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NCT ID: NCT02111083 Completed - Healthy Volunteers Clinical Trials

A Study of 2 Different Formulations of Insulin Lispro in Healthy Participants

Start date: May 2014
Phase: Phase 1
Study type: Interventional

The study involves 4 injections of insulin lispro and its purpose is to: - Determine if 2 formulations of insulin lispro are treated by the body in a similar way. - Compare how the 2 formulations of insulin lispro affect blood sugar level. - Determine the safety of each insulin lispro formulations and any side effects that might be associated with them when given to healthy participants. The study is expected to last up to approximately 9 weeks for each participant.

NCT ID: NCT02108964 Completed - Clinical trials for Advanced Non-small Cell Lung Cancer

A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies

Start date: June 6, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/II, multi-center, open-label study, composed with a Phase I part (dose-escalation phase) followed by a Phase II part (expansion phase). The dose escalation phase was designed to determine as primary objective the maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of EGF816 monotherapy in adult subjects with locally advanced (stage IIIB) or metastatic (stage IV) NSCLC harboring specific EGFR mutations. Patients may have or not have received prior lines of antineoplastic therapy. An adaptive Bayesian Logistic Regression Model (BLRM) employing the escalation with overdose control (EWOC) principle will be used during the dose escalation part for dose level selection and MTD recommendation. The primary objective of the Phase II part is to estimate antitumor activity of EGF816 as measured by overall response rate (ORR) determined by Blinded Independent Review Committee (BIRC) assessment in accordance to RECIST 1.1.

NCT ID: NCT02108314 Completed - Mammogram Scheduled Clinical Trials

Video-assisted Intervention for Increasing Mammography Uptake in Private Primary Care in Singapore

Start date: February 2014
Phase: N/A
Study type: Interventional

Breast cancer is the leading female cancer in Singapore, but 3 in 5 women are not going for their regular mammography screenings at recommended frequencies despite 15 years of nationwide efforts by Breast Screen Singapore. The investigators aim to determine the efficacy of opportunistic health promotion for uptake of mammography screening in Singaporean women attending private sector primary care clinics in Singapore by implementing a simple and feasible questionnaire to identify potential candidates for mammography screening, coupled with recommendations by the primary care provider and a directed promotional video produced by Kandang Kerbau Hospital (KKH) that is aimed at addressing some of the barriers to screening.

NCT ID: NCT02104947 Completed - Hemorrhage Clinical Trials

Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

Start date: May 6, 2014
Phase: Phase 3
Study type: Interventional

Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

NCT ID: NCT02104934 Completed - Clinical trials for Analgesia in Total Knee Arthroplasty

A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty

Start date: March 2014
Phase: N/A
Study type: Interventional

Total knee arthroplasty or replacement (TKA), a commonly performed surgery for osteoarthritis of the knee, is a painful procedure and requires a multimodal analgesic approach. A method for analgesia is local infiltration analgesia (LIA), where a mixture of drugs is injected around the knee joint. Adductor canal block (ACB) is an alternative regional anaesthesia technique which has been shown to result in minimal thigh weakness. The investigators aim to study if the analgesia provided by ACB is superior to LIA while preserving quadriceps strength.

NCT ID: NCT02100514 Completed - Hyperlipidemia Clinical Trials

Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events

SPIRE-LL
Start date: October 28, 2014
Phase: Phase 3
Study type: Interventional

This study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy.

NCT ID: NCT02099721 Completed - Clinical trials for Ventricular Arrythmia

Improve Sudden Cardiac Arrest Study

Start date: March 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate that primary prevention patients with one or more additional risk factors (1.5 prevention criteria: syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent pre-ventricular contractions (PVCs), and low left ventricular ejection fraction (LVEF)) are at a similar risk of life-threatening ventricular arrhythmias (LTVA) when compared to secondary prevention patients, and would receive similar benefit from an implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy- defibrillator (CRT-D) implant.

NCT ID: NCT02096705 Completed - Diabetes Clinical Trials

Phase III Insulin Add-On Asia Regional Program - ST

Start date: March 2014
Phase: Phase 3
Study type: Interventional

The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.

NCT ID: NCT02092519 Completed - Pancreatic Neoplasm Clinical Trials

RCT: Difference in Diagnostic Yield Between EUSFNA Needles With and Without a Side Port in Pancreatic Masses

Start date: April 2013
Phase: Phase 4
Study type: Interventional

Background: EUS-guided fine needle aspiration (EUSFNA) is a well established technique for tissue acquisition and diagnosis with excellent safety profile. The overall diagnostic yield of EUSFNA exceeds 80%, with higher rates in EUSFNA of lymph nodes, where rates of >90% may be expected, as compared to pancreatic masses, where lower diagnostic rates were reported. To maximize the diagnostic yield, at least 3 needle passes are required for lymph nodes and at least 4 passes for pancreatic masses. Olympus has recently made commercially available a new 22 gauge FNA needle (EZ Shot 2 with side port) with a side port at the needle tip. The theoretical basis for introduction of the side port is to increase the diagnostic yield. Preliminary unpublished retrospective data suggested the yield might be raised. However, there are no prospective multicenter randomized controlled studies to ascertain the validity of the assumption. Aim: To determine whether there is a difference in diagnostic yield between EZ-Shot 2 and EZ-Shot 2 with side port in patients with pancreatic masses for evaluation. Methods: Patients with pancreatic masses referred for EUSFNA will be recruited prospectively and randomized to either EZ-Shot 2 or EZ Shot 2 with sideport for the first puncture, and then the alternative needle will be used for repeated punctured. The cytological and diagnostic yield at first pass for both needles will be compared. Clinical significance: This will determine whether the new needle design can further improve the diagnostic yield of EUSFNA of pancreatic masses.

NCT ID: NCT02092506 Completed - Clinical trials for Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

RCT: Triple vs Sequential vs Concomitant Therapy H Pylori

Start date: December 2011
Phase: Phase 4
Study type: Interventional

Triple therapy (TT) comprising proton pump inhibitor (PPI), amoxicillin 1g and clarithromycin 500mg twice daily has long been considered one of the standard treatment for H. pylori infection as initial studies demonstrated success rates of > 90% on per protocol analysis (PP) and > 80% on intention to treat (ITT) analysis. However increasing bacterial resistance, especially to clarithromycin, has been reported and there are concerns that the efficacy of TT has decreased. Sequential therapy (ST) is an alternative first line therapy that consists of 5 days of treatment with a PPI and amoxicillin followed by 5-day treatment with the PPI and clarithromycin and metronidazole. The rationale for this approach is that amoxicillin may weaken the bacterial cell wall in the initial phase of treatment, and prevent the development of drug efflux channels that inhibit clarithromycin from binding to ribosomes and thus help to improve the efficacy of clarithromycin in the second phase of treatment. A recent meta-analysis based on mainly European studies showed that the success rate of ST compared to TT was 92.8 - 96% vs. 76.2 - 78.8%. Concomitant therapy (CT) is another alternative first line treatment that consists of 10 days of PPI, amoxicillin, clarithromycin and metronidazole. The rationale for using CT as a first line treatment option is to address the possibility of clarithromycin resistance which is increasingly encountered in clinical practice. Currently there are no randomized controlled studies that compared TT with ST in Singapore, although both regimens are being used in routine clinical practice. The hypothesis is that ST is superior to TT as first line treatment for H. pylori infection. The study aim to compare 10-day TT versus 10-day ST versus 10-day CT as first line treatment for H. pylori infection in Singapore.