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NCT ID: NCT03237676 Not yet recruiting - Clinical trials for Cognitive Impairment

The Effect of Cognitive Rehabilitation Therapy in Improving Cognitive Function of Attention Following Mild Traumatic Brain Injury

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

This research is a randomised controlled study. The study hypothesis is cognitive rehabilitation for attention deficits following mild traumatic brain injury will improve patient's cognitive outcome, measured by neuropsychological and neuroimaging parameters. Participant recruitment is from University Malaya Medical Centre, Malaysia. All mild traumatic brain injury participants have to fulfil the study inclusion criteria and written consented for therapy. Control group receives existing patient-centred cognitive treatment whereas intervention group receives individualised structured cognitive rehabilitation therapy. The intervention begins at three months post injury and ends at six months post injury. Study outcome measurements are applied at pre and post treatment. This study was ethically approved by Medical Research Ethics Committee University Malaya Medical Centre (MREC ID NO: 2016928-4293).

NCT ID: NCT03228706 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

Effectiveness of an Intervention in Improving Medication Adherence Among Malay Patients With Underlying Type 2 Diabetes Mellitus in Malaysia

MedAdh-RCT
Start date: July 1, 2017
Phase: N/A
Study type: Interventional

Poor medication adherence (MA) among Type 2 Diabetes Mellitus (T2DM) patients had found to be gnarly and devastating (Krass et al 2015; Sharma et al 2014). It was estimated that more than half of the patients failed to achieve recommended glycaemic goals due to nonadherence (García-Pérez 2013; World Health Organization 2003). Furthermore, greater adherence rate was significantly associated with better glycemic control, fewer hospital visits and admissions, and lower medical costs. On the other hand, lower adherence rate was significantly associated with poor medication tolerance, the frequency of medication intake (> 2 times a day), having concomitant depression and negative belief about the medications. Consequently, patients who poorly adhere to medications would take more medications due to the poor glycemic control and development of micro- and macrovascular complications (American Diabetes Association 2013). Such condition would further worsen their adherence due to more complex medications and a greater chance of experiencing drug-related side effects (García-Pérez 2013). This inevitably increases the economic burden and wastage to the healthcare system (Meng et al 2017). Hence breaking the vicious cycle is an urgent call to all stakeholders. Notably, Ministry of Health Malaysia (MOH) had initiated several interventions in curbing the MA problems at national level. One of those which has been perpetuated and led by pharmacists is "Know Your Medicine" (KYM) Campaign since 2007. The national KYM campaign aims to promote the quality use of medicines through mass communication and group-based approach. The messages conveyed include information on their medication management such as why, how and when to take medicines, reporting adverse drug events, awareness on the rational use of medicines and medications that need special precautions. In specific, assuring and improving medication adherence among patients is one of the important components of the campaign (PSD 2008). In term of improving medication adherence among Malay T2DM patients, a structured group-based intervention (SGBI) called "Know Your Medicine - Take It For Health" with abbreviation KYM-TIGF, was created by the researchers of this study who work at Sarawak Pharmaceutical Services Division in 2016 under the KYM campaign. The KYM-TIGF is a theoretical based, patient empowerment, culturally appropriate and a combination of psychosocial, educational and behavioral intervention. It is a one-off SGBI that aims to improve the medication adherence through the message specially designed with a cross-theoretical framework as recommended by Slater (1999). The model to measure the effectiveness of the SGBI is an integrated model with Theory of Planned Behaviour (Ajzen 1991) as main theory and Information-Motivation-Behavioural Skills Model (Fisher et al. 2006) as supporting theory. The primary outcome of this study is the medication adherence level using a locally validated scale MALMAS (Chung et al. 2015). The secondary outcomes of this study are the psychosocial variables of the integrated model which include attitude to medication adhere, the subjective norm to medication adherence, perceived behavioral control towards medication adherence, adherence information, adherence skill and intention to adhere.

NCT ID: NCT03225586 Recruiting - Cancer Clinical Trials

Prospective Urban Rural Epidemiology Study

PURE
Start date: January 1, 2002
Phase: N/A
Study type: Observational

To examine the impact of health determinants at the individual (e.g. health related behaviors) and societal level (e.g. environmental factors, health related policy, quality of health systems) on health outcomes (e.g. death, non-communicable disease development) across a range of socioeconomic and health resource settings. Additional components of this study will examine genetic factors for non-communicable diseases. This will be examined both through a cross sectional component, and prospectively (cohort component).

NCT ID: NCT03221426 Not yet recruiting - Gastric Cancer Clinical Trials

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)

Start date: August 24, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS), event-free survival (EFS) and pathological complete response (pathCR) rate.

NCT ID: NCT03200275 Not yet recruiting - Clinical trials for Legionella Pneumophila Pneumonia

Impact of Legionella Urine Antigen Testing (LUAT) on the Local Epidemiology and Diagnosis of Legionella Pneumonia

Start date: September 2017
Phase: N/A
Study type: Observational

There has never been a paper published or research done to determine the rate of Legionella species as a cause of community or nosocomial acquired pneumonia requiring hospitalization in Malaysia. Anecdotally, Legionnaires' disease is thought to be uncommon in Malaysia. This is one of the first prospective hospital-based studies to comprehensively evaluate the epidemiological and demographical factors of patients hospitalized with Legionella infection in Malaysia.

NCT ID: NCT03199053 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus Aged 10 to Below 18 Years Old

Start date: August 31, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to evaluate the efficacy and safety of the drugs dapagliflozin and saxagliptin in patients with Type 2 Diabetes who are aged 10 to below 18 years old and are currently taking metformin, insulin, or both drugs. Dapagliflozin and saxagliptin are both approved for use in patients with Type 2 Diabetes aged 18 years or older. This study will assess how well dapagliflozin and saxagliptin work by finding out how these treatments affect blood glucose (sugar) levels compared to placebo (a pill that contains no active drug), in children and adolescents. Dapagliflozin and saxagliptin are considered investigational products in this study since while they have been approved for use in adults (patients 18 years or older), they haven't been approved for children and adolescents due to lack of clinical studies in this specific population. Patients with Type 2 Diabetes have higher levels of blood glucose (sugar) than patients who do not have this disease. The high level of sugar in the blood can lead to serious short-term and long-term medical problems. The main goal of treating diabetic patients is to lower blood glucose to a normal level. Lowering and controlling blood glucose help prevent or delay complications of diabetes, such as heart disease, kidney, eye and nerve diseases, and the possibility of amputation. Dapagliflozin is a drug that helps to reduce blood glucose (sugar) levels by helping the kidneys to remove excess glucose from the blood and excrete it in the urine. It prevents the kidneys from returning glucose from the urine back into the bloodstream. Saxagliptin increases insulin production when blood glucose levels are high. Insulin is a hormone made by the pancreas that allows the body to use sugar (glucose) from the food that is eaten for energy or to store glucose for future use. Saxagliptin helps to improve blood sugar levels in response to a meal and between meals if blood glucose levels are not lowered effectively. Saxagliptin does not work when the blood glucose is low. Saxagliptin also helps to decrease the amount of sugar made by the body. Together, these processes reduce blood glucose levels and help to control Type 2 Diabetes. Dapagliflozin (alone or in combination with other antidiabetic drugs) has been shown to be effective in lowering blood glucose in adults with Type 2 Diabetes and is available for use in adults (patients 18 years or older) in approximately 40 countries worldwide including the USA and Europe. Dapagliflozin has not yet been studied in children (pediatric patients). Saxagliptin (alone or in combination with other antidiabetic drugs) has been shown to be effective in lowering blood glucose in adults with Type 2 Diabetes and is available for use in adults (patients 18 years or older) in approximately 90 countries worldwide. Saxagliptin also has not yet been studied in children (pediatric patients). The subject will either receive one of the active study drugs or a placebo (a pill that looks identical but contains inactive drug). This study will be double blind; this means that neither the subject, nor the study doctor will know which treatment the subject will receive. Which treatment the subject receives is decided by a computer, purely by chance; this is called a "random assignment". For this study, there will first be a screening phase of up to 6 weeks, followed by a 2 week lead in phase. Thereafter there will be a 26 week short-term treatment phase (week 1-week 26), and a 26 week long-term treatment phase (week 27-week 52). Following this there will be a follow-up telephone call on week 56 and a post study visit at week 104. At day 1 visit after the lead in phase the subject will be randomly assigned to receive one of 3 treatments: dapagliflozin 5 mg, saxagliptin 2.5 mg or placebo in a blinded manner. This treatment will continue up to week 14. Then after week 14, and until the end of the study, the subject will be assigned to receive one of the following 5 treatments: dapagliflozin 5 mg, dapagliflozin 10 mg, saxagliptin 2.5 mg, saxagliptin 5 mg or placebo in a blinded manner. The drugs assigned after week 14 will be the same drugs as at Day 1, but some of the groups will receive them at a higher dose. After completion of the 26-week short-term phase, the subject will enter a 26 week long-term phase. The same treatment that the subject had been assigned to at week 14 visit will be continued. This long-term phase is primarily designed to provide additional information on how well dapagliflozin and saxagliptin are tolerated. Following the treatment phases, there will be a follow-up telephone call at week 56. The subject will be asked to visit the clinic at week 104 again for a final evaluation of the physical development (based on the stage of puberty).

NCT ID: NCT03196726 Recruiting - Clinical trials for Postnatal Depression

Behavioural Interventions for Postnatal Depression: a RCT Study

Start date: March 2, 2017
Phase: N/A
Study type: Interventional

Randomized-controlled trial on the effectiveness of managing postnatal depression mothers at primary care clinics using Cognitive-behavioural therapy treatment by nurses as adjunct to management by Medical Officer as compared to Medical Officer alone

NCT ID: NCT03196284 Recruiting - Clinical trials for Congenital Bleeding Disorder

A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors

explorerâ„¢4
Start date: August 10, 2017
Phase: Phase 2
Study type: Interventional

This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.

NCT ID: NCT03196154 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Association Between Insulin Resistance and Beta Cell Function With HbA1C in Diabetics

InsuReB
Start date: July 3, 2017
Phase: N/A
Study type: Observational

Progression of T2DM is widely accepted to be contributed by two main components: beta cell function deterioration where insulin secretion is impaired and insulin resistance where insulin physiological response is reduced. Insulin resistance and beta cell function will be estimated through a mathematical model, homeostasis model assessment. Fasting insulin and C-peptide will be measured using liquid chromatography tandem mass spectrometry. Insulin resistance and beta cell function is then compared with the glycaemic control, HbA1C.

NCT ID: NCT03190694 Not yet recruiting - Proteinuria Clinical Trials

Effects of Dapagliflozin in Non-diabetic Patients With Proteinuria

DIAMOND
Start date: October 12, 2017
Phase: Phase 2
Study type: Interventional

This study tests the hypothesis that dapagliflozin lowers proteinuria in patients with non-diabetic chronic kidney disease.