scholarly journals Losartan/hydrochlorothiazide combination vs. high-dose losartan in patients with morning hypertension—a prospective, randomized, open-labeled, parallel-group, multicenter trial

2012 ◽  
Vol 35 (7) ◽  
pp. 708-714 ◽  
Author(s):  
Tamenobu Ueda ◽  
◽  
Hisashi Kai ◽  
Tsutomu Imaizumi
Keyword(s):  
Multicenter Trial ◽  
High Dose ◽  
Parallel Group ◽  
Morning Hypertension

scholarly journals Acupuncture in diabetic peripheral neuropathy—protocol for the randomized, multicenter ACUDPN trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
J. Dietzel ◽  
S. Hörder ◽  
I. V. Habermann ◽  
G. Meyer-Hamme ◽  
K. Hahn ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Peripheral Neuropathy ◽  
Nerve Conduction ◽  
Diabetic Peripheral Neuropathy ◽  
Clinical Symptoms ◽  
Multicenter Trial ◽  
Routine Care ◽  
Open Label ◽  
Diabetes Type Ii ◽  
Parallel Group

Abstract Background Acupuncture is used to treat patients with diabetic peripheral neuropathy; however, the evidence is unclear. We present the design and methodology of the ACUDPN (ACUpuncture in Diabetic Peripheral Neuropathy) trial, which investigates the effectiveness of acupuncture for the treatment of diabetic peripheral neuropathy (DPN) symptoms. The aim of this study is to investigate whether acupuncture is effective for the treatment of DPN symptoms. Methods This study is a two-armed, randomized, controlled, parallel group, open-label, confirmatory, multicenter trial (8-week intervention period plus 16 weeks of follow-up). Physicians in outpatient units in Germany who specialize in acupuncture treatment will treat 110 diabetes type II patients with clinical symptoms of peripheral neuropathy in the feet and legs with signs of neuropathy according to nerve conduction testing. The patients will be randomized in a 1:1 ratio to one of the following two groups: (a) semi-standardized acupuncture plus routine care or (b) routine care alone. Acupuncture will consist of 12 treatments per patient over 8 weeks. The primary outcome will be the overall DPN-related complaints in the extremities after 8 weeks as measured by the Visual Analog Scale (VAS). Further outcome measures will include DPN-related pain, the Neuropathic Pain Symptom Inventory (NPSI), Diabetic Peripheral Neuropathic Pain Impact (DPNPI) scores, and nerve conduction parameters of the sural nerve at weeks 8, 16, and 24. Discussion The results of this trial will be available in 2021 and will help clarify whether acupuncture can be considered effective for the treatment of DPN with regard to the subdimensions of the neuropathic clinical picture. Trial registration ClinicalTrials.gov NCT03755960. Registered on 11 August 2018.

scholarly journals ETMR-15. USE OF HIGH-DOSE CHEMOTHERAPY FOR TWO CHILDREN WITH EMBRYONAL TUMOR WITH MULTILAYERED ROSETTES

2020 ◽  
Vol 22 (Supplement_3) ◽  
pp. iii326-iii326
Author(s):  
Shimpei Kusano ◽  
Junya Fujimura ◽  
Megumi Fujiwara ◽  
Akinori Yaguchi ◽  
Takeshi Ishibashi ◽  
...  
Keyword(s):  
Local Recurrence ◽  
Tumor Resection ◽  
Radical Resection ◽  
Multicenter Trial ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Embryonal Tumor ◽  
The Central Nervous System ◽  
Classification Of Tumors ◽  
Multiagent Chemotherapy

Abstract Embryonal tumor with multilayered rosettes (ETMR) is new entity defined in the 4th revised edition of the WHO classification of tumors of the central nervous system. Although radical resection, radiotherapy, and multiagent chemotherapy are considered to be necessary for ETMR, the efficacy of chemotherapy for ETMR in Japan has not been established. Here, we report different clinical courses for two children with localized ETMR treated with the St. Jude medulloblastoma-96 (SJMB96) regimen, which consists of four cycles of high-dose chemotherapy with autologous peripheral blood stem cell transplantation. For both children, the diagnosis of ETMR, C19MC-altered was confirmed after gross total tumor resection. Multiagent chemotherapy was administered following cranio-spinal irradiation with local boost. One month after completion of the treatment, one patient experienced local recurrence but has been in remission for over 2 years after tumor resection and stereotactic irradiation with a CyberKnife and treatment every three weeks with bevacizumab. The other patient also experienced local recurrence after the third cycle of chemotherapy and several times thereafter. Although she again underwent tumor resection and local irradiation, her tumor grew larger and invaded. Because her prognosis was very poor, her parents choose only palliative care. Based on our experience, we believe that continuous chemotherapy at conventional doses is preferred over intensive-dose chemotherapy such as SJMB96. However, the number of reports on chemotherapy for ETMR is still small, and a prospective multicenter trial is needed to establish effective chemotherapy for ETMR.

scholarly journals Patients with Primary Central Nervous System Lymphoma Not Eligible for Clinical Trials: Prognostic Factors, Treatment and Outcome

Cancers ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 2934
Author(s):  
Sabine Seidel ◽  
Michelle Margold ◽  
Thomas Kowalski ◽  
Alexander Baraniskin ◽  
Roland Schroers ◽  
...  
Keyword(s):  
Central Nervous System ◽  
Clinical Trials ◽  
Nervous System ◽  
Prognostic Factors ◽  
Central Nervous System Lymphoma ◽  
Initial Response ◽  
Early Response ◽  
Multicenter Trial ◽  
High Dose ◽  
Therapeutic Trials

Patients with primary central nervous system lymphoma (PCNSL) not fulfilling inclusion criteria for clinical trials represent an underreported population. Thirty-four consecutive PCNSL patients seen at our center between 2005 and 2019 with exclusion criteria for therapeutic trials were analyzed (non-study patients) and compared with patients from the G-PCNSL-SG-1 (German PCNSL Study Group 1) study (study patients), the largest prospective multicenter trial on PCNSL, comprising 551 patients. Median follow up was 68 months (range 1–141) in non-study patients and 51 months (1–105) in study patients. Twenty-seven/34 (79.4%) non-study patients received high dose methotrexate (HDMTX), while seven/34 (20.6%) with a glomerular filtration rate (GFR) < 50 mL/min did not. Median overall survival (OS) was six months (95% confidence interval [CI] 0–21 months) in those 34 non-study patients. The 27 non-study patients treated with HDMTX were compared with 526/551 G-PCNSL-SG-1 study patients who had received HDMTX as well. Median OS was 20 months (95% CI 0–45)/21 months (95% CI 18–25) in 27 non-study/526 study patients (p = 0.766). Favorable prognostic factors in non-study patients were young age, application of HDMTX and early response on magnet resonance imaging (MRI). If HDMTX-based chemotherapy can be applied, long-term disease control is possible even in patients not qualifying for clinical trials. Initial response on early MRI might be useful for decision on treatment continuation.

The effect of caloric restriction on working memory in healthy non-obese adults

CNS Spectrums ◽  
2019 ◽  
Vol 25 (1) ◽  
pp. 2-8 ◽  
Author(s):  
Emilie Leclerc ◽  
Alisson Paulino Trevizol ◽  
Ruth B. Grigolon ◽  
Mehala Subramaniapillai ◽  
Roger S. McIntyre ◽  
...  
Keyword(s):  
Working Memory ◽  
Energy Expenditure ◽  
Sleep Quality ◽  
Caloric Restriction ◽  
Neuropsychological Tests ◽  
Spatial Working Memory ◽  
Multicenter Trial ◽  
Obese Adults ◽  
Parallel Group ◽  
Lower Protein

Objective.We aim to evaluate the effect of caloric restriction (CR) in cognition by comparing performance in neuropsychological tests for working memory between a group of non-obese healthy subjects doing CR for 2 years with another consuming ad libitum diet (AL).Methods.This study was part of a larger multicenter trial called CALERIE that consisted of a randomized clinical trial with parallel-group comparing 2 years of 25% CR and AL in 220 volunteers with a BMI between 22 and 28 kg/m2, across 3 sites. The cognitive tests used were the Cambridge Neuropsychological Tests Automated Battery (CANTAB) for Spatial Working Memory (SWM) including the total number of errors (SWMTE) and strategy (SWMS). Included as possible moderators were sleep quality, mood states, perceived stress, and energy expenditure. Analyses were performed at baseline and months 12 and 24.Results.After adjustments, there was a significantly greater improvement in working memory assessed by the SWM for CR individuals, compared to AL. At month 24, it was related mostly to lower protein intake, compared to other macronutrients. Changes in SWM were moderated by changes in sleep quality, physical activity, and energy expenditure.Conclusion.On the long term, CR in healthy individuals seems to have a slightly positive effect on working memory. The study of brain CR targets opens new possibilities to prevent and treat cognitive deficits.

High-Dose Intravenous Immune Globulin in the Management of Severe Guillain-Barre Syndrome

1992 ◽  
Vol 26 (1) ◽  
pp. 32-33 ◽  
Author(s):  
Miguel Urtasun ◽  
Adolfo López de Murrain ◽  
Nieves Carrera ◽  
José F. Martí-Massó ◽  
Gonzalo López de Dicastillo ◽  
...  
Keyword(s):  
Ad Hoc ◽  
Care Center ◽  
Tertiary Care ◽  
Final Analysis ◽  
Multicenter Trial ◽  
Guillain Barre Syndrome ◽  
High Dose ◽  
The North ◽  
Guillain Barré Syndrome ◽  
Guillain Barré

OBJECTIVE: To evaluate the efficacy of high-dose intravenous gammaglobulin (IGIV) versus plasmapheresis in patients with severe Guillain-Barré syndrome (GBS) and compare the costs of both treatments. DESIGN: Retrospective review of all severely disabled GBS patients admitted between January 1 and December 31, 1990. SETTING: Neurologic unit of a tertiary-care center. PATIENTS: Six patients fulfilling the criteria for the diagnosis of GBS agreed upon by the ad hoc National Institute of Neurological and Communicative Disorders and Stroke committee. INTERVENTION: Four patients treated with plasmapheresis underwent three to six sessions of plasma exchange. Two patients received IGIV 0.4 g/kg/d administered over a five-day period. MAIN OUTCOME MEASURES: Recovery time, functional assessment (performed according to the grading scale used in the North American trial) at 30, 60, and 90 days after treatment. Cost of plasmapheresis, IGIV, and bed/day were compared. RESULTS: Clinical recovery appeared to be faster and more complete in the IGIV group than in the plasmapheresis group. No adverse reactions related to IGIV treatment appeared. The total cost was greater in the plasmapheresis group. CONCLUSIONS: These preliminary results suggest that IGIV may be more beneficial and less expensive than plasmapheresis in treatment of GBS. Definitive conclusions regarding the efficacy of IGIV in GBS will need to await the final analysis of the Ducht randomized multicenter trial comparing IGIV with plasmapheresis.

Safety and Efficacy of High-dose Rhesus-Human Reassortant Rotavirus Vaccines-Report of the National Multicenter Trial

PEDIATRICS ◽  
1996 ◽  
Vol 98 (1) ◽  
pp. A38-A38 ◽  
Author(s):  
Margaret B. Rennels ◽  
Roger I. Glass ◽  
Penelope H. Dennehy ◽  
David I. Bernstein ◽  
Michael E. Pichichero ◽  
...  
Keyword(s):  
United States ◽  
Medical Center ◽  
The United States ◽  
Multicenter Trial ◽  
High Dose ◽  
Rotavirus Vaccine ◽  
Kaiser Permanente ◽  
Safety And Efficacy ◽  
Rotavirus Vaccines ◽  
Medical Office

In the January 1996 article titled "Safety and Efficacy of High-dose Rhesus Human Reassortant Rotavirus Vaccines—Report of the National Multicenter Trial" (Rennels et al. Pediatrics, 1996:97:7-13), the Acknowledgments section on page 12 included an incorrect location for one member of the United States Rotavirus Vaccine Efficacy Group, and another member was inadvertently omitted. The correct list should include: Stephen Fries, MD, Boulder Medical Center, Boulder, CO; and Hervey Froehlich, MD, Kaiser Permanente Medical Office, Fresno, CA.

Efficacy, toxicity, and applicability of high-dose sequential chemotherapy as adjuvant treatment in operable breast cancer with 10 or more involved axillary nodes: five-year results.

1997 ◽  
Vol 15 (6) ◽  
pp. 2312-2321 ◽  
Author(s):  
A M Gianni ◽  
S Siena ◽  
M Bregni ◽  
M Di Nicola ◽  
S Orefice ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Standard Dose ◽  
Treated Group ◽  
Multicenter Trial ◽  
Control Group ◽  
High Dose ◽  
Axillary Nodes ◽  
Major Toxicity ◽  
Nonhematologic Toxicity

PURPOSE To assess the efficacy, toxicity, and applicability of high-dose therapy administered as adjuvant initial treatment to women with breast cancer with extensive nodal involvement. PATIENTS AND METHODS Sixty-seven patients with stage II to III breast cancer involving > or = 10 axillary nodes received a novel high-dose sequential (HDS) regimen, including the high-dose administration of three non-cross-resistant drugs (cyclophosphamide, methotrexate, and melphalan) given within the shortest interval of time as possible with hematologic and nonhematologic toxicity. RESULTS Sixty-three patients completed the program as planned, one patient died of acute toxicity, and three patients were switched to standard-dose adjuvant therapy. After a median follow-up duration of 48.5 months and a lead follow-up of 78 months, actuarial relapse-free survival for all 67 registered patients is 57% and overall survival is 70%, respectively. Comparison with a historical control group of 58 consecutive patients showed a significantly superior rate of freedom from relapse for the HDS-treated group (57% v 41%, respectively), in particular when two subgroups of patients, more homogeneous for their number of involved nodes, were compared (65% v 42%). Overall, treatment was of short duration (median, 70 days), required a median of 32 days of hospital stay, and was associated with only a few severe side effects (the most distressing being oral mucositis after melphalan therapy). CONCLUSION HDS therapy emerges as an effective and applicable regimen, whose major toxicity was occasional. Final assessment of its value in a randomized, multicenter trial is presently underway.

scholarly journals High-Dose Intravenous Immunoglobulin Is Effective in Painful Diabetic Polyneuropathy Resistant to Conventional Treatments. Results of a Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial

Pain Medicine ◽  
2020 ◽  
Vol 21 (3) ◽  
pp. 576-585 ◽  
Author(s):  
Stefano Jann ◽  
Raffaella Fazio ◽  
Dario Cocito ◽  
Antonio Toscano ◽  
Angelo Schenone ◽  
...  
Keyword(s):  
Placebo Group ◽  
Intravenous Immunoglobulin ◽  
Short Form ◽  
Diabetic Polyneuropathy ◽  
Multicenter Trial ◽  
Diabetic Patients ◽  
High Dose ◽  
Double Blind ◽  
Clinical Patient ◽  
Global Impression Of Change

Abstract Objectives The efficacy and safety of high-dose intravenous immunoglobulin (IVIG) in treatment-resistant diabetic painful polyneuropathy (DPN) were assessed. Design This was a randomized, double-blind, placebo-controlled, multicenter trial (EudraCT 2010–023883–42). Setting This trial was conducted at eight sites in Italy with a neurology specialist level of care. Subjects Twenty-six diabetic patients with DPN who reported baseline severity of pain &gt;60 units (mm) on a VAS scale at enrollment and were resistant to antidepressants and antiepileptic drugs were enrolled; 23 were randomized (11 in the IVIG arm and 12 in the placebo arm). All patients completed the study and were evaluated. All patients were Caucasian, 15 were male, and 21 had a diagnosis of type II diabetes. Methods IVIG (0.4 g/kg/d) or placebo was given for five consecutive days. Pain intensity (visual analog scale, Neuropathic Pain Symptom Inventory) and quality of life (36-Item Short-Form Health Survey, Clinical/Patient Global Impression of Change questionnaires) assessments were performed at visits: baseline, start of therapy (one week later), end of therapy (five days later), and follow-up (four and eight weeks later). Results The study achieved its prespecified primary end point of ≥50% pain reduction at four weeks after IVIG, achieved in seven of 11 patients (63.6%) in the IVIG group vs zero of 12 in the placebo group (P = 0.0013). Only two adverse events were reported during the study: one patient in the treatment arm reported a mild “dermatitis psoriasiform,” whereas one patient from the placebo group reported a mild “influenza.” Conclusions Treatment with IVIG at the dose given was efficacious and safe for patients with DPN resistant to standard therapies.

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