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NCT ID: NCT01934361 Completed - Clinical trials for Recurrent Glioblastoma Multiforme

Phase Ib/II Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme

Start date: February 28, 2014
Phase: Phase 1
Study type: Interventional

This is a multi-center, phase Ib/ II study (two parts) with patients that had recurrent glioblastoma multiforme. The first part (phase Ib) was to investigate the maximum tolerated dose/Recommended phase ll dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin or buparlisib once daily in combination with every-six-week lomustine (CCNU) using a Bayesian model. Once MTD/ RP2D is established in either of the 2 arms, the corresponding phase II portion of the study was to start. Phase II was to assess the treatment effect of buparlisib in combination with carboplatin in terms of Progression Free Survival (PFS) and was to compare the treatment effect of buparlisib with lomustine versus lomustine plus placebo in terms of PFS. A preliminary assessment for both combinations (buparlisib plus carboplatin or lomustine) demonstrated that there was not enough antitumor activity compared to historical data with single agent carboplatin or lomustine. Based on the overall safety profile, and preliminary anti-tumor activity observed in this study, Novartis decided that no additional patients would be enrolled into this study. As a consequence, the Phase II part of the study was not conducted.

NCT ID: NCT01934257 Completed - Clinical trials for Common Infant Feeding Problems

The Evaluation of Infant Formulas Fed to Infants With Common Feeding Problems

Start date: June 1994
Phase: N/A
Study type: Interventional

This clinical trial will determine if the formula given to infants experiencing fussiness, crying, cramping, gas, and/or diarrhea, is accepted and well tolerated and helps to resolve symptoms.

NCT ID: NCT01934127 Completed - Influenza Clinical Trials

Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 21 to 64 Years of Age

Start date: August 26, 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 21 to 64 years of age. The study will evaluate safety related events and antibody immune responses to different formulations of study vaccine and placebo.

NCT ID: NCT01934023 Completed - Schizophrenia Clinical Trials

Effects of Varenicline on Plasticity in Schizophrenia

VAR-PAS
Start date: September 2013
Phase: Phase 2
Study type: Interventional

This laboratory pilot study will explore the effects of varenicline tartrate on long-term potentiation (LTP)-like mechanisms of (1) the motor cortex and (2) the dorsolateral prefrontal cortex (DLPFC) and working memory in non-smoking patients with schizophrenia and healthy controls using a Paired Associative Stimulation (PAS) method. The present study will use this novel PAS method to evaluate the effects of five doses of varenicline (Champix) 0.5 mg BID treatment on neuroplasticity changes and working memory in 28 non-smokers with schizophrenia and 28 non-smoking controls in a placebo-controlled, double-blinded, cross-over design. The hypothesis is that varenicline will increase LTP-like facilitation of the DLPFC as compared with placebo in patients with schizophrenia, with less or a null effect in healthy controls. Likewise, it is hypothesized that varenicline will specifically improve working memory in patients with schizophrenia as compared with placebo and healthy controls. We Hypothesize that: 1.Patients with Schizophrenia(SCZ) will have reduced cortical LTP and impaired working memory compared to healthy controls 2. Sub-chronic varenicline challenge will attenuate the cortical LTP and working memory deficit in patients with SCZ. 3.Reversal of the cortical LTP deficit by varenicline in patients with SCZ will be associated with improvement in working memory.

NCT ID: NCT01933945 Completed - Clinical trials for Carcinoma, Hepatocellular

Outcomes of HCC (Hepatocellular Carcinoma) Patients Treated With TACE (Transarterial Chemoembolization) and Early, Not Early or Not at All Followed by Sorafenib

OPTIMIS
Start date: October 28, 2013
Phase:
Study type: Observational

This study will collect data of patients who are treated with TACE followed by sorafenib for hepatocellular carcinoma (HCC) or patients without Sorafenib after TACE. In contrast to a prior observational study on sorafenib (GIDEON study), where pre-treatment with TACE was documented retrospectively, this study will collect more detailed information about the TACE treatment and the status of a patient when treatment with sorafenib is started.

NCT ID: NCT01933334 Completed - Systemic Sclerosis Clinical Trials

Safety and Tolerability of Pirfenidone in Patients With Systemic Sclerosis−Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)

Start date: September 2013
Phase: Phase 2
Study type: Interventional

PSSc-001 (LOTUSS) This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in patients with systemic sclerosis−related interstitial lung disease (SSc-ILD).

NCT ID: NCT01932840 Completed - General Population Clinical Trials

Attitudes and Understanding of Plant Sterol Claims on Food Labels

Start date: September 2011
Phase: N/A
Study type: Observational

Daily consumption of plant sterols have been demonstrated to lower blood cholesterol. The Canadian government has recently allowed plant sterols to be added to certain foods and has also approved a disease risk reduction claim to be allowed on products containing plant sterols. However, it is unknown how Canadian consumers respond to plant sterol claims. The objective of this study was to evaluate the attitudes and understanding of different types of plant sterol claims on food labels

NCT ID: NCT01932827 Completed - General Population Clinical Trials

Attidutes and Understanding of Oat Fibre Claims on Food Labels

Start date: September 2011
Phase: N/A
Study type: Observational

Oat fibre consumption has been shown to lower blood cholesterol, which is advantageous for heart health. Oat and fibre claims on food labels should help people find heart healthy food choices; however consumer attitudes and understanding of such claims are unknown. The objective of this study was to evaluate the attitudes and understanding to different types of permitted oat fibre claims.

NCT ID: NCT01932580 Completed - Clinical trials for Gastric Adenocarcinoma

Pilot Study of Perioperative Docetaxel, Oxaliplatin, and 5-Fluorouracil (FLOT) in Gastroesophageal Adenocarcinoma

Start date: August 2013
Phase: Phase 2
Study type: Interventional

Gastric or gastroesophageal junction adenocarcinoma is commonly treated with chemotherapy before and after surgery. The chemotherapy regimen used in our institution, called DCF (docetaxel,cisplatic, 5-fluorouracil) is active, resulting in tumor reduction and dysphagia relief. however, it is toxic, causing approximately half of patients severe inflammation of the mucosa (lining) of the mouth and gut. This results, in turn, in mouth sores, vomiting and diarrhea. Similar regimen called FLOT (5-FU, oxaliplatin,docetaxel) appears to be at least equally active, but less toxic. Our ultimate plan is to perform a randomized comparison of DCF and FLOT. Before embarking upon this, we are conducting this pilot trial in 10 subjects with the FLOT regimen. If less than 5 patients develop severe mouth sores, vomiting or diarrhea, plans will be made to proceed with the next trial, a randomized comparison of DCF and FLOT

NCT ID: NCT01932463 Completed - Essential Tremor Clinical Trials

ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) for Treatment of Tremor

Start date: May 2011
Phase: N/A
Study type: Interventional

A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor