Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy.
Techniques and strategies which include the use of coding sequences and other conventional or radical means to transform or modify cells for the purpose of treating or reversing disease conditions.
New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.
The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results.
Non-invasive method of demonstrating internal anatomy based on the principle that atomic nuclei in a strong magnetic field absorb pulses of radiofrequency energy and emit them as radiowaves which can be reconstructed into computerized images. The concept includes proton spin tomographic techniques.
Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.

A multicomponent intervention to prevent delirium in hospitalized older patients. (1/2588)

BACKGROUND: Since in hospitalized older patients delirium is associated with poor outcomes, we evaluated the effectiveness of a multicomponent strategy for the prevention of delirium. METHODS: We studied 852 patients 70 years of age or older who had been admitted to the general-medicine service at a teaching hospital. Patients from one intervention unit and two usual-care units were enrolled by means of a prospective matching strategy. The intervention consisted of standardized protocols for the management of six risk factors for delirium: cognitive impairment, sleep deprivation, immobility, visual impairment, hearing impairment, and dehydration. Delirium, the primary outcome, was assessed daily until discharge. RESULTS: Delirium developed in 9.9 percent of the intervention group as compared with 15.0 percent of the usual-care group, (matched odds ratio, 0.60; 95 percent confidence interval, 0.39 to 0.92). The total number of days with delirium (105 vs. 161, P=0.02) and the total number of episodes (62 vs. 90, P=0.03) were significantly lower in the intervention group. However, the severity of delirium and recurrence rates were not significantly different. The overall rate of adherence to the intervention was 87 percent, and the total number of targeted risk factors per patient was significantly reduced. Intervention was associated with significant improvement in the degree of cognitive impairment among patients with cognitive impairment at admission and a reduction in the rate of use of sleep medications among all patients. Among the other risk factors per patient there were trends toward improvement in immobility, visual impairment, and hearing impairment. CONCLUSIONS: The risk-factor intervention strategy that we studied resulted in significant reductions in the number and duration of episodes of delirium in hospitalized older patients. The intervention had no significant effect on the severity of delirium or on recurrence rates; this finding suggests that primary prevention of delirium is probably the most effective treatment strategy.  (+info)

Can we cure indolent lymphomas? (2/2588)

The current consensus is that indolent lymphomas are incurable disorders. There are some indications that these malignancies are potentially curable. Indeed, not all indolent lymphomas are currently incurable. For example, patients with Ann Arbor stage I-II indolent lymphomas can experience long-term disease-free survival and probable cure. Also, from the available literature data, it seems that the achievement of a molecular complete remission is a desirable objective. Patients who achieve a persistently negative PCR state seldom relapse, whereas the opposite is true for persistently positive cases. In view of its excellent correlation with disease-free survival when examined serially in multiple blood or marrow samples, the PCR technique has the potential of providing a tumor marker that can be used as an early end point for clinical trials. By serving as an early surrogate end point, PCR could play an important role in expediting the development of new treatment strategies. Whether IFN is capable of increasing the molecular complete remission rate as measured by PCR is not known. However, it is clear that from the clinical standpoint, IFN has been able to increase 2-fold the length of remission in patients with advanced indolent lymphomas. In at least two studies, this has been associated with prolongation of survival. More intensive regimens such as alternating triple therapy, when used in combination with IFN, seem to have improved the quality of remissions as judged by the PCR assay. Finally, the site where the bcl-2 breakpoint occurs seems to have clinical significance. Those follicular lymphomas with germ-line bcl-2, in our experience, have behaved more aggressively than the others, and their failure-free survival seems different from the usual indolent lymphomas and more closely resembles the large cell lymphomas. Although the biological significance of this observation is not yet understood, this group might actually constitute a prognostically different subset with a more aggressive and perhaps more curable lymphoma. Whether the plateau observed in their failure-free survival curve will be maintained with more follow-up and whether they might be a curable subset remain to be determined.  (+info)

Low-molecular-weight heparin in outpatient treatment of DVT. (3/2588)

Patients with a diagnosis of acute deep venous thrombosis have traditionally been hospitalized and treated with unfractionated heparin followed by oral anticoagulation therapy. Several clinical trials have shown that low-molecular-weight heparin is at least as safe and effective as unfractionated heparin in the treatment of uncomplicated deep venous thrombosis. The use of low-molecular-weight heparin in an outpatient program for the management of deep venous thrombosis provides a treatment alternative to hospitalization in selected patients. Use of low-molecular-weight heparin on an outpatient basis requires coordination of care, laboratory monitoring, and patient education and participation in treatment. Overlapping the initiation of warfarin permits long-term anticoagulation. Advantages include a decreased incidence of heparin-induced thrombocytopenia and fewer episodes of bleeding complications. Future clinical trials evaluating the safety and efficacy of low-molecular-weight heparin in the treatment of complicated deep venous thrombosis will further define appropriate indications for use and strategies for outpatient management.  (+info)

Time course of respiratory decompensation in chronic obstructive pulmonary disease: a prospective, double-blind study of peak flow changes prior to emergency department visits. (4/2588)

The aim of this study was to look at changes in peak expiratory flow rates (PEFR) prior to emergency department visits for decompensated chronic obstructive pulmonary disease (COPD). It was designed as a prospective, double-blind study at the Albuquerque Veterans Affairs Medical Center. Twelve patients with an irreversible component of airflow obstruction on pulmonary function tests were assessed. At entry, all subjects were instructed in the use of a mini-Wright peak flow meter with electronic data storage. They then entered a 6-month monitoring phase in which they recorded PEFR twice daily, before and after bronchodilators. The meter displays were disabled so that the patients and their physicians were blinded to all values. Medical care was provided in the customary manner. Patients were considered to have respiratory decompensation if they required treatment for airflow obstruction in the Emergency Department (ED) and no other causes of dyspnea could be identified. Simple linear regression was used to model changes in PEFR over time. The 12 subjects had 22 episodes of respiratory decompensation during 1741 patient-days of observation. Two episodes could not be analysed because of missing values. Ten episodes in seven subjects were characterized by a significant linear decline in at least one peak flow parameter prior to presentation. The mean rates of change for the four daily parameters varied from 0.22% to 0.27% predicted per day (or 1.19 to 1.44 1 min-1 day-1). The average decrement in these parameters ranged from 30.0 to 33.8 1 min-1 (or 18.6%-25.9% of their baseline values). No temporal trends were found for the 10 episodes occurring in the other five subjects. We concluded that respiratory decompensation is characterized by a gradual decline in PEFR in about half of cases. Future studies should be done to elucidate the mechanisms of respiratory distress in the other cases.  (+info)

Enhancing the identification of excessive drinkers on medical wards: a 1-year follow-up study. (5/2588)

This paper describes a 1-year follow-up study examining whether hospital ward doctors and nurses continue to take quantitative alcohol histories and provide brief intervention to problem drinkers on general medical wards after the introduction of a simple protocol. Regular training in the use of this protocol was stipulated in the annual service contract between the Health Authority and the Hospital Trusts. Improvements in staff practice persisted at 1-year follow-up, although it fell from a peak at an earlier phase of the study. The positive role of state purchasers of health services in sustaining improvements in clinical practice is discussed.  (+info)

Agreeing criteria for audit of the management of induced abortion: an approach by national consensus survey. (6/2588)

OBJECTIVE: To obtain a national consensus view of suggested criteria for good quality care in induced abortion to serve as a basis for standards for audit to assess current clinical practice. DESIGN: Postal, questionnaire survey assessing consensus agreement with criteria identified from a literature review and refined by an invited panel of four gynaecologists and the gynaecology audit project in Scotland (GAPS) committee. SETTING: Scotland. SUBJECTS: All 132 practising consultant gynaecologists. MAIN MEASURES: Overall level of agreement with each of 20 suggested audit criteria. RESULTS: 121 completed questionnaires were received (response rate 92%), of which 119 were returned in time for analysis; 107 came from consultants who practised abortion routinely and were included in the analysis. Nineteen of 20 suggested criteria were validated by an overall balance of agreement. The most strongly supported criterion (agreement score +93) was for ascertaining rhesus status of the woman and prophylaxis after abortion, if indicated. The only criterion to elicit a negative agreement score (-27) was that dilatation and evacuation is the best method of abortion at 12-15 weeks' gestation. The ranked and prioritised criteria resulting from this exercise are being used within a national audit project. CONCLUSIONS: A postal questionnaire survey among interested clinicians resulted in a good response rate and enabled the audit criteria to be validated and ranked more objectively and among more clinicians, than would have been possible by group discussion.  (+info)

Audit of thrombolysis initiated in an accident and emergency department. (7/2588)

Early thrombolytic therapy after acute myocardial infarction is important in reducing mortality. To evaluate a system for reducing in-hospital delays to thrombolysis pain to needle and door to needle times to thrombolysis were audited in a major accident and emergency (A and E) department of a district general hospital and its coronary care unit (CCU), situated about 5 km away. Baseline performance over six months was assessed retrospectively from notes of 43 consecutive patients (group 1) transferred to the CCU before receiving thrombolysis. Subsequently, selected patients (23) were allowed to receive thrombolysis in the A and E department before transfer to the CCU. The agent was administered by medical staff in the department after receiving oral confirmation of myocardial infarction from the admitting medical officer in the CCU on receipt of fax transmission of the electrocardiogram. A second prospective audit during six months from the start of the new procedure established time intervals in 23 patients eligible to receive thrombolysis in the A and E department (group 2b) and 30 ineligible patients who received thrombolysis in the CCU (group 2a). The groups did not differ significantly in case mix, pre-hospital delay, or transfer time to the CCU. In group 2b door to needle time and pain to needle time were reduced significantly (geometric mean 38 min v 121 min (group 2a) and 128 min (group 1); 141 min v 237 min (group 2a) and 242 min (group 1) respectively, both p < 0.0001). The incidence of adverse effects was not significantly different. Nine deaths occurred (six in group 1, three in group 2b), an in-hospital mortality of 9.9%. Thrombolysis can be safely instituted in the A and E department in selected patients, significantly reducing delay to treatment.  (+info)

Improving quality through cost recovery in Niger. (8/2588)

New evidence on the quality of health care from public services in Niger is discussed in terms of the relationships between quality, costs, cost-effectiveness and financing. Although structural attributes of quality appeared to improve with the pilot project in Niger, significant gaps in the implementation of diagnostic and treatment protocols were observed, particularly in monitoring vital signs, diagnostic examination and provider-patient communications. Quality improvements required significant investments in both fixed and variable costs; however, many of these costs were basic input requirements for operation. It is likely that optimal cost-effectiveness of services was not achieved because of the noted deficiencies in quality. In the test district of Boboye, the revenues from the copayments alone covered about 34% of the costs of medicines or about 20% of costs of drugs and administration. In Say, user fees covered about 50-55% of the costs of medicines or 35-40% of the amount spent on medicines and cost-recovery administration. In Boboye, taxes plus the additional copayments covered 120-180% of the cost of medicines, or 75-105% of the cost of medicines plus administration of cost recovery. Decentralized management and legal conditions in the pilot districts appeared to provide the necessary structure to ensure that the revenues and taxes collected would be channelled to pay for quality improvements.  (+info)

Clinical protocols, also known as clinical practice guidelines or care paths, are systematically developed statements that assist healthcare professionals and patients in making decisions about the appropriate healthcare for specific clinical circumstances. They are based on a thorough evaluation of the available scientific evidence and consist of a set of recommendations that are designed to optimize patient outcomes, improve the quality of care, and reduce unnecessary variations in practice. Clinical protocols may cover a wide range of topics, including diagnosis, treatment, follow-up, and disease prevention, and are developed by professional organizations, government agencies, and other groups with expertise in the relevant field.

Genetic therapy, also known as gene therapy, is a medical intervention that involves the use of genetic material, such as DNA or RNA, to treat or prevent diseases. It works by introducing functional genes into cells to replace missing or faulty ones caused by genetic disorders or mutations. The introduced gene is incorporated into the recipient's genome, allowing for the production of a therapeutic protein that can help manage the disease symptoms or even cure the condition.

There are several approaches to genetic therapy, including:

1. Replacing a faulty gene with a healthy one
2. Inactivating or "silencing" a dysfunctional gene causing a disease
3. Introducing a new gene into the body to help fight off a disease, such as cancer

Genetic therapy holds great promise for treating various genetic disorders, including cystic fibrosis, muscular dystrophy, hemophilia, and certain types of cancer. However, it is still an evolving field with many challenges, such as efficient gene delivery, potential immune responses, and ensuring the safety and long-term effectiveness of the therapy.

Neoplasms are abnormal growths of cells or tissues in the body that serve no physiological function. They can be benign (non-cancerous) or malignant (cancerous). Benign neoplasms are typically slow growing and do not spread to other parts of the body, while malignant neoplasms are aggressive, invasive, and can metastasize to distant sites.

Neoplasms occur when there is a dysregulation in the normal process of cell division and differentiation, leading to uncontrolled growth and accumulation of cells. This can result from genetic mutations or other factors such as viral infections, environmental exposures, or hormonal imbalances.

Neoplasms can develop in any organ or tissue of the body and can cause various symptoms depending on their size, location, and type. Treatment options for neoplasms include surgery, radiation therapy, chemotherapy, immunotherapy, and targeted therapy, among others.

Reproducibility of results in a medical context refers to the ability to obtain consistent and comparable findings when a particular experiment or study is repeated, either by the same researcher or by different researchers, following the same experimental protocol. It is an essential principle in scientific research that helps to ensure the validity and reliability of research findings.

In medical research, reproducibility of results is crucial for establishing the effectiveness and safety of new treatments, interventions, or diagnostic tools. It involves conducting well-designed studies with adequate sample sizes, appropriate statistical analyses, and transparent reporting of methods and findings to allow other researchers to replicate the study and confirm or refute the results.

The lack of reproducibility in medical research has become a significant concern in recent years, as several high-profile studies have failed to produce consistent findings when replicated by other researchers. This has led to increased scrutiny of research practices and a call for greater transparency, rigor, and standardization in the conduct and reporting of medical research.

Medical Definition:

Magnetic Resonance Imaging (MRI) is a non-invasive diagnostic imaging technique that uses a strong magnetic field and radio waves to create detailed cross-sectional or three-dimensional images of the internal structures of the body. The patient lies within a large, cylindrical magnet, and the scanner detects changes in the direction of the magnetic field caused by protons in the body. These changes are then converted into detailed images that help medical professionals to diagnose and monitor various medical conditions, such as tumors, injuries, or diseases affecting the brain, spinal cord, heart, blood vessels, joints, and other internal organs. MRI does not use radiation like computed tomography (CT) scans.

Treatment outcome is a term used to describe the result or effect of medical treatment on a patient's health status. It can be measured in various ways, such as through symptoms improvement, disease remission, reduced disability, improved quality of life, or survival rates. The treatment outcome helps healthcare providers evaluate the effectiveness of a particular treatment plan and make informed decisions about future care. It is also used in clinical research to compare the efficacy of different treatments and improve patient care.

"Clinical packages & Protocols". katetchanturia.com. "Academy of Europe: Tchanturia Kate". www.ae-info.org. Retrieved 28 ... Pathway for Eating disorders and Autism developed from Clinical Experience). This clinical pathway was funded by The Health ... She has developed a novel clinical pathway for patients with comorbid autism and eating disorders at the South London and ... After relocating to London in 1997, she became a clinical research fellow at the Institute of Psychiatry, King's College London ...
"Clinical protocol. Gene Therapy of Canavan Disease: AAV-2 Vector for Neurosurgical Delivery of Aspartoacylase Gene (ASPA) to ...
Limited clinical protocols for patient management. Limited technical operational manuals for program implementation. Health ...
Perlman, Sally E.; Nakajyma, Steven T.; Hertweck, S. Paige (2004). Clinical protocols in pediatric and adolescent gynecology. ... Perlman, Sally E.; Nakajyma, Steven T.; Hertweck, S. Paige (2004). Clinical protocols in pediatric and adolescent gynecology. ... Clinical and Pathological Aspects, Greenwich Medical Media: London, a)p.453, b)p.455 c)p.460. "Muslim women in France regain ...
Perlman, Sally E.; Nakajyma, Steven T.; Hertweck, S. Paige (2004). Clinical protocols in pediatric and adolescent gynecology. ... Clinical and Pathological Aspects, Greenwich Medical Media: London, a)p.453, b)p.455 c)p.460. The Marks of Childhood or the ... vaginal examinations for verifying a woman's virginity are a clinical practice which are at times state-enforced. These types ...
ISBN 978-0-7131-4452-9. Perlman SE, Nakajyma ST, Hertweck SP (2004). Clinical protocols in pediatric and adolescent gynecology ... Alldredge BK, Corelli RL, Ernst ME (2012). Koda-Kimble and Young's Applied Therapeutics: The Clinical Use of Drugs. Lippincott ... Sirven JI, Malamut BL (2008). Clinical Neurology of the Older Adult. Lippincott Williams & Wilkins. pp. 230-232. ISBN 978-0- ... Balon R, Segraves RT (2009). Clinical Manual of Sexual Disorders. American Psychiatric Pub. p. 258. ISBN 978-1-58562-905-3. ...
Perlman, Sally E.; Nakajyma, Steven T.; Hertweck, S. Paige (2004). Clinical protocols in pediatric and adolescent gynecology. ... Clinical and Pathological Aspects, Greenwich Medical Media: London, a)p.453, b)p.455 c)p.460. ISBN 978-1-84-110026-5 Heger, ... Journal of Clinical Forensic Medicine. 13 (4): 172-180. doi:10.1016/j.jcfm.2006.02.006. ISSN 1353-1131. PMID 16564196. Hymen ...
In 2006, an invited group of clinicians met in Chicago and reviewed clinical evidence and protocols, and adopted a new term for ... Large majorities of respondents opposed standard clinical protocols. A 2016 follow-up to the 2006 Consensus Statement, termed a ... a US professor of Clinical Medical Humanities and Bioethics, argues that little has changed in actual clinical practice in ... The committee stated: "clinical intervention pathways stated to be based on probabilities of cancer risk may be encapsulating ...
In 2006, an invited group of clinicians met in Chicago and reviewed clinical evidence and protocols, argued that and adopted a ... Large majorities of respondents opposed standard clinical protocols. A 2016 follow-up to the 2006 Consensus Statement, termed a ... There are no controlled clinical trials of the efficacy of early (less than 12 months of age) versus late surgery (in ... Clinical Pediatric and Adolescent Endocrinology.. Philadelphia: Saunders. An example of a now-obsolete recommendation to ...
"What stops hospital clinical staff from following protocols? An analysis of the incidence and factors behind the failure of ... These tools can predict clinical deterioration based upon the patient's trait (e.g. has epilepsy) and detect deterioration ... UK National Institute for Health and Clinical Excellence (NICE) (July 2007). "Acutely ill patients in hospital: recognition of ... A rapid response system consists of two clinical components, an afferent component, an efferent component, and two ...
Clinical Applications of Capillary Electrophoresis: Methods and Protocols. Methods in Molecular Biology. Vol. 1972. New York, ...
... in Clinical Practice Using SEE-Fim Protocol". JNCI Cancer Spectrum. 2 (4): pky061. doi:10.1093/jncics/pky061. ISSN 2515-5091. ... The SEE-FIM protocol is a pathology dissection protocol for Sectioning and Extensively Examining the Fimbria (SEE-FIM). This ... The SEE-FIM protocol consists of five steps (See Figure): The tube is fixed for at least 2 hours in laboratory fixative. The ... The protocol is used to exclude occult cancer. A recent study of over 25,000 women who underwent this procedure reported no ...
In a clinical trial, the protocol is carefully designed to safeguard the health of the participants as well as answer specific ... While in a clinical trial, participants following a protocol are seen regularly by research staff to monitor their health and ... A good clinical protocol ensures that blinding is as effective as possible within ethical and practical constrains. During the ... In fact, such predefined protocols are an essential component of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP ...
Protocols in Clinical Embryology and ART. JP Medical Ltd. pp. 379-. ISBN 978-93-5025-765-4. Kuhl H (August 2005). "Pharmacology ...
Clinical trial protocols are the centerpiece of the IND. Detailed protocols for proposed clinical studies to assess whether the ... If the FDA detects a problem, it may place a clinical hold on the IND, prohibiting the start of the clinical studies until the ... Once an IND is submitted, the FDA has 30 days to object to the IND or it automatically becomes effective and clinical trials ... About half of the INDs fail in preclinical and clinical phases of drug development. The FDA runs a medical marijuana IND ...
Wyatt, Richard Jed; Chew, Robert H. (2008). Wyatt's Practical Psychiatric Practice: Forms and Protocols for Clinical Use. ... Shin, Jin; Park, Doo-Heum; Ryu, Seung-Ho; Ha, Jee Hyun; Kim, Seol Min; Jeon, Hong Jun (2020-07-24). "Clinical implications of ... Ch 1 in Barlow, D. H. (Ed) Clinical handbook of psychological disorders: A step-by-step treatment manual. New York: Guilford. ... The disappearance of residual and sub-clinical agoraphobic avoidance, and not simply of panic attacks, should be the aim of ...
Forms and Protocols for Clinical Use. American Psychiatric Pub. pp. 142-. ISBN 978-1-58562-687-8. Fortinash KM, Worret PA (13 ... Larsson M, Axelsson R, Forsman A (1984). "On the pharmacokinetics of perphenazine: a clinical study of perphenazine enanthate ... Abstract.). 19th Annual Midyear Clinical Meeting of the American Society of Hospital Pharmacists. Dallas, Texas. Janssen PA, ... The Journal of Clinical Psychiatry. 45 (5 Pt 2): 50-9. PMID 6143748. Curry SH, Whelpton R, de Schepper PJ, Vranckx S, Schiff AA ...
Kellams A, Harrel C, Omage S, Gregory C, Rosen-Carole C (May 2017). "ABM Clinical Protocol #3: Supplementary Feedings in the ... Eglash A, Simon L (September 2017). "ABM Clinical Protocol #8: Human Milk Storage Information for Home Use for Full-Term ... Boies EG, Vaucher YE (December 2016). "ABM Clinical Protocol #10: Breastfeeding the Late Preterm (34-36 6/7 Weeks of Gestation ... Boies EG, Vaucher YE (December 2016). "ABM Clinical Protocol #10: Breastfeeding the Late Preterm (34-36 6/7 Weeks of Gestation ...
MOMENTUM 3 IDE Clinical Study Protocol (HM3). U.S. National Institutes of Health. ClinicalTrials.gov. Retrieved September 16, ... is still in clinical trials for destination therapy. In a two-year randomized controlled clinical trial published in 2009 ... It began undergoing clinical trials in the U.S. and internationally in mid 2014. In mid 2014, CE Mark trials also started for ... It is cleared for clinical use up to six hours, and can be used as a short-term solution to support the circulation while ...
AIDS Clinical Trials Protocol 5015 Team (2010). "Age-Related Changes in Plasma Concentrations of the HIV Protease Inhibitor ... In the following year, he served as a Clinical Fellow in Infectious Diseases and Clinical Pharmacology at the Johns Hopkins ... results of AIDS Clinical Trials Group (ACTG) A5073, a 48-week randomized controlled trial. Clinical Infectious Diseases, 50, ... American Society for Clinical Pharmacology and Therapeutics 1995 - Pfizer Visiting Professor of Medicine and Clinical ...
Spinifex Pharmaceuticals Pty Limited (2011). "CLINICAL STUDY PROTOCOL: Protocol No. EMA401-003". {{cite journal}}: Cite journal ... Spinifex Pharmaceuticals Pty Limited (2011). "CLINICAL STUDY PROTOCOL: Protocol No. EMA401-003". {{cite journal}}: Cite journal ... Spinifex Pharmaceuticals Pty Limited (2011). "CLINICAL STUDY PROTOCOL: Protocol No. EMA401-003". {{cite journal}}: Cite journal ... Phase I clinical trial have indicated that doses of EMA401 up to 400 mg are safe in humans. Spinifex Pharmaceuticals reported ...
"Clinical Study Protocol mRNA-1273-P301" (PDF). Moderna. 20 August 2020. Archived from the original (PDF) on 17 September 2020. ... The clinical trial is ongoing and is set to conclude in late 2022. Pregnant and breastfeeding women were also excluded from the ... A review by the FDA in December 2020, of interim results of the phase III clinical trial on mRNA-1273 showed it to be safe and ... The vaccine in low doses was deemed safe and effective in order to advance a phase III clinical trial using two 100-μg doses ...
"ABM Clinical Protocol #26: Persistent Pain with Breastfeeding". Breastfeeding Medicine. 11 (2): 46-53. doi:10.1089/bfm. ... Kulkarni, Dhananjay (2020). "Clinical Presentations of Breast Disorders in Pregnancy and Lactation". Diseases of the Breast ... Berens, Pamela D. (December 2015). "Breast Pain: Engorgement, Nipple Pain, and Mastitis". Clinical Obstetrics & Gynecology. 58 ... "Practice-based interpretation of ultrasound studies leads the way to more effective clinical support and less pharmaceutical ...
The clinical protocol began on May 22, 1989, and included 10 patients. The procedure was shown to be safe. Rosenberg went on to ... Only after approval by that formal public governmental review did the gene therapy clinical protocol move on for review by the ... Microinjecting a few non-stem cells was clearly not an efficient procedure for a clinical protocol. In 1984, Anderson published ... Anderson, together with bioethicist John Fletcher, set the ethical standard for this type of clinical protocol in his 1980 ...
Hippocrates introduced the first healthcare system based on science and clinical protocols. Hippocrates' theories about physics ... "Clinical pharmacology in the Middle Ages: Principles that presage the 21st century". Clinical Pharmacology & Therapeutics. 67 ( ... and the introduction of clinical pharmacology. Institutionalization of medicine was another important achievement in the ...
He improved and standardized clinical protocols for conducting Laryngeal electromyography in patients. He established clinical ... Later he moved to Norway, where he did a specialization degree in clinical neurophysiology at Oslo University in 1970. He then ... Kotby, M. Nasser (2018-12-28). "Egypt: Four Decades of Voice Research and Clinical Application". The ASHA Leader. 11 (7): 30-32 ... Kotby, M. Nasser; Haugen, L. K. (1970). "Clinical Application of Electromyography in Vocal Fold Mobility Disorders". Acta Oto- ...
Bagatto, M; Moodie, S; Scollie, S; Seewald, R; Moodie, S; Pumford, J; Liu, KP (2005). "Clinical protocols for hearing ... As with most clinical tests, standardized calibration of the test environment, the equipment and the stimuli is needed before ... Although pure-tone audiometry has many clinical benefits, it is not perfect at identifying all losses, such as 'dead regions' ... Handbook of clinical audiology. Katz, Jack., Burkard, Robert, 1953-, Medwetsky, Larry. (5th ed.). Philadelphia: Lippincott ...
Typical stimulation protocols used in clinical FES involves trains of electric pulses. Biphasic, charged balanced pulses are ... Initial Phase II clinical trials conducted with FEST for reaching and grasping, and walking were carried out at KITE, the ... Taylor PN, Burridge JH, Dunkerley AL, Wood DE, Norton JA, Singleton C, Swain ID (1999). "Clinical use of the Odstock dropped ... initial clinical results" (PDF). Artificial Organs. 26 (3): 267-270. doi:10.1046/j.1525-1594.2002.06949.x. PMID 11940030.{{cite ...
... and the protocol has not been shown to be effective in clinical trials. Despite the lack of clinical efficacy, the protocol has ... Guaifenesin protocol is an unapproved treatment for fibromyalgia suggested in the 1990s by R. Paul St. Amand. The protocol ... He has recommended a follow-up study be conducted which controls for all elements of the protocol. The lead author of the study ... Amand, who participated as a "Study Advisor" to this clinical trial, has stated that the study did not control for salicylate ...
"Clinical Management Protocol for Covid-19 (in Adults)" (PDF). Ministry of Health and Family Welfare. 24 May 2021. "Health ... ministry issues revised clinical management protocols for Covid-19 amid spurt in cases". Times of India. Press Trust of India. ... Plasma or serum concentrations are usually in a range of 0.1-1.6 mg/L during therapy and 6-20 mg/L in cases of clinical ... "No clinical benefit from use of hydroxychloroquine in hospitalised patients with COVID-19". Recovery Trial, Nuffield Department ...
This protocol will enable researchers to use this pipeline to address further research questions regarding the tumor ... The protocol maximizes the information yield from limited tissue and includes both the preservation of bulk tissue, which can ... of the unique characteristics of individual tumor types and their microenvironment is of considerable importance for clinical ... A protocol for rapid monocyte isolation and generation of singular human monocyte-derived dendritic cells. PLoS One 15, ...
Feb 2, 2007 , Clinical Chemistry, Clinical Chemistry Analyzers, Clinical Chemistry Test Kits, Lean & Six Sigma Protocols, ... Adapting Lean Management and Six Sigma Techniques in the Clinical Lab. Feb 4, 2006 , Lean & Six Sigma Protocols, Miscellaneous ... Oct 7, 2011 , Calibrators, Controls, Lean & Six Sigma Protocols, Quality Control Programs, Quality Systems, Software, Standards ... Organizing clinical laboratory workflows to increase efficiency can be a major challenge for laboratory managers and directors ...
Professional and Clinical Guidance. * Clinical protocols and guidelines * Guidance Pages * Clinical Protocols ...
... ... Castro will explain the key components of a protocol and how to design a feasible clinical trial. ... What is a protocol?. A protocol describes the objectives, design, methodology, population, statistical considerations, ethical ... conduct, and organization of a clinical trial.. In this video, Dr. ...
Anne Pariser on Clinical trial designs for rare diseases 2: trial protocols, part of a collection of multimedia lectures. ... Clinical trial designs for rare diseases 2: trial protocols. Part 2 of 2 *Part 1 of 2 ... Clinical trial designs for rare diseases 2: trial protocols. Embed in course/own notes ... Pariser, A. (2019, May 30). Clinical trial designs for rare diseases 2: trial protocols [Video file]. In The Biomedical & Life ...
Experts have created a new minimum content guideline addressing quality gaps seen in many trial protocols. ... Related tags Clinical trial Clinical trial protocol Experts have created a new minimum content guideline addressing quality ... New Guideline Lays Out Minimum Content of a Clinical Trial Protocol. By Zachary Brennan 15-Jan-2013. - Last updated on 15-Jan- ... Control Towers in clinical trials: Harnessing logistics best practice to address pain points in the clinical trials market By ...
These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive co ... A central goal of The Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical ... ABM clinical protocol #21: guidelines for breastfeeding and substance use or substance use disorder, revised 2015 Breastfeed ... A central goal of The Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical ...
Protocol for Metagenomic Virus Detection in Clinical Specimens. Emerging Infectious Diseases. 2015;21(1):48-57. doi:10.3201/ ... Protocol for Metagenomic Virus Detection in Clinical Specimens1 On This Page ... Kohl C, Brinkmann A, Dabrowski PW, Radonić A, Nitsche A, Kurth A. Protocol for Metagenomic Virus Detection in Clinical ... Protocol for Metagenomic Virus Detection in Clinical Specimens. Volume 21, Number 1-January 2015 ...
The purpose of the Safe & Sound Protocol (SSP) is to initiate and access a physiological state conducive to well-being, ...
To statistically test the long-term efficacy of the BST treatment protocols for BN and BED through one-year post-treatment. ... Objective: to statistically test the long-term efficacy of the BST treatment protocols for BN and BED through one-year post- ... Brief Strategic Therapy for Bulimia Nervosa and Binge Eating Disorder: A Clinical and Research Protocol. Giada Pietrabissa1,2* ... a clinical and research protocol of a one-group observational study. BMJ Open 6:e009118. doi: 10.1136/bmjopen-2015-009118 ...
... ... Although the small number of patients, data clearly show the effectiveness of rehabilitation protocol clinical experience, thus ... Italian Guidelines use of antiretroviral drugs and the diagnostic-clinical management of people infected with HIV-1. July 2012 ... Entry criteria included: at least 6 months of treatment, stabilized clinical parameters, good knowledge of Italian, no ...
Here, we present the protocol of a randomized clinical trial for comparing clinical and biomechanical outcomes of dynamic ... This study is a prospective, single blinded, randomized, multicenter, multimodal (clinical and biomechanical) clinical trial. ... To date, data on clinical outcomes are scarce and on biomechanical outcomes of the dynamic MPFL reconstruction are lacking. ... and clinical and functional outcomes will be measured. Patient-reported knee function and anterior knee pain as assessed with ...
Despite this, a standard, reproducible protocol for intracompartmental pressure testing has not been described. This results in ... Intracompartmental pressure testing: results of an international survey of current clinical practice, highlighting the need for ... Intracompartmental pressure testing: results of an international survey of current clinical practice, highlighting the need for ... which confirms that a uniform approach is currently not used in clinical practice. This highlights the need for a consensus and ...
Diagnosis and Treatment of Femoral Head Osteonecrosis: A Protocol for Development of Evidence-Based Clinical Practice ... a set of evidence-based clinical practice guidelines will be proposed for the management of patients who have ONFH. ... it was clear that developing evidence-based clinical practice guidelines would provide more structure and uniformity to ...
Clinical Management of Rape Survivors: Developing Protocols for Use with Refugees and Internally Displaced Persons. IGWG Gender ... Clinical Management of Rape Survivors: Developing Protocols for Use with Refugees and Internally Displaced Persons ... Clinical Management of Rape Survivors: Developing Protocols for Use with Refugees and Internally Displaced Persons ... Clinical Management of Rape Survivors: Developing Protocols for Use with Refugees and Internally Displaced Persons ...
On September 15, 2019, MAPS responded to the U.S. Food and Drug Administrations (FDA) continued clinical hold with Protocol ... MAPS Responds to FDA Continue Clinical Hold with Protocol A3V1, Agreed to All. ...
... a protocol for a systematic review and narrative synthesis of clinical measures ... a protocol for a systematic review and narrative synthesis of clinical measures ... SA drafted the protocol with guidance and feedback from NRH, AR and DF. NRH, AR and DF reviewed the manuscript and commented on ... Methods and analysis This protocol has been designed using the Preferred Reporting Items for Systematic Reviews and Meta- ...
... protocol for the TOPSY randomised controlled trial. Trials, 21 (1), Art. No.: 837. https://doi.org/10.1186/s13063-020-04738-9 ... Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: ... Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: ... A process evaluation will run parallel to the trial, the protocol for which is reported in a companion paper. Discussion The ...
... for the psychological and social aspects of concussive injuries have remained largely absent from concussion protocols. The ... Journal of Clinical Sport Psychology, 13(2), 274-289. https://doi.org/10.1123/jcsp.2019-0004 ... Psychological and Social Needs: Athletes and Mental Performance Consultants Perspectives on a Gap in Concussion Protocols in ... Clinical Journal of Sport Medicine, 32(2), 82-85. https://doi.org/10.1097/JSM.0000000000000874 ...
... clinical and diagnostic membership had input into this protocol. ... In this protocol, we describe the rationale and methods for a ... Clinical data include suspected clinical diagnosis, comorbidities and types of specialists previously seen. A detailed family ... Patients without a clear clinical indication for prospective clinical genomic testing will be excluded in the baseline cohort, ... Secondary outcomes will include change in clinical diagnosis following genomic testing, change in clinical management following ...
Learn key considerations for IBs, informed consent, and protocol writing. ... This web seminar includes a high-level review of the key considerations and the current trends for the clinical study protocol ... Describe current trends and key considerations for clinical study protocol writing. *Review required and optional elements of ... Key Considerations in Medical Writing: The Clinical Study Protocol, Investigators Brochure, Informed Consent Form, and Adverse ...
Screening over Speech in Unselected Populations for Clinical Trials in AD (PROSPECT-AD) : Study Design and Protocol. *Mark ... The study protocol is planned to run according to sites between 12 and 18 months. Measurements: The speech protocol includes ... The study protocol is planned to run according to sites between 12 and 18 months. Measurements: The speech protocol includes ... Screening over Speech in Unselected Populations for Clinical Trials in AD (PROSPECT-AD) : Study Design and Protocol}}, url = {{ ...
A core outcome set for clinical trials on non-specific low back pain: Study protocol for the development of a core domain set. ... Clinical trials, Core outcome set, Domains, Effectiveness, Efficacy, Health interventions, Non-specific low back pain ... This protocol describes the methods used in the initial step in developing a COS for NSLBP, namely, establishing a core domain ... To address these issues, the development of a core outcome set (COS) that should be measured in all clinical trials for a ...
What is digital about a digital protocol?. When sponsors or vendors talk about a digital protocol, or a protocol design tool, ... 1 the clinical protocol describes the processes and procedures directing the conduct and analysis of a clinical trial of ... The protocol presents unique challenges in terms of version control and its longevity. A clinical trial can take years to ... In the clinical development area, the potential is considerable. Several elements that are defined in the study protocol ...
The aim is not only to provide support for the flexible specification and execution of clinical guidelines or protocols but ... rule-based clinical protocols? in Proceedings of the IEEE Symposium on Computer-Based Medical Systems, 2002, pp 288-294 ... Framework and architecture for the management of event-condition-action (ECA) rule-based clinical protocols. ... Computer-based support for the incorporation of clinical practice guidelines and protocol into daily practice has recently ...
Clinical Sequelae of COVID-19 & Associated Healthcare Utilization: A Study Protocol. Authors: Ivan Chun Hang Lam, Yi Chai, ... Home › Clinical Sequelae of COVID-19 & Associated Healthcare Utilization: A Study Protocol ...
The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world ... Each protocol specifies the time allocated to each body region. The manualized 30- and 60-min protocols were implemented in a ... The manualized protocol addressed identical specified body regions with distinct 30- and 60-min protocols, using standard ... as well as implementation of this protocol in two randomized clinical trials. The manualization process involved a ...
This protocol has been registered with PROSPERO, https://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016033178 . An ... Relevant abstracts from professional society meetings and web-based registries of clinical trials will also be included. ... the effect of withholding medication before contrast procedures on the risk of CI-AKI and other clinical outcomes and (2) the ... of current evidence on the discontinuation of drugs prior to contrast procedures and its effect on CI-AKI and other clinical ...
mastectomy; the proportion in whom OPBCS is successful and clinical and patient-reported outcomes of different techniques at 3 ... T1 - Protocol for a mixed-method study to inform the feasibility of undertaking a large-scale multicentre study comparing the ... Protocol for a mixed-method study to inform the feasibility of undertaking a large-scale multicentre study comparing the ... Protocol for a mixed-method study to inform the feasibility of undertaking a large-scale multicentre study comparing the ...
  • The master protocols which includes at the moment basket trials, umbrellas, and platforms. (hstalks.com)
  • The aims, both now and aspirationally are, increased efficiencies for these targeted drug approaches, and we're moving ever more towards personalized medicines, and how are we going to be able to study what may be one or a very small numbers of patients in clinical trials. (hstalks.com)
  • The guideline is the result of Canadian research that found more than half of clinical trials inadequately identified treatment allocation methods, about one quarter of trials failed to adequately describe their primary outcomes, and more than 40 percent of trials lacked adequate methods for reporting adverse events. (outsourcing-pharma.com)
  • COVID-19 demonstrated that clinical trials can be run much. (outsourcing-pharma.com)
  • Future clinical AD trials on disease modifying drugs will require a shift to very early identification of individuals at risk of dementia. (lu.se)
  • Conclusion: The outcome of PROSPECT-AD may support AD drug development research as well as primary or tertiary prevention of dementia by providing a validated tool using a remote approach for identifying individuals at risk of dementia and monitoring individuals over time, either in a screening context or in clinical trials. (lu.se)
  • Several interventions for patients with NSLBP have been assessed in clinical trials, but heterogeneous reporting of outcomes in these trials has hindered comparison of results and performance of meta-analyses. (eur.nl)
  • To address these issues, the development of a core outcome set (COS) that should be measured in all clinical trials for a specific health condition has been recommended. (eur.nl)
  • This protocol describes the methods used in the initial step in developing a COS for NSLBP, namely, establishing a core domain set that should be measured in all clinical trials. (eur.nl)
  • This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials. (biomedcentral.com)
  • The protocol has been applied in two randomized clinical trials. (biomedcentral.com)
  • Among the challenges in research in complementary and alternative medicine (CAM) is the necessity to design clinical trials that are methodologically rigorous as well as consistent with prevailing clinical practice patterns [ 1 - 3 ]. (biomedcentral.com)
  • Thus, standardization of interventions for clinical trials poses a particular challenge. (biomedcentral.com)
  • Relevant abstracts from professional society meetings and web-based registries of clinical trials will also be included. (biomedcentral.com)
  • Nuclear medicine technologists and investigators who perform imaging procedures in clinical trials often have not received training on clinical research regulations, such as Title 21, part 312, of the Code of Federal Regulations or Good Clinical Practices. (snmjournals.org)
  • Although not following the protocol does not result in criminal penalties per se, errors and omissions can lead to regulatory consequences such as warning letters to the investigator or sponsor, which if not resolved can lead to barring a site or investigator from participation in any future research trials. (snmjournals.org)
  • In conditions such as cancer or heart disease, waiting for a hard outcome such as recurrence of disease or heart attack in order to measure the effectiveness of therapy means that clinical trials lasting months or years are needed to measure whether a treatment is effective compared with a gold standard. (snmjournals.org)
  • I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. (medrxiv.org)
  • Brexit has introduced new levels of uncertainty for the life sciences sector and this uncertainty still exists in the field of clinical trials in terms of market access and QP release between EU27 and UK. (almacgroup.com)
  • Our integrated and adaptable solutions offer the most flexible approach to support the delivery of global clinical trials from protocol right through to patient delivery. (almacgroup.com)
  • The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. (ox.ac.uk)
  • The trial was registered prospectively with the Australian New Zealand Clinical Trials Registry on 3rd December 2021 (ACTRN12621001669886). (biomedcentral.com)
  • Seven bibliographic databases will be searched from their inception to September 30, 2012 for systematic reviews, randomized controlled trials, quasi-randomized controlled trials, controlled clinical trials, controlled before-and-after studies, interrupted time series and cohort studies. (biomedcentral.com)
  • In Clinical Trials: What You Need to Know, Part One , we discussed types of trials which are conducted as biomedical or health-related research studies in human beings. (brassandivory.org)
  • These trials, including interventional studies and observational studies, are designed to follow a pre-defined protocol. (brassandivory.org)
  • A protocol is a study plan on which all clinical trials are based. (brassandivory.org)
  • Ideas for clinical trials usually come from researchers. (brassandivory.org)
  • After researchers test new therapies or procedures in the laboratory and in animal studies, the experimental treatments with the most promising laboratory results are moved into clinical trials. (brassandivory.org)
  • A common misconception spread by some sites is that clinical trials provide medical care, and this is simply not true. (brassandivory.org)
  • With that being said, clinical trials can be a great way to earn some extra money, see what medications may work better for you as opposed to what is already available, and the chance to receive excellent medical attention (not care). (brassandivory.org)
  • Exclusion of pregnant people from emergency vaccine clinical trials: A systematic review of clinical trial protocols and reporting from 2009 to 2019. (bvsalud.org)
  • Our objective was to conduct a systematic review of vaccine clinical trials during active epidemic periods. (bvsalud.org)
  • We searched for Phase II and Phase III vaccine clinical trials initiated during the H1N1 influenza , Middle East Respiratory Syndrome Coronavirus ( MERS-CoV ), Zika, and Ebola virus disease (EVD) outbreaks from 2009 to 2019. (bvsalud.org)
  • Data were extracted from clinical trial protocols identified in the following registries ClinicalTrials.gov, Pan African Clinical Trial Registry (PACTR), and all primary registries indicated by the World Health Organization 's International Clinical Trials Registry Platform (ICTRP). (bvsalud.org)
  • Published studies from registered clinical trials were located through PubMed . (bvsalud.org)
  • 71 serious adverse events pertaining to pregnancy were reported from all clinical trials with results. (bvsalud.org)
  • Pregnant people are underrepresented in vaccine clinical trials conducted during outbreaks , resulting in underreporting of pregnancy -related outcomes and a lack of protection for pregnant people and neonates from infectious diseases . (bvsalud.org)
  • The most notable changes in these guidelines reflect both the findings of clinical trials that evaluated new drug regimens for treating and preventing TB among HIV-infected persons and recent advances in the use of antiretroviral therapy. (cdc.gov)
  • Clinical trials are research studies that test how well new medical approaches work in people. (medlineplus.gov)
  • Clinical trials may also compare a new treatment to a treatment that is already available. (medlineplus.gov)
  • An Institutional Review Board (IRB) reviews, monitors, and approves many clinical trials. (medlineplus.gov)
  • Who Pays for Clinical Trials? (medlineplus.gov)
  • To date, data on clinical outcomes are scarce and on biomechanical outcomes of the dynamic MPFL reconstruction are lacking. (springer.com)
  • Here, we present the protocol of a randomized clinical trial for comparing clinical and biomechanical outcomes of dynamic versus static medial patellofemoral ligament reconstruction. (springer.com)
  • Preoperative magnetic resonance imaging, upright radiographs, surgical reports and patient records will be evaluated, and clinical and functional outcomes will be measured. (springer.com)
  • Secondary outcomes will include change in clinical diagnosis following genomic testing, change in clinical management following genomic testing and the cost-effectiveness of genomic testing compared with usual care. (bmj.com)
  • The purpose of this systematic review is to assess (1) the effect of withholding medication before contrast procedures on the risk of CI-AKI and other clinical outcomes and (2) the incidence of adverse events occurring after withholding these drugs prior to contrast procedures. (biomedcentral.com)
  • This systematic review will provide a synthesis of current evidence on the discontinuation of drugs prior to contrast procedures and its effect on CI-AKI and other clinical outcomes. (biomedcentral.com)
  • the proportion in whom OPBCS is successful and clinical and patient-reported outcomes of different techniques at 3 and 12-months post-surgery. (bris.ac.uk)
  • Late intestinal toxicity after radiotherapy (LITAR) not only limits the radiation dose, which subsequently leads to unfavorable clinical outcomes, but also significantly lowers the quality of life in an increasing number of cancer survivors. (biomedcentral.com)
  • Conclusions: The CIRT is the largest observational study on radioembolization to date and will provide valuable insights to the clinical application of this treatment modality and its real-life outcomes. (unav.edu)
  • These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. (nih.gov)
  • Italian Guidelines use of antiretroviral drugs and the diagnostic-clinical management of people infected with HIV-1. (natap.org)
  • After qualitative and quantitative analysis of the data extracted from studies pertaining to each of the three research questions, a set of evidence-based clinical practice guidelines will be proposed for the management of patients who have ONFH. (nih.gov)
  • As there is no consensus on the optimal treatment for various stages of disease, it was clear that developing evidence-based clinical practice guidelines would provide more structure and uniformity to management of these patients. (nih.gov)
  • This publication provides detailed guidelines on the clinical management of women, men and children who have been raped. (igwg.org)
  • Computer-based support for the incorporation of clinical practice guidelines and protocol into daily practice has recently attracted a lot of research interest within the healthcare informatics area. (tcd.ie)
  • The aim is not only to provide support for the flexible specification and execution of clinical guidelines or protocols but also the dynamic management of these guidelines or protocols. (tcd.ie)
  • Manualization was initially developed for the creation of standardized treatment protocols for psychotherapy, both to help provide methodologic rigor for evaluation, and as a means to provide specificity and guidelines regarding individualized treatment [ 31 ]. (biomedcentral.com)
  • Customizable sample clinical protocols created in response to requests for clinical guidelines. (urgentcareassociation.org)
  • Customizable sample clinical protocols created in response to requests for clinical guidelines nuanced to on-demand, episodic clinical care for common, and some uncommon , presentations to urgent care centers (UCCs). (urgentcareassociation.org)
  • The European Academy of Allergy and Clinical Immunology is developing guidelines about how to prevent and manage food allergy. (biomedcentral.com)
  • Methods and analysis This protocol has been designed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. (bmj.com)
  • Methods and analysis: Mixed methods will be used to inform feasibility and design of a future large-scale study comparing the clinical and cost-effectiveness of OPBCS and mastectomy +/- IBR. (bris.ac.uk)
  • Cognizant of these limitations, we evaluated the extraction-free methods described in the literature and have developed an innovative, simplified and easy protocol employing limited reagents to extract RNA for subsequent RT-PCR analysis. (medrxiv.org)
  • Methods and Design: The 775 participants of the Whitehall II Imaging cohort, aged 65 years or older in 2019, have received cardiovascular and clinical assessments at 5-year-intervals since 1985, as well as a 3T brain MRI scan and neuropsychological tests between 2012-2016 (Whitehall II Wave MRI-1). (ox.ac.uk)
  • Methods Prospective observational cohort study of adults (age ≥18 years) with confirmed or highly suspected COVID-19 recruited into the International Severe Acute Respiratory and emerging Infections Consortium (ISARIC) WHO Clinical Characterisation Protocol UK (CCP-UK) study in 306 hospitals across England, Scotland and Wales. (ox.ac.uk)
  • METHODS: An iterative process was used to establish and refine an ecologically valid video acquisition and observation protocol to assess key activities, tasks, and performance components of dental hygiene work. (cdc.gov)
  • This systematic review therefore aims to investigate the measurement properties of PBOM of trunk muscle strength measures appropriate for use in a clinical setting. (bmj.com)
  • This systematic review is one of seven inter-linked evidence syntheses that are being undertaken in order to provide a state-of-the-art synopsis of the current evidence base in relation to epidemiology, prevention, diagnosis and clinical management, and impact on quality of life, which will be used to inform clinical recommendations. (biomedcentral.com)
  • On September 15, 2019, MAPS responded to the U.S. Food and Drug Administration's (FDA) continued clinical hold with Protocol A3V1 and agreed to all. (maps.org)
  • Nine acute Grade 3 emergencies were active during the reporting period from 1 January to 31 December 2022 (see Table), including emergencies in Afghanistan, Ethiopia, Somalia, and Ukraine that were covered by United Nations Inter-Agency Standing Committee System-Wide Scale-Up protocols. (who.int)
  • 3) have a cohort, case-control, randomized controlled trial and controlled clinical trial study design. (biomedcentral.com)
  • This report describes the available demographic and clinical data abstracted from available tecovirimat EA-IND and clinical characteristics, clinical indications for use, clinical treatment forms were analyzed. (cdc.gov)
  • As summarized by the International Conference on Harmonization's (ICH) M11 Guideline, 1 the clinical protocol describes the processes and procedures directing the conduct and analysis of a clinical trial of medicinal product(s) in humans. (appliedclinicaltrialsonline.com)
  • This paper describes the study protocol, data pre-processing and overarching objectives. (ox.ac.uk)
  • Experts have created a new minimum content guideline addressing quality gaps seen in many trial protocols. (outsourcing-pharma.com)
  • To address this, the guideline ​ for the minimum content of a protocol was published in the Annals of Internal Medicine ​ last week. (outsourcing-pharma.com)
  • The guideline, however, does encompass parts of the International Conference on Harmonisation's (ICH) Good Clinical Practice E6 guidance, as well as other requirements from the World Health Organization (WHO), International Committee of Medical Journal Editors and the U.S.-based ClinicalTrials.gov. (outsourcing-pharma.com)
  • The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. (ox.ac.uk)
  • SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. (ox.ac.uk)
  • Tchanturia developed group therapy protocols for the inpatient treatment programme for eating disorders as well as two evidence-based individual psychological interventions: cognitive remediation therapy (CRT) and Cognitive Remediation and Emotion Skills Training (CREST). (wikipedia.org)
  • Let's switch gears and now talk about some innovative or newer clinical trial approaches that are beginning to be used. (hstalks.com)
  • In this study, we quantifiably and extensively compared classical and modern experimental approaches for virus purification and enrichment to finalize a protocol for unbiased detection of emerging viruses directly from organ tissues (tissue-based unbiased virus detection for viral metagenomics [TUViD-VM]) for an increased signal-to-noise ratio (ratio of virus genome to host genome) in virus detection. (cdc.gov)
  • This article will briefly review what's meant by the concept of a digital clinical trial protocol and provide a framework for the wide range of approaches and software solutions in this space. (appliedclinicaltrialsonline.com)
  • Clinical trial sites have varying levels of experience and quality, but monitoring approaches are not designed to manage potential differences. (transceleratebiopharmainc.com)
  • Study protocol: The clinical features, epidemiology, and causes of paediatric encephalitis in southern Vietnam. (ox.ac.uk)
  • In cancer research, advancing a comprehensive understanding of the unique characteristics of individual tumor types and their microenvironment is of considerable importance for clinical translation. (nature.com)
  • This protocol will enable researchers to use this pipeline to address further research questions regarding the tumor microenvironment. (nature.com)
  • New, innovative clinical trial technology is helping to revolutionize the research landscape. (outsourcing-pharma.com)
  • While research advancements have substantially improved concussion management efforts, consideration for the psychological and social aspects of concussive injuries have remained largely absent from concussion protocols. (humankinetics.com)
  • And finally, the HL7-FHIR Vulcan Accelerator was initiated to lay the groundwork that will help connect clinical research to clinical care. (appliedclinicaltrialsonline.com)
  • This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings. (biomedcentral.com)
  • The overview of literature produced will help to identify knowledge gaps and inform future research in the use of GRS and checklists in clinical simulation-based assessments. (researchsquare.com)
  • Lack of understanding of the regulatory expectations in clinical research can lead to unintended errors or omissions in critical data that are needed for development of a new drug. (snmjournals.org)
  • Pharmaceutical sponsors, device sponsors, and federal granting agencies such as the National Cancer Institute enter into contracts with imaging sites under the expectation that the investigator and all research staff know and understand clinical research regulations. (snmjournals.org)
  • This article is intended to teach imaging personnel what any sponsor (pharmaceutical, device, or federal agency) is expecting from research imaging and how lack of understanding of Good Clinical Practices and federal regulations can impede the optimal success of a research study. (snmjournals.org)
  • Molecular imaging techniques such as PET and SPECT can used by sponsors of clinical research to test the therapeutic effectiveness of a new drug or regimen for cancer, neurologic conditions, heart disease, or any other number of clinical conditions. (snmjournals.org)
  • Sponsors of clinical research can use these techniques in early phases of drug development to see whether there is a physiologic response to a therapy and make decisions about whether research should continue. (snmjournals.org)
  • In the specific case of Ophthalmology, within the Centro de Retina Médica y Quirúrgica S.C. We have a clinical research unit that is certified to carry out clinical protocols, being one of the few places where Ophthalmology clinical protocols are carried out in Mexico. (ic-retina.com)
  • Writing clinical research protocols : ethical considerations / Evan G. DeRenzo and Joel Moss. (who.int)
  • To keep your protocol focused, at Cato Research we recommend no more than 1-2 (preferably 1) major/primary objectives and no more than 3 minor/secondary objectives. (allucent.com)
  • Her main research interests include cultural differences in illness presentations, cognitive profiles in eating disorders, and experimental work in emotion processing and translational research from experimental findings to real clinical practice. (wikipedia.org)
  • After relocating to London in 1997, she became a clinical research fellow at the Institute of Psychiatry, King's College London in 1998. (wikipedia.org)
  • Tchanturia's research primarily concerns the cognitive and socio-emotional aspects of eating disorders, implementing positive psychology in clinical practice. (wikipedia.org)
  • After relocating to the United Kingdom, Tchanturia worked as a Clinical Research Fellow at Institute of Psychiatry, Psychology and Neuroscience, King's College London from 1998-2003. (wikipedia.org)
  • Furthermore, recent studies in high-income settings have suggested autoimmune encephalitis has now surpassed infectious aetiologies, mainly due to increased awareness and diagnostic capacity, which further challenges routine diagnosis and clinical management, especially in developing countries. (ox.ac.uk)
  • A process evaluation will run parallel to the trial, the protocol for which is reported in a companion paper. (stir.ac.uk)
  • AbstractThe SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. (ox.ac.uk)
  • There has been great progress over the past several years on adoption of the TransCelerate Common Protocol Template, 2 with the majority of TransCelerate member pharma companies and many other sponsors aligning on a consistent, high-level structure for protocols. (appliedclinicaltrialsonline.com)
  • Acknowledging that many of the descriptive elements in the Protocol reappear in other study documents including the Statistical Analysis Plan and the Clinical Study Report, TransCelerate went one step further and created the eTemplate Suite (eTS) of document templates. (appliedclinicaltrialsonline.com)
  • Instead, efficacy data protocol that facilitates access to and use of tecovirimat for that supported FDA approval of tecovirimat for smallpox were treatment of monkeypox. (cdc.gov)
  • efficacy treatment and adverse event reporting forms to monitor safety studies were also conducted in macaque monkeys and prairie and ensure intended clinical use in accordance with FDA dogs ( 4 , 5 ). (cdc.gov)
  • To statistically test the long-term efficacy of the BST treatment protocols for BN and BED through one-year post-treatment. (frontiersin.org)
  • Entry criteria included: at least 6 months of treatment, stabilized clinical parameters, good knowledge of Italian, no comorbidity with psychiatric path. (natap.org)
  • Although the small number of patients, data clearly show the effectiveness of rehabilitation protocol clinical experience, thus identifying an intervention strategy effective in the treatment of ANI and MND. (natap.org)
  • In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated. (biomedcentral.com)
  • A randomised clinical trial, CopenHeart VR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. (biomedcentral.com)
  • Despite recent advances in the treatment and management of adults hospitalised with COVID-19, both scores can continue to inform clinical decision making. (ox.ac.uk)
  • However, large-scale prospective observational data on the application of this treatment in a real-life clinical setting is lacking. (unav.edu)
  • Objective: The main objective is to collect data on the clinical application of radioembolization with 90Y resin microspheres to improve the understanding of the impact of this treatment modality in its routine practice setting. (unav.edu)
  • Will I Always Get the Experimental Treatment in a Clinical Trial? (medlineplus.gov)
  • From an operational and regulatory perspective, the protocol is the defining document that sits in the center of every clinical trial. (appliedclinicaltrialsonline.com)
  • Over the past 10 years as a clinical and regulatory scientist I have seen plenty of clinical study protocols from a lot of different companies: small virtual companies, medium-sized biotech companies with several products in the pipeline, and well-established global pharma with numerous marketed products. (allucent.com)
  • Trial registration The study protocol was registered at clinicaltrials.gov (NCT04849130). (springer.com)
  • This web seminar includes a high-level review of the key considerations and the current trends for the clinical study protocol, the Investigator's Brochure (IB), the informed consent form, and adverse event narratives. (barnettinternational.com)
  • The study protocol is planned to run according to sites between 12 and 18 months. (lu.se)
  • The eTS showed the potential to automate downstream use of information derived from the study protocol. (appliedclinicaltrialsonline.com)
  • This study protocol is for a 2-year randomized controlled trial that aims to evaluate the clinical and economic effects of a primary care, anchored, collaborative, electronic health (eHealth) lifestyle coaching program (long-term Lifestyle change InterVention and eHealth Application [LIVA] 2.0) in obese participants with and without type 2 diabetes. (researchprotocols.org)
  • Almost a Holy Grail for the pharma/biotech world, the perfect clinical study protocol requires no amendments, collects only the data needed for the planned analysis, is fully feasible, and is enrolled on time. (allucent.com)
  • This TUViD-VM protocol can be used in metagenomic and virome studies to increase the likelihood of detecting viruses from any biological source. (cdc.gov)
  • Eligibility criteria include studies investigating measurement properties of PROM for trunk muscle strength for use in a clinical setting in adults with and without spinal musculoskeletal complaints. (bmj.com)
  • First, is the ability to reuse protocol content elements, including shorter elements like objectives, endpoints, eligibility criteria and study procedures, as well as longer narrative components, either throughout the clinical trial lifecycle, or across other studies or clinical programs. (appliedclinicaltrialsonline.com)
  • When we talk about ophthalmology clinical protocols in Mexico, it is important to know that, like clinical studies, not just anyone can do them and verification is needed to perform them. (ic-retina.com)
  • Based on findings from their qualitative studies that mapped out the needs for the three stakeholders, Tchanturia and colleagues collaboratively engaged people with lived experience, carers, and clinicians from the National Eating Disorder Service to develop the PEACE clinical pathway. (wikipedia.org)
  • Are Clinical Studies for You? (medlineplus.gov)
  • This article reports the protocol for a randomized controlled trial of Men in Mind , a self-paced online training program purpose-built to advance the clinical competencies of practitioners who provide psychotherapy to male clients. (biomedcentral.com)
  • Therefore, we conduct a prospective observational study to characterise the clinical, microbiological, and epidemiological features of encephalitis in a major children's hospital in southern Vietnam. (ox.ac.uk)
  • TransCelerate's Digital Data Flow (DDF) partnered with Clinical Data Interchange Standards Consortium (CDISC) to create a new Unified Study Definition Model (USDM) data standard that will help move the industry toward a common information model to represent protocol information. (appliedclinicaltrialsonline.com)
  • Second is the ability to structure specific protocol elements and apply data standards, usually to support automated workflows, such as the automated configuration of clinical systems like electronic data capture (EDC) or laboratory management systems (LMS). (appliedclinicaltrialsonline.com)
  • One common error is not following the protocol exactly as written, or modifying the imaging parameters in some way as to make the data nonstandard from site to site. (snmjournals.org)
  • To produce standardized data, sites must follow the protocol precisely as intended and not alter it in any way that would affect multisite analysis. (snmjournals.org)
  • Admission clinical samples will be collected alongside meta clinical data and from each study participants. (ox.ac.uk)
  • Individual data from the LIVA 2.0 platform are combined with clinical measurements, questionnaires, and participants' usage of municipality and health care services. (researchprotocols.org)
  • Improved protocol deviation processes should ultimately lead to improved patient safety, reliability of study data, human subjects protections and data quality and more rapid identification of protocol deviations. (transceleratebiopharmainc.com)
  • Synopsis: Creation of the study synopsis through the addition of logistical and data collection, and data analysis details requires input from medical, data management, statistics, and clinical operations. (allucent.com)
  • While many sponsors and vendors talk about achieving a "digital protocol" they are often referring to different types of applications to meet different objectives. (appliedclinicaltrialsonline.com)
  • A recent protocol I reviewed had nine different study objectives. (allucent.com)
  • All too often we see protocol objectives that are too broad, unclear, or missing key information. (allucent.com)
  • For this reason, the aim of this work is to suggest a model of clinical protocol that will help the systematization and standardization of care to evaluate and control health-caries disease process. (bvsalud.org)
  • The aim of this study is to explore the clinical utility and cost-effectiveness of genomic testing within a national cohort of patients with suspected genetic kidney disease who attend multidisciplinary renal genetics clinics. (bmj.com)
  • The manualized 30- and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. (biomedcentral.com)
  • This webinar will explore the possible scenarios of a post-Brexit landscape, the impact on clinical supply chains, the core strategies available to Sponsors to ensure robust logistics and QP release while maintaining compliant, cost-effective and patient-centric operations through the transition period and beyond. (almacgroup.com)
  • These protocols are valuable tools for training, peer review, health record audits and as a day to day patient care resource as well as a perfect complement to the UCA Policy & Procedure Manual. (urgentcareassociation.org)
  • Join our community of clinical and operational professionals who believe in a patient-centered healthcare ecosystem. (urgentcareassociation.org)
  • These protocols allow physicians to reduce the need for unnecessary examinations, which can put the patient at risk or in other cases complicate their situation. (ic-retina.com)
  • We carry out preliminary evaluations of each protocol and tests of them, always attached to the patient to guarantee compliance with the visits required by each protocol. (ic-retina.com)
  • Aside from these limited capabilities, any reusable content, process, or system that needs to be set up according to study-specific specification requires a user to refer back to the protocol document and effectively copy-paste that information into downstream products. (appliedclinicaltrialsonline.com)
  • Participants: N= 1000 participants aged 50 or older will be included in total, with a clinical dementia rating scale (CDR) score of 0 or 0.5. (lu.se)
  • Most protocols, if not all, are represented in a document format, with the "source of truth" for a given Protocol contained in either a Microsoft Word (.docx) or Adobe Acrobat (.pdf) file. (appliedclinicaltrialsonline.com)
  • Despite this, a standard, reproducible protocol for intracompartmental pressure testing has not been described. (bmj.com)
  • The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists' clinical judgment and maintaining consistency with a prior pilot study. (biomedcentral.com)
  • The results of the study will clarify whether the reported surgery success for patella stabilization via dynamic MPFL reconstruction is due to muscle contraction or to the passive tenodesis effect combined with clinical outcome measures. (springer.com)
  • Organizing clinical laboratory workflows to increase efficiency can be a major challenge for laboratory managers and directors, especially in light of qualified staff shortages and tight budgets. (clpmag.com)
  • The primary objective of the Cardiovascular and Interventional Radiological Society of Europe Registry for SIR-Spheres Therapy (CIRT) is to observe the clinical application of radioembolization. (unav.edu)
  • We will be including all identified sources published in English after 1 January 2010 that relate to the use of GRS and/or checklists in clinical simulation-based assessments. (researchsquare.com)
  • This information will be valuable and useful for all stakeholders that are interested in clinical simulation-based assessments. (researchsquare.com)
  • Conclusion Both 4C risk stratification models demonstrate consistent performance to predict clinical deterioration and mortality in a large prospective second wave validation cohort of UK patients. (ox.ac.uk)
  • Clinical laboratories are tasked with producing reliable, accurate and timely results. (clpmag.com)
  • Moreover, clinical laboratories are facing several challenges that include cost, reagents, instrumentation, turn-around time, trained personnel, and supply-chain constraints to efficiently implement and sustain testing. (medrxiv.org)
  • NCHS developed and distributed a quality control protocol for all the contract laboratories which outlined the Westgard rules used when running NHANES specimens. (cdc.gov)
  • However, for clinical specimens, such as blood, other fluids, or infected organ tissues, successful detection of viruses is less likely because virus-to-host genome ratios are insufficient ( 3 - 6 ). (cdc.gov)
  • The intervention group will receive pessary self-management teaching, a self-management information leaflet, a follow up phone call and access to a local telephone number for clinical support. (stir.ac.uk)
  • This paper presents a framework and architecture for the management of clinical protocols whose specification and execution models are based on the event-condition-action (ECA) rule paradigm. (tcd.ie)
  • The Protocol Deviations Initiative has developed a toolkit to reduce confusion in definition and a holistic approach to the management of protocol deviations. (transceleratebiopharmainc.com)
  • Survey results from sponsors, sites and IRBs confirmed protocol deviation (PD) management processes are complex, varied and broadly impacted by a wide range of definitions for identification and classification. (transceleratebiopharmainc.com)
  • In response, the Protocol Deviations Initiative has developed a toolkit to support clarity in definition and a holistic approach to the management of protocol deviations. (transceleratebiopharmainc.com)
  • Global rating scales (GRS) and checklists enjoy widespread use within simulation-based education but there is a question regarding how the two strategies are used within clinical simulation assessment. (researchsquare.com)
  • The need for clinical trial sponsors to put in place robust strategies to ensure continuity of supply, compliantly and cost-effectively, post-transition is paramount. (almacgroup.com)
  • 97.7% of patients were men, with a median age protocol for Monkeypox virus infection in the United States. (cdc.gov)
  • Therefore, identifying clinical risk factors for LITAR is important for establishing a predictive model in the clinical setting of decision-making for these patients. (biomedcentral.com)
  • This review aims to systematically summarize and clarify the clinical factors that can be potentially associated with an increased risk of moderate/severe LITAR in patients with abdominal or pelvic malignancies. (biomedcentral.com)
  • Undiagnosed patients with clinical presentations compatible with autoimmune encephalitis will then be tested for common forms of the disease. (ox.ac.uk)
  • Clinical protocols are instruments developed that require theoretical bases of a medical nature and help health professionals to make decisions, whether simple or complex, in order to assist their patients. (ic-retina.com)
  • She has developed a novel clinical pathway for patients with comorbid autism and eating disorders at the South London and Maudsley NHS Foundation Trust National Eating Disorders Service. (wikipedia.org)
  • Professor Tchanturia and colleagues have developed and implemented a novel clinical pathway tailored to the needs of autistic patients with eating disorders: The PEACE Pathway (Pathway for Eating disorders and Autism developed from Clinical Experience). (wikipedia.org)
  • This protocol has been registered with PROSPERO, https://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016033178 . (biomedcentral.com)
  • A central goal of The Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. (nih.gov)
  • The IRDI protocol or clinical indicators of risk for child development were applied and the mothers of the babies were interviewed. (bvsalud.org)
  • But all too often medical writers go it alone in the protocol development process, and only look for input on the final product, when substantive changes are time consuming and often shunned. (allucent.com)
  • In this video, Dr. Castro will explain the key components of a protocol and how to design a feasible clinical trial. (futurelearn.com)
  • It will also introduce a simple taxonomy for protocol design and authoring solutions to help sponsors venturing into this area. (appliedclinicaltrialsonline.com)
  • When sponsors or vendors talk about a digital protocol, or a protocol design tool, or a protocol authoring tool, they are usually referring to one or more of three types of functionalities. (appliedclinicaltrialsonline.com)
  • Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. (biomedcentral.com)
  • Its use will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial. (ox.ac.uk)
  • And while it is widely recognized in our industry that protocol design and complexity is a key cost driver, our industry struggles to make the changes necessary to address this issue. (allucent.com)
  • While isokinetic dynamometry is considered the gold-standard PBOM, the associated costs, size/weight and operational complexity of this equipment preclude its use in a clinical setting. (bmj.com)
  • The protocol maximizes the information yield from limited tissue and includes both the preservation of bulk tissue, which can be performed within 1 h following surgical resection, as well as tissue dissociation for an in-depth characterization of individual TIME cell populations, which typically takes several hours depending on tissue quantity and further downstream processing. (nature.com)