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NCT ID: NCT06135233 Completed - Pancreas Disease Clinical Trials

Implementation and Outcome of Minimally Invasive Pancreatoduodenectomy in Europe:

E-MIPS
Start date: January 1, 2019
Phase:
Study type: Observational

A planned analysis of outcomes among consecutive patients after MIPD from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.

NCT ID: NCT06134349 Recruiting - Bipolar Disorder Clinical Trials

The Bipolar Lithium Imaging Scan Study.

BLISS
Start date: March 13, 2024
Phase:
Study type: Observational [Patient Registry]

The primary goal of this observational study is to explore to which extent lithium concentrations in the brains in BD subjects correlate with clinical treatment response. Secondary, to determine correlations of brain lithium concentrations with serum lithium levels. Participants will undergo lithium magnetic resonance spectroscopy imaging (MRSI) within two weeks of reaching adequate serum lithium level. A blood sample will be drawn to determine lithium serum level and after one year a validated questionnaire will be used to assess clinical lithium response. Participants start with lithium treatment as part of their regular treatment.

NCT ID: NCT06133244 Recruiting - Systemic Sclerosis Clinical Trials

Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME)

Start date: April 19, 2024
Phase:
Study type: Observational

Almost 90% of systemic sclerosis (SSc) patients experience hand function limitation, which leads to impaired daily functioning and work participation. An important cause of impaired hand function are contractures of the hand, which are reported in up to a half of patients. With this longitudinal cohort study in patients with SSc and VEDOSS (very early diagnosis of systemic sclerosis) the investigators aim to gain more insight into processes involved in hand function impairment.

NCT ID: NCT06132958 Recruiting - Endometrial Cancer Clinical Trials

Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)

Start date: December 6, 2023
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to compare sacituzumab tirumotecan to Treatment of Physician's Choice (TPC) with respect to progression-free survival (PFS) per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR), and overall survival (OS). The primary hypotheses are that sacituzumab tirumotecan is superior to TPC with respect to PFS per RECIST 1.1, as assessed by BICR, and that sacituzumab tirumotecan is superior to TPC with respect to OS.

NCT ID: NCT06132750 Recruiting - Clinical trials for SELENON-related Myopathy

A 5-year Natural History Study in LAMA2-related Muscular Dystrophy and SELENON-related Myopathy.

Start date: October 6, 2023
Phase:
Study type: Observational

SELENON-related myopathy (SELENON-RM) and LAMA2-related muscular dystrophy (LAMA2-MD) are congenital neuromuscular disorders presenting with slowly, progressive axial muscle weakness, spinal rigidity, scoliosis and respiratory insufficiency. Currently, no curative treatment options exist, yet promising preclinical trials are ongoing. Clinical trials are expected to start within 5 years. Natural history data and outcome measures for measuring therapy effectiveness were lacking. Therefore, the LAST STRONG Study (a 1.5-year natural history study) started in 2020. With the extended LAST STRONG Study, we aim to further analyze and expand the 1.5-year natural history data on SELENON-RM or LAMA2-MD to provide a detailed clinical description of the Dutch and Flemish cohort. This will enable a smooth transition towards implementation into clinical care and clinical trials. The extended LAST STRONG Study is a prospective, observational natural history study in Dutch-speaking patients of all ages diagnosed with SELENON-RM and LAMA2-MD. Patients will be invited to visit our hospital two times (3- and 5-years) after the first visit in the LAST STRONG Study. During both visits, patients will undergo a subset of tests (neurological examination, functional measurements, questionnaires, muscle ultrasound, MRI, pulmonary assessment and accelerometry). All measurements are adapted to the patient's age and functional disabilities.

NCT ID: NCT06132607 Completed - Lung Cancer Clinical Trials

3D Lung Reconstructions Using Open-source Software for Lung Cancer Surgery

3D-LUNG
Start date: December 21, 2022
Phase: N/A
Study type: Interventional

Preoperative three-dimensional (3D) lung reconstructions can reduce intraoperative blood loss, conversion rate, and operation duration. Commercial products predominantly provide these 3D reconstructions, hence the aim of this study was to assess the usability and performance of preoperative 3D lung reconstructions created with open-source software.

NCT ID: NCT06131034 Recruiting - Sleep Clinical Trials

Does Perioperative Music Prevent Sleep Disturbances in Hospitalized Surgical Patients

DREAMERS
Start date: August 9, 2023
Phase: N/A
Study type: Interventional

Sleep disturbances are known to be a prevalent problem in hospitalized, surgical patients, which is of importance since sleep disturbances can lead to a range of negative health outcomes. Music interventions have shown potential in improving sleep quality. Unfortunately, the studies on the effect of music on sleep in surgical patient populations are still scarce and of low quality. Therefore, the aim of this study is to study the effect of music on sleep quality in oncological, gastro-intestinal surgical patients in the form of a randomized controlled trial. Participants will be divided in 2 groups, a music group and a control group, where the music group will receive music interventions perioperatively. The researchers will compare both groups to see if there is a difference in sleep quality.

NCT ID: NCT06130553 Recruiting - Clinical trials for Advanced Solid Tumours That Are MTAP Deficient

A Study of AZD3470, a PRMT5 Inhibitor, in Patients With MTAP Deficient Advanced/Metastatic Solid Tumours

PRIMROSE
Start date: January 18, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a first time in human (FTiH) Phase I/IIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumours with MTAP deficiency. The study consists of several study modules, evaluating the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of AZD3470 as monotherapy or in combination with other anti-cancer agents.

NCT ID: NCT06130111 Active, not recruiting - Breast Cancer Clinical Trials

Spatial Location of Breast Cancer Local Recurrence After Mastectomy

Secret
Start date: September 1, 2021
Phase:
Study type: Observational

Rationale:To improve the definition of the target volume for radiotherapy of the chestwall after different types of mastectomy, the exact localization of regions at risk for a local recurrence should be known. However, there are currently insufficient data in literature showing where local recurrences occur after different types of mastectomy. Objective: The primary objective of the proposed study is to determine whether the spatial, location of a breast cancer recurrence after mastectomy, differs for different types of mastectomy. Study design: Retrospective study evaluating spatial location and site of recurrences after mastectomy. Study population: The investigators aim to include all breast cancer patients treated with mastectomy in the Netherlands between 2003- 2008, and known to have experienced a local recurrence as the first site of failure. Primary endpoint: Spatial location of local recurrence (e.g., primary tumour bed, scar, skin, subcutaneous, nipple, areola, pectoral muscles).

NCT ID: NCT06129669 Enrolling by invitation - Surgery Clinical Trials

ICG Indocyanine Green in Reconstructive Surgery

ICG-R
Start date: May 9, 2023
Phase:
Study type: Observational

The success or failure of a reconstruction is largely related to the vascularization of the operated area. Near infrared fluorescence (also near infrared fluorescence angiography, NIR FA) with ICG administration is an innovative technique to quantify tissue perfusion. Based on the results obtained in other subspecialties, NIR fluorescence appears to be a promising way to quantify tissue perfusion in reconstructive surgery. Fluorescence research has previously been used in the context of microsurgery and breast reconstructions using implants, but structural objective determinations are lacking. Our study is successful if we are able to determine a cut off value for the absolute or relative perfusion parameters.