Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Immune System Diseases

Musculoskeletal Diseases

Wounds and Injuries

Behaviors and Mental Disorders

Mouth and Tooth Diseases

Heart and Blood Diseases

Rare Diseases

Obesity

Diabetes Mellitus

Eclampsia

Pre-Eclampsia

Asthma

Arthritis

Fractures, Bone

Mental Disorders

Birth Weight

Pregnancy Complications

Body Weight

Psychotic Disorders

Vitamin D Deficiency

Tooth Diseases

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Hypertension

Hypertension, Pregnancy-Induced

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Stomatognathic Diseases

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Vitamins

Vitamin D

Cholecalciferol

Vitamin D3

Calciferol

1. Individuals born between June1983 and May1985 were exposed to the mandatory vitamin D margarine fortification during fetal life.
2. Cases: individuals defined as having one of the aforementioned diseases of interest from the registers

1. Individuals born between September1986 and August 1988 were not exposed to the mandatory vitamin D margarine fortification during fetal life.
2. Controls: cohort of matched disease-free individuals

1. This study is based on a unique Danish social experiment that took place during a well-defined period between 1937 and December 1985, when it was mandatory to fortify all margarine with vitamin D (1.25 μg/100 g). This well-defined vitamin D fortification period makes it possible to investigate the impact of fetal exposure to extra vitamin D from food fortification on the risk of developing diseases later on. This study is possible due not only to the well-defined adjacent time window but also to the complete registration of every citizen via a civil registration number. This number can be linked, on an individual level, to Danish birth, patient and medical registries; social and ethnic registries; and clinical and other large databases
2. Case-cohort study: vitamin D measurements from dried blood spots and the risk of diseases later on

D-tect

Vitamin D deficiency is common among otherwise healthy pregnant women and may have consequences for them as well as the early development and long-term health of their children. However, the importance of maternal vitamin D status has not been widely studied.

The present study is divided into a societal experiment (1) and a case-cohort study (2):

1. The present study includes an in-depth examination of the influence of exposure to vitamin D early in life and during critical periods of growth for development of type 1 diabetes (T1D), type 2 diabetes, gestational diabetes, pre-eclampsia, obesity, asthma, arthritis, cancer, mental and cognitive disorders, congenital disorders, dental caries and bone fractures during child- and adulthood. The study is based on the fact that mandatory fortification of margarine with vitamin D, which initiated in 1937, was terminated in 1985.

   Apart from determining the influences of exposure prior to conception and during pre- and postnatal life, the investigators examined the importance of vitamin D exposure during specific seasons and trimesters, by comparing disease incidence among individuals born before and after the fortification.
2. Additionally, a validated method was used to determine neonatal vitamin D status using stored dried blood spots (DBS) from individuals who develop the aforementioned disease entities as adults and their time and gender-matched controls.

Unparalleled, the study will help determine the effects of vitamin D exposure during critical periods in life. There are a sufficient number of individuals to verify any effects during different gestation phases and seasons of the year. The results, which will change our current understanding of the significance of vitamin D, will enable new research in related fields, including interventional research designed to assess supplementation needs for different subgroups of pregnant women. Also, other health outcomes can subsequently be studied to generate multiple new interdisciplinary health research opportunities involving vitamin D.

D-tecting Disease - From Exposure to Vitamin D During Critical Periods of Life

The Danish Council for Strategic Research

Bispebjerg Hospital

Professor

People with cancer, diabetes, or mental disorders answering the EMPOWER-UP questionnaire

Participants are asked to respond to the EMPOWER-UP questionnaire to test the psychometric properties of the questionnaire.

EMPOWER-UP questionnaire

Vibeke Zoffmann, Professor

Empowerment is widely acknowledged as an important approach in long-term care. The concept relates to the individual's ability to manage their own life and make rational decisions. Despite good intentions of working empowerment-based, research has shown that it can be difficult to realize and achieve in everyday practice within the healthcare system. To this date, no measurement instrument (questionnaire) exists that evaluate people's perceptions of whether their relationship with a healthcare provider promotes their empowerment process. The EMPOWER-UP questionnaire was therefore developed to provide such a measure. The EMPOWER-UP study aims to finalize the development process of the questionnaire and to test whether it is a valid and reliable measure.

People at the age of 18 years or above can participate if they have ever been diagnosed with a type of cancer, diabetes, or a mental illness and because of that diagnosis have been in contact with the healthcare system within the past six months.

The study is conducted online and requires participants to fill out an online questionnaire on a single occasion. Participation is expected to take no more than 10-15 minutes.

By participating, people may experience an increased awareness as to the nature of their interactions with healthcare providers. For some, this awareness may be beneficial and may alone enable them to ask for better care, while others may experience it as a burden if they are not able to seek better care.

By participating, people are helping to ensure that EMPOWER-UP will be a good questionnaire that may help raise awareness of the quality of relationships within the healthcare system and in term lead to better care.

The study is led by a team of researchers at the Danish University Hospital Rigshospitalet and the University of Copenhagen, Denmark.

The UK lead of the study is located at King's College London, UK. The Australian lead of the study is located at Deakin University, Melbourne, Australia.

This study is financially supported by the Novo Nordisk Foundation's Steno Collaborative Grant and by the Trygfonden foundation (Denmark)

The Development and Validation of EMPOWER-UP: a Generic Questionnaire for Measuring Empowerment in Patient-provider Relationships

King's College London

Deakin University

Rigshospitalet, Denmark

Ph.d. student, MSc

Depression

Caregiver Burden

Depressive Disorder

Pain

Behavioral Symptoms

Central Nervous System Stimulants

Psychotropic Drugs

Anti-Dyskinesia Agents

Cardiotonic Agents

Escitalopram

Methylphenidate

Citalopram

Sertraline

Fluoxetine

Antidepressive Agents

Bupropion

Selective Serotonin Reuptake Inhibitors

Paroxetine

Dexetimide

Venlafaxine Hydrochloride

Serotonin

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Neurotransmitter Agents

Serotonin Receptor Agonists

During the 18-day blind treatment period, subjects will be prescribed methylphenidate 5-10 mg twice per day and selective serotonin reuptake inhibitor (SSRI). Subjects already receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.

During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and selective serotonin reuptake inhibitor (SSRI). Subjects already receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not receiving a SSRI will be prescribed 10-20 mg per day Citalopram.

Subjects will take methylphenidate 5 mg twice daily (bid) for 3 days, then 10 mg bid for the remainder of the study. Should a subject have a 50% decrease in their depressive symptoms as measured by the Montgomery Asberg Depression Rating Scale (MADRS) at the initial dose of methylphenidate, they will be maintained at that lower dose as long as their MADRS score remains reduced by 50%. During the 18-day blinded treatment period the total daily dose will not exceed 20 mg.

If subjects have side effects when increasing to 10 mg bid, they will drop back to 5 mg bid. If the participant develops psychosis or cardiac events, they will be discontinued from methylphenidate.

Subjects who receive methylphenidate and respond with a 50% reduction in MADRS score will have the option to continue in the open label portion of the study for up to 6 weeks. For patients taking methylphenidate 10 mg bid whose MADRS score is \> 10 at day 18, the dose may be increased to 15 mg bid.

Subjects assigned to placebo will receive 1 capsule of placebo twice per day (bid) for 3 days and then 2 capsules bid for the remainder of the study. Should a subject have a 50% decrease in their depressive symptoms as measured by the Montgomery Asberg Depression Rating Scale (MADRS) at the initial dose of placebo, they will be maintained at that lower dose as long as their MADRS score remains reduced by 50%.

If subjects have side effects when increasing the dose to 2 capsules bid, they will drop back to 1 capsule bid. If the participant develops psychosis or cardiac events, they will be discontinued from the intervention.

Placebo

Each subject will be treated with a SSRI. Patients who are taking an SSRI at the time of enrollment will continue on the same medication during the 18-day blind treatment period. The prescribed dose will only be adjusted if it is more than the highest dose in the recommended range (fluoxetine to 40 mg, paroxetine to 40 mg, citalopram to 40 mg, sertraline to 150 mg). Patients who are not on a SSRI at the time of enrollment will be prescribed citalopram 10 mg per day for 2 weeks, then 20 mg per day.

A subject's SSRI may be discontinued if the subject experiences moderate to severe side effects likely attributable to a SSRI. If subjects experience similar symptoms when increasing their citalopram dose to 20 mg per day, they will drop back to 10 mg per day. During the open label extension, the SSRI may be increased, decreased, or changed to a different SSRI or other antidepressant with the exception of venlafaxine and bupropion

Selective Serotonin Uptake Inhibitor (SSRI)

Linda K. Ganzini, MD MPH

The purpose of this study is to determine whether methylphenidate is an effective treatment for depression and to document the safety and tolerability of methylphenidate in combination with an Selective Serotonin Reuptake Inhibitor (SSRI) in SSRI treated, terminally ill, hospice and palliative care cancer patients. The investigators hypothesize that depressed hospice and palliative care patients will be more likely to have a 50% reduction in scores on a clinical measure of depression after treatment with Methylphenidate plus an SSRI compared to those patients who are taking a placebo plus an SSRI.

Background: Major depressive disorder can be diagnosed in between 5% and 26% of terminally ill patients. This disorder causes suffering, and is associated with suicidality, increased pain, and increased caregiver burden and caregiver depression. Treatment of depression in cancer patients in hospice and palliative care is complicated by shortened life expectancy. Currently-approved antidepressants take several weeks to be effective. Methylphenidate has been reported in case series and very small randomized trials in patients without cancer as a rapidly effective treatment for depression in medically ill patients. There are no randomized controlled trials to test this agent in terminally ill cancer patients.

Objectives: (1) To determine the effectiveness and safety of methylphenidate for depression treatment in cancer patients receiving hospice and palliative care, (2) to explore whether successful treatment of depression is associated with improved quality of life, and (3) to explore whether effective treatment of depression influences caregiver depression and caregiver burden.

Methods: We will conduct an 18-day randomized, double-blind, fixed-dose (10 mg bid), placebo-controlled clinical trial of methylphenidate for depression in eligible veteran and non-veteran cancer patients with advanced cancer in the following settings: inpatient and outpatient hospice, inpatient and outpatient palliative care, and inpatient and outpatient cancer clinics. We will determine whether improvement in depression is mediated by decreased pain and document the safety and tolerability of methylphenidate in these patients. We will explore whether improvement in depression results in improved quality of life for these patients, and decreases caregiver depression and burden.

Eligible patients who answer yes to the question "are you sad or depressed" will be invited to participate. They will complete measures of depression \[Structured Clinical Interview for Diagnosis (SCID), Montgomery-Asberg Depression Rating Scale (MADRS) as primary outcome, Hospital Anxiety and Depression Scale (HADS) as secondary outcome\], quality of life, pain, and cognition at baseline. MADRS scores must be greater than 19 and SCID positive for depression at study entry. Subjects will be randomized to either methylphenidate plus an SSRI, or placebo plus an SSRI. Subjects may continue any previously prescribed SSRI, or will be prescribed citalopram if untreated. Participants will be evaluated with the same measures as baseline on days 3, 6, 12 and 18 of the study. In an open label portion of the study, methylphenidate-treated patients whose depression has improved will be followed up to 2 months. Cox proportional hazard analysis will be used to analyze the primary outcome. An estimated 104 subjects will be entered over five years. Caregivers will complete measures of depression and caregiver burden at days 0 and 18.

Methylphenidate for Depressed Cancer Patients Receiving Palliative Care

Methylphenidate for Depressed Cancer Patients in Hospice

Days to a 50% or greater reduction in initial Montgomery-Asberg Depression Rating Scale (MADRS) score.

Oregon Health and Science University

US Department of Veterans Affairs

During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.

Methylphenidate + SSRI

During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.

Placebo + SSRI

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Married

Single

Divorced

Widowed

Partnership

Marital Status

Education

Gastrointestinal

Pulmonary

Urogenital

Breast

Prostate

Neurological

Dermatological

Head and Neck

Hematological

Type of Cancer

The number of baseline participants is the number of subjects who received the intervention

Frequency threshold for reporting nonserious adverse events was not determined at the start of the study, but a % was required to be entered in order to complete the adverse event module

Dr. Linda Ganzini

The number of participants analyzed is the number of who received the intervention

Days to Remission of Depression

Received Intervention

Open Label for SSRI+Methylphenidate Arm

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
D-tecting Disease - From Exposure to Vitamin D During Critical Periods of Life	NCT03330301	Vitamin D Defic... Obesity Diabetes Mellit... Pre-Eclampsia Arthritis Asthma Bone Fracture Tooth Diseases Birth Weight Birth Disorder Pregnancy Compl... Mental Disorder Cancer Congenital Diso...	D-tect	-	Bispebjerg Hospital
The Development and Validation of EMPOWER-UP: a Generic Questionnaire for Measuring Empowerment in Patient-provider Relationships	NCT05277805	Cancer Diabetes Mental Disorder	EMPOWER-UP ques...	18 Years -	Rigshospitalet, Denmark
Methylphenidate for Depressed Cancer Patients Receiving Palliative Care	NCT00129467	Depression Palliative Care Cancer Mental Disorder	Methylphenidate Placebo Selective Serot...	18 Years -	VA Office of Research and Development
D-tecting Disease - From Exposure to Vitamin D During Critical Periods of Life	NCT03330301	Vitamin D Defic... Obesity Diabetes Mellit... Pre-Eclampsia Arthritis Asthma Bone Fracture Tooth Diseases Birth Weight Birth Disorder Pregnancy Compl... Mental Disorder Cancer Congenital Diso...	D-tect	-	Bispebjerg Hospital
D-tecting Disease - From Exposure to Vitamin D During Critical Periods of Life	NCT03330301	Vitamin D Defic... Obesity Diabetes Mellit... Pre-Eclampsia Arthritis Asthma Bone Fracture Tooth Diseases Birth Weight Birth Disorder Pregnancy Compl... Mental Disorder Cancer Congenital Diso...	D-tect	-	Bispebjerg Hospital

Spots Global Cancer Trial Database for mental disorder