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NCT ID: NCT06414824 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

The isCGM Use and Hypoglycemic Episodes and Fear of Hypoglycemia in Newly Diagnosed Type 1 Diabetes

PENELOPE
Start date: May 1, 2022
Phase: N/A
Study type: Interventional

The aim of this trial is to investigate the impact of FreeStyle Libre use compared to SMBG on hypoglycemia episodes and fear of hypoglycemia in adults aged 18-35 with newly diagnosed type 1 diabetes. This trial is conducted in university centers in Poland (Bialystok, Krakow, Poznan, Zabrze).

NCT ID: NCT06414265 Recruiting - Heart Failure Clinical Trials

Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation

CASSINI-EU
Start date: April 4, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter approach. The main questions it aims to answer are: - is the use of the device feasible? - is it safe (defined as freedom from device-related major adverse events at 30 days)? - does it perform (defined as reduction of MR Grade to ≤ 1+ at 30 days)? Participants will need to do the following as part of the clinical trial: - complete 6-Minute Walking Test - complete Quality of Life Questionnaires - undergo blood evaluations - CT scan - 12 lead ECG - Transesophageal Echocardiography - Transthoracic Echocardiogram - the study procedure (valve implantation, right heart catheterization, left arterial pressure, fluoroscopy/ angiogram)

NCT ID: NCT06412562 Recruiting - Depressive Disorder Clinical Trials

M3VAS Validation in Polish Population

Start date: May 9, 2024
Phase:
Study type: Observational

Low mood and anhedonia represent the fundamental symptoms of major depressive disorder (MDD). Nevertheless, there is currently no standardized visual analogue scale available to assess the extent of both symptoms concurrently. The Maudsley 3-item Visual Analogue Scale (M3VAS) is a newly developed tool for participants to self-assess core symptoms of depression: mood quality, pleasure experience (anhedonia), and suicidality. Despite suicidality not being a primary symptom, it is included due to its critical relevance to safety. Participants will be instructed to rate the intensity and frequency of their experiences over the preceding two weeks by marking a 100 mm ungraded line. A researcher will then assign a numerical value based on the mark's position, utilizing the left edge as 0 and the right as 100. The total score range, combining the three symptoms, ranged from 0 (minimum) to 300 (maximum). The M3VAS exhibited good psychometric properties in British population. In this study, the objective is to assess the psychometric properties of the scale within the Polish population diagnosed with major depressive episode within major depressive disorder or bipolar disorder.

NCT ID: NCT06408441 Recruiting - Sarcoma,Soft Tissue Clinical Trials

The Epithelioid Hemangioendothelioma Registry of the European Reference Network on Rare Adult Solid Cancers (EURACAN)

EHE
Start date: December 1, 2023
Phase:
Study type: Observational [Patient Registry]

Epithelioid hemangioendothelioma (EHE) is an ultra-rare sarcoma, marked by distinctive molecular and pathological features and with a variable clinical behavior. Its natural history is still partially understood, reliable prognostic and predictive factors are lacking and many questions are still open on the optimal management. In the context of EURACAN, a prospective registry specifically dedicated to EHE was developed and launched with the aim of providing, through high-quality prospective data collection, a better understanding of this disease. The study design is a registry-based cohort study including only new cases of patients with a pathological and molecularly confirmed diagnosis of EHE. The objectives are to improve the understanding of EHE natural history, validate and identify new prognostic and predictive factors, clarify the activity and efficacy of currently available treatment options, describe treatment pattern. It is an hospital-based registry established in centres with expertise in EHE including adult patients with a new pathological and molecularly confirmed diagnosis of EHE starting from the 1st December 2023. The characteristics of each patient in the facility who meets the above-mentioned inclusion criteria will be collected prospectively and longitudinally with follow-up at cancer progression and / or cancer relapse or patient death. The data analyses will include descriptive statistics and analytical analyses. Multivariable Cox's proportional hazards model and Hazard ratios (HR) for all-cause or cause-specific mortality will be used to determine independent predictors of overall survival, recurrence and progression. The registry has been joined by 21 sarcoma reference centers across EU and UK, covering 10 countries. Patients' recruitment started in December 2023. The estimated completion date is December 2033 upon agreement on the achievement of all the registry objectives. The already established collaboration and participation of EHE patient's associations involved in the project will help in promoting the registry and fostering accrual. This registry has been developed with the support of EHE Rare Cancer Charity UK, STATER (Grant Agreement number: 947604, HP-PJ-2019) and EURACAN 2022 (Grant Agreement number: 101085486, EU4H-2022-ERN-IBA) European Health and Digital Executive Agency (HaDEA)

NCT ID: NCT06406920 Recruiting - Cardiac Arrest Clinical Trials

Intravascular Clotting (POCUS) - Marker of the Timing and Severity of Cardiac Arrest; Indicator of Futile Resuscitation

Start date: April 29, 2024
Phase:
Study type: Observational [Patient Registry]

The scientific goals of the project: 1. ultrasound assessment of the incidence of clotting in deep veins in patients after cardiac arrest during resuscitation and after the declaration of death; comparison to the incidence of clotting in the heart cavities 2. comparison of resuscitation results in patients with and without clotting detected in deep veins during resuscitation 3. determining the time from cardiac arrest to the occurrence of clotting in deep veins; comparison to the time until clotting occurs in the heart cavities Confirmation of the usefulness of the ultrasound-detected clotting in deep veins during resuscitation in assessing the severity of cardiac arrest and the prognosis of resuscitation, which is the aim of the project, will have an impact on international guidelines for determining the prognosis and potential futility of resuscitation.

NCT ID: NCT06399393 Recruiting - Multiple Myeloma Clinical Trials

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

KarMMa-9
Start date: October 16, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

NCT ID: NCT06395831 Recruiting - Spinal Canal Tumors Clinical Trials

Assessment of Quality of Life and Independence, as Well as Received Social Support for Spinal Cancer.

Start date: June 15, 2023
Phase:
Study type: Observational

- Evaluation of the quality of life of patients before and after surgery for benign and malignant spinal cancers, assessing whether it depends on the size of the tumor, type of cancer, malignancy and its location - evaluation of patients' independence before and after surgery for benign and malignant spinal tumors, evaluation of what factors influenced patients' different independence - multidimensional assessment of perceived social support of patients before and after surgery for benign and malignant spinal cancers, taking into account three sources of support: significant person, family and friends

NCT ID: NCT06395805 Recruiting - Head Cancer Clinical Trials

Evaluation of Quality of Life and Self-assurance and Social Support Earned for Non-cellular Head Cancer

Start date: June 15, 2023
Phase:
Study type: Observational

Research objectives: - To evaluate the quality of life of patients before and after surgery for benign head tumors ( meningiomas) and malignant tumors at stage I, II and III, to assess whether it depends on the size of the tumor, type of tumor, malignancy and its location - evaluation of the independence of patients before and after surgery for head tumors at different stages of the disease - benign tumors (meningiomas) and malignant tumors in stage I, II and III, evaluation of what factors affected the different independence of patients - Multidimensional evaluation of perceived social support of patients before and after surgery for head cancers - benign ( meningiomas) and malignant tumors in stage I, II and III, taking into account three sources of support: significant person, family and friends Scientific (research) problems: - What is the quality of life of patients before and after surgery for benign ( meningiomas) and malignant head cancers at stages I, II and III ? Is quality of life in patients with head cancer dependent on tumor size, malignancy, location or type of cancer ?

NCT ID: NCT06395766 Recruiting - Colorectal Cancer Clinical Trials

Assessment of Quality of Life and Social Support Gained in Patients Before and After Colorectal Cancer Surgery

Start date: May 15, 2023
Phase:
Study type: Observational

- evaluation of the quality of life of patients before and after laparoscopic surgery for rectal cancer and cancer of the right part of the intestine at different stages of the disease, whether it depends on the size of the tumor, neoadjuvant treatment, type of cancer and its location - Multidimensional assessment of perceived social support (considering three sources of support: significant person, family and friends) of patients before and after laparoscopic surgery for rectal cancer and cancer of the right part of the intestine, whether it depends on the stage of the disease, the location of the tumor lesion and the treatment undertaken

NCT ID: NCT06394453 Recruiting - Newborn Asphyxia Clinical Trials

Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

Therapeutic hypothermia (TH) is the standard of care for newborns with moderate to severe hypoxic-ischaemic encephalopathy (HIE) born at 35 weeks or more of gestation. Many neonatal units do not use enteral feeding during TH, in fear of increased risk of complications. Withholding enteral feedings during TH lacks supporting evidence. The aim of the study is to determine if enteral feeding during TH in patients with HIE is safe and assess its effects. Investigators will perform multicenter randomized controlled study in level III neonatal intensive care units on infants qualified for TH. Infants will be randomized into 2 groups: (1) unfed during 72 hours of TH; (2) fed group, which will start receive enteral feeding with mother milk or human donor breast milk at 10 ml/kg/day during first day of TH, 20 ml/kg/day during second day, 30 ml/kg/day during third day. The primary outcome will be (1) combined necrotizing enterocolitis or death, (2) length of hospital stay. The secondary outcomes will be (1) time to full enteral feeding, (2) late-onset sepsis, (3) Test of Infant Motor Performance scoring, (4) MRI scoring, (5) MR spectroscopy parameters.