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NCT ID: NCT03667547 Completed - Clinical trials for Human Immunodeficiency Virus (HIV) Infection

Safety, Tolerability, and Pharmacokinetics of Raltegravir (MK-0518) in Healthy Japanese Male Participants (MK-0518-851)

Start date: September 27, 2018
Phase: Phase 4
Study type: Interventional

This study is designed to evaluate safety, tolerability, and pharmacokinetics of a single 1200-mg dose of raltegravir (MK-0518, ISENTRESS®) in healthy Japanese male participants.

NCT ID: NCT03667352 Completed - Clinical trials for Condition: Abdominal Bone Flap Cranioplasty; Focus of Study: Perioperative Analgesia

Efficacy Of Scalp Block And Ultrasound Guided TAP Block With Clonidine As Adjuvant To Ropivacaine Versus Intravenous Fentanyl On Intraoperative Hemodynamics And Perioperative Analgesia In Abdominal Bone Flap Cranioplasties

Start date: July 15, 2017
Phase: Phase 4
Study type: Interventional

This study assesses efficacy of scalp block and Ultrasound guided transverse abdominis plane (TAP) block with 1µg/kg clonidine as adjuvant to 0.2% ropivacaine versus intravenous fentanyl (0.1µg/kg/hr) on intraoperative hemodynamics and perioperative analgesia in abdominal bone flap cranioplasties (ABFC).

NCT ID: NCT03667157 Completed - Liver Diseases Clinical Trials

Liver Function After Intravenous Methylprednisolone Administration

Start date: January 1, 2012
Phase: Phase 4
Study type: Interventional

Graves' orbitopathy (GO) is a characterized by orbital soft tissue inflammation and oedema associated with glycosaminoglycan deposition and fibrosis. The most frequent cause is Graves' disease. The classification is comprised based on the severity of orbital changes ranging from mild, moderate-to-severe GO and sight-threatening GO, which includes dysthyroid optic neuropathy (DON). Intravenous methylprednisolone (IVMP) pulse therapy is the first-line treatment in the active-phase of moderate-to-severe GO and DON. This therapy is more effective and better tolerated than oral glucocorticoids (GCs). The current recommendation of the European Group of Graves' Orbitopathy (EUGOGO) is that cumulative doses of IVMP should not exceed 8.0g in each treatment course, and pulses should not be given on consecutive or alternate days, except in the case of DON. According to EUGOGO recommendations patients with moderate-to-severe GO are treated with IVMP cumulative dose 4.5g during a 12-week period (for the first 6 weeks 0.5g IVMP per week, for the next 6 weeks 0.25g IVMP per week). According to EUGOGO recommendations patients with DON should receive 3.0g IVMP (1.0g/day for 3 consecutive days) as the basic treatment. This limitation in doses are due to the necessity of the prevention of severe side effects that are rare but may be fatal. One of the most severe adverse events is acute liver injury (ALI), in some cases irreversible and/or fatal. The estimated morbidity and mortality of ALI was found to be 1-4 % and 0.01-0.3%, respectively. Since 2000, there were 5 reported fatal cases. Mechanisms causing an IVMP-induced ALI remains incompletely elucidated. There are some possible hypotheses that may explain the occurrence of ALI. Firstly, GCs can lead to reactivation of autoimmune hepatitis: an immune "rebound phenomenon" following GCs withdrawal. The second mechanism of ALI is reactivation of viral hepatitis. Finally, there is well known direct toxic effect of GCs on hepatocytes, probably dose-dependent. This study was performed to evaluate the influence of two different, routinely used schemes of therapy with IVMP in patients with moderate-to-severe GO (first scheme) and DON (second scheme) on biochemical liver parameters. Patients included into the study were treated according to EUGOGO recommendations with routine doses of IVMP and routine scheme of administration for moderate-to-severe GO and DON. No additional treatment was performed during the study protocol.

NCT ID: NCT03666845 Completed - Clinical trials for Regional Anesthesia Morbidity

Plasma Ropivacaine Concentrations After Sciatic Nerve Block in Patients With Chronic Kidney Disease

Start date: October 1, 2019
Phase:
Study type: Observational

This prospective observational study aimed to examine the pharmacokinetics of ropivacaine in patients with chronic kidney disease after sciatic nerve block. Sciatic nerve block for foot and ankle surgery will be performed using ropivacaine under ultrasound-guidance, and arterial blood test will be taken for total plasma ropivacaine concentration at 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block.

NCT ID: NCT03666585 Completed - Clinical trials for Routine Rehabilitation Exercise Guidance

Comparison of the Accuracy in Rehabilitation Exercise Between Mobile Application Actuated Rehabilitation Exercise Guidance and Routine Rehabilitation Exercise Guidance for the Primary Osteoarthritis Knee Patients

Start date: September 4, 2018
Phase: N/A
Study type: Interventional

Evaluate the accuracy of physical therapy in various positions after 4 weeks of training, comparison of the accuracy in rehabilitation exercise between mobile application actuated rehabilitation exercise guidance and routine rehabilitation exercise guidance for the primary osteoarthritis knee patients

NCT ID: NCT03666455 Completed - Chronic Pain Clinical Trials

Treating Pain With Acceptance and Commitment Therapy Trial

T-PACT
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The long-term goal is to define best practices for diminishing the risk of high opioid doses used to treat chronic non-cancer pain (CNCP) patients while optimizing pain outcomes and functional levels of activity, emotional functioning, and quality of life. The short-term goal is to assess the feasibility of multiple Clinical and Translational Research Award (CTSA) sites working together to perform and study the effects of a cognitive behavioral therapy intervention in a future randomized controlled trial (RCT) among CNCP patients in rural primary care practices in each CTSA state.

NCT ID: NCT03666273 Completed - Clinical trials for Advanced Solid Tumor

Phase 1 Study of BAY1905254 - An Early Clinical Research Study to Evaluate a New Drug Called Bapotulimab (BAY1905254) in the Expansion Cohort in Combination With Pembrolizumab in Head and Neck Cancer That Has Returned or is Discovered to be Metastatic and is Expressing PDL1.

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

This study is being done to learn more about a new drug called Bapotulimab given in combination with Pembrolizumab. The purpose of this study is to learn if this new combination of drugs is safe for the participants, how it affects the body and to try to find the best dose of the new drug to give to participants and to obtain a preliminary assessment of the tumor response efficacy in the recurrent or metastatic Head and Neck Cancer.

NCT ID: NCT03666208 Completed - Clinical trials for End Stage Renal Failure on Dialysis

Sirolimus Coated Angioplasty Balloon in the Salvage of Thrombosed Arteriovenous Graft

Start date: July 1, 2018
Phase: Phase 2
Study type: Interventional

End stage renal disease is on increasing trend. Haemodialysis is the main dialysis modality among these patients which accounts for the incidence of 81.3% in 2015 based on data from Singapore renal registry. Thus, A functioning dialysis vascular access (either arteriovenous Fistula or graft) is critical to the delivery of life-saving haemodialysis treatment to these patients. The main focus in our study is thrombosed (blocked) AVG as it has higher thrombosis rate and poorer patency rate. Conventionally, to restore the function of the dialysis access, the thrombus (clot) will be lysed with the use of lytic agent; followed by treatment of the underlying stenosis (narrowing) with plain balloon angioplasty (dilatation). However narrowing often recur and multiple repeated angioplasty procedures are needed keep the AVG flowing to prevent clots formation. Recently developed balloons called drug eluting balloons, are coated with medications to prevent the narrowing from recurring after angioplasty. With these drug balloons, the AVG can potentially continue to have good flow for a longer period of time, hence, decreasing the chance of clotting. A newer generation of drug-eluting balloon, called sirolimus coated balloon, are coated with a medicine called sirolimus. It has been successfully used in the treatment of narrowing of vessels in the leg and heart and it were superior than conventional paclitaxel coated balloon angioplasty. We hypothesis that sirolimus coated balloon is superior to conventional plain balloon angioplasty with decreased re-stenosis of target lesion, improved access circuit and target lesion patency, and decreased number of interventions needed to maintain patency.

NCT ID: NCT03665805 Completed - Clinical trials for Postoperative Residual Curarization

Postoperative Residual Curarization in 2018

Start date: July 30, 2018
Phase:
Study type: Observational

The primary objective of this study is to evaluate the incidence of postoperative residual curarization, as defined by a train-of-four <90%, upon postanaesthesia care unit arrival. Anesthetists tend to use train-of-four monitoring in the operating theatre to interpret muscle tone. Train-of-four monitoring is a widely used term for the peripheral nerve stimulation used in neuromuscular blockade monitoring. Hypothesizing a change in our practice since 2006-2012 (Cammu G, Anesth Analg 2006; 102: 426-9 and Cammu G, Anaesth Intensive Care 2012; 40: 999-1006), residual neuromuscular block as well as the use of intraoperative neuromuscular transmission monitoring and reversal of neuromuscular blocking agents will again be prospectively evaluated in 2018. The present study aims to compare these three periods (2006-2012-2018) in terms of management of neuromuscular block in the operating room and to look for a relationship with the incidence of postoperative residual curarization.

NCT ID: NCT03665779 Completed - Clinical trials for Induction of Labor Affected Fetus / Newborn

Nitric Oxide Donor Isosorbide Mono Nitrate for Induction of Labor With Pre-labor Rupture of Membranes

Start date: August 1, 2018
Phase: Phase 3
Study type: Interventional

The study aims to evaluate and assess the effectiveness and safety of vaginal administration of isosorbide mono nitrate (IMN) to induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor at term or post term with prelabor rupture of membrane. Research Hypothesis: In women undergoing induction of labor at term or post term with pre-labor rupture of membrane, vaginal administration of isosorbide mono nitrate (IMN) is effective to induce cervical ripening and shorten the interval time between induction and delivery. Research Questions: Does vaginal administration of isosorbide mono nitrate (IMN) induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor at term or post term with prelabor rupture of membrane?