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NCT ID: NCT02141217 Completed - Clinical trials for Focal Infection, Dental

AUGMENTIN™ in Dental Infections

AUGDENT
Start date: March 21, 2013
Phase: Phase 4
Study type: Interventional

In clinical practice, amoxicillin + clavulanic acid is widely used in the treatment of odontogenic infection. Therefore, this study is designed to generate data to support its use by demonstrating efficacy, safety and tolerability in comparison with clindamycin in subjects with acute odontogenic infections with or without abscess. This will be a two-arm, parallel, comparative, observer blind, randomised study to assess efficacy, safety and tolerability of amoxicillin + clavulanic acid (875mg/125mg) in comparison with clindamycin (150mg) administered for 5-7 days in subjects with acute odontogenic infections with or without abscess. The study will be performed in adult subjects both male and female ≥18 years of age who present with acute odontogenic infections. A total of 472 subjects will be randomized in 1:1 ratio, i.e. 236 subjects in each treatment arm. The treatment duration of the study will be at least 5 days or maximum 7 days depending upon the treatment response. Subjects will be assessed on Day 5 and if Investigator feels the need of continuing the treatment at Day 5 then treatment will be continued till Day 7. For subjects who do not show treatment response on Day 5, assessments will be performed on Day 7.

NCT ID: NCT02141074 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

paradigm™6
Start date: July 2, 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.

NCT ID: NCT02137850 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

pathfinder™6
Start date: June 26, 2014
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.

NCT ID: NCT02137226 Completed - Clinical trials for Arthritis, Rheumatoid

BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis

Start date: January 26, 2015
Phase: Phase 3
Study type: Interventional

Primary Objective: The primary objective of this trial is to establish an equivalence in efficacy between BI 695501 and US-licensed Humira® in patients with active Rheumatoid arthritis based on a statistical comparison of the proportion of patients meeting American College of Rheumatology 20% (ACR20) response rate at Week 12 and ACR20 response rate at Week 24 between BI 695501 and US-licensed Humira®. Secondary Objectives: The secondary objectives of this trial are to compare the efficacy, safety and immunogenicity of BI 695501 and US-licensed Humira® in patients with active RA including those undergoing the transition from US-licensed Humira® to BI 695501 after 24 weeks.

NCT ID: NCT02125877 Completed - Clinical trials for Chronic Iron Overload Due to Transfusion-dependant Anemias

Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet)

Start date: July 8, 2014
Phase: Phase 2
Study type: Interventional

Assessed the new film-coated tablet formulation to the currently approved dispersible tablet formulation with regards to overall safety, Gastrointestinal (GI) tolerability, palatability, satisfaction and compliance

NCT ID: NCT02123342 Completed - Physical Activity Clinical Trials

SMS Reminders for Exercise Among Older Adults. Malaysian Physical Activity for Health Study

myPAtHS
Start date: June 2014
Phase: N/A
Study type: Interventional

The purpose of the study is: 1) To evaluate the efficacy and feasibility of an SMS reminder intervention for promoting an health-related exercise programme (myPAtHS) among older Malaysian adults, in a randomized controlled trial (RCT). Hypothesis: Frequency and duration of the exercise programme execution will be higher for the SMS reminder condition compared to the programme only condition. The effect may be reduced from post- to follow-up measurement (24 weeks after baseline and 12 weeks after post-measurement) but all outcomes will remain significantly higher at 24 weeks.

NCT ID: NCT02117154 Completed - Clinical trials for Diabetes Mellitus, Type 2

Relationship Between HbA1c, Fasting Plasma Glucose, Post-prandial Glucose and Other Measures of Glycemic Control

Start date: June 2013
Phase: N/A
Study type: Observational

This study aims to evaluate relative contributions of fasting plasma glucose and postprandial glucose at various HbA1c levels using 6-day CGM. Evaluation of the relationship between HbA1c, CGM, serum fructosamine and eAG, will also be looked into. HYPOTHESES: 1. Fasting hyperglycaemia is the main contributor in Malaysian T2DM patients with poor glycaemic control (high HbA1c), postprandial hyperglycaemia plays a more important role with lower HbA1c levels. 2. There is good correlation between HbA1c, CGM, serum fructosamine and eAG in Malaysian patients.

NCT ID: NCT02112812 Completed - Clinical trials for Quality of Life Outcomes

Effects of Helicobacter Pylori Infection Eradication in Patients With Parkinson's Disease

Start date: December 2012
Phase: N/A
Study type: Interventional

A higher prevalence of Helicobacter pylori infection rate has been demonstrated among PD patients compared to controls. As H. pylori infection is known to interfere with levodopa absorption, we embarked on this is a study to understand the effects of Helicobacter pylori infection eradication among a selected Malaysian population with Parkinsons disease, in relation to levodopa effectiveness and motor improvements. The study hypotheses are: 1. H. pylori eradication improves L-dopa 'onset' time and prolongs the L-dopa 'on-time' duration. 2. PD patients with H. pylori infection show clinical improvement in motor disability and quality of life after eradication therapy of H. pylori, assessed using UPDRS-III / PDQ39 questionnaires.

NCT ID: NCT02112656 Completed - Clinical trials for Hepatocellular Carcinoma

Study of ThermoDox With Standardized Radiofrequency Ablation (RFA) for Treatment of Hepatocellular Carcinoma (HCC)

OPTIMA
Start date: June 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether ThermoDox, a thermally sensitive liposomal doxorubicin, is effective in the treatment of non-resectable hepatocellular carcinoma when used in conjunction with standardized radiofrequency ablation (sRFA).

NCT ID: NCT02112409 Completed - Clinical trials for Adolescent Idiopathic Scoliosis

Intraoperative Cell Salvage and Hemodilution Technique in Scoliosis Surgery

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

Surgical correction of scoliosis with instrumentation carries significant blood loss and needs for blood transfusion with its inherent risk and cost. In recent years, there is an increased interest in utilizing autologous blood as part of perioperative blood conservation strategy. The foremost mechanical methods of perioperative conservation of red blood cells including intraoperative cell salvage (ICS) and acute normovolemic hemodilution (ANH). They should be considered in all cases where significant blood loss (>1000 ml) or >20% estimated blood volume is expected, in patients with multiple antibodies or rare blood types and those who refuse allogenic blood products. Literature search has revealed that both cell salvage method and ANH utilized in elective surgeries are capable of minimizing allogenic blood transfusion respectively. Surgeries which are of significant relevance are aortic surgery, cardiac surgery and arthroplasty orthopaedic surgery. Combining the above two techniques such as in ATIS trial 2002 also shows that it is safe and significantly reduced allogenic blood requirements in aortic surgery. However till date, there is still lack of strong evidence that autologous blood transfusion technique is beneficial for scoliosis surgery in reducing allogenic blood transfusion. Hypothesis: The investigators hypothesize that the addition of ANH to ICS would confer additional benefit than using cell saver alone. By combining cell saver with hemodilution technique, the difference between pre-operative and post-operative Hemoglobin level will be smaller than using cell saver technique alone, hence minimizing the variation in perioperative Hemoglobin level - a predictor of allogenic blood transfusion.