely administered.

NCT ID: NCT02203331 Completed - Endometriosis Clinical Trials

Bay98-7196, Dose Finding / POC Study

Start date: October 16, 2014
Phase: Phase 2
Study type: Interventional

Purpose of the study is to test efficacy and safety of BAY98-7196 intravaginal ring as a new treatment option for patients with endometriosis-associated pelvic pain

NCT ID: NCT02201719 Completed - Adenomyosis Clinical Trials

Norwegian Adenomyosis Study I

NAPPED I
Start date: July 2014
Phase: N/A
Study type: Observational

Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population. The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Subfertility and infertility have been correlated with adenomyosis. Parity, age and uterine abrasion increase the risk of adenomyosis. Hormonal factors such as local hyperestrogenism and elevated levels of prolactin have been identified, but autoimmune and mechanical factors are also hypothesized. Regarding treatment, the most effective measure is hysterectomy. As this is a very drastic measure in younger women, levonogestrel-releasing intrauterine devices, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried, but studies are few in number, retrospective, and have small sample sizes. Adenomyosis has so far not been subject to extensive research efforts. The pathogenesis of adenomyosis remains still unclear, there are not many satisfying treatment options and diagnostics include mostly magnetic resonance imaging (MRI) and histology. The investigators designed a series of 3 studies with a broad approach in understanding adenomyosis. This is part 1. NAPPED-1: comparison of 3D-transvaginal ultrasound with MRI and histology in the diagnostic of adenomyosis

NCT ID: NCT02200692 Completed - Allergy Clinical Trials

Allergic Transfusion Reactions in Plasma Transfusion

Start date: June 2014
Phase:
Study type: Observational

Allergic transfusion reactions are a common complication of transfusion by blood components containing plasma. This study aims to investigate passive transfer of Immunoglobin E antibodies as a risk factor of allergic reactions to plasma transfusion by use of Solvent Detergent plasma.

NCT ID: NCT02197936 Terminated - Infertility Clinical Trials

Norwegian Adenomyosis Study III: Peristalsis

NAPPEDIII
Start date: July 2014
Phase:
Study type: Observational

Spontaneous contractions (peristalsis) of the non-pregnant uterus is widely investigated and the role of correct peristalsis is most important for correct sperm transport towards the fallopian tubes and implantation of the embryo, thus obtaining pregnancy. At the same time, an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and may also account for heavy menstrual bleedings and menstrual pain. In this study, the uterine peristalsis of women with adenomyosis will be investigated. This condition is associated to heavy menstrual bleeding, menstrual pain and infertility.

NCT ID: NCT02197923 Active, not recruiting - Adenomyosis Clinical Trials

Norwegian Adenomyosis Study II: Gene Expression Profiling of Adenomyosis

NAPPED II
Start date: August 6, 2014
Phase:
Study type: Observational

Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population. The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Subfertility and infertility have been correlated with adenomyosis. Parity, age and uterine abrasion increase the risk of adenomyosis. Hormonal factors such as local hyperestrogenism and elevated levels of prolactin (PRL) have been identified, but autoimmune and mechanical factors are also hypothesized. Regarding treatment, the most effective measure is hysterectomy. As this is a very drastic measure in younger women, levonogestrel-releasing intrauterine devices, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried, but studies are few in number, retrospective, and have small sample sizes. Adenomyosis has so far not been subject to extensive research efforts. The pathogenesis of adenomyosis remains still unclear, there are not many satisfying treatment options and diagnostics include mostly magnetic resonance imaging (MRI) and histology. The investigators designed a series of 3 studies with a broad approach in understanding adenomyosis. This is part 2. In this study the investigators take both tissue samples and blood samples that will be investigated in order to understand the basic processes leading to adenomyosis.

NCT ID: NCT02197468 Completed - Clinical trials for Mixed Flora; Infection

Preterm Infant Gut (PINGU) - a Norwegian Multi Centre Study

PINGU
Start date: March 2015
Phase:
Study type: Observational [Patient Registry]

Necrotizing enterocolitis (NEC) is a leading cause of morbidity and mortality among infants in the neonatal intensive care unit (NICU). It has been postulated that abnormal colonization of the preterm gut, or an unfavorable balance between gut bacteria may contribute to the development of NEC. Recent clinical randomized studies and meta-analysis have shown that proactive colonization of probiotic bacteria reduce the frequency of NEC. Based on this evidence, in April 2014 all Norwegian NICUs started routinely administration of probiotics to all extremely premature neonates susceptible to NEC (gestational age <28 weeks/birth weight <1000g). The current project is investigating the gut microbiome in patients receiving probiotics and compare the the gut microbiome with moderate premature infants not receiving probiotics. In addition, we are including a control of healthy full-term infants. Samples containing feces from participants will be analyzed by state of the art whole-genome sequencing techniques. Bacterial diversity will be analysed with bioinformatic tools. Study hypotheses: - Probiotics given to extremely preterm infants will change the biodiversity of the gut microflora. - Antibiotics given to these patients may influence the gut microflora also in infants receiving probiotics. In particular use of vancomycin may change the gut flora. - After cessation of probiotic prophylaxis the gut flora of infants receiving probiotics will gradually resemble the gut flora of infants not receiving probiotics. - A cross-contamination of probiotic bacteria between patients treated with probiotics and patients not treated with antibiotics may occur.

NCT ID: NCT02197416 Completed - Clinical trials for Venous Thromboembolism

Safety of Dabigatran Etexilate in Blood Clot Prevention in Children

Start date: September 29, 2014
Phase: Phase 3
Study type: Interventional

This open-label, single arm prospective cohort study will assess the safety of dabigatran etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children from 0 to less than 18 years of age will be eligible to participate.