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NCT ID: NCT04461613 Enrolling by invitation - Polyneuropathies Clinical Trials

Physical Activity in Persons With Charcot-Marie-Tooth: Developing a Measurement Instrument

Start date: September 15, 2020
Phase: N/A
Study type: Interventional

The project will develop knowledge about physical activity in persons with Charcot-Marie-Tooth (CMT) in Norway. We plan to explore instruments to measure physical activity level for the target-group at the community level. We want to understand which type of activities, activity intensities and how persons with CMT perform habitual physical activity. Subsequently, a physical activity measurement instrument adapted to persons with CMT will be developed. This instrument can be used in a future intervention project to promote physical activity in this group.

NCT ID: NCT04458012 Enrolling by invitation - Dry Eye Clinical Trials

Epidemiological Study of Dry Eye Disease in Stavanger: Dry Eye Disease in Patients Treated With Intravitreal Injections

EPISTA1
Start date: June 25, 2020
Phase:
Study type: Observational

To investigate prevalence of dry eye disease in Norwegian patients with age-related macular degeneration receiving intravitreal injections, as well as to reveal possible risk factors of DED in this population.

NCT ID: NCT04432285 Enrolling by invitation - Cervical Dystonia Clinical Trials

Long-term Outcome of DBS Versus Botulinum Toxin Treatment in Cervical Dystonia

Start date: August 6, 2020
Phase:
Study type: Observational

Cervical dystonia (CD) is the most common isolated dystonia in adults. Cervical dystonia symptoms can in most patients be managed well by botulinum toxin (BTX) injections, and supporting treatment measures. However, one-fifth to one-third of patients do not obtain sufficient relief from long-term BTX therapy, resulting in reduced quality of life. Deep brain stimulation (DBS) is a treatment method in which electrodes are surgically implanted permanently in the brain to modulate brain networks and function. In cervical dystonia, DBS of the postero-ventral part of the internal globus pallidus (GPi-DBS) has been established as an effective treatment for severe cases. However, the outcome of GPi-DBS in cervical dystonia has been reported mostly in some smaller series with up to 3 years follow-up. Thus, there is a lack of documentation of outcome of GPi-DBS in CD beyond 3 years of treatment and in larger patient materials. In this study the investigators will perform a long-term follow-up study of patients who were operated with a DBS-device targeting the GPi bilaterally, and who have been treated with chronic GPi-DBS for a minimum of 3 years. The investigators will measure the severity of symptom burden and quality of life with validated rating scales. The investigators will compare this DBS-treated cohort with an age- and gender matched group of CD patients who are receiving the standard treatment with botulinum neurotoxin (BoNT) injections and have been treated for at least 3 years as well. The investigators hypothesize that the DBS-treated group will have a significantly lower burden of symptoms at long-term follow-up than the BoNT treated group.

NCT ID: NCT04290650 Enrolling by invitation - Sleep Disturbance Clinical Trials

Sleep Disturbances in Patients With Psychotic Symptoms (AkuSleep)

AkuSleep
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Sleep disturbance is recognized as a major problem for patients with psychosis and is seen in nearly all patients admitted in acute crisis to a psychiatric hospital. Cognitive behavioral treatment is recommended as first-line treatment for insomnia in national and international guidelines. This study explores effect of adapting the milieu therapy to comply with the principles of CBT for insomnia. Our aim is to rethink our day to day psychological interventions and our around the clock milieu therapy for patients with acute and severe mental illness in light of established knowledge on how sleep is obtained and maintained.

NCT ID: NCT04260269 Enrolling by invitation - Solid Tumor Clinical Trials

Feasibility of Switching Fluoropyrimidine Due to Cardiotoxicity Study

CardioSwitch
Start date: June 1, 2018
Phase:
Study type: Observational

The purpose of the present study is to evaluate cardiotoxicity during re-challenge of a different modality of fluoropyrimidine (primary end-point S-1 and secondary any other fluoropyrimidine) after having perceived cardiotoxicity with a fluoropyrimidine based regimen previously. The patient population is being treated for solid tumors.

NCT ID: NCT04239586 Enrolling by invitation - Clinical trials for Insulin-dependent Diabetes Mellitus

Switching From Insulin to Sulfonylurea in Diabetes Associated With Variants in MODY Genes

SUtoChildT1D
Start date: April 18, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to switch from insulin to oral sulfonylurea in patients with apparent type 1 diabetes or maturity onset diabetes in the young that are insulin treated. The molecular cause will be DNA variants in the HNF1A, HNF4A, or HNF1B genes that are of unknown significance (VUS, class 3) or known to be pathogenic (class 4 and 5).

NCT ID: NCT04138927 Enrolling by invitation - Clinical trials for Warm Antibody Autoimmune Hemolytic Anemia

A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Start date: October 30, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is: • To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

NCT ID: NCT04106947 Enrolling by invitation - Quality of Life Clinical Trials

Transition of Care for Patients With Hirschsprung Disease and Anorectal Malformations

NOHARM
Start date: August 12, 2019
Phase:
Study type: Observational [Patient Registry]

Transition from paediatric to adult health care is crucial for preventing deterioration of chronic diseases. At present, transitional care (TC) is not established for patients with the Hirschsprung disease (H) and Anorectal Malformations (ARM). To set up a program for TC and to treat persisting symptoms in adults, data on outcome in adult patients are needed. At present such data are very limited. Therefore, we want to investigate clinical and PROM in H and ARM adolescents and adults. A cross sectional study in all H and ARM patients operated in Norway from 1970-2000 and in all adolescents operated at Oslo University Hospital from 2002-2006 will examine somatic, psychosocial and mental health, and quality of life (QoL). In children operated for H and ARM a large body of evidence shows that bowel problems, reduced QoL and impaired psychosocial and mental health are common. There are papers on sexual and urological impairment in these patients, but large studies on the topic is missing. It is a general assumption among paediatric surgeons that both somatic and mental health problems related to H and ARM improve during adolescence and adult life. Therefore, no standardized guidelines for TC in these patients have been established. Interestingly, very few studies have actually examined H and ARM patients beyond adolescence. Reports from patient organizations showing significant long-term sequels and inadequate understanding of the unique problems of H and ARM patients among health professionals treating adults. Hypothesis:H and ARM adults and adolescents have bowel, urinary and sexual difficulties and reduced QoL, psychosocial and mental health. H and ARM adults receive insufficient treatment of their chronic congenital disease. H and ARM patients with syndromes have particularly bad functional outcome. Anal dilatations and repeated rectal enemas have a negative impact on adolescent psychosocial and mental health. Main aim: Acquire knowledge about long-term bowel, urinary and sexual function, QoL and psychosocial and mental health in adult and adolescent H and ARM patients. Results: from this large study of H and ARM patients will have significant influence on treatment and follow-up, both nationally and internationally. Since very few countries except the Nordic countries have the possibility to follow patients with congenital malformations into adulthood, it is important that studies like this are done.

NCT ID: NCT04077580 Enrolling by invitation - Clinical trials for Recurrent Urinary Tract Infection

The Effect of Methenamine Hippurate to Reduce Antibiotic Prescribing in Elderly Women With Recurrent UTI

ImpresUWP3
Start date: November 1, 2019
Phase: Phase 4
Study type: Interventional

Recurrent urinary tract infection (UTI) in elderly women is a major driver of antibiotic prescription. Hence, the question of feasible and appropriate preventive measures are important issues in this field. Methenamine hippurate is frequently prescribed in Norway and Sweden as prophylaxis for recurrent UTI. Methenamine hippurate acts via the production of formaldehyde from hexamine, which in turn acts as a bacteriostatic agent, therefore methenamine hippurate is not defined as an antibiotic. According to a Cochrane review 2012 the rates of adverse events for preventing UTI was low. Although this review showed methenamine hippurate might be effective in preventing UTI in the short term, there is a need for large well-conducted randomised controlled trial (RCT) to clarify both the safety and effectivity of preventive methenamine hippurate for longer term use. This is particularly important for longer term use for people without neuropathic bladder disorders. A Norwegian longitudinal observational study including women aged 50-80 years with recurrent UTI indicated a significant and large reduction of more than 50% in antibiotic prescriptions for UTI after start of prophylactic methenamine hippurate. This further strengthens the need for an RCT of methenamine hippurate as prophylaxis for recurrent UTI.

NCT ID: NCT04056884 Enrolling by invitation - Clinical trials for Siblings of Children With Chronic Illness

SIBS-Intervention for Siblings and Parents of Children With Chronic Illness

SIBS-RCT
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

SIBS-RCT is a randomized controlled trial comparing the effect of a 5-session group intervention for siblings and parents of children with chronic illness to 12-week waitlist. Participants randomized to waitlist will receive the intervention after waitlist. The main outcome is sibling mental health, and secondary outcomes include family communication, sibling disorder knowledge, quality of life, and adaption. Outcomes will be examined at pre-, post, 3-, 6- and 12- month follow-up.