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NCT ID: NCT06065540 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

REIMAGINE 2
Start date: September 27, 2023
Phase: Phase 3
Study type: Interventional

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).

NCT ID: NCT06060990 Recruiting - Clinical trials for Trace Element Deficiency

Determination of Copper and Other Trace Elements in Serum Samples From Patients With Biliary Tract Cancers

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

The aim of the study is to determine the total concentration of selected trace elements (Cu, Zn, Fe), the proportion of free Cu and Cu bound to ceruloplasmin and the isotopic ratio of Cu65/Cu63 in blood serum samples from healthy volunteers and cancer patients using inductively coupled plasma mass spectrometry-based methods. The results will be statistically evaluated and the potential applications of the analytical methods used in cancer diagnosis and therapy will be assessed.

NCT ID: NCT06025123 Recruiting - Hypothermia Clinical Trials

Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2

PRINCESS2
Start date: March 27, 2024
Phase: N/A
Study type: Interventional

The aim of this clinical trial is to study the impact of ultra-early transnasal evaporative cooling after cardiac arrest and subsequent hypothermia at hospital, on survival with complete neurologic recovery, compared to currently recommended normothermia. The study population will consist of patients 18-79 years old, with out-of-hospital cardiac arrest with initial shockable rhythm. The main research question it aims to answer is whether there is a difference in survival with complete neurologic recovery at 90 days after cardiac arrest between the group of patients that received ultra-early cooling, compared to the group that was treated with normothermia. Participants will be randomized to two groups. One group (the intervention group) will receive ultra-early trans-nasal evaporative cooling initiated by EMS personnel at the scene of the cardiac arrest, and subsequent systemic hypothermia for 24 hours at hospital arrival. The other group (the control group), will receive standard of care (advanced cardiac life support and normal body temperature (normothermia)).

NCT ID: NCT06023550 Not yet recruiting - Sinusitis Clinical Trials

Complicated Infections in Otorhinolaryngology

ENT_infect
Start date: August 2024
Phase:
Study type: Observational [Patient Registry]

This observational study aims to learn more about complicated infections treated by otorhinolaryngologists. The main questions to answer are: - What is the management of complicated sinonasal infections in Ljubljana, Slovenia, - What is the management of complicated ear and temporal bone infections in Ljubljana, Slovenia, - What is the management of complicated neck soft tissue infections in Ljubljana, Slovenia, - What is the management of complicated laryngeal infections in Ljubljana, Slovenia Participants will receive standard treatment according to the established evidence-based clinical practice.

NCT ID: NCT06012604 Not yet recruiting - Clinical trials for Xerostomia Following Radiotherapy

Treatment of Post-radiation Xerostomia With Allogeneic Mesenchymal Stromal Stem Cells

Start date: September 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to learn about toxicity of allogeneic mesenchymal stromal stem cells (MSC, derived from umbilical cord tissue) treatment in head and neck cancer patients with for post-radiation xerostomia. The main question it aims to answer is the toxicity of intervention and the secondary objective is to assess preliminary efficacy. Participants will receive MSC in both parotid and submandibular glands: the toxicity of the intervention will be assessed using CTCAE v5.0 and its effect will be evaluated through measuring salivary flow and composition, radiologically (ultrasonography, magnetic resonance imaging), with scintigraphy and questionnaires. In the control group, salivary gland function (salivary flow and saliva composition) will be assessed for comparison with the intervention group.

NCT ID: NCT06012071 Recruiting - Clinical trials for Edentulous Alveolar Ridge

Two-piece Zirconia Implants With Two Various Platforms

ZircImpl
Start date: July 3, 2022
Phase: N/A
Study type: Interventional

24 patients with missing premolar teeth and healed sockets will be recruited. They will be randomized into two groups to supplied with tissue-level (n=12) or bone-level (n=12) 10-mm long 4-mm wide zirconia implants. Primary and secondary stabilities will be measured with International Stability Quotient (ISQ) device. After 3 months, ceramic crowns will be supplied. Implant survival rates and parameters in relation to periimplant soft-tissues and bone health and anatomy will be recorded and evaluated after 1, 3 and 5 years.

NCT ID: NCT06009367 Completed - Fascia; Anomaly Clinical Trials

Fascial Manipulation Effect on Shoulder Range of Motion and Strength in Handball Players

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

The investigators conducted a prospective randomized controlled trial on the female and male handball players from the Izola Handball Club (Slovenia) who volunteered to participate in the study. Data were collected in the first part of the competition season 2022/2023. The participants were randomly divided into investigated and control groups so that each group had approximately the same number of participants regarding sex and age. The Fascial manipulation (FM) was performed in the investigated group, whereas, in the control group, the participants did not receive the FM. Demographics (sex, age, height, weight, throwing shoulder, playing position, years of playing) were collected. The study protocol complied with the Declaration of Helsinki and was approved by the National Medical Ethics Committee of the Republic of Slovenia (0120-78/2022/9). The aim of this research was to determine whether and how FM affects IR, HADD ROM and the strength of ER in handball players. The hypotheses include: (1) an increase in IR, HADD ROM, and strength of ER immediately after FM compared to the control group, (2) maintenance of increased ROM and ER strength one month after FM compared to baseline and the control group, (3) a decrease in the subjective feeling of tightness immediately and one month after and (4) the size of the FM effect increases with years of playing and vice versa.

NCT ID: NCT06007001 Recruiting - Cancer Clinical Trials

Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA

eCAN
Start date: September 25, 2023
Phase: N/A
Study type: Interventional

The integration of teleconsultation (TC) and telemonitoring (TM) in cancer patients care may allow to improve person-centered care and patients' empowerment. The eCAN JA explores the role of telemedicine tools (i.e. TC & TM) in clinical trials focusing on tele-rehabilitation and tele-psychological support in different populations of cancer patients in 10 European countries. The pilots will be conducted among 354 patients affected by breast (BC, pilot 1a), head & neck (H&N, pilot 1b) and advanced (pilot 2) cancers. The main aim is to assess the effect of TC and TM program focused on rehabilitation and psychological support for cancer patients on patient reported outcomes measures (PROMs) in three pilots compare to usual care. Patients will be randomly assigned either to the intervention or control groups using a 1:1 ratio. Patients in the intervention group will receive weekly TC of 30 minutes during 8 weeks through the secure Edumeet platform. In pilot 1, tele-rehabilitation training will be performed by a remote physiotherapist and will consist of a series of rehabilitation exercises. In pilot 2, tele-psychological support will be performed by a remote psychologist and will consist of techniques for managing emotions and stress. In the intervention group, patients will also have the possibility to wear a smartwatch to automatically collect physical parameters. Patients in the control group will receive usual care. PROMs (i.e. quality of life, distress and pain) and physical parameters (i.e. physical activity, sleep quality and heart rate) will be monitored by a dedicated telemonitoring systems. A secure web platform will provide dashboard to clinicians for decision support. Patients' experience and costs data will be also collected. The results of the eCAN project will improve our knowledge on benefits and risks for TC and TM in cancer patients care.

NCT ID: NCT05974462 Recruiting - Acute Myocarditis Clinical Trials

MYTHS-MR Trial (MYocarditis THerapy With Steroids in Patients With Mildly Reduced Ejection Fraction)

MYTHS-MR
Start date: May 24, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to demonstrate the efficacy of pulsed intravenous methylprednisolone in a single-blind randomized controlled trial versus standard therapy in patients with acute myocarditis and a mildly reduced LVEF. The main question[s] it aims to answer are: - is there an increase in LVEF (≥55% or an absolute increase in LVEF ≥ 10%) on echocardiogram after 5 days from randomization in patients treated with pulsed corticosteroid therapy vs. standard therapy? - is there a reduction in the proportion of patients with LVEF < 55% AND/OR LV dilation on a 6-month CMRI in patients treated pulsed corticosteroid therapy vs. standard therapy? - To assess the effect of corticosteroids on the occurrence of the combined endpoint(1) all-cause death or (2) HTx or (3) long-term LVAD implant or (4) first rehospitalization due to HF or ventricular arrhythmias, or advanced AV block. Participants will be randomized in two arms in a 1:1 ratio. The experimental group will receive pulsed corticosteroid therapy on top of the standard therapy and patients in the placebo group will be treated with a saline solution on top of their standard therapy. All other tests are executed according to standard of care.

NCT ID: NCT05967598 Completed - Parkinson Disease Clinical Trials

Effect of taVNS of Brainstem Activation in Early and Late Parkinson's Disease Patients - an fMRI Study

Start date: February 15, 2023
Phase: N/A
Study type: Interventional

This is a randomised, within-subject, double-blinded, placebo-controlled study to assess the fMRI correlates of central nervous system (CNS) response to taVNS in early vs late-stage Parkinsons disease (PD), at two different frequencies. Forty PD patients will be included: twenty patients with early-stage (Hoehn and Yahr stage (HY) 1-2) and twenty patients with late-stage (HY 3-4) PD. Each patient will undergo one stimulation session, where they will receive active taVNS at 100 Hz (taVNS100), taVNS at 25Hz (taVNS25) or will have positioned electrodes without stimulation (xVNS). The order of taVNS100, taVNS25 and xVNS will be randomized between subjects. The session will include (1) xVNS and taVNS; (2) MRI and fMRI and (3) heart rate and breathing rate monitoring. Clinical assessment with the Movement Disorder Society-Unified Parkinson's Disease Rating Scale will be done before the session.