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NCT ID: NCT02562755 Completed - Clinical trials for Hepatocellular Carcinoma (HCC)

Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone

PHOCUS
Start date: October 2015
Phase: Phase 3
Study type: Interventional

This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.

NCT ID: NCT02562118 Recruiting - Breast Cancer Clinical Trials

Neoadjuvant Lenvatinib Combined With Letrozole in Hormone Receptor Positive Breast Cancer

Start date: September 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single-centre study comprising two phases: a lead-in phase Ib and a phase II randomized portion. Lead-in Phase Ib study A lead-in phase I study will be built into this protocol to confirm the dose of lenvatinib that can safely be combined with letrozole. We expect that the optimal phase II dose level will be determined after recruiting 12-18 subjects into phase Ib. This dose level will be the one to be tested in the phase II portion of the study. Phase II open label study In this part of the study, eligible patients will be treated with single agent lenvatinib at the phase II recommended dose for 2 weeks, followed by lenvatinib combined with letrozole 2.5mg daily for 12 weeks. A total of 30 patients with ER positive breast cancer and measurable primary tumor will be enrolled over a period of 24-30 months

NCT ID: NCT02559336 Completed - Cancer Clinical Trials

Pilot Study of the SPaRK (Supportive and Palliative Care Review Kit) Model of Care for Advanced Cancer Patients Who Have an Unplanned Admission to Singapore General Hospital

SPaRK
Start date: November 22, 2015
Phase: N/A
Study type: Interventional

Advanced cancer patients have a poor quality of life and a high rate of unplanned hospital admissions. Palliative care has been shown to improve patient outcomes such as quality of life and symptom burden. Our long-term aim is to study the effect of Supportive and Palliative Care Review Kit (SPaRK) - a novel model of early palliative care in the acute hospital inpatient setting. To this end, we propose a pilot study that will provide the necessary information for the planning of a subsequent larger scale Phase III trial of SPaRK. The specific aims of this pilot study are: 1) to estimate the recruitment rate and ability of advanced cancer patients to complete the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, which measures health-related quality of life (QOL) in the four domains of physical well-being, social/family well-being, emotional well-being, and functional well-being, 2) to obtain a tentative estimate of the effect size of the SPaRK model of care on change in patient QOL over 6 days, 3) to explore the responsiveness to change of FACT-G over 3 days and 4) to explore views of healthcare professionals and stakeholders on SPaRK as a model of integrated palliative care and oncology care service delivery. In the short term, the results from this study will be used to plan a larger scale Phase III study of SPaRK. In the long term, a resource-efficient and effective model of care needs to be developed for the aging population and rising palliative care needs of patients. If successful, this pilot study will lead on to the testing of SPaRK, which does not rely wholly on specialist palliative care manpower, but involves both specialists and non-specialists working together to provide palliative care, and hence can be feasibly scaled up across institutions and extended to non-cancer patients.

NCT ID: NCT02559102 Completed - Clinical trials for Neurodevelopmental Disorder

Dexmedetomidine Sedation Versus General Anaesthesia for Inguinal Hernia Surgery in Infants

DEGA
Start date: July 2015
Phase: Phase 3
Study type: Interventional

This is a prospective randomized controlled trial comparing dexmedetomidine sedation with caudal anaesthesia, and general sevoflurane anaesthesia with caudal anaesthesia for inguinal herniotomies in neonates and infants below 3 months of age. The investigators will compare the efficacy and adverse events associated with each of these techniques and neurodevelopmental outcomes of the infants in each group at 6 months and 2 years of age.

NCT ID: NCT02555683 Completed - Asthma Clinical Trials

Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.

Start date: December 11, 2015
Phase: Phase 3
Study type: Interventional

This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations: - patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population) - patients with inadequately controlled severe asthma (overall study population) Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).

NCT ID: NCT02555228 Completed - Lesion of Stomach Clinical Trials

Small Volume Simethicone Before Gastroscopy: Any Benefit?

Start date: August 2015
Phase: Phase 2/Phase 3
Study type: Interventional

A randomized controlled and endoscopist-blinded study which compares the efficacy of liquid simethicone (100mg) in 5 mls water, versus placebo ( 5mls of water), as premedication (given at least 30 minutes) before gastroscopy towards improvement of the total mucosal visibility score.

NCT ID: NCT02548039 Completed - Infertility, Female Clinical Trials

To Study The Influence Of Genomic Factors On Metabolism And Effects Of Clomiphene In Asian Normogonadotrophic Anovulatory Patients.

Start date: January 2015
Phase:
Study type: Observational

The purpose of this study is to match the genetic component and clinical attributes of anovulatory patients with response to clomiphene treatment. By improving our understanding on patient-specific clomiphene response will allow optimization of treatment, reduction of side-effects and shorten the time-to-pregnancy.

NCT ID: NCT02546908 Completed - Prostatic Neoplasms Clinical Trials

A Registry of Participants With Prostate Cancer in Asia

Start date: September 9, 2015
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to document prostate cancer (PC) management including diagnosis, prognosis, treatment, and care in real-world practice.

NCT ID: NCT02545049 Completed - Clinical trials for Diabetic Kidney Disease

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

FIGARO-DKD
Start date: September 17, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.

NCT ID: NCT02545010 Recruiting - Ovarian Cancer Clinical Trials

Phase I Low Dose WART in Combination With Weekly Paclitaxel for Platinum Resistant Ovarian Cancer

Start date: September 2015
Phase: Phase 1
Study type: Interventional

Background: Epithelial Ovarian Cancer is the most lethal amongst the gynecologic malignancies and is the fifth leading cause of cancer death in women in the United States.1 Despite initial high response rates, 50% to 75% of women who present with advanced disease suffer relapse and require re treatment2.The optimal treatment for platinum resistant ovarian cancer remains hotly debated. Combination chemotherapy is not favored due to its increased toxicity and lack of convincing benefit when compared to single agent chemotherapy.3,4 Recently, the addition of bevacizumab to single agent chemotherapy in the AURELIA study improved progression free survival (PFS) from 3.4 months to 6.7 months. Response rates were also improved from 11.8% versus 27.3% (p= 0 .001).9 Aim: To determine the maximal tolerated dose (MTD) of weekly paclitaxel in combination with LDWART. The recommended phase II dose (RP2D) will be based on the MTD in this Phase I study. Method: This study is designed as a prospective, single arm phase I study with 3+3 with dose de-escalation and cohort expansion. All patients will receive weekly paclitaxel at a pre specified dose of 80 mg/m2, 70 mg/m2, 60mg/m2 or 50 mg/m2 via intravenous infusion according to institution specific standard practices. Cycles of chemotherapy will be administered weekly without interruption on Days 1,8,15,22,29,36 for a total of 6 weekly cycles in combination with LDWART(Fig.1). LDWART will be given at 60 cGy fractions, twice daily for two days, with a minimum of 4 hours inter fraction interval, starting on day 1 of each cycle of weekly paclitaxel for 6 weeks.(Fig.1). Importance of proposed research: The combination of a LDWART with weekly paclitaxel may improve the efficacy of the current standard weekly paclitaxel in platinum resistant ovarian cancer patients. Potential benefits and risks: The combination may improve treatment response. Adding LDWART may increase treatment risks, but these will be monitored closely.