Clinical Trials Logo

Filter by:
NCT ID: NCT03197480 Recruiting - Clinical trials for Diabetic Macular Edema

Diabetic Macular Edema Asian Response (DEAR) Study: Biomarkers for Response to Aflibercept in Asian Patients With Center Involving DME

Start date: April 17, 2019
Phase: Phase 4
Study type: Interventional

To investigate whether ocular imaging and proteomic biomarkers; and systemic biochemical, metabolomic, and genetic biomarkers predict treatment response to intravitreal aflibercept in a cohort of patients with DME.

NCT ID: NCT03194503 Completed - Clinical trials for Intubation Complication

Tracheal Intubation Coaching in NICUs

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

The purpose of the study is to determine the efficacy of video coaching training for neonatology attending providers on tracheal intubation procedural outcomes in neonatal ICUs.

NCT ID: NCT03192293 Recruiting - Breast Cancer Clinical Trials

Metformin and Simvastatin in Addition to Fulvestrant

Start date: January 20, 2017
Phase: Phase 2
Study type: Interventional

This is a prospective single arm open-label Phase 2 study utilising the combination of Fulvestrant, Metformin and Simvastatin in post-menopausal ER-positive metastatic breast cancer, with the primary endpoint being Clinical Benefit Rate (defined as complete response, partial response or stable disease, equal to or more than 24 weeks). The hypothesis is that the addition of Metformin and Simvastatin to Fulvestrant will improve the Clinical Benefit Rate from 40% (historical data from control arm of PALOMA-3 study) to 60%. A total of 28 patients will be enrolled over a period of 24 months. Eligible patients will receive 500 mg Fulvestrant by intramuscular injection on days 1 and 15 of cycle one and then on day one of each subsequent cycle (28 days). Patients will be given 850mg oral Metformin twice-a-day (based on xenograft models which showed that Metformin had anti-tumor effects at a minimum dose of 1500mg per day), and 20mg oral Simvastatin every night (drawing reference from the investigators' group's window-of-opportunity study), daily throughout the cycle. As part of the in-build safety and tolerability design, all patients will have a lead-in period of 7 days where they receive 850mg oral Metformin twice-a-day and 20mg oral Simvastatin every night. Special adverse events of interest include lactic acidosis, diarrhea, bloatedness, transaminitis and rhabdomyolysis. If no dose-limiting toxic effects (DLT) occur, Fulvestrant will be commenced, and considered the start of cycle 1. If DLT occurs in any of the patients, the combination of Metformin and Simvastatin will be modified for the affected patient as per protocol, with further monitoring for another 7 days. This combination will be deemed safe for that patient if no DLT occurs, following which cycle 1 can officially commence. At the time of study entry, blood samples will be drawn to establish baseline physiological parameters including fasting insulin, glucose, lipids and Homeostasis Model Assessment 2 (HOMA2). In patients who have accessible tumor sites and are willing to provide tissue for translational research, pre- and post-treatment (at end of 8 weeks) biopsies will be taken for correlative biomarker studies. Patients will be evaluated on an 8-weekly basis for toxicities and efficacy assessments during the first 6 months of treatment, followed by 12-weekly thereafter until disease progression, unacceptable toxicities, or patient withdrawal.

NCT ID: NCT03191682 Recruiting - Clinical trials for Advanced Solid Tumors

A First-in-Human Study of PRL3-ZUMAB

Start date: February 20, 2017
Phase: Phase 1
Study type: Interventional

This study is carried out to test the safety of a study drug called PRL3-ZUMAB. PRL3-ZUMAB is an investigational drug that has not yet been approved by the Food and Drug Administration (FDA) or any other regulatory authorities for commercial purposes. This is the first study in which PRL3-ZUMAB will be given to humans. The study drug has been tested in animals and was found to be well-tolerated with minimal side effects. This research study will test different doses of the drug to see which dose is safest in people.

NCT ID: NCT03188965 Completed - Clinical trials for Advanced Solid Tumor

First-in-human Study of ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumors and Lymphomas

Start date: July 6, 2017
Phase: Phase 1
Study type: Interventional

The ATR (ataxia-telangiectasia and Rad3 related protein) inhibitor BAY1895344 is developed for the treatment of patients with advanced solid tumors and lymphomas. The purpose of the proposed trial is to evaluate the safety and tolerability of BAY1895344, and to identify the maximum tolerated dose of BAY1895344 that could be safely given to cancer patients. Further, the response of the cancer to the treatment will be determined.

NCT ID: NCT03188159 Recruiting - Ovarian Cancer Clinical Trials

Vinorelbine in Relapsed Platinum Resistant or Refractory C5 High Grade Serous, Endometrioid, or Undifferentiated Primary Peritoneum, Fallopian Tube or Ovarian Cancer

Start date: July 1, 2017
Phase: Phase 2
Study type: Interventional

This is a phase II study in patients with recurrent platinum resistant or refractory C5 high-grade serous, endometrioid or undifferentiated ovarian, primary peritoneal or fallopian tube cancer. All patients with high-grade serous, endometrioid or undifferentiated primary peritoneum, fallopian tube or ovarian cancer will be eligible to be screened for this trial and will be required to sign a pre-screening consent form.

NCT ID: NCT03182244 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation

A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation

Start date: January 15, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated AML who are refractory to or have relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study will evaluate safety as well as determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.

NCT ID: NCT03180931 Completed - Clinical trials for Tomography, Optical Coherence

Independent OCT Registry on Very Late Bioresorbable Scaffold Thrombosis

INVEST
Start date: December 2, 2016
Phase: N/A
Study type: Observational [Patient Registry]

Bioresorbable vascular scaffold (BVS, ABSORB BVS1.1, Abbott Vascular) has been approved (CE mark) and is used in daily clinical practice. While recent randomized controlled trials comparing BVS versus metallic drug-eluting stent showed higher risk of definite or probable device thrombosis after BVS implantation, the causes underlying thrombotic events occurring beyond one year after scaffold implantation remain unclear and require investigation in an independent manner. The INVEST registry is a world-wide, multi-center, observational, retrospective, investigator-initiated registry, which will include any patients who suffered from very late (>1 year) scaffold thrombosis, underwent optical coherence tomography (OCT) at the time of thrombosis and provided informed consent for the further use of their health related data for this registry.

NCT ID: NCT03178552 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)

B-FAST
Start date: September 22, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays.

NCT ID: NCT03177200 Completed - Clinical trials for Population Segmentation Healthcare

Defining and Evaluating Norms for Health and Social Service (HASS) Use

Start date: November 20, 2017
Phase:
Study type: Observational

Background In view of expected growth of the older population in Singapore in the next decades, the volume and complexity of needs for health care services is expected to increase, which amplifies stress on the current healthcare system. One approach to addressing this challenge is to consider service utilization in relationship to needs based on "population segmentation" and to plan and evaluate new services in light of unmet needs. Specific Aims and Hypotheses Primary Aim 1: To establish health and social service (HASS) norms for population segments as defined by the Simple Segmentation Tool (SST) via a modified-Delphi methodology. Primary Aim 2: To evaluate the concordance between the types of HASS that patients in each population segment actually utilize versus the types of HASS normatively defined for each population segment over a 3-month period from the point of hospital discharge. Primary Hypothesis: The concordance between the actual utilization of different types of HASS versus normative HASS is not better than fair. Secondary Aim: To assess the association between concordance of normative HASS and incidence of adverse outcomes which includes emergency department visits, unplanned hospital readmissions, nursing home placement, and all-cause mortality over a 12-month period from point of hospital discharge for all population segments. Secondary Hypothesis: Patients with disagreement between normative HASS and actual utilization of HASS will have a higher incidence of adverse outcomes. Methodology The investigators will use a modified-Delphi methodology to develop HASS norms and conduct a follow-up study of inpatients to evaluate the concordance between the types of HASS utilized and norm HASS, and to evaluate the association between this concordance and adverse outcomes in each population segment. Significance to Health Services Delivery The transformation of the health care system to effectively meet growing needs in a patient-centric way requires practical tools for population planning and program development. The norms and evaluation approaches developed here will guide clinical and public policy decision makers in prioritizing population needs, and thus contribute to tangible improvements in health services delivery, patient care and health outcomes for an aging Singapore population.