Combined therapy in advanced stages (III and IV) of follicular lymphoma increases the possibility of cure: results of a large controlled clinical trial

Numerous Virtual Reality (VR) systems address post-stroke functional recovery of the lower extremity (LE), most of them with low early applicability due to the gait autonomy they require. The aim of the present study was to evaluate the feasibility of a specific VR treatment and its clinical effect on LE functionality, gait, balance, and trunk control post-stroke. A controlled, prospective, clinical trial was carried out with 20 stroke patients, who were divided into two groups: the first group (VR + CP; n = 10) received combined therapy of 1 h VR and 1 h of conventional physiotherapy (CP) and the second group (CP; n = 10) received 2 h of CP (5 days/week, for 3 weeks). The following pre-post-intervention measuring scales were used: Functional Ambulatory Scale (FAC), Functional Independence Measure (FIM), Fugl-Meyer Assessment (FM), Berg Balance Scale (BBS), and Trunk Control Test (TCT). Only VR + CP showed a significant improvement in FAC. In FIM, CP presented a tendency to significance, whereas VR + CP showed significance. Both groups improved significantly in FM (especially in amplitude/pain in VR + CP and in sensitivity in CP) and in BBS. In TCT, there was a non-significant improvement in both groups. The results indicate that the intervention with VR is a feasible treatment in the post-stroke functional re-education of the LE, with the potential to be an optimal complement of CP.

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High Response Rate in Relapsed/Refractory Follicular Lymphoma Following Personalised Immunotherapy with Intranodal IFN-Alfa-Dendritic-Cell and Rituximab

Blood ◽

10.1182/blood-2018-99-114533 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 5334-5334

Author(s):

M. Christina Christina Cox ◽

Carmela Rozera ◽

Mauro Mattei ◽

Elena Muraro ◽

Eleonora Aricò ◽

...

Keyword(s):

Clinical Trial ◽

Follicular Lymphoma ◽

Stable Disease ◽

Low Dose ◽

Mononuclear Cells ◽

Conflicts Of Interest ◽

Combined Therapy ◽

Objective Response ◽

Tumour Burden ◽

Incurable Cancer

Abstract Purpose: We have developed a novel DC population differentiated from human monocytes in the presence of GM-CSF and IFN-alpha (IFN-DC), which is highly efficient in internalizing tumour cell antigens and in the cross-priming of CD8+T cells, promoting efficient anti-lymphoma response. Preclinical results prompted us to start a clinical trial of IFN-DC combined with low-dose Rituximab(RTX) in patients with Follicular lymphoma (FL), which is an indolent, immune-responsive, but still incurable cancer. Patients and Methods: In October 2014 we started a phase I clinical trial (EudraCT: 2013-003158-25) testing safety, immunogenicity and systemic clinical responses of low-dose RTX combined with autologous IFN-DC, administered by intra-nodal injections. Patients features: age 18-75y, indolent FL, relapsed or refractory (R/R), stage III-IV low tumour burden, with at least 1 superficial pathologic lymph node. One leukapheresis was scheduled at study entry for harvesting mononuclear cells. Eight cycles of RTX (5-20mg) and IFN-DC (30±10x106) were planned: the first 4 every two weeks, followed by other 4 cycles administered monthly. All injections were delivered with the aid of an ultrasound guide. Blood test for immune-responses and autoimmunity markers were scheduled at 0,+72d, +132 days ; +9; +18;+24 months. Results: as of the 31st July 2018, 8 patients have completed treatment and have been evaluated for response (median follow-up=24 months; range=8-45 mo). Median age of the study population was 60 years (range 27-76). All subjects had disseminated disease and enlarged lymph nodes or lesions greater than 1.5 cm at multiple sites available for local injections and monitoring for distant response. All patients were R/R after previous systemic therapy (median lines=2, range1-4) and 3/8 (37.5%) after auto-transplantation. The treatment was very well tolerated and manageable. No relevant adverse events were observed. Four out of 8 (50%) patients had objective response (OR) with 3/8(37.5%) attaining complete remission (CR); 2/8 (25%) are in stable disease at +8 and +25 months; 2/8 (25%), who did not achieve OR, progressed at +8 and +14 respectively. One patient progressed 4 months after achieving CR (Figure1). In all patients who achieved OR or who are in stable disease, induction of a tumour specific immune response was observed. Conclusions: local RTX and IFN-DC combined therapy was effective in eliciting in 50% of R/R FL with low tumour burden systemic and durable responses, which were associated with induction of specific anti-FL T cell responses. Disclosures No relevant conflicts of interest to declare.

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Antioxidant effects of astaxanthin and metformin combined therapy in type 2 diabetes mellitus patients: a randomized double-blind controlled clinical trial

Research in Pharmaceutical Sciences ◽

10.4103/1735-5362.335179 ◽

2022 ◽

Vol 17 (2) ◽

pp. 218

Author(s):

NikooRoustaei Rad ◽

Ahmad Movahedian ◽

Awat Feizi ◽

Ashraf Aminorroaya ◽

MohammadHosein Aarabi

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Clinical Trial ◽

Type 2 Diabetes Mellitus ◽

Combined Therapy ◽

Controlled Clinical Trial ◽

Double Blind ◽

Antioxidant Effects

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Comparison of Early Effectiveness of Three Different Intervention Methods in Patients with Chronic Orofacial Pain: A Randomized, Controlled Clinical Trial

Pain Research and Management ◽

10.1155/2019/7954291 ◽

2019 ◽

Vol 2019 ◽

pp. 1-9 ◽

Cited By ~ 2

Author(s):

Bartosz Dalewski ◽

Agata Kamińska ◽

Michał Szydłowski ◽

Małgorzata Kozak ◽

Ewa Sobolewska

Keyword(s):

Clinical Trial ◽

Pain Perception ◽

Orofacial Pain ◽

Myofascial Pain ◽

Combined Therapy ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Dry Needling ◽

Randomized Controlled

Background. Occlusal appliances are still widely used instruments in the management of orofacial pain in dentistry, yet alone or as a part of multimodal therapy. However, some of those modalities have been lacking thorough randomized assessment, and there is a conflicting evidence available. It is hypothesized that pain symptoms might improve faster and in more tangible way due to combined therapy. Also, to our best knowledge, nimesulide was never examined in this aspect, too. Objective. The aim of this study was to compare early effectiveness of routine intervention methods in patients with myofascial pain (MP) after 3 weeks’ notice. Three modalities were evaluated: occlusal appliance (OA) with nonsteroidal anti-inflammatory drug (NSAID) therapy (nimesulide), occlusal appliance with dry needling (DN), and occlusal appliance (OA-control group) therapy. Design. Randomized controlled clinical trial (RCT) in which ninety patients with MP, who met the inclusion criteria, were randomly assigned to one of the three treatment groups. Sealed, opaque envelopes were used. Methods. For evaluation, each patient completed a Visual Analogue Scale (VAS) and Sleep and Pain Activity Questionnaire (SPAQ) twice, first at the beginning of the study and again after 3 weeks (0–3). Results. Posttreatment test comparison between the control group and both treated groups reveal significant differences between the control and the NSAID + occlusal appliance groups. There were also differences reported between the control and the DN + occlusal appliance groups, but these differences were, however, not statistically significant. Conclusions. Occlusal appliances in conjunction with NSAID showed better orofacial pain relief after 3 weeks of therapy, compared to the use of occlusal appliances alone or in conjunction with dry needling. Additionally, differences between pain perception and quality of life between OA and DN + OA groups were not found to be statistically significant.

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