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NCT ID: NCT04016454 Completed - Anesthesia Clinical Trials

Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes

HandiCAP
Start date: June 21, 2019
Phase: N/A
Study type: Interventional

Our goal is to conduct a prospective, national, randomized-controlled, multicenter trial to investigate the effect of handover of anesthesia care on the occurrence of adverse outcomes in the perioperative period.

NCT ID: NCT04015427 Completed - Tooth Loss Clinical Trials

Cement Excess at Single Implant Crowns Malmö/Lund

Start date: June 27, 2018
Phase: N/A
Study type: Interventional

Abstract Aim: The primary aim of this study is to test whether or not cement residues in the submucosal environment of implants lead to a change in the microbiota and induce inflammation of the periimplant tissues. Material and Methods: 24 patients in need of a single tooth replacement will be enrolled in this cross-over controlled clinical study. All patients will receive a two-piece dental implant, which will be restored with both a cemented and a screw-retained single crown. At the time of impression taking, patients will be randomized into two groups. Patients in group A will receive a screw-retained crown. Every 8 weeks microbiological samples using sterile paper points will be collected and analyzed for bacterial content by real-time PCR. Additionally, two host markers (MMP8, IL-1ß) will be determined by ELISA. Following this first period of 16 weeks, the screw-retained crown will be replaced by a new intraorally cemented crown. Cement removal will be preformed according to best clinical procedure. These crowns will again be left for another period of 16 weeks and followed up for the harvesting of microbiological samples every 8 weeks. After the second 16-week the crowns will be removed to evaluate any excess cement. All patients will be fitted with the original screw-retained crown. Clinical parameters for inflammation and probing depths will be obtained after each 16 week-period. In group B the crowns will be incorporated in a reverse pattern. During the first 16 weeks any possible cement residues will be removed according to best clinical procedure, while for the second period of 16 weeks patients will be fitted with a screw-retained single crown. Again, microbiological and clinical parameters will be obtained at the same intervals as in Group A. After the second 16 week period the screw-retained crowns will be (re-) inserted in all patients, single tooth x-rays taken and clinical baseline values obtained. Additionally, a soft tissue biopsy will be harvested at the time of insertion of the final screw-retained crown. Patients will be followed up for another 16-week period.

NCT ID: NCT04014634 Completed - Clinical trials for Cluster Headache, Episodic

GON-injection for a Sooner and Better Treatment of Cluster Headache

CHIANTI
Start date: August 1, 2019
Phase: Phase 4
Study type: Interventional

Cluster headache is a very severe primary headache disorder. In episodic cluster headache, attacks occur in 'bouts' (clusters) lasting weeks to months. Management of cluster headache entails a combination of attack and prophylactic treatment. Current first choice prophylactic treatment (verapamil) has considerable side effects which can be serious and include possibly fatal cardiac arrhythmias; and it can take weeks to titrate to an effective dose. Evidence has emerged that local steroid injection of the greater occipital nerve (GON) may be effective in cluster headache, but this method has not been investigated as a first line prophylactic treatment in a large, well-documented group of episodic cluster headache patients who are still free of prophylactic medication and just entered a new cluster headache episode. As such, GON-injection has not yet found its way into current treatment protocols. The investigators plan to perform this multicentre double-blind randomized controlled trial to investigate whether GON-injection is efficacious as a first-line prophylactic treatment, aiming to remove the need for high doses of daily medication - such as verapamil - with associated side effects.

NCT ID: NCT04014491 Completed - Clinical trials for Shoulder Impingement Syndrome

The Effects of Exercise Training on Corticospinal System in Overhead Athletes With Shoulder Impingement Syndrome

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

Shoulder impingement syndrome is the most common shoulder disorder in overhead athletes. It describes a mechanical compression of subacromial bursa and rotator cuff tendons during arm movement, which results in pain and injuries. Most of previous studies focus on investigating motor performance in individuals with shoulder impingement syndrome and found altered scapular kinematics and muscle activation may contribute to the impingement. Recently few studies found changes in the central nervous system, decreases in corticospinal excitability and increases in inhibition in scapular muscles, by using transcranial magnetic stimulation (TMS). Although more studies are still needed to investigate the changes in central nervous system in the individuals with impingement syndrome, the changes in central nervous system are believed to be associated with the deficits of impingement syndrome. However, the exercise protocols for the impingement syndrome are usually designed to restore scapular kinematics and muscle activation, including scapular muscle strengthening exercise and scapular control exercise. To our knowledge, no study has investigated whether these exercise protocols can reverse these changes in the corticospinal system. The objectives of this proposal are to understand neuromuscular and neurophysiological mechanisms of the scapula-focused exercise protocols to improve the effectiveness of treatment. The study aims to investigate the effects of scapular muscle strengthening training and scapular control training on the scapular kinematics, muscle activation and corticospinal system. The study also aims to investigate whether any other cortical mechanisms are also affected by the shoulder impingement syndrome. We will recruit 70 overhead athletes with shoulder impingement syndrome and 22 healthy control athletes. Subjects with shoulder impingement syndrome will randomly receive either scapular muscle strengthening or scapular control training. When performing the exercise, subjects in the scapular control training group will receive electromyography feedback and cues but those in the strengthening training group will not. Immediate effects of these two training protocols on scapular kinematics, muscle activation, and neurophysiological measures will be tested before and after the training. Neurophysiological measures will be tested by TMS, including corticospinal excitability, cortical inhibition, intracortical inhibition, and intracortical facilitation.

NCT ID: NCT04014088 Completed - Clinical trials for Acute Cardiogenic Pulmonary Edema

Helmet CPAP vs Facemask CPAP in ACPE (hCPAP vs fCPAP)

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

This study objectively held to compare the physiological outcomes in the non-invasive (NIV) treatment of Acute Cardiogenic Pulmonary Edema (ACPE) patients in the Emergency Department (ED) delivered by helmet CPAP (hCPAP) and facemask CPAP (fCPAP).Patients will be randomized to receive either hCPAP or fCPAP.

NCT ID: NCT04014075 Completed - Clinical trials for Adenocarcinoma - GEJ

DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)

Start date: November 26, 2019
Phase: Phase 2
Study type: Interventional

This study will find out if trastuzumab deruxtecan is safe and works for participants with gastric or gastroesophageal junction cancer. They must have human epidermal growth factor receptor 2 (HER2)-positive gastric or gastro-esophageal junction (GEJ) cancer: - that cannot be removed surgically - that has moved to other parts of the body - that got worse during or after treatment that included trastuzumab The study will enroll about 80 participants. Sites will be in North America and the European Union.

NCT ID: NCT04014062 Completed - Clinical trials for Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers

Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.

Start date: February 12, 2018
Phase: Phase 1
Study type: Interventional

The study was an assessor-blind, balanced, randomized, two-treatment, two-period, single-dose, two-way crossover, comparative, pharmacokinetic (PK) and pharmacodynamic (PD) study of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; INTP5 and US-Neulasta) in healthy, adult, human subjects under fed conditions.

NCT ID: NCT04014010 Completed - Surgery Clinical Trials

Machine Learning Modeling of Intraoperative Hemodynamic Predictors of Postoperative Outcomes

Start date: January 1, 2013
Phase:
Study type: Observational

With population aging and limited resources, strategies to improve outcomes after surgery are ever more important. There is a limited understanding of what ranges of hemodynamic variables under anesthesia are associated with better outcomes. This retrospective cohort study will analyze how hemodynamic variables during surgeries predict mortality, morbidity, Intensive Care Unit admission, length of hospital stay, and hospital readmission. The use of machine learning in a large, broad surgery population dataset could detect new relationships and strategies that may inform current practice, and generate ideas for future research.

NCT ID: NCT04013932 Completed - Clinical trials for Schizophrenia Spectrum and Other Psychotic Disorders

Family Psychoeducation for Adults With Psychotic Disorders in Tanzania

Start date: August 6, 2019
Phase: N/A
Study type: Interventional

The goal of this study is to pilot test a culturally tailored Family Psychoeducation model (KUPAA) for adults with psychotic disorders and their relatives that is appropriate for cultural settings inclusive of both traditional and biomedical ideas about mental illness and that incorporates relatives as co-facilitators of the intervention.

NCT ID: NCT04013386 Completed - Clinical trials for Nausea and Vomiting, Postoperative

Effects of Aprepitant/Dexamethasone Versus Mertazepine /Dexamethasone on Postoperative Nausea and Vomiting

Start date: July 15, 2019
Phase: Phase 4
Study type: Interventional

Laparoscopic sleeve gastrectomy (LSG) is an emerging treatment modality among the various types of surgical approach to obesity (1). The incidence of PONV in obese patients undergoing bariatric surgery, who did not receive antiemetic prophylaxis, is high at nearly 70-80 % (2,3). Postoperatively, bariatric patients appear to suffer from nausea and vomiting more frequently than normal weight or obese patients.