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NCT ID: NCT06253754 Recruiting - Clinical trials for Post-Dural Puncture Headache

Pathophysiological Mechanisms and Implication of Treatment in Postural Puncture Headache

PDPH
Start date: January 30, 2024
Phase:
Study type: Observational

To improve treatment for post dural puncture headache, its pathophysiology needs to be explored. Dural puncture alters CNS dynamics; using advanced MRI, we aim to investigate PDPHs pathophysiology explained by brain movement, cerebral blood flow, CSF dynamics and the effect of epidural blood patch.

NCT ID: NCT06250998 Recruiting - Clinical trials for AAA - Abdominal Aortic Aneurysm

Prediction of Abdominal Aortic Aneurysm Shrinkage After Stent-placement With Artificial Intelligence

ARTinEVAR
Start date: April 3, 2024
Phase:
Study type: Observational

The goal of this observational study is to find out what factors contribute to a good treatment outcome in patients who have received a stent for their dilation of the main abdominal artery (abdominal aortic aneurysm or AAA). The primary goal of this study is to build a prediction model for abdominal aortic aneurysm shrinkage one year after the treatment.

NCT ID: NCT06248996 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients

ARTSCAN VI
Start date: March 4, 2024
Phase: Phase 3
Study type: Interventional

There is an unmet need to personalise treatment for patients with head and neck squamous cell carcinoma (HNSCC) and to improve treatment results for patients with advanced disease. In this phase III study, HNSCC patients with prognostic factors indicating increased risk of treatment failure that are aimed for curative treatment with radiotherapy (RT) will be randomised between standard treatment (conventionally fractionated RT with final RT dose 68.0 Gy) and hyperfractionated RT (HFX-RT) with final RT dose 83.0 Gy. In order to find better prognostic and predictive tools the study also includes exploratory and translational analyses including evaluation of grade of hypoxia with Magnetic Resonance Imaging (MRI) and gene profiling by RNA-sequencing, tumour immune profiling, comparisons of global gene expression, gene aberrations and protein expression, and texture analyses of CT, FDG-PET and MRI images used during RT preparation and during patient follow-up. Patients with tumours with lower risk of recurrence, not eligible for randomisation in the study, can still participate in the translational parts of the study not investigating response to altered fractionation.

NCT ID: NCT06248957 Recruiting - Allergy Clinical Trials

SYSTEMS-LEVEL ANALYSES OF IMMUNE DYSREGULATION

SAID
Start date: January 1, 2024
Phase:
Study type: Observational

The aim of the SAID study is to create a national resource in Sweden to enable comprehensive immunological analyses of an extremely complex and clinically challenging group of individuals with variable forms of immune system dysregulation. We hope to establish a biobank of primarily blood and fecal samples from children and adults, with confirmed or suspected immune dysregulation, as well as age- and sex- matched healthy controls, for comparisons of immune cell/mediator alongside various clinical presentations of these immunological diseases as well as microbiome samples as possible a possible modifier of clinical presentations. The project will also include the establishment of a national database with deep immunological data, treatment and clinical outcomes for these patients, accessible to participating researchers and clinicians.

NCT ID: NCT06248450 Recruiting - Cancer Clinical Trials

Medical YOga dUring CANcer Treatment in a Digital or Physical Setting - a PREFERensbased Study

YouCanPrefer
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

To enhance the implementation of yoga in cancer care, studies that explore patients with cancer preferences for the execution of yoga, effects, and the experience of participating in group yoga sessions online compared to in-person sessions is required. The aim of the YouCanPrefer-study is to explore preferences, expectations, implementation, experiences, and effects of participating in in-person group yoga sessions at a yoga studio compared to participating in online-yoga at home for patients with cancer undergoing oncological treatment. Additionally, the aim is to study health-related outcomes of yoga. Patients diagnosed with cancer undergoing oncological treatment at two hospitals in Sweden will be included in the study. A preference-based allocation will be used, participants chose self if they want to participate in in-person yoga at a studio or in yoga online. Regardless of allocation, the yoga sessions will take place in a group setting once a week for a duration of 12 weeks. All participants will also have access to a yoga application on their tablets or cell phones, with a recommendation to engage in self-guided yoga for at least 10 minutes per day.

NCT ID: NCT06247397 Recruiting - Clinical trials for Interstitial Lung Disease

Effect of HIgh-flow Therapy in Long-term Oxygen Therapy

HILOT
Start date: June 10, 2024
Phase: N/A
Study type: Interventional

This is a registry-based, randomized, controlled clinical trial of the effect of added high-flow oxygen therapy (using the device Lumis HFT) during one year in people with long-term oxygen therapy (LTOT) for chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).

NCT ID: NCT06246448 Recruiting - Gall Bladder Cancer Clinical Trials

Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer (ROBOCOP)

ROBOCOP
Start date: January 23, 2024
Phase: N/A
Study type: Interventional

The Robocop trial is an international multi-centre, single blinded, randomized controlled superiority trial conducted in centres experienced in robotic-assisted liver surgery. Eligible patients for radical cholecystectomy will be randomized in a 1:1 ratio to undergo robotic-assisted or open resection within an enhanced recovery setting. The primary endpoint is time to functional recovery. Secondary endpoints include length of hospital stay, resection margin, number of retrieved lymph nodes, postoperative complications, quality of life, abdominal wall complaints and direct and indirect costs.

NCT ID: NCT06244602 Recruiting - Clinical trials for Chronic Non-Cancer Pain

Test-retest and Experiences During Balance Assessment With the Mini-BESTest

Start date: February 14, 2024
Phase:
Study type: Observational

The goal of this observational study is to test psychometric properties of a clinical balance assessment scale, the Mini-BESTest, as well as to explore experiences and beliefs about balance and being balance tested. The main research questions are: - What is the test-retest reliability of the Mini-BESTest balance assessment scale for individuals with long-term pain? - What is the individual's subjective beliefs and experiences about their own balance and being balance tested with the Mini-BESTest? Tow samples of participants will be included. One sample for a) the test-retest evaluation or b) an interview during and after performing the Mini-BESTest.

NCT ID: NCT06242600 Recruiting - Clinical trials for Tolerability of the CytaCoat LIP Foley Catheter

Evaluation of Safety and Performance of the CytaCoat Lubricious Infection Prevention (LIP) Foley Catheter

Start date: January 29, 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this pilot safety and tolerability study is to determine whether the novel CytaCoat LIP (Lubricious Infection Prevention) Foley catheter is safe to use in patients during short term use. The primary objective of this study is to determine the safety and tolerability for the medical device CytaCoat LIP Foley catheter in patients undergoing Transurethral Resection of the Bladder (TUR-B) surgery. Safety will be assessed by evaluation of adverse events. The secondary objective is to assess the overall performance by evaluating if there were any Foley catheter handling problems experienced by the healthcare personnel with the use of the CytaCoat LIP Foley catheter. Exploratory objectives are to assess bacterial culture of urine samples taken before and after catheterization and to assess pain, irritation and discomfort measured by asking patients about their experience using the catheter using a questionnaire. Participants will be catheterized with either a CytaCoat Foley catheter or an uncoated silicone catheter, for a maximum of 24 hrs. After removal of the catheter, participants will be asked to assess if they experienced any pain, irritation and discomfort measured with the Numerical Rating Scale (NRS) (0-10). A similar assessment will be performed 7-10 days after removal of the catheter. In addition, the healthcare personnel will be asked to assess the functionality of the coated catheter with the NRS scale (0-10), using a questionnaire. Urine samples will be taken before and after catheterization and evaluated through quantification.

NCT ID: NCT06241313 Recruiting - Migraine Clinical Trials

Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine

ECLIPSE
Start date: March 25, 2024
Phase: Phase 3
Study type: Interventional

A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often accompanied by throbbing, sensitivity to light, sensitivity to sound, nausea, or other symptoms. The main goal of the study is to see if atogepant is effective, safe, and well-tolerated in treating migraine attacks quickly. Atogepant is a medicine currently approved for the preventive treatment of migraine in adults and has been shown to be effective and well tolerated when taken daily to prevent migraine attacks. This study includes double-blind phase means that neither the participants nor the study doctors know who is given which study treatment (atogepant or placebo) followed by an open-label phase meaning that both participants and study doctors know which study treatment is given. All participants will receive atogepant during the open-label part of the study. This study will include 1300 participants aged 18-75 years with a history of migraine at approximately 160 sites across the world. All participants will receive both atogepant and placebo to treat qualifying migraines. At the start of the study, participants will be randomized to 1 of 4 dosing sequences to determine when they will receive atogepant and when they will receive placebo during the study. After treating 4 qualifying migraine attacks, participants will receive open-label atogepant for any additional migraine attacks they have until the end of the study (Week 24). There may be a bigger responsibility for participants in this study than there would be in participants receiving standard of care treatment. participants will attend regular visits during the study at a hospital or clinic, as well as telephone visits, and the effects of treatment will be checked by completion of questionnaires in an electronic diary, medical assessments, blood tests, and checking for side effects.