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NCT ID: NCT05782010 Recruiting - Clinical trials for Gastrointestinal Diseases

SCI-Pex Study - Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids

SCI-Pex
Start date: June 15, 2023
Phase: N/A
Study type: Interventional

The SCI-Pex study is a multicenter, prospective, non-controlled investigation on PexyEazy®, a new device for treatment of hemorrhoids based on the mucopexy method. Mucopexy is a well established method where sutures are applied above the hemorrhoids. When knots are tied, the hemorrhoids are lifted inwards to their normal position, which makes them swell down and symptoms disappears. PexyEazy® perform a mukopexy in a semiautomatic, faster and easier way on awake patient in less than 10 minutes. The SCI-Pex study will evaluate the safety and performance of PexyEazy on 35 patients with hemorrhoids grade II and III with a follow-up after 1 week, 3 months and 5 years. Adverse events, pain and other complications will be recorded, quality of life and hemorrhoid symptom questionnaires and clinical examination after 3 months will be monitored to evaluate the result after a PexyEazy® procedure.

NCT ID: NCT05781763 Recruiting - Clinical trials for Axial Spondyloarthritis

High-intensity Training in Patients With Spondyloarthritis: a Randomized Controlled Trial

Start date: March 21, 2022
Phase: N/A
Study type: Interventional

Project summary Background: For people diagnosed with a spondyloarthritis (SpA) e.g. ankylosing spondylitis or undifferentiated spondyloarthritis, physical activity and exercise are important components in the self-management. Exercise, in addition to physical and mental symptoms related to the disease can easily feel overwhelming to exercise, and low adherence may result. By studying the effects of high-intensity interval training (HIIT) in comparison with training as usual on physiological, inflammatory, and self-reported disease parameters in patients with SpA, we intend to further investigate the short-term and longitudinal training effects, and refine the knowledge to tailor, coach, and stimulate to self-performed HIIT. Objective: The purpose of this study is to investigate the short- and long-term effects of high- intensity interval training (HIIT) on physiological, inflammatory, and self-reported health parameters in patients with SpA. The aim is also to study the adherence to physical activity and exercise recommendations. Design: A randomized controlled trial (RCT) design. Participants: One hundred adults with a confirmed axial SpA from rheumatology clinics in southern Sweden will be recruited and randomized into two groups, the intervention group and the control group. Intervention: Three high-intensity training sessions per week for three months, of which two interval sessions, with coaching both from a clinical physiotherapist and digital devices (watch and app) followed by nine months with sporadic coaching. The control group will go on with exercise as usual. Primary outcome: Self-reported disease activity, inflammatory biomarkers (acute phase proteins). Secondary outcomes: Physical fitness (aerobic capacity (VO2max), blood pressure, grep strength), body composition and self-reported physical function, health status, well-being, pain, fatigue, adherence to physical activity and exercise recommendations, and confidence in one's own ability to manage pain, symptoms and high-intensity exercise, and additional serum biomarkers.

NCT ID: NCT05781490 Completed - Healthy Clinical Trials

A Healthy Volunteer Trial Investigating MR-enterography Image Quality of Lumentin® 44

Start date: February 6, 2023
Phase: Phase 2
Study type: Interventional

A healthy volunteer, open, PoC single center trial investigating a new oral contrast agent for use in combination of MR examination of the abdomen and pelvis. The main purpose of the trial is to evaluate if Lumentin® 44 used as a bowel filling agent in MRE examination generates images with acceptable diagnostic quality. In addition, the plasma electrolytes concentration levels, including, potassium, sodium, phosphate, and calcium, as well as ionized calcium will be evaluated over a 24 hour time period after intake of Lumentin.

NCT ID: NCT05779475 Enrolling by invitation - Parkinson Disease Clinical Trials

An Observational Study of Patients With Moderate Parkinson's Disease

TRANSCEND 1
Start date: April 5, 2023
Phase:
Study type: Observational

The main purpose of this study is to follow and observe a group of people living with Parkinson's disease to see how study participation affects their signs and symptoms in the months after starting in the study. While taking part in this study participants will take their usual medication as prescribed. However, the study doctor may recommend adjustments to their medication to provide a better treatment of their Parkinson's disease. Participation will last from 3 up to 24 months. During visits to the clinic, the study doctor or study nurse will evaluate signs and symptoms of Parkinson's disease using several different assessments. At a minimum of 2 visits participants will be asked to undergo 'off'-assessments.

NCT ID: NCT05776602 Recruiting - Brain Tumor Clinical Trials

Fast Brain MRI in Children With Suspected Brain Tumor

Fast MRI
Start date: May 1, 2023
Phase:
Study type: Observational

This study aims to assess the diagnostic performance of a new fast MRI sequence named Neuromix compared to routine clinical MRI for brain tumor in pediatric patients

NCT ID: NCT05775679 Recruiting - Clinical trials for Cleft Lip and Palate

Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q

CLEFT-QSwePsyc
Start date: February 15, 2022
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to test the questionnaire CLEFT-Q in a population of patients with cleft lip and/or palate. The main questions it aims to answer are: 1. Are CLEFT-Q scores reliable over time? 2. Can CLEFT-Q detect change following surgical treatment intervention? 3. What is the norm for CLEFT-Q within a control population who do not have cleft lip and/or palate? 4. What is the Minimal Clinically Important Change of CLEFT-Q in different subpopulations of cleft lip and/or palate? 5. Do changes in CLEFT-Q scores correlate with changes in objective outcomes following a surgical intervention? 6. What are the main expectations that patients express before a surgical intervention? 7. How do patients perceive that the results after surgical interventions meet their expectations? 8. Do patients express concepts of importance postoperatively that are not examined by CLEFT-Q? 9. How do healthcare professionals perceive that the use of CLEFT-Q affects clinical decisions and processes? Participants will 1. Fill out the questionnaire CLEFT-Q twice with a two-week space. 2. Before and 1 year after an operation. 3. Be interviewed about their experiences related to an operation or using CLEFT-Q. Researchers will compare results from the cleft lip and palate population to see if there is a difference between them and a population without cleft lip and palate.

NCT ID: NCT05775328 Recruiting - Hypertrichosis Clinical Trials

Treatment of Hypertrichosis With Intense Pulsed Light

Start date: December 1, 2023
Phase:
Study type: Observational

The goal of this observational cohort study is to investigate the effect of intense pulsed light (IPL) for excessive hair in patients >18 years of age and in need of gender affirmative treatment, refered to the department of dermatology and venereology, Umeå University Hospital, Sweden. The main questions this study aims to answer are: - [To evaluate the effect of consecutive IPL treatments in women with hirsutism due to polycystic ovarial syndrome (PCOS), with or without anti-androgen treatment] - [To evaluate the effect of consecutive IPL treatments in individuals born as biologically men but in transition to become women, with or without hormonal treatment]. Patients will use self-assessed questionnaires evaluating: - Background characteristics and time spend on concealing, reducing and treating hypertrichosis at home. - Ferriman-Gallwey scale, regarding the intensity of their hypertrichosis. - Dermatology Life Quality Index (DLQI) for quality of life Patients will be recruited consecutively and assessed at each visit, at the clinic before the treatments, ranging from baseline to a minimum of 5 treatment sessions.Since this is an observational study, all patients are treated by others than the researchers according to the routines och the clonic and there will be no other groups to compare the patients with.

NCT ID: NCT05775029 Recruiting - Clinical trials for Complication of Anesthesia

RSI Observation Follow-up

Start date: May 5, 2022
Phase:
Study type: Observational

The purpose of this prospective observational study is to determine if compliance to local guildelines for the RSI procedure, after introduction of a RSI-check list, persists over time (36-60months). Any changes in complication rates will also be evaluated.

NCT ID: NCT05774938 Recruiting - Quality of Life Clinical Trials

QoL After Complex Endovascular Aortic Repair

Start date: February 28, 2023
Phase:
Study type: Observational

The goal of this prospective observational cohort study is to compare health related quality of life in patients with abdominal aortic aneurysms treated by either standard or complex EVAR (endovascular aneurysm repair) devices. The main question it aims to answer are: - Compare differences between the physical scores from the preoperative to the postoperative settings between patients treated with standard EVAR vs non-stnadard endovascular aortic repair (F-/BEVAR) - To compare long-term physical scores postoperatively between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR) at one year. - To explore at which time points (if ever) patients treated with standard-EVAR and nonstandard endovascular aortic repair (F-/BEVAR) have restored or normalized physical scores measured by SF-12, measured at 30 days, 6 months, 1 and 3 years. Participants will be asked to fill out forms pre- and postoperatively with regards to health related quality of life. The different groups for comparison will be either standard EVAR for infrarenal aortic aneurysms or complex EVAR (fenestrated or branched) for paravisceral aortic aneurysms (PVAAA).

NCT ID: NCT05773261 Active, not recruiting - Osteoarthritis, Hip Clinical Trials

Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups

Start date: September 9, 2022
Phase: N/A
Study type: Interventional

A randomised controlled study comparing two types of ultra-porous coated uncemented cups in total hip arthroplasty. Primary objective is to investigate if the clinical, radiological and patient-reported outcome of the new MobileLINK TabecuLINK cup combined with an X-LINKed insert is non-inferior to the clinical and radiological outcome of the Pinnacle Gription series 100 cup combined with the Marathon liner. Patients are evaluated up to 15 years postoperatively.