Search results for "PHASES"

Clinical experience of lomitapide therapy in patients with homozygous familial hypercholesterolaemia.

2014

The microsomal triglyceride transfer protein (MTP) inhibitor lomitapide is a licenced adjunct to a low-fat diet and other lipid-lowering medication, with or without low-density lipoprotein apheresis, for the treatment of adults with homozygous familial hypercholesterolaemia (HoFH). In a recently published phase 3 study, patients with HoFH received lomitapide in addition to maximally tolerated lipid-lowering therapy. Treatment with lomitapide resulted in a mean approximate 50% reduction in LDL-C levels after 26 weeks compared with baseline levels (p < 0.0001). This decrease in LDL-C was maintained at Weeks 56 and 78 (44% [p < 0.0001] and 38% [p = 0.0001], respectively). This paper offers cli…

PAN-EX: a pooled analysis of two trials of neoadjuvant chemotherapy followed by chemoradiotherapy in MRI-defined, locally advanced rectal cancer

2016

This analysis confirms that administering neoadjuvant chemotherapy (NACT) before chemoradiotherapy (CRT) could be a potential option for high-risk, locally advanced rectal cancer. In this setting, MRI tumour regression grade is an independent prognostic factor and, when assessed after NACT, may predict the probability and magnitude of incremental benefit from sequential CRT.EXPERT and EXPERT-C were phase II clinical trials of neoadjuvant chemotherapy (NACT) followed by chemoradiotherapy (CRT) in high-risk, locally advanced rectal cancer (LARC). We pooled individual patient data from these trials. The primary objective was overall survival (OS) in the intention-to-treat (ITT) population. Pro…

Long Term Results of Stanford V Regimen and Highly Active Antiretroviral Therapy (HAART) In 59 Patients (pts) with HD and HIV Infection (HD-HIV)

2010

Abstract Abstract 4827 Background: The introduction of HAART has significantly improved the outcome of pts with HD-HIV. However there are no data on the long term follow-up of HD-HIV pts treated with conventional chemotherapy (CT) regimens. In 2002, we reported the results of a prospective phase II study with the intensive 12-week CT with adjuvant radiotherapy (Stanford V) and concomitant HAART in 59 pts (Spina et al. Blood 2002;100:1984-1988). Methods: To analyze the long term outcome of patients included in the Stanford V and HAART protocol. Results: The median follow-up is 67months (range 3–156 months The 5-yr overall survival (OS), freedom from progression (FFP), disease free survival a…

Ibrutinib as Treatment for Patients With Relapsed/Refractory Follicular Lymphoma : results From the Open-Label, Multicenter, Phase II DAWN Study

2018

Purpose The Bruton's tyrosine kinase inhibitor ibrutinib has demonstrated clinical activity in B-cell malignancies. The DAWN study assessed the efficacy and safety of single-agent ibrutinib in chemoimmunotherapy relapsed/refractory follicular lymphoma (FL) patients. Methods DAWN was an open-label, single-arm, phase II study of ibrutinib in patients with FL with two or more prior lines of therapy. Patients received ibrutinib 560 mg daily until progressive disease/unacceptable toxicity. The primary objective was independent review committee–assessed overall response rate (ORR; complete response plus partial response). Exploratory analyses of T-cell subsets in peripheral blood (baseline/cycle …

Quantum Phases and Spin Liquid Properties of 1T-TaS2

2021

Quantum materials exhibiting magnetic frustration are connected to diverse phenomena including high-Tc superconductivity, topological order and quantum spin liquids (QSLs). A QSL is a quantum phase (QP) related to a quantum-entangled fluid-like state of matter. Previous experiments on QSL candidate materials are usually interpreted in terms of a single QP, although theories indicate that many distinct QPs are closely competing in typical frustrated spin models. Here we report on combined temperature-dependent muon spin relaxation and specific heat measurements for the triangular-lattice QSL candidate material 1T-TaS2 that provide evidence for competing QPs. The measured properties are assig…

Molecular structures of Se(SCH3)2 and Te(SCH3)2 using gas-phase electron diffraction and ab initio and DFT geometry optimisations

2005

The molecular structures of Se(SCH3)2 and Te(SCH3)2 were investigated using gas-phase electron diffraction (GED) and ab initio and DFT geometry optimisations. While parameters involving H atoms were refined using flexible restraints according to the SARACEN method, parameters that depended only on heavy atoms could be refined without restraints. The GED-determined geometric parameters (rh1) are: rSe-S 219.1(1), rS-C 183.2(1), rC-H 109.6(4) pm; S-Se-S 102.9(3), Se-S-C 100.6(2), S-C-H (mean) 107.4(5), S-Se-S-C 87.9(20), Se-S-C-H 178.8(19)° for Se(SCH3)2, and rTe-S 238.1(2), rS-C 184.1(3), rC-H 110.0(6) pm; S-Te-S 98.9(6), Te-S-C 99.7(4), S-C-H (mean) 109.2(9), S-Te-S-C 73.0(48), Te-S-C-H 180.…

Appearance of Fermion-Condensation Quantum Phase Transition in Fermi Systems

2014

As high-\(T_c\) superconductors are represented primarily by 2D layered structures, in Sect. 5.1 we discuss the superconducting state of a 2D liquid of heavy electrons, and within the framework of Gor’kov microscopic equations construct the Green functions of the FC state. On the other hand, our study can easily be generalized to the 3D case. To show that there is no fundamental difference between the 2D and 3D cases, we derive Green’s functions for the 3D case in Sect. 5.1.1. In Sect. 5.2, we consider the dispersion law and lineshape of single-particle excitations. Section 5.3 is devoted to the behavior of heavy-electron liquid with FC in magnetic field. In Sect. 5.4, we analyze conditions…

FIRST APPLICATION OF MINIMAL RESIDUAL DISEASE ANALYSIS IN SPLENIC MARGINAL ZONE LYMPHOMA TRIALS: PRELIMINARY RESULTS FROM BRISMA/IELSG36 PHASE II STU…

2019

Revised recommendations of the Italian Society of Pediatrics about the general management of Kawasaki disease

2021

AbstractAim of these revised recommendations for the general management of Kawasaki disease is to encourage its prompter recognition and warrant the most appropriate therapy, based on ascertained scientific data, raising awareness of the complications related to misdiagnosis or delayed treatment. A set of 20 synthetic operative statements is herein provided, including the definition of Kawasaki disease, its protean presentations, clinical course and seminal treatment modalities of all disease phases. The application of these recommendations should improve prognosis of Kawasaki disease and prevent the progression to permanent vascular abnormalities, thereby diminishing morbidity and mortalit…

Phase I trial of recombinant human tumour necrosis factor alpha in patients with advanced malignancy.

1991

A phase I clinical trial was conducted with recombinant human tumour necrosis factor alpha (rhTNF-alpha) in 62 patients with advanced malignancy refractory to previous standard therapy. rhTNF-alpha was given as a 30 min infusion twice a day at 6 h intervals. A total of 10 different dose levels was escalated in cohorts of 6 patients ranging from 2.5 to 200 micrograms/m2 twice a day for 5 days every second week for a total of 8 weeks followed by a 4-week observation period. Major side-effects of TNF-alpha therapy, seen in almost all patients studied, were fever and chills. As dose-limiting side-effects hypotension and liver toxicity were recorded in 4 of 5 patients treated with 200 micrograms…