scholarly journals Improvement in the appearance of cellulite and skin laxity resulting from a single treatment with acoustic subcision: Findings from a multicenter pivotal clinical trial

2021 ◽  
Author(s):  
Elizabeth L. Tanzi ◽  
Christopher C. Capelli ◽  
David W. Robertson ◽  
Brenda LaTowsky ◽  
Carolyn Jacob ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Single Treatment ◽  
Skin Laxity ◽  
Pivotal Clinical Trial

Prospective Clinical Trial of the Latest Generation of Noninvasive Monopolar Radiofrequency for the Treatment of Facial and Upper Neck Skin Laxity

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Kunal Angra ◽  
Marwan Alhaddad ◽  
Monica Boen ◽  
Michael B. Lipp ◽  
Ramya Kollipara ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Prospective Clinical Trial ◽  
Skin Laxity

scholarly journals Approaches to cervical spine mobilization for neck pain: a pilot randomized controlled trial

2020 ◽  
Vol 28 (1) ◽  
Author(s):  
Claire Lagoutaris ◽  
Justin Sullivan ◽  
Michelle Hancock ◽  
Andrew M. Leaver
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Cervical Spine ◽  
Neck Pain ◽  
Controlled Trial ◽  
Trial Registration ◽  
Single Treatment ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Study design Pilot randomized controlled trial. Background Better understanding of the relative effectiveness of different approaches to cervical spine mobilization has been identified as a research priority in manual therapy practice. Two distinct approaches to the practice of mobilization have emerged in recent years, based on different reasoning models for selection of mobilization techniques. The objective of this pilot study was to assess feasibility aspects for a future randomized clinical trial by exploring short-term pain and disability outcomes after a single treatment with pragmatic versus prescriptive approaches to cervical mobilization for people with recent-onset neck pain at 48-h follow-up after randomization. Methods Twenty adults with a new episode of mechanical neck pain were randomly allocated to either pragmatic or prescriptive mobilization intervention groups. The pragmatic group received a single treatment of cervical mobilization with the technique, target segment, and grade selected by their treating therapist. The prescriptive group received a single treatment of standardized mobilization with techniques similar to a previous mobilization clinical trial. Feasibility outcomes were recruitment rates, randomization audit and completion of treatment and follow-up per protocol. The primary clinical outcome of interest was disability level measured at 48-h follow-up after randomization. Results Recruitment rates were approximately 2.5 participants per week and 100% of eligible participants were deemed suitable for treatment with cervical mobilization. There was sufficient variety in the range of pragmatic treatments selected and the data collection process imposed minimal burden on participants. Conclusions Our results provide supporting evidence for the feasibility of a future larger scale randomized clinical trial. Trial registration Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12616000446460). Registered 6th April 2016. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370448&isReview=true

scholarly journals Buffy coat-derived platelets cryopreserved using a new method: Results from a pivotal clinical trial on thrombocytopenic patients with acute leukaemia

2019 ◽  
Vol 58 (6) ◽  
pp. 102666
Author(s):  
Mariasanta Napolitano ◽  
Salvatrice Mancuso ◽  
Simona Raso ◽  
Lucio LoCoco ◽  
Piera Stefania Arfò ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Acute Leukaemia ◽  
Buffy Coat ◽  
New Method ◽  
Pivotal Clinical Trial

scholarly journals Flexible selection of a single treatment incorporating short-term endpoint information in a phase II/III clinical trial

2015 ◽  
Vol 34 (23) ◽  
pp. 3104-3115 ◽  
Author(s):  
Nigel Stallard ◽  
Cornelia Ursula Kunz ◽  
Susan Todd ◽  
Nicholas Parsons ◽  
Tim Friede
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Single Treatment ◽  
Short Term ◽  
Selection Of

Design and rational of the natural history study in preparation for the pivotal clinical trial for the treatment of Sanfilippo syndrome type A

2017 ◽  
Vol 120 (1-2) ◽  
pp. S25-S26
Author(s):  
Soraya Bekkali ◽  
Samantha Parker ◽  
Anupam Chakrapani ◽  
Roberto Giugliani ◽  
Benedicte Heron ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Natural History ◽  
Type A ◽  
Syndrome Type ◽  
Sanfilippo Syndrome ◽  
Natural History Study ◽  
Pivotal Clinical Trial

Multimodal hyperspectroscopy as a triage test for cervical neoplasia: Pivotal clinical trial results

2013 ◽  
Vol 130 (1) ◽  
pp. 147-151 ◽  
Author(s):  
Leo B. Twiggs ◽  
Nahida A. Chakhtoura ◽  
Daron G. Ferris ◽  
Lisa C. Flowers ◽  
Marc L. Winter ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cervical Neoplasia ◽  
Pivotal Clinical Trial ◽  
Clinical Trial Results ◽  
Triage Test

scholarly journals Repeat infection with SARS COV-2, a worrisome situation: report of two cases from India

2021 ◽  
Vol 8 (3) ◽  
pp. 1512
Author(s):  
Deepak Kumar ◽  
Garima Gupta
Keyword(s):  
Clinical Trial ◽  
Disease Severity ◽  
Viral Genome ◽  
Treatment Method ◽  
Community Level ◽  
Effective Vaccine ◽  
Single Treatment ◽  
The World ◽  
Current Scenario ◽  
Repeat Infection

Number of COVID cases and mortalities are still growing globally. There is no single treatment method found effective in reducing the disease severity. Several vaccines have been developed recently and most of them are under clinical trial only.  Availability of an effective vaccine and its use at the community level is the only hope left with us. However, the emergence of re-infective cases from various part of the world has put a big question on the ongoing vaccination research and its use. Most of these re-infection cases reported were not studied for viral genome, different mutated virus causing repeat infection have been isolated in few reports only. In these situations, either a newer vaccine has to be developed every time for a new mutated virus or the multiple doses of the vaccine have to be administered if same strain of the virus is causing the re-infection. We report two cases from India who acquired repeat SARS COV 2 infection, adding up the much-required information in the current scenario.

scholarly journals Effect of Multimodal Intervention Care on Cachexia in Patients with Advanced Cancer Compared To Conventional Management (MIRACLE): An Open-Label, Parallel, Randomized, Phase 2 Trial

2021 ◽  
Author(s):  
Chi Hoon Maeng ◽  
Bo-Hyung Kim ◽  
Jinmann Chon ◽  
Won Sub Kang ◽  
Kyounglan Kang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Palliative Chemotherapy ◽  
Handgrip Strength ◽  
Complex Interventions ◽  
Omega 3 ◽  
Single Treatment ◽  
Nutritional Counseling ◽  
Multimodal Intervention

Abstract Background: the context and purpose of the studyCancer cachexia (CC) is a multifactorial process characterized by progressive weight loss, muscle mass, and fat tissue wasting, which adversely affects the quality of life and survival of patients with advanced stages of cancer. CC has a complex and multifactorial pathophysiology, and there is no established standard treatment. Therefore, it is often irreversible and a single treatment modality is unlikely to suppress its progression. We are conducting a randomized trial to investigate the efficacy and safety of a multimodal intervention compared to the best supportive care for patients who received palliative chemotherapy.Methods: how the study will be performedPatients with lung or gastrointestinal cancers undergoing palliative chemotherapy are eligible. Patients are randomized into a multimodal intervention care (MIC) arm versus a conventional palliative care (CPC) arm. MIC includes ibuprofen, omega-3-fatty acid, oral nutritional supplement, weekly physical, psychiatric assessment, nutritional counseling, and complementary and alternative medicine. CPC includes basic nutritional counseling and megestrol acetate as needed (i.e., anorexia ≥ grade 2). All interventions are performed for 12 weeks per subject. The co-primary outcomes are median change (kg) in total lean body mass and handgrip strength (kg) from the baseline. A total of 112 patients will be assigned to the two arms (56 in each group). Discussion: a brief summary and potential implicationsThe purpose of this study is to evaluate the effect of MIC in preventing or alleviating CC in patients who underwent palliative chemotherapy. As there is no established single treatment for CC, it is expected that the results of this clinical trial will provide new insights to significantly improve the quality of life of patients with cancer. Considering the complex mechanisms of cachexia, the effect of MIC rather than a single specific drug is more promising. In this study, we did not overly restrict the type of cancer or chemotherapy. Therefore, we attempted to measure the effects of complex interventions while preserving clinical situations. Thus, it is expected that the results of this study can be applied effectively to real-world practice.Trial registration: If your article reports the results of a health care intervention on human participants, it must be registered in an appropriate registry and the registration number and date of registration should be in stated in this section. If it was not registered prospectively (before enrollment of the first participant), you should include the words 'retrospectively registered'. See our editorial policies for more information on trial registration.This clinical trial was registered in the Clinical Research Information Service (KCT0004967), Korean Clinical Trial Registry on April 27, 2020, and ClinicalTrial.gov (NCT 04907864) on June 1, 2021.

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