There are about 3491 clinical studies being (or have been) conducted in Singapore. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized. Part 1: Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms: 1. LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm) 2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or 3. vemurafenib 960 mg BID (denoted as vemurafenib arm) Part 2: Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms: 1. LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or 2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm)
The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with placebo on overall survival in subjects with advanced hepatocellular carcinoma who have received prior sorafenib.
Background Stapled skin closure is frequently performed following open colectomies. However, its pain and cosmetic outcomes have been suboptimal. Monocryl sutured skin closure has been shown to be cosmetically superior and does not require removal of the sutures. But its association with wound infection has been questioned Aims This study aims to compare the outcomes using skin stapler or Monocryl suture in the skin closure following open colectomy. Hypotheses We believe Monocryl suture is associated with reduced pain and better cosmesis. Methodology Inclusion criteria: All patients who underwent elective open colectomy for various etiologies Exclusion criteria: i) Emergency laparotomies ii) Patient who require the creation of a stoma After consenting for the trial, patients will be randomized into either the skin stapler or the Monocryl suture group. Randomization is performed using a computer model. To minimize confounders, the pre-operative preparation and antibiotics regime will be standardized. The closure of the fascia and the skin will also be performed by at least a Registrar. The wounds will then be covered with a thick sterile dressing to blind the patient and the research assistant. The wound will only be reviewed on the POD 3. The patient is scheduled to return on POD 14, POD 30, 3 and 6 months post operatively upon discharge. Some of the variables that will be collected for this study include: 1. Time taken for skin closure 2. Superficial surgical site infection 3. Pain score 4. Cosmesis We aim to enrol 72 participants in each group. Importance/Impact to Medicine This study will validate the role of Monocryl suture as an effective method for skin closure following open colectomy. We believe Monocryl sutured closure can potentially change the practice of surgeons worldwide for the benefits of the patients.
The primary hypothesis tested in this randomized control trial is that a tele-rehabilitation intervention involving video-conferencing with a therapist and use of wearable monitoring devices in the first three months after stroke results greater functional recovery using the Jette Late Life Functional and Disability Instrument (LLFDI) (primary outcome) among stroke at three months survivors compared to usual care. The secondary hypotheses tested in this randomized control trial are that a tele-rehabilitation intervention involving video-conferencing with a therapist and use of wearable monitoring devices in the first three months after stroke results in: - Functional recovery using the LLFDI at 6 months, - Functional recovery using gait speed, 2-minute walk test and Shah modified Barthel Index at 3 and 6 months, - Greater contact time with a therapist at 3 & 6 months, - Better balance at 3 & 6 months, - Better self-report health-related quality of life at 3 & 6 months, - Decreased health service utilization at 3 & 6 months, - Reduced caregiver burden at three months survivors compared to usual care at 3 & 6 months.
The objective of the study is to provide long term access to bosutinib treatment and assess long term safety, tolerability and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint.
This multicenter, open-label study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities of onartuzumab as single agent or in combination with sorafenib in participants with advanced hepatocellular carcinoma. Participants in Cohort 1 will receive onartuzumab as single agent on Day 1 of each 21-day cycle. Participants in Cohorts 2 or 3 will receive onartuzumab on Day 1 of each 21-day cycle in combination with sorafenib 400 mg orally daily or twice daily. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Stroke is the most common cause of adult disability. Current treatments for functional loss of the upper extremity post-stroke remain limited in efficacy, particularly for those with moderate to severe impairment. Previous studies have demonstrated the efficacy of transcranial direct current stimulation (tDCS) for motor recovery post-stroke, a technique of neuromodulation. Motor imagery is effective to enhance motor recovery, with activation of neural pathways similar to that of motor execution. This treatment is accessible to more severely impaired stroke survivors. Our previous studies have demonstrated feasibility and efficacy of motor imagery-based brain computer interface (MI-BCI) for post-stroke motor impairment, in which motor imagery is detected by surface EEG and translated to execution of the target movement with the aid of an arm robot (MIT-Manus). In this study, we investigate the feasibility of combining robot-assisted MI-BCI training, with tDCS to facilitate post-stroke motor recovery in moderate to severe impairment of upper extremity function. We hypothesise that both tDCS-BCI and sham-BCI will improve motor function in the stroke-affected arm; but that tDCS-BCI will be more effective than sham-BCI. Our secondary aim is to gain insight into the neurophysiological mechanism by comparing the cortical excitability changes following sham-BCI vs tDCS-BCI, using transcranial magnetic stimulation (TMS). We will conduct a randomized, double-blinded study with MI-BCI combined with tDCS (tDCS-BCI) vs MI-BCI combined with sham-tDCS (sham tDCS-BCI). Subjects will undergo 10 sessions of tDCS each lasting 20 minutes, followed by 40 minutes of robot-assisted MI-BCI training at each session. Primary outcome will be functional ability measured by upper extremity component of the Fugl-Meyer Assessment. Secondary outcome measures will be the Box & Block Test, Modified Ashworth Score (measuring spasticity), grip strength and measures of brain activity including transcranial magnetic stimulation (TMS) measures of magnetic resonance imaging (MRI) measures including functional MRI and diffusion tensor imaging (DTI). This study will be important to develop a new and effective treatment (tDCS-BCI) for post-stroke motor impairment.
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy of ipatasertib in combination with oxaliplatin, 5-fluorouracil, and leucovorin (modified FOLFOX6 [mFOLFOX6]) chemotherapy in participants with advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. Participants will be randomized to receive either ipatasertib or placebo orally daily on Days 1 to 7 of each 14-day cycle in combination with mFOLFOX6 on Day 1 of each cycle.
Smoking cessation improves mortality, even in patients with existing smoking-related morbidity. Telephone follow-up after smoking cessation counselling as been shown to be an important method to provide support to smokers and to improve quit rates, especially if three or more calls were used in addition to face-to-face counselling. While it is reasonable to assume that more counselling leads to better smoking cessation outcomes, little evidence exists over the amount of telephone follow-up counselling that is required for optimal and sustained abstinence. We aim to investigate if six-months of weekly telephone follow-up is superior to one-month of weekly telephone follow-up.
The purpose of this study is to test the overall effects of incentives on physical activity among older taxi drivers, and whether mental accounting exists in this context.