Use of protocol-synchronous LIMS structures to expand the role of the centralized clinical trial laboratory in pharmaceutical research

1995 ◽  
pp. 71-96
Author(s):  
F. D. Morrow
Keyword(s):  
Clinical Trial ◽  
Pharmaceutical Research

Role of convalescent plasma therapy in new Coronavirus disease (nCOVID-19): A review

2020 ◽  
Vol 11 (SPL1) ◽  
pp. 546-549
Author(s):  
Shweta Dadarao Parwe ◽  
Milind Abhimanyu Nisargandha ◽  
Rishikesh Thakre
Keyword(s):  
Clinical Trial ◽  
Immune Responses ◽  
Indian Population ◽  
Preventive Treatment ◽  
The Body ◽  
Therapeutic Antibodies ◽  
Plasma Therapy ◽  
Host Immune Responses ◽  
Transparent Liquid

Hitherto, there is no proper line of treatment for the new (nCOVID19). The development of unique antiviral drugs has taken precedence. Therapeutic antibodies () will be a significantly beneficial agent against nCOVID-19. Here the host immune responses to new discussed in this review provide strategy and further treatment and understanding of clinical interventions against nCOVID-19. Plasma therapy uses the antibodies found in the blood of people recovering (or convalesced) from an infection to treat infected patients. When an infection occurs, the body begins producing proteins specially made to kill the germ, called antibodies. Those antibodies coat specifically plasma in the blood of survivors, the yellow transparent liquid blood portion for months or even years. research assesses plasma use from Convalescent patients of infected with nCOVID-19 as a possible preventive treatment. But it is not yet recommended as a line of treatment, and it is used as a clinical trial in the new in Indian population.

scholarly journals Does intervention with GLP-1 receptor agonist semaglutide modulate perception of sweet taste in women with obesity: study protocol of a randomized, single-blinded, placebo-controlled clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mojca Jensterle ◽  
Simona Ferjan ◽  
Tadej Battelino ◽  
Jernej Kovač ◽  
Saba Battelino ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Neural Response ◽  
Taste Perception ◽  
Taste Bud ◽  
Controlled Clinical Trial ◽  
Food Cues ◽  
Link Type ◽  
Visual Food Cues ◽  
Taste Bud Cells

Abstract Background Preclinical studies demonstrated that glucagon-like peptide 1 (GLP-1) is locally synthesized in taste bud cells and that GLP-1 receptor exists on the gustatory nerves in close proximity to GLP-1-containing taste bud cells. This local paracrine GLP-1 signalling seems to be specifically involved in the perception of sweets. However, the role of GLP-1 in taste perception remains largely unaddressed in clinical studies. Whether any weight-reducing effects of GLP-1 receptor agonists are mediated through the modulation of taste perception is currently unknown. Methods and analysis This is an investigator-initiated, randomized single-blind, placebo-controlled clinical trial. We will enrol 30 women with obesity and polycystic ovary syndrome (PCOS). Participants will be randomized in a 1:1 ratio to either semaglutide 1.0 mg or placebo for 16 weeks. The primary endpoints are alteration of transcriptomic profile of tongue tissue as changes in expression level from baseline to follow-up after 16 weeks of treatment, measured by RNA sequencing, and change in taste sensitivity as detected by chemical gustometry. Secondary endpoints include change in neural response to visual food cues and to sweet-tasting substances as assessed by functional MRI, change in body weight, change in fat mass and change in eating behaviour and food intake. Discussion This is the first study to investigate the role of semaglutide on taste perception, along with a neural response to visual food cues in reward processing regions. The study may identify the tongue and the taste perception as a novel target for GLP-1 receptor agonists. Ethics and disseminations The study has been approved by the Slovene National Medical Ethics Committee and will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Results will be submitted for publication in an international peer-reviewed scientific journal. Trial registration ClinicalTrials.govNCT04263415. Retrospectively registered on 10 February 2020

scholarly journals X-change symposium: status and future of modern radiation oncology—from technology to biology

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Stefanie Corradini ◽  
Maximilian Niyazi ◽  
Dirk Verellen ◽  
Vincenzo Valentini ◽  
Seán Walsh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Radiation Oncology ◽  
Trial Design ◽  
Rapid Development ◽  
Clinical Trial Design ◽  
Current Status ◽  
Treatment Modalities ◽  
Special Treatment ◽  
Image Guided Radiotherapy

AbstractFuture radiation oncology encompasses a broad spectrum of topics ranging from modern clinical trial design to treatment and imaging technology and biology. In more detail, the application of hybrid MRI devices in modern image-guided radiotherapy; the emerging field of radiomics; the role of molecular imaging using positron emission tomography and its integration into clinical routine; radiation biology with its future perspectives, the role of molecular signatures in prognostic modelling; as well as special treatment modalities such as brachytherapy or proton beam therapy are areas of rapid development. More clinically, radiation oncology will certainly find an important role in the management of oligometastasis. The treatment spectrum will also be widened by the rational integration of modern systemic targeted or immune therapies into multimodal treatment strategies. All these developments will require a concise rethinking of clinical trial design. This article reviews the current status and the potential developments in the field of radiation oncology as discussed by a panel of European and international experts sharing their vision during the “X-Change” symposium, held in July 2019 in Munich (Germany).

The role of body mass index or metabolic syndrome components causing depression in women: An observation from weight reduction clinical trial

2021 ◽  
Author(s):  
Ranakishor Pelluri ◽  
Srikanth Kongara ◽  
Jithendra Chimakurthy ◽  
Shriraam Mahadevan ◽  
Vanitharani Nagasubramanian
Keyword(s):  
Metabolic Syndrome ◽  
Clinical Trial ◽  
Body Mass Index ◽  
Body Mass ◽  
Weight Reduction ◽  
Metabolic Syndrome Components

Role of Ready to Drink Nutritional Formula (Protison Enriched with ω-3 FA and BCAA) Supplemented by Nasogastric Tube Feeding in Various Cancer Patients: A Clinical Trial

2021 ◽  
Vol 17 (3) ◽  
pp. 113-121
Author(s):  
Sheng-Chang Lin ◽  
Hsien-Chun Tseng ◽  
Hui-Fang Chiu ◽  
Zhuang Shuru ◽  
Ming-Yi Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cancer Patients ◽  
Nasogastric Tube ◽  
Tube Feeding ◽  
Nasogastric Tube Feeding

scholarly journals Elements of a clinical trial protocol for medical devices

2017 ◽  
Vol 7 (6) ◽  
pp. 65
Author(s):  
Raymond P. Briggs ◽  
Lois Ramer
Keyword(s):  
Clinical Trial ◽  
Medical Device ◽  
De Novo ◽  
Evidence Based ◽  
Trial Protocol ◽  
Risk Class ◽  
Clinical Trial Protocol ◽  
Fda Approval ◽  
Near Future

Based on a Class 2 limited risk hospital based clinical trial, and a subsequent project retrospective, Briggs and Ramer propose an expanded clinical trial protocol.  Such an expanded protocol would be especially helpful for evaluating De Novo devices:  new inventions which require new processes for full hospital integration.  Since these new processes would often require training of nurses and supporting professionals, Briggs and Ramer suggest that nurse investigators could be very effective in carrying out such expanded protocol studies.  We briefly describe the FDA approval process, the role of the nurse in evidence based medical device evaluation, the Ramer, et al. clinical trial, the proposed expanded clinical trial protocol, and candidate categories of devices that might employ the limited risk Class 2 Medical Device clinical trial protocol.  The investigators look forward to carrying out such a medical device clinical trial in the near future.

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