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NCT ID: NCT03768674 Completed - Clinical trials for Cognitive Impairment

Extreme Challenges - Psychopathology & Treatment Experiences Among Severly Selfharming Inpatients in Norway

Start date: October 1, 2019
Phase:
Study type: Observational

Patients who self-harm are a heterogeneous population. Outpatient treatments structured for borderline personality disorder are often recommended and hospitalization kept to a minimum. However, few studies have focused on the most severe, complex conditions with extreme suicide risk. A recent national investigation from Norway (2017) demonstrated a far larger cohort of extensively hospitalized inpatients with extreme self-harming behaviors than was expected (N=427) - identified in all health regions. Reported challenges were high-risk situations, severe medical sequelae, difficult collaborations across services, and uncertainty about psychiatric diagnoses. Severe, often bizarre, self-harm is thus a major challenge for both patients and health services. In hospitals, safety measures can involve restrictions and involuntary regimes. As research on this target population is sparse, the current project seeks further understanding of complex conditions - psychopathology, treatment experiences and service collaboration. The project is a national, multi-center cooperation including patients in psychiatric hospitals in all health regions. It is cross sectional. Data is based on diagnostic interviews, patients' self-reported symptoms and both patients and service providers treatment experiences. The inclusion period for inpatients (N=300) and a comparison sample of outpatients (N=300) is one year. The target group is inpatients with extreme hospitalization and severe self-mutilation. A comparison group is patients with personality pathology attending outpatient treatments. Recruitment is across health regions. Aim 1: Investigate psychopathology of patients in the target population and compare to a clinical sample admitted to outpatient treatment Aim 2: Investigate personality functioning in the target population and compare to a clinical sample admitted to outpatient treatment Aim 3: a) Investigate health service use in the target population and compare to a clinical sample admitted to outpatient treatment. b) Investigate treatment experiences and health service collaborations in the target population. The project will provide rational for future preventive treatment interventions

NCT ID: NCT03768063 Recruiting - Cancer Clinical Trials

A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

IMbrella B
Start date: February 28, 2019
Phase: Phase 3
Study type: Interventional

This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study.

NCT ID: NCT03766581 Completed - Clinical trials for Acute Ischemic Stroke

A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel

AXIOMATIC-SSP
Start date: January 27, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention.

NCT ID: NCT03766035 Completed - Clinical trials for Primary Sclerosing Cholangitis (PSC)

Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

Start date: December 6, 2018
Phase:
Study type: Observational

To demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard endoscopic retrograde cholangiopancreatography (ERCP) with brushing cytology for diagnosis and early detection of cholangiocarcinoma in patients diagnosed with primary sclerosing cholangitis (PSC).

NCT ID: NCT03764982 Active, not recruiting - Rehabilitation Clinical Trials

RehabNytte - A Study of Rehabilitation Processes in Specialized Care in Norway

Start date: January 2, 2019
Phase:
Study type: Observational

The main objective of the study is to describe function and health related to quality of life during the first year after rehabilitation, to measure the degree and impact of user involvement in the rehabilitation process, assess factors associated with change in work -ability and -participation, and to test measurement properties of a new core set of outcome measures for rehabilitation launched by the Norwegian Directorate of Health.

NCT ID: NCT03764618 Completed - Clinical trials for Warm Antibody Autoimmune Hemolytic Anemia

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA

Start date: April 24, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

NCT ID: NCT03764423 Completed - Clinical trials for Impaired Glucose Tolerance

Health Effects of Salmon Fishmeal in Humans

FishMeal
Start date: September 14, 2018
Phase: N/A
Study type: Interventional

Diabetes contributes significantly to the burden of disease in Norway and cardiovascular disease is the main cause of mortality. Both lean and fatty fish are shown to have beneficial health effects. In addition to omega-3 fatty acids, fish contain potential health-promoting components such as taurine, vitamin D, vitamin B12, iodine, selenium and more unspecified components such as bioactive peptides. With the expected growth in the aquaculture sector, more protein-rich by-products will become available. The overall aim of this project is to investigate the health beneficial effects of fish protein in the form of salmon fishmeal in a human intervention study with regard to metabolic risk markers. We will include subjects with impaired glucose tolerance to a randomized controlled parallel study. The subjects will receive capsules with fishmeal or placebo.

NCT ID: NCT03763292 Completed - Anxiety Clinical Trials

Effect of Preoperative Information to Parents Before Ear-nose-throat Pediatric Surgery

Start date: December 10, 2018
Phase: N/A
Study type: Interventional

Children who will have surgery and need anesthesia, and their parents are often anxious and show signs of stress and discomfort. A main reason for concern and anxiety is fear of anesthesia and surgery, and lack of knowledge of what is going to happen. The purpose of the study is to see if a specific preoperative information brochure aimed at the parents will make the parents feel better prepared for the procedures.

NCT ID: NCT03761420 Completed - Breast Neoplasm Clinical Trials

Adjuvant Endocrine Therapy in Early Stage Breast Cancer: Adherence and Clinical Outcome

Start date: August 1, 2019
Phase:
Study type: Observational

Breast cancer is the most common cancer among women in Norway. In 2016, 3402 new cases were diagnosed (3371 in women). Breast cancer is still the second most common cause of death from cancer among women with 585 breast cancer deaths in Norway in 2015. The majority of the patients (70-75 %) belong to the Luminal subtypes, which comprise the hormone receptor (oestrogen receptor (ER) and/or progesterone receptor (PR)) positive tumours. The most important systemic adjuvant therapy in luminal breast cancers is a long-lasting administration of per-oral anti-oestrogen medication. A systemic hypo estrogenic state in the body may be created by the selective oestrogen receptor modulator tamoxifen or by inhibitors of the peripheral systemic aromatization of adrenal androgens into estrogens (aromatase inhibitors). Initially, tamoxifen was given adjuvant for 2 years, later prolonged to 5 years and recently an extension to 10 years has been recommended for premenopausal women. Aromatase inhibitors were introduced in Norwegian treatment guidelines in 2002. Currently, they are recommended in postmenopausal patients for 5 years, either as monotherapy or in concert with tamoxifen (aromatase inhibitors for 2 years followed by tamoxifen for 3 years). In premenopausal breast cancer patients, tamoxifen still is the drug of choice. Two of the major underlying reasons for late recurrences in luminal breast cancer subtypes are development of endocrine resistance to tamoxifen and aromatase inhibitors or failure of taking the medication as prescribed. Higher mortality has been shown for breast cancer patients with reduced tamoxifen adherence. The patients' ability to follow instructions and recommendations are probably overestimated in controlled trials due to patient selection and close follow-up in the study setting. Some patients experience distressing side effects like hot flushes, fatigue, joint pain, mood swings and vaginal dryness. To the investigators' knowledge, there are few studies in Norway regarding discontinuation of endocrine treatment in breast cancer. In this study they will investigate the long-term discontinuation pattern to oral adjuvant systemic endocrine therapy in a large cohort of breast cancer patients treated in St. Olav's hospital in Trondheim, Norway, and the association between adherence to endocrine treatment and long-term survival.

NCT ID: NCT03760588 Active, not recruiting - Heart Failure Clinical Trials

Prevention of Cardiac Dysfunction During Breast Cancer Therapy

PRADAII
Start date: January 14, 2019
Phase: Phase 2
Study type: Interventional

Breast cancer is the most common cancer among women. The modern post-surgery treatment with chemotherapy, immunotherapy, radiation and hormone therapy has improved the overall 5-years survival drastically. However, an unwanted effect of the post-surgery treatment is its potentially deleterious effect on the heart resulting in cardiac dysfunction. Angiotensin antagonists are used as part of the heart failure treatment. In smaller studies angiotensin antagonists have shown to have a cardioprotective effect during breast cancer treatment. Sacubitril/valsartan is a potent drug that in addition to an angiotensin antagonist contains a neprilysin inhibitor. Sacubitril/valsartan has proved to be superior to enalapril in chronic heart failure. In this randomized placebo controlled double blind trial we hypothesize that sacubitril/valsartan used concomitantly during anthracycline containing chemotherapy for breast cancer treatment prevents cardiac dysfunction as measured by cardiac magnetic resonance imaging (CMR). PRADA II is a Norwegian multicenter trial intending to recruit 214 patients and follow them for 18 months with CMR, cardiac ultrasound, blood samples, functional capacity tests and health related quality of life questionnaires.