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NCT ID: NCT03874156 Recruiting - Clinical trials for Statin Adverse Reaction

MUscle Side-Effects of Atorvastatin in Coronary Patients

Start date: March 5, 2019
Phase: Phase 4
Study type: Interventional

The study aims to estimate the effect of atorvastatin on muscular symptom intensity in coronary patients with subjective statin-associated muscle symptoms (SAMS) and to determine the association with blood levels of atorvastatin and its metabolites, to obtain an objective marker for true SAMS. A randomized study will include 80 coronary patients with SAMS during ongoing atorvastatin therapy or previous muscle symptoms that led to discontinuation of atorvastatin. Patients will be randomized to 7-weeks treatment with atorvastatin 40 mg/day in the first period and matched placebo in the second 7-weeks period, or placebo in the first period and atorvastatin in the second period. A control group (n=40) without muscle symptoms will have 7 weeks open treatment with atorvastatin 40 mg/day. Blood samples will be collected at baseline and after each treatment period, and muscular symptom intensities will be rated by the patients weekly. The primary outcome is the difference in aggregated mean Visual Analogue Scale (VAS) scores between the last three weeks of atorvastatin treatment and of placebo treatment. The main purpose is to develop an objective marker for true SAMS, by comparing SAMS associated with blinded atorvastatin treatment with blood concentrations of atorvastatin and its metabolites. Diagnostic and discrimination performance will be determined. The study provides new clinical knowledge on SAMS in coronary patients and may contribute to more personalized statin treatment and monitoring, fewer side-effects and consequently improved adherence and lipid management in future practice.

NCT ID: NCT03870724 Enrolling by invitation - Clinical trials for Type 2 Diabetes Mellitus

Women and Risk of Type 2 Diabetes

Start date: April 2019
Study type: Observational

This is a follow-up survey of women, 10-12 years after they were included in the population-based Stork Groruddalen study of pregnant women, primarily set up to study gestational diabetes and related health issues in pregnancy in a multiethnic population. The investigators will now update the information about the health status of these women to study the development of risk factors for type 2 diabetes and cardiovascular diseases.

NCT ID: NCT03869177 Recruiting - Psychotic Disorders Clinical Trials

Implementation of Guidelines on Family Involvement During Primary Psychotic Disorders.

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

This study will develop and evaluate a complex intervention to implement guidelines on family involvement for patients with primary psychotic disorders (F20-29 in International Classification of Diseases ICD-10) in the psychiatric outpatient clinic, by using a cluster randomised design. Fifteen Norwegian outpatient clinics participate in the study, and each of them constitutes a single cluster, except for two collaborating clinics who are considered one cluster. Of the fourteen clusters, half will receive implementation support and training immediately, whereas the other half will receive it one and a half year later. The study will assess both service level outcomes, by measuring fidelity scores, and selected outcomes for patients and caregivers, by collecting questionnaires and data from central health registers and patient records. In addition, qualitative interviews will be performed with patients, caregivers and health care personnel. The study will also include an economic analysis and a political economy analysis.

NCT ID: NCT03862365 Recruiting - Neuropathic Pain Clinical Trials

Exploring the Genetics of Neuropathic Pain

Start date: August 1, 2018
Study type: Observational [Patient Registry]

In the present study the investigators will search for new genetic variants relevant for the development of neuropathic pain.

NCT ID: NCT03860844 Recruiting - Clinical trials for Acute Myeloid Leukemia

Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

Start date: March 11, 2019
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) Secondary Objectives: - Safety and tolerability assessments - Assessment of infusion reactions (IRs) - Pharmacokinetics (PK) of isatuximab - Minimal residual disease - Overall response rate - Overall survival - Event free survival - Duration of response

NCT ID: NCT03859505 Not yet recruiting - Low Back Pain Clinical Trials

Photobiomodulation Therapy on Inflammatory Mediators on Low Back Pain

Start date: March 18, 2019
Phase: N/A
Study type: Interventional

Low back pain (LBP) is ranked as one of the most prevalent health conditions. It is likely that some inflammatory mediators could be associated with pain and disability in these patients. Photobiomodulation therapy (PBMT) is a non-pharmacological therapy often used in patients with LBP that decrease release of inflammatory mediators and accelerate muscle repair in different muscle skeletal conditions, as mechanisms of action. The present research project aims to evaluate the effects of PBMT on systemic levels of inflammatory markers and levels of pain intensity in patients with chronic non-specific low back pain.

NCT ID: NCT03859063 Not yet recruiting - Stroke Clinical Trials

Long-term Follow-up After Stroke (The LAST-long Trial)

Start date: March 2019
Phase: N/A
Study type: Interventional

Despite the improved treatment of acute stroke over the past decades, those suffering from stroke still are at an increased risk of functional and cognitive decline in the long term. The most common consequences of stroke are functional impairments, cognitive impairments, depression and fatigue. These are also regarded as barriers to achieve optimal adherence to the guidelines regarding secondary prevention. The primary aim of this project is to evaluate the effectiveness of a multimodal individualized intervention to prevent functional decline in the long term after stroke.

NCT ID: NCT03854279 Recruiting - Clinical trials for Tonsillar Hypertrophy, Tonsillitis

Comparison of Bizact With Electroscissor for Tonsillectomy

Start date: February 20, 2019
Phase: Phase 4
Study type: Interventional

In a randomized, partly double-blind prospective setup we want to compare traditional adult electro-scissor tonsillectomy With ultrasound Technology, Bizact.

NCT ID: NCT03852953 Active, not recruiting - Breast Cancer Clinical Trials

Under- and Overdiagnosis in BreastScreen Norway

Start date: July 1, 2018
Study type: Observational

This PhD project will describe tumour characteristics and survival associated with of under- and overdiagnosed breast cancers, the rate of overdiagnosis in BreastScreen Norway, and whether women and family doctors are aware of, and knowledgeable about, under- and overdiagnosis in breast cancer screening.

NCT ID: NCT03852160 Not yet recruiting - Clinical trials for Depressive Disorder, Treatment-Resistant

A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression

Start date: May 15, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of treating participants with treatment-resistant depression (TRD) who have failed at least 2 (and no more than 6) prior antidepressant (AD) treatments in the current moderate to severe depressive episode with flexibly-dosed esketamine nasal spray plus a newly initiated oral standard-of-care AD compared with placebo nasal spray plus a newly-initiated standard-of-care oral AD, in achieving remission and staying relapse-free after remission.