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NCT ID: NCT04111679 Completed - Clinical trials for Laparoscopic Surgery

EffectS of prEferred Music on Laparoscopic performancE

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

The main objective is to investigate whether listening to recorded music has a positive effect on the execution of laparoscopic skills. Secondary objectives are to investigate the effects of music during surgical performance on blood pressure, mental workload and heart rate. Study design: This will be a 4-period 4-sequence 2-treatment crossover study, participants will be exposed to both control (noise cancelling headphones without music) and the intervention (preferred music via headphones) whilst performing a laparoscopic task in a box trainer. Every period consists of 5 repetitions of a laparoscopic peg transfer task. In total participants will perform in each condition 10 peg transfer tasks. Prior to the experiment, all participants practice the laparoscopic peg transfer task 20 times Study population: Healthy volunteering medicine students without laparoscopic experience. Intervention (if applicable): Participants will perform 2 periods of 5 laparoscopic peg transfer task whilst listening to preferred recorded music via headphones and 2 periods of 5 laparoscopic peg transfer tasks while wearing noise cancelling headphones without music (2 periods of 5 tasks). Main study parameters/endpoints: The primary endpoint is laparoscopic performance as defined by time of task completion Secondary endpoints are: laparoscopic task performance (path length, jerk, error score, economy of motion) vital parameters (heart rate, and post test blood pressure) and mental workload (SURG-TLX)

NCT ID: NCT04109066 Completed - Breast Cancer Clinical Trials

Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

CheckMate 7FL
Start date: November 20, 2019
Phase: Phase 3
Study type: Interventional

A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.

NCT ID: NCT04108884 Completed - Atrial Fibrillation Clinical Trials

RedStroke - Reducing Europe's Stroke Incidence

RedStroke
Start date: October 22, 2019
Phase: N/A
Study type: Interventional

In the RedStroke study, the effect of a smartphone application in detecting Atrial Fibrillation (AF) will be assessed in a double-blind randomised controlled multicenter trial. Outpatients with an elevated risk for atrial fibrillation will be randomized to an intervention arm (app group) and to a standard-of-care arm (control group). Both groups will have the app installed on their private smartphones and will be asked to perform a predefined measurement protocol. All patients will continue their prior therapy with their general practitioner and obtain every medical treatment indicated. This study will not cause any restrictions on the usual treatment of the study patients. The only difference between the two groups will be, that patients in the app group will be informed by their local PI, if the recordings of the app indicate AF (and obtain a 14 day Holter ECG for AF verification), whereas the patients in the "usual care" group will obtain the read out of the app at the end of the study.

NCT ID: NCT04106557 Completed - Clinical trials for Primary Disease or Condition Being Studied: Angelman Syndrome (AS)

A Study of OV101 in Individuals With Angelman Syndrome (AS)

NEPTUNE
Start date: September 9, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of oral OV101 (gaboxadol) in pediatric subjects with Angelman syndrome.

NCT ID: NCT04103749 Completed - Clinical trials for Endoscopic Retrograde Cholangiopancreatography

Global Prospective Case Series Using a Single-Use Duodenoscope

Start date: March 22, 2021
Phase: N/A
Study type: Interventional

Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures

NCT ID: NCT04096092 Completed - Clinical trials for Bacterial Infections

Pharmacokinetics of Teicoplanin in Intensive Care and Haematology Patients

PLATO
Start date: January 15, 2020
Phase:
Study type: Observational

Characterize teicoplanin PK in critically ill patients with a specific focus on alterations of exposure due to variability in renal function. In a prospective, observational, open-label study the investigators aim to define PK of free drug concentrations of teicoplanine in ICU and heamatology patients and define a PK model for Bayesian dose individualization.

NCT ID: NCT04093999 Completed - Breast Cancer Clinical Trials

Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction

Start date: August 1, 2016
Phase:
Study type: Observational

Restoring the sensation of the breast becomes increasingly recognized as a critical part of autologous breast reconstruction. A prospective study was conducted of all patients who underwent either innervated or non-innervated deep inferior epigastric perforator (DIEP) flap breast reconstruction in Maastricht University Medical Center between August 2016 and August 2018 and who returned between for a follow-up visit between the start of the study and August 2019. Semmes-Weinstein monofilaments were used for sensory testing of the breast.

NCT ID: NCT04093908 Completed - Parkinson Disease Clinical Trials

Prediction of STN DBS Motor Response in PD

DBS-PREDICT
Start date: August 1, 2019
Phase:
Study type: Observational

Despite careful patient selection for subthalamic nucleus deep brain stimulation (STN DBS), some Parkinson's disease (PD) patients show limited improvement of motor disability. Non-conclusive results and the lack of a practical implantable prediction algorithm from previous prediction studies maintain the need for a simple tool for neurologists that provides a reliable prediction on postoperative motor improvement for individual patients. In this study, a prior developed prediction model for motor response after STN DBS in PD patients is validated. The model generates individual probabilities for becoming a weak responder one year after surgery. The model will be validated in a validation cohort collected from several international centers. The predictive model is made public accessible before data collection on: https://github.com/jgvhabets/DBSPREDICT

NCT ID: NCT04090788 Completed - Glucose Intolerance Clinical Trials

The Effect of Momordica Charantia Supplementation on Blood Glucose Levels

Bitter-sweet
Start date: September 17, 2019
Phase: N/A
Study type: Interventional

The study is a randomized, cross-over, double blind, controlled trial in which study participants will receive two 4-week interventions with a washout period of 4 weeks between interventions. Study subjects will visit the research facility before and after each intervention period for a test day. In the third intervention week participants are provided with a 3-day controlled diet and glucose responses will be monitored via a continuous glucose monitoring device.

NCT ID: NCT04090086 Completed - Healthy Clinical Trials

A Study to Assess Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy Participants

Start date: September 16, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of single and multiple dose (once daily for 7 days) oral JNJ-64417184 and JNJ-53718678 on the pharmacokinetic (PK) of single and multiple-dose (once daily for 7 days) oral JNJ 53718678 and JNJ-64417184, respectively when coadministered to healthy adult participants under fed conditions.