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NCT ID: NCT04722692 Recruiting - Breast Cancer Clinical Trials

Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ

SENTINOT_2
Start date: March 1, 2020
Phase: Phase 3
Study type: Interventional

The trial aims to investigate the use of superparamagnetic iron oxide (SPIO) nanoparticles as a tracer for delayed sentinel lymph node dissection (d-SLND) in patients where upfront axillary surgery (SLND) is oncologically deemed unnecessary and should be avoided. This includes but is not limited to patients with a preoperative diagnosis of ductal cancer in situ of the breast (DCIS), an unclear BIRADS 4-5 planned for diagnostic excision or women planned for risk reducing mastectomy. SPIO is injected in the primary operation, and should final specimen pathology demonstrate invasive breast cancer, only then is an operation in the axilla (d-SLND) performed.

NCT ID: NCT04722159 Recruiting - Hypertension, Renal Clinical Trials

Clinical Outcome of Patients With Resistant Hypertension Undergoing Renal Denervation

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

Studies on the impact of RDN on cardiovascular surrogate markers have shown a variety of beneficial effects: RDN is associated with a decrease blood pressure (BP), left ventricular mass (LVM), a reduction in aortic pulse-wave velocity and BP variability as well as an increase in heart rate-recovery. Several of these aspects have been observed independently of office BP response, and might be mediated by a direct modulation of the sympathetic nervous system. Moreover, several independent real - world registries have shown an association of renal denervation and sustained blood pressure reductions of clinically relevant magnitude up to 36 months of follow - up. Whether the sum of these effects may translate into an improvement of clinical outcomes remains unclear and constitutes the primary subject of proposed registry based study.

NCT ID: NCT04720482 Recruiting - Cardiac Arrest Clinical Trials

Pupillometry and Somatosensory Evoked Potential in Cardiac Arrest

PASCA
Start date: February 3, 2020
Phase:
Study type: Observational

Somatosensory Evoked Potentials (SSEP) and Pupillary Light Reflex (PLR) are key methods for neurologic prognostication in comatose survivors of cardiac arrest. Both methods have low false positive rates.Though they assess different functions of the brain, they should both be sensitive to severe anoxic/ischemic injury from cardiac arrest. The aim of this observational prospective study with an estimated recruitment of 50 patients is to examine the interrelation between PLR and SSEP. PLR will be assessed by Neurological Pupil index (NPi) and SSEP by the cortical N20 response to stimulation of the median nerve.

NCT ID: NCT04718389 Recruiting - Asthma Clinical Trials

A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype

NIMBLE
Start date: January 26, 2021
Phase: Phase 3
Study type: Interventional

This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic Baseline standard of care (SoC) asthma treatment.

NCT ID: NCT04714463 Recruiting - Breast Cancer Clinical Trials

Effects of Expectations and Body Image in Breast Reconstruction

Start date: February 1, 2021
Phase:
Study type: Observational

A breast reconstruction after mastectomy, either due to breast cancer or a high lifetime risk for cancer, is performed to increase the patient's quality of life. However, there are studies that show that some women regret their decision to have breast reconstruction. There are also studies demonstrating similarities in the general patterns of psychosocial adjustment and quality of life among women with breast cancer who have undergone breast-conserving surgery, mastectomy alone, and mastectomy combined with breast reconstruction. Hence, it is unclear which women actually benefit from a breast reconstruction. The concept of quality of life is connected to patient satisfaction and body image/investment. Therefore, the aim of this project is to examine the effects of patient expectations and body image on the patient reported outcomes of breast reconstruction, to improve preoperative information and postoperative care for women considering a breast reconstruction.

NCT ID: NCT04712474 Recruiting - Hoarding Disorder Clinical Trials

In-home Decluttering Augmentation of Group CBT for HD

Start date: January 29, 2021
Phase: N/A
Study type: Interventional

The primary aim of trial is to determine the clinical efficacy of in-home decluttering augmentation of group CBT for reducing hoarding severity in adults with HD. The trial takes place in Sweden.

NCT ID: NCT04710355 Recruiting - Clinical trials for Failed Back Surgery Syndrome

Objective Data on Daily Activity in Patients Treated With SCS: the Intellis Study

Start date: August 1, 2020
Phase:
Study type: Observational

In spinal cord stimulation (SCS), most outcome data are based on patient questionnaires. The lack of tools for objective evaluation of the effects of SCS on chronic pain has posed a barrier for providing solid proof of the therapy. Currently, however, SCS-devices with an accelerator included are available on the market. The position orientation data provided by the neurostimulator therefore gives new possibilities for objective measurement of gross activity in daily life.

NCT ID: NCT04706195 Recruiting - Chronic Pain Clinical Trials

Early Accessible Person-centred Rehabilitation for Patients With Chronic Pain

EAPER-P
Start date: August 15, 2021
Phase: N/A
Study type: Interventional

The goal of the research project EAPER-P is to evaluate PCC person-centred care (PCC) in the form of a combined eHealth and telephone support for patents with chronic pain. A developed PCC eHealth platform, together with person-centred telephone conversations, will be used as a tool to identify patients´ resources to enhance coping and living with their illness by means of a dialog and partnership with staff and relatives. PCC in the form of a combined eHealth and telephone support will not replace, but instead be used as add on treatment to usual care (guideline directed care). In addition, a process evaluation of the intervention will be performed in order to evaluate the mechanisms behind the intervention and evaluate which parts of the interventions the participants find useful.

NCT ID: NCT04702711 Recruiting - Primary Health Care Clinical Trials

Experiences of Anger in Patients in Primary Health Care With Symptoms of Generalized Anxiety

Start date: October 19, 2020
Phase:
Study type: Observational

Symptoms of generalized anxiety is common in the general population and is often treated in primary health care. Anger is an emotion that can lead to interpersonal problems but can also be an agent for justice and change. Previous research has shown a link between generalized anxiety and anger but there is a lack of qualitative research investigating how individuals with symptoms of generalized anxiety experience anger. The aim of this research study is to increase knowledge about how anger is experienced in adult patients in primary health care with symptoms of generalized anxiety and about the experiences of health care professionals working with patients with symptoms of generalized anxiety.

NCT ID: NCT04701853 Recruiting - Colon Cancer Clinical Trials

Specific Training After Stoma Surgery

STASS
Start date: May 1, 2021
Phase: N/A
Study type: Interventional

In Sweden, approximately 43,000 people have undergone surgery with ileo-, colo- or urostomy. The most common type of stomy is a sigmoidostomy. A large proportion, about 50%, of patients who receive a permanent sigmoidostomy develop a parastomal hernia which may have major impact. There are indications that specific abdominal exercise may reduce the risk of parastomal hernias, but randomized studies are lacking. The aims of the study are: 1. to evaluate the effect of specific exercise to counteract the development of parastomal hernia in sigmoidostomy and the hernia's impact on ostomy function, physical function and quality of life. 2. to examine patients' experience of living with parastomal hernia. The study plans to include 240 patients who on will undergo surgery and receive a sigmoidostomy. These will be randomized to receive only advice according to the usual routine to avoid the development of parastomal hernia or these advice with the addition of specific abdominal muscle training. The training is initiated before the operation and is then carried out during the first postoperative year. Follow-up will be done with a clinical assessment and with measurement of bulge and size of the parastomal hernia manually, with electronic measuring equipment and via computed tomography images. Patients will assess their stoma and stoma function and assess any discomfort and its consequences of hernia via a study-specific questionnaire. Type of ostomy bandage will also be registered. The evaluation will be carried out 6, 12 and 36 months postoperatively. Prior to the start of sub-study a, the planned measurement methods to assess whether a parastomal hernia is present will be tested for validity. In addition, a group of patients (≥15 people) with parastomal hernia will be included in a qualitative sub-study where they will be interviewed about their experiences of the hernia hernia and how it may affect daily life. The present study will be able to answer whether specific exercise can reduce the risk of parastomal hernia. Methods for clinically assessing and evaluating bulging and hernias will be tested and evaluated in relation to patient-reported symptoms. In addition, the study will provide information about the patient's experience of having a parastomal hernia and how it affects daily life and physical activity. The results will provide an increased understanding of parastomal hernias, which may change the follow-up of patients in the future.