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NCT ID: NCT04418856 Recruiting - Breast Cancer Clinical Trials

The Effects of Light Therapy to Treat Cancer-related Side Effects

Start date: June 8, 2020
Phase: N/A
Study type: Interventional

Severe fatigue, depression, sleep problems and cognitive impairment are the most commonly reported side effects of cancer treatment. These aversive side effects are hypothesized to be related to the disruption of circadian rhythms associated with cancer and its treatment. Exposure to Bright White Light (BWL) has been found to synchronize the circadian activity rhythms but research with cancer patients has been scarce. Therefore, the proposed randomized control trial (RCT) will test if systematic light exposure (sLE) will minimize overall levels of cancer-related fatigue (CRF), depression, sleep problems and cognitive impairment among breast cancer patients undergoing breast cancer treatment (i.e., surgery, chemotherapy). SLE incorporates the delivery of harmless UV-protected BWL or Dim White Light (DWL - standard comparison in light studies) delivered to patients by using special glasses for 30 minutes each morning, during their treatment. The proposed study, including a delineated comparison condition, will investigate the effects of BWL on CRF, sleep, depression, cognition, circadian rhythms, and inflammation markers among patients undergoing breast cancer treatment. The proposed RCT could have major public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention reduces common side effects (e.g., CRF, depression, cognitive impairment) of cancer treatment (i.e., surgery, chemotherapy). Aim 1 - Assess whether Bright White Light (BWL) compared with Dim White Light (DWL) among breast cancer patients undergoing breast cancer treatment will minimize overall levels of CRF, depression, sleep problems, and cognitive impairment during and after breast cancer treatment, compared to healthy controls. Aim 2 - Determine whether the BWL intervention affects cortisol rhythms, circadian activity rhythms, melatonin rhythms, and inflammation markers that have been identified as correlates/causes of cancer-related side effects (e.g., CRF, depression, sleep problems). Aim 3 - Exploratory: Explore whether the effects of BWL compared to DWL on the cancer-related side effects (e.g., CRF, cognitive impairment) are mediated by the beneficial effects of the BWL in synchronizing circadian rhythms. Aim 4 - Exploratory: Explore potential moderators of the intervention including seasonality, chronobiology, personality, and social factors.

NCT ID: NCT04378517 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder Combined

Evaluating the Feasibility of FAM-SOTC Intervention for Families of Adolescents With ADHD: Pilot Study

Start date: November 13, 2018
Phase: N/A
Study type: Interventional

Attention-deficit/hyperactivity disorder (ADHD), is a highly genetic and complex neurological disorder, where disruptive behavior, emotional imbalance, and lack of attention can interrupt with normal development of adolescents, self-awareness, and self-regulation in a way that has an impact on the family unit. Effective family intervention programs, that empower resilience and strength, to cope with the stressful situation from ADHD, are therefore needed. Nevertheless, there is a lack of knowledge regarding what type of interventions are the most effective for these families. As well as, little is known about the benefits of family-level intervention for families of adolescents with ADHD at outpatient care and what amount of combination in an intervention is appropriate. Psychiatric advanced practical nurse (APN) practitioners are in a key role to offer such an intervention. Therefore, the aim of this pilot study is to evaluate the feasibility of offering a family-level intervention, for parents of 13-17 years old adolescents with ADHD, at a Children and Adolescents' Psychiatric Outpatient Unit (BUGL). Also, to evaluate if the intervention, which consists of group educational sessions, family sessions, and access to evidence-based information's on ADHD, fitted the families. A nurse-led educational and support intervention will be offered for parents of adolescents with ADHD once a week over a 5-week time period. First, there will be offered three group support sessions, with information about the general impact of the ADHD disorder on the family's daily life. Second, two special therapeutic conversations and support interviews will be offered to each family, where each parent can discuss their daily situation specifically and its impact on the family as a whole. Third, caregivers will have access to about 140 pages of evidence-based material on a closed website (pan pale) regarding the ADHD disorder in adolescents and its impact on the family. The outcome of this process will help in determining the feasibility of subjecting the intervention to a more expensive and time-consuming randomized controlled trial (RCT) study.

NCT ID: NCT04357990 Completed - COVID-19 Clinical Trials

Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19

KONS-COVID19
Start date: September 4, 2020
Phase: N/A
Study type: Interventional

Viruxal Oral and Nasal Spray is a Class I CE marked medical device manufactured by Kerecis hf (the "Device"). A double blind clinical trial will be conducted to evaluate the Device against placebo in COVID-19 positive, symptomatic patients in Iceland. Immediate access to COVID-19 patients is available through a well-organized COVID-19 outpatient follow-up clinic. Up to 128 patients with mild to moderate symptoms of COVID-19 will be recruited (so called "higher end of the low risk group"). These patients will be positive for COVID-19, be symptomatic with upper respiratory symptoms, but without involvement of the entire respiratory system. The patients will be randomized to receive treatment with the Study Device or to receive placebo. 64 patients will be randomized into the Study Device group and 64 patients into the Control group. Patients will administer Study Device or Control for 14 days and will have their symptoms recorded until no further symptoms are reported, up to a maximum of 28 days follow-up.

NCT ID: NCT04342416 Completed - Trauma Clinical Trials

Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women

Start date: September 8, 2020
Phase: N/A
Study type: Interventional

This research study is an extension on a study already preregistered NCT04209283 and is designed to investigate the use of a simple cognitive task (a memory cue followed by playing the computer game "Tetris") for decreasing the number of intrusive memories of trauma among trauma-exposed women in Iceland. This is a single case series using a within subject multiple baseline AB design. Participants will aim to complete a no-intervention phase ('A': baseline phase) of one week followed by a one-week intervention phase ('B'), including a one-session intervention with a researcher comprising the simple cognitive task, followed by instructions to continue using the technique self-guided in subsequent weeks. Participants will be asked to monitor the occurrence of intrusive memories of trauma in a daily diary. It is predicted that participants will report fewer intrusive memories during the intervention phase than during the preceding baseline phase and that the frequency of targeted intrusive memories is going to decrease relative to non-targeted intrusive memories. Furthermore, the investigators will explore whether having fewer intrusive memories has an impact on function and/or PTSD, depressive or anxiety symptoms.

NCT ID: NCT04323761 Approved for marketing - SARS-CoV2 Infection Clinical Trials

Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19)

Start date: n/a
Phase:
Study type: Expanded Access

The primary objective of this study is to provide expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.

NCT ID: NCT04307576 Recruiting - Clinical trials for Leukemia, Acute Lymphoblastic

A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia

Start date: July 13, 2020
Phase: Phase 3
Study type: Interventional

ALLTogether collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new master protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised and interventional trials included in the study-design.

NCT ID: NCT04271085 Completed - Terminal Care Clinical Trials

Living Well, Dying Well. A Research Programme to Support Living Until the End

iLIVE
Start date: September 1, 2020
Phase:
Study type: Observational

The iLIVE project involves a cohort study in which patients with an estimated life expectancy of six months or less are followed until they die. In total, the investigators will include 2200 patients in 11 countries, i.e. 200 per country. The primary outcome for the cohort study is a descriptive assessment of the concerns, expectations and preferences around dying and end-of-life care of patients and their relatives, in different settings and cultures..

NCT ID: NCT04270760 Completed - Clinical trials for Cardiovascular Disease

Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study

Start date: July 28, 2020
Phase: Phase 2
Study type: Interventional

Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp[a]).

NCT ID: NCT04265755 Completed - Migraine Clinical Trials

Biomarker and Genetic Predictors of Erenumab Treatment Response

INTERROGATE
Start date: October 26, 2020
Phase: Phase 4
Study type: Interventional

To explore the relationship between clinical response to erenumab and genetic biomarkers

NCT ID: NCT04260737 Completed - Prostate Cancer Clinical Trials

Interactive Decision Aid for Men Diagnosed With Prostate Cancer

Start date: February 26, 2020
Phase: N/A
Study type: Interventional

Prostate cancer is the second leading cause of cancer related deaths in the western world (National Cancer Institute, 2011). Prostate cancer diagnosis relates to significant psychological distress (Roesch et al, 2005; Hervouet et al, 2005). The management options available for men with localized prostate cancer typically offer similar survival rate and one treatment has not been determined more effective than other. Variance in severity, duration and frequency of side effects between treatments is considerable (National Cancer Institute, 2011). This can make the choice between management options challenging and distressing. Researches show that patients that are actively involved and provided with sufficient information have better health outcomes (Stewart, 1995). The study involves implementing interactive, web-based decision-aid to assist men with localized prostate cancer with their decision regarding their prostate cancer management options. Participants will be randomized to standard-care (SC) and SC + interactive decision-aid (IDA). The SC group will meet with their urologist and receive and information brochure. In addition the IDA group will receive a website that includes a wealth of information (e.g., overview about prostate cancer, overview of different treatment options, pros and cons of different treatment options and a value clarification exercise that is designed to assist participants to weigh the risks and benefits of each prostate cancer management option). The effectiveness of the intervention will be evaluated with questionnaires administered prior to randomization (baseline) and then again two weeks, one, three and six months after the randomization. Aim 1. Evaluate the relative impact of SC versus SC + IDA on medical decision making. It is hypothesized that participants randomized to the SC + IDA arms will have improved decision making (e.g., reduced decisional conflict) and psychosocial outcomes (e.g., distress), compared to those randomized to SC only. Aim 2. Identify mechanisms by which the interventions impact patient outcomes. It is hypothesized that: 1) improved decision making and psychosocial outcomes for the IDA arms will be mediated by increased knowledge; 2) participants who are undecided about the treatment decision and those that have information-seeking decision styles will benefit most from the decision-aid interventions.