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NCT ID: NCT03697941 Completed - Clinical trials for Mitral Valve Disease

Percutaneous Plug-based Arteriotomy Closure Device Use in Minimally Invasive Mitral Valve Surgery

Start date: February 2016
Phase:
Study type: Observational

A single-center prospective study. Patients undergoing minimally invasive mitral valve surgery between February 2016 and December 2018 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed either with surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review and from the Swedish Web system for Enhancement and Development of Evidence based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) electronic data collection platform.

NCT ID: NCT03697265 Completed - Clinical trials for Premenstrual Dysphoric Disorder

A Study of Efficacy and Safety of Sepranolone (UC1010) in Patients With Premenstrual Dysphoric Disorder (PMDD)

Start date: April 20, 2018
Phase: Phase 2
Study type: Interventional

The objective of this phase IIb study is to evaluate the effect and safety of Sepranolone (UC1010) on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD). Patients will be taking Sepranolone or Placebo (blinded to patient and study doctor) during the two weeks preceding the menstruation of three menstrual cycles. Effect (change from baseline) will be assessed by comparison of symptoms recorded daily by the patients using a validated rating scale for assessment of PMDD symptoms. Sepranolone is an endogenous steroid.

NCT ID: NCT03696888 Completed - Clinical trials for Alcohol Use Disorder

Skills-training for Reducing Risky Alcohol Use in App Form

Start date: December 7, 2018
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of a skills training web-based mobile phone application, Telecoach among individuals in the general population seeking help for their risky alcohol consumption on the Internet. The design is a two-armed randomized controlled design, and outcomes are measured in terms of changes in excessive alcohol use at follow up 6, 12 and 26 weeks after study initiation and baseline data gathering. The Telecoach web app delivers skills training in the form of exercises commonly used in psychosocial interventions for risky alcohol use. The controll condition is a web app providing information on the effects of alcohol on the consumers' health.

NCT ID: NCT03695445 Completed - Hypotension Clinical Trials

Safety of Norepinephrine Administered Through Peripheral Venous Catheter

Start date: February 20, 2019
Phase:
Study type: Observational

Norepinephrine is a drug that elevates the blood pressure. It is routinely administered through peripheral catheters during surgery. There is a risk of tissue damage in case of leakage of Norepinephrine from the catheter to the surrounding tissue. Another risk is irregular administration of Norepinephrine due to kinking of the peripheral catheter. This could lead to fluctuations in blood pressure. The primary aim of the study is to investigate complications from Norepinephrine administered in peripheral venous catheters. The secondary aim is to investigate if comorbidity, placement of the peripheral catheter or the duration of the infusion are associated with a higher rate of complications. 1000 patients will be included. Inclusion criteria: Patients who will undergo surgery with need for vasopressor support. Exclusion criteria: The patient has a central venous catheter, a peripherally inserted central venous catheter or lack of informed consent.

NCT ID: NCT03694340 Completed - Child Clinical Trials

Optimization of Cochlear Implant MAP-parameters in Children

Start date: October 25, 2018
Phase: N/A
Study type: Interventional

This project will complete a long-term follow up for children that have received cochlear implants (CI) early in life and had their CI's programmed based on objective measurements. At Sahlgrenska University Hospital in Gothenburg, generally, all younger children (0-3 years), the last ten years, had their CI's programmed based on objective measurements. The programming of the CI carried out during the first year after the surgical insertion is done on the foundation of the objective measurements and is generally what the child will live with thereafter. This method also seem to be close to other clinics in Sweden and the rest of the world, however, there are no specific guidelines regarding the how the programming of the CI is to be carried out on small children. To this date there are no studies, to our knowledge, that have confirmed the validity of using these objective measurements and if it is the best for the child. We therefore aim to do a long term follow up on children that have received CI and programmed this way, and study if there would be beneficial to redo the programming when the child is old enough to actively participate. The aim with this project is evaluate how suitable it is to mainly use objective measurements when programming the cochlear implant and, in addition to this, examine if the children's hearing can be improved if the programming is based on the behavioral measurements of sound when the children are old enough to participate in such. It will examine what happens with the end result if the programming foundation differentiates from one another; if there are any measurable differences in hearing skills. The result from this project expects to generate knowledge that is highly important for those working with small children receiving CI's, and by extension it will benefit the children that rely on this device in there every day life.

NCT ID: NCT03693521 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effects of Measurement of Handgrip Strength on Physical Activity Level for Patients With Diabetes Type 2

Start date: October 7, 2019
Phase: N/A
Study type: Interventional

Background: It is recommended that patients with diabetes type 2 keep themselves physically active and it is known that good muscular strength has a positive effect on these patients. Aim: To determine whether physical activity level increases and whether other risk factors for cardiovascular disease are positively affected by including measurement of handgrip strength as part of the regular care program for patients with diabetes type 2 in primary care. Method: Patients with diabetes type 2 who go to regular check-ups by participating diabetes-nurses in primary care are randomized to either intervention or control group. In the intervention group, handgrip strength is measured in addition to standard care. the control group receives standard care at inclusion. Handgrip strength is measured in both groups at 1 year follow-up. Physical activity level is measured in both groups at inclusion and 1 year follow-up with a questionnaire. Measurement of other risk factors for cardiovascular morbidity are measured at both inclusion and follow-up in both groups as dictated by standard care routines. Expected results: Measurement of handgrip strength can give health care personnel greater possibilities to identify those patients with diabetes type 2 who need to increase their activity level and to give them more concrete support. It is possible that the attention given to handgrip strength and physical activity may motivate patients to increase their activity level, become stronger and eventually reduce other risk factors for cardiovascular morbidity.

NCT ID: NCT03693378 Completed - Clinical trials for Pancreatic Ductal Adenocarcinoma

A Study of IMMray™ PanCan-d Test for Early Detection of Pancreatic Cancer in High-risk Groups

Start date: January 19, 2016
Phase:
Study type: Observational

PanFAM-1 is a clinical study for early detection of pancreatic cancer in high-risk groups. The goals of the study are to assess the performance and diagnostic accuracy of the IMMray™ PanCan-d test compared to standard-of-care imaging.

NCT ID: NCT03691116 Completed - Mental Health Clinical Trials

Digital Self-help Support for Lifestyle Behavior Changes Among Primary Care Outpatients With Mental Health Problems

Start date: January 23, 2017
Phase: N/A
Study type: Interventional

All patients, who have booked a first appointment with a psychologist or counselor at two primary care clinics, are asked to fill out a lifestyle screening questionnaire within the Electronic Medical Record (EMR) system. Up to 150 patients will be screened. The patients who have filled out the first screening and given informed consent are randomized to either Group A: A digital health check-up, with more questions and brief feedback; or Group B: Treatment as usual. The digital health check-up is based on "Hälsoprofilen", a material that successfully has been used with thousands of patients in Western Sweden. This material generates brief feedback to the patients about the status of their lifestyle behavior and indicates the need for change when necessary for better health. After 10 weeks, the patients fill in the first short screening again. Outcome analyses will compare the two groups.

NCT ID: NCT03687801 Completed - Hearing Impairment Clinical Trials

Clinically Implementing Online Hearing Support Within Hearing Organization

Start date: September 24, 2018
Phase: N/A
Study type: Interventional

Previous research has proposed employing telehealth in hearing healthcare to improve clinical care and increase access to hearing services. Several studies have shown that hearing support can be carried out without in-person meetings and lead to significant benefits for hearing aid users. Interventions for persons with hearing impairment improve communication and improve outcomes more than hearing aid use alone. The first purpose of this study is needs-oriented and the second purpose is research-oriented. The needs-oriented purpose of this project is to, via a national website of health information and services for Sweden, provide needed online support to hearing aid users. The research-oriented purpose of this project is to document the effectiveness of the online support compared to traditional support that the Hearing Organization, provides ("standard care").

NCT ID: NCT03684941 Completed - Clinical trials for Intermittent Urethral Catheterization

Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization.

Start date: August 29, 2018
Phase: N/A
Study type: Interventional

This is a prospective, double-blinded, randomized, multi-centre, cross-over study. All subjects will use both the study device (test catheter) and the comparator (control catheter) for one week each.