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NCT ID: NCT03723070 Recruiting - Atrial Fibrillation Clinical Trials

Cryoablation System First in Man Clinical Study

Start date: May 15, 2018
Phase: N/A
Study type: Interventional

Multi-center, open label, prospective first in man (FIM) clinical study to establish the acute safety and performance of the Cryterion Cardiac Cryoablation System

NCT ID: NCT03719833 Recruiting - Breast Cancer Clinical Trials

Sentinel Lymph Node Biopsy After Neoadjuvant Treatment in Breast Cancer Patents

Start date: September 21, 2018
Phase:
Study type: Observational [Patient Registry]

This clinical trial is designed as observational study of overall duration of 8-9 years, but the first results and conclusions could be achieved in 4-5 years. In the first phase, that would last 3-4 years, the investigators will form three predetermined groups of breast cancer patients that would be monitored in the second phase for 5 postoperative years. All patients involved in this trial would undergo defined protocol. All patients participating in this trial and all members of investigation team would be completely introduced to plan and aims of this trial. The main hypothesis of this study is to establish that sentinel lymph node biopsy, in node positive breast cancer patients that achieve clinical remission after neoadjuvant treatment, is reliable surgical approach. Data would be collected individually for each patient and recorded on appropriated forms. After data completion, leading investigator would import encoded data in register.Data collected in this trial would be used for publications and self-control of multidisciplinary team for breast cancer.

NCT ID: NCT03718013 Not yet recruiting - Clinical trials for Major Depressive Disorder

Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil (dTMS)

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the efficacy and safety of accelerated transcranial magnetic stimulation with H1-coil (deep TMS) for treatment of patients diagnosed with major depressive disorder (MDD). Subjects will be randomized into two groups: experimental (treated with accelerated deep TMS: twice a day (6-8 hours between two applications), during 2 weeks) and control group (standard deep TMS treatment: once a day, during 4 weeks). Participants and designated clinicians will complete a battery of instruments that measure relevant symptoms (HAM-D17 and BDI-II scales), global functioning (CGI and PHQ-9 scales), quality of life (EQ-5D-5L questionnaire), and cognitive functions (MoCA test). Measurements will be done in 4 time points: after the inclusion, after the first week of treatment, after the second week (the end of treatment for experimental group), after the fourth week (the end of treatment for control group), and after 1 month (follow-up for both groups). Interim data analysis is planned at the time when at least 30 participants are involved in both groups. Patients whose baseline score on HAM-D17 is equal or greater than 24 (very severe depression) will be included in another study; they will be treated with accelerated deep TMS twice a day during 4 weeks.

NCT ID: NCT03705442 Recruiting - Clinical trials for Colorectal Cancer Metastatic

Probiotics as Adjuvant Therapy in the Treatment of Metastatic Colorectal Cancer

Probat-tmcc-17
Start date: February 9, 2018
Phase: Phase 2
Study type: Interventional

The research will be prospective, randomised, placebo controlled and double-blinded.The research will be carried on with regards to Helsinki Declaration and following the guidelines of Good Clinical Practice.

NCT ID: NCT03704038 Recruiting - Clinical trials for Mechanical Ventilation

Electrical Impedance Tomography Guided Assessment of Optimum PEEP Levels During Mechanical Ventilation in Lateral Decubitus Position

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Goal of this study is to determine optimal PEEP levels for patients undergoing surgery in lateral decubitus position. Patients will be randomized into 3 groups - PEEP 0, 5 and 10 mbar. Endotracheal anesthesia will be conducted with propofol, fentanyl, rocuronium and sevoflurane/O2/air gas mixture. Patients with preexisting lung disease, organ transplants and disseminated malignant disease will be excluded. Demographic data - age, weight, height, ASA status, smoking history will be recorded. EIT measured parameters - tidal variation ratio of nondependent and dependent lung, regional end-tidal and end-expiratory lung impedances as well as horizontal and vertical centers of ventilation will be recorded and calculated at 3 time points - before anesthesia induction, 5 minutes after lateral positioning of the patient and 90 minutes after lateral positioning. ABGs will be sampled to calculate aA gradient and Horovitz quotient at those time points as well as measured hemodynamic parameters (HR, BP, CI, SVI). Primary endpoints for the study are nondependent/dependent tidal variation ratios measured at predefined time points and changes in ABGs. Secondary endpoints are number of postoperative pulmonary complications (defined as new onset of pneumonia during 28 days of followup), length of hospital stay and changes in hemodynamic parameters.

NCT ID: NCT03703531 Recruiting - Clinical trials for Cardiopulmonary Resuscitation

Istria County CPR Survival 2011-2017

Start date: July 1, 2018
Phase:
Study type: Observational

Analysis of factors that influence CPR survival of 1440 patients that were resuscitated in Istria County, Croatia between 2011-2017.

NCT ID: NCT03689374 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

SUSTAIN 11
Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

This study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily as add on to metformin and insulin glargine in people with type 2 diabetes. Participants will either get insulin glargine and semaglutide or insulin glargine and insulin aspart - which treatment the participant get is decided by chance. Insulin glargine is taken once a day and semaglutide once a week. Insulin aspart is taken three times per day before a meal. All three medicines come in pre-filled pens for injection under the skin. The study will last for about 71 weeks. If participant's blood sugar gets under or over certain values participant will only participate in 14 weeks. The study doctor will inform the participant about this. The participant will have 15 clinic visits and 22 phone calls with the study doctor.

NCT ID: NCT03687255 Recruiting - Clinical trials for Urinary Tract Infections

Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections

Start date: September 24, 2018
Phase: Phase 3
Study type: Interventional

Multi-center, randomized, double-blind, non-inferiority study of cefepime 2 g/AAI101 500 mg combination compared to piperacillin 4 g/tazobactam 500 mg in a population of adult patients with cUTI or AP. The study will be conducted in approximately 115 sites located in the EU, the US, Central, South America and South Africa.

NCT ID: NCT03670407 Recruiting - Clinical trials for Diminished Ovarian Reserve

Follicular Activation by Fragmentation of Ovarian Tissue

FAFOT
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

The primary objective of this study is to assess the chances of increasing the number of antral follicles in ovarian tissue of patients with diminished ovarian reserve by activation of primordial follicles through ovarian cortex fragmentation. Secondary objectives are to assess potential association with the number of oocytes retrieved and pregnancy rates after IVF.

NCT ID: NCT03659851 Recruiting - Clinical trials for Left Ventricular Dysfunction

Levosimendan In Patients Undergoing LVAD Implantation

Start date: June 1, 2009
Phase:
Study type: Observational [Patient Registry]

According to the results from the literature, it has been shown that levosimendan usage 24-48 hours before LVAD implementation can improve short and long-term outcome in these patients regarding to the patients without preoperative pretreatment. The aim is to compare short and long-term outcome in patients who underwent to LVAD implementation and pretreated with levosimendan regarding the patient without pretreatment or with other medications.