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NCT ID: NCT02628041 Completed - Prostate Cancer Clinical Trials

HDR Brachytherapy vs. LDR Brachytherapy Monotherapy in Localized Prostate Cancer

HDRvsLDR
Start date: October 2015
Phase: Phase 2
Study type: Interventional

High-dose rate brachytherapy (HDRB) used as monotherapy is emerging as an alternative to Low-Dose Rate brachytherapy (LDRB) with excellent PSA-progression free survival as high as 90-100% for favorable prostate cancer at a median follow-up of 3-5 years. HDRB has many advantages over LDRB such as prospective dosimetry not impacted by setup errors, organ motion and prostate swelling during treatment delivery. In addition, HDRB causes less acute and late urinary toxicity compared with LDRB. Acute urinary retention can lead to prolonged catheterization, pericatheter urine leakage, urinary tract infection and Trans-Urethral Resection of the Prostate resulting in diminished quality of life (QOL) and increased psychological distress. The goal of the investigators' phase II randomized study is to evaluate the differences in QOL in the urinary domain between patients with favourable intermediate risk or extensive low-risk prostate cancer treated with LDRB and HDRB at 3 months using the Expanded Prostate Cancer Index Composite (EPIC) QOL scores. The 3 months cut-off endpoint has been chosen since HDRB-induced urinary toxicity subsides at 12 weeks compared to 12 months with LDRB. Secondary objectives include: bowel and sexual domain EPIC scores and International Prostate Symptom Score. The absolute PSA nadir and a prostate biopsy at 36 months will be reported to assess local control.

NCT ID: NCT02627963 Completed - Clinical trials for Carcinoma, Renal Cell

A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)

Start date: May 24, 2016
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (RCC). Participants will be randomized (1:1) to treatment with tivozanib or sorafenib. Participants will be stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior checkpoint inhibitor [programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor] plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent). All participants will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability. Pharmacokinetic (PK) analyses are also included in study.

NCT ID: NCT02627274 Completed - Breast Cancer Clinical Trials

A Study Evaluating Safety, Pharmacokinetics, and Therapeutic Activity of RO6874281 as a Single Agent (Part A) or in Combination With Trastuzumab or Cetuximab (Part B or C)

Start date: December 7, 2015
Phase: Phase 1
Study type: Interventional

This first-in-human, open-label, multicenter, Phase Ia/Ib, adaptive, multiple ascending-dose study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of RO6874281 as a single agent (Part A) or in combination with trastuzumab or cetuximab (Part B or C).

NCT ID: NCT02626936 Completed - Type 1 Diabetes Clinical Trials

Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation

Start date: January 2016
Phase: Phase 2
Study type: Interventional

In previous studies, investigators have studied if a pre-meal insulin bolus based on estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without a significant degradation in postprandial glucose control. With this strategy, the patient would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular, large or very large) It is however important to establish safety of this simplified meal bolus approach. The safety of overestimating a meal insulin bolus in the context of single and dual-hormone CLS with the simplified meal strategy needs to be determined. Computer simulation will be used to get a reasonable estimate of risks related to over-estimation with single-hormone closed-loop while over-estimation with dual-hormone closed-loop will be tested in adults with type 1 diabètes Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an adequately estimated meal size bolus

NCT ID: NCT02626000 Completed - Clinical trials for Carcinoma of the Head and Neck

Talimogene Laherparepvec With Pembrolizumab for Recurrent Metastatic Squamous Cell Carcinoma of the Head and Neck (MASTERKEY232 / KEYNOTE-137)

MASTERKEY232
Start date: April 6, 2016
Phase: Phase 1
Study type: Interventional

The primary objective of this study was to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

NCT ID: NCT02625909 Completed - Hepatitis C Clinical Trials

Randomised Study of Interferon-free Treatment for Recently Acquired Hepatitis C in PWID and People With HIV Coinfection.

REACT
Start date: March 9, 2017
Phase: Phase 3
Study type: Interventional

The aim of the study is to determine if treatment for recently acquired hepatitis C infection (with or without HIV coinfection) can be shortened when treating with the interferon-free therapy sofosbuvir/velpatasvir (SOF/VEL). SOF/VEL is a new treatment for hepatitis C called direct acting antiviral which targets the hepatitis C virus replication cycle and has been shown in phase II studies in chronic HCV to be highly effective (SVR12 >95%) when given for 12 weeks. Data has shown that treatment can be shortened when treating recently acquired HCV with interferon containing treatments. It is not known whether treatment with SOF/VEL can be shortened. This study aims to find out if treatment for 6 weeks with open-label SOF/VEL is equivalent to treatment for 12 weeks with SOF/VEL in participants with recently acquired hepatitis C infection. The project is a randomised study where both participants and investigators would not find out the treatment duration of the participants until week 6 of treatment.

NCT ID: NCT02625610 Completed - Clinical trials for Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction

Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)

Start date: December 24, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.

NCT ID: NCT02625324 Completed - Clinical trials for Aortic Aneurysm, Thoracic

Valiant Evo International Clinical Trial

Start date: April 2016
Phase: N/A
Study type: Interventional

The purpose of the Valiant Evo International Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair.

NCT ID: NCT02625129 Completed - Travel Medicine Clinical Trials

Effectiveness of and Satisfaction With a Pharmacist-managed Travel Medicine Clinic

Start date: February 2016
Phase: N/A
Study type: Observational

This study will evaluate the clinical effectiveness of, and patient satisfaction with, pre-travel consultations provided by a pharmacist with specialty training in travel medicine and the authorization to prescribe medications and administer vaccinations.

NCT ID: NCT02624869 Completed - Clinical trials for Familial Hypercholesterolemia

Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)

HAUSER-OLE
Start date: September 10, 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.