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NCT ID: NCT05361460 Completed - Biomarkers Clinical Trials

Patients Experiences of Early Postoperative Cognition

COME
Start date: October 17, 2019
Phase:
Study type: Observational

The study has a mixed-methods design i.e. integration of qualitative and quantitative data within a single investigation. Participants included will be patients ≥60 years that are undergoing major elective joint replacement surgery (n=40) and their relative. Patient's experience of his/her cognition will be capture by interviews on postoperative day 13-16 during the follow-up visit and after 1 year. A relative will also be interviewed once on postoperative day 13-16. Cognitive function will be measured preoperatively and on postoperative day 13-16 using the International Study Group of Postoperative Cognitive Dysfunction (ISPOCD) test battery. Symptoms / discomfort will be measured pre- and postoperatively (on postoperative day 1 and 2 and at the follow up visit day 13-16) by the Swedish version of Quality of Recovery (SwQoR) and by a visual analogue scale assessing pain intensity. Biomarkers will also be collected at the same time points. The findings from the interviews will be sorted out depending on group stratification (no delayed neurocognitive recovery and delayed neurocognitive recovery). The qualitative and quantitative findings will be compared to seek for similarities and differences.

NCT ID: NCT05361083 Completed - Clinical trials for Adrenocortical Carcinoma

First-in-human Evaluation of [18F]CETO

Start date: September 1, 2019
Phase: Early Phase 1
Study type: Interventional

Purpose of this clinical phase 1 trial was to determine if para-chloro-2-[18F]fluoroethyletomidate positron emission computed tomography ([18F]CETO-positron emission computed tomography(PET)/computed tomography(CT)) can be used in diagnostics of adrenal tumors and if the biochemical/pharmacological states conditions in humans with various illnesses, compared to healthy humans, such as the radio tracer is suitable?

NCT ID: NCT05361018 Recruiting - Clinical trials for Breast Neoplasm, Exercise

Sensorimotor Training Using Whole Body Vibration Exercise to Reduce Chemotherapy-induced Peripheral Neuropathy

Sensi-Ex
Start date: October 17, 2022
Phase: N/A
Study type: Interventional

CIPN is induced by neurotoxic chemotherapeutic agents and manifests with sensory and/or motor deficits. It is associated with significant disability and poor recovery. Common symptoms include pain, altered sensation, reduced or absent reflexes, muscle weakness, reduced balance control and insecure gait. The purpose of the study is to compare effects of sensory vibrations training to conventional aerobic and strenght exercise on neurophatic symptoms related to chemotherapy treatment.

NCT ID: NCT05359783 Active, not recruiting - Breast Cancer Clinical Trials

Sentinel Node Localization and Staging With Low Dose Superparamagnetic Iron Oxide

MAGSNOW
Start date: November 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Sentinel lymph node (SLN) status is pivotal for treatment decisions in breast cancer patients. The dual technique with Technetium99m (Tc99) and blue dye (BD) is yet the current routine for SLN detection. However, the same reliability has been presented by superparamagnetic iron oxide nanoparticles (SPIO). The aim of this study was to determine if SLN detection using ultra-low dose SPIO is feasible.

NCT ID: NCT05359367 Recruiting - Stroke Clinical Trials

A Novel Approach to Enhance True Recovery After Stroke

Start date: November 29, 2023
Phase:
Study type: Observational

The purpose of this study is to elucidate pathophysiological mechanisms behind gait disturbances during the early recovery phase after hemiparetic stroke to identify targets for new treatment strategies. Using an explorative, observational study design, pathophysiological mechanisms at play during the early recovery phase will be monitored, by repeated clinical assessments during inpatient rehabilitation as well as examinations of muscle activation patterns, kinematics of walking, corticospinal and reticulospinal function < 1 month, 3 and 6 months after hemiparetic stroke. Inclusion: Eligible patients will have suffered a stroke, verified by CT or MRI examination and are admitted to inpatient care at the University Department of Rehabilitation Medicine Danderyd Hospital (RUDS). Thirty patients will be included consecutively. With an anticipated loss of 4-10 patients, at least 20 are expected to complete the study. The clinical assessment protocols include standardized measures for the assessment of clinical and self-perceived aspects of functioning and disability. These assessments will be performed and repeated < 1 month, at 3 months and 6 months post-stroke by a therapist not responsible for rehabilitation interventions. At each of these assessment instances, laboratory movement analysis including electromyography (EMG) and ultrasound of the lower extremity muscle will be performed. In addition, a short assessment of body function and activity will be performed weekly during inpatient rehabilitation.

NCT ID: NCT05356039 Recruiting - Quality of Life Clinical Trials

Survival, Quality of Life and Resectability in Locally Advanced Pancreatic Cancer

SQUARE
Start date: April 19, 2022
Phase:
Study type: Observational

This study aims to assess overall survival, quality of life and resection rates in locally advanced pancreatic cancer

NCT ID: NCT05355337 Recruiting - Depression Clinical Trials

Pramipexole for Anhedonic Depression

PRIME-PRAXOL
Start date: February 8, 2023
Phase: Phase 3
Study type: Interventional

The heterogeneity of depression suggests that several different neurocircuits and pathophysiological mechanisms are involved. Anhedonia - the inability to experience pleasure from, or the lack of motivation to carry out, usually enjoyable activities - is a promising endophenotype within the depression spectrum, with a distinct pathophysiology involving dopaminergic mesolimbic projections. Anhedonia is common in depression and associated with treatment resistance. Pramipexole, an agonist to the dopamine -receptor 3, is an established treatment of Parkinson's disease. Based on its mechanism of action, pramipexole might be efficacious in a subtype of depression characterized by anhedonia and lack of motivation - symptoms linked to dopaminergic hypofunction. This is supported by animal data, clinical experience, and recent pilot study data, but randomized controlled trials (RCTs) are lacking. In this double-blind placebo-controlled RCT the anti-anhedonic and antidepressant effects of add-on pramipexole will be tested, using an "enriched population study design" including only depressed patients with significant anhedonia. To better understand the neurobiology of anhedonia in depression and to identify treatment predictors, simultaneous assessments of anhedonia-related neurocircuitry using (f)MRI will be done, and anhedonia-related biomarkers in blood and cerebrospinal fluid analyzed. The aim of the study is to confirm the efficacy of pramipexole in this depression subtype, which would be an important step towards personalized medicine in psychiatry.

NCT ID: NCT05354284 Active, not recruiting - Clinical trials for Pregnancy Complications

Physical and Mental Health Among Sexual and Gender Minorities During Pregnancy, Birth and Postpartum

Start date: October 1, 2021
Phase:
Study type: Observational [Patient Registry]

Mental illness increases the risk of adverse birth outcomes (e.g. preterm birth), obstetric complications (e.g. emergency caesarean, birth injuries), and birth trauma. Sexual and gender minority (SGM) people on average experience increased mental illness. Therefore these risks are increased, with risk of prolonged ill health. Despite this, research in this area is scanty. The present project will provide important knowledge for improving the reproductive health of SGM people. The overall purpose of the project is to increase knowledge about physical and mental health (including fear of childbirth) during pregnancy and postpartum in SGM people. The project has the following aims: PART I 2017 - 2021Pilotstudy 1. To study fear of childbirth (FOC) among SGM people in Sweden; prevalence and factors associated to FOC 2. To investigate reasons to and consequences of FOC in SGM people PART II 2022-2027 Main study 3. To explore whether SGM people in Sweden have an increased incidence of mental illness during and after pregnancy, adverse birth outcomes, obstetric complications and birth trauma. 4. To explore how pre- and postnatal mental health, minority stress, and fear of childbirth correlate to birth outcomes, birth experience, and obstetric complications in SGM people. This is important for identifying specific risk factors for difficult births, and to explore postpartum health effects. 5. To explore in-depth how SGM people have experienced adverse birth outcomes, obstetric complications, and birth trauma, with a specific focus on minority stress and experiences of care during and after pregnancy and childbirth.

NCT ID: NCT05353829 Recruiting - Clinical trials for Rheumatoid Arthritis

Methotrexate in Patients With Early Rheumatoid Arthritis

MTXRA
Start date: April 28, 2022
Phase: Phase 4
Study type: Interventional

Rheumatoid arthritis (RA) is a chronic inflammatory disease primarily affecting the small joints of hands and feet, but may also present with systemic, extraarticular features. The Swedish Rheumatology Quality Register (SRQ) is a nationwide quality register with the aim of continuously improving the treatment and follow-up of patients with rheumatic disease. Using this type of quality registers, it is possible to perform a Registrybased Randomised Clinical Trial (R-RCT), that is a randomised clinical trial this is carried out by screening, recruitment and registration of study data is performed based on information given by a quality register. All patients with newly diagnosed RA are included in SRQ. Treatment options for RA include different types of immunosuppression and corticosteroids as bridging therapy. Methotrexate, a synthetic conventional disease modifying antirheumatic drug (csDMARD), which can be given either orally or subcutaneously, is considered a first-line treatment. Studies have shown the beneficial efficacy and improved quality of life for patients with RA treated with methotrexate, however this is not studied in a setting of unselected patients with newly diagnosed RA in northern Sweden. Moreover, it is not known to what extent patients prefer oral or subcutaneous administration route, or if there are any health economic benefits from either of the two administration routes. Further, changes in gut microbiota is not studied in this setting.

NCT ID: NCT05351879 Completed - Clinical trials for Diabetes Mellitus, Type 1

Evaluation of a Booster Administration of GAD-alum (Diamyd®) in Individuals With Type 1 Diabetes

Start date: May 9, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of the study is to evaluate the feasibility and safety of administering a 4th or 5th intralymphatic booster dose of GAD-alum (Diamyd®) to T1D patients carrying HLA DR3-DQ2, who have earlier been treated with three or four intralymphatic doses of GAD-alum (Diamyd®) respectively.