The young-HUNT study is a renowned, representative, population-based study where all adolescents living in the Nord-Trøndelag county have been invited to participate in four subsequent waves, from 1995 to 2019. Information about the study can be found here: https://www.ntnu.edu/hunt/young-hunt. In this study data from the Young-HUNT1-4 studies (1995-2019) will be linked to longitudinal, individual data from the Norwegian prescription Database (NorPD) (2004-2020), providing a unique, longitudinal dataset in which research questions will be explored. To obtain good, reliable follow-up data and outcome measures for the young-HUNT3 participants (2006-2008) the investigators will additionally include longitudinal data from the HUNT4 study of young adults (2017-2019); applicable for those participating in both the YoungHUNT3 and the YoungHUNT4.

PTSD

Psychiatric Illness

Prescription Drug Dependence

Addiction

Age & Development

Socioeconomy

Traumatic Events

Psychosocial conditions

Physical activity, BMI, nutrition, smoking …

Lifestyle

I.e. Epilepsy or juvenile rheumatoid arthritis ...

Chronic conditions

Somatic symptoms

PTSS, anxiety, depressive symptoms & loneliness ...

Psychological symptoms

Non-prescription analgesics

Analgetic, sedative & anxiolytic medication

Prescription drugs

Norwegian Centre for Violence and Traumatic Stress Studies

Killing Pain - Use of Analgesic, Sedative and Anxiolytic Medication and the Development of Psychiatric Illness in Adolescents

Medically treated severe mental illness, i.e. depression, psychosis, dependency or addiction disorders

Synne O. B. Stensland

Principal Investigator (MD, PhD)

Norwegian Center for Violence and Traumatic Stress Studies

Oslo University Hospital

The Change Factory

Norwegian Council for Mental Health

Dam Foundation

Norwegian Institute of Public Health

A patient who has a diagnosis of GCA or PMR

Serum, plasma, cellular and subcellular fractions of blood, urine or arterial tissue, DNA, RNA, proteins and metabolites

Giant Cell Arteritis

Polymyalgia Rheumatica

Stoke Mandeville Hospital - Buckinghamshire Healthcare NHS Trust

Barnsley NHS Foundation Trust

Basildon & Thurrock University Hospital NHS Foundation Trust

Royal National Hospital for Rheumatic Diseases

Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust

Queen Elizabeth Hospital, University Hospitals Birmingham

Queens Hospital, University Hospitals of Derby and Burton NHS Foundation Trust

West Suffolk NHS Foundation Trust

Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust

Chelsea and Westminster Hospital NHS Foundation Trust

West Middlesex University Hospital, Chelsea and West Minster NHS Foundation Trust

Ashford & St Peters Hospitals NHS Foundation Trust

Croydon University Hospital

Doncaster Royal Infirmary

Ninewells Hospital and Medical School, NHS Tayside

NHS Lothian, Edinburgh

Royal Devon and Exeter NHS Foundation Trust

Frimley Park Hospital NHS Foundation Trust

Queen Elizabeth Hospital, Gateshead

Inverclyde Royal Hospital, NHS Greater Glasgow and Clyde

Royal Alexandra Hospital, NHS Greater Glasgow and Clyde

Vale of Leven Hospital, NHS Greater Glasgow and Clyde

James Paget University Hospitals NHS Foundation Trust

Royal Surrey County Hospital

Harrogate and District NHS Foundation Trust

Hull Royal Infirmary, Hull and East Yorkshire Hospitals

The Ipswich Hospital, Colchester Hospital University NHS Trust

Airedale General Hospital, Airedale NHS Foundation Trust

Westmorland General Hospital, University Hospitals of Morecambe Bay NHS Foundation Trust

The Queen Elizabeth Hospital, Kings Lynn Foundation Trust

Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Foundation Trust

Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust

Royal Glamorgan Hospital, Cwm Taf University Health Board

Kings College Hospital NHS Foundation Trust, London

Royal Free Hospital, Royal Free London NHS Foundation Trust

University College London NHS Foundation Trust

Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust

The Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust

North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust

Northampton General Hospital

Norfolk and Norwich University Hospital Foundation Trust

Queens Medical Centre, Nottingham University Hospitals NHS Trust

Oxford Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Trust

Peterborough and Stamford Hospitals NHS Foundation Trust

Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust

Scarborough General Hospital, York Teaching Hospital HS Foundation Trust

Southend University Hospital NHS Foundation Trust

Lister Hospital, East and North Hertfordshire NHS Trust

Haywood Hospital, Staffordshire and Stoke on Trent Partnership NHS Trust

Great Western Hospitals NHS Foundation Trust

St George's University Hospitals NHS Foundation Trust, London

Torbay and South Devon NHS Foundation Trust

Royal Cornwall Hospital NHS Trust

Pinderfields Hospital, Mid Yorkshire Hospitals NHS Trust

Warrington and Halton Hospital NHS Foundation Trust

South Warwickshire NHS Foundation Trust

Arrowe Park Hospital, Wirral University Hospital NHS Foundation Trust

York Teaching Hospital NHS Foundation Trust

Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)

UK GCA Consortium: Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)

Diagnosis of GCA (or PMR), confirmed by a specialist (e.g. rheumatologist, ophthalmologist) with relevant expertise.

Clinical phenotype or subtype of GCA/PMR based on disease features and imaging undertaken as part of routine clinical practice, and on research tests, such as imaging performed for research purposes, cells, subcellular fractions and molecules in the circulation and/or arterial tissue and genetic/ epigenetic/ transcriptomic/ proteomic or metabolomic factors, including next generation sequencing (whole exome sequencing) of selected cases.

Assessment of the impact the disease and treatment has on the patients' lives as reported by the patient

Longitudinal follow-up of patients (as far as is possible from medical and electronic records and without requiring additional study visits) to define prognosis/disease outcomes, such as ischaemic manifestations, aneurysm formation, duration of steroid therapy, disease flares, complications related to steroid therapy.

Diagnosis in patients presenting with suspected GCA/PMR (prospective study).

To investigate role of genetics, environmental factors (e.g. diet and sunlight) and co-morbidities (e.g. periodontal disease) on disease phenotype and outcome as assessed by the patient-administered questionnaires.

Participants commencing a synthetic or biological disease modifying anti-rheumatic drug with or without additional steroid therapy will have their disease activity assessed.

A variety of 'omic technologies will be applied to cell populations isolated from the blood and/or routine diagnostic arterial biopsies, including, but not limited to, RNASeq and a variety of proteomic approaches.

Ann Morgan

Professor of Molecular Rheumatology and Honorary Consultant Rheumatologist

University of Leeds

University of Oxford

Patients in this group will receive:
Ibuprofen
Oral
At a dosage of 30 to 40 mg/kg/day, divided into 3 or 4 doses/day, max 2400 mg/day, given with food, in the form of suspension or tablets.
Duration of therapy: 4 - 6 weeks.

Steroids:
Pednisone (for mild/moderate cases):
Oral
Single daily morning dosage of 0.05-2.0 mg/kg/day, or in 2 - 4 divided doses, max 80 mg/d.
Duration: 4 - 6 weeks, with gradual tapering to the lowest effective dose.
Methylprednisolone (for severe/acute cases):
IV
10-30 mg/kg/dose (max 1 g), over 1 hr daily for 1-5 days, followed by oral prednisone, with gradual tapering to the lowest effective dose.
The duration is variable according to the condition of the patient.

Patients in this group will receive:
Methotrexate
Oral
At a dosage of 10 to 20 mg/m2/wk (0.35 to 0.65 mg/kg/wk), max dose 25 mg/wk.
Duration of therapy: 6 - 12 weeks.

Vasculitis

Infants and children with vasculitis attending AssiutU, aged > 1 mo. - 17 yr. of both genders will be included during 2 years of study.
Besides full clinical history and thorough examination, all cases will have: CBC, CRP, ESR, Renal function tests & Albumin / creatinine ratio.
All cases will have an initial estimation as well as follow up estimation after treatment by Ibuprofen for ANCA, C3, C4 &C5a levels done, measured By ELISA technique.

Ibuprofen

Infants and children with vasculitis attending AssiutU, aged > 1 mo. - 17 yr. of both genders will be included during 2 years of study.
Besides full clinical history and thorough examination, all cases will have: CBC, CRP, ESR, Renal function tests & Albumin / creatinine ratio.
All cases will have an initial estimation as well as follow up estimation after treatment by Steroids for ANCA, C3, C4 &C5a levels done, measured By ELISA technique.

Prednisone

Infants and children with vasculitis attending AssiutU, aged > 1 mo. - 17 yr. of both genders will be included during 2 years of study.
Besides full clinical history and thorough examination, all cases will have: CBC, CRP, ESR, Renal function tests & Albumin / creatinine ratio.
All cases will have an initial estimation as well as follow up estimation after treatment by Methotrexate for ANCA, C3, C4 &C5a levels done, measured By ELISA technique.

Methotrexate

Nelson Textbook of Pediatrics Expert Consult, Chapter 161, 1-8.

American College of Rheumatology (ACR) Juvenile Idiopathic Arthritis Guideline Project Plan - June 2017

Assiut University Pediatric Hospital

The Effect of Some Drugs Used in Treatment of Vasculitis on the Complement System in Children

The Effect of Some Drugs Used in Treatment of Vasculitis on the Complement System in Children Attending Assiut University Hospital.

An initial estimation as well as follow up estimation after treatment for ANCA, C3, C4 &C5a levels done, measured By ELISA technique.

There is a plan to make IPD and related data dictionaries available.

RIHassan

Principal investigator

Assiut University

The aim of this work is to assess the effect of various forms of treatment of vasculitis on C3, C4, C5a & ANCA levels in blood, in infants & children.

No other parties are masked in this clinical trial.

Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.

Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.
Tocilizumab: Therapeutic/Pharmacologic Class of Drug:
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.
Type of Dosage Form:
Concentrate for solution for infusion.
Route of Administration:
Intravenous (i.v.) infusion.

Tocilizumab

Sex: Female, Male

The Brief Assessment of Cognition in Schizophrenia (BACS) is the metric used to characterize cognition in this study. The BACS consists of 6 subscales: Verbal Memory (range 0-75), Working Memory (range 0-28), Motor Speed (range 0-100), Verbal Fluency (measure is total number of words generated in two 60 second trials), Attention and Processing speed (range 0-110), and Executive Function (range 0-22). For each subscale, higher scores reflect better cognition. For each subscale, a Standard Deviation Score was calculated based on normative data (Keefe et al. Norms and standardization of the Brief Assessment of Cognition in Schizophrenia (BACS). Schizophrenia Research 102 (2008) 108-115). The BACS composite score is calculated as the average Standard Deviation Score of the 6 subscale scores. The change in BACS composite score was calculated as the BACS composite score at 8 weeks minus the BACS composite score at baseline.

Change in Cognition

The Positive and Negative Symptoms Scale (PANSS) is the metric used to characterize psychotic symptoms in this study. The PANSS consists of 30 items, each scored 1-7. The range for the PANSS total score is 30-210. There are 3 subscales - PANSS positive score (range 7-49), PANSS negative score (range 7-49), and PANSS general score (range 16-112). PANSS total score is the summation of these 3 subscales. Higher values for the total and subscale scores reflect more severe psychopathology. A positive change in PANSS total score reflects an increase in psychopathology. A negative change in PANSS total score reflects a decrease in psychopathology.

Change in Total Psychotic Symptoms

Following a screening evaluation, participants will receive two infusions of Tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of Tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.
Tocilizumab: Therapeutic/Pharmacological Class of Drug:
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.
Type of Dosage Form:
Concentrate for solution for infusion.
Route of Administration:
Intravenous (i.v.) infusion.

Overall Study

Dr. Brian Miller

Schizophrenia

Therapeutic/Pharmacologic Class of Drug:
Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.
Type of Dosage Form:
Concentrate for solution for infusion.
Route of Administration:
Intravenous (i.v.) infusion.

antirheumatics/kopfschmerz

Killing Pain - Use of Analgesic, Sedative and Anxiolytic Medication and the Development of Psychiatric Illness in Adolescents

Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)

The Effect of Some Drugs Used in Treatment of Vasculitis on the Complement System in Children

An Open-Label Trial of Tocilizumab in Schizophrenia

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