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NCT ID: NCT06155812 Recruiting - Shock, Septic Clinical Trials

Multimodal Vasopressor Strategy in Septic Shock

Start date: November 3, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this prospective randomized controlled trial is to compare the effects of classic stepwise vs. early balanced multimodal vasopressor strategies in septic shock.

NCT ID: NCT06154044 Recruiting - Heart Failure Clinical Trials

Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support

CELL-VAD
Start date: May 1, 2022
Phase: Phase 2
Study type: Interventional

The goal of CELL-VAD Pilot trial is to investigate a personalized stem cell therapy approach for patients with advanced non-ischemic chronic heart failure (NICM) who are supported by LVAD. In the clinical trial, the investigators aim to enroll 10 patients with NICM, scheduled for LVAD implantation. After successful LVAD implantation, patients will be enrolled and followed for 2 months to allow for postoperative rehabilitation and heart failure medical therapy and LVAD support optimization. All patients will then undergo autologous CD34+ cell therapy which will be intracoronaryly delivered to the target myocardium using NOGA electromechanical mapping system. All patients will be followed for 6 months after cell therapy. At baseline, and at 1, 3, and 6 months after cell therapy, the investigators will perform comprehensive clinical evaluation.

NCT ID: NCT06153160 Recruiting - Cardiac Arrest Clinical Trials

"The Effect of the Use of an Autotransfusion Device on Hemodynamic Parameters During Resuscitation".

Start date: November 22, 2023
Phase: N/A
Study type: Interventional

The purpose of the research (pilot study) is to determine the impact of the use of the autotransfusion device on hemodynamic parameters during resuscitation. 24 people will be included in the pilot study (12 people will be included in the intervention group - with the usage of "autotransfusion socks" during resuscitation and 12 people in the control group - without "autotransfusion socks"). Investigators will compare the hemodynamic parameters and also neurological outcome between both groups.

NCT ID: NCT06143124 Recruiting - Clinical trials for Helicobacter Pylori Infection

Bismuth Quadruple Therapy Versus Standard Triple Therapy

BismoHelP
Start date: March 3, 2022
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare the standard triple therapy with Bismuth quadruple therapy in children infected with Helicobacter pylori. The main questions to answer are: - the safety - the efficacy of the quadruple protocol with Bismuth subcitrate Participants will be randomised in 7-days eradication therapy group and 14-days eradication control group.

NCT ID: NCT06141733 Recruiting - Death Clinical Trials

2 Year Follow up of COSGOD III

COSGODIII-FU
Start date: January 1, 2024
Phase:
Study type: Observational

The COSGOD III trial performed follow up until term age or discharge from the neonatal intensive care unit, whatever came first. The first neonate was randomised in September 2017 and the last in October 2021. A prospective follow up of the included neonates until an age of two years was not feasible in the COSGOD III trial since funding for long-term follow-up was not available. However, data on long-term outcome of the included neonates into COSGOD III trial are of high interest. In many centres, who participated in the COSGOD III trial neonates are assessed routinely for long term outcome in outpatient clinics with Bayleys III/IV test or PARCA-R (Parent Report of Children's Abilities) questionnaire. Aim of the present study is therefore to analyse in neonates, who were included into the COSGOD III trial, in a retrospective observational study routinely performed long-term survival and neurodevelopmental outcome assessment at a corrected age of 2 years (18-30 months).

NCT ID: NCT06141291 Completed - Physical Inactivity Clinical Trials

Bed Rest Study SBI 2023

Start date: August 21, 2023
Phase: N/A
Study type: Interventional

The study will consist of three groups of subjects. Ten young male subjects (18-30 years) will lie supine for 21 days, 10 older male subjects (65+ years) will lie supine for 10 days, and a third group of 10 older male subjects (65+ years) will also lie supine for 10 days but will receive interventions (see below) to counteract the physical changes caused by supine lying. All three groups will be bedridden in the premises of Izola General Hospital. Subjects will be housed in 5-bed rooms at the hospital and will receive 24-hour medical care, proper hygiene, nutrition, passive exercise, Internet, a relaxing environment, and visits. After their stay, subjects return home but receive 21 days of care at local fitness centers. Rehabilitation consists of interval training, in which subjects perform high-intensity exercise for 4 times 5 minutes. A number of important health parameters are measured before, during, and after bed rest. Some of these measurements will be invasive (blood and muscle sampling), for which appropriate medical personnel, sterile instruments, and environment will be available. Measurements will include normal voluntary efforts (indoor cycling, various jumps, short stretches) and electrically evoked muscle contractions (electrical stimulation with single impulses). All tests are normal tests and come from normal lifestyles and routine medical examinations.

NCT ID: NCT06135012 Recruiting - Pancreatic Fistula Clinical Trials

Influence of Pancreatic Transection With CUSA on Postoperative Pancreatic Fistula Incidence (PANCUT)

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

Objective: To compare the outcomes after elective pancreatic resections using cavitron ultrasonic surgical aspirator (CUSA) and selective closure of small blood vessels and branch pancreatic ducts versus surgical scalpel or stapler for the transection of pancreatic tissue. Study design: A randomized controlled, single centre trial. Study population: Two groups of 80 patients (160 in total) scheduled for elective open pancreaticoduodenectomy (PD) for any indication. Intervention: Transection of pancreatic tissue with CUSA. Control: Standard transection of pancreatic tissue with surgical scalpel (in PD) or stapler (in DP)

NCT ID: NCT06134752 Enrolling by invitation - Clinical trials for Persistent Atrial Fibrillation

Electroporation for Treatment of Atrial Fibrillation

ELECTROAF
Start date: December 5, 2023
Phase: N/A
Study type: Interventional

Comparison of pulmonary vein and left atrial posterior wall isolation durability and clinical outcome between radiofrequency and pulse field ablation in patients with persistent and longstanding persistent atrial fibrillation.

NCT ID: NCT06123364 Completed - Overactive Bladder Clinical Trials

Extracorporeal Magnetic Innervation in Combination With Mirabegron in the Treatment of Overactive Bladder

Start date: October 14, 2019
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about impact of extracorporeal electromagnetic stimulation in addition to medical treatment with mirabegron on the treatment of overactive bladder (OAB). The study will include female patients, aged between 30 and 80, with signs of OAB, including urinary frequency, urgency and urinary urgency incontinence. The main questions it aims to answer are: - Does the addition of extracorporeal electromagnetic stimulation to medical treatment with mirabegron influence the urinary urgency incontinent or frequency? - Does the addition of extracorporeal electromagnetic stimulation to medical treatment with mirabegron influence the urine flow or post-void residual volume? - Does the addition of extracorporeal electromagnetic stimulation to medical treatment with mirabegron influence the patients' quality of life. Participants will: - receive 50 mg of mirabegron daily in the form of tablets, which is used to treat OAB according to current treatment guidelines. - Twice a week receive extracorporeal electromagnetic stimulation in the duration of 20 minutes. The patients will be divided into 2 groups, namely one group will receive actual electromagnetic stimulation, and the other group will receive placebo stimulation. - Have a urogynecological examination, with ultrasound measurements of the remaining urine in the bladder and determination of the thickness of the bladder wall, as well as a uroflow examination, after 4 and 8 weeks of treatment. - Have to to submit urine for laboratory tests and to fill out questionnaires regarding participants' symptoms, after 4 and 8 weeks of treatment. Researchers will compare both study groups to see if the addition of extracorporeal electromagnetic stimulation has influence on the research questions stated above.

NCT ID: NCT06097754 Active, not recruiting - Hypoxia Clinical Trials

Intermittent Exogenous Ketosis (IEK) at High Altitude

Start date: September 18, 2023
Phase: N/A
Study type: Interventional

Altitude-related hypoxia decreases human functional capacity, especially during exercise. Even with prolonged acclimatization, the physiological adaptations are insufficient to preserve exercise capacity, especially at higher altitudes completely. Consequently, there has been an ongoing search for various interventions to mitigate the negative effects of hypoxia on human performance and functional capacity. Interestingly, early data in rodents and humans indicate that intermittent exogenous ketosis (IEK) by ketone ester intake improves hypoxic tolerance, i.e.by facilitating muscular and neuronal energy homeostasis and reducing oxidative stress. Furthermore, there is evidence to indicate that hypoxia elevates the contribution of ketone bodies to adenosine-triphosphate (ATP) generation, substituting glucose and becoming a priority fuel for the brain. Nevertheless, it is reasonable to postulate that ketone bodies might also facilitate long-term acclimation to hypoxia by upregulation of both hypoxia-inducible factor-1α and stimulation of erythropoietin production. The present project aims to comprehensively investigate the effects of intermittent exogenous ketosis on physiological, cognitive, and functional responses to acute and sub-acute exposure to altitude/hypoxia during rest, exercise, and sleep in healthy adults. Specifically, we aim to elucidate 1) the effects of acute exogenous ketosis during submaximal and maximal intensity exercise in hypoxia, 2) the effects of exogenous ketosis on sleep architecture and quality in hypoxia, and 3) the effects of exogenous ketosis on hypoxic tolerance and sub-acute high-altitude adaptation. For this purpose, a placebo-controlled clinical trial (CT) in hypobaric hypoxia (real high altitude) corresponding to 3375 m a.s.l. (Rifugio Torino, Courmayeur, Italy) will be performed with healthy individuals to investigate both the functional effects of the tested interventions and elucidate the exact physiological, cellular, and molecular mechanisms involved in acute and chronic adaptation to hypoxia. The generated output will not only provide novel insight into the role of ketone bodies under hypoxic conditions but will also be of applied value for mountaineers and athletes competing at altitude as well as for multiple clinical diseases associated with hypoxia.